Many legal specialists in the US and the UK will be watching with interest as the first pelvic mesh trial against Ethicon, a division of Johnson & Johnson, starts in a US court this week. Bloomberg News reports that the first trial will involve a lawsuit filed by Linda Gross who needed multiple surgeries to try to remedy complications she claims were caused by the ‘Prolift’ pelvic mesh implant produced by Ethicon Gynecare . The South Dakota woman says she has been left in constant pain after the surgery in July 2006 and is unable to return to her nursing job. The company denies Gross’s claims which involve failure to warn of the risks, defective design and negligence.
Lawyers will be paying close attention to this case, as it is classed as a ‘bellwether’ trial – it may determine how juries will respond to future cases in consolidated or Multi-District Litigation (MDL) which involve common legal issues, similar evidence and allegations. There are around 1,800 Ethicon transvaginal mesh lawsuits pending in a consolidated litigation in New Jersey Superior Court, Atlantic County Division. If the Gross trial is successful and results in a settlement from Johnson & Johnson, the company may decide to attempt to negotiate a settlement in these subsequent cases. However, if the jury decides J&J adequately warned doctors and patients of the risks of the device, the company could decide to proceed with these cases until a jury verdict is reached.
Jury selection takes place on 9th January 2013, followed by opening statements on 10th January 2013 and witness testimony on 14th January 2013. The trial is predicted to last more than a month.
Was Prolift Pelvic Mesh sold without being FDA cleared?
Ethicon put the Prolift pelvic mesh product on the market in 2005 without filing a new application under the FDA’s 510(k) clearance process, which requires companies to show that a medical device is “substantially similar” to others on the market. According to an email, J&J determined that it was substantially similar to the Gynecare Gynemesh, one of the company’s devices already approved by the FDA. The FDA did not agree with the company’s interpretation and required a new application in August 2007, saying Prolift sales began without appropriate clearance. But J&J has said it began sales under the FDA guidance, “Deciding When to Submit a 510(k) for a Change to an Existing Device”. The company faced no sanctions because the FDA decided that J&J applied the guidance in good faith and promptly complied when the FDA required a new application. The device was subsequently cleared by the FDA in May 2008.
FDA Public Health Notifications re Pelvic mesh Risks and Complications
Then, in October 2008 the FDA published a Public Health Notification which described serious but rare complications from pelvic mesh.
In July 2011, following further studies and a growing number of women reporting complications from pelvic mesh, the FDA issued a Safety Communication notifying the public and health professionals that injuries experienced with the use of pelvic mesh for pelvic organ prolapse were ‘not rare’.
FDA Order Post Marketing Surveillance
In January 2012, following continued concerns about the safety of pelvic mesh implants, the FDA mandated postmarket surveillance studies by manufacturers of urogynaecologic surgical mesh devices. The FDA issued 88 postmarket study orders to 33 manufacturers of urogynaecologic surgical mesh for Pelvic Organ Prolapse; and 11 postmarket study orders to seven manufacturers of single-incision mini-slings for Stress Urinary Incontinence.
The manufacturers were required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for POP and single-incision mini-sling devices for SUI. Data from the studies were intended to enable the agency to better understand the safety and effectiveness of these devices.
J&J announced it will stop Sales of Prolift and other Pelvic Mesh Products
Following this, in June 2012 J&J announced that it would be ceasing sales worldwide of four transvaginal mesh products but this would take between three and nine months. The Ethicon products, which were used to treat pelvic organ prolapse and stress urinary incontinence in women, were: Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift, and Gynecare Prolift+M mesh products, . This followed shortly after a report in May 2012 that hundreds of transvaginal mesh lawsuits had been filed against the company, but a J&J spokesman asserted in the “Wall Street Journal” at the time that it was not a product recall and that withdrawal of the products from the market was not related to safety issues but because of “changing market dynamics.”
In letters to the judges presiding over the MDL in West Virginia and the judge presiding over the litigation in New Jersey, Ethicon confirmed that is was halting sales of the four mesh products and that it had asked the FDA to place the existing orders requiring post-marketing studies for these products on hold.
Pelvic Mesh Lawsuits
A growing number of women have filed lawsuits in US state and federal courts alleging they experienced painful and debilitating injuries following implantation of vaginal mesh to treat pelvic organ prolapse and stress urinary incontinence. Complications include mesh erosion into the vagina and organs, pelvic and nerve pain, infection, mesh shrinkage, urinary problems, a return of incontinence and prolapse, and in some cases death.
As well as the Ethicon lawsuits, hundreds of transvaginal mesh claims filed against CR Bard Inc are pending in a second consolidated proceeding underway in Atlantic County Superior Court.
Consolidated litigations involving several manufacturers of pelvic mesh devices have also been established in US District Court, Southern District of West Virginia. The manufacturers include American Medical Systems, Boston Scientific Corp, CR Bard, and Ethicon. This trial is expected to be heard later in the year.
Bloomberg News: J&J Faces First Vaginal Mesh Implant Trial in New Jersey http://www.businessweek.com/news/2013-01-07/j-and-j-faces-first-vaginal-mesh-implant-trial-in-new-jersey
New Jersey News: Johnson & Johnson trial to start in Atlantic City over pelvic mesh implants http://www.nj.com/business/index.ssf/2013/01/johnson_johnson_trial_to_start.html