Huskey V. Ethicon: Case Survives Federal Preemption Argument by Ethicon

Johnson & Johnson’s Ethicon division tried, as it had before, to have its upcoming federal transvaginal mesh case thrown out of court. The healthcare giant was unsuccessful.

On July 8, Judge Joseph Goodwin, who is overseeing about 75,000 federal transvaginal mesh cases in Charleston, West Virginia, ruled that federal preemption should not preempt the case of Huskey v. Ethicon (2:12-cv-05201). 

Polypropylene molecule. Polypropylene molecule.

Jo Huskey was implanted with a TVT-O, a vaginal sling made of Prolene mesh, on February 23, 2011.  She experienced mesh erosion and dyspareunia (painful sex). As a result of the complications, she had a revision surgery November 18, 2011. Only part of the medical device could be removed so her stress urinary incontinence returned as well as constant pelvic and vaginal pain.

Her product liability trial is set to begin in West Virginia on August 25, 2014.

Ethicon wanted to have the case thrown out on the basis of federal preemption, a movement by the tort reformers to keep Americans from the courtroom door.

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

Why not? Because the Medical Device Amendments of 1976 created federal oversight for medical devices. That means the states cannot challenge federal Premarket Approval (PMA). The Riegels had sued under New York state law.

Ethicon had tried the federal preemption argument in the last pelvic mesh case in Charleston.  Moving for a partial summary judgment (Doc #178) in the Lewis v. Ethicon case, the company argued that PROLENE mesh was actually approved by the Food and Drug Administration under its “rigorous Premarket Approval (PMA) process rather than the less stringent 510(k) clearance process.”

Ethicon tried to argue that the PROLENE suture, a single filament of polypropylene, a few inches long, is the same as the TVT-O mesh used to treat incontinence. Never mind that the TVT is one-half 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.  The 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 argued the PROLENE suture which is a “component part of the TVT-O” made it to market under PMA, therefore the entirely different medical devices should be considered a PMA approval, despite the fact that they are vastly different medical devices.

Fortunately Judge Goodwin said that Ethicon ignored the fact that the TVT mesh tape used to treat stress urinary incontinence and Prolene sutures are two entirely different medical devices. They went through entirely different FDA approval processes.  Just because they are the same material “It does not automatically follow that the material is safe in both devices.”

Fortunately for the Plaintiffs seeking access to court, pelvic meshes were approved under the 510(k) after an exchange of paperwork and a few thousand dollars and an approval to sell. Unfortunately for the Plaintiffs, that sort of approval did nothing to guarantee they would not suffer a lifetime of pain and suffering.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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