Consumers' Right to Sue Weakening
By Arthur Allen
The Washington Independent
Friday 21 March 2008
Upcoming case could bar public from taking drug makers to court.
For more than a century, the regulation of U.S. food and drugs has seen its share of challenges -- from the filthy slaughterhouses of Upton Sinclair's Chicago to the tainted Chinese-made blood thinner that recently killed at least 19 people. The regulatory shortcomings on display in 1937, when ethylene glycol killed 105 antibiotic consumers, were still glaring six decades later, when Vioxx users started having heart attacks.
But throughout the history of the Food and Drug Administration, and its precursor agencies, U.S. consumers could always bring the manufacturer of a faulty product to court. Now, with the FDA woefully underfunded in its key role of assuring the safety and effectiveness of foods and drugs, and with political ideologues in the agency pushing industry prerogatives, the White House and the courts may be on the verge of stripping Americans of the right to sue. This would take away the last option for those seeking protection from --or recourse for -- faulty products.
Last month, in a 8-1 decision, the Supreme Court ruled that most people using medical devices do not have the right to sue manufacturers. In October, the court is expected to take up a more far-reaching case, Levine V. Wyeth, that could stop most lawsuits involving drugs. The court will examine the legality of a lawsuit preemption quietly written into an innocuous FDA labeling law in 2006. The author was Daniel Troy, then the FDA counsel, now an industry lobbyist. With major cuts in food and drug safety inspections, the take-home message, increasingly, is caveat emptor. Watch out for yourself, because the government won't.
"Consumers are getting the worst of both worlds," says David C. Vladeck, a Georgetown Law School professor. "They don't get the protection the FDA promises because the agency is incapable these days of truly providing a safeguard for the drugs we get. And at the same time, the FDA is claiming that if we're injured by a product falling through this quite penetrable safety net, all our rights to compensation are cut off by virtue of the FDA's regulations - inadequate though they may be." Few of those who care about the FDA question that it is in deep trouble. A 180-member umbrella committee that includes academics, former government officials, business and consumer groups is pushing for more funding. At a Jan. 29 hearing of a House energy and commerce subcommittee, an expert panel reported that the FDA "cannot fulfill its mission" because of weaknesses in its staff, organization and information technology. "Science at the Food and Drug Administration today is in a precarious position," said Peter Barton Hutt, a former FDA counsel who has chronicled the history of the agency. Hutt recommended a 50 percent increase in the FDA's $2-billion budget over the next two years.
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