WASHINGTON – When hearings on Supreme Court nominee Neil Gorsuch begin later this month, questions will likely center on hot-button issues like women’s reproductive rights, travel bans, immigrant deportations and state voter identification laws.
But one of the most strongly expressed opinions Gorsuch would bring to the nation’s highest judicial body is a belief that federal law protects medical device makers from lawsuits filed by patients injured by their products.
As an appeals court judge in the U.S. 10th Circuit, Gorsuch wrote an important 2015 opinion that denied a woman the right to sue Medtronic for injuries she said were caused by the company’s improper off-label promotion of its Infuse bone graft.
The Supreme Court declined to hear that case — Patricia Caplinger v. Medtronic — on appeal. In doing so the high court cemented Gorsuch’s interpretation of a legal concept called pre-emption that scholars say will largely deny people hurt by medical devices the right to sue manufacturers in state courts, even if their products were used in ways the U.S. Food and Drug Administration never approved.
In the Caplinger opinion, Gorsuch asserted: “Nothing depends on whether the plaintiff seeks to use state law to impose requirements for off-label uses or on-label uses. Rather, by its terms, the statute pre-empts any effort to use state law to impose a new requirement on a federally approved medical device.”
Gorsuch added that “a state’s judgment that a device is unsafe for a particular off-label use could require design changes that adversely affect the device’s safety for on-label uses.”
Having a Supreme Court justice who takes such an approach is good news for the medical device industry, which employs tens of thousands of workers in Minnesota and is home to one of the country’s most robust medical technology sectors, said John Dornik, an attorney at the Minneapolis firm of Siegel Brill, who also teaches product liability at the University of Minnesota.
