Jeffrey Segal, MD, JD

Physicians are permitted to prescribe drugs off-label. By off-label, I really mean “silent label.” Silent label implies the manufacturer has not received FA approval to market the drug as safe and effective for treating the off-label condition.

An example: some antibiotics have been approved for those 18 or older. The label granted by the FDA likely reflects the submission. The manufacturer might have wanted to keep costs down and only test adults. Most manufacturers know that if a drug is approved for adults, some physicians will prescribe the medication for younger patients. And the law generally allows physicians to do precisely that. (We are aware of only a narrow class of restrictions where the federal government dictates the uses for which a drug can be prescribed – anabolic steroids and human growth hormone). Eventually, the literature will accumulate data about the safety and efficacy of the antibiotic’s use in minors.

So doctors have had significant latitude to prescribe medications off-label.

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Here’s one doctor not afraid of the future of healthcare in the U.S.

Meet rheumatologist Dr. Ephraim Engleman who will turn 102 in March.

He said he has no plans on retiring. He drives from San Mateo to the campus of UCSF three days a week. He treats eight long term patients (one wonders just how long term). He spends the rest of his time directing the Rosalind Russell Medical Research Center for Arthritis. He has held that position since 1979.

Dr. Engleman also plays the violin once a week with a chamber music group.

His only ailment: spinal stenosis which forces him to walk stooped over with a cane.

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A good question was posed on physician forum. Why do doctors treat medical malpractice differently than being in an auto accident? Shouldn’t we just turn it over to our carriers and be done with it?

The reason: The two systems have little in common. First, a med-mal lawsuit is packaged as an assault on your reputation. If you doubt that statement, just read the typical cut and paste summons. It often includes language such as “with willful and wanton neglect” and so on. It’s never couched in language such as “you are a talented doctor who made a mistake. We understand you are human and care deeply about your patients. But, with Mr. Smith, the injury has cost him lost wages and future medical costs.”

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Finally…a non-controversial blog post.

My mother taught me not say anything if I could not say something nice. Suffice it to say, many times I have fallen short of that aspirational goal. And, diving deep into the Affordable Care Act, I could not find much positive to say.

In particular, there was almost nothing written about reigning in the dysfunctional medico-legal tort system. To the extent anything about med mal is buried in the ACA, it is limited to a “sense of the Senate” – a nonbinding statement used to express the position of the Senate on a particular issue. Through this language, the ACA suggests states should be prodded to “develop and test” alternatives to the existing medico-legal tort system. And Congress should “consider establishing a State demonstration” to run pilot projects on such solutions.” The ACA, however, includes no funding or binding provisions to those ends.

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In 1997, Dr. Robert Smith, a Scottish surgeon saw a patient with an atypical request. He wanted the surgeon to amputate his perfectly healthy left leg. Why the request? The patient argued his left foot wasn’t part of him. “It felt alien.” Dr. Smith had the patient see a psychiatrist. The patient was diagnosed with Body Integrity Identity Disorder (BIID). Smith performed the operation. At follow-up a couple of years later, the patient reported his life was positively transformed by the operation. Word got out. Smith saw another such patient and performed a similar amputation. And the second patient also reported a positive result.

Then, the story hit the media. The public reacted. Smith was ordered by his hospital to cease and desist.

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Surgeons are typically afforded great latitude in choosing whether or not to operate on a patient. For example, Jehovah’s Witnesses generally eschew transfusion of blood products. If a Jehovah’s Witness needs a coronary artery bypass, you are not obligated to operate on this patient. You can, of course, send the patient to another surgeon who will accede to the restrictions. If you make the decision to cut, you must honor the patient’s religious request to avoid using blood products. But, if you’re not comfortable with the demand, you can Just Say No.

Further, you can generally refuse to operate on an elective patient because you don’t like him. If that is the real reason, and it’s not based on the fact the patient belongs to a particular protected class, such as race or religion, you’re typically on safe ground.

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