High Court Nominee Favorable on Preemption Doctrine
A review of cases that president Donald Trump’s U.S. Supreme Court nominee Neil Gorsuch has decided shows that he is supportive of the federal preemption doctrine that could serve the medical product industry well when defending product liability lawsuits, according to the Drug & Device Law blog.
The blog post found that the most important Gorsuch preemption decision was Caplinger v. Medtronic, Inc., characterized as “the very favorable PMA medical device preemption decision that we discussed previously here and named as our #2 best case of the year for 2015... His dissatisfaction with the Supreme Court’s tortured approach to express preemption in medical device product liability cases is very clear.” The Caplinger decision concluded: “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.”
After examining other Gorsuch-related preemption cases, the blog said it can tell that the judge is a “textualist in preemption matters. That comes through loud and clear in both Caplinger and Cook. We are cautiously optimistic that he will be inclined to do away with the ‘general vs. specific’ and ‘parallel claim’ exceptions to express MDA preemption in Lohr, and would be content to interpret that broad preemption language in §360k in accordance with its terms, leaving Congress to amend the statute if it does not like the scope of its own language. We also think that judge Gorsuch would be a friend of Buckman preemption, since it is also based on a statutory provision of broad applicability.”
How judge Gorsuch would view generic preemption is harder to tell, the blog said, “as he has never adjudicated an impossibility preemption case. It will probably depend on how convincing the evidence of impossibility is. Since unilateral alteration of the design of prescription medical products is pretty emphatically precluded by the FDA scheme, we would again be cautiously optimistic that such claims would be preempted. We’re less sure, however, of whether judge Gorsuch would trim Wyeth v. Levine, 555 U.S. 555 (2009), insofar as it applies to warning claims. Since there is no express preemption clause for drugs, this is a place where — at least under the current FDA scheme — his textualist views might require our side to go to Congress (or to the FDA) to seek broader preemption.”