Ethicon Media Monitoring 12/12/2016

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

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1. Women In Mesh MDL Must Show Safer Design Was Feasible

   Dec 9, 2016 | Law 360

   By Emily Field
   
   
   The West Virginia federal judge overseeing multidistrict litigation over Johnson & Johnson's Ethicon Inc. surgical mesh sided with the company on Friday when he ruled that a consumer would have to prove a safer, alternative design to a defective product was feasible at time of its manufacture.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Women In Mesh MDL Must Show Safer Design Was Feasible

   Dec 9, 2016 | Law 360

   By Emily Field

   The West Virginia federal judge overseeing multidistrict litigation over Johnson & Johnson's Ethicon Inc. surgical mesh sided with the company on Friday when he ruled that a consumer would have to prove a safer, alternative design to a defective product was feasible at time of its manufacture.
   
   U.S. District Judge Joseph R. Goodwin’s ruling concerns the consolidation of 31 cases in the MDL; the West Virginia women in the suits were implanted with Ethicon’s Tension-free Vaginal 2 Tape to treat stress urinary incontinence. In August, the judge had ruled that there’s no West Virginia authority that would require a plaintiff to prove that a proposed safer design would have reduced an individual’s specific injuries.
   
   But the West Virginia Supreme Court of Appeals later published its pattern jury instructions for civil cases, including a section on product liability law in the state.
   
   “Specifically, the West Virginia Supreme Court has adopted the following pattern jury instruction: There are many designs which, although they may eliminate a particular risk, are not practicable to produce,” Judge Goodwin said. “To prove that a design is defective, [name of plaintiff] must prove that there was an alterfeasible design that eliminated the risk that injured [him/her].”
   
   After the jury instructions were published, Ethicon asked the judge to reconsider his August ruling, arguing that it now contradicted the instructions.
   
   For their part, the women argued that the pattern jury instructions were optional and not binding on courts, according to the opinion.
   
   Judge Goodwin agreed that the instructions weren’t binding in the way that a published opinion would be, but he noted that they were written by lawyers, judges and a West Virginia high court justice and adopted after extensive research, editing and committee review.
   
   “Thus, while the pattern jury instruction is certainly not binding precedent in the way a published opinion is, the persuasive force behind the PJI in helping me predict how the West Virginia Supreme Court would rule on this issue is substantial,” he said.
   
   The judge said he came to the “inescapable conclusion” that a plaintiff must prove there was an alternative, feasible alternative at the time the product was made that would have wiped out the risk that hurt her.
   
   “This interpretation is not in conflict with the binding precedent of the West Virginia Supreme Court; instead, it appears to clarify what was already required,” he said.
   
   The women also contended that they can choose other routes than showing a safer design to prove their cases.
   
   “Specifically, the plaintiffs argue that they may prove their respective cases by ‘choosing’ to apply the risk-utility test or by ‘choosing’ to establish the existence and remedial efficacy of an alternative, feasible design,” the judge said. The risk-utility test determines whether the benefits of a product’s design outweighs its risks.
   
   But they offered no legal authority to support that conclusion, which the judge characterized as an “illogical proposition,” according to the ruling.
   
   The women claim the mesh caused problems including pain and injuries that required corrective surgeries. Because the surgeries all occurred in West Virginia, the suits are subject to the state's relevant laws, Judge Goodwin had said in an earlier ruling upholding his decision to consolidate the cases.
   
   Last year, the judge ruled that their state law claims are not preempted by federal regulators' approval of medical devices.
   
   His ruling cited the U.S. Supreme Court's 1996 decision in Medtronic v. Lohr, in which the high court found that the 510(k) clearance process for medical devices — which requires new products to demonstrate their "equivalence" to approved ones — doesn't preempt design defect claims brought under state law. Since the approval process emphasizes "equivalence" and not safety, the state law claims are not preempted, Judge Goodwin found.
   
   "We are pleased with the judge's ruling that is consistent with West Virginia law," an Ethicon spokeswoman told Law360 on Friday.
   
   Representatives for the plaintiffs didn’t immediately respond to requests for comment.
   
   The plaintiffs steering committee is represented by Renee Baggett and Bryan F. Aylstock of Aylstock Witkin Kreis & Overholtz PLLC and Thomas P. Cartmell and Jeffrey M. Kuntz of Wagstaff & Cartmell LLP.
   
   Ethicon and J&J are represented by David B. Thomas of Thomas Combs & Spann PLLC and Christy D. Jones of Butler Snow LLP.
   
   The MDL is In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, case number 2:12-md-02327, in the U.S. District Court for the Southern District of West Virginia.
   
   --Additional reporting by Sindhu Sundar. Editing by Brian Baresch.
   

   http://www.law360.com/articles/871179/women-in-mesh-mdl-must-show-safer-design-was-feasible
   

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