Dr. Henry A. Nasrallah’s recent Editorial on borderline personality disorder (BPD) (Current Psychiatry, From the Editor, April 2014, p. 19-20, 32 [http://bit.ly/1e8yAwE]) describes BPD as a heritable brain disease. I have been arguing this point for many years, often finding support from my colleague, Hagop Akiskal, MD, and opposition from my psychoanalytic colleagues.

In recent papers^1,2 on brain changes in BPD and the connection between BPD and bipolar disorders, I wrote that there often is a heritable aspect to the condition. There are exceptions to such heritability, as in the setting of a horrific environment (eg, father-daughter incest, parental brutality), where the same symptoms seen in BPD develop primarily from post-natal influences. Dr. Akiskal and I were discussing this a long time back, before MRI. Now I feel vindicated, with generous help from someone of Dr. Nasrallah’s prestige and influence.

There also is electrophysiological (including evoked potential) evi­dence for neural pathology in BPD, as well as data derived from single photon emission CT scanning. The burgeoning literature on MRI and functional MRI studies of BPD is in good agreement about the brain changes most relevant to BPD and that are found with regularity in this condition.

Particularly when BPD is diag­nosed in people (usually women) who do not have a history of neglect, sexual molestation, parental humili­ation or cruelty, or head injury, what else is there, if not genetically pre­disposed alterations in the fronto­limbic structures (and maybe the periaqueductal gray) that underlie the so-called “personality disorder,” and, not surprisingly, bipolar dis­orders, especially bipolar II disor­der, which often is the other side of the coin as BPD, and amenable to the same combination of medication and psychotherapy?

Michael H. Stone, MD
Professor of Clinical Psychiatry Columbia College of Physicians and Surgeons
New York, New York

----------------------------------------------------------------------------------------------------------

As a psychiatrist/psychoanalyst who works with BPD patients, I read Dr. Nasrallah’s April 2014 Editorial with great interest and enthusiasm. Over the past 10 years, I have been impressed with the number of patients with BPD whose nonverbal learning disorders and auditory and visual pro­cessing disorders have gone undiag­nosed. Recently, I lectured on this topic to the staff of a school for children with a range of neuropsychiatric disorders; the staff found my observations about such comorbidity consistent with their observations. These dysfunctions, or neurological variations—unknown to the parent and the child—interfere with early object-relation formation, attachment capacity, and learning. Neuropsychiatry and psychological development are, in fact, part of the same system.

An example: For 12 years, I have been treating a patient who has audi­tory processing and working memory problems, meaning that she could not process the connections among different ideas. This difficulty frus­trated her parents, who, in their frus­tration, criticized her for not paying attention. She was labeled “bad” and assumed the role of the “black sheep” in her family. Although she was intelligent, she was often wrong in her judgments and choices, and easily frustrated. In therapy, as I realized what part of her prob­lem was, I changed my technique.

When my patient asked me to tell her the sequence of understandings that we had just put together, I invited her to take my pad and write down her sense of it. As she described each part of that sequence to me, we would discuss it and I would remind her of lost fragments. Gradually, she learned to put ideas together; however, I also watched her struggle to hold these ideas in working memory and to use them.

Over time, she has improved and is more functional. After several years of dis­ability, she returned to work, although she still struggles interpersonally.

With many of such patients, I have had to modify traditional techniques of psy­chotherapy. I am fascinated by, and enjoy, such intensive psychotherapy. I am also amazed to see the impact of previously unknown neuropathologic variations on development. The more I learn about the impact of neuropsychiatry on psychologi­cal development, the more I can help my patients.

Howard Wishnie, MD
Cambridge, Massachusetts

Dr. Nasrallah responds
I appreciate Dr. Stone’s kind words and concur­rence with my thinking about BPD. It would have been appropriate to include discussion of neuro­physiological findings in my Editorial, but I opted to use my limited space to focus on structural and functional neuroimaging and genetics.

Henry A. Nasrallah, MD
Professor and Chairman Department of Neurology & Psychiatry
Saint Louis University School of Medicine
St. Louis, Missouri

Dr. Henry A. Nasrallah’s recent Editorial on borderline personality disorder (BPD) (Current Psychiatry, From the Editor, April 2014, p. 19-20, 32 [http://bit.ly/1e8yAwE]) describes BPD as a heritable brain disease. I have been arguing this point for many years, often finding support from my colleague, Hagop Akiskal, MD, and opposition from my psychoanalytic colleagues.

In recent papers^1,2 on brain changes in BPD and the connection between BPD and bipolar disorders, I wrote that there often is a heritable aspect to the condition. There are exceptions to such heritability, as in the setting of a horrific environment (eg, father-daughter incest, parental brutality), where the same symptoms seen in BPD develop primarily from post-natal influences. Dr. Akiskal and I were discussing this a long time back, before MRI. Now I feel vindicated, with generous help from someone of Dr. Nasrallah’s prestige and influence.

There also is electrophysiological (including evoked potential) evi­dence for neural pathology in BPD, as well as data derived from single photon emission CT scanning. The burgeoning literature on MRI and functional MRI studies of BPD is in good agreement about the brain changes most relevant to BPD and that are found with regularity in this condition.

Particularly when BPD is diag­nosed in people (usually women) who do not have a history of neglect, sexual molestation, parental humili­ation or cruelty, or head injury, what else is there, if not genetically pre­disposed alterations in the fronto­limbic structures (and maybe the periaqueductal gray) that underlie the so-called “personality disorder,” and, not surprisingly, bipolar dis­orders, especially bipolar II disor­der, which often is the other side of the coin as BPD, and amenable to the same combination of medication and psychotherapy?

Michael H. Stone, MD
Professor of Clinical Psychiatry Columbia College of Physicians and Surgeons
New York, New York

----------------------------------------------------------------------------------------------------------

As a psychiatrist/psychoanalyst who works with BPD patients, I read Dr. Nasrallah’s April 2014 Editorial with great interest and enthusiasm. Over the past 10 years, I have been impressed with the number of patients with BPD whose nonverbal learning disorders and auditory and visual pro­cessing disorders have gone undiag­nosed. Recently, I lectured on this topic to the staff of a school for children with a range of neuropsychiatric disorders; the staff found my observations about such comorbidity consistent with their observations. These dysfunctions, or neurological variations—unknown to the parent and the child—interfere with early object-relation formation, attachment capacity, and learning. Neuropsychiatry and psychological development are, in fact, part of the same system.

An example: For 12 years, I have been treating a patient who has audi­tory processing and working memory problems, meaning that she could not process the connections among different ideas. This difficulty frus­trated her parents, who, in their frus­tration, criticized her for not paying attention. She was labeled “bad” and assumed the role of the “black sheep” in her family. Although she was intelligent, she was often wrong in her judgments and choices, and easily frustrated. In therapy, as I realized what part of her prob­lem was, I changed my technique.

When my patient asked me to tell her the sequence of understandings that we had just put together, I invited her to take my pad and write down her sense of it. As she described each part of that sequence to me, we would discuss it and I would remind her of lost fragments. Gradually, she learned to put ideas together; however, I also watched her struggle to hold these ideas in working memory and to use them.

Over time, she has improved and is more functional. After several years of dis­ability, she returned to work, although she still struggles interpersonally.

With many of such patients, I have had to modify traditional techniques of psy­chotherapy. I am fascinated by, and enjoy, such intensive psychotherapy. I am also amazed to see the impact of previously unknown neuropathologic variations on development. The more I learn about the impact of neuropsychiatry on psychologi­cal development, the more I can help my patients.

Howard Wishnie, MD
Cambridge, Massachusetts

Dr. Nasrallah responds
I appreciate Dr. Stone’s kind words and concur­rence with my thinking about BPD. It would have been appropriate to include discussion of neuro­physiological findings in my Editorial, but I opted to use my limited space to focus on structural and functional neuroimaging and genetics.

Henry A. Nasrallah, MD
Professor and Chairman Department of Neurology & Psychiatry
Saint Louis University School of Medicine
St. Louis, Missouri

Dr. Henry A. Nasrallah’s recent Editorial on borderline personality disorder (BPD) (Current Psychiatry, From the Editor, April 2014, p. 19-20, 32 [http://bit.ly/1e8yAwE]) describes BPD as a heritable brain disease. I have been arguing this point for many years, often finding support from my colleague, Hagop Akiskal, MD, and opposition from my psychoanalytic colleagues.

In recent papers^1,2 on brain changes in BPD and the connection between BPD and bipolar disorders, I wrote that there often is a heritable aspect to the condition. There are exceptions to such heritability, as in the setting of a horrific environment (eg, father-daughter incest, parental brutality), where the same symptoms seen in BPD develop primarily from post-natal influences. Dr. Akiskal and I were discussing this a long time back, before MRI. Now I feel vindicated, with generous help from someone of Dr. Nasrallah’s prestige and influence.

There also is electrophysiological (including evoked potential) evi­dence for neural pathology in BPD, as well as data derived from single photon emission CT scanning. The burgeoning literature on MRI and functional MRI studies of BPD is in good agreement about the brain changes most relevant to BPD and that are found with regularity in this condition.

Particularly when BPD is diag­nosed in people (usually women) who do not have a history of neglect, sexual molestation, parental humili­ation or cruelty, or head injury, what else is there, if not genetically pre­disposed alterations in the fronto­limbic structures (and maybe the periaqueductal gray) that underlie the so-called “personality disorder,” and, not surprisingly, bipolar dis­orders, especially bipolar II disor­der, which often is the other side of the coin as BPD, and amenable to the same combination of medication and psychotherapy?

Michael H. Stone, MD
Professor of Clinical Psychiatry Columbia College of Physicians and Surgeons
New York, New York

----------------------------------------------------------------------------------------------------------

As a psychiatrist/psychoanalyst who works with BPD patients, I read Dr. Nasrallah’s April 2014 Editorial with great interest and enthusiasm. Over the past 10 years, I have been impressed with the number of patients with BPD whose nonverbal learning disorders and auditory and visual pro­cessing disorders have gone undiag­nosed. Recently, I lectured on this topic to the staff of a school for children with a range of neuropsychiatric disorders; the staff found my observations about such comorbidity consistent with their observations. These dysfunctions, or neurological variations—unknown to the parent and the child—interfere with early object-relation formation, attachment capacity, and learning. Neuropsychiatry and psychological development are, in fact, part of the same system.

An example: For 12 years, I have been treating a patient who has audi­tory processing and working memory problems, meaning that she could not process the connections among different ideas. This difficulty frus­trated her parents, who, in their frus­tration, criticized her for not paying attention. She was labeled “bad” and assumed the role of the “black sheep” in her family. Although she was intelligent, she was often wrong in her judgments and choices, and easily frustrated. In therapy, as I realized what part of her prob­lem was, I changed my technique.

When my patient asked me to tell her the sequence of understandings that we had just put together, I invited her to take my pad and write down her sense of it. As she described each part of that sequence to me, we would discuss it and I would remind her of lost fragments. Gradually, she learned to put ideas together; however, I also watched her struggle to hold these ideas in working memory and to use them.

Over time, she has improved and is more functional. After several years of dis­ability, she returned to work, although she still struggles interpersonally.

With many of such patients, I have had to modify traditional techniques of psy­chotherapy. I am fascinated by, and enjoy, such intensive psychotherapy. I am also amazed to see the impact of previously unknown neuropathologic variations on development. The more I learn about the impact of neuropsychiatry on psychologi­cal development, the more I can help my patients.

Howard Wishnie, MD
Cambridge, Massachusetts

Dr. Nasrallah responds
I appreciate Dr. Stone’s kind words and concur­rence with my thinking about BPD. It would have been appropriate to include discussion of neuro­physiological findings in my Editorial, but I opted to use my limited space to focus on structural and functional neuroimaging and genetics.

Henry A. Nasrallah, MD
Professor and Chairman Department of Neurology & Psychiatry
Saint Louis University School of Medicine
St. Louis, Missouri

Dear Dr. Mossman,

My patient, Ms. A, asked me to write a let­ter to her landlord (who has a “no pets” policy) stating that she needed to keep her dog in her apartment for “therapeutic” pur­poses—to provide comfort and reduce her posttraumatic stress (PTSD) and anxiety. I hesitated. Could my written statement make me liable if her dog bit someone?

Submitted by “Dr. B”

Studies showing that animals can help outpatients manage psychiatric condi­tions have received a lot of publicity lately. As a result, more patients are asking physicians to provide documentation to sup­port having pets in their apartments or letting their pets accompany them on planes and buses and at restaurants and shopping malls.

But sometimes, animals hurt people. The Centers for Disease Control and Prevention reports that dogs bite 4.5 million Americans each year and that one-fifth of dog bites cause injury that requires medical atten­tion; in 2012, more than 27,000 dog-bite vic­tims needed reconstructive surgery.¹ If Dr. B writes a letter to support letting Ms. A keep a dog in her apartment, how likely is Dr. B to incur professional liability?

To answer this question, let’s examine:
   • the history and background of “pet therapy”
   • types of assistance animals
   • potential liability for owners, land­lords, and clinicians.

History and background
Using animals to improve hospitalized patients’ mental well-being dates back to the 18th century.² In the late 1980s, medical pub­lications began to document systematically how service dogs whose primary role was to help physically disabled individuals to navigate independently also provided social and emotional benefits.^3-7 Since the 1990s, accessibility mandates in Title III of the Americans with Disabilities Act (ADA) (Table 1⁸) have led to the gradual acceptance of service animals in public places where their presence was previously frowned upon or prohibited.^9,10

If service dogs help people with physical problems feel better, it only makes sense that dogs and other animals might lessen emo­tional ailments, too.^11-13 Florence Nightingale and Sigmund Freud both recognized that involving pets in treatment reduced patients’ depression and anxiety,¹⁴ but credit for for­mally introducing animals into therapy usu­ally goes to psychologist Boris Levinson, whose 1969 book described how his dog Jingles helped troubled children communi­cate.¹⁵ Over the past decade, using animals— trained and untrained—for psychological assistance has become an increasingly popu­lar therapeutic maneuver for diverse mental disorders, including autism, anxiety, schizo­phrenia, and PTSD.^16-19

Terminology
Because animals can provide many types of assistance and support, a variety of terms are used to refer to them: service animals, com­panion animals, therapy pets, and so on. In certain situations (including the one described by Dr. B), carefully delineating animals’ roles and functions can reduce confusion and mis­interpretation by patients, health care profes­sionals, policy makers, and regulators.

Parenti et al²⁰ have proposed a “taxon­omy” for assistance dogs based on variables that include:
   • performing task related to a disability
   • the skill level required of the dog
   • who uses the dog
   • applicable training standards
   • legal protections for the dog and its handler.

Table 2²⁰ summarizes this classification system and key variables that differentiate types of assistance dogs.

Certification
Health care facilities often require that visit­ing dogs have some form of “certification” that they are well behaved, and the ADA and many state statutes require that service dogs and some other animals be “certified” to perform their roles. Yet no federal or state statutes lay out explicit training standards or requirements for certification. Therapy Dogs International²¹ and Pet Partners²² are 2 orga­nizations that provide certifications accepted by many agencies and organizations.

Assistance Dogs International, an assis­tance animal advocacy group, has proposed “minimum standards” for training and deployment of service dogs. These include responding to basic obedience commands from the client in public and at home, being able to perform at least 3 tasks to mitigate the client’s disability, teaching the client about dog training and health care, and scheduled follow-ups for skill maintenance. Dogs also should be spayed or neutered, properly vac­cinated, nonaggressive, clean, and continent in public places.²³

Liability laws
Most U.S. jurisdictions make owners liable for animal-caused injuries, including inju­ries caused by service dogs.²⁴ In many states (eg, Minnesota²⁵), an owner can be liable for dog-bite injury even if the owner did noth­ing wrong and had no reason to suspect from prior behavior that the dog might bite someone. Other jurisdictions require evi­dence of owner negligence, or they allow liability only when bites occur off the own­er’s premises²⁶ or if the owner let the dog run loose.²⁷ Many homeowners’ insurance policies include liability coverage for dog bites, and a few companies offer a special canine liability policy.

Landlords often try to bar tenants from having a dog, partly to avoid liability for dog bites. Most states have case law stating that, if a tenant’s apparently friendly dog bites someone, the landlord is not liable for the injury^28,29; landlords can be liable only if they know about a dangerous dog and do nothing about it.³⁰ In a recent decision, however, the Kentucky Supreme Court made landlords statutory owners with potential liability for dog bites if they give tenants permission to have dogs “on or about” the rental premises.³¹

Clinicians and liability
Asking tenants to provide documentation about their need for therapeutic pets has become standard operating procedure for landlords in many states, so Ms. A’s request to Dr. B sounds reasonable. But could Dr. B’s written statement lead to liability if Ms. A’s dog bit and injured someone else?

The best answer is, “It’s conceivable, but really unlikely.” Donna Vanderpool, MBA, JD, an author and attorney who develops and implements risk management services for psychiatrists, has not seen any claims or case reports on litigation blaming mental health clinicians for injury caused by emotional support pets after the clinicians had written a letter for housing purposes (oral and written communications, April 7-13, 2014).

Dr. B might wonder whether writing a let­ter for Ms. A would imply that he had evalu­ated the dog and Ms. A’s ability to control it. Psychiatrists don’t usually discuss—let alone evaluate—the temperament or behavior of their patients’ pets; even if they did they aren’t experts on pet training. Recognizing this, Dr. B’s letter could include a statement to the effect that he was not vouching for the dog’s behavior, but only for how the dog would help Ms. A.

Dr. B also might talk with Ms. A about her need for the dog and whether she had obtained appropriate certification, as dis­cussed above. The ADA provisions pertain­ing to use and presence of service animals do not apply to dogs that are merely patients’ pets, notwithstanding the genuine emotional benefits that a dog’s companionship might provide. Stating that a patient needs an ani­mal to treat an illness might be fraud if the doctor knew the pet was just a buddy.

Bottom Line
Psychiatrists can expect that more and more patients will ask them for letters to support having pets accompany them at home or in public. Although liability seems unlikely, cautious psychiatrists can state in such letters that they have not evaluated the animal in question, only the potential benefits that the patient might derive from it.

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

Dear Dr. Mossman,

My patient, Ms. A, asked me to write a let­ter to her landlord (who has a “no pets” policy) stating that she needed to keep her dog in her apartment for “therapeutic” pur­poses—to provide comfort and reduce her posttraumatic stress (PTSD) and anxiety. I hesitated. Could my written statement make me liable if her dog bit someone?

Submitted by “Dr. B”

Studies showing that animals can help outpatients manage psychiatric condi­tions have received a lot of publicity lately. As a result, more patients are asking physicians to provide documentation to sup­port having pets in their apartments or letting their pets accompany them on planes and buses and at restaurants and shopping malls.

But sometimes, animals hurt people. The Centers for Disease Control and Prevention reports that dogs bite 4.5 million Americans each year and that one-fifth of dog bites cause injury that requires medical atten­tion; in 2012, more than 27,000 dog-bite vic­tims needed reconstructive surgery.¹ If Dr. B writes a letter to support letting Ms. A keep a dog in her apartment, how likely is Dr. B to incur professional liability?

To answer this question, let’s examine:
   • the history and background of “pet therapy”
   • types of assistance animals
   • potential liability for owners, land­lords, and clinicians.

History and background
Using animals to improve hospitalized patients’ mental well-being dates back to the 18th century.² In the late 1980s, medical pub­lications began to document systematically how service dogs whose primary role was to help physically disabled individuals to navigate independently also provided social and emotional benefits.^3-7 Since the 1990s, accessibility mandates in Title III of the Americans with Disabilities Act (ADA) (Table 1⁸) have led to the gradual acceptance of service animals in public places where their presence was previously frowned upon or prohibited.^9,10

If service dogs help people with physical problems feel better, it only makes sense that dogs and other animals might lessen emo­tional ailments, too.^11-13 Florence Nightingale and Sigmund Freud both recognized that involving pets in treatment reduced patients’ depression and anxiety,¹⁴ but credit for for­mally introducing animals into therapy usu­ally goes to psychologist Boris Levinson, whose 1969 book described how his dog Jingles helped troubled children communi­cate.¹⁵ Over the past decade, using animals— trained and untrained—for psychological assistance has become an increasingly popu­lar therapeutic maneuver for diverse mental disorders, including autism, anxiety, schizo­phrenia, and PTSD.^16-19

Terminology
Because animals can provide many types of assistance and support, a variety of terms are used to refer to them: service animals, com­panion animals, therapy pets, and so on. In certain situations (including the one described by Dr. B), carefully delineating animals’ roles and functions can reduce confusion and mis­interpretation by patients, health care profes­sionals, policy makers, and regulators.

Parenti et al²⁰ have proposed a “taxon­omy” for assistance dogs based on variables that include:
   • performing task related to a disability
   • the skill level required of the dog
   • who uses the dog
   • applicable training standards
   • legal protections for the dog and its handler.

Table 2²⁰ summarizes this classification system and key variables that differentiate types of assistance dogs.

Certification
Health care facilities often require that visit­ing dogs have some form of “certification” that they are well behaved, and the ADA and many state statutes require that service dogs and some other animals be “certified” to perform their roles. Yet no federal or state statutes lay out explicit training standards or requirements for certification. Therapy Dogs International²¹ and Pet Partners²² are 2 orga­nizations that provide certifications accepted by many agencies and organizations.

Assistance Dogs International, an assis­tance animal advocacy group, has proposed “minimum standards” for training and deployment of service dogs. These include responding to basic obedience commands from the client in public and at home, being able to perform at least 3 tasks to mitigate the client’s disability, teaching the client about dog training and health care, and scheduled follow-ups for skill maintenance. Dogs also should be spayed or neutered, properly vac­cinated, nonaggressive, clean, and continent in public places.²³

Liability laws
Most U.S. jurisdictions make owners liable for animal-caused injuries, including inju­ries caused by service dogs.²⁴ In many states (eg, Minnesota²⁵), an owner can be liable for dog-bite injury even if the owner did noth­ing wrong and had no reason to suspect from prior behavior that the dog might bite someone. Other jurisdictions require evi­dence of owner negligence, or they allow liability only when bites occur off the own­er’s premises²⁶ or if the owner let the dog run loose.²⁷ Many homeowners’ insurance policies include liability coverage for dog bites, and a few companies offer a special canine liability policy.

Landlords often try to bar tenants from having a dog, partly to avoid liability for dog bites. Most states have case law stating that, if a tenant’s apparently friendly dog bites someone, the landlord is not liable for the injury^28,29; landlords can be liable only if they know about a dangerous dog and do nothing about it.³⁰ In a recent decision, however, the Kentucky Supreme Court made landlords statutory owners with potential liability for dog bites if they give tenants permission to have dogs “on or about” the rental premises.³¹

Clinicians and liability
Asking tenants to provide documentation about their need for therapeutic pets has become standard operating procedure for landlords in many states, so Ms. A’s request to Dr. B sounds reasonable. But could Dr. B’s written statement lead to liability if Ms. A’s dog bit and injured someone else?

The best answer is, “It’s conceivable, but really unlikely.” Donna Vanderpool, MBA, JD, an author and attorney who develops and implements risk management services for psychiatrists, has not seen any claims or case reports on litigation blaming mental health clinicians for injury caused by emotional support pets after the clinicians had written a letter for housing purposes (oral and written communications, April 7-13, 2014).

Dr. B might wonder whether writing a let­ter for Ms. A would imply that he had evalu­ated the dog and Ms. A’s ability to control it. Psychiatrists don’t usually discuss—let alone evaluate—the temperament or behavior of their patients’ pets; even if they did they aren’t experts on pet training. Recognizing this, Dr. B’s letter could include a statement to the effect that he was not vouching for the dog’s behavior, but only for how the dog would help Ms. A.

Dr. B also might talk with Ms. A about her need for the dog and whether she had obtained appropriate certification, as dis­cussed above. The ADA provisions pertain­ing to use and presence of service animals do not apply to dogs that are merely patients’ pets, notwithstanding the genuine emotional benefits that a dog’s companionship might provide. Stating that a patient needs an ani­mal to treat an illness might be fraud if the doctor knew the pet was just a buddy.

Bottom Line
Psychiatrists can expect that more and more patients will ask them for letters to support having pets accompany them at home or in public. Although liability seems unlikely, cautious psychiatrists can state in such letters that they have not evaluated the animal in question, only the potential benefits that the patient might derive from it.

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

Dear Dr. Mossman,

My patient, Ms. A, asked me to write a let­ter to her landlord (who has a “no pets” policy) stating that she needed to keep her dog in her apartment for “therapeutic” pur­poses—to provide comfort and reduce her posttraumatic stress (PTSD) and anxiety. I hesitated. Could my written statement make me liable if her dog bit someone?

Submitted by “Dr. B”

Studies showing that animals can help outpatients manage psychiatric condi­tions have received a lot of publicity lately. As a result, more patients are asking physicians to provide documentation to sup­port having pets in their apartments or letting their pets accompany them on planes and buses and at restaurants and shopping malls.

But sometimes, animals hurt people. The Centers for Disease Control and Prevention reports that dogs bite 4.5 million Americans each year and that one-fifth of dog bites cause injury that requires medical atten­tion; in 2012, more than 27,000 dog-bite vic­tims needed reconstructive surgery.¹ If Dr. B writes a letter to support letting Ms. A keep a dog in her apartment, how likely is Dr. B to incur professional liability?

To answer this question, let’s examine:
   • the history and background of “pet therapy”
   • types of assistance animals
   • potential liability for owners, land­lords, and clinicians.

History and background
Using animals to improve hospitalized patients’ mental well-being dates back to the 18th century.² In the late 1980s, medical pub­lications began to document systematically how service dogs whose primary role was to help physically disabled individuals to navigate independently also provided social and emotional benefits.^3-7 Since the 1990s, accessibility mandates in Title III of the Americans with Disabilities Act (ADA) (Table 1⁸) have led to the gradual acceptance of service animals in public places where their presence was previously frowned upon or prohibited.^9,10

If service dogs help people with physical problems feel better, it only makes sense that dogs and other animals might lessen emo­tional ailments, too.^11-13 Florence Nightingale and Sigmund Freud both recognized that involving pets in treatment reduced patients’ depression and anxiety,¹⁴ but credit for for­mally introducing animals into therapy usu­ally goes to psychologist Boris Levinson, whose 1969 book described how his dog Jingles helped troubled children communi­cate.¹⁵ Over the past decade, using animals— trained and untrained—for psychological assistance has become an increasingly popu­lar therapeutic maneuver for diverse mental disorders, including autism, anxiety, schizo­phrenia, and PTSD.^16-19

Terminology
Because animals can provide many types of assistance and support, a variety of terms are used to refer to them: service animals, com­panion animals, therapy pets, and so on. In certain situations (including the one described by Dr. B), carefully delineating animals’ roles and functions can reduce confusion and mis­interpretation by patients, health care profes­sionals, policy makers, and regulators.

Parenti et al²⁰ have proposed a “taxon­omy” for assistance dogs based on variables that include:
   • performing task related to a disability
   • the skill level required of the dog
   • who uses the dog
   • applicable training standards
   • legal protections for the dog and its handler.

Table 2²⁰ summarizes this classification system and key variables that differentiate types of assistance dogs.

Certification
Health care facilities often require that visit­ing dogs have some form of “certification” that they are well behaved, and the ADA and many state statutes require that service dogs and some other animals be “certified” to perform their roles. Yet no federal or state statutes lay out explicit training standards or requirements for certification. Therapy Dogs International²¹ and Pet Partners²² are 2 orga­nizations that provide certifications accepted by many agencies and organizations.

Assistance Dogs International, an assis­tance animal advocacy group, has proposed “minimum standards” for training and deployment of service dogs. These include responding to basic obedience commands from the client in public and at home, being able to perform at least 3 tasks to mitigate the client’s disability, teaching the client about dog training and health care, and scheduled follow-ups for skill maintenance. Dogs also should be spayed or neutered, properly vac­cinated, nonaggressive, clean, and continent in public places.²³

Liability laws
Most U.S. jurisdictions make owners liable for animal-caused injuries, including inju­ries caused by service dogs.²⁴ In many states (eg, Minnesota²⁵), an owner can be liable for dog-bite injury even if the owner did noth­ing wrong and had no reason to suspect from prior behavior that the dog might bite someone. Other jurisdictions require evi­dence of owner negligence, or they allow liability only when bites occur off the own­er’s premises²⁶ or if the owner let the dog run loose.²⁷ Many homeowners’ insurance policies include liability coverage for dog bites, and a few companies offer a special canine liability policy.

Landlords often try to bar tenants from having a dog, partly to avoid liability for dog bites. Most states have case law stating that, if a tenant’s apparently friendly dog bites someone, the landlord is not liable for the injury^28,29; landlords can be liable only if they know about a dangerous dog and do nothing about it.³⁰ In a recent decision, however, the Kentucky Supreme Court made landlords statutory owners with potential liability for dog bites if they give tenants permission to have dogs “on or about” the rental premises.³¹

Clinicians and liability
Asking tenants to provide documentation about their need for therapeutic pets has become standard operating procedure for landlords in many states, so Ms. A’s request to Dr. B sounds reasonable. But could Dr. B’s written statement lead to liability if Ms. A’s dog bit and injured someone else?

The best answer is, “It’s conceivable, but really unlikely.” Donna Vanderpool, MBA, JD, an author and attorney who develops and implements risk management services for psychiatrists, has not seen any claims or case reports on litigation blaming mental health clinicians for injury caused by emotional support pets after the clinicians had written a letter for housing purposes (oral and written communications, April 7-13, 2014).

Dr. B might wonder whether writing a let­ter for Ms. A would imply that he had evalu­ated the dog and Ms. A’s ability to control it. Psychiatrists don’t usually discuss—let alone evaluate—the temperament or behavior of their patients’ pets; even if they did they aren’t experts on pet training. Recognizing this, Dr. B’s letter could include a statement to the effect that he was not vouching for the dog’s behavior, but only for how the dog would help Ms. A.

Dr. B also might talk with Ms. A about her need for the dog and whether she had obtained appropriate certification, as dis­cussed above. The ADA provisions pertain­ing to use and presence of service animals do not apply to dogs that are merely patients’ pets, notwithstanding the genuine emotional benefits that a dog’s companionship might provide. Stating that a patient needs an ani­mal to treat an illness might be fraud if the doctor knew the pet was just a buddy.

Bottom Line
Psychiatrists can expect that more and more patients will ask them for letters to support having pets accompany them at home or in public. Although liability seems unlikely, cautious psychiatrists can state in such letters that they have not evaluated the animal in question, only the potential benefits that the patient might derive from it.

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

Prescription medications

Credit: CDC

Patients who delay filling a prescription of clopidogrel after coronary stenting may increase their risk of recurrent myocardial infarction (MI) and death, according to a study published in the Journal of the American Heart Association. 

Researchers analyzed records of more than 15,000 patients who received drug-eluting or bare metal stents.

Roughly 30% of patients in each group failed to fill their prescription of the anticoagulant clopidogrel within 3 days of hospital discharge.

And this roughly doubled the patients’ risk of death and recurrent MI, regardless of their stent type.

“It is very important that patients take clopidogrel after having a coronary stent implanted to prevent blood clots forming within the stent,” said study author Nicholas Cruden, MBChB, PhD, of the Royal Infirmary of Edinburgh in the UK.

He and his colleagues analyzed hospital administrative, community pharmacy, and cardiac revascularization data from all patients who received a coronary stent in British Columbia between 2004 and 2006, with follow-up out to 2 years.

Of the 15,629 patients, 3599 had received at least 1 drug-eluting stent (DES), and 12,030 had received a bare metal stent (BMS). Thirty percent (n=1064) of patients in the DES group, and 31% (n=3758) of patients in the BMS group failed to fill their prescription for clopidogrel within 3 days of hospital discharge.

And a delay of more than 3 days was predictive of mortality and recurrent MI, regardless of the stent type. The hazard ratios (HRs) for mortality were 2.4 for the DES group and 2.2 for the BMS group. The HRs for recurrent MI were 2.0 and 1.8, respectively.

The excess risk associated with a delay in filling the prescription was greatest in the immediate period after hospital discharge—up to 30 days. In all patients, the HRs were 5.5 for mortality and 3.1 for recurrent MI.

Delaying filling the prescription for more than 3 days remained an independent predictor of death and MI beyond 30 days from hospital discharge. The HRs were 2.1 and 2.0, respectively, for patients in the DES group and 2.0 and 1.8, respectively, for patients in the BMS group.

“This study highlights the importance of ensuring patients have access to medications as soon as they leave the hospital,” Dr Cruden said. “Even a delay of a day or 2 was associated with worse outcomes.”

Discharging patients from the hospital with enough medicine for the highest-risk period (the first month or so) could help, he added.

Prescription medications

Credit: CDC

Patients who delay filling a prescription of clopidogrel after coronary stenting may increase their risk of recurrent myocardial infarction (MI) and death, according to a study published in the Journal of the American Heart Association. 

Researchers analyzed records of more than 15,000 patients who received drug-eluting or bare metal stents.

Roughly 30% of patients in each group failed to fill their prescription of the anticoagulant clopidogrel within 3 days of hospital discharge.

And this roughly doubled the patients’ risk of death and recurrent MI, regardless of their stent type.

“It is very important that patients take clopidogrel after having a coronary stent implanted to prevent blood clots forming within the stent,” said study author Nicholas Cruden, MBChB, PhD, of the Royal Infirmary of Edinburgh in the UK.

He and his colleagues analyzed hospital administrative, community pharmacy, and cardiac revascularization data from all patients who received a coronary stent in British Columbia between 2004 and 2006, with follow-up out to 2 years.

Of the 15,629 patients, 3599 had received at least 1 drug-eluting stent (DES), and 12,030 had received a bare metal stent (BMS). Thirty percent (n=1064) of patients in the DES group, and 31% (n=3758) of patients in the BMS group failed to fill their prescription for clopidogrel within 3 days of hospital discharge.

And a delay of more than 3 days was predictive of mortality and recurrent MI, regardless of the stent type. The hazard ratios (HRs) for mortality were 2.4 for the DES group and 2.2 for the BMS group. The HRs for recurrent MI were 2.0 and 1.8, respectively.

The excess risk associated with a delay in filling the prescription was greatest in the immediate period after hospital discharge—up to 30 days. In all patients, the HRs were 5.5 for mortality and 3.1 for recurrent MI.

Delaying filling the prescription for more than 3 days remained an independent predictor of death and MI beyond 30 days from hospital discharge. The HRs were 2.1 and 2.0, respectively, for patients in the DES group and 2.0 and 1.8, respectively, for patients in the BMS group.

“This study highlights the importance of ensuring patients have access to medications as soon as they leave the hospital,” Dr Cruden said. “Even a delay of a day or 2 was associated with worse outcomes.”

Discharging patients from the hospital with enough medicine for the highest-risk period (the first month or so) could help, he added.

Prescription medications

Credit: CDC

Patients who delay filling a prescription of clopidogrel after coronary stenting may increase their risk of recurrent myocardial infarction (MI) and death, according to a study published in the Journal of the American Heart Association. 

Researchers analyzed records of more than 15,000 patients who received drug-eluting or bare metal stents.

Roughly 30% of patients in each group failed to fill their prescription of the anticoagulant clopidogrel within 3 days of hospital discharge.

And this roughly doubled the patients’ risk of death and recurrent MI, regardless of their stent type.

“It is very important that patients take clopidogrel after having a coronary stent implanted to prevent blood clots forming within the stent,” said study author Nicholas Cruden, MBChB, PhD, of the Royal Infirmary of Edinburgh in the UK.

He and his colleagues analyzed hospital administrative, community pharmacy, and cardiac revascularization data from all patients who received a coronary stent in British Columbia between 2004 and 2006, with follow-up out to 2 years.

Of the 15,629 patients, 3599 had received at least 1 drug-eluting stent (DES), and 12,030 had received a bare metal stent (BMS). Thirty percent (n=1064) of patients in the DES group, and 31% (n=3758) of patients in the BMS group failed to fill their prescription for clopidogrel within 3 days of hospital discharge.

And a delay of more than 3 days was predictive of mortality and recurrent MI, regardless of the stent type. The hazard ratios (HRs) for mortality were 2.4 for the DES group and 2.2 for the BMS group. The HRs for recurrent MI were 2.0 and 1.8, respectively.

The excess risk associated with a delay in filling the prescription was greatest in the immediate period after hospital discharge—up to 30 days. In all patients, the HRs were 5.5 for mortality and 3.1 for recurrent MI.

Delaying filling the prescription for more than 3 days remained an independent predictor of death and MI beyond 30 days from hospital discharge. The HRs were 2.1 and 2.0, respectively, for patients in the DES group and 2.0 and 1.8, respectively, for patients in the BMS group.

“This study highlights the importance of ensuring patients have access to medications as soon as they leave the hospital,” Dr Cruden said. “Even a delay of a day or 2 was associated with worse outcomes.”

Discharging patients from the hospital with enough medicine for the highest-risk period (the first month or so) could help, he added.

In November 2013, The American College of Obstetricians and Gynecologists (ACOG) published the results of its Task Force on Hypertension in Pregnancy.¹ The Task Force aimed to help clinicians become familiar with the state of research in hypertension during pregnancy as well as to assist us in standardizing management approaches to such patients.

The Task Force reported that, worldwide, hypertensive disorders complicate approximately 10% of pregnancies. In addition, in the United States, the past 20 years have brought a 25% increase in the incidence of preeclampsia. According to past ACOG President James N. Martin, Jr, MD, in the last 10 years, the pathophysiology of preeclampsia has become better understood, but the etiology remains unclear and evidence that has emerged to guide therapy has not translated into clinical practice.¹

Related articles:
The latest guidance from ACOG on hypertension in pregnancy. Jaimey E. Pauli, MD (Audiocast, January 2014)
Update on Obstetrics. Jaimey E. Pauli, MD, and John T. Repke, MD (January 2014)

The Task Force document contained 60 recommendations for the prevention, prediction, and management of hypertensive disorders of pregnancy, including preeclampsia, gestational hypertension, chronic hypertension, HELLP syndrome, and preeclampsia superimposed on an underlying hypertensive disorder (see box below). One recommendation was that women at high risk for preeclampsia, particularly those with a history of preeclampsia that required delivery before 34 weeks, could possibly benefit from taking aspirin (60–81 mg) daily starting at the end of the first trimester. They further noted that this benefit could include prevention of recurrent severe preeclampsia, or at least a reduction in recurrence risk.

The ACOG Task Force made its recommendation based on results of a meta-analysis of low-dose aspirin trials, involving more than 30,000 patients,² suggesting a small decrease in the risk of preeclampsia and associated morbidity. More precise risk reduction estimates were difficult to make due to the heterogeneity of the studies reviewed. And the Task Force further stated that this (low-dose aspirin) approach had no demonstrable acute adverse fetal effects, although long-term adverse effects could not be entirely excluded based on the current data.

Unfortunately, according to the ACOG document, the strength of the evidence supporting their recommendation was “moderate” and the strength of the recommendation was “qualified” so, not exactly a resounding endorsement of this approach, but a recommendation nonetheless.

OBSTETRIC PRACTICE CHANGERS 2014
Hypertension and pregnancy and preventing the first cesarean delivery

Data suggest aspirin for high-risk women could be reasonable
A recent study by Henderson and colleagues presented a systematic review for the US Preventive Services Task Force (USPSTF) on the potential for low-dose aspirin to prevent morbidity and mortality from preeclampsia.³ The design was a meta-analysis of 28 studies: two large, multisite, randomized clinical trials (RCTs); 13 smaller RCTs of high-risk women, of which eight were deemed “good quality”; and six RCTs and two observational studies of average-risk women, of which seven were deemed to be good quality.

The results essentially supported the notion that low-dose aspirin had a beneficial effect with respect to prevention of preeclampsia and perinatal morbidity in women at high risk for preeclampsia. Additionally, no harmful effects were identified, although the authors acknowledged potential rare or long-term harm could not be excluded.

Questions remain
While somewhat gratifying, the results of the USPSTF systematic review still leave many questions. First, the dose of aspirin used in the studies analyzed ranged from 50 mg/d to 150 mg/d. In the United States, “low-dose” aspirin is usually prescribed at 81 mg/d, so the applicability of this review’s findings to US clinical practice is not exact. Second, the authors acknowledged that the putative positive effects observed could be secondary to so-called “small study effects,” and that when only the larger studies were analyzed the effects were less impressive.

Related article: A stepwise approach to managing eclampsia and other hypertensive emergencies. Baha M. Sibai (October 2013)

In my opinion, both the USPSTF study and the recommendations from the ACOG Task Force provide some reassurance for clinicians that the use of daily, low-dose aspirin by women at high risk for preeclampsia probably does afford some benefit, and seems to be a safe approach—as we have known from the initial Maternal-Fetal Medicine Units (MFMU) trial published in 1993 on low-risk women⁴ and the follow-up MFMU study on high-risk women.⁵

The need for additional studies is clear, however. The idea that preeclampsia is the same in every patient would seem to make no more sense than thinking all cancer is the same, with the same risk factors, the same epidemiology and pathophysiology, and the same response to similar treatments. Fundamentally, we need to further explore the different pathways through which preeclampsia develops in women and then apply the strategy best suited to treating (or preventing) their form of the disease—a personalized medicine approach.

In the meantime, most patients who have delivered at 34 weeks or less because of preeclampsia and who are contemplating another pregnancy are really not interested in hearing us tell them that we cannot do anything to prevent recurrent preeclampsia because we are awaiting further studies. At least the ACOG recommendations and the results of the USPSTF’s systematic review provide us with a reasonable, although perhaps not yet optimal, therapeutic option.

Related article: 10 practical, evidence-based recommendations to improve outcomes in women who have eclampsia. Baha M. Sibai (November 2011)

The bottom line
In my own practice, I discuss the option of initiating low-dose aspirin (81 mg/d) as early as 12 weeks’ gestation for patients who had either prior early-onset preeclampsia requiring delivery before 34 weeks’ gestation or preeclampsia during more than one pregnancy.

QUICK POLL
Do you offer low-dose aspirin for preeclampsia prevention?
When faced with a patient with prior preeclampsia in more than one pregnancy or with preeclampsia that resulted in delivery prior to 34 weeks, do you offer low-dose aspirin as an option for preventing preeclampsia?
Visit the Quick Poll on the right column of the OBGManagement.com home page to register your answer and see how your colleagues voted.

WE WANT TO HEAR FROM YOU!
Share your thoughts on this article. Send your Letter to the Editor to: [email protected]

In November 2013, The American College of Obstetricians and Gynecologists (ACOG) published the results of its Task Force on Hypertension in Pregnancy.¹ The Task Force aimed to help clinicians become familiar with the state of research in hypertension during pregnancy as well as to assist us in standardizing management approaches to such patients.

The Task Force reported that, worldwide, hypertensive disorders complicate approximately 10% of pregnancies. In addition, in the United States, the past 20 years have brought a 25% increase in the incidence of preeclampsia. According to past ACOG President James N. Martin, Jr, MD, in the last 10 years, the pathophysiology of preeclampsia has become better understood, but the etiology remains unclear and evidence that has emerged to guide therapy has not translated into clinical practice.¹

Related articles:
The latest guidance from ACOG on hypertension in pregnancy. Jaimey E. Pauli, MD (Audiocast, January 2014)
Update on Obstetrics. Jaimey E. Pauli, MD, and John T. Repke, MD (January 2014)

The Task Force document contained 60 recommendations for the prevention, prediction, and management of hypertensive disorders of pregnancy, including preeclampsia, gestational hypertension, chronic hypertension, HELLP syndrome, and preeclampsia superimposed on an underlying hypertensive disorder (see box below). One recommendation was that women at high risk for preeclampsia, particularly those with a history of preeclampsia that required delivery before 34 weeks, could possibly benefit from taking aspirin (60–81 mg) daily starting at the end of the first trimester. They further noted that this benefit could include prevention of recurrent severe preeclampsia, or at least a reduction in recurrence risk.

The ACOG Task Force made its recommendation based on results of a meta-analysis of low-dose aspirin trials, involving more than 30,000 patients,² suggesting a small decrease in the risk of preeclampsia and associated morbidity. More precise risk reduction estimates were difficult to make due to the heterogeneity of the studies reviewed. And the Task Force further stated that this (low-dose aspirin) approach had no demonstrable acute adverse fetal effects, although long-term adverse effects could not be entirely excluded based on the current data.

Unfortunately, according to the ACOG document, the strength of the evidence supporting their recommendation was “moderate” and the strength of the recommendation was “qualified” so, not exactly a resounding endorsement of this approach, but a recommendation nonetheless.

OBSTETRIC PRACTICE CHANGERS 2014
Hypertension and pregnancy and preventing the first cesarean delivery

Data suggest aspirin for high-risk women could be reasonable
A recent study by Henderson and colleagues presented a systematic review for the US Preventive Services Task Force (USPSTF) on the potential for low-dose aspirin to prevent morbidity and mortality from preeclampsia.³ The design was a meta-analysis of 28 studies: two large, multisite, randomized clinical trials (RCTs); 13 smaller RCTs of high-risk women, of which eight were deemed “good quality”; and six RCTs and two observational studies of average-risk women, of which seven were deemed to be good quality.

The results essentially supported the notion that low-dose aspirin had a beneficial effect with respect to prevention of preeclampsia and perinatal morbidity in women at high risk for preeclampsia. Additionally, no harmful effects were identified, although the authors acknowledged potential rare or long-term harm could not be excluded.

Questions remain
While somewhat gratifying, the results of the USPSTF systematic review still leave many questions. First, the dose of aspirin used in the studies analyzed ranged from 50 mg/d to 150 mg/d. In the United States, “low-dose” aspirin is usually prescribed at 81 mg/d, so the applicability of this review’s findings to US clinical practice is not exact. Second, the authors acknowledged that the putative positive effects observed could be secondary to so-called “small study effects,” and that when only the larger studies were analyzed the effects were less impressive.

Related article: A stepwise approach to managing eclampsia and other hypertensive emergencies. Baha M. Sibai (October 2013)

In my opinion, both the USPSTF study and the recommendations from the ACOG Task Force provide some reassurance for clinicians that the use of daily, low-dose aspirin by women at high risk for preeclampsia probably does afford some benefit, and seems to be a safe approach—as we have known from the initial Maternal-Fetal Medicine Units (MFMU) trial published in 1993 on low-risk women⁴ and the follow-up MFMU study on high-risk women.⁵

The need for additional studies is clear, however. The idea that preeclampsia is the same in every patient would seem to make no more sense than thinking all cancer is the same, with the same risk factors, the same epidemiology and pathophysiology, and the same response to similar treatments. Fundamentally, we need to further explore the different pathways through which preeclampsia develops in women and then apply the strategy best suited to treating (or preventing) their form of the disease—a personalized medicine approach.

In the meantime, most patients who have delivered at 34 weeks or less because of preeclampsia and who are contemplating another pregnancy are really not interested in hearing us tell them that we cannot do anything to prevent recurrent preeclampsia because we are awaiting further studies. At least the ACOG recommendations and the results of the USPSTF’s systematic review provide us with a reasonable, although perhaps not yet optimal, therapeutic option.

Related article: 10 practical, evidence-based recommendations to improve outcomes in women who have eclampsia. Baha M. Sibai (November 2011)

The bottom line
In my own practice, I discuss the option of initiating low-dose aspirin (81 mg/d) as early as 12 weeks’ gestation for patients who had either prior early-onset preeclampsia requiring delivery before 34 weeks’ gestation or preeclampsia during more than one pregnancy.

QUICK POLL
Do you offer low-dose aspirin for preeclampsia prevention?
When faced with a patient with prior preeclampsia in more than one pregnancy or with preeclampsia that resulted in delivery prior to 34 weeks, do you offer low-dose aspirin as an option for preventing preeclampsia?
Visit the Quick Poll on the right column of the OBGManagement.com home page to register your answer and see how your colleagues voted.

WE WANT TO HEAR FROM YOU!
Share your thoughts on this article. Send your Letter to the Editor to: [email protected]

In November 2013, The American College of Obstetricians and Gynecologists (ACOG) published the results of its Task Force on Hypertension in Pregnancy.¹ The Task Force aimed to help clinicians become familiar with the state of research in hypertension during pregnancy as well as to assist us in standardizing management approaches to such patients.

The Task Force reported that, worldwide, hypertensive disorders complicate approximately 10% of pregnancies. In addition, in the United States, the past 20 years have brought a 25% increase in the incidence of preeclampsia. According to past ACOG President James N. Martin, Jr, MD, in the last 10 years, the pathophysiology of preeclampsia has become better understood, but the etiology remains unclear and evidence that has emerged to guide therapy has not translated into clinical practice.¹

Related articles:
The latest guidance from ACOG on hypertension in pregnancy. Jaimey E. Pauli, MD (Audiocast, January 2014)
Update on Obstetrics. Jaimey E. Pauli, MD, and John T. Repke, MD (January 2014)

The Task Force document contained 60 recommendations for the prevention, prediction, and management of hypertensive disorders of pregnancy, including preeclampsia, gestational hypertension, chronic hypertension, HELLP syndrome, and preeclampsia superimposed on an underlying hypertensive disorder (see box below). One recommendation was that women at high risk for preeclampsia, particularly those with a history of preeclampsia that required delivery before 34 weeks, could possibly benefit from taking aspirin (60–81 mg) daily starting at the end of the first trimester. They further noted that this benefit could include prevention of recurrent severe preeclampsia, or at least a reduction in recurrence risk.

The ACOG Task Force made its recommendation based on results of a meta-analysis of low-dose aspirin trials, involving more than 30,000 patients,² suggesting a small decrease in the risk of preeclampsia and associated morbidity. More precise risk reduction estimates were difficult to make due to the heterogeneity of the studies reviewed. And the Task Force further stated that this (low-dose aspirin) approach had no demonstrable acute adverse fetal effects, although long-term adverse effects could not be entirely excluded based on the current data.

Unfortunately, according to the ACOG document, the strength of the evidence supporting their recommendation was “moderate” and the strength of the recommendation was “qualified” so, not exactly a resounding endorsement of this approach, but a recommendation nonetheless.

OBSTETRIC PRACTICE CHANGERS 2014
Hypertension and pregnancy and preventing the first cesarean delivery

Data suggest aspirin for high-risk women could be reasonable
A recent study by Henderson and colleagues presented a systematic review for the US Preventive Services Task Force (USPSTF) on the potential for low-dose aspirin to prevent morbidity and mortality from preeclampsia.³ The design was a meta-analysis of 28 studies: two large, multisite, randomized clinical trials (RCTs); 13 smaller RCTs of high-risk women, of which eight were deemed “good quality”; and six RCTs and two observational studies of average-risk women, of which seven were deemed to be good quality.

The results essentially supported the notion that low-dose aspirin had a beneficial effect with respect to prevention of preeclampsia and perinatal morbidity in women at high risk for preeclampsia. Additionally, no harmful effects were identified, although the authors acknowledged potential rare or long-term harm could not be excluded.

Questions remain
While somewhat gratifying, the results of the USPSTF systematic review still leave many questions. First, the dose of aspirin used in the studies analyzed ranged from 50 mg/d to 150 mg/d. In the United States, “low-dose” aspirin is usually prescribed at 81 mg/d, so the applicability of this review’s findings to US clinical practice is not exact. Second, the authors acknowledged that the putative positive effects observed could be secondary to so-called “small study effects,” and that when only the larger studies were analyzed the effects were less impressive.

Related article: A stepwise approach to managing eclampsia and other hypertensive emergencies. Baha M. Sibai (October 2013)

In my opinion, both the USPSTF study and the recommendations from the ACOG Task Force provide some reassurance for clinicians that the use of daily, low-dose aspirin by women at high risk for preeclampsia probably does afford some benefit, and seems to be a safe approach—as we have known from the initial Maternal-Fetal Medicine Units (MFMU) trial published in 1993 on low-risk women⁴ and the follow-up MFMU study on high-risk women.⁵

The need for additional studies is clear, however. The idea that preeclampsia is the same in every patient would seem to make no more sense than thinking all cancer is the same, with the same risk factors, the same epidemiology and pathophysiology, and the same response to similar treatments. Fundamentally, we need to further explore the different pathways through which preeclampsia develops in women and then apply the strategy best suited to treating (or preventing) their form of the disease—a personalized medicine approach.

In the meantime, most patients who have delivered at 34 weeks or less because of preeclampsia and who are contemplating another pregnancy are really not interested in hearing us tell them that we cannot do anything to prevent recurrent preeclampsia because we are awaiting further studies. At least the ACOG recommendations and the results of the USPSTF’s systematic review provide us with a reasonable, although perhaps not yet optimal, therapeutic option.

Related article: 10 practical, evidence-based recommendations to improve outcomes in women who have eclampsia. Baha M. Sibai (November 2011)

The bottom line
In my own practice, I discuss the option of initiating low-dose aspirin (81 mg/d) as early as 12 weeks’ gestation for patients who had either prior early-onset preeclampsia requiring delivery before 34 weeks’ gestation or preeclampsia during more than one pregnancy.

QUICK POLL
Do you offer low-dose aspirin for preeclampsia prevention?
When faced with a patient with prior preeclampsia in more than one pregnancy or with preeclampsia that resulted in delivery prior to 34 weeks, do you offer low-dose aspirin as an option for preventing preeclampsia?
Visit the Quick Poll on the right column of the OBGManagement.com home page to register your answer and see how your colleagues voted.

WE WANT TO HEAR FROM YOU!
Share your thoughts on this article. Send your Letter to the Editor to: [email protected]

Woman loses both legs after salpingectomy: $64.3M award
Due to an ectopic pregnancy, a 29-year-old woman underwent laparoscopic salpingectomy in October 2009. A resident supervised by Dr. A (gynecologist) performed the surgery. Although the patient reported abdominal pain and was febrile, Dr. B (gynecologist) discharged her on postsurgical day 2.

The next day, she returned to the emergency department (ED) with abdominal swelling and pain. Dr. C (ED physician), Dr. D (gynecologist), and Dr. E (general surgeon) examined her. Dr. D began conservative treatment for bowel obstruction. Two days later she was in septic shock. Dr. E repaired a 5-mm injury to the sigmoid colon and created a colostomy. The patient was placed in a medically induced coma for 3 weeks. She experienced cardiac arrest 3 times during her 73-day ICU stay. She  underwent skin grafts, and suffered hearing loss as a result of antibiotic treatment. Due to gangrene, both legs were amputated below the knee.

At the trial’s conclusion in January 2014, the colostomy had not been reversed. She has difficulty caring for her daughter and has not worked since the initial operation.

PATIENT’S CLAIM The resident, who injured the colon and did not detect the injury during surgery, was improperly supervised by Dr. A. Hospital staff did not communicate the patient’s problem reports to the physicians. Dr. B should not have discharged her after surgery; based on her reported symptoms, additional testing was warranted. Drs. C, D, and E did not react to the patient’s pain reports in a timely manner, nor treat the resulting sepsis aggressively enough, leading to gangrene.

DEFENDANTS’ DEFENSE The patient’s colon injury was diagnosed and treated in a timely manner, but her condition deteriorated rapidly. The physicians acted responsibly based on the available information; a computed tomography scan did not show the colon injury. The injury likely occurred after the procedure due to an underlying bowel condition and is a known risk of the procedure. The colostomy can be reversed. Their efforts saved her life.

VERDICT The patient and Dr. E negotiated a $2.3 million settlement. A $62 million New York verdict was returned. The jury found the hospital 40% liable; Dr. A 30% liable; Dr. B 20% liable; and Dr. D 10% liable. Claims were dropped against the resident and Dr. C.

Related article: Oophorectomy or salpingectomy—which makes more sense? William H. Parker, MD (March 2014)

PARENTS REQUESTED EARLIER CESAREAN: CHILD HAS CP
A woman was in labor for 2 full days before her ObGyn performed a cesarean delivery. The child was born with abnormal Apgar scores and had seizures. Imaging studies revealed brain damage. She received a diagnosis of cerebral palsy.

PARENTS’ CLAIM The parents first requested cesarean delivery early on the second day, but the ObGyn allowed labor to progress. When the fetal heart-rate monitor showed signs of fetal distress 3 hours later, the parents made a second request; the ObGyn continued with vaginal delivery. The child was ultimately born by cesarean delivery. Her brain damage was caused by lack of oxygen from failure to perform an earlier cesarean delivery.

DEFENDANTS’ DEFENSE The case was settled during the trial.

VERDICT A $4.25 million Massachusetts settlement was reached.

BLADDER INJURED DURING CESAREAN DELIVERY
A 33-year-old woman gave birth via cesarean delivery performed by her ObGyn. During the procedure, the patient’s bladder was lacerated and the injury was immediately repaired. The patient reports occasional urinary incontinence and pain.

PATIENT’S CLAIM The ObGyn should have anticipated that the bladder would be shifted because of the patient’s previous cesarean delivery.

PHYSICIAN’S DEFENSE The injury is a known risk of the procedure. The patient had developed adhesions that caused the bladder to become displaced. She does not suffer permanent residual effects from the injury.

VERDICT A $125,000 New York verdict was returned.

Related article: 10 practical, evidence-based recommendations for improving maternal outcomes of cesarean delivery. Baha M. Sibai (March 2012)

PARENTS REQUESTED SPECIFIC GENETIC TESTING, BUT CHILD IS BORN WITH RARE CHROMOSOMAL CONDITION: $50M VERDICT
Parents sought prenatal genetic testing to determine if their fetus had a specific genetic condition because the father carries a rare chromosomal abnormality called an unbalanced chromosome translocation. This defect can only be identified if the laboratory is told precisely where to look for the specific translocation; it is not detected on routine prenatal genetic testing. After testing, the parents were told that the fetus did not have the chromosomal abnormality.

The child was born with the condition for which testing was sought, resulting in severe physical and cognitive impairments and multiple physical abnormalities. He will require 24-hour care for life.

PARENTS’ CLAIM Testing failed to identify the condition; the couple had decided to terminate the pregnancy if the child was affected. Due to budget cuts in the maternal-fetal medicine clinic, the medical center borrowed a genetic counselor from another hospital one day a week. The parents told the genetic counselor of the family’s history of the defect and explained that the laboratory’s procedures require the referring center to obtain and share the necessary detailed information with the lab. The lab was apparently notified that the couple had a family history of the defect, but the genetic counselor did not transmit specific information to the lab, and lab personnel did not appropriately follow-up.

DEFENDANTS’ DEFENSE The medical center blamed the laboratory: the lab’s standard procedures state that the lab should call the referring center to obtain the necessary detailed information if it was not provided; the lab employee who handled the specimen did not do so. The lab claimed that the genetic counselor did not transmit the specific information to the lab.

The laboratory disputed the child’s need for 24/7 care, maintaining that he could live in a group home with only occasional nursing care.

VERDICT A $50 million Washington verdict was returned against the medical center and laboratory; each defendant will pay $25 million.

Related article: Noninvasive prenatal testing: Where we are and where we’re going. Lee P. Shulman, MD (Commentary; May 2014)

NECROTIZING FASCIITIS AFTER SURGERY
A 57-year-old woman underwent surgery to repair vaginal vault prolapse, rectocele, and enterocele, performed by her gynecologist. Several days after discharge, the patient returned to the hospital with an infection in her leg that had evolved into necrotizing fasciitis. She underwent five fasciotomies and was hospitalized for 3 weeks.

PATIENT’S CLAIM The gynecologist should have administered prophylactic antibiotics before, during, and after surgery. The patient has massive scarring of her leg.

PHYSICIAN’S DEFENSE The infection was not a result of failing to administer antibiotics. The patient failed to seek timely treatment of symptoms that developed after surgery.

VERDICT A $400,000 New York verdict was returned but reduced because the jury found the patient 49% at fault.

OXYTOCIN BLAMED FOR CHILD’S CP
A mother had bariatric surgery 12 months before becoming pregnant, and she smoked during pregnancy. She developed placental insufficiency and labor was induced shortly after she reached 37 weeks’ gestation.

During delivery, the mother was given oxytocin to increase the frequency and strength of contractions. Nurses repeatedly stopped the oxytocin in response to decelerations in the fetal heart rate, but physicians ordered the oxytocin resumed, even after fetal heart-rate monitoring showed fetal distress.

Three days after birth, the child was transferred to another hospital, and was found to have cerebral palsy and other injuries. At age 5, the child is nonverbal, cannot walk, and requires a feeding tube.

PARENTS’ CLAIM Oxytocin should have been stopped and a cesarean delivery performed when fetal distress was first noted.

DEFENDANTS’ DEFENSE There was no need for cesarean delivery. Apgar scores, blood gases, and fetal presentation indicated that the injury occurred prior to labor.

VERDICT A $6 million Texas settlement was reached during the trial.

Related article: Q: Following cesarean delivery, what is the optimal oxytocin infusion duration to prevent postpartum bleeding? Robert L. Barbieri, MD (Editorial; April 2014)

MOTHER DISCHARGED DESPITE SEVERE ABDOMINAL PAIN
A woman had prenatal care at different locations. Her history included two cesarean deliveries.

Reporting severe abdominal pain, she was taken from a homeless shelter to an ED by ambulance. The mother was uncertain of the fetus’ gestational age; a 4th-year obstetric resident determined by physical examination that the pregnancy was at 36.5 weeks. The resident discussed the case with the attending ObGyn, who said to discharge the mother if her pain was gone. After 11 hours, the mother was returned to the shelter.

The mother returned to the ED 12 hours later. Thirty-five minutes after fetal distress was identified, an emergency cesarean delivery was performed. At birth, the child was found to be at 38 to 39 weeks’ gestation. He received a diagnosis of severe hypoxic ischemic encephalopathy and was transferred to a children’s hospital for brain cooling.

The child lives in a long-term care facility and is dependent on a ventilator and gastronomy tube.

PARENT’S CLAIM The mother should not have been discharged after the first visit. A cesarean delivery should have been performed at that time. The attending ObGyn never saw the mother.

DEFENDANTS’ DEFENSE The mother should have given her correct due date, which was in her prenatal records based on previous ultrasonograpy. The first discharge was proper, as the pain had improved. The homeless shelter should have called an ambulance earlier for the second admission.

VERDICT A $7.5 million California settlement was reached, plus payment of medical expenses exceeding $300,000. 

Timing of child’s injury disputed
Vaginal birth after cesarean (VBAC) had been planned. After reporting to her ObGyn that she was in labor, a mother went to the ED.

During the next few hours, hospital staff called the ObGyn twice to report that fetal monitor strips indicated tachycardia. The ObGyn then spoke to the mother by phone and told her that cesarean delivery was necessary but could wait for him to get to the hospital. After the ObGyn arrived, he removed the fetal heart-rate monitor to prepare the mother’s abdomen; cesarean delivery occurred 15 minutes later.

The child has spastic dystonic quadriplegia and requires 24-hour care.

PARENT’S CLAIM The ObGyn should have come to the hospital and performed cesarean delivery when he was first notified that the fetus was tachycardic. The baby suffered an hypoxic ischemic event in the 15-minute period between when the monitor was removed and birth, causing hypoxic ischemic encephalopathy.

PHYSICIAN’S DEFENSE There was no indication of a need for earlier delivery. The brain injury occurred prior to labor and delivery.

VERDICT The hospital settled for a confidential amount before the trial. An Illinois defense verdict was returned for the ObGyn.

Were mammograms properly interpreted?
After reporting a lump in her breast, a 39-year-old woman underwent mammography in 2008 and 2009. Two different radiologists reported their findings as negative for cancer.

In 2010, the patient was found to have breast cancer. She underwent a mastectomy, chemotherapy, and radiation therapy, and was given a 75%–80% chance of 5-year survival.

PATIENT’S CLAIM The ObGyn failed to follow-up on the patient’s reports of a breast lump. The radiologists did not correctly interpret the 2008 and 2009 mammograms. If cancer had been detected earlier, treatment would have been less extreme.

PHYSICIANS’ DEFENSE The ObGyn claimed that he would have felt a lump if it was present. The first radiologist claimed that the 2008 mammography report was correct, noting that the patient’s cancer was a lobular carcinoma that does not always show on mammography or in patients with dense breasts, which this patient has. 

VERDICT A directed verdict was granted to the radiologist who interpreted the 2009 mammography, as the results were lost. An Ohio defense verdict was returned for the ObGyn and the other radiologist.

Related article: Does screening mammography save lives? Janelle Yates, Senior Editor (April 2014)

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

TELL US WHAT YOU THINK! Drop us a line and let us know what you think about this or other current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice.
Tell us what you think by emailing us at: [email protected] Please include your name, city and state.
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Woman loses both legs after salpingectomy: $64.3M award
Due to an ectopic pregnancy, a 29-year-old woman underwent laparoscopic salpingectomy in October 2009. A resident supervised by Dr. A (gynecologist) performed the surgery. Although the patient reported abdominal pain and was febrile, Dr. B (gynecologist) discharged her on postsurgical day 2.

The next day, she returned to the emergency department (ED) with abdominal swelling and pain. Dr. C (ED physician), Dr. D (gynecologist), and Dr. E (general surgeon) examined her. Dr. D began conservative treatment for bowel obstruction. Two days later she was in septic shock. Dr. E repaired a 5-mm injury to the sigmoid colon and created a colostomy. The patient was placed in a medically induced coma for 3 weeks. She experienced cardiac arrest 3 times during her 73-day ICU stay. She  underwent skin grafts, and suffered hearing loss as a result of antibiotic treatment. Due to gangrene, both legs were amputated below the knee.

At the trial’s conclusion in January 2014, the colostomy had not been reversed. She has difficulty caring for her daughter and has not worked since the initial operation.

PATIENT’S CLAIM The resident, who injured the colon and did not detect the injury during surgery, was improperly supervised by Dr. A. Hospital staff did not communicate the patient’s problem reports to the physicians. Dr. B should not have discharged her after surgery; based on her reported symptoms, additional testing was warranted. Drs. C, D, and E did not react to the patient’s pain reports in a timely manner, nor treat the resulting sepsis aggressively enough, leading to gangrene.

DEFENDANTS’ DEFENSE The patient’s colon injury was diagnosed and treated in a timely manner, but her condition deteriorated rapidly. The physicians acted responsibly based on the available information; a computed tomography scan did not show the colon injury. The injury likely occurred after the procedure due to an underlying bowel condition and is a known risk of the procedure. The colostomy can be reversed. Their efforts saved her life.

VERDICT The patient and Dr. E negotiated a $2.3 million settlement. A $62 million New York verdict was returned. The jury found the hospital 40% liable; Dr. A 30% liable; Dr. B 20% liable; and Dr. D 10% liable. Claims were dropped against the resident and Dr. C.

Related article: Oophorectomy or salpingectomy—which makes more sense? William H. Parker, MD (March 2014)

PARENTS REQUESTED EARLIER CESAREAN: CHILD HAS CP
A woman was in labor for 2 full days before her ObGyn performed a cesarean delivery. The child was born with abnormal Apgar scores and had seizures. Imaging studies revealed brain damage. She received a diagnosis of cerebral palsy.

PARENTS’ CLAIM The parents first requested cesarean delivery early on the second day, but the ObGyn allowed labor to progress. When the fetal heart-rate monitor showed signs of fetal distress 3 hours later, the parents made a second request; the ObGyn continued with vaginal delivery. The child was ultimately born by cesarean delivery. Her brain damage was caused by lack of oxygen from failure to perform an earlier cesarean delivery.

DEFENDANTS’ DEFENSE The case was settled during the trial.

VERDICT A $4.25 million Massachusetts settlement was reached.

BLADDER INJURED DURING CESAREAN DELIVERY
A 33-year-old woman gave birth via cesarean delivery performed by her ObGyn. During the procedure, the patient’s bladder was lacerated and the injury was immediately repaired. The patient reports occasional urinary incontinence and pain.

PATIENT’S CLAIM The ObGyn should have anticipated that the bladder would be shifted because of the patient’s previous cesarean delivery.

PHYSICIAN’S DEFENSE The injury is a known risk of the procedure. The patient had developed adhesions that caused the bladder to become displaced. She does not suffer permanent residual effects from the injury.

VERDICT A $125,000 New York verdict was returned.

Related article: 10 practical, evidence-based recommendations for improving maternal outcomes of cesarean delivery. Baha M. Sibai (March 2012)

PARENTS REQUESTED SPECIFIC GENETIC TESTING, BUT CHILD IS BORN WITH RARE CHROMOSOMAL CONDITION: $50M VERDICT
Parents sought prenatal genetic testing to determine if their fetus had a specific genetic condition because the father carries a rare chromosomal abnormality called an unbalanced chromosome translocation. This defect can only be identified if the laboratory is told precisely where to look for the specific translocation; it is not detected on routine prenatal genetic testing. After testing, the parents were told that the fetus did not have the chromosomal abnormality.

The child was born with the condition for which testing was sought, resulting in severe physical and cognitive impairments and multiple physical abnormalities. He will require 24-hour care for life.

PARENTS’ CLAIM Testing failed to identify the condition; the couple had decided to terminate the pregnancy if the child was affected. Due to budget cuts in the maternal-fetal medicine clinic, the medical center borrowed a genetic counselor from another hospital one day a week. The parents told the genetic counselor of the family’s history of the defect and explained that the laboratory’s procedures require the referring center to obtain and share the necessary detailed information with the lab. The lab was apparently notified that the couple had a family history of the defect, but the genetic counselor did not transmit specific information to the lab, and lab personnel did not appropriately follow-up.

DEFENDANTS’ DEFENSE The medical center blamed the laboratory: the lab’s standard procedures state that the lab should call the referring center to obtain the necessary detailed information if it was not provided; the lab employee who handled the specimen did not do so. The lab claimed that the genetic counselor did not transmit the specific information to the lab.

The laboratory disputed the child’s need for 24/7 care, maintaining that he could live in a group home with only occasional nursing care.

VERDICT A $50 million Washington verdict was returned against the medical center and laboratory; each defendant will pay $25 million.

Related article: Noninvasive prenatal testing: Where we are and where we’re going. Lee P. Shulman, MD (Commentary; May 2014)

NECROTIZING FASCIITIS AFTER SURGERY
A 57-year-old woman underwent surgery to repair vaginal vault prolapse, rectocele, and enterocele, performed by her gynecologist. Several days after discharge, the patient returned to the hospital with an infection in her leg that had evolved into necrotizing fasciitis. She underwent five fasciotomies and was hospitalized for 3 weeks.

PATIENT’S CLAIM The gynecologist should have administered prophylactic antibiotics before, during, and after surgery. The patient has massive scarring of her leg.

PHYSICIAN’S DEFENSE The infection was not a result of failing to administer antibiotics. The patient failed to seek timely treatment of symptoms that developed after surgery.

VERDICT A $400,000 New York verdict was returned but reduced because the jury found the patient 49% at fault.

OXYTOCIN BLAMED FOR CHILD’S CP
A mother had bariatric surgery 12 months before becoming pregnant, and she smoked during pregnancy. She developed placental insufficiency and labor was induced shortly after she reached 37 weeks’ gestation.

During delivery, the mother was given oxytocin to increase the frequency and strength of contractions. Nurses repeatedly stopped the oxytocin in response to decelerations in the fetal heart rate, but physicians ordered the oxytocin resumed, even after fetal heart-rate monitoring showed fetal distress.

Three days after birth, the child was transferred to another hospital, and was found to have cerebral palsy and other injuries. At age 5, the child is nonverbal, cannot walk, and requires a feeding tube.

PARENTS’ CLAIM Oxytocin should have been stopped and a cesarean delivery performed when fetal distress was first noted.

DEFENDANTS’ DEFENSE There was no need for cesarean delivery. Apgar scores, blood gases, and fetal presentation indicated that the injury occurred prior to labor.

VERDICT A $6 million Texas settlement was reached during the trial.

Related article: Q: Following cesarean delivery, what is the optimal oxytocin infusion duration to prevent postpartum bleeding? Robert L. Barbieri, MD (Editorial; April 2014)

MOTHER DISCHARGED DESPITE SEVERE ABDOMINAL PAIN
A woman had prenatal care at different locations. Her history included two cesarean deliveries.

Reporting severe abdominal pain, she was taken from a homeless shelter to an ED by ambulance. The mother was uncertain of the fetus’ gestational age; a 4th-year obstetric resident determined by physical examination that the pregnancy was at 36.5 weeks. The resident discussed the case with the attending ObGyn, who said to discharge the mother if her pain was gone. After 11 hours, the mother was returned to the shelter.

The mother returned to the ED 12 hours later. Thirty-five minutes after fetal distress was identified, an emergency cesarean delivery was performed. At birth, the child was found to be at 38 to 39 weeks’ gestation. He received a diagnosis of severe hypoxic ischemic encephalopathy and was transferred to a children’s hospital for brain cooling.

The child lives in a long-term care facility and is dependent on a ventilator and gastronomy tube.

PARENT’S CLAIM The mother should not have been discharged after the first visit. A cesarean delivery should have been performed at that time. The attending ObGyn never saw the mother.

DEFENDANTS’ DEFENSE The mother should have given her correct due date, which was in her prenatal records based on previous ultrasonograpy. The first discharge was proper, as the pain had improved. The homeless shelter should have called an ambulance earlier for the second admission.

VERDICT A $7.5 million California settlement was reached, plus payment of medical expenses exceeding $300,000. 

Timing of child’s injury disputed
Vaginal birth after cesarean (VBAC) had been planned. After reporting to her ObGyn that she was in labor, a mother went to the ED.

During the next few hours, hospital staff called the ObGyn twice to report that fetal monitor strips indicated tachycardia. The ObGyn then spoke to the mother by phone and told her that cesarean delivery was necessary but could wait for him to get to the hospital. After the ObGyn arrived, he removed the fetal heart-rate monitor to prepare the mother’s abdomen; cesarean delivery occurred 15 minutes later.

The child has spastic dystonic quadriplegia and requires 24-hour care.

PARENT’S CLAIM The ObGyn should have come to the hospital and performed cesarean delivery when he was first notified that the fetus was tachycardic. The baby suffered an hypoxic ischemic event in the 15-minute period between when the monitor was removed and birth, causing hypoxic ischemic encephalopathy.

PHYSICIAN’S DEFENSE There was no indication of a need for earlier delivery. The brain injury occurred prior to labor and delivery.

VERDICT The hospital settled for a confidential amount before the trial. An Illinois defense verdict was returned for the ObGyn.

Were mammograms properly interpreted?
After reporting a lump in her breast, a 39-year-old woman underwent mammography in 2008 and 2009. Two different radiologists reported their findings as negative for cancer.

In 2010, the patient was found to have breast cancer. She underwent a mastectomy, chemotherapy, and radiation therapy, and was given a 75%–80% chance of 5-year survival.

PATIENT’S CLAIM The ObGyn failed to follow-up on the patient’s reports of a breast lump. The radiologists did not correctly interpret the 2008 and 2009 mammograms. If cancer had been detected earlier, treatment would have been less extreme.

PHYSICIANS’ DEFENSE The ObGyn claimed that he would have felt a lump if it was present. The first radiologist claimed that the 2008 mammography report was correct, noting that the patient’s cancer was a lobular carcinoma that does not always show on mammography or in patients with dense breasts, which this patient has. 

VERDICT A directed verdict was granted to the radiologist who interpreted the 2009 mammography, as the results were lost. An Ohio defense verdict was returned for the ObGyn and the other radiologist.

Related article: Does screening mammography save lives? Janelle Yates, Senior Editor (April 2014)

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

TELL US WHAT YOU THINK! Drop us a line and let us know what you think about this or other current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice.
Tell us what you think by emailing us at: [email protected] Please include your name, city and state.
Stay in touch! Your feedback is important to us!

Woman loses both legs after salpingectomy: $64.3M award
Due to an ectopic pregnancy, a 29-year-old woman underwent laparoscopic salpingectomy in October 2009. A resident supervised by Dr. A (gynecologist) performed the surgery. Although the patient reported abdominal pain and was febrile, Dr. B (gynecologist) discharged her on postsurgical day 2.

The next day, she returned to the emergency department (ED) with abdominal swelling and pain. Dr. C (ED physician), Dr. D (gynecologist), and Dr. E (general surgeon) examined her. Dr. D began conservative treatment for bowel obstruction. Two days later she was in septic shock. Dr. E repaired a 5-mm injury to the sigmoid colon and created a colostomy. The patient was placed in a medically induced coma for 3 weeks. She experienced cardiac arrest 3 times during her 73-day ICU stay. She  underwent skin grafts, and suffered hearing loss as a result of antibiotic treatment. Due to gangrene, both legs were amputated below the knee.

At the trial’s conclusion in January 2014, the colostomy had not been reversed. She has difficulty caring for her daughter and has not worked since the initial operation.

PATIENT’S CLAIM The resident, who injured the colon and did not detect the injury during surgery, was improperly supervised by Dr. A. Hospital staff did not communicate the patient’s problem reports to the physicians. Dr. B should not have discharged her after surgery; based on her reported symptoms, additional testing was warranted. Drs. C, D, and E did not react to the patient’s pain reports in a timely manner, nor treat the resulting sepsis aggressively enough, leading to gangrene.

DEFENDANTS’ DEFENSE The patient’s colon injury was diagnosed and treated in a timely manner, but her condition deteriorated rapidly. The physicians acted responsibly based on the available information; a computed tomography scan did not show the colon injury. The injury likely occurred after the procedure due to an underlying bowel condition and is a known risk of the procedure. The colostomy can be reversed. Their efforts saved her life.

VERDICT The patient and Dr. E negotiated a $2.3 million settlement. A $62 million New York verdict was returned. The jury found the hospital 40% liable; Dr. A 30% liable; Dr. B 20% liable; and Dr. D 10% liable. Claims were dropped against the resident and Dr. C.

Related article: Oophorectomy or salpingectomy—which makes more sense? William H. Parker, MD (March 2014)

PARENTS REQUESTED EARLIER CESAREAN: CHILD HAS CP
A woman was in labor for 2 full days before her ObGyn performed a cesarean delivery. The child was born with abnormal Apgar scores and had seizures. Imaging studies revealed brain damage. She received a diagnosis of cerebral palsy.

PARENTS’ CLAIM The parents first requested cesarean delivery early on the second day, but the ObGyn allowed labor to progress. When the fetal heart-rate monitor showed signs of fetal distress 3 hours later, the parents made a second request; the ObGyn continued with vaginal delivery. The child was ultimately born by cesarean delivery. Her brain damage was caused by lack of oxygen from failure to perform an earlier cesarean delivery.

DEFENDANTS’ DEFENSE The case was settled during the trial.

VERDICT A $4.25 million Massachusetts settlement was reached.

BLADDER INJURED DURING CESAREAN DELIVERY
A 33-year-old woman gave birth via cesarean delivery performed by her ObGyn. During the procedure, the patient’s bladder was lacerated and the injury was immediately repaired. The patient reports occasional urinary incontinence and pain.

PATIENT’S CLAIM The ObGyn should have anticipated that the bladder would be shifted because of the patient’s previous cesarean delivery.

PHYSICIAN’S DEFENSE The injury is a known risk of the procedure. The patient had developed adhesions that caused the bladder to become displaced. She does not suffer permanent residual effects from the injury.

VERDICT A $125,000 New York verdict was returned.

Related article: 10 practical, evidence-based recommendations for improving maternal outcomes of cesarean delivery. Baha M. Sibai (March 2012)

PARENTS REQUESTED SPECIFIC GENETIC TESTING, BUT CHILD IS BORN WITH RARE CHROMOSOMAL CONDITION: $50M VERDICT
Parents sought prenatal genetic testing to determine if their fetus had a specific genetic condition because the father carries a rare chromosomal abnormality called an unbalanced chromosome translocation. This defect can only be identified if the laboratory is told precisely where to look for the specific translocation; it is not detected on routine prenatal genetic testing. After testing, the parents were told that the fetus did not have the chromosomal abnormality.

The child was born with the condition for which testing was sought, resulting in severe physical and cognitive impairments and multiple physical abnormalities. He will require 24-hour care for life.

PARENTS’ CLAIM Testing failed to identify the condition; the couple had decided to terminate the pregnancy if the child was affected. Due to budget cuts in the maternal-fetal medicine clinic, the medical center borrowed a genetic counselor from another hospital one day a week. The parents told the genetic counselor of the family’s history of the defect and explained that the laboratory’s procedures require the referring center to obtain and share the necessary detailed information with the lab. The lab was apparently notified that the couple had a family history of the defect, but the genetic counselor did not transmit specific information to the lab, and lab personnel did not appropriately follow-up.

DEFENDANTS’ DEFENSE The medical center blamed the laboratory: the lab’s standard procedures state that the lab should call the referring center to obtain the necessary detailed information if it was not provided; the lab employee who handled the specimen did not do so. The lab claimed that the genetic counselor did not transmit the specific information to the lab.

The laboratory disputed the child’s need for 24/7 care, maintaining that he could live in a group home with only occasional nursing care.

VERDICT A $50 million Washington verdict was returned against the medical center and laboratory; each defendant will pay $25 million.

Related article: Noninvasive prenatal testing: Where we are and where we’re going. Lee P. Shulman, MD (Commentary; May 2014)

NECROTIZING FASCIITIS AFTER SURGERY
A 57-year-old woman underwent surgery to repair vaginal vault prolapse, rectocele, and enterocele, performed by her gynecologist. Several days after discharge, the patient returned to the hospital with an infection in her leg that had evolved into necrotizing fasciitis. She underwent five fasciotomies and was hospitalized for 3 weeks.

PATIENT’S CLAIM The gynecologist should have administered prophylactic antibiotics before, during, and after surgery. The patient has massive scarring of her leg.

PHYSICIAN’S DEFENSE The infection was not a result of failing to administer antibiotics. The patient failed to seek timely treatment of symptoms that developed after surgery.

VERDICT A $400,000 New York verdict was returned but reduced because the jury found the patient 49% at fault.

OXYTOCIN BLAMED FOR CHILD’S CP
A mother had bariatric surgery 12 months before becoming pregnant, and she smoked during pregnancy. She developed placental insufficiency and labor was induced shortly after she reached 37 weeks’ gestation.

During delivery, the mother was given oxytocin to increase the frequency and strength of contractions. Nurses repeatedly stopped the oxytocin in response to decelerations in the fetal heart rate, but physicians ordered the oxytocin resumed, even after fetal heart-rate monitoring showed fetal distress.

Three days after birth, the child was transferred to another hospital, and was found to have cerebral palsy and other injuries. At age 5, the child is nonverbal, cannot walk, and requires a feeding tube.

PARENTS’ CLAIM Oxytocin should have been stopped and a cesarean delivery performed when fetal distress was first noted.

DEFENDANTS’ DEFENSE There was no need for cesarean delivery. Apgar scores, blood gases, and fetal presentation indicated that the injury occurred prior to labor.

VERDICT A $6 million Texas settlement was reached during the trial.

Related article: Q: Following cesarean delivery, what is the optimal oxytocin infusion duration to prevent postpartum bleeding? Robert L. Barbieri, MD (Editorial; April 2014)

MOTHER DISCHARGED DESPITE SEVERE ABDOMINAL PAIN
A woman had prenatal care at different locations. Her history included two cesarean deliveries.

Reporting severe abdominal pain, she was taken from a homeless shelter to an ED by ambulance. The mother was uncertain of the fetus’ gestational age; a 4th-year obstetric resident determined by physical examination that the pregnancy was at 36.5 weeks. The resident discussed the case with the attending ObGyn, who said to discharge the mother if her pain was gone. After 11 hours, the mother was returned to the shelter.

The mother returned to the ED 12 hours later. Thirty-five minutes after fetal distress was identified, an emergency cesarean delivery was performed. At birth, the child was found to be at 38 to 39 weeks’ gestation. He received a diagnosis of severe hypoxic ischemic encephalopathy and was transferred to a children’s hospital for brain cooling.

The child lives in a long-term care facility and is dependent on a ventilator and gastronomy tube.

PARENT’S CLAIM The mother should not have been discharged after the first visit. A cesarean delivery should have been performed at that time. The attending ObGyn never saw the mother.

DEFENDANTS’ DEFENSE The mother should have given her correct due date, which was in her prenatal records based on previous ultrasonograpy. The first discharge was proper, as the pain had improved. The homeless shelter should have called an ambulance earlier for the second admission.

VERDICT A $7.5 million California settlement was reached, plus payment of medical expenses exceeding $300,000. 

Timing of child’s injury disputed
Vaginal birth after cesarean (VBAC) had been planned. After reporting to her ObGyn that she was in labor, a mother went to the ED.

During the next few hours, hospital staff called the ObGyn twice to report that fetal monitor strips indicated tachycardia. The ObGyn then spoke to the mother by phone and told her that cesarean delivery was necessary but could wait for him to get to the hospital. After the ObGyn arrived, he removed the fetal heart-rate monitor to prepare the mother’s abdomen; cesarean delivery occurred 15 minutes later.

The child has spastic dystonic quadriplegia and requires 24-hour care.

PARENT’S CLAIM The ObGyn should have come to the hospital and performed cesarean delivery when he was first notified that the fetus was tachycardic. The baby suffered an hypoxic ischemic event in the 15-minute period between when the monitor was removed and birth, causing hypoxic ischemic encephalopathy.

PHYSICIAN’S DEFENSE There was no indication of a need for earlier delivery. The brain injury occurred prior to labor and delivery.

VERDICT The hospital settled for a confidential amount before the trial. An Illinois defense verdict was returned for the ObGyn.

Were mammograms properly interpreted?
After reporting a lump in her breast, a 39-year-old woman underwent mammography in 2008 and 2009. Two different radiologists reported their findings as negative for cancer.

In 2010, the patient was found to have breast cancer. She underwent a mastectomy, chemotherapy, and radiation therapy, and was given a 75%–80% chance of 5-year survival.

PATIENT’S CLAIM The ObGyn failed to follow-up on the patient’s reports of a breast lump. The radiologists did not correctly interpret the 2008 and 2009 mammograms. If cancer had been detected earlier, treatment would have been less extreme.

PHYSICIANS’ DEFENSE The ObGyn claimed that he would have felt a lump if it was present. The first radiologist claimed that the 2008 mammography report was correct, noting that the patient’s cancer was a lobular carcinoma that does not always show on mammography or in patients with dense breasts, which this patient has. 

VERDICT A directed verdict was granted to the radiologist who interpreted the 2009 mammography, as the results were lost. An Ohio defense verdict was returned for the ObGyn and the other radiologist.

Related article: Does screening mammography save lives? Janelle Yates, Senior Editor (April 2014)

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

TELL US WHAT YOU THINK! Drop us a line and let us know what you think about this or other current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice.
Tell us what you think by emailing us at: [email protected] Please include your name, city and state.
Stay in touch! Your feedback is important to us!

Cancer patient receives therapy

Credit: Rhoda Baer

Results of a large study suggest certain malignanices are more concentrated in areas with high levels of poverty, while other cancer types arise more often in wealthy regions.

The research, conducted using data from nearly 3 million US cancer cases, also indicated that areas with higher poverty levels tended to have a lower cancer incidence but higher mortality rate than areas with lower poverty levels.

Researchers reported these findings in the journal Cancer.

Francis Boscoe, PhD, of the New York State Cancer Registry in Albany, and his colleagues conducted this research to evaluate the role of socioeconomics in cancer incidence and mortality.

So the team compared individuals living in areas with the highest poverty levels to those living in areas with the lowest poverty levels.

The researchers collected information on nearly 3 million cancer cases diagnosed between 2005 and 2009 in16 states, plus Los Angeles (an area covering 42% of the US population). Cases were divided into 1 of 4 groupings based on the poverty rate of the residential census tract at the time of diagnosis.

For all malignancies combined, there was a negligible association between cancer incidence and poverty. However, 32 of 39 cancer types showed a significant association with poverty.

Fourteen cancers were positively associated with poverty, and 18 were negatively associated. Myeloma, Hodgkin lymphoma, and non-Hodgkin lymphoma (NHL) were among the negatively associated malignancies.

The cancers most significantly associated with higher poverty levels were Kaposi sarcoma and cancers of the larynx, cervix, penis, and liver. The cancers most significantly associated with lower poverty levels were melanoma, thyroid cancer, other non-epithelial skin cancers, and testis cancer.

Overall, male malignancy rates were more sensitive to poverty level than female rates. And, in general, the race-specific cancer incidence rates differed, but the poverty gradients were similar.

For example, there was a roughly 20-fold difference in rates of melanoma between white and black individuals, but the relationship between poverty and incidence remained regardless of race.

This was not true for NHL, however. Among black individuals, the incidence of NHL increased as the poverty level increased. But among white individuals, the incidence of NHL decreased as the poverty level increased.

The researchers pointed out that—for all cancer sites, races, and sexes combined—the difference in risk between the greatest and lowest poverty category was less than 2%.

“At first glance, the effects seem to cancel one another out,” Dr Boscoe said. “But the cancers more associated with poverty have lower incidence and higher mortality, and those associated with wealth have higher incidence and lower mortality. When it comes to cancer, the poor are more likely to die of the disease, while the affluent are more likely to die with the disease.”

Dr Boscoe noted that recent gains in technology have made it much easier to link patient addresses with neighborhood characteristics, therefore making it possible to incorporate socioeconomic status into cancer surveillance.

“Our hope is that our paper will illustrate the value and necessity of doing this routinely in the future,” he concluded.

Cancer patient receives therapy

Credit: Rhoda Baer

Results of a large study suggest certain malignanices are more concentrated in areas with high levels of poverty, while other cancer types arise more often in wealthy regions.

The research, conducted using data from nearly 3 million US cancer cases, also indicated that areas with higher poverty levels tended to have a lower cancer incidence but higher mortality rate than areas with lower poverty levels.

Researchers reported these findings in the journal Cancer.

Francis Boscoe, PhD, of the New York State Cancer Registry in Albany, and his colleagues conducted this research to evaluate the role of socioeconomics in cancer incidence and mortality.

So the team compared individuals living in areas with the highest poverty levels to those living in areas with the lowest poverty levels.

The researchers collected information on nearly 3 million cancer cases diagnosed between 2005 and 2009 in16 states, plus Los Angeles (an area covering 42% of the US population). Cases were divided into 1 of 4 groupings based on the poverty rate of the residential census tract at the time of diagnosis.

For all malignancies combined, there was a negligible association between cancer incidence and poverty. However, 32 of 39 cancer types showed a significant association with poverty.

Fourteen cancers were positively associated with poverty, and 18 were negatively associated. Myeloma, Hodgkin lymphoma, and non-Hodgkin lymphoma (NHL) were among the negatively associated malignancies.

The cancers most significantly associated with higher poverty levels were Kaposi sarcoma and cancers of the larynx, cervix, penis, and liver. The cancers most significantly associated with lower poverty levels were melanoma, thyroid cancer, other non-epithelial skin cancers, and testis cancer.

Overall, male malignancy rates were more sensitive to poverty level than female rates. And, in general, the race-specific cancer incidence rates differed, but the poverty gradients were similar.

For example, there was a roughly 20-fold difference in rates of melanoma between white and black individuals, but the relationship between poverty and incidence remained regardless of race.

This was not true for NHL, however. Among black individuals, the incidence of NHL increased as the poverty level increased. But among white individuals, the incidence of NHL decreased as the poverty level increased.

The researchers pointed out that—for all cancer sites, races, and sexes combined—the difference in risk between the greatest and lowest poverty category was less than 2%.

“At first glance, the effects seem to cancel one another out,” Dr Boscoe said. “But the cancers more associated with poverty have lower incidence and higher mortality, and those associated with wealth have higher incidence and lower mortality. When it comes to cancer, the poor are more likely to die of the disease, while the affluent are more likely to die with the disease.”

Dr Boscoe noted that recent gains in technology have made it much easier to link patient addresses with neighborhood characteristics, therefore making it possible to incorporate socioeconomic status into cancer surveillance.

“Our hope is that our paper will illustrate the value and necessity of doing this routinely in the future,” he concluded.

Cancer patient receives therapy

Credit: Rhoda Baer

Results of a large study suggest certain malignanices are more concentrated in areas with high levels of poverty, while other cancer types arise more often in wealthy regions.

The research, conducted using data from nearly 3 million US cancer cases, also indicated that areas with higher poverty levels tended to have a lower cancer incidence but higher mortality rate than areas with lower poverty levels.

Researchers reported these findings in the journal Cancer.

Francis Boscoe, PhD, of the New York State Cancer Registry in Albany, and his colleagues conducted this research to evaluate the role of socioeconomics in cancer incidence and mortality.

So the team compared individuals living in areas with the highest poverty levels to those living in areas with the lowest poverty levels.

The researchers collected information on nearly 3 million cancer cases diagnosed between 2005 and 2009 in16 states, plus Los Angeles (an area covering 42% of the US population). Cases were divided into 1 of 4 groupings based on the poverty rate of the residential census tract at the time of diagnosis.

For all malignancies combined, there was a negligible association between cancer incidence and poverty. However, 32 of 39 cancer types showed a significant association with poverty.

Fourteen cancers were positively associated with poverty, and 18 were negatively associated. Myeloma, Hodgkin lymphoma, and non-Hodgkin lymphoma (NHL) were among the negatively associated malignancies.

The cancers most significantly associated with higher poverty levels were Kaposi sarcoma and cancers of the larynx, cervix, penis, and liver. The cancers most significantly associated with lower poverty levels were melanoma, thyroid cancer, other non-epithelial skin cancers, and testis cancer.

Overall, male malignancy rates were more sensitive to poverty level than female rates. And, in general, the race-specific cancer incidence rates differed, but the poverty gradients were similar.

For example, there was a roughly 20-fold difference in rates of melanoma between white and black individuals, but the relationship between poverty and incidence remained regardless of race.

This was not true for NHL, however. Among black individuals, the incidence of NHL increased as the poverty level increased. But among white individuals, the incidence of NHL decreased as the poverty level increased.

The researchers pointed out that—for all cancer sites, races, and sexes combined—the difference in risk between the greatest and lowest poverty category was less than 2%.

“At first glance, the effects seem to cancel one another out,” Dr Boscoe said. “But the cancers more associated with poverty have lower incidence and higher mortality, and those associated with wealth have higher incidence and lower mortality. When it comes to cancer, the poor are more likely to die of the disease, while the affluent are more likely to die with the disease.”

Dr Boscoe noted that recent gains in technology have made it much easier to link patient addresses with neighborhood characteristics, therefore making it possible to incorporate socioeconomic status into cancer surveillance.

“Our hope is that our paper will illustrate the value and necessity of doing this routinely in the future,” he concluded.

Monoclonal antibodies

Credit: Linda Bartlett

The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for ofatumumab (Arzerra), a monoclonal antibody targeting CD20.

The CHMP is recommending that ofatumumab receive conditional approval for use in combination with chlorambucil or bendamustine to treat patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and are not eligible for fludarabine-based therapy.

The European Commission (EC) will take the CHMP’s opinion into account when deciding whether to approve ofatumumab for this indication.

Ofatumumab already has conditional approval in the Europe Union to treat CLL patients who are refractory to fludarabine and alemtuzumab.

Ofatumumab received conditional approval because the drug’s benefits appear to outweigh the risks it poses. The drug will not receive full

approval until the companies developing ofatumumab, GlaxoSmithKline and Genmab, submit results of additional research to the EC.

The CHMP’s recommendation for expanded approval is based on results from 2 trials in patients with CLL who were ineligible for fludarabine-based treatment.

The first is a phase 2 study (OMB115991) in which researchers evaluated the efficacy of ofatumumab in combination with bendamustine. The second is the phase 3 COMPLEMENT 1 study (OMB110911), a randomized trial in which researchers compared ofatumumab and chlorambucil in combination to chlorambucil alone.

Phase 2 study

Results from this single-arm study were presented at the 2013 International Workshop on CLL. Researchers enrolled 97 patients with CLL, 44 of whom were previously untreated and 53 who had relapsed. The median ages were 62.5 and 68 years, respectively.

Treatment began with acetaminophen, an antihistamine, and a glucocorticoid. Patients then received ofatumumab at 300 mg on day 1 and 1000 mg on day 8 of cycle 1. For cycles 2 through 6, they received 1000 mg on day 1 every 28 days.

Patients received bendamustine on days 1 and 2, every 28 days for up to 6 cycles. The initial dose was 90 mg/m² for the untreated patients and 70 mg/m² for relapsed patients.

However, patients required a dose reduction due to toxicity. The previously untreated patients were reduced to 60 mg/m², and the relapsed patients were reduced to 50 mg/m².

The overall response rate was 95% in the previously untreated group and 74% in the relapsed group. Complete responses occurred in 43% and 11%, respectively.

CT results showed the overall response rate was 82% in the previously untreated group and 70% in the relapsed group. Complete responses occurred in 27% and 9%, respectively. The median time to response was 0.95 months for both groups.

Grade 3 or higher adverse events occurred in 25% of patients in the previously untreated group and 38% of those in the relapsed group.

This included infusion reactions (11% and 8%, respectively), neutropenia (16% and 29%, respectively), infections (11% and 15%, respectively), rash (2% of previously untreated patients), febrile neutropenia (4% of relapsed patients), and thrombocytopenia (4% of relapsed patients).

There were no deaths in the previously untreated group, but 4 patients died in the relapsed group. Two of these deaths may have been related to study treatment. One patient died of pneumonia and hemolytic anemia 15 days after the last dose of treatment, and 1 patient died of sepsis 4 days after the last dose of  treatment.

Phase 3 study

Data from the COMPLEMENT 1 study were presented at ASH 2013. Researchers compared ofatumumab plus chlorambucil to chlorambucil alone in 447 previously untreated patients with CLL who were ineligible for fludarabine-based therapy.

Patients had a median age of 69 years (range, 35 to 92). Seventy-two percent had 2 or more comorbidities, and 48% had a creatinine clearance of less than 70 mL/min.

Patients in the ofatumumab arm received the drug at 300 mg in cycle 1 on day 1, 1000 mg in cycle 1 on day 8, and 1000 mg administered on day 1 of all subsequent 28-day cycles.

In both arms, patients received chlorambucil at a dose of 10 mg/m² orally on days 1 to 7, every 28 days. Prior to each infusion of ofatumumab, patients received acetaminophen, an antihistamine, and a glucocorticoid.

The overall response rate was 82% in the ofatumumab-chlorambucil group and 69% in the chlorambucil-alone group (P=0.001). Complete response rates were 12% and 1%, respectively.

At a median follow-up of 29 months, the median overall survival was not reached for either treatment arm. However, ofatumumab-treated patients had longer progression-free survival than patients who received chlorambucil alone—22.4 months and 13.1 months, respectively (P<0.001).

Grade 3 or higher adverse events occurred in 50% of ofatumumab-treated patients and 43% of patients who received chlorambucil alone. The most common event was neutropenia, which occurred in 26% and 14% of patients, respectively.

Grade 3 or higher infections occurred in 15% of ofatumumab-treated patients and 14% of patients who received chlorambucil alone. The most common was pneumonia, which occurred in 4% and 3%, respectively.

In the entire cohort, grade 3 or higher infusion-related events occurred in 10% of patients, but there were no fatal infusion reactions. Two percent of subjects in both arms died during treatment.

Monoclonal antibodies

Credit: Linda Bartlett

The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for ofatumumab (Arzerra), a monoclonal antibody targeting CD20.

The CHMP is recommending that ofatumumab receive conditional approval for use in combination with chlorambucil or bendamustine to treat patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and are not eligible for fludarabine-based therapy.

The European Commission (EC) will take the CHMP’s opinion into account when deciding whether to approve ofatumumab for this indication.

Ofatumumab already has conditional approval in the Europe Union to treat CLL patients who are refractory to fludarabine and alemtuzumab.

Ofatumumab received conditional approval because the drug’s benefits appear to outweigh the risks it poses. The drug will not receive full

approval until the companies developing ofatumumab, GlaxoSmithKline and Genmab, submit results of additional research to the EC.

The CHMP’s recommendation for expanded approval is based on results from 2 trials in patients with CLL who were ineligible for fludarabine-based treatment.

The first is a phase 2 study (OMB115991) in which researchers evaluated the efficacy of ofatumumab in combination with bendamustine. The second is the phase 3 COMPLEMENT 1 study (OMB110911), a randomized trial in which researchers compared ofatumumab and chlorambucil in combination to chlorambucil alone.

Phase 2 study

Results from this single-arm study were presented at the 2013 International Workshop on CLL. Researchers enrolled 97 patients with CLL, 44 of whom were previously untreated and 53 who had relapsed. The median ages were 62.5 and 68 years, respectively.

Treatment began with acetaminophen, an antihistamine, and a glucocorticoid. Patients then received ofatumumab at 300 mg on day 1 and 1000 mg on day 8 of cycle 1. For cycles 2 through 6, they received 1000 mg on day 1 every 28 days.

Patients received bendamustine on days 1 and 2, every 28 days for up to 6 cycles. The initial dose was 90 mg/m² for the untreated patients and 70 mg/m² for relapsed patients.

However, patients required a dose reduction due to toxicity. The previously untreated patients were reduced to 60 mg/m², and the relapsed patients were reduced to 50 mg/m².

The overall response rate was 95% in the previously untreated group and 74% in the relapsed group. Complete responses occurred in 43% and 11%, respectively.

CT results showed the overall response rate was 82% in the previously untreated group and 70% in the relapsed group. Complete responses occurred in 27% and 9%, respectively. The median time to response was 0.95 months for both groups.

Grade 3 or higher adverse events occurred in 25% of patients in the previously untreated group and 38% of those in the relapsed group.

This included infusion reactions (11% and 8%, respectively), neutropenia (16% and 29%, respectively), infections (11% and 15%, respectively), rash (2% of previously untreated patients), febrile neutropenia (4% of relapsed patients), and thrombocytopenia (4% of relapsed patients).

There were no deaths in the previously untreated group, but 4 patients died in the relapsed group. Two of these deaths may have been related to study treatment. One patient died of pneumonia and hemolytic anemia 15 days after the last dose of treatment, and 1 patient died of sepsis 4 days after the last dose of  treatment.

Phase 3 study

Data from the COMPLEMENT 1 study were presented at ASH 2013. Researchers compared ofatumumab plus chlorambucil to chlorambucil alone in 447 previously untreated patients with CLL who were ineligible for fludarabine-based therapy.

Patients had a median age of 69 years (range, 35 to 92). Seventy-two percent had 2 or more comorbidities, and 48% had a creatinine clearance of less than 70 mL/min.

Patients in the ofatumumab arm received the drug at 300 mg in cycle 1 on day 1, 1000 mg in cycle 1 on day 8, and 1000 mg administered on day 1 of all subsequent 28-day cycles.

In both arms, patients received chlorambucil at a dose of 10 mg/m² orally on days 1 to 7, every 28 days. Prior to each infusion of ofatumumab, patients received acetaminophen, an antihistamine, and a glucocorticoid.

The overall response rate was 82% in the ofatumumab-chlorambucil group and 69% in the chlorambucil-alone group (P=0.001). Complete response rates were 12% and 1%, respectively.

At a median follow-up of 29 months, the median overall survival was not reached for either treatment arm. However, ofatumumab-treated patients had longer progression-free survival than patients who received chlorambucil alone—22.4 months and 13.1 months, respectively (P<0.001).

Grade 3 or higher adverse events occurred in 50% of ofatumumab-treated patients and 43% of patients who received chlorambucil alone. The most common event was neutropenia, which occurred in 26% and 14% of patients, respectively.

Grade 3 or higher infections occurred in 15% of ofatumumab-treated patients and 14% of patients who received chlorambucil alone. The most common was pneumonia, which occurred in 4% and 3%, respectively.

In the entire cohort, grade 3 or higher infusion-related events occurred in 10% of patients, but there were no fatal infusion reactions. Two percent of subjects in both arms died during treatment.

Monoclonal antibodies

Credit: Linda Bartlett

The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for ofatumumab (Arzerra), a monoclonal antibody targeting CD20.

The CHMP is recommending that ofatumumab receive conditional approval for use in combination with chlorambucil or bendamustine to treat patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and are not eligible for fludarabine-based therapy.

The European Commission (EC) will take the CHMP’s opinion into account when deciding whether to approve ofatumumab for this indication.

Ofatumumab already has conditional approval in the Europe Union to treat CLL patients who are refractory to fludarabine and alemtuzumab.

Ofatumumab received conditional approval because the drug’s benefits appear to outweigh the risks it poses. The drug will not receive full

approval until the companies developing ofatumumab, GlaxoSmithKline and Genmab, submit results of additional research to the EC.

The CHMP’s recommendation for expanded approval is based on results from 2 trials in patients with CLL who were ineligible for fludarabine-based treatment.

The first is a phase 2 study (OMB115991) in which researchers evaluated the efficacy of ofatumumab in combination with bendamustine. The second is the phase 3 COMPLEMENT 1 study (OMB110911), a randomized trial in which researchers compared ofatumumab and chlorambucil in combination to chlorambucil alone.

Phase 2 study

Results from this single-arm study were presented at the 2013 International Workshop on CLL. Researchers enrolled 97 patients with CLL, 44 of whom were previously untreated and 53 who had relapsed. The median ages were 62.5 and 68 years, respectively.

Treatment began with acetaminophen, an antihistamine, and a glucocorticoid. Patients then received ofatumumab at 300 mg on day 1 and 1000 mg on day 8 of cycle 1. For cycles 2 through 6, they received 1000 mg on day 1 every 28 days.

Patients received bendamustine on days 1 and 2, every 28 days for up to 6 cycles. The initial dose was 90 mg/m² for the untreated patients and 70 mg/m² for relapsed patients.

However, patients required a dose reduction due to toxicity. The previously untreated patients were reduced to 60 mg/m², and the relapsed patients were reduced to 50 mg/m².

The overall response rate was 95% in the previously untreated group and 74% in the relapsed group. Complete responses occurred in 43% and 11%, respectively.

CT results showed the overall response rate was 82% in the previously untreated group and 70% in the relapsed group. Complete responses occurred in 27% and 9%, respectively. The median time to response was 0.95 months for both groups.

Grade 3 or higher adverse events occurred in 25% of patients in the previously untreated group and 38% of those in the relapsed group.

This included infusion reactions (11% and 8%, respectively), neutropenia (16% and 29%, respectively), infections (11% and 15%, respectively), rash (2% of previously untreated patients), febrile neutropenia (4% of relapsed patients), and thrombocytopenia (4% of relapsed patients).

There were no deaths in the previously untreated group, but 4 patients died in the relapsed group. Two of these deaths may have been related to study treatment. One patient died of pneumonia and hemolytic anemia 15 days after the last dose of treatment, and 1 patient died of sepsis 4 days after the last dose of  treatment.

Phase 3 study

Data from the COMPLEMENT 1 study were presented at ASH 2013. Researchers compared ofatumumab plus chlorambucil to chlorambucil alone in 447 previously untreated patients with CLL who were ineligible for fludarabine-based therapy.

Patients had a median age of 69 years (range, 35 to 92). Seventy-two percent had 2 or more comorbidities, and 48% had a creatinine clearance of less than 70 mL/min.

Patients in the ofatumumab arm received the drug at 300 mg in cycle 1 on day 1, 1000 mg in cycle 1 on day 8, and 1000 mg administered on day 1 of all subsequent 28-day cycles.

In both arms, patients received chlorambucil at a dose of 10 mg/m² orally on days 1 to 7, every 28 days. Prior to each infusion of ofatumumab, patients received acetaminophen, an antihistamine, and a glucocorticoid.

The overall response rate was 82% in the ofatumumab-chlorambucil group and 69% in the chlorambucil-alone group (P=0.001). Complete response rates were 12% and 1%, respectively.

At a median follow-up of 29 months, the median overall survival was not reached for either treatment arm. However, ofatumumab-treated patients had longer progression-free survival than patients who received chlorambucil alone—22.4 months and 13.1 months, respectively (P<0.001).

Grade 3 or higher adverse events occurred in 50% of ofatumumab-treated patients and 43% of patients who received chlorambucil alone. The most common event was neutropenia, which occurred in 26% and 14% of patients, respectively.

Grade 3 or higher infections occurred in 15% of ofatumumab-treated patients and 14% of patients who received chlorambucil alone. The most common was pneumonia, which occurred in 4% and 3%, respectively.

In the entire cohort, grade 3 or higher infusion-related events occurred in 10% of patients, but there were no fatal infusion reactions. Two percent of subjects in both arms died during treatment.