Posted by The tort system is the favorite whipping boy of the anti-regulation crowd. That’s because once you remove regulation, something the Bush administration has championed and done effectively, the only recourse someone injured by the fraud or negligence of a product or drug manufacturer is through a lawsuit for damages. Since the anti-regulation crowd serves Big Pharma and their cronies, this is the perfect solution: no constraints. The propaganda machine, aided an abetter by a compliant congress and a business dominated media, has been extremely successful in promoting the idea that tort suits are overwhelmingly “frivolous” (e.g., the McDonald’s hot coffee case) and are jamming the courts, although tort suits constitute only about 10% of the docket, the majority being taken up by routine business cases like contract disputes. But if you want to see frivolous lawsuits you don’t have to look any farther than the MPAA and RIAA copyright actions against teenagers and grannies. But that’s another story. Meanwhile the tort suit is one of the most important behavior modifiers for careless manufacturers. But “meanwhile” might not last much longer, if a case currently before the Supreme Court goes the way Big Pharma and the Bush administration want it to. They want labeling decisions made by the Food and Drug Administration to pre-empt an cause of action brought by any person under the laws of their state:
The pharmaceutical industry, and the Bush administration, say patients are amply protected by the Food and Drug Administration, which approves drugs after reviewing their benefits and risks. In the case called Wyeth vs. Levine, business groups and the government are asking the Supreme Court to impose strict new limits on lawsuits against drug firms.
Such suits, industry advocates say, can expose drugmakers to a conflicting hodgepodge of jury decisions in multiple state courts that often contradict the expert judgment of the FDA when it decides what warnings belong on a drug label. The FDA-approved label, they argue, should trump the findings of juries who lack the same expertise. Wyeth and its supporters want the high court to rule that the FDA’s powers pre-empt state court lawsuits that claim stricter drug warnings were needed.
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That logic is known as the pre-emption argument, which maintains that the federal government has the last word on drug labeling. And, therefore, government warnings override legal challenges after a drug has been approved. (Bernadette Tansey, San Francisco Chronicle)
Information obtained by Representative Henry Waxman (D., CA) show that neither FDA staffers nor FDA experts agree with the pre-emption position of the Bush administration:
“We know that many currently approved drug labels are out of date and in many cases contain incorrect information,” the committee report quoted top FDA official Dr. John Jenkins as saying in a 2003 internal policy memo.
What makes the whole thing especially outrageous is that the Bush FDA now requires approval to change a warning label when new adverse event information becomes known to the manufacturer. In previous administrations the FDA actually encouraged drug makers to update their labels immediately.
A recent Supreme Court decision upheld federal pre-emption clauses in legislation for medical devices, but this language isn’t in the same statutes concerning drugs. Nevertheless, Big Pharma and the Bush administration argue it is “implied.”
There is now a developing consensus, even amongst in the public health establishment that FDA is a broken agency. Thus to maintain that this hollow husk of a regulatory agency’s warning labels is all we need to protect consumers is a very cruel joke.
But cruelty and bad jokes are a hallmark of the Bush administration. 76 days left.
November 4, 2008
November 4, 2008
November 4, 2008
November 7, 2008