Caplinger v. Medtronic Inc., the lawsuit in which a patient accused Medtronic of allowing doctors to use its INFUSE Bone Graft product in ways not approved by the FDA, made it all the way to the U.S. Supreme Court, but the Court announced it has declined to hear the case.
Patricia Caplinger brought her suit to Oklahoma’s federal court in 2012, saying she was injured by the device after spine surgery. Approximately 6,000 people besides Caplinger were also suing the Dublin-based medical technology company on similar grounds.
As the Minneapolis Star Tribune explained in its own coverage of the lawsuit (Medtronic runs operational headquarters out of Minneapolis, Minn.) a previous Supreme Court decision gave medical device companies “broad immunity from liability for almost every use of a product if the FDA had approved it for any use.” INFUSE was originally approved by the FDA for use in the lower back with anterior lumbar interbody fusion surgery.
Caplinger’s side argued, however, that Medtronic could be sued under state laws for its promotion of uses not approved by the FDA.
The Star Tribune quoted Allison Zieve of Public Citizen Litigation Group, one of Caplinger’s attorneys, who questioned how companies could avoid being sued if they suggest a product can be used in ways not studied by the FDA.
“It’s totally illogical and certainly not just,” Zieve said.
Glenn G. Lammi, writing for Forbes, called the decision by the Supreme Court a “win” for free enterprise.
Medtronic has made no public statement on the Court’s decision.