No Failure to Warn of Transvaginal Mesh Danger, 4th Circuit Rules

By William Vogeler, Esq. on May 12, 2017 | Last updated on March 21, 2019

A federal appeals court affirmed a summary judgment against a woman who sued a manufacturer for failure to warn about the dangers of a transvaginal mesh implant.

The U.S. Fourth Circuit Court of Appeals said Martha Carlson provided no evidence that she or her doctor knew of the manufacturer's allegedly inadequate warning about the mesh. In Carlson v. Boston Scientific Corporation, the court said she did not even prove the doctor would have read it.

"Appellant woefully failed to meet her burden of production in opposition to summary judgment to establish a triable issue of fact as to proximate cause," the court said.

Transvaginal Mesh

Carlson received the surgical implant because she suffered from pelvic organ prolapse, which occurs when a pelvic organ drops into the lower belly and pushes against the vagina. The U.S. Food and Drug Administration is investigating complaints about the mesh.

She sued because the implant allegedly injured her, and she claimed she would not have undergone the procedure if she had known of the dangers. Carlson is one of tens of thousands of women who have sued over problems with the transvaginal mesh.

Her case was joined with multi-district litigation handling such cases, but she lost a summary judgment motion because she could not show a failure to warn had caused her injuries. The court allowed her to proceed separately on other claims, which she also lost.

On appeal, Carlson asked the court to reverse the summary judgment and her motion for reconsideration based on additional evidence she presented in her separate trial. The appeals court declined.

"Zero Evidence"

The Fourth Circuit said Carlson presented "zero" evidence to support her claim that her doctor read the manufacturer's Directions for Use, which she claimed inadequately warned about the dangers of the mesh. She cited additional testimony from her doctor to show that he had, in fact, read the directions before recommending the procedure for her.

"Appellant argues that we should consider this newly submitted evidence in reviewing not just the district court's ruling on the motion for reconsideration but also the MDL court's summary judgment ruling." the panel said. "In doing so, Appellant asks us to completely disregard the Federal Rules of Civil Procedure governing summary judgment motion practice."

The court said Carlson already had the opportunity to present her evidence in opposition to the summary judgment and in her motion to reconsider.

"The responsibility to comb through the record in search of facts relevant to summary judgment falls on the parties -- not the court," the judges said.

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