CVN screenshot of plaintiff attorney Caio Formenti delivering his opening statement
Portland, OR - An Oregon state court jury heard opening statements Tuesday in a medical malpractice lawsuit accusing a urologist and hospital of responsibility for implanting a pelvic mesh device in a woman despite the FDA advising against it, and the full trial is being webcast gavel-to-gavel by Courtroom View Network.
Plaintiff Tamarie Richards claims the use of Boston Scientific’s “Uphold Lite” transvaginal mesh to treat her pelvic organ prolapse in 2019 left her with “catastrophic injuries” and required additional surgery to try to remove the device. She alleges that while her surgeon and the hospital where the procedure took place supposedly received notice that morning to halt its use that she never provided fully informed consent for the operation.
Boston Scientific is no longer an active defendant in the case, but the remaining defendants, Dr. Michael Lemmers and Legacy Health, both maintain the Uphold mesh was never subject to a formal recall order, that Dr. Lemmers had extensive discussions with Richards about the risks associated with her surgery, and that her current symptoms can be attributed to earlier surgeries which also included the implantation of a mesh device from another manufacturer.
Plaintiff attorney Caio Formenti of the Ben Martin Law Group told jurors during his opening statement that the FDA gave increased scrutiny to mesh devices made from polypropylene for nearly a decade before Richards’ surgery amidst increasing reports the devices could contract after implantation and cause adverse reactions in the surrounding tissue. With regards to the Uphold Lite device, he said this culminated with an April 16, 2019 manufacturers notice issued by the FDA - the same day as Richards' surgery.
Formenti argued while Dr. Lemmers discussed this development with Richards that morning, while noting the device had not been formally subject to a recall, that she did not have a meaningful opportunity to provide informed consent without supposedly knowing the full scope of the FDA’s manufacturer notice.
“The standard of care for a doctor and a hospital in Oregon is that once they got an alert, and that alert told them this device is dangerous, its benefits do not outweigh its risks, that the FDA was taking this action to protect womens health, and that this shouldn’t be used in women anymore - they should have pulled 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 a condition known as pudendal neuralgia, which Formenti said causes permanent, stabbing pain in a patient’s saddle region. Despite a subsequent surgery with a specialist in mesh removal, he said part of the device will remain inside Richards for the rest of her life.
“Ms. Richards’ problems are never going to go away,” he said, without disclosing the amount of damages his team will eventually seek. “They’re permanent, which is exactly what the FDA warned doctors and hospitals could happen if they implanted the Uphold Lite.”
Representing Dr. Lemmers, defense attorney Karen O’Kasey of Hart Wagner LLP repeatedly stressed that the notice from the FDA at issue in the trial went to Boston Scientific, not doctors and hospitals, and that Lemmers never received a so-called “Dear Doctor” letter related to use of the Uphold Lite.
She confirmed the device was not subject to a recall at the time of Richards’ surgery, and that while engaging in allegedly extensive discussions with Richards about her various treatment options that Dr. Lemmers noted he had used the device since 2002 “with no problems in his clinical experience.”
O’Kasey relied on Richards’ own deposition testimony to refute the allegation that she never provided informed consent for the procedure. O’Kasey maintained that both in pre-surgical consultations and the morning of the proceduer that Dr. Lemmers explained to Richards every available treatment alternative along with the potential risks.
“She elects to proceed as planned,” O’Kasey emphasized.
She also detailed how Richards was previously implanted with a TVT-O mesh device, manufactured by Johnson & Johnson subsidiary Ethicon. The TVT-O device has also been the subject of mesh injury litigation (including in previous trials similarly filmed by CVN), and like Boston Scientific, Ethicon was originally named a defendant in Richards’ lawsuit but was dropped from the case by the time it went to trial.
Defense attorney Peter Eidenberg of Keating Jones Hughes PC, representing Legacy Health, expressed regret that the hospital’s in-house systems for monitoring FDA notices did not prevent the use of the Uphold Lite, but he stressed that treatment decision ultimately rested with Dr. Lemmers and that the FDA notice went to Boston Scientific, not to doctors and hospitals.
The trial is expected to conclude sometime next week, and CVN’s gavel-to-gavel coverage, including all expert witness testimony, will continue for the duration of the proceedings.
The case is captioned Tamarie Richards v. Legacy Health, et al. case number 21CV15859 in Multnomah County Circuit Court.
E-mail David Siegel at dsiegel@cvn.com
