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Ethicon Media Monitoring 10/4/2017
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Vaginal mesh lawsuit: executive denies prioritising Johnson & Johnson interests
Oct 3, 2017 | The Guardian
By Christopher Knaus
A senior Johnson & Johnson (J&J) executive has denied placing corporate interests ahead of traumatised transvaginal mesh patients when he advised against referring a serious complaint to health regulators. -
J&J Cries Foul Over Additional Pelvic Mesh Depositions
Oct 3, 2017 | The Legal Intelligencer (In New Jersey Law Journal)
By Max Mitchell
Johnson & Johnson subsidiary Ethicon has balked at deposition requests aimed at gathering information central to a recently reignited venue dispute in the pelvic mesh mass tort in Philadelphia. -
Supreme Court won’t review $3m pelvic mesh loss for J&J’s Ethicon
Oct 3, 2017 | Mass Device
By Brad Perriello
The U.S. Supreme Court yesterday declined to review a $3 million loss for Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon in a product liability lawsuit brought over its TVT-O pelvic mesh. -
Strong recommendations on surgical mesh but still no government action
Oct 4, 2017 | New Zealand Doctor Online
By Keira Stephenson
A leading trans-Tasman gynaecologists body is pulling no punches in its latest recommendations on surgical mesh implants. -
Transvaginal Mesh “Like Being Cut with a Cheese Wire”
Oct 3, 2017 | Lawyers and Settlements
By Gordon Gibb
An exhaustive story in The Guardian (08/31/17) sheds some interesting sidelights into transvaginal mesh side effects, an issue that has proven to mushroom in size and breadth since the advent of transvaginal mesh, or TVM mesh repair for various health issues affecting a wide cross section of women at middle age.
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Vaginal mesh lawsuit: executive denies prioritising Johnson & Johnson interests
Oct 3, 2017 | The Guardian
By Christopher Knaus
Vice-president denies playing down adverse effects during proceedings brought by hundreds of Australian women
A senior Johnson & Johnson (J&J) executive has denied placing corporate interests ahead of traumatised transvaginal mesh patients when he advised against referring a serious complaint to health regulators.
More than 700 Australian women launched a federal court class action against the medical giant three months ago, alleging their lives were all but destroyed by flaws with J&J-produced medical implants.
The J&J devices, transvaginal mesh and tape, were used to treat pelvic organ prolapse and urinary incontinence – common complications of childbirth.
But in a large number of cases worldwide, flaws with the meshes left women in debilitating pain. Sexual intercourse was made impossible and many women suffered the breakdown of relationships.
J&J is accused of playing down the risks of the products and, instead, using aggressive marketing on surgeons, focusing on the cheap and easily replicable nature of the surgery. The company is also alleged to have sought to avoid the scrutiny of regulators and suppress unfavourable data.
On Wednesday, the multinational’s vice-president of medical affairs, Piet Hinoul, was forced to defend the approach taken to one complaint that J&J and its product development arm, Ethicon, became aware of in 2009.
A woman in the UK had suffered two infections related to sinus complications after having the tape implanted in 2002. The first infection occurred 12 months after the implant and the next occurred three years later, the court heard.
But the court was shown emails in which Hinoul described those complications as a “transitory foreign body response”, a normal reaction that was contemplated in the company’s instructions for use to surgeons.
The company only has an obligation to report adverse reactions if they are not included in a product’s instructions for use. Hinoul recommended against reporting the case to the UK’s medical products regulator.
Barrister Tony Bannon SC, who is acting for the 700 women on behalf of Shine Lawyers, accused Hinoul of using “word games” to avoid reporting the case. Bannon said the infections, occurring so long after the initial operation, were obviously not transitory.
“Do you say you are comfortable in forming a view, when you wrote this email, that an affliction that occurred three years after – three years after – the implantation of this device was the result of a transitory foreign body response? Is that your evidence?” Bannon asked.
Hinoul said the transitory foreign body response in the patient had become “sustained”.
“I don’t play word games,” Hinoul said.
Bannon later pressed Hinoul on the issue: “You were putting the company’s interests ahead of the patients interests. Do you agree with that?”
Hinoul responded: “Not at all.”
Bannon asked: “Do you agree you took an unreasonable approach to the [instructions for use] in order to protect the company’s interests?”
Hinoul said: “No, certainly not.”
Later on Wednesday, Hinoul was forced to agree the company knew its products, as a matter of certainty, would not be suitable for some patients. But Hinoul said that was the same for all medical interventions and there was no way of knowing which patients would have adverse reactions to the implants.
“The answer, as I said, is yes, but that is the same as any kind of intervention in medicine … Unfortunately, medicine isn’t perfect and that is the same of surgery,” Hinoul said. “Certain surgeries, unfortunately, go wrong and have complications – we’re not denying that.”
The case continues before Justice Anna Katzmann in the federal court on Wednesday.
https://www.theguardian.com/australia-news/2017/oct/04/vaginal-mesh-lawsuit-executive-denies-prioritising-johnson-johnson-interests
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J&J Cries Foul Over Additional Pelvic Mesh Depositions
Oct 3, 2017 | The Legal Intelligencer (In New Jersey Law Journal)
By Max Mitchell
Johnson & Johnson subsidiary Ethicon has balked at deposition requests aimed at gathering information central to a recently reignited venue dispute in the pelvic mesh mass tort in Philadelphia.
Ethicon, which is facing more than 100 lawsuits in the Philadelphia Court of Common Pleas over its pelvic mesh products, filed a motion asking the Philadelphia Court of Common Pleas to quash deposition notices the plaintiffs sent to company officials, including Ethicon's strategic sourcing manager. The depositions are aimed at gathering information about the extent to which a Pennsylvania-based company, Secant, supplied biomaterials to Ethicon for use in its mesh products, but the defendant has contended the depositions are overkill and would create an unfair burden.
"Plaintiffs' deposition notices are too late, constitute unreasonable annoyance and harassment, and they impose an undue burden," Ethicon said in the brief filed Sept. 29 by Drinker Biddle & Reath attorney Melissa Merk. "They are completely unnecessary, too, because defendants, as well as Secant, have already provided thousands of pages of discovery on these topics."
Kline & Specter attorney Shanin Specter, who is representing the plaintiffs, said in an emailed statement that he plans to file a response soon.
"Johnson & Johnson is trying the old tactic of ducking responsibility by ducking a deposition," Specter said.
The plaintiffs' deposition notices were issued after Philadelphia Court of Common Pleas Judge Arnold New held a hearing last month focusing on what effect the U.S. Supreme Court's decision in Bristol-Myers Squibb v. Superior Court of California may have on the pelvic mesh mass tort program.
The Bristol-Myers Squibb decision, which has been characterized as a game-changing decision by some, made clear that out-of-state plaintiffs can't sue companies where the defendants aren't considered to be "at home," or haven't conducted business directly linked to the claimed injury.
Ethicon, which is based in New Jersey, has argued that Bristol-Myers Squibb means 90 cases that were filed in Philadelphia court by out-of-state plaintiffs should be tossed, leaving just 30 cases pending in the state court. That ruling hinged on the relationship between Bristol-Myers Squibb and a California-based pharmaceutical distributor, with the court finding their relationship was not significant enough for non-California residents to sue Bristol-Myers Squibb in the Golden State.
In the pelvic mesh program, plaintiffs have pointed to the fact that Secant, which is located in Bucks County, manufactured the plastic mesh materials used in the mesh implants as the basis for their argument that jurisdiction is proper in Pennsylvania even though Ethicon is based in New Jersey.
Ethicon's recent motion seeking to quash the depositions and to have a protective order imposed contended that the depositions requests far exceeded the scope of New's Sept. 15 order calling for post-argument briefing on the extent to which Ethicon uses Secant's materials.
"Secant's role in this litigation has long been understood, and this court long ago dismissed all claims against Secant," Ethicon said in the brief. "This court's request for supplemental briefing did not entitle plaintiffs to additional discovery, and the additional discovery they seek has no bearing on the personal jurisdiction arguments at issue."
The plaintiffs have contended that, although the Bristol-Myers decision is significant as it is the Supreme Court's first time dealing with specific jurisdiction for mass torts, it does not change the law, or alter the defendant's underlying conduct in Pennsylvania.
In prior briefing to the court, the plaintiffs have cited testimony from Ethicon and Secant officers saying Ethicon provided Secant with specifications about the mesh, directed Secant's production of the mesh, and tested the resulting samples. Ethicon, the plaintiffs have further noted, traveled to Pennsylvania to meet with Secant officials, and observe the manufacturing process.
A spokeswoman for Ethicon declined to comment beyond the filing.
http://www.njlawjournal.com/this-weeks-news/id=1202799563406/JampJ-Cries-Foul-Over-Additional-Pelvic-Mesh-Depositions?mcode=1202617207189&curindex=3
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Supreme Court won’t review $3m pelvic mesh loss for J&J’s Ethicon
Oct 3, 2017 | Mass Device
By Brad Perriello
The U.S. Supreme Court yesterday declined to review a $3 million loss for Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon in a product liability lawsuit brought over its TVT-O pelvic mesh.
A jury in the U.S. District Court for Southern West Virginia originally awarded Jo Huskey and her husband damages of $3.3 million, finding in September 2014 that the TVT-O transvaginal sling caused her injuries and that the company failed to warn about the stress urinary incontinence treatment’s risks.
A federal judge later shot down Ethicon’s bid to overturn the verdict and denied the company’s move for a new trial; Ethicon then appealed to the U.S. Court of Appeals for the 4th Circuit. In January a 3-judge panel at the 4th Circuit denied that appeal, ruling that the Huskeys had proved their case.
That prompted a petition for certiorari from the Supremes in May, with Ethicon alleging that the appellate court improperly excluded product review evidence after misreading the relevant precedent.
Yesterday the high court denied certiorari with no explanation.
http://www.massdevice.com/supreme-court-wont-review-3m-pelvic-mesh-loss-jjs-ethicon/
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Strong recommendations on surgical mesh but still no government action
Oct 4, 2017 | New Zealand Doctor Online
By Keira Stephenson
A leading trans-Tasman gynaecologists body is pulling no punches in its latest recommendations on surgical mesh implants.
In a strongly worded statement, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists says transvaginal polypropylene mesh is not recommended as the first-line treatment for any vaginal prolapse.
The RANZCOG statement follows up with a second recommendation for newer, lightweight transvaginal meshes, saying an extensive discussion with the patient about other available options needs to take place prior to use, and clinicians should consider referring patients to get a second opinion.
The statement points out the newer meshes have not been tested in randomised clinical trials, so any patient who still decides to go ahead with the implant should be recruited to a trial. It also encourages clinical audit of all mesh procedures.
Years before problems surfaceRANZCOG New Zealand committee coordinator Jane Cummings says new surgical mesh products are being produced all the time, but problems may not surface until years later.
As well as encouraging surgeons to discuss this with their patients, Ms Cummings would like GPs to communicate the potential for future harm from surgical mesh to patients considering this treatment, and encourage them to read up on the risks.
“We’ve been really pushing informed consent. We want everyone to be cautious of all forms of mesh,” she says.
Awareness of the dangersMs Cummings believes there is now a heightened awareness of mesh’s potential dangers. She is confident surgeons have noted class actions against companies selling the mesh and mesh-related deaths reported in the media.
“The warning bells are really ringing very well,” she says.
Only surgeons with very advanced training should use surgical mesh, Ms Cummings says, and only two or three doctors in New Zealand are able to remove it.
The clinical audit process is a practice audit and reflection activity. It is designed to improve patient care and outcomes through a systematic review of care against explicit criteria and the implementation of change as part of a cycle of quality improvement.
Although more clinical audits are taking place, a register of all implants is yet to be set up, despite this being called for last year by a health select committee inquiry into the mesh, she says.
This lack of action on the register and other health select committee recommendations has the authors of the petition which sparked the inquiry and report, up in arms.
Complaint over lack of government actionIn a letter to health minister Jonathan Coleman, campaign group Mesh Down Under, complains of governmental inaction despite the number of mesh-related treatment injury claims over the last few years “escalating at an alarming rate”.
There has been a 74 per cent increase in decided claims to ACC for surgical mesh injuries in the last three years, the letter says.
In June, the Sunday Star Times reported four deaths related to mesh complications.Since 2005, ACC has received 265 treatment injury claims for mesh hernia repairs, 403 for vaginal repair and 112 for other surgeries – at a cost to the taxpayer of $12 million, the newspaper reports.
RANZCOG not recommending a banHowever, rather than banning surgical mesh completely, as Scotland has done, Ms Cummings says RANZCOG wants women to have some choice in the matter.
In most cases, mesh urinary incontinence slings are very useful and the reoccurring prolapse they help prevent can be so dreadful women are willing to take risks as other options don’t always work, she says.
“I know some surgeons who would never use mesh for prolapses but would for urinary incontinence…Sometimes a little bit of mesh can make all the difference.
“It’s a really hard decision for women to make.”
For women looking to prevent or delay the onset of prolapses, Ms Cummings points to the work of some physiotherapists on pelvic floor muscle training.Pelvic floor training
Pelvic floor physiotherapist Liz Childs says pelvic floor muscle training should be offered as a first-line conservative treatment option, as there is compelling evidence to show it can reduce the symptoms and severity of stage one, two and three, pelvic prolapse to the point of not needing surgery.
Even for women who go on to have surgery, outcomes are better if they have better pelvic floor function beforehand, Ms Childs says.
She says she is now seeing a lot of patients seeking options other than mesh, in some cases with the support of their gynaecologists.
Pelvic floor muscle training involves pelvic floor muscle strengthening as well as advice about lifestyle modifications to control for risk factors that put stress on the pelvic floor.
This includes advice around constipation and straining, heavy lifting, weight loss and coughing and sneezing.
Training has a high success rateThe training also has an 80 per cent cure rate for urinary stress incontinence with the International Continence Society guidelines recommending it as a first-line treatment.
Continence NZ and pelvic physiotherapists are running workshops for fitness trainers on pelvic floor function and suitable exercises for women, Ms Childs says.
They have a screening tool to help trainers decide if they should refer their clients or suggest exercises as “many women may not be comfortable telling their 18-year-old gym instructor that they wet their pants,” she says.
Half of the women who only follow written or verbal instructions on pelvic floor muscle exercises are not doing them correctly, which is why Ms Childs advocates supervised training with a qualified pelvic floor physiotherapist to get the technique right.
It may only be necessary to see a pelvic floor physiotherapist two or three times over a two or three-month period, she says.
Ms Childs would like to see every woman who has given birth receive a number of funded sessions with a pelvic floor physiotherapist.
Surgical mesh timeline2002: US Food and Drug Administration approves first mesh implant for vaginal use.
October 2008: Following complaints, the FDA issues a statement recommending surgeons undertake specialised training before attempting vaginal mesh repairs and notify patients that mesh is a permanent implant which can lead to unresolvable complications. Serious complications are still considered rare.
July 2011: With increasing use of vaginal mesh and more reported adverse events, the FDA states serious vaginal mesh complications are no longer considered rare. It concludes there is no compelling evidence to show using vaginal mesh has greater success rates or durability than conventional surgery. However, the agency accepts there is some evidence for the greater efficacy of mesh in the anterior compartment. It recommends all this information be discussed with patients and alternatives offered prior to using mesh.
January 2012: The FDA introduces post-market surveillance of all vaginal mesh implants and Johnson & Johnson and American Medical Systems withdraw their transvaginal mesh kits from the market.
March 2014: Carmel Berry and Charlotte Korte’s petition number 2011/102 on surgical mesh is referred to the New Zealand health select committee.
January 2016: The FDA reclassifies transvaginal mesh as a high-risk device.
June 2016: The New Zealand Health Committee presents its surgical mesh report to the House.
August 2016: The Government responds to the report’s recommendations, but does not commit to a timeline for implementing them.
August 2017: Australia holds senate hearing on mesh.
Health select committee recommendations include:Looking at creating a centralised surgical mesh registry informed by the International Urogynaecological Association classification for recording mesh surgery complications
Colleges reviewing best practice around informed consent for mesh procedures
Encouraging health providers to ensure that coding for mesh surgery is consistent, including a system to allow patients with mesh complications to be identified and monitored
Encouraging use of the adverse events reporting system for medical devices
Ongoing education for surgeons on the use of surgical mesh and mesh-removal surgery
Expanding Medsafe’s role in assessing the safety of a medical device before it can be used in New Zealandhttps://www.nzdoctor.co.nz/news/2017/october-2017/04/strong-recommendations-on-surgical-mesh-but-still-no-government-action.aspx
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Transvaginal Mesh “Like Being Cut with a Cheese Wire”
Oct 3, 2017 | Lawyers and Settlements
By Gordon Gibb
London, UK An exhaustive story in The Guardian (08/31/17) sheds some interesting sidelights into transvaginal mesh side effects, an issue that has proven to mushroom in size and breadth since the advent of transvaginal mesh, or TVM mesh repair for various health issues affecting a wide cross section of women at middle age. The number of plaintiffs having filed a transvaginal mesh lawsuit has mushroomed in kind: The Guardian reports that no fewer than 100,000 lawsuits have been filed in the US alone by women alleging TVM mesh complications.
The use of transvaginal mesh for the treatment of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) has grown in recent years. POP and SUI are common conditions affecting middle-aged women who have borne children. Traditionally, supportive slings often fashioned from a patient’s own tissue are stitched into place to shore up sagging organs that put stress on the bladder and uterus. However, the latter is considered invasive surgery with large incisions resulting in heightened blood loss, and requiring longer recovery and healing windows.
In contrast urogynaecological mesh, or TVM mesh is inserted in a compressed format through a small incision via laparoscopy and then deployed at the appropriate site. Blood loss is minimal and healing time is much faster, putting less stress on hospital resources.
The Guardian reports that by 2010, the use of transvaginal mesh accounted for nearly 25 percent of prolapse interventions in some countries. “Because outcomes of using the mesh for incontinence and hernia were so good people were enthusiastic and confident it would also be good for prolapse,” said Christopher Maher, a urogynaecologist and associate professor at the University of Queensland, in comments published in The Guardian. “That’s what the mindset was when it was introduced for prolapse around 2002.”
However, transvaginal mesh side effects have become a problem for scores of women.
What’s more, The Guardian reports that while high efficacy and low complication rates have been observed for TVT mesh employed for treatment of SUI, the same can’t be said for POP: “There is a growing body of evidence that efficacy is lower and complication rates are higher for pelvic organ prolapse,” The Guardian wrote, without breaking out just what that evidence is.
However, The Guardian reports the National Health Service (NHS) in the UK has data that reflects one, in 15 women undergoes revision surgery to have a problematic mesh removed, if it is even possible.
The Guardian also reports that a consumer survey undertaken by the Health Issues Center, a consumer advocacy organization, found that of 2,220 women who had undergone pelvic mesh implants to treat stress urinary incontinence and pelvic organ prolapse, 59 percent said the procedure did not resolve their original issue, and 58 percent said they experienced pain during intercourse.
One of the most compelling, first-person accounts of transvaginal mesh complication was published earlier this year by The Guardian (04/27/17), when Kath Sansom in an Op / Ed piece shared that she had set up the support page Sling the Meshon Facebook in June, 2015 about ten weeks after she had transvaginal mesh implanted to treat SUI stemming from having children.“The pain in my legs and feet was so intense, along with burning pains in my vagina – like being cut with a cheese wire – that I knew something was terribly wrong.” She noted the government regulator in the UK, the Medicines and Healthcare Products Regulatory Agency, was still saying as of March of this year that the benefits of transvaginal mesh outweighed the risks.
Sansom believes women are still hurting. “[In April], after I appeared on the Victoria Derbyshire show on the BBC to discuss the issue, 200 women joined Sling the Mesh within 24 hours.”https://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/transvaginal-mesh-lawsuit-10-22616.html
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