Anne Bucher ย |ย  August 29, 2024

Category: Legal News
Close up of FDA signage, representing the prolapse mesh trial.
(Photo Credit: rafapress/Shutterstock)

Prolapse mesh lawsuit overview:

  • Who: A trial has begun over claims prolapse mesh was implanted in a woman after the U.S. Food and Drug Administration ordered the manufacturer to stop selling it.
  • Why: The mesh allegedly caused the plaintiff to suffer debilitating injuries the FDA warned about.
  • Where: The prolapse mesh trial is taking place in Oregon.

A trial has begun over claims against an Oregon hospital and surgeon for allegedly implanting prolapse mesh nearly two weeks after the U.S. Food and Drug Administration ordered the manufacturer to immediately stop selling the product, Law360 reports.

Plaintiff Tamarie Richards allegedly underwent surgery to improve her pelvic organ prolapse on April 29, 2019. The procedure involved Uphold LITE transvaginal mesh manufactured by Boston Scientific.

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

On April 16, 2019, the FDA reportedly issued a public bulletin ordering Boston Scientific to immediately stop selling and distributing the Uphold LITE transvaginal mesh product.

Prolapse mesh lawsuit alleges Legacy staff failed to pull remaining stock

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

Richards allegedly โ€œsuffered catastrophic injuries โ€ฆ the very injuries that the [FDA] warned the medical community about 13 days before,โ€ one of Richardsโ€™ attorneys said during the prolapse mesh trial. โ€œThe standard of care for a hospital and a doctor in Oregon is that once they got that alert and that alert told them this device is dangerous โ€ฆ and that it shouldnโ€™t be used in women anymore, they should have pulled it off the shelves and not used it.โ€

Richardsโ€™ lawyer told the jury she developed a debilitating pain condition due to the changes the prolapse mash caused near her pudendal nerve. She underwent a follow up surgery to remove the mesh but it was only partially successful, the lawyer said.

The prolapse mesh lawsuit alleged Lemmers knew of the April 16 FDA alert but used the mesh anyway.ย 

Less than an hour before Richardsโ€™ surgery, Legacyโ€™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 the people involved in Richardsโ€™ surgery in time, her attorneys said.

Legacy staff allegedly emailed Lemmers about the prolapse mesh recall multiple times between April 16 and April 29, but Lemmersโ€™s attorney says he never saw those emails because they were sent to an account he does not use.

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

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

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

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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