Endo accused of negligence for selling a defective medical device and failing to warn about safety risks and fraudulent concealment of the magnitude of risks.
Endo Pharmaceuticals (Endo) acquired American Medical Systems, Inc. in April, 2011. AMS is the maker of transvaginal mesh (TVM) products including the SPARC retropubic sling, Monarc transobturator (TOT) sling, and its pelvic organ prolapse (POP) devices. Unfortunately the shareholders of Endo bought AMS’ future liability which grew to over 40,000 lawsuits. Wisely, Endo Pharmaceutical may have mitigated the cost by being the first manufacturer to settle their cases and probably at a large discount. AMS was part of the largest Multidistrict Litigation in history that grew to over 105,000 cases.
Endo announced on March 31, 2016 that it had failed to find a buyer of its vaginal mesh division (Astora Women’s Health) and closed its operations on March 31, 2016 to “reduce the potential for product liability related to future mesh implants.”
On November 8, 2019, Endo was hit by a lawsuit in the United States District Court for the Northern District of Idaho alleging injury including neuropathic pain caused by the placement of the defectively designed Monarc TOT sling implanted on September 12, 2013. Endo is accused of negligence for selling a defective medical device and failing to warn about safety risks and fraudulent concealment of the magnitude of risks. Other allegations in the complaint include that the Monarc is required by design to be placed blindly and is a permanent implant but will “contract over time which can pull, cause fibrosis of muscles, adhesions between tissues, and inflammation” (Case 2:19-cv-00431-DCN).
“I predict that the manufacturers of these devices will come to understand that the second wave of litigation will be more costly than the MDL as the catastrophic injuries appear.” – Dr. Greg Vigna
The Plaintiff is represented by Ben C. Martin and Laura Baughman of Martin Baughman, PLLC and Greg Vigna, MD, JD. Ben Martin and Laura Baughman are national pharmaceutical injury attorneys in Dallas, Texas. Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic injuries and the neurological injuries caused by transvaginal mesh devices including pudendal neuralgia, obturator neuralgia, complex regional pain syndrome, and ilioinguinal neuralgia. Local Idaho counsel is Reed Larsen, Esq. of Cooper & Larsen, Chartered.
Greg Vigna, MD, JD, practicing physician, national pharmaceutical injury attorney, and Certified Life Care Planner states, “TOT slings by their design place the pudendal nerve and obturator nerve in peril to direct trauma during blind placement of the device or over time as the device shrinks leading to catastrophic pain syndromes, including pudendal neuralgia, obturator neuralgia, and/or complex regional pain syndrome. We have injured women coming in 5-12 years after implantation with newly developed pain.”
Dr. Vigna adds, “Latent injuries will appear for decades as the ilioinguinal nerve, pudendal nerve, and obturator nerve are compressed by scar tissue and pulled by traction. I predict that the manufacturers of these devices will come to understand that the second wave of litigation will be more costly than the MDL as the catastrophic injuries appear.”