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Ethicon Media Monitoring 8/10/2017
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Mesh Ruling Signals Tough Road For Non-Pa. Cases In Philly
Aug 10, 2017 | Law 360
By Matt Fair
A judge’s decision to rethink whether out-of-state residents can sue a Johnson & Johnson unit in Philadelphia County over allegedly defective pelvic mesh products, which follows two landmark U.S. Supreme Court rulings on similar jurisdictional questions, could signal a new normal of heightened scrutiny for non-Pennsylvania plaintiffs who have historically flocked to the forum. -
Federal Court Overseeing Ethicon Physiomesh Lawsuits Convenes Initial Conference
Aug 9, 2017 | RX Injury Help (blog)
By Sandy Liebhard
The multidistrict litigation established earlier this year for federally-filed product liability lawsuits involving Ethicon, Inc.’s Physiomesh line of hernia patches is now underway, after an Initial Case Management Conference was convened in the U.S. District Court, Northern District of Georgia, on August 1st. -
Johnson & Johnson Face Further Scrutiny in Vaginal Mesh Case
Aug 9, 2017 | ConsumerSafety.org
By Lindsey Pasieka
The only mesh bellwether case to be found in favor of the defense is now facing a post-trial motion for a damages hearing. Plaintiff Kimberly Adkins had originally placed the suit after experiencing pain and injury she claimed was caused by a vaginal mesh implant. -
Drugmaker Endo cuts full-year sales forecast, shares slide
Aug 8, 2017 | Reuters
By Akankshita Mukhopadhyay and Manas Mishra
Endo International Plc on Tuesday lowered its full-year revenue forecast, saying it expected lower sales of branded drugs to add to the pricing pressure its generic drugs are facing, sending the company's shares to their lowest since 2003. -
Endo Announces $775 Settlement for Transvaginal Mesh Claims
Aug 9, 2017 | DrugWatch
By Elaine Silvestrini
Trying to end its surgical mesh legal woes, Endo International says it has reached agreements and will pay out $775 million to settle the approximately 22,000 remaining, known claims filed by women in the U.S. who say they were injured from procedures that used the Irish company’s transvaginal mesh. -
Damning studies led US doctors to suspend controversial vaginal mesh surgery over safety but the NHS has ignored the evidence and destroyed the lives of thousands of women
Aug 9, 2017 | Daily Mail
By Stephen Matthews and Alexandra Thompson
The NHS has been accused of ignoring damning studies that show the damage controversial vaginal mesh procedures cause is much higher than the health service is willing to admit.
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Mesh Ruling Signals Tough Road For Non-Pa. Cases In Philly
Aug 10, 2017 | Law 360
By Matt Fair
Law360, Philadelphia (August 9, 2017, 7:08 PM EDT) -- A judge’s decision to rethink whether out-of-state residents can sue a Johnson & Johnson unit in Philadelphia County over allegedly defective pelvic mesh products, which follows two landmark U.S. Supreme Court rulings on similar jurisdictional questions, could signal a new normal of heightened scrutiny for non-Pennsylvania plaintiffs who have historically flocked to the forum.
Judge Arnold New in the Philadelphia County Court of Common Pleas agreed last Wednesday that new precedent from the Supreme Court required reconsideration of his two-year-old finding that Ethicon Inc. had sufficient ties to Pennsylvania for it to be subject to general jurisdiction in the state in a string of lawsuits of injuries linked to its mesh products.
The renewed jurisdiction fight comes after two major rulings from the high court earlier this year — Bristol-Myers Squibb Co. v. Superior Court of California and BNSF Railway Co. v. Tyrrell — narrowing plaintiffs’ ability to pursue claims in venues outside either where they were injured or where a defendant is headquartered.
“Judge New’s ruling is a recognition of the tighter requirements imposed by the Supreme Court for exercising general jurisdiction over non-Pennsylvania defendants,” said Duane Morris LLP partner Kenneth Argentieri.
Ethicon pressed Judge New for reconsideration of the jurisdiction question as it pointed to an 8-to-1 decision by the justices in June that found 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.
The opinion came just weeks after the Supreme Court found 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.
James Beck, a product liability specialist with Reed Smith LLP, said that the decisions could disproportionately affect litigation in Philadelphia County given the high volume of cases filed there by out-of-state plaintiffs.
“They’re in the range where it’s not just a majority, but a great majority of the cases are from out of state,” he said.
But things may be changing after the justices upended a ruling allowing nonresidents to bring Plavix-related claims in California due to Bristol-Myers’ marketing and distribution work related to the drug in the state, as well as the research and development facilities it maintained there.
"The relevant plaintiffs are not California residents and do not claim to have suffered harm in that state," the justices said. "All the conduct giving rise to the non-residents’ claims occurred elsewhere. It follows that the California courts cannot claim specific jurisdiction."
Cozen O’Connor partner Abby Sacunas said the same logic applied to cases filed in Philadelphia involving companies with limited business links to the state.
“Historically, the reason why we get so much product liability litigation here in Pennsylvania is that plaintiffs will say a company had a sales office, or they reached out to doctors or sold to hospitals in the state, and that’s enough to confer specific jurisdiction,” she said. “This decision will prevent that.”
Beck suggested that the ruling meant that a drug targeted in litigation would actually have to be manufactured in a state in order to subject a company to jurisdiction there.
“The language in the Bristol-Myers Squibb decision is very good for the defense,” he said. “Unless you have some kind of injury in the state, or actual manufacturing of the drug in the state, it’s not going to be enough.”
In the mesh litigation, however, attorneys for the plaintiffs have argued that Ethicon, which is looking to have nearly a hundred cases excised from a mass tort program over its mesh products, did have sufficient ties to Pennsylvania to allow the litigation to move forward.
In fighting Ethicon’s original bid to have claims from out-of-state residents transferred out of Philadelphia, the plaintiffs pointed to the company’s reliance on a Pennsylvania-based company for the manufacture of the mesh used in its products. They likewise argued that J&J was registered to do business in the state.
Shanin Specter, an attorney for the plaintiffs, told Law360 last week that additional evidence had come up during the course of litigation further cementing Ethicon’s links to Pennsylvania.
“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.
While preparing to fight to keep its cases against Ethicon in Philadelphia County, the plaintiffs agreed last month to voluntarily withdraw three sets of claims from nonresidents that had been pending in the city against Boston Scientific Corp. after the company raised similar arguments about its lack of business ties to Pennsylvania.
Specter declined to say specifically whether the Supreme Court’s jurisdictional pronouncements had anything to do with the decision to move the cases.
“We had several considerations,” he told Law360 at the time.
Max Kennerly, an attorney with plaintiffs firm Kennerly Loutey LLC, noted that Judge New’s move to reconsider whether Ethicon could be sued in Philadelphia over its mesh products was not necessarily an indicator that he was going to change his decision.
“I don't think Judge New taking up the issue is a sign that the court would rule one way or another,” he said. “It's typical the parties would be given an opportunity to brief a new relevant Supreme Court case.”
Regardless of whether the cases ultimately will end up staying in Philadelphia, however, it’s clear that companies are likely to more aggressively seek to challenge whether they can be subject to jurisdiction in the court.
“What you’re likely to see is more of a fight from out-of-state defendants with regard to jurisdiction here in Philadelphia,” Sacunas said.
Another potential outcome of the Supreme Court’s decision in the Bristol-Myers case, ironically, could be an uptick in cases from out-of-state plaintiffs against the many pharmaceutical companies located in the greater Philadelphia area.
“That’s also a likely consequence of this decision,” Sacunas said. “As other jurisdictions become inhospitable, you could see an uptick in filings against companies that do have a presence here.”
Ethicon is represented by Kenneth Murphy and Melissa Merk of Drinker Biddle & Reath LLP, and Julie Callsen of Tucker Ellis LLP.
The plaintiffs are represented by Shanin Specter, Lee Balefsky, Michelle Tiger and Christopher Gomez of Kline & Specter PC, and Clayton Clark of Clark Love & Houston.
The case is In re: Pelvic Mesh Litigation, case number 140200829, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Additional reporting by Emily Field and Dan Packel. Editing by Christine Chun and Breda Lund.https://www.law360.com/lifesciences/articles/952688/mesh-ruling-signals-tough-road-for-non-pa-cases-in-philly
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Federal Court Overseeing Ethicon Physiomesh Lawsuits Convenes Initial Conference
Aug 9, 2017 | RX Injury Help (blog)
By Sandy Liebhard
Sandy Liebhard is an Senior Partner at Bernstein Liebhard LLP
The multidistrict litigation established earlier this year for federally-filed product liability lawsuits involving Ethicon, Inc.’s Physiomesh line of hernia patches is now underway, after an Initial Case Management Conference was convened in the U.S. District Court, Northern District of Georgia, on August 1st.
According to an Order filed just days after the Conference, the Court has directed the parties to meet and confer on the preparation of an order that would allow future Physiomesh lawsuits to be filed directly in the Northern District of Georgia. The August 3rd Order also directs the parties to meet and confer regarding the procedural, case management, and discovery issues discussed during initial conference and prepare proposals governing case management. The Court will take up those proposals at the next scheduled status conference.
Finally, the Order sets forth a schedule of regular, monthly status conferences through the remainder of the year as follows:eptember 12, 2017 at 2:00 p.m. EDTOctober 10, 2017 at 2:00 p.m. EDTNovember 16, 2017 at 2:00 p.m. ESTDecember 7, 2017 at 2:00 p.m. ESTEthicon Physiomesh: What’s the Problem?
Ethicon obtained regulatory clearance for its first Physiomesh products in 2010, via the U.S. Food & Drug Administration’s (FDA) 510(K) program. This faster route to clearance allows a medical device to come to market without human clinical trials, as long as a manufacturer can demonstrate that it is “substantially equivalent” to another product previously approved by the agency.
All of the hernia mesh patches included in the Physiomesh line are made from non-absorbable polypropylene (plastic) filaments that are woven into fabric and laminated with an absorbable film coating. According to Ethicon, the coating helps the hernia mesh incorporate into the body and reduces inflammation. However, plaintiffs pursuing Physiomesh lawsuits claim that this multilayer construction actually hinders incorporation and increases the risk that patients will develop serious complications, including adhesions, perforations, infections, mesh erosion, hernia recurrence, and the need for Physiomesh revision surgery.
Ethicon announced it was withdrawing Physiomesh Flexible Composite Mesh from the worldwide market in May 2016, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair.
“Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,” the company’s notification stated.
Ethicon has indicated that the Physiomesh products listed in the notification will not be returning to the market.
http://www.rxinjuryhelp.com/news/2017/08/09/federal-court-overseeing-ethicon-physiomesh-lawsuits-convenes-initial-conference/
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Johnson & Johnson Face Further Scrutiny in Vaginal Mesh Case
Aug 9, 2017 | ConsumerSafety.org
By Lindsey Pasieka
The only mesh bellwether case to be found in favor of the defense is now facing a post-trial motion for a damages hearing. Plaintiff Kimberly Adkins had originally placed the suit after experiencing pain and injury she claimed was caused by a vaginal mesh implant. While the jury and the defense were unconvinced that Ms. Adkins’ continuing issues were caused by the implant, both sides and all the experts agreed that some injury was caused by the implantation.
The motion said, “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.”
https://www.consumersafety.org/news/safety/breast-implant-cancer-vaginal-mesh-roundup/
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Drugmaker Endo cuts full-year sales forecast, shares slide
Aug 8, 2017 | Reuters
By Akankshita Mukhopadhyay and Manas Mishra
(Reuters) - Endo International Plc on Tuesday lowered its full-year revenue forecast, saying it expected lower sales of branded drugs to add to the pricing pressure its generic drugs are facing, sending the company's shares to their lowest since 2003.
Generic drugmakers are being hurt by an acceleration in the decline of drug prices as U.S. retail pharmacies wield more leverage during purchases at a time when regulators are pushing for faster approval of these copycat drugs.
Teva Pharmaceutical Industries Ltd, the world's largest generic drugmaker, last week posted dismal second-quarter results due to the accelerated price erosion in the United States.
Endo's revenue from its U.S. generics unit in the second quarter was virtually unchanged from a year earlier as a sharp 34 percent decline in sales of its older generics drug was offset by strength in its sterile injectables as well as new launches and alternative dosages businesses.
Cowen & Co analyst Ken Cacciatore said the pressure on Endo's generics was unlikely to relent and any near-term stabilization could prove elusive.
"We have very little faith in the consistency of the operations from quarter to quarter," Cacciatore said.
Endo said it continues to expect sales at its generics business to decline in the high single- to low double-digit percentage range this year.
The company lowered its full-year total revenue forecast to $3.38 billion to $3.53 billion from $3.45 billion to $3.60 billion.
The lowered forecast reflects, in part, the withdrawal of Endo's branded opioid painkiller Opana ER. Endo agreed to pull the drug in early July at the behest of a U.S. regulator, due to the burgeoning opioid epidemic.
Endo now expects full-year sales of its branded drugs to decline in the mid- to high-teens percent range, compared with its previous forecast of a drop in the low- to mid-teens range.
The company cut its forecast for adjusted profit from continuing operations to $3.35-$3.65 per share from $3.45-$3.75.
Endo's second-quarter adjusted profit of 93 cents per share handily beat Thomson Reuters I/B/E/S estimates by 20 cents.
Endo on Monday agreed to resolve long-standing claims over certain vaginal mesh products by increasing its liability reserve by $775 million and making payments from the fourth quarter through 2019.
The lawsuits stemmed from thousands of women who said they were injured after using the devices.
Endo shares were trading down 6.3 percent at $8.75. They fell as much as 10 percent earlier.
https://uk.reuters.com/article/us-endo-intl-results-idUKKBN1AO14I
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Endo Announces $775 Settlement for Transvaginal Mesh Claims
Aug 9, 2017 | DrugWatch
By Elaine Silvestrini
Trying to end its surgical mesh legal woes, Endo International says it has reached agreements and will pay out $775 million to settle the approximately 22,000 remaining, known claims filed by women in the U.S. who say they were injured from procedures that used the Irish company’s transvaginal mesh.
Under agreements Endo has reached with plaintiffs, the company will start making installment payments in the fourth quarter of this year, continuing until the end of 2019. The $775 million is expected to cover all known international mesh product liability claims as well.
That amount is on top of the $2.8 billion Endo has previously agreed to pay in 48,0000 cases filed since 2013, according to Endo’s December 31, 2016 filing with the U.S. Securities and Exchange Commission. In 2016 alone, the company paid out more than $1.1 billion in mesh legal settlements.
“Beginning in the second quarter of 2017, we aggressively executed a settlement strategy in connection with Endo’s mesh litigation. 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 Aug. 7, 2017. “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.”
The $775 million settlement contributed to the company’s consolidated net loss of nearly $1.4 million for the second quarter of 2017.State Attorneys General Investigate Mesh
But Endo may also be facing legal action from various states’ attorneys general in connection with transvaginal surgical mesh products.
According to the December SEC filing, Endo has continued to cooperate with investigations by California and other states, dating back to at least October 2012 when the company was contacted regarding “a civil investigation initiated by a number of state attorneys general into mesh products.”
In May 2016, Kamala D. Harris, who was then the attorney general of California, filed a lawsuit against Johnson & Johnson, accusing it of false advertising and deceptive marketing of its surgical mesh products for women. The lawsuit said that J&J failed to warn patients and doctors of possible, severe complications, and misrepresented the frequency and severity of the risk.
Transvaginal mesh is a product made of plastic or animal tissue that is implanted vaginally to repair pelvic organ prolapse or stress urinary incontinence, conditions which can occur in women following menopause, childbirth, or a hysterectomy.FDA Calls Mesh ‘High Risk’ Medical Device
The U.S. Food and Drug Administration has classified the mesh as a “high risk” medical device, and some surgeons have stopped using it. In July 2011, the FDA issued a notification stating that adverse events associated with transvaginal mesh are not rare, and it questioned its effectiveness for treatment of pelvic organ prolapse compared to other available treatments.
In March 2016, Endo closed Astora Women’s Health division subsidiary, which manufactured the mesh, in an attempt to stem the costs of the continuing litigation. Other companies, such as J&J, have stopped selling some product lines.
On another front, Endo bowed to a request from the FDA on July 6 when it acceded to the agency’s unprecedented request that it remove the opioid drug Opana ER from the U.S. market because of concerns about addiction. The drug is twice as powerful as Oxycontin and three times as powerful as morphine.
Opana ER was the company’s highest revenue generator last year, bringing in nearly $159 million in revenue. Endo said it will cease shipments by Sept. 1.
In second quarter financial results released Aug. 8, Endo said it experienced a 15 percent decrease of revenues from branded pharmaceuticals, compared to the same quarter in 2016, partly because of generic competition and the withdrawal of Opana ER from the market.
https://www.drugwatch.com/2017/08/09/endo-announces-775m-settlement-for-transvaginal-mesh-claims/
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Aug 9, 2017 | Daily Mail
By Stephen Matthews and Alexandra Thompson
· In recent years, studies suggest complications strike up to 40 per cent of women
· But health officials in England have turned their nose up at the host of research
· Currently, the NHS and MHRA state only 1 to 3 per cent report any complications
The NHS has been accused of ignoring damning studies that show the damage controversial vaginal mesh procedures cause is much higher than the health service is willing to admit.
Published in various journals, the alarming evidence prompted doctors in three US states to suspend the controversial practice - used to treat incontinence - and saw them call for a review into its safety.
The studies, handed exclusively to MailOnline following our calls to review the safety of mesh implants, revealed pain, erosion and perforation from the surgery can strike up to 40 per cent of women. Others suggest it could be as high as 75 per cent.
But English health officials have yet to acknowledge the risks of the brittle implants which can break into tiny fragments and cause nerve damage. Currently, the NHS and MHRA state only 1 to 3 per cent will experience complications such as pain.
Vaginal mesh has been considered a high-risk device for nearly a decade in the US, with officials accepting that up to 40 per cent of women may experience injury.
Outraged women have consistently argued for UK health bodies to adopt a similar stance as thousands of British women have been left suicidal and unable to have sex as a result of the controversial procedure.
Tireless fights by campaigners have helped gather momentum for a public inquiry into the implants, with MPs now beginning to ask questions about the safety of mesh and calling for further investigations over the devices.
Its usage has been suspended in Scotland since 2014 pending a safety review, but hundreds of women are still believed to be having the surgery. And just last month the English MHRA insisted the mesh was safe.
Kath Sansom, founder of Sling The Mesh, a campaign dedicated to reviewing the usage of mesh, has backed our calls for addressing the problem.
She told MailOnline: 'I wish the NHS would wake up to the number of women suffering.
'I don’t know why they are unwilling to accept the higher complication rates that have seen the surgery suspended in three US states and Scotland.
'However, it could have something to do with a large number of studies that have received funding from manufacturers of the controversial implants.
'I really wish they were willing to acknowledge the results of various studies and accept the true risks to the procedure, for the thousands of affected women.
'It's clear to see that US doctors have acknowledged the results of multiple studies suggesting much higher complication rates.'
Her concerns come just days after we revealed that having mesh implants fitted had destroyed the lives of two women.
The scandal came to light earlier this year, but its true extent is yet to be uncovered - though mounting pressure is being placed on health officials to address concerns.
Senior doctors have already called for a public inquiry into the use of vaginal mesh surgery in Britain, saying it could be akin to the thalidomide scandal.
An editorial published in European Urology five years ago suggested adverse effects strike nearly half of women who are fitted with the implant.
Author Dr Firouz Daneshgari, of the Department of Urology, Case Western Reserve University, slammed the alarming rates.
He said: 'By any modern industrial standards of quality, a 30–40 per cent rate of adverse events is simply unacceptable.
'Can any of us imagine what would happen if one-third of all cars, computers, food packages, or any other commodity we purchase would fail or result in recalls?
'Moreover, it is unlikely that the manufacturer would remain in business after such recalls and failures.'
Reporting in the journal Nature in 2015, nine leading researchers concluded the risk to be more in the region of 15 per cent.
Research led by Loyola University Chicago in November 2012 showed adverse episodes occur in up to 42 per cent of women.
However, the scientists wrote in the America Journal of Obstetrics and Gynaecology that mesh was still acceptable to use.
Of women suffering problems from vaginal mesh, a study published in the same journal showed 77 per cent to have severe effects.
The mesh, introduced 20 years ago, was promoted as a quick, cheap alternative to complex surgery for incontinence.
Because it did not require specialist training to implant, outraged women have since begged for tougher regulations to conduct such surgery.
More than 10,000 women a year have the procedure. But only 7,800 have suffered lacerations and nerve damage from the mesh breaking into tiny fragments.
However, campaigners stress these are just the tip of the iceberg and that actually there are thousands more - but they have been kept silent.
A three-year investigation by NHS England confirmed many more women have complained of injuries than previously suggested.
But it steered away from looking at the safety of mesh, and stopped short of demanding a register of all implant operations.
Professor Keith Willett, of NHS England, said: 'There’s no doubt there has been significant progress to improve information, care and support for women affected by stress urinary incontinence and pelvic organ prolapse.'
John Wilkinson, Director of Devices at MHRA, said: 'We are not aware of a robust body of evidence which would lead to the conclusion these devices are unsafe if used as intended.
'What we continue to see is that evidence supports the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances.'
http://www.dailymail.co.uk/health/article-4771578/Damning-studies-showing-complication-rates-vaginal-mesh.html
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