|Boston Scientific's Obtryx sling|
Boston Scientific was hit hardest: it must pay $73 million to a woman treated with its Obtryx sling. Jurors at a Texas state court in Dallas awarded the patient, Martha Salazar, roughly $23 million in compensatory damages and $50 million in punitive damages.
Salazar had been treated with the Obtryx device four years ago and afterwards suffered from chronic pain and nerve damage. She alleges that Boston Scientific was aware that the product was defective and marketed it anyway.
"This woman was seeking help with minor urine leakage and wound up with a catastrophic, life-altering injury that required four major surgeries," said Salazar's attorney Dave Matthews as quoted by Bloomberg. "It's a tragedy that these slings are still on the market."
Boston Scientific faces thousands of additional lawsuits related to its transvaginal mesh devices.
Johnson & Johnson's Ethicon subsidiary , which also faces thousands of such lawsuits, was recently ordered to pay $3.27 million after a federal jury in West Virginia awarded another patient $3.27 million in a trial related to transvaginal mesh devices.
The jury deliberated less than half a day September 5 before finding Ethicon liable for selling a defective device and failing to warn patients and doctors of possible side effects, including pain, bleeding and infection, according to a report by Reuters.
It was the second case against Ethicon to go to trial among the thousands that have been consolidated in U.S. District Court for the Southern District of West Virginia. An Ethicon spokesperson said the company would appeal.
In February 2011, plaintiff Jo Huskey had an Ethicon TVT-O pelvic mesh device implanted to treat stress urinary incontinence, according to a report by Mealey's. Huskey claimed she suffered near-immediate hip pain and had vaginal bleeding and painful intercourse the following month. Her surgeon found exposed mesh in her vaginal cavity and oversewed it, the Mealey's report said.
Huskey was referred to another doctor for exposed mesh in July 2011, and had the device removed in November of that year. Huskey maintains she is in constant pelvic and vaginal pain that prevents her from working, exercising or having intercourse, the Mealey's report said.
Ethicon maintains that Huskey's surgeon was warned of the complications and that Huskey failed to show that the risk of the device outweighs its benefits. The company also argues that a design defect did not cause Huskey's alleged injury and that the U.S. Food and Drug Administration had approved the device's Prolene polypropylene filaments as sutures, the Mealey's report said.
Ethicon won the first pelvic mesh case in West Virginia federal court in February, Reuters said. In a mesh trial last year in New Jersey state court, the company was ordered to pay $11.11 million in compensatory and punitive damages to the plaintiff. A Texas state court trial in April this year yielded a $1.2 million verdict against the company, Reuters and Mealey's reported.
As of mid-August, 19,380 pelvic mesh cases against Ethicon were pending in the multidistrict litigation involving several types of devices, Mealey's said. In 2012, the company stopped selling some types of devices.
In April this year, the FDA issued two proposed orders to address health risks associated with surgical mesh used to repair pelvic organ prolapse. If finalized, the orders would reclassify the mesh from a Class II device to a Class III device and require manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness.
Other companies that have faced lawsuits over vaginal mesh products include American Medical Systems, Boston Scientific Corp., C.R. Bard, Cook Medical, and Coloplast. Dublin, Ireland-based Endo agreed to settle about 20,000 claims against its American Medical Systems subsidiary for approximately $830 million in April.
Coloplast in March agreed to pay about $16 million to settle about 400 cases involving its transvaginal mesh implants, and C.R. Bard has been settling some suits, qmed.com reported.
|Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.|
Nancy Crotti is a contributor to Qmed and MPMN.
Like what you're reading? Subscribe to our daily e-newsletter.