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Branded manufacturer liable for failure to warn, when consumer uses generic drug

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In an interesting case that enacts a proposal put forth last year by my research assistant, Mr. Wesley Weeks, the Alabama Supreme Court has just held that a name-brand manufacturer is liable for failure to warn if a patient consumes a GENERIC drug with the same inadequate warning as had appeared on the name brand product.

The case, Weeks v. Wyeth (the plaintiff has no relation that I know of with my research assistant!), involves the drug Reglan. Mr. Weeks claimed that he had developed tardive dyskinesia (involuntary, repetitive body movements such as grimacing, tongue protrusion, lip smacking, puckering of the lips and rapid eye blinking) after taking generic versions of Reglan to treat his acid reflux. Mr. Weeks sued Actavis and Teva, the generic companies that made the drugs he took, as well as Wyeth, which developed the drug and marketed the brand exclusively during its patent protected period, for failing to adequately warn about Reglan's risks.

The generic manufacturers, however, have successfully sought protection following a 2011 Supreme Court decision in Pliva v. Mensing. In Pliva the Court accepted the FDA's interpretation of the Food and Drug Act, as amended in 1984 [the "Hatch-Waxman Amendments"] to encourage generic manufacturing, as prohibiting generic manufacturers from altering approved warnings on the brand name drugs they were copying. Since the generic manufacturers could not decide the warnings, the court reasoned in Pliva, they could not be held liable if the warning proved insufficient.

Only a few courts have concluded that, as a result, the brand-name manufacturer is liable in such cases. Most jurisdictions hold that product liability of any kind requires that the defendant's product have injured the plaintiff. Here the product was made by firms other than the defendant firm. But Alabama law has always and not unreasonably held that false information given to a third party can result in liability. [For example, if your doctor tells you that drug X will not make you sleepy, and you take X and drive, falling asleep at the wheel and hitting the victim, the victim has a tort suit against the doctor.] This reasoning was applied by analogy to hold Wyeth liable for the predictable results of an allegedly inadequate warning given with Reglan, even though the plaintiff did not consume that drug.

The defense bar will react to this case with dismay, but in my opinion the real culprit is not the Alabama Supreme Court, but the FDA and the USSC. To quote my research assistant:

"[T]he FDA has interpreted the [1984] Hatch-Waxman Amendments as requiring generic drugs to have identical warning labels as their brandname counterparts; FDA approval can be withdrawn if this continuing "sameness" requirement is not met. This means that unlike brand-name drugs, generic drug manufacturers cannot unilaterally change their warning labels. The FDA has used a similar interpretation to decide that generic manufacturers may not use "Dear Doctor Letters." [page 1263 of the Wesley Weeks article].

No statutory text required this interpretation by the FDA. The interpretation has tied the hands of generic manufacturers, redounding to their own benefit under Pliva. Following this case, risks of making the branded drug in the first place are now exponentially increased, as manufacturers and their insurers must calculate expected risks far into the future, when the branded drug is perhaps no longer even being marketed. Yes, it's only one state, but the reasoning is perfectly logical and I think there is a distinct potential for expansion to other states.

Either the Pliva case or the FDA interpretation of the Hatch-Waxman Amendments, or both, have got to go. To get the whole lowdown and read about excellent proposals for change read my research assistant's law review article, hotlinked in the first paragraph of this comment.

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.