Protecting pharmaceuticals

Our view : Consumers must be able to challenge manufacturers of dangerous drugs in court

November 07, 2008

In the waning months of the Bush administration, the Food and Drug Administration is asking the courts to extend the Republican Party's anti-regulatory zealotry well beyond the president's last day in office. This week, the U.S. Supreme Court heard arguments on whether a woman who lost an arm after being improperly injected with a drug could sue the company that manufactured it, and the administration was on exactly the wrong side of the issue.

The case involved musician Diana Levine, who was given the anti-nausea drug Phenergan, made by Wyeth Pharmaceuticals, after she visited a Vermont clinic in 2000 seeking relief from a migraine. But rather than administering the drug by intravenous drip, doctors injected Ms. Levine with a syringe using a technique known as "IV push," which can cause serious complications if done improperly. The botched injection caused her right arm to develop gangrene that later forced doctors to amputate it.

Ms. Levine sued Wyeth for negligence in failing to warn of the heightened risk associated with injecting the drug with a syringe. A Vermont jury awarded her nearly $7 million in damages, and Vermont's highest court upheld the judgment. Wyeth then appealed to the U.S. Supreme Court on the ground that the FDA's approval of the drug pre-empted consumers' rights to hold the company liable. And in a reversal of long-standing policy, the FDA sided with Wyeth in arguing that consumers harmed by prescription medications cannot sue drugmakers for damages.

The Bush administration tried for years to win immunity for drug manufacturers in Congress. Now it has simply rewritten the FDA rules to reflect its wishes - even though the FDA admits it doesn't have the staff or resources to thoroughly vet every new product on the market and has long relied on consumer complaints and lawsuits to alert it to potentially hazardous products that its inspectors miss.

If the justices rule in Wyeth's favor, the next president could take office hamstrung by regulations locking in drug manufacturers' immunity from lawsuits. That would thwart efforts to make the industry more accountable and leave thousands of consumers vulnerable to potentially harmful drugs for years to come. Protecting consumers from such dangers was the whole rationale for giving the FDA regulatory powers when it was established in 1906. The Bush administration's last-minute effort to take the county back to the unregulated era of 19th-century patent medicines, with their questionable ingredients and marginal or nonexistent benefits, is a throwback the country can't afford and the court must not permit.

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