Marilyn McGoldrick on Feb 3, 2014 3:32:00 PM
On Friday, the federal judge overseeing the Ethicon transvaginal mesh (TVM) litigation ruled that Johnson & Johnson (J&J) and its subsidiary, Ethicon, will not be allowed to introduce evidence that the FDA had previously approved surgical sutures made out of the same polypropylene used in Gynecare transvaginal mesh products. Gynecare transvaginal mesh products were manufactured and sold by J&J’s Ethicon unit until 2012, when J&J announced it was discontinuing manufacture of the devices.
Pretrial motions are being ruled on before the start of the bellwether trial of plaintiff Carolyn Lewis in the Ethicon Pelvic Repair System Products Liability MultiDistrict Litigation (MDL no. 3237). Those cases are consolidated in the U.S. District Court for the Southern District of West Virginia. Lewis’ trial alleging that her Gynecare TVT (transvaginal tape) sling is defective, is scheduled to begin on February 10, 2014. This is the first federal bellwether trial in the West Virginia consolidated cases to go forward against J&J and Ethicon. A state court jury in New Jersey returned a verdict for Plaintiff Linda Gross last year for compensatory and punitive damages in the amount of 11 million dollars. Ms. Gross claimed she was injuried from J&J and Ethicon’s Gynecare Prolift product used to treat pelvic organ prolapse.
J&J and Ethicon sought to introduce evidence that the FDA approved the use of polypropylene in J&J’s Prolene sutures, so that it could argue, as summarized by Judge Goodwin: “… that because the FDA confirmed the safety and effectiveness of the Prolene suture, and the TVT is composed of the same material as the Prolene suture, the plaintiffs should be barred from arguing that the Prolene material is defective… At first glance, this argument appears to have some merit — after all, the FDA gave the Prolene suture its stamp of approval and confirmed its safety and efficacy.”
But Judge Goodwin ultimately ruled that “ [a]lthough Ethicon represents that the products are primarily composed of the same material, it does not automatically follow that the material is safe in both devices,” and that while “Ethicon would like the court to determine that because the FDA found polypropylene is safe to use as a suture, it is automatically safe to use in transvaginal mesh … Although purportedly constructed of the same material, it is a different product, used in a different manner, for a different purpose.”
This ruling is an important victory for the plaintiffs in the Ethicon litigation. By his ruling, Judge Goodwin has effectively stopped J&J and Ethicon from confusing the jury by introducing evidence about an entirely different product that underwent an entirely different FDA approval process.
Thornton Law Firm offers free, confidential case evaluations to any person who may have been implanted with a defective transvaginal mesh or surgical mesh product. Please contact us at 1-888-341-1405 or tell us your story here.