WASHINGTON - The Supreme Court earlier this year reinterpreted a 32-year-old federal law as barring suits against makers of government-approved medical devices. 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 that are also government approved.
If it does, 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.
Now they stand on the verge of shutting down thousands of lawsuits that could 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.
The new case before the court concerns Diana Levine, 62, a musician from Vermont whose right arm was amputated after an antinausea drug was improperly injected into an artery and caused gangrene.
She sued the drugmaker and was awarded $6.7 million by a Vermont jury. The Supreme Court agreed to hear the drugmaker'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. In 2005 alone, 17,000 suits were filed against drugmakers, 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. The same logic applies to prescription drugs, he said.
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, saying 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 v. 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, a law passed after 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 Supreme 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 therefore the federal law "preempted" these suits.
Nov. 3, the court will hear the case of Wyeth v. Levine to decide whether to block suits against drugmakers.
On Wyeth's side, a broad collection of business groups argues that the FDA had approved the warning label for Phenergan and that a Vermont jury did not have the authority or expertise to decide whether a stronger warning was needed.
Vladeck responds: "If I drive my car and the brakes fail and I hit someone, I'm liable for the damage I caused. Why should companies have an immunity from liability that ordinary citizens don't have?"