It’s not unusual for us to disagree with a decision from a state’s highest court. Indeed, we did so vehemently not long ago with a decision by the Pennsylvania Supreme Court. But even when we disagree, we rarely encounter decisions that make us cringe as much as Russell v. Johnson & Johnson, ___ S.W.3d ___, 2020 WL 6390218 (Ky. Oct. 29, 2020). Consider it a post-Halloween haunted special.
Russell was about preemption in the context of an investigational medical device (“IDE”). Early on, there had been something of a split about whether the statute’s preemption clause, 21 U.S.C. §360k(a), conferred significant preemptive protection on manufacturers of IDE devices, but federal appellate precedent universally recognized broad preemption. In re Orthopedic Bone Screw Prod. Liab. Litig., 193 F.3d 781, 786 (3d Cir. 1999); Chambers v. Osteonics Corp., 109 F.3d 1243, 1247-48 (7th Cir. 1997); Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090, 1097 (6th Cir. 1997); Becker v. Optical Radiation Corp., 66 F.3d 18, 20 (2d Cir. 1995); Slater v. Optical Radiation Corp., 961 F.2d 1330, 1333-34 (7th Cir. 1992).
After Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), pretty much every decision for over a decade recognized the same extensive preemption as was applicable to premarket approved (“PMA”) devices. See Bush v. Goren, 2014 WL 4160245, at *7-8 (Mich. App. Aug. 21, 2014); Robinson v. Endovascular Technologies, Inc., 119 Cal. Rptr.3d 158, 164-165 (Cal. App. 2010); Parks v. Howmedica Osteonics Corp., 2016 WL 7220707, at *6 (M.D. Fla. March 11, 2016); Grant v. Corin Group PLC, 2016 WL 4447523, at *3 (S.D. Cal. Jan. 15, 2016); Day v. Howmedica Osteonics Corp., 2015 WL 13469348, at *4-5 (Mag. D. Col. Dec. 24, 2015); Caccia v. Biomet, Inc., 2013 WL 4502211, at *2 (N.D. Ind. Aug. 21, 2013); Burgos v. Satiety, Inc., 2013 WL 801729, at *7-8 (E.D.N.Y. March 5, 2013); Killen v. Stryker Spine, 2012 WL 4498865, at *1 (W.D. Pa. Sept. 28, 2012); Williams v. Allergan USA, Inc., 2009 WL 3294873, at *2-3 (D. Ariz. Oct. 14, 2009); Dorsey v. Allergan, Inc., 2009 WL 703290, at *5-7 (M.D. Tenn. March 11, 2009).
Another case that had done so, following this precedent, was Russell v. Johnson & Johnson, Inc., 2018 WL 5851101, at *4 (Ky. App. Nov. 9, 2018). No longer. That was the case that Russell, 2020 WL 6390218, overruled.
Our biggest problem with Russell is that it just doesn’t make much sense. It describes §360k(a) as “limited,” in the following sense:
This limited preemption clause only applies to state “requirements,” meaning state standards and regulations—not state claims and causes of action.
2020 WL 6390218, at *3. Russell looked for “guidance” to the definition of “preemption” in Black’s Law Dictionary. Id. (“The principle (derived from the Supremacy Clause) that a federal law can supersede or supplant any inconsistent state law or regulation.”). Russell therefore purports to hold that “when this preemption clause applies, it only preempts the state regulations that apply to the medical device.” Id.
That’s malarkey. Instead of consulting a general law dictionary, Russell would have done well to review the aforementioned Riegel decision, which dealt with and rejected the same argument – both generally and in the specific context of §360k(a):
Congress is entitled to know what meaning this Court will assign to terms regularly used in its enactments. Absent other indication, reference to a State’s “requirements” includes its common-law duties. . . . [C]ommon-law liability is “premised on the existence of a legal duty,” and a tort judgment therefore establishes that the defendant has violated a state-law obligation. . . . In the present case, there is nothing to contradict this normal meaning. To the contrary, in the context of this legislation excluding common-law duties from the scope of pre-emption would make little sense.
552 U.S. at 324-25 (emphasis added). So, right off the bat, Russell fell for an argument decisively rejected twelve years ago in Riegel as making “little sense.” Last time we checked, United States Supreme Court precedent was controlling on federal preemption questions.
But the logic of what Russell held should have been the end of the case: no preemption, because − according to the Court’s decision to ignore the express holding in Riegel − there were no Kentucky statutory requirements at issue (other than a consumer fraud claim). Id. at *3. But no, Russell goes on to discuss “parallel” violation claims. 2020 WL 6390218, at *3, 5-6. Why? We’re not sure, but because Russell did, we will, too.
Russell meandered through several PMA preemption cases involving allegations of “parallel” claims, id. at *3, discussing in no discernible order Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015); Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010); Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc); and Hughes v. Boston Scientific Corp., 631 F.3d 762, 770 (5th Cir. 2011). But Kentucky does not allow parallel claims for independent state-law reasons. The same Kentucky Supreme Court has twice interpreted a Kentucky statute, Ky. Rev. Stat. §446.070, as forbidding common-law negligence per se claims based on violations of any and all federal statutes. St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529, 534 & n.14 (Ky. 2011); T & M Jewelry, Inc. v. Hicks, 189 S.W.3d 526, 530 (Ky. 2006). See our discussion, here.
Rather than reconciling Kentucky law and parallel claims (or even recognizing the conflict), Russell then held, without discussing any IDE precedent at all (which, as we mentioned above is extensive), that it mattered that this product was still at the IDE stage and did not get full PMA from the FDA until a year after the plaintiff’s surgery:
Here, in contrast to the above cases, the [product] had not received FDA premarket approval and only had investigational device exemption status. Although [it] ultimately received FDA premarket approval, it was . . . after [plaintiff’s] surgery. Even if we assume medical devices with the investigational device exemption are able to qualify for federal preemption, Kentucky’s parallel tort claims are allowed; the federal preemption would only restrict the state standard that applies to the device.
Russell, 2020 WL 6390218, at *3.
We’re not at all sure what that word salad means, except for the bottom line, which is no preemption. Is it that (contrary to Riegel) because there are no state “requirements”? Is it because IDE preemption is less robust than PMA preemption? Or is it dispositive that all the plaintiff’s claims are “parallel”? Russell is totally unclear, except that preemption is a bad thing – United States Supreme Court precedent be damned:
Justice Ginsburg’s Riegel dissent provides insight. . . . “FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection. . . . Preemption of all such claims would result in the loss of a significant layer of consumer protection . . . .” 552 U.S. at 337-38 (emphasis added). We agree and reiterate that Kentucky’s parallel tort claims are not preempted by federal law.
2020 WL 6390218, at *4 (emphasis original with Russell). So the only thing that is really clear is that Russell “agrees” with a dissent in Riegel and thus refuses to apply the preemption that the eight other justices recognized in that case.
But even then we’re not sure – because Russell goes on to celebrate Kentucky’s “requirement of bare-bones, notice pleading.” Id. at *5. “[A] complaint couched in general and conclusory terms, complie[s] with” Kentucky pleading rules. Id. at *4 (citation and quotation marks omitted).
Three cheers for nuisance value.
Thus, preemption can’t be decided in Kentucky state litigation without the defendant being subjected to costly and time-consuming discovery. Down the road somewhere, maybe there will be preemption and maybe there will not:
Under Kentucky’s notice pleading standards, the motion for judgment on the pleadings should have been denied. Even if investigational medical devices (such as the [product] at the time it was used with [plaintiff]) qualify for federal preemption, a party may pursue parallel state tort claims, and those claims are not preempted under federal law. Here, under Kentucky’s notice pleading standard, [defendant] was properly put on notice of parallel claims.
2020 WL 6390218, at *6.
So we’re still scratching our heads at this one. Even when some other appellate court decides to thumb its nose at controlling Supreme Court precedent, as happened here and here, we at least knew what the court had held and why. In Russell we have something akin to Churchill’s “riddle” (Riegel and state “requirements”) “wrapped in a mystery” (parallel claims when Kentucky law rejects federal violations as negligence per se) “inside an enigma” (what happens when the pleadings finally get pierced).