Recent First Amendment-related court decisions have opened the door to increased state tort product liability lawsuits that previously foundered because of FDA’s strict authority over industry activity, according to a Washington Legal Foundation working paper.
While the Caronia and Sorrell decisions recognized due process and First Amendment protections for drug and medical device marketers’ information dissemination, they have also invited new theories and approaches to state tort liability challenges, declares author and Strasburger & Price partner Michael A. Walsh in the paper.
“The emerging tort claims may be poorly fashioned and are initially being dismissed, but plaintiffs’ lawyers will adapt and continue to advance more sophisticated pleadings,” Walsh says. “It will be years before this area of the law is settled.”
Walsh notes that the issue that has not yet been decided is whether the courts will recognize “intent” as a determination that is solely within FDA’s expertise to determine.