The Federal District Court for the Eastern District of Louisiana recently held that state failure-to-warn claims are not preempted by the labeling requirements of the Food and Drug Administration. The ruling denied Merck & Co.’s summary judgment motion in the consolidated cases of Arnold v. Merck & Co., Inc. and Gomez v. Merck & Co., Inc., No. MDL 1657 (E.D.La.), two of the thousands of cases across the country alleging adverse cardiovascular effects associated with the anti-inflammatory drug Vioxx.
In its summary judgment motion, Merck relied on statements made by the FDA in the preamble to its labeling requirements that explicitly state that state failure-to-warn claims would be preempted by the regulatory scheme. In the FDA’s opinion, allowing such state law claims to proceed would undermine the agency’s role in ensuring the proper balance of information on drug labels. Failure-to-warn claims would result in exaggerated warnings on labels, discouraging the use of effective treatments.
In holding that state failure-to-warn claims are not preempted by the FDA labeling requirements, the court explained that there is a strong presumption against preemption in fields traditionally occupied by state law, including health and safety regulation. Noting that the majority of federal courts have declined to give effect to the FDA’s statement regarding preemption, the court explained that it did not need to defer to the FDA’s opinion in this matter because the agency’s opinion was not promulgated pursuant to its rulemaking authority.
The court’s full opinion is available here.