Products Liability Law Reporter

A federal district court denied summary judgment in a case brought by a surgical mesh patient who alleged strict liability and negligence claims against Ethicon, Inc., for injuries she suffered after being implanted with a Tension-free Vaginal Tape Obturator (TVT-O) device.

Annette Sutphin, a West Virginia resident, suffered from stress urinary incontinence, as well as a prolapsed bladder and uterus. Her physician implanted her with a TVT-O device manufactured by Ethicon, Inc. After the surgery, she suffered from mesh erosion, pelvic pain, recurrent stress urinary incontinence, and other problems.

She sued Ethicon, and the case was assigned to a federal district judge as one of seven MDLs. Suit alleged strict liability design defect, failure to warn, and negligence. The defendant moved to dismiss.

Denying the motion, the district court noted that to prove strict liability design defect, a plaintiff must offer sufficient evidence that a product is defective and that the alleged defect was the proximate cause of injury. Citing West Virginia case law, the court added that a plaintiff in a strict liability design defect case must prove the existence of an alternative, feasible design existing at the time of the allegedly defective product’s manufacture but need not show specific causation—a separate inquiry from design defect.

Here, the court said, the plaintiff offered evidence on various feasible alternative designs to the TVT-O, including lighter weight mesh. The plaintiff asserted that these purportedly safer alternatives would have reduced her injuries without affecting the product’s utility. Thus, the court concluded that a genuine issue of material fact existed regarding safer alternative design for the TVT-O, and summary judgment on the plaintiff’s strict liability design defect claim was not appropriate.

Turning to the plaintiff’s failure to warn claim, the court noted that the learned intermediary doctrine applies to West Virginia cases involving prescription medical devices. Under this doctrine, a drug manufacturer is not required to warn each patient who receives a product where the manufacturer provides a proper warning to the prescribing physician. The court concluded there was a material question of fact as to whether the defendant had properly warned pelvic floor surgeons as a group about the risks of the TVT-O or whether all of the product’s adverse risks and warnings were included in the products Instructions for Use (IFU). The plaintiff’s treating physician testified at deposition that he remained unaware of specific health risks associated with the TVT-O despite reading the product’s IFU. Finding a jury question existed on the sufficiency of the defendant’s warnings, the court denied summary judgment on the plaintiff’s failure to warn claim.

The court also denied summary judgment on the plaintiff’s claim that the defendant had failed to conform to reasonable design standards in creating the TVT-O. The plaintiff was not required to prove an alternative feasible design to prove negligence, the court said, adding that negligence focuses not on the product’s condition but on the manufacturer’s conduct.

Citation: Sutphin v. Ethicon, Inc., 2020 WL 2517237 (S.D. W. Va. May 15, 2020).

Plaintiff counsel: AAJ members Benjamin O. Present, Christopher A. Gomez, Colin Burke, Elia A. Robertson, Kila B. Baldwin, Lee B. Balesfsky, Michael A. Cavaliere, Thomas E. Bosworth, and Lorraine Donnelly, all of Philadelphia; and AAJ member Michelle L. Tiger, Newtown Square, Pa.