Drug makers seek shield from lawsuits

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.