Drug makers seek shield from suits
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.
On Capitol Hill, Democrats reacted angrily. Sen. Edward M. Kennedy (D-Mass.) and Rep. Henry A. Waxman (D-Beverly Hills) had been sponsors of the 1976 law, and they said lawsuits provided extra protection for injured persons. During the summer, they introduced a bill to reverse the court’s ruling. But Democrats say they will not take up the measure until next year.
On Nov. 3, the day before the presidential election, the court will hear the case of Wyeth vs. Levine to decide whether to block suits against drug makers.
“I never thought I would sue anybody,” said Diana Levine, a Vermont musician who has migraine headaches.
Her case involves a rare but previously reported complication of Phenergan, a drug made by Wyeth. She had gone to a local clinic suffering from a severe headache. She was given Demerol to relieve the pain and the second drug to prevent vomiting and nausea. The warning label for Phenergan urges extreme caution when administering the drug via injection so as to avoid striking an artery.
The use of an intravenous drip would have posed no danger, medical experts say, but instead the physician’s assistant injected the drug into Levine’s arm and, apparently, struck an artery.
Within days, Levine was in a hospital with gangrene. Surgeons removed her hand and then the lower part of her right arm. Levine, a widow, thought she had lost her livelihood along with her arm, and she faced huge medical bills.
She settled a case with the clinic and the physician’s assistant and then sued Wyeth, asserting that the drug maker should have warned against injecting Phenergan under any circumstances. “Their drug is wonderful. The problem is the method of administering it, and they knew it was dangerous,” she said.
A jury in Montpelier, Vt., heard the evidence during a weeklong trial and awarded Levine $6.7 million in damages. “It was so reassuring to think, ‘My God, our system of justice really works,’ ” Levine said.
But earlier this year, about the same time it shielded Medtronic and other makers of medical devices, the Supreme Court agreed to hear Wyeth’s appeal.
A broad collection of business groups, including the U.S. Chamber of Commerce and the pharmaceutical industry, joined with the U.S. solicitor general, representing the FDA, on Wyeth’s side. They argue 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.
In response, consumer rights advocates say lawsuits can compensate patients for injuries as well as alert the public to dangers the FDA might have overlooked. “If I drive my car and the brakes fail and I hit someone, I’m liable for the damage I caused,” said law professor Vladeck. “Why should companies have an immunity from liability that ordinary citizens don’t have? And that’s what they are asking for.”