A simple procedure was
supposed to help fix an embarrassing women's health problem. Instead it left
women in pain -- and in a fight for their dignity.
Hal
Samples
Aaron Horton as her alter
ego: the Mesh Warrior.
It felt like fishing line was scratching him:
That's how he knew something was wrong. His wife had been complaining for a
while that sex hurt, but he thought maybe she just didn't want him anymore.
Until, in the act, he felt it himself: something rough and wiry inside her
body.
“Problem: Vagina is very odd-shaped, so you
cannot use a preformed implant.”
Before the pain, Betty and John (not their real
names), just 45 and 54, were the kind of aging but active patients that have
been a boon to the medical industry, suffering from an array of maladies but
happy to accept whatever treatment was available to keep enjoying life. Betty
got her tubes tied in her early 20s, then, after a complication, agreed to get
a hysterectomy at just 23. That weakened her bladder, so she got surgery to fix
it. After six months, her bladder irritated her just like it had before the
operation — always feeling like she needed to pee, leaking when she rushed to
the toilet. She tried a second surgery, but that didn't work either.
There were other problems, too. She'd worked in
an assembly line years before but quit after she developed carpal tunnel
syndrome. Both she and her husband have diabetes. Still, they enjoyed life,
staying in or going fishing at a lake near their Missouri home. They always
expected to have many more years of sex.
Joleen
Chambers
Aaron Horton, left, showed up almost every day to
watch the Dallas trial of Linda Batiste, right.
"I'm an old man, but I'm not that old,"
John says. "It'd be early to be quitting already."
Betty had a guess of what was causing her pain. A
few months earlier, her doctor had pitched her on a third surgery to fix her
bladder. At the time, in 2004, it was a somewhat new, exciting procedure. The
surgery itself would be minimally invasive, and she would leave with a
promising new medical implant. "The way he described it to me, it was like
a hammock," Betty says.
The hammock didn't bother her at first. But after
a few months, she started to notice cramps in her pelvis and sharp pains when
she used the bathroom. Sometimes she felt a strange pressure in her lower body.
Tired of surgeries, she decided to accept the discomfort. "I'm just going
to have to deal with it," she recalls thinking.
But the sex got worse, taking a toll on their
love life. John agreed to do an exam of sorts on his wife, thinking maybe it
was just some scar tissue. Instead, he found something odd: four plastic
strings appeared to be coming out of her body, poking through back of her
vagina.
Back at the doctor's office, a nurse took a look
and found the cords, too. But if the wires coming out of Betty were strange,
the response by the gynecologist who had assisted with the surgery was even
stranger.
"There's nothing wrong," John says the
doctor told them after taking a look. "I can't find anything."
Answerless, the couple turned to the Internet. It
was there that Betty learned she was part of a growing group of women whose
"hammocks" were causing intense pain — a pain that doctors,
device-makers and the Food and Drug
Administration were reluctant to even acknowledge, let alone respond
to.
Those "hammocks," it turned out, were
actually surgical mesh made out of polypropylene plastic, the same cheap
material Betty knew from her fishing lines. She was horrified. She knew how
breakable the material was. Yet it was supposed to stay inside of her body for
the rest of her life. "If I would have known that ahead of time, I would
not have let them be put in me," she says.
Eventually she found a doctor who believed her,
she says, who confirmed that the mesh was in fact eroding through her vaginal
wall. But the doctor didn't know how to get it out. He offered her some
estrogen cream. Betty used up the whole tube in a few months.
She resolved to just live with it, and try to
improve her health around the pain. She lost 130 pounds and left the wheelchair
to which her diabetes had confined her. Yet sexually, her health deteriorated.
She frequently got bladder infections that were passed to her husband, then passed
back to her. The cords coming out of her grew longer. To this day, when she
sits, it's like sitting on a tack.
Then, a couple years ago, they saw it: a brash,
late-night infomercial from a personal injury attorney who was hunting for
victims of transvaginal mesh surgery. It wasn't long before they were on the
phone, making the same call women across the country have been making, and soon
Betty found herself in the same situation: hoping the legal system would
acknowledge what their doctors wouldn't.
When you get so old that the Lord lets you pee on
yourself, Gynecare can help. That's the way Dr. Melvyn
Anhalt explains it, anyway.
"God gave women three mechanisms to be dry,"
Anhalt said one day last month, testifying in a Dallas
courtroom in one of many ongoing lawsuits against manufacturers of transvaginal
mesh. Dressed in a crisp black suit with cropped white hair, Dr. Anhalt, in a
thick Southern drawl, carefully explained how the female anatomy worked when
all its mechanisms were functioning properly. As former head of the Incontinence
Center at the Memorial
Hermann-Memorial City Hospital in Houston,
he understood those mechanisms well.
Gravity takes its toll on all human bodies
eventually, but giving birth can wear out the bladder even faster. Young,
healthy women who've had children can suddenly leak urine when they laugh,
sneeze or exercise, a type of incontinence doctors call Stress Urinary
Incontinence, or SUI. Throw in other risk factors like hysterectomies, obesity
or smoking, and an incontinence diagnosis is even more likely.
There have always been surgeries to fix incontinence,
and whichever method was best depended on the surgeon. A procedure commonly
referred to as the "Burch," involving opening the abdomen and
stitching loose parts back together, was considered the gold standard by many,
but it was technically difficult. Doctors also sometimes took a graft of the
patient's own tissue and used it to create a natural "sling" to
support the bladder — also a fairly major surgery. Then, in the 1990s, a
cheaper solution appeared on the market: mesh.
The material had long been in use to support soft
tissues for surgery, inserted through the abdomen to treat hernias. It was Dr. Ulf Ulmsten,
a Swedish professor, who discovered that the mesh could be inserted through a
woman's vagina, threaded around her urethra and attached to the pubic bone.
That meant less time under the knife for the patient and less time in the
operating room for the doctor.
Once inside, the mesh theoretically would be held
in place by scar tissue. Dr. Axel Arnaud,
the Medical Affairs Director for Ethicon, a subsidiary of Johnson &
Johnson, traveled to Sweden
to watch Ulmsten perform the procedure in person. The surgery was truly a
"mini-invasive" one, done in under 30 minutes. "It looked quite
easy to perform and was very patient-friendly," he reported in an internal
company memo.
The FDA cleared the first synthetic transvaginal
sling for sale in the United States in 1996. Ethicon wasn't the first company
to come out with its sling, but it soon dominated the market with its
"TVT" devices, or tension-free vaginal tape, a similar mesh sling introduced
in 1999 under the company's new Gynecare brand.
As the surgery became more common, doctors and
device makers pushed to make broader use of it. A few years later, the FDA
agreed to let manufacturers sell the mesh to treat a more complex condition: pelvic
organ prolapse.
Pelvic organ prolapse, a condition in which a
woman's pelvic organs come loose, is traditionally harder to treat than
incontinence. But when Ethicon rolled out its product, the procedure became
relatively easy. The drug-maker even provided doctors with pre-assembled kits
that contained not just the mesh but all of the tools surgeons needed to create
a sort of bird's nest to support a patient's organs.
Anhalt, the Houston doctor, was one of many who
worked as a consultant for Ethicon, teaching doctors how to implant the slings
in training sessions. Soon, the mainstream medical societies agreed: Synthetic
slings were the new "gold standard" for treating stress incontinence.
On the witness stand, Anhalt described the
invention of the sling in almost biblical terms. "That was the evolution
of how the sling came to pass," he said, "that we as urologists and
most everybody has determined is the standard of care at this time."
Anhalt was talking to a group of 12 jurors in a Dallas County
courtroom, for his latest gig: acting as an expert witness for
J&J/Ethicon's legal defense team. Linda Batiste,
the woman who filed the suit, watched sitting with a pillow on her chair.
"Are you aware of any surgeries doctor, that
have no risks?" the J&J attorney asked Anhalt.
"Only surgeries that are not done,"
Anhalt replied in his folksy manner.
The attorney laughed. "Fair enough,
doctor."
One woman was doubled over in pain, holding her
hands over her groin, crying hysterically. Another waited outside with her,
sitting in a wheelchair. They were close to the University of California in Los
Angeles, where they were headed to a doctor's appointment, but not close
enough. They needed a ride because they couldn't walk.
Aaron Horton
was with them at the time. She'd left the house so fast she was still in her
pajama bottoms, suede slippers and a pink T-shirt that read "Trailer
Cakes." She frantically tried to hail them a cab.
"No one would help us," she says, with
enough distance from the story to laugh about it. When a cab finally pulled
over, he was annoyed about the short distance they needed to go and refused to
help with the wheelchair. The ride ended, Horton says, with her pointing to
UCLA on a map and screaming at him.
They were headed to see UCLA's Dr. Shlomo Raz,
one of the few known for being able to remove mesh without hurting patients
even more in the process. His schedule is booked six months in advance. Horton
didn't need the surgery herself; she was visiting L.A. to do reporting for her
blog and offer support for the women.
For 16 years, Horton was gainfully employed in
food marketing. She shared a home in Lakewood
with her husband. She describes being raised by loving, supportive parents. She
was always the "fun friend."
That changed in 2009. Her mom had undergone
surgery to repair her pelvic organs. Immediately after, something was wrong. It
took the doctors years, Horton says, to admit the same.
She remembers watching her mother sob outside of
the doctor's office in 2011, terror in her eyes. "They had to give her IV
morphine just to give her a mental break from the pain," she says. Trying
to understand what was happening, Horton slowly threw herself into a new
passion: learning everything she could about mesh.
She discovered a news site called the Mesh
Medical Device News Desk and contributed an emotional story about watching her
mother suffer, though careful to protect her mom's identity. The response
surprised her: The story generated a flood of calls and emails and 61
thoughtful public comments.
Feeling a new purpose, Horton got to work on her
new cause: The Mesh Warrior, a blog that features personal stories about
confronting doctors, research news and polls trying to figure out how to
organize a local support group.
Horton now spends much of her time on the phone
with women too ashamed to talk to anyone else. Their stories follow a
disturbing pattern: doctors who won't listen, sometimes family members who
won't either. "I can tell you 10 women I can probably think of right now
who started off this surgery with three kids, beautiful house," Horton
says. Now, "their husband has left them, they've lost their house, they've
lost their job because they can't work and now they're on disability and living
in isolation in Section 8 housing."
Sandy (not her real name) is one of them. She
returned to her gynecologist initially and got no answers, she says. "She
did a pelvic on me, and said everything was fine and her work was — I'll never
forget this word — 'pristine,'" she says. But there was a strange tailbone
and leg pain in Sandy's body that got worse over time. It spread to her back
and hips.
Sandy got more surgeries to fix those problems.
They didn't work. Finally, she says, a doctor determined it was the mesh
causing the pain. Sandy went to UT Southwestern,
she says, but the doctors told her the surgery was too risky. She wasn't
convinced, so she found another doctor who was willing to take the mesh out.
Now the mesh is gone, but it's not clear that she's better off. The surgery
left her severely incontinent, with a fistula and pain so intense she can't sit
without popping pain pills. Her husband divorced her. "He didn't want to
be with a wife who could not have sex with him," she says, crying into the
phone.
She lives alone, too ashamed to ask her adult
children if she can move in. She's living on her retirement checks but expects
to run out of money and isn't sure what will happen next.
Dr. Daniel
Elliott, a surgeon at the Mayo Clinic,
specializes in removing mesh. He says patients complain "all the
time" about doctors who've ignored their pain. "I have a feeling,
unfortunately, there are certain individuals who have put this in, they're not
high volume [surgeons], they don't have advanced training and then they have a
complication and they don't know how to deal with it," he says.
Horton blogs from a friend's barn house in East Texas,
where she and her husband spend many weekends. Aside from occasional rifle
shots in the background, the land is peaceful, home to a small farm business
and trees. She writes from the balcony. For meals, she and her husband visit a
local organic restaurant and chat with the owner, a former gynecologist who
tried implanting mesh once and didn't like it. "To me, it looks kind of
like, what's that material? A body scrubber thing," he said one recent
afternoon.
When she's not writing, she's drumming up
support, teaming up with Joleen Chambers,
another Dallas-based patient advocate, and Hal Samples,
a Dallas photographer who suffered complications when he got mesh for a hernia
surgery. To show his gratitude, he gave Horton a free photo shoot. She asked to
be made up in blue makeup, like a feminine warrior. Before the shoot was over,
she bought some textiles from Home Depot
and tore them up, giving the material the appearance of mesh. She stuck it over
her lips for the final picture — the photo she uses on her Mesh Warrior site.
"I said, 'I've got to have this picture because this is how these women
feel,'" she says. "They feel silenced."
She's trying to get a formal foundation going
too, and has had meetings so far with Consumer Reports
and the UCLA marketing department. But mostly she's a welcoming ear to patients
with no one else to turn to. A welcome ear and a comfortable couch in Lakewood,
where she's let more than one plaintiff crash when they've come to Dallas to watch
the mesh battles play out in court.
One day in 1998, a young pharmaceutical rep
showed up at Dr. Tom Margolis'
office, pitching him on a new device. The rep wanted Margolis' business, badly.
"I said, 'Nope, no way,'" Margolis recalls. "I told him that
they were going to have all sorts of problems."
Whatever those problems would be, doctors
wouldn't know until it was too late. Unlike drugs, the Food and Drug
Administration allows any device on the market if the company argues that it is
"substantially equivalent" to an existing device — no clinical trials
required. A recent report from the Institute of
Medicine called the FDA's device-regulation procedure "fatally
flawed." But no matter: Transvaginal mesh went straight to market without
trials.
"The way they've set this up legislatively,
it's making it very profitable for these companies to continue putting out any
kind of implant [on the market] and innovate on them and not have any
requirement to prove it with patient outcomes," says Joleen Chambers, a
Dallas-based patient advocate who blogs at the FAILED Implant Device Alliance.
The problems revealed themselves quickly. First
was the fact that the product was inserted through the vagina, an organ doctors
say can't be sterilized like the abdomen can. Even in the early years, mesh
manufacturer Ethicon knew how problematic that would be.
"It was broadly admitted that the use of any
mesh through a vaginal route was associated with a high rate of
complications," the company's medical affairs director, Axel Arnaud, wrote
in a memo. Yet he ultimately decided to trust the sling inventor and sign a deal
with him.
Anhalt, the Houston doctor, was one of the early
sling users. The first plastic transvaginal sling, called the Protegen, was
marketed by a company called Boston
Scientific. Anhalt implanted a woman named Patricia Joyce
with it in June 1997, after she complained about her incontinence.
Yet several weeks later, Joyce couldn't urinate.
She went back to Anhalt, who concluded that he may have placed her tissues
"too high" but that he would wait another month before doing
anything, she later argued in court papers. He performed surgery on her again,
cutting part of the sling to loosen it "in attempt to allow the bladder
and the urethra to come down to a more normal position," her lawsuit says.
In December, Anhalt performed a third surgery to remove the scar tissue. Joyce
finally left him and went to another doctor the next year. The new doctor said
she had a hyper-suspended urethra and performed three more surgeries to try
fixing it. (The suit was settled in 2001. Dr. Anhalt did not return messages
seeking comment.)
Joyce's problems were hardly unique. In 2000,
Boston Scientific announced that it was recalling its sling, citing a high
number of customer complaints. Yet dozens of other companies, including
Ethicon, were able to keep their slings on the market without FDA scrutiny,
even though they shared many characteristics with the Protegen sling.
And they worked hard to make sure doctors kept
using them. In 2000, Lisa Kwiatek,
Ethicon's Director of Incontinence, ordered sales reps to get in touch with surgeons
presenting at that year's American Urogynecologic Surgeons. She wanted to make
sure they wouldn't make any "incorrect statements."
"Let's do what we can to make sure what is
being presented is positive to TVT," she wrote, "and alert me to
potential challenges."
Greg Slusser,
Ethicon's Eastern Regional manager, forwarded the message along to employees.
"The only way to ensure this is to talk to your doctors who will be presenting,"
he wrote, apparently referencing doctors who had been employed as Ethicon
consultants. "If any concerns are identified, let's get them back on the
TVT bandwagon prior to the meeting before they can negatively impact the
attendees who attend their lecture."
It was 2000 when Ethicon first learned that its
TVT products had a tendency to break off in pieces of lint and rope,
potentially sending pieces of plastic through women's bodies. By 2003, Ethicon
reported having received 58 complaints about fraying mesh.
"Fraying is inherent in the design and
construction of the product," wrote Marty Weisberg,
Ethicon's Senior
Medical Director, in a company memo. He decided, however, that
fraying wasn't necessarily a bad thing. "There is no reason to expect that
the fraying of the mesh or the particles generated would create any safety
risks," he wrote. As a result, "it has been determined not to pursue
any corrective actions at this time."
When Ethicon introduced a TVT product in a blue
color the next year, the fraying became more obvious. "Already at the
operation it is embarrassing to see how the tape is crumbling," Dr. J.
Ebard, a German doctor who consulted with Ethicon, complained to the company in
a 2004 email. With the blue color, he said, "everyone has realized that
the quality of the tape is terrible."
In 2004, Gynecare's
Research and Development head Dan Smith
got word that two more doctors had complained about blue plastic particles. He
wasn't surprised. He'd warned them — not that it wouldn't work, but that they
shouldn't make the problems so obvious.
"This is not going to go away anytime soon
and competition will have a field day," Smith warned in an email.
"Major damage control offensive needs to start to educate the reps and
surgeons UPFRONT that they will see BLUE shit and it is OK. This is why I
wanted to launch TVT-O in clear!!!!"
There was also dyspareunia, the medical term for
painful sex caused by the mesh. Before a company clinical trial was scheduled,
Ethicon employees searched for a way to avoid discussing that undesirable side
effect.
"I ACCEPT THAT WE NEED TO REPORT THE CASE OF
DYSPAREUNIA BECAUSE I WOULD AGREE IT WOULD BE UNETHICAL NOT TO MENTION SINCE WE
KNOW ABOUT IT," Kimberly
Hunsicker, Ethicon's Research Operations Manager, wrote in 2004.
"HOWEVER THE WAY IT IS PRESENTED IN THE ABSTRACT IS GOING TO KILL
US."
In a follow-up note, she added that dyspareunia
data are low in the study because it is a self-reported adverse event and not
part of the questionnaire given to patients. Her solution was to keep it that
way: "To my knowledge, we will not have 'solicited' information
(questionnaires) on dyspareunia at the end of the trial."
Patients who suffered complications could report
it through the FDA's adverse event database, a voluntary system that provided
the only legitimacy for many patients. In the public database, Ethicon
responded to the complaints with the same refrain: No conclusions could be
drawn. But behind closed doors, Ethicon worked closely with surgeons to figure
out how to improve the mesh.
"Need to learn more about special anatomic
features in the vaginal region," read company notes from a 2007
"brainstorming session" with surgeons. Apparently, the human vagina
was something that was eluding a few of the gynecologists Ethicon had met with.
"Problem: Vagina is very odd-shaped, so you cannot use a preformed
implant," the report adds.
Finally, in 2008, the FDA took action, albeit
minor. It posted a warning online about mesh use for POP and SUI, issuing a
broad statement: "Over the past three years, FDA has received over 1,000
reports from nine surgical mesh manufacturers of complications that were
associated with surgical mesh devices used to repair POP and SUI," the
FDA's notice says, adding that adverse events were "rare" but
serious.
Carolyn Lewis
didn't see that report before she agreed to get a sling in 2009. It didn't get
much publicity, and she trusted her doctor enough not to fact-check her words
online. A housewife from Corsicana,
she traveled to Dr. Muriel
Boreham's office at Baylor to do something about her leaking, and
circled "yes" three times in the medical form when asked if she'd
consider surgery, court records show.
Under the knife, Lewis' bladder was accidentally
perforated — twice. (In a court deposition, Dr. Boreham blamed the accident on
a physician's assistant. She didn't return messages.) That was another issue
that became apparent with the slings: the "blind" angle at which
surgeons inserted them, combined with the seemingly easy nature of the surgery,
had created a potentially dangerous situation in which some doctors didn't
realize that they were in over their heads.
In 2011, Ethicon interviewed surgeons to
investigate why erosion was happening so often, with the pelvic floor surgeries
in particular. According to company documents, the surgeons "maintain that
mesh is sometimes used in cases where it is not necessary by an enthusiastic
but less skilled general gynecological surgeon."
"What I would say is that the industry is
guilty of making it [the surgery] look awfully easy to doctors,"
acknowledges Dr. Brian
Feagins, founder of the Dallas Center
for Pelvic Medicine and a consultant for pharmaceutical companies
that sell the devices. Feagins has taught how to implant the slings at courses
with catchy titles such as the "Sling-a-thon" and remains confident
in his skill level, telling patients that they risk just a 4 to 8 percent
complication rate. "Mesh is still an excellent tool when used in the right
situation by the right doctor. That's why I keep using it."
Eventually, Ethicon would improve its mesh
products, introducing a thinner, softer plastic cut with lasers that didn't
leave particles in the operating room. The company never recalled the original
mechanically cut mesh, instead leaving both on the market at the same time. An
Ethicon marketing executive wrote in 2005 that "we do get a high number of
complaints on linting and roping" on the older mesh. She asked for help
telling "a nice story without overtly admitting that the current product
may have some perceived aesthetic problems (not clinically relevant)." (In
a statement, an Ethicon spokesman said "millions of pages of documents
have been provided" and "selective disclosure of certain sentences or
phrases without proper context can be extremely misleading.")
Yet research still showed problems with the newer
mesh, and Ethicon kept investigating. Ethicon had donated its POP kits for
researchers to study erosion. In a 2010 study, the researchers reported that
after just three months, 15.6 percent of the women had suffered the
complication. The trial was halted early for ethical reasons.
The FDA took notice and, in 2011, issued a new
statement about mesh, zeroing in on its use for pelvic organ prolapse.
Complications from that procedure, the FDA warned, were "not rare"
after all. Still, the agency never demanded a formal recall. Instead, Johnson
& Johnson quietly took its mesh for POP off the market the next year,
describing it as a business decision. Mesh for incontinence remains available,
with the FDA still not issuing a clear guideline on whether those complications
are also rare.
The industry is clinging to the idea that mesh
for incontinence is very different from mesh for POP. And doctors are following
that lead. The American
Urogynecologic Society has acknowledged problems with mesh for
pelvic organ prolapse but has stood firm in its support of the mesh for
incontinence. It blames lawyers and the media for creating "confusion,
fear, and an unbalanced negative perception regarding the midurethral sling as
a treatment for SUI [stress urinary incontinence]." Then again, half of
the AUG board members have disclosed business ties to device manufacturers.
"They are not just apples to oranges, they
are apples to watermelons. It's completely different," says Dr. Cheryl
Iglesia, a urogynecologist who helped craft the FDA's 2011
statement, and had also led the study showing a 15.6 erosion rate in Ethicon's
pelvic mesh.
The doctors at UT-Southwestern share her
philosophy. "Nobody in the Urogynecology division here at UTSW uses
transvaginal mesh devices for POP," UTSW surgeon Dr. David Rahn
writes in an email. He defends mesh use for incontinence, adding: "In
general, I find that patients are now very fearful of all vaginal meshes used
for SUI and POP, which is unfortunate because there is a substantial difference
between the two."
But medical literature and lawsuits describe
women injured by both types of implants. Dr. Elliott, from the Mayo Clinic, and
Dr. Margolis, the California doctor, say they remove both types of mesh in the
complicated explant surgeries, at least when it's possible. Most recently, Dr.
Elliott said he saw an older woman in horrible pelvic pain from prolapse
surgery whom he didn't feel comfortable operating on. "She can't sit, she
can't lie down, she can't walk because of pain following a mesh surgery, and we
don't have a fix for her," he says. "That's it."
Adds Margolis, the mesh critic: "The sling
is like plastic chicken wire. Once it's embedded into the vagina, and once it's
scarred into place, it or portions of it are part of that woman for life. You
can't get it all out."
One morning in March, Linda Batiste walked slowly
through the courtroom, using a cane for support. Her team of attorneys and
their young paralegals helped her get the door. At 64, Batiste, who lives in
South Dallas, has had a long life of health problems. In her 20s, she was
diagnosed with endometriosis, a painful condition in which the lining of the
uterus grows into other parts of the body. She'd had a hysterectomy, back
surgery and heart surgery. Though not overweight, she suffered from diabetes
and a history of strokes. She continued to smoke cigarettes through it all.
Still, life wasn't about just coping. She had a
boyfriend, and they talked about getting married. That was back in 2011. It was
around then that she visited Dr. John McNabb
at Baylor to do something about her stress urinary incontinence. His solution:
an Ethicon sling, called the TVT-O.
Afterward, sex became too painful and her incontinence
got worse, she says. She sued Ethicon and its parent company, Johnson &
Johnson.
It's a common tactic. The FDA's 2011 notice put
personal injury attorneys on alert. Drug attorneys found thousands of new,
desperate, angry customers. Infomercials urged women who received
"transvaginal mesh" to call the hotline immediately.
So many women signed up that the courts decided
to consolidate most of the cases in West Virginia,
before a single judge. He's now responsible for more than 17,000 lawsuits just
against Ethicon. The suits against other device manufacturers, including Boston
Scientific, American Medical
Systems and C.R. Bard,
are also in his court, bringing the grand total of pending pelvic mesh cases to
more than 50,000. A few of those cases have been heard, but delays plague the
West Virginia system. Most recently, Carolyn Lewis, the woman from Corsicana
whose bladder was perforated at Baylor, had her trial in the West Virginia
court. But before the jury could even deliberate, the judge sided with Johnson
& Johnson and tossed the case.
The Batiste case managed to escape that slow
system, instead ending up in Dallas County Court. The proceedings provided a
rare preview of how thousands of other mesh trials may play out.
On the witness stand, Anhalt reviewed Batiste's
medical records for the defense. Young men and women in business suits typed
furiously on their laptops behind the Johnson & Johnson attorneys as Anhalt
discussed her bathroom habits and other health ills.
Johnson & Johnson's lawyers unsuccessfully
tried to introduce an apparent sexual abuse Batiste suffered from more than 40
years ago into evidence. In videotaped deposition, they grilled her former
fiancé about how many cigarettes she smoked. Under cross-examination from
Batiste's attorneys, he said they broke up after the sex wasn't possible.
"I love her, but not like I used to,"
he testified, blaming it on "the problems she's having downstairs with
that mesh."
Horton, the Mesh Warrior, came to the trial with
Chambers, the local failed device implant advocate, almost every day, and
waited in the courtroom as the jury deliberated. In April, they made their
decision: Johnson & Johnson owed Batiste $1.2 million in damages. It was a
rare victory for the injured women. "Great day for #American
#JUSTICE!!," Horton tweeted.
Johnson & Johnson does not seem concerned. In
2012, it warned investors about the growing litigation, but added: "The
Company believes that the ultimate resolution of these matters ... is not
expected to have a material adverse effect on the Company's financial
position."
FiDA comment
If U.S. justice does not extend to profiteering medical
providers and CEO's of medical device manufacturers that cannot clinically
prove the value of the products to human health, PREVENTABLE harm will increase
and the cost to our nation will be quickly unsustainable. Why isn't PCORI
(patient centered outcomes research institute) funding grants that compare
implanted medical device outcomes? Why does FDA only legally require
surgeons to report fatalities as an adverse event? Why isn't a MSDS
(materials safety data sheet) a part of informed consent? Why doesn't CMS
require the implant manufacturer to provide a basic product warranty? Why
can you knowingly torture human beings with these implants with the assurance
that you will see no jail time? Why is protection inherent to the
corporation but so illusive to the harmed individual?
