A Lawyer Who Won $20 Million For His Client Says We Are Facing “The Greatest Women’s Health Crisis Of Our Generation”


“Even just a few months after the operation I was raw with pain
and I had this feeling that my urine was absolutely hot and
scalding.”

Posted on June 04, 2017, 04:32 GMT

It was supposed to be a 50th birthday present to herself.

But the urogynaecological surgical mesh – sometimes called a
bladder sling – that Janelle had inserted in September 2014
left the Brisbane mother-of-two in excruciating and
life-defining pain.

She can’t wear underwear. She can’t have sex. She can’t fall
asleep without a handful of painkillers and a pillow propped
between her legs.

“Sometimes it is so aggravating that it is teeth clenching,”
Janelle, who asked to be identified by her first name only,
told BuzzFeed News.

The 53-year-old is one of more than 700 Australian women
registered for a class action against the maker of the mesh,
Ethicon (a subsidiary of Johnson & Johnson), which will
go to trial on July 4.

The polypropylene implant was inserted by her gynaecologist
to treat stress urinary incontinence (poor bladder control).

“[The doctor] suggested they put the bladder sling in at the
same time as my hysterectomy, so it was a gift to myself to
change my life so I didn’t have to wear pads or worry about
[the urinary incontinence].”

Urogynaecological meshes, sometimes known as transvaginal
meshes, are inserted into women as a treatment option for
urinary incontinence or pelvic organ prolapse – when the
connective tissue securing the vagina and uterus to the
pelvis gives way after childbirth.

In the latter case the mesh – which is non-absorbable and
acts as a permanent implant – is inserted under the urethra
(the tube that empties urine from the bladder).

The pain began straight after the operation.

“Even just a few months after the operation I was raw with
pain and I had this feeling that my urine was absolutely hot
and scalding,” Janelle said.

“The pain in my groin was like someone had belted me with a
cricket bat.”

She said she was passed between specialists who refused to
take her pain seriously.

“Every doctor just looked at me like ‘it can’t be that bad’
while I was weeping.”

Eventually, she was told the implant had eroded through her
vaginal wall, so she had surgery to partially remove the
device.

The pain continued through another treatment suggestion –
cortisone injections into her pubic area.

Today, it hurts Janelle too much to even wipe after
urinating, and she is unable to have sex.

“The nerve damage just shoots down your leg from your groin
to your ankle.” she said.

“My lower back sometimes feels like it is in labour. Bending
down to get washing or stepping over something is like being
ripped in half.”

Janelle is determined to continue working most days as she
doesn’t want her husband to be “smothered with the financial
burden”.

“I just have to suck it up and take it one day at a time…
I’m just not the person I used to be, but the old me is still
stuck in there somewhere.”

Many Australian women have flown to St. Louis, Missouri,
to see obstetrician-gynecologist Dionysios Veronikis and have
their implants partially removed.

Veronikis
said he has performed more than 1,000 mesh removal
surgeries since 1994, and seen a rapid increase in patients
over the past five years.

“I can’t afford that because it would be upwards of $30,000,”
Janelle said.

She didn’t think any legal recourse would be available until
she joined the class action with Shine Lawyers.

In the statement of claim, supplied to BuzzFeed News,
patients have listed a raft of symptoms and complications
following the insertion of nine different Ethicon mesh
devices.

Chronic and constant vaginal pain, visceral pain with bowel
movements, dyspareunia (pain during sex), vaginal bleeding,
the granulation of vaginal tissue, pain through the glutes,
inflammatory reactions, “offensive discharge”, incontinence,
leg weakness, haemorrhages.

Many women listed subsequent mental health issues as well as
repeated erosions through the vaginal wall or rectum.

Janelle lives in fear of another perforation into one of her
organs.

“The unknown is the most terrifying part… I am worried it
will perforate into the bowel.”

Shine Lawyers principal Jan Saddler said her clients had
suffered complications with their mesh implants and those
complications had had a “severe and extreme impact on their
daily lives”.

“These complications range from erosion into the tissues of
the body through to pain during intercourse, infections,
chronic pain,” Saddler told BuzzFeed News.

“These issues arose because there was no adequate testing and
evaluation of the products.”

Almost all (95%) of her clients in this class action had had
revision surgery – operations to try and assist with the
complications, or to partially remove the mesh.

“We have ladies who have had seven or eight revision
surgeries and there is no compensation scheme in place.”

Saddler estimated “up to 100,000” of the nine products had
been implanted in Australian women.

“It is really heartbreaking to hear stories day in and day
out of marriages breaking down and careers being thrown away,
and women who can’t enjoy a normal life with their
children.”

Saddler is confident she can win compensation for her
clients.

Bloomberg estimated there were more than 54,000 lawsuits
pending over Johnson & Johnson’s vaginal mesh inserts.
The company has lost at least five jury awards to the tune of
US$35 million over the devices since 2014.

Ohio lawyer Ben Anderson was the lead plaintiff’s attorney on
a case where
last month Johnson & Johnson was ordered to pay US$20
million to a New Jersey woman who blamed the company’s
TVT-Secur mesh for her chronic and unresolved pain.

“The vagina, rectum and bladder are flexible organs that need
to be able to move and stretch and you can’t do that with a
bunch of hardened fishing lines around your organs,”
Anderson, who has liaised with Shine Lawyers to help its
case, told BuzzFeed News.

“This is the greatest women’s health crisis of our
generation.

“A theme that runs through these pelvic mesh lawsuits is that
these companies knew there were complications, and they
failed to tell doctors and patients because it would hurt
their precious profits.”

An Australian Johnson & Johnson spokeswoman told BuzzFeed
News the company was “always concerned” when a patient
believed they had experienced an unexpected or undesirable
outcome.

“Our priority is and always has been patient safety, and
pelvic mesh is backed by years of medical research,” she
said.

“This is a complex court case. We are confident the evidence
will show that Ethicon acted responsibly and appropriately.”

In a defence filed to the Federal Court, Johnson &
Johnson has outlined its defence for the upcoming July
case.

On June 4, 2012,
Ethicon announced that four versions of transvaginal mesh
would be withdrawn from the market including that
embedded in Anderson’s client, the Gynecare TVT Secur System.

Anderson said there were two main points he had to prove to
win the case.

“I had to prove that the product was defective in design,
which I did… the mesh itself caused too much scarring and
inflammation and because it was too short and sharp it was
just cutting through tissue.

“I also had to prove that Johnson & Johnson had failed to
warn the doctors and their medical directors testified under
oath that they knew before they sold the product of this list
of horrible and chronic lifelong permanent injuries like
pain, painful intercourse, erosions and the need for multiple
surgeries.

“Not only was I able to prove a ‘failure to warn’ claim but
we showed malicious intent.”

Johnson & Johnson will appeal the decision.

Anderson warned the looming Australian case would be tough on
any women asked to give evidence and described the experience
of his lead plaintiff Margaret Engleman.

“If someone testifies she has to talk about painful sex and
wetting herself and foecal incontinence and putting her
fingers in her vagina as a splint to defecate properly in
front of a courtroom and I understand that women don’t want
to do that.

“But I have tens of thousands of clients and these women want
to be heard and that was more important than any dollar sign.

“Twelve jurors said, ‘we believe you; we believe that you
were injured; we believe that this company was wrong and this
company should be punished’.”

Dave Hunt / AAPIMAGE

Court documents are wheeled from the Supreme Court in
Brisbane.

But unlike in the US, class actions cases are not heard by a
jury in Australia, so Shine Lawyers will be trying to
convince a judge.

It is easier to commence and maintain a class action in
Australia than in the US, but because the unsuccessful party
has to bear the cost of the proceedings here – in the United
States each party pays its own fees regardless of outcome –
“speculative litigation” is deterred, a
recent paper published by leading Australian law firm Allens
found.

Anderson said settlement payments could take years to be
distributed to patients.

“You can’t give someone back their life and you can’t take
away the pain, but money is the only language these
corporations understand.”

An Australian Senate inquiry launched in February will
hear from women affected by the implants and doctors, and
will also examine the Therapeutic Goods Administration’s
“knowledge of women suffering from health problems after
having transvaginal mesh implants”.

Submissions to the inquiry close at the end of the month and
the committee will report in November this year.

Another 300 Australian women have registered with Shine
Lawyers for a second class action against American Medical
Systems over 10 of its different mesh implants. Shine said
the group may eventually exceed ,2000 women.

Gina Rushton is a breaking news reporter for BuzzFeed News
and is based in Sydney.

Contact Gina Rushton at gina.rushton@buzzfeed.com.


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