The scales of justice are set to weigh the case brought by Linda Gross of Watertown, S.D., against Johnson & Johnson (J&J) and its Ethicon division for alleged injuries she suffered after being implanted with the company’s Gynecare Prolift vaginal mesh device in 2006. According to a report that appeared on Bloomberg.com on January 7, 2013, jury selection has begun, and opening arguments are to commence on January 10.
Gynecare Prolift Never Received Proper FDA Approval
One of the most crucial elements of this trial will be the relevance of how the Gynecare Prolift device was introduced to the market in March 2005. J&J did not file the necessary applications to receive 510(k) premarket approval for the device from the U.S. Food and Drug Administration (FDA). Receiving 510(k) approval for a medical device means that it is “substantially equivalent” to another device already for sale. J&J claims that the Gynecare Prolift device that was implanted in Ms. Gross was similar to its Gynecare Gynemesh device that had previously received FDA approval. Instead of applying for approval through the 510(k) process, J&J determined on its own that the Prolift device did not require FDA clearance. The FDA disagreed with the company’s actions and required it to submit a new application in August 2007. Gynecare Prolift was not officially approved for use until May 2009. Superior Court Judge Carol E. Higbee, who is presiding over all the Gyncare cases that are part of a multicounty litigation (MCL) in the New Jersey Superior Court in Atlantic City, has been contemplating whether this information should be shared with the jury by Ms. Gross’s attorneys.
In the time leading up to the trial, Ms. Gross has undergone 18 subsequent surgeries after initially receiving the device to correct symptoms of pelvic organ prolapse (POP). According to court papers, “She can no longer sit comfortably for more than a few minutes without having to either stand up or lay down to try to reduce the level of pain. She [also] requires various daily medications to treat her severe chronic pain.”
J&J plans to argue that it acted “appropriately and responsibly” when researching, developing, and marketing the Prolift device. Ms. Gross’s attorneys will state that the injuries she suffered have prevented her from returning to work as a nurse, and have ruined her quality of life.
The Rottenstein Law Group Can Help Women Injured by Vaginal Mesh
If you or someone you know has had surgery for pelvic organ prolapse or another type of pelvic surgery that involved the implantation of surgical mesh manufactured by Ethicon or another company and is experiencing symptoms consistent with malfunction, seek medical attention immediately. The next step is to contact an experienced attorney to see whether you or the person you know has grounds to file a lawsuit against the manufacturer.
The attorneys at the Rottenstein Law Group have over 25 years of collective experience advocating for victims of dangerous drugs and defective medical devices, as well as other products liability claims. RLG is offering free, confidential legal consultations, and all you need to do is fill out out this confidential contact form or call 1-800-624-9567 and one of our vaginal mesh attorneys will call you as soon as possible.
For more information download RLG’s free transvaginal mesh brochure.