Clinical Innovation

Question: Intending to help an elderly patient suffering from dementia and Parkinsonism, a neurologist applied a series of therapeutic ultrasound treatments to her head. The patient had seen other neurologists previously, but their conventional measures were ineffective. The neurologist had used the novel method in the past, and claims it had been safe and effective. The medical literature contains only a few anecdotal reports on such use. Assuming the patient experienced no harm, but derived no benefit from the new treatment, which of the following statements is most accurate?

A. The treatment method is best characterized as clinical innovation.

B. Clinical innovation, like human experimentation, can help advance medical progress.

C. Intended patient benefit, clear safety, and informed consent are minimum requirements when the use of novel diagnostic or therapeutic modalities is considered.

D. The physician cannot be successfully sued because no harm came to patient.

E. All are correct.

Answer: E. This hypothetical is adapted from an actual case in Singapore in which the court ruled in favor of the treating neurologist. In striking the balance between inhibiting novel approaches that benefit patients vs. exposing patients to unwarranted risk, U.S. courts have occasionally allowed innovation, even though by definition it represents a departure from a customary or acceptable standard. However, clinical innovation can place a patient at risk for injuries, and can invite medical malpractice lawsuits and state medical board investigations into professional misconduct. It is definitely not something a clinician should indulge in casually or carelessly.

In medical experimentation, which typically takes the form of clinical trials, efficacy is still unproven, and any potential benefit is directed at future patients, not those being studied who may be on a standard drug or even a placebo. Accordingly, the courts tend to demand a higher standard of care, especially in regard to disclosure of risks. Investigators also are obligated to obtain prior approval from an institutional review board that is governed by the Food and Drug Administration and Department of Health and Human Services. Clinical innovation, on the other hand, is usually within the doctor-patient relationship, and refers to the use of a testing or treatment method that is not generally in use or accepted by peers, but whose intent is to benefit a particular patient based on published data or experience of efficacy and safety.

In Brook v. St .John’s Hickey Memorial Hospital (380 N.E. 2d 72 [Ind. 1978]), a radiologist injected contrast dye intramuscularly into the calves of a 23-month-old infant after he was unable to locate a vein for intravenous administration. He had successfully done this in the past because there were reports that use of the recommended sites (the buttocks or thighs) had met with occasional adverse results. The patient subsequently developed a shortening of the Achilles tendon that was arguably related to the injection. The court declined to characterize the technique as a medical experiment or find the defendant negligent in choosing an injection site that had not been specifically recommended by the medical community. The court wrote that "too often courts have confused judgmental decisions and experimentation. Therapeutic innovation has long been recognized as permissible to avoid serious consequences. The everyday practice of medicine involves constant judgmental decisions by physicians as they move from one patient to another in the conscious institution of procedures, special tests, trials and observations recognized generally by their profession as effective in treating the patient or providing a diagnosis of a diseased condition. Each patient presents a slightly different problem to the doctor. A physician is presumed to have the knowledge and skill necessary to use some innovation to fit the peculiar circumstances of each case."

When the patient’s condition is critical or terminal, or when usual measures have failed, an innovative or even experimental approach may be the only option. Such a case was Karp v. Cooley (493 F.2d 408 [5th Cir. 1974]), in which Dr. Denton Cooley, a well-known cardiac surgeon, transplanted a mechanical heart for the first time to save a patient who was dying from heart failure. There was no evidence that the patient’s treatment was other than therapeutic, and fully informed consent was obtained for all aspects of the novel surgery. The patient died within 3 days following transplant surgery. In the wrongful death suit that followed, the court, relying on conventional malpractice evidentiary standards, ruled in favor of Dr. Cooley on the issue of experimentation.

Sometimes a so-called "innovative" treatment stems from the doctor’s inexperience and poor judgment. In Felice v. Valleylab (520 So.2d 920 [La. 1987]), two medical trainees negligently used an electrosurgical unit to perform a circumcision on a child, burning and destroying his penis in the process. They had been trained in – but chose not to use – the time-tested surgical technique with a scalpel. The court ruled that the doctors were negligent, as they had used an unorthodox technique without reading the manual or the warning label on the device. In Edenfield v. Vahid (621 So.2d 1192 [La. 1993]), the court found a surgeon liable for his use of a polypropylene nonabsorbable suture during an anal fistulectomy operation. A medical review panel concluded that nonresorbable sutures were inappropriate in the anorectal area because they predisposed the wound to infection. The court held that it was more probable than not that the patient’s injuries were caused by the doctor’s improper choice of suture.

Physicians should tread cautiously when considering novel and unproven modalities. Depending on the facts and circumstances, a doctor’s unorthodox use of drugs, devices, or complementary and alternative medicine may be deemed to be below the standard of care and thus may invite state disciplinary investigation and/or civil action.

Dr. S. Y. Tan is an emeritus professor at the University of Hawaii. He reported no conflicts of interest related to this column. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: Intending to help an elderly patient suffering from dementia and Parkinsonism, a neurologist applied a series of therapeutic ultrasound treatments to her head. The patient had seen other neurologists previously, but their conventional measures were ineffective. The neurologist had used the novel method in the past, and claims it had been safe and effective. The medical literature contains only a few anecdotal reports on such use. Assuming the patient experienced no harm, but derived no benefit from the new treatment, which of the following statements is most accurate?

A. The treatment method is best characterized as clinical innovation.

B. Clinical innovation, like human experimentation, can help advance medical progress.

C. Intended patient benefit, clear safety, and informed consent are minimum requirements when the use of novel diagnostic or therapeutic modalities is considered.

D. The physician cannot be successfully sued because no harm came to patient.

E. All are correct.

Answer: E. This hypothetical is adapted from an actual case in Singapore in which the court ruled in favor of the treating neurologist. In striking the balance between inhibiting novel approaches that benefit patients vs. exposing patients to unwarranted risk, U.S. courts have occasionally allowed innovation, even though by definition it represents a departure from a customary or acceptable standard. However, clinical innovation can place a patient at risk for injuries, and can invite medical malpractice lawsuits and state medical board investigations into professional misconduct. It is definitely not something a clinician should indulge in casually or carelessly.

In medical experimentation, which typically takes the form of clinical trials, efficacy is still unproven, and any potential benefit is directed at future patients, not those being studied who may be on a standard drug or even a placebo. Accordingly, the courts tend to demand a higher standard of care, especially in regard to disclosure of risks. Investigators also are obligated to obtain prior approval from an institutional review board that is governed by the Food and Drug Administration and Department of Health and Human Services. Clinical innovation, on the other hand, is usually within the doctor-patient relationship, and refers to the use of a testing or treatment method that is not generally in use or accepted by peers, but whose intent is to benefit a particular patient based on published data or experience of efficacy and safety.

In Brook v. St .John’s Hickey Memorial Hospital (380 N.E. 2d 72 [Ind. 1978]), a radiologist injected contrast dye intramuscularly into the calves of a 23-month-old infant after he was unable to locate a vein for intravenous administration. He had successfully done this in the past because there were reports that use of the recommended sites (the buttocks or thighs) had met with occasional adverse results. The patient subsequently developed a shortening of the Achilles tendon that was arguably related to the injection. The court declined to characterize the technique as a medical experiment or find the defendant negligent in choosing an injection site that had not been specifically recommended by the medical community. The court wrote that "too often courts have confused judgmental decisions and experimentation. Therapeutic innovation has long been recognized as permissible to avoid serious consequences. The everyday practice of medicine involves constant judgmental decisions by physicians as they move from one patient to another in the conscious institution of procedures, special tests, trials and observations recognized generally by their profession as effective in treating the patient or providing a diagnosis of a diseased condition. Each patient presents a slightly different problem to the doctor. A physician is presumed to have the knowledge and skill necessary to use some innovation to fit the peculiar circumstances of each case."

When the patient’s condition is critical or terminal, or when usual measures have failed, an innovative or even experimental approach may be the only option. Such a case was Karp v. Cooley (493 F.2d 408 [5th Cir. 1974]), in which Dr. Denton Cooley, a well-known cardiac surgeon, transplanted a mechanical heart for the first time to save a patient who was dying from heart failure. There was no evidence that the patient’s treatment was other than therapeutic, and fully informed consent was obtained for all aspects of the novel surgery. The patient died within 3 days following transplant surgery. In the wrongful death suit that followed, the court, relying on conventional malpractice evidentiary standards, ruled in favor of Dr. Cooley on the issue of experimentation.

Sometimes a so-called "innovative" treatment stems from the doctor’s inexperience and poor judgment. In Felice v. Valleylab (520 So.2d 920 [La. 1987]), two medical trainees negligently used an electrosurgical unit to perform a circumcision on a child, burning and destroying his penis in the process. They had been trained in – but chose not to use – the time-tested surgical technique with a scalpel. The court ruled that the doctors were negligent, as they had used an unorthodox technique without reading the manual or the warning label on the device. In Edenfield v. Vahid (621 So.2d 1192 [La. 1993]), the court found a surgeon liable for his use of a polypropylene nonabsorbable suture during an anal fistulectomy operation. A medical review panel concluded that nonresorbable sutures were inappropriate in the anorectal area because they predisposed the wound to infection. The court held that it was more probable than not that the patient’s injuries were caused by the doctor’s improper choice of suture.

Physicians should tread cautiously when considering novel and unproven modalities. Depending on the facts and circumstances, a doctor’s unorthodox use of drugs, devices, or complementary and alternative medicine may be deemed to be below the standard of care and thus may invite state disciplinary investigation and/or civil action.

Dr. S. Y. Tan is an emeritus professor at the University of Hawaii. He reported no conflicts of interest related to this column. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: Intending to help an elderly patient suffering from dementia and Parkinsonism, a neurologist applied a series of therapeutic ultrasound treatments to her head. The patient had seen other neurologists previously, but their conventional measures were ineffective. The neurologist had used the novel method in the past, and claims it had been safe and effective. The medical literature contains only a few anecdotal reports on such use. Assuming the patient experienced no harm, but derived no benefit from the new treatment, which of the following statements is most accurate?

A. The treatment method is best characterized as clinical innovation.

B. Clinical innovation, like human experimentation, can help advance medical progress.

C. Intended patient benefit, clear safety, and informed consent are minimum requirements when the use of novel diagnostic or therapeutic modalities is considered.

D. The physician cannot be successfully sued because no harm came to patient.

E. All are correct.

Answer: E. This hypothetical is adapted from an actual case in Singapore in which the court ruled in favor of the treating neurologist. In striking the balance between inhibiting novel approaches that benefit patients vs. exposing patients to unwarranted risk, U.S. courts have occasionally allowed innovation, even though by definition it represents a departure from a customary or acceptable standard. However, clinical innovation can place a patient at risk for injuries, and can invite medical malpractice lawsuits and state medical board investigations into professional misconduct. It is definitely not something a clinician should indulge in casually or carelessly.

In medical experimentation, which typically takes the form of clinical trials, efficacy is still unproven, and any potential benefit is directed at future patients, not those being studied who may be on a standard drug or even a placebo. Accordingly, the courts tend to demand a higher standard of care, especially in regard to disclosure of risks. Investigators also are obligated to obtain prior approval from an institutional review board that is governed by the Food and Drug Administration and Department of Health and Human Services. Clinical innovation, on the other hand, is usually within the doctor-patient relationship, and refers to the use of a testing or treatment method that is not generally in use or accepted by peers, but whose intent is to benefit a particular patient based on published data or experience of efficacy and safety.

In Brook v. St .John’s Hickey Memorial Hospital (380 N.E. 2d 72 [Ind. 1978]), a radiologist injected contrast dye intramuscularly into the calves of a 23-month-old infant after he was unable to locate a vein for intravenous administration. He had successfully done this in the past because there were reports that use of the recommended sites (the buttocks or thighs) had met with occasional adverse results. The patient subsequently developed a shortening of the Achilles tendon that was arguably related to the injection. The court declined to characterize the technique as a medical experiment or find the defendant negligent in choosing an injection site that had not been specifically recommended by the medical community. The court wrote that "too often courts have confused judgmental decisions and experimentation. Therapeutic innovation has long been recognized as permissible to avoid serious consequences. The everyday practice of medicine involves constant judgmental decisions by physicians as they move from one patient to another in the conscious institution of procedures, special tests, trials and observations recognized generally by their profession as effective in treating the patient or providing a diagnosis of a diseased condition. Each patient presents a slightly different problem to the doctor. A physician is presumed to have the knowledge and skill necessary to use some innovation to fit the peculiar circumstances of each case."

When the patient’s condition is critical or terminal, or when usual measures have failed, an innovative or even experimental approach may be the only option. Such a case was Karp v. Cooley (493 F.2d 408 [5th Cir. 1974]), in which Dr. Denton Cooley, a well-known cardiac surgeon, transplanted a mechanical heart for the first time to save a patient who was dying from heart failure. There was no evidence that the patient’s treatment was other than therapeutic, and fully informed consent was obtained for all aspects of the novel surgery. The patient died within 3 days following transplant surgery. In the wrongful death suit that followed, the court, relying on conventional malpractice evidentiary standards, ruled in favor of Dr. Cooley on the issue of experimentation.

Sometimes a so-called "innovative" treatment stems from the doctor’s inexperience and poor judgment. In Felice v. Valleylab (520 So.2d 920 [La. 1987]), two medical trainees negligently used an electrosurgical unit to perform a circumcision on a child, burning and destroying his penis in the process. They had been trained in – but chose not to use – the time-tested surgical technique with a scalpel. The court ruled that the doctors were negligent, as they had used an unorthodox technique without reading the manual or the warning label on the device. In Edenfield v. Vahid (621 So.2d 1192 [La. 1993]), the court found a surgeon liable for his use of a polypropylene nonabsorbable suture during an anal fistulectomy operation. A medical review panel concluded that nonresorbable sutures were inappropriate in the anorectal area because they predisposed the wound to infection. The court held that it was more probable than not that the patient’s injuries were caused by the doctor’s improper choice of suture.

Physicians should tread cautiously when considering novel and unproven modalities. Depending on the facts and circumstances, a doctor’s unorthodox use of drugs, devices, or complementary and alternative medicine may be deemed to be below the standard of care and thus may invite state disciplinary investigation and/or civil action.

Dr. S. Y. Tan is an emeritus professor at the University of Hawaii. He reported no conflicts of interest related to this column. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].