As jury deliberations continue in Gross v. Gynecare Inc., one of the first vaginal mesh lawsuits to reach trial, the question remains: how could Johnson & Johnson accept a 27 percent failure rate in its Prolift implant?
In 2006, Linda Gross underwent surgery to correct pelvic organ prolapse (POP). The doctor used a Johnson & Johnson product, Gynecare Prolift, implanting the device into her pelvic wall through incisions in her vagina. The goal was to alleviate the POP symptoms Mrs. Gross was experiencing and allow her to return to her normal activities. The device was introduced by Johnson & Johnson in 2005 and according to Bloomberg News was touted as an “‘innovative and effective surgical option’ for weakened pelvic muscles.” However, the device was not FDA-approved at the time it was introduced or when it was implanted in Mrs. Gross. In fact, the device did not receive FDA approval until May 2008.
The first witness in the Gross v. Gynecare Inc. trial was a Johnson & Johnson official who testified last month that the company had identified and accepted a failure rate of 27 percent in the first year, six months before the product was first sold in 2005. While Johnson & Johnson continued to market the product, Mrs. Gross found herself joining the countless number of women who would experience the painful and debilitating side effects of Prolift failure. To date, Mrs. Gross has undergone 18 surgeries to correct the complications associated with the Prolift implant and is currently taking more than 20 pills a day to deal with chronic pain and other complications.
Mrs. Gross and her attorneys contend that Johnson & Johnson developed and marketed a defectively designed product; failed to warn Mrs. Gross of the potential side effects; and fraudulently misrepresented the safety and effectiveness of their product. Attorneys for Johnson & Johnson allege that Mrs. Gross was adequately warned about the possible complications from the surgery and she assumed the risks associated with the Prolift implant. While the jury will ultimately decide if Johnson & Johnson is legally responsible for the pain and trauma Mrs. Gross has suffered, it is hard to imagine that anyone would accept the risk of multiple corrective surgeries and a daily medication regime to treat a condition that was inconvenient and frustrating, but not debilitating.
For women across the country who are suffering from pelvic mesh failure and other complications, the verdict in the Gross v. Gynecare Inc. case will be extremely important. The first case often provides insight into how the other pending cases may be resolved. It is my sincere hope that Mrs. Gross prevails and sends the message that a 27 percent failure rate cannot be accepted in medical devices.
It is also important to note that Johnson & Johnson is no longer selling the Prolift mesh in the U.S. and it plans to end sales of Prolift and its other pelvic mesh products on a worldwide basis. In June 2012, the company claimed the decision was not a recall but was based on the commercial viability of the product. I imagine that commercial viability was certainly a concern with thousands of lawsuits filed against Johnson & Johnson relating to the failure of their pelvic mesh products.
Author Bio: H. Lee Thompson is the founder of The Thompson Law Firm. Mr. Thompson, with over 30 years of experience, is dedicated to protecting the rights of clients in cases involving personal injury, medical malpractice, and wrongful death. For more information, please visit http://www.thethompsonlawfirm.com/.