"Generic Drug Companies Get Even More Immunity From The Roberts Five"
Monday’s U.S. Supreme Court ruling immunizing drug companies from lawsuit for egregious injuries wasn’t terribly surprising for those who have been following along. Two years ago, in a case called PLIVA v. Mensing, the U.S. Supreme Court held that generic drug companies were largely immune from lawsuits alleging their failure to warn of harmful consequences. On Monday, in a 5-4 ruling along ideological lines, the court extended this holding to apply to other types of claims against generic drug manufacturers, and held that a federal statute precluded suit by a woman who incurred burns on 60 percent of her body and was rendered legally blind by an alleged drug defect.
This ruling was a predictable addition to the line of cases immunizing big business from liability, but it was not an inevitable follow-up to PLIVA. In conjunction with two other rulings Monday that stomped on workplace protections for minorities and women, this decision brings the top corporate lobby’s win rate before the U.S. Supreme Court term to 13-3. With one case remaining in which the Chamber of Commerce weighed in, it is clear that however that final case is decided, big business won very big at the expense of the little guy.
As has been a frequent practice by the Roberts Court, the five-justice majority found that federal law trumped state law protecting patients, over protestations from the four dissenting justices that both federal and state law could co-exist. Interpreting a federal law requirement that generic drug companies simply follow the warnings and design of the brand name drug, the court held that generic companies cannot be held liable for its flaws. This means that a generic company that distributes a dangerous product has no obligation to simply stop selling that drug, and can go on dispensing the potentially dangerous substance with immunity. As Justice Sonia Sotomayor wrote in dissent, the court justified its holding through “an implicit and undefended assumption that federal law gives pharmaceutical companies a right to sell a federally approved drug free from common-law liability.”
The majority holding in this case overturned a $21 million verdict — upheld by the appeals court — for the plaintiff’s alleged injuries. Now, the company owes nothing. With 80 percent of U.S. prescriptions filled by generics, this ruling not only wipes away generic manufacturers’ responsibility to halt the sale of dangerous products; it also impacts safety for the great majority of consumers.
According to a Public Citizen report released Monday, much of the safety information about a drug emerges after FDA approval, once the drug enters the market. And it is often not the case that the FDA revisits approval. As Justice Stephen Breyer explains in his dissent, it is “far more common for a manufacturer to stop selling its product voluntarily after the FDA advises the manufacturer that the drug is unsafe and that its risk-benefit profile cannot be adequately addressed through labeling changes or other measures” than for the FDA to formally withdraw approval based on new information.
In the wake of the PLIVA decision, members of Congress had asked FDA to revise its regulations in ways that will now be doubly essential to consumer safety. In the absence of clarity from Congress or the FDA, today’s decision paves the way for a whole lot of malfeasance.