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U.S District Judge Joseph R. Goodwin, who is presiding over five Multi-District Litigations (MDLs) established for lawsuits over vaginal mesh, has laid out the process for selecting the first cases that will go to trial in the federal court system.
Several thousand women have filed a product liability lawsuit after experiencing severe and debilitating complications from vaginal mesh used for surgical repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).
The U.S. Judicial Panel on Multidistrict Litigation (JPML) has established separate consolidated proceedings in the federal court system for complaints filed against different manufacturers of the vaginal mesh, including lawsuits against C.R. Bard, American Medical Systems (AMS), Boston Scientific, Ethicon and Coloplast.
All five of the vaginal mesh MDLs have been centralized before Judge Goodwin in the U.S. District Court for the Southern District of West Virginia, as they all involve similar allegations that design defects caused women to experience infections, erosion of the mesh through the vagina and other complications from the surgical mesh.
According to the latest updated (PDF) provided by the U.S. JPML on January 14, Judge Goodwin is currently presiding over 1,669 Bard Avaulta lawsuits; 2,807 AMS vaginal mesh lawsuits; 1,647 Boston Scientific pelvic mesh lawsuits; 2,985 Ethicon Gynecare mesh lawsuits and about 100 Coloplast bladder sling lawsuits.
Vaginal Mesh Bellwether Trial Cases
As part of the consolidated pre-trial proceedings, Judge Goodwin has indicated that a small group of cases will be prepared for early trial dates, known as bellwether vaginal mesh cases, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.
The outcomes of these trials are designed to facilitate additional vaginal mesh settlement agreements, which may help resolve the litigation without scheduling individual trial dates in each of the 7,500 lawsuits pending in the federal court system.
The Bard Avaulta MDL was established several years before the other consolidated litigations, and a group of bellwether cases have already gone through most of the steps to prepare for a first trial date, which is expected to be held over the next few months.
Late last year, Judge Goodwin indicated that an additional series of three vaginal mesh bellwether trials will be scheduled starting in December 2013, involving one case brought on behalf of women who have experienced problems with vaginal mesh manufactured by AMS, Ethicon and Boston Scientific.
According to pretrial orders issued by on January 18, Judge Goodwin has outlined the process that will govern the early trial selection process for lawsuits filed against American Medical Systems (AMS) (PDF), Boston Scientific (PDF), and Ethicon (PDF)
The vaginal mesh cases eligible for the first trial dates will be limited to complaints filed before January 1, 2013. In the case of Boston Scientific and Ethicon, a subsidiary of Johnson & Johnson, the initial pool of vaginal mesh lawsuits to be considered for early trial dates will consist of 80 cases each, with plaintiffs’ attorneys and defendants choosing 40 cases each to make up the pool. The AMS pool of early test cases will consist of only 30 cases total, with each side selecting 15.
The AMS pool of cases must be selected by February 25, the Ethicon pool must be submitted by March 1, and the Boston Scientific pool by March 15. As the spring progresses, those pools of cases will be whittled down further until the court selects just five bellwether test cases for each, with the first trial date expected to begin in December 2013.
State Court Vaginal Mesh Litigation
In addition to lawsuits pending in the federal court system, the manufacturers of vaginal mesh also face a number of lawsuits pending in various state courts throughout the country.
The first lawsuit to reach a jury was held in California state court, concluding in July 2012 with a $5.5 million verdict for a women who experienced problems with Bard Avaulta mesh.
In the New Jersey state court system, centralized proceedings have been established for lawsuits against Johnson & Johnson’s Ethicon subsidiary, as well as C.R. Bard. As of mid-February 2013, there were at least 377 Bard Avaulta lawsuits and 2143 Ethicon mesh lawsuits consolidated as part of a Multi-County Litigation (MCL) in Atlantic County.
A jury in New Jersey is currently deliberating in the first bellwether vaginal mesh trial held in the state court system, involving an Ethicon Gynecare Prolift mesh lawsuit filed by Linda Gross, who required 18 surgeries due to problems with vaginal mesh. Gross claims that she could have avoided the pain and suffering if the manufacturer had provided adequate warnings for her or her doctor about the risks associated with use of transvaginal mesh.
In July 2011, the FDA issued a warning after receiving at least 2,874 reports of problems with vaginal mesh products between January 2008 and December 2010. After a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse.
In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, and establish whether they pose an unreasonable risk of injury for women.
Rather than following through with the safety studies, which many lawsuits allege should have been done before the products were ever introduced, many of the manufacturers have decided to stop selling the pelvic mesh products for transvaginal repair or pelvic organ prolapse and stress urinary incontinence.