( – promoted by DocHoc)
Americans rely on the Food and Drug Administration to protect them from dangerous drugs and medical devices.
All too often the protections are woefully inadequate.
Today the U.S. Supreme Court heard arguments in a case that could give Big Pharma and others a free pass to harm the sick.
Wyeth v. Levine involves a Vermont musician’s loss of an arm from improperly administered anti-nausea drug Phenergan.
The drug’s manufacturer, Wyeth, argues that it shouldn’t be subject to state liability laws because the FDA approved the drug’s use and labeling – a legal concept called preemption.
Should Wyeth prevail, it won’t matter if drugs are later found to be defective, even dangerous; the only thing that will matter is if the FDA signed off on them.
Among the briefs filed in support of Levine is one from current and former editors of the New England Journal of Medicine, the nation’s leading medical publication.
Oklahoma is one of dozens of states to sign a brief supporting Levine.
Preemption may not sound provocative, but it’s hugely important to people’s safety and to the ever-changing body of knowledge about prescription drug dangers.
Although the Wyeth case involves pharmaceuticals, preemption can affect anything that has differing federal and state standards, from railroad and car-crash safety to medical devices.
Preemption is a radical extension of the Constitution’s supremacy clause. Preemption is so brazen as to be almost unbelievable.
Read a newspaper for a few days and you’ll find examples of the FDA and other agencies failing to protect the public.
The Bush Administration argues that juries can’t be trusted to second-guess federal regulators.
Well, I’d trust Oklahomans’ common sense over the FDA’s experts on Vioxx, Fen-Phen, Avandia and other drugs that have ruined lives they were supposed to improve. The FDA’s track record doesn’t exactly inspire confidence.
Drug companies have known about risks associated with their products but have kept data from the FDA, which relies on them for the information it needs to regulate the industry.
This is the classic case of the fox guarding the henhouse, and one that bears watching.
This won’t be the last time you’ll hear about preemption, and I sincerely hope you don’t ever need the protections you may be on the verge of losing.
Oklahoma Foundation for Consumer & Patient Rights