Preview Newsletter
Ethicon Media Monitoring 4/19/2019
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UPDATE: Jury finds J&J’s Ethicon not liable in Philly pelvic mesh trial
Apr 18, 2019 | Mass Device
By Fink Densford
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon has been found not liable in a suit claiming that an allegedly faulty pelvic mesh implant had caused a patient’s condition to worsen, alongside other complications, according to a report from TheLawFirm.com. -
Phila. Jury Hands J&J Subsidiary a Defense Win in Latest Pelvic Mesh Trial
Apr 18, 2019 | The Legal Intelligencer
By Max Mitchell
The defense win in 'Krolikowski v. Ethicon Women's Health and Urology' was handed up Wednesday after more than three weeks of trial before Philadelphia Court of Common Pleas Judge Charles Cunningham III. -
Law360's Weekly Verdict: Legal Lions & Lambs
Apr 18, 2019 | Law 360
By Sam Reisman
Legal lions this week include the team that helped secure a favorable jury verdict for a Johnson & Johnson unit in pelvic mesh litigation, while the lambs include a Tennessee man charged with fraud after he was caught allegedly pretending to be a team of lawyers from Cravath. -
Transvaginal mesh: FDA orders remaining products off US market
Apr 18, 2019 | British Medical Journal
By Owen Dyer
The US Food and Drug Administration has told the two manufacturers of the remaining three transvaginal mesh products to present a plan within 10 days for withdrawing from the US market, after they failed to provide evidence to allay safety concerns. -
Washington suit against Ethicon over pelvic mesh implant begins Monday
Apr 18, 2019 | Legal News Line
By John Sammon
The lawsuit of Washington State’s Attorney General Bob Ferguson against Johnson & Johnson subsidiary Ethicon for selling a pelvic mesh implant to women that allegedly caused chronic pain, infections and medical complications will begin on Monday, another in a long line of lawsuits over the past several years that contend the implants are dangerous. -
U.S. FDA orders transvaginal surgical mesh pulled from market
Apr 18, 2019 | PersonalTech MD
By Jackie Ramsey
The FDA has instructed Boston Scientific and Coloplast to stop selling their meshes for transvaginal fix of pelvic organ prolapse (POP), saying there was no proof that their use was an improvement over surgery without them. -
Pa. Supreme Court set to consider jurisdiction questions in pelvic mesh litigation
Apr 18, 2019 | The Pennsylvania Record
By Nicholas Malfitano
Pelvic mesh litigation in Philadelphia may now be greatly affected by the Supreme Court of Pennsylvania’s choice to examine a landmark U.S. Supreme Court decision pivotal to the issue of jurisdiction. -
US Food and Drug Administration halts pelvic organ mesh sales
Apr 18, 2019 | Stuff.co.nz
By Cate Broughton
The US Food and Drug Administration (FDA) has ordered an immediate halt to the sale of surgical mesh products to treat pelvic organ prolapse (POP). -
Boston Scientific sees $25 million hit to 2019 revenue from mesh withdrawal
Apr 18, 2019 | Sb Dirty South Soccer.
By Traci Edwards
USA health regulators ordered two medical device companies to stop selling surgical mesh used in pelvic fix surgeriesafter saying there isn't enough evidence that the product embroiled in thousands of lawsuits is safe or effective. -
Quick Hits: Transvaginal Mesh Pulled, New Weight Loss Drug & More
Apr 18, 2019 | MED Shadow
By Jonathan Block
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments -
FDA Orders Surgical Mesh To Treat POP Be Removed From Market
Apr 18, 2019 | Inside Health Policy
FDA has ordered surgical mesh for transvaginal repair of pelvic organ prolapse (POP) manufacturers Boston Scientific and Coloplast to stop selling and distributing the products, the agency announced Tuesday (April 16). -
Did the FDA Drag Its Feet on Mesh for Prolapse Ban?
Apr 19, 2019 | Medpage Today
After years of lawsuits and safety complaints, the FDA halted sales of all remaining surgical mesh products used for transvaginal repair of pelvic organ prolapse. -
FDA Bans Sales Of Transvaginal Mesh
Apr 18, 2019 | WLTZ
The U.S. Food and Drug Administration has ordered the sales of transvaginal mesh to be halted, due to safety concerns.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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UPDATE: Jury finds J&J’s Ethicon not liable in Philly pelvic mesh trial
Apr 18, 2019 | Mass Device
By Fink Densford
UPDATE: Includes comment from J&J’s Ethicon
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon has been found not liable in a suit claiming that an allegedly faulty pelvic mesh implant had caused a patient’s condition to worsen, alongside other complications, according to a report from TheLawFirm.com.
A jury in Philadelphia yesterday took less than a full day of deliberations to return a verdict that cleared Ethicon of claims that the product was the cause of the plaintiff’s injuries, according to the report. The jury did conclude, however, that Ethicon had been negligent in designing, marketing and selling the device.
In the case, plaintiff Malgorzata Krolikowski claims that a TVT-Secur mesh implant that they received in October 2008 to treat a mild case of urinary stress incontinence caused her condition to worsen. The plaintiff also claimed that the mesh was responsible for other complications, including pain during sexual intercourse, according to TheLawFirm.com’s report.
Counsel for Ethicon argued that the company was not responsible for the device’s failure to completely resolve the plaintiff’s condition, and argued that there were other medical reasons for her complications, including pain during sexual intercourse, according to the report.
Lawyers for the plaintiffs said they believed J&J and Ethicon had been motivated by money and that they rushed an unsafe medical device to market, according to TheLawFirm.com
“Obviously, we’re disappointed, but we respect the jury’s decision. They found that the defendants, Ethicon and Johnson & Johnson, were negligent. We had the evidence to prove that,” Colin Burke, a lawyer representing Ms. Krowlikowski said, according to the report.
“We empathize with women suffering from stress urinary incontinence, which can be a serious and debilitating condition. There are various treatment choices for women with this condition seeking to improve their quality of life, including surgical treatment with implantable mesh, which is backed by years of clinical research and is considered by most doctors to be the gold standard treatment,” Ethicon spokewoman Mindy Tinsley told MassDevice.com in an email. “The jury’s decision reflects the facts in this case. The evidence showed Ethicon’s TVT-Secur device was properly designed and did not cause the Plaintiff’s alleged injuries.”
Earlier this month, a state appeals court in Pennsylvania upheld the plaintiff’s $13.7 million win in a product liability lawsuit brought over one of Ethicon’s pelvic mesh products.
https://www.massdevice.com/jury-finds-jjs-ethicon-not-liable-in-philly-pelvic-mesh-trial/
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Phila. Jury Hands J&J Subsidiary a Defense Win in Latest Pelvic Mesh Trial
Apr 18, 2019 | The Legal Intelligencer
By Max Mitchell
The defense win in 'Krolikowski v. Ethicon Women's Health and Urology' was handed up Wednesday after more than three weeks of trial before Philadelphia Court of Common Pleas Judge Charles Cunningham III.
A Philadelphia jury has declined to hold Johnson & Johnson subsidiary Ethicon liable for injuries that a woman claimed she suffered as a result of the company’s allegedly defective pelvic mesh product.
The defense win in Krolikowski v. Ethicon Women’s Health and Urology was handed up Wednesday after more than three weeks of trial before Philadelphia Court of Common Pleas Judge Charles Cunningham III.
Plaintiffs suing in Philadelphia over Ethicon’s mesh products have repeatedly won multimillion-dollar verdicts, including a $41 million award in January. The verdict in Krolikowski marks only the second time a Philadelphia jury has found in favor of Ethicon over its pelvic mesh product, although the prior defense win was subsequently reversedby the trial court judge, a decision that is currently on appeal.
The plaintiff, Malgorzata Krolikowski, was represented by Kline & Specter attorneys Colin Burke and Elia Robertson, and Ethicon was represented by Butler Snow attorney Andrea La’Verne Edney, as well as Melissa Merk and Eileen Somers of Drinker Biddle & Reath and Julie Callsen and Jennifer Steinmetz of Tucker Ellis.
In an emailed statement Burke said the case presented unique challenges because of Krolikowski’s related medical issues and gaps in her medical coverage and treatment. He also noted that, although the jury found Ethicon’s conduct was not causally related to the injuries, the jury also determined that the company had failed to exercise due care in its design, marketing and sale of the mesh device.
“We have witnessed this finding of negligence against the defendants consistently throughout these cases. The juries in Philadelphia had uniformly made it clear to the defendants that their conduct is unacceptable,” he said. “We look forward to continuing our fight on behalf of women and holding Ethicon and Johnson & Johnson responsible for the harm they have caused women.”
Mindy Tinsley, a spokeswoman for Ethicon, said the evidence showed the company’s TVT-Secur device was properly designed and not the cause of the injuries.
“We empathize with women suffering from stress urinary incontinence, which can be a serious and debilitating condition,” Tinsley said in the statement. “There are various treatment choices for women with this condition seeking to improve their quality of life, including surgical treatment with implantable mesh, which is backed by years of clinical research and is considered by most doctors to be the gold standard treatment.”
Krolikowski’s was one of nearly 90 lawsuits pending in Philadelphia over claims that Ethicon negligently designed mesh products and failed to warn doctors and patients about the dangers. More than 10,000 suits are also pending against Ethicon in federal court over the same products.
The first pelvic mesh case in Philadelphia was tried in late 2015, and since then six cases have resulted in wins for plaintiffs, with awards ranging from $2.16 million to $57.1 million.
The only other case to come to a defense win was Adkins v. Ethicon. That case was handled by Bryan Aylstock of Aylstock, Witkin, Kreis & Overholtz. About a month after the win in that case, the judge who handled Adkins issued a one-page order granting Adkins’ posttrial motion, which had contended that the jury’s findings were inconsistent on the issue of whether the alleged design defect caused the injuries. The judge ultimately determined that the case should proceed to a damages hearing, but that decision is currently on appeal to the Pennsylvania Superior Court.
https://www.law.com/thelegalintelligencer/2019/04/18/phila-jury-hands-jj-subsidiary-a-defense-win-in-latest-pelvic-mesh-trial/?slreturn=20190319003512
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Law360's Weekly Verdict: Legal Lions & Lambs
Apr 18, 2019 | Law 360
By Sam Reisman
Law360 (April 18, 2019, 6:29 PM EDT) -- Legal lions this week include the team that helped secure a favorable jury verdict for a Johnson & Johnson unit in pelvic mesh litigation, while the lambs include a Tennessee man charged with fraud after he was caught allegedly pretending to be a team of lawyers from Cravath.
Legal Lions
Attorneys for Johnson & Johnson unit Ethicon Inc. notched a win on Wednesday when a Philadelphia jury turned back claims that a defective pelvic mesh implant exacerbated incontinence and caused pain. Ethicon is represented by Julie Callsen and Jennifer Steinmetz of Tucker Ellis LLP, Sean Gallagher of Bartlit Beck LLP, Andrea La'Verne Edney of Butler Snow LLP and Kimberly Gustafson Bueno of Scott Douglas & McConnico LLP.
The Second Circuit on April 12 ruled in favor of Sprint contractor Credico, finding a group of workers that helped implement the federal Lifeline Assistance program, which provides free cellphones to low-income people, are not owed overtime because they are “outside salespeople” under the Fair Labor Standards Act. Credico is represented by Jason Schwartz, Greta Williams, Ryan Stewart and Theodore Boutrous of Gibson Dunn & Crutcher LLP.
Next up is BakerHostetler, which helped bring home a $62 million jury verdict for client Castex Offshore Inc. The jury reached its 10-2 decision on April 12, after a monthlong trial in the lawsuit initiated almost four years ago. Castex's former business partner Apache Corp. had accused Castex of failing to pay its share of the bills related to projects in the Atchafalaya Bay area of Louisiana, totaling more than $18 million. Castex counterclaimed that it was Apache's mismanagement that caused construction to be delayed and costs to skyrocket. Castex is represented by W. Ray Whitman, James H. Nye, Joshua C. Thomas, Kristen H. Luck, Sushant Mohan, Glen Shu and Daniella Martinez of BakerHostetler LLP.
Meanwhile, attorneys for engineering firm FloaTEC helped secure a Fifth Circuit decision on Wednesday affirming the dismissal of claims that it should be held liable for the $500 million underwriters paid to Chevron after an offshore rig failed. FloaTEC is represented by Andrew Struben de Klerk, Timothy Patrick O'Leary and Brandon Kyle Thibodeaux of Frilot LLC.
Legal Lambs
First up on the legal lambs list is ex-Skadden Arps Slate Meagher & Flom LLP partner Gregory Craig, who pled not guilty on Friday to lying to federal officials about a report he helped write, which was commissioned by Paul Manafort as part of his foreign lobbying work for the Ukrainian government. Craig faces two felony counts: One for concealing material facts from national security officials and another for making false statements to that group.
Next up is a Pennsylvania state judge, whose habit of looking at dirty pictures in chambers has pushed prosecutors to repeatedly move for his recusal in sexual assault and domestic violence cases. At a hearing on Monday, Judge Michael Muth expressed contrition for his actions, saying it was “so far past embarrassing, it's mortifying.” The Court of Judicial Discipline had ruled in November that Judge Muth violated rules barring sexual harassment and requiring judges to promote "public confidence in the integrity and impartiality of the judiciary."
The final lamb this week isn’t even a lawyer. Tennessee man John Lambert was arrested Tuesday for allegedly posing online as a team of attorneys and defrauding clients seeking legitimate legal advice. According to New York federal prosecutors, Lambert and a co-conspirator advertised their fake firm by mimicking the website profiles of what appear to be several Cravath Swaine & Moore LLP partners. Although Lambert never attended law school, he did business under the firm name Pope & Dunn Law PLLC, according to court documents.
--Additional reporting by Matt Fair, Braden Campbell, Michelle Casady, Jeff Sistrunk, Andrew Strickler and Dave Simpson. Editing by Philip Shea.
For a reprint of this article, please contact reprints@law360.com.
https://www.law360.com/legalindustry/articles/1151352/law360-s-weekly-verdict-legal-lions-lambs
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Transvaginal mesh: FDA orders remaining products off US market
Apr 18, 2019 | British Medical Journal
By Owen Dyer
The US Food and Drug Administration has told the two manufacturers of the remaining three transvaginal mesh products to present a plan within 10 days for withdrawing from the US market, after they failed to provide evidence to allay safety concerns.
More than 100 000 women have sued over transvaginal mesh devices, complaining of symptoms such as persistent vaginal bleeding or discharge, chronic pelvic pain, or pain during sex.
Boston Scientific, which makes two of the three devices, has been named in 48 000 lawsuits by women claiming injury. The maker of the other device is a Danish company, …
https://www.bmj.com/content/365/bmj.l1839.full
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Washington suit against Ethicon over pelvic mesh implant begins Monday
Apr 18, 2019 | Legal News Line
By John Sammon
SEATTLE (Legal Newsline) – The lawsuit of Washington State’s Attorney General Bob Ferguson against Johnson & Johnson subsidiary Ethicon for selling a pelvic mesh implant to women that allegedly caused chronic pain, infections and medical complications will begin on Monday, another in a long line of lawsuits over the past several years that contend the implants are dangerous.
The proceedings will be streamed live courtesy of Courtroom View Network (CVN).
The pelvic mesh implant manufactured by Ethicon is supposed to support a prolapsed or sagging bladder. This case will feature state attorneys in the Kings County Superior Court (Washington state) arguing that the implants sold to women violated the state’s consumer protection laws and caused medical problems or extinguished sexual function.
Nearly 12,000 Ethicon implants were sold to women in Washington state, according to a CVN report.
Ethicon is part of the medical devices arm of Johnson & Johnson, a New Jersey-based conglomerate well known for its talcum baby power which in recent years has also generated lawsuits filed by women who claimed the powder was tainted with asbestos, causing them to develop ovarian cancer and in some cases mesothelioma.
The implant device is a clear plastic-looking polypropylene mesh with connecting arms. Critics of the device say it is too large and causes the body to form scar tissue in efforts to reject it and that it also constricts, causing intense pain.
Allegations will include that the polypropylene mesh inflames pelvic tissue and that the device causes body erosion resulting in the formation of scar tissue. The tissue-mesh combination results in a foreign body reaction, plaintiff attorneys will allege. The inflammation works on the mesh fibers to contract the implant.
In past trials, plaintiff attorneys have maintained that less-invasive measures to deal with sagging bladder in women are available, for example the use of sutures rather than pelvic mesh.
Defense attorneys will argue that pelvic mesh devices are safe and effective and offer a less-serious solution to sagging bladder than major surgery.
Both sides will present their own expert witnesses and will try to undermine the credibility of the other side’s witnesses, questioning their experience and the amount of pay they receive to testify in court.
According to the CVN report, the case could result in a judgment in the tens of millions of dollars.
The trial will take place without a jury and will be presided over by King County Superior Court Judge Suzanne R. Parisien and is expected to take five weeks, CVN reports.
It will be closely watched by other states such as California, Mississippi and Kentucky, where similar cases are pending. Additional states could pursue litigation based on the outcome.
Former California Attorney General Kamala Harris filed suit against Ethicon that is set to start this July in San Diego and could result in a greater compensation award as more mesh implant devices have been sold in that state, approximately 42,000 between 2008 and 2014, the CVN report noted.
The Washington Attorney General's Office will use its own in-house attorneys. The representation of J&J and Ethicon will be handled by attorneys from O’Melveny & Meyers based in the firm’s Washington, D.C. office, Los Angeles-based Covington & Burling, and Calfo Eakes & Ostrovsky in Seattle.
https://legalnewsline.com/stories/512440044-washington-suit-against-ethicon-over-pelvic-mesh-implant-begins-monday
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U.S. FDA orders transvaginal surgical mesh pulled from market
Apr 18, 2019 | PersonalTech MD
By Jackie Ramsey
The FDA has instructed Boston Scientific and Coloplast to stop selling their meshes for transvaginal fix of pelvic organ prolapse (POP), saying there was no proof that their use was an improvement over surgery without them.
But now the FDA has turned the submissions down, stating that they failed to demonstrate "a reasonable assurance of safety and effectiveness".
To continue selling their devices, the companies had to submit a premarket approval (PMA) application with additional data to prove the effectiveness of surgical mesh for transvaginal fix of POP.
"We couldn't assure women that these devices were safe and effective long term", said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
Jeopardy's Alex Trebek Gives an Update After Stage 4 Pancreatic Cancer Diagnosis
With the game already a runaway, James Holzhauer bafflingly wagered $60,013 on his answer of "Atticus Finch". I'm touched beyond words", he said. " Jeopardy! " is produced by Sony Pictures Television.The companies will have 10 days to submit their plans for withdrawing their devices, the agency said. Most pelvic mesh products have already been taken off the market, according to the Associated Press. It is estimated that about one in eight women has surgery in her lifetime to treat the condition. The company said the FDA action will "severely limit" options for women seeking treatment for pelvic organ prolapse.
Although the surgical meshes represent only about 0.2 percent of Coloplast's total revenue, the FDA removal of the products suggest the more than 48,000 surgical mesh patients suing Boston Scientific could have a strong case. The FDA first approved the mesh specifically for that use in 2002 and manufacturers promoted mesh as a way to speed patients' recovery time compared to surgery with stitches. Mesh is also used in hernia fix surgeries, but some patient advocates say that using mesh in any soft tissue comes with an unacceptably high risk of devastating side effects. There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms. However, the percentage of women undergoing transvaginal POP mesh procedures has decreased in recent years after the FDA began issuing warnings about the risks associated with using transvaginal mesh used for POP fix.
Women who were planning to have transvaginal mesh fix of POP should discuss other treatment options with their doctors, the FDA advised. The claims were documented against Boston Scientific, Johnson and Johnson, Coloplast and C.R. Minstrel, presently a unit in Becton Dickinson and Co. While the FDA was reviewing these submissions the meshes were allowed to remain on sale.
Removing POP mesh is a "wonderful start", patient advocate and mesh survivor Tammy Jackson told Drugwatch.
Amazon and Google end spat, bring YouTube to Amazon devices
YouTube will soon be available on select Amazon devices and Prime Video will be coming to Chromecast devices. The next salvo was Google's when it blocked Amazon's Echo Show smart display from accessing YouTube content.Starting in the 1990s, gynecologists adapted surgical mesh to treat pelvic collapse in women, which can cause the bladder or reproductive organs to slip out of place, causing pain, constipation and urinary issues. Women who were planning to have mesh placed transvaginally for the fix of POP should discuss other treatment options with their doctors.
While some mesh makers - like Coloplast - have settled all their cases, Boston Scientific still faces about 18,000 suits over the controversial implants.
Boston, meanwhile, spent $103m on litigation, primarily in connection with transvaginal surgical mesh claims, in 2018 alone.
Last year, the FDA released its Medical Device Safety Action Plan, a program meant to overhaul the process for manufacturers that want to market medical devices in the nation.
Google lets Android users choose browsers to ease European Union antitrust concerns
If any additional search or browser app is installed, more instructions screens will follow to help the user set up the new app. Apps not already installed on the device will be chosen based on their popularity and shown in a random order, Google said.http://personaltechmd.com/2019/04/19/u-s-fda-orders-transvaginal-surgical-mesh-pulled-from-market/
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Pa. Supreme Court set to consider jurisdiction questions in pelvic mesh litigation
Apr 18, 2019 | The Pennsylvania Record
By Nicholas Malfitano
HARRISBURG – Pelvic mesh litigation in Philadelphia may now be greatly affected by the Supreme Court of Pennsylvania’s choice to examine a landmark U.S. Supreme Court decision pivotal to the issue of jurisdiction.
On April 10, the Supreme Court of Pennsylvania issued a single page-order to approve an appeal from Ethicon, Inc., a manufacturer of pelvic mesh and a subsidiary of Johnson & Johnson, from a prior decision reached in the Superior Court of Pennsylvania, though only limited to a single point of consideration:
“Whether the due process clause of the Fourteenth Amendment to the United States Constitution and 42 Pa.C.S. Section 5322(c) precludes Pennsylvania from asserting personal jurisdiction over two New Jersey companies in a case brought by an Indiana resident asserting claims under the Indiana Product Liability Act.”
The ruling ties into the pelvic mesh personal injury litigation brought by Indiana-based plaintiff Patricia Hammons against Ethicon, which is based in New Jersey.
Hammons suffered a prolapsed bladder in 2009 and to treat her condition, she had a Prolift-brand mesh device surgically implanted. According to the plaintiff, the mesh’s density led to the build-up and movement of scar tissue, causing erosion to Hammons’ bladder, terrible pain and numerous other symptoms.
The mesh device ultimately failed. As a result, surgeries were necessary to remove the device. However, Hammons claimed that pieces of the device attached themselves to what remained of her bladder and were unable to be extracted.
A Philadelphia jury first awarded Hammons $5.5 million in compensatory damages, and later, punitive damages of $7 million against Ethicon in December 2015. Delay damages in the case were later approved through judicial order.
Ethicon appealed the verdict to the Superior Court of Pennsylvania, alleging among other things, that Hammons failed to state a claim, failed to do so in a timely fashion and that a punitive damages award should have been disallowed.
In June of last year, the Superior Court shot down Ethicon’s appeal and upheld the $12.85 million jury verdict reached in the trial court in an 82-page ruling.
Stabile referred to the U.S. Supreme Court’s decision in Bristol-Myers Squibb v. Superior Court of California when he ruled on behalf of the Superior Court that the connection between Ethicon and Pennsylvania was “considerably stronger” than the one between Bristol-Myers Squibb and the state of California.
In Bristol-Myers Squibb, the U.S. Supreme Court ruled in 2017 that out-of-state plaintiffs are not permitted to bring litigation against companies in venues where the defendants aren’t based or headquartered, or where they have not conducted business relevant to the cause of action.
Furthermore, Stabile spoke of a strong tie between Ethicon and Secant Medical, based in Pennsylvania, to create the pelvic mesh at issue.
“Emails between Ethicon and Secant officials demonstrate that Ethicon repeatedly communicated its requirements for mesh design and development, manufacturing, quality control, testing, and certification to Secant – all issues central to this litigation,” Stabile stated.
“The emails also show that Ethicon employees visited Secant’s plant in Pennsylvania on multiple occasions to observe the mesh production process. This evidence establishes an affiliation between Pennsylvania and Hammons’ cause of action against Ethicon for defective design of the Prolift device.”
Now, Pennsylvania's highest court will consider how jurisdiction factors into the Hammons case.
Almost 100 similar cases to that of Hammons are currently being contested in the Philadelphia County Court of Common Pleas, and its mass tort program in the Complex Litigation Center.
https://pennrecord.com/stories/512435648-pa-supreme-court-set-to-consider-jurisdiction-questions-in-pelvic-mesh-litigation
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US Food and Drug Administration halts pelvic organ mesh sales
Apr 18, 2019 | Stuff.co.nz
By Cate Broughton
The US Food and Drug Administration (FDA) has ordered an immediate halt to the sale of surgical mesh products to treat pelvic organ prolapse (POP).
The FDA said the action this week was taken as two remaining manufacturers of the product, Boston Scientific and Coloplast, had not been able to prove the products were safe to treat pelvic prolapse – when the uterus bulges through weakened tissue into the vagina.
Ministry of Health chief medical officer Dr Andrew Simpson welcomed the FDA decision.
Supplies of mesh products for POP to New Zealand stopped in December 2017 after the ministry required companies to supply additional safety information.
This came a month after Australia's Therapeutic Goods Administration (TGA) cancelled approval of the products.
But other surgical mesh products for stress urinary incontinence, hernia and some plastic surgery remain available in the US, New Zealand and Australia.
While some doctors and patients say the products have successfully treated these conditions, others say they have caused agonising life-long pain and disability.
The New York Times reported seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, were paying nearly $US8 billion ($NZ11.95b) in more than 100,000 lawsuits brought by women who have experienced severe complications associated with the devices.
New Zealanders cannot join international lawsuits because cover for injuries is provided by the Accident Compensation Corporation (ACC).
The most recent ACC figures available showed there were 578 surgical mesh claims for POP procedures from July 2005 to June 2018 .
Of those claims, 125 (22 per cent) were declined.
New Zealand requires no pre-market approval for medical devices, but manufacturers are required to list products on a Medsafe database prior to sale.
Simpson said a draft Therapeutic Products Bill would bring improved oversight of medical devices and address existing gaps in the regulatory requirements.
Patient advocate Charlotte Korte said the FDA had known about surgical mesh complications since 2008.
"Their inability to address this issue properly has resulted in hundreds of thousands of patients around the world being harmed. Sadly, they could have stopped this devastation sooner but it has been allowed to continue."
Those in New Zealand who had been implanted with a POP device should have access to fully funded treatment and financial support, she said.
"Now that the FDA have come out and said these devices are no longer safe to use, ACC should accept every single claim for a POP device because they were implanted with a product that isn't safe."
The FDA and other regulatory bodies needed to look at stress urinary incontinence products as they were also causing severe injuries in some women, Korte said.
Most surgeons implanting surgical mesh for stress urinary incontinence in New Zealand could not fully remove the mesh devices if necessary, she said.
"When a patient is implanted [with mesh] they need to know that if something goes wrong they will be left permanently implanted and the surgeon may not be able to remove it themselves."
In September 2018, the Ministry of Health asked DHBs to ensure surgeons undertaking urogynaecological surgical mesh procedures met Australian guidelines.
Simpson said 24 surgeons at eight DHBs were sufficiently credentialed. The other 12 DHBs had stopped offering the procedure either temporarily, while surgeons gained credentials, or permanently.
Korte said the requirements only applied to implanting surgical mesh and not removing it.
https://www.stuff.co.nz/national/health/112106164/us-food-and-drug-administration-halts-pelvic-organ-mesh-sales
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Boston Scientific sees $25 million hit to 2019 revenue from mesh withdrawal
Apr 18, 2019 | Sb Dirty South Soccer.
By Traci Edwards
USA health regulators ordered two medical device companies to stop selling surgical mesh used in pelvic fix surgeriesafter saying there isn't enough evidence that the product embroiled in thousands of lawsuits is safe or effective.
The agency said the companies, Boston Scientific and Coloplast, had not demonstrated a "reasonable assurance" of safety and effectiveness for the devices for use over the long term, and will have 10 days to submit plans for withdrawing them from the market.
Women who have had transvaginal mesh placed for the surgical fix of POP should continue with their annual and other routine check-ups and follow-up care, the FDA said.
In a statement, Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said the agency determined it needed evidence showing the devices worked to fix pelvic organ prolapse better than corrective surgery without the devices.
"The inaccessibility of these products will severely limit treatment options for the 50 percent of women in the US who will suffer from pelvic organ prolapse during their lives", she said. In addition to uncovering thousands of deaths and millions of injuries presumably caused by medical implants, the report known as the "Implant Files" also claimed that manufacturers have paid out at least $1.6 billion across the globe to settle charges of regulatory violations, including corruption and fraud. The proportion of transvaginal procedures using surgical mesh decreased after the FDA issued warnings about risks associated with transvaginal mesh. Boston Scientific said that it was profoundly frustrated by the FDA's choice and will work with the office to decide the subsequent stages. In 2002, the first mesh device for transvaginal fix of POP was cleared for use as a class II moderate-risk device. In 2016, the FDA reclassified the mesh as class III (high risk) devices, requiring manufacturers to obtain approval of premarket approval applications (PMAs), the agency's most stringent level of review.
Women who have had transvaginal mesh surgically implanted should "continue with their annual and other routine check-ups and follow-up care", the FDA advised.
Uphold LITE Vaginal Support System with Capio SLIM (Medical Device licence: 98223) from Boston Scientific.
The FDA action does not apply to net products used to treat conditions such as even rash or hernias. The FDA issued new recommendations for use in July 2011, and later that year ordered manufacturers to conduct new postmarket studies, after which most companies elected to stop selling the products.
Health Canada added it is also reviewing mesh implants used in the treatment of stress urinary incontinence in women. "SUI mesh causes the same complications", she said.
Restorelle Polypropylene mesh (Medical Device licence: 87285) from Coloplast.
The agency said Tuesday that women with the pelvic mesh should continue regular checkups. The company has faced thousands of lawsuits over the mesh inserts, which are used by surgeons to buttress the pelvic wall. "The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care".
"Patients should notify their healthcare professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex", according to the statement.
http://sbdirtysouthsoccer.com/2019/04/18/boston-scientific-sees-25-million-hit-to-2019-revenue-from/
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Quick Hits: Transvaginal Mesh Pulled, New Weight Loss Drug & More
Apr 18, 2019 | MED Shadow
By Jonathan Block
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments."FDA has ordered that manufacturers of transvaginal mesh products, the most common item used in pelvic organ prolapse (POP) repair, stop selling them. The agency’s move comes amid growing concern about their safety. Just two companies, Boston Scientific and Coloplast, make transvaginal mesh for POP repair. In 2016, transvaginal mesh was reclassified as a Class III device (https://www.medshadow.org/9967-2), meaning that there is high risk associated with the product. At the time, the FDA also ordered the two companies to submit applications showing that transvaginal mesh worked better than surgery without mesh for POP repair. The agency says that the companies did not do so and “have not demonstrated a reasonable assurance of safety and effectiveness.” Posted April 16, 2019. Via FDA.
The FDA has approved Plenity, a new prescription drug for weight loss. Plenity (Gelesis100) is considered a hydrogel therapeutic and is taken as a capsule twice a day before lunch and dinner, along with a diet and exercise program. After ingestion, the drug works by releasing thousands of tiny particles in the stomach that absorb water, creating small gel pieces with the firmness of plant-based foods but without the calories. The pieces increase the volume of contents in the stomach and small intestine, leading to a feeling of fullness. The most common side effects seen in Plenity studies were gastrointestinal in nature. It should also be avoided by pregnant women and those with esophageal abnormalities or with issues from gastrointestinal tract surgeries. Gelesis, which manufactures Plenity, says the product will have a targeted release in the second half of the year, with widespread availability next year. Posted April 16, 2019. Via Gelesis.
People who regularly use marijuana may need more sedatives and anesthesia before surgery as a result. Researchers analyzed the medical records of 250 people who underwent an endoscopy or colonoscopy. Twenty-five people said they smoked marijuana or consumed edible cannabis products on a daily or weekly basis. On average, those who used cannabis required 220% more propofol, 20% more midazolam and 14% more fentanyl before the procedure. Researchers noted that this is concerning, since higher doses of sedatives and anesthesia increase the risks for side effects. Posted April 15, 2019. Via Journal of the American Osteopathic Association.
https://medshadow.org/transvaginal-mesh-weight-loss-drug/
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FDA Orders Surgical Mesh To Treat POP Be Removed From Market
Apr 18, 2019 | Inside Health Policy
FDA has ordered surgical mesh for transvaginal repair of pelvic organ prolapse (POP) manufacturers Boston Scientific and Coloplast to stop selling and distributing the products, the agency announced Tuesday (April 16). The companies, FDA says, have not demonstrated a reasonable assurance of safety and effectiveness for the mesh, and they now have 10 days to submit plans for how they will withdraw their products from the market. The announcement comes five months after FDA device center chief Jeff Shuren said...
Subscription required, for full text: https://insidehealthpolicy.com/daily-news/fda-orders-surgical-mesh-treat-pop-be-removed-market
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Did the FDA Drag Its Feet on Mesh for Prolapse Ban?
Apr 19, 2019 | Medpage Today
After years of lawsuits and safety complaints, the FDA halted sales of all remaining surgical mesh products used for transvaginal repair of pelvic organ prolapse.
Subscription Required, for full text: https://www.medpagetoday.com/surveys/surveys/79335
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FDA Bans Sales Of Transvaginal Mesh
Apr 18, 2019 | WLTZ
(CNN) – The U.S. Food and Drug Administration has ordered the sales of transvaginal mesh to be halted, due to safety concerns.
The FDA said it’s “determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”
Each year, thousands of women undergo transvaginal surgery to repair pelvic organ prolapse.
That’s a condition where weakened muscles and ligaments cause the pelvic organs to drop lower in the pelvis.
The FDA has advised women who have had transvaginal mesh surgically implanted to “continue with routine check-ups.”
Patients who have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, should notify their health care professionals.
https://www.wltz.com/2019/04/18/fda-bans-sales-of-transvaginal-mesh/
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