Tamarie Richards vs. Legacy Health et al

Case Background

On April 23, 2021, Plaintiff Tamarie Richards filed a Product liability lawsuit in the Oregon State, Circuit Court of Multnomah County (Case number: 21CV15859). Judges Judith H. Matarazzo, Andrew M. Lavin, Stephen K. Bushong, Kathleen M. Dailey, Eric L. Dahlin, Christopher J. Marshall, Jenna Plank, Angela F. Lucero, Thomas M. Ryan, Jonathan W. Monson, Timothy W. Grabe, and Bronson D. James presided over the case.

Cause

The plaintiff underwent surgery on April 18, 2019, to implant two pelvic mesh products: a Boston Scientific Uphold Lite and an Ethicon TVT-O. These devices were designed to treat stress urinary incontinence and pelvic organ prolapse. The mesh contained monofilament polypropylene, known to be biologically incompatible with human tissue, often causing severe foreign body reactions. On November 7, 2019, the plaintiff sought treatment for post-implant symptoms, including urethral pain, tailbone pain, buttocks pain, incontinence, numbness, back pain, leg pain, and groin pain.

On December 20, 2019, Dr. Meredith Baker informed the plaintiff that the pelvic mesh products were causing her problems but did not recommend removal due to concerns about further nerve damage. The plaintiff was unaware of the defective nature of the products before this date. The complaint alleges that Boston Scientific and Ethicon knew of the risks associated with their pelvic mesh products but failed to adequately study these risks or warn patients and physicians. The FDA had issued warnings about serious complications with transvaginal mesh products as early as 2011.

Injuries

The plaintiff developed chronic pain in her pelvis, vagina, groin, and leg starting in November 2019 when the pelvic mesh products eroded into surrounding tissues. She suffered chronic inflammation and nerve injury, leading to permanent pain in her pelvis, vagina, groin, leg, back, tailbone, and buttocks. The mesh caused tissue contraction, erosion into adjacent structures, and dyspareunia (painful sexual intercourse). The plaintiff endured physical pain, humiliation, and psychological distress. She became sick, sore, embarrassed, anxious, and humiliated. She also experienced inconvenience, stress, and a loss of normal daily activities. Many of these complications are intractable and not surgically correctable.

Damages

The plaintiff incurred approximately $200,000 in medical expenses, including costs for doctor visits, diagnostic tests, medications, and potential surgeries to address mesh complications. She will require future medical care, with the exact amount to be determined at trial. This care may include additional surgeries, ongoing pain management, and treatment for chronic infections or inflammation. The plaintiff seeks non-economic damages not to exceed $10,000,000 for her pain, suffering, loss of enjoyment of life, and emotional distress. She is also seeking compensation for all past and future medical costs related to mesh complications, plus pre-judgment interest.

Key Arguments and Proceedings

Legal representation

  • Plaintiff(s): Tamarie Richards
    • Counsel for Plaintiff: Keith Dozier | Rachel L. Wright | Ben Martin | Laura Baughman | Rebecca Neumann | Dahlia Weber | Martin Baughman
  • Defendant(s):Boston Scientific Corporation | Ethicon, Inc. | Johnson & Johnson | Legacy Health | Legacy Silverton Health |  Michael Lemmers, MD | Silverton Specialists, LLC
    • Counsel for Defendants: Nancy M. Erfle| David W. Corneil | Jeanne F. Loftis | Chad Byrd | Cally J. Korach | Karen O’Kasey | David L. Johnson | Ashley J. Markham | Jin Yoshikawa | Kenneth Conour | Peter D. Eidenberg | Dan L. Murphy

Claims

The plaintiff has brought claims for strict liability design defect, strict liability failure to warn, and negligence against Boston Scientific and Ethicon. She alleges that the pelvic mesh products were defectively designed. According to the complaint, the products were unreasonably dangerous. They were prone to degrade, fragment, and cause chronic inflammation. The products also led to severe complications. The complaint asserts that the products lacked adequate warnings. These warnings should have included risks such as chronic pain, nerve damage, erosion, and infection. It also claims that there was no warning about the need for revisional surgeries.

The plaintiff also brought negligence claims against her surgeon, Dr. Lemmers, and the hospital, Legacy Health. These claims allege a failure to properly inform the plaintiff of risks, negligently selecting an unsafe product that had been removed from the market by the FDA, and failing to promptly remove the eroded mesh. The complaint states that Dr. Lemmers and Legacy should have been aware of safer alternatives for treating stress urinary incontinence.

Defense

Boston Scientific, Johnson & Johnson, and Ethicon responded to the pelvic mesh lawsuit with similar defenses. All three companies denied wrongdoing and liability, asserting that their products were safe and effective when used as intended. They claimed they provided adequate warnings to physicians, invoking the learned intermediary doctrine, and argued that the benefits of their devices outweighed the risks. The companies contended that the injuries might have resulted from third parties, pre-existing conditions, or the plaintiff’s actions rather than their products.

In their legal responses, the companies invoked statutes of limitations and repose, asserted federal preemption for certain claims, and maintained they had complied with FDA regulations and requirements. They argued that the plaintiff failed to mitigate damages and challenged the constitutionality of punitive damages. All three requested jury trials.

Boston Scientific, responding to Tamarie Richards’ third amended complaint, argued that no safer alternative designs existed at the time and raised contributory negligence as a defense. Johnson & Johnson claimed the injuries were not foreseeable given the state of scientific knowledge and argued that FDA approval of warnings and labeling made them presumptively adequate. They also asserted that indispensable parties had not been joined. Ethicon invoked estoppel and laches as potential bars to claims, argued that the FDA had primary jurisdiction over labeling requirements, and claimed their device conformed to state-of-the-art specifications.

Throughout their responses, all companies reserved the right to amend their answers or add defenses as the case progressed. Their collective strategy focused on denying liability, shifting responsibility, and invoking various legal doctrines to counter the plaintiff’s claims.

Jury Verdict

On August 28, 2024, the jury rendered a verdict in favor of the defendant and against the plaintiff.

Court Documents:

Available Upon Request