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.
Gorsuch’s take on pre-emption means device makers can seek FDA approval for an easily documented, limited use of a product but enjoy virtual immunity for all untested, potentially dangerous off-label uses of the product, including those it knows about and promotes, Dornik said.
“Once they get FDA approval, they get to escape any lawsuit for anything that states like Minnesota would hold them accountable for,” Dornik said of Gorsuch’s interpretation.
Product liability specialist David Prince, professor emeritus at Mitchell Hamline School of Law, agreed. Gorsuch’s opinion “lets device companies off the hook for injuries caused by off-label uses,” Prince said.
Prince, who studied Gorsuch’s opinion when it was issued in 2015, reread it when President Donald Trump nominated Gorsuch for the high court. Prince called the judge a “classic textualist,” meaning he is loath to read anything into a law. In that sense, Prince believes, Gorsuch assumes the absence of references to excluding off-label uses from federal pre-emption are intentional, not an oversight.
Gorsuch’s take is that “if Congress had wanted to say it, they would have written it down,” Prince explained.
Device companies Medtronic and St. Jude Medical did not comment on Gorsuch, nor did the Advanced Medical Technology Association, a national trade group known as AdvaMed. Medical Alley, the trade group that represents more than 600 medical technology businesses in Minnesota, took no position on Gorsuch’s nomination. The organization’s chief executive, Shaye Mandle, said the judge’s position on pre-emption was consistent with many other federal jurists. And, he added, it is the right call given the need for flexibility in developing new medical treatments.
Untested off-label uses of medical devices are a matter for doctors and patients, not device companies, Mandle maintained. Once the FDA approves a device for a single use, “doctors and patients are free to use the device any way they see fit.”
Dragging device companies into court every time “a doctor and patient decision doesn’t work out” would create “chaos in the system,” Mandle said.
How a company’s promotion of off-label uses of products figures into that system remains an ongoing legal debate. In the case of Infuse, the discussion surrounds a product used 85 to 90 percent of the time in ways the FDA did not approve.
Lawyers representing thousands of patients who, like Caplinger, claim injuries related to off-label Infuse uses say the product could not have spontaneously achieved such a high level of off-label use and that Medtronic pushed unproven, risky uses. They point to what they say are examples of Medtronic teaching doctors to use Infuse off-label and paying them incentives to do so.
Medtronic denies that it has improperly promoted Infuse or violated federal misbranding and product adulteration statutes.
“Doctors are governed by standards of care,” said Dornik, who has handled medical malpractice cases. They don’t typically take chances on off-label uses. “They are educated on them by manufacturers.”
With Gorsuch on the Supreme Court, Dornik added, users of Infuse or any other medical device would face a “patient beware” system.
Without data to support a device’s safety, patients will be exposed to unknown risks. No law compels physicians to warn patients that devices are being used on them in off-label, untested ways.
“How does the patient even know that they are taking a risk?” Dornik asked. “If they don’t know, they are still stuck with the result.”
The solution for Gorsuch is legislative, not judicial.
“Not everyone may agree with how Congress balanced the competing interests it faced in this sensitive and difficult area,” he wrote in the Caplinger opinion. “We can surely imagine a different statute embodying a different judgment. But strike a balance Congress had to and did, and it is not for this court to revise it by beating a new path around pre-emption nowhere authorized in the text of the statute and nowhere recognized in any of the Supreme Court’s many forays into this field.”