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Results In Cases Reveal Untenable Double Standard

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The Tampa Tribune

Published: March 18, 2009

The Supreme Court's recent ruling that federal approval of a drug is no protection from lawsuits is a victory for patients in a climate that lately has allowed businesses to hide behind government regulations.

The case pitted the pharmaceutical company Wyeth Laboratories against a Vermont musician who lost an arm to gangrene after she was improperly injected with the anti-nausea drug Phenergan.

Diana Levine claimed the drug's label needed stronger warnings and won a $6.7 million jury award against the drug maker. Wyeth failed to convince the court that the suit was barred by the Food and Drug Administration's approval of the drug and warning label.

Justice John Paul Stephens, writing for a 6-3 majority, properly rejected the company's argument. Instead, the court put the burden for manufacturing safe drugs and writing proper labels on the manufacturer.

Ironically, just last year the court went in the other direction, ruling 8-1 that manufacturers of defective medical devices such as pacemakers cannot be sued in state court. So what's the difference between medical devices and drugs, both of which must meet FDA approval? In the medical device case, state lawsuits were expressly forbidden by language in the regulatory legislation.

The legal doctrine in both cases is known as pre-emption. The theory behind it is that some activities require nationally uniform federal legislation and that federal law trumps state law. Businesses have increasingly used the doctrine to stop tort claims from being brought in state courts.

Wyeth, backed by the Bush administration and its "Big Pharma" allies, argued the FDA is the only agency with enough expertise to regulate drug makers and that the agency's decisions should not be second-guessed by courts.

But such reasoning would have the effect of immunizing companies from lawsuits, even for problems that arise after a device is on the market, which would have been a mistake grossly unfair to patients and to physicians dependent on warnings and updated pharmaceutical information when determining treatment.

If the FDA were given the final word on safety, manufacturers would have less incentive to conduct safety studies, monitor the drugs in the marketplace or supply doctors with updated information. Plus it's hardly realistic to believe the overloaded employees of the FDA can spot all problems when a medical device or drug is approved and released to the market.

The judicial process, to be sure, should weed out "junk" lawsuits. Warnings cannot be expected for every conceivable bad outcome.

But, as the court found, giving drug companies a free pass to market defective products is wrong.

Legislation will soon be introduced in Congress to allow state lawsuits for injuries caused by defective medical devices. Those patients, like people hurt by dangerous drugs, deserve the same legal protections.

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