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Safety Last | The Nation

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Safety Last

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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.

About the Author

David C. Vladeck
David C. Vladeck is a professor of law at Georgetown University Law Center.

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.

Cars. The same pattern is being repeated with safety regulations applicable to cars and light trucks. The statute creating the National Highway Transportation Safety Agency pre-empts state laws and regulations that are different from or in addition to those of NHTSA, but the statute declares it does not prevent injury suits under state tort law. Nonetheless, in 2000 the Supreme Court, in Geier v. American Honda Co., ruled that NHTSA regulatory actions may pre-empt tort claims. Alexis Geier was seriously hurt when her Honda, which did not have air bags, was involved in a head-on collision. She argued that the absence of air bags rendered the car's design defective. The Supreme Court ruled that her claim was pre-empted by NHTSA's decision to permit car manufacturers to phase in air bags. And lower courts have since held that NHTSA rules generally pre-empt state tort law. In 1995 Tina Griffith was seriously injured in a car crash even though she was wearing her lap belt. She contended that the car should have had been equipped with a shoulder harness as well, an option NHTSA's rules permitted. But in 2002, a federal appeals court found that her claim was pre-empted because NHTSA's rules gave manufacturers a choice of restraints--here, the choice to use cheap, less protective restraints system instead of more effective ones.

Every year, more than 10,000 Americans are killed and nearly 25,000 are seriously injured in rollover crashes. Until Geier and Griffith, people injured in rollover crashes could sue the vehicle's manufacturer and often prevailed if they could show that the car's roof should have been designed to protect occupants in a rollover. Many of those killed and injured in Ford Explorer rollovers won cases against Ford for just this reason. But NHTSA now sides with auto manufacturers that want to put an end to these cases. NHTSA recently proposed a new roof strength standard that it admitted would do little to save lives because virtually all new vehicles already exceed the proposed standard. Nevertheless, NHTSA claims that the standard pre-empts all state law claims in roof-crush cases. It will be up to the courts to decide whether NHTSA is right.

Mattresses and other Consumer Products. The safety of mattresses, clothes, hazardous consumer products and poisons are all regulated by the Consumer Product Safety Commission. But this agency too now argues in favor of broad pre-emption, even though courts have long taken the position that CPSC standards do not pre-empt state tort law. For instance, reversing field, the agency argues that its new mattress flammability standard pre-empts state tort law. Courts have yet to address whether the CPSC position is right; but if federal judges agree, people injured by fire-prone mattresses and other defective consumer products will have no recourse.

The foregoing was made worse by a recent decision by the influential DC Circuit Court of Appeals denying consumer groups judicial access when they challenge an agency action that fails to safeguard the public health. In Public Citizen v. NHTSA, the consumer group challenged an industry-favored NHTSA rule regulating tire-pressure gauges on the ground that the rule would permit the use of cheap gauges that could not detect significantly underinflated tires. But because Public Citizen could not prove that one its members would be likely to sustain injury as a result of a tire that remained underinflated because of NHTSA's rule, the court threw out the case. Meanwhile, business groups continue to have unimpeded access to the courts. A judge recently appointed by President Bush wrote the court's opinion.

Other Contributions to the Forum

"The Supreme Court and the Election: What's at Stake," by Herman Schwartz

"Health Cares," by Sara Rosenbaum

"Senior Rights & Wrongs," by Harper Jean Tobin

"Debtor Nation," by Robert M. Lawless

"Hard Knocks in the Workplace," by Eric Schnapper

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