US District Judge Joseph R. Goodwin added a new obstacle for West Virginia plaintiffs in Transvaginal Mesh Litigation consolidated in MDL 2327 against Ethicon, ruling that they must prove there is an alternative design for the transvaginal pelvic mesh (TVT) feasible at the time of manufacture that would have eliminated the risk of injury.
The case, Terreski Mullins v. Ethicon, Inc., Case No. 2:12-cv-02952, represents the consolidation of 31 out of nearly 28,000 cases filed against Ethicon. This action involves thirty-one West Virginia plaintiffs who were implanted with Tension-free Vaginal 2 Tape, a mesh product manufactured by Ethicon to treat stress urinary incontinence.
The Ethicon MDL is one of seven MDLs assigned to Goodwin related to pelvic mesh, collectively encompassing nearly 58,000 cases:
- Ethicon (J&J) Transvaginal Mesh Litigation MDL 2327 — 31,752 cases
- Boston Scientific TVM Litigation MDL 2362 — 16,251 cases
- Bard TVM Litigation MDL 2187 — 8,211 cases
- American Medical Systems TVM Litigation, MDL 2325 — 4,280 cases
- Cook TVM Litigation MDL 2440 — 485 cases
- Coloplast TVM Litigation MDL 2387 — 622 cases
- Neomedic TVM Litigation MDL 2511 — 11 cases
New jury instruction
Transvaginal mesh was approved under a fast-track FDA process that deemed it similar to older mesh products. It took the FDA until the beginning of this year to classify the transvaginal mesh as a class III, or high-risk, medical device.
The judge ruled that a new pattern jury instruction for product liability cases, issued by the Supreme Court of Appeals of West Virginia, required the West Virgina plaintiffs to show an alternative, feasible design for the mesh product. The women charge that the mesh caused pain and injuries that required corrective surgeries. Because all the surgeries occurred in West Virginia, the lawsuits are subject to the state’s laws.
West Virginia Pattern Jury Instructions (PJI) § 411 reads: “Design Defect—Necessity of an Alternative, Feasible Design—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].”
“The PJI was written by lawyers, judges, and a justice of the West Virginia Supreme Court and was adopted after extensive research, editing, and committee review,” the judge wrote. “Thus, while the PJI is certainly not binding precedent in the way a published opinion is, the persuasive force behind the PJI in helping me predict how the West Virginia Supreme Court would rule on this issue is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.”