Court: District Court, S.D. West Virginia; February 22, 2017; Federal District Court
On February 14, 2017, the court instructed the parties to provide simultaneous briefs on the scope of an alternative, feasible design under West Virginia law, considering various tort theories. The parties submitted their initial briefs on February 20, followed by responses on February 21. The court's order addresses the legal arguments presented during these submissions and a subsequent pretrial conference.
West Virginia law allows plaintiffs to present multiple products liability theories—strict liability, negligence, and warranty—without requiring them to choose only one for jury consideration. The state’s Supreme Court has affirmed that plaintiffs can pursue any or all applicable theories, as evidenced in the case of Ilosky v. Michelin Tire Corp. The West Virginia Pattern Jury Instructions outline distinct elements for each theory, confirming that only theories supported by trial evidence can be submitted to the jury.
Regarding alternative, feasible design, the court emphasized that this concept must be assessed in relation to the product rather than the surgical procedures associated with it. Citing Talley v. Danek Medical Inc., the court noted that evidence questioning the efficacy of a surgical procedure compared to a device does not qualify as proof of a design flaw in the product itself. Such considerations pertain to medical judgment about patient treatment rather than the safety of the product's design. Therefore, alternatives in surgical procedures do not provide relevant insights into how the design of the TVT device could have been improved to mitigate risks linked to the plaintiffs’ injuries.
Plaintiffs contend that polypropylene sutures represent a feasible alternative design for the TVT device, arguing that the TVT essentially consists of woven sutures forming a mid-urethral sling. However, the court finds this argument unpersuasive, noting that Ethicon has previously used this assertion to support federal preemption claims, which the court has deemed meritless. The court distinguishes between the Prolene suture, a non-absorbable surgical suture, and the TVT, a transvaginal mesh, emphasizing their differing FDA processes, sizes, functions, and intended interactions with human tissue. The Prolene suture is designed for easy removal, while the TVT requires invasive surgical removal. The court concludes that these products are fundamentally different and rules that polypropylene sutures cannot be legally considered as an alternative design for the TVT. Plaintiffs must provide evidence of a viable alternative design; whether such a design qualifies as a feasible alternative for the TVT is a question for the jury.
Furthermore, the court addresses the defendants' argument that an alternative design is necessary for claims of both strict liability and negligence, clarifying that the two claims have different elements as established by West Virginia law. The court highlights that the relevant jury instructions for negligence in product liability cases do not require proof of an alternative feasible design, thus separating the standards for negligence and strict liability.
Negligence in product liability focuses on the manufacturer's conduct rather than the product's defective condition, contrasting with strict liability, which holds the manufacturer liable based on the defect alone. Under West Virginia law, plaintiffs do not need to present evidence of an alternative feasible design in negligence claims related to products liability. The malfunction theory allows plaintiffs to prove strict liability using circumstantial evidence, even if the exact defect is unidentified, provided they demonstrate that the malfunction occurred without abnormal use or other reasonable secondary causes. The plaintiffs may assert the malfunction theory even if they have identified specific design flaws, as multiple theories can be presented to the jury. The court emphasizes the need to evaluate whether sufficient evidence exists to create a triable issue regarding the safety of the product's components. Thus, the plaintiffs are permitted to pursue their case under the malfunction theory of strict products liability.
An alternative, feasible design is not a required element of proof under the malfunction theory in West Virginia law. The court finds no precedent in the cases of Anderson and Bennett that necessitates such evidence. The applicable jury instruction, PJI 407, does not include the requirement for an alternative design. Additionally, the Restatement (Third) of Torts supports the notion that proving a reasonable alternative design is unnecessary when a product fails to perform its intended function. The Supreme Court of Appeals of West Virginia has effectively adopted these principles. Consequently, the plaintiffs are not required to provide evidence of an alternative design to establish a prima facie case under the malfunction theory.
The court's conclusions include:
1. Plaintiffs may present various products liability theories supported by trial evidence, but only those sufficiently backed by admitted evidence can be submitted to the jury.
2. Evidence suggesting an alternative surgical procedure instead of the TVT device does not constitute an alternative, feasible design.
3. A polypropylene suture is also deemed not an alternative, feasible design for the TVT device.
4. The determination of whether a comparable product or design concept is an alternative, feasible design is a factual question for the jury.
5. Under negligence theory in products liability, plaintiffs are not required to show an alternative, feasible design.
6. Plaintiffs can proceed under the malfunction theory of strict products liability.
7. Under West Virginia law, no evidence of an alternative, feasible design is required under the malfunction theory.
The court instructs the Clerk to send a copy of this Order to relevant parties.
West Virginia law diverges from the Restatement (Third) of Torts: Products Liability regarding the handling of defective-design and failure-to-warn claims, which should not be presented to a jury under different legal labels if they are factually identical. Both types of claims are based on a risk-utility assessment, and presenting them under various doctrines could lead to confusion and inconsistent verdicts. The Restatement allows local law to determine the procedural stage at which a plaintiff must choose a theory for their case, yet West Virginia applies differing proof elements across products liability theories. The Fifth Circuit supports this view, noting that products not using pedicle screws may serve as alternative designs, challenging the assumption that all such screws are defective. This criticism, however, focuses more on the physician's treatment choice rather than on the defect of the specific product sold. A plaintiff asserting a design defect faces a tougher burden than one relying on circumstantial evidence under the malfunction theory. The West Virginia Supreme Court ruled that a product defect cannot be assumed solely from an accident; rather, evidence must show that the product malfunctioned in its intended use. Therefore, plaintiffs must demonstrate that the TVT device failed to perform as intended before inferring a defect, indicating distinct challenges for both direct and circumstantial evidence claims in strict products liability cases in West Virginia.
