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Big Pharma Faces Big Problem In West Virginia

July 01, 2007

By Greedy Trial Lawyer

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Category: In Your Face

Question: If drug manufacturers have decided they can safely market to consumers and spend millions on TV advertising that extols the magical power of endless prescription drugs, is there any reason to continue the charade of the learned intermediary doctrine (which gives Big Pharma a pass on giving warnings to patients)?

Answer: Not in West Virginia.

Drug and Device Law reports on this enlightened opinion - with a certain painful exasperation.

Take me home, country roads (W. Va. rejects learned intermediary doctrine)

Take me home -- so long as home is not West Virginia.

On Wednesday, the Supreme Court of Appeals of West Virginia refused to adopt the learned intermediary doctrine. State of West Virginia ex rel. Johnson & Johnson Corp. v. Hon. Mark A Karl, No. 33211, slip op. (W. Va. June 27, 2007).

The learned intermediary doctrine provides, in general, that manufacturers of prescription drugs fulfill their duty to warn by warning prescribing physicians of the risks associated with a product. Manufacturers are not required to give warnings directly to patients.

That doctrine is widely, widely accepted.

The high court [of West Virginia] squarely rejected the doctrine on Wednesday.

Justice Davis' decision....concludes that direct-to-consumer advertising "obviates each of the premises upon which the [learned intermediary] doctrine rests." In a world of DTC [Direct to Consumer] advertising, patients become active participants in their health care, and they ask for particular drugs by name. And the existence of DTC ads supposedly proves that it is possible to explain accurately the risks and benefits of drugs directly to patients. The court therefore sees no benefit to adopting the learned intermediary doctrine. Manufacturers should simply warn patients directly of the risks associated with prescription drugs.

I do not pretend to know how much consumers are able to understand regarding the risks of a given drug. But, apparently, the manufacturers have determined they are perfectly able to understand the benefits and ask for the miracle pills by name.

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