“F.D.A. Rule Could Open Generic Drug Makers to Suits”

Speaking of class action lawsuits and how severely the Supreme Court has recently slashed apart individual plaintiffs’ right to sue for damages when they are injured by corporations, the Times Katie Thomas reported this good news yesterday:

The Food and Drug Administration on Wednesday signaled its intention to permit generic drug makers to make changes to their safety labels, a move that could open the door to lawsuits against generic drug companies for the first time since a Supreme Court decision barred such suits two years ago.

Consumer advocates applauded the development, calling it a necessary fix for a system that they say is unfair to patients who take generic medicines.

“It’s common sense,” said Dr. Sidney M. Wolfe, a senior adviser to the Health Research Group at Public Citizen, which in 2011 petitioned the F.D.A. to pass just such a rule. “It will obviously end this situation where people are being harmed physically and yet, although they are harmed, they have no right to go into court and get redress for serious damages.”

Dozens of lawsuits against generic drug manufacturers have been dismissed since 2011, when the Supreme Court ruled that because the generic companies must, by law, use the same label warnings as their brand name counterparts they cannot be sued for failing to alert patients about the risks of taking their drugs. Last month, the Supreme Court ruled — on similar grounds — that patients also may not sue generic drug makers by claiming that the drug was defectively designed.

The article tells stories of real people harmed by the Supreme Court’s rulings. It made me think of how, when Congress can’t or doesn’t act for the benefit of its citizens, federal agencies and other areas of our government can and do.

Another reason to be glad for (at least some of) federal bureaucracy.


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