Two bellwether trials are scheduled in an Ethicon multidistrict litigation (MDL) involving injury allegations concerning transvaginal pelvic mesh manufactured by the Johnson & Johnson subsidiary.
Thousands of patients have brought lawsuits against transvaginal mesh manufacturers, such as Ethicon, C.R. Bard, Boston Scientific, Endo Health Solutions, Cook Medical, and Coloplast, according to MassDevice.com. Many cases in federal courts have been consolidated into the MDL overseen by Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia, according to MassDevice.com.
Meanwhile, the judge ruled last week against permitting testimony about the loss or destruction of thousands of pages of evidence on the part of Ethicon. Just prior, Magistrate Judge Cheryl Eifert found that, while Ethicon did destroy or lose “documents that should have been preserved in anticipation of this litigation … Ethicon’s loss of evidence was negligent, not willful or deliberate,” among other issues, according to court documents, MassDevice.com reported.
Judge Eifert also wrote that “…plaintiffs are entitled to monetary sanctions to compensate them for the additional time spent by their counsel piecing together missing custodial files and preparing for depositions of key employees for whom scant information was provided by Ethicon.” Judge Eifert also recommended that the plaintiffs be allowed to introduce evidence of spoliation on a case-by-case basis, which provides patients bringing lawsuits a better chance to show that Ethicon intentionally hid or destroyed the documents.
Transvaginal mesh devices are used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Thousands of women allege in lawsuits that the devices are defective and have causes severe and, sometimes, permanent and life-altering injuries.
Transvaginal mesh implants were approved with minimal or no clinical testing, which has been emphasized in patient lawsuits. A regulatory loophole known as the 510(k) enables manufacturers to sell and implant transvaginal mesh devices in thousands of women without much clinical evidence proving efficacy and safety. The 510(k) process eliminates clinical testing should a device be shown to be similar enough to an older, approved device. The 510(k) has been the focus of significant controversy in recent months.
The U.S. Food and Drug Administration (FDA) has indicated that complications tied to transvaginal mesh implants are “not rare,” warning that use of these devices may actually be more harmful when compared to alternative methods. The agency also recently reported that the most common complications associated with these devices may include:
- Dyspareunia (pain during sexual intercourse)
- Exposure, extrusion, or protrusion (mesh erosion through the vagina)
- Organ perforation
- Urinary problems