Americans assume that federal regulatory agencies assure that our drugs, medical devices, cars and other consumer products are safe, and that the tort system deters manufacturers from selling products that pose unreasonable risks and compels them to compensate those injured by defective products. These assumptions are under assault. Not only are public health agencies headed by political appointees committed more to business interests than to public safety but Bush-appointed pro-business judges now dominate the Supreme Court and the federal bench. And the administration is subverting the tort system by claiming that agency actions “pre-empt,” or wipe away, the right to sue. If this trend continues, the public will soon have the worst of both worlds–agencies that don’t protect them and judges who deny them access to the tort system when they are injured.
Medical Devices. The Supreme Court’s 2008 ruling in Riegel v. Medtronic is, to date, the most serious blow to consumers. The ruling nullifies the right of people injured by FDA-approved medical devices to sue. Charlie Riegel nearly died when a catheter doctors were using to clear his arteries burst. He and his wife sued Medtronic, the catheter’s manufacturer. The FDA had once said that its premarket approval of a medical device did not pre-empt state law. But in 2002 the agency switched positions, and the Supreme Court agreed, ruling that FDA approval of a medical device effectively insulates its manufacturer from tort liability. The decision bodes ill for consumers. In the past few years there have been massive recalls of medical devices endorsed by the FDA, including defibrillators, pacemakers, heart valves, hip and knee prostheses, and heart pumps. When these devices fail, they exact a toll of injuries to thousands of patients, who face the prospect of replacement surgery. Patients will now have to bear their medical and other costs, even though the devices are defective. Congress should act to overrule Riegel.
Drugs. On November 3, the day before the election, the Supreme Court will hear arguments in Wyeth v. Levine. Diana Levine, a musician, had her arm amputated because Wyeth’s anti-nausea drug inadvertently came into contact with her artery when it was injected into her vein. Levine claimed, and the Vermont Supreme Court agreed, that intravenous injection was so risky that Wyeth should have told physicians not to use it. Until 2002, the FDA had said that state tort law was a complement to FDA regulatory efforts. But the FDA now argues that its approval of a drug’s label bars any tort litigation over inadequate warnings, even though drug companies know most about the safety of their drugs and generally initiate labeling changes. The problem is a serious one: adverse reactions to drugs are a leading cause of injury and death in the United States. Just in the past few years tens of thousands of patients have been killed and injured by improperly labeled drugs, including pain relievers like Vioxx, Celebrex and Bextra, diabetes medications like Rezulin and Avandia, and antidepressants like Zyprexa and Paxil, and have sued to be compensated for their loss. If the Court agrees with the FDA in Wyeth v. Levine, others injured by drugs will be out of court and drug companies will have virtual immunity from liability even when they fail to warn doctors and patients of the risks associated with their drugs.