When the FDA is weak, we rely on strong courts.

http://www.prospect.org/web/page.ww?section=root&name=ViewWeb&articleId=8996

The White House doesn't seem too worried about the medicines we take. Chief of Staff Andrew Card said recently that the Food and Drug Administration (FDA) is doing a "spectacular" job overseeing drug safety. Really? Even though the agency reportedly didn't act on warning signs linking blockbuster arthritis painkillers to increased risk of heart trouble and strokes? When it failed to warn doctors and parents about the risk of suicide among children taking antidepressants? Meanwhile, the president is calling for "tort reform." As a first step, his Republican allies in Congress are working on a bill to limit the liability of pharmaceutical companies from lawsuits brought by people injured by drugs or medical devices the FDA had okayed. But the administration can't have it both ways. Either it should move to strengthen regulatory agencies or it should allow private lawsuits. Take away both, and consumers are in deep trouble.

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This tort liability system is also imperfect. Lawsuits are expensive and risky for plaintiffs. Large portions of awards go to attorneys. Verdicts can be devastatingly expensive for companies that are found liable. Cases are often complex, and juries can at times be swayed more by emotion than by logic.

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Both systems are now under considerable stress, partly because the U.S. economy has changed dramatically, faster than either system's ability to adapt. Even a quarter-century ago, most U.S. industries were

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tested because they're under greater pressure to show profits for investors who are much quicker to abandon a stock that's not performing as well as they'd like it to be.

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Under current law, the FDA has no power to mute such promotional hype -- all it can do is approve new drugs as safe and effective, or not. Nor does the agency have any systematic way to monitor the safety of drugs once they've been approved, other than by relying on the manufacturers to report side effects and injuries. It can't require manufacturers to undertake post-approval studies. (The studies that eventually discovered heart problems associated with these drugs were done independently of the FDA.)

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Merck & Co. decided on its own to take Vioxx off the market last fall. Pfizer Inc. continues to sell Celebrex but has stopped advertising it pending further study. Manufacturers took milder action on two other painkillers: Warnings about heart risks have been added to Bextra's label, and Aleve users are being instructed not to take it for more than 10 consecutive days. These were the manufacturers' decisions. An important factor in convincing Merck to remove Vioxx from the market was the mounting threat of lawsuits. Hundreds have already been filed, representing thousands of plaintiffs and including a number of class actions, blaming Vioxx for heart attacks and strokes and alleging a link to more than 1,200 deaths.