The first bellwether trial in the multidistrict litigation over the Ethicon vaginal mesh pelvic repair system is slated to open next Monday in the Southern District of West Virginia.

U.S. District Judge Joseph R. Goodwin, reversing himself, ruled Feb. 3 that the plaintiffs will have to establish a safer alternative design in order to show that Ethicon is strictly liable for alleged design defects in a product that addresses female pelvic prolapse.

While Texas Civil Practice & Remedies Code § 82.055 states that a safer alternative design does not apply to drugs and devices as defined in the federal Food, Drug and Cosmetic Act, Goodwin said he must ignore that part of the statute because the code also states that it does not change the common law.

The Texas Supreme Court has held in Caterpillar, Inc. v. Shears (1995) and other cases that, under the common law, plaintiffs must establish the existence of a safer alternative design, Goodwin said. The plaintiffs had argued they do not need to prove the existence of an alternative design.

In a separate opinion, Goodwin rejected the plaintiffs’ request to reconsider four of his rulings. Three were Daubert rulings on expert testimony and evidence and one was his summary judgment rejecting the plaintiffs’ failure-to-warn claim.

The plaintiffs argued that they still should be able to use their expert evidence of allegedly inadequate warnings to prove their design-defect claim. The plaintiff’s counsel pointed to the fourth and fifth risk-utility factors that can be used to prove a design-defect claim: “(4) the user’s anticipated awareness of the dangers inherent in the product and their avoidability because of general public knowledge of the obvious condition of the product, or of the existence of suitable warnings or instructions; and (5) the expectations of the ordinary consumer.” Goodwin rejected the plaintiff’s argument that the user includes a consumer and favored Ethicon’s argument that the user is a health-care professional.

“The plaintiff may not circumvent the learned intermediary rule by introducing evidence or argument that suggests or otherwise implies that Ethicon had a duty to warn,” Goodwin said.

Two of the opinions of plaintiffs’ expert, Dr. Uwe Klinge, were excluded. That included his analysis of “explanted” mesh samples. The judge said he had no way to judge if Klinge’s 485-sample size is representative or how those samples were chosen. Thus, Goodwin said, he had no way to judge the potential rate of error in Klinge’s observations. Goodwin also excluded Klinge’s opinion regarding secondary infections from vaginal mesh. That opinion is limited to cases where the mesh has remained in a woman’s body, Goodwin said, while this plaintiff did not suffer a secondary infection from mesh that only partially explanted from her body.

A trial in New Jersey involving Ethicon’s Prolift mesh resulted in a $11 million plaintiffs verdict, and a bellwether trial involving American Medical Systems resulted in a $2 million plaintiffs verdict, according to a report on