CVN screenshot of defense attorney Karen O’Kasey delivering her closing argument
Portland, OR - An Oregon state court jury returned a defense verdict Wednesday in favor of a urologist and hospital accused of implanting a pelvic mesh device in a woman the FDA previously warned against using, and the full trial was recorded gavel-to-gavel by Courtroom View Network.
The Multnomah County jury returned their verdict in the medical malpractice trial that began August 20. Plaintiff Tamarie Richards accused her urologist, Dr. Michael Lemmers and the Legacy Health hospital network of failing to obtain her informed consent before implanting Boston Scientific’s “Uphold Lite” mesh device to treat her pelvic organ prolapse in 2019.
Richards claimed the device, which the FDA warned to stop using prior to her surgery, left her suffering from severe chronic pain and required additional surgery to unsuccessfully remove. However attorneys for both defendants argued that Richards was fully informed of the risks associated with the procedure, and that the FDA’s warnings to mesh manufacturers did not amount to a formal recall.
The full trial, including all witness testimony, was recorded gavel-to-gavel by CVN. It is available for unlimited on-demand viewing, in addition to numerous other medical malpractice and pelvic mesh product liability trials with a subscription to CVN’s online trial video library.
Richards’ attorneys sought over $9 million in damages, maintaining that FDA warnings issued 11 days before Richards’ surgery and another just hours before should have prompted Dr. Lemmers to halt the non-emergency operation, and that the Uphold Lite should have been removed from the hospital's inventory. The device’s manufacturer, Boston Scientific, was originally named in the complaint but was no longer an active defendant when the case proceeded to trial.
Richards alleged Dr. Lemmers did not fully explain the risks associated with mesh devices made with polypropylene, a compound that can contract after contact with human tissue and leave patients with disabling pain and other side effects. Her attorneys said safer alternatives existed to treat her condition, and that her surgery should not have gone forward after Dr. Lemmers became aware of the FDA safety advisory.
Attorneys for Legacy Health and Dr. Lemmers successfully argued the hospital followed standard policy after learning of the FDA alerts, which they maintained was directed at mesh manufacturers, and that the Uphold Lite had full FDA approval when Richards’ surgery was initially scheduled.
They relied heavily on Richards’ own pre-trial deposition testimony, which they told jurors showed that she was fully informed of the device’s status and its associated risks and still provided her full consent to move forward after discussions with Dr. Lemmers in a pre-op outpatient appointment and the morning of the surgery in the hospital.
Counsel for Dr. Lemmers also argued that Richards’ post-operative problems actually stemmed from pre-existing conditions, including the prior implantation of another mesh device from a different manufacturer. Jurors heard argument that Dr. Lemmers specifically used the Uphold Lite device for nearly two decades prior to Richards’ surgery without patients suffering any adverse outcomes.
Attorney Greg Vigna of Vigna Law Group, part of Richards’ legal team, told CVN after the trial they are disappointed by the verdict, and he expressed regret that more evidence about Boston Scientific’s supposed direct communications with Dr. Lemmers and Legacy staff did not make it into evidence after the mesh manufacturer successfully squashed a subpoena.
Vigna’s co-counsel, Ben Martin of the Ben Martin Law Group, expressed similar sentiments.
“Though we are disappointed for our client who is very special to us, we respect the jury’s verdict,” he said.
Attorneys for the defendants did not respond to a request for comment from CVN.
Dr. Lemmers was represented by Karen O’Kasey of Hart Wagner LLP.
Legacy Health was represented by Peter Eidenberg of Keating Jones Hughes PC.
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