Pharmaceutical

Johnson and Johnson’s Mentor unit found liable in pelvic mesh case

2012 TVM serious complications Johnson and Johnsons Mentor unit found liable in pelvic mesh caseJohnson and Johnson has been found liable in another pelvic mesh trial, with the verdict this time going against its unit Mentor Worldwide LLC ‘s pelvic mesh implant device known as the ObTape sling.

In December the drug and device manufacturer lost in a case where plaintiff Patricia Hammons alleged subsidiary Ethicon’s Prolift transvaginal mesh implant eroded inside her body, leaving her unable to have sex. The jury found in favor of Hammonds and awarded her a total of $12.5 million in compensatory and punitive damages.

Then, on Feb. 11, Ethicon’s transvaginal tape product, known as TVT, was the next of its devices to be found negligently designed. The jury also found that Johnson and Johnson and Ethicon did not adequately warn plaintiff Sharon Carlino’s physician of the product’s risks and awarded a $13.5 million verdict. Carlino endured multiple surgical procedures to remove mesh that became exposed and, like Hammonds, was left unable to have sex and in constant pain.

According to Law360, a Georgia federal court jury on Thursday Feb. 18, found Johnson and Johnson unit Mentor Worldwide LLC guilty of negligence in warning plaintiff Tessa Taylor’s doctor about the risks of their device, the ObTape sling. They also found that the pelvic mesh device’s defective design caused the plaintiff’s recurring infections and incontinence. The total verdict amounted to $4.4 million, with $400,000 in compensatory damages and an additional $4 million in punitive damages.

This is one of thousands of cases Johnson and Johnson is up against across the country involving various transvaginal mesh devices. According to Bloomberg Business, Johnson and Johnson agreed earlier this year to pay more than $120 million to resolve 2,000 to 3,000 suits in the transvaginal mesh litigation against its Ethicon unit alone but it still faces another 42,400 suits.

These mesh devices are used to treat stress urinary incontinence where during physical activity like sneezing, coughing or heavy lifting a person experiences unintentional loss of small amounts of urine. The FDA issued an order this January changing the status of these devices to a class III, high-risk device and ordering the manufacturers of these devices to submit premarket approval applications giving evidence of their safety and effectiveness if they are to remain on the market.

The device in this current suit, the ObTape sling, is already off the market. It was discontinued in 2006. Taylor received an ObTape sling to treat incontinence in 2004 and for seven years she suffered continued pain in her bladder and back and repeated infections culminating in a rediagnosis of stress incontinence and recommendation by her doctor to remove the sling and replace it with another.

According to Law360 “The jury said that $4 million in punitive damages would serve to punish Mentor and ‘discourage others from behaving in a similar way.’”

Sources
Law360
Bloomberg Business
Righting Injustice
Righting Injustice