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
by JANET ST. JAMES
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."
"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."
