Monday, April 20, 2009

Off-Label Use And Medical Malpractice

Off-label use -- using a drug or medical device for an indication other than that set forth in the FDA-approved label -- poses tricky legal issues.

Off-label use is entirely legal: The FDA doesn't regulate the practice of medicine, so physicians can use drugs or devices for any appropriate purpose, approved by the FDA or not.

But if the physician is later sued for malpractice, a lay jury may give disproportionate weight to the fact that the use was off-label.

To help combat that problem, one of your humble scribes (Herrmann) teamed up with a co-author (Pearson Bownas, of Jones Day) to publish an article explaining why in cases of mere off-label use (as opposed to, say, making a contraindicated use), the package insert should not be admissible in evidence at trial. That article appears in today's Northwestern University Law Review: Colloquy, the online journal affiliated with the Northwestern Law Review. For those who are interested, here's a link to "Keeping The Label Out Of The Case."


Anonymous said...

Medicene claims to be fundamentally based on science and evidence. In the case of Off Label use there are no clinical trials there are no large scale studies so how does any provider or consumer know that the off label use is even marginally safe or the safest standard of care? If the manufacturers and the FDA are not held responsible for Off Label Use then absolute strict liability must be applied to Physicians! Herrmann and Bownas are promoting a return to vodoo and witchcraft. 62% of the public feels that off label use should be prohibited not because they are mis-informed but because they actually have some basic common sense.

wisdom teeth removal said...

why in the world should off label use not be allowed. many conditions and problems do not have drugs specifically designed to treat them but drugs already on the market can be used and often times can help.

Mark Castrillo said...

That is indeed a very tricky situation, and it is sad to note that even if off-label use appears to be recognized in the medical society, it can put a health care provider in jeopardy during medical malpractice. However, I support the first comment here. Off-label use must be based on clinical or trial studies; otherwise, there is no slightest assurance that the treatment can work.

Anonymous said...

Medicine is an artform just as much as it is science based.

Nevertheless the problem is that for many clinical conditions trials do not exist. These may include cases where such trials may be unethical or for diseases that are too rare to conduct trials that will yield any scientific result.

In these circumstances the doctor takes known scientific uses of an agent and applies them to another patient population based on the mechanism of action and liely benefit to his patient. Stating that non FDA uses are to be forbidden will condemn a rather large group of patients suffering from a variety of relatively rare illnesses to go without any treatment options whatseoever.

I do think it is important for a physician to disclose tha particular medicine is being used off-label. It is then the patient's choice to do what he feels is best.

Anonymous said...

haven't read the inserts in a while, but wouldn't banning off-label use mean no more birth control prescriptions for acne or endometriosis?

that would go over really well.

Beck/Herrmann said...

Banning off-label use would do a lot of things. It would prohibit doctors from giving patients anything new - no matter how life-saving the advance - until the FDA regulatory process continues. How many more AIDS patients would have died if doctors were forced to wait for the FDA once AZT proved to be effective.

A lot of effective off-label treatments involving older drugs would simply be banned, because no drug company has an incentive to pay for studies of off-patent drugs.

Then there are the rare diseases. A lot of them have no on-label treatments at all. Again, the culprit is economics. There aren't enough people suffering from this or that rare disease to justify the expense of a clinical trial.

62% of the public probably believes in angels. That doesn't mean we should structure our legal system to depend on miracles.

Alice Jones said...

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johan said...

Thanks for Sharing helpful information with everyone.
I have a question:
Does a Doctor’s mistake always constitute Medical Malpractice?

Anonymous said...

The most important issue here is informing the patient. If a doctor wants to give a patient a drug off label he should clearly explain to his patient what it is, why he's prescribing it and give them the side effect profile that every drug in use has. Discuss the suspected risks and benefits of this treatment. He should explain other options if there are any and Then get the approval of the patient. No doctor should be sued after doing all this unless he is negligent in that the care he suggested was inferior to known options and his reasoning flawed.