Editorials Address Supreme Court Case On Pre-Emption

Main Category: Pharma Industry / Biotech Industry
Also Included In: Litigation / Medical Malpractice
Article Date: 10 Nov 2008 - 11:00 PST

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Three newspapers on Friday published editorials on Wyeth v. Levine, a case on which the U.S. Supreme Court heard opening arguments on Monday that could determine whether patients have the ability to file product liability lawsuits against pharmaceutical companies in state courts. Summaries appear below.

• Baltimore Sun: A decision in favor of Wyeth in the case could leave the next president "hamstrung by regulations locking in drug manufacturers' immunity from lawsuits" that "would thwart efforts to make the industry more accountable and leave thousands of consumers vulnerable to potentially harmful drugs for years to come," the editorial states. Meanwhile, the Bush administration, which "tried for years to win immunity for drug manufacturers in Congress," has "simply rewritten the FDA rules to reflect its wishes -- even though the FDA admits it doesn't have the staff or resources to thoroughly vet every new product on the market and has long relied on consumer complaints and lawsuits to alert it to potentially hazardous products that its inspectors miss." The editorial concludes, "The Bush administration's last-minute effort to take the country back to the unregulated era of 19th-century patent medicines, with their questionable ingredients and marginal or nonexistent benefits, is a throwback the country can't afford and the court must not permit" (Baltimore Sun, 11/7).
  
  
• Boston Globe: Wyeth seeks to "have the justices legislate from the bench by finding that an FDA-approved label gives the firm pre-emptive protection," and the court "should say no," a Globe editorial states. "For years, pharmaceutical companies have asked Congress to pass a law protecting them from liability lawsuits for drugs," and lawmakers, "knowing only too well the fallibility of the FDA in approving drugs and monitoring their safety after approval, have rightly refused," according to the editorial. The editorial adds, "Suits in state courts force drug companies to do better monitoring of drugs after approval, and the discovery process in such suits often reveals to the public and the FDA much of the internal data companies have on problems with a drug, both before and after its approval." The editorial states, "From the justices' questions Monday, it was unclear how they might rule," but the "court should not let the FDA be Wyeth's scapegoat" (Boston Globe, 11/7).
  
  
• New York Times: "The drug industry and its administration allies now want the court to ignore the absence of express legal language and grant drug companies immunity based on a phony assertion that state lawsuits improperly usurp federal regulatory authority," a Times editorial states. The editorial states, "For the court to broadly endorse the concept of 'implied pre-emption' in this case would show disrespect for the considered decisions of Congress and could foreclose injury suits involving" medications and other products. "The ultimate effect would be to undermine consumer safety," according to the editorial. The editorial states, "Far from usurping" the authority of FDA, "litigation aimed at holding drug companies liable for problems like those in this case complement the agency's efforts to protect the public." The editorial adds, "Only under President Bush did the agency overrule its top staff members and try to pre-empt such suits." The editorial concludes, "We hope this business-friendly Supreme Court will preserve the consumer protection that state tort actions often provide," or "the incoming president and Congress will need to pass corrective legislation" (New York Times, 11/7).

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