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Drug makers seek shield from suits

The Supreme Court this fall will consider barring liability claims involving medications approved by the FDA.

September 07, 2008|David G. Savage | Times Staff Writer

WASHINGTON — Bridget Robb was awakened last December by a powerful electric shock to her chest. "It was a jolt of electricity. It felt like being shot in the chest or being hit by lightning," said the 34-year-old mother from a Philadelphia suburb.

She knew the cause of her agony. A device implanted in her chest was supposed to shock her, but only if her heart had quit. Instead, because of frayed wires, it misfired 31 times in 13 minutes.

She underwent two operations to replace the defective device, requiring months of recovery.

Robb appears to be blocked from suing the manufacturer for compensation. Earlier this year, the Supreme Court reinterpreted a 32-year-old federal law as barring suits against makers of government-approved medical devices.

Now, in a case to be heard this fall, the court will consider whether to extend this shield against lawsuits to the makers of prescription medicines and over-the-counter drugs.

If so, it could make for a far-reaching change in the law, one brought about with little public debate. Having failed to persuade Congress or the states to limit such suits, the Bush administration and the pharmaceutical industry went to court, and now they stand on the verge of shutting down tens of thousands of lawsuits that have cost the industry billions of dollars in jury verdicts and settlements.

"This is a radical restructuring of the American civil justice system," said Georgetown law professor David C. Vladeck, formerly of the consumer advocacy group Public Citizen.

Until recently, the right to a civil jury trial has been a historic protection for consumers. People hurt by a defective product could sue and ask a jury to award them damages. But the high court has been increasingly skeptical of lawsuits and civil juries. A series of recent rulings has limited lawsuits against businesses, but the biggest test will come before the court on the day before the presidential election.

The new case before the court concerns a 62-year-old musician from Vermont whose right arm was amputated after an anti-nausea drug was improperly injected into an artery and caused gangrene. She sued the drug maker and was awarded $6.7 million by a Vermont jury. The high court agreed to hear the drug maker's appeal that the woman's suit, and others like it, should be thrown out.

Advocates for the pharmaceutical industry say it makes more sense to have experts at the Food and Drug Administration -- rather than jurors -- decide whether a drug is safe or dangerous. In 2005 alone, 17,000 suits were filed against drug makers, they say.

"Do we really want a jury in Peoria or Santa Fe deciding whether the design of a medical device needs to be changed?" asked Washington lawyer Ted Olson, who represented Medtronic this year in the medical devices case. And the same logic applies to prescription drugs, he said.

Manufacturers have long chafed at this right to sue and the resulting big jury verdicts. During the 1980s and 1990s, business lawyers and lobbyists tried, with limited success, to persuade state legislatures and judges to disallow some lawsuits and to limit damage awards.

The Bush administration tried a different approach. Bypassing Congress, it had federal agencies reinterpret the laws on the books to conclude that jury verdicts would conflict with federal policy.

Nowhere is this approach having more effect than in the area of drugs and medical devices.

Before this decade, the FDA had maintained that regulatory laws passed by Congress did not bar such lawsuits. Under the Bush administration, the FDA changed course and said that its federal oversight of drugs and medical devices barred most lawsuits concerning those products.

In February, the Supreme Court endorsed the administration's view in the case of Riegel vs. Medtronic. The justices in an 8-1 decision rejected a suit filed by a New York man whose balloon catheter burst in his chest.

The ruling was based on the Medical Device Amendments of 1976:+21USC360k, a law passed in the wake of the Dalkon Shield disaster. This birth control device, introduced in 1970, was blamed for 12 deaths and thousands of severe infections in young women.

To protect the public from unsafe devices, Congress told the FDA to approve new medical devices before they went on the market. Nothing was said about limiting lawsuits. At the time, California had its own law regulating the sale of medical devices, and the new federal law said states could not enforce "any requirement" that differed from the FDA rules.

This phrase was crucial to the high court's decision in February. The justices said that a lawsuit filed under a state's consumer protection law could impose an extra "requirement" on device makers and that, therefore, the federal law "preempted" these suits.

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