Verdict Against Pelvic Mesh Case. A California jury returned a $5.7 million verdict against Johnson & Johnson last week in the first test case over one of its newest pelvic mesh slings. Similar devices have been named in thousands of lawsuits across the country.
Johnson & Johnson’s subsidiary, Ethicon Inc., has lost verdicts over other mesh devices. This trial was the first involving Ethicon’s TVT-Abbrevo device, which is used to treat urinary incontinence. The plaintiff alleged she had pain and her urinary problems continued after the device was implanted in 2011, The Associated Press (AP) reports.
The Device Was Defectively Designed
The jury, in Kern County, California, Superior Court, found that the device was defectively designed and that Ethicon failed to warn doctors of its problems. The jury awarded $700,000 in compensatory damages and $5 million in punitive damages, the AP reports. Johnson & Johnson said it planned to appeal. The company believes the sling was “properly designed and Ethicon acted appropriately and responsibly in the research, development and marketing of the product,” according to Ethicon spokesman Matthew Johnson.
Ethicon is one of seven manufacturers being sued over pelvic mesh devices used in the treatment of pelvic organ prolapse and stress urinary incontinence. Women who have had these devices implanted allege injuries and side effects including mesh erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. Lawsuits have been filed against mesh makers including C.R. Bard, Boston Scientific, and Ethicon.
The Food and Drug Administration (FDA) has rejected a call for a total ban on pelvic mesh devices, but is considering a reclassification that would move the devices to Class III, by definition, the highest risk category.
The California verdict comes as Ethicon began trial on March 2 in a bellwether case from among more than 23,000 lawsuits in U.S. District Court for the Southern District of West Virginia, the AP reports.