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.