News Comment K, Presumptive and Medical Device Design Defects under Texas Law
Although we like these parts DePuy Orthopedics, Inc., Pinnacle Hip Implant Product Liability Litigation, 888 F.3d 753 (5th Cir. 2018) (applicable to Texas law), overturning a $500 million judgment resulting from a combination of attorney misconduct and judicial laxity, and we recognize that certain other Fifth Circuit The issue of the ruling affects that decision.although the good part peak buttocks Enough to earn the decision a spot in our top 10 cases of 2018, the downside of the decision was bad enough that it landed on our list of the top 10 worst decisions of 2018 as well. Specifically, we observed:
The most serious error the court committed was refusing to apply established Texas law, which holds that k-comments exclude strict liability across the board. peak buttocks Ignored – really ignored – there were half a dozen previous decisions on this issue (including one of its own). Even without any precedent (there has been), it is not the job of federal courts to extend state legal liability where state courts do not.
Texas law has long favored sweeping application of Restatement of Torts (Title II), §402A, comment k (1965). The Texas Supreme Court recognized the applicability of comment k “particularly to the medical field and unavoidably unsafe products, such as prescription drugs.” Centocor, Inc. v. Hamilton, 372 SW3d 140, 165 (Texas, 2012).long ago, in Reyes v. Wyeth Laboratories498 F.2d 1264 (5th Cir. 1974) (applying Texas law), the Fifth Circuit held:
[T]o Concluding that the manufacturer of an unavoidably unsafe product did not act unreasonably in placing it on the market does not relieve him of his duty to market the product in a manner that would prevent unreasonable danger. In a . . . vaccine, this translates into an obligation to provide appropriate warnings when the product is marketed. As indicated in comment k of section 402A, an unavoidably unsafe product is neither a defect nor an unreasonable hazard if the product is “properly prepared and accompanied by appropriate instructions and warnings.”
ID. in 1274 (footnote omitted). A non-precedent Fifth Circuit decision held that “[u]Under Comment K of Restatement (Second) § 402A of Torts, a drug manufacturer is liable for damages only if it fails to warn of a defect it knew or should have known about. ” Schwarz v. Block Drug Co. Inc., 1999 WL 274409, at *1 (5th Cir. April 15, 1999) (in table at 180 F.3d 261) (Texas law applies). None of these cases provides a case-by-case analysis of plaintiffs’ design defect claims.
Other Texas decisions follow Reyes‘ As a matter of law, foot and hold products are ‘inevitably unsafe’ McKay v. Novartis Pharmaceuticals Corp.934 F. Supp. 2d 898, 909-10 (WD Tex. 2013); Massa v. Genentech2012 WL 956192, at *5 (SD Tex. March 19, 2012); Netherlands v. Hoffman-La Roche, Inc.2007 WL 4042757, at *3 (ND Tex. November 15, 2007); McNeill v Wyeth2005 WL 544222, at *6 (ND Tex. March 4, 2005), for other reasons462 F.3d 364 (5th Cir. 2006) (reversion involves warning issues); Blackmon v. American Home Products Corp.328 F. Supp.2d 659, 664-65 (SD Tex. 2004); and Hackett v. GD Searle & Co., 246 F. Supp. 2d 591, 595 (WD Tex. 2002). Also, no case analysis can be found in any of them. Thus, the defense made good progress (if incomplete) in establishing comment k as a general defense to a Texas design defect claim.
This came to an abrupt end in less than two paragraphs peak buttocksthe Fifth Circuit decided:
[I]Ton [the Texas Supreme Court] The exemption rules have never been explicitly extended to medical implants, let alone 510(k)-approved devices, on a class or product-by-product basis. Jurisdictions are divided on whether medical devices enjoy blanket immunity, and most courts tend to deal with them on a case-by-case basis. Defendants are asking us to stray from this trend and drop all implant-based lawsuits based on the speculation that Texas courts may one day redefine the lines of liability in their favor.But the defendant did not provide sufficient predictive indicators from texas We do this by refusing to get ahead of the Texas courts, and against the majority, to preclude a broad avenue of litigation.
888 F.3d at 772 (footnote omitted) (emphasis original).While emphasizing that the defendants provided “very few predictive from texas” For their overall position, ID., peak buttocks supply Texas has no precedent at all to its opposite conclusion. As noted above, the Texas case has applied comment k’s exclusion of design defect claims across the board to cases involving vaccines (Reyes) and biological products (massa), and drugs (all the other cases we just cited), so doing this in the device case is much “far ahead” of existing Texas law peak buttocks suggestion.
but peak buttocks That’s it.
Bexis was re-examining hundreds of recent non-informative deficiencies cases for his soon-to-be-updated Chapter III of Drug and Medical Device Product Liability Statements after he came across a case that offered a possible way forward for defendants facing design deficiencies Filing a claim under Texas law peak buttocksThe decision in . Atkinson v. Luitpold Pharmaceuticals, Inc.448 F. Supp.3d 441 (ED Pa. 2020), applicable Texas law, assuming the same “case-by-case” approach applied peak buttocks – although never cited peak buttocks itself — nonetheless dismissed the plaintiff’s claim of design defect. ID. In 452-53.
We start by commenting on the relevant language of k itself – a verbatim quote peak buttocks:
k. Unavoidable unsafe products. There are some products that, to the present state of human knowledge, are simply not safe for their intended and everyday use. These are especially common in the pharmaceutical field. A prominent example is Pasteur’s vaccine against rabies, which, when administered, often resulted in very serious and devastating consequences. . . . such products, when properly prepared and accompanied by proper directions and warnings, are free from defects and free from unreasonable hazards. The same goes for many other drugs, vaccines, etc. . . .
888 F.3d at 771-72 (cited restating §402A, comment k). Thus, in the case-by-case approach of comment k, the specific prescription medical product at issue must (1) be “properly prepared” and (2) have “proper instructions and warnings.”
As with most product liability lawsuits against manufacturers of prescription medical products, plaintiffs in atkinson There was no basis for any manufacturing defect claims that challenged whether a specific, allegedly harmful product was “properly prepared.” To bring such a claim under Texas law, a plaintiff must prove that “the product deviates in construction or quality from specifications or planned production volumes such that it is unreasonably dangerous.” Casey v. Toyota Motor Engineering & Manufacturing North America, Inc., 770 F.3d 322, 326 (5th Cir. 2014) (Texas law applies). The “litmus test” for manufacturing defect claims “proves that the allegedly defective product is different from other products in the same product line.” ID. at 329. Look Harrison v Medtronic, 2022 WL 17443711, at *2 (5th Circuit, Dec. 6, 2022) (applicable to Texas law), application of this standard in Texas medical device decisions. Most so-called drug/device “manufacturing defect” claims we come across actually claim a global attack on how all similar products are manufactured, thus failing to raise any “individual” challenges to “properly prepared” products.
So, like atkinsonwe set aside genuine manufacturing defects and recognize that, under Texas law, peak buttocksCases of manufacturing defects are outside the scope of comment k “inevitably unsafe” product principles.
what’s really interesting atkinson It argues that another prerequisite for applying comment k on a case-by-case basis — that products have “correct instructions and warnings” — is also legally met. Unlike most states, Texas enforces a strong statutory presumption that warnings for prescription medical products that comply with FDA’s requirement for “premarket approval or licensing” are legally sufficient.
In a product liability action alleging that the injury was caused by failure to provide adequate warning or information about the drug product, there is a rebuttable presumption that the defendant or defendants, including . . . the manufacturer, . . . will not be liable for allegations involving failure to provide adequate warning or information if:
(1) Warnings or information accompanying a product have been approved by the U.S. Food and Drug Administration.
Texas Civilization. practise. & Rem. C. §82.007(a). atkinson Pointing out the main exception—fraud against the FDA—preempts the otherwise not easily refutable presumption of adequacy of the warning. 448 F.Supp.3d at 453 (quoted and followed Lofton v. McNeil Consumer Products and Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012) (Texas law applies). Thus, Texas’ presumption of adequacy legally satisfies the second caveat-related branch in Comment k, which in turn precludes plaintiff’s design defect claim:
Comment k states that a manufacturer is not strictly liable for design defects “if appropriate warnings are given”. As discussed. . . , Texas has a rebuttable presumption that FDA-approved prescription drug labels are adequate, and the plaintiffs here cannot rebut that presumption. Because the caveat here is sufficient, comment k applies, and there cannot be a strict liability defective design claim, given the unique circumstances set forth in section 82.007(b)(1).
448 F. Supp. 3d at 453.
Thus, assuming that the Texas warning presumption enacted in §82.007(a) applies, restating any “case-by-case” application of §402A, comment k is hardly like other purely common law states. Assuming no case-by-case manufacturing defect/”properly prepared” claim, the note k warning prog would be satisfied under §82.007(a) as long as the product bears an FDA-approved warning.Although this is not as good as applying comment k across the board to ban all design-related claims Reyes and its descendants, it is much better than commenting on the invalidity of k peak buttocks Called the “majority” rule. 888 F.3d 772.
The biggest fly in the ointment is whether §82.007 applies to medical device claims. The statutory language itself is ambiguous — referring to “drugs” on the one hand and “premarket approval or clearance” by the FDA on the other. Again, Texas case law is surprisingly sparse. Only two Texas decisions have addressed the applicability of §82.007 to any type of “equipment.” They both thought it was true. Look Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supplement. 2d 808, 820 (SD Tex. 2013) (applying the Texas warning presumption to contraceptive devices); Elmazouni v. Mylan, Inc.220 F. Supp.3d 736, 742-43 (ND Tex. 2016) (Applying Texas Warning presumption to generic drug-eluting patches).
However, we are not sure whether any of these cases actually involved the medical devices at issue in §510(k) peak buttocks. does avoid the case of this problem. Look Isaac v. CR Bard, Inc.2021 WL 1177882, at *9 n.4 (Mag. WD Tex. March 29, 2021) (does not reach §82.007 argument), use2021 WL 2773018 (WD Texas April 20, 2021); Robles v. CR Bard, Inc.2015 WL 11120857, at *2 (ND Tex. March. 23, 2015) (same); Lewis v. Johnson & Johnson, 991 F. Supp.2d 748, 761 (SDW Va. 2014) (finding §82.007 inapplicable because all cautionary statements “rejected”) (applicable Texas law). Thus, it appears that the arguments we discuss in this article have never actually been decided by any courts.