Preview Newsletter
Ethicon Media Monitoring 3/23/2017
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Risperdal Cases Against J&J Continue to Grow in PA Mass Tort Program
Mar 22, 2017 | New Brunswick
By Dave Schatz
In Philadelphia's mass tort program, thousands are suing Brunswick-based Johnson & Johnson (J&J) over alleged injuries caused by the Pharma's Risperdal medication and the volume of cases on file has grown. -
EDITORIAL: Surgical mesh failures a global problem
Mar 23, 2017 | Newcastle Herald
ON her final night as Australian prime minister, Julia Gillard wrote to Newcastle Herald journalist Joanne McCarthy, to say that it was her “persistence and courage” that had “in large measure” led to the creation of the Royal Commission into Institutional Responses to Child Sexual Abuse. -
Woman speaks out over devastating impact of mesh surgery
Mar 23, 2017 | The Sydney Morning Herald
By Joanne McCarthy
Jan Wise is "rotting from the inside" after being implanted with a high-risk pig-intestine pelvic mesh device in 2012 by a doctor with a history of botched surgery involving women in the US. -
The TRUE Story Of How One Woman's Vagina Tore Apart Her Man's Penis
Mar 22, 2017 | Your Tango
By Kiarra Sylvester
The act of sex in and of itself can be mortifying without any outside help, but most as a woman, there are always extra fears. -
Woman's Vagina "Grows Teeth" and "Bites" Man's Penis
Mar 22, 2017 | Men's Health
By Reegan Von Wildenradt
A bladder surgery gone very wrong led to a couple's worst bedroom nightmare. According to an article published in The Sun, Theresa Bartram and her partner were mid-intercourse when her vagina "grew teeth" and left her partner's genitalia severely damaged. Two years prior, Bartram had a bladder operation where a plastic mesh was inserted to lift her bladder. But the mesh was fitted too low and it ended up eroding through her vaginal wall, essentially resulting in a row of plastic teeth. Ugh. -
Botched surgery leaves lady with 'Venus fly trap vagina' that BIT lover's penis during sex
Mar 22, 2017 | Daily Star
By Sarah Buchanan
A MUM reveals how her vagina “grew teeth” after surgery to improve her sex life went horribly wrong. WARNING: GRAPHIC CONTENT. -
Botched vaginal surgery mutilates penis
Mar 22, 2017 | 6Minutes
A British woman who underwent surgery to improve her sex life ended up with none — after her vagina mutilated her partner’s penis. Theresa Bartram, 50,...
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Risperdal Cases Against J&J Continue to Grow in PA Mass Tort Program
Mar 22, 2017 | New Brunswick
By Dave Schatz
Another Case Began on March 20, And Many More Are On Deck
PHILADELPHIA, PA–In Philadelphia's mass tort program, thousands are suing Brunswick-based Johnson & Johnson (J&J) over alleged injuries caused by the Pharma's Risperdal medication and the volume of cases on file has grown.
The amount of cases increased by 550 last year, up nearly 40% from 2015, reports the Legal Intelligencer.
The drugmaker is simply not settling the cases compiled in Philadelphia state court over its antipsychotic, Risperdal, once a blockbuster drug for J&J, but one that got the company in trouble because of the way it was marketed by the company.
Though Janssen, the J&J unit responsible for marketing Risperdal, has settled with attorneys on the West Coast for small amounts of about $2,000 a case, that's simply not enough for a group of other attorneys partnering in Risperdal litigation in Philadelphia. And that group has filed thousands of cases against the pharma that are, except for a couple, not being settled out of court.
“J&J does whatever they can to win,” like "bringing [to court] new experts" to testify for the Pharma, said a person familiar with the matter, or changing law firms that represent them, on top of appealing each and every case they lose.
Thomas Kline, an attorney spearheading Risperdal litigation in partnership with attorneys Jason Itkin and Stephen Sheller, recently said they’ve added more than 540 new cases to the mass tort during a recent two month period.
But so-called “tolling agreements” between law firms and company’s prevent the public from knowing the actual number of cases in the system.
Kline cited Janssen’s decision to end a tolling agreement, following its $70 million loss in a Risperdal case in Philadelphia this past July as a one factor that might be driving the increase in Risperdal cases.
Moreover, when J&J does settle out of court, it usually insists on secrecy – not revealing to the public the dollar amount it agrees to pay the plaintiff. Thus, the only time figures are typically disclosed would come after juries reach verdicts against the company, and payouts are awarded to plaintiffs in open court.
Risperdal allegedly causes boys to grow female breast tissue. The recent $70 verdict was among one of the six largest product-defect cases in the U.S. during 2016, as Bloomberg Businessweek, points out in its March 13 issue.
The other five large product-defect verdicts that J&J was hit with in 2016 are a $1 billion hip implant judgment in Dallas federal court, three Talcum Powder verdicts in St. Louis state court awarding: $72 million, $70 million, and $55 million respectively, and an additional $502 million hip implant loss, again in Dallas.
J&J is up against more than "17 trials in state and federal courts this year in cases blaming five J&J products for injuries and death," writes Marget Cronin Fisk and Jef Feeley in the Businessweek article titled: The Lawsuits Keep Coming For Johnson & Johnson.
"[The cases] follow trial losses on some of those products, including a $1 billion verdict against the company in December over hip implants and an earlier $72 million verdict over claims its talcum powder causes ovarian cancer."
Though "litigation is routine for drugmakers," like J&J, the magazine cites 100,000 claims against the pharma, with the number of claims increasing, referring to a rare "pileup of bad verdicts."
Still, J&J has "$42 billion of cash on hand," notes the magazine, describing a "mushrooming caseload combined with [a myriad of] product recalls and little innovation," as reasons the Hub City pharma giant's growth and profit have been stalled.
“I think that has been part of what has weighed on J&J’s shares the past few years,” Jason McGorman, a financial analyst, with Bloomberg Intelligence, told Businessweek, while a portfolio manager was quoted as saying the verdicts have damaged J&J's reputation.
But "J&J disputes the claims in the suits and is fighting them, says [J&J] spokeswoman Samantha Gilham," according to the magazine. And, "the coming cases [also] include the first trials, starting in April, about claims that blood thinner Xarelto causes uncontrolled bleeding."
Gilham also told the magazine that the pharma believes it has strong "grounds for reversal.”
The magazine suggests that some of the trials are "test cases" and could help determine how much J&J may have to dish out.
At the end of last year, the pharma giant also "lost an appeal to throw out an $11.1 million award to a South Dakota woman who sued over the pain caused by the company’s vaginal mesh implant, used to strengthen weak pelvic muscles," wrote Fisk and Feeley.
"Almost 55,000 claims over the mesh are pending in courts [nationwide]," they continue, noting J&J said in a recent regulatory filing that many new cases dealing with alleged J&J product-defects continue to be filed.
http://newbrunswicktoday.com/article/risperdal-cases-against-jj-continue-grow-pa-mass-tort-program
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EDITORIAL: Surgical mesh failures a global problem
Mar 23, 2017 | Newcastle Herald
ON her final night as Australian prime minister, Julia Gillard wrote to Newcastle Herald journalist Joanne McCarthy, to say that it was her “persistence and courage” that had “in large measure” led to the creation of the Royal Commission into Institutional Responses to Child Sexual Abuse.
As readers of the Herald will know, Ms McCarthy had worked for years to expose the wrongdoings of the region’s Catholic and Anglican churches: her reporting built a well-head of pressure that would only be eased by the top-to-bottom investigation of a royal commission.
As Herald readers will also know, Ms McCarthy has more recently turned her attention to the problems afflicting hundreds – and probably thousands – of Australian women after surgery to insert a class of products known as “transvaginal mesh”.
The first articles covered complaints about a single surgeon, Richard Reid. But it became quickly apparent that this was about more than the actions of a single surgeon, or the failings of a particular product.
Transvaginal mesh products were originally approved to treat urinary incontinence, a common problem for women after childbirth. But from 2001, they were increasingly used to treat a different problem; pelvic organ prolapse. It has since emerged that the American regulator, the Food and Drug Administration or FDA, did little if any checking into the efficacy and safety of these devices until it was far too late.
By 2011, at least eight of 18 devices evaluated by the FDA had been removed from the market, and a range of class action court cases were to follow. Individual court cases have resulted in multi-million dollar awards against doctors and manufacturers alike, and experts say the combined class action payouts could hit $20 billion.
The Australian situation mirrors that of the US, albeit on a smaller scale. And as was the case with the churches prior to the royal commission, the Australian victims of this surgery gone wrong are having to take their chances in an adversarial legal system that seems stacked in favour of the manufacturers and their insurers, and ill-suited to a search for basic truths. The recently announced Senate inquiry is a start, but it may take a more aggressive inquisitorial investigation to get to the bottom of a medical scandal that has used trusting women as guinea pigs. In the meantime, the Herald will help provide these women with a voice.
http://www.theherald.com.au/story/4548404/mesh-surgery-a-global-decade-of-disaster/
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Woman speaks out over devastating impact of mesh surgery
Mar 23, 2017 | The Sydney Morning Herald
By Joanne McCarthy
Jan Wise is "rotting from the inside" after being implanted with a high-risk pig-intestine pelvic mesh device in 2012 by a doctor with a history of botched surgery involving women in the US.
The doctor – former Newcastle University associate professor Richard Reid – is the subject of complaints being prosecuted by the NSW Health Care Complaints Commission after a number of women alleged serious injuries following pelvic mesh surgery by him over nearly a decade.
The pelvic mesh implanted in Mrs Wise – Cook Medical's Surgisis for women's prolapse repair after childbirth complications – is still classified as high risk nine years after it was cleared for use in Australia in 2008, and later promoted by Dr Reid as having "no mesh complication risk".
Mrs Wise, 52, of northern Victoria, cannot speak of the devastating impacts of the mesh surgery on her life without crying.
"I try to wake up hoping the thoughts of the nightmare won't take up too much of that day," she said. "I allow myself only one period of sadness and crying per day."
In an adverse event report in 2016 to Australia's drug and medical device regulator, the Therapeutic Goods Administration (TGA), Mrs Wise said she could no longer have sex. She has back and leg pain and "shooting electrical shock pain from my lower body up through to my head".
She advised the TGA she had suffered "permanent incontinence" since the surgery, her vaginal vault had collapsed and she had been diagnosed with a "putrid seroma", or build-up of fluid in her pelvis, which caused "continuous pelvic discharge with a foul smell".
"I am physically rotting away from the inside," she said, adding she now lived with "the threat of timebombs" of further complications.
"It's a dreadful mess down there, but I have to accept it's now part of me," she said. "I'm no longer embarrassed by my health issues. I've accepted things that I can't go back and change, but I can't let the hurt just be buried and forgotten."
Mrs Wise said that speaking in public about her pelvic mesh surgery and supporting the Australian Pelvic Mesh Support Group, which demanded the TGA list 30 known mesh complications on its website in 2016, had helped her keep going. She will make a submission to an upcoming Senate inquiry on transvaginal (surgery via the vagina rather than the abdomen) mesh devices and procedures.
Several specialists have told her they cannot provide further surgical options to alleviate the symptoms. One offered pain management. A major legal firm declined to take legal action on Mrs Wise's behalf because the number of women implanted with Surgisis for prolapse in Australia was relatively small, the risks involved with legal action were high, and her case would not be "commercially viable".
She no longer teaches people to drive, or rides a motorbike, or enjoys the social events with her husband at a motorcycle club that were a significant part of their lives.
"I did not have any of these issues before being implanted with this product," Mrs Wise said. "Before the surgery I'd lost a lot of weight and I felt so fit and healthy. I had the surgery because of incontinence and I went to a doctor who was promoted as a women's health expert. He told me he had done the repair procedure many hundreds of times and to him it was a simple fix.
"People were waiting to see me get well, but I didn't get well. No one knew what was going on, and you can't talk about what's happened because it's so awful and so private. I thought I was the only one."
Asked about Mrs Wise's surgery, Dr Reid said he had "no recollection of that and I don't want to comment".
Dr Reid disclosed to a urogynaecological conference in April 2011 that he had "received financial support from the manufacturer, developer, distributor of the Surgisis device". He told the Newcastle Herald the support related to speaker's fees at conferences.
In 2006 Cook Medical released a public statement in America claiming a "94 per cent success rate" for a version of Surgisis pig intestine prolapse mesh, based on "research conducted by Dr Richard Reid" in Australia.
Dr Reid said he had "no idea what they're relying on" to make the statement. He said he had completed "audits" of his surgery and presented them at a conference, but only held "discussions" with Cook about his results. He said he was unaware of the 2006 Cook Medical statement.
In 2015 Cook Medical cited research by Dr Reid and other doctors in an unsuccessful attempt to stop the US Food and Drug Administration from reclassifying its transvaginal pig intestine meshes to high risk. The administration found there was "no data" from randomised controlled trials with long-term follow-up to demonstrate clinical effectiveness, compared with conventional prolapse repair.
In September, 2011 Dr Reid had conditions placed over his practice that included the need to obtain valid informed consent for the surgery he performed, after a complaint to the NSW Medical Council from a woman who had Surgisis transvaginal mesh implanted by him.
In 2014 the NSW Medical Council suspended Dr Reid after further complaints from women, including at least two who were implanted with Surgisis mesh. The suspension was overturned after a NSW Civil and Administrative Tribunal appeal.
The NSW Health Care Complaints Commission is prosecuting fresh complaints against Dr Reid in the NSW Civil and Administrative Tribunal. The matter is listed for a directions hearing in April.
Dr Reid was suspended for three months by the Michigan Board of Medicine in 1998 and fined $10,000 after findings of "incompetence" following surgery on three women, leading to at least one substantial financial settlement.
The disciplinary actions were not carried out because Dr Reid returned to Australia in November 1996 to resume work after more than a decade as a gynaecologist and obstetrician in America. Dr Reid told the Newcastle Herald he had advised the then NSW Medical Board of the Michigan suspension when he returned to Australia.
The NSW Medical Board (which became the NSW Medical Council) did not become aware of the US board's action against Dr Reid until 2006 after a complaint from an Australian patient, the Medical Council told the Herald in a statement.
Under disclosure rules applying to doctors in 1996 Dr Reid was only required to complete a non-identifying questionnaire when he returned to Australia, which was filed with the Department of Health for statistical purposes. It was not until an amendment to the Medical Practice Act in 2000 that doctors were required to record if they had been suspended in Australia or elsewhere in the previous year, the Medical Council said.
One of the American women in the Michigan Board case, who was 23 when she first saw Dr Reid in 1989, was awarded $7.6 million in a civil case after she was left with serious complications following eight surgical procedures. Dr Reid told the board the surgical procedures were carried out as part of approved research.
The Herald understands the conduct of the US proceedings and decisions on settlements were made by Dr Reid's insurers.
A Cook Medical spokesperson said every patient's case was unique and "it wouldn't be appropriate for us to comment without all of the information about this specific case".
http://www.smh.com.au/national/health/woman-speaks-out-over-surgery-that-left-her-rotting-from-inside-20170322-gv3ybd.html
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The TRUE Story Of How One Woman's Vagina Tore Apart Her Man's Penis
Mar 22, 2017 | Your Tango
By Kiarra Sylvester
Ouch.
The act of sex in and of itself can be mortifying without any outside help, but most as a woman, there are always extra fears.
How does my vagina feel? How does my vagina smell weird?
However, after one British woman admits to nearly ruining her significant other's penis with her vagina — I think it's safe to say we may have to start subjecting ourselves to more thorough interrogations before sex. Because what WTF does that even mean? How does someone's vagina RUIN someone's penis?!
Well, it means exactly how it sounds.
Theresa Bartum, a British woman, admits that after having sex for the first time in nine years due to stress incontinence, her vagina appeared to have "had teeth" and as a result. her husband's "Willy was bright red and sprouting blood."
She continued to describe the horrific and unimaginable incident that led to their ultimate breakup, just six month later.
"There was a big red stain spreading between us on the sheets. After that, he was scared of my lady garden and approached it as if it was a Venus flytrap and he was a bluebottle (fly)."
According to the New York Post, this comes after having an operation to lift her prolapsed bladder with what is known as transvaginal tape, a plastic mesh material; this procedure was done after several years without sex, but only managed to give her a couple more good years of sex before things took the aforementioned and gruesome turn in 2009.
Although there have been folk tales of the "toothed vagina" also known as Vagina Dentata — a reference that victimizes vaginas by making them out to be evil "things" that castrate and emasculate men — it is also a reference to a medical condition better known as Vaginal Dermoid Cyst.
But that doesn't seem to be the case with this vagina.
After initially writing Bartrum's concerns off, medical professionals have since discovered (due to a string of other medical issues) that the mesh placed during her first surgery "breached her vaginal wall" and created a septic abscess, which she describes as feeling like "razor sharp teeth."
After her vagina began leaking green pus, doctors finally decided to take a closer look.
This was all seemingly caused by the mesh being placed too low and according to the Sun "eroded her vaginal walls," so doctors have had to remove it all together — sadly making this poor woman eternally incontinent and understandably hopeless as far as her sex life is concerned.
Bartrum's exact feelings after this entire ordeal?
“I was told this simple procedure would cure my incontinence and give me more confidence on the bedroom, but it has ruined my life. It made my vagina deadly and forced me into a life of celibacy. It could have killed me."
Sheesh, I can't even begin to imagine how she feels.
Not only in knowing that she must abstain from penetrative sex for the rest of her life, but also in having to live with the possible guilt that comes with your vagina almost taking a (penile) head off.
However, it has left her in a position to fight for other women to have this mesh banned, and is even part of a private group "sling the mesh" that hopes to make people aware. For that, we can all be grateful.
http://www.yourtango.com/2017300985/womans-vagina-tears-up-her-husbands-penis-bleeding-vaginal-mesh-incontinence
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Woman's Vagina "Grows Teeth" and "Bites" Man's Penis
Mar 22, 2017 | Men's Health
By Reegan Von Wildenradt
A bladder surgery gone very wrong led to a couple's worst bedroom nightmare. According to an article published in The Sun, Theresa Bartram and her partner were mid-intercourse when her vagina "grew teeth" and left her partner's genitalia severely damaged. Two years prior, Bartram had a bladder operation where a plastic mesh was inserted to lift her bladder. But the mesh was fitted too low and it ended up eroding through her vaginal wall, essentially resulting in a row of plastic teeth. Ugh.
The couple immediately stopped intercourse, and couldn't bring themselves to try again. “After that he was scared of my lady garden and approached it as if it was a Venus flytrap and he was a bluebottle," said Bartram, “It felt like razor-sharp teeth, hence why it had ripped a chunk from my boyfriend’s willy."
Apparently, doctors did not originally buy Bartram's story, insisting that nothing was wrong with the mesh despite her concerns. They finally removed the mesh six years after the original ordeal, confirming that the teeth did indeed stem from the mesh. Bartram now campaigns against bladder mesh surgery, technically called transvaginal tape, or TVT. “It made my vagina deadly and forced me into a life of celibacy. It could have killed me."
As for the couple, the two ended up splitting six months later.
http://www.menshealth.com/sex-women/vagina-teeth-bites-penis-sex
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Botched surgery leaves lady with 'Venus fly trap vagina' that BIT lover's penis during sex
Mar 22, 2017 | Daily Star
By Sarah Buchanan
A MUM reveals how her vagina “grew teeth” after surgery to improve her sex life went horribly wrong. WARNING: GRAPHIC CONTENT.
Theresa Bartram suffered from stress incontinence after giving birth – meaning she lacked confidence in the bedroom.
The 50-year-old was so ashamed that she’d sworn off sex for seven years.
Finally in 2007 she was referred for an operation to lift her prolapsed bladder using a plastic mesh sling called a transvaginal tape (TVT) to stop her leaking.
The surgery worked and sex was better than ever – until two years later when she almost sliced off the end of her partner’s penis.
Theresa, from Brighton, said: “It was like it had grown teeth.
“His willy was bright red and spouting blood. There was a big red stain spreading between us on the sheets.
“After that he was scared of my lady garden and approached it as if it was a Venus flytrap.”
Theresa said the operation – which was supposed to boost her sex life – left her vagina with “teeth” that “bit” her lover’s manhood.
She was sure her fella’s gory injury had been caused by the mesh she could feel inside her. But every time she saw her doctor she was assured it was working just fine.
Theresa and her partner avoided sex because they were too scared to try again – and six months later they ended up splitting.
Fearful of getting intimate with anyone new, as she didn’t want to risk injuring them, her confidence yet again hit rock bottom.
Theresa went on a diet and started exercising, transforming her physique and dropping from a size 20 to a size 14.
Her operation involved having a plastic mesh sling called a transvaginal tape (TVT) inserted to lift her prolapsed bladder and stop her leaking.
In TVT surgery, a mesh tape is placed under your urethra like a sling or hammock to keep it in its normal position.
The tape is inserted through tiny incisions in your abdomen and vaginal wall, with the procedure normally taking around 30 minutes.
Around 13,500 women have the operation annually on the NHS and it’s the most common way to treat stress incontinence.
Theresa read up on complications with the op, which had caused the it to be banned elsewhere in the UK.
There has been an increase in the women coming forward with post-op problems, leading it to be suspended in Scotland two years ago, where around 400 lawsuits are ongoing.
The mum-of-one had been noticing a decline in her general health and visited her GP, where she was diagnosed with IBS and later prescribed antidepressants.
Over the next few years she had her gallbladder removed and saw 25 different doctors, but she was still concerned that her problems stemmed from her mesh.
But it wasn’t until 2015, when her vagina began leaking green puss and emitting a foul smell, that she was properly examined.
A consultant told her the mesh needed to be removed urgently. It had eroded through the belly button side of her vaginal wall, causing her to grow an abscess which had become infected and turned septic.
Then in November 2015 it was removed in a complicated operation. The mesh had secured itself with cartilage to her pelvis, first shrinking then turning hard.
Theresa said: “It felt like razor-sharp teeth, hence why it had ripped a chunk from my boyfriend’s willy.”
She was finally told the mesh had been fitted too low, which is why she had injured her partner’s penis and suffered such awful complications.
The removal left her completely incontinent and her vagina is now numb.
At just 50-years-old, she fears she will remain celibate forever.
She said: “I was told this simple procedure would cure my incontinence and give me more confidence on the bedroom, but it has ruined my life.”
Theresa is currently campaigning to have the treatment banned across the country.
http://www.dailystar.co.uk/real-life/598861/Vagina-teeth-venus-fly-trap-bit-penis-botched-TVT-surgery
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Botched vaginal surgery mutilates penis
Mar 22, 2017 | 6Minutes
A British woman who underwent surgery to improve her sex life ended up with none — after her vagina mutilated her partner’s penis. Theresa Bartram, 50,...
Access to full text unavailable – subscription required. For full story:
http://www.6minutes.com.au/world-watch/botched-tvt-surgery-mutilates-penis
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