Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, April 7, 2014

Plaintiff awarded $1.2M by Texas jury for defective surgical mesh product

 April 04, 2014 at 11:38 AM

Johnson & Johnson was ordered by a Texas jury to pay $1.2 million to a woman who alleged one of the company’s lines of vaginal-mesh implants to treat incontinence was defectively designed, in the first verdict against the company over those devices.
Jurors in state court in Dallas concluded the design of the TVT-O mesh sling implanted in Linda Batiste was flawed and the 64-year-old woman deserved $1.2 million in compensatory damages, her lawyers said. They argued Batiste suffered pelvic pain when the device eroded inside her.
J&J, based in New Brunswick, faces more than 12,000 lawsuits accusing its Ethicon unit of making improperly designed vaginal inserts, such as the slings, that damaged women’s organs and made sex painful. Most of the cases have been consolidated before a federal judge in West Virginia for pretrial information exchanges while other cases are being heard in state courts.
The U.S. Food and Drug Administration has ordered J&J, C.R. Bard Inc. and 31 other vaginal-implant makers to study rates of organ damage and complications linked to the implants after manufacturers faced a wave of lawsuits over the devices.
Doctors inserted more than 70,000 mesh devices in the U.S. in 2010 alone, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court filings.
Appeal Planned
J&J officials noted the Dallas jury rejected Batiste’s claims that Ethicon didn’t provide proper warnings about the slings’ health risks and declined to award punitive damages.
“The jury’s verdict on design defect is disappointing, and we believe we have strong grounds for appeal,” Matthew Johnson, an Ethicon spokesman, said yesterday in an e-mailed statement.
J&J officials decided in 2012 to stop selling some lines of vaginal-mesh implants after being hit with a wave of lawsuits over the devices. The TVT-O sling Batiste, a former nurse, received is still on the market, Thomas Cartmell, one of her lawyers, said in a phone interview.
“This verdict represents the first time an impartial jury had the opportunity to decide whether Ethicon’s sling products are defective and they found exactly that,” Bryan Aylstock, a plaintiffs’ lawyer helping to oversee cases gathered before U.S. District Judge Joseph Goodwin in West Virginia, said in a phone interview. “We believe this is the first of many more verdicts to come over this dangerous product,” he added.
NJ Verdict
Last year, a New Jersey jury ruled J&J must pay $11.1 million in damages to a woman who blamed a Prolift device for her injuries in the first case over any of the company’s implants to go to trial. The Prolift implants help support sagging organs.
Lawyers for J&J, the world’s biggest maker of medical products, argued in court papers that the TVT-O slings are safe and effective and the company properly warned consumers about their risks.
In February, Goodwin threw out a woman’s claims that another line of the company’s sling inserts was def

Updated April 24, 2014


FiDA Highlights
WFAA TV  Dallas, TX
Posted on April 24, 2014 at 10:37 PM
Updated yesterday at 10:43 PM

DALLAS — It's not just walking that's painful for 64-year-old Linda Batiste. Life, in general, is a physical struggle.
"I have pelvic pain," she said through tears. "It actually does feel like a scouring pad in your body. You can feel in your women parts, what it is. It's there."
The condition that brought Batiste to tears is embarrassing for her discuss. That feeling comes from a product left inside her body to fix urinary incontinence.
More than 20-million women in the United States suffer from urinary incontinence and/or pelvic prolapse. In thousands of cases — including Batiste's — doctors use a pliable, gauze-like mesh sling to support the bladder and other organs.
But what Batiste got from her 2011 procedure was not relief.
"I have never been pain-free since then,” she said.
Surgical mesh is a synthetic material manufactured by several companies and routinely used for urinary incontinence, pelvic prolapse, and hernia operations.
Attorney Tim Goss, a parner at the Dallas law firm Freese & Goss, represented Batiste in a product liability case against the Johnson & Johnson subsidiary Ethicon. It was the first mesh cast to go before a Texas jury.
"The polypropylene mesh, it degrades, it disintegrates, it extrudes, it frays, it ropes, and it has particle loss,” he said. “And all of those problems cause other problems — like scarring, chronic pain, for example."
The American Urogynecologic Society says mesh is "safe, effective, and has improved the quality of life for millions..."
"It can be a bend-over pain, where it will be a sharp stab," he said.
Samples was forced to travel out of state for surgery to remove the mesh. The procedure was not a complete success, and Samples continues to have some pain, even now.
The FDA first issued a "Public Health Notification" in 2008, saying it had received "over 1,000" reports of "adverse events" "for surgical mesh devices."
In 2011, The FDA sent out another warning, saying "serious complications associated with surgical mesh" "are not rare" and that mesh "may expose patients to greater risk" than traditional procedures.
Since then, women across the country have formed organizations and online support groups trying to get mesh removed from the market.
Linda Batiste won a $1.2 million judgment against the maker of her mesh, Ethicon.
"It's significant because there are almost 100,000 other cases pending around the country regarding this type of product,” said Goss, who represents 9,000 mesh cases.
Goss said the lawsuits have the potential to become the largest mass-tort in history — bigger than the Phen-Fen diet drug mess.
A statement from Ethicon spokesman Matthew Johnson called the Dallas verdict mixed:
"A jury in the 95th Judicial District Court of Dallas County, Texas, returned a mixed verdict today in a product liability trial concerning Ethicon’s TVT-O pelvic mesh, which is used as a minimally invasive treatment for women suffering from stress urinary incontinence (SUI).
"The jury found Ethicon properly informed of the known risks associated with TVT-O. The jury also found that the product was defectively designed. The jury awarded $1,200,000 in compensatory damages. The jury declined to award punitive damages.
“We believe the evidence showed Ethicon’s TVT-O pelvic mesh was properly designed and that Ethicon acted appropriately and responsibly in the research, development and marketing of the product. The jury’s verdict on design defect is disappointing, and we believe we have strong grounds for appeal.
“We empathize with all women suffering from SUI, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events,” Johnson continued. “TVT-O has been deemed safe and effective by regulators and practitioners alike, and it continues to be an important option for treating physicians to offer to women suffering from SUI.”
In the meantime, Linda Batiste has had several surgeries to try to remove the mesh, which is embedded in her tissue. Her original problem of incontinence is back.
"And it's compounded the pain that I normally would have had,” she said. “I never wish for any other woman to feel this way or to have it happen to them."

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