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Drug & Device News

By ALM Staff | Law Journal Newsletters |
April 02, 2014

Bellwether Trial Opening in Vaginal Mesh MDL

In the first bellwether trial in the multidistrict litigation over the Ethicon vaginal mesh pelvic repair system, U.S. District Judge Joseph R. Goodwin of the Southern District of West Virginia reversed himself, ruling 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.

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