Seuferer's claim is one of many thousands of suspended cases across the country that hang on the decision of the U.S. Supreme Court in a pivotal case to be argued Monday. The question before the high court is whether patients such as Seuferer should be able to sue when they believe drugmakers failed to warn them adequately about the risks of medicines.
"How else would an individual protect themselves?" is the way Seuferer, 64, sees it.
The pharmaceutical industry, and the Bush administration, say patients are amply protected by the Food and Drug Administration, which approves drugs after reviewing their benefits and risks. In the case called Wyeth vs. Levine, business groups and the government are asking the Supreme Court to impose strict new limits on lawsuits against drug firms.
Multiple jurisdictions
Such suits, industry advocates say, can expose drugmakers to a conflicting hodgepodge of jury decisions in multiple state courts that often contradict the expert judgment of the FDA when it decides what warnings belong on a drug label. The FDA-approved label, they argue, should trump the findings of juries who lack the same expertise. Wyeth and its supporters want the high court to rule that the FDA's powers pre-empt state court lawsuits that claim stricter drug warnings were needed.
"The states cannot come along and say you should have done something different," said Bert Rein, Wyeth's attorney, in its effort to overturn a Vermont jury's $6.7 million verdict in favor of an injured clinic patient, Diana Levine.
That logic is known as the pre-emption argument, which maintains that the federal government has the last word on drug labeling. And, therefore, government warnings override legal challenges after a drug has been approved.
That pre-emption argument raised an uproar among consumer organizations and others who warn that a sweeping change in the ground rules for drug product liability could endanger patient safety. Among the opponents are legislators, personal injury attorneys, former FDA commissioners, 47 states including California and the California Medical Association.
Consumer advocates argue that drug manufacturers must retain responsibility to provide current, accurate warnings to the public. FDA rules allow them to propose label updates. State drug safety laws, enforced through court action, help to hold drugmakers to those obligations, such advocates maintain.
"Our entire system is based on checks and balances," said Bijan Esfandiari, an attorney with the Los Angeles law firm Baum, Hedlund, Aristei & Goldman, which represents patients. He said drugmakers can be reluctant to share risk information with consumers. "One impetus that encourages them to be forthcoming is the tort system."
Warning labels
Career FDA experts have resisted the Bush administration's support of the pre-emption stance, according to a report prepared for Rep. Henry Waxman, D-Los Angeles, chairman of the House Oversight and Government Reform Committee. The report, issued amid a last-minute flurry of position papers by both sides last week, said FDA staffers also protested when the agency said drugmakers could no longer heighten label warnings without prior FDA approval. The FDA had previously welcomed companies to beef up risk disclosures immediately.
"We know that many currently approved drug labels are out of date and in many cases contain incorrect information," the committee report quoted top FDA official Dr. John Jenkins as saying in a 2003 internal policy memo.
The right to seek court damages for allegedly inadequate medical warnings was upheld for decades. In February, however, the Supreme Court restricted lawsuits concerning many medical devices, citing pre-emption language in the law governing those products. No such explicit pre-emption wording exists in the law that covers drugs. But industry advocates are urging the Supreme Court to find in the Wyeth case that FDA pre-emption in the arena of drug warnings is implied.
That case arose after Levine, a guitarist, was treated for a severe migraine headache and nausea in 2000. A practitioner injected Wyeth's anti-nausea drug Phenergan into Levine's vein, inadvertently penetrating an artery. The drug reacted with arterial blood to cause gangrene, and Levine's arm was amputated below the elbow. In her lawsuit, Levine said Wyeth should have warned doctors not to inject the drug directly into a vein, which raised the risk of gangrene.
Risk disclosed
Rein, Wyeth's attorney, said the FDA knew of that risk but preserved the direct injection method because it can control severe nausea faster than injection into muscle or an IV drip solution. Rein said only rare cases of gangrene had been reported since Phenergan was approved in 1955, and the occurrences had not been increasing before Levine received the drug.
If the Supreme Court rules that suits such as Levine's are pre-empted, Rein said, it would protect companies such as Wyeth that had disclosed all risk information to the FDA. But he said it probably would not shield companies that had concealed drug dangers the agency needed to weigh when it approved the warnings on the drug label, he said.
But personal-injury attorneys said a broad pre-emption ruling could raise obstacles to suits against manufacturers accused of withholding risk information. Such cases against Vioxx manufacturer Merck, which agreed to pay $4.85 billion last year to settle most of the claims, might not have made it to court under such a ruling, said Mike Seuferer's attorney, Mark Burton of San Francisco. Nor might suits by Seuferer and other plaintiffs who claim that Avandia manufacturer GlaxoSmithKline concealed or downplayed the heart risks of the diabetes drug, he said. To get such a case to a jury, patients' attorneys might first have to persuade a judge that the FDA lacked crucial information, Burton said.
Whatever the outcome of the Wyeth case, the Supreme Court will probably leave many questions unanswered, said Esfandiari.
The political battle over pre-emption is hardly over, said John Calfee, a legal scholar at the American Enterprise Institute who supported the Bush administration position in an article this week. The next session of Congress will probably see an attempt to overturn the court decision insulating medical device makers from lawsuits, he said.
"If Wyeth wins any sort of victory at the Supreme Court, we can anticipate that similar legislation will be proposed for pharmaceutical litigation pre-emption," Calfee said.
sfgate.com
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