Preview Newsletter
Ethicon Media Monitoring 7/27/2018
-
Ireland suspends transvaginal mesh procedures
Jul 26, 2018 | Mass Device
By Fink Densford
Earlier this week, Ireland temporarily suspended all procedures using transvaginal mesh devices to treat stress urinary incontinence or pelvic organ prolapse at Health Service Executive funded hospitals, according to a government release from the country. -
J&J Can't Get New Judge For Philly Pelvic Mesh Trial
Jul 26, 2018 | Law 360
By Daniel Siegal
A Pennsylvania state judge has rebuffed Johnson & Johnson's argument that because his mother is suing the company, he should recuse himself from an upcoming trial of a woman’s claims that she suffered injuries from a pelvic mesh implant. -
Group of women take legal action against hospital trust over now-banned operation
Jul 26, 2018 | Oxford Mail
By Harrison Jones
Women in Oxfordshire are taking legal action against an Oxfordshire health trust after claiming to have suffered ‘catastrophic’ side effects from the now-banned 'mesh' procedure. -
Women are vindicated by medical device ban
Jul 26, 2018 | Limerick Post
By Bernie English
The Limerick solicitor who is leading the campaign to ban a medical device which she says is causing serious injury and pain to women has welcomed a decision to suspend its use. -
Court Denies Bid for En Banc Review of Pelvic Mesh Decision That Spurred Judge-Shopping Charge
Jul 26, 2018 | Law.com
By Max Mitchell
The Pennsylvania Superior Court has denied a bid by a Johnson & Johnson subsidiary that had sought to have its appeal of a $13.5 million pelvic mesh verdict heard by the appeals court en banc. -
Review: In ‘The Bleeding Edge,’ Victims of Medical Devices
Jul 26, 2018 | New York Times
By Ken Jaworowski
The surgery scenes in “The Bleeding Edge” are squirm-in-your-seat uncomfortable. But it’s the interviews — watching patients recount agonies they’ve suffered from poorly researched and regulated medical devices — that are hardest to sit through. -
Review: Kirby Dick and Amy Ziering expose FDA, $400 billion-dollar medical devise industry in wrenching doc ‘The Bleeding Edge
Jul 26, 2018 | Los Angeles Times
By Robert Abele
If body-horror auteur David Cronenberg had dramatized any of the nightmarish stories in Kirby Dick and Amy Ziering’s medical documentary “The Bleeding Edge,” you wouldn’t hesitate to call it a fright film. -
Shocking exposé of dodgy medical devices
Jul 27, 2018 | The Irish Times
By Tara Brady
You’ve heard of big pharma: well, there’s a new menace looming in medicine. In fact, it’s not so new.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Ireland suspends transvaginal mesh procedures
Jul 26, 2018 | Mass Device
By Fink Densford
Earlier this week, Ireland temporarily suspended all procedures using transvaginal mesh devices to treat stress urinary incontinence or pelvic organ prolapse at Health Service Executive funded hospitals, according to a government release from the country.
Minister for Health Simon Harris announced the pause, saying that the Department Chief Medical Officer requested the pause in use of the devices following a review by the Dept. of Health, HSE and the country’s Health Products Regulatory Agency.
The suspension is set to stay in place “until a set of conditions to mitigate the risks of injury are met,” according to the announcement.
“There is understandable public and patient anxiety about the ongoing safety of mesh devices following the considerable publicity that this issue has received and this has been heightened by recent developments in the NHS. It is important that this be addressed as comprehensively as possible. A pause on the use of mesh procedures, pending confirmation by the Executive that the key recommendations below have been implemented, is now considered proportionate and necessary to provide public assurance that these procedures are being carried out in accordance with internationally accepted good practice,” Harris said in a press release.
The Dept. of Health said that the HSE will look to confirm implementation of certain recommendations related to surgical training, informed consent ant development of an agreed dataset of mesh procedures before it removes the suspension.
The agency said it has also contacted the Institute of Obstetricians and Gynecologists, the Royal College of Surgeons in Ireland and the Continence Foundation of Ireland for assistance and recommendations in the matter.
The decision comes only two weeks after the UK accepted a recommendation to temporarily ban use of the devices for women with urinary incontinence until next March, according to an IrishTimes posting.
In July, reports emerged that Johnson & Johnson (NYSE:JNJ) attempted to stop health authorities in France from publishing a report which warned against the use of untested pelvic mesh devices for fear that it would damage their business.
https://www.massdevice.com/ireland-suspends-transvaginal-mesh-procedures/
-
J&J Can't Get New Judge For Philly Pelvic Mesh Trial
Jul 26, 2018 | Law 360
By Daniel Siegal
A Pennsylvania state judge has rebuffed Johnson & Johnson's argument that because his mother is suing the company, he should recuse himself from an upcoming trial of a woman’s claims that she suffered injuries from a pelvic mesh implant.
In a one-sentence order Tuesday, Philadelphia Court of Common Pleas Judge Kenneth Powell denied the motion for recusal from J&J and its unit Ethicon Inc. in the case brought by Diana Perigo, which is scheduled to head to trial Monday.
In their recusal bid, the defendants had stated that Judge Powell’s mother is a plaintiff in a mass-tort litigation proceeding in Philadelphia against J&J companies, and that this case will deal with similar legal and evidentiary issues, such as product liability law and causation, as those at the heart of the Perigo case.
“Accordingly, this court will be called on to make rulings in the Perigo case that could bear on your mother’s case and place Your Honor in a difficult circumstance,” J&J argued. “Ethicon and Johnson & Johnson respectfully submit that Your Honor’s mother’s pending lawsuit against Johnson & Johnson companies is a sufficient ground to warrant recusal from the Perigo trial.”
J&J also said that the judge had not previously disclosed his mother’s lawsuit during the pelvic mesh mass-tort litigation, and said that this, along with the similarity of the suits, raises “serious concerns about the appearance of impropriety that justify recusal.”
In her response, Perigo blasted J&J’s recusal bid as “judge shopping,” arguing that the company recently asked the judge overseeing the pelvic mesh mass-tort litigation, Philadelphia Court of Common Pleas Judge Arnold New, to recuse Judge Powell from the transvaginal mesh cases, and that Judge New had responded “unfavorably” to the request.
“Instead of filing a motion to recuse Judge Powell with Judge New and knowing the likely order of Judge New, Johnson & Johnson instead filed this motion with Judge Powell,” Perigo argued. “This appears to be judge shopping."
Perigo also argued that J&J’s recusal bid rested on an “empty allegation” that there are issues in common between her case and the case involving Judge Powell’s mother, and that it failed to back up the allegations with actual examples.
Perigo, who filed suit in 2013, is among thousands of women nationwide who have filed suits alleging Ethicon and J&J failed to fully disclose the risks associated with the Gynecare Prolift pelvic floor support mesh product and the so-called TVT, or transvaginal tape
Perigo’s attorneys at Kline & Specter PC also represent another woman, Sharon Carlino, who in 2016 won a $13.7 million verdict in her suit alleging she suffered irreversible injuries from the TVT.
In January, Judge Powell rejected Ethicon’s bid to strike down that verdict.
An attorney for Perigo declined to comment Thursday.
An attorney for Ethicon did not immediately respond to a request for comment.
Perigo is represented by Shanin Specter, Michael A. Trunk, Kila B. Baldwin, Priscilla A. Jimenez and Thomas Bosworth of Kline & Specter PC.
Ethicon and J&J are represented by Joseph E. O’Neil, Julia M. Rafferty and Camille L. Eastebrook of Lavin O’Neil Cedrone & DiSipio.
The case is Diana Perigo v. Ethicon Inc. et al., case number 130701491 in the Philadelphia County Court of Common Pleas.https://www.law360.com/articles/1067437/j-j-can-t-get-new-judge-for-philly-pelvic-mesh-trial
-
Group of women take legal action against hospital trust over now-banned operation
Jul 26, 2018 | Oxford Mail
By Harrison Jones
WOMEN in Oxfordshire are taking legal action against an Oxfordshire health trust after claiming to have suffered ‘catastrophic’ side effects from the now-banned 'mesh' procedure.
At least 15 women are seeking damages against Oxford University Hospitals NHS Foundation Trust, with a temporary government ban on the practice announced this month.
A group of women, many of whom underwent the controversial procedure at the John Radcliffe Hospital in Oxford, are calling for a complete bans after the practice was stopped as a treatment for incontinence.
Mesh has been blamed for a host of issues, including chronic pain, the loss of sex lives and mobility problems by women nationwide.
"The implants have reportedly cut into women’s bladders, bowels and vaginas.
The practice was still being used by the JR to treat incontinence prior to last week’s ban, despite various patients subsequently having problems and removals.
Until eight years ago, vaginal mesh procedures were also being used by the hospital for organ prolapse.
Most of the women involved want to remain anonymous, with at least 15 legal cases being pursued.
One previous patient, who labelled the operation ‘catastrophic’ claimed she was not told of the risks or alternative.
She said: “This operation changed my life for the worse. Having done my research now, my stress incontinence did not warrant an operation. I never knew that if I had a problem with the mesh it was difficult to remove and only a handful of surgeons could do this. I never knew it was plastic. I never knew it was done blind.
"I was in pain. I ended up having months off work and nearly losing my business. I am so much better without mesh."
Another JR patient, who tells a remarkably similar story,said she felt 'ignored' over her symptoms.
Kath Sansom, a journalist based in Cambridge, who started the nationwide ‘Sling the Mesh’ campaign, told the Oxford Mail that Oxford ‘is a problem area because mesh has been heavily used in the area.’
She added that the studies used by the JR to justify the use of mesh are ‘flawed’ and that precise figures were difficult to obtain, particularly since the NHS regarded ‘successful’ procedures as ones after which women were no longer incontinent – regardless of side effects.
Ingrid Granne, Clinical Director for Gynaecology for the Trust, said: "The Trust has not carried out mesh operations for prolapse since 2010.
"However, it has still been performing a limited number of mesh operations for stress urinary incontinence (known as TVT) after a full discussion with patients.
"We will be in contact with all patients currently listed for TVT operations over the coming days."
The trust did not provide further information.
Baroness Cumberlege, who is reviewing the use of mesh, will be in Oxford on Monday, September 17, to hear from those affected.
Linda Millband, head of medical negligence at Thompsons Solicitors, representing over 220 mesh-injured clients, welcomed the ‘immediate and decisive’ ban.
She said: “For all the women Thompsons is acting for, injured by the use of mesh for stress incontinence, the suspension comes too late - but if it prevents one more woman being left injured for life, as many of our clients have been, then that is welcome.”
http://www.oxfordmail.co.uk/news/16378961.group-of-women-take-legal-action-against-hospital-trust-over-now-banned-operation/
-
Women are vindicated by medical device ban
Jul 26, 2018 | Limerick Post
By Bernie English
THE LIMERICK solicitor who is leading the campaign to ban a medical device which she says is causing serious injury and pain to women has welcomed a decision to suspend its use.
Health Minister Simon Harris announced this Tuesday that he has ordered surgeons to stop using trans vaginal mesh for the treatment of female incontinence.
Solicitor Melanie Power told the Limerick Post that the campaign started when women clients came to her with horrendous problems caused by the device cutting into internal organs.
This resulted in the establishment of the Mesh Survivors Ireland group which now has more than 400 members.
“We are absolutely delighted with this news,” said Ms Power, who headed a delegation that met with Minister Harris three weeks ago.
“This is a suspension but we are certain that when the full facts of the damage that this has done and the pain women have suffered as a result of complications, there will be no choice but to ban it entirely”.
The ban became effective from Tuesday night, with operations to insert fresh devices cancelled from Wednesday. This follows a similar ban in the UK and Northern Ireland which took effect some weeks ago.
The issue was highlighted in the Limerick Post last May when the Dooradoyle based solicitor explained that there is no medical means in Ireland of even examining the plastic mesh device once it is inserted.
“Women were not warned there could be serious side effects. This device needs to be looked at on a special scan which is not available here. It can’t even be seen, only the damage it causes and it can’t be removed by surgery in this country.
“Women have mortgaged their homes to go to the UK to have this device taken out, They’ve become reliant on walking sticks and wheelchairs and have been given no option but to medicate their pain, often with drugs containing opiates.
“One woman who contacted the group said she had planned her suicide until she discovered this could be the reason for the terrible pain she has been suffering for years and which doctors have told her is all in her head”.Ms Power said the decision is a vindication of “all the women who have suffered terrible pain and injury and all those women who were told there was nothing wrong with them, that it was all in their heads”.A statement issued on behalf of Minster Harris said: “This announcement follows a review by the Department of Health together with the HSE and the Health Products Regulatory Agency (HPRA), of the decision by health authorities in England and Northern Ireland to pause the use of mesh in those countries on the recommendation of the Independent Medicines and Medical Devices Safety Review (IMMDS) until a set of conditions to mitigate the risks of injury are met”.“There is understandable public and patient anxiety about the ongoing safety of mesh devices following the considerable publicity that this issue has received and this has been heightened by recent developments in the NHS. It is important that this be addressed as comprehensively as possible,” the statement concluded.
https://www.limerickpost.ie/2018/07/26/women-are-vindicated-by-medical-device-ban/
-
Court Denies Bid for En Banc Review of Pelvic Mesh Decision That Spurred Judge-Shopping Charge
Jul 26, 2018 | Law.com
By Max Mitchell
The Pennsylvania Superior Court has denied a bid by a Johnson & Johnson subsidiary that had sought to have its appeal of a $13.5 million pelvic mesh verdict heard by the appeals court en banc.
Ethicon, the J&J subsidiary that is the focus of much of the pelvic mesh litigation in Philadelphia, had asked the Superior Court to bypass having the case initially reviewed by a three-judge panel, saying that, “given the importance” of jurisdictional arguments being raised, it should be consolidated for argument with two other pelvic mesh dockets that are raising similar issues to the first-line appellate court.
The company made the request July 3, specifically asking that Carlino be heard by the same expanded panel that may hear argument in Hammons v. Ethicon, which came to a $12.5 million verdict in late 2015, and in In re Pelvic Mesh Litigation, which is the global docket for Philadelphia’s pelvic mesh mass tort. Both of those appeals raise questions about whether the pelvic mesh plaintiffs can establish jurisdiction in Pennsylvania in the wake of the U.S. Supreme Court’s decision in Bristol-Myers Squibb v. Superior Court of California.
The request to bypass review by a three-judge panel had prompted counsel for plaintiff Sharon Carlino to allege that Ethicon was attempting to judge-shop, since two of the three judges set to be on that panel previously ruled against Ethicon last month in Hammons.
On Thursday, the three-judge Superior Court panel set to hear oral argument Aug. 8 in Carlino issued a two-page per ciruam order denying Ethicon’s request.
Kline & Specter attorney Shanin Specter, who is representing Carlino, agreed with the Superior Court’s decision.
“The Superior Court is right in not giving a litigant special treatment and the right to jump the line ahead of others in contravention of its rules and operating procedure,” Specter said.
A spokeswoman for Ethicon did not immediately return a request for comment Thursday afternoon.
https://www.law.com/thelegalintelligencer/2018/07/26/court-denies-bid-for-en-banc-review-of-pelvic-mesh-decision-that-spurred-judge-shopping-charge/
-
Review: In ‘The Bleeding Edge,’ Victims of Medical Devices
Jul 26, 2018 | New York Times
By Ken Jaworowski
The surgery scenes in “The Bleeding Edge” are squirm-in-your-seat uncomfortable. But it’s the interviews — watching patients recount agonies they’ve suffered from poorly researched and regulated medical devices — that are hardest to sit through.
“When it comes to medical devices, we built a system that doesn’t work” for proper regulation, says Dr. David A. Kessler, a former commissioner of the Food and Drug Administration. The multibillion dollar industry has exploited those flaws, and Kirby Dick (“The Invisible War,” “Twist of Faith”), the documentary’s director, spotlights infuriating examples and conflicts of interest.
We learn of former F.D.A. officials hired by companies they once regulated, and see business executives named to government positions. That revolving door has been reported elsewhere, and often. Yet as outlined here, corporate influence has reached a point that might seem comical were patients’ lives not being wrecked.
Mr. Dick smartly summarizes complex procedures and cites exasperating statistics. His script is better still at introducing people affected by the products. The interviewers — Amy Ziering, aided by Amy Herdy and Mr. Dick — coax out dozens of quotes and anecdotes you’ll wish were heard by every government official.
Ana Fuentes, a mother of four, chose Essure as a contraceptive. She and others say they have experienced excruciating pain since being implanted with it. (Last week, Bayer, the maker of Essure, said it will end sales of the device.) Ms. Fuentes says she is now unable to work because of complications. Her experiences described here, and the toll they take on her children, are heartbreaking.
Stephen Tower, a physician, received a chrome-cobalt replacement hip, which he suspects poisoned him and led to a mental breakdown. Another segment, on complications said to be caused by vaginal mesh, is particularly harrowing; the mesh, whose potential to create serious problems was long known, “costs about $25 to bring to market, and they sell for about $2,000,” says an obstetrician. In such cases, if there’s a disagreement between the marketing and the medicine, “the marketing is always going to win out,” says a lawyer for injured patients.
A sales representative, whose identity is shielded, discusses financial incentives used to coax surgeons to implant devices: “It’s gotten worse over time because of greed.” An onscreen statistic notes that medical companies paid doctors more than $2 billion in 2016.
“The Bleeding Edge” isn’t an anti-medical film, but a look at calamities caused when the obsession for profit overwhelms an industry. Mr. Dick uses no devious camera tricks, and the soundtrack, by Jeff Beal, is tense yet restrained. Indeed, the filmmakers aren’t shouting “Fire” in a crowded theater. For them and their subjects, the inferno has already occurred. Now they’re sweeping up the ashes, and warning of new blazes sure to come.
https://www.nytimes.com/2018/07/26/movies/bleeding-edge-review-medical-devices.html
-
Jul 26, 2018 | Los Angeles Times
By Robert Abele
If body-horror auteur David Cronenberg had dramatized any of the nightmarish stories in Kirby Dick and Amy Ziering’s medical documentary “The Bleeding Edge,” you wouldn’t hesitate to call it a fright film. Such is the grim impact of this investigative, wince-inducing examination of the $400 billion medical device industry, which routinely sends FDA-approved products into the marketplace for use on and in patients without any rigorous clinical safety-testing on humans.
For director Dick and producer Ziering, it’s another effectively enraging, eye-opening look at a systemic case of neglected wrongdoing, one that follows their rape-in-the-military expose “The Invisible War” and campus sexual assault documentary “The Hunting Ground.” That their new film also involves the wanton mistreatment of bodies, and how difficult it often is to find justice for the afflicted, makes “Bleeding Edge” a queasy continuation of the previous films’ concerns.
At the heart of the film’s thesis, and spoken aloud by many of the health care professionals interviewed, is a suspicion about whether innovation and new technologies in medicine should automatically be treated as a better option for patients over standard, proven and research-driven treatments. With our bodies increasingly housing non-biological devices — a previous age’s wonder at the pacemaker giving way to the full-speed-ahead (70 million Americans in the last decade alone) implantation of life-extending technologies — it’s shocking to learn how harmful this revolution has become, especially when medical error was recently declared by a Johns Hopkins study to be the third leading cause of death in the U.S.
The living, though, are the film’s most convincing subjects, offering heartbreaking testimonials to the deleterious effects of a few key devices, starting with a permanent birth control device called Essure that promised 99% effectiveness, yet has often resulted in intense pain, bleeding, and even more severe problems. As with another heavily sold, under-scrutinized gynecological product — vaginal mesh that hardens, causing horrible pelvic damage, and in one couple’s instance, cutting the husband’s penis during intercourse — getting such devices removed (when they were intended to be permanent) can be as undefined and risk-laden a decision as leaving them in.
What the filmmakers reveal is that the FDA approvals process — which hasn’t been updated to meet our technological overwhelm and increasingly powerful corporations — doesn’t require objective testing (score one for industry) and signs off with scant evidence that a product is safe. It leaves doctors assuming heavily pushed devices, because they’ve received FDA’s okay, have been rigorously vetted. But video secured from Essure’s approval hearing shows not only the board’s safety questions barely answered by the company’s advocates but also post-vote laughing from panelists about the very lack of rigor just exhibited.
Combined with the forces of anti-regulation in government and profit-driven companies who know how to market to doctors and cover up their mistakes, the movie lays bare a blueprint for countless suffering. Left behind are people such as Ana, a Southern California woman whose unending medical needs after having Essure implanted wrecked her marriage and job, as well as her ability to take care of her four children.
Aside from the story of an orthopedic doctor who experienced neurological deterioration after getting a metal-on-metal hip replacement, then turned the experience into a heavily researched crusade against the material used, the movie’s tales of debilitating woe come primarily from women. It points to an unspoken but hard-to-miss aspect of Dick and Ziering’s well-argued outrage about the lack of attention given to untested devices. When a group of Essure survivor-activists take their cause to the halls of Congress to demand action against parent company Bayer, longtime patients’-rights advocate, New York Congresswoman Louise Slaughter (who died in March) meets their opprobrium with a pointedly weary, “Women just seem to be expendable, don’t they?”
The good news is that “The Bleeding Edge” can already be called a change agent: Last week, in advance of the movie’s release, Bayer pulled Essure from the U.S. market.
http://www.latimes.com/entertainment/movies/la-et-mn-bleeding-edge-review-20180726-story.html
-
Shocking exposé of dodgy medical devices
Jul 27, 2018 | The Irish Times
By Tara Brady
You’ve heard of big pharma: well, there’s a new menace looming in medicine. In fact, it’s not so new.
Not too far into this shocking documentary, the director of The Hunting Ground, Kirby Dick, dusts down an ancient monochrome public service film featuring the late Raymond Massey. The veteran actor cautions that while the old-time medicine man and his snake oil are being eliminated by tighter regulations, there’s a new kind of quackery which is “equally dangerous and far more difficult to control: phoney machines and devices which are supposed to diagnose and treat. Unlike new drugs, therapeutic devices do not have to be proved safe or effective before they are sold and used.”
Decades after that film was first broadcast, the $400 billion medical device industry is no better regulated. If anything, as various whistleblowers from the US’s Food and Drugs Authority (FDA) explain, there are even fewer safeguards. “When it comes to medical devices, we built a system that doesn’t work,” explains David Kessler, a former FDA commissioner for both the Bush and Clinton administrations.
The Bleeding Edge carefully teases out tricky relevant legislation: a 1976 Bill allowed manufacturers to “grandfather” in any product – no matter how unreliable – that happened to be on the market before that date. A newer amendment fast-tracks any product that is equivalent to something else on market, even when that means the product is equivalent to something that has already been recalled. There is, damningly, a nexus of employees moving between the FDA, hedge funds and the medical tech industry.
Scott Gottlieb, who was appointed head of the FDA by Trump, has promised to recuse himself for one year from any decisions involving the 20 healthcare companies for which he has worked.
Between startling facts and figures – more than 70 million Americans have been implanted with medical devices in the past 10 years; medical companies paid doctors more than $2 billion in the US in 2016 – there are terrifying case studies. Essure, a permanent contraceptive implant used by millions of women, has left many of them with persistent bleeding, chronic pain and ongoing corrective surgeries. Patients who were given hysterectomies by the robotic surgeries of the Da Vinci System describe colons and intestines falling out as a consequence of vaginal cuff dehiscence, a complication that turns out to be even more gruesome than it sounds.
Vaginal mesh implants make for another round of horror stories. Vaginal mesh lawsuits have cost manufacturer Johnson & Johnson $300 million in the past decade. But that’s chump change beside their revenues of $683 billion over the same period.
Perhaps the most discombobulating aspect of Kirby Dick’s investigation is that doctors and specialists are often as uninformed as their patients. Alaskan orthopaedic surgeon Stephen Tower describes the Alzheimer’s symptoms and tremors he experienced after opting for a cobalt hip implant. He has subsequently documented dozens of patients who experienced similar symptoms, which were immediately relieved when the cobalt implant was replaced by a traditional ceramic one.
The only non-surprise in this eye-opening chronicle is that no representatives for the manufacturers or for the FDA agreed to be interviewed.
https://www.irishtimes.com/culture/film/shocking-expos%C3%A9-of-dodgy-medical-devices-1.3575099
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested