This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.
Plaintiffs Rest their Case
As the plaintiffs rested their case in this defective product trial against Johnson & Johnson and its polypropylene pelvic mesh, the defense immediately launched an attempt to end the case in its favor.
That is the same thing lawyers for the healthcare giant were granted last February in Lewis v. Ethicon, another pelvic mesh case also tried before Judge Joseph Goodwin in the same Charleston, WV courtroom.
This time the motion failed.
Judge Goodwin did grant a J&J request to disallow punitive damages in the ongoing trial.
Dave Thomas, an attorney for Ethicon, a division of J&J that makes medical devices, argued the plaintiffs have not shown any adverse event warning to the doctors contained in the product label would have changed the treatment of Mrs. Huskey.
Jo Huskey, 54, received J&J’s TVT-O pelvic mesh sling in February of 2011. She has since experienced chronic pelvic pain despite the fact she’s had two partial removals. Her implanting physician, Dr. Gretchen Byrkit had told jurors if there was a contraindication that active women (such as Huskey) should not receive a pelvic implant, she might not have used the TVT-O.
The case hinges on whether there were adequate warnings to her physician as to the dangers and potential risks of the device. The plaintiffs must also show, by the preponderance of the evidence, that the TVT-O is defective in its design and manufacture.
Thomas argued that federal preemption should be the basis of granting J&J a favorable ruling. I’ve already ruled on that, said Judge Goodwin.
J&J had argued its mesh had been approved by the U.S. Food and Drug Administration (FDA) therefore could not be the basis of a defective product claim. Prolene filaments had FDA approval decades ago, but a thread is not the same as a new device, Judge Goodwin had ruled.
Then in an impassioned plea Thomas argued the product label contained adequate warnings about the product – warnings about the potential for infection, nerve damage, the puncturing of vessels and nerves and of scarring.
Judge Goodwin asked Thomas if he drew a distinction between warning of pain and warning of chronic pain. “Its well known,” said Thomas, “And Dr. Bykrit (implanting physician) was well aware of that risk and that means we don’t have to warn what she already knows.”
Thomas blamed the second attempt to remove the pelvic mesh on a physician, and that, he said, was what actually caused scarring and therefore Mrs. Huskey’s pain.
The case will continue on Tuesday after the holiday break with the defense telling jurors why the polypropylene pelvic mesh implant is not defective and how the company reveals all potential risks to doctors in its product labels, also known as the IFU (instructions for use). ##