(Reuters) - A federal jury in West Virginia on Friday awarded a woman $3.27 million in one of 33,000 lawsuits that accuse Johnson & Johnson’s Ethicon Inc unit of selling defective transvaginal mesh devices.
Following a nearly two-week trial, jurors found Ethicon liable for selling faulty devices and failing to warn patients and their doctors that users were at risk from side effects that include pain, bleeding and infection.
It was the second case to go to trial among thousands that have been consolidated in West Virginia federal court, after the first ended in February with a win for Ethicon. The company had previously been hit with an $11 million verdict in a mesh trial in New Jersey state court last year, and a $1.2 million verdict following a trial in Texas state court in April.
The plaintiff, Jo Huskey, was 52 when she was implanted with a Gynecare TVT Obturator, or TVT-O, transvaginal mesh device in 2011 to treat stress urinary incontinence, according to her lawyer, Fidelma Fitzpatrick of Motley Rice. Huskey and her husband sued the next year, claiming problems with the device led to serious side effects including pelvic pain.
Fitzpatrick said the Huskeys were thrilled with the verdict. “I think it sends a very clear message to Ethicon that these products and these cases are extremely serious,” she said. “These women are very seriously injured from these products.”
A spokesman for Ethicon, Matthew Johnson, said the company was disappointed with the verdict and intends to appeal. “Ethicon’s TVT-O midurethral sling was properly designed, and Ethicon acted appropriately and responsibly in the research, development and marketing of the product,” he said in a statement.
While the Huskey verdict is not binding on thousands of other Ethicon mesh cases, it will help both sides assess the strengths and weaknesses of the litigation as a whole as they decide whether to press forward with more trials or consider a settlement.
Ethicon is among seven companies facing a wave of litigation over mesh devices. Other defendants include C.R. Bard Inc and Boston Scientific Corp. Boston Scientific recently won the first two mesh cases to go to trial against it in Massachusetts state court. Last year, C.R. Bard was hit with a $2 million verdict in the first mesh trial in West Virginia federal court.
In April, Endo International’s American Medical Systems [ENDPAM.UL] subsidiary became the first major manufacturer to largely bow out of mesh litigation, agreeing to pay $830 million to resolve thousands of these cases.
The U.S. Food and Drug Administration said earlier this year that it was considering proposals to tighten safety standards for transvaginal mesh devices used to treat pelvic organ prolapse. If finalized, the proposals would require manufacturers to submit data proving the devices’ safety and effectiveness before allowing them to be sold.
The case is Huskey v. Ethicon, U.S. District Court for the Southern District of West Virginia, No. 12-5201.
Reporting by Jessica Dye in New York; Editing by Alexia Garamfalvi, Bernard Orr
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