Saturday, May 16, 2009

Comment on a bill that would eliminate the learned intermediary doctrine

Back in April, I posted a note about a pending bill in New York to eliminate the "learned intermediary doctrine" (see here), which says a drug manufacturer only has a duty to provide warnings to the doctors who prescribe the medication because the doctors are in a better position to provide the information to the patient.

This doctrine has been universally adopted but has come under attack in recent years in large part because of the changing circumstances regarding the contact between drug manufacturers and their consumers and doctors and their patients. Here is a link to a comment by the Drug &Device Law Blog on the bill. Those of you who are familiar with that blog will not be surprised that they think the bill is a terrible idea. Also, here is a link to a memo in opposition to the bill filed by NY Tort Reform

The bill is actually very simple. All it says is that manufacturers who engage in direct to consumer advertising have a duty to provide adequate warnings to consumers directly. They cannot avoid liability by claiming that they provided the warnings to the doctors and that it was the doctor's duty to provide them to the patients.

Opponents of the statute argue that this is a bad idea because it will result in "overwarnings" by manufacturers which the consumers will not understand or ignore altogether. Their analysis, however, is based on the flawed premise that (to quote from the D&D Blog) "abolishing the learned intermediary rule would only take the most knowledgeable person, the doctor, out of the equation" as if doctors would suddenly stop providing warnings and information to their patients. This would only be true if eliminating the doctrine were to relieve doctors of their duty to provide warnings, information and full advice to their patients, which is not the case. In fact, it would be absurd for doctors to stop advising their patients fully and just rely on manufacturers to provide the information to their patients (because it would increase the risk possible liability) which in turn means it would also be absurd for manufacturers to stop providing warnings and information to the doctors (for the same reason).

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