Jury selection August 22. Pelvic mesh trial to start August 25.

TVT-O from TVT Mums website

TVT-O from TVT Mums website

The case of Huskey v. Ethicon (Johnson & Johnson) has survived a summary judgment motion and will continue to federal court in Charleston, West Virginia.

Jo Huskey is a 54-year-old woman who was implanted with a TVT-O pelvic mesh device in February, 2011 to treat incontinence.

Jury selection in her case is set for August 22 with the trial commencing in the federal court August 25. The case number is 2:12-cv-05201.

Huskey filed a product liability action that alleges the polypropylene mesh is defective in its design and manufacture as well as its directions for use and that the company made false and fraudulent promises to the public and to the doctors. Her implanting physician was Gretchen L. Byrkit, MD Ob-Gyn. See here

The Huskey lawsuit is just one of 20,072 product liability lawsuits facing Ethicon in this federal court.

Judge Joseph R. Goodwin

Judge Joseph R. Goodwin

The Husky case might not have gone forward except for a ruling July 8 by federal Judge Joseph Goodwin who is overseeing actions filed against seven manufacturers and 62,691 federal transvaginal mesh cases. Ethicon tried to have the Huskey case dismissed on the basis of federal preemption. Federal preemption essentially means if you are injured by a medical device, that was approved by the U.S. Food and Drug Administration’s Premarket Approval (PMA), you should not be allowed to sue. The device maker has immunity.

As most readers of Mesh News Desk know, pelvic and hernia mesh never underwent the FDA’s more stringent PMA. Instead it was approved under the fast-track 510(k) approval which does not require clinical trials before it is marketed.

Riegel v. Medtronic

Decided February 2008 by the U.S. Supreme Court, the famous case Riegel v. Metronic established that Charles Riegel and his wife Donna Riegel should not be allowed to sue over the Medtronic catheter that ruptured in Riegel’s coronary artery while he underwent heart surgery. It later killed him.

See Riegel v. Medtronic here.

Why not?

Because the Medical Device Amendments of 1976 created federal oversight for medical devices. States cannot challenge federal Premarket Approval or PMA. The Riegels had sued under New York state law.

The bottom line- 510(k) approved devices can face defective product litigation while devices approved by the FDA under the PMA cannot.

Ethicon moved for the partial summary judgment (Doc #178), arguing that PROLENE mesh, the proprietary name for J&J’s polypropylene that makes up the TVT-O, underwent the Food and Drug Administration’s “rigorous premarket approval process, rather than the less stringent 510(k) clearance process.”

Readers of Mesh News Desk know hernia and pelvic mesh were approved under 510(k).

Ethicon argued the Prolene suture which is a “component part of the TVT-O” made it to market under PMA, therefore the entire device also should be considered a PMA-approved device. That argument had been made previously in the Lewis v. Ethicon case in the same court.

Judge Joseph Goodwin said that Ethicon ignored the fact that the TVT transvaginal mesh and Prolene sutures are two entirely different medical devices.

Prolene mesh

Prolene mesh

The TVT mesh, made of Prolene is as woven from knitted Prolene filaments.The Prolene suture is a single filament of polypropylene. 

Other differences- the average suture is a few inches long, the TVT is .5 inch by 16 inches, in other words, a lot more polypropylene.

The suture is not intended to adhere to human tissue but the TVT is designed to integrate with the body. Suture is designed to be removed from the body, easily pulled out, while the TVT is a permanent medical device and cannot be removed” without invasive surgery.”Ethicon  200

The FDA’s approval of the Prolene suture it said it was safe and effective “for use as recommended in the submitting labeling.” The FDA did not approve Prolene in a larger format in a knit material or in a permanent transvaginal mesh implant.

Judge Goodwin ruled just because they are the same material “It does not automatically follow that the material is safe in both devices.”

Ethicon’s motion for a partial summary judgment based on preemption was denied. #