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Ethicon feb 5
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J&J to Pay $120 Million to Settle Thousands of Vaginal Mesh Lawsuits
Feb 4, 2016 | New Brunswick Today
By Dave Schatz
Johnson & Johnson (J&J) has made a serious move to settle thousands of lawsuits filed by women who assert they suffered injuries from vaginal mesh inserts made by its Ethicon subsidiary, according to a report from Bloomberg. The settlement offer, said to be more than $120 million, would resolve between 2,000 to 3,000 law suits over the... -
Boston Scientific, C.R. Bard Win Defense Verdicts In Mesh Trial
Feb 4, 2016 | Reuters
By Jessica Dye
A Missouri jury has cleared medical device manufacturers Boston Scientific and C.R. Bard of liability in the first trial involving a woman who said she was injured by transvaginal mesh devices made by more than one company. Following a two-month trial in Jackson County, Missouri, jurors voted 10-2 on Tuesday to return a double... -
Steven Mostyn's Clients Win Order in Pelvic Mesh Case
Feb 4, 2016 | Texas Lawyer
By Miriam Rozen
In the 55th District Court in Houston, Judge Jaclanel McFarland issued an order barring Boston Scientific, the medical equipment and devices company, from disposing or altering supplies of a resin material allegedly used in surgical vaginal mesh products. McFarland set a hearing for Feb. 13 on a proposed temporary ... -
Heart Devices Dent Quarterly Revenue As Boston Scientific Looks For Growth In 2016
Feb 4, 2016 | Star Tribune
By Joe Carlson
A worse-than-expected dip in sales of pacemakers and implantable defibrillators is leaving its mark on Boston Scientific, but the situation is expected to improve for the device maker later this year with new product launches. The Massachusetts-based med-tech manufacturer, which employs more than 5,000 people in Plymouth and Arden Hills... -
Royston Mesh Slinger Is ‘So Pleased’ That Campaign To End Painful Operation Is Taken To Westminster
Feb 4, 2016 | Royston Crow
By Rebecca Day
Real life stories of how women have gone from being healthy and active to suffering terrible pain were shared at the Westminster summit on the devastating consequences of TVT mesh surgery. The issue was brought to the attention of MPs by campaign group Sling The Mesh, launched last year by journalist Kath ...
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J&J to Pay $120 Million to Settle Thousands of Vaginal Mesh Lawsuits
Feb 4, 2016 | New Brunswick Today
By Dave Schatz
Johnson & Johnson (J&J) has made a serious move to settle thousands of lawsuits filed by women who assert they suffered injuries from vaginal mesh inserts made by its Ethicon subsidiary, according to a report from Bloomberg.
The settlement offer, said to be more than $120 million, would resolve between 2,000 to 3,000 law suits over the inserts, according to Bloomberg, which notes it is the “first big mesh settlement” for the Hub City-based medical-device manufacturer.
The “suits [allege] women suffered organ damage and were left in constant pain by mesh surgical inserts that eroded in their bodies, according to three people who asked not to be named because they weren’t authorized to speak publicly about the settlement,” wrote Bloomberg.
The total amount breaks down to about $40,000 to $60,000 per case, before legal fees and outstanding debt.
"This would not even touch the expenses most of us have incurred," wrote one commenter on the article. "I myself have already had 9 surgeries to date then the care for the rest of my life for the continual pain. Easy way out Johnson and Johnson!!"
"J&J needs to be charged criminally, Offering 40,000 is nothing," wrote another person, who appeared to be a victim of the company's product.
"My life as a woman is over and besides the pain, humiliation and depression I know i have to be repaired at some point.... J&J destroyed so many lives, even preyed on children.. How many more lives need to be trashed before people get a clue and shut them down. And how long will the judicial system let them make a joke of all of it.
Ethicon is one of the corporate giant's subsidiaries that is facing numerous product liability claims and lawsuits.
Many products are involved, and the claimants "seek substantial compensatory and, where available, punitive damages," J&J said in a regulatory filing.
J&J said in its most recent quarterly report, for the period ending September 27, that "The number of pending product liability lawsuits continues to increase, and [J&J] continues to receive information with respect to potential costs and the anticipated number of cases."
But, “[J&J] has established an accrual with respect to product liability litigation associated with Ethicon's pelvic mesh products,” according to the filing.
It added that cases filed in U.S. federal courts are organized as mulit-district litigation in the U.S. District Court for the Southern District of West Virginia (In Re Ethicon Inc. Pelvic Repair System Products Liability Litigation, docket #12-MDL-2327, U.S. District Court, Southern District of West Virginia)
Still, J&J is up against another 42,400 similar cases, according to a regulatory filing.
“It’s unclear what J&J’s exposure will be after those suits are resolved through verdicts, settlements or dismissals because average payouts will vary,” wrote Bloomberg.
“From time to time we have appropriately agreed to resolve some cases,” J&J spokesman, Ernie Knewitz, said in an e-mailed statement.
“We will not discuss the terms, nor discuss our ongoing litigation strategy."
J&J did not disclose the amount of a designated “reserve” fund, for pay-outs in the mesh cases and other product-liability claims, according to its October Securities and Exchange Commission filing.
And the company has played down the financial risk from the vaginal mesh cases, while incurring costly legal expenses.
The company says it spent “$141 million in total litigation expenses in 2015, down from $1.2 billion in 2014 legal costs and $2.2 billion in 2013,” according to the Bloomberg report.
“J&J still has a ton of cases to deal with, but this settlement may encourage other lawyers to consider taking their offer,” Carl Tobias, a product-liability law professor, at the University of Richmond in Virginia, told Bloomberg.
"While other mesh manufacturers such as American Medical Systems and C.R. Bard have agreed to settle its outstanding product liability actions regarding pelvic mesh, J&J has not done so to date until the eve of a jury trial or, in one case, just as the case was about to go to the jury," reads a report from the Mesh Medical Device News Desk.
J&J's Ethicon unit has the most pelvic mesh cases consolidated in federal court in Charleston, West Virgiania -- more than 30,500. And that number does not include similar cases filed in: Australia, Belgium, Canada, England, Israel, Italy, the Netherlands, Scotland and Venezuela.
Almost four years ago the company quietly removed four meshes from the market. One was the Prolift, a large mesh used to treat pelvic organ prolapse, reportedly the most difficult to remove.
The company recently announced it is restructuring its medical device division and cutting 3,000 jobs after lower than expected sales.
J&J's annual shareholders meeting will take place April 28 in New Brunswick.
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Boston Scientific, C.R. Bard Win Defense Verdicts In Mesh Trial
Feb 4, 2016 | Reuters
By Jessica Dye
A Missouri jury has cleared medical device manufacturers Boston Scientific and C.R. Bard of liability in the first trial involving a woman who said she was injured by transvaginal mesh devices made by more than one company.
Following a two-month trial in Jackson County, Missouri, jurors voted 10-2 on Tuesday to return a double defense verdict in the 2012 lawsuit brought by Eve Sherrer, who was implanted with Boston Scientific' s Solyx device and Bard's Align to treat stress urinary incontinence. Reuters viewed the proceedings on Courtroom View Network.
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Steven Mostyn's Clients Win Order in Pelvic Mesh Case
Feb 4, 2016 | Texas Lawyer
By Miriam Rozen
In the 55th District Court in Houston, Judge Jaclanel McFarland issued an order barring Boston Scientific, the medical equipment and devices company, from disposing or altering supplies of a resin material allegedly used in surgical vaginal mesh products.
McFarland set a hearing for Feb. 13 on a proposed temporary restraining order that would extend the order.
Steven Mostyn and his Houston-based firm Mostyn Law represent the plaintiffs who asked McFarland to issue the order. Steven Mostyn's clients have filed racketeering and negligence allegations against Boston Scientific in two companion lawsuits, the one in the Houston court and another in a Charleston, West Virginia, federal court.
According to the Mostyn firm, the plaintiffs are women who have suffered severe discomfort, infections and other complications from plastic mesh implants used to treat a variety of medical issues.
Tom Keppeler, a spokesman for Boston Scientific, wrote in an email: "This is an unnecessary legal maneuver."
Keppeler said the company had no intention to destroy or alter evidence, regardless of the ruling.
Amber Mostyn, a shareholder in the Mostyn firm, wrote in an email that there are approximately a thousand cases of women who received the vaginal mesh during the time that the material in question was allegedly used.
"Mostyn Law will be filing claims for those women in the best venue for those particular clients based on their residences and the respective laws of their states," Amber Mostyn said.
"Ultimately, Mostyn Law will use whatever remedies are available to the women harmed by Boston Scientific until Boston Scientific either voluntarily agrees to take this product off of the market or it is forced to," she added.
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Heart Devices Dent Quarterly Revenue As Boston Scientific Looks For Growth In 2016
Feb 4, 2016 | Star Tribune
By Joe Carlson
A worse-than-expected dip in sales of pacemakers and implantable defibrillators is leaving its mark on Boston Scientific, but the situation is expected to improve for the device maker later this year with new product launches.
The Massachusetts-based med-tech manufacturer, which employs more than 5,000 people in Plymouth and Arden Hills, saw its stock price fall more than 3 percent at one point Thursday after announcing that revenue from heart-rhythm devices fell short of expectations for the quarter.
The Cardiac Rhythm Management division was the only one at the company to see a sales decline in the quarter.
Boston Scientific reported $1.98 billion in total sales for the quarter that ended Dec. 31, which was 5 percent higher than the same period last year after removing the effect of acquisitions and divested businesses, which is known as organic growth.
“Our overall performance as a company was quite good,” Chief Executive Mike Mahoney said. “We grew at 5 percent organically and about 10 percent per quarter with the impact of acquisitions. CRM was a little bit slower, and that was in line with what we thought it would be.”
Analysts had been expecting the sales of pacemakers and defibrillators to slip by about 2 percent during the quarter. Instead, the tally fell by about 6 percent, to $440 million during the quarter. CEO Mike Mahoney said he expected the Cardiac Rhythm Management division to slip in 2015 and rebound in 2016.
Boston Scientific executives had predicted the sales decline, following Medtronic’s launch of pacemakers and defibrillators that are compatible with magnetic resonance imaging scanners. St. Jude Medical, in Little Canada, has reported a similar slowdown in its non-MRI-compatible heart-rhythm machines.
Mahoney said Boston Scientific plans to launch a MRI-safe pacemaker system in the second quarter of 2016, among other product approvals are expected later in the year that will benefit the division.
For the fourth quarter 2015, the company reported a net loss of $142 million. But that includes the effect of setting aside $456 million during the period for increased legal expenses.
In late January, the Court of Special Appeals of Maryland declined Boston Scientific’s appeal to throw out a jury verdict for unpaid royalties totaling $309 million. The verdict went in favor of Mirowski Family Ventures, LLC, a group that receives royalties allegedly owed to Dr. Michel Mirowski, the now-deceased owner of the patent to the implantable defibrillator.
Boston Scientific also set aside an undisclosed amount to cover potential settlement costs related to some of the 35,000 lawsuits filed against the company by women who say they were injured by its pelvic-mesh products.
More than 135,000 such lawsuits have been filed against a half-dozen companies that sell the devices. Boston Scientific now has $1.9 billion in accumulated legal reserves.
Removing the fourth-quarter expenses related to litigation, debt payments, and changes from acquisitions and divestitures, the company reported adjusted net income of $362 million for the quarter, which was about 10 percent higher than the same period last year. On a per share basis, the company’s adjusted earnings of 26 cents was a penny above what analysts had been expecting.
For the full year of 2016, the company is projecting between $7.9 billion and $8.1 billion in revenue, which would represent growth of 6 to 8 percent.
That would compare with 2015 net sales of $7.5 billion, which was 8 percent growth over the prior year.
The company predicts adjusted earnings per share in a range of $1.03 to $1.07 for 2016. Adjusted earnings per share were 93 cents last year, 10 percent above the prior year.
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Royston Mesh Slinger Is ‘So Pleased’ That Campaign To End Painful Operation Is Taken To Westminster
Feb 4, 2016 | Royston Crow
By Rebecca Day
Real life stories of how women have gone from being healthy and active to suffering terrible pain were shared at the Westminster summit on the devastating consequences of TVT mesh surgery.
The issue was brought to the attention of MPs by campaign group Sling The Mesh, launched last year by journalist Kath Sansom.
Anne Cook from Royston, who bravely shared her story in order to prevent others from suffering the same fate, said: “I am so pleased that the issue is being highlighted in parliament so that hopefully more women are aware of the risks involved with mesh slings.
“My mesh pain, problems that I have suffered, medication that I still have to take for the pain I am left with and the need for two further corrective surgeries must have cost the NHS a fortune. Such great risks are not worth it.”
Ten action points were outlined at the meeting, as part of a pledge to look at problems with the NHS operation – which is used to treat incontinence, often caused by childbirth.
The operation involves putting a mesh tape made of the same plastic used in drinks bottles under the urethra to keep it in place. After six weeks the mesh knits itself into live tissue.
Issues discussed at the summit included the need for better information on the NHS website, the creation of a national register to track the number of women with mesh implant problems – figures currently rely on women reporting it themselves – and the possibility of upping the device to a higher risk category so it needs stricter testing.
North East Cambs MP Steve Barclay spearheaded the parliamentary meeting.
He said: “This is not about party politics – this is about getting the right care for women.
“Kath deserves huge credit for the work she has done to raise awareness of the risks involved when vaginal mesh implants go wrong and, following my meeting with Professor Keith Willett in the summer at the House of Commons, it was great this time to have the benefit of Kath’s input and first-hand experience.”
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