Topic: Product Liability

As we discussed here, the United States Supreme Court last week ruled that state law claims for failure to include an adequate warning on a pharmaceutical label are not preempted by the federal Food and Drug Administration’s (“FDA”) prior approval of the product’s label. 

As previously reported here, the U.S. Supreme Court heard oral arguments in Wyeth v. Levine on November 3, 2008.  The case involves the question of whether the Food and Drug Administration’s (“FDA”) regulation of prescription drug labeling pursuant to Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (“FDCA”) preempts state common law tort claims. To date, the Supreme Court has not released its decision. 

The United States District Court for the Central District of California recently held that state law consumer fraud claims and federal fraud claims pursuant to the Racketeer Influenced and Corrupt Organizations Act (“RICO”) are not preempted by the federal Food, Drug and Cosmetics Act (“FDCA”) if such claims are based on specifically identifiable false or misleading representations or material omissions. 

The United States Court of Appeals for the Second Circuit recently reversed the dismissal of a lawsuit alleging that drug manufacturer Pfizer, Inc. violated the Federal Alien Tort Statute (“ATS”) and certain state statutes by conducting a medical experimentation on humans without their informed consent or knowledge. 

On December 15, 2008, the United States Supreme Court held that state law fraud claims are not preempted by the federal Cigarette Labeling and Advertising Act, 15 U.S.C. §§ 1331-1341, (“Labeling Act”) or the Federal Trade Commission’s (“FTC”) policy on “light” cigarette advertising and sales.