Preview Newsletter
Ethicon Media Monitoring 10/11/2017
-
J&J Is Said to Weigh the Sale of Its Vaginal Mesh Product
Oct 9, 2017 | Bloomberg Terminal
By Manuel Baigorri and Cynthia Koons
Johnson & Johnson is considering a divestiture of its vaginal mesh surgical product as the U.S. -
MPs to debate use of controversial vaginal mesh implants
Oct 10, 2017 | The Gurdian
By Hannah Devlin
Parliament will discuss risks associated with implants after women report debilitating complications, including perforated organs and chronic pain -
Parliament set to debate controversial vaginal mesh which has destroyed the lives of thousands of women as pressure mounts to ban procedure
Oct 10, 2017 | The Daily Mail
By Stephen Matthews And Alexandra Thompson
Scandal-hit vaginal mesh implants will be debated in parliament next week amid mounting pressure to ban the controversial procedure. -
If a car had this many faults it would be recalled - professor speaks about mesh implants on the day a Parliamentary debate is announced on the growing controversy
Oct 10, 2017 | Cambs Times
By Kath Sansom
Mesh implants are the third major medical device disaster in the last decade, a bioengineer has warned, as campaigners wept on hearing that the growing controversy is to be debated in Parliament. -
Public Inquiry Urged Into 'Disregarding' Of Safety Over Vaginal mesh Implants
Oct 10, 2017 | Press Association
By Harriet Line
The Government has been urged to launch a public inquiry into why the safety of many women who received -
FDA Archived Material on Pelvic Mesh
Oct 10, 2017 | Mesh Medical Device Newsdesk
The U.S. Food and Drug Administration has been looking at the issue of pelvic or transvaginal mesh for more than ten years now. -
Endo International Announces Plan to Resolve Remaining Mesh-Related Lawsuits
Oct 10, 2017 | US Recall News
By Sean Lally
Endo International recently indicated that it would set aside $775 million to resolve thousands of remaining lawsuits regarding the faulty vaginal mesh devices sold by the company. -
What Duties Do Lead Lawyers Owe MDL Plaintiffs?
Oct 10, 2017 | Law 360
By Elizabeth Chamblee Burch
There is a persistent question in multidistrict proceedings: what duties do lead lawyers owe to individual plaintiffs who have no direct attorney-client relationship with them?
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
J&J Is Said to Weigh the Sale of Its Vaginal Mesh Product
Oct 9, 2017 | Bloomberg Terminal
By Manuel Baigorri and Cynthia Koons
Johnson & Johnson is considering a divestiture of its vaginal mesh surgical product as the U.S.
The health-care giant ramps up a review of its medical technologies business to raise cash, according to people familiar with the matter.
J&J’s vaginal mesh could fetch from $500 million to $1 billion in a sale and attract both health-care companies as well as private equity firms, the people said, asking not to be identified because the matter is private. Considerations are at an early stage and no final decision has been made, the people said.
A representative for New Brunswick, New Jersey-based J&J declined to comment.
The mesh has been a legal problem for J&J. The company has been sued by thousands of women who say they were injured by the devices, which are used in surgeries to strengthen walls inside the pelvis. Last month, J&J was ordered to pay $57.1 million to a Pennsylvania woman who blames the mesh inserts for damaging her organs and causing chronic pain.
Some drugmakers are selling or winding down women’s health lines as they seek to refocus their portfolios and raise cash.
In September, Teva Pharmaceutical Industries Ltd. agreed to sell its women’s health unit in three separate transactions totaling about $2.5 billion. In February of last year, Endo said it would wind down its women’s health business. Novartis AG said it sold the trademark rights on a package of anti-infective medicines used for women’s health to Samara Capital, a private equity firm.
J&J has sought to trim its portfolio of medical technologies to raise cash. It announced in January that it was evaluating options for the diabetes-care business, including a sale, partnership or joint venture. J&J is working with Goldman Sachs Group Inc. on the review of the asset, which could fetch
$2 billion and has attracted interest from private equity firms including Hellman & Friedman and GTCR Golder Rauner, people with knowledge of the matter said in March.
After buying Actelion for $30 billion this year, Johnson & Johnson has signaled that a new generation of medicines hold the key to its future profits as the dominance of a number of its best-selling drugs begins to fray.
-
MPs to debate use of controversial vaginal mesh implants
Oct 10, 2017 | The Gurdian
By Hannah Devlin
Parliament will discuss risks associated with implants after women report debilitating complications, including perforated organs and chronic pain
The use of controversial vaginal mesh implants will be debated by MPs next week, amid concerns over the traumatic complications suffered by some patients.
Parliament will discuss the risks associated with the implants, which are widely used to treat incontinence and pelvic organ prolapse, common conditions in women who have had children. During the past decade, more than 100,000 women in the UK have been fitted with the implants.
For many women, the operation is quick and successful but some have suffered debilitating complications including perforated organs and chronic pain. In July, the government released its three-year investigation into mesh implants, which concluded that the use of mesh to treat women with urinary incontinence and prolapse “is a safe option for women”.
However, since then further evidence has emerged about apparently high rates of complications, and the issue is gaining political momentum. Figures obtained by the Guardian suggested that around one in 15 women fitted with the most common type of mesh support later require surgery to have it extracted and a recent US trial involving Johnson & Johnson, a leading manufacturer of the implants, heard of new products being used in patients without clinical trials.
The question of safety is complicated because a large variety of different vaginal mesh implants, made by different manufacturers, have been used without any systematic registry existing to collect data on long-term outcomes or safety. The success of the procedure also depends on surgical expertise, making it hard to know whether complications are wholly caused by problems with the device.
Emma Hardy, Labour MP for Hull West and Hessle, secured the debate on 18 October after hearing the experiences of several women in her constituency who she said had, until recently, been “suffering in silence”. “It’s a topic that people have felt ashamed and embarrassed about,” she told the Guardian. Hardy is calling for a public inquiry into the use of mesh, aimed at establishing the risks associated with the procedure and whether mesh removal helps resolve complications.
Kath Sansom, founder of the campaign group Sling the Mesh, welcomed the debate. “Women have been campaigning since 2007 but sadly it has taken until 2017 for us to be taken seriously,” she said. “So many have joined [the support group] describing their feeling of isolation having been told they were the only ones suffering and are shocked to see there are so many others.”
https://www.theguardian.com/society/2017/oct/10/mps-to-debate-use-of-controversial-vaginal-mesh-implants
-
Oct 10, 2017 | The Daily Mail
By Stephen Matthews And Alexandra Thompson
· MPs will discuss the safety of the operation next week, it has been announced
· The implant has wrecked the lives of thousands of women and left many suicidal
· Ministers are concerned it was introduced with 'little evidence' to support it
· Campaigners and scores of outraged women have welcomed the announcement
Scandal-hit vaginal mesh implants will be debated in parliament next week amid mounting pressure to ban the controversial procedure.MPs will next week discuss the safety of the operation, which has destroyed the lives of thousands of women, and left many suicidal and unable to have sex.
The scandal, compared to thalidomide, came to light earlier this year, but its true extent is yet to be uncovered. Some 800 British women have since sued.
After previously denying their implants were causing women's discomfort, mesh manufacturer Johnson & Johnson paid out $57 million to a sufferer from Philadelphia last month after a jury found the company to be negligent and its product defective.
Ministers are concerned the procedure, used to treat pelvic organ prolapse and incontinence after childbirth, was introduced with 'little evidence' to support it.
Campaigners have welcomed the announcement, refusing for their vocal concerns to be swept under the carpet and have to 'suffer in silence'.
But experts, backed by MailOnline, are still demanding a public inquiry into the use of the procedure, which 10,000 women undergo each year, according to figures.
Kath Sansom, founder of Sling The Mesh, a campaign group which has doubled in size in recent months as more women join, was emotional.
She tweeted: 'Not enough words to thank you for securing a debate on behalf of so many women whose lives have been devastated by #mesh.'
Julie Gilsenan, 49, from Liverpool, also tweeted: 'Emotional is not the word! Let our voices be heard...we will NOT suffer in silence #banmesh'
Mrs Gilsenan's heartbreaking story has previously been revealed by MailOnline, as she went from running 5km before her surgery to now wetting herself.
Who secured the debate?
Emma Hardy, Labour MP for Hull West and Hessle, secured the debate on October 18 after hearing the heartbreaking stories of women affected in her constituency.
Health officials have repeatedly been accused of attempting to cover up the vaginal mesh scandal, as the NHS and MHRA state only 1 to 3 per cent of women will suffer complications.
GROWING CALLS FOR A PUBLIC INQUIRY
Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, has previously called for a public inquiry.
Shadow health minister Sharon Hodgson has backed him, and said the procedure carries 'unacceptable complication rates'.
During health questions in the Commons today, Ms Hodgson said: 'It is, though, deeply worrying that this procedure was introduced with so little evidence to support it, which has led to - we all, I think, have to agree - unacceptable complication rates for certain products.
'Will the Minister heed the words of Professor Heneghan and hold a public inquiry into the numbers of women adversely affected and why the safety of so many women was disregarded.'
Health Minister Jackie Doyle-Price told MPs she knew many women suffer substantial side effects and complications after the procedure, but it was 'equally the case that many women also experience considerable relief from symptoms'.
She said Nice strongly recommends that the implants are not offered routinely for the first surgical intervention in prolapse, and that the current guidance was being updated and would be published early next year.
Responding to Ms Hodgson, Ms Doyle-Price said: 'I would say again that many women have received relief from their symptoms with this procedure but I think that it is important that we have more evidence before we can properly review this.
'And I think it's very important that the work that Nice are doing should be allowed to be undertaken so that we can actually make a very clear view of this.'
Government rejects a ban
Just last month the Government released its three-year investigation and rejected calls for a widespread ban on the implants, which can shrink, twist and curl at the edges and cause nerve damage.
Vaginal mesh has been considered a high-risk device for nearly a decade in the US, with bodies accepting up to 40 per cent of women may experience injury.
Some studies, published in an array of scientific journals, have shown that pain, erosion and perforation from the surgery can strike up to 75 per cent of women.
The alarming evidence prompted officials in three US states to suspend the practice and saw them call for an urgent review into its safety.
Suspended in Scotland
Its usage has also been suspended in Scotland since 2014 pending a similar safety review, but hundreds of women are still believed to be having the surgery.
The mesh, introduced 20 years ago, was promoted as a quick, cheap alternative to complex surgery for incontinence. It was dubbed the 'gold-standard' treatment.
Because it did not require specialist training to implant, outraged women have since begged for tougher regulations to conduct such surgery.
More than 10,000 women a year have the procedure. But only 7,800 have suffered lacerations and nerve damage from the mesh breaking into tiny fragments.
Women receiving pay outs
After previously denying their implants were causing women's discomfort, mesh manufacturer Johnson & Johnson paid out $57 million to a sufferer last month after a jury found the company to be negligent and its product defective.
Ella Ebaugh, 51, from Philadelphia, was fitted with a mesh for urinary incontinence that eroded into her vagina and required three surgeries to reverse the damage.
More lawsuits remain as thousands say they too are experiencing problems with the gold-standard device.
Five years ago, Johnson & Johnson stopped selling four of its mesh inserts after people said they were faulty.
HOW MANY WOMEN SUFFER?According to the NHS and MHRA, the risk of vaginal mesh pain after an implant is between one and three per cent.
Yet, a study by Case Western Reserve University found that up to 42 per cent of patients experience complications.
Of which, 77 per cent report severe pain and 30 per cent claim to have a lost or reduced sex life.
Urinary infections have been reported in around 22 per cent of cases, while bladder perforation occurs in up to 31 per cent of incidences.
Critics of the implants say trials confirming their supposed safety have been small or conducted in animals, who are unable to describe pain or a loss of sex life.
According to Kath Samson, head of the Sling The Mesh campaign, surgeons often refuse to accept vaginal mesh implants are causing recipient's pain, and are not obligated to report such complications anyway.
She said: 'Less than 40 per cent of surgeons report vaginal mesh implant side effects.
'In last 10 years, 126,000 mesh and tape implants have been fitted in England alone.
'In that period around 7,800 women have gone into hospital with a mesh complication, but the number reported to the MHRA is just over 1,000.
'Many more women would have experienced pain but never gone to hospital.'
http://www.dailymail.co.uk/health/article-4966576/Parliament-set-debate-controversial-vaginal-mesh.html
-
Oct 10, 2017 | Cambs Times
By Kath Sansom
Mesh implants are the third major medical device disaster in the last decade, a bioengineer has warned, as campaigners wept on hearing that the growing controversy is to be debated in Parliament.
Tom Joyce, professor of orthopaedic engineering at Newcastle University, says if similar concerns existed over a car it would likely have been taken off the market and investigated by now.
Labour MPs have secured a Parliamentary debate next week on behalf of Sling The Mesh and have pledged to call for a public inquiry into the growing controversial pelvic mesh implants.
When women heard the news they took to social media to celebrate knowing campaigners have been trying for more than 10 years to have their voices heard
Professor Joyce, who was among the first to contact Scottish Parliament when Scottish Mesh Survivors called for a suspension of the polypropylene plastic devices in 2014, said: “Unlike drugs, which someone can stop taking, a medical device is usually intended to be permanent.
“It leaves patients stuck with their suffering if an implant goes wrong or having to undergo complicated and traumatic removal surgery.
“Mesh is fast becoming the biggest health controversy of our time causing life changing injuries from implants used to treat incontinence, prolapse and hernias.
“It follows on from metal on metal hips which caused chronic pain when the metal was worn away and PIP breast implants that used mattress grade instead of human grade silicone.
“In the case of mesh I find it hard to believe there’s so many patients with problems but when you go to the regulators they say they are not getting the complication numbers through,” he said.
“Therefore it appears that systems are not in place to capture what is actually happening.
“That means the failings may go on for years before regulators or Governments realise something is wrong - and often only as a result of patient campaign groups.”
Speaking on BBC Radio Four Inside Health, Professor Carl Heneghan, director of the centre for evidence-based medicine at Oxford University said: “Medical device approval system is shambolic.”
Professor Joyce called for simple measures to improve patient safety:
• All implanted medical devices to go on a registry, so that every implant is tracked.
“for artificial hips and knees, it only costs around £20 per implant. That’s a trivial amount to pay for the valuable information it brings to identify poorly performing implants.”
• Phased introduction of new medical implants undertaken at specialist centres where all patients are fully tracked.
“Only once the efficacy is shown after a certain amount of time, should the implant be introduced more widely,” he said.
• A Europe-wide implant database, like the MAUDE (Manufacturer and User Facility Device Experience) database in America, where anyone can search medical devices to see how they are performing.
• Reporting of ‘failed’ medical implants should be mandatory. “We need true and full data to ensure patient safety”
Medical device regulation “can be a complex area of legislation and lacking in transparency,” Professor Joyce added, which is why patient safety groups may struggle to prove to bodies like the MHRA that implants are failing and why.
“The priority for regulators should be patient safety. If that means regulators stop medical devices being implanted while patient concerns are investigated, then so be it,” he said.
“Look at all the women campaigning about mesh – why aren’t they being listened to?”
A spokesman for Sling The Mesh said: “When a woman’s life is ruined from a so called simple operation and you are then ignored it is devastating - many women suffer severe depression from this. To know we finally have a Parliamentary debate has been a very emotional day for many.”
http://www.cambstimes.co.uk/news/campaigners-weep-at-news-that-parliament-will-debate-controversial-mesh-implants-if-car-had-this-many-faults-it-would-be-taken-off-the-market-1-5231284
-
Public Inquiry Urged Into 'Disregarding' Of Safety Over Vaginal mesh Implants
Oct 10, 2017 | Press Association
By Harriet Line
The Government has been urged to launch a public inquiry into why the safety of many women who received
vaginalmesh implants was "disregarded".
Shadow health minister Sharon Hodgson said it was deeply worrying that the procedure - used to treat pelvic
organ prolapse and incontinence after childbirth - was introduced with "little evidence" to support it.
More than 1,000 adverse incidents related to the implants have been reported in the last five years, according
to data from the Medicines and Healthcare products Regulatory Agency, with some women reporting severe
discomfort and inability to walk or have sex.
Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, has previously called for
an inquiry into the use of the procedure.
During health questions in the Commons, Ms Hodgson said: "It is, though, deeply worrying that this
procedure was introduced with so little evidence to support it, which has led to - we all, I think, have to agree -
unacceptable complication rates for certain products.
"Will the Minister heed the words of Professor Heneghan and hold a public inquiry into the numbers of women
adversely affected and why the safety of so many women was disregarded."
Health Minister Jackie Doyle-Price told MPs she knew many women suffer substantial side effects and
complications after the procedure, but it was "equally the case that many women also experience
considerable relief from symptoms".
She said the National Institute for Health and Care Excellence (Nice) strongly recommends that the implants
are not offered routinely for the first surgical intervention in prolapse, and that the current guidance was
being updated and would be published early next year.
Responding to Ms Hodgson, Ms Doyle-Price said: "I would say again that many women have received relief
from their symptoms with this procedure but I think that it is important that we have more evidence before we
can properly review this.
"And I think it's very important that the work that Nice are doing should be allowed to be undertaken so that
we can actually make a very clear view of this."
-
FDA Archived Material on Pelvic Mesh
Oct 10, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, October 10, 2017 ~ The U.S. Food and Drug Administration has been looking at the issue of pelvic or transvaginal mesh for more than ten years now.
Though slow to act to recall mesh, to follow up on ordered studies, to create a medical device registry, there have been some decisions, such as reclassifying mesh for pelvic organ prolapse to Class III.
It is worth reminding ourselves what’s going on with this so-called watchdog agency.
**Note many of the long-standing FDA releases on mesh including Public Safety Notification have been moved or cannot be found in the archive. MND is trying to track them down.
Archive-It is a data archive business. Here is a list of the articles mined from within the FDA by Archive-It.FDA Related Information from FDA Website
This link is no longer active:Federal Register Notice: Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh
This is the January 2016 order that reclassifies POP (pelvic organ prolapse) mesh to Class III. Tremendously important in that manufacturers now have to prove the safety and efficacy of their product BEFORE it is sold via clinical trials.FDA Press Release: FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks
This link is no longer active:Final Order for Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair
This link is no longer active:Final Order for Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair
This is the July 13, 2011 order that finally says mesh complications are “not rare” and a complete turnaround from the 2008 safety communication that said they were rare! See under Purpose:UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication [ARCHIVED]
White Paper July 2011 on What the FDA knows to date on urogynecologic surgical mesh. 15 pages. Its link to 2008 says it has been moved.Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse (July 2011)(PDF – 243KB)
News release on July 13, 2011 announcement that POP mesh poses risks.Press Release: Surgical placement of mesh to repair pelvic organ prolapse poses risks[ARCHIVED]
Not found:Federal Register Notice: Urogynecologic Surgical Mesh
Not found:Federal Register Notice Ammendment: Urogynecologic Surgical Mesh
Some of you may have been in attendance of the September 8-9, 2011 expert panel on pelvic mesh. Some of you may have testified. The transcript is here but the testimony from many injured patients is not. Janet Holt- Page 86. Sherri Palm Page 89. Note* The FDA said it would be monitoring pelvic mesh used for SUI. It has not done so to date!2011 Meeting Materials of the Obstetrics and Gynecology Devices Panel [ARCHIVED]
FDA Public Health Notification, October 20, 2008, updated July 13, 2011, This is the one that says the complications from POP and SUI mesh are “rare.” This after the FDA received over 1,000 reports from nine surgical mesh makers of complications that were associated with surgical mesh devices used on women and placed transvaginally.
https://wayback.archive-it.org/7993/20161022130905/http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm
https://www.meshmedicaldevicenewsdesk.com/fda-archived-material-pelvic-mesh/
-
Endo International Announces Plan to Resolve Remaining Mesh-Related Lawsuits
Oct 10, 2017 | US Recall News
By Sean Lally
Endo International recently indicated that it would set aside $775 million to resolve thousands of remaining lawsuits regarding the faulty vaginal mesh devices sold by the company. The mesh devices have been linked to numerous accounts of related incontinence and pain, leading the company to cease all sales of the product last year. The $775 million should bring closure to the 22,000 legal disputes that still require settlements. According to the Securities and Exchange Commission, Endo, a company based in Ireland, has spent a total of $2.6 billion on lawsuits filed against the company for issues related to the defective mesh device, which, prior to being discontinued, was known to deteriorate inside patients.OTHER SIMILAR SUITS
Nonetheless, other companies who have sold similarly defective devices remain embroiled in thousands of lawsuits. Johnson & Johnson, one of the companies, currently has over 50,000 cases to sort through and Boston Scientific Corp. is in the midst of over 40,000 similar disputes.FDA INTERVENTION AND DISCONTINUATION
In 2014, the FDA ordered these companies to commence studies regarding the effects of mesh products on a person’s internal organs. And in 2016, the agency required all companies wishing to sell mesh-implants to submit a pre-market approval (PMA) application. Now, the devices must be proven safe before being sold on the market. After shutting down the mesh product, Endo suffered in the stock market. Stock prices fell by 21 percent right after the closure was made public.STRATEGIC THINKING
The decision to close the product, rather than sell it to the highest bidder, was strategic in nature: “[B]y shutting down the business as opposed to selling it, we are able to reduce the potential for product liability related to future mesh implants, which would have not been achievable in the event of a sale of the Astora business,” the company said.THE FUTURE
Looking forward, the company will use the $775 million to make payments starting in the final quarter of 2017. In 2019, when the company ends the payments, Endo hopes the many legal disputes will be resolved.
Paul Campanelli, CEO of Endo, said in a statement, “We believe it is a very important milestone for Endo to have reached agreements to resolve virtually all known U.S. mesh product liability claims.”
But according to a statement published by Business Insider, the company cannot explicitly promise that the legal disputes will be resolved as anticipated, and thus, Endo “will not report or comment on its progress during a current quarter.” This is due to various externalities such as fluctuations in the market, technological advancements, unforeseen changes in “regulatory decisions,” and of course unpredictable shifts in the legal proceedings.MASS TORT
Transvaginal mesh disputes, when combined, constitute one of the largest mass tort filings in US history. There are currently over 100,000 lawsuits underway in federal courts. 75 percent of those suits are being heard in West Virginia where there are seven multi-district litigation cases in process. The remaining 25 percent are being heard in state courts.REGRETS
Surely, Endo executives are kicking themselves, as they bought American Medical Systems, the manufacturer of the device, in 2011 for $2.9 billion. Even then, the product was known to be risky and various lawsuits had already been filed. It’s uncertain what the future holds for Endo, but consumer advocates hope the people harmed by the company’s negligence will receive adequate compensation for their injuries.
https://www.usrecallnews.com/endo-international-announces-plan-resolve-remaining-mesh-related-lawsuits/
-
What Duties Do Lead Lawyers Owe MDL Plaintiffs?
Oct 10, 2017 | Law 360
By Elizabeth Chamblee Burch
There is a persistent question in multidistrict proceedings: what duties do lead lawyers owe to individual plaintiffs who have no direct attorney-client relationship with them?
That’s the question at the heart of a recent opinion by Judge David Herndon in the Yazmin/Yaz litigation, although the opinion itself is about whether remand to state court is appropriate. (Spoiler: Judge Herndon thinks it isn’t.)
As to the federal jurisdiction question, given the way that the complaint is framed, jurisdiction appears to lie under CAFA, 28 U.S.C. 1332(d)(2), because the complaint is pled on behalf of a class. But the parties take less direct routes to address subject matter jurisdiction. Disgruntled plaintiffs argue that it’s a mass action that contains fewer than 100 people (despite it being pled as a class action), whereas defendants argue that it presents federal question jurisdiction under § 1331. Relying on Grable and Gunn, the court agrees.
I confess, I’m not convinced that these state-law malpractice claims implicate a federal issue under Grable. But designating the matter a federal question means that even if the plaintiffs dropped the class allegations, jurisdiction would remain in federal court.
Why might that matter? As Judge Herndon (and lead lawyers) framed it, even if the dissatisfied plaintiffs sued individually, federal question jurisdiction would lie over their claims thereby allowing defendants to remove and send it to Judge Herndon. Judge Herndon, you may recall, presides over the original Yasmin/Yaz MDL and appointed the leaders in the first place.
Put simply, Judge Herndon gets to decide whether the lead lawyers that he handpicked have erred — not a state court judge who might be more sympathetic to plaintiffs who have been swept up in a federal MDL. So, there is no opportunity for a second judge with some distance from the proceedings to review lead lawyers’ actions.
This happens frequently, by the way. Just last week, the Judicial Panel on Multidistrict Litigation had before it a motion to transfer, as a tag-along case, a malpractice claim arising out of the pelvic-mesh MDL against Blasingame Burch Garrard & Ashley PC (the Burch is of no relation to me).
Henry Garrard is one of the lead lawyers in all of the centralized mesh proceedings and is one of a small handful of lawyers on the Common Benefit Fee and Cost Committee. Predictably, the firm removed the malpractice action from Marion County, Tennessee, into federal court where it promptly requested a stay pending its motion to transfer the claim before Judge Joseph Goodwin, the very same judge who appointed Garrard to multiple positions of power.
After engaging in a years-long common endeavor with these lead lawyers, which judges find “immensely satisfying, ‘roll up one's sleeves,’ work,”[1] judges may find it difficult to revise their opinions about the lead attorneys they selected and objectively adjudicate the malpractice claims against them.
Moving then to the heart of the issue, understanding lead plaintiffs’ lawyers’ obligations to non-client plaintiffs in the Yasmin/Yaz litigation requires some context. After the leaders negotiated a global non-class settlement for the arterial thromboembolism cases, Judge Herndon issued a series of orders designed to usher plaintiffs into the deal (all at the leaders’ request).
One of those was a Lone Pine order that required every non-settling plaintiff to produce fact sheets, over three years worth of pharmacy and medical records and a case-specific expert on general and specific causation — all within three months. (Although settling plaintiffs had to submit pharmacy and medical records as part of the settlement program’s claims package, no experts were required.) Those who didn’t comply faced dismissal.
As you might guess, the plaintiffs currently suing missed that deadline and their various attorneys failed to respond to Bayer’s motion to dismiss. As such, with new counsel, they are now suing lead counsel (Michael S. Burg, Roger Denton, Michael A. London and Mark R. Niemeyer) for legal malpractice under Illinois common law.
Of course, the malpractice question hinges on the bigger issue: what duties do lead lawyers owe non-client plaintiffs in a multidistrict proceeding?
There hasn’t been a ton written on the fiduciary question, but Professor Charlie Silver’s work comes readily to mind. In his article, The Responsibilities of Lead Lawyers and Judges in Multidistrict Litigation, he writes:
Given that both lawyers who represent individual claimants and lawyers who handle class actions are fiduciaries, it would be surprising to discover that lead lawyers in MDLs were not. ... Given the dearth of authority directly on point, judges may take guidance from other bodies of law. If they do, they will quickly conclude that lead attorneys are fiduciaries. Mass tort lawyers are fiduciaries, and so are lawyers who represent plaintiff classes. These examples are the most analogous to lead counsel.[2]
My own view is similar.[3] While lead plaintiffs’ lawyers lack an individual attorney-client relationship with the plaintiffs who are not their clients, leaders’ fiduciary obligations run to all plaintiffs within the proceeding equally.[4]
Leaders apply for the right to control others’ lawsuits. Allowing them to exert control without incurring a corollary duty to represent plaintiffs loyally would permit attorneys to exploit non-clients to their own advantage, something Amchem would plainly forbid if the court had certified the litigation as a class action.[5] It would also mean that leaders’ procedural appointment would divest plaintiffs of the substantive, contractual rights they would have had if their own attorneys retained control.[6] When procedure abridges or modifies substantive rights, it violates the Rules Enabling Act.[7]
Practically speaking, failing to impose fiduciary obligations on lead lawyers could result in all sorts of mischief. Of course, whether lead lawyers in Yasmin/Yaz breached those duties in a way that amounts to malpractice is a separate question. But, given the lengths they’ve taken to have the malpractice claims heard before Judge Herndon, leaders clearly think they have a much better chance there than in an Illinois state court.
On Sept. 8, 2017, Judge Herndon granted the plaintiffs’ leave to file their amended complaint, but advised that he intended to “first dispose of the issues concerning MDL leadership/liaison counsel before considering others” and stayed discovery until then.[8] After the amended complaint, lead lawyers (now the defendants), filed a motion for judgment on the pleadings.
Their response seems to miss the mark. Judge Herndon did not certify the original case as a class action (though, quite questionably, he did require plaintiffs to “opt out” of the gallbladder settlement as if it were a class), and leaders defend on this ground: that because there was no class certified, that they had no duties to non-clients.
That is not my reading of the amended complaint. The plaintiffs are now bringing a putative class action against the lead lawyers for malpractice, not claiming that the original proceeding was litigated as a class.
The question is not the well-settled one of what duties class counsel owe to class members, but rather what duties lead lawyers in a non-class MDL owe to plaintiffs with whom they have no attorney-client relationship. On that front, lead lawyers argue that their duties included only those enumerated in Judge Herndon’s order appointing them as leaders. Casey et. al. v. Roger Denton, et. al., No. 17-cv-521-DRH (S.D. Ill.) is worth following.Elizabeth Chamblee Burch is a professor at the University of Georgia School of Law, was named the holder of the Charles H. Kirbo Chair of Law in 2016 and is a visiting professor at Harvard Law School in 2017. Burch's teaching and research interests include civil procedure, class actions and mass torts.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.https://www.law360.com/articles/972461/what-duties-do-lead-lawyers-owe-mdl-plaintiffs-
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested