As many are aware, the United States Supreme Court has been down a judge since the February death of Antonin Scalia. However, shortly after President Trump took office, he nominated Neil Gorsuch to fill the vacancy.
While many people have been focused on what a Gorsuch appointment could mean from a social issue perspective (women’s and gay rights, immigration, etc.) one area that would almost certainly be impacted is that of medical device manufacturing. Gorsuch is a textualist in that he primarily interprets the law based on the ordinary meaning of the legal text and does not consider non-textual sources, like intention of the law.
When Gorsuch was an appeals court judge in the United States’ 10th Circuit, he published an Opinion in Caplinger v. Medtronic, Inc., that heavily referenced preemption in a case where a woman was attempting to sue a medical device manufacturing company after suffering injuries from an off-label use of one of the company’s devices. In the United States, the regulations of the Food and Drug Administration (FDA) permit physicians to prescribe approved medications and devices for other than their intended indications. This practice is known as off-label use.
Gorsuch referenced §360k(a) which preempts state laws that impose “any requirement” that relates to the safety or effectiveness of [a] device that is different from, or in addition to, any requirement applicable . . . to the device.”
Gorsuch felt that if Congress wanted to preempt claims as to uses, as opposed to the devices themselves, it knew how to do it. More specifically, Congress specifically protected off-label uses when it provided that “[n]othing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device.” Looking at preemption in this context, the Gorsuch concluded that Congress proceeded in §360k(a) to preempt any state tort suit challenging the safety of a federally approved device without qualification about the manner of its use.
One of the reasons why Gorsuch took such a stance was that if a state were to make a judgement that a medical device is unsafe for a certain off-label use, it could cause design changes to be made that would negatively impact the device’s on-label uses and would impact consumers by making life-saving products unavailable for extended periods of time.
Gorsuch’s interpretation of §360k(a) would almost certainly be welcomed by medical device manufacturers as it is quite possible that potential plaintiffs will be unable to sue manufacturers in state court if they have been injured by a product after using them in ways that the Food and Drug Administration never intended. Manufacturers could seek FDA approval for the limited use of a product while leaving open the ability to market the product for off-label uses that will have never been tested.
Opponents of Gorsuch’s interpretation of federal statutes say that without data to support a device’s safety, patients will be exposed to unknown risks.
Time will tell as to whether Gorsuch will be appointed to the high court and whether his textualist views will change medical product liability litigation for years to come.
About the Author