United States: A Gem On Alternative Design From A Pelvic Mesh MDL

Last Updated: December 15 2016
Article by Steven Boranian

We don't write a lot on the various pelvic mesh MDLs in West Virginia because we are so heavily involved in two of them. But the MDL court entered an order last week on design defect and alternative design that we consider to be a real gem.  The case is Mullins v. Ethicon, Inc., No. 2:12-cv-02952, 2016 WL 7197441 (S.D. W. Va. Dec. 9, 2016), and we recommend it to all of you.  We say that not only because the district court held that West Virginia law requires that each plaintiff must prove a feasible alternative design—which is the correct result—but also because the order is particularly well reasoned.

Not every state requires proof of a feasible alternative design, but it is nevertheless a basic product liability concept. It is a particularly good fit when dealing with products that always bear risks—such as implanted medical devices.  The Restatement (Third) of Torts, Product Liability § 2 is as good a place as any to start, as it bakes alternative design right into the definition of a design defect:  "A product . . . (b) is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe."  (emphasis added).

Take the obvious example of a machine with sharp spinning parts. The same machine with a protective guard may be a safer alternative design.  Or it might not.  The point is that the plaintiff has to prove it.  Take also the example we discussed in Bexis' aptly named post " On Alternative Design."  That case involved hernia mesh, not pelvic mesh, and the plaintiffs' claims failed because, among other reasons, they had failed to prove that a mesh of a different design would have been any safer.  Consider hormone-based contraceptives.  Cholesterol drugs.  We could go on and on.  All these products bear known and unavoidable risks, and those risks should not be labeled "defects" and result in potential liability unless the plaintiff can prove an alternate design would feasibly mitigate them.  And, no, it is not sufficient to say that the feasible alternative is to use a different product or not use any product at all.  As we observed in the aforementioned post, that would convert strict liability into absolute liability.  As we asked in yet another post on this topic, are motorcycles defective because full-sized automobiles are generally safer?  You get the point.

So back to the Mullins order.  The district court had previously ruled that the plaintiffs bore no burden under West Virginia law to prove that a safer alternative design would have reduced an individual plaintiff's specific injuries.  2016 WL 7197441, at *1.  But the manufacturer defendant asked the court to reconsider in light of a newly published West Virginia pattern jury instruction, which reads, "There are many designs which although they may eliminate a particular risk, are not practicable to produce. To prove that a design is defective [the plaintiff] must prove that there was an alternative, feasible design that eliminated the risk that injured [him/her]." Id. at *2 (citing W. Va. Pattern Jury Inst. § 411, emphasis added).  The pattern jury instructions were promulgated by a committee that included a justice of the West Virginia Supreme Court, and the official reporter of the pattern instructions is the Chief Justice.

The instruction seems pretty clear to us, but the plaintiffs did not agree. First, they argued that pattern jury instructions are not binding.  That is true, but the district court replied that "[a]t best, the plaintiffs ask me to simply ignore § 411 because it is not binding, and at worst, the plaintiffs ask me to find that § 411 is an incorrect statement of West Virginia law.  I will do neither." Id. at *3.  This is really interesting because the district court invoked the Erie doctrine and relied on the pattern jury instruction as a reliable indicium of state law upon which a federal court can rely.

Second, the plaintiffs argued that the pattern jury instruction applies only in a "non-consolidated trial context" and only when a plaintiff "chooses to defend her design defect claim by advocating a safer alternative design." Id. The district court found no support for these arguments, which is not the least bit surprising.  If a "non-consolidated trial context" refers to multidistrict litigation, the obvious response is that an MDL is a procedural device, a venue transfer under section 1407.  MDL transfer does not affect substantive law, which is what pattern jury instructions endeavor to reflect.  Consolidating cases for trial should not affect substantive law either, because that too is just another procedural device.  As for the argument that a plaintiff can "choose to defend her design defect claim" by reference to alternate design or not, this is like saying a plaintiff can opt out of the elements of her cause of action.  The district court rejected that argument.

Third, the plaintiffs argued another variation on choice—that there are alternate pathways to prove design defect. Id. at **3-4.  In our view, this is where the district court's order really sings, as the district court systematically walks through a plaintiff's burden under West Virginia law.  The plaintiff has to prove that the defendant made the product, that the plaintiff was harmed while using the product in a foreseeable way, that the product was defective in design, and causation. Id. at *4 (citing W. Va. Pattern Jury Inst. § 409).  Drilling down further, the plaintiff has to prove design defect by reference to multiple factors, three of which require consideration of an alternative feasible design. Id. (citing W. Va. Pattern Jury Inst. § 410).  This is very similar to the Restatement (Third), which assesses a design defect only by comparison to a feasible alternative design.

Finally, section 411 "ties everything together by instructing the jury on what exactly an alternative, feasible design must achieve," i.e., that an alternative, feasible design "eliminated the risk that injured [the plaintiff]." Id. at *4.  In other words, the pattern jury instruction requires proof of a feasible alternative design when considered on its own and in the context of the entire scheme.  There is no other path that the plaintiffs can "choose" under West Virginia law.

We do not know exactly the impact that this order will have, and we will not purport to speculate. We do know, however, that the order makes a great deal of sense in adopting what we consider to be a prevailing rule of product liability.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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