In a brief order, the U.S Court of Appeals for the 10th Circuit declined plaintiff Patricia Caplinger’s bid for an en banc re-hearing of a 2-1 decision dismissing the case. Caplinger had argued that her claims survived preemption because the device was used in a manner not approved by the FDA.
The appeals court in April found that Caplinger’s claims relied on dubious grounds – that state laws parallel federal statutes, which would cut off preemption.
"Ms. Caplinger relies exclusively on a legally inapplicable provision in her effort to establish a parallel claim, fails anywhere to discuss the apparently applicable one, and offers no answer to the conundrum how she might impose a state tort duty on Medtronic to revise a label that federal regulation precludes it from revising. … In these circumstances, we cannot see how the district court can be faulted for dismissing her claims" Judge Neil Gorsuch wrote for the majority.
That’s not to say that another plaintiff won’t succeed, Gorsuch added.
"For example, we don’t question the possibility that buried somewhere in the heap of federal law parallel provisions exist to save claims like Ms. Caplinger’s. After all, the FDA’s medical device regulations alone cover 592 pages of 8-point type and the Supreme Court has suggested that in searching for a parallel federal duty a plaintiff may scour them all as well as the statute itself," he wrote.
"Not everyone may agree with how Congress balanced the competing interests it faced in this sensitive and difficult area. 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 preemption nowhere authorized in the text of the statute and nowhere recognized in any of the Supreme Court’s many forays into this field," the judge wrote.