MADISON, N.J., March 4 /PRNewswire-FirstCall/ -- The U.S. Supreme Court's ruling in Wyeth v. Levine is disappointing, not only for Wyeth, but for patients and public health in general. Patients are best served by a national standard for the labeling of prescription medications -- set by the medical and scientific experts at the U.S. Food and Drug Administration (FDA). When lay juries are permitted to second-guess the experts at FDA on the benefits and risks of particular medicines, the result is uncertainty for patients and doctors alike about how and when to use prescription drugs.
"Wyeth's labeling of Phenergan(R) provided clear instructions and warnings about its use, including clear warnings about the very risk at issue in this case," says Bert Rein, an attorney from Wiley Rein, a Washington D.C. law firm representing Wyeth in this matter. "The medical and scientific experts at FDA are in the best position to weigh the benefits and risks of a medicine and to assess how those benefits and risks should be described in the product's label."
In the dissenting opinion, Justice Alito stated, "This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs ... To be sure, state tort suits can peacefully coexist with the FDA's labeling regime, and they have done so for decades. But this case is far from peaceful coexistence. The FDA told Wyeth that Phenergan's label renders its use 'safe.' But the State of Vermont, through its tort law, said: 'Not so.'"
The Court's decision upholds a verdict from the Vermont Supreme Court awarding over $6 million to Diana Levine, who sued Wyeth after receiving a financial settlement from the Vermont clinic that was treating her for migraine headaches.
Wyeth (NYSE: WYE) is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
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