A West Virginia jury has reached a $3.27 million verdict in a federal bellwether product liability case brought over the Ethicon transvaginal TVT-O sling. Transvaginal mesh implants are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI); Ethicon is a unit of Johnson & Johnson.
The jury ordered that Ethicon must pay the multi-million compensatory damages amount in a case that included allegations that the its TVT-O transvaginal sling was defectively designed. Allegations also included that Ethicon neglected to warn the public about the device’s potential risks, wrote Law360. Although punitive damages have not been awarded, the jury found in favor of the plaintiff on all counts: Strict liability, design defect, failure to warn, and negligence.
This case represents the first time a federal court jury found Ethicon’s TVT-O sling to be defective, according to the woman’s attorney, wrote Law360. The lawsuit was filed in 2012 over claims that the device’s polypropylene mesh in the woman’s Ethicon TVT-O sling eroded, leading to severe, ongoing pain. Despite surgical attempts, the mesh could not be completely removed. Meanwhile, a Texas jury ordered a $1.2 million verdict in the first Ethicon TVT-O case to reach trial. In that case the Texas jurors ruled that the 64-year-old plaintiff deserved the $1.2 million for injuries allegedly associated with the Ethicon TVT-O mesh sling.
Johnson & Johnson still faces 12,000 lawsuits over mesh implants, according to a prior Bloomberg report, with most of the cases filed into the federal multidistrict litigation (MDL) underway in West Virginia. Lawsuits have also been brought against device makers C.R. Bard; Boston Scientific; and American Medical Systems Inc., an Endo International PLC subsidiary, as well as others.
Mounting litigation prompted the U.S. Food and Drug Administration (FDA) to order 33 device makers, including Johnson & Johnson, to study the rates of organ damage and other complications tied to pelvic mesh implants. In 2011, the agency also indicated that complications related to these devices are “not rare,” warning that the devices may be more harmful when compared to other methods of treating POP.
In related news, a magistrate judge in the federal MDL found that Johnson & Johnson negligently lost or destroyed documents related to the transvaginal mesh litigation. A consumer advocacy group asked U.S. attorney general Eric Holder Jr. to open a criminal investigation into the matter.
In 2013, a New Jersey jury ordered Johnson & Johnson to pay $11.1 million in damages to a woman brought a lawsuit over its Prolift device.
Trials continue and a number of mesh manufacturers have settled their cases as opposed to having claims heard in front of a jury. For example, this April, Endo reached an $830 million settlement that resolved the majority of the 22,000 vaginal mesh lawsuits brought against AMS.