Medicolegal Issues

Hospitalists often are involved in the postoperative care of the surgical patient. However, HM is emerging in the admitting/attending role for procedural patients. Confusion can arise as to the nature of the hospitalist service, and whether it is deemed billable. Knowing the surgical package requirements can help hospitalists consider the issues.

Global Surgical Package Period¹

Surgical procedures, categorized as major or minor surgery, are reimbursed for pre-, intra-, and postoperative care. Postoperative care varies according to the procedure’s assigned global period, which designates zero, 10, or 90 postoperative days. (Physicians can review the global period for any given CPT code in the Medicare Physician Fee Schedule, available at www.cms.gov/apps/physician-fee-schedule/search/search-criteria.aspx.)

Services classified with “XXX” do not have the global period concept. “ZZZ” services denote an “add-on” procedure code that must always be reported with a primary procedure code and assumes the global period assigned to the primary procedure performed.

Major surgery allocates a 90-day global period in which the surgeon is responsible for all related surgical care one day before surgery through 90 postoperative days with no additional charge. Minor surgery, including endoscopy, appoints a zero-day or 10-day postoperative period. The zero-day global period encompasses only services provided on the surgical day, whereas 10-day global periods include services on the surgical day through 10 postoperative days.

Global Surgical Package Components²

The global surgical package comprises a host of responsibilities that include standard facility requirements of filling out all necessary paperwork involved in surgical cases (e.g. preoperative H&P, operative consent forms, preoperative orders). Additionally, the surgeon’s packaged payment includes (at no extra charge):

• Preoperative visits after making the decision for surgery beginning one day prior to surgery;
• All additional postoperative medical or surgical services provided by the surgeon related to complications but not requiring additional trips to the operating room;
• Postoperative visits by the surgeon related to recovery from surgery, including but not limited to dressing changes; local incisional care; removal of cutaneous sutures and staples; line removals; changes and removal of tracheostomy tubes; and discharge services; and
• Postoperative pain management provided by the surgeon.
• Examples of services that are not included in the global surgical package, (i.e. are separately billable and may require an appropriate modifier) are:
• The initial consultation or evaluation of the problem by the surgeon to determine the need for surgery;
• Services of other physicians except where the other physicians are providing coverage for the surgeon or agree on a transfer of care (i.e. a formal agreement in the form of a letter or an annotation in the discharge summary, hospital record, or ASC record);
• Postoperative visits by the surgeon unrelated to the diagnosis for which the surgical procedure is performed, unless the visits occur due to complications of the surgery;
• Diagnostic tests and procedures, including diagnostic radiological procedures;
• Clearly distinct surgical procedures during the postoperative period that do not result in repeat operations or treatment for complications;
• Treatment for postoperative complications that requires a return trip to the operating room (OR), catheterization lab or endoscopy suite;
• Immunosuppressive therapy for organ transplants; and
• Critical-care services (CPT codes 99291 and 99292) unrelated to the surgery where a seriously injured or burned patient is critically ill and requires constant attendance of the surgeon.

Classification of “Surgeon”

For billing purposes, the “surgeon” is a qualified physician who can perform “surgical” services within their scope of practice. All physicians with the same specialty designation in the same group practice as the “surgeon” (i.e. reporting services under the same tax identification number) are considered a single entity and must adhere to the global period billing rules initiated by the “surgeon.”

Alternately, physicians with different specialty designations in the same group practice (e.g. a hospitalist and a cardiologist in a multispecialty group who report services under the same tax identification number) or different group practices can perform and separately report medically necessary services during the surgeon’s global period, as long as a formal (mutually agreed-upon) transfer of care did not occur.

Medical Necessity

With the growth of HM programs and the admission/attending role expansion, involvement in surgical cases comes under scrutiny for medical necessity. Admitting a patient who has active medical conditions (e.g. hypertension, diabetes, emphysema) is reasonable and necessary because the patient has a well-defined need for medical management by the hospitalist. Participation in the care of these patients is separately billable from the surgeon’s global period package.

Alternatively, a hospitalist might be required to admit and follow surgical patients who have no other identifiable chronic or acute conditions aside from the surgical problem. In these cases, hospitalist involvement may satisfy facility policy (quality of care, risk reduction, etc.) and administrative functions (discharge services or coordination of care) rather than active clinical management. This “medical management” will not be considered “medically necessary” by the payor, and may be denied as incidental to the surgeon’s perioperative services. Erroneous payment can occur, which will result in refund requests, as payors do not want to pay twice for duplicate services. Hospitalists can attempt to negotiate other terms with facilities to account for the unpaid time and effort directed toward these types of cases.

Consider the Case

A patient with numerous medical comorbidities is admitted to the hospitalist service for stabilization prior to surgery, which will occur the next day. The hospitalist can report the appropriate admission code (99221-99223) without need for modifiers because the hospitalist is the attending of record and in a different specialty group. If a private insurer denies the claim as inclusive to the surgical service, the hospitalist can appeal with notes and a cover letter, along with the Medicare guidelines for global surgical package. The hospitalist may continue to provide postoperative daily care, as needed, to manage the patient’s chronic conditions, and report each service as subsequent hospital care (99231-99233) without modifier until the day of discharge (99238-99239). Again, if a payor issues a denial (inclusive to surgery), appealing with notes might be necessary.

Carol Pohlig is a billing and coding expert with the University of Pennsylvania Medical Center, Philadelphia. She is faculty for SHM’s inpatient coding course.

References

1. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual: Chapter 12, Section 40. Centers for Medicare & Medicaid Services website. Available at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf. Accessed May 5, 2012.
2. Centers for Medicare & Medicaid Services. ICD-10: HHS proposes one-year delay of ICD-10 compliance date. Centers for Medicare & Medicaid Services website. Available at: http://www.cms.gov/Medicare/Coding/ICD10/index.html?redirect=/ICD10. Accessed May 5, 2012.
3. Abraham M, Ahlman J, Anderson C, Boudreau A, Connelly J. Current Procedural Terminology 2012 Professional Edition. Chicago: American Medical Association Press; 2011.

Hospitalists often are involved in the postoperative care of the surgical patient. However, HM is emerging in the admitting/attending role for procedural patients. Confusion can arise as to the nature of the hospitalist service, and whether it is deemed billable. Knowing the surgical package requirements can help hospitalists consider the issues.

Global Surgical Package Period¹

Surgical procedures, categorized as major or minor surgery, are reimbursed for pre-, intra-, and postoperative care. Postoperative care varies according to the procedure’s assigned global period, which designates zero, 10, or 90 postoperative days. (Physicians can review the global period for any given CPT code in the Medicare Physician Fee Schedule, available at www.cms.gov/apps/physician-fee-schedule/search/search-criteria.aspx.)

Services classified with “XXX” do not have the global period concept. “ZZZ” services denote an “add-on” procedure code that must always be reported with a primary procedure code and assumes the global period assigned to the primary procedure performed.

Major surgery allocates a 90-day global period in which the surgeon is responsible for all related surgical care one day before surgery through 90 postoperative days with no additional charge. Minor surgery, including endoscopy, appoints a zero-day or 10-day postoperative period. The zero-day global period encompasses only services provided on the surgical day, whereas 10-day global periods include services on the surgical day through 10 postoperative days.

Global Surgical Package Components²

The global surgical package comprises a host of responsibilities that include standard facility requirements of filling out all necessary paperwork involved in surgical cases (e.g. preoperative H&P, operative consent forms, preoperative orders). Additionally, the surgeon’s packaged payment includes (at no extra charge):

• Preoperative visits after making the decision for surgery beginning one day prior to surgery;
• All additional postoperative medical or surgical services provided by the surgeon related to complications but not requiring additional trips to the operating room;
• Postoperative visits by the surgeon related to recovery from surgery, including but not limited to dressing changes; local incisional care; removal of cutaneous sutures and staples; line removals; changes and removal of tracheostomy tubes; and discharge services; and
• Postoperative pain management provided by the surgeon.
• Examples of services that are not included in the global surgical package, (i.e. are separately billable and may require an appropriate modifier) are:
• The initial consultation or evaluation of the problem by the surgeon to determine the need for surgery;
• Services of other physicians except where the other physicians are providing coverage for the surgeon or agree on a transfer of care (i.e. a formal agreement in the form of a letter or an annotation in the discharge summary, hospital record, or ASC record);
• Postoperative visits by the surgeon unrelated to the diagnosis for which the surgical procedure is performed, unless the visits occur due to complications of the surgery;
• Diagnostic tests and procedures, including diagnostic radiological procedures;
• Clearly distinct surgical procedures during the postoperative period that do not result in repeat operations or treatment for complications;
• Treatment for postoperative complications that requires a return trip to the operating room (OR), catheterization lab or endoscopy suite;
• Immunosuppressive therapy for organ transplants; and
• Critical-care services (CPT codes 99291 and 99292) unrelated to the surgery where a seriously injured or burned patient is critically ill and requires constant attendance of the surgeon.

Classification of “Surgeon”

For billing purposes, the “surgeon” is a qualified physician who can perform “surgical” services within their scope of practice. All physicians with the same specialty designation in the same group practice as the “surgeon” (i.e. reporting services under the same tax identification number) are considered a single entity and must adhere to the global period billing rules initiated by the “surgeon.”

Alternately, physicians with different specialty designations in the same group practice (e.g. a hospitalist and a cardiologist in a multispecialty group who report services under the same tax identification number) or different group practices can perform and separately report medically necessary services during the surgeon’s global period, as long as a formal (mutually agreed-upon) transfer of care did not occur.

Medical Necessity

With the growth of HM programs and the admission/attending role expansion, involvement in surgical cases comes under scrutiny for medical necessity. Admitting a patient who has active medical conditions (e.g. hypertension, diabetes, emphysema) is reasonable and necessary because the patient has a well-defined need for medical management by the hospitalist. Participation in the care of these patients is separately billable from the surgeon’s global period package.

Alternatively, a hospitalist might be required to admit and follow surgical patients who have no other identifiable chronic or acute conditions aside from the surgical problem. In these cases, hospitalist involvement may satisfy facility policy (quality of care, risk reduction, etc.) and administrative functions (discharge services or coordination of care) rather than active clinical management. This “medical management” will not be considered “medically necessary” by the payor, and may be denied as incidental to the surgeon’s perioperative services. Erroneous payment can occur, which will result in refund requests, as payors do not want to pay twice for duplicate services. Hospitalists can attempt to negotiate other terms with facilities to account for the unpaid time and effort directed toward these types of cases.

Consider the Case

A patient with numerous medical comorbidities is admitted to the hospitalist service for stabilization prior to surgery, which will occur the next day. The hospitalist can report the appropriate admission code (99221-99223) without need for modifiers because the hospitalist is the attending of record and in a different specialty group. If a private insurer denies the claim as inclusive to the surgical service, the hospitalist can appeal with notes and a cover letter, along with the Medicare guidelines for global surgical package. The hospitalist may continue to provide postoperative daily care, as needed, to manage the patient’s chronic conditions, and report each service as subsequent hospital care (99231-99233) without modifier until the day of discharge (99238-99239). Again, if a payor issues a denial (inclusive to surgery), appealing with notes might be necessary.

Carol Pohlig is a billing and coding expert with the University of Pennsylvania Medical Center, Philadelphia. She is faculty for SHM’s inpatient coding course.

References

1. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual: Chapter 12, Section 40. Centers for Medicare & Medicaid Services website. Available at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf. Accessed May 5, 2012.
2. Centers for Medicare & Medicaid Services. ICD-10: HHS proposes one-year delay of ICD-10 compliance date. Centers for Medicare & Medicaid Services website. Available at: http://www.cms.gov/Medicare/Coding/ICD10/index.html?redirect=/ICD10. Accessed May 5, 2012.
3. Abraham M, Ahlman J, Anderson C, Boudreau A, Connelly J. Current Procedural Terminology 2012 Professional Edition. Chicago: American Medical Association Press; 2011.

Hospitalists often are involved in the postoperative care of the surgical patient. However, HM is emerging in the admitting/attending role for procedural patients. Confusion can arise as to the nature of the hospitalist service, and whether it is deemed billable. Knowing the surgical package requirements can help hospitalists consider the issues.

Global Surgical Package Period¹

Surgical procedures, categorized as major or minor surgery, are reimbursed for pre-, intra-, and postoperative care. Postoperative care varies according to the procedure’s assigned global period, which designates zero, 10, or 90 postoperative days. (Physicians can review the global period for any given CPT code in the Medicare Physician Fee Schedule, available at www.cms.gov/apps/physician-fee-schedule/search/search-criteria.aspx.)

Services classified with “XXX” do not have the global period concept. “ZZZ” services denote an “add-on” procedure code that must always be reported with a primary procedure code and assumes the global period assigned to the primary procedure performed.

Major surgery allocates a 90-day global period in which the surgeon is responsible for all related surgical care one day before surgery through 90 postoperative days with no additional charge. Minor surgery, including endoscopy, appoints a zero-day or 10-day postoperative period. The zero-day global period encompasses only services provided on the surgical day, whereas 10-day global periods include services on the surgical day through 10 postoperative days.

Global Surgical Package Components²

The global surgical package comprises a host of responsibilities that include standard facility requirements of filling out all necessary paperwork involved in surgical cases (e.g. preoperative H&P, operative consent forms, preoperative orders). Additionally, the surgeon’s packaged payment includes (at no extra charge):

• Preoperative visits after making the decision for surgery beginning one day prior to surgery;
• All additional postoperative medical or surgical services provided by the surgeon related to complications but not requiring additional trips to the operating room;
• Postoperative visits by the surgeon related to recovery from surgery, including but not limited to dressing changes; local incisional care; removal of cutaneous sutures and staples; line removals; changes and removal of tracheostomy tubes; and discharge services; and
• Postoperative pain management provided by the surgeon.
• Examples of services that are not included in the global surgical package, (i.e. are separately billable and may require an appropriate modifier) are:
• The initial consultation or evaluation of the problem by the surgeon to determine the need for surgery;
• Services of other physicians except where the other physicians are providing coverage for the surgeon or agree on a transfer of care (i.e. a formal agreement in the form of a letter or an annotation in the discharge summary, hospital record, or ASC record);
• Postoperative visits by the surgeon unrelated to the diagnosis for which the surgical procedure is performed, unless the visits occur due to complications of the surgery;
• Diagnostic tests and procedures, including diagnostic radiological procedures;
• Clearly distinct surgical procedures during the postoperative period that do not result in repeat operations or treatment for complications;
• Treatment for postoperative complications that requires a return trip to the operating room (OR), catheterization lab or endoscopy suite;
• Immunosuppressive therapy for organ transplants; and
• Critical-care services (CPT codes 99291 and 99292) unrelated to the surgery where a seriously injured or burned patient is critically ill and requires constant attendance of the surgeon.

Classification of “Surgeon”

For billing purposes, the “surgeon” is a qualified physician who can perform “surgical” services within their scope of practice. All physicians with the same specialty designation in the same group practice as the “surgeon” (i.e. reporting services under the same tax identification number) are considered a single entity and must adhere to the global period billing rules initiated by the “surgeon.”

Alternately, physicians with different specialty designations in the same group practice (e.g. a hospitalist and a cardiologist in a multispecialty group who report services under the same tax identification number) or different group practices can perform and separately report medically necessary services during the surgeon’s global period, as long as a formal (mutually agreed-upon) transfer of care did not occur.

Medical Necessity

With the growth of HM programs and the admission/attending role expansion, involvement in surgical cases comes under scrutiny for medical necessity. Admitting a patient who has active medical conditions (e.g. hypertension, diabetes, emphysema) is reasonable and necessary because the patient has a well-defined need for medical management by the hospitalist. Participation in the care of these patients is separately billable from the surgeon’s global period package.

Alternatively, a hospitalist might be required to admit and follow surgical patients who have no other identifiable chronic or acute conditions aside from the surgical problem. In these cases, hospitalist involvement may satisfy facility policy (quality of care, risk reduction, etc.) and administrative functions (discharge services or coordination of care) rather than active clinical management. This “medical management” will not be considered “medically necessary” by the payor, and may be denied as incidental to the surgeon’s perioperative services. Erroneous payment can occur, which will result in refund requests, as payors do not want to pay twice for duplicate services. Hospitalists can attempt to negotiate other terms with facilities to account for the unpaid time and effort directed toward these types of cases.

Consider the Case

A patient with numerous medical comorbidities is admitted to the hospitalist service for stabilization prior to surgery, which will occur the next day. The hospitalist can report the appropriate admission code (99221-99223) without need for modifiers because the hospitalist is the attending of record and in a different specialty group. If a private insurer denies the claim as inclusive to the surgical service, the hospitalist can appeal with notes and a cover letter, along with the Medicare guidelines for global surgical package. The hospitalist may continue to provide postoperative daily care, as needed, to manage the patient’s chronic conditions, and report each service as subsequent hospital care (99231-99233) without modifier until the day of discharge (99238-99239). Again, if a payor issues a denial (inclusive to surgery), appealing with notes might be necessary.

Carol Pohlig is a billing and coding expert with the University of Pennsylvania Medical Center, Philadelphia. She is faculty for SHM’s inpatient coding course.

References

1. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual: Chapter 12, Section 40. Centers for Medicare & Medicaid Services website. Available at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf. Accessed May 5, 2012.
2. Centers for Medicare & Medicaid Services. ICD-10: HHS proposes one-year delay of ICD-10 compliance date. Centers for Medicare & Medicaid Services website. Available at: http://www.cms.gov/Medicare/Coding/ICD10/index.html?redirect=/ICD10. Accessed May 5, 2012.
3. Abraham M, Ahlman J, Anderson C, Boudreau A, Connelly J. Current Procedural Terminology 2012 Professional Edition. Chicago: American Medical Association Press; 2011.

In response to your April 25 eWire article “Study: Medicare Pay for Performance Might Not Work as Currently Designed,” we would like to point out that although the analyses you cite may be correct, the conclusion of the article is overly broad.

The Hospital Quality Incentive Demonstration (HQID) was designed to test whether incentives would improve care processes and a limited number of outcomes in hospitals beyond what was possible with public reporting alone. It accomplished that goal. HQID hospitals improved quality scores, achieving an 18.6% improvement, administering more than 960,000 additional evidence-based care measures.

Further, HQID was distinguished by the rapid nature of improvements. As HQID progressed, non-participant hospitals ultimately “caught up” in the second three-year measure period. Considering HQID hospital average composite quality scores were close to perfect, averaging between 95% and 98% across all clinical areas at the end of the project, this is a result that is certainly good for healthcare overall.

Too often, researchers, including the authors of the New England Journal of Medicine study, assume the 30-day measurement of mortality is the gold standard of effectiveness. That’s a highly flawed assumption. In many cases, 30-day mortality is a very blunt measure of quality because it is a relatively rare event, and it comprises an extremely narrow time frame. In fact, most studies evaluating interventions find it much more effective to look at long-term outcomes, not an arbitrary 30-day window.

Moreover, in the 10 years since HQID was designed, the science of medicine has advanced, as have measures to evaluate performance. What is important and unquestioned is that an HQID-type execution strategy is a good one for driving rapid and sustainable improvements. That is why we used the best of what we learned in HQID and combined it with new measures to drive a higher level of performance in the QUEST quality and cost-reduction collaborative.  QUEST has produced strong results in reducing mortality, harm rates, and readmissions, saving nearly 25,000 lives while reducing healthcare spending by nearly $4.5 billion in just three years. The Centers for Medicare & Medicaid Services (CMS) has followed a similar approach, combining what was successful in HQID with newer measures of performance in the national hospital value-based purchasing program.

To conclude that value-based purchasing will have a limited effect based on a narrow measure of outcomes, without an acknowledgement of how the program has evolved over the course of a decade, is a very big leap. We can all agree that today’s status quo is not producing the optimized results we’d like, but casting doubt on public policies before they have even been implemented is not the solution. The more helpful approach would be to foster a constructive dialogue on how we can take what has worked and improve upon it.

Richard Bankowitz, MD, MBA, FACP,

chief medical officer,

Premier Inc. healthcare alliance

In response to your April 25 eWire article “Study: Medicare Pay for Performance Might Not Work as Currently Designed,” we would like to point out that although the analyses you cite may be correct, the conclusion of the article is overly broad.

The Hospital Quality Incentive Demonstration (HQID) was designed to test whether incentives would improve care processes and a limited number of outcomes in hospitals beyond what was possible with public reporting alone. It accomplished that goal. HQID hospitals improved quality scores, achieving an 18.6% improvement, administering more than 960,000 additional evidence-based care measures.

Further, HQID was distinguished by the rapid nature of improvements. As HQID progressed, non-participant hospitals ultimately “caught up” in the second three-year measure period. Considering HQID hospital average composite quality scores were close to perfect, averaging between 95% and 98% across all clinical areas at the end of the project, this is a result that is certainly good for healthcare overall.

Too often, researchers, including the authors of the New England Journal of Medicine study, assume the 30-day measurement of mortality is the gold standard of effectiveness. That’s a highly flawed assumption. In many cases, 30-day mortality is a very blunt measure of quality because it is a relatively rare event, and it comprises an extremely narrow time frame. In fact, most studies evaluating interventions find it much more effective to look at long-term outcomes, not an arbitrary 30-day window.

Moreover, in the 10 years since HQID was designed, the science of medicine has advanced, as have measures to evaluate performance. What is important and unquestioned is that an HQID-type execution strategy is a good one for driving rapid and sustainable improvements. That is why we used the best of what we learned in HQID and combined it with new measures to drive a higher level of performance in the QUEST quality and cost-reduction collaborative.  QUEST has produced strong results in reducing mortality, harm rates, and readmissions, saving nearly 25,000 lives while reducing healthcare spending by nearly $4.5 billion in just three years. The Centers for Medicare & Medicaid Services (CMS) has followed a similar approach, combining what was successful in HQID with newer measures of performance in the national hospital value-based purchasing program.

To conclude that value-based purchasing will have a limited effect based on a narrow measure of outcomes, without an acknowledgement of how the program has evolved over the course of a decade, is a very big leap. We can all agree that today’s status quo is not producing the optimized results we’d like, but casting doubt on public policies before they have even been implemented is not the solution. The more helpful approach would be to foster a constructive dialogue on how we can take what has worked and improve upon it.

Richard Bankowitz, MD, MBA, FACP,

chief medical officer,

Premier Inc. healthcare alliance

In response to your April 25 eWire article “Study: Medicare Pay for Performance Might Not Work as Currently Designed,” we would like to point out that although the analyses you cite may be correct, the conclusion of the article is overly broad.

The Hospital Quality Incentive Demonstration (HQID) was designed to test whether incentives would improve care processes and a limited number of outcomes in hospitals beyond what was possible with public reporting alone. It accomplished that goal. HQID hospitals improved quality scores, achieving an 18.6% improvement, administering more than 960,000 additional evidence-based care measures.

Further, HQID was distinguished by the rapid nature of improvements. As HQID progressed, non-participant hospitals ultimately “caught up” in the second three-year measure period. Considering HQID hospital average composite quality scores were close to perfect, averaging between 95% and 98% across all clinical areas at the end of the project, this is a result that is certainly good for healthcare overall.

Too often, researchers, including the authors of the New England Journal of Medicine study, assume the 30-day measurement of mortality is the gold standard of effectiveness. That’s a highly flawed assumption. In many cases, 30-day mortality is a very blunt measure of quality because it is a relatively rare event, and it comprises an extremely narrow time frame. In fact, most studies evaluating interventions find it much more effective to look at long-term outcomes, not an arbitrary 30-day window.

Moreover, in the 10 years since HQID was designed, the science of medicine has advanced, as have measures to evaluate performance. What is important and unquestioned is that an HQID-type execution strategy is a good one for driving rapid and sustainable improvements. That is why we used the best of what we learned in HQID and combined it with new measures to drive a higher level of performance in the QUEST quality and cost-reduction collaborative.  QUEST has produced strong results in reducing mortality, harm rates, and readmissions, saving nearly 25,000 lives while reducing healthcare spending by nearly $4.5 billion in just three years. The Centers for Medicare & Medicaid Services (CMS) has followed a similar approach, combining what was successful in HQID with newer measures of performance in the national hospital value-based purchasing program.

To conclude that value-based purchasing will have a limited effect based on a narrow measure of outcomes, without an acknowledgement of how the program has evolved over the course of a decade, is a very big leap. We can all agree that today’s status quo is not producing the optimized results we’d like, but casting doubt on public policies before they have even been implemented is not the solution. The more helpful approach would be to foster a constructive dialogue on how we can take what has worked and improve upon it.

Richard Bankowitz, MD, MBA, FACP,

chief medical officer,

Premier Inc. healthcare alliance

A hospitalist was recently offered a lucrative position in his community and was concerned that his previous employment agreement would prohibit him from accepting the new job opportunity. His former employment contract contained a noncompetition clause that made him and his prospective employer rightfully concerned. Upon a comprehensive review of his former employment contract, the noncompetition provision was not as restrictive as he and his prospective employer had previously thought. As it turned out, in his case, and in many others, the noncompetition clause was penetrable, and the physician accepted the new employment offer knowing he was not in violation of his previous contract.

What Is a Noncompetition Clause?

A noncompetition clause, also known as a covenant not to compete or a restrictive covenant, is a provision in a contract that precludes one party from engaging in competition with another party by working 1) in a particular field, 2) within a specific geographic area, and 3) for a stated period of time. A well-written noncompetition provision will prevent a physician from practicing within a certain geographical area surrounding the employer or the employer’s hospital relationships and for a prescribed period of time after the termination of the physician’s employment.

Often, the physician will be permitted to practice within the parameters of the restricted geographical area or time period if they (or the prospective employer) “buy out” of the clause. This is an especially good option when the reasonableness of the noncompetition is not black and white, and both parties want to avoid the expense of litigating the enforceability of the noncompetition clause. Otherwise, in the event the physician breaches the noncompetition clause, the former employer will usually first seek injunctive relief that prohibits the physician’s new employment, then follow with a request for monetary damages arising from the physician’s breach.

In states where noncompetition clauses for physicians are enforceable, the provision must: 1) protect the employer’s legitimate business interest, 2) be specific in geographical scope, and 3) have a narrowly tailored durational scope. Each of these factors is described below. If the language in the clause is vague or does not clearly describe the exact terms of the restrictions on practice, the clause might be unenforceable or open to greater interpretation than either party anticipated.

Do Employers Have a Legitimate Business Interest to Protect?

In order for a noncompetition clause to be enforceable, it must protect the employer’s legitimate business interest. Some examples of a legitimate business interest in the HM context are the employer’s goodwill and the retention of the employer’s clients (hospitals and medical practices). Moreover, since noncompetition clauses are not looked upon with favor by courts because they operate as a restraint of trade, the language needs to be narrowly tailored in order to protect the employer’s legitimate interests.

Is Geographical Scope Reasonable?

Noncompetition clauses must also specify the restricted geographical area where the physician is prohibited from practicing. However, whether a geographical scope is overly broad will not only depend on state law, but also the location of the employer and the surrounding community.

Typically, contracts will provide a radius in miles surrounding the employer’s location or locations as the restricted territory. But whether a geographic limitation is “reasonable” is a relative term. A five-mile radius in an urban area like New York City might be home to millions of people, whereas a five-mile radius in a suburb of New York might only be home to a few thousand people. For hospitalists, the geographic restriction might prohibit the physician from practicing at or for the employer’s clients (e.g. hospitals).

Although the following might seem obviously overly broad to some, a review of contracts with the following geographic restrictions should be considered red flags:

• Prohibition to practice anywhere in the U.S.;
• Prohibition to practice anywhere in a specific state;
• Prohibition to practice in a territory comprised of excessive miles from the employer’s location; and
• Prohibition to practice in certain counties.

Please note that exclusion to practice in certain counties might be overly broad in some situations but might be acceptable in others. For example, a hospitalist sold his ownership stake in his practice, and part of the deal required him to agree not to practice in Los Angeles County. This particular county restriction would be difficult, if not impossible, to enforce because Los Angeles County includes more than 80 cities and covers more than 4,000 square miles.

Is Durational Scope Reasonable?

A noncompetition clause should identify the length of time in which the physician is prohibited from practicing within the restricted geographic area. Whether the durational scope is reasonable will vary from state to state. As a general rule of thumb, if the restricted time frame is two years or less after termination of the contract, the time restriction will likely be considered “reasonable.” However, state laws vary on whether time restraints in excess of two years are enforceable.

A common pitfall with time restrictions is excessiveness based on the state’s laws and the specific circumstances of the physician and the employer. In negotiating the restricted length of time in a noncompetition clause, it is more common to have a longer time restriction when a physician is selling an ownership interest in a practice than for a physician entering into an employment relationship.

Prospective Employers: What You Need to Know

Great care must be taken when hiring a physician. States recognize the legal theory of interference with a contract. If an employer is recruiting a hospitalist who is subject to an employment agreement with a noncompetition clause, the prospective employer must be very careful in the recruiting process. It is recommended that the employment agreement include a representation by the physician-employee that he or she is not subject to any other agreement that would prohibit the physician from entering into the new employment relationship.

If a prospective employer is aware of an existing employment contract that contains practice restrictions on a recruited physician, the prospective employer could be held responsible for damages if a dispute arises between the parties.

It’s All in the Words

Although it might seem like semantics, a few words can change your future. Before you put pen to paper, be sure to have any contract containing a noncompetition clause reviewed by a lawyer who is well-versed in your state’s laws. If you have already signed an agreement with a noncompetition clause and you are considering your next career move, a lawyer can shed some light on a seemingly impenetrable clause.

Steven M. Harris, Esq., is a nationally recognized healthcare attorney and a member of the law firm McDonald Hopkins LLC in Chicago. Write to him at [email protected].

A hospitalist was recently offered a lucrative position in his community and was concerned that his previous employment agreement would prohibit him from accepting the new job opportunity. His former employment contract contained a noncompetition clause that made him and his prospective employer rightfully concerned. Upon a comprehensive review of his former employment contract, the noncompetition provision was not as restrictive as he and his prospective employer had previously thought. As it turned out, in his case, and in many others, the noncompetition clause was penetrable, and the physician accepted the new employment offer knowing he was not in violation of his previous contract.

What Is a Noncompetition Clause?

A noncompetition clause, also known as a covenant not to compete or a restrictive covenant, is a provision in a contract that precludes one party from engaging in competition with another party by working 1) in a particular field, 2) within a specific geographic area, and 3) for a stated period of time. A well-written noncompetition provision will prevent a physician from practicing within a certain geographical area surrounding the employer or the employer’s hospital relationships and for a prescribed period of time after the termination of the physician’s employment.

Often, the physician will be permitted to practice within the parameters of the restricted geographical area or time period if they (or the prospective employer) “buy out” of the clause. This is an especially good option when the reasonableness of the noncompetition is not black and white, and both parties want to avoid the expense of litigating the enforceability of the noncompetition clause. Otherwise, in the event the physician breaches the noncompetition clause, the former employer will usually first seek injunctive relief that prohibits the physician’s new employment, then follow with a request for monetary damages arising from the physician’s breach.

In states where noncompetition clauses for physicians are enforceable, the provision must: 1) protect the employer’s legitimate business interest, 2) be specific in geographical scope, and 3) have a narrowly tailored durational scope. Each of these factors is described below. If the language in the clause is vague or does not clearly describe the exact terms of the restrictions on practice, the clause might be unenforceable or open to greater interpretation than either party anticipated.

Do Employers Have a Legitimate Business Interest to Protect?

In order for a noncompetition clause to be enforceable, it must protect the employer’s legitimate business interest. Some examples of a legitimate business interest in the HM context are the employer’s goodwill and the retention of the employer’s clients (hospitals and medical practices). Moreover, since noncompetition clauses are not looked upon with favor by courts because they operate as a restraint of trade, the language needs to be narrowly tailored in order to protect the employer’s legitimate interests.

Is Geographical Scope Reasonable?

Noncompetition clauses must also specify the restricted geographical area where the physician is prohibited from practicing. However, whether a geographical scope is overly broad will not only depend on state law, but also the location of the employer and the surrounding community.

Typically, contracts will provide a radius in miles surrounding the employer’s location or locations as the restricted territory. But whether a geographic limitation is “reasonable” is a relative term. A five-mile radius in an urban area like New York City might be home to millions of people, whereas a five-mile radius in a suburb of New York might only be home to a few thousand people. For hospitalists, the geographic restriction might prohibit the physician from practicing at or for the employer’s clients (e.g. hospitals).

Although the following might seem obviously overly broad to some, a review of contracts with the following geographic restrictions should be considered red flags:

• Prohibition to practice anywhere in the U.S.;
• Prohibition to practice anywhere in a specific state;
• Prohibition to practice in a territory comprised of excessive miles from the employer’s location; and
• Prohibition to practice in certain counties.

Please note that exclusion to practice in certain counties might be overly broad in some situations but might be acceptable in others. For example, a hospitalist sold his ownership stake in his practice, and part of the deal required him to agree not to practice in Los Angeles County. This particular county restriction would be difficult, if not impossible, to enforce because Los Angeles County includes more than 80 cities and covers more than 4,000 square miles.

Is Durational Scope Reasonable?

A noncompetition clause should identify the length of time in which the physician is prohibited from practicing within the restricted geographic area. Whether the durational scope is reasonable will vary from state to state. As a general rule of thumb, if the restricted time frame is two years or less after termination of the contract, the time restriction will likely be considered “reasonable.” However, state laws vary on whether time restraints in excess of two years are enforceable.

A common pitfall with time restrictions is excessiveness based on the state’s laws and the specific circumstances of the physician and the employer. In negotiating the restricted length of time in a noncompetition clause, it is more common to have a longer time restriction when a physician is selling an ownership interest in a practice than for a physician entering into an employment relationship.

Prospective Employers: What You Need to Know

Great care must be taken when hiring a physician. States recognize the legal theory of interference with a contract. If an employer is recruiting a hospitalist who is subject to an employment agreement with a noncompetition clause, the prospective employer must be very careful in the recruiting process. It is recommended that the employment agreement include a representation by the physician-employee that he or she is not subject to any other agreement that would prohibit the physician from entering into the new employment relationship.

If a prospective employer is aware of an existing employment contract that contains practice restrictions on a recruited physician, the prospective employer could be held responsible for damages if a dispute arises between the parties.

It’s All in the Words

Although it might seem like semantics, a few words can change your future. Before you put pen to paper, be sure to have any contract containing a noncompetition clause reviewed by a lawyer who is well-versed in your state’s laws. If you have already signed an agreement with a noncompetition clause and you are considering your next career move, a lawyer can shed some light on a seemingly impenetrable clause.

Steven M. Harris, Esq., is a nationally recognized healthcare attorney and a member of the law firm McDonald Hopkins LLC in Chicago. Write to him at [email protected].

A hospitalist was recently offered a lucrative position in his community and was concerned that his previous employment agreement would prohibit him from accepting the new job opportunity. His former employment contract contained a noncompetition clause that made him and his prospective employer rightfully concerned. Upon a comprehensive review of his former employment contract, the noncompetition provision was not as restrictive as he and his prospective employer had previously thought. As it turned out, in his case, and in many others, the noncompetition clause was penetrable, and the physician accepted the new employment offer knowing he was not in violation of his previous contract.

What Is a Noncompetition Clause?

A noncompetition clause, also known as a covenant not to compete or a restrictive covenant, is a provision in a contract that precludes one party from engaging in competition with another party by working 1) in a particular field, 2) within a specific geographic area, and 3) for a stated period of time. A well-written noncompetition provision will prevent a physician from practicing within a certain geographical area surrounding the employer or the employer’s hospital relationships and for a prescribed period of time after the termination of the physician’s employment.

Often, the physician will be permitted to practice within the parameters of the restricted geographical area or time period if they (or the prospective employer) “buy out” of the clause. This is an especially good option when the reasonableness of the noncompetition is not black and white, and both parties want to avoid the expense of litigating the enforceability of the noncompetition clause. Otherwise, in the event the physician breaches the noncompetition clause, the former employer will usually first seek injunctive relief that prohibits the physician’s new employment, then follow with a request for monetary damages arising from the physician’s breach.

In states where noncompetition clauses for physicians are enforceable, the provision must: 1) protect the employer’s legitimate business interest, 2) be specific in geographical scope, and 3) have a narrowly tailored durational scope. Each of these factors is described below. If the language in the clause is vague or does not clearly describe the exact terms of the restrictions on practice, the clause might be unenforceable or open to greater interpretation than either party anticipated.

Do Employers Have a Legitimate Business Interest to Protect?

In order for a noncompetition clause to be enforceable, it must protect the employer’s legitimate business interest. Some examples of a legitimate business interest in the HM context are the employer’s goodwill and the retention of the employer’s clients (hospitals and medical practices). Moreover, since noncompetition clauses are not looked upon with favor by courts because they operate as a restraint of trade, the language needs to be narrowly tailored in order to protect the employer’s legitimate interests.

Is Geographical Scope Reasonable?

Noncompetition clauses must also specify the restricted geographical area where the physician is prohibited from practicing. However, whether a geographical scope is overly broad will not only depend on state law, but also the location of the employer and the surrounding community.

Typically, contracts will provide a radius in miles surrounding the employer’s location or locations as the restricted territory. But whether a geographic limitation is “reasonable” is a relative term. A five-mile radius in an urban area like New York City might be home to millions of people, whereas a five-mile radius in a suburb of New York might only be home to a few thousand people. For hospitalists, the geographic restriction might prohibit the physician from practicing at or for the employer’s clients (e.g. hospitals).

Although the following might seem obviously overly broad to some, a review of contracts with the following geographic restrictions should be considered red flags:

• Prohibition to practice anywhere in the U.S.;
• Prohibition to practice anywhere in a specific state;
• Prohibition to practice in a territory comprised of excessive miles from the employer’s location; and
• Prohibition to practice in certain counties.

Please note that exclusion to practice in certain counties might be overly broad in some situations but might be acceptable in others. For example, a hospitalist sold his ownership stake in his practice, and part of the deal required him to agree not to practice in Los Angeles County. This particular county restriction would be difficult, if not impossible, to enforce because Los Angeles County includes more than 80 cities and covers more than 4,000 square miles.

Is Durational Scope Reasonable?

A noncompetition clause should identify the length of time in which the physician is prohibited from practicing within the restricted geographic area. Whether the durational scope is reasonable will vary from state to state. As a general rule of thumb, if the restricted time frame is two years or less after termination of the contract, the time restriction will likely be considered “reasonable.” However, state laws vary on whether time restraints in excess of two years are enforceable.

A common pitfall with time restrictions is excessiveness based on the state’s laws and the specific circumstances of the physician and the employer. In negotiating the restricted length of time in a noncompetition clause, it is more common to have a longer time restriction when a physician is selling an ownership interest in a practice than for a physician entering into an employment relationship.

Prospective Employers: What You Need to Know

Great care must be taken when hiring a physician. States recognize the legal theory of interference with a contract. If an employer is recruiting a hospitalist who is subject to an employment agreement with a noncompetition clause, the prospective employer must be very careful in the recruiting process. It is recommended that the employment agreement include a representation by the physician-employee that he or she is not subject to any other agreement that would prohibit the physician from entering into the new employment relationship.

If a prospective employer is aware of an existing employment contract that contains practice restrictions on a recruited physician, the prospective employer could be held responsible for damages if a dispute arises between the parties.

It’s All in the Words

Although it might seem like semantics, a few words can change your future. Before you put pen to paper, be sure to have any contract containing a noncompetition clause reviewed by a lawyer who is well-versed in your state’s laws. If you have already signed an agreement with a noncompetition clause and you are considering your next career move, a lawyer can shed some light on a seemingly impenetrable clause.

Steven M. Harris, Esq., is a nationally recognized healthcare attorney and a member of the law firm McDonald Hopkins LLC in Chicago. Write to him at [email protected].

New mother dies from pulmonary embolism

A 39-YEAR-OLD WOMAN’S SECOND CHILD WAS BORN by cesarean delivery. The mother died the next day from a pulmonary embolism.

ESTATE’S CLAIM Physicians and nurses at the hospital were negligent in failing to recognize the mother’s risk factors for pulmonary embolism, including obesity, being over age 35, and hypertension. They failed to ensure that compression boots were in place and working prior to delivery. Although orders had been given for the woman to walk within 8 hours of delivery, she did not get out of bed and walk for 24 hours after delivery.

DEFENDANTS’ DEFENSE The case was settled before trial.

VERDICT A $3.5 million Illinois settlement was reached.

Woman told “Biopsy isn’t urgent”

TWO MONTHS AFTER HER INITIAL VISIT, a 58-year-old woman returned to the gynecologist with vaginal bleeding. In March 2004, ultrasonography (US) showed slight thickening of the endometrial lining and a “pin dot” described as being a prepolyp. Vaginal bleeding was determined to be due to thinning of the vaginal wall with menopause.

The patient reported daily vaginal bleeding when she saw the gynecologist in January 2005. A new, large, rounded, solid mass within the endometrial cavity consistent with a large endometrial polyp was seen on US. The radiologist recommended hysteroscopic biopsy with excision, but the gynecologist told the patient it was not urgent.

In March 2005, hysteroscopy confirmed carcinosarcoma of the uterus. The patient underwent a hysterectomy followed by pelvic radiation and brachytherapy.

Eight months later, metastasis was found in the lungs; she died in October 2006.

ESTATE’S CLAIM The gynecologist failed to react when the patient first reported vaginal bleeding. An earlier diagnosis could have prevented her death.

PHYSICIAN’S DEFENSE The case was settled before trial.

VERDICT An $820,000 Massachusetts settlement was reached.

US report misses fetal abnormalities

A PREGNANT WOMAN UNDERWENT US. The preliminary report indicated echogenic cardiac focus and unilateral pyelectasis. Twenty-five days later, the mother underwent a level II US. A radiologist wrote that fetal anatomy was normal in both reports. The mother had two additional sonograms, with no reported abnormality.

The baby was born with aplasia and hypoplasia with both arms absent below a short humerus, an absent left leg, and a shortened right leg with a remnant foot and three small toes.

PARENTS’ CLAIM The radiologist’s US reports failed to accurately describe the fetal anatomy, depriving the parents of the chance to terminate the pregnancy.

DEFENDANTS’ DEFENSE Proper treatment was given.

VERDICT A $4.5 million Florida verdict was returned. Fault was assigned to the radiologist (85%) and the level II technologist (15%).

Forceps delivery injures mother’s pelvic floor

DURING A TRIAL OF LABOR, a 34-year-old woman experienced deep transverse arrest and lack of progress due to pelvic restriction. The ObGyn proceeded to deliver the baby vaginally using forceps, which caused pelvic floor injuries to the mother.

Several months later, she underwent corrective repair surgery for pelvic floor prolapse. She has continuing vaginal and rectal pain and dysfunction.

PATIENT’S CLAIM A cesarean delivery should have been performed as soon as pelvic restriction was found. The injuries reduce the woman’s chances of having another child.

PHYSICIAN’S DEFENSE A trial of labor was proper. The patient’s continuing fertility problems are related to chronic yeast infections and prescription birth control.

VERDICT A $1,716,469 Illinois verdict was returned, which included $484,000 to the patient’s husband for loss of consortium.

7 CASES OF INJURED BOWEL

1 Woman dies from bowel injury

DURING A SLING PROCEDURE for vaginal prolapse, a 50-year-old woman required a transfusion. The next day, she was nauseated and constipated. A day later, she went to the ED with shortness of breath and chest and abdominal pain. Her symptoms persisted for 8 days before an injury to her transverse colon was found during exploratory surgery. She suffered massive organ failure caused by sepsis and died 3 weeks after the initial surgery.

ESTATE’S CLAIM The gynecologist should have investigated why she needed a transfusion during surgery. He should have reacted earlier to her postsurgical complaints.

PHYSICIAN’S DEFENSE Bowel injury is a known risk of the procedure. The patient suffered multiple strokes after being readmitted to the hospital.

VERDICT A $2.4 million South Carolina verdict was returned.

2 Colostomy, coma after hysterectomy

DUE TO FIBROID TUMORS and pelvic pain, a 39-year-old woman’s ObGyn suggested laparoscopic-assisted vaginal hysterectomy. A third-year resident performed most of the procedure. The ObGyn’s associate covered postsurgical care.

When the patient reported increasing pain and rectal bleeding, an exploratory laparotomy was performed 3 days after surgery. Bowel and ureter injuries were repaired and a permanent colostomy was created. The patient developed septic shock with multiple organ failure, and was placed in a chemically induced coma for 3 weeks, after which she had to relearn to walk, talk, and care for herself.

PATIENT’S CLAIM The ObGyn was negligent in performing the surgery. He failed to obtain consent for the resident’s participation. The associate failed to respond to her declining postoperative condition in a timely manner.

DEFENDANTS’ DEFENSE Surgery was properly performed and postoperative care was appropriate. The bowel injury was a thermal or pressure necrosis that occurred 3 days after surgery. Two different consent forms signed by the patient included notification that a resident might assist; the resident was introduced to the patient prior to surgery. The patient’s injury claims were exaggerated; her future medical bills would be limited to colostomy supplies.

VERDICT A $1,926,069 Texas verdict was returned.

3 Were physicians qualified on robot?

A 48-YEAR-OLD WOMAN UNDERWENT robotic-assisted total hysterectomy and oophorectomy for uterine fibroids and cysts. During surgery, the physicians realized that the sigmoid colon had been perforated. A general surgeon repaired the injury with a loop ileostomy, which was successfully reversed 3 months later. The patient continues to have constipation, with occasional bleeding, pain, and burning.

PATIENT’S CLAIM The risks of robotic surgery were never fully explained to her. Failure to properly visualize her internal organs led to the injury; the extent of damage exceeded what is considered “acceptable risk” of the procedure. The physicians had little experience and training in robotic surgery.

PHYSICIANS’ DEFENSE The case was settled before trial.

VERDICT A $350,000 Massachusetts settlement was reached.

4 Adhesions limit view of bowel

A 76-YEAR-OLD WOMAN UNDERWENT surgical removal of an ovarian cyst. The ObGyn attempted a laparoscopic procedure but converted to laparotomy when extensive adhesions were encountered. The next morning, the patient discovered that her navel was discharging fecal matter. Exploratory surgery determined that the bowel had been perforated. She required additional surgery and had a long recovery.

PATIENT’S CLAIM The ObGyn was negligent in failing to diagnose and treat bowel perforation in a timely manner. An intraoperative bowel inspection should have occurred due to the likelihood of a bowel injury related to the adhesions.

PHYSICIAN’S DEFENSE Adhesions restricted inspection of every area.

VERDICT A $225,000 New York settlement was reached.

5 Skydiver’s ongoing postop pain

AFTER REPORTING DYSMENORRHEA and menometrorrhagia, a 34-year-old woman underwent dilatation and curettage, thermal endometrial ablation, and diagnostic laparoscopy. A day later, she reported increasing pain. The ObGyn’s examination revealed minimal abdominal distension, sluggish bowel sounds, and some guarding, with no rebound tenderness or acute distress. US showed a 3-cm pocket of fluid in the abdomen. Two hours later, an exam revealed a soft abdomen and normal bowel sounds. She was sent home with instructions to return the next day or, if her condition worsened, to go to the ED.

Her husband called the next day to report she was feeling better. The patient woke the following morning with massive distension, worse pain, and severe shortness of breath. At the ED, a CT scan revealed a large amount of abdominal fluid. During emergency laparotomy, an injury was found in the jejunum, necessitating a 3-inch resection.

PATIENT’S CLAIM The ObGyn was negligent in not treating her postoperative symptoms in a more proactive manner. Adhesions developed from peritonitis, leading to chronic abdominal pain. Several operations were required.

PHYSICIAN’S DEFENSE Bowel injury is a known complication of the procedure. There was no indication during surgery or at the office visit that the jejunum was injured. Adhesions were not the cause of the patient’s ongoing pain; very few adhesions were found during subsequent operations. The woman was an avid skydiver who had completed 200 jumps since her initial surgery.

VERDICT An Illinois defense verdict was returned.

6 Bowel injury at laparoscopy

WHEN THE GYNECOLOGIST recognized a bowel injury during laparoscopic salpingectomy, he called a general surgeon, who repaired three areas of bowel. The patient was released 2 days after surgery. She called the gynecologist 2 days later to report fever and vaginal bleeding. She was told to come to the office, but she cancelled when the fever subsided. The next day, she went to the ED, where sepsis was diagnosed. She was flown to another hospital for surgery. A 1-cm small-bowel perforation was found in an area of earlier repair because a suture had been disrupted. A temporary colostomy was reversed 3 months later.

PATIENT’S CLAIM The gynecologist was negligent in performing laparoscopic salpingectomy. The patient should not have been discharged because her white blood cell count and heart rate were elevated.

DEFENDANTS’ DEFENSE Performance of a laparoscopic procedure was proper. Discharge was reasonable, as there was only a potential for complications with no evident problems.

VERDICT An Missouri defense verdict was returned.

7 Was treatment of abscess delayed?

A 49-YEAR-OLD WOMAN with menorrhagia underwent cryoablation. Two weeks later, she went to the ED with pain and constipation. Following CT scans and US, she was found to have a tubo-ovarian abscess. After an enema and subsequent bowel movement, her pain improved. She was discharged with instructions to follow-up with her gynecologist. Six days later, the gynecologist prescribed triple antibiotics, analgesics, and weekly visits for the abscess. Two weeks later, she reported unbearable pain and was sent to the ED. She was found to have a microperforation of the sigmoid colon and multiple gynecologic pathologies, including myomata, right serous cystadenoma, and left tubo-ovarian complex suggestive of endometriosis. Hysterectomy and colostomy were performed; the colostomy was reversed several months later.

PATIENT’S CLAIM She should have been hospitalized when the abscess was found so that the infection could be treated properly. She alleged lack of informed consent for the cryoablation.

PHYSICIAN’S DEFENSE Hospitalization was unnecessary; the patient had initially improved, and the outcome would not have changed with intravenous antibiotics. The patient was fully informed of the risks of the procedure.

VERDICT A Pennsylvania defense verdict was returned.

New mother dies from pulmonary embolism

A 39-YEAR-OLD WOMAN’S SECOND CHILD WAS BORN by cesarean delivery. The mother died the next day from a pulmonary embolism.

ESTATE’S CLAIM Physicians and nurses at the hospital were negligent in failing to recognize the mother’s risk factors for pulmonary embolism, including obesity, being over age 35, and hypertension. They failed to ensure that compression boots were in place and working prior to delivery. Although orders had been given for the woman to walk within 8 hours of delivery, she did not get out of bed and walk for 24 hours after delivery.

DEFENDANTS’ DEFENSE The case was settled before trial.

VERDICT A $3.5 million Illinois settlement was reached.

Woman told “Biopsy isn’t urgent”

TWO MONTHS AFTER HER INITIAL VISIT, a 58-year-old woman returned to the gynecologist with vaginal bleeding. In March 2004, ultrasonography (US) showed slight thickening of the endometrial lining and a “pin dot” described as being a prepolyp. Vaginal bleeding was determined to be due to thinning of the vaginal wall with menopause.

The patient reported daily vaginal bleeding when she saw the gynecologist in January 2005. A new, large, rounded, solid mass within the endometrial cavity consistent with a large endometrial polyp was seen on US. The radiologist recommended hysteroscopic biopsy with excision, but the gynecologist told the patient it was not urgent.

In March 2005, hysteroscopy confirmed carcinosarcoma of the uterus. The patient underwent a hysterectomy followed by pelvic radiation and brachytherapy.

Eight months later, metastasis was found in the lungs; she died in October 2006.

ESTATE’S CLAIM The gynecologist failed to react when the patient first reported vaginal bleeding. An earlier diagnosis could have prevented her death.

PHYSICIAN’S DEFENSE The case was settled before trial.

VERDICT An $820,000 Massachusetts settlement was reached.

US report misses fetal abnormalities

A PREGNANT WOMAN UNDERWENT US. The preliminary report indicated echogenic cardiac focus and unilateral pyelectasis. Twenty-five days later, the mother underwent a level II US. A radiologist wrote that fetal anatomy was normal in both reports. The mother had two additional sonograms, with no reported abnormality.

The baby was born with aplasia and hypoplasia with both arms absent below a short humerus, an absent left leg, and a shortened right leg with a remnant foot and three small toes.

PARENTS’ CLAIM The radiologist’s US reports failed to accurately describe the fetal anatomy, depriving the parents of the chance to terminate the pregnancy.

DEFENDANTS’ DEFENSE Proper treatment was given.

VERDICT A $4.5 million Florida verdict was returned. Fault was assigned to the radiologist (85%) and the level II technologist (15%).

Forceps delivery injures mother’s pelvic floor

DURING A TRIAL OF LABOR, a 34-year-old woman experienced deep transverse arrest and lack of progress due to pelvic restriction. The ObGyn proceeded to deliver the baby vaginally using forceps, which caused pelvic floor injuries to the mother.

Several months later, she underwent corrective repair surgery for pelvic floor prolapse. She has continuing vaginal and rectal pain and dysfunction.

PATIENT’S CLAIM A cesarean delivery should have been performed as soon as pelvic restriction was found. The injuries reduce the woman’s chances of having another child.

PHYSICIAN’S DEFENSE A trial of labor was proper. The patient’s continuing fertility problems are related to chronic yeast infections and prescription birth control.

VERDICT A $1,716,469 Illinois verdict was returned, which included $484,000 to the patient’s husband for loss of consortium.

7 CASES OF INJURED BOWEL

1 Woman dies from bowel injury

DURING A SLING PROCEDURE for vaginal prolapse, a 50-year-old woman required a transfusion. The next day, she was nauseated and constipated. A day later, she went to the ED with shortness of breath and chest and abdominal pain. Her symptoms persisted for 8 days before an injury to her transverse colon was found during exploratory surgery. She suffered massive organ failure caused by sepsis and died 3 weeks after the initial surgery.

ESTATE’S CLAIM The gynecologist should have investigated why she needed a transfusion during surgery. He should have reacted earlier to her postsurgical complaints.

PHYSICIAN’S DEFENSE Bowel injury is a known risk of the procedure. The patient suffered multiple strokes after being readmitted to the hospital.

VERDICT A $2.4 million South Carolina verdict was returned.

2 Colostomy, coma after hysterectomy

DUE TO FIBROID TUMORS and pelvic pain, a 39-year-old woman’s ObGyn suggested laparoscopic-assisted vaginal hysterectomy. A third-year resident performed most of the procedure. The ObGyn’s associate covered postsurgical care.

When the patient reported increasing pain and rectal bleeding, an exploratory laparotomy was performed 3 days after surgery. Bowel and ureter injuries were repaired and a permanent colostomy was created. The patient developed septic shock with multiple organ failure, and was placed in a chemically induced coma for 3 weeks, after which she had to relearn to walk, talk, and care for herself.

PATIENT’S CLAIM The ObGyn was negligent in performing the surgery. He failed to obtain consent for the resident’s participation. The associate failed to respond to her declining postoperative condition in a timely manner.

DEFENDANTS’ DEFENSE Surgery was properly performed and postoperative care was appropriate. The bowel injury was a thermal or pressure necrosis that occurred 3 days after surgery. Two different consent forms signed by the patient included notification that a resident might assist; the resident was introduced to the patient prior to surgery. The patient’s injury claims were exaggerated; her future medical bills would be limited to colostomy supplies.

VERDICT A $1,926,069 Texas verdict was returned.

3 Were physicians qualified on robot?

A 48-YEAR-OLD WOMAN UNDERWENT robotic-assisted total hysterectomy and oophorectomy for uterine fibroids and cysts. During surgery, the physicians realized that the sigmoid colon had been perforated. A general surgeon repaired the injury with a loop ileostomy, which was successfully reversed 3 months later. The patient continues to have constipation, with occasional bleeding, pain, and burning.

PATIENT’S CLAIM The risks of robotic surgery were never fully explained to her. Failure to properly visualize her internal organs led to the injury; the extent of damage exceeded what is considered “acceptable risk” of the procedure. The physicians had little experience and training in robotic surgery.

PHYSICIANS’ DEFENSE The case was settled before trial.

VERDICT A $350,000 Massachusetts settlement was reached.

4 Adhesions limit view of bowel

A 76-YEAR-OLD WOMAN UNDERWENT surgical removal of an ovarian cyst. The ObGyn attempted a laparoscopic procedure but converted to laparotomy when extensive adhesions were encountered. The next morning, the patient discovered that her navel was discharging fecal matter. Exploratory surgery determined that the bowel had been perforated. She required additional surgery and had a long recovery.

PATIENT’S CLAIM The ObGyn was negligent in failing to diagnose and treat bowel perforation in a timely manner. An intraoperative bowel inspection should have occurred due to the likelihood of a bowel injury related to the adhesions.

PHYSICIAN’S DEFENSE Adhesions restricted inspection of every area.

VERDICT A $225,000 New York settlement was reached.

5 Skydiver’s ongoing postop pain

AFTER REPORTING DYSMENORRHEA and menometrorrhagia, a 34-year-old woman underwent dilatation and curettage, thermal endometrial ablation, and diagnostic laparoscopy. A day later, she reported increasing pain. The ObGyn’s examination revealed minimal abdominal distension, sluggish bowel sounds, and some guarding, with no rebound tenderness or acute distress. US showed a 3-cm pocket of fluid in the abdomen. Two hours later, an exam revealed a soft abdomen and normal bowel sounds. She was sent home with instructions to return the next day or, if her condition worsened, to go to the ED.

Her husband called the next day to report she was feeling better. The patient woke the following morning with massive distension, worse pain, and severe shortness of breath. At the ED, a CT scan revealed a large amount of abdominal fluid. During emergency laparotomy, an injury was found in the jejunum, necessitating a 3-inch resection.

PATIENT’S CLAIM The ObGyn was negligent in not treating her postoperative symptoms in a more proactive manner. Adhesions developed from peritonitis, leading to chronic abdominal pain. Several operations were required.

PHYSICIAN’S DEFENSE Bowel injury is a known complication of the procedure. There was no indication during surgery or at the office visit that the jejunum was injured. Adhesions were not the cause of the patient’s ongoing pain; very few adhesions were found during subsequent operations. The woman was an avid skydiver who had completed 200 jumps since her initial surgery.

VERDICT An Illinois defense verdict was returned.

6 Bowel injury at laparoscopy

WHEN THE GYNECOLOGIST recognized a bowel injury during laparoscopic salpingectomy, he called a general surgeon, who repaired three areas of bowel. The patient was released 2 days after surgery. She called the gynecologist 2 days later to report fever and vaginal bleeding. She was told to come to the office, but she cancelled when the fever subsided. The next day, she went to the ED, where sepsis was diagnosed. She was flown to another hospital for surgery. A 1-cm small-bowel perforation was found in an area of earlier repair because a suture had been disrupted. A temporary colostomy was reversed 3 months later.

PATIENT’S CLAIM The gynecologist was negligent in performing laparoscopic salpingectomy. The patient should not have been discharged because her white blood cell count and heart rate were elevated.

DEFENDANTS’ DEFENSE Performance of a laparoscopic procedure was proper. Discharge was reasonable, as there was only a potential for complications with no evident problems.

VERDICT An Missouri defense verdict was returned.

7 Was treatment of abscess delayed?

A 49-YEAR-OLD WOMAN with menorrhagia underwent cryoablation. Two weeks later, she went to the ED with pain and constipation. Following CT scans and US, she was found to have a tubo-ovarian abscess. After an enema and subsequent bowel movement, her pain improved. She was discharged with instructions to follow-up with her gynecologist. Six days later, the gynecologist prescribed triple antibiotics, analgesics, and weekly visits for the abscess. Two weeks later, she reported unbearable pain and was sent to the ED. She was found to have a microperforation of the sigmoid colon and multiple gynecologic pathologies, including myomata, right serous cystadenoma, and left tubo-ovarian complex suggestive of endometriosis. Hysterectomy and colostomy were performed; the colostomy was reversed several months later.

PATIENT’S CLAIM She should have been hospitalized when the abscess was found so that the infection could be treated properly. She alleged lack of informed consent for the cryoablation.

PHYSICIAN’S DEFENSE Hospitalization was unnecessary; the patient had initially improved, and the outcome would not have changed with intravenous antibiotics. The patient was fully informed of the risks of the procedure.

VERDICT A Pennsylvania defense verdict was returned.

New mother dies from pulmonary embolism

A 39-YEAR-OLD WOMAN’S SECOND CHILD WAS BORN by cesarean delivery. The mother died the next day from a pulmonary embolism.

ESTATE’S CLAIM Physicians and nurses at the hospital were negligent in failing to recognize the mother’s risk factors for pulmonary embolism, including obesity, being over age 35, and hypertension. They failed to ensure that compression boots were in place and working prior to delivery. Although orders had been given for the woman to walk within 8 hours of delivery, she did not get out of bed and walk for 24 hours after delivery.

DEFENDANTS’ DEFENSE The case was settled before trial.

VERDICT A $3.5 million Illinois settlement was reached.

Woman told “Biopsy isn’t urgent”

TWO MONTHS AFTER HER INITIAL VISIT, a 58-year-old woman returned to the gynecologist with vaginal bleeding. In March 2004, ultrasonography (US) showed slight thickening of the endometrial lining and a “pin dot” described as being a prepolyp. Vaginal bleeding was determined to be due to thinning of the vaginal wall with menopause.

The patient reported daily vaginal bleeding when she saw the gynecologist in January 2005. A new, large, rounded, solid mass within the endometrial cavity consistent with a large endometrial polyp was seen on US. The radiologist recommended hysteroscopic biopsy with excision, but the gynecologist told the patient it was not urgent.

In March 2005, hysteroscopy confirmed carcinosarcoma of the uterus. The patient underwent a hysterectomy followed by pelvic radiation and brachytherapy.

Eight months later, metastasis was found in the lungs; she died in October 2006.

ESTATE’S CLAIM The gynecologist failed to react when the patient first reported vaginal bleeding. An earlier diagnosis could have prevented her death.

PHYSICIAN’S DEFENSE The case was settled before trial.

VERDICT An $820,000 Massachusetts settlement was reached.

US report misses fetal abnormalities

A PREGNANT WOMAN UNDERWENT US. The preliminary report indicated echogenic cardiac focus and unilateral pyelectasis. Twenty-five days later, the mother underwent a level II US. A radiologist wrote that fetal anatomy was normal in both reports. The mother had two additional sonograms, with no reported abnormality.

The baby was born with aplasia and hypoplasia with both arms absent below a short humerus, an absent left leg, and a shortened right leg with a remnant foot and three small toes.

PARENTS’ CLAIM The radiologist’s US reports failed to accurately describe the fetal anatomy, depriving the parents of the chance to terminate the pregnancy.

DEFENDANTS’ DEFENSE Proper treatment was given.

VERDICT A $4.5 million Florida verdict was returned. Fault was assigned to the radiologist (85%) and the level II technologist (15%).

Forceps delivery injures mother’s pelvic floor

DURING A TRIAL OF LABOR, a 34-year-old woman experienced deep transverse arrest and lack of progress due to pelvic restriction. The ObGyn proceeded to deliver the baby vaginally using forceps, which caused pelvic floor injuries to the mother.

Several months later, she underwent corrective repair surgery for pelvic floor prolapse. She has continuing vaginal and rectal pain and dysfunction.

PATIENT’S CLAIM A cesarean delivery should have been performed as soon as pelvic restriction was found. The injuries reduce the woman’s chances of having another child.

PHYSICIAN’S DEFENSE A trial of labor was proper. The patient’s continuing fertility problems are related to chronic yeast infections and prescription birth control.

VERDICT A $1,716,469 Illinois verdict was returned, which included $484,000 to the patient’s husband for loss of consortium.

7 CASES OF INJURED BOWEL

1 Woman dies from bowel injury

DURING A SLING PROCEDURE for vaginal prolapse, a 50-year-old woman required a transfusion. The next day, she was nauseated and constipated. A day later, she went to the ED with shortness of breath and chest and abdominal pain. Her symptoms persisted for 8 days before an injury to her transverse colon was found during exploratory surgery. She suffered massive organ failure caused by sepsis and died 3 weeks after the initial surgery.

ESTATE’S CLAIM The gynecologist should have investigated why she needed a transfusion during surgery. He should have reacted earlier to her postsurgical complaints.

PHYSICIAN’S DEFENSE Bowel injury is a known risk of the procedure. The patient suffered multiple strokes after being readmitted to the hospital.

VERDICT A $2.4 million South Carolina verdict was returned.

2 Colostomy, coma after hysterectomy

DUE TO FIBROID TUMORS and pelvic pain, a 39-year-old woman’s ObGyn suggested laparoscopic-assisted vaginal hysterectomy. A third-year resident performed most of the procedure. The ObGyn’s associate covered postsurgical care.

When the patient reported increasing pain and rectal bleeding, an exploratory laparotomy was performed 3 days after surgery. Bowel and ureter injuries were repaired and a permanent colostomy was created. The patient developed septic shock with multiple organ failure, and was placed in a chemically induced coma for 3 weeks, after which she had to relearn to walk, talk, and care for herself.

PATIENT’S CLAIM The ObGyn was negligent in performing the surgery. He failed to obtain consent for the resident’s participation. The associate failed to respond to her declining postoperative condition in a timely manner.

DEFENDANTS’ DEFENSE Surgery was properly performed and postoperative care was appropriate. The bowel injury was a thermal or pressure necrosis that occurred 3 days after surgery. Two different consent forms signed by the patient included notification that a resident might assist; the resident was introduced to the patient prior to surgery. The patient’s injury claims were exaggerated; her future medical bills would be limited to colostomy supplies.

VERDICT A $1,926,069 Texas verdict was returned.

3 Were physicians qualified on robot?

A 48-YEAR-OLD WOMAN UNDERWENT robotic-assisted total hysterectomy and oophorectomy for uterine fibroids and cysts. During surgery, the physicians realized that the sigmoid colon had been perforated. A general surgeon repaired the injury with a loop ileostomy, which was successfully reversed 3 months later. The patient continues to have constipation, with occasional bleeding, pain, and burning.

PATIENT’S CLAIM The risks of robotic surgery were never fully explained to her. Failure to properly visualize her internal organs led to the injury; the extent of damage exceeded what is considered “acceptable risk” of the procedure. The physicians had little experience and training in robotic surgery.

PHYSICIANS’ DEFENSE The case was settled before trial.

VERDICT A $350,000 Massachusetts settlement was reached.

4 Adhesions limit view of bowel

A 76-YEAR-OLD WOMAN UNDERWENT surgical removal of an ovarian cyst. The ObGyn attempted a laparoscopic procedure but converted to laparotomy when extensive adhesions were encountered. The next morning, the patient discovered that her navel was discharging fecal matter. Exploratory surgery determined that the bowel had been perforated. She required additional surgery and had a long recovery.

PATIENT’S CLAIM The ObGyn was negligent in failing to diagnose and treat bowel perforation in a timely manner. An intraoperative bowel inspection should have occurred due to the likelihood of a bowel injury related to the adhesions.

PHYSICIAN’S DEFENSE Adhesions restricted inspection of every area.

VERDICT A $225,000 New York settlement was reached.

5 Skydiver’s ongoing postop pain

AFTER REPORTING DYSMENORRHEA and menometrorrhagia, a 34-year-old woman underwent dilatation and curettage, thermal endometrial ablation, and diagnostic laparoscopy. A day later, she reported increasing pain. The ObGyn’s examination revealed minimal abdominal distension, sluggish bowel sounds, and some guarding, with no rebound tenderness or acute distress. US showed a 3-cm pocket of fluid in the abdomen. Two hours later, an exam revealed a soft abdomen and normal bowel sounds. She was sent home with instructions to return the next day or, if her condition worsened, to go to the ED.

Her husband called the next day to report she was feeling better. The patient woke the following morning with massive distension, worse pain, and severe shortness of breath. At the ED, a CT scan revealed a large amount of abdominal fluid. During emergency laparotomy, an injury was found in the jejunum, necessitating a 3-inch resection.

PATIENT’S CLAIM The ObGyn was negligent in not treating her postoperative symptoms in a more proactive manner. Adhesions developed from peritonitis, leading to chronic abdominal pain. Several operations were required.

PHYSICIAN’S DEFENSE Bowel injury is a known complication of the procedure. There was no indication during surgery or at the office visit that the jejunum was injured. Adhesions were not the cause of the patient’s ongoing pain; very few adhesions were found during subsequent operations. The woman was an avid skydiver who had completed 200 jumps since her initial surgery.

VERDICT An Illinois defense verdict was returned.

6 Bowel injury at laparoscopy

WHEN THE GYNECOLOGIST recognized a bowel injury during laparoscopic salpingectomy, he called a general surgeon, who repaired three areas of bowel. The patient was released 2 days after surgery. She called the gynecologist 2 days later to report fever and vaginal bleeding. She was told to come to the office, but she cancelled when the fever subsided. The next day, she went to the ED, where sepsis was diagnosed. She was flown to another hospital for surgery. A 1-cm small-bowel perforation was found in an area of earlier repair because a suture had been disrupted. A temporary colostomy was reversed 3 months later.

PATIENT’S CLAIM The gynecologist was negligent in performing laparoscopic salpingectomy. The patient should not have been discharged because her white blood cell count and heart rate were elevated.

DEFENDANTS’ DEFENSE Performance of a laparoscopic procedure was proper. Discharge was reasonable, as there was only a potential for complications with no evident problems.

VERDICT An Missouri defense verdict was returned.

7 Was treatment of abscess delayed?

A 49-YEAR-OLD WOMAN with menorrhagia underwent cryoablation. Two weeks later, she went to the ED with pain and constipation. Following CT scans and US, she was found to have a tubo-ovarian abscess. After an enema and subsequent bowel movement, her pain improved. She was discharged with instructions to follow-up with her gynecologist. Six days later, the gynecologist prescribed triple antibiotics, analgesics, and weekly visits for the abscess. Two weeks later, she reported unbearable pain and was sent to the ED. She was found to have a microperforation of the sigmoid colon and multiple gynecologic pathologies, including myomata, right serous cystadenoma, and left tubo-ovarian complex suggestive of endometriosis. Hysterectomy and colostomy were performed; the colostomy was reversed several months later.

PATIENT’S CLAIM She should have been hospitalized when the abscess was found so that the infection could be treated properly. She alleged lack of informed consent for the cryoablation.

PHYSICIAN’S DEFENSE Hospitalization was unnecessary; the patient had initially improved, and the outcome would not have changed with intravenous antibiotics. The patient was fully informed of the risks of the procedure.

VERDICT A Pennsylvania defense verdict was returned.

Undiluted acid used for vulvar surgery

WIDE LOCAL EXCISION was performed on a 42-year-old woman with vulvar intraepithelial neoplasm, VIN II, with moderate dysplasia. Her ObGyn performed the surgery.

Instead of applying a diluted solution of acetic acid wash to delineate the borders of the dysplastic area, a highly concentrated acetic acid or trichloroacetic acid was used. The patient suffered severe chemical burns of the vulva that took several months to heal. She has permanent scarring of the vulvar area, severe tenderness, discoloration, and atrophy of the vaginal opening, with a band of thick scar tissue at the posterior fourchette. The perineum, extending to the anal area, is scarred, including a 2-mm plaque layer.

PATIENT’S CLAIM Sexual intercourse is extremely painful, and therefore impossible. She suffers discomfort at all times. Additional surgery has been recommended to alleviate her condition.

DEFENDANTS’ DEFENSE The case was settled before trial.

VERDICT A $600,000 Ohio settlement was reached.

Large baby with cervical spine injury

A WOMAN WAS IN LABOR with her third child. Her first baby was born by cesarean delivery. During the vaginal birth of her second child, shoulder dystocia was encountered; this child weighed 8 lb 4 oz at birth.

Using ultrasonography, the ObGyn determined vaginal birth was appropriate. Shoulder dystocia was encountered and the infant suffered injuries to the cervical spine and right arm. The newborn weighed 9 lb 13 oz.

PATIENT’S CLAIM The baby’s weight was grossly underestimated prior to delivery; ultrasonography was not properly performed or evaluated. The mother’s history, large fundal height, estimated fetal weight, and the mother’s request for a cesarean delivery should have resulted in the performance of a cesarean delivery.

PHYSICIAN’S DEFENSE Shoulder dystocia was not reasonably foreseeable. Injuries to the baby were due to the forces of labor.

VERDICT A confidential Texas settlement was reached.

Suture causes nerve damage

PELVIC PROLAPSE RECONSTRUCTION was performed; surgery included a pubovaginal sling procedure with graft, and repairs of Grade 2 cystocele and Grade 3 rectocele. The gynecologist used transvaginal sutures to attach the mesh to the sacrospinous ligament.

The patient immediately reported pain, tingling, and weakness in her buttocks and legs. The gynecologist diagnosed a hematoma and continued conservative treatment while waiting for the hematoma to resorb.

After 10 days, the patient terminated the gynecologist’s services and left the hospital. She saw a neurologist, who diagnosed proximal sciatic nerve irritation secondary to suturing. When a suture was removed from the sacral spinous ligament plexus, many of the patient’s neurologic symptoms immediately resolved. She still has pain and walks with a noticeable limp using a cane.

PATIENT’S CLAIM The gynecologist failed to determine that a suture was causing nerve damage. Removal of the suture within the first 3 days would have avoided neurologic injury.

PHYSICIAN’S DEFENSE Postsurgical care was proper. A neurologist was consulted, and a sonogram had ruled out deep vein thrombosis.

VERDICT A $1.58 million Illinois verdict was returned.

Colon damage after embolization

UTERINE FIBROID EMBOLIZATION was performed on a 51-year-old woman. The next day, she reported severe abdominal pain and was readmitted. A uterine infection was suspected, and she underwent a hysterectomy. Necrosis of the colon was found; a surgeon removed one-third of the colon and performed a colostomy. She underwent several operations, including rectal-vaginal fistula repair, before the colostomy was corrected.

PATIENT’S CLAIM Misdirected embolization injured an artery supplying the colon. She continues to suffer ongoing fecal urgency and frequency.

PHYSICIAN’S DEFENSE An anomalous connection between the patient’s uterine artery and mesenteric artery was impossible for the physician to have known prior to the embolization procedure.

VERDICT A California defense verdict was returned.

$1.18 M verdict set aside because of Facebook   postings

SEVERAL HOURS AFTER A WOMAN’S LABOR BEGAN, fetal bradycardia developed precipitously. The on-call ObGyn arrived after 10 minutes and ordered an immediate cesarean delivery, which occurred 22 minutes later. The child suffered a catastrophic, irreversible brain injury. He lived for 39 days before life support was removed and he died.

ESTATE’S CLAIM The nurses did not report decelerations to the ObGyn, and they were slow to notify him of the fetal bradycardia. The child would not have been injured if the nursing staff had reacted appropriately.

DEFENDANTS’ DEFENSE Isolated heart-rate decelerations during labor are not troubling. A cord accident occurred, which could not be predicted nor avoided. The ObGyn was called promptly; the emergency cesarean delivery was performed quickly. However, the injury already had occurred and was irreparable.

VERDICT A $1.18 million Kentucky verdict was returned. The hospital sought a mistrial because Facebook postings by a juror proved the case had been discussed and prejudged. The court found in favor of the hospital on its post-trial motion.

Bilateral mastectomy: nipples not spared

A 46-YEAR-OLD WOMAN UNDERWENT prophylactic bilateral mastectomy. A plastic surgeon drew presurgical markings on the day of surgery; the breast surgeon removed the nipples.

PATIENT’S CLAIM All parties had agreed the nipples would be spared. The plastic surgeon drew improper markings and failed to remind the breast surgeon prior to surgery that the nipples would be preserved.

PHYSICIAN’S DEFENSE The breast surgeon was at fault for misinterpreting the markings.

VERDICT The patient reached a pretrial settlement with the breast surgeon. The case proceeded against the plastic surgeon. A Maryland defense verdict was returned for the plastic surgeon.

Signs of intrauterine growth restriction; stillborn child

AT 24 WEEKS’ GESTATION, a 17-year-old woman who smoked reported spotting. An ultrasound demonstrated significant fetal growth restriction. The mother was hospitalized to assess the spotting; no testing was ordered to assess fetal growth. When blood was not found in the birth canal, she was discharged. During the next month, she saw the ObGyn three times; testing indicated that the fetus was at least 3 weeks behind the stage of pregnancy. The ObGyn did not order additional testing nor consult a specialist. At 31 weeks’ gestation, ultrasonography found no fetal heart tones. The stillborn was delivered by cesarean section.

ESTATE’S CLAIM A wrongful death suit was filed by the parents, who also claimed lack of informed consent concerning the risk of stillbirth in the presence of intrauterine growth restriction.

PHYSICIANS’ DEFENSE The mother’s smoking was mentioned at trial as a possible explanation of why fetal development was delayed. The ObGyn denied negligence.

VERDICT A $800,000 Maryland verdict was awarded to the parents.

Three BrCa patients share $72.6 M

THREE MENOPAUSAL WOMEN took Premarin (conjugated estrogens) plus Provera (medroxyprogesterone), and/or Prempro (conjugated estrogens/medroxyprogesterone acetate). Each discontinued hormone therapy after being diagnosed with hormone-positive breast cancer.

PATIENTS’ CLAIM The only source of hormonal stimulation for their cancer was the use of estrogen plus progestin.

DEFENDANTS’ DEFENSE Science is currently unable to determine precisely what causes breast cancer. Each plaintiff had risk factors.

VERDICT The three cases were consolidated to a reverse-bifurcated trial, with causation and damages assessed first. The Pennsylvania jury found the Wyeth Pharmaceutical products to be factual causes of the patients’ cancer, and awarded a total of $72.6 million in compensatory damages. The parties settled for confidential amounts before the liability phase began.

Undiluted acid used for vulvar surgery

WIDE LOCAL EXCISION was performed on a 42-year-old woman with vulvar intraepithelial neoplasm, VIN II, with moderate dysplasia. Her ObGyn performed the surgery.

Instead of applying a diluted solution of acetic acid wash to delineate the borders of the dysplastic area, a highly concentrated acetic acid or trichloroacetic acid was used. The patient suffered severe chemical burns of the vulva that took several months to heal. She has permanent scarring of the vulvar area, severe tenderness, discoloration, and atrophy of the vaginal opening, with a band of thick scar tissue at the posterior fourchette. The perineum, extending to the anal area, is scarred, including a 2-mm plaque layer.

PATIENT’S CLAIM Sexual intercourse is extremely painful, and therefore impossible. She suffers discomfort at all times. Additional surgery has been recommended to alleviate her condition.

DEFENDANTS’ DEFENSE The case was settled before trial.

VERDICT A $600,000 Ohio settlement was reached.

Large baby with cervical spine injury

A WOMAN WAS IN LABOR with her third child. Her first baby was born by cesarean delivery. During the vaginal birth of her second child, shoulder dystocia was encountered; this child weighed 8 lb 4 oz at birth.

Using ultrasonography, the ObGyn determined vaginal birth was appropriate. Shoulder dystocia was encountered and the infant suffered injuries to the cervical spine and right arm. The newborn weighed 9 lb 13 oz.

PATIENT’S CLAIM The baby’s weight was grossly underestimated prior to delivery; ultrasonography was not properly performed or evaluated. The mother’s history, large fundal height, estimated fetal weight, and the mother’s request for a cesarean delivery should have resulted in the performance of a cesarean delivery.

PHYSICIAN’S DEFENSE Shoulder dystocia was not reasonably foreseeable. Injuries to the baby were due to the forces of labor.

VERDICT A confidential Texas settlement was reached.

Suture causes nerve damage

PELVIC PROLAPSE RECONSTRUCTION was performed; surgery included a pubovaginal sling procedure with graft, and repairs of Grade 2 cystocele and Grade 3 rectocele. The gynecologist used transvaginal sutures to attach the mesh to the sacrospinous ligament.

The patient immediately reported pain, tingling, and weakness in her buttocks and legs. The gynecologist diagnosed a hematoma and continued conservative treatment while waiting for the hematoma to resorb.

After 10 days, the patient terminated the gynecologist’s services and left the hospital. She saw a neurologist, who diagnosed proximal sciatic nerve irritation secondary to suturing. When a suture was removed from the sacral spinous ligament plexus, many of the patient’s neurologic symptoms immediately resolved. She still has pain and walks with a noticeable limp using a cane.

PATIENT’S CLAIM The gynecologist failed to determine that a suture was causing nerve damage. Removal of the suture within the first 3 days would have avoided neurologic injury.

PHYSICIAN’S DEFENSE Postsurgical care was proper. A neurologist was consulted, and a sonogram had ruled out deep vein thrombosis.

VERDICT A $1.58 million Illinois verdict was returned.

Colon damage after embolization

UTERINE FIBROID EMBOLIZATION was performed on a 51-year-old woman. The next day, she reported severe abdominal pain and was readmitted. A uterine infection was suspected, and she underwent a hysterectomy. Necrosis of the colon was found; a surgeon removed one-third of the colon and performed a colostomy. She underwent several operations, including rectal-vaginal fistula repair, before the colostomy was corrected.

PATIENT’S CLAIM Misdirected embolization injured an artery supplying the colon. She continues to suffer ongoing fecal urgency and frequency.

PHYSICIAN’S DEFENSE An anomalous connection between the patient’s uterine artery and mesenteric artery was impossible for the physician to have known prior to the embolization procedure.

VERDICT A California defense verdict was returned.

$1.18 M verdict set aside because of Facebook   postings

SEVERAL HOURS AFTER A WOMAN’S LABOR BEGAN, fetal bradycardia developed precipitously. The on-call ObGyn arrived after 10 minutes and ordered an immediate cesarean delivery, which occurred 22 minutes later. The child suffered a catastrophic, irreversible brain injury. He lived for 39 days before life support was removed and he died.

ESTATE’S CLAIM The nurses did not report decelerations to the ObGyn, and they were slow to notify him of the fetal bradycardia. The child would not have been injured if the nursing staff had reacted appropriately.

DEFENDANTS’ DEFENSE Isolated heart-rate decelerations during labor are not troubling. A cord accident occurred, which could not be predicted nor avoided. The ObGyn was called promptly; the emergency cesarean delivery was performed quickly. However, the injury already had occurred and was irreparable.

VERDICT A $1.18 million Kentucky verdict was returned. The hospital sought a mistrial because Facebook postings by a juror proved the case had been discussed and prejudged. The court found in favor of the hospital on its post-trial motion.

Bilateral mastectomy: nipples not spared

A 46-YEAR-OLD WOMAN UNDERWENT prophylactic bilateral mastectomy. A plastic surgeon drew presurgical markings on the day of surgery; the breast surgeon removed the nipples.

PATIENT’S CLAIM All parties had agreed the nipples would be spared. The plastic surgeon drew improper markings and failed to remind the breast surgeon prior to surgery that the nipples would be preserved.

PHYSICIAN’S DEFENSE The breast surgeon was at fault for misinterpreting the markings.

VERDICT The patient reached a pretrial settlement with the breast surgeon. The case proceeded against the plastic surgeon. A Maryland defense verdict was returned for the plastic surgeon.

Signs of intrauterine growth restriction; stillborn child

AT 24 WEEKS’ GESTATION, a 17-year-old woman who smoked reported spotting. An ultrasound demonstrated significant fetal growth restriction. The mother was hospitalized to assess the spotting; no testing was ordered to assess fetal growth. When blood was not found in the birth canal, she was discharged. During the next month, she saw the ObGyn three times; testing indicated that the fetus was at least 3 weeks behind the stage of pregnancy. The ObGyn did not order additional testing nor consult a specialist. At 31 weeks’ gestation, ultrasonography found no fetal heart tones. The stillborn was delivered by cesarean section.

ESTATE’S CLAIM A wrongful death suit was filed by the parents, who also claimed lack of informed consent concerning the risk of stillbirth in the presence of intrauterine growth restriction.

PHYSICIANS’ DEFENSE The mother’s smoking was mentioned at trial as a possible explanation of why fetal development was delayed. The ObGyn denied negligence.

VERDICT A $800,000 Maryland verdict was awarded to the parents.

Three BrCa patients share $72.6 M

THREE MENOPAUSAL WOMEN took Premarin (conjugated estrogens) plus Provera (medroxyprogesterone), and/or Prempro (conjugated estrogens/medroxyprogesterone acetate). Each discontinued hormone therapy after being diagnosed with hormone-positive breast cancer.

PATIENTS’ CLAIM The only source of hormonal stimulation for their cancer was the use of estrogen plus progestin.

DEFENDANTS’ DEFENSE Science is currently unable to determine precisely what causes breast cancer. Each plaintiff had risk factors.

VERDICT The three cases were consolidated to a reverse-bifurcated trial, with causation and damages assessed first. The Pennsylvania jury found the Wyeth Pharmaceutical products to be factual causes of the patients’ cancer, and awarded a total of $72.6 million in compensatory damages. The parties settled for confidential amounts before the liability phase began.

Undiluted acid used for vulvar surgery

WIDE LOCAL EXCISION was performed on a 42-year-old woman with vulvar intraepithelial neoplasm, VIN II, with moderate dysplasia. Her ObGyn performed the surgery.

Instead of applying a diluted solution of acetic acid wash to delineate the borders of the dysplastic area, a highly concentrated acetic acid or trichloroacetic acid was used. The patient suffered severe chemical burns of the vulva that took several months to heal. She has permanent scarring of the vulvar area, severe tenderness, discoloration, and atrophy of the vaginal opening, with a band of thick scar tissue at the posterior fourchette. The perineum, extending to the anal area, is scarred, including a 2-mm plaque layer.

PATIENT’S CLAIM Sexual intercourse is extremely painful, and therefore impossible. She suffers discomfort at all times. Additional surgery has been recommended to alleviate her condition.

DEFENDANTS’ DEFENSE The case was settled before trial.

VERDICT A $600,000 Ohio settlement was reached.

Large baby with cervical spine injury

A WOMAN WAS IN LABOR with her third child. Her first baby was born by cesarean delivery. During the vaginal birth of her second child, shoulder dystocia was encountered; this child weighed 8 lb 4 oz at birth.

Using ultrasonography, the ObGyn determined vaginal birth was appropriate. Shoulder dystocia was encountered and the infant suffered injuries to the cervical spine and right arm. The newborn weighed 9 lb 13 oz.

PATIENT’S CLAIM The baby’s weight was grossly underestimated prior to delivery; ultrasonography was not properly performed or evaluated. The mother’s history, large fundal height, estimated fetal weight, and the mother’s request for a cesarean delivery should have resulted in the performance of a cesarean delivery.

PHYSICIAN’S DEFENSE Shoulder dystocia was not reasonably foreseeable. Injuries to the baby were due to the forces of labor.

VERDICT A confidential Texas settlement was reached.

Suture causes nerve damage

PELVIC PROLAPSE RECONSTRUCTION was performed; surgery included a pubovaginal sling procedure with graft, and repairs of Grade 2 cystocele and Grade 3 rectocele. The gynecologist used transvaginal sutures to attach the mesh to the sacrospinous ligament.

The patient immediately reported pain, tingling, and weakness in her buttocks and legs. The gynecologist diagnosed a hematoma and continued conservative treatment while waiting for the hematoma to resorb.

After 10 days, the patient terminated the gynecologist’s services and left the hospital. She saw a neurologist, who diagnosed proximal sciatic nerve irritation secondary to suturing. When a suture was removed from the sacral spinous ligament plexus, many of the patient’s neurologic symptoms immediately resolved. She still has pain and walks with a noticeable limp using a cane.

PATIENT’S CLAIM The gynecologist failed to determine that a suture was causing nerve damage. Removal of the suture within the first 3 days would have avoided neurologic injury.

PHYSICIAN’S DEFENSE Postsurgical care was proper. A neurologist was consulted, and a sonogram had ruled out deep vein thrombosis.

VERDICT A $1.58 million Illinois verdict was returned.

Colon damage after embolization

UTERINE FIBROID EMBOLIZATION was performed on a 51-year-old woman. The next day, she reported severe abdominal pain and was readmitted. A uterine infection was suspected, and she underwent a hysterectomy. Necrosis of the colon was found; a surgeon removed one-third of the colon and performed a colostomy. She underwent several operations, including rectal-vaginal fistula repair, before the colostomy was corrected.

PATIENT’S CLAIM Misdirected embolization injured an artery supplying the colon. She continues to suffer ongoing fecal urgency and frequency.

PHYSICIAN’S DEFENSE An anomalous connection between the patient’s uterine artery and mesenteric artery was impossible for the physician to have known prior to the embolization procedure.

VERDICT A California defense verdict was returned.

$1.18 M verdict set aside because of Facebook   postings

SEVERAL HOURS AFTER A WOMAN’S LABOR BEGAN, fetal bradycardia developed precipitously. The on-call ObGyn arrived after 10 minutes and ordered an immediate cesarean delivery, which occurred 22 minutes later. The child suffered a catastrophic, irreversible brain injury. He lived for 39 days before life support was removed and he died.

ESTATE’S CLAIM The nurses did not report decelerations to the ObGyn, and they were slow to notify him of the fetal bradycardia. The child would not have been injured if the nursing staff had reacted appropriately.

DEFENDANTS’ DEFENSE Isolated heart-rate decelerations during labor are not troubling. A cord accident occurred, which could not be predicted nor avoided. The ObGyn was called promptly; the emergency cesarean delivery was performed quickly. However, the injury already had occurred and was irreparable.

VERDICT A $1.18 million Kentucky verdict was returned. The hospital sought a mistrial because Facebook postings by a juror proved the case had been discussed and prejudged. The court found in favor of the hospital on its post-trial motion.

Bilateral mastectomy: nipples not spared

A 46-YEAR-OLD WOMAN UNDERWENT prophylactic bilateral mastectomy. A plastic surgeon drew presurgical markings on the day of surgery; the breast surgeon removed the nipples.

PATIENT’S CLAIM All parties had agreed the nipples would be spared. The plastic surgeon drew improper markings and failed to remind the breast surgeon prior to surgery that the nipples would be preserved.

PHYSICIAN’S DEFENSE The breast surgeon was at fault for misinterpreting the markings.

VERDICT The patient reached a pretrial settlement with the breast surgeon. The case proceeded against the plastic surgeon. A Maryland defense verdict was returned for the plastic surgeon.

Signs of intrauterine growth restriction; stillborn child

AT 24 WEEKS’ GESTATION, a 17-year-old woman who smoked reported spotting. An ultrasound demonstrated significant fetal growth restriction. The mother was hospitalized to assess the spotting; no testing was ordered to assess fetal growth. When blood was not found in the birth canal, she was discharged. During the next month, she saw the ObGyn three times; testing indicated that the fetus was at least 3 weeks behind the stage of pregnancy. The ObGyn did not order additional testing nor consult a specialist. At 31 weeks’ gestation, ultrasonography found no fetal heart tones. The stillborn was delivered by cesarean section.

ESTATE’S CLAIM A wrongful death suit was filed by the parents, who also claimed lack of informed consent concerning the risk of stillbirth in the presence of intrauterine growth restriction.

PHYSICIANS’ DEFENSE The mother’s smoking was mentioned at trial as a possible explanation of why fetal development was delayed. The ObGyn denied negligence.

VERDICT A $800,000 Maryland verdict was awarded to the parents.

Three BrCa patients share $72.6 M

THREE MENOPAUSAL WOMEN took Premarin (conjugated estrogens) plus Provera (medroxyprogesterone), and/or Prempro (conjugated estrogens/medroxyprogesterone acetate). Each discontinued hormone therapy after being diagnosed with hormone-positive breast cancer.

PATIENTS’ CLAIM The only source of hormonal stimulation for their cancer was the use of estrogen plus progestin.

DEFENDANTS’ DEFENSE Science is currently unable to determine precisely what causes breast cancer. Each plaintiff had risk factors.

VERDICT The three cases were consolidated to a reverse-bifurcated trial, with causation and damages assessed first. The Pennsylvania jury found the Wyeth Pharmaceutical products to be factual causes of the patients’ cancer, and awarded a total of $72.6 million in compensatory damages. The parties settled for confidential amounts before the liability phase began.

Discuss this article at www.facebook.com/CurrentPsychiatry

Dear Dr. Mossman:
Could providing a “curbside” consultation to a colleague leave me medico legally vulnerable if an adverse event leads to a malpractice lawsuit? If so, what can I do to address this risk?—Submitted by “Dr. W”

Medicine is a collaborative profession. Surgeons often combine skills to perform complex operations together, and specialists pool their expertise when they collectively manage patients with several medical problems. Doctors share their knowledge when they give lectures to medical audiences, write reports to referring physicians, or respond verbally to colleagues’ requests for information or advice.¹

Doctors use the phrase “curbside consult” to refer (with humor and self-deprecation) to informal conversations with colleagues about patients’ medical management—advice-seeking that falls short of asking a colleague to make recommendations based on a formal, personal examination. Many physicians seek or provide curbside advice several times a month.² Curbside consults transmit knowledge and cement professional bonds among physicians, making them “an integral part of our medical culture.”³

More than a dozen legal decisions mention curbside consultations. Judges think informal information-sharing improves medical practice and don’t want doctors to stop soliciting ideas or offering suggestions because they fear lawsuits.^4,5 However, courts have found that, under certain conditions, giving advice can create liability for a bad outcome, even though the doctor never met the patient who was harmed.

In this article, we’ll look at:

• when such liability might occur, and
• what you can do to minimize it.

A doctor-patient relationship?

Legally, doctors are obligated to provide competent care for just 1 group of people: their patients. Therefore, to decide if plaintiffs could pursue malpractice claims in cases where doctors offered comments about patients they did not personally examine, courts have asked whether the circumstances, actions undertaken, or nature of information that was exchanged created a professional relationship.

Reynolds v Decatur Memorial Hospital⁴ describes an informal consultation that did not create a physician-patient relationship. In this case, a boy was admitted to a hospital after he had fallen. The treating pediatrician telephoned a neurosurgeon, who asked whether the boy’s neck was stiff, discussed diagnostic possibilities with the pediatrician, and suggested doing a lumbar puncture. The neurosurgeon offered to see the boy if requested, but he never did, and he did not bill for the telephone consultation. Guillain-Barré syndrome was first suspected, but a spinal cord injury was discovered after the boy—who developed quadriplegia—was transferred to another hospital.

In a subsequent lawsuit, the boy’s mother claimed her son’s paralysis resulted from negligence by the first hospital and its doctors, but the trial court dismissed the case against the neurosurgeon. Affirming the trial court’s ruling, an Illinois appeals court explained that the neurosurgeon had not been asked to provide medical services, conduct tests, or interpret test results. “A doctor who gives an informal opinion at the request of a treating physician does not owe a duty of care to the patient whose case was discussed,” the Reynolds court said.

Campbell v Haber⁶ describes circumstances that differed slightly from those described in the Reynolds decision but appeared to create a doctor-patient relationship. Campbell concerned a patient who came to an emergency room (ER) complaining of chest pain. The ER physician’s findings indicated possible heart muscle damage, so he telephoned a cardiologist (whom the ER doctor believed was “on call”) and described the patient’s symptoms and test results. The cardiologist thought the test results were not consistent with a cardiac event. The ER physician told the patient and his wife about the cardiologist’s opinion and, relying on what the cardiologist said, discharged the patient. Shortly after, the patient had a heart attack.

The patient sued not just the ER physician, but the cardiologist, who sought dismissal from the suit because he never saw the patient, had no treatment relationship with him, and never billed for services. However, the trial judge ruled that the patient could sue the cardiologist and the appellate court agreed, saying that a jury had to decide whether the cardiologist had incurred a doctor-patient relationship and might be liable. “An implied physician-patient relationship may arise when a physician gives advice to a patient,” the appeals court said, “even if that advice is communicated through another health care professional.”

Telling the difference

So what differentiates a no-liability curbside consult from a medical discussion that creates a doctor-patient duty and potential for liability for adverse results?

You create a physician-patient relationship when you assume responsibility to diagnose or treat someone.⁷ Although typically this requires an in-person encounter with a patient, it can happen indirectly—electronically (through e-mail), by telephone, or through a family member or another professional. But if you do nothing that implies consent to act for the patient’s benefit, you should have no actual malpractice liability if something goes wrong.^3,8 As a Kansas Supreme Court decision explains, you “cannot be liable for medical malpractice” if you “merely consult with a treating physician and [do] nothing more.”⁵

Several legal cases discuss doctors’ efforts to extricate themselves from lawsuits arising from clinical encounters that the doctors mistakenly thought were just curbside consults. Table 1^8-12 lists situations in which talking about patients goes beyond just being “curbsided.”

Table 1

When it’s not a ‘curbside consultation’

How to respond

Should you decline to provide curbside consultations to keep yourself out of lawsuits? Some authors think so, pointing out that informally transmitted clinical data may be faulty, which means you may give bad advice based on incomplete information or a verbal misunderstanding.^13-16 These authors suggest that if you’re curbsided you should ask to see the patient for a formal consultation, decline to give informal advice, or provide a response that lacks specifics.

Other authors feel that these approaches are needlessly cautious and would harm patients by impeding doctors’ ability to help and learn from each other.^3,17 These authors think the risk of incurring liability from a curbside consult is low. Also, getting advice from a colleague is a valuable risk management strategy; it helps you make sure you’re on the right track, and it shows you are a thoughtful clinician whose patients benefit from your own and your colleagues’ medical expertise.

Even if you’re comfortable soliciting and providing curbside advice, sometimes circumstances make it wise to follow-up an informal initial inquiry with a formal consultation. Table 2^3,17 lists examples of when you should follow-up with a formal consultation.

Table 2

Considerations that favor formal consultation

Documentation

Experts disagree about whether the requesting or receiving physician should document a curbside consultation, and if so, how. On one hand, making a notation in a patient’s record documents the treating doctor’s diligence and may provide a measure of liability protection in a malpractice action. Doing this, however, exposes the identity of the consultant, who might be named among the defendants in a lawsuit.

One commonly recommended strategy is to request the consultant’s permission before identifying him or her in the record,^13,16,17 a position that is defensible on grounds of courtesy alone. But omitting a consultant’s name from record does not guarantee that the consultant’s involvement won’t be discovered in the course of litigation.³ For example, treating doctors who get sued often are asked during their depositions about whether they talked with anyone about the case, and they have to answer honestly.

If a consulted doctor makes written notes, it might suggest that the consultation was more than the sort of informal information-sharing implied by the term “curbside.” However, in the unlikely event that a lawsuit arose and included the consultant as a defendant, documentation of advice given would help the consultant recall and defend what was said.

Related Resources

• Grant-Kels JM, Kels BD. The curbside consultation: legal, moral, and ethical considerations. J Am Acad Dermatol. 2012;66(5):827-829.
• Kreichelt R, Hilbert ML, Shinn D. Minimizing the legal risk with ‘curbside’ consultation. J Healthc Risk Manag. 2008;28(1):27-29.
• Atkinson L. Curbside consults: what is your liability risk? Iowa Med. 2003;93(4):15.

Disclosure

Dr. Mossman reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

Dear Dr. Mossman:
Could providing a “curbside” consultation to a colleague leave me medico legally vulnerable if an adverse event leads to a malpractice lawsuit? If so, what can I do to address this risk?—Submitted by “Dr. W”

Medicine is a collaborative profession. Surgeons often combine skills to perform complex operations together, and specialists pool their expertise when they collectively manage patients with several medical problems. Doctors share their knowledge when they give lectures to medical audiences, write reports to referring physicians, or respond verbally to colleagues’ requests for information or advice.¹

Doctors use the phrase “curbside consult” to refer (with humor and self-deprecation) to informal conversations with colleagues about patients’ medical management—advice-seeking that falls short of asking a colleague to make recommendations based on a formal, personal examination. Many physicians seek or provide curbside advice several times a month.² Curbside consults transmit knowledge and cement professional bonds among physicians, making them “an integral part of our medical culture.”³

More than a dozen legal decisions mention curbside consultations. Judges think informal information-sharing improves medical practice and don’t want doctors to stop soliciting ideas or offering suggestions because they fear lawsuits.^4,5 However, courts have found that, under certain conditions, giving advice can create liability for a bad outcome, even though the doctor never met the patient who was harmed.

In this article, we’ll look at:

• when such liability might occur, and
• what you can do to minimize it.

A doctor-patient relationship?

Legally, doctors are obligated to provide competent care for just 1 group of people: their patients. Therefore, to decide if plaintiffs could pursue malpractice claims in cases where doctors offered comments about patients they did not personally examine, courts have asked whether the circumstances, actions undertaken, or nature of information that was exchanged created a professional relationship.

Reynolds v Decatur Memorial Hospital⁴ describes an informal consultation that did not create a physician-patient relationship. In this case, a boy was admitted to a hospital after he had fallen. The treating pediatrician telephoned a neurosurgeon, who asked whether the boy’s neck was stiff, discussed diagnostic possibilities with the pediatrician, and suggested doing a lumbar puncture. The neurosurgeon offered to see the boy if requested, but he never did, and he did not bill for the telephone consultation. Guillain-Barré syndrome was first suspected, but a spinal cord injury was discovered after the boy—who developed quadriplegia—was transferred to another hospital.

In a subsequent lawsuit, the boy’s mother claimed her son’s paralysis resulted from negligence by the first hospital and its doctors, but the trial court dismissed the case against the neurosurgeon. Affirming the trial court’s ruling, an Illinois appeals court explained that the neurosurgeon had not been asked to provide medical services, conduct tests, or interpret test results. “A doctor who gives an informal opinion at the request of a treating physician does not owe a duty of care to the patient whose case was discussed,” the Reynolds court said.

Campbell v Haber⁶ describes circumstances that differed slightly from those described in the Reynolds decision but appeared to create a doctor-patient relationship. Campbell concerned a patient who came to an emergency room (ER) complaining of chest pain. The ER physician’s findings indicated possible heart muscle damage, so he telephoned a cardiologist (whom the ER doctor believed was “on call”) and described the patient’s symptoms and test results. The cardiologist thought the test results were not consistent with a cardiac event. The ER physician told the patient and his wife about the cardiologist’s opinion and, relying on what the cardiologist said, discharged the patient. Shortly after, the patient had a heart attack.

The patient sued not just the ER physician, but the cardiologist, who sought dismissal from the suit because he never saw the patient, had no treatment relationship with him, and never billed for services. However, the trial judge ruled that the patient could sue the cardiologist and the appellate court agreed, saying that a jury had to decide whether the cardiologist had incurred a doctor-patient relationship and might be liable. “An implied physician-patient relationship may arise when a physician gives advice to a patient,” the appeals court said, “even if that advice is communicated through another health care professional.”

Telling the difference

So what differentiates a no-liability curbside consult from a medical discussion that creates a doctor-patient duty and potential for liability for adverse results?

You create a physician-patient relationship when you assume responsibility to diagnose or treat someone.⁷ Although typically this requires an in-person encounter with a patient, it can happen indirectly—electronically (through e-mail), by telephone, or through a family member or another professional. But if you do nothing that implies consent to act for the patient’s benefit, you should have no actual malpractice liability if something goes wrong.^3,8 As a Kansas Supreme Court decision explains, you “cannot be liable for medical malpractice” if you “merely consult with a treating physician and [do] nothing more.”⁵

Several legal cases discuss doctors’ efforts to extricate themselves from lawsuits arising from clinical encounters that the doctors mistakenly thought were just curbside consults. Table 1^8-12 lists situations in which talking about patients goes beyond just being “curbsided.”

Table 1

When it’s not a ‘curbside consultation’

How to respond

Should you decline to provide curbside consultations to keep yourself out of lawsuits? Some authors think so, pointing out that informally transmitted clinical data may be faulty, which means you may give bad advice based on incomplete information or a verbal misunderstanding.^13-16 These authors suggest that if you’re curbsided you should ask to see the patient for a formal consultation, decline to give informal advice, or provide a response that lacks specifics.

Other authors feel that these approaches are needlessly cautious and would harm patients by impeding doctors’ ability to help and learn from each other.^3,17 These authors think the risk of incurring liability from a curbside consult is low. Also, getting advice from a colleague is a valuable risk management strategy; it helps you make sure you’re on the right track, and it shows you are a thoughtful clinician whose patients benefit from your own and your colleagues’ medical expertise.

Even if you’re comfortable soliciting and providing curbside advice, sometimes circumstances make it wise to follow-up an informal initial inquiry with a formal consultation. Table 2^3,17 lists examples of when you should follow-up with a formal consultation.

Table 2

Considerations that favor formal consultation

Documentation

Experts disagree about whether the requesting or receiving physician should document a curbside consultation, and if so, how. On one hand, making a notation in a patient’s record documents the treating doctor’s diligence and may provide a measure of liability protection in a malpractice action. Doing this, however, exposes the identity of the consultant, who might be named among the defendants in a lawsuit.

One commonly recommended strategy is to request the consultant’s permission before identifying him or her in the record,^13,16,17 a position that is defensible on grounds of courtesy alone. But omitting a consultant’s name from record does not guarantee that the consultant’s involvement won’t be discovered in the course of litigation.³ For example, treating doctors who get sued often are asked during their depositions about whether they talked with anyone about the case, and they have to answer honestly.

If a consulted doctor makes written notes, it might suggest that the consultation was more than the sort of informal information-sharing implied by the term “curbside.” However, in the unlikely event that a lawsuit arose and included the consultant as a defendant, documentation of advice given would help the consultant recall and defend what was said.

Related Resources

• Grant-Kels JM, Kels BD. The curbside consultation: legal, moral, and ethical considerations. J Am Acad Dermatol. 2012;66(5):827-829.
• Kreichelt R, Hilbert ML, Shinn D. Minimizing the legal risk with ‘curbside’ consultation. J Healthc Risk Manag. 2008;28(1):27-29.
• Atkinson L. Curbside consults: what is your liability risk? Iowa Med. 2003;93(4):15.

Disclosure

Dr. Mossman reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

Dear Dr. Mossman:
Could providing a “curbside” consultation to a colleague leave me medico legally vulnerable if an adverse event leads to a malpractice lawsuit? If so, what can I do to address this risk?—Submitted by “Dr. W”

Medicine is a collaborative profession. Surgeons often combine skills to perform complex operations together, and specialists pool their expertise when they collectively manage patients with several medical problems. Doctors share their knowledge when they give lectures to medical audiences, write reports to referring physicians, or respond verbally to colleagues’ requests for information or advice.¹

Doctors use the phrase “curbside consult” to refer (with humor and self-deprecation) to informal conversations with colleagues about patients’ medical management—advice-seeking that falls short of asking a colleague to make recommendations based on a formal, personal examination. Many physicians seek or provide curbside advice several times a month.² Curbside consults transmit knowledge and cement professional bonds among physicians, making them “an integral part of our medical culture.”³

More than a dozen legal decisions mention curbside consultations. Judges think informal information-sharing improves medical practice and don’t want doctors to stop soliciting ideas or offering suggestions because they fear lawsuits.^4,5 However, courts have found that, under certain conditions, giving advice can create liability for a bad outcome, even though the doctor never met the patient who was harmed.

In this article, we’ll look at:

• when such liability might occur, and
• what you can do to minimize it.

A doctor-patient relationship?

Legally, doctors are obligated to provide competent care for just 1 group of people: their patients. Therefore, to decide if plaintiffs could pursue malpractice claims in cases where doctors offered comments about patients they did not personally examine, courts have asked whether the circumstances, actions undertaken, or nature of information that was exchanged created a professional relationship.

Reynolds v Decatur Memorial Hospital⁴ describes an informal consultation that did not create a physician-patient relationship. In this case, a boy was admitted to a hospital after he had fallen. The treating pediatrician telephoned a neurosurgeon, who asked whether the boy’s neck was stiff, discussed diagnostic possibilities with the pediatrician, and suggested doing a lumbar puncture. The neurosurgeon offered to see the boy if requested, but he never did, and he did not bill for the telephone consultation. Guillain-Barré syndrome was first suspected, but a spinal cord injury was discovered after the boy—who developed quadriplegia—was transferred to another hospital.

In a subsequent lawsuit, the boy’s mother claimed her son’s paralysis resulted from negligence by the first hospital and its doctors, but the trial court dismissed the case against the neurosurgeon. Affirming the trial court’s ruling, an Illinois appeals court explained that the neurosurgeon had not been asked to provide medical services, conduct tests, or interpret test results. “A doctor who gives an informal opinion at the request of a treating physician does not owe a duty of care to the patient whose case was discussed,” the Reynolds court said.

Campbell v Haber⁶ describes circumstances that differed slightly from those described in the Reynolds decision but appeared to create a doctor-patient relationship. Campbell concerned a patient who came to an emergency room (ER) complaining of chest pain. The ER physician’s findings indicated possible heart muscle damage, so he telephoned a cardiologist (whom the ER doctor believed was “on call”) and described the patient’s symptoms and test results. The cardiologist thought the test results were not consistent with a cardiac event. The ER physician told the patient and his wife about the cardiologist’s opinion and, relying on what the cardiologist said, discharged the patient. Shortly after, the patient had a heart attack.

The patient sued not just the ER physician, but the cardiologist, who sought dismissal from the suit because he never saw the patient, had no treatment relationship with him, and never billed for services. However, the trial judge ruled that the patient could sue the cardiologist and the appellate court agreed, saying that a jury had to decide whether the cardiologist had incurred a doctor-patient relationship and might be liable. “An implied physician-patient relationship may arise when a physician gives advice to a patient,” the appeals court said, “even if that advice is communicated through another health care professional.”

Telling the difference

So what differentiates a no-liability curbside consult from a medical discussion that creates a doctor-patient duty and potential for liability for adverse results?

You create a physician-patient relationship when you assume responsibility to diagnose or treat someone.⁷ Although typically this requires an in-person encounter with a patient, it can happen indirectly—electronically (through e-mail), by telephone, or through a family member or another professional. But if you do nothing that implies consent to act for the patient’s benefit, you should have no actual malpractice liability if something goes wrong.^3,8 As a Kansas Supreme Court decision explains, you “cannot be liable for medical malpractice” if you “merely consult with a treating physician and [do] nothing more.”⁵

Several legal cases discuss doctors’ efforts to extricate themselves from lawsuits arising from clinical encounters that the doctors mistakenly thought were just curbside consults. Table 1^8-12 lists situations in which talking about patients goes beyond just being “curbsided.”

Table 1

When it’s not a ‘curbside consultation’

How to respond

Should you decline to provide curbside consultations to keep yourself out of lawsuits? Some authors think so, pointing out that informally transmitted clinical data may be faulty, which means you may give bad advice based on incomplete information or a verbal misunderstanding.^13-16 These authors suggest that if you’re curbsided you should ask to see the patient for a formal consultation, decline to give informal advice, or provide a response that lacks specifics.

Other authors feel that these approaches are needlessly cautious and would harm patients by impeding doctors’ ability to help and learn from each other.^3,17 These authors think the risk of incurring liability from a curbside consult is low. Also, getting advice from a colleague is a valuable risk management strategy; it helps you make sure you’re on the right track, and it shows you are a thoughtful clinician whose patients benefit from your own and your colleagues’ medical expertise.

Even if you’re comfortable soliciting and providing curbside advice, sometimes circumstances make it wise to follow-up an informal initial inquiry with a formal consultation. Table 2^3,17 lists examples of when you should follow-up with a formal consultation.

Table 2

Considerations that favor formal consultation

Documentation

Experts disagree about whether the requesting or receiving physician should document a curbside consultation, and if so, how. On one hand, making a notation in a patient’s record documents the treating doctor’s diligence and may provide a measure of liability protection in a malpractice action. Doing this, however, exposes the identity of the consultant, who might be named among the defendants in a lawsuit.

One commonly recommended strategy is to request the consultant’s permission before identifying him or her in the record,^13,16,17 a position that is defensible on grounds of courtesy alone. But omitting a consultant’s name from record does not guarantee that the consultant’s involvement won’t be discovered in the course of litigation.³ For example, treating doctors who get sued often are asked during their depositions about whether they talked with anyone about the case, and they have to answer honestly.

If a consulted doctor makes written notes, it might suggest that the consultation was more than the sort of informal information-sharing implied by the term “curbside.” However, in the unlikely event that a lawsuit arose and included the consultant as a defendant, documentation of advice given would help the consultant recall and defend what was said.

Related Resources

• Grant-Kels JM, Kels BD. The curbside consultation: legal, moral, and ethical considerations. J Am Acad Dermatol. 2012;66(5):827-829.
• Kreichelt R, Hilbert ML, Shinn D. Minimizing the legal risk with ‘curbside’ consultation. J Healthc Risk Manag. 2008;28(1):27-29.
• Atkinson L. Curbside consults: what is your liability risk? Iowa Med. 2003;93(4):15.

Disclosure

Dr. Mossman reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Initial trophic feedings effective for patients with acute lung injury
2. IM vs. IV benzodiazepines in status epilepticus
3. CDI risk following antibiotic cessation
4. Acid suppression associated with increased complications in CDI patients
5. Perioperative statins and cardiac events in surgical patients
6. Enoxaparin vs. unfractionated heparin during PCI
7. Optimal serum potassium levels for AMI patients
8. PPIs superior to H2-blockers for lowering UGI bleeding following ACS and STEMI

Initial Lower-Volume Enteral Feeding Better Tolerated, but Has No Mortality Benefit

Clinical question: In mechanically ventilated patients with acute lung injury, do initial lower-volume enteral feedings (trophic feedings) improve clinical outcomes when compared with full enteral feedings?

Background: Malnutrition in critically ill patients is associated with poor outcomes, but conflicting data exist regarding the best timing, amount, and formulation of enteral nutrition to initiate. Initiation of lower-volume enteral feeding with periodic assessment of gastric residual volume is common practice, but the effects of this practice are unknown.

Study design: Multicenter randomized controlled open-label study.

Setting: Forty-four hospitals in the National Heart, Lung, and Blood Institute (NHLBI) Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network.

Synopsis: One thousand patients with acute lung injury receiving mechanical ventilation for longer than 72 hours were randomized using a Web-based system to receive either trophic or full enteric feedings for the first six days of mechanical ventilation. After the sixth day, a full enteric feeding protocol was used in all patients. All analyses were by intention-to-treat.

There was no significant difference between the trophic and full enteral feeding groups with regard to the primary outcome of ventilator-free days through Day 28 (14.9% vs. 15.0%, P=0.89). There were also no significant differences between groups in secondary outcomes, which included 60-day mortality, ICU-free days, organ-failure-free days, or the incidence of new infections. However, gastrointestinal intolerances occurred less often in the trophic feeding group, and these patients received fewer anti-diarrheal and prokinetic agents. The full feeding group gained 2.1 liters of fluid by Day 7, but this fluid gain did not cause significant differences in measures of circulatory or pulmonary physiology.

Limitations include open-label study design and inclusion of only critically ill adult medical patients with acute lung injury.

Bottom line: Initial lower-volume tube feedings in mechanically ventilated patients with acute lung injury did not improve clinical outcomes compared with full enteral feedings, but they were associated with fewer instances of gastrointestinal intolerance.

Citation: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012;307:795-803.

Intramuscular Benzodiazepines as Good as IV Benzodiazepines in Status Epilepticus

Clinical question: Is intramuscular (IM) midazolam noninferior to intravenous lorazepam in patients in status epilepticus?

Background: Studies have shown that IV benzodiazepines, particularly lorazepam, are effective for patients in status epilepticus. Studies have not evaluated IM benzodiazepines. However, many emergency medical service (EMS) agencies use IM midazolam because IM administration is easier than IV administration, and midazolam has a longer nonrefrigerated shelf life than lorazepam does.

Study design: Randomized, double-blinded clinical trial.

Setting: Thirty-three EMS agencies across the United States.

Synopsis: Based on the 893 adults and children in status epilepticus included in this double-blind study, the researchers found IM midazolam to be noninferior to, and in fact superior to, IV lorazepam for treating seizures prior to arrival at EDs. Specifically, they found 10% more (95% CI 4.0% to 16.1%; P<0.001 for noninferiority and P<0.001 for superiority) seizure-free patients arriving at EDs when IM midazolam was administered. Seizures ceased in patients given IM midazolam in less time on average than it took for paramedics to administer IV lorazepam.

Hospitalists might be less inclined than EMS personnel to use IM midazolam because their patients have established IV access and refrigerated drugs are readily available. However, since IM midazolam was superior to IV lorazepam in this prehospital study, a similar trial in hospitalized patients is warranted. In subsequent trials, it would be useful to administer both midazolam and lorazepam via IM and IV routes, and IM injections by an autoinjector could be compared with the conventional manner.

Bottom line: In the prehospital setting, IM midazolam is at least as good as IV lorazepam in treating status epilepticus in children and adults.

Citation: Silbergleit R, Durkalski V, Lowenstein D, et al. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med. 2012;366:591-600.

Clostridium Difficile Infection Risk Remains High at Least Three Months after Antibiotics Are Stopped

Clinical question: How long are patients at higher risk for Clostridium difficile infection (CDI) after completing antibiotics?

Background: Studies have shown that patients given antibiotics are at higher risk for CDI than those who are not, particularly if they take multiple antibiotics at high doses for a prolonged period of time. However, it is not known how long a patient remains at high risk for CDI after completing antibiotic therapy.

Study design: Case-control study.

Setting: Nine hospitals in Netherlands.

Synopsis: The study compared 337 hospitalized patients who had CDI with 337 nondiarrheal controls and 227 non-CDI diarrheal controls. The study showed a seven- to tenfold increased risk for CDI during antibiotic treatment and in the 30 days following cessation of antibiotics. A 2.7-fold increased risk of CDI was seen in the one- to three-month period after antibiotic treatment was stopped.

Because researchers only obtained information about antibiotic use in the three months preceding the onset of diarrhea, it is unknown if CDI risk remains elevated longer than three months after antibiotics are stopped. Also of note, the enzyme immunoassays used in this study to diagnose C. diff had sensitivities of between 60% and 85%.

As hospitalists, this information can be used to advise patients about their continued risk for CDI after cessation of antibiotics. Further studies are needed to determine the risk after three months.

Bottom line: Patients are at highest risk for CDI up to one month after stopping antibiotics but continue to be at higher risk for at least two additional months.

Citation: Hensgens MPN, Goorhuis A, Dekkers OM, Kuijper EJ. Time interval of increased risk for Clostridium difficile infection after exposure to antibiotics. J Antimicrob Chemother. 2012;67:742-748.

Acid Suppression and Poor Outcomes in C. Diff Patients

Clinical question: What are potential modifiable risk factors associated with increased complications and mortality in patients hospitalized with C. diff infection (CDI)?

Background: CDI is a growing cause of morbidity and mortality in hospitalized patients. Evidence is growing for the association of acid suppression, among other modifiable risk factors, with complications and mortality in patients with CDI.

Study design: Retrospective case review.

Setting: Naval medical center.

Synopsis: A laboratory, medical record, and pharmacy database query found 485 patients with CDI. Complications of CDI were defined as ICU admission, surgery, and megacolon. Factors significantly associated with CDI complications and mortality were admission for CDI, corticosteroid use >5 mg per day, age ≥80 years, and prescription acid suppression (including H2-blockers and proton-pump inhibitors).

The latter two risk factors were associated with mortality alone. In multivariable regression, the odds of mortality among patients on acid suppression was more than four times the odds of those not on acid suppression (OR 4.74, 95% CI, 1.57 to 14.36).

Although this is a retrospective cohort study and cannot prove a causal relationship, the data add to a growing body of evidence supporting the risk of CDI complications and mortality for those on acid suppression.

Bottom line: In hospitalized patients with CDI, acid suppression is associated with increased complications and mortality and should be discontinued in this population when possible.

Citation: Morrison RH, Hall NS, Said M, et al. Risk factors associated with complications and mortality in patients with Clostridium difficile infection. Clin Infect Dis. 2011;53:1173-1178.

Perioperative Statins Reduce Cardiac Events for Surgical Patients

Clinical question: Does perioperative statin use improve cardiac outcomes (death, myocardial infarction, atrial fibrillation, and ICU and hospital lengths of stay) in statin-naive patients undergoing cardiac or non-cardiac surgery?

Background: Statins have been hypothesized to reduce perioperative cardiac complications because they reduce vascular and systemic inflammation caused by surgery, and several meta-analyses have demonstrated their efficacy. To date, no meta-analyses have specifically evaluated the benefits of perioperative statins in non-cardiac surgery from randomized controlled trials.

Study design: Systematic review of the literature and meta-analysis.

Setting: Fifteen randomized controlled trials of hospitalized surgical patients.

Synopsis: A systematic review examined the effects of statins on a variety of perioperative cardiac outcomes (death, myocardial infarction, atrial fibrillation, and ICU and hospital lengths of stay); 11 of the 15 patients were undergoing cardiac surgery.

Perioperative statins decreased the risk of atrial fibrillation in patients undergoing cardiac surgery (RR 0.56; 95% CI 0.45-0.69; number needed to treat [NNT], 6). In both cardiac and non-cardiac surgical patients, statins reduced the risk of myocardial infarction (RR 0.53; 95% CI 0.38 to 0.74; NNT 23). Statin treatment also reduced the mean length of hospital stay (in days, mean difference -0.32; 95% CI, -0.53 to -0.11) but did not reduce the length of ICU stay (mean difference -0.08; 95% CI, -0.25 to 0.10). Risk of death was not reduced with statin treatment (RR 0.62; 95% CI, 0.34 to 1.14).

Bottom line: Perioperative statins reduce the risk of postoperative atrial fibrillation in cardiac surgical patients, the risk of postoperative MI in cardiac and non-cardiac surgical patients, and the mean length of hospital stay.

Citation: Chopra V, Wesorick DH, Sussman JB, et al. Effect of perioperative statins on death, myocardial infarction, atrial fibrillation, and length of stay: a systematic review and meta-analysis. Arch Surg. 2012;147:181-188.

Enoxaparin Safe and Effective during Percutaneous Coronary Intervention

Clinical question: Is enoxaparin safe and efficacious compared with unfractionated heparin during percutaneous coronary intervention (PCI)?

Background: Despite problems with the use of unfractionated heparin during PCI, current guidelines give it a Class 1 recommendation for PCI in ST-elevation myocardial infarction (MI). There is growing evidence that enoxaparin can provide predictable, effective anticoagulation during PCI. Although several trials have examined this issue, none have been sufficiently powered to evaluate mortality.

Study design: Systematic review and meta-analysis.

Setting: Twenty-three trials or registries of patients undergoing PCI.

Synopsis: A systematic review found 23 trials representing 30,966 patients that examined the effects of enoxaparin versus unfractionated heparin on risk of mortality, MI, complications of MI, and major bleeding. Of these, 10,243 (33.1%) patients underwent primary PCI for ST elevation MI, 8,750 (28.2%) underwent PCI after fibrinolysis, and 11,973 (38.7%) patients had either scheduled PCI or PCI for non-ST elevation acute coronary syndrome.

Of all the patients, 13,943 (45%) received enoxaparin and 17,023 (55%) received unfractionated heparin. Enoxaparin was associated with significant reductions in all-cause mortality (RR 0.66; 95% CI, 0.57 to 0.76), composite of death or MI (RR 0.68; 95% CI, 0.57 to 0.81), and complications of MI (RR 0.75; 95% CI, 0.6 to 0.85). For patients who received primary PCI for ST elevation MI, enoxaparin reduced the risk of complications of MI by 44% (RR 0.56; 95% CI, 0.42 to 0.76). Enoxaparin also reduced the risk of major bleeding (RR 0.80, 95% CI, 0.68 to 0.95) with even more striking results for the 14 studies that compared intravenous enoxaparin to unfractionated heparin (RR 0.66; 95% CI, 0.52 to 0.83).

Bottom line: Enoxaparin is safe and efficacious when used during PCI. Patients who receive enoxaparin during PCI have reduced risk for death, MI, complications of MI, and major bleeding when compared with patients who receive unfractionated heparin.

Citation: Silvain J, Beygui F, Barthelmy O, et al. Efficacy and safety of enoxaparin versus unfractionated heparin during percutaneous coronary intervention: systematic review and meta-analysis. BMJ. 2012;344:e553.

Serum Potassium Levels and Mortality in Acute Myocardial Infarction

Clinical question: What is the relationship between serum potassium levels and mortality in acute myocardial infarction (AMI) patients?

Background: Several smaller studies in the pre-beta-blocker and pre-reperfusion era recommended maintaining serum potassium levels between 4.0 mEq/L and 5.0 mEq/L in AMI patients. However, current studies examining the relationship between potassium levels and mortality in AMI patients are lacking.

Study design: Retrospective cohort study.

Setting: Multicenter study involving 67 hospitals in the U.S.

Synopsis: Using the Cerner Health Facts database, which included 38,689 patients with biomarker-confirmed AMI, this study showed there was a U-shaped relationship between mean post-admission serum potassium level and in-hospital mortality.

Compared with the reference group of 3.5 mEq/L to less than 4.0 mEq/L (mortality rate 4.8%; 95% CI, 4.4% to 5.2%), mortality was comparable for those with mean post-admission potassium of 4.0 mEq/L to less than 4.5 mEq/L (5.0%; 95% CI, 4.7% to 5.3%). Mortality was twice as great for potassium of 4.5 mEq/L to less than 5.0 mEq/L (10.0%; 95% CI, 9.1% to 10.9%), and even greater for higher potassium strata. Similarly, mortality rates were higher for potassium levels of less than 3.5 mEq/L. Rates of ventricular fibrillation or cardiac arrest were higher among patients with potassium levels of less than 3.0 mEq/L or more than 5.0 mEq/L.

Bottom line: For inpatients with AMI, serum potassium levels of 3.5 mEq/L to 4.5 mEq/L should be maintained for the best outcomes. Repletion of serum potassium to levels greater than 4.5 mEq/L is associated with increased mortality and should be avoided.

Citation: Goyal A, Spertus JA, Gosch K, et al. Serum potassium levels and mortality in acute myocardial infarction. JAMA. 2012;307:157-164.

Proton-Pump Inhibitors Better than H2-Blockers in ACS and STEMI

Clinical question: Are proton-pump inhibitors (PPIs) better than H2-blockers at preventing UGI bleeding in patients after acute coronary syndrome (ACS) or ST-elevation myocardial infarction (STEMI)?

Background: It is not definitively known if PPIs are the same or better than H2-blockers in preventing UGI bleeding in patients on high-risk medications (aspirin, clopidogrel, and anticoagulants) after ACS or STEMI.

Study design: Randomized double-blinded controlled trial.

Setting: Single hospital.

Synopsis: Patients with ACS or STEMI were treated with aspirin, clopidogrel, and enoxaparin or thrombolytics. They were then randomized to either esomeprazole 20 mg or famotidine 40 mg, both administered nightly. They were followed throughout their hospital stay and were then followed between four and 52 weeks after discharge (mean duration: 19 weeks for esomeprazole, 18 weeks for famotidine). The primary end point was time to a composite outcome, consisting of UGI bleeding, obstruction, or perforation. Overall, 313 patients were randomized (164 to esomeprazole and 149 to famotidine).

The treatment groups were equivalent in baseline characteristics, and compliance in both groups was excellent (>98%). The primary endpoint occurred in three patients in the esomeprazole group and in 12 patients in the famotidine group (hazard ratio 0.21; 95% CI, 0.06 to 0.75; P=0.008).

Bottom line: PPIs are superior to H2-blockers in reducing UGI bleeding in patients on high-risk medications (aspirin, clopidogrel, and enoxaparin or thrombolytics) after ACS and STEMI. This confirms the recommendations of the 2010 ACCF/ACG/AHA Expert Consensus that PPIs should be used in those on dual antiplatelet therapy on anticoagulants.

Citation: Ng FH, Tunggal P, Chu WM, et al. Esomeprazole compared with famotidine in the prevention of upper gastrointestinal bleeding in patients with acute coronary syndrome or myocardial infarction. Am J Gastroenterol. 2012;107:389-396.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Initial trophic feedings effective for patients with acute lung injury
2. IM vs. IV benzodiazepines in status epilepticus
3. CDI risk following antibiotic cessation
4. Acid suppression associated with increased complications in CDI patients
5. Perioperative statins and cardiac events in surgical patients
6. Enoxaparin vs. unfractionated heparin during PCI
7. Optimal serum potassium levels for AMI patients
8. PPIs superior to H2-blockers for lowering UGI bleeding following ACS and STEMI

Initial Lower-Volume Enteral Feeding Better Tolerated, but Has No Mortality Benefit

Clinical question: In mechanically ventilated patients with acute lung injury, do initial lower-volume enteral feedings (trophic feedings) improve clinical outcomes when compared with full enteral feedings?

Background: Malnutrition in critically ill patients is associated with poor outcomes, but conflicting data exist regarding the best timing, amount, and formulation of enteral nutrition to initiate. Initiation of lower-volume enteral feeding with periodic assessment of gastric residual volume is common practice, but the effects of this practice are unknown.

Study design: Multicenter randomized controlled open-label study.

Setting: Forty-four hospitals in the National Heart, Lung, and Blood Institute (NHLBI) Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network.

Synopsis: One thousand patients with acute lung injury receiving mechanical ventilation for longer than 72 hours were randomized using a Web-based system to receive either trophic or full enteric feedings for the first six days of mechanical ventilation. After the sixth day, a full enteric feeding protocol was used in all patients. All analyses were by intention-to-treat.

There was no significant difference between the trophic and full enteral feeding groups with regard to the primary outcome of ventilator-free days through Day 28 (14.9% vs. 15.0%, P=0.89). There were also no significant differences between groups in secondary outcomes, which included 60-day mortality, ICU-free days, organ-failure-free days, or the incidence of new infections. However, gastrointestinal intolerances occurred less often in the trophic feeding group, and these patients received fewer anti-diarrheal and prokinetic agents. The full feeding group gained 2.1 liters of fluid by Day 7, but this fluid gain did not cause significant differences in measures of circulatory or pulmonary physiology.

Limitations include open-label study design and inclusion of only critically ill adult medical patients with acute lung injury.

Bottom line: Initial lower-volume tube feedings in mechanically ventilated patients with acute lung injury did not improve clinical outcomes compared with full enteral feedings, but they were associated with fewer instances of gastrointestinal intolerance.

Citation: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012;307:795-803.

Intramuscular Benzodiazepines as Good as IV Benzodiazepines in Status Epilepticus

Clinical question: Is intramuscular (IM) midazolam noninferior to intravenous lorazepam in patients in status epilepticus?

Background: Studies have shown that IV benzodiazepines, particularly lorazepam, are effective for patients in status epilepticus. Studies have not evaluated IM benzodiazepines. However, many emergency medical service (EMS) agencies use IM midazolam because IM administration is easier than IV administration, and midazolam has a longer nonrefrigerated shelf life than lorazepam does.

Study design: Randomized, double-blinded clinical trial.

Setting: Thirty-three EMS agencies across the United States.

Synopsis: Based on the 893 adults and children in status epilepticus included in this double-blind study, the researchers found IM midazolam to be noninferior to, and in fact superior to, IV lorazepam for treating seizures prior to arrival at EDs. Specifically, they found 10% more (95% CI 4.0% to 16.1%; P<0.001 for noninferiority and P<0.001 for superiority) seizure-free patients arriving at EDs when IM midazolam was administered. Seizures ceased in patients given IM midazolam in less time on average than it took for paramedics to administer IV lorazepam.

Hospitalists might be less inclined than EMS personnel to use IM midazolam because their patients have established IV access and refrigerated drugs are readily available. However, since IM midazolam was superior to IV lorazepam in this prehospital study, a similar trial in hospitalized patients is warranted. In subsequent trials, it would be useful to administer both midazolam and lorazepam via IM and IV routes, and IM injections by an autoinjector could be compared with the conventional manner.

Bottom line: In the prehospital setting, IM midazolam is at least as good as IV lorazepam in treating status epilepticus in children and adults.

Citation: Silbergleit R, Durkalski V, Lowenstein D, et al. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med. 2012;366:591-600.

Clostridium Difficile Infection Risk Remains High at Least Three Months after Antibiotics Are Stopped

Clinical question: How long are patients at higher risk for Clostridium difficile infection (CDI) after completing antibiotics?

Background: Studies have shown that patients given antibiotics are at higher risk for CDI than those who are not, particularly if they take multiple antibiotics at high doses for a prolonged period of time. However, it is not known how long a patient remains at high risk for CDI after completing antibiotic therapy.

Study design: Case-control study.

Setting: Nine hospitals in Netherlands.

Synopsis: The study compared 337 hospitalized patients who had CDI with 337 nondiarrheal controls and 227 non-CDI diarrheal controls. The study showed a seven- to tenfold increased risk for CDI during antibiotic treatment and in the 30 days following cessation of antibiotics. A 2.7-fold increased risk of CDI was seen in the one- to three-month period after antibiotic treatment was stopped.

Because researchers only obtained information about antibiotic use in the three months preceding the onset of diarrhea, it is unknown if CDI risk remains elevated longer than three months after antibiotics are stopped. Also of note, the enzyme immunoassays used in this study to diagnose C. diff had sensitivities of between 60% and 85%.

As hospitalists, this information can be used to advise patients about their continued risk for CDI after cessation of antibiotics. Further studies are needed to determine the risk after three months.

Bottom line: Patients are at highest risk for CDI up to one month after stopping antibiotics but continue to be at higher risk for at least two additional months.

Citation: Hensgens MPN, Goorhuis A, Dekkers OM, Kuijper EJ. Time interval of increased risk for Clostridium difficile infection after exposure to antibiotics. J Antimicrob Chemother. 2012;67:742-748.

Acid Suppression and Poor Outcomes in C. Diff Patients

Clinical question: What are potential modifiable risk factors associated with increased complications and mortality in patients hospitalized with C. diff infection (CDI)?

Background: CDI is a growing cause of morbidity and mortality in hospitalized patients. Evidence is growing for the association of acid suppression, among other modifiable risk factors, with complications and mortality in patients with CDI.

Study design: Retrospective case review.

Setting: Naval medical center.

Synopsis: A laboratory, medical record, and pharmacy database query found 485 patients with CDI. Complications of CDI were defined as ICU admission, surgery, and megacolon. Factors significantly associated with CDI complications and mortality were admission for CDI, corticosteroid use >5 mg per day, age ≥80 years, and prescription acid suppression (including H2-blockers and proton-pump inhibitors).

The latter two risk factors were associated with mortality alone. In multivariable regression, the odds of mortality among patients on acid suppression was more than four times the odds of those not on acid suppression (OR 4.74, 95% CI, 1.57 to 14.36).

Although this is a retrospective cohort study and cannot prove a causal relationship, the data add to a growing body of evidence supporting the risk of CDI complications and mortality for those on acid suppression.

Bottom line: In hospitalized patients with CDI, acid suppression is associated with increased complications and mortality and should be discontinued in this population when possible.

Citation: Morrison RH, Hall NS, Said M, et al. Risk factors associated with complications and mortality in patients with Clostridium difficile infection. Clin Infect Dis. 2011;53:1173-1178.

Perioperative Statins Reduce Cardiac Events for Surgical Patients

Clinical question: Does perioperative statin use improve cardiac outcomes (death, myocardial infarction, atrial fibrillation, and ICU and hospital lengths of stay) in statin-naive patients undergoing cardiac or non-cardiac surgery?

Background: Statins have been hypothesized to reduce perioperative cardiac complications because they reduce vascular and systemic inflammation caused by surgery, and several meta-analyses have demonstrated their efficacy. To date, no meta-analyses have specifically evaluated the benefits of perioperative statins in non-cardiac surgery from randomized controlled trials.

Study design: Systematic review of the literature and meta-analysis.

Setting: Fifteen randomized controlled trials of hospitalized surgical patients.

Synopsis: A systematic review examined the effects of statins on a variety of perioperative cardiac outcomes (death, myocardial infarction, atrial fibrillation, and ICU and hospital lengths of stay); 11 of the 15 patients were undergoing cardiac surgery.

Perioperative statins decreased the risk of atrial fibrillation in patients undergoing cardiac surgery (RR 0.56; 95% CI 0.45-0.69; number needed to treat [NNT], 6). In both cardiac and non-cardiac surgical patients, statins reduced the risk of myocardial infarction (RR 0.53; 95% CI 0.38 to 0.74; NNT 23). Statin treatment also reduced the mean length of hospital stay (in days, mean difference -0.32; 95% CI, -0.53 to -0.11) but did not reduce the length of ICU stay (mean difference -0.08; 95% CI, -0.25 to 0.10). Risk of death was not reduced with statin treatment (RR 0.62; 95% CI, 0.34 to 1.14).

Bottom line: Perioperative statins reduce the risk of postoperative atrial fibrillation in cardiac surgical patients, the risk of postoperative MI in cardiac and non-cardiac surgical patients, and the mean length of hospital stay.

Citation: Chopra V, Wesorick DH, Sussman JB, et al. Effect of perioperative statins on death, myocardial infarction, atrial fibrillation, and length of stay: a systematic review and meta-analysis. Arch Surg. 2012;147:181-188.

Enoxaparin Safe and Effective during Percutaneous Coronary Intervention

Clinical question: Is enoxaparin safe and efficacious compared with unfractionated heparin during percutaneous coronary intervention (PCI)?

Background: Despite problems with the use of unfractionated heparin during PCI, current guidelines give it a Class 1 recommendation for PCI in ST-elevation myocardial infarction (MI). There is growing evidence that enoxaparin can provide predictable, effective anticoagulation during PCI. Although several trials have examined this issue, none have been sufficiently powered to evaluate mortality.

Study design: Systematic review and meta-analysis.

Setting: Twenty-three trials or registries of patients undergoing PCI.

Synopsis: A systematic review found 23 trials representing 30,966 patients that examined the effects of enoxaparin versus unfractionated heparin on risk of mortality, MI, complications of MI, and major bleeding. Of these, 10,243 (33.1%) patients underwent primary PCI for ST elevation MI, 8,750 (28.2%) underwent PCI after fibrinolysis, and 11,973 (38.7%) patients had either scheduled PCI or PCI for non-ST elevation acute coronary syndrome.

Of all the patients, 13,943 (45%) received enoxaparin and 17,023 (55%) received unfractionated heparin. Enoxaparin was associated with significant reductions in all-cause mortality (RR 0.66; 95% CI, 0.57 to 0.76), composite of death or MI (RR 0.68; 95% CI, 0.57 to 0.81), and complications of MI (RR 0.75; 95% CI, 0.6 to 0.85). For patients who received primary PCI for ST elevation MI, enoxaparin reduced the risk of complications of MI by 44% (RR 0.56; 95% CI, 0.42 to 0.76). Enoxaparin also reduced the risk of major bleeding (RR 0.80, 95% CI, 0.68 to 0.95) with even more striking results for the 14 studies that compared intravenous enoxaparin to unfractionated heparin (RR 0.66; 95% CI, 0.52 to 0.83).

Bottom line: Enoxaparin is safe and efficacious when used during PCI. Patients who receive enoxaparin during PCI have reduced risk for death, MI, complications of MI, and major bleeding when compared with patients who receive unfractionated heparin.

Citation: Silvain J, Beygui F, Barthelmy O, et al. Efficacy and safety of enoxaparin versus unfractionated heparin during percutaneous coronary intervention: systematic review and meta-analysis. BMJ. 2012;344:e553.

Serum Potassium Levels and Mortality in Acute Myocardial Infarction

Clinical question: What is the relationship between serum potassium levels and mortality in acute myocardial infarction (AMI) patients?

Background: Several smaller studies in the pre-beta-blocker and pre-reperfusion era recommended maintaining serum potassium levels between 4.0 mEq/L and 5.0 mEq/L in AMI patients. However, current studies examining the relationship between potassium levels and mortality in AMI patients are lacking.

Study design: Retrospective cohort study.

Setting: Multicenter study involving 67 hospitals in the U.S.

Synopsis: Using the Cerner Health Facts database, which included 38,689 patients with biomarker-confirmed AMI, this study showed there was a U-shaped relationship between mean post-admission serum potassium level and in-hospital mortality.

Compared with the reference group of 3.5 mEq/L to less than 4.0 mEq/L (mortality rate 4.8%; 95% CI, 4.4% to 5.2%), mortality was comparable for those with mean post-admission potassium of 4.0 mEq/L to less than 4.5 mEq/L (5.0%; 95% CI, 4.7% to 5.3%). Mortality was twice as great for potassium of 4.5 mEq/L to less than 5.0 mEq/L (10.0%; 95% CI, 9.1% to 10.9%), and even greater for higher potassium strata. Similarly, mortality rates were higher for potassium levels of less than 3.5 mEq/L. Rates of ventricular fibrillation or cardiac arrest were higher among patients with potassium levels of less than 3.0 mEq/L or more than 5.0 mEq/L.

Bottom line: For inpatients with AMI, serum potassium levels of 3.5 mEq/L to 4.5 mEq/L should be maintained for the best outcomes. Repletion of serum potassium to levels greater than 4.5 mEq/L is associated with increased mortality and should be avoided.

Citation: Goyal A, Spertus JA, Gosch K, et al. Serum potassium levels and mortality in acute myocardial infarction. JAMA. 2012;307:157-164.

Proton-Pump Inhibitors Better than H2-Blockers in ACS and STEMI

Clinical question: Are proton-pump inhibitors (PPIs) better than H2-blockers at preventing UGI bleeding in patients after acute coronary syndrome (ACS) or ST-elevation myocardial infarction (STEMI)?

Background: It is not definitively known if PPIs are the same or better than H2-blockers in preventing UGI bleeding in patients on high-risk medications (aspirin, clopidogrel, and anticoagulants) after ACS or STEMI.

Study design: Randomized double-blinded controlled trial.

Setting: Single hospital.

Synopsis: Patients with ACS or STEMI were treated with aspirin, clopidogrel, and enoxaparin or thrombolytics. They were then randomized to either esomeprazole 20 mg or famotidine 40 mg, both administered nightly. They were followed throughout their hospital stay and were then followed between four and 52 weeks after discharge (mean duration: 19 weeks for esomeprazole, 18 weeks for famotidine). The primary end point was time to a composite outcome, consisting of UGI bleeding, obstruction, or perforation. Overall, 313 patients were randomized (164 to esomeprazole and 149 to famotidine).

The treatment groups were equivalent in baseline characteristics, and compliance in both groups was excellent (>98%). The primary endpoint occurred in three patients in the esomeprazole group and in 12 patients in the famotidine group (hazard ratio 0.21; 95% CI, 0.06 to 0.75; P=0.008).

Bottom line: PPIs are superior to H2-blockers in reducing UGI bleeding in patients on high-risk medications (aspirin, clopidogrel, and enoxaparin or thrombolytics) after ACS and STEMI. This confirms the recommendations of the 2010 ACCF/ACG/AHA Expert Consensus that PPIs should be used in those on dual antiplatelet therapy on anticoagulants.

Citation: Ng FH, Tunggal P, Chu WM, et al. Esomeprazole compared with famotidine in the prevention of upper gastrointestinal bleeding in patients with acute coronary syndrome or myocardial infarction. Am J Gastroenterol. 2012;107:389-396.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Initial trophic feedings effective for patients with acute lung injury
2. IM vs. IV benzodiazepines in status epilepticus
3. CDI risk following antibiotic cessation
4. Acid suppression associated with increased complications in CDI patients
5. Perioperative statins and cardiac events in surgical patients
6. Enoxaparin vs. unfractionated heparin during PCI
7. Optimal serum potassium levels for AMI patients
8. PPIs superior to H2-blockers for lowering UGI bleeding following ACS and STEMI

Initial Lower-Volume Enteral Feeding Better Tolerated, but Has No Mortality Benefit

Clinical question: In mechanically ventilated patients with acute lung injury, do initial lower-volume enteral feedings (trophic feedings) improve clinical outcomes when compared with full enteral feedings?

Background: Malnutrition in critically ill patients is associated with poor outcomes, but conflicting data exist regarding the best timing, amount, and formulation of enteral nutrition to initiate. Initiation of lower-volume enteral feeding with periodic assessment of gastric residual volume is common practice, but the effects of this practice are unknown.

Study design: Multicenter randomized controlled open-label study.

Setting: Forty-four hospitals in the National Heart, Lung, and Blood Institute (NHLBI) Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network.

Synopsis: One thousand patients with acute lung injury receiving mechanical ventilation for longer than 72 hours were randomized using a Web-based system to receive either trophic or full enteric feedings for the first six days of mechanical ventilation. After the sixth day, a full enteric feeding protocol was used in all patients. All analyses were by intention-to-treat.

There was no significant difference between the trophic and full enteral feeding groups with regard to the primary outcome of ventilator-free days through Day 28 (14.9% vs. 15.0%, P=0.89). There were also no significant differences between groups in secondary outcomes, which included 60-day mortality, ICU-free days, organ-failure-free days, or the incidence of new infections. However, gastrointestinal intolerances occurred less often in the trophic feeding group, and these patients received fewer anti-diarrheal and prokinetic agents. The full feeding group gained 2.1 liters of fluid by Day 7, but this fluid gain did not cause significant differences in measures of circulatory or pulmonary physiology.

Limitations include open-label study design and inclusion of only critically ill adult medical patients with acute lung injury.

Bottom line: Initial lower-volume tube feedings in mechanically ventilated patients with acute lung injury did not improve clinical outcomes compared with full enteral feedings, but they were associated with fewer instances of gastrointestinal intolerance.

Citation: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012;307:795-803.

Intramuscular Benzodiazepines as Good as IV Benzodiazepines in Status Epilepticus

Clinical question: Is intramuscular (IM) midazolam noninferior to intravenous lorazepam in patients in status epilepticus?

Background: Studies have shown that IV benzodiazepines, particularly lorazepam, are effective for patients in status epilepticus. Studies have not evaluated IM benzodiazepines. However, many emergency medical service (EMS) agencies use IM midazolam because IM administration is easier than IV administration, and midazolam has a longer nonrefrigerated shelf life than lorazepam does.

Study design: Randomized, double-blinded clinical trial.

Setting: Thirty-three EMS agencies across the United States.

Synopsis: Based on the 893 adults and children in status epilepticus included in this double-blind study, the researchers found IM midazolam to be noninferior to, and in fact superior to, IV lorazepam for treating seizures prior to arrival at EDs. Specifically, they found 10% more (95% CI 4.0% to 16.1%; P<0.001 for noninferiority and P<0.001 for superiority) seizure-free patients arriving at EDs when IM midazolam was administered. Seizures ceased in patients given IM midazolam in less time on average than it took for paramedics to administer IV lorazepam.

Hospitalists might be less inclined than EMS personnel to use IM midazolam because their patients have established IV access and refrigerated drugs are readily available. However, since IM midazolam was superior to IV lorazepam in this prehospital study, a similar trial in hospitalized patients is warranted. In subsequent trials, it would be useful to administer both midazolam and lorazepam via IM and IV routes, and IM injections by an autoinjector could be compared with the conventional manner.

Bottom line: In the prehospital setting, IM midazolam is at least as good as IV lorazepam in treating status epilepticus in children and adults.

Citation: Silbergleit R, Durkalski V, Lowenstein D, et al. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med. 2012;366:591-600.

Clostridium Difficile Infection Risk Remains High at Least Three Months after Antibiotics Are Stopped

Clinical question: How long are patients at higher risk for Clostridium difficile infection (CDI) after completing antibiotics?

Background: Studies have shown that patients given antibiotics are at higher risk for CDI than those who are not, particularly if they take multiple antibiotics at high doses for a prolonged period of time. However, it is not known how long a patient remains at high risk for CDI after completing antibiotic therapy.

Study design: Case-control study.

Setting: Nine hospitals in Netherlands.

Synopsis: The study compared 337 hospitalized patients who had CDI with 337 nondiarrheal controls and 227 non-CDI diarrheal controls. The study showed a seven- to tenfold increased risk for CDI during antibiotic treatment and in the 30 days following cessation of antibiotics. A 2.7-fold increased risk of CDI was seen in the one- to three-month period after antibiotic treatment was stopped.

Because researchers only obtained information about antibiotic use in the three months preceding the onset of diarrhea, it is unknown if CDI risk remains elevated longer than three months after antibiotics are stopped. Also of note, the enzyme immunoassays used in this study to diagnose C. diff had sensitivities of between 60% and 85%.

As hospitalists, this information can be used to advise patients about their continued risk for CDI after cessation of antibiotics. Further studies are needed to determine the risk after three months.

Bottom line: Patients are at highest risk for CDI up to one month after stopping antibiotics but continue to be at higher risk for at least two additional months.

Citation: Hensgens MPN, Goorhuis A, Dekkers OM, Kuijper EJ. Time interval of increased risk for Clostridium difficile infection after exposure to antibiotics. J Antimicrob Chemother. 2012;67:742-748.

Acid Suppression and Poor Outcomes in C. Diff Patients

Clinical question: What are potential modifiable risk factors associated with increased complications and mortality in patients hospitalized with C. diff infection (CDI)?

Background: CDI is a growing cause of morbidity and mortality in hospitalized patients. Evidence is growing for the association of acid suppression, among other modifiable risk factors, with complications and mortality in patients with CDI.

Study design: Retrospective case review.

Setting: Naval medical center.

Synopsis: A laboratory, medical record, and pharmacy database query found 485 patients with CDI. Complications of CDI were defined as ICU admission, surgery, and megacolon. Factors significantly associated with CDI complications and mortality were admission for CDI, corticosteroid use >5 mg per day, age ≥80 years, and prescription acid suppression (including H2-blockers and proton-pump inhibitors).

The latter two risk factors were associated with mortality alone. In multivariable regression, the odds of mortality among patients on acid suppression was more than four times the odds of those not on acid suppression (OR 4.74, 95% CI, 1.57 to 14.36).

Although this is a retrospective cohort study and cannot prove a causal relationship, the data add to a growing body of evidence supporting the risk of CDI complications and mortality for those on acid suppression.

Bottom line: In hospitalized patients with CDI, acid suppression is associated with increased complications and mortality and should be discontinued in this population when possible.

Citation: Morrison RH, Hall NS, Said M, et al. Risk factors associated with complications and mortality in patients with Clostridium difficile infection. Clin Infect Dis. 2011;53:1173-1178.

Perioperative Statins Reduce Cardiac Events for Surgical Patients

Clinical question: Does perioperative statin use improve cardiac outcomes (death, myocardial infarction, atrial fibrillation, and ICU and hospital lengths of stay) in statin-naive patients undergoing cardiac or non-cardiac surgery?

Background: Statins have been hypothesized to reduce perioperative cardiac complications because they reduce vascular and systemic inflammation caused by surgery, and several meta-analyses have demonstrated their efficacy. To date, no meta-analyses have specifically evaluated the benefits of perioperative statins in non-cardiac surgery from randomized controlled trials.

Study design: Systematic review of the literature and meta-analysis.

Setting: Fifteen randomized controlled trials of hospitalized surgical patients.

Synopsis: A systematic review examined the effects of statins on a variety of perioperative cardiac outcomes (death, myocardial infarction, atrial fibrillation, and ICU and hospital lengths of stay); 11 of the 15 patients were undergoing cardiac surgery.

Perioperative statins decreased the risk of atrial fibrillation in patients undergoing cardiac surgery (RR 0.56; 95% CI 0.45-0.69; number needed to treat [NNT], 6). In both cardiac and non-cardiac surgical patients, statins reduced the risk of myocardial infarction (RR 0.53; 95% CI 0.38 to 0.74; NNT 23). Statin treatment also reduced the mean length of hospital stay (in days, mean difference -0.32; 95% CI, -0.53 to -0.11) but did not reduce the length of ICU stay (mean difference -0.08; 95% CI, -0.25 to 0.10). Risk of death was not reduced with statin treatment (RR 0.62; 95% CI, 0.34 to 1.14).

Bottom line: Perioperative statins reduce the risk of postoperative atrial fibrillation in cardiac surgical patients, the risk of postoperative MI in cardiac and non-cardiac surgical patients, and the mean length of hospital stay.

Citation: Chopra V, Wesorick DH, Sussman JB, et al. Effect of perioperative statins on death, myocardial infarction, atrial fibrillation, and length of stay: a systematic review and meta-analysis. Arch Surg. 2012;147:181-188.

Enoxaparin Safe and Effective during Percutaneous Coronary Intervention

Clinical question: Is enoxaparin safe and efficacious compared with unfractionated heparin during percutaneous coronary intervention (PCI)?

Background: Despite problems with the use of unfractionated heparin during PCI, current guidelines give it a Class 1 recommendation for PCI in ST-elevation myocardial infarction (MI). There is growing evidence that enoxaparin can provide predictable, effective anticoagulation during PCI. Although several trials have examined this issue, none have been sufficiently powered to evaluate mortality.

Study design: Systematic review and meta-analysis.

Setting: Twenty-three trials or registries of patients undergoing PCI.

Synopsis: A systematic review found 23 trials representing 30,966 patients that examined the effects of enoxaparin versus unfractionated heparin on risk of mortality, MI, complications of MI, and major bleeding. Of these, 10,243 (33.1%) patients underwent primary PCI for ST elevation MI, 8,750 (28.2%) underwent PCI after fibrinolysis, and 11,973 (38.7%) patients had either scheduled PCI or PCI for non-ST elevation acute coronary syndrome.

Of all the patients, 13,943 (45%) received enoxaparin and 17,023 (55%) received unfractionated heparin. Enoxaparin was associated with significant reductions in all-cause mortality (RR 0.66; 95% CI, 0.57 to 0.76), composite of death or MI (RR 0.68; 95% CI, 0.57 to 0.81), and complications of MI (RR 0.75; 95% CI, 0.6 to 0.85). For patients who received primary PCI for ST elevation MI, enoxaparin reduced the risk of complications of MI by 44% (RR 0.56; 95% CI, 0.42 to 0.76). Enoxaparin also reduced the risk of major bleeding (RR 0.80, 95% CI, 0.68 to 0.95) with even more striking results for the 14 studies that compared intravenous enoxaparin to unfractionated heparin (RR 0.66; 95% CI, 0.52 to 0.83).

Bottom line: Enoxaparin is safe and efficacious when used during PCI. Patients who receive enoxaparin during PCI have reduced risk for death, MI, complications of MI, and major bleeding when compared with patients who receive unfractionated heparin.

Citation: Silvain J, Beygui F, Barthelmy O, et al. Efficacy and safety of enoxaparin versus unfractionated heparin during percutaneous coronary intervention: systematic review and meta-analysis. BMJ. 2012;344:e553.

Serum Potassium Levels and Mortality in Acute Myocardial Infarction

Clinical question: What is the relationship between serum potassium levels and mortality in acute myocardial infarction (AMI) patients?

Background: Several smaller studies in the pre-beta-blocker and pre-reperfusion era recommended maintaining serum potassium levels between 4.0 mEq/L and 5.0 mEq/L in AMI patients. However, current studies examining the relationship between potassium levels and mortality in AMI patients are lacking.

Study design: Retrospective cohort study.

Setting: Multicenter study involving 67 hospitals in the U.S.

Synopsis: Using the Cerner Health Facts database, which included 38,689 patients with biomarker-confirmed AMI, this study showed there was a U-shaped relationship between mean post-admission serum potassium level and in-hospital mortality.

Compared with the reference group of 3.5 mEq/L to less than 4.0 mEq/L (mortality rate 4.8%; 95% CI, 4.4% to 5.2%), mortality was comparable for those with mean post-admission potassium of 4.0 mEq/L to less than 4.5 mEq/L (5.0%; 95% CI, 4.7% to 5.3%). Mortality was twice as great for potassium of 4.5 mEq/L to less than 5.0 mEq/L (10.0%; 95% CI, 9.1% to 10.9%), and even greater for higher potassium strata. Similarly, mortality rates were higher for potassium levels of less than 3.5 mEq/L. Rates of ventricular fibrillation or cardiac arrest were higher among patients with potassium levels of less than 3.0 mEq/L or more than 5.0 mEq/L.

Bottom line: For inpatients with AMI, serum potassium levels of 3.5 mEq/L to 4.5 mEq/L should be maintained for the best outcomes. Repletion of serum potassium to levels greater than 4.5 mEq/L is associated with increased mortality and should be avoided.

Citation: Goyal A, Spertus JA, Gosch K, et al. Serum potassium levels and mortality in acute myocardial infarction. JAMA. 2012;307:157-164.

Proton-Pump Inhibitors Better than H2-Blockers in ACS and STEMI

Clinical question: Are proton-pump inhibitors (PPIs) better than H2-blockers at preventing UGI bleeding in patients after acute coronary syndrome (ACS) or ST-elevation myocardial infarction (STEMI)?

Background: It is not definitively known if PPIs are the same or better than H2-blockers in preventing UGI bleeding in patients on high-risk medications (aspirin, clopidogrel, and anticoagulants) after ACS or STEMI.

Study design: Randomized double-blinded controlled trial.

Setting: Single hospital.

Synopsis: Patients with ACS or STEMI were treated with aspirin, clopidogrel, and enoxaparin or thrombolytics. They were then randomized to either esomeprazole 20 mg or famotidine 40 mg, both administered nightly. They were followed throughout their hospital stay and were then followed between four and 52 weeks after discharge (mean duration: 19 weeks for esomeprazole, 18 weeks for famotidine). The primary end point was time to a composite outcome, consisting of UGI bleeding, obstruction, or perforation. Overall, 313 patients were randomized (164 to esomeprazole and 149 to famotidine).

The treatment groups were equivalent in baseline characteristics, and compliance in both groups was excellent (>98%). The primary endpoint occurred in three patients in the esomeprazole group and in 12 patients in the famotidine group (hazard ratio 0.21; 95% CI, 0.06 to 0.75; P=0.008).

Bottom line: PPIs are superior to H2-blockers in reducing UGI bleeding in patients on high-risk medications (aspirin, clopidogrel, and enoxaparin or thrombolytics) after ACS and STEMI. This confirms the recommendations of the 2010 ACCF/ACG/AHA Expert Consensus that PPIs should be used in those on dual antiplatelet therapy on anticoagulants.

Citation: Ng FH, Tunggal P, Chu WM, et al. Esomeprazole compared with famotidine in the prevention of upper gastrointestinal bleeding in patients with acute coronary syndrome or myocardial infarction. Am J Gastroenterol. 2012;107:389-396.