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It was negligent to prescribe naltrexone for appetite suppression to a patient taking hydrocodone.

A psychiatrist was seeing a patient for anxiety, depression and obsessive compulsive disorder. The patient managed his back pain with hydrocodone, which was prescribed by a different physician, but was entered into the patient’s record at the psychiatrist’s office. The psychiatrist believed the patient’s anxiety and depression were exacerbated by his morbid obesity. The psychiatrist had read an article about using naltrexone off-label as an appetite suppressor and believed the patient was a good candidate. He did not remember that the patient was taking hydrocodone and, therefore, did not appreciate the warnings against giving naltrexone to patients on opioids. After taking his first dose of naltrexone, the patient suffered from acute withdrawal syndrome. He sued the psychiatrist for his pain and suffering and alleged permanent brain damage caused by the drug reaction.

Experts were not supportive of the psychiatrist’s prescription of naltrexone. They believed the psychiatrist should not have been prescribing medications for the purpose of weight loss, particularly since the medication was being prescribed off-label and outside his area of expertise. Further, experts did not believe the medical literature supported the use of naltrexone for weight loss. Finally, they believed the psychiatrist should not have prescribed the medication without knowing how it would interact with the patient’s other medications.

An integrative approach to treatment can increase patient health and well-being; however, the desire to treat the whole patient should not obscure the need to refer to specialists when necessary. Consider the following recommendations:

• When planning treatment, determine whether the patient would be better served by referral to a specialist.
• When prescribing unfamiliar medications, conduct a thorough patient history and physical to determine if there are any potential contraindications.
• If you are using a medication off-label, be aware of its intended use, directions and warnings.
• Advise the patient that the medication is being used off-label; discuss the risks, benefits and alternatives; and obtain the patient’s consent for off-label use.
• Before prescribing a medication off-label for a condition usually treated by physicians outside your area of specialty, determine whether the off-label use is accepted among those specialty physicians.

The dermatologist’s prescription of fentanyl patches was negligent.

After many years of working together, a dermatologist was very aware and concerned about his office manager’s chronic pain. So, in addition to treating her dermatological conditions, the dermatologist sporadically prescribed pain medications to her. After obtaining no relief from various pain medications prescribed by her family physician (FP) and the dermatologist, the office manager asked the dermatologist if he would prescribe fentanyl patches. Based on the office manager’s report of the average amount of other opioids she had been taking, the dermatologist calculated a fentanyl patch dose and provided a prescription for a month’s supply. The dermatologist went over the instructions for proper fentanyl patch use, but the next evening the office manager was found deceased, with two patches affixed to her lower back.

The office manager’s family filed a wrongful death lawsuit. Plaintiff’s experts believed the dermatologist should have refused to treat the patient for back pain and should not have prescribed fentanyl because of his lack of training and experience in treating muscular skeletal or neurologic conditions.

If a physician is treating an employee, the employee should be treated exactly like any other patient,⁷ which may be difficult because, among other issues, thorough physical examinations and histories can become embarrassing for both parties. In this case, the dermatologist’s intentions were good — he just wanted to alleviate his employee’s suffering. But the situation became complicated when the employee apparently overstated the amount of pain medication she was taking to convince the dermatologist to give her something stronger. Investigations indicated she was more opiate naïve than she claimed, which resulted in the dermatologist overestimating her fentanyl dose. That the dermatologist had never prescribed a fentanyl patch and had no pain management experience or training also complicated the defense.

Malpractice liability is not the only risk associated with prescribing to employees. The foregoing case is similar to a New Jersey medical board case against a Rutgers University physician who prescribed Percocet for his secretary’s back pain. He considered himself a good Samaritan. But the medical board disciplined him, finding that prescribing pain medications was outside the usual course of the physician’s professional practice — he specialized in “non-invasive ventilation techniques to improve the breathing of patients suffering from neuromuscular diseases.”⁸

For many reasons, referral may be the best strategy for managing a request for treatment outside the scope of specialty from family, friends and employees, except under rare circumstances. A thoughtfully executed recommendation to a trusted colleague can send a message that your policy is to refer. Consider the following strategies:⁹

• Determine whether the treatment would be within the limits of your scope of practice.
  • Would an independent observer reach the same conclusion?
• Have a plan, or script, prepared when family, friends and employees request treatment that is outside the limits of your practice scope; for example, “Professional guidelines and regulations prevent me from prescribing fentanyl for you.”
  • Be honest and describe your discomfort.
  • Soften the blow of the refusal of treatment with knowledgeable guidance about referral options.
• If you do treat family, friends and employees, do so as you would with any other patients.
  • Document in a manner that demonstrates treatment met the standard of care.
    • Provide the patient’s primary care physician with the documentation.

Do not let family, friends and employees talk you into treatment that you would not otherwise offer.

The patient suffered permanent scarring from chemical burns due to negligent sclerotherapy.

A patient scheduled sclerotherapy for spider vein treatment with her gynecologist. The gynecologist had taken a weekend sclerotherapy course and had since treated approximately 10 patients. She started the procedure, but the patient’s reaction to the first three injections in her left shin indicated the concentration was too strong. Therefore, the gynecologist completed the rest of the procedure with a weaker solution. Following the procedure, the patient developed blisters on her shin where the solution had been too concentrated. Over the next six weeks, the gynecologist treated the patient’s wounds, but ultimately referred her to a plastic surgeon for debridement and follow-up care. At the time she filed the lawsuit, the patient had a four-by-two-inch depressed, hyperpigmented scar on her left shin that was not expected to improve.

The patient sued the gynecologist for malpractice. She alleged the gynecologist did not have the proper training to perform sclerotherapy and/or treat the known complications of the procedure. She additionally alleged that she did not give an informed consent.

Multiple issues complicated the defense of this case. Although the patient suffered from recognized complications of sclerotherapy, there was no documentation to prove she had given an informed consent. The gynecologist stated it would have been her practice to discuss the possibility of extravasation, ulceration and necrosis; however, without documentation it was the physician’s word against the patient’s — a credibility contest.

The patient also alleged the gynecologist should have advised her that her training consisted only of a two-day course and that she had only performed the procedure on 10 prior occasions. She claimed she would not have undergone the procedure if she had known about the gynecologist’s qualifications. Although the gynecologist felt confident in her abilities, experts who reviewed the case commented that the area of injury required a heightened level of expertise. Sclerotherapy on the shin can be complicated because the capillaries are very small and pass over bone; therefore, the solution must not be too concentrated and the pressure must be gentle to avoid extravasation. Experts were concerned that the large area affected could be used as evidence of poor technique and inadequate qualification.

While it could be argued that the standard of care for informed consent does not require physicians to advise patients of their qualification to provide treatment outside their original area of practice, there are opposing positions that indicate this information should be provided. For example, the FSMB recently issued a position statement on the topic of practice drift that states:

This official FSMB statement could influence expert opinion regarding informed consent requirements.

Another issue experts raised was the gynecologist’s wound care treatment. Although the gynecologist provided care that was acceptable for the purposes of healing and infection control, she did not provide care that would produce the most cosmetically pleasing result possible. Experts believed that a plastic or cosmetic surgeon would have approached wound care from a cosmetic perspective, and the patient would have had a better outcome. They also believed the gynecologist should have referred the patient to the plastic surgeon more expediently.

Physicians who perform cosmetic procedures will likely be held to the standard of a plastic or cosmetic surgeon if the treatment becomes the subject of malpractice litigation. Consider the following recommendations:¹

• Carefully consider whether it is in the patient’s best interest to receive treatment from you as opposed to receiving treatment from someone with more training and expertise.
• Do not perform a procedure that is outside your training, skill or comfort level.
• Seek additional training when appropriate.
  • Confirm the quality of training programs by researching their accreditation status and the nature of any oversight involved.
• Be prepared to confirm your qualifications to perform any treatment or procedure you offer to patients.
  • If a patient asks about your qualifications to perform a proposed procedure, respond truthfully.
• Maintain records of continuing education, literature review, self-study opportunities and mentoring.
• Ensure your medical liability insurance adequately covers new areas of practice.
• Document discussions with the patient, particularly on risks and alternatives that were covered during the consent discussion.
  • Spend as much time as necessary with the patient to ensure that he or she fully understands the risks and alternatives.
• Review your consent documents to ensure they adequately cover risks and alternatives.
  • Provide the patient with a copy of consent documents, and then document in the medical record that the patient received copies.

The pain management specialist’s negligent mesotherapy technique resulted in induration and skin discoloration.

A 26-year-old woman, who had very little body fat, regularly accompanied her father to pain management appointments. The pain management specialist displayed mesotherapy flyers in his waiting room, which prompted the woman to ask him about using mesotherapy to remove uneven “banana rolls” below her buttocks. She was scheduled for mesotherapy that day, and the risks and alternatives were discussed and documented. The procedure was performed without apparent complication; however, induration and skin discoloration in the treated areas did not resolve, and the patient sued.

When the patient followed up with a cosmetic surgeon to repair the unsatisfactory results, the cosmetic surgeon was highly critical of the pain management specialist. In his opinion, mesotherapy should only be done by a cosmetic or plastic surgeon. He told the patient that the field of mesotherapy was still evolving and a pain management specialist would not be aware of the most effective or safest combination of ingredients. He also told the patient that the formulation used on her was not FDA approved, that it was impossible to ensure consistency in mesotherapy solutions because of the need for compounding, and that the pain management specialist was not appropriately trained in achieving aesthetically pleasing results. He was very vocal with the patient about his opposition to physicians in specialties outside cosmetic or plastic surgery practicing aesthetics for financial gain. The patient’s dissatisfaction with the results and the cosmetic surgeon’s criticism prompted the patient to contact an attorney to file a lawsuit.

Appropriate patient selection can become complicated in a cosmetics practice. Consider the following recommendations:

• Establish and follow specific patient selection protocols.
  • Consider whether the patient is an appropriate candidate for the procedure and whether the patient’s expectations are realistic.
  • If the patient asks for difficult or impossible outcomes, reiterate the realistic goals of the proposed surgery with the patient. If there continues to be a mismatch between the patient’s goals and the likely outcome, exercise your right to decline to proceed with the cosmetic procedure.
  • Document the examination of the patient and support the clinical reasoning for the procedure with examination findings.
• Be extra vigilant in discussing risks and alternatives.
  • Discuss the expected outcome and healing stages.
    • Be compassionate when describing unanticipated outcomes and how they will be addressed.
  • Do not guarantee results.
  • Accurately inform patients about non-FDA-approved, compounded and off-label use of medications.
• Know the FDA status of the cosmetic treatments you are offering. Carefully consider the risks and potential malpractice insurance coverage issues associated with prescribing drugs that are not FDA-approved.
• Keep up with cosmetic procedure technique improvements through hands-on training, didactic continuing medical education courses, cosmetic practice community dialogue and medical journal review.