A federal judge last week dismissed Anulex Technologies from a lawsuit alleging unfair & deceptive trade practices for alleged off-label promotion of its Xclose soft tissue repair device.
Bennie Evans sued Anulex, his back surgeon and the doctor’s medical practice in 2010, alleging claims of negligent misrepresentation, fraud, unfair and deceptive trade practices, and breach of implied warranty.
But Judge Terence Boyle, of the U.S. District Court for Eastern North Carolina, ruled that the sole claim against Anulex for unfair & deceptive trade practices is preempted by federal medical device law, according to court documents.
"In his amended complaint, plaintiff alleges that Anulex conspired with physicians to use X-close sutures in annular repairs where patients had excellent prognoses for recovery in order to "stockpile" positive outcome cases so that it might gain FDA approval for use of X-close devices in annular repairs. At bottom, plaintiff seeks to hold Anulex liable for off-label promotion of its X-close suture device, but such claim is impliedly preempted as it exists solely by virtue of the requirements of the [Food, Drug & Cosmetic Act]," Boyle wrote in his June 4 ruling.
Dr. Kenneth Rich, the surgeon who performed Evans’s microdiscectomy with annular repair, still faces a claim for negligent misrepresentation; Rich and Capital Neurosurgery jointly face claims for fraud, assault & battery and breach of contract, according to the documents.