AFJ is counting down the 10 worst decisions of the Corporate Court’s 2010-11 term. Yesterday, at #7, we talked about Ashcroft v. Al-Kidd, which protected the unfair tactics used to detain an American citizen.
Worst Decisions of the 2010-11 Corporate Court Term: #6 PLIVA v. Mensing
Giving Generic Drug Makers a Free Pass to Withhold Information About Drug Safety
In PLIVA, Inc., the Court’s 5-4 conservative majority immunized generic drug manufacturers, whose drugs comprise 75 percent of the market, from state tort liability when they fail to inform the Federal Drug Administration (FDA) that their labels inadequately warn consumers of health risks.
Brand-name drug manufacturers have the ability and the duty to change label warnings based on newly-discovered risks without consulting the FDA, but generic drug manufacturers need only copy brand-name warnings. To enhance drug safety, the FDA took the position that generic-drug makers must inform the agency when its warning labels, copied from the brand-name label, do not account for newly discovered risks. Often generic manufacturers will know of such risks because more people take generic drugs and because they come on the market later than brand-name drugs, which offers more time to assess side effects. In this case, the risks stemmed from taking Reglan, a drug that caused a severe and irreversible neurological disorder as a side effect in a growing number of patients.
The majority concluded that it was impossible for generic-drug makers to meet both the federal requirement that they copy brand-name labels, and state law duties to provide adequate warnings, and therefore gave no effect to FDA’s position that the generic drug makers should have taken steps to warn the agency of the problems with Reglan. The majority acknowledged that, from the perspective of plaintiffs, its ruling “makes little sense.”
In the dissent’s view, the generic-drug makers should not have been permitted to claim “impossibility” because they never even attempted to warn the FDA that the newly-discovered risks of Reglan were not included in the brand-name or generic warning labels for the drug. It is implausible that the FDA would not have asked the brand-name manufacturer, and by extension the generic makers, to change labels if the defendants had warned the agency of adverse effects. It is equally implausible that Congress intended to protect only consumers of brand-name drugs while leaving users of generic drugs without recourse.
In a cruel twist, the plaintiffs received the generic version of Reglan only because their pharmacist substituted it for the brand-name drug their doctors prescribed. Had they received the brand-name version, they would have at least been able to sue because of the greater duties of brand-name drug manufacturers. Instead, the Corporate Court’s decision leaves them with no remedy.
PLIVA v. Mensing is number six on the Worst Decisions of the 2010-11 Corporate Court term because it gives generic-drug manufacturers a free pass to sit back and do nothing when their warning labels are dangerously inadequate.