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Ethicon 24/12
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Pelvic Mesh Plaintiff Wants $1.2M Ethicon Win Restored
Dec 23, 2015 | Law360
By Jess Davis
A Texas woman who won a $1.2 million judgment against Johnson & Johnson in a pelvic mesh suit on Monday asked the Texas Supreme Court to restore her win after an appellate court determined she didn’t adequately prove an alleged defect in the product caused her injuries. -
Johnson & Johnson Hit With $12.5 Million Judgment in Mesh Case
Dec 23, 2015 | Outpatient Surgery
By Jim Burger
An Indiana woman who sued Johnson & Johnson, claiming that a vaginal mesh implant made by the company caused extreme pain during sex and required numerous corrective surgeries, has been awarded $12.5 million. -
Peace on Earth and Health to All this Holiday Season !!!
Dec 23, 2015 | Mesh Medical Device News Desk
By Jane Akre
...I feel honored by your appreciation…. but I see this as a site for stories, answers and hopefully progress in helping bring an end to this horrendous chapter in women’s health...
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Pelvic Mesh Plaintiff Wants $1.2M Ethicon Win Restored
Dec 23, 2015 | Law360
By Jess Davis
A Texas woman who won a $1.2 million judgment against Johnson & Johnson in a pelvic mesh suit on Monday asked the Texas Supreme Court to restore her win after an appellate court determined she didn’t adequately prove an alleged defect in the product caused her injuries.
Plaintiff Linda Batiste is asking the high court to restore her win against J&J and its Ethicon Inc. unit after a November decision from the Fifth Court of Appeals in Dallasreversed the judgment on causation grounds. Batiste argues she needed only to prove her injuries were caused by a defective product as a whole, in this case J&J’s TVT-O bladder sling product, used to treat stress urinary incontinence, and contends the appellate court wrongly required her to prove her injuries were caused by a specific defect in the product.
Batiste said in a petition for review that Texas appellate courts have split on the question of whether medical device cases are specifically exempted from a Texas product liability law that requires plaintiffs to isolate the cause of their injuries to a specific defect in the product.
“If Texas common law requires a plaintiff to isolate a specific defect as the cause of her injuries in a drug and device case (which it does not), and if proving causation requires direct evidence of how specific defective elements of a drug or device are reacting within the complex and hidden systems of the human body (which it should not), then it will be virtually impossible for any plaintiff to prevail on a product liability claim against a drug or device manufacturer in Texas,” Batiste said.
An Ethicon spokesman did not immediately respond to a request for comment Wednesday.
Batiste’s case was the first in the U.S. to hold Ethicon responsible for the bladder sling product used to treat stress urinary incontinence. After a 12-day trial in Dallas district court, a jury awarded her $1.2 million in compensatory damages, but declined to award punitive damages.
During oral argument before the Fifth Court of Appeals, Batiste defended the win against what she called a “kitchen sink approach” from J&J, and said the company was asking the appeals court to reweigh evidence already considered by the jury. J&J argued to the court Batiste had presented only speculative evidence that injuries could have been caused by defective pelvic mesh, without reaching the necessary threshold of showing her injuries were actually caused by its product.
The Dallas appellate court said in November that while it’s undisputed implantation of the TVT-O device can cause a number of complications and it’s undisputed Batiste suffered from those complications, the law of products liability doesn’t guarantee a product will be risk-free. The Dallas court held Batiste was required to show a specific link between an alleged defect in the TVT-O — like its use of mechanically cut, heavyweight, small-pore mesh that was allegedly subject to degradation and particle loss — and her injuries, instead of just showing her injuries were caused by the device as a whole.
The lower court said while proving causation may be difficult, it’s not impossible, and determined Batiste had failed to produce more than a scintilla of evidence that any of the alleged defects caused her injuries.
Batiste is represented by Peter de la Cerda of Edwards & de la Cerda PLLC, Richard A. Capshaw of Capshaw & Associates, Tim Goss and Sara Turman-Vedral of Freese & Goss PLLC and David P. Matthews of Matthews and Associates.
Johnson & Johnson is represented by Stephen Brody and Charles Lifland of O’Melveny & Myers LLP and Scott Stolley of Cherry Petersen Landry Albert LLP.
The case is Batiste v. Johnson & Johnson et al., case number 15-0975, in the Supreme Court of Texas. -
Johnson & Johnson Hit With $12.5 Million Judgment in Mesh Case
Dec 23, 2015 | Outpatient Surgery
By Jim Burger
An Indiana woman who sued Johnson & Johnson, claiming that a vaginal mesh implant made by the company caused extreme pain during sex and required numerous corrective surgeries, has been awarded $12.5 million.
A jury in Philadelphia ordered the company to pay Patricia Hammons, 65, $5.5 million in compensatory damages for ongoing health problems and inability to have sex, and tacked on an additional $7 million in punitive damages. A spokesperson says Johnson & Johnson will appeal.
The trial was one of what could end up being thousands aimed at manufacturers of pelvic mesh implants. According to the Philadelphia Inquirer, there had previously been 16 verdicts against pelvic mesh manufacturers, including J&J, totaling $247 million.
J&J began marketing its "Prolift" product in 2005, and pulled it in 2012. The company's defense may have been weakened by revelations that it knew in 2005 that pelvic mesh had been linked to dyspareunia (pain during sex), but did not include a warning on its product label.
Additionally, during Ms. Hammons's trial, a product engineer for Ethicon, the J&J subsidiary that made the mesh, said the company had never given any thought to how the mesh would be removed if it failed. The engineer said such procedures would be extremely difficult, calling the situation a surgical "train wreck."
"We believe the evidence showed Ethicon's Prolift pelvic organ prolapse repair kit was properly designed," says Matthew Johnson, director of communications for Ethicon. "Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and Prolift was not the cause of the plaintiff's continuing medical problems. Studies demonstrated that Prolift was efficacious and had a low rate of post-operative complications when used with appropriate patient selection and proper surgical technique."
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Peace on Earth and Health to All this Holiday Season !!!
Dec 23, 2015 | Mesh Medical Device News Desk
By Jane Akre
We can wish can’t we? First of all, it is an honor to have so many readers gather on Mesh News Desk, and to get to know many of you AND to see you connecting with each other to offer support and love. I feel honored by your appreciation…. but I see this as a site for stories, answers and hopefully progress in helping bring an end to this horrendous chapter in women’s health.
It’s an honor to write these stories and pursue answers. I wish this holiday season to have a magic wand and make your pain disappear…. May you all find some peace and resolution to the difficulties you face. Let’s hope that the veil of secrecy lifts and those in the position to help the injured do so – Finally! As long as we are wishing, how about the Precautionary Principle being applied to the manufacture of all medical devices, err on the side of caution and of the patient when it comes to the manufacture of a device, especially one that is permanently implanted!
That is just common sense, which as it turns out, is not so common after all.
I’ve enjoyed meeting many of you, on the phone and in person and I am in awe of your grace under pressure.
May 2016 bring you some answers, you all deserve it!
With respect and love and admiration,
Jane Akre
Editor Mesh News Desk
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