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Ethicon Media Monitoring 5/10/2017
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'The pain is like petrol burning inside me': Mother in constant 'unbearable' agony from a faulty medical implant slowly disintegrating inside her vagina
May 9, 2017 | Daily Mail
By Nic White and Roger Byrom
A mother's life has been 'destroyed' after her transvaginal mesh implant began to disintegrate inside her body. -
4th Circ. Backs Boston Scientific Win In Pelvic Mesh Suit
May 9, 2017 | Law 360
By Melissa Daniels
A Fourth Circuit panel affirmed Tuesday a lower court’s decision to toss a failure to warn claim from a transvaginal surgical mesh patient against Boston Scientific, saying in a published decision the patient couldn't prove the company failed to provide an adequate warning about potential risks. -
Boston Scientific Plans Mass Pelvic Mesh Settlements
May 9, 2017 | Mesh Medical Device Newsdesk
According to its quarterly federal filing, Boston Scientific, one of seven medical device manufacturers facing thousands of product liability cases over its pelvic mesh, plans to settle 37,000 cases with certain plaintiff attorneys without admitting any fault.
Online Sources
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May 9, 2017 | Daily Mail
By Nic White and Roger Byrom
·Stella Channing got a transvaginal mesh implant to treat pelvic organ prolapse
· Two weeks later started bleeding and was in intense pain that only got worse
· It 'destroyed her life' and she was in such agony that she almost killed herself
· Senate inquiry launched into the faulty mesh after 200 Australians complained
A mother's life has been 'destroyed' after her transvaginal mesh implant began to disintegrate inside her body.
Stella Channing said the constant nerve pain she lives with is so intense, 'like petrol burning inside me', that she almost took her own life.
'The raw pain of the erosion is like broken glass in your rectum and vagina. As we speak I am losing blood from my rectum and vagina and the pain is unbearable. This has totally destroyed my life,' she told WAToday.
The mesh is now the subject of a Senate inquiry after more than 200 women reported report 'adverse events' to the Therapeutic Goods Administration.
The Perth woman suffered from pelvic organ prolapse in her late 40s after having three children, and had the mesh inserted between her vagina and rectum.
Just a week after her eight-day hospital stay, the mesh already began to fall apart and she started bleeding with such severe pain she needed three months off work.
Ms Channing was only able to return to her full time retail job after they created a customer service role for her that could be done while seated on a cushion.
By 14 months post-surgery the pain was unbearable and she began having transient ischaemic attacks, or 'mini strokes'.
As the mesh fell apart and shrunk it constricted her vagina and hardened her rectum, trapping and scarring the nerves running through the rectum and legs and, damaging the flesh and muscles in her pelvis.
The mesh was threatening to punch through her vagina wall and cause blood poisoning.
Ms Channing cut her work hours to two days a week before her worsening condition forced her to quit altogether, and ruined her active fitness and social life.
Now she can't even sit still long enough to watch a movie, pick up her grandchildren, or walk around without a cane. She has to sleep on her side in a hammock.
'All that has been stolen. I am financially ruined. I lie down all day. I am isolated. Sometimes I cannot shower because the pain flare will be so great it will take days to recover,' she said.
Ms Channing said her situation made her so depressed she would likely have killed herself if it wasn't for her GP, pain psychologist and occupational therapist.
'Some days, I wake up and don't know why I have bothered waking up. Sometimes I think it would be better if I just didn't,' she said.
As the meshes are not supposed to be removed, only one surgeon in the U.S. knows a successful technique he has performed thousands of times.
But Ms Channing is not healthy enough to sit on a plane for the longhaul flight, and with only her meager disability pension could not afford the trip.
She hoped the doctor would travel to Australia to treat her and some of the other more than 200 women stuck in her horrifying situation.
The pelvic mesh implant was approved for use in Australia without going through clinical trials after it was endorsed by the U.S. regulator in 2002.
It is now the subject of an Senate inquiry, with Senator Derryn Hinch calling it 'one of the greatest medical scandals and abuses of mothers in Australia's history'.
After thousands of women reported disastrous side effects, the USA Food and Drug Administration in 2011 said serious complications were 'not rare' and it was concerned.
The year after, Johnson & Johnson, the company behind the faulty mesh, dropped the product from sale worldwide, but others were still in use.
The company also agreed to pay more than $120 million to resolve 3,000 American lawsuits, but more than 80,000 other transvaginal mesh lawsuits brought against it and other producers were yet to be settled.
http://www.dailymail.co.uk/news/article-4488474/Mother-constant-agony-faulty-medical-implant.html -
4th Circ. Backs Boston Scientific Win In Pelvic Mesh Suit
May 9, 2017 | Law 360
By Melissa Daniels
Law360, Los Angeles (May 9, 2017, 6:43 PM EDT) -- A Fourth Circuit panel affirmed Tuesday a lower court’s decision to toss a failure to warn claim from a transvaginal surgical mesh patient against Boston Scientific, saying in a published decision the patient couldn't prove the company failed to provide an adequate warning about potential risks.
Martha Carlson in July 2010 received an implant of a mesh device, according to court records, but then suffered pain, recurrent pelvic organ and bladder prolapse, incontinence and urinary and bowel problems. Her subsequent lawsuit lobbed a host of claims at Boston Scientific, including failure to warn of the dangers associated with the mesh.
In a unanimous published decision written by U.S. Circuit Judge Stephanie D. Thacker, the court affirmed a multidistrict litigation court’s ruling that granted summary judgment to Boston Scientific over tossing the failure to warn claim, finding Carlson didn’t prove that the company failed to provide an adequate warning.
“[Carlson] cited zero evidence establishing that either she or Dr. [Michael] Kennelly so much as read the allegedly inadequate warning in the [directions for use],” the panel said. “The portions of Dr. Kennelly’s testimony to which [Carlson] cited attempted to establish the inadequacy of the warnings in the [directions for use], but importantly, those portions did not indicate that if the [directions for use] included an adequate warning, Dr. Kennelly would have read it.”
The panel also affirmed a lower court’s decision declining to reconsider the summary judgment ruling. Judge Thacker shut down Carlson’s argument that the court abused its discretion by denying her reconsideration bid despite the fact she cited new excerpts of Kennelly’s deposition.
“The entirety of Dr. Kennelly’s deposition testimony was available well before summary judgment briefing, and the additional portions of testimony [Carlson] provided to the district court for ‘reconsideration’ thus did not amount to the type of evidence constituting grounds for a valid motion for reconsideration,” the opinion said.
Judge Thacker also noted that the case is “one of the tens of thousands” that have gone through an MDL over the transvaginal surgical mesh, which is used as a treatment for pelvic organ prolapse and stress urinary incontinence.
Carlson first directly filed her case into the MDL that was before U.S. District Judge Joseph R. Goodwin in West Virginia federal court, according to court records. That court in April 2015 granted Boston Scientific’s bid to toss Carlson’s failure to warn claim, but allowed design defect and breach of warranty claims to proceed.
Carlson’s case in May 2015 was transferred to North Carolina and then consolidated with that of Ramona Winebarger, who settled in September of that year.
Carlson had asked the trial court to reconsider the MDL court’s order tossing her failure to warn claim, but that motion was denied.
Then a North Carolina federal jury in October 2015 found in favor of Boston Scientific on Carlson’s other existing counts, finding that Carlson hadn’t proved her design defect or breach of warranty claims.
After that, Carlson appealed, challenging the MDL court’s partial summary judgment award and the trial court’s denial of her motion to reconsider it.
Court records show oral arguments were held in March of this year.
Representatives for the parties didn’t immediately respond to requests for comment Tuesday.
U.S. Circuit Judges Thacker, Allyson K. Duncan and Barbara Milano Keenan sat on the panel for the Fourth Circuit.
Carlson is represented by William Louis Hurlock, David Martin and Andres C. Pereira of Mueller Law LLC and Rachael K. Jones of Carlson Law Firm PC.
Boston Scientific is represented by Daniel Brandon Rogers of Shook Hardy & Bacon LLP and Leslie C. Packer of Ellis & Winters LLP.
The case is Martha Carlson v. Boston Scientific Corp., case number 15-2440, in the U.S. Court of Appeals for the Fourth Circuit.
--Additional reporting by Jody Godoy. Editing by Alyssa Miller.https://www.law360.com/productliability/articles/922237/4th-circ-backs-boston-scientific-win-in-pelvic-mesh-suit-
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Boston Scientific Plans Mass Pelvic Mesh Settlements
May 9, 2017 | Mesh Medical Device Newsdesk
According to its quarterly federal filing, Boston Scientific, one of seven medical device manufacturers facing thousands of product liability cases over its pelvic mesh, plans to settle 37,000 cases with certain plaintiff attorneys without admitting any fault.
Quarterly reports that shareholders read are always enlightening as to how a company deals with allegedly defective products. In its latest quarterly report (10-Q), filed with the Securities and Exchange Commission (SEC) May 3, Boston Scientific (BSC) says whether patent infringement, intellectual property rights or product liability, lawsuits are a “normal course of business.”
But extraordinary within its pages is the admission that 37,000 of a pending 43,000 product liability cases filed against BSC will be resolved. Of those approximately 12,000 have met the condition of settlement and are final.
BSC likes to point out that the settlements came about through compromise with “without any admission or concessions by us of any liability or wrongdoing.”
The cost of legal matters was $2 billion as of the last day of December. Another $1.75 billion, including the estimated costs of settlement, damage and defense, has been accrued by March 31, 2017.
The 10-Q filing does not specify how much has been set aside specifically for transvaginal mesh settlements.
“We recorded $3 million of litigation-related charges during the first three months of 2017 and $10 million of litigation-related charges during the first three months of 2016.”
BSC says it has put aside money for these and future cases and claims which it believes is adequate but, “changes to this accrual may be required in the future as additional information becomes available.”
The pending cases are filed in both state and federal courts and include eight class actions filed in Canada (one certified and three potential class actions) and fewer than 25 class claims in the UK.
These are claims for design and manufacturing defects, a failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium.
RICO CLAIMS
The SEC filing specifically points to Teresa Stevens, who in January 2016 filed a RICO claims against BSC on behalf of women who allegedly received mesh made from counterfeit or adulterated resin products imported (smuggled) from China.
RICO stands for Racketeer Influenced and Corrupt Organizations Act, charges of which are usually reserved for organized criminal activity.
On January 26, 2016, the Court issued an order staying the case and directing the plaintiff to submit information to allow the FDA to weigh in. The FDA deferred to Boston Scientific to determine if its resin from China implants were substantially different from resin sources in the U.S. There’s been no update from BSC.
The 10-Q continues, “In addition, we are in contact with the United States Attorney’s Office for the Southern District of West Virginia and are responding voluntarily to their requests in connection with that office’s review of the allegations concerning the use of mesh resin in the complaint.”
Another complaint alleging RICO violations was filed February 27, 2017 in the U.S. District Court for the Middle District of Florida, Orlando Division against Boston Scientific. Carolyn Turner also alleges violations of the Racketeer Influenced and Corrupt Organizations Act (RICO) and heads a class alleging she was harmed by vaginal mesh made from counterfeit resin brought in from China. This was served against the company April 7, 2017.
“We deny the plaintiff’s allegations and intend to defend ourselves vigorously.”
Another RICO case was filed in the Eastern District of New York by Frances Peel Hennington, who heads the class. See Mesh News Desk story here. Read the Complaint here:
BSC says it has put aside money for these and future cases and claims which it believes is adequate, “changes to this accrual may be required in the future as additional information becomes available.”
In the federal court in Charleston West Virginia, May 5 the court entered PTO Order #160appointing Cathy Yanni as special master for private settlement agreements between BSC and certain plaintiffs’ counsel, among them Skikos, Crawford, Skikos & Joseph LLP.
TRIALS SO FAR
Trial results have been both favorable and unfavorable but BSC says it does not believe that is an indicator of potential outcomes of all cases related to transvaginal mesh.
There are more than 3,100 cases filed in state court in Massachusetts and certain state attorneys general are also considering actions and have filed discovery requests on BSC.
The Southern District of West Virginia is the federal home of the bulk of transvaginal mesh claims against Boston Scientific. As of today there are 24,751 cases filed with 9,190 that claim to be closed. This includes cases filed as early as May 2011.
The Charleston, West Virginia court is where multidistrict litigation (MDL) assembled more than 102,000 claims against six manufacturers. Boston Scientific is MDL 2326.
March 1, 2017, on the eve of a product liability trial, Sullivan v. Boston Scientific settled. See MND story.
A Mass. appeals court decided last September that the Albright case against Boston Scientific should receive a new trial because of information omitted by the Massachusetts trial court judge. See MND coverage here.
A RICO case was filed last June in federal court in Charleston, WV alleging Boston Scientific purchased counterfeit Marlex to make its pelvic mesh from a Chinese counterfeiter. See MNDcoverage here.
A North Carolina jury found for Boston Scientific and its Uphold mesh in the trial of Carlson v. Boston Scientific, October, 2015. See MND coverage here.
In September and again in November 2014, Boston Scientific lost two trials, one in Miami and another in Charleston, West Virginia that represented four plaintiffs each. The Eghnayem trial in Miami concerned BSC’s Pinnacle and resulted in a award total of $26.7 million. See MNDcoverage here.
In the Tyree case, which involved BSC’s Obtryx pelvic mesh, the litigants were awarded a total of $18.5 million. See MND coverage here.
The largest mesh award so far went to plaintiff Martha Salazar who was implanted with the Boston Scientific Obtryx. A Texas jury awarded her $73.46 million, which was later reduced by the trial court judge to $34.6 million under tort reform restrictions. See MND coverage here.
STILL ON THE MARKET
Boston Scientific still sells mid-urethral slings – the Advantage Fit, Advantage, Lynx, Obtryx II, Solyx, according to its website here.
The Pinnacle, pelvic organ prolapse mesh has been removed from the market. The only other pelvic floor mesh includes the Repliform, a human dermal graft, Uphold LITE Vaginal support System, and Upsylon Y-Mesh.
A year ago Boston Scientific bolstered its pelvic mesh warning label. See the MND story here.
The notice also makes changes to the label on the BSC Pinnacle LITE pelvic floor mesh, not current available in the Boston Scientific U.S brochure, but the label changes for the international community indicate it is still being used overseas. Boston Scientific surgical mesh made after 2012 may be made from counterfeit resin smuggled to the U.S. from China. See the background here.Michael Mahoney is CEO who reaped a total of $35.7 million in total compensation in 2016, according to bizjournals Boston.
Mahoney was hired away from Ethicon/ Johnson & Johnson in September 2011, (See MND story here) where he worked in sales and marketing selling nuclear medicine cardiology systems to small hospitals in the Carolinas.
While at J&J he worked alongside the president of DePuy Orthopaedics. In 2007, he was promoted to J&J’s knee and hip joint business. By August 2010, the DePuy ASR XL acetabular hip replacement was recalled because it was failing in the patients it was supposed to help. Marketed as an alternative hip replacement for the younger, athletic patient, the metal-on-metal prosthesis led to metal poisoning and repeated revisions. J&J did not warn physicians or patients and J&J paid out nearly $1 billion in legal costs and settlements.
Instead of losing his job, Mahoney was promoted within J&J to the head of J&J’s medical device and diagnostics group.
In 2011, J&J insisted on enforcing a non-compete clause to keep Mahoney from joining Boston Scientific, but then relented allowing the transition if Mahoney agreed not to work in any competing business to J&J such as stents or implantable defibrillators. ###
LEARN MORE:
Mesh News Desk, Boston Scientific Must Pay Salazar $73.5 Million, September 8, 2014
http://meshmedicaldevicenewsdesk.com/patient-profiles/breaking-news-boston-scientific-must-pay-salazar-72-million/See Mesh winners and losers so far
http://www.meshmedicaldevicenewsdesk.com/transvaginal-mesh-trials-far-winners-losers/http://www.meshmedicaldevicenewsdesk.com/boston-scientific-plans-mass-pelvic-mesh-settlements/
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