Brand-Name Drug Cos. Can Be Sued Over Generic Labels: Ala. Sup. Ct.
Vicki and Danny Weeks sued five drug companies in federal court over injuries Danny Weeks suffered after years of taking metoclopramide, the generic version of Reglan. The U.S. District Court for the Middle District of Alabama, in turn, certified to the Alabama Supreme Court the question of whether brand-name manufacturers can be held liable for fraudulent misrepresentation due to injuries sustained from generics.
This Is a Narrow Decision (They Say)
At the outset, the court took great pains to narrowly tailor its decision. The answer to the certified question applies only to prescription drug manufacturers, not distributors, and then, only when the plaintiff alleges that the prescription manufacturer "fraudulently misrepresented or suppressed information about the manner in which (i.e., the duration) the drug was to be taken."
The court wasn't deciding anything about a product defect. (Of course, an appellate attorney is paid to wrench open a narrow decision and drive his client's truck through it, so a court's claim to narrowness doesn't mean very much.)
FDA Regulation Is Key
Actually, the narrowness is important. The case hinges on the FDA's strict regulations, which require a generic manufacturer's warning label to match that of a name-brand prescription manufacturer. Generic manufacturers can't even advise doctors of newly discovered risks or side effects unless the name-brand prescription manufacturer does so first. This is because the generic's labeling is tied directly to the name-brand prescription drug's labeling.
Consequently, the name-brand prescription drug manufacturer owes a duty to third parties like the Weekses, who could foreseeably be harmed by a fraudulent statement on a generic's label, which is there only because there was a fraudulent statement on the prescription drug's label.
Chief Justice Roy Moore dissented, however. He didn't believe that the question presented fit the statutory requirements for a certified question. Among other things, the question must be "determinative" of the outcome of the case, and he didn't think the court would be doing anything determinative. "[T]he Weekses may proceed with their cause of action for misrepresentation, but the ultimate success of their claims will depend upon facts not before us," he wrote.
Justice Tom Parker also dissented, arguing that federal legislation essentially making a prescription manufacturer liable for generics' labeling doesn't require the court "to ignore, modify, or override our bedrock legal principles of duty and privity with regard to the originator of a pharmaceutical drug and a consumer who has not consumed a drug manufactured by the originator of the drug."
Justice Glenn Murdock's dissent was centered on public policy. In Murdock's opinion, the court's ruling disregarded the standard notions of duty and foreseeability that preserved the delicate balance in tort law between fairness to the plaintiff and fairness to the defendant. There just wasn't a sufficient relationship between the prescription manufacturer and the end customer of the generic to hold the prescription company liable for the generic's labeling.
- Brand-Name Drug Makers' Liability for Generics Upheld by Ala. Court (FindLaw's Decided)
- FDA Proposes Letting Generic-Drug Makers Change Labels (The Wall Street Journal)
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