UPDATED: U.S. Supreme Court protects generic drugmakers in 5-4 ruling

You win some and you lose some, but when the umpire is the U.S. Supreme Court, odds are the issue is significant. Just a week after the top court said U.S. drugmakers can be sued over agreements that delay generics, the court has found that generic drugmakers cannot be sued in state courts when their products cause adverse reactions.

The court ruled 5-4 in a decision that broke along ideological lines, that a patient could not expect a state court case to preempt federal law and sue when a drug design has already been approved by the FDA, Reuters reports.

The ruling immediately generated backlash from a host of groups that point out 80% of the prescriptions in the U.S. are for generics and saying they don't believe such a blanket exemption from litigation is fair. According to the Los Angeles Times, Senate Judiciary Committee Chairman Patrick Leahy and 5 other Democrat lawmakers wrote to FDA Commissioner Margaret Hamburg following the ruling asking her to rewrite FDA regs so people harmed by a generic drug can sue the manufacturer for injuries. "A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug," Leahy said.

But the lawyer representing the drugmaker said the decision was the only logical conclusion, The New York Times reported. "It makes much more sense to rely on the judgments of the scientific and medical experts at the F.D.A, who look at drug issues for the nation at large, than those of a single state court jury that only has in front of it the terribly unfortunate circumstances of an adverse drug reaction," said Jay P. Lefkowitz.

The ruling came from the case of Mutual Pharmaceutical Company v. Bartlett. Karen Bartlett suffered a rare severe skin reaction three weeks after starting therapy with a generic version of the pain reliever Clinoril. She is now legally blind. She claimed not only that Mutual didn't adequately warn of its drug's dangers, but also that the product was defective and shouldn't have been sold. A jury awarded her $21 million for her injuries. Mutual, which is owned by Sun Pharmaceuticals, argued that the product and its label were FDA-approved and that those approvals preempt Bartlett's state-court claims.

The justices said Bartlett's situation was "tragic and evokes deep sympathy," Reuters reported, but said the law requires that the judgment of the lower court be reversed.

The ruling came a week after the Supreme Court voted 5-3 that the Federal Trade Commission has the right to challenge brand-name drugmakers' patent settlements with generics companies. That case was not a complete loss for drugmakers who opposed it. The opinion stopped short of buying the FTC's position that these patent settlements should be assumed anticompetitive unless proven otherwise, but it did reverse a circuit court's ruling that shielded the companies from most lawsuits challenging their patent deals, thus opening the way for more lawsuits from payers, retailers, wholesalers and others, as well as the FTC.

- read the Reuters story
- see the NYT piece
- here's more from the LA Times

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