Judge Rules Suits Are Not Barred Against Drug Makers


A New Jersey Superior Court Judge has ruled that a federal law giving the FDA (Food and Drug Administration) the exclusive right to determine if a drug’s label or package insert has adequate health risk information does not bar state lawsuits alleging that drug companies did not adequately warn about the medication’s risk. Judge Bryan Garruto’s ruling comes in response to a suit filed by Ellen Deutsch, who took the hormone replacement therapy Prempro for six years as well as Premarin, a drug used to treat the symptoms of menopause. Both drugs are manufactured by Wyeth Pharmaceuticals. Deutsch alleges the drugs caused her to develop breast cancer.

Prempro contains estrogen and progestin and was prescribed to treat symptoms of menopause before research linked the drug to a 24% increase in the risk for invasive breast cancer and other health risks. Six million women have been prescribed Prempro, and approximately 10,000 lawsuits have been filed over use of the drug. New Jersey has 250 Prempro lawsuits pending at this time.

Since 2006, pharmaceutical companies have said that product liability suits are barred because of the Food, Drug, and Cosmetic Act, but Judge Garruto’s ruling is at least the third by state and federal judges that says the law does not pre-empt such suits.

Deutsch’s attorney explained it rather simply, “The point is, a drug being approved by the FDA does not protect drug companies from being sued. The FDA regulations are a floor, not a ceiling.”