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). Here’s a link to the opinion. The case was decided by a three to two vote, with four opinions.

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. In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 806-09 (E.D. Tex. 2002), for example, provides a chart showing that 44 states, the District of Columbia, and Puerto Rico have either applied or recognized the learned intermediary doctrine. Frankly, we didn’t think this was an issue any more.

In West Virginia, it is.

Actually, it isn’t any more. The high court squarely rejected the doctrine on Wednesday.

Justice Davis’ decision doesn’t agree that virtually all states have adopted the learned intermediary doctrine. Justice Davis counts “decisions of only the highest state courts,” slip op. at 8, and concludes that “a mere” 21 states have expressly adopted the doctrine.

And Justice Davis rejects all of the usual justifications for the doctrine. “At the outset,” she notes, “the learned intermediary doctrine is not a modern doctrine. Rather, its origins may be traced as far back as 1925.” Id. at 10.

Say what? Correct us if we’re wrong, but we thought we lived in a common law system, where the idea was to follow precedent. A doctrine that has been on the books, and increasingly embraced, for more than 80 years, strikes us as the sort of thing that courts should follow to provide certainty in the law. Are we really supposed to read the words “venerable precedent” to mean “out-dated stuff that should be ignored”?

The decision then launches into a pages-long attack on the proliferation of direct-to-consumer advertising and the many harms it has supposedly caused. (We — or, at least, the one of us writing this post — are agnostic on this subject. We know that DTC advertising is routine these days, and perhaps there have been excesses, but we haven’t given much thought to how, if at all, it should be regulated or whether, overall, DTC advertising does more harm than good.)

Justice Davis’ decision then concludes that direct-to-consumer advertising “obviates each of the premises upon which the [learned intermediary] doctrine rests.” Id. at 17. In a world of DTC 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. Id. at 19. 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.

We’re taking a deep breath here.

Where do we start?

First, if you’re unhappy with direct-to-consumer advertising, work to end it. But don’t enact a rule of law that forces manufacturers to do even more of it. A rule that compels drug manufacturers to speak directly to patients will encourage more, not less, DTC advertising.

Second, although there’s a great deal of DTC advertising these days, there are plenty of drugs that are not advertised this way. We don’t know the numbers, but we bet only a relatively few blockbuster drugs are promoted with expensive ad campaigns; ordinary drugs wouldn’t merit the cost. Shouldn’t the learned intermediary doctrine apply to drugs that were (1) never advertised DTC or (2) advertised DTC, but the particular plaintiff-patient never saw or heard the ad? That’s what the typical version of the learned intermediary doctrine says, with a DTC exception to the general rule in some states.

Third, it’s not easy to warn patients directly about the risks associated with drugs. Bascially every doctor has access to the Physicians’ Desk Reference and can locate and understand prescription drug labeling. Patients are less able to find the package inserts and less able to understand them. Some pharmacies don’t distribute package inserts when they dispense prescriptions.

Fourth, let’s keep an eye on reality here. Who — other than some physicians and product liability lawyers — actually read drug package inserts from cover to cover? The average patient surely doesn’t. What purpose does it serve for courts to dictate the contents of documents that go unread?

Fifth, what about related doctrines? Is the “sophisticated user” doctrine still viable under the logic of this case? Or is that one too old and venerable to be followed, too?

We’ll stop now. But we’re not happy.

In the eyes of these humble bloggers, you’re not heaven, West Virginia.

  • Ask the pharmaceutical companies how many “learned intermediaries” using their catheters, contact lenses, or other implanted medical devices know what biofilms are.

    NIH estimates that more than 80% of microbial infectins in the hunman body are caused by biofilms, including Pseudomonas aeruguinosa, that forms in the trachea of cystic fiborosis patients and the hospital-acquired infectins resulting from biofilm formation on implanted medical devices.

    The “learned intermediary defense” is from another century when there were less than a few hundred prescription drugs and medical devices available. Now with thousands of prescription drugs and medical devices on the market, the DTC advertising and passive prescriptions on the Internet have forced Courts to revisit the rules of the game in the 21st Century.

    Those that ignore the importance of the West Virginia and New Jerey Supreme Court opinions risk the wrath of doctors that will refuse to be scapegoats for an industry that winks at the FDA.

    Neal Taslitz, Esq.
    Loxahatchee, Florida

  • Hell, even we know what biofilms are (and we haven’t litigated a case involving them). Their basically thin layers of bacteria that coat the surfaces of practically everything in the world. Some biofilms are harmful, others are benign – sort of like bacteria generally.

    We’d guess most doctors would learn about biofilms by not later than the second year of med school – probably by the first time they see a hospital sterilizer in action.

    As long as the FDA requires doctors to prescribe drugs, the learned intermediary rule reflects how the real world works. Internet prescribing is illegal, as it should be. I don’t care how much DTC goes on (apparently none concerning the drug in the West Virginia case), a doctor still has to prescribe the drug. Doctors who prescribe something they don’t think will work because of some ad abdicate their professional responsibility – just as we lawyers would if we allowed our clients to tell us how to practice law.

    As for the FDA, the proper response is for congress to give the agency more power – which it is in fact doing. The solution is not for common law courts to ignore how federal law operates to place physicians in the position of learned intermediaries.