Judge Orders New Bellwether Case Selections for Boston Scientific Transvaginal Mesh Trial
Cases chosen for bellwether trials from both sides engaged in the Boston Scientific MDL were deemed unacceptable by the judge presiding over the federal litigation and were recently ordered to make new selections.
U.S. District Judge Joseph R. Goodwin, who is presiding over Boston Scientific vaginal mesh MDL 2326, in the U.S. District Court for the Southern District of West Virginia issued a pre-trial order on August 7, as he was dissatisfied with the initial selection of cases for potential bellwether trials. Consequently, he issued the order for both sides to submit new lists by August 12, at noon.
The bellwether trials are intended to be representative of the majority of the nearly 5,500 cases filed under the MDL and Judge Goodwin felt the Boston Scientific vaginal mesh lawsuit selections did not serve this purpose. He criticized that the original cases selected did not represent the group as a whole based on age and other factors that caused these designated cases to be more unique. Plaintiff attorneys chose cases of women who received many different transvaginal mesh products, while the defendants’ choices were subject to potential statute of limitations issues.
Judge issues bellwether case selection guidelines
To ensure both sides selected appropriate cases to try during the transvaginal mesh trial, Judge Goodwin created a set of guidelines for them to follow, citing what will be regarded as a representative case. Both the plaintiffs and defendants are permitted to select a maximum of eight cases from women who received implants of the following Boston Scientific products — Obtryx, Advantage/Fit, Pinnacle, and Uphold.
Representative plaintiffs who filed a Boston Scientific vaginal mesh lawsuit are required to have been between 40-60 years of age when the product was implanted. Complications with the vaginal mesh product must have been resolved with a maximum of three revision surgeries. Judge Goodwin also requires that selected cases not be held to a statute of limitations, comorbidities, or any other conditions causing the plaintiffs chosen for bellwether trials to not be representative of the majority of cases in the MDL.
Upon receipt of the modified vaginal mesh lawsuit selections, Judge Goodwin is expected to choose six bellwether cases that will be suitable for three rounds of trials. Start dates are scheduled for February 11, June 17, and September 9, 2014.
Boston Scientific vaginal mesh lawsuit allegations
Plaintiffs that filed a Boston Scientific vaginal mesh lawsuit originally had the device implanted to treat pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), but claim they suffered complications when the surgical mesh eroded through the vagina, causing them to contract infections and other severe health problems.
In July 2011, the FDA issued a warning on vaginal mesh products, revealing that thousands of patients had reported problems with the implants. The warning suggested that using vaginal mesh to repair POP may not be the best treatment alternative, as previously believed.
Following the warning, in early 2012, the FDA sent a letter to several manufacturers of vaginal mesh products requiring them to run additional tests to ensure the implants were safe for patients and to determine if they do indeed pose a high risk of injury to women.