A federal judge has scheduled the first bellwether trial in the multidistrict litigation (MDL) over Boston Scientific’s transvaginal mesh implants for early next year.
Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia, who is overseeing MDLs involving a number of pelvic mesh device makers, designated four cases to serve as bellwethers for the entire set of lawsuits, MassDevice reports. In large litigations, the outcome of bellwether cases, chosen as representative cases, can indicate trends in litigation and can provide a basis for negotiating a settlement.
Thousands of transvaginal mesh lawsuits have been formulated into six MDLs pending in U.S. District Court for the Southern District of West Virginia. In addition to Boston Scientific, defendants in the MDLs include American Medical Systems, C.R. Bard, Inc., Coloplast Corp., and Johnson & Johnson’s Ethicon unit. Court documents indicate that Fawcett et al v. Boston Scientific Corp is set for trial on March 10, 2014.
Transvaginal mesh implant devices were approved by the U.S. Food and Drug Administration (FDA) to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), but plaintiffs in the lawsuits allege that the devices have caused a variety of serious and permanent injuries.
The FDA, in a 2011 safety communication, reported that complications linked to transvaginal mesh implants are “not rare” and listed the following as among the most common ones associated with the devices: mesh erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. Many of the plaintiffs needed additional surgeries to remove the mesh and repair organ damage. The agency has asked 33 manufacturers to conduct safety studies to assess whether the mesh devices cause organ damage and other health problems.
The first transvaginal mesh lawsuit to go to trial resulted in an $11.1 million verdict for the plaintiff (Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey), according to Bloomberg News.