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Ethicon Media Monitoring 8/8/2017
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Phila. Judge to Take New Look at Jurisdiction in Pelvic Mesh Mass Tort
Aug 7, 2017 | The Legal Intelligencer
By Max Mitchell
The judge overseeing the pelvic mesh mass tort in Philadelphia has agreed to reconsider the state court's jurisdiction over 91 cases pending in the venue. -
Adkins’ Pelvic Mesh Trial Will Revisit Damages, Despite J&J Win
Aug 7, 2017 | Mesh Medical Device Newsdesk
Johnson & Johnson won a pelvic mesh trial in Philadelphia on June 9th, the first after four other pelvic mesh trials awarded damages to the mesh-injured plaintiff. The case isn’t over yet. -
Endo Settles Most U.S. Claims on Mesh Products
Aug 7, 2017 | The Wall Street Journal
By Imani Moise
Endo International ENDP -0.75% PLC said Monday that it reached settlements to resolve most of the U.S. product-liability claims regarding the safety of its vaginal mesh products, potentially bringing total settlement costs up to $3.58 billion. -
Endo Sets Aside $775 Million to Settle Remaining Mesh Lawsuits
Aug 8, 2017 | Bloomberg Markets
By Jef Feeley
Endo International Plc said it agreed to set aside $775 million to resolve the last batch of lawsuits alleging the company’s vaginal-mesh implants eroded in some women, leaving them incontinent and in pain. -
Endo To Pay $775M To End 'Virtually All Known' Mesh Suits
Aug 7, 2017 | Law 360
By Emily Field
Endo International PLC on Monday said it has reached agreements to end “virtually all known” mesh product liability claims in the U.S. and that it expects to pay out $775 million to cover the costs of those as well as all known international claims. -
*Breaking News** Endo to Resolve All U.S. Pelvic Mesh Product Liability Claims
Aug 8, 2017 | Mesh Medical Device Newsdesk
Endo International has set aside $775 million to bring to a close its outstanding pelvic mesh U.S. claims, according to the Dublin, Ireland-based company.
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Online Sources
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Phila. Judge to Take New Look at Jurisdiction in Pelvic Mesh Mass Tort
Aug 7, 2017 | The Legal Intelligencer
By Max Mitchell
The judge overseeing the pelvic mesh mass tort in Philadelphia has agreed to reconsider the state court's jurisdiction over 91 cases pending in the venue.
Philadelphia Court of Common Pleas Judge Arnold New recently granted defendant Johnson & Johnson's motion that sought to revisit the state court's jurisdiction over numerous cases in the mass tort program in the wake of the U.S. Supreme Court's game-changing decision in Bristol-Myers Squibb v. Superior Court of California. New's decision, made public last week, is the first and so far only bid to have Bristol-Myers applied to a Philadelphia mass tort program.
In its June ruling in Bristol-Myers Squibb, the Supreme Court made 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. The ruling was widely seen as a game-changing decision that promised to reshape the geography of mass tort litigation across the country.
A spokeswoman for Ethicon said in an emailed statement, "We are pleased that Judge New has called for briefs on this very important issue."
Kline & Specter attorney Shanin Specter, who is a lead attorney representing plaintiffs, said in an emailed statement that he is confident Pennsylvania continues to have jurisdiction over Ethicon, a Johnson & Johnson subsidiary. He added that the Bristol-Myers Squibb ruling restated precedent outlined in the Supreme Court's 2014 decision in Daimler v. Bauman, which New initially relied on when he ruled on jurisdiction in 2015.
"The basis for jurisdiction against Ethicon in Pennsylvania is even stronger now than when Judge New first denied Ethicon's objections to jurisdiction, because of additional evidence of Ethicon's already substantial and specific conduct within the commonwealth in relation to the development and marketing of transvaginal mesh, which we'll provide to the court," he said.
New issued the ruling Aug. 1, and the six-page order was made public Aug. 2. The order vacated a ruling from March 2015 that found Philadelphia had jurisdiction over the cases, and called for more briefing on the issue to be submitted to the court over the next month.
The ruling came several weeks after plaintiffs in three pelvic mesh cases pending in Philadelphia agreed to move their lawsuits against another pharmaceutical company to state court venues outside Pennsylvania. That defendant, Boston Scientific, had raised similar jurisdictional challenges related to Bristol-Myers Squibb.
According to New's Aug. 1 order, the plaintiffs in the cases against Ethicon hale from as close as New Jersey and as far away as California, with their surgeries to implant the mesh devices having taken place in states across the country as well.
In its motion to have the initial ruling on jurisdiction vacated, Ethicon, which is being represented by Drinker Biddle & Reath attorney Kenneth Murphy, said it and its parent company, J&J, are incorporated and have their principal places of business in New Jersey. The motion further noted that, soon after the Bristol-Myers Squibb ruling, a judge in Missouri state court ordered a mistrial in a products liability case that had been brought by a nonresident plaintiff against a company that was not at home in the venue.
According to the court's most recent statistics, the pelvic mesh mass tort grew 7 percent in the past year, rising from 164 to 176.
http://www.thelegalintelligencer.com/id=1202794880466/Phila-Judge-to-Take-New-Look-at-Jurisdiction-in-Pelvic-Mesh-Mass-Tort?slreturn=20170708015554
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Adkins’ Pelvic Mesh Trial Will Revisit Damages, Despite J&J Win
Aug 7, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, August 7, 2017 ~ Johnson & Johnson won a pelvic mesh trial in Philadelphia on June 9th, the first after four other pelvic mesh trials awarded damages to the mesh-injured plaintiff. The case isn’t over yet.
Kimberly Adkins was the first plaintiff in the Philadelphia Court of Common Pleas to lose her pelvic mesh trial against Johnson & Johnson and its subsidiary Ethicon.
Now she getting another bite of the apple.
On July 19, Judge Michael Erdos granted her motion for a new hearing limited to damages, specifically on design defect, contending the jury findings were against the weight of evidence and inconsistent on whether the TVT-SECUR (TVT-S) pelvic mesh caused her injuries.
What this unprecedented ruling means and how it will play out is uncertain to both sides, according to a rash of documents being filed in the case (No. 130700919).
Will a new jury be convened for a new trial or will the issue be heard by a judge? If so, how would a jury understand enough of the nuances of the case to award damages? Will punitive damages be on the table? These questions are, at the present time, unanswered.
WHAT WE DO KNOW
On June 9, after a three-week trial, a Philadelphia jury concluded Ms. Adkins’ injures were not caused by her mesh implant, the TVT-S.
She was implanted with the polypropylene small pore, laser cut, mid-urethral sling July 20, 2010 in Portsmouth, Ohio to treat stress urinary incontinence (SUI). Dr. George Pettit was the implanting physician.
At the same time in an apparent contradiction, the jury decided the TVT-S (Secur) was defectively designed and that Ethicon had failed to warn doctors about its potential risks.
Plaintiffs’ counsel, Bryan Aylstock noted Adkins should be awarded damages since her June trial delivered an inconsistent message.
At the trial’s conclusion he told MND, “They found the product defective in design and in warning under OH law. (Adkins is from Ohio). They found however it wasn’t the cause of her injuries. We will be moving for new trial as the defense had stipulated to at least it cause some of her injuries.”
This was a first.
In the five previous trials in this Philadelphia court, the juries had found for the mesh-injured plaintiff awarding compensatory and punitive damages to the injured in the amounts of $2.16 million, $12.5 million, $13.5 million and most recently, $20 million.
If she had not been injured by the implantation of the TVT-Secur, which was defectively design, how then did you explain its erosion into her vagina and chronic pain?
THE QUESTION OF CAUSATION
One of Ms Adkins’ treating doctors told jurors the mesh erosion caused her pain.
Defense expert, Dr. John Wagner told the jury Adkin’s pain with intercourse was caused by mesh erosion and she would not have the mesh erosion but for the mesh having been implanted in her. Wagner testified it is impossible to “say definitely why anybody get an erosion specifically,” rather he said it is a known complication that happens in about one to two percent of patient who have any type of mesh implant in the vagina.
He did not rule out her smoking history as a contributing factor to her mesh erosion.
An Ethicon expert testified that mesh can cause dyspareunia and erosions into the vagina and these are known complications, not defects. They are risks the implanting surgeon must weigh against the benefit of the device said Dr. Jaime Sepulveda.
There is no “risk-free mesh,” said the doctor.
Dr. Sepulveda said when TVT Secur was marketing in 2006, there was a learning curve for doctors to adopt to implanting this new device, resulting in higher rates of erosions and dyspareunia (painful sex) during this learning curve. The rate of erosion is reduced nearly to zero after the doctor passed the learning curve, he said.
THE ISSUE OF JUROR #1
In post-trial motions, Adkins’ lawyers argued they should have been allowed to strike juror #1. That juror was a biopharmaceutical engineer with GlaxoSmithKline (GSK) who had worked with polypropylene mesh. Adkins’ attorneys say the juror made comments suggesting Adkins’ injuries were pre-existing.
The outcome could potentially adversely effect GSK, the juror’s employer, said Adkin’s team.
Judge Erdos denied that motion.
DEFENSE ARGUES PERSONAL JURISDICTION
Despite its win, J&J filed a Motion for Reconsideration July 26 that asked the court to deny the damages hearing saying it’s improper because the jury decided the defectively designed TVT-Secur was not liable for her injuries.
Then there is the issue of personal jurisdiction.
The U.S. Supreme Court recently ruled ( See MNDstory here) that defendants and plaintiffs must stick to courts that are close to their corporate or personal interests, not file in courts that produce more favorable results for either side. Three pelvic mesh cases were recently moved out of the Philadelphia court for that very reason.
See Mesh News Desk story here.
Defense said the issue of personal jurisdiction had been raised earlier in the litigation but Judge New denied a defense motion to dismiss for lack of personal jurisdiction. Mesh makers Boston Scientific and Johnson & Johnson are trying to have nearly 100 pelvic mesh cases dismissed from this court based on a lack of jurisdiction.
See the Mesh News Desk story on the issue here.
The issue of personal jurisdiction does not stand as an impediment to the Court ordering a new trial, Lee Balefsky (Kline Specter) wrote for the plaintiff.
This is the first Ethicon trial where the doctor who implanted the device did not appear. Because of unspecified medical reasons, Dr. Pettit never testified about the impact a more adequate warning would have made on his implanting of the TVT-Secur.
Because of that, defense argued that case law dictates the failure to warn should be dismissed summarily.
It will be up to Judge Erdos to decide just how big a bit of the apple Ms. Adkins wins. ###
https://www.meshmedicaldevicenewsdesk.com/adkins-pelvic-mesh-trial-will-revisit-damages-despite-jj-win/
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Endo Settles Most U.S. Claims on Mesh Products
Aug 7, 2017 | The Wall Street Journal
By Imani Moise
Endo International ENDP -0.75% PLC said Monday that it reached settlements to resolve most of the U.S. product-liability claims regarding the safety of its vaginal mesh products, potentially bringing total settlement costs up to $3.58 billion.
The drug company said it plans to set aside an additional $775 million to cover mesh product liability, which is expected to cover over 22,000 claims.
Endo had $714.4 million set aside to cover outstanding liability claims in the vaginal mesh cases as of March 31. Earlier this year, the company said it had settled roughly 49,000 mesh-related claims since 2013 for roughly $2.8 billion.
Endo and other medical manufacturers have been hit with lawsuits after injuries linked to the inserts. Vaginal-mesh products are intended to treat pelvic organ prolapse as well as urinary incontinence.
Endo shuttered its litigation-burdened Astora Women’s Health division in 2016 after failing to find a buyer for it. This followed Endo’s 2015 sale of its men’s health and prostate business to Boston Scientific Corp. as Endo focused on its core pharmaceutical business.
“While it remains possible that additional claims will be filed, we believe today’s announcement will assist most mesh claimants to move forward with their lives and will permit Endo to move forward,” said Chief Executive Paul Campanelli in prepared remarks.
The company said it is in talks to resolve the remaining known U.S. claims at “reasonable values.”
Shares in Endo fell 3.5% to $8.98 after hours. The stock has lost 43% of its value so far this year.
https://www.wsj.com/articles/endo-settles-most-u-s-claims-on-mesh-products-1502147946
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Endo Sets Aside $775 Million to Settle Remaining Mesh Lawsuits
Aug 8, 2017 | Bloomberg Markets
By Jef Feeley
Accord brings company’s reserves over devices to $2.6 billion
Other mesh makers still face thousands of suits over implants
Endo International Plc said it agreed to set aside $775 million to resolve the last batch of lawsuits alleging the company’s vaginal-mesh implants eroded in some women, leaving them incontinent and in pain.
Endo’s settlement of the remaining 22,000 mesh suits means the company has now set aside more than $2.6 billion to wipe out cases over the flawed medical devices, according to filings with the U.S. Securities and Exchange Commission.
The accord comes a year after Dublin-based Endo shut down one of its units that makes mesh implants, used to support internal organs or treat incontinence, after being hit with numerous complaints over the devices.
“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,” Paul Campanelli, Endo’s president and chief executive officer, said Monday in a statement.
Other mesh-insert makers, including Johnson & Johnson and Boston Scientific Corp., still face thousands of claims in the U.S. and worldwide from women who blame the devices for injuring them.
J&J, based in New Brunswick, New Jersey, said in SEC filings in February that it was defending 54,800 cases over its inserts while Marlborough, Massachusetts-based Boston Scientific said that same month it faced 43,000 mesh claims. Both companies have settled some mesh suits.
The U.S. Food and Drug Administration increased regulatory restrictions on the mesh inserts after concluding in 2014 they were high-risk. The agency ordered Endo’s American Medical Systems unit, J&J and other mesh makers to study organ-damage rates linked to the devices. J&J dropped some of its mesh lines in 2012.
The consolidated AMS cases are In re American Medical Systems Inc. Pelvic Repair Systems Products Liability Litigation, 12-md-02325, U.S. District Court, Southern District of West Virginia (Charleston).
https://www.bloomberg.com/news/articles/2017-08-07/endo-sets-aside-775-million-to-settle-remaining-mesh-lawsuits
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Endo To Pay $775M To End 'Virtually All Known' Mesh Suits
Aug 7, 2017 | Law 360
By Emily Field
Law360, New York (August 7, 2017, 8:08 PM EDT) -- Endo International PLC on Monday said it has reached agreements to end “virtually all known” mesh product liability claims in the U.S. and that it expects to pay out $775 million to cover the costs of those as well as all known international claims.
Dublin-based Endo said in a statement that, under the agreements, it is slated to end the known U.S. claims at "reasonable values" and will make installment payments starting in the fourth quarter of this year and continue making payments until the end of 2019. The company said it intends to set aside $775 million to cover about 22,000 mesh implant claims in the U.S., in addition to all known international mesh product liability claims and other mesh-related matters.
At this time, Endo said it isn’t aware of any claims that won’t be covered by the $775 million, though it can’t predict the number of any future claims or the resolution of any unresolved claims.
“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," Endo CEO Paul Campanelli said in a statement. "While it remains possible that additional claims will be filed, we believe today's announcement will assist most mesh claimants to move forward with their lives and will permit Endo to move forward with an even greater focus on executing against our core strategic priorities.”
In March 2016, Endo said it was winding down its Astora Women’s Health unit, formerly AMS Women's Health, to reduce the potential for product liability claims related to future mesh implants.
Endo’s subsidiary had been hit by suits alleging health complications allegedly caused by a number of vaginal mesh devices.
In April 2014, Endo said that it had reached settlements with several of the remaining plaintiffs suing American Medical Systems Inc. over allegedly harmful vaginal mesh products, resolving “substantially all” of the claims in the case without admitting any liability or fault.
The 2014 settlement announcement came just five months after the company announced it would pay $830 million to settle "a substantial majority" of the lawsuits related to AMS' vaginal mesh devices.
The day before, the U.S. Food and Drug Administration issued two proposed orders that would reclassify surgical mesh for transvaginal repair of pelvic organ prolapse as a high-risk device and require manufacturers to apply for premarket approval with the agency.
The two orders would address the health risks associated with the mesh, which is used to treat women whose internal structures become so weak or broken that their organs drop from their normal position and bulge into the vagina. The surgical mesh is classified as a moderate-risk device, the agency said at the time of the orders.
Other manufacturers, such as Ethicon Inc., have been hit by suits over allegedly defective mesh implants, spanning seven MDLs encompassing thousands of suits.
A spokeswoman for Endo declined to state counsel or information for the remaining claims, citing confidentiality reasons.
--Editing by Philip Shea.https://www.law360.com/articles/952059/endo-to-pay-775m-to-end-virtually-all-known-mesh-suits
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*Breaking News** Endo to Resolve All U.S. Pelvic Mesh Product Liability Claims
Aug 8, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, August 8, 2017 ~ Endo International has set aside $775 million to bring to a close its outstanding pelvic mesh U.S. claims, according to the Dublin, Ireland-based company.
Endo International, which owns the American Medical Systems (AMS) pelvic mesh lawsuits, has agreed to settle the 22,000 unresolved pelvic mesh product liability lawsuits that have been lingering in court, according to a press release (here) the Wall Street Journal.
The company will set aside $775 million to resolve the last lawsuits, bringing to a total of more than $3.58 billion paid to settle lawsuits filed by women who claim they were injured by the allegedly defective devices made by AMS.
Endo will make installment payments beginning in the fourth quarter of 2017 and continuing through the fourth quarter of 2019, according to a company statement.
At the present time there are 21,127 defective product cases amassed against Endo, filed in federal court in Charleston, West Virginia.
Johnson & Johnson is facing almost 39,000 alone in Charleston and thousands more in New Jersey as well as cases filed around the country. The other large mesh maker, Boston Scientific, has 25,029 cases consolidated in the federal court in Charleston, West Virginia.
Judge Joseph Goodwin had announced to lawyers earlier this year that he wanted to resolve all 104,000 cases before him in multidistrict litigation in WV.
“While it remains possible that additional claims will be filed, we believe today’s announcement will assist most mesh claimants to move forward with their lives and will permit Endo to move forward,” said Chief Executive Paul Campanelli in prepared remarks.
The company said it is in talks to resolve the remaining known U.S. claims at “reasonable values” reports the WSJ.
One woman, Samantha, who had a Caldera claim filed against AMS over its patented surgical tools used in the Caldera mesh kit. The law firm overseeing AMS/Endo $1.6 billion Qualified Settlement Fund told her, in a series of emails, that no more settlements would be paid.
See the MND background story here.
This is good news for mesh-injured claimants like Suzanne, (not her real name), who was implanted with an AMS TVT-O in 2012. Because there have been no trials involving AMS transvaginal mesh, she is one of thousands who are lingering, awaiting an offer from the company to settle.
Read her MND story here.
AMS/ENDO SETTLEMENTS TO DATE
Monarc by AMS for SUI
In April 2014, AMS/Endo agreed to an $830 million settlement fund to resolve about 20,000 claims. One year earlier, AMS/Endo announced a $54.5 million settlement to resolve pelvic mesh lawsuits.
In September 2014, AMS/Endo announced a master settlement of $1.6 billion to resolve the lawsuits.
Valued at $2 billion, Endo purchased American Medical Systems urology products for $2.9 billion in 2011. See the story here.
In March 2015, Endo International announced it sold the urology division to Boston Scientific for up to $1.65 billion. The women’s health division was renamed as Astora Women’s Health.
Astora Women’s Health was closed by Endo in March 2016 due to litigation costs. Astora announced it had suspended all commercial activity and is no longer making or distributing any women’s health products. See the MND story here. *Breaking News** Endo to Resolve All U.S. Pelvic Mesh Product Liability Claims
Mesh Medical Device News Desk, August 8, 2017 ~ Endo International has set aside $775 million to bring to a close its outstanding pelvic mesh U.S. claims, according to the Dublin, Ireland-based company.
Endo International, which owns the American Medical Systems (AMS) pelvic mesh lawsuits, has agreed to settle the 22,000 unresolved pelvic mesh product liability lawsuits that have been lingering in court, according to a press release (here) the Wall Street Journal.
The company will set aside $775 million to resolve the last lawsuits, bringing to a total of more than $3.58 billion paid to settle lawsuits filed by women who claim they were injured by the allegedly defective devices made by AMS.
Endo will make installment payments beginning in the fourth quarter of 2017 and continuing through the fourth quarter of 2019, according to a company statement.
At the present time there are 21,127 defective product cases amassed against Endo, filed in federal court in Charleston, West Virginia.
Johnson & Johnson is facing almost 39,000 alone in Charleston and thousands more in New Jersey as well as cases filed around the country. The other large mesh maker, Boston Scientific, has 25,029 cases consolidated in the federal court in Charleston, West Virginia.
Judge Joseph Goodwin had announced to lawyers earlier this year that he wanted to resolve all 104,000 cases before him in multidistrict litigation in WV.
“While it remains possible that additional claims will be filed, we believe today’s announcement will assist most mesh claimants to move forward with their lives and will permit Endo to move forward,” said Chief Executive Paul Campanelli in prepared remarks.
The company said it is in talks to resolve the remaining known U.S. claims at “reasonable values” reports the WSJ.
Suzanne and her pups
One woman, Samantha, who had a Caldera claim filed against AMS over its patented surgical tools used in the Caldera mesh kit. The law firm overseeing AMS/Endo $1.6 billion Qualified Settlement Fund told her, in a series of emails, that no more settlements would be paid.
See the MND background story here.
This is good news for mesh-injured claimants like Suzanne, (not her real name), who was implanted with an AMS TVT-O in 2012. Because there have been no trials involving AMS transvaginal mesh, she is one of thousands who are lingering, awaiting an offer from the company to settle.
Read her MND story here.
AMS/ENDO SETTLEMENTS TO DATE
Monarc by AMS for SUI
In April 2014, AMS/Endo agreed to an $830 million settlement fund to resolve about 20,000 claims. One year earlier, AMS/Endo announced a $54.5 million settlement to resolve pelvic mesh lawsuits.
In September 2014, AMS/Endo announced a master settlement of $1.6 billion to resolve the lawsuits.
Valued at $2 billion, Endo purchased American Medical Systems urology products for $2.9 billion in 2011. See the story here.
In March 2015, Endo International announced it sold the urology division to Boston Scientific for up to $1.65 billion. The women’s health division was renamed as Astora Women’s Health.
Astora Women’s Health was closed by Endo in March 2016 due to litigation costs. Astora announced it had suspended all commercial activity and is no longer making or distributing any women’s health products. See the MND story here.
AMS PELVIC MESHES
AMS made the Apogee and Perigee Systems, ElevateTM Anterior and Posterior Pelvic Floor Repair System and IntePro Y sling to treat pelvic organ prolapse. The MiniArc, RetroArc, Monarc, In-Fast, BioArc and SPARC slings all treat stress urinary incontinence.
Since it took Apogee off the market, AMS no longer has to conduct FDA mandated three years of post approval monitoring on those models of pelvic mesh products. ###
https://www.meshmedicaldevicenewsdesk.com/endo-resolve-u-s-pelvic-mesh-product-liability-claims/
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