Jury in Oregon learns of new developments in pelvic mesh malpractice trial

CVN screenshot of plaintiff's attorney Caio Formenti during his opening statement

Portland, Ore. – An Oregon jury heard opening arguments Tuesday in a medical malpractice trial accusing a urologist and a hospital of being responsible for implanting pelvic mesh in a woman despite FDA advice against it. The entire trial will be broadcast online from start to finish by the Courtroom View Network.

Plaintiff Tamarie Richards alleges that the use of Boston Scientific's Uphold Lite transvaginal mesh to treat her pelvic organ prolapse in 2019 caused her “catastrophic injuries” and required further surgery to remove the device. She claims that while her surgeon and the hospital where the procedure took place were allegedly instructed to stop its use that morning, she never gave her fully informed consent to the surgery.

Boston Scientific is no longer a defendant in the case, but the remaining defendants, Dr. Michael Lemmers and Legacy Health, both claim that there was never a formal recall order for the Uphold mesh, that Dr. Lemmers had extensive discussions with Richards about the risks associated with her surgery, and that her current symptoms were due to previous surgeries in which she also had mesh implanted by a different manufacturer.

Plaintiff's attorney, Caio Formenti of the Ben Martin Law Group, told jurors in his opening statement that the FDA had been increasing its scrutiny of polypropylene mesh implants nearly a decade before Richards' surgery, as there were increasing reports that the implants could contract after implantation and cause adverse reactions in surrounding tissue. Regarding the Uphold Lite device, he said this culminated with a manufacturer's notice from the FDA on April 16, 2019 – the same day as Richards' surgery.

As Dr. Lemmers discussed this development with Richards that morning, Formenti argued that the device had not been formally subject to a recall and that she had not had a meaningful opportunity to provide informed consent without allegedly knowing the full extent of the manufacturer's notice to FDA.

“The duty of care owed by a doctor and a hospital in Oregon is that, after they received a warning and were advised in that warning that this device was dangerous, its benefits did not outweigh the risks, that the FDA took this action to protect women's health and that it should no longer be used on women – they should have taken it off the shelves and not used it,” Formenti told the jury, according to CVN's webcast of the proceedings.

After the surgery, Richards developed what's known as pudendal neuralgia, which Formenti said causes constant, sharp pain in the patient's saddle region. Despite subsequent surgery with a specialist to remove the mesh, Formenti said part of the device will remain in Richards for the rest of her life.

“Ms. Richards' problems will never go away,” he said, without disclosing the amount of damages his team will ultimately seek. “They are permanent, and that is exactly what could happen if doctors and hospitals implant Uphold Lite, as the FDA has warned.”

Defense attorney Karen O'Kasey of Hart Wagner LLP, who represented Dr. Lemmers, repeatedly emphasized that the FDA notice at issue in the case was sent to Boston Scientific, not to doctors and hospitals, and that Lemmers never received a so-called “Dear Doctor” letter related to the use of Uphold Lite.

She confirmed that the device was not subject to a recall at the time of Richards' surgery and that during allegedly extensive discussions with Richards about her various treatment options, Dr. Lemmers noted that he had been using the device since 2002 “without any problems in his clinical experience.”

O'Kasey relied on Richards' own testimony to refute the claim that she never consented to the procedure. O'Kasey claimed that Dr. Lemmers explained to Richards all available treatment alternatives and the potential risks both in the pre-operative consultations and on the morning of the procedure.

“She has chosen to proceed as planned,” O'Kasey stressed.

She also explained that Richards had previously been implanted with a TVT-O mesh implant, manufactured by Johnson & Johnson subsidiary Ethicon. The TVT-O device was also the subject of a lawsuit over mesh injuries (including previous trials also filmed by CVN)and like Boston Scientific, Ethicon was originally named as a defendant in Richards' lawsuit but was excluded from the case pending trial.

Defense attorney Peter Eidenberg of Keating Jones Hughes PC, representing Legacy Health, expressed regret that the hospital's internal systems for monitoring FDA notifications did not prevent the use of Uphold Lite, but stressed that the treatment decision ultimately rested with Dr. Lemmers and that the FDA notification went to Boston Scientific, not to doctors and hospitals.

The trial is expected to conclude sometime next week, and CVN's full coverage, including all expert witness testimony, will continue throughout the trial.

The case is titled Tamarie Richards v. Legacy Health et al. Case number 21CV15859 in Multnomah County District Court.

Email David Siegel at [email protected]