Courts Reject Efforts by Medtronic To Close Doors To Courthouse
Two courts have recently ruled that lawsuits may proceed and are not preempted where the injured patient alleges that the device manufacturer engaged in off-label promotion of medical devices, in violation of the Food Drug, and Cosmetic Act.
Preemption is a legal doctrine. Of relevance to injured Medtronic Infuse bone graft patients, under this doctrine medical device makers have asserted complete immunity – in federal or state court – because the device at issue was approved by the U.S. Food and Drug Administration. If the corporation’s preemptions claims succeed, the result can be a full escape from accountability even when the corporation knowingly injured and endangered Americans. The injured patient receives no recovery and must bear the burden and financial consequences of the damages he or she has suffered.
On August 9, 2012, the New Jersey Supreme Court allowed suits to go forward for drug-eluting stents where the manufacturer promoted the devices off-label. The Court wrote: “[t]o the extent … plaintiffs’ failure to warn claim is founded on promotion by defendants of off-label uses of the … the claim is not preempted.”
Similarly, in a lawsuit Medtronic for its Infuse device, Los Angeles Superior Court Judge Michael Linfield ruled on August 20, 2012 that a another plaintiffs’ suit could proceed. The plaintiff’s “claim is not based on allegations that Medtronic’s device violated state tort law, notwithstanding compliance with the relevant federal requirements,” Judge Linfield wrote in his ruling.
Judge Linfield further noted that the plaintiff submitted evidence supporting her allegations that, in violation of federal law and FDA regulations, Medtronic paid consultants to train physicians, including plaintiff’s own physician, to implant Infuse during allegedly off-label surgeries. The complaint charged that Infuse had only been approved for a limited surgical procedure, and that Medtronic illegally promoted the bone graft for various of off-label procedures.
These rulings confirm that medical device manufacturers who violate federal law and promote their devices for non-approved surgeries can be held accountable for any injuries innocent patients suffer as a result such non-approved surgeries.