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For design defect claims, a key issue is whether the relevant jurisdiction requires evidence that a suitable alternative design existed that would have allowed the plaintiff to dodge the alleged injury.  This blog has posted at length about alternative design requirements and their nuances.  These posts address everything from the existential question of “What is an alternative design?” to a 50-state survey about the alternative design requirement for negligent design defect claims

But the new news on alternative design is that the West Virginia Supreme Court has decided Shears v. Ethicon, Inc., 2024 W. Va. LEXIS 272, 2024 WL 2932375 (W.Va. June 11, 2024), and definitively held that in West Virginia, a plaintiff cannot prevail on a strict liability design defect claim without proof that an alternative, feasible design, existing at the time the subject product was made, would have substantially reduced the risk of the specific injury suffered by the plaintiff. 

This is a decision that has been a long, long time coming. 

To recap:  More than a decade ago, in 2013, the Shears mesh product liability lawsuit was filed, and made part of an MDL.  See Shears v. Ethicon, Inc., 64 F.4th 556, 559 (4th Cir. 2023).  In 2015, the MDL court consolidated the cases of 37 West Virginia plaintiffs for a single trial under the caption Mullins v. Ethicon, Inc., 117 F. Supp. 3d 810 (S.D. W. Va. 2015). 

As the cases progressed, the MDL court ruled that West Virginia did not require proof of a safer alternative design, then backtracked on that decision in 2016 after “the Supreme Court of Appeals of West Virginia published its West Virginia Pattern Jury Instructions for Civil Cases: Instructions on the Law in Plainer Language (2016 ed.)”.  See Mullins v. Ethicon, Inc., 2016 U.S. Dist. LEXIS 170445, 2016 WL 7197441 (S.D. W. Va. Dec. 9, 2016).

Pattern Instruction § 411 (“Design Defect — Necessity of an Alternative, Feasible Design”) was the key to the course-correction in Mullins.  It provides:

There are many designs which, although they may eliminate a particular risk, are not practicable to produce. To prove that a design is defective, [name of plaintiff] must prove that there was an alternative, feasible design that eliminated the risk that injured [him/her].

Years passed, the MDL slowly chugged along.  In November 2020, the MDL court remanded 9 cases, including Shears, back to their home districts for trial.  For Shears, home was the Northern District of West Virginia.

Eventually the Northern District of West Virginia considered the alternative design issue, in the context of a defense motion to exclude a plaintiffs’ expert.  The expert had opined that there were two alternatives to the design of the “TVT mesh” at issue, namely “polyvinylidene fluoride” and “Ultrapro”, and these alternatives would have reduced—but not eliminated—the risk of injury that plaintiff allegedly experienced.  See Shears v. Ethicon, Inc., 64 F.4th 556, 562 (4th Cir. 2023). 

Understanding Pattern Instruction § 411 as requiring proof of an alternative design that would have eliminated—not just reduced—the risk, the Northern District of West Virginia excluded the expert’s testimony as inapposite to strict liability design defect.

The Shears case then went to trial, and the jury found for the defendant on the sole remaining claim for negligent design defect.[1] (see below).

The plaintiffs’ appeal landed in the Fourth Circuit last year, and the Fourth Circuit was not at all convinced that Pattern Instruction § 411 was a correct statement of West Virginia law regarding alternative design, going so far as to declare:

[W]e are satisfied that “there is no controlling appellate decision, Constitutional provision or statute” of the State of West Virginia that resolves the question of whether Section 411 sets forth a correct statement of law — nor is there sufficient authority that would permit us to reasonably guess how the Supreme Court of Appeals of West Virginia might resolve that question

Shears v. Ethicon, Inc., 64 F.4th 556, 563 (4th Cir. 2023) (emphasis added).

Given that West Virginia’s supreme court had published the pattern instructions, and stated in the preface that “[a]lthough these instructions are not binding, they have gone through multiple edits and revisions after extensive research and editing by the reporters, the review committees, Judge Alsop, and Justice Ketchum,” it is interesting that the Fourth Circuit felt there was insufficient authority for it to even guess at how West Virginia would decide the legal question.  So many times, federal courts happily make expansive Erie guesses based on far less authority (or none at all).

Believing itself to be without guidance for an Erie guess, the Fourth Circuit punted the question to the state, by certifying the issue to the Supreme Court of Appeals of West Virginia.  Bexis was not amused by this turn of events. 

The Fourth Circuit at least was clear in what it wanted:

It is of importance to us, however, that at no point has the Supreme Court of Appeals definitively stated — in a signed, published opinion — “one way or the other whether a design defect claim requires proof of a safer alternative design of the allegedly defective product.”

Which brings us to the present day, and Shears v. Ethicon, Inc., 2024 W. Va. LEXIS 272, 2024 WL 2932375 (W.Va. June 11, 2024).  In it, the Supreme Court of Appeals of West Virginia, more or less, responded:  “Ok, fine, here is your signed, published opinion.  For a strict liability design defect claim, West Virginia law requires proof of the existence of an alternative, feasible product design existing at the time of the subject product’s manufacture.”

Of course, having taken on the certified question, the Supreme Court of Appeals of West Virginia put a finer point on the issue.  The court concluded that Pattern Instruction § 411 did not correctly state the plaintiff’s burden with respect to the alternative design requirement, because the plaintiff must prove the alternative, feasible design “would have substantially reduced the risk of the specific injury suffered by the plaintiff” whereas § 411 required the alternative design to “eliminate the risk.”

Analyzing the risk reduction standard for the proposed alternative design, the court turned to its seminal product liability decision in Morningstar v. Black & Decker Manufacturing Co., 162 W. Va. 857, 253 S.E.2d 666 (1979) and “the general test for establishing strict liability in tort” being “whether the involved product is defective,” meaning “not reasonably safe for its intended use.”

Viewed in the context of an alternative design, this means that an appropriate alternative, feasible design should be, at least, “reasonably safe.” See [Morningstar, 162 W.Va. 857] (holding, in part, that “[t]he standard of reasonable safeness is determined not by the particular manufacturer, but by what a reasonably prudent manufacturer’s standards should have been at the time the product was made.” (emphasis added)). Morningstar‘s use of the term “reasonably” signifies that a product is safe if it meets “fair or sensible standards.”

Because of this “reasonably safe” standard, the plaintiff must have prima facie evidence the alternative design would “substantially reduce” the risk, not just be “safer”:

While some jurisdictions require only that the alternative, feasible design be “safer,” we find this criterion is too vague and does not meet Morningstar’s “reasonably safe” standard for an alternative design. Because a product could be safer than a defective product yet remain defective or “not reasonably safe,” this standard is an ineffective guide for what a reasonably prudent manufacturer should have produced.

Indeed, because West Virginia’s high court concluded that a mere “safer” alternative design was not sufficient, it also rejected the Restatement (Third) of Torts: Prod. Liab. § 2 approach to alternative design as too lax.  The Restatement (Third) of Torts: Prod. Liab. § 2 requires an alternative design that “could have reduced” the foreseeable risks of harm posed by the product.  As a result, Ford Motor Co. v. Tyler, 2023 W. Va. App. LEXIS 337, 2023 WL 8588042 (W.Va. Ct. App. Dec. 8, 2023)—which we discussed at West Virginia Appellate Court Requires Safer Alternative for Negligent Design Defect Claims)—was overruled to the extent it adopted the Restatement’s design defect standard. Thus, West Virginia now indisputably imposes an alternative design element in design defect cases. While not quite as pro-defense as the formulation in the pattern jury instruction, Shears‘ “substantially reduce” standard is more demanding than either the Third Restatement or the alternative design standards of many states, so it is a favorable development overall.

With West Virginia having answered the certified questions posed by the Fourth Circuit, the case returns to federal court for the Fourth Circuit to now decide the still-pending appeal (perhaps after requesting further briefing from the parties). We will keep you posted when they do.

[1] Plaintiffs also put on evidence of a “malfunction” theory of strict liability—in other words, that a malfunction occurred and would not ordinarily have happened in the absence of a defect.  However, because the plaintiffs’ own evidence established that the alleged injury was a known risk of any pelvic surgery involving mesh, it was something that could ordinarily happen regardless of defect, and the trial court granted judgment as a matter of law for the defense on that claim.