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Ethicon Media Monitoring 9/25/2017
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The mesh implant scandal is a global catastrophe: Former health secretary Alex Neil calls for international summit to tackle escalating crisis
Sep 24, 2017 | The Sunday Post
By Marion Scott
FORMER health secretary Alex Neil yesterday branded the mesh implant crisis a “worldwide catastrophe” and demanded international action to help victims. -
J&J Unit Presses Pa. Judge To Toss $57M Pelvic Mesh Verdict
Sep 25, 2017 | Law 360
By Matt Fair
A Johnson & Johnson unit is pushing a Pennsylvania state judge to throw out a $57.1 million pelvic mesh injury verdict it was slapped with earlier this month on grounds that the victim in the case had waited too long after learning about her injury to file suit. -
Pennsylvania Woman Praises $57 Million Verdict in Ethicon Transvaginal Mesh Lawsuit
Sep 22, 2017 | RX Injury Help
By Laurie Villanueva
The Pennsylvania woman at the center of the state’s latest transvaginal mesh lawsuit trial is now going public with her story, just weeks after a Philadelphia jury ordered Johnson & Johnson and its Ethicon, Inc. subsidiary to pay her more than $57 million in punitive and compensatory damages. -
Docs Still Support Mid-Urethral Slings
Sep 22, 2017 | Mesh Medical Device Newsdesk
Many doctors cling to the assessment of their medical societies that mid-urethral slings, also known as polypropylene “tape” or “hammocks,” are the Gold Standard for the treatment of incontinence.
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Sep 24, 2017 | The Sunday Post
By Marion Scott
FORMER health secretary Alex Neil yesterday branded the mesh implant crisis a “worldwide catastrophe” and demanded international action to help victims.
He urged the Scottish Government to stage a summit bringing together experts from around the world as the scandal of women left badly injured by the polypropylene implants escalates.
Scotland became the first country to suspend use of the implants after Mr Neil, then health secretary, met scores of victims crippled by the surgery.
Mesh manufacturers have already paid out almost £3 billion in the US to victims and withdrawn mesh products for “commercial reasons”.
However, medical watchdogs insist the potential benefits of mesh outweighs the risks.
Yesterday, Mr Neil said: “A global response is required to one of the biggest medical scandals of modern times. Scotland should continue taking the lead on this issue and host an international summit.”
He is calling on his successor Shona Robison to support a summit. Earlier this year, Ms Robison was criticised after accepting the findings of a safety review branded a “whitewash” by campaigners.
Two campaigners and one review expert had resigned from the review claiming evidence highlighting concerns around use of the implants, used to treat bladder problems and pelvic organ prolapse, had been ignored or withheld.
They will explain their concerns and resignations to Holyrood’s Public Petitions Committee on Thursday.
The Sunday Post recently revealed all the medical experts on the review formerly had links to mesh manufacturers, but were only asked for declarations of interest dating back one year.
Mr Neil, whose call for an international summit has cross-party support in the Scottish Parliament and the backing of East Renfrewshire MP Paul Masterton, Conservative, who is campaigning at Westminster, said: “Due to doctors failing to report complications and manufacturers having links to many surgeons, there are huge gaps in official figures.
“Independent evidence has been difficult to access because too many medical ‘watchdogs’ are also mostly funded by the medicines industry.”
Dutch campaigner Maria Smit from Meshed-Up EU, said: “We know of 1000 victims but believe numbers are higher. Eleven have died or committed suicide. ”
Scottish Mesh Survivors campaigner Elaine Holmes said: “We applaud Mr Neil. The world is finally waking up to this scandal.”
Almost 450 mesh victims have launched the biggest legal action in Scottish history with the NHS facing a £70 million legal bill.
A Scottish Government spokesman said: “We take issues around surgical mesh very seriously. This is why in 2014 we established the independent review.”
https://www.sundaypost.com/fp/the-mesh-implant-scandal-is-a-global-catastrophe-it-will-need-global-action/
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J&J Unit Presses Pa. Judge To Toss $57M Pelvic Mesh Verdict
Sep 25, 2017 | Law 360
By Matt Fair
Law360, Philadelphia (September 22, 2017, 2:59 PM EDT) -- A Johnson & Johnson unit is pushing a Pennsylvania state judge to throw out a $57.1 million pelvic mesh injury verdict it was slapped with earlier this month on grounds that the victim in the case had waited too long after learning about her injury to file suit.
Ethicon argued in a post trial motion that Ella Ebaugh had been told by physicians in June 2011 that the so-called TVT Secur implant she received had eroded into her urethra, requiring corrective surgery, but that she had nonetheless waited until July 2013, a month beyond the close of the two-year statute of limitations for her claims, to file suit.
“By at least June 2011, plaintiff knew or had reason to know that there was some problem with her mesh,” the company argued in a brief docketed in the Philadelphia County Court of Common Pleas on Monday. “A mesh erosion cannot occur without mesh.”
A Philadelphia County jury awarded Ebaugh $7 million in compensatory damages at the beginning of the month on claims that a pair of Ethicon mesh implants she received to treat her urinary stress incontinence had “mutilated” her urethra and left her with next to no control of her urinary flow.
The verdict also included another $50 million in punitive damages based on what Ebaugh’s attorneys argued during trial was Ethcion’s failure to properly test one of the mesh products before allowing it go to market.
Ebaugh was implanted with a TVT Secur mesh device in May 2007 to treat symptoms of stress urinary incontinence and ultimately received a second TVT implant in the summer after her condition did not improve.
Ethcion argued in its post-trial motion that Ebaugh’s claims arguably accrued as early as June 2007 when a doctor determined that her initial implant had failed.
“Pennsylvania law is clear that when a surgical patient knows or has reason to know that there was some problem with the surgery, the statute of limitations begins to run and the patient is obligated to investigate whether he or she has a potential cause of action,” the company said.
The company also argued that the punitive damages far exceeded a statutory cap limiting such awards to five times the amount of compensatory damages.
Even reducing the punitive damages to five times the $7.1 million compensatory portion of the verdict, the company said, was inadequate given what it said was the lack of evidence that the company’s conduct had been out of line.
“Ethicon undertook to warn and educate physicians about the risks of TVT and TVT Secur, including the very risk (urethral erosion) plaintiff encountered, even though those risks are well known in the medical community,” the company said. “This evidence negates a finding that defendants’ conduct evinced an indifference to or a reckless disregard of the health or safety of others.”
An attorney for Ebaugh did not immediately return a message seeking comment on Friday.
Ethicon is represented by Kenneth Murphy, Melissa Merk and Molly Flynn of Drinker Biddle & Reath LLP, Kat Gallagher and W. Curt Webb of Beck Redden LLP, Phillip Combs and Daniel Higginbotham of Thomas Combs & Spann PLLC, Julie Callsen of Tucker Ellis LLP, ad Jordan Walker of Butler Snow LLP.
Ebaugh is represented by Lee Balefsky, Kila Baldwin, Michael Cavaliere, Christopher Gomez, Tracie Palmer, Elia Robertson, Charles “Chip” Becker and Ruxandra Laidacker of Kline & Specter PC, Daniel Thornburgh of Aylstock Witkin Kreis & Overholtz PLLC and Benjamin Anderson of the Anderson Law Offices LLC.
The case is Ella Ebaugh v. Ethicon Inc. et al., case number 130700866, in the Court of Common Pleas of Philadelphia County, Pennsylvania.https://www.law360.com/lifesciences/articles/966902/j-j-unit-presses-pa-judge-to-toss-57m-pelvic-mesh-verdict
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Pennsylvania Woman Praises $57 Million Verdict in Ethicon Transvaginal Mesh Lawsuit
Sep 22, 2017 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LLP
The Pennsylvania woman at the center of the state’s latest transvaginal mesh lawsuit trial is now going public with her story, just weeks after a Philadelphia jury ordered Johnson & Johnson and its Ethicon, Inc. subsidiary to pay her more than $57 million in punitive and compensatory damages.
“I’m just glad Johnson & Johnson is finally getting their hand smacked when it should be,” she said. “They’re doing things seriously hurting and harming women everywhere.”
Ella Ebaugh, 51, was implanted with Ethicon’s TVT-Secur mesh implant in 2007 to treat incontinence. She later underwent corrective surgery due to mid-urethral erosion, at which time she was implanted with a different TVT product.
In June 2011, Ebaugh was forced to undergo yet another transvaginal mesh revision surgery. However, she continued to experience complications that required her to endure a fifth surgery just last year.
In her lawsuit, Ebaugh charged that the TVT devices were defective, and accused Johnson & Johnson and Ethicon of failing to warn doctors and patients of their risks. Last month a jury in the Philadelphia Court of Common Pleas agreed, and awarded her $7.1 million in compensatory and $50 million in punitive damages.“I Will Struggle with That Pain Every Day for the Rest of My Life.”
Ebaugh discussed her ordeal last week in an interview with the York Daily Record.
“A lot of days, I can’t get out of bed,” she said “I struggle every day. I will struggle with that pain every day for the rest of my life.”
Ebaugh now carries a diaper bag with her wherever she goes, and is forced to sit in a special chair when she visits her mother. Though her 16-year-old son’s athletic events continue to be a highlight in her life, she is now “chained to the bathroom,” and must be sure to sit near a restroom when she attends.
“Yes, I will wear diapers the rest of my life. Yes, I can’t be intimate with my husband,” Ebaugh continued. “Yes, I’m depressed. These are things I will carry with me for the rest of my life.”Ethicon Transvaginal Mesh Litigation
Ebaugh’s verdict was the fifth for an Ethicon plaintiff in the transvaginal mesh mass tort program currently underway in Philadelphia. Four previous juries have awarded plaintiffs compensatory and punitive damages ranging from $2.16 million to $20 million.
Johnson & Johnson and Ethicon won their first Pennsylvania case in June. However, that plaintiff was recently granted a motion for a new hearing on damages, after arguing that the verdict was inconsistent with the evidence presented at trial.
Nationwide, Johnson & Johnson and Ethicon have been named a defendant in more than 55,000 transvaginal mesh lawsuits.
https://www.rxinjuryhelp.com/news/2017/09/22/pennsylvania-woman-praises-57-million-verdict-in-ethicon-transvaginal-mesh-lawsuit/
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Docs Still Support Mid-Urethral Slings
Sep 22, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, September 22, 2017 ~ Many doctors cling to the assessment of their medical societies that mid-urethral slings, also known as polypropylene “tape” or “hammocks,” are the Gold Standard for the treatment of incontinence.
The only thing that seems to be changing a bit is the realization that there needs to be true informed consent.
This is the latest in a series of articles on Informed Consent, the process by which a patient is brought into the decision-making about her treatment plan.
While mesh-injured women continue to fight “slings” or polypropylene “hammocks” as the gold standard, citing life-altering catastrophic harm, many doctors continue to fight the realization of real-life patient harm. It’s a standoff that has gone on for far too long.
Last year when I attended the AUGS (American Urogynecology Society) annual meeting, I was taken aback to hear the then-president of the society call the mesh-injured community names such as the “Anti-Mesh Movement.” Doctors voiced the opinion that women were urged by their lawyers to seek a “payday” hoping to cash in on their mesh injuries.
This newly published article in the International Urogynecology Journal (IUJ), Informed Consent checklists for midurethral slings: a common-sense approach, at least suggests there should be a pre-operative checklist to supplement the standard informed consent form.
The realization may come as much from a practical need to cover one’s behind when implanting a controversial medical device subject of thousands of defective product lawsuits.
UNREASONABLE ADVERSE ATTENTION
The authors of this IUJ article recognize a lot of, “new-found, unreasonable amount of adverse attention to the current gold standard for treating stress urinary incontinence, namely, the polypropylene mid-urethral sling.”
They then go on to name all of the medical societies, many populated a led by Key Opinion Leaders (KOL) who do double duty as consultants to industry. They “have all issued statements supporting the use of mid-urethral slings as the preferred first-line surgical management for SUI.”
Complications are low with an erosion/extrusion rate of around 2%, the authors write with post-operative groin pain at 1.3 to 6.4% with ”most reports noting resolution of groin pain within weeks of surgery.”
(Readers: Is this your experience?)
SHOULD WE EVEN INFORM PATIENTS? The authors ask considering all of the unresolved questions and debate, “Whether it is clinically appropriate or sensible to inform patients during the informed consent process? Should we discuss ad nauseum all of the possible rare complications associated with any kind of surgery (including death or permanent disabilities) at the time of counselling?”Complications include permanent disabilities, untreatable chronic pain, sexual dysfunction, loss of ability to have sexual intercourse, or even death… if patients learn of this, “We might end up not treating any patients, leaving them to deal with their urinary incontinence,” conclude the authors.
“Even if patients decide to proceed with surgery, this strategy will extend counselling sessions to possibly hours, providing an overwhelming amount of information that will only confuse our patients.”
So should one assume the implication is the paternalistic model of “Doctor knows best” is a better alternative than informed consent?
BOLAM TEST in the UK
The authors cite the Bolam standard to explain the court’ reaction to patient informed consent.
In 1957, Mr. Bolam was a patient at a mental health institution in UK. He underwent electroconvulsive therapy but was not given muscle relaxants. His body was not restrained during the procedure. He suffered serious injuries when he flailed violently during the procedure and suffered a fracture. He sued the hospital because his doctors did not issue relaxants, did not restrain him, or inform him about the risks involved.
The majority of medical opinion at the time was opposed to using relaxants and restraints and it was common practice not to warn patients of the risk of treatment, when it is small. Therefore, the doctor acted in accordance with responsible medical opinion and was not negligent, the courts decided. There was no breach of standard of care if others in the profession agree. The treating doctor just needed to find experts to testify on his behalf.
It became the standard of professional negligence.
This reasoning totally negates the right of the patient to informed consent opting for the paternalistic “Doctor Knows Best” reasoning. It also overlooks the fact that medical opinion changes and doctors are sometimes the last to adopt the changes. Consider that medicine once encouraged smoking because it “relaxed the patient.”
Eventually that opinion caught up with the fact that smoking causes cancer.
In 2015, the Bolam test was overturned by an appeals court in England and fell out of favor and these authors conclude, in order to avoid the risk of a lawsuit for medical negligence, their duty needs to be to provide all possible information to help patients make decision and to respect their final decision.
SO WHAT IS ENOUGH INFORMATION?
The authors conclude, clinicians should adopt a guidance checklist, but that is difficult at best because there is so much opinion concerning transvaginal and hernia mesh. What are the potential outcomes and risks? What is the chance of a procedure going wrong? Can it be removed? Are there satisfactory options if I want a non-mesh repair?
There has not been a procedure specific checklist in other gynecologic surgeries such as hysterectomy or tubal ligation. However doctors are keenly aware they are entering a potentially litigious arena in regard to polypropylene mesh in vaginal surgery.
“It could be argued that one downside to employing an informed consent checklist is that we appear to be defensive and trying to justify performing the current gold standard procedure for correcting SUI. Instead of using it a means of trying to avoid/reduce the risk of lawsuits, we should use it to promote an open discussion with our patients about risks and benefits of the midurethral sling.”
SO WHAT SHOULD PATIENTS BE TOLD?
The authors do suggest that only experienced and skilled surgeons implant permanent mid-urethral slings and manage complications related to them. They characterize competence as doctors who have received appropriate training in the management of SUI and work within a multidisciplinary team and regularly carry out anti-incontinence surgery in women with a sufficient workload per year to maintain a high skill level.
The authors conclude it is time to rethink the informed consent process and use this as an opportunity to promote better understanding “by our patients.”
“Ideally women should be able to access public records, audit data, and registries of national and international professional scientific societies to better understand the published success, failure, improvement and other complication rates associated with mid-urethral slings.”
Your Editor asks – Does that include patient-centered websites? Let’s settle on some realistic numbers for the rate of erosion, need for mesh excision, complication rate. Let’s tell patients that it is very difficult, if not impossible to remove a mesh implant in the delicate pelvic area and that there is a potential for pudendal nerve injury and entrapment of the nerve, as well as damage from the trocars or needles used to place mesh.
Let’s tell prospective patients that the mesh may shrink, may cause chronic infection, may spark an autoimmune reaction, may cause dyspareunia, or painful sex. Let’s come to some agreement on the actual rate of erosion, complications, mesh removal. And let’s tell patients that after jurors have listened to evidence from both sides at trial, they have concluded many of the pelvic meshes still on the market, are defectively designed.
That might be a good way to start the informed consent process.
Note* Conflict of interest disclosures for the authors of this report include – G. Alessandro Digesu (Dept of Urogynaecology, St. Mary’s Hospital, London, UK) – consultant to AMS, Astellas, Medtronic, Dompe, Standard Innovation Corporation, a speaker for industry and trial participant. Steven E. Swift (Department of Ob Gyn, Medical University of South Carolina) has done research for Astellas and Cook.
Lawyer Victoria Handley (Handley Law Limited, Liverpool, England) reports no conflict of interest.
LEARN MORE:
Informed Consent, What We Are Learning, August 2017
https://www.meshmedicaldevicenewsdesk.com/informed-consent-learning/What Should Informed Consent Look Like, August 2016
https://www.meshmedicaldevicenewsdesk.com/informed-consent-look-like/Dr. V on Informed Consent, December 2013
https://www.meshmedicaldevicenewsdesk.com/dr-veronikis-informed-consent/AUGS Informed Consent Toolkit, March 2013
https://www.meshmedicaldevicenewsdesk.com/highlights-from-augs-informed-consent-toolkit/https://www.meshmedicaldevicenewsdesk.com/docs-still-support-mid-urethral-slings/
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