As much as we liked those parts of In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753 (5th Cir. 2018) (applying Texas law), that overturned a half-billion dollar verdict caused by a combination of attorney misconduct and judicial lassitude, we also recognized the problematic effects of certain other Fifth Circuit rulings in that decision. While the good parts of Pinnacle Hip were good enough to win that decision a spot in our 2018 top ten cases, that decision’s adverse aspects were bad enough that it also landed on our list of 2018’s worst ten decisions. Specifically we observed:
The most serious error the court made was refusing to apply established Texas law that comment k precludes strict liability across the board. Pinnacle Hip ignored – really ignored − a half dozen prior decisions (including one of its own) on this issue. Even if there wasn’t any precedent (which there was), expanding state-law liability where the state courts have not is not the job of a federal court sitting in diversity.
Texas law had been leaning in the direction of applying Restatement (Second) of Torts §402A, comment k (1965) in an across-the-board fashion for a long time. The Texas Supreme Court had recognized comment k’s applicability “particularly to the medical field and unavoidably unsafe products like prescription drugs.” Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 165 (Tex. 2012). Long before that, In Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974) (applying Texas law), the Fifth Circuit had held:
[T]o conclude that the maker of an unavoidably unsafe product did not act unreasonably in placing it on the market is not to relieve him of the responsibility to market it in such a way as to prevent unreasonable danger. In the case of a . . . vaccine, this translates into a duty to provide proper warnings in selling the product. As comment k to Section 402A instructs, an unavoidably unsafe product is neither defective nor unreasonably dangerous if such a product is “properly prepared, and is accompanied by proper directions and warning.”
Id. at 1274 (footnote omitted). A non-precedential Fifth Circuit decision had held that “[u]nder comment K of the Restatement of Torts (Second) §402A, a drug manufacturer is responsible in damages only if it failed to warn of a defect of which it knew or should have known.” Schwarz v. Block Drug Co. Inc., 1999 WL 274409, at *1 (5th Cir. April 15, 1999) (in table at 180 F.3d 261) (applying Texas law). None of these cases engaged in case-by-case analysis of the plaintiffs’ design defect claims.
Other Texas decisions following in Reyes’ footsteps and holding products “unavoidably unsafe” as a matter of law were McKay v. Novartis Pharmaceuticals Corp., 934 F. Supp.2d 898, 909-10 (W.D. Tex. 2013); Massa v. Genentech Inc., 2012 WL 956192, at *5 (S.D. Tex. March 19, 2012); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007); McNeil v. Wyeth, 2005 WL 544222, at *6 (N.D. Tex. March 4, 2005), rev’d on other grounds, 462 F.3d 364 (5th Cir. 2006) (reversal concerned warning issues); Blackmon v. American Home Products Corp., 328 F. Supp.2d 659, 664-65 (S.D. Tex. 2004); and Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002). Again, no case-by-case analysis to be found in any of them. So the defense side had made good – if incomplete − progress towards establishing comment k as a general defense to design defect claims in Texas.
As to medical devices, that came to a screeching halt in less than two paragraphs in Pinnacle Hip, with the Fifth Circuit deciding:
[I]t [the Texas Supreme Court] has never expressly extended the immunity rule to medical implants, let alone 510(k)-cleared devices, on either a categorical or a product-by-product basis. Jurisdictions are split on whether medical devices enjoy blanket immunity, with the majority of courts favoring the case-by-case methodology. Defendants ask that we deviate from that trend and foreclose all implant-based litigation, based on the conjecture that Texas courts might one day redraw liability boundaries in their favor. But defendants present scant predictive indicia from Texas to that effect, and we decline to step so far ahead of Texas courts, and against the majority view, in foreclosing broad avenues to suit.
888 F.3d at 772 (footnotes omitted) (emphasis original). While emphasizing that the defendants offered “scant predictive indicia from Texas” for their across-the-board position, id., Pinnacle Hip offered no Texas precedent at all for its contrary conclusion. As demonstrated above, Texas cases had already applied comment k’s preclusion of design defect claims across-the-board to cases involving vaccines (Reyes) and biologics (Massa), as well as drugs (all the other cases we just cited), so to do so in a device case would have been a lot less “far ahead” of existing Texas law than Pinnacle Hip suggests.
But Pinnacle Hip is what it is.
Bexis is in the process of re-reviewing literally hundreds of recent non-informational defect cases for his upcoming update to Chapter Three of his drug and medical device product liability deskbook, and he’s encountered a case adopting a possible way forward for medical device defendants facing design defect claims under Texas law after Pinnacle Hip. (Note: Pinnacle Hip does not seem to have changed generalized application of comment k to Texas prescription drug litigation, see Moncibaiz v. Pfizer Inc., 532 F. Supp.3d 452, 460-461 (S.D. Tex. 2021)). The decision in Atkinson v. Luitpold Pharmaceuticals, Inc., 448 F. Supp.3d 441 (E.D. Pa. 2020), applied Texas law, assumed that the application of the same “case-by-case” approach discussed in Pinnacle Hip – albeit never citing Pinnacle Hip itself – and nonetheless dismissed the plaintiff’s design defect claim. Id. at 452-53.
We start with the relevant language of comment k itself – as quoted verbatim in Pinnacle Hip:
k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like. . . .
888 F.3d at 771-72 (quoting Restatement §402A, comment k). Thus, on a case-by-case approach to comment k, the particular prescription medical product at issue must both be (1) “properly prepared,” and (2) have “proper directions and warning.”
As in most product liability litigation brought against manufacturers of prescription medical products, the plaintiff in Atkinson had no basis for a manufacturing defect claim that challenged whether the particular, allegedly injurious product was “properly prepared.” To assert such a claim under Texas law, a plaintiff must establish that the “product deviates, in its construction or quality, from the specifications or planned output in a manner that renders it unreasonably dangerous.” Casey v. Toyota Motor Engineering & Manufacturing North America, Inc., 770 F.3d 322, 326 (5th Cir. 2014) (applying Texas law). The “touchstone” of a manufacturing defect claim “is proof that the allegedly defective product differs from other products in the same product line.” Id. at 329. See Harrison v. Medtronic, Inc., 2022 WL 17443711, at *2 (5th Cir. Dec. 6, 2022) (applying Texas law), applying this standard in a Texas medical device decision. Most purported drug/device “manufacturing defect” claims we encounter actually assert global attacks on how all similar products were built, and thus fail to make any “case-by-case” challenge to a product being “properly prepared.”
So, like Atkinson, we put aside true manufacturing defects and recognize that, under Texas law as decreed by Pinnacle Hip, manufacturing defect cases would be outside of the ambit of the comment k “unavoidably unsafe” product doctrine.
What’s really interesting about Atkinson is its holding that the other prerequisite to case-by-case application of comment k – that the product have “proper directions and warning” – was also satisfied as a matter of law. Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law.
In a products liability action alleging that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product, there is a rebuttable presumption that the defendant or defendants, including a . . . manufacturer, . . . are not liable with respect to the allegations involving failure to provide adequate warnings or information if:
(1) the warnings or information that accompanied the product in its distribution were those approved by the United States Food and Drug Administration.
Tex. Civ. Pract. & Rem. C. §82.007(a). Atkinson pointed out that the main exception – fraud on the FDA − to this otherwise not easily rebutted presumption of warning adequacy is preempted. 448 F.Supp.3d at 453 (citing and following Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012) (applying Texas law)). The Texas presumption of adequacy thus satisfied the second, warning-related prong of comment k as a matter of law, which in turn precluded the plaintiff’s design defect claim:
Comment k states that manufacturers are not strictly liable for design defects if “proper warning is given.” As discussed . . ., Texas has a rebuttable presumption that FDA-approved prescription drug labels are adequate, and Plaintiff here is unable to rebut that presumption. Because the warning here was adequate, given the unique circumstance presented by Section 82.007(b)(1), comment k applies, and there can be no strict liability defective design claim.
448 F. Supp.3d at 453.
Thus, assuming that the Texas warning presumption enacted in §82.007(a) applies, any “case-by-case” application of Restatement §402A, comment k isn’t nearly as difficult for defendants to win as is the case in other purely common-law states. Assuming no case-by-case manufacturing defect/”proper preparation” claim exists, under §82.007(a) the comment k warning prong is satisfied whenever the product carries FDA-approved warnings. While that’s not as good as the across-the-board application of comment k to prohibit all design-related claims suggested by Reyes and its progeny, it is far better than the judicial nullification of comment k that tends to prevail in what Pinnacle Hip referred to as the “majority” rule. 888 F.3d at 772.
The biggest fly in the ointment is whether §82.007 applies to medical device claims. The statutory language itself is equivocal – referring, on the one hand, to “pharmaceuticals,” but on the other hand to FDA “pre-market approval or licensing.” Once again, Texas case law is surprising sparse. Only two Texas decisions have addressed the applicability of §82.007 to any sort of “device.” Both of them held that it did. See Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp. 2d 808, 820 (S.D. Tex. 2013) (applying the Texas warning presumption to a contraceptive device); Elmazouni v. Mylan, Inc., 220 F. Supp.3d 736, 742-43 (N.D. Tex. 2016) (applying the Texas warning presumption to a generic drug eluting patch).
However, we aren’t sure if either of these cases actually involved the sort of §510(k)-cleared medical device at issue in Pinnacle Hip. Cases that do have avoided the issue. See Isaac v. C.R. Bard, Inc., 2021 WL 1177882, at *9 n.4 (Mag. W.D. Tex. March 29, 2021) (not reaching §82.007 argument), adopted, 2021 WL 2773018 (W.D. Tex. April 20, 2021); Robles v. C.R. Bard, Inc., 2015 WL 11120857, at *2 (N.D. Tex. March. 23, 2015) (same); Lewis v. Johnson & Johnson, 991 F. Supp.2d 748, 761 (S.D.W. Va. 2014) (finding §82.007 inapplicable because all warning claims “have been dismissed”) (applying Texas law). So it appears that the argument we’re discussing in this post has never actually been decided by any court.