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Ethicon 6/1
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Pa. Judge Urged To Keep 1st Pelvic Mesh Cases In Philly
May 29, 2015 | Law 360
By Matt Fair
A Pennsylvania state judge was recently urged to reject a Johnson & Johnson unit’s contention that Philadelphia County was too inconvenient a forum to allow the court to continue presiding over a cluster of cases that allege injuries from pelvic mesh products -
Del. Jury Awards Plaintiff $100 Million in Boston Scientific Transvaginal Mesh Action
May 29, 2015 | Harris Martin Publishing
A Delaware jury has awarded a woman $100 million in a transvaginal mesh action brought against Boston Scientific Corp., finding the company negligently designed and manufactured its Pinnacle and Advantage Fit devices and failed to adequately warn doctors and patients of their risks. -
$100M Mesh Payout
May 31, 2015 | Sunday Mail (Print Edition)
By Marion Scott
A mesh victim has won $100million compensation for injuries caused by the controversial implants. -
Delaware woman wins $100m in transvaginal mesh case
May 29, 2015 | The Guardian
A Delaware jury has ordered a medical device manufacturer to pay $100m to a woman who, despite two surgeries, still has pieces of transvaginal mesh embedded inside her. -
Boston Scientific Hit With $100M Verdict in Pelvic Mesh Case
May 29, 2015 | Delaware Law Weekly
By Gina Passarella
A Delaware Superior Court jury in Wilmington awarded Thursday $100 million to a woman who experienced complications from transvaginal mesh implants made by Boston Scientific Corp. -
Boston Scientific to pay $100 million to Delaware woman
May 29, 2015 | Uncover Michigan
By Amy McClellan
On Thursday, a Delaware jury ordered Boston Scientific Corp. to pay $100 million to a woman who claimed she was injured by a device that is the subject of more than 25,000 lawsuits. -
Jury in Delaware awards $100M to 51-year-old woman in transvaginal mesh case
May 29, 2015 | ABA Journal
By Martha Neil
...But on Thursday a jury there awarded a 51-year-old former bank teller $25 million in compensatory damages and $75 million in punitives against Boston Scientific Corp. Deborah Barba said she suffered constant discomfort, urinary tract infections and painful sex—despite two corrective surgeries—because of being implanted with the company’s transvaginal mesh... -
Boston Scientific ordered to pay $100 million to Delaware woman
May 30, 2015 | Maine News Online
By Tanya Campbell
Boston Scientific Corp. has been ordered by a Delaware jury to pay $100 million to a woman who got injured while using the company's transvaginal mesh inserts device that attracted thousands of lawsuits. Deborah Barba, 51, will receive$75 million in punitive damages and $25 million in compensatory damages. -
Pharmalot.. Pharmalittle.. As the Weekend Nears: We’re Catching up on Merck, Lundbeck and Much More!!
May 29, 2015 | The Wall Street Journal
By Ed Silverman
...Boston Scientific was ordered by a Delaware state court jury to pay $100 million to a woman who blamed its vaginal-mesh inserts for leaving her in constant pain and unable to have sex, Bloomberg News reports...
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Pa. Judge Urged To Keep 1st Pelvic Mesh Cases In Philly
May 29, 2015 | Law 360
By Matt Fair
A Pennsylvania state judge was recently urged to reject a Johnson & Johnson unit’s contention that Philadelphia County was too inconvenient a forum to allow the court to continue presiding over a cluster of cases that allege injuries from pelvic mesh products.
The plaintiffs said in a Wednesday brief that Philadelphia was no more inconvenient a venue for the cases — the first seven slated for trial out of some 230 that are pending as part of a mass tort program in the court — than other options including federal multidistrict litigation in West Virginia and similar consolidated proceedings in New Jersey state court.
“The facts indicate that Pennsylvania is no less convenient than anywhere else,” the brief said. “The backlog of cases in the MDL and the New Jersey consolidated proceedings demonstrate that alternative fora are not more convenient, sensible or appropriate.”
This is the second bid by Ethicon Inc. to move pelvic mesh cases out of the Court of Common Pleas of Philadelphia County.
A judge at the end of March rejected the company’s arguments that plaintiffs in many of the mass tort cases had not claimed that their injuries had any specific ties to Pennsylvania sufficient to grant the court jurisdiction.Despite the court’s rejection of that bid, the company filed a new motion earlier this month aimed at having the cases moved on the basis of forum non conveniens.
Ethicon argued that using Philadelphia as a base for cases involving plaintiffs from five different states was an inefficient way of managing the litigation. Instead, the company asked that the cases be moved either to the plaintiffs’ home states or to New Jersey, where Ethicon says it “made decisions concerning the design, manufacture and labeling of its pelvic mesh devices.”
“The public interest will be served by relieving Philadelphia courts and juries from the costs and burdens of resolving claims asserted by out-of-state plaintiffs against out-of-state defendants that have no meaningful connection to Pennsylvania,” the company said.
The plaintiffs argued in their response, however, that case management orders entered in Philadelphia had sufficiently eased potential discovery burdens and that there had been no problems conducting depositions with out-of-state witnesses.
“The importance of the CMOs entered in these consolidated proceedings is that they create ease of access to sources of proof and provide an agreed-upon procedure for scheduling witness depositions,” the plaintiffs said. “Because plaintiffs have either provided all relevant medical records, or authorizations which permit the defendants to obtain the records directly, there is no issue regarding sources of proof in other jurisdictions.”
They also argued that moving the cases to other jurisdictions would delay adjudication of their claims. The plaintiffs pointed out that there were some 26,000 claims pending against Ethicon in the MDL and nearly 8,000 in the consolidated litigation in New Jersey.
“If they are forced to dismiss and re-file elsewhere, their claims would be at the back of the line,” the brief said. “Plaintiffs would be severely prejudiced of their cases were re-filed in either of these venues, whose backlog is much larger than the current … inventory of the Philadelphia mass tort program.”
An attorney for Ethicon did not immediately return a message seeking comment on Friday.
The plaintiffs are represented by Thomas Kline, Lee Balefsky and Michelle Tiger of Kline & Specter PC.
J&J is represented by Andrew Reeve, Kenneth Murphy and Melissa Graff of Drinker Biddle & Reath LLP.
The case is In Re: Pelvic Mesh Litigation, case number 140200829, in the Philadelphia County Court of Common Pleas. -
Del. Jury Awards Plaintiff $100 Million in Boston Scientific Transvaginal Mesh Action
May 29, 2015 | Harris Martin Publishing
A Delaware jury has awarded a woman $100 million in a transvaginal mesh action brought against Boston Scientific Corp., finding the company negligently designed and manufactured its Pinnacle and Advantage Fit devices and failed to adequately warn doctors and patients of their risks.
On May 28, the New Castle County Superior Court jury awarded Deborah Barba, 51, $25 million in compensatory damages and $75 million in punitive damages. The trial, overseen by Judge Mary M. Johnston, began on May 11.
Barba was implanted with the Pinnacle Pelvic Floor Repair Kit and the Advantage Fit Mid-Urethral Sling System ...
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May 31, 2015 | Sunday Mail (Print Edition)
By Marion Scott
A mesh victim has won $100million compensation for injuries caused by the controversial implants.
Deborah Barbara was awarded the record payout, equivalent to £65million, after her life was ruined following an operation
Ajury in a civil action in the state of Delaware found manufacturers Boston Scientific were negligent in the design of their Advantage Fit and Pinnacle mesh implants.
They also ruled the firm's warnings to unsuspecting doctors and their patients were insufficient.
The case is hugely significant to victims in Scotland as it is the first major payout involving a mesh used to treat stress urinary incontinence.
The jury awarded Deborah $25million in damages and added a further $75million in punitive damages, after hearing evidence that the company hid the flaws in their product.
Deborah, who had two implants fitted in 2009 to treat pelvic organ prolapse and stress urinary incontinence, said: "I hope my story can help other women who are suffering from mesh complications to receive the resolution they deserve."
Boston Scientific have not commented but it is understood they intend appealing the case.
Scotland suspended the use of mesh implants last June after a campaign by the Sunday Mail and Scottish Mesh Survivors.
More than 400 women have come forward to report crippling and life-changing injuries.
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Delaware woman wins $100m in transvaginal mesh case
May 29, 2015 | The Guardian
A Delaware jury has ordered a medical device manufacturer to pay $100m to a woman who, despite two surgeries, still has pieces of transvaginal mesh embedded inside her.
The News Journal of Wilmington reports the 51-year-old Newark woman was awarded damages on Thursday, following a two-week trial in superior court in Wilmington against Boston Scientific.
Court documents say the woman had transvaginal mesh inserts, a net-like product used to treat incontinence and sagging pelvic organs in women, implanted in May 2009. Since then, she has had complications, including urinary tract infections and pain during sex.
The jury found Boston Scientific failed to warn doctors and patients of the risk of the poorly designed inserts.
Boston Scientific spokeswoman Kelly Leadem says the company dedicates significant resources to ensure products are safe.
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Boston Scientific Hit With $100M Verdict in Pelvic Mesh Case
May 29, 2015 | Delaware Law Weekly
By Gina Passarella
A Delaware Superior Court jury in Wilmington awarded Thursday $100 million to a woman who experienced complications from transvaginal mesh implants made by Boston Scientific Corp.
The verdict, according to attorneys for plaintiff Deborah Barba, was composed of $25 million in compensatory damages and $75 million in punitive damages.
Barba's attorneys, Fred Thompson III and Fidelma Fitzpatrick of Motley Rice, said in a statement that the punitive damages award sends a message and, they hope, will cause Boston Scientific and other pelvic mesh manufacturers to settle other cases quickly.
Barba's case is one of thousands faced by manufacturers of pelvic mesh who have been sued over plaintiffs' complications from the mesh implants. Those complications have included pain, urinary problems, bleeding and organ perforation. Barba had to undergo two surgeries to repair her failed implant, but portions of the mesh still remain "painfully embedded" with little hope of being fully removed, her attorneys said.
There are nearly 17,000 cases that have been part of In re Boston Scientific Pelvic Repair System Products Liability Litigation, a multidistrict litigation in the Southern District of West Virginia. About 200 of those cases have been resolved. None originated from Delaware, while more than 400 have been brought into the MDL from the Eastern District of Pennsylvania. Several other state court cases are pending across the country. Between federal and state court actions, Boston Scientific is facing at least 24,000 cases, according to several media reports.
Boston Scientific announced last month that it allotted $119 million to settle close to 3,000 of the cases.
"The punitive damages the jury awarded in this verdict speak very boldly for themselves," Thompson said in a statement about Barba. "With all the evidence we presented, the jury chose the damages according to the irresponsible behavior it thought Boston Scientific demonstrated. We are pleased that Boston Scientific may finally be receiving the message about the dangers of its transvaginal mesh where it hurts most, its wallet."
A Boston Scientific spokeswoman said in an emailed statement that, “At Boston Scientific, patient safety is of the utmost importance and we dedicate significant resources to deliver safe, high-quality products. We strongly disagree with the jury’s finding and intend to appeal based on the strength of our evidence.”
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Boston Scientific to pay $100 million to Delaware woman
May 29, 2015 | Uncover Michigan
By Amy McClellan
On Thursday, a Delaware jury ordered Boston Scientific Corp. to pay $100 million to a woman who claimed she was injured by a device that is the subject of more than 25,000 lawsuits.
The verdict over Boston Scientific's transvaginal mesh inserts awarded 51-year-old Deborah Barba of Delaware $25 million in compensatory damages and $75 million in punitive damages.
According to Barba's lawsuit, which was filed in 2011, she was implanted with Boston Scientific's Pinnacle and Advantage Fit mesh products in 2009. It was done to pelvic organ prolapse and stress urinary incontinence.
However, she claimed the devices caused serious complications. She also underwent two subsequent surgeries to try to fix the problems. However, despite the surgeries, parts of the devices are still in her body and continue to give her pain.
According to Fidelma Fitzpatrick, one of Barba's lawyers, mesh complications had profoundly changed Barba's life. She just wanted that lawsuit's verdict would persuade Boston Scientific and other mesh makers to settle the remaining cases.
Jurors found that Boston Scientific had been negligent in designing and making the devices and had failed to warn patients and doctors about potential risks.
The verdict is the largest one in litigation over transvaginal mesh devices against any other mesh manufacturer. A Boston Scientific spokeswoman said the company strongly disagreed with the verdict and wants to appeal against it.
Last month, the company announced that it had reached agreements to pay about $119 million to resolve 2,970 cases about transvaginal mesh.
Vijay Kumar, an analyst at Evercore ISI in New York, said, "From a headline perspective, $100 million is a big number. It might make Boston Scientific rethink its litigation strategy. It might force the company to think about settling more of these claims".
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Jury in Delaware awards $100M to 51-year-old woman in transvaginal mesh case
May 29, 2015 | ABA Journal
By Martha Neil
Delaware is not a state known for big jury verdicts in individual personal injury cases.
But on Thursday a jury there awarded a 51-year-old former bank teller $25 million in compensatory damages and $75 million in punitives against Boston Scientific Corp. Deborah Barba said she suffered constant discomfort, urinary tract infections and painful sex—despite two corrective surgeries—because of being implanted with the company’s transvaginal mesh.
The verdict in the Delaware Superior Court case is the eighth-largest in the country so far this year and leaves in the dust a $73 million Texas jury verdict against Boston Scientific last year in another vaginal mesh case, Bloomberg reports. (The $73 million verdict was later reduced to $34 million, Reuters reports.)
A spokeswoman said Boston Scientific plans to appeal.
The punitive damages award, in particular, is surprising, law and business professor Erik Gordon of the University of Michigan told Bloomberg.
“Corporation-friendly Delaware juries rarely award punitive damages,” he said. “A good portion of Delaware’s economy is driven by its business of domiciling most of the country’s largest corporations.”
The cases in Delaware and Texas were among the earliest to be tried of some 100,000 vaginal mesh lawsuits, in state and federal court, against Boston Scientific, C.R. Bard and the Ethicon unit of Johnson & Johnson, Reuters reports.
Last month, Boston Scientific said the company would pay $119 million to settle nearly 3,000 of the suits.
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Boston Scientific ordered to pay $100 million to Delaware woman
May 30, 2015 | Maine News Online
By Tanya Campbell
Boston Scientific Corp. has been ordered by a Delaware jury to pay $100 million to a woman who got injured while using the company's transvaginal mesh inserts device that attracted thousands of lawsuits. Deborah Barba, 51, will receive$75 million in punitive damages and $25 million in compensatory damages.
According to Barba's lawsuit, which was filed in 2011, she was implanted with Boston Scientific's Pinnacle and Advantage Fit mesh products in 2009. It was done to pelvic organ prolapse and stress urinary incontinence.
However, she claimed the devices caused serious complications. She also underwent two subsequent surgeries to try to fix the problems. However, despite the surgeries, parts of the devices are still in her body and continue to give her pain.
According to Fidelma Fitzpatrick, one of Barba's lawyers, mesh complications had profoundly changed Barba's life. She just wanted that lawsuit's verdict would persuade Boston Scientific and other mesh makers to settle the remaining cases.
Jurors found that Boston Scientific had been negligent in designing and making the devices and had failed to warn patients and doctors about potential risks.
The verdict is the largest one in litigation over transvaginal mesh devices against any other mesh manufacturer. A Boston Scientific spokeswoman said the company strongly disagreed with the verdict and wants to appeal against it.
Last month, the company announced that it had reached agreements to pay about $119 million to resolve 2,970 cases about transvaginal mesh.
Vijay Kumar, an analyst at Evercore ISI in New York, said, "From a headline perspective, $100 million is a big number. It might make Boston Scientific rethink its litigation strategy. It might force the company to think about settling more of these claims".
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May 29, 2015 | The Wall Street Journal
By Ed Silverman
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, as you know, our treasured signal to daydream about weekend plans. Our agenda is, once again, rather modest. Our plans include tidying up around the castle, spending time with assorted short people and promenading the official mascots. And what about you? This is a delightful time of year to enjoy the great outdoors, you could plan some summer fun or simply catch up on the sundries of life. Whatever you do, have a grand time, but be safe. See you soon…
Merck submitted a new drug application to the FDA for an experimental drug combination to treat certain chronic hepatitis C patients, according to The Wall Street Journal. The combined tablet, which demonstrated a 95% cure rate in a late-stage study, poses a potential threat to Gilead Sciences, which analysts estimate raked in at least $12 billion in combined sales in 2014 from the blockbuster drug Sovaldi and the first all-oral combination drug, Harvoni.
Puma Bio is turning away some investors and at least one analyst from a company event scheduled during the annual American Society of Clinical Oncology meeting, TheStreet writes, adding that the restriction comes after Puma selectively disclosed important info to people deemed friendly to the company. Recently, Puma stock fell almost 20% after releasing an ASCO abstract with disappointing results about its breast cancer drug. Puma provided additional data not in the abstract to two analysts with positive stock ratings and they defended Puma in research notes.
Drug makers have not been paid by Greek hospitals and the government health insurance agency since December 2014 and are now owed more than $1.2 billion,Reuters reports, citing the European Federation of Pharmaceutical Industries and Associations. The rising unpaid bill reflects the growing struggle by the nearly bankrupt country to muster cash, and creates a dilemma for companies under moral pressure not to cut off supplies of life-saving medicines.
Lundbeck, which sells the Selincro treatment targeting alcohol cravings, ran a successful campaign to convince the European Parliament to push the European Commission to adopt a policy curbing the harmful effects from alcohol, Politicoreports. Among its tactics, the drug maker mobilized members of Parliament, anti-alcohol non-governmental organizations and academics, as well as groups representing patients with liver disease, some of which received grants.
The World Health Organization was asked by the World Health Assembly to probe the vaccines industry, particularly transparency around pricing, BioPharma Reporter tells us. The global agency was asked to look at barriers that can “undermine robust competition that can enable price reductions for new vaccines” and affect availability, but the WHO has yet to decide how to investigate if barriers to competition are preventing vaccine price cuts.
Claris Lifesciences’ plans to sell its generic sterile injectables business might hit a speed bump after one of its sites received an adverse observation letter from the FDA, The Business Standard says.
Cellectic shares hit an all-time high on hopes it would be the latest in a string of bid targets in the healthcare sector, after reported interest from companies including Pfizer,Reuters writes.
AstraZeneca and Eli Lilly will combine two of their cancer drugs in a new clinical trial against solid tumors in the latest sign that such cocktails may be the way forward in fighting the disease, Reuters informs us.
The China Food & Drug Administration jacked up its registration fees for medical devices and drugs to help it cope with a rising backlog of applications, MassDevice tells us.
Boston Scientific was ordered by a Delaware state court jury to pay $100 million to a woman who blamed its vaginal-mesh inserts for leaving her in constant pain and unable to have sex, Bloomberg News reports.
A U.S. district court has ruled that the Vascepa fish oil pill sold by Amarin is eligible for five years of marketing exclusivity, setting aside an FDA decision, according to Reuters.
The FDA asked manufacturers of dermal fillers to update their labeling to reflect the possible risk of serious injuries caused by unintentional injection of the fillers into the blood vessels in the face, Reuters says.
Otsuka Pharmaceutical officially lost its bid to prevent the FDA from allowing generic versions of its antipsychotic drug Abilify after a federal judge issued a final ruling,Reuters reports.
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