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Mullins v. Johnson & Johnson

United States District Court, S.D. West Virginia, Charleston Division

February 23, 2017

TERRESKI MULLINS, et al., Plaintiffs,
JOHNSON & JOHNSON, et al. Defendants.



         On February 14, 2017, I directed the parties to submit simultaneous briefing regarding the contours of what an alternative, feasible design can be under West Virginia law. I asked the parties to cover this issue as broadly as possible, taking into consideration the multiple tort theories available to a plaintiff under West Virginia law. On February 20, 2017, the parties filed their respective briefs [ECF Nos. 1867 & 1868]. On February 21, 2017, the parties filed their respective responses [ECF Nos. 1872 & 1873]. This Order will discuss many of the legal arguments made by the parties in their briefing and at the February 22, 2017, final pretrial conference.

         I. Multiple Products Liability Theories

         West Virginia law permits plaintiffs to submit multiple products liability theories to the jury. The Supreme Court of Appeals of West Virginia has determined the following:

Product liability actions may be premised on three independent theories-strict liability, negligence, and warranty. Each theory contains different elements which plaintiffs must prove in order to recover. No rational reason exists to require plaintiffs in product liability actions to elect which theory to submit to the jury after the evidence has been presented when they may elect to bring suit on one or all of the theories.

Syl. pt. 6, Ilosky v. Michelin Tire Corp., 307 S.E.2d 603, 605 ( W.Va. 1983) (emphasis added). Additionally, the West Virginia Pattern Jury Instructions (“PJI”), § 401, enumerates the three separate theories available to a plaintiff in a products liability case. Further, the PJI establishes different elements for each products liability theory. See generally W.Va. P.J.I. § 401, et seq. Accordingly, I FIND that the plaintiffs in this consolidated trial may present evidence on one or more products liability theories available under West Virginia law, but only the theories sufficiently supported by the evidence admitted at trial may be submitted to the jury.[1]

         II. Alternative, Feasible Design

         I am convinced that an alternative, feasible design must be examined in the context of products-not surgeries or procedures. The Fourth Circuit, in applying Virginia law, has addressed this issue squarely. In Talley v. Danek Med., Inc., 179 F.3d 154 (4th Cir. 1999), the Court evaluated an expert's theory that spinal fixation screws were defective because spinal fusion procedures with the screws were not more successful than spinal fusion procedures without the screws. The Court ruled as follows:

This testimony, however, did not indicate any design flaw in the Dyna-Lok Device. Rather, it questioned the medical judgment of doctors who use spinal fixation devices in surgery. While such an opinion might be relevant in a malpractice suit against a doctor, it is irrelevant in a suit against the product manufacturer. Thus, the district court did not abuse its discretion in refusing to consider this evidence in a suit against the manufacturer of a spinal fixation device. In summary, we agree with the district court's conclusion that Talley has failed to come forth with admissible evidence which would permit a jury to conclude that the Dyna-Lok Device was defectively designed.

Talley, 179 F.3d at 162. I am persuaded by the reasoning in Talley.[2]

         Evidence that a surgical procedure should have been used in place of a device is not an alternative, feasible design in relation to the TVT. Whether an alternative procedure could have been preformed without the use of the TVT does nothing to inform the jury on the issue of an alternative, feasible design for the TVT. Instead, alternative surgeries or procedures raise issues wholly within the context of what a treating physician has recommended for patients based on the individual needs and risk factors associated with individual patients. In other words, alternative surgeries or procedures concern the medical judgment of the doctors who use TVT devices to treat stress urinary incontinence (“SUI”); other surgeries or procedures do not inform the jury on how the TVT's design could have feasibly been made safer to eliminate the risks that caused the plaintiffs' injuries. See Talley, 179 F.3d at 162; W.Va. P.J.I. § 411.

         The plaintiffs have also argued that polypropylene sutures should be considered an alternative, feasible design for the TVT. The basis of their argument is that the TVT device is essentially made up of woven-together sutures, forming a mid-urethral sling. I am not persuaded by this argument. In fact, Ethicon has made the exact argument in order to invoke relevant federal preemption doctrines, and I have previously found that Ethicon's argument lacks merit:

Ethicon's argument ignores the fact that the Prolene suture and the TVT are two entirely different medical devices that went through different FDA processes. Although Ethicon represents that the products are primarily composed of the same material, it does not automatically follow that the material is safe in both devices. The Prolene suture is a nonabsorbable surgical suture; the TVT is a form of transvaginal mesh. The Prolene suture consists of a single filament of polypropylene; the TVT is a mesh woven from knitted Prolene filaments. The average Prolene suture is a few inches long; the TVT measures one-half inches by sixteen inches, and contains many times the amount of polypropylene material. The Prolene suture is not intended to adhere to human tissue; the TVT is designed to adhere to human tissue. The Prolene suture is designed to be easily pulled out of the body; the TVT cannot be removed without invasive surgery.

Huskey v. Ethicon, Inc., 29 F.Supp.3d 736, 747 (S.D. W.Va. 2014) (quoting Lewis v. Johnson & Johnson, 991 F.Supp.2d 748, 757-59 (S.D. W.Va. 2014)). Thus, I have previously ruled that a polypropylene suture and the TVT device are entirely different products, performing different functions. Accordingly, I FIND that a polypropylene suture is ...

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