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The Michigan Supreme Court has upheld the constitutionality of a statute that limits lawsuits against drug makers for defective drugs when the drugs have been approved by the U.S. Food and Drug Administration (FDA) and comply with its labeling requirements. Taylor v. Smith-Kline Beecham Corp., No. 120624; Robards v. Gate Pharmaceuticals, No. 120641. “It’s the end of drug products liability in Michigan,” plaintiffs’ lawyer David Parker of Detroit’s Charfoos & Christensen said. The ruling arose in the appeal of four separate lawsuits filed against four different manufacturers of the diet drug combination known as fen-phen, after trial courts reached opposite results on the defendants’ motions for summary judgment. Each of those motions were based on the provision known as MCL 600.2946(5). Passed as part of “tort reform” legislation in 1995, the statute says that “a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy” by the FDA, and that the drug complied with FDA labeling standards “at the time the drug left the control of the manufacturer or seller.” The state’s intermediate Court of Appeals held that the statute was an unconstitutional delegation of legislative power because it made the FDA the federal arbiter of whether a drug was safe. Michigan’s high court, however, disagreed, reversing the appeals court, 6-1. The statute, it said, “represents a legislative determination as a matter of law of when a manufacturer or seller of a prescription drug has acted sufficiently reasonably, solely for the purpose of defining the limits of a cognizable products liability claim under Michigan law.” Ronald Graham, now of Freeman, Cotton & Norris in Bloomfield Hills, Mich., represented one of the defendants, Gate Pharmaceuticals. He said the statute is good public policy to the extent that it takes cases not backed by hard science out of litigation. But, he concedes, “there will always be circumstances when one could argue that someone should have had an opportunity to bring a claim for redress for an injury allegedly related to a defective product,” he says. Parker, whose clients allegedly suffered from pulmonary hypertension after taking FDA-approved drugs, questioned whether Michigan residents will be able to participate in global settlements of future pharmaceutical cases. Jim O’Reilly, law professor at the University of Cincinnati and author of treatises on the FDA and product warnings, said the Michigan statute is unusual because states do not usually cede power to the federal government without pre-emption. A former associate general counsel at Procter & Gamble, O’Reilly added, “the state is deciding to give away the rights of the individual” so that career federal agency employees in Washington “are now exercising the delegated power of a jury.” The practical political consequence, he predicted, is that many more states will follow Michigan’s lead. “The drug industry found a way to achieve total immunity in a way that was obviously not understood by the public or the Legislature,” said consumer activist Herb Denenberg, publisher of the Denenberg Report, an online newsletter. “This suggests to would-be tort reformers that if they are crafty enough they can abolish the right to sue by taking new tacks.” Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America, said that the association is not actively tracking the case. He added, however, that the association has long supported an “FDA defense” to punitive damages if a drug company can prove that it followed all of the agency’s rules and regulations in good faith.

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