Consumer Drug Safety

J&J Pays $11.11 Million in Transvaginal Mesh Lawsuit

In February 2013, an Atlantic City jury ordered Johnson & Johnson to pay $11.11 million to Linda Gross. The jury concluded that J&J failed to adequately warn Gross and other users of the risks associated with its transvaginal mesh product. Additionally, the company was found guilty of fraudulently representing the transvaginal mesh product to consumers. Of the total awards to Gross, $3.35 million was for compensatory damages, while the remaining $7.76 million was for punitive damages.

Gross filed a lawsuit against J&J after receiving a transvaginal mesh implant to treat a case of pelvic organ prolapse. After receiving the transvaginal mesh implant, Gross sustained injuries. The implant eroded into her organ walls, causing constant severe pain. Gross noted that she was extremely uncomfortable while sitting, and experienced pain during sexual intercourse. She underwent 18 additional operations to fix the problems caused by the mesh.

J&J Misconduct

During the trial, Gross’s attorneys revealed J&J internal documents showing that the company was aware of the harm that could be caused by the transvaginal mesh implants. In his summation on February 15, 2013, Gross’s attorney Adam Slater stated: “We’ve established during this trial that this is something that never should have been sold. You had the words of the people at the company saying it shouldn’t have been sold. You saw them talking about that before it ever went on the market, that it was unreasonably dangerous.”

Johnson & Johnson has also been found guilty of engaging in deceptive marketing practices for its hip implants and transvaginal mesh products. The state of California is leading a 42-state investigation of J&J’s transvaginal mesh marketing practices. In October 2012, the attorney general of California contacted J&J regarding the mesh products. J&J is reportedly cooperating, according to Bloomberg.

Transvaginal Mesh Complications

A number of transvaginal mesh patients have reported complications after receiving transvaginal mesh for cases of pelvic organ prolapse. Pelvic organ prolapse is a condition during which the vaginal walls become weak and unable to support surrounding organs. As a result, the patient’s organs may slip out of place. In severe cases, the organs may protrude into the vaginal canal.

The U.S. Food and Drug Administration (FDA) has received thousands of adverse event reports from transvaginal mesh patients. Erosion of the mesh into the vagina and other organs can cause severe infection in patients. One surgeon reported that it may take five revision surgeries to successfully remove the mesh, as it begins to grow into the patient’s tissue after implanted.

Show Sources
  1. "FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 13 Jul 2011. Web. 19 Apr 2013.
  2. Liang, Ching-Chung, Tsia-Shu Lo, et al. "Sexual function in women following transvaginal mesh procedures for the treatment of pelvic organ prolapse." International Urogynecology Journal. 23.10 (2012): 1455-1460. Web. 6 Apr. 2013.
  3. Voreacos, David. "J&J Owes $7.76 Million in Punitives in Vaginal Mesh Case." Bloomberg. Bloomberg, 28 Feb 2013. Web. 19 Apr 2013.