J&J Loses Transvaginal-Mesh Lawsuit

Posted in Regulatory and Compliance by Bob Michaels on February 27, 2013

Johnson & Johnson, a global healthcare giant based in New Brunswick, New Jersey, lost a product liability lawsuit surrounding its transvaginal mesh implants manufactured by Ethicon, a subsidiary of the company. This latest ruling against the company follows a disclosure that J&J is facing an investigation in 42 states regarding the marketing practices of its mesh implants.

A New Jersey jury ruled in favor of Linda Gross, a plaintiff who received a transvaginal mesh implant manufactured by Ethicon. Gross alleges that her physicians failed to warn her about all the potential risks of the device. In the lawsuit, Gross alleged that the device left her in chronic pain.

As the case stands, Ethicon will be required to pay out $3.4 million in damages. However, the company plans to appeal the ruling.

Sheri Woodruff is the communications vice president at Ethicon Surgical Care. In remarks shared with the press, she said, "We will present evidence to the jury ... in the punitive phase of the trial, which followed a mixed verdict by the jury.” She continued, "While we are always concerned when a patient experiences medical conditions like those suffered by the plaintiff, all surgeries for pelvic organ prolapse present risks of complications."

The implications of this case could spell dire news for Ethicon and other companies that manufacture transvaginal mesh implants. As of now, approximately 1,800 related cases are on the New Jersey docket alone.

Ethicon's surgical meshes, of which transvaginal mesh is an example, saw a spike in adverse events in 2012.

References

www.sec.gov/Archives/edgar/data/200406/000020040613000038/ex13-form10xk2...

www.reuters.com/article/2013/02/25/usa-jj-vaginalmesh-idUSL1N0BL4F120130225