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An Invincible Shield For Medical Manufacturers

Legal Affairs


Jane King thought she had a solid case against Collagen Corp., makers of a wrinkle-softening treatment called Zyderm. In 1987, a plastic surgeon injected King with a test dose of Zyderm to remove two lines around her mouth. Soon after, the then 35-year-old waitress from Salem, Mass., came down with an incurable disease that causes her immune system to attack skin and muscle tissues. She sued Collagen--as have several other women--for knowingly marketing an unsafe product. But King lost--though whether Zyderm was unsafe or not had nothing to do with it.

In January, a federal appeals court in Massachusetts threw out her case, ruling that Congress intended the Food & Drug Administration--not judges and juries--to be the final authority on the safety and efficacy of medical devices such as Zyderm. The King decision and a similar case involving Collagen, if upheld by the U.S. Supreme Court, will drastically alter the legal rights of the more than 11 million Americans using medical devices that are injected or implanted in the body, including heart valves, pacemakers, and artificial joints. The ruling does not apply to drugs.

WIDE IMPACT. The judges' decisions would bar consumers from suing companies whose products have the FDA's premarket stamp of approval--even in cases where design or manufacturing flaws are detected. One ruling states that suits would be banned in the event of fraud. Such instances would only be open to criminal prosecution, since consumers could not sue the FDA. "To think that fraud and misrepresentation can be shielded by this law is mind-boggling," says King's lawyer, Susan Allinger.

The two Collagen decisions are already beginning to have impact. The issue was raised recently by Shiley Inc. in a case brought by 300 recipients of its FDA-sanctioned heart valve. Although a California appeals court ruled on July 22 that the King decision did not warrant dismissal of the case, Shiley will undoubtedly continue to press the point. Had the King ruling been around last year, the company's $500 million settlement with other heart-valve customers might never have occurred. Indeed, the legal and economic impact of the courts' decisions could be staggering, with hundreds of cases pending nationwide involving everything from optical implants to hip prostheses.

For medical-device makers, the Collagen cases offer the first relief after years of rising legal costs. "We spend millions proving to ourselves and the FDA that our products are safe and effective long before they go into commercial use," says David Foster, Collagen's chief financial officer. "The argument we've tried to use is that review by the FDA ought to be worth something."

The FDA's review is certainly arduous. The agency requires manufacturers to submit reams of clinical and safety testing data, explanations of how their devices will be produced, and proposals on warning labels. Now, manufacturers contend that freedom from the threat of litigation will result in lower prices for consumers as well as more innovation.

NOT INFALLIBLE. The companies are also cheering legislative efforts to limit their liability or to keep them out of court altogether. Industry groups are pressing Congress to adopt a uniform liability standard because they say having different laws in every state is unfair. Their complaints have already led five states to pass statutes that shield from punitive damages companies whose devices have FDA approval, except in instances of fraud or bribery. A national version of the law is before Congress.

These measures are by no means a sure thing. First they will have to get past such lawmakers as Representative John Dingell (D-Mich.), who is dubious about the merits of transforming the FDA into an insurance policy for manufacturers. The King ruling "is a strained reading of current law and doesn't appear to be what Congress had intended," Dingell says. His reluctance to give the FDA exclusive authority over medical devices stems from a report he issued in May blasting the agency for inadequately assessing the safety of these products. Dingell's stance is buttressed by some notable agency lapses, such as the FDA's failure to detect flaws in silicone breast implants. The FDA declined to comment for this story.

Organizations such as the Association of Trial Lawyers of America say they are simply fighting for consumer's rights. "It's unfair that you could have a device that's truly defective and harmful, but as long as it has the FDA's approval, recipients would never be able to do anything about it," says plaintiff's lawyer Neal Shapero.

It's clear that makers of medical devices and manufacturers of other products have been stung by ever-increasing legal burdens. The question is whether turning the FDA into a shield against consumer action is the best or fairest way to solve the problem.Linda Himelstein in New York

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