Preview Newsletter
Ethicon Media Monitoring 7/25/2017
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J&J's Pelvic Mesh Defense Win Is Reversed
Jul 24, 2017 | Delaware Law Weekly
By Max Mitchell
An Ohio woman suing Johnson & Johnson over its surgical pelvic mesh has won a damages hearing a little more than a month after a jury found the product did not cause her claimed damages. -
Three Pelvic Mesh Cases Moved Out of Phila. Court
Jul 24, 2017 | The Legal Intelligencer
By Max Mitchell
Three plaintiffs suing Boston Scientific in Philadelphia over allegedly defective pelvic mesh have agreed to litigate their cases elsewhere in light of the latest jurisdictional pronouncement from the U.S. Supreme Court. -
Mesh Cases Against Boston Scientific Withdrawn From Philly
Jul 24, 2017 | Law 360
By Matt Fair
Three non-Pennsylvania residents pursuing pelvic mesh injury claims against Boston Scientific Corp. in the state agreed on Friday to withdraw their lawsuits in the wake of a pair of U.S. Supreme Court rulings restricting the ability of state courts to retain jurisdiction over non-residents. -
International Media Headlines on Mesh Mess
Jul 24, 2017 | Mesh Medical Device Newsdesk
Unlike the U.S., the media in UK and AU have been making the mesh mess front page news. Here are some of the headlines recently. -
Mesh Around the World
Jul 24, 2017 | Mesh Medical Device Newsdesk
While the U.S. seems to be slowing down in mesh litigation while settlements take place behind the scene, across the globe a collective energy and consistent voice demanding change is being heard. -
Australian Health Advocates Articulate Goals for Mesh-Injured
Jul 24, 2017 | Mesh Medical Device Newsdesk
What Australian women want for their government to become more responsive to the needs of the mesh-injured and to prevent further injuries. Isn’t this a global goal to prevent more injuries in the future? -
Scotland Mesh Ban Continues With Your Help
Jul 24, 2017 | Mesh Medical Device Newsdesk
Scotland has led the way with a ban on mesh procedures due to the tireless campaigning of the mesh injured.
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J&J's Pelvic Mesh Defense Win Is Reversed
Jul 24, 2017 | Delaware Law Weekly
By Max Mitchell
An Ohio woman suing Johnson & Johnson over its surgical pelvic mesh has won a damages hearing a little more than a month after a jury found the product did not cause her claimed damages.
Philadelphia Court of Common Pleas Judge Michael Erdos last week granted plaintiff Kimberly Adkins' post-trial motion requesting a damages hearing in her lawsuit against J&J subsidiary Ethicon. On June 9, a Philadelphia jury had handed up a defense verdict in the case. It was the fifth pelvic mesh case to be tried out of Philadelphia's pelvic mesh mass tort program, and the only case to have ended in a defense win.
Erdos' one-page order filed July 19 granted Adkins' post-trial motion contending that the jury's findings were inconsistent on the issue of whether the alleged design defect caused the injuries, and said the case should proceed to a damages hearing.
Adkins' motion, which was filed June 19, argued that the jury's determination that the product had been defectively designed but not the cause of the plaintiff's injuries was against the weight of the evidence.
"Even if the jury disbelieved plaintiff's testimony, found the testimony inconsistent or concluded plaintiff was exaggerating her injuries, the jury was not free to reject the undisputed consensus of both sides' experts and the treating physician that plaintiff suffered some injury from the implantation of mesh," the motion said.
Adkins' attorney, Bryan Aylstock of Aylstock, Witkin, Kreis & Overholtz, said in an emailed statement that his client was pleased with the ruling.
"Ms. Adkins is pleased and grateful that the court agreed that a new trial on damages was appropriate in this case and grateful to the jury that they found Ethicon's product defectively designed and defective in its warning to unsuspecting physicians and patients," Aylstock said.
Kenneth Murphy of Drinker Biddle & Reath handled the case for J&J.
In an emailed statement, a spokeswoman for Ethicon said, "We are considering our next legal options in this case in light of this decision."
The defense win in Adkins' case came about two months after another Philadelphia jury awarded a woman $20 million, including $17.5 million in punitive damages. In May, a jury awarded another plaintiff $2.1 million over similar claims.
The first case to hit trial out of Philadelphia's pelvic mesh mass tort ended with a $12.5 million award in December 2015. Soon after, the second pelvic mesh case came to a $13.5 million award, with the jury awarding $10 million in punitive damages.
As part of her post-trial arguments in the wake of the defense verdict, Adkins noted the testimony of defense expert Dr. John Wagner, who, she argued, had admitted the mesh caused her initial injuries and only disputed whether her current complaints were mesh-related.
Adkins also contended that she should have been allowed to strike one of the jurors off the case because that juror was a biopharmaceutical engineer with GlaxoSmithKline. The motion noted some comments the juror made suggesting the injuries often claimed in pelvic mesh cases stem from pre-existing injuries, and said the outcome of the case could potentially have an economic impact on the juror, given the juror's employer.
Erdos, however, denied that portion of the post-trial motions.
http://www.delawarelawweekly.com/id=1202793807827/JJs-Pelvic-Mesh-Defense-Win-Is-Reversed?mcode=1202615337490&curindex=0&slreturn=20170625024126
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Three Pelvic Mesh Cases Moved Out of Phila. Court
Jul 24, 2017 | The Legal Intelligencer
By Max Mitchell
Three plaintiffs suing Boston Scientific in Philadelphia over allegedly defective pelvic mesh have agreed to litigate their cases elsewhere in light of the latest jurisdictional pronouncement from the U.S. Supreme Court.
Last month, Boston Scientific had asked the court to remove any cases pending against it in the Philadelphia Court of Common Pleas, citing the Supreme Court's recent game-changing decisions in Bristol-Myers Squibb v. Superior Court of California and BNSF Railway v. Tyrrell. But, according to a lead attorney in the litigation, the parties have agreed to litigate the cases in either Massachusetts, where Boston Scientific has its principal place of business, or Delaware.
"We agreed with Boston Scientific to go forward and litigate the case in a different court," Kline & Specter attorney Shanin Specter said.
Although Boston Scientific's motion from last month seeking to remove the cases listed 94 lawsuits it wanted dismissed, Specter said only three cases had been proceeding against Boston Scientific.
Shook, Hardy & Bacon attorney Joseph Blum is representing Boston Scientific. Blum did not return a call seeking comment Monday morning.
Last month, Boston Scientific filed a motion seeking to have Philadelphia Court of Common Pleas Judge Arnold New reconsider his March 2015 decision that the state court had jurisdiction over the cases. New, who is the supervising judge of Philadelphia's Complex Litigation Center, issued a one-page order Monday saying Boston Scientific's motion was moot.
As part of the motion, Boston Scientific had sought to have New's 2015 ruling vacated to allow for additional briefs on the issue.
Another major defendant in the pelvic mesh mass tort, Johnson & Johnson subsidiary Ethicon, also filed a motion last month seeking to have the cases dismissed pending the Supreme Court's recent decisions. Plaintiffs, however, have asked New to hold off on making a ruling on the issue, since the Pennsylvania Superior Court has agreed to consider the matter in a case that is pending before the intermediate court on appeal.
The Supreme Court's ruling from late June in Bristol-Myers Squibb was largely seen as a game-changing decision that promised to reshape the geography of mass tort litigation across the country.In the ruling, a majority of the Supreme Court determined that plaintiffs suing Bristol-Myers Squibb in California who were not California residents had failed to establish specific jurisdiction over the pharmaceutical giant, since there was no significant link between the claims and Bristol-Myers' conduct in California. The ruling, according to observers, makes clear that out-of-state plaintiffs can't sue companies in states where the defendants aren't considered to be "at home," or haven't conducted business directly linked to the claimed injury.
Earlier this month, J&J filed a motion in Missouri seeking to dismiss more than 1,300 lawsuits against it over talcum powder, claiming the lawyers had engaged in "blatant forum shopping on a grand scale."
In its motion for reconsideration regarding the recent Supreme Court decisions, Boston Scientific contended that Pennsylvania state courts no longer have jurisdiction over it. Specifically, the motion said Boston Scientific is a Delaware corporation with its principal place of business in Massachusetts, it does not have sufficient ties to Pennsylvania to render it "at home" in the Keystone State, and the plaintiffs are not Pennsylvania residents. The company further says that finding Pennsylvania has jurisdiction simply because the company complies with the state's business registration statute violates the due process clause of the U.S. Constitution.
"It is undisputed that Boston Scientific's principal place of business is Massachusetts while its place of incorporation is Delaware," the motion said. "Those are the only two jurisdictions where Boston Scientific is so heavily engaged in activity as to render it 'at home.'"
http://www.thelegalintelligencer.com/id=1202793760838/Three-Pelvic-Mesh-Cases-Moved-Out-of-Phila-Court?slreturn=20170625024128
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Mesh Cases Against Boston Scientific Withdrawn From Philly
Jul 24, 2017 | Law 360
By Matt Fair
Law360, Philadelphia (July 24, 2017, 7:04 PM EDT) -- Three non-Pennsylvania residents pursuing pelvic mesh injury claims against Boston Scientific Corp. in the state agreed on Friday to withdraw their lawsuits in the wake of a pair of U.S. Supreme Court rulings restricting the ability of state courts to retain jurisdiction over non-residents.
The three cases, each of which was being pursued by a Delaware resident, were withdrawn after the Massachusetts-based BSC urged a Philadelphia County judge last month to boot them from the state following a pair of rulings by the U.S. Supreme Court narrowing the scope of jurisdiction for plaintiffs looking to pursue claims in venues outside either where they were injured or where a defendant is headquartered.
“We are refiling those three claims against Boston Scientific in state court in Delaware,” said Shanin Specter, an attorney with Kline & Specter PC representing the plaintiffs in each of the three cases.
The lawsuits against BSC had been lodged as part of a mass tort program established in the Philadelphia County Court of Common Pleas in 2014 aimed at consolidating a glut of claims over alleged pelvic mesh injuries.
BSC had previously looked to have claims it was facing from out-of-state plaintiffs thrown out of Philadelphia for lack of jurisdiction, but a judge rejected the company’s bid in March 2015.
The company renewed its bid for dismissal of the out-of-state claims late last month, however, as it cited new precedent from the Supreme Court in two landmark cases over jurisdictional issues.
In the first, the justices ruled in May that two out-of-state employees couldn’t sue BNSF Railway Co. in Montana given the company’s lack of a bona fide business presence in the state.
The second ruling came in June as the justices found that Bristol Myers-Squibb Co. did not have sufficient business contacts in California to confer courts there with jurisdiction over some 600 lawsuits brought by out-of-state plaintiffs over injuries allegedly caused by the blood-thinner Plavix.
BSC argued in its motion earlier at the end of June that it could not be subjected to jurisdiction in Philadelphia County because it was incorporated in Delaware and headquartered in Massachusetts.
Specter declined to say for certain whether the rulings were a factor in the decision to withdraw the three cases.
"We had several considerations," he said.
An attorney for BSC did not immediately return a message seeking comment on Monday.
Johnson & Johnson unit Ethicon Inc. has likewise urged the court to throw out claims pending in Philadelphia County from out-of-state plaintiffs claiming they were injured by mesh products manufactured by the company.
Specter, however, told Law360 on Monday that he had no intention of voluntarily withdrawing any of the nearly 100 cases his firm is pursuing on behalf of out-of-state plaintiffs against the company in Philadelphia.
He pointed to a prior decision from the court finding it had sufficient business ties to Pennsylvania to establish jurisdiction over the lawsuit, and said that the ruling remained valid even under the new precedent handed down by the Supreme Court earlier this year.
“We are not changing anything with respect to Ethicon,” he said. “We have a solid ruling from the trial court on jurisdiction.”
The plaintiffs in the three cases are represented by Lee Balefsky and Christopher Gomez of Kline & Specter PC.
BSC is represented by Joseph Blum of Shook Hardy & Bacon LLP.
The cases are June Chambers et al. v. Boston Scientific Corp., case number 150803710, Dawn Lamb et al. v. Boston Scientific Corp., case number 161102865, and Jo Ann Mason v. Boston Scientific Corp., case number 161201296, all before the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Editing by Kelly Duncan.https://www.law360.com/pennsylvania/articles/947599
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International Media Headlines on Mesh Mess
Jul 24, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, July 24, 2017 ~ Unlike the U.S., the media in UK and AU have been making the mesh mess front page news. Here are some of the headlines recently.
SKY News coverage is here on an alleged cover up by the UK regulatory body concerning the under reporting of mesh implant complications.
BBC video is here about the rally at Parliament, July 18, 2017.
The Guardian here, Senior Doctors call for an inquiry into vaginal mesh surgery in the UK. They compare it thalidomide.
From the Daily Mail- “I told my husband he could sleep with someone else, here, is the story of a 43-year-old mother of three who can no longer have sexual relations because of her transvaginal mesh implant.
From Michael West, Sydney AU, Journalist and Assoc. Professor with Sydney Democracy Network, michael@michaelwest.com.au,
exposes here, how J&J cut its risk in vaginal mesh lawsuit, July 20, 2017. Reports on how J&J and its auditor reduced accounting disclosures and transparency, in essence reducing its exposure to medical negligence lawsuits. Basically the company has reduced the pool of assets which can be attached in a legal claim. Previously there were seven J&J companies that guaranteed each others’ debts. J&J is a $71 billion a year company.From Western Australia here women say they have been experimented on like guinea pigs. There will be a Senate inquiry on pelvic mesh August 25th in Perth, Australia.
CBS News Australia, here, on the trial of more than 700 Australian women in a class action lawsuit begins Tuesday, July 4. In the U.S. that’s Independence Day! Shine Lawyers represents the group in a trial expected to take 6 months.
The Herald AU, here, Compares mesh to child sexual abuse.
The Herald, Mesh implant Doc, Richard Reid goes sailing, by Joanne McCarthy, July 21, 2017. In her article, here, McCarthy states Dr. Reid is under investigation by two state health departments and eight women are suing him for damages and he is going before regulators in Australia in December. So Dr. Reid is sailing in the Philippines. He was also sued after working in Michigan for 19 yr.
MND has more background on Dr. Reid here. ###
http://www.meshmedicaldevicenewsdesk.com/international-media-headlines-mesh-mess/
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Jul 24, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, July 24, 2017 ~ While the U.S. seems to be slowing down in mesh litigation while settlements take place behind the scene, across the globe a collective energy and consistent voice demanding change is being heard.
In Philadelphia
In Philadelphia, preparations for the Ebaugh v. Ethicon trial coming up Monday, July 31, in the Philadelphia Court of Common Pleas. Case No. 1307-00866.
Kline & Specter represent Ella Ebaugh and her husband who are from Pennsylvania. She is suing Johnson & Johnson, Ethicon, Prodesco, Inc., Gynecare, Secant Medical. Drinker, Biddle & Reach represent the defendant.
She was implanted May 2007 with the Gynecare TVT Secur by Dr. Paul Douglass. On or about July 2007 she underwent a mesh revision and was implanted with Gynecare TVT. She had a mesh removal in July 2011 performed by Dr. Howard Mirsky. She had another corrective surgery in March 2012 by Dr. Toby Chai. She has suffered pain, loss, permanent injury, mental suffering, and medical expenses.
The last TVT-Secur trial was won by Johnson & Johnson last month, the first of five cases in this Philadelphia venue to be won by the defendant corporation. Here is MND coverage.
In Australia
A trial pitting 700 women against Johnson & Johnson continues and is expected to take six months. Caz Chisholm of Australian Public Mesh Support Group, articulates a thorough and thoughtful call to action here.
The Herald reports, here, J&J has reduced its pool of possible assets in case the plaintiffs win the action. A deed cross guaranteeing seven J&J subsidiaries was allowed to lapse. Until 2017, the companies had guaranteed each others’ debts.
It’s estimated at least 100,000 transvaginal mesh medical devices have been sold in Australia and 8,000 women have been implanted there.
In the United Kingdom
In the UK, a report by the English Group Working Party into mesh is due out this week.
Kath Sansom, Sling The Mesh Campaign says Roland Morley, mesh consultant and urologist, is on the English Group Working Party into mesh group. Throughout last weeks gathering of mesh-injured at Parliament, he rolled his eyes, says Sansom. Mr. Morley laughed when patient safety campaigner Ken Lownds spoke about suffering and broke down into tears.
He probably thought because he was at the back nobody would see. But I did,” she says. “Such behavior is disgraceful and disrespectful but sums up how surgeons view women suffering,” reports Sansom.
Here is the Mesh Working Group Interim Report, December 2015.
While it encourages more reporting of adverse events and collection of that data, informed consent is important and should be reviewed every two years. True informed consent might take longer. It does not call for any ban into the procedure or on the use of transvaginal mesh.
The question is will it be another whitewash as campaigners called the Scottish report on mesh, which is here. (March 2017).
It essentially recommends that informed consent, clinician’s reactions to women with adverse events, data gathering could all be improved, but in the meantime it does not call for the suspension of mesh implants while the improvements are underway.
Here is what you can do to help Scottish Mesh Survivors continue the ban in their country. ###
http://www.meshmedicaldevicenewsdesk.com/mesh-around-world/
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Australian Health Advocates Articulate Goals for Mesh-Injured
Jul 24, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, July 24, 2017 ~ What Australian women want for their government to become more responsive to the needs of the mesh-injured and to prevent further injuries. Isn’t this a global goal to prevent more injuries in the future?
Joint submission by Health Consumers Councils across Australia:
Health Issues Centre (Vic)
Health Consumers Queensland
Health Consumers’ Council (WA)
Health Consumers Alliance of SA
Health Care Consumers Association (ACT)
Health Consumers New South WalesThis submission was prepared by Dr Martin Whitely, Manager Policy and Research Health Consumers’ Council (WA) with substantial assistance from Carolyn Chisholm from the Australian Pelvic Mesh Support Group, Danny Vadasz of Health Issues Centre (Victoria) and Melissa Fox, CEO of Health Consumers Queensland. The survey cited in this paper was conducted by the Health Issues Centre (Victoria). Recommendations
For the reasons outlined above we support the call to action by the APMSG and recommend:
1. The suspension of the use of mesh for prolapse and stress urinary incontinence, due to the severity of complications, with the suspension not to be lifted unless and until their safety and efficacy is established.
2. Free medical expertise and help being made to women already injured including access to experienced mesh removal surgeons sourced internationally if necessary.
3. Acknowledgement and ongoing support for adversely affected women. The host organization, format and language of information and promotional materials should be co-designed with affected women and consumer organisations. The support provided should include:
i. A consumer help line.
ii. Website for women with evidence based information around risks and benefits of treatment options.
iii. Recognition and support for women with ongoing incontinence issues.
iv. Recognition and support for women with ongoing disability issues and facilitate access to NDIS funding.
v. Referral to specialist surgeon who can advise and treat the complications.4. Explicit and clear warnings to clinicians, patients and families of potential adverse effects of mesh (Including appropriate information for women with hearing or sight impairment or from CALD backgrounds).
5. Full public disclosure of the clinical trials and other evidence used by the TGA in determining that the products were fit for market.
6. Full public disclosure of how the TGA has responded to adverse events reported by women injured through pelvic mesh devices.
7. A broader Senate inquiry into the operations of Therapeutic Goods Administration TGA in relation to its failure to ensure the safety and efficacy of pharmaceuticals and medical devices in Australia.
8. We call on the Commonwealth Government to:
Establish a Gynecological Mesh User Registry along the lines of the Australian Orthopedic Association National Joint Replacement Registry (AONJRR). The purpose of the AONJRR is to ‘benefit patients by enhancing the outcome of joint replacement surgery through the provision of comprehensive, quality, validated information’. A Gynecological Mesh User Registry would fulfill a similar purpose for women suffering from, or concerned about, potential adverse effects. The database should also have a consumer-friendly interface which facilitates women logging in and self-reporting their complications.9. Consider having a Register for all mesh devices implanted in patients. In line with previous Senate inquiry recommendations we also call on the Commonwealth Government to direct:
10. Commonwealth Government to legislate to introduce mandatory reporting for health practitioners and pharmacists to the Therapeutic Goods Administration for a range of (yet to be specified) severe adverse events for medications and medical devices.
11. Furthermore, we recommend that the TGA regularly publish full de-identified details (not just summaries) of adverse
events associated with the use of medications and medical devices on a publicly accessible website.
12. The Department of Health to undertake further work to address the issue of inducements paid by pharmaceutical companies and medical device manufacturers to doctors and teaching hospitals, in line with the Physician Payment Sunshine provisions of the Patient Protection and Affordable Care Act of 2009 in the United States. The definition of inducements should include a commercial interest in a company or device; any cash payments or discounts offered to medical practitioners; and any other gifts provided to medical practitioners.
We also recommend that:
13. There needs to be enhanced participation of consumers in all the TGA processes with a formal place in the assessment for input from consumers and consumer organisations which would form part of the data package used for that assessment in line with international best practice on consumer involvement in health technology assessment. There should be robust consumer participation on all TGA committees with a transparent process for nominating and publication of the results of any such process.14. In our efforts to gather women’s experiencesof transvaginal mesh, we have heard of concerning complications experienced by men and women who have had mesh inserted for other conditions. We think this warrants the further investigation of use of all mesh devices. ###
http://www.meshmedicaldevicenewsdesk.com/australian-health-advocates-articulate-goals-mesh-injured/
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Scotland Mesh Ban Continues With Your Help
Jul 24, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, July 24, 2017 ~ Scotland has led the way with a ban on mesh procedures due to the tireless campaigning of the mesh injured.
You can help them and here’s how:
In Scotland – Elaine Holmes of Scottish Mesh Survivors is urging women across the world to add their own views and experiences to help campaigners persuade the Scottish government to keep the mesh implant suspension in place.
Scotland does not have the authority to outright ban mesh that lies with the MHRA, Scotland’s version of the FDA. It is almost wholly funded by the medical industry many of which make mesh implants, according to the group.
However Scotland can continue the suspension for as long as it takes for more awareness to show the dangers.
If Scotland’s leads the way in protecting women from further injury. “Let’s hope other countries will follow suit and stop playing Russian Roulette with women’s lives,” says Elaine.
Doctors have failed to lodge the true injury figures allowing manufacturers and watchdogs to continue claiming these procedures are safe. Women everywhere need to use their voice to get the truth out there We hope women all over will send their views to our Parliament so we can make a difference around d the world,” says Elaine.
The links are below and it is vital that campaigners around the world help each other by spreading the truth about these dangerous devices. If woman will please take a few moments to write their views to add to the petition, this will help influence our politicians and hopefully others will follow.
Secretary Shona Robison to continue to suspend the use of such implants in hospitals. Campaigners hope that if Scotland continues to suspend the use of mesh, other countries will follow suit. Submissions must be no more than that which fill 3 A4 sides of paper. Please include full name and mark it clearly Scottish Mesh Survivors “Hear Our Voice” Petition PE1517 and email it to: petitions@parliament.scot for consideration by the Petition’s Committee. It must be received by 1 September 2017.
http://www.meshmedicaldevicenewsdesk.com/scotland-mesh-ban-continues-help/
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