A Pennsylvania state judge has issued an order for the creation of a mass tort to coordinate product liability lawsuits brought over pelvic mesh products. The lawsuits have been filed against some of the largest medical device makers.
Judge Arnold New, director of the Complex Litigation Center at the Philadelphia Court of Common Pleas, issued the order on February 11, 2014 that stated, in part, that “all currently filed pelvic mesh matters shall be transferred to the Complex Litigation Center Pelvic Mesh Mass Tort Program” for coordination, the court documents indicate, MassDevice.com reported.
Court records reveal that 44 lawsuits are pending classification in the mass tort, which names, among the device makers of female urinary incontinence treatments C.R. Bard, Boston Scientific, and Johnson & Johnson. C.R. Bard; Boston Scientific; Ethicon, which is a unit of Johnson & Johnson; Endo Health Solutions; and Cook Medical, all face thousands of product liability and personal injury lawsuits brought over their pelvic mesh devices, according to MassDevice.com. Many lawsuits have also been consolidated into a multidistrict litigation (MDL) organized under Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia.
In other recent news, two bellwether trials were being scheduled in an Ethicon MDL that involves injury allegations brought over transvaginal mesh devices manufactured by the Johnson & Johnson subsidiary.
Pelvic mesh devices are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Thousands of women allege in lawsuits that these devices are defective and have also led to severe and, sometimes, permanent and life-altering injuries and pain.
These devices were approved with little or no clinical testing, a point which has been emphasized in patient lawsuits. A regulatory loophole, commonly known as the 510(k) has enabled device manufacturers to sell these transvaginal mesh devices, which have been implanted in thousands of women without much clinical evidence to prove their efficacy and safety. The 510(k) process eliminates clinical testing should a device be shown to be sufficiently similar to an older, approved device, and has been the focus of significant controversy in recent months.
The U.S. Food and Drug Administration (FDA) indicates that complications tied to transvaginal mesh implants are “not rare,” and also warns that use of these devices may actually be more harmful when compared to alternative methods. The agency recently reported that the most common adverse reactions linked to these devices may include:
- Dyspareunia (pain during sexual intercourse)
- Exposure, extrusion, or protrusion (mesh erosion through the vagina)
- Organ perforation
- Urinary problems