Last week in Hricik v. Stryker Biotech, LLC, E.D. Penn No. 14-3228, 2015 WL 418118, (Jan. 30, 2015), the trial court remanded a medical device case back to state court after the defendants attempted to assert diversity jurisdiction to have the claims heard in federal court. The defendants, the medical device manufacturer and two individual sales representatives, claimed the sales reps were fraudulently joined to the action and should be disregarded for the purposes of determining whether the district court had diversity jurisdiction. The sales reps and plaintiff were all from Pennsylvania.
The plaintiff alleged that the defendants, including the individual sales reps, promoted an off-label use of a the combined use of two medical devices, an OP-1 Implant and Calstrux. The OP-1 Implant is designed to stimulate, repair, and regenerate bone. The medical device received limited FDA approval for use in patients experiencing long bone fractures that failed to heal with other treatment. Surgeons complained that the OP-1 Implant was insufficient and the medical device manufacturer created Calstrux as a carrier or extender to be used with the OP-1 medical device. The FDA, however, only approved Calstrux to be marketed as a bone void filler based on the representations of the medical device manufacturer.
The plaintiff alleged that the defendants promoted the off-label combined use of the OP-1 Implant and Calstrux to medical providers. The plaintiff underwent spinal surgery. His surgeon used the combination and about a year after the surgery, imagining studies revealed that excessive bone growth encased the plaintiff's nerves causing debilitating injuries. The defendants were aware of this problem well-before the plaintiff's surgery, but failed to warn the plaintiff's physician and continued to promote the combination despite the lack of approval. That allegation that the failure to warn was predicated on affirmative misrepresentations was important.
The district court summarily disposed of the defendant's claims that the individual sales reps could not be held liable for their efforts in promoting the off-label use, holding that there is no per se preclusion to filing claims against individual drug or medical device company executives based on claims of affirmative misrepresentations. A plaintiff is only required to assert colorable claims of individual malfeasance for the purposes of determining whether the medical device company executives were properly joined. In this case, the sales reps repeated promotion of the off-label use and knowledge of excessive bone growth were sufficient to deem their inclusion as non-fraudulent in determining that the District Court lacked jurisdiction over the plaintiff's claims.
