The “almost no deviations” limitation is directly applicable to device design because all significant design alterations (“major” or “moderate”) must receive FDA approval prior to being implemented. E.g., Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012); Blunt v. Medtronic, Inc., 760 N.W.2d 396, 409 (Wis. 2009); McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804, 810 (E.D. Pa. 2016); Kitchen v. Biomet, Inc., 2014 WL 694226, at *3 (E.D. Ky. Feb. 21, 2014); Miller v. DePuy Spine, Inc., 638 F. Supp.2d 1226, 1229 (D. Nev. 2009).
This restriction upon the immediate availability of alternative designs implicates Restatement (Second) of Torts §402A, comment k (1965), “which insulates from liability manufacturers of unavoidably unsafe products that are properly prepared and accompanied by an adequate warning.” Rodriguez v. Stryker Corp., 680 F.3d 568, 575 (6th Cir. 2012) (applying Tennessee law). Putting aside the separate, and widely litigated, issue of whether comment k applies to prescription medical products generally or only on a case-by-case basis, courts on both sides of that question equate comment k’s “unavoidably unsafe” standard with the absence of an alternative design:
[N]umerous state and federal courts ha[ve] interpreted comment k to mean that a product is “unavoidably unsafe” when, given proper manufacture and labeling, no feasible alternative design would reduce the safety risks without compromising the product’s cost and utility.
Bruesewitz v. Wyeth LLC, 562 U.S. 223, 256 (2011) (Breyer, J. concurring) (footnote omitted) (emphasis added). In other words, “a defendant seeking to invoke the [comment k] defense must first show that the product is highly useful and that the danger imposed by the product could not have been avoided through a feasible alternative design.” Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2487 (2013) (applying New Hampshire law). Thus, to surmount a claim of “unavoidable risk [under comment k], there must be, at the time of the subject product’s distribution, no feasible alternative design which on balance accomplishes the subject product’s purpose with a lesser risk.” Toner v. Lederle Laboratories, 732 P.2d 297, 306 (Idaho 1987). “The purpose of comment k is to protect from strict liability products that cannot be designed more safely.” Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991).
Thus, FDA’s requirement that PMA-approved devices be made with “almost no deviations” from approved specified designs (putting aside preemption) necessarily precludes existence of legal alternative designs that would allow a plaintiff in a given case to avoid a manufacturer’s comment k defense. To use a non-approved alternative design would be illegal—and illegal designs cannot be “feasible” alternative designs in product liability litigation. Lewis v. American Cyanamid Co., 715 A.2d 967, 981 (N.J. 1998} (“plaintiff may not succeed on an alternative design theory that would have required the defendant manufacturer to violate the law”); White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 753-54 (Ohio 1988) (alternative design not feasible where “it was not possible for [defendant] to have legally marketed a [product] design using [the alternative design] at the time [plaintiff] was inoculated”); Ackley v. Wyeth Laboratories, Inc., 919 F.2d 397, 401 (6th Cir. 1990) (following White; alternative designs did not “exist” where it was “indisputable” that “[w]ithout an FDA license to produce another design, [defendant] was legally prohibited from distributing” those designs) (applying Ohio law); Wolfe v. McNeil-PPC, Inc., 773 F. Supp.2d 561, 572 (E.D. Pa. 2011) (when “[t]here exists no FDA-approved alternative form of [the product],” “there is no available alternative design”); Militrano v. Lederle Laboratories, 769 N.Y.S.2d 839, 847-48 (N.Y. Sup. 2003) (where plaintiff proposed a non-FDA-approved alternative, defendant “could not have marketed a reasonable alternative”), aff’d, 810 N.Y.S.2d 506 (N.Y.A.D. 2006); In re Alloderm Litigation, 2015 WL 5022618, at *12 (N.J. Super. Law Div. Aug. 14, 2015 (no feasible alternative where design plaintiff advocated “was not approved by the Food and Drug Administration until” after plaintiffs’ surgeries); Totterdale v. Lederle Laboratories, 2008 WL 972657 (W.Va. Cir. March 19, 2008) (where FDA approval happened only after plaintiff’s injury, plaintiff did “not provide any new material facts to raise a genuine issue as to whether [the product] was avoidably unsafe”).
Applying these principles, Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. 2012), recognized that the comment k defense extended to “a Class III medical device which received FDA approval pursuant to the PMA process.” Id. at 481 (footnote omitted).
[T]he inherently rigorous nature of the premarket approval process and the contraindications, warnings, and precautions described in the [device’s] Summary of Safety and Security Data all suggest that [it] is an “unavoidably unsafe” product to which strict liability does not apply.
Id. at 482. “As a result, the [device] can be considered a prescription medical device that falls within the scope of comment k to §402A.” Id.
Similarly, the court employed the non-preemption rationale of comment k in Aaron v. Medtronic, Inc., 209 F. Supp.3d 994 (S.D. Ohio 2016). While Ohio (at the relevant time, which has since changed, Ohio Rev. Code Ann. §2307.75(D)) was a case-by-case comment k state, the PMA-approved status of the device, and the constraints that the FDA’s approval imposed on alternative designs, meant that comment k necessarily controlled:
Defendant argues . . . that [the device’s] classification by the FDA as a Class III medical device inherently means that it is unavoidably unsafe and that Comment K’s prohibition of strict liability claims therefore applies. Defendant’s argument is well taken. Class III devices . . . are, as relevant here, defined as devices that are “for a use which is of substantial importance in preventing impairment of human health, or...present a potential unreasonable risk of illness or injury.” 21 U.S.C. §360c(a)(1)(C)(ii). . . .
[T]here is no alternative design for [the device] that could lawfully be marketed. “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications...that would affect safety or effectiveness.” There is therefore no basis for an in-depth evidentiary inquiry into alternative designs.
Aaron, 209 F. Supp.3d at 1013-14 (quoting Riegel, 552 U.S. at 319) (other citations omitted).
So, while preemption should remain the first and foremost argument against design defect claims involving PMA-approved medical devices, some courts may nonetheless be more easily persuaded by this alternative, non-constitutional argument that the lack of any legal alternative design under Restatement §402A, comment k likewise requires dismissal of such claims under controlling state law. Defendants should therefore consider giving judges this other way to the same result.