In updating chapter three of his book, on non-informational causes of action, Bexis had the opportunity to add the last several years of “alternative design” opinions. Quite a few states, as well as the Third Restatement of Torts, require plaintiffs alleging design defects to identify a “feasible” alternative design for the product as a prerequisite for asserting a design defect claim. Even where an alternative product design is not mandatory, plaintiffs frequently offer such evidence. In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.”
But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Thus, as a matter of logic and semantics, “feasibility” would seem to demand that any proposed “alternative” to the existing design of a product subject to FDA scrutiny must likewise have passed the same level of FDA scrutiny. For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims.
In Bruesewitz v. Wyeth LLC, 562 U.S. 223, 238 (2011), the United States Supreme Court reacted to a plaintiff’s unconstrained claims of “alternative” vaccine design:
[T]he [design] decision is surely not an easy one. Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one. Striking the right balance between safety and efficacy is especially difficult with respect to vaccines, which affect public as well as individual health.
Id. at 237-38. If design defect litigation involving FDA-approved products were not limited to FDA-approved designs, then what limit could there be?
Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution . . . Or does it suffice that a vaccine design has been approved in other countries? Or could there be liability for failure to use a design that exists only in a lab?
Id. at 238. Without such limits “the universe of alternative designs to be limited only by an expert’s imagination.” Id.
Bruesewitz, of course, interpreted the Vaccine Act to bar design defect litigation against vaccines altogether. Before the Vaccine Act existed, the Ohio Supreme Court – the only state high court to address FDA approval in the context of alternative designs – held that a purported “alternative” design for a DPT vaccine could not support a design defect claim because that alternative had never been submitted to, let alone approved by, the FDA:
[Defendant] was not licensed by the FDA to manufacture [its product] containing either [alleged alternative design] at the time [of product use]. As a result, appellee was prohibited by federal law from employing either of these [alternatives]. . . . In view of the foregoing, it was not possible for [defendant] to have legally marketed a [product] design using a fractionated cell pertussis vaccine at the time [of product use].
White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 753-54 (Ohio 1988). Ackley v. Wyeth Laboratories, Inc., 919 F.2d 397 (6th Cir. 1990), applying Ohio law, reached the same conclusion as White:
[Defendant] was prohibited by law from manufacturing anything but the [FDA-approved] design at the time of distribution of the [product] to the respective plaintiffs. That point is indisputable. Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations.
919 F.2d at 401. Accord Miller v. Connaught Laboratories, Inc., 1995 WL 579969, at *7 (D. Kan. Sept. 13, 1995) (summary judgment granted for lack of “a safe and effective alternative”; “There is no evidence that either product met FDA standards or was approved by the FDA”); Pease v. American. Cyanamid Co., 795 F. Supp. 755, 760 (D. Md. 1992) (plaintiff failed “to establish . . . that [an safer] vaccine was available as an alternative to [defendant] at the time that plaintiff was vaccinated” because “plaintiff must prove, inter alia, that [defendant] could have manufactured − and that the FDA would have licensed – [that alternative] vaccine”); Totterdale v. Lederle Laboratories, 2008 WL 972657 (W. Va. Cir. March 19, 2008) (“It is very difficult to see what else these defendants could have done” when one claimed alternative “was never licensed by the FDA” and the other “was not approved by the FDA until” nearly a decade after plaintiff’s vaccination).
Yet another vaccine case addressed at length the reasons why viable design alternatives for products governed by the FDCA must be limited to those that the FDA has allowed onto the market. Applying Restatement (Third) of Torts, Products Liability §6(c) (1998), Militrano v. Lederle Laboratories recognized that courts, generally, are “reluctan[t] . . . to determine whether a proposed alternative drug would have received FDA approval.” 769 N.Y.S.2d 839, 851 (N.Y. Sup. 2003), aff’d, 810 N.Y.S.2d 506 (N.Y. App. Div. 2006), app. denied, 857 N.E.2d 1137 (N.Y. 2006).
For physicians to prescribe such a safer drug, it must reach the market. To reach the market, a prescription drug must be approved by the FDA. Thus, the question of whether a new alternative drug should have been developed by the defendant must be recast as whether the proposed alternative drug would have won FDA approval in time to help the plaintiff. . . . Given that a drug manufacturer cannot market a drug in the United States without FDA approval, for a court to find that an alternative drug should have been developed would require it to predict with confidence that the alternative drug would have actually been approved. No expert could honestly opine that approval would have been granted without engaging in rank speculation. The approval process is accompanied by countless opportunities to decline or delay further progress.
Id. at 851-52 (quoting Henderson & Twerski, “Drug Designs are Different,” 111 Yale L.J. 151, 163-68 (2001)) (lengthy discussion of FDA regulatory process omitted). The plaintiff’s expert’s opinion in Militrano that a non-approved “alternative existed was “rejected on this basis alone” Id. at 852.
The only other state appellate decision to weigh in on FDA approval and alternative designs, Trejo v. Johnson & Johnson, 220 Cal. Rptr.3d 127 (Cal. App. 2017), review denied (Cal. Oct 11, 2017), is much more recent, and involved a claim that an OTC drug should have been designed to substitute a non-FDA-approved active ingredient. Id. at 158 (“the theory that [the alternative molecule] was a safer product that defendants should have sold”). It was “undisputed that [the alternative] ha[d] not been approved by the FDA.” Id. at 163 n.23. The purported alternative, even if it was an “isomer” of the FDA approved ingredient, lacked federal approval and thus was not feasible. “‘[T]here exists no FDA-approved alternative form of [the drug], meaning there is no available alternative design of the drug for defendants to adopt.’” Id. at 164 (quoting Wolfe v. McNeil-PPC, Inc. 773 F. Supp.2d 561, 572 (E.D. Pa. 2011)).
Under plaintiff’s theory, the design of [the drug] was inherently defective because defendants used [the FDA-approved ingredient] instead of [plaintiff’s alternative]. However, federal law prohibited defendants from changing the design of [the drug] by selling [plaintiff’s alternative] without prior FDA approval. Defendants accordingly could not have avoided design defect liability without violating federal law.
Trejo, 220 Cal. Rptr.3d at 163 (footnote omitted).
Not surprisingly, Wolfe addressed the same isomer-related claim of a non-FDA-approved alternative design. The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. Lack of FDA approval was “dispositive”:
The consequences of imposing on defendants a duty to develop a safer [OTC] product . . . would be severe because there exist no other FDA-approved forms of [the active ingredient]. In at least the short term, a popular pain reliever would have to be removed from pharmacies. This would run counter to . . . the public’s interest in continued use of a product it values for its palliative abilities. In sum, defendants do not have a duty to plaintiff to manufacture a safer ibuprofen product.
773 F.2d at 571. Nor, for essentially the same reasons, could there be strict liability for design defect where the “alternative” was not FDA approved:
[The drug] is a widely used product, and plaintiff has produced no evidence that it can be made safer (other than through the additions of warnings). There exists no FDA-approved alternative form of [the drug], meaning there is no available alternative design of the drug for defendants to adopt. . . . Finally, there is no evidence in the record about the feasibility of increasing the costs of [the drug].
Id. at 572-73. See In re Alloderm Litigation, No. 0295, 2015 WL 5022618, at *12 (N.J. Super. Law Div. Aug. 14, 2015) (claimed alternative could not be considered for plaintiffs who “had their surgeries prior to the commercial availability of” the claimed alternative because it “was not approved by the Food and Drug Administration until June 2007 and was not commercially available until late” that year).
Currently, most of the litigation over non-FDA-approved design defect claims arises in the context of mesh (pelvic or hernia) litigation, where the other side’s expert witnesses regularly advocate non-FDA approved alternatives to the types of mesh that the FDA has, in fact, allowed to be marketed. The recent decision in Baksic v. Ethicon, Inc., 2023 WL 1192538 (Mag. W.D. Tex. Jan. 27, 2023), which we discussed here, addressed at length the plaintiff’s attempt to rely on “alternatives” that “existed,” but “were not yet cleared by the FDA for the purpose of treating” the plaintiff’s condition. Id. at *7. Baksic rejected non-FDA-approved designs as “feasible” alternatives, first, because selling non-FDA alternatives was illegal:
A device must be approved or cleared by the FDA before it can be sold in the United States. Because mesh such as [plaintiff’s claimed alternatives] were not cleared by the FDA for treatment of stress [plaintiff’s condition] at the time of [her] surgery, they were not legally available at the time and, in this Court’s view, they do not qualify as safer alternative designs as a matter of law.
Id. To the extent the plaintiff in Baksic was arguing that, notwithstanding lack of FDA review, these other mesh designs were nonetheless “capable of being developed,” plaintiff lacked evidence that, “at the time of [plaintiff’s] surgery” – in 2010 − the “regulatory process” was sufficiently advanced that a hypothetical application “would have been viewed by the FDA” favorably. Id. at *7-8. That the product had been approved in “other countries” could not create a triable issue of fact because, even for other uses that the FDA eventually allowed, the necessary clinical trials had not been completed in 2010. Id. at *8. Thus, “[e]ven assuming arguendo that [plaintiff’s alternatives] were alternative designs and were safer, there is no genuine issue of material fact presented regarding their availability in 2010.” Id.
Baksic relied on Pizzitola v. Ethicon, Inc., ___ F. Supp.3d ___, 2022 WL 6225596 (S.D. Tex. Oct. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. The answer was likewise, “no.”
In the instant case, the Defendants contend, and the Plaintiff does not contest, that neither [of plaintiff’s preferred designs] were approved by the FDA at the time of her surgery. Since they were not FDA approved, it was not feasible for either to be used by Plaintiff’s physicians. The fact that they may have been in development and might eventually be on the market for use in humans is not relevant or material to prove a design defect.
Id. at *3. Another decision in the same case reached the same result:
In the United States, the FDA regulates the sale of medical devices. Before a medical device can be used in a hospital, the device must have FDA clearance. Here, Plaintiff concedes that some of the proposed designs . . . were not approved by the FDA in 2009. . . . These designs had not been used or tested by hospitals at the time the [devices at issue] were implanted in Plaintiff because the FDA had not yet cleared the use of these designs. Because these designs had not been used or tested, they were not technologically feasible in 2009. Therefore, any alternative designs . . . that had not been cleared by the FDA at the time of implantation cannot be considered safer alternative designs.
Pizzitola v. Ethicon, Inc., 2020 WL 6365545, at *5 (S.D. Tex. Aug. 31, 2020); see Pizzitola v. Ethicon, Inc., 2022 WL 6225661, at *5 (S.D. Tex. Oct. 7, 2022) (“Suffice it to say, in the field of prescription drugs and medical devices, FDA approval is the key to making such a device feasible and available for physicians to use outside of an experimental setting.”); Pizzitola v. Ethicon, Inc., No. 4:20-CV-02256, 2022 WL 6225573, at *3 (S.D. Tex. Oct. 7, 2022) (a claimed design alternative “must also be FDA-approved, or it would not be feasible for use by the treating physician”).
Texas being the largest state to impose an absolute alternative design requirement on design defect claims, it has generated a large number of FDA-related decisions in mesh litigation. Another recent and thorough treatment of this subject is found in Robinson v. Ethicon, Inc., 2021 WL 5054648 (S.D. Tex. Nov. 1, 2021), which likewise rejected non-FDA-cleared alternatives. Cases involving unregulated products simply did not apply:
While the “capable of being developed” language in these cases posits the question of whether the non-FDA approved devices, and particularly one that was already being used in Europe, can be considered safer alternative designs . . ., these cases are different than the instant case because there was no regulatory agency in charge of [those products] that had an impact on the feasibility determination.
Id. at *8. Favorable FDA review was essential to the existence of an alternative design because “a reasonable juror [must be able] to determine that [an alternative] mesh device was capable of being developed here in the United States” and “that it would have been safer for [plaintiff].” Id. at *9. See Labiche v. Johnson & Johnson, 2021 WL 3719554, at *2 (S.D. Tex. Aug. 9, 2021) (an “alternative design must have been legally available at the time for proper use”; plaintiff’s alternatives were either “not approved by the Food & Drug Administration at the time” or “did not have the Administration’s approval to be used” for plaintiff’s condition and thus “could not have been used”).
It’s not just Texas, either. Courts applying other states’ laws have also precluded plaintiffs from relying on “alternative” designs that lacked FDA sanction at the time of the surgeries at issue. Last year, in Davis v. Johnson & Johnson, 2022 WL 2115075 (D. Kan. June 9, 2022), rejected non-FDA purported alternative designs for many of the same reasons. Kansas law did not mandate alternative design as an essential element, but plaintiffs offering such evidence had to advance “an alternative design that is feasible, adequate, and effective.” Id. at *4 (citation omitted).
Plaintiff argues that [the alternative] existed at the time of her procedure, though she concedes it was not available in the United States at the time. Based on this, the Court agrees with Defendants that mesh made with [that substance] could not have been a “feasible” alternative design if [it] was not available for use in the United States. . . . While FDA clearance may not bear on the reliability of whether [the substance] was a safer alternative, it certainly bears on whether it was a feasible alternative.
Id. at *5. Therefore, Davis excluded as “not relevant” expert testimony about non-FDA-approved alternatives. Id.
Similarly, a Colorado court excluded expert testimony about “alternative” designs that never received the okay from the FDA:
[T]estimony about [claimed alternatives] is inadmissible because neither is available to American patients. To recover for a claim of negligent design in Colorado, a plaintiff must show not only that the alternative is safer but that it was practicable and available at the time the allegedly dangerous product was sold. But [plaintiff’s expert] testified at his deposition that neither [claimed alternative] is available in the United States for treatment of [plaintiff’s condition. His testimony is thus irrelevant and inadmissible.
Wood v. American Medical Systems, Inc., 2021 WL 1178547, at *10 (D. Colo. March 26, 2021) (citations and quotation marks omitted). See Davis v. Johnson & Johnson, 2022 WL 2116236, at *1 (D. Kan. June 9, 2022) (“mesh made from [a different alternative] has not relevant alternative-design evidence because [the alternative] has not been approved in the United States and therefore is not a feasible alternative design”); Shostrom v. Ethicon, Inc., 2022 WL 900157, at *5 (D. Colo. March 28, 2022) (“[S]uch mesh is not commercially available and . . . the FDA has never cleared or approved such mesh for treatment of [plaintiff’s condition]. Therefore, these alternatives are not feasible alternative designs where they could not have been used in lieu of [defendant’s device] at the time of [plaintiff’s] surgery.”); Roeder v. American Medical Systems, Inc., 2021 WL 4819443, at *4 n.2 (D. Kan. Oct. 15, 2021) (“this product was not available in the United States and therefore is not a feasible alternative design”); id. at *9 (“these alternative designs or products are not feasible as the products were not available in the United States”); Hanifl v. Ethicon, Inc., 2021 WL 830183, at *3 (W.D. Mo. March 4, 2021) (expert could not testify to alternatives where “no products using these materials [are] available in the United States) (device); Willet v. Johnson & Johnson, 465 F. Supp.3d 895, 907-08 (S.D. Iowa 2020) (applying Iowa law) (claimed alternative that “was never approved by the FDA and never commercialized” failed because merely “target[ing] FDA approval . . . satisfies none of the relevant considerations for determining the reliability of an expert’s opinion about an alternative design”).
As we’ve said many times before, the Blog does not do the other side’s research for them. That said, we are struck by the relative paucity of reasoning in those decisions that take the opposite position and allow experts to testify to non-FDA-reviewed “alternatives” in prescription medical product liability litigation. There simply aren’t any equivalent pithy block quotes from the other side of this issue.
The mesh cases, in particular, blindly parrot a couple of decisions in the MDL that themselves contain next to no reasoning. First, In re Ethicon Inc. Pelvic Repair Systems Products Liability Litigation, 2020 WL 1060970 (S.D.W. Va. Feb. 13, 2020), provided two sentences:
To the extent [defendant] argues that [expert] testimony that [a substance] was a safer alternative is unreliable because [that substance] was not cleared by the FDA, this does not render [that] testimony unreliable. This has no bearing on whether [alternative] mesh is a safer alternative to other mesh products.
Id. at *3. No FDA-related authority is cited, nor is any distinguished. Moreover, this brief discussion is couched entirely in terms of “reliability” whereas state-law alternative design requirements turn on feasibility. A second MDL decision sometimes cited for the contrary proposition, Bellew v. Ethicon, Inc., 2014 WL 12685965, at *6 (S.D.W. Va. Nov. 20, 2014), does not even mention the FDA.
Some of the “anti” decisions also asserted that the defendants failed to cite persuasive precedent in support the proposition that lack of FDA approval precludes a purported alternative design from being feasible. E.g., Bell v. Ethicon, Inc., 2021 WL 1111071, at *7 (S.D. Tex. March 23, 2021) (“This Court did not find any authority in Texas, nor did [defendant] point to any, establishing that lack of FDA approval precludes an alternative design.”). Well, that’s what the Blog is here for – and that’s what prompted this post. Bell’s purported “research” missed the aforementioned Pizzitola decision, decided the previous year, altogether, and four more well-reasoned Texas law decisions now refute Bell’s minimal reasoning – as well they should since the bottom line here is both simple, and stark: an illegal (not FDA approved or cleared) alternative design simply is not “feasible.”