Trial begins in legal dispute over prolapse mesh implantation following FDA ban

Overview of the prolapse mesh lawsuit:

• WHO: A trial has begun over allegations that a woman had a prolapse mesh implanted after the U.S. Food and Drug Administration (FDA) ordered the manufacturer to stop selling the mesh.
• Why: The net allegedly caused the plaintiff serious injuries that the FDA had warned about.
• Where: The prolapse mesh trial is taking place in Oregon.

A lawsuit has begun against a hospital and a surgeon in the US state of Oregon. The accusation: they implanted a prolapse mesh. Almost two weeks after the US Food and Drug Administration (FDA) ordered the manufacturer to immediately stop selling the product, reports Law360.

Plaintiff Tamarie Richards is said to have undergone surgery to treat her pelvic organ prolapse on April 29, 2019. The procedure involved the use of Boston Scientific’s transvaginal Uphold LITE mesh.

She filed the prolapse mesh lawsuit against Legacy Health and urologist Michael Lemmers.

On April 16, 2019, the FDA reportedly issued a public bulletin requiring Boston Scientific to immediately stop the sale and distribution of the Uphold LITE transvaginal mesh product.

Prolapse Network lawsuit claims Legacy employees failed to pick up remaining inventory

During the prolapse mesh trial, the jury was reportedly told that 11 hospital employees discussed the FDA warning but failed to retrieve their remaining supplies of Uphold LITE.

Richards allegedly suffered “catastrophic injuries… exactly the injuries that the [FDA] “warned the medical community about 13 days in advance,” one of Richards' attorneys said during the prolapse mesh trial. “The standard of care for a hospital and a doctor in Oregon is that after they received that warning, and that warning told them that this device was dangerous … and that it should no longer be used in women, they should have taken it off the shelves and not used it.”

Richards' attorney told the jury that she developed a debilitating pain condition due to changes the prolapsed mesh caused near her pudendal nerve. She underwent follow-up surgery to remove the mesh, but it was only partially successful, the attorney said.

The prolapse mesh lawsuit alleges that Lemmers knew about the FDA warning on April 16 but used the mesh anyway.

Less than an hour before Richards' surgery, Legacy's alert system was reportedly notified that the FDA and Boston Scientific were recalling the Uphold LITE mesh. However, news of the prolapse mesh recall did not reach those involved in Richards' surgery in time, her lawyers said.

Legacy employees allegedly sent Lemmers several emails between April 16 and April 29 about the Prolapse Net recall, but Lemmers' attorney says he never saw those emails because they were sent to an account he doesn't use.

Lemmers said he contacted his Boston Scientific sales representative before performing the surgery on Richards and was told there would be no recall, his attorney told the jury.

Do you think the plaintiff should prevail in the prolapse mesh lawsuit? Let us know in the comments.

Richards is represented by Ben Martin, Narmada Sapkota and Caio Formenti of the Ben Martin Law Group.

The Prolapse mesh lawsuit Is Richards v. Legacy Health et al.Case No. 21CV15859, in the 4th Judicial District of Oregon.

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