Preview Newsletter
Ethicon Media Monitoring - December 28, 2018
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New pelvic health co-ordinators for Wales in wake of mesh review
Dec 28, 2018 | Nursing Times
By Steve Ford
A network of pelvic health and well-being co-ordinators is to be created across Wales, as part of the Welsh government’s response to the vaginal mesh and tape review. -
Mesh Year in Review
Dec 26, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
What happened with the Mesh Mess in 2018? Here are just some of the highlights of coverage in the U.S. in 2018 with many more stories reported globally and domestically. -
Dangerous Medical Devices Harm Patients Worldwide
Dec 27, 2018 | Legal Examiner
By Joseph H. Saunders
A recent report from the International Consortium of Investigative Journalists has provided the most exhaustive and in-depth look at the failures of governments worldwide to ensure the safety of medical devices.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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New pelvic health co-ordinators for Wales in wake of mesh review
Dec 28, 2018 | Nursing Times
By Steve Ford
A network of pelvic health and well-being co-ordinators is to be created across Wales, as part of the Welsh government’s response to the vaginal mesh and tape review.
The government said the co-ordinators would work with a national pathway manager to implement improvements to pelvic health across Wales.
The work is to be led by the Women’s Health Implementation Group (WHIG), which has been seen set up this year by the Welsh government with £1m a year provided for its work.
The group have decided that the first year’s funding will be spent on establishing a number of key posts to deliver some of the recommendations of the vaginal mesh and tape review.
Health minister for Wales Vaughan Gething, said: “The WHIG has listened to concerns from the Mesh Survivors Group and has decided to appoint a national pathway manager to deliver the recommendations of the vaginal mesh and tape review.
This will lead to the creation of a network of pelvic health and wellbeing co-ordinators within each health board,” said Mr Gething.
He said: “They will have a clinical background from an appropriate discipline, e.g. physiotherapy or pain management and will work with the national lead to deliver the required changes to local services.
“The group is also taking advice from patients and clinicians on how to achieve the consistent provision of translabial scans where they are appropriate across Wales,” he said.
He added: “The group will now consider the recommendations from the report into endometriosis services in Wales produced by the Endometriosis Task and Finish Group.”
The WHIG was established in May 2018 to oversee specific areas of women’s health requiring urgent attention and improvement.
It is chaired by Tracy Myhill, chief executive of Abertawe Bro Morgannwg University Health Board.
In July, the government and NHS in England accepted a recommendation from the Independent Medicines and Medical Devices Safety Review to pause the use of vaginally inserted surgical mesh.
The inquiry, ordered by the health secretary and chaired by Baroness Julia Cumberlege, concluded in May that the surgery must be stopped until steps have been taken to mitigate the risks to patients.
In 2014 the Scottish government put in place a suspension in the use of mesh for stress urinary incontinence.
However, there is currently no suspension in Northern Ireland or Wales.
https://www.nursingtimes.net/news/policies-and-guidance/new-pelvic-health-co-ordinators-for-wales-in-wake-of-mesh-review/7027225.article
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Dec 26, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
What happened with the Mesh Mess in 2018? Here are just some of the highlights of coverage in the U.S. in 2018 with many more stories reported globally and domestically. Your editor thanks you for visiting often and being part of this massive mesh community. Stay well and have a better 2019!
January 5~ Can you change your law firm and what is a legal referral service were some of the topics included in a series “Working With Lawyers” HERE
March 9~ Barbara Kaiser won her product liability trial against Ethicon in a Hammond, Indiana court in March with jurors awarding her $35 million which includes $25 million in punitive damages. The case had been remanded back to Indiana from multidistrict litigation
in Charleston, W.V. Kaiser was represented by Wexler Wallace and Wagstaff
Cartmell with Indiana attorney Plouff. She was implanted with a
six-arm Prolift. See story HERE.April 15~ While bypassing the big story of Big Pharma and its use of pelvic mesh implants on women, the New York Times focuses in this story on middlemen, both doctors and lawyers, who allegedly “lure” (loaded word) women into “unnecessary surgeries” to have their mesh removed. The end game is to raise the settlement dollars which are based on the number of revision surgeries. See story HERE.
April 19~ The Bleeding Edge documentary premiered at the Tribeca Film Festival in New York focusing on those patient injured by medical devices which enter the market through the FDA’s 510(k) clearance process, that is, with very little oversight. Pelvic mesh, Essure birth control, and metal-on-metal hips were featured. Essure is now off the market and the film is available on Netflix. Read more HERE.
April 9~ The McGinnis trial ended in a New Jersey court with jurors deciding two pelvic meshes made by CR Bard were defective and awarding Mary McGinnis $33 million. It was the first trial in New Jersey for any pelvic mesh made by CR Bard. April 13th- the jury added another $35 million in punitive damages making this jury award $68 million, the largest compensatory and punitive award of any pelvic mesh plaintiff so far. Read HERE and HERE and HERE.
May 10 ~ 60 Minutes reported on polypropylene resin misbranded and smuggled into the U.S. from China by Boston Scientific then made into pelvic mesh implants. With revelations of sordid business practices, a polymer expert was quoted as saying polypropylene does
not belong in the body, no matter where it is sourced! HEREJune 18~ The Martinez trial in Woburn Mass. came back concluding the Boston Scientific Pinnacle and Obtryx pelvic mesh products were not defective and the company did not fail to warn end user doctors about the dangers of PP mesh. HERE
John Nealon
June 18 ~ An AMS executive wants to put the company’s pelvic mesh back on the market. John Nealon formed a new company, UroCure, and raised millions from investors to reintroduce a sling for female incontinence. The sling will rely on the same patented technology used to create the AMS Sparc and Monarc. HERE
August 24~ Sherrer receives new mesh trial in Kansas City, Missouri. Eve Sherrer had two different incontinence meshes implanted the Solyx by Boston Scientific and Bard’s Align sling. Her law firm has requested a new trial and received it after a Missouri appellate court ruled the trial court erroneously barred evidence of Bard’s previous criminal convictions that should have been allowed into trial even though it concerned a different medical device. HERE
August 6 ~ Thousands purged from Ethicon MDL Women who have “mesh in place” that is, with no revisions, had their cases urged from
multidistrict litigation by Judge Joseph Goodwin after pressure from Johnson & Johnson. These women have the option to have some form of surgery within five years and refile their cases or they will be dismissed
permanently. HERESeptember 24~ The mesh trial of Susan McFarland deadlocked and ended in a mistrial in the Philadelphia court of Common Pleas. She had been implanted with a TVT-O McFarland Philadelphia case mistrial in TVT-O and jurors couldn’t decide whether it was negligently designed. they were also given the option to award punitive damages. Her law firm has requested a new trial. HERE
October 15~ Though AUGS still stands by SUI mesh, mesh injured women went to Chicago to speak to members of the American Urogynecologic Society at their annual meeting. Unlike previous years, this year a small group actually had a face-to-face with some of the leading doctors of this medical society. More is promised for the future. HERE
October 3~ Mary Dickson Pro Se litigant is deposed by JNJ. She is carrying on her mother’s wrongful death case claiming her
mother died from antibiotic resistant infections caused by her TVT and
TVT-O mesh implants. Vada Mae Smith died in 2016 from massive infections and organ failure. Johnson & Johnson is taking Mary seriously enough to try and win its case against her which is filed in the MDL in Charleston. Mary still has no attorney. HERE.November 1 ~ Washington State has set a trial date to hold J&J liable for mesh injuries among the residents of its state. in 2016, the
Washington State Attorney Generals office sued j&J over the costs it
advanced to take care of the injured residents of Washington. The state
wants a reimbursement rate of $24 million or a trial will commence
April 22, 2019. HERE.December 12- The first TOT case filed in State court in Arizona. With the multidistrict litigation closing to any new cases,
lawyers are now seeking to have cases remanded back to state court
where they will be heard. Here is the first filed in Arizona, which accuses
Boston Scientific of manufacturing a defective Solyx Transvaginal mesh sling.
Since pelvic mesh is still being used, expect to see the newly implanted
women taking their cases to court. In this case she was implanted in
November 2016. HERE.December 5 -The Suzanne Emmett trial started in Philadelphia, in the Court of Common Pleas but almost as quickly
adjourned due to a missing juror. Expect it to reconvene January 5th.
Emmett has two meshes made by Ethicon (JNJ) – a Prolift to treat pelvic
organ prolapse (no longer on the market) and a TVT-O (obturator) which is still on the market. HERE.December 4- Professor Elizabeth Burch, of the University of Georgia Law School, posts a survey to determine how women entered into the pelvic mesh MDL have fared. In many cases, women never spoke to their attorneys and were not kept up to date on their cases. Often, the plaintiff was told to settle or their case would be dropped. HERE.
December 3 ~ Philadelphia law firm, Kline Specter requested that half of the common benefit fund be returned to plaintiffs. Calling it “excessive and unreasonable given the outcome of this litigation” millions should be returned rather than go to the law firms, that in many
cases, just lined their clients up for settlement with no trial preparation.
HERE.October- Mary Dickson Pro Se litiganat is deposed by JNJ
https://www.meshmedicaldevicenewsdesk.com/mesh-year-in-review/
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Dangerous Medical Devices Harm Patients Worldwide
Dec 27, 2018 | Legal Examiner
By Joseph H. Saunders
A recent report from the International Consortium of Investigative Journalists has provided the most exhaustive and in-depth look at the failures of governments worldwide to ensure the safety of medical devices. It presents the case that, “health authorities across the globe have failed to protect millions of patients from poorly tested implants that can puncture organs, deliver errant shocks to the heart, rot bones and poison blood, spew overdoses of opioids and cause other needless harm.”
The report, Medical Devices Harm Patients Worldwide As Governments Fail on Safety, doesn’t deny that for many, medical devices are of clear benefit and improve patient’s quality of life. But too often, patients are harmed because in the quest to maximize profit, safety and long term testing are often compromised. The United States and other countries hold even complex implants to a lower safety-testing standard than most new drugs. Flawed devices linger on the market as injuries mount. Under a free-for-all global system, device companies pull implants in some countries while continuing to sell them in others. Ultimately, the thirst for profit has led manufacturers to rush products to market and risk the lives of the patients they were supposed to help.
They key findings in the report include;
– Medical devices improve and save lives, but governments have allowed products on the market with little or no human testing that went on to cause great harm
– Devices pulled off the market in some countries over safety concerns remain for sale in others
– The device industry, and the regulators that oversee it struggle to quickly identify hazardous implants after they are released, leaving patients exposed
– Manufacturers, doctors, and others potentially linked more than 1.7 million injuries and nearly 83,000 deaths to medical devices in reports to U.S. regulators over the last decade
– Some of the highest-profile controversies in recent years involve products marketed to women, including contraceptive coils, vaginal mesh, and breast implants.
None of the findings in this exceptional article by the ICIJ came as a surprise to me. For most of my career I have defended patients in the United States who were harmed by defective and dangerous medical devices. In most of those cases it was always revealed that the underlying cause plaintiffs were willing to risk the health of the patients they served was plain and simply greed. Take Johnson & Johnson for instance, roughly 80 percent of the company’s revenue and 91 percent of its profit—comes from high-margin medical devices: artificial hips and knees, heart stents, surgical tools and monitoring devices; and from still higher-margin prescription drugs. In 2014 Johnson & Johnson had over $74 billion in annual revenue.
The recent failure of metal-on-metal hip implants is the worst medical device failure in history and the most glaring example of how this thirst for profit can drive an industry into negligence and disregard for patient safety.
The J&J ASR hip implant lawsuits claimed metal-on-metal hips caused a muscle-eating, metal poisoning called metallosis. In 2013 it was revealed that J&J was aware of problems with its ASR hips as early as 2005 but waited until 2010 to issue a global recall. Between 2013 and 2015 this mass failure drove J&J to settle 9,000 ASR lawsuits in the U.S. for $4.4 billion.
It was revealed during the lawsuits that J&J was aware of the risks many of its products posed, even as it continued to aggressively market them. This same pattern also emerged in other high profile lawsuits J&J faced – the mental health drug Risperdal for causing men to grow breasts and accusations its talcum powder products caused cancer.
It is hard not to see the calculus in the business decisions behind all these product failures. In 2017 Johnson & Johnson reported $76 billion in revenue with more than a third of that coming from medical devices such as hip replacements. The pharmaceutical giants annual report for that same year also showed the company faced roughly 132,000 lawsuits over its products in U.S. courts, and seven of the 10 largest jury verdicts against medical companies in the U.S. were against J&J. and totaled more than $900 million.
But those court losses amounted to only a fraction of company revenues. In 2017, despite accusations of faulty products and massive jury awards, J&J’s revenue actually grew by more than 6 percent. Their annual report announced that the weight of pending lawsuits “is not expected to have a material adverse effect on the Company’s financial position.” Even taking into account the hundreds of millions of dollars in legal fees the company spent, and is still willing to spend to fight actions against it, they seemingly don’t fear product failure or harming patients as long as there is profit to be gained.
This attitude that profits trump safety is prevalent in the industry and seems to have regulatory support. From 2008 to 2012, the FDA approved 400 implanted devices of moderate to high risk without any clinical testing. There remains a public assumption that medical device approval requires rigorous testing. But in fact, the overwhelming majority of medical devices on the market that are implanted in patients undergo no clinical trials. Of the very high-risk devices capable of causing serious injury or death only 5 percent even underwent two clinical trials.
In this advantageous regulatory climate, drug and device manufacturers offer financial incentives to tip the scales even farther in their favor. The U.S. requires drug and device manufacturer to disclose payments to physicians and according to an ICIJ analysis of data from the Centers for Medicare & Medicaid Services the 10 largest medical device companies paid nearly $600 million to doctors or their hospitals in 2017. This figure doesn’t include device-related payments from heavyweights that sell other products such as Johnson & Johnson or Allergan.
In this market climate of lax safety, high profits, and favorable regulatory oversight, drug and device manufacturers can choose to ride out what have become seemingly routine court verdicts or settlements in the billions of dollars. There is often incentive not to act even when problems arise with products. At Saunders & Walker see daily the damages that has been wrought on patients. We are representing clients who were injured, or families of patients who died because of defective drugs and medical devices. These currently include device lawsuits for hip implants, the Essure birth control device, IVC filters, and transvaginal mesh; and drug lawsuits for Risperdal, talc products, Taxotere, Propecia, Irbestaran, and Zostovax.
https://pinellas.legalexaminer.com/legal/dangerous-medical-devices-harm-patients-worldwide/
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