January 8, 2013 ~ Jurors are being selected today for the first of 1,974 lawsuits to be heard in a New Jersey state court against Johnson & Johnson, maker of the Gynecare Prolift Pelvic Floor Repair System (here) transvaginal mesh.
Plaintiff Linda Gross from Watertown, South Dakota and her lawyers argue that Ethicon, a division of Johnson & Johnson (J&J) which makes the Prolift, failed to warn consumers about the risks behind the polypropylene mesh implanted in her to treat prolapse in 2006.
She is unable to work as a nurse and suffers severe chronic pain, cannot sit for any time, suffered mesh erosion, inflammation and infection. She has undergone numerous surgeries which have been unsuccessful in returning her health.
New Jersey is the home state of J & J. The trial is predicted to last at least two months.
Gynecare Prolift, West Coast Medical Resources
This action differs from the Multidistrict Litigation (MDL) consolidated in the Southern District of West Virginia which will be heard at the end of the year.
The outcome of the Gross trial could result in an early victory for the thousands of plaintiff cases yet to be heard if it results in a settlement from J&J. On the other hand, if the jury decides J&J did provide adequate warning to doctors and patients, the company could decide to stand firm and face many more plaintiffs.
Besides Johnson & Johnson, the other major mesh makers include American Medical Systems, Boston Scientific, C. R. Bard, and Covidien.
Prolift Eased Off the Market
Last June, J & J announced it would stop selling four of the mesh implants including the Gynecare Prolift. See background story here. More than 600 women has sued J&J claiming the products caused complications including mesh erosion, pain, nerve damage, autoimmune disorders and infection.
J&J still sells the Gynecare Gynemesh line with a new label and restrictions.
The Prolift is the same mesh that J&J decided to sell in 2005 bypassing any FDA approval or notification. By the time it went to the FDA to seek approval to sell the next generation Prolift M, the agency discovered the lapse, however, Prolift received FDA approval with no sanctions in May 2008.
The FDA at the time said J&J acted in good faith and promptly filled out a new application for approval. The fact that the device was sold bypassing any FDA notification or clearance is expected to be an issue at trial.
J & J’s attorney told the judge “We continually hear that we marketed the device without clearance…That’s not true. We marketed it under the guidance,” Bloomberg reports quoting the J&J attorney.
Judge Carol Higbee has barred the plaintiff attorneys from using words such as “illegal,” “fraud,” or any inflammatory language when making an opening statement.
Alex Gorsky, CEO J & J
J &J’s CEO Alex Gorsky could be called to the stand to answer questions.
MDND will monitor the proceedings via a courtroom feed provided to the media through the pool camera provided by Courtroom View Network which sells access to subscribers (here).
The case is Gross v. Gynecare Inc. Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City). Case No. 291 in state court.
Complaint long form