Supreme Court Hands Generic Drug Makers a Big Win

The U.S. Supreme Court ruled yesterday that consumers may not sue generic drug makers under state laws for failing to warn of <"">drug side effects so long as warnings on generic labels are identical to those of their brand name counterparts. In his majority opinion, Justice Clarence Thomas said that the state laws under which such lawsuits are brought conflict with and are therefore pre-empted by federal generic drug regulations

The narrow 5-4 ruling was a victory for generic drug manufacturers, which had argued that federal law left them no choice but to use the same product label as the brand manufacturer.

According to the Associated Press, even the majority opinion acknowledged that the decision dealt an “unfortunate hand” that “makes little sense” to those injured as a result of generic drug side effects.

In her strongly worded dissenting opinion, Justice Sonia Sotomayor agreed on that point. “The court gets one thing right: This outcome makes little sense,” she wrote.

The case before the court, Pliva Inc. v. Mensing, involved metoclopramide, which is sold under the brand name Reglan. Reglan was approved in 1980 as a treatment for digestive track problems. Two women had sued Croatia-based Pliva Inc. and other generic drug manufacturers for failing to provide warnings about tardive dyskinesia. Reglan did not have a warning about the disorder, which causes involuntary muscle movements, when the women started using metoclopramide, but cautions were added to the drug’s label in 2009.

On first glance, it would appear that yesterday’s decision conflicts with a 2008 Supreme Court ruling which held that consumers were entitled to sue makers of brand name drugs for side effect injuries if manufacturers failed to update warning labels when new safety data became available. But Thomas, who was joined in his opinion by Justices John Roberts, Antonin Scalia, Anthony Kennedy and Samuel Alito, pointed out that under federal law, name-brand drug manufacturers can revise their labels when necessary. However, the makers of generics lack the authority to change their labels, and are limited under federal law to bringing new safety information to the attention of the U.S. Food & Drug Administration (FDA).

According to the Journal, state laws that require the makers of both name-brand and generic drugs to modify labels when new safety information is available are in conflict with federal regulation. Thomas wrote that because it is “impossible” for generic drug makers to comply with both, federal law trumps state regulations.

Sotomayor pointed out in her dissent that the generic manufacturers didn’t even try to get the FDA to change the labels of Reglan when new safety information became available. Had they acted, the agency might have mandated the label change earlier, she said.

“Today’s decision leads to so many absurd consequences that I cannot fathom Congress would have intended to pre-empt state law in these cases,” Sotomayor wrote. She was joined in dissent by Justices Ruth Bader Ginsburg, Stephen Breyer and Elena Kagan.

One of those “absurd consequences” is obviously the fact that consumers injured by generic drug side effects are left without legal recourse, while users of brand name equivalents may still file suit over identical injuries. Another baffling outcome could turn out to be the impact the ruling has on makers of brand name drugs. According to the Journal, lower courts have long held that brand name manufacturers can’t be sued for inadequate warnings on generics made by other companies. But an attorney who represented plaintiffs in Pliva Inc. v. Mensing told the Journal that yesterday’s decision “will provide a powerful impetus for courts to revisit those rulings.”

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