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Courts Review Liability of Brand-Name and Generic Drug Manufacturers in Products Liability Cases

Posted by Paul Levin | Mar 05, 2013 | 0 Comments

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.

About the Author

Paul Levin

Attorney Levin was admitted to practice law in the State of Connecticut beginning 1989 and in New York Federal district court beginning 1992. He is a member of the Connecticut Trial Lawyers Association, Connecticut Bar Association, and the National Association for American Justice. Prior to establishing his own law firm, Attorney Levin was associated with the…

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