It is quite unusual for a state trial court to depart from that state’s highest court precedent. But consider that old Hebrew National frankfurter advertising campaign: “We answer to a higher authority.” If the United States Supreme Court comes out with a case that renders your state supreme court’s opinion null, void, or wrong, you go with SCOTUS. That is what happened in Russell v. Johnson & Johnson, Inc., 2017 WL 2261136 (Ky. Circuit Court May 8, 2017). To see intervening SCOTUS authority dislodge a vexing state ruling is remarkable enough. When that SCOTUS authority compels application of preemption – well, you just know we’re going to blog about it.
The plaintiff in Russell alleged injuries from a cardiac ablation procedure in which doctors used an “SF catheter.” The plaintiff’s claims included strict liability, design defect, negligence (including failure to test), failure to warn, breach of warranties, fraud, unjust enrichment, and violation of Kentucky’s consumer protection statute. The defendant filed a motion for judgment on the pleadings, arguing that the SF catheter was a Class III medical device that had gone through the pre-market application (PMA) process, thereby earning the protection of conflict preemption. That is, no state jury could, via its verdict, impose obligations on a defendant that were in any way different from the FDA’s federal scheme.
If a product went through the PMA process, product liability litigation involving that product is usually a laydown. No matter what theories are invoked by the plaintiff, preemption applies. Sure, there is that annoying “parallel violation” exception, which we have written about endlessly, but let’s for the moment put that aside and pretend that the Supreme Court in Riegel had never penned that unfortunate dicta, and that appellate courts around the country had not wrestled with that same dicta in ways various and often incoherent. This doctrinal confusion really is an instance of “what the SCOTUS giveth, the SCOTUS taketh away,” for it was the Riegel decision that established medical device preemption, and it was the Riegel case that permitted the Russell court to dispense with a bothersome Kentucky precedent.
The complication in the Russell case is that the SF catheter at issue had gone through several modifications since the initial PMA approval. The SF catheter used in the procedure was part of an FDA-approved clinical trial under the auspices of an FDA investigational device exemption (IDE). The legal question front and center in Russell was whether the IDE regulations involve the same sort of rigorous, device-specific safety requirements as the PMA process, such that full-blown preemption should apply. The Russell court held that they did, and that preemption therefore foreclosed all of the plaintiff’s claims.
The plaintiff resisted preemption by contending that the SF catheter at issue did not receive PMA approval until 14 months after the procedure. On the date of the procedure, all the SF catheter had going for it was an IDE, and a Kentucky Supreme Court decision back in 1997, Niehoff v. Surgidev Corp., 950 S.W.2d 816 (Ky. 1997), had held that certain state law claims were not preempted in a case involving an intraocular lens used during a clinical trial under an IDE. That non-preemption ruling would seem to be squarely relevant and binding precedent — save for Riegel, which SCOTUS decided 11 years after Niehoff.
The facts in Niehoff were distinguishable from Russell in two significant ways: (1) the product in Niehoff never received PMA approval, whereas the SF Catheter in Russell had, and (2) unlike the plaintiff in Niehoff, the plaintiff in Russell had signed a lengthy, FDA approved consent form acknowledging that the medical procedure in question was investigational. Even aside from those factual distinctions, the Russell court concluded that Riegel and its progeny made clear that the IDE procedure involved the same rigorous safety review process as pertains to a PMA, and that preemption applied. We do not know of a single IDE case after Riegel that has failed to apply extensive PMA preemption. Put another way, an IDE was much more like the PMA process covered by Riegel preemption than like the 510(k) substantial equivalence process that the earlier Lohr decision held did not merit preemption. Plus there is the additional fact that the device in Riegel had gone through the PMA supplemental process, making it very like the SF catheter in terms of FDA posture. (It really pays to read the details of a case, not just the headnotes.)
Once the Russell court decided that Riegel preemption applied to the SF catheter, the rest was easy. Would the causes of action impose requirements different from or additional to the federal requirements? The answer for every claim in the complaint was Yes. And now inevitably, we come to the issue of whether there was a parallel violation alleged. The Russell court reasoned that such a parallel violation must include: (1) a violation of a specific federal regulation (that “specific” is important and right away makes the Russell decision better than most), (2) a violation of an identical state law duty, and (3) a showing that violation of the federal rule caused the injuries. The plaintiff’s claims failed this test. For one, the plaintiff alleged no deviation from the IDE requirements. Beyond that, the plaintiff’s claims essentially demanded that the defendant do more (secure a more detailed informed consent) or say more (additional warnings) than required by the federal scheme. That is the stuff of preemption, not any parallel violation, and the court dismissed all of the plaintiff’s claims with prejudice.