Johnson & Johnson’s Ethicon unit has been ordered by a Philadelphia jury to pay $80 million to a woman whose vaginal mesh implant eroded following a 2008 procedure, and who said it caused pain, inflammation and infections.
The Pennsylvania state court’s verdict Friday includes $50 million in punitive damages; the jury found that Ethicon’s Prolift mesh was defective and that J&J had failed to adequately describe the device’s risks when treating pelvic organ prolapse, according to a report from the Philadelphia Inquirer.
The case comes on the heels of a single $120 million verdict issued against Ethicon last month, also in a Philadelphia court, related to a woman who received a mesh implant to treat urinary incontinence. In separate statements, a J&J spokesperson said the findings in both cases were “inconsistent with the science” and that the company plans to appeal both verdicts.
Other Philadelphia plaintiffs have won multimillion-dollar verdicts against J&J, including earlier this year and before—however, April also saw a jury land in Ethicon’s favor. Attorneys for the plaintiff in that case cited unique challenges due to other medical issues and gaps in coverage and said that the jury still found the company did not exercise due care in the design and marketing of its mesh implants, according to a report from The Legal Intelligencer.
Meanwhile, last month the FDA ordered the two remaining manufacturers of vaginal mesh products in the U.S. to immediately halt their sale and distribution.
The agency said that Boston Scientific and Coloplast were unable to prove that the mesh products were safe and effective for the treatment of pelvic organ prolapse, compared to repair procedures using native tissues after three years.
The implants were reclassified as higher-risk, Class III devices in 2016, requiring the manufacturers to submit new applications and evidence to maintain their marketing approvals. Both companies are required to continue their postmarket surveillance studies of patients who received the mesh implants. The FDA did not issue a recall.