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Wyeth, maker of Prempro, not protected by U.S. Food, Drug and Cosmetic Act

07/5/2007
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Wyeth, the manufacturer of women’s hormone replacement drug Prempro, is not protected by a federal law which would have moved any case brought against the manufacturer to federal court. A ruling by a New Jersey judge earlier this week, stated that “federal law does not bar state lawsuits alleging drugmakers did not adequately warn about a product’s risks.”

Wyeth, the manufacturer of women’s hormone replacement drug Prempro, is not protected by a federal law which would have moved any case brought against the manufacturer to federal court. A ruling by a New Jersey judge earlier this week, stated that “federal law does not bar state lawsuits alleging drugmakers did not adequately warn about a product’s risks.”

This is not the first time a state or federal judge has reached the same conclusion concerning these types of product liability suits against drugmakers. Several judges have ruled that these lawsuits are not pre-empted by the U.S. Food, Drug and Cosmetic Act. For years, manufacturers have argued, in multiple types of product liability and mass tort ligitation, that these types of lawsuits are “pre-empted” (not allowed) because federal law gives the Food and Drug Administration (FDA) the right to determine whether a drug’s label, or detailed package insert, contains adequate warnings about any health risks. The manufacturer’s thinking is that because the FDA holds that exclusive right, no state court judge is allowed to hear the merits of a case filed.

Studies carried out by the Women’s Health Initiative during the early years of this decade, appear to support the theory that use of drugs with combined estrogen plus progestin, like Prempro, cause a substantial increase in health risks.

The decision in New Jersey will not only assist women filing these types of cases in New Jersey, over issues like whether Prempro contained adequate warnings on their packaging and product insert, but women around the country. There are currently several hundred Prempro cases pending in New Jersey and thousands filed nationwide.

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