Questions of liability arise at times between manufacturers of brand-name prescription drugs and manufacturers of their generic equivalents. The U.S. Supreme Court ruled several years ago that federal law preempts state laws regarding drug labeling. This led the Alabama Supreme Court recently to find that a brand-name manufacturer could be held liable for a generic manufacturer's failure to warn, as federal law required generic drugs to have identical labels as the brand-name drug. The U.S. Supreme Court is preparing to hear arguments in a case that seeks to hold a generic manufacturer liable for a design or manufacturing defect in the drug, with the manufacturer claiming that they are only allowed by federal law to copy the approved drug design.
The U.S. District Court for the Middle District of Alabama recently certified a question to that state's supreme court regarding whether state law could hold a brand-name drug manufacturer liable for injuries caused by a generic equivalent from a different manufacturer. In re Wyeth V. Weeks, No. 1101397, slip op. (Ala., Jan. 11, 2013). The Alabama Supreme Court held that federal law, in the form of Food and Drug Administration (FDA) regulations, required generic manufacturers to use the same drug labels as those used for the brand-name drug. The court held that it was “not fundamentally unfair to hold the brand-name manufacturer liable” on a failure to warn claim, when the “alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer.” Slip op. at 52.