We had been waiting for the Utah Supreme Court’s decision in Burningham v. Wright Medical for some time. As we pointed out in a blogpost when Burningham was first certified by the district court (Utah is one of the few courts allowing district court certification), over a year ago, “[p]ractically no court has . . . treat[ed] prescription drugs and prescription medical devices differently under [Restatement (Second) of Torts §402A] comment k [(1965)].” We presented a 50 state survey indicating that was so – whether the state had adopted an “across-the-board” or a “case-by-case” approach to comment k. Likewise the Third Restatement had treated all prescription medical products identically, even though it used a different test than comment k.
The Utah Supreme Court in Burningham accepted certification of four questions:
Under Utah law, does the unavoidably unsafe exception to strict products liability in design defect claims recognized in Comment k to Section 402A of the Restatement (Second) of Torts apply to implanted medical devices?
If the answer to Question 1 is in the affirmative, does the exception apply categorically to all implanted medical devices, or does the exception apply only to some devices on a case-by-case basis?
If the exception applies on a case-by-case basis, what is the proper analysis to determine whether the exception applies?
If the answer to Question 1 is in the affirmative, does the exception require a showing that such devices were cleared for market through the FDA’s premarket approval process as opposed to the § 510(k) clearance process?
Burningham v. Wright Medical Technology, Inc., ___ P.3d ___, 2019 WL 4231947, at *2 (Utah Sept. 5, 2019).
Well, last week, Burningham decided to go its own way, not even mentioning the overwhelming precedent to the contrary. In a prescription drug case, Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991), almost “thirty years ago,” “this court agreed ‘with the principle comment k embodies, that manufacturers of unavoidably dangerous products should not be liable for a claim of design defect” and “categorically immunize[d] all prescription drugs from strict liability design defect claims.” Burningham, 2019 WL 4231947, at *3 (quoting Grundberg, 813 P.3d at 95).
Grundberg had followed Brown v. Superior Court, 751 P.2d 470, 475-83 (Cal. 1988), in applying comment k across the board to abolish prescription drug design defect strict liability. At the time (we were younger and less jaded than now), we had hoped that would become a trend, but it didn’t – so we’re now counting on preemption instead. But when Burningham was accepted, our greatest fear was that the court would reverse Grundberg. Fortunately, that didn’t happen. Instead, Burningham reiterated the “compelling reason” that undergirds Grundberg:
And we are still cognizant of the problems associated with such a[ case-by-case] approach. But we were able to avoid those problems in suits involving prescription drugs only because of the rigorous FDA approval process to which they were subject.
2019 WL 4231947, at *6. So prescription drug design defect cases remain barred by Utah state law. The worst was avoided.
In initially sorting out the four certified questions, Burningham did something that manufacturers of FDA pre-market approved (“PMA”) medical devices will like quite a bit. It declined to answer the final question on the basis of federal preemption:
In Riegel v. Medtronic, Inc., the Court held that the MDA preempts state law tort claims involving PMA-approved medical devices. See 552 U.S. 312, 321-25 (2008). . . . The fourth certified question asks whether the unavoidably unsafe exception requires a showing that the implanted medical device was cleared for market through the PMA process rather than the 510(k) process. However, Riegel holds that all state law tort claims, including strict liability design defect claims, involving a PMA-approved device are preempted by the MDA. So, regardless of our conclusion as to whether a PMA-approved device should be deemed unavoidably unsafe as a matter of law, such devices are already immune from strict products liability claims.
So, with regard to question four, we do not opine on whether PMA-approved medical devices are unavoidably unsafe as a matter of law because they are already exempt from all state product liability claims.
2019 WL 4231947, at *5-6 (emphasis added). See Id. at *9 (“PMA-approved medical devices . . . are already exempt from all state products liability claims under [Riegel]”). So the good news for any PMA medical device manufacturer facing a Utah-law suit is that the state’s highest court has held, in no uncertain terms, that all state-law claims are preempted. Utah evidently doesn’t follow the Riegel dictum that has fooled so many courts into allowing so-called “parallel” violation claims. Utah went its own way.
But that’s all the good news out of Burningham. Trading thirty-year-old precedent for an outdated (and almost as old) view of the FDA’s §510(k) “substantial equivalence” device clearance procedure, Burningham relies on Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999) (citing Lohr), to denigrate 510(k) clearance as insufficiently rigorous to justify applying Grundberg to such medical devices. 2019 WL 4231947, at *4-5.
To extend our reasoning in Grundberg to the medical device or any other context would require an equally compelling reason, such as a similarly rigorous oversight process.
Based on the applicable regulations, we are not persuaded that 510(k) is such a process. Comment k’s premise is that there are some products that are “incapable of being made safe for their intended and ordinary use.” Without an FDA evaluation of a medical device’s safety, we cannot know whether the device is incapable of being made safe (although it is beneficial), or whether it is “unreasonably dangerous.”
Id. at *6 (quoting comment k).
As we laid out in great detail in our “Lohr Has Two Shadows” post, the 510(k) process that Lohr (and cases like Goodlin that parrot Lohr) described no longer exists. Rather, Congress revamped the relevant statutory sections in the Safe Medical Devices Act (“SMDA”) to impose the same “reasonable assurance of safety and effectiveness” standard to 510(k) that Lohr (and later Riegel) held would have preemptive effect. 21 U.S.C. §360c(f)(2)(a)(v). But nobody on the bench seems to care. It’s almost as if there is a judicial conspiracy of silence in product liability cases with respect to the SMDA.
End of rant.
Be that as it may, in Burningham, the Court used its view of “substantial equivalence” to apply a case-by-case” comment k approach to 510(k) medical devices while retaining the “across-the-board” approach for prescription drugs.
[W]e answer the first certified question conditionally. Although the unavoidably unsafe exception might immunize some implanted medical devices from strict products liability, when such a device enters the market through the 510(k) process, we cannot say that this will always be the case as a matter of law.
2019 WL 4231947, at *7. Therefore some sort of case-by-case approach necessarily applied. “Accordingly, the answer to the second question is that courts applying Utah law should treat this exception as an affirmative defense to be determined by the factfinder on a case-by-case basis.” Id.
Burningham tossed defendants some crumbs in exactly what this “affirmative defense” would look like. Plaintiffs had argued that, in addition to proving that the device was unavoidably unsafe, defendants also had to prove that the product was “properly manufactured” and had “adequate warnings.” Id. The Utah Supreme Court held that, no, defendants did not have to prove the negative of manufacturing and warning defect claims in order to satisfy comment k. Rather, plaintiffs retained the burden of proof on those other kinds of defects. Grundberg did not “treat proper preparation and adequate warnings as elements of the unavoidably unsafe affirmative defense.” Id. at *8.
Rather, these are separate claims a plaintiff must make and prove. If a plaintiff alleges manufacturing flaws or inadequate warnings and the factfinder finds the plaintiff has proved either one by a preponderance of the evidence, then the unavoidably unsafe exception is unavailable to a defendant as an affirmative defense. But if the plaintiff does not raise either claim, or is unable to prove them, the exception is available to the defendant.
Id. That’s better than nothing, but experience has taught us that having to prove over and over again to multiple juries what the same defendant already had to prove to the FDA is an expensive and wasteful process, leading to Pyrrhic victories, or worse to lay juries disregarding the FDA’s marketing clearances.