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Ethicon 4/29
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Boston Scientific inks $119m pelvic mesh deal
Apr 28, 2015 | Mass Device
...It is 1 of 7 companies, including Johnson & Johnson's (NYSE:JNJ) Ethicon unit and C.R. Bard (NYSE:BCR), which have also been hit with thousands of lawsuits over the products... -
Boston Sci partners with Brainlab, as revenue outlook goes flat and legal costs weigh
Apr 28, 2015 | Fierce Medical Devices
By Stacy Lawrence
...But the past keeps weighing upon it as litigation costs pile up from vaginal mesh lawsuits and the recent settlement with Johnson & Johnson ($JNJ) over the long-standing Guidant dispute... -
UPDATE 1-Boston Scientific reaches first transvaginal mesh settlement
Apr 28, 2015 | Reuters
By Susan Kelly
...It is one of seven companies, including Johnson & Johnson's Ethicon unit and C.R. Bard Inc, which have been hit with lawsuits over the products... -
Boston Scientific to pay $119 million to settle some mesh claims
Apr 28, 2015 |
By Lisa Schencker
Boston Scientific Corp. has agreed to pay $119 million to settle nearly 3,000 cases and claims over its transvaginal surgical mesh products, the company disclosed Tuesday in a filing with the Securities and Exchange Commission -
Strong dollar and lawsuits continue to weigh on Boston Scientific results
Apr 28, 2015 | Star Tribune
By Joe Carlson
Legal expenses and international currency headaches dragged down earnings at Boston Scientific Corp., but analysts and executives remain relatively upbeat on the medical device company’s underlying sales and future outlook. -
*New* Boston Scientific Offers First Settlement to 3,000 Pelvic Mesh-Injured Women
Apr 28, 2015 | Mesh Medical Device News Desk
By Jane Akre
In a regulatory filing (here), Boston Scientific Corp announced today it’s reached a settlement of $119 million to resolve 2,970 product liability cases concerning pelvic mesh. -
*New* May Brings Two Defective Mesh Trials Naming Boston Scientific
Apr 28, 2015 | Mesh Medical Device News Desk
By Jane Akre
...Boston Scientific along with C.R. Bard, Ethicon (Johnson & Johnson) Coloplast and Cook have been called to a status conference before Judge Joseph Goodwin June 2, 2015 to update any efforts to reach settlement in the outstanding product liability actions...
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Boston Scientific inks $119m pelvic mesh deal
Apr 28, 2015 | Mass Device
Boston Scientific (NYSE:BSX) today said it reached its 1st settlement agreement to resolve a portion of the legal claims it faces involving its transvaginal mesh products to treat urinary incontinence.
The medical device maker, in a regulatory filing, said it expects to pay about $119 million to resolve 2,970 cases.
The Marlborough, Mass.-based company said it faces more than 25,000 mesh claims in total in U.S. federal and state courts. Last November, it lost its 1st 2 federal trials, in West Virginia and Miami.
The new agreement includes a case in the district court of Dallas County, Texas, for which there is a judgment of about $35 million that is subject to appeal, Boston Scientific said.
The agreement doesn't include an admission of liability or wrongdoing, the company said, adding it will complete payment of settlement funds into an escrow account by Oct. 1. It's also establishing a procedure for claimants to participate in the settlement.
In the Miami case, Boston Scientific was ordered to pay $26.7 million to 4 women after a federal court jury found the company liable for selling faulty transvaginal mesh devices. Plaintiffs said they suffered pain, bleeding and infection from the company's Pinnacle device.
In West Virginia, a federal jury returned an $18.5 million verdict against Boston Scientific involving claims of injuries caused by mesh devices.
Boston Scientific has fought back against claims that the devices are defective or were to blame for the women's complications. It won its 1st 2 mesh trials in Massachusetts state court.
It is 1 of 7 companies, including Johnson & Johnson's (NYSE:JNJ) Ethicon unit and C.R. Bard(NYSE:BCR), which have also been hit with thousands of lawsuits over the products.
Boston Scientific shares were down 0.7% at $17.86 in early afternoon trading on the New York Stock Excha
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Boston Sci partners with Brainlab, as revenue outlook goes flat and legal costs weigh
Apr 28, 2015 | Fierce Medical Devices
By Stacy Lawrence
Boston Scientific ($BSX) is looking determinedly toward the future with a new partnership with deep brain stimulation player Brainlab and positive data for its peripheral artery disease (PAD) drug-eluting stent. But the past keeps weighing upon it as litigation costs pile up from vaginal mesh lawsuits and the recent settlement with Johnson & Johnson ($JNJ) over the long-standing Guidant dispute.
In addition, the company had to reel in revenue guidance for the year, so that it expects to have only flat or decreasing revenues in 2015. It expects to have 2015 revenues of $7.225 to $7.375 billion, down from prior guidance of $7.3 billion to $7.5 billion. It also reduced its GAAP EPS estimate to $0.32 to $0.38 from $0.42 to $0.48.
And the legal costs are piling up. In February, Boston Scientific said it would pay J&J $600 million to settle a lawsuit over the acquisition of Guidant in 2005. The first $300 million installment was paid in April, with the remainder already accounted for in the $1.45 billion legal reserve that Boston Scientific had set aside as of March 31. The second $300 million payment is due on or before Oct. 1.
In addition, Boston Scientific disclosed that it has settled about 2,790 vaginal mesh cases and claims for about $119 million. Last quarter, it paid $193 million in litigation-related charges that were mostly due to bolstering its reserves for the vaginal surgical mesh lawsuits.
Investors were displeased, sending Boston Scientific shares down 2% in early trading on the April 28 earnings news.
The company tried to lighten the burden of all this bad news by also highlighting a new partnership and fresh data. Boston Scientific will sell the deep brain stimulation (DBS) products from Brainlab. Specifically, it will distribute the Brainlab DBS surgical planning software portfolio with its Vercise DBS System in undisclosed countries.
"We have a terrific Spinal Cord Stimulation business, we're very early with what we think is a disruptive deep brain stimulation portfolio that we're enrolling the IDE trial now in the U.S. and we're approved in Europe, but we don't have as much scale in the neuro industry," explained Boston Scientific President and CEO Michael Mahoney on an earnings conference call.
He added, "Brainlab has an excellent relationship with neurosurgeons. They have excellent guidance and mapping capabilities, so they would prove to be a smart distributor for us to align with to help build our commercial capabilities and broaden the depth of that portfolio."
As for the PAD data, Boston Scientific said that its Eluvia Drug-Eluting Vascular Stent System met the primary endpoint with more than 94% of lesions remaining open 9 months after implantation with a target lesion revascularization rate of 3.6%.Eluvia is the first stent built for the superficial femoral artery that uses a polymer and paclitaxel combination for sustained drug release to reduce restenosis, according to the company.
"You saw the breakthrough results in our early results of our drug-eluting stent trial in terms of patency rates, but we feel like the Bard alliance is a great complement to that," Mahoney said on the call. In February, Boston Scientific partnered with C.R. Bard ($BCR) to sell its Lutonix drug-coated balloon to treat PAD.
It's been a very busy year for Boston Scientific, which also in March received a long-pursued approval for its Watchman Left Atrial Appendage Closure Device to reduce stroke risk in atrial fibrillation patients and agreed to acquire the urology portfolio from Endo ($ENDP) for up to $1.65 billion.
Wall Street has largely approved of the company's big moves--sending its share price up by almost one-third so far this year.
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UPDATE 1-Boston Scientific reaches first transvaginal mesh settlement
Apr 28, 2015 | Reuters
By Susan Kelly
Boston Scientific Corp on Tuesday said it reached its first settlement agreement to resolve a portion of the legal claims it faces involving its transvaginal mesh product to treat urinary incontinence.
The medical device maker, in a regulatory filing, said it expects to pay about $119 million to resolve 2,970 cases.
The Marlborough, Massachusetts-based company said it faces more than 25,000 mesh claims in total in U.S. federal and state courts. In November, it lost its first two federal trials, in West Virginia and Miami.
The new agreement includes a case in the district court of Dallas County, Texas, for which there is a judgment of about $35 million that is subject to appeal, Boston Scientific said.
The agreement does not constitute an admission of liability or wrongdoing, the company said, adding it will complete payment of settlement funds into an escrow account by Oct. 1. It is also establishing a procedure for claimants to participate in the settlement.
In the Miami case, Boston Scientific was ordered to pay $26.7 million to four women after a federal court jury found the company liable for selling faulty transvaginal mesh devices. Plaintiffs said they suffered pain, bleeding and infection from the company's Pinnacle device.
In West Virginia, a federal jury returned an $18.5 million verdict against Boston Scientific involving claims of injuries caused by mesh devices.
Boston Scientific has fought back against claims that the devices are defective or were to blame for the women's complications. It won its first two mesh trials in Massachusetts state court.
It is one of seven companies, including Johnson & Johnson's Ethicon unit and C.R. Bard Inc, which have been hit with lawsuits over the products.
Boston Scientific shares were down 0.7 percent at $17.86 in early afternoon trading on the New York Stock Exchange. (Reporting by Susan Kelly in Chicago; editing by Nick Zieminski, G Crosse)
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Boston Scientific to pay $119 million to settle some mesh claims
Apr 28, 2015 |
By Lisa Schencker
Boston Scientific Corp. has agreed to pay $119 million to settle nearly 3,000 cases and claims over its transvaginal surgical mesh products, the company disclosed Tuesday in a filing with the Securities and Exchange Commission.
Marlborough, Mass.-based Boston Scientific said in the SEC filing it reached the tentative settlement agreement “solely by way of compromise” and the agreement “does not constitute an admission or concession by the company of any liability or wrongdoing.”
Patients have alleged they were injured by the mesh products—which are meant to treat stress urinary incontinence and pelvic organ prolapse. As of February, more than 25,000 product liability cases or claims regarding the mesh products had been made against the company, according to Boston Scientific filings.
Boston Scientific spokesperson Kelly Leadem said in an e-mail Tuesday that when it comes to those other cases and claims, the company continues to look at all of its options.
"If there are opportunities to settle cases at reasonable terms in the future, then we will consider settling," Leadem wrote. "Otherwise, we will continue to contest these claims vigorously."
The settlement announced Tuesday includes, among the 2,970 cases and claims it resolves, a case in the District Court of Dallas County in Texas for which there has been a judgment of about $35 million that is subject to appeal. -
Strong dollar and lawsuits continue to weigh on Boston Scientific results
Apr 28, 2015 | Star Tribune
By Joe Carlson
Legal expenses and international currency headaches dragged down earnings at Boston Scientific Corp., but analysts and executives remain relatively upbeat on the medical device company’s underlying sales and future outlook.
Boston Scientific, which employs more than 5,000 people in the state, has amassed a litigation reserve of about $1.1 billion to cover its outstanding legal expenses. That includes $119 million to settle claims from nearly 3,000 women who say they were injured by the company’s vaginal mesh products for urinary incontinence and pelvic organ prolapse.
Assuming the plaintiffs accept the settlement offer revealed Tuesday in securities filings, Boston Scientific will still face active claims from another 22,000 women who say they were injured by the same devices. Chief Executive Michael Mahoney said the company will work to settle many of those cases, too.
“It will take some time. We haven’t publicly discussed it, but it will likely take place over the next 24 months,” Mahoney said in an interview. “We continue to try cases as appropriate, but we’re open to settling specific cases if it makes sense, and if we think it’s fair and justifiable.”
But in the quarter that ended March 31, it was a $600 million settlement with health care’s largest company, Johnson and Johnson, that hit Boston Scientific’s earnings. The two companies settled a decade-old lawsuit Feb. 17, just before a verdict was expected on J&J’s claim that Boston Scientific’s heart-device subsidiary Guidant violated the terms of a confidentiality agreement during a bidding war to acquire Guidant in 2006. J&J had asked for more than $7 billion in damages and interest.
On Tuesday, shares in Boston Scientific dropped 23 cents, or about 1 percent, closing at $17.75.
The company met analyst expectations by reporting adjusted earnings of 21 cents per share for the first quarter. By adjusting the figures to remove the effects of international currency fluctuations, the company reported sales growth of 6 percent compared with the same period last year.
Sales of cardiovascular devices, the company’s largest division, rose 10 percent to $712 million on an adjusted basis. Sales of neuromodulation devices that interact directly with the central nervous system rose an adjusted 6 percent to $114 million.
Analysts at Leerink Partners noted that it was the third consecutive quarter of growth of at least 6 percent, after adjusting for currencies. “BSX continued its sales turnaround story, delivering meaningful growth acceleration,” Leerink analysts wrote, using Boston Scientific’s stock ticker abbreviation.
But like many U.S.-based companies with significant sales overseas, the financial picture was much less rosy without adjusting for the way that the strong dollar makes sales in other currencies appear smaller on paper.
Unadjusted sales were flat at $1.77 billion compared with the year-ago period, causing the company to report a $1 million loss for the quarter compared with net income of $133 million for the comparable period last year.
The company lowered its revenue expectation for the year, based partly on worse-than-expected challenges from currencies. It now expects revenue of as much as $7.3 billion for the year, down from previous guidance of up to $7.5 billion.
“The underlying strength of the company is very strong. But currency is a nearly $500 million head wind in sales, and about a 6- to 7-cent earnings-per-share head wind” for the full year, Mahoney said.
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*New* Boston Scientific Offers First Settlement to 3,000 Pelvic Mesh-Injured Women
Apr 28, 2015 | Mesh Medical Device News Desk
By Jane Akre
In a regulatory filing (here), Boston Scientific Corp announced today it’s reached a settlement of $119 million to resolve 2,970 product liability cases concerning pelvic mesh.
That would amount to an average award of just $40,000 per claim. Claims are generally awarded based on the degree of injury resulting from a pelvic mesh implant so an award could amount to more or less than that number.
This does not resolve the bulk of the 25,000 cases filed in U.S. and federal state courts but it would include the Martha Salazar case which resulted in a $35 million award against the company last year.
There is no admission of liability or wrongdoing if an agreement is reached reports Reuters. The funds could be set aside in an escrow account by October 1.
Here is the portion of the SEC report:
ITEM 8.01. OTHER EVENTS
On April 28, 2015, the Company announced that it reached an agreement with certain plaintiffs’ counsel to settle substantially all of their inventories of product liability cases and claims pending against the Company related to transvaginal surgical mesh products designed to treat stress urinary incontinence and pelvic organ prolapse. This settlement has been memorialized in a Master Settlement Agreement (the “Agreement”), which was entered into solely by way of compromise and does not constitute an admission or concession by the Company of any liability or wrongdoing. The Agreement provides that the Company will pay approximately $119 million to resolve 2,970 cases and claims, including a case in the District Court of Dallas County (TX) for which there is a judgment of approximately $35 million that is currently subject to appeal. Under the terms of the Agreement, the Company will make two payments into a settlement fund held in escrow with full funding to be completed on or before October 1, 2015. The Agreement establishes a procedure for claimants to participate in the settlement. The settlement and the distribution of settlement funds to participating claimants are conditioned upon, among other things, achieving minimum required claimant participation thresholds. If the participation thresholds are not satisfied, the Company may terminate the Agreement.
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*New* May Brings Two Defective Mesh Trials Naming Boston Scientific
Apr 28, 2015 | Mesh Medical Device News Desk
By Jane Akre
Add these two upcoming cases to your mesh calendar.
Sanchez Trial
On May 5th in a federal court in Los Angeles, Roseanne Sanchez will take her product liability case against Boston Scientific before a jury. The Honorable John F. Walter of the Central District of California will oversee the five-day trial. (Sanchez v. Boston Scientific 2:12-cv-05762)
Roseanne Sanchez was implanted with a Boston Scientific Pinnacle Pelvic Floor Repair Kit.
Her attorneys are Scott Love of Clark, Love Hutson of Houston, TX and Jim Perdue (Perdue Kidd). Both law firms won a $28 million award for four plaintiffs last November in a Miami federal courtroom.
In that case, each woman, also implanted with the Pinnacle Pelvic Mesh Repair Kit, was awarded between $6.5 and 6.7 million. The case is on appeal. See Mesh News Nov 13, 2014, where the jury decided:
The nine-person jury decided the Pinnacle was defectively designed and its instruction to physicians were also defective; that the company was negligent and failed to warn patients about the dangers of the Pinnacle.
Barba Trial
Motley Rice attorney Fidelma Fitzpatrick will try the case of Deborah Barba v. Boston ScientificMay 11th in a Delaware court. Deborah Barba was implanted with a Boston Scientific Pinnaclemesh as well as an Advantage Fit retropubic sling. She has since had two revision surgeries.
Her trial will be in in Superior Court of New Castle Co. Delaware before Judge Mary M. Johnston and should take approximately two weeks. (Barba v. Boston Scientific No. N11C-08-050 MMJ).
*New* Today in a regulatory filing, (here) Boston Scientific announced its reached a settlement of $119 million to resolve 2,970 pelvic mesh cases. There will be no admission of liability if an agreement is reached. This would be the first mesh settlement offered by the company. See theMesh News Desk story here.
The funds could be set aside in an escrow account by October 1.
Background
Boston Scientific has seen mixed results in the courtroom over its pelvic mesh products.
In November, four women implanted with the Boston Scientific Obtryx mesh, a mid-urethral sling to treat incontinence, were together awarded $18.5 million by a West Virginia jury. (Tyree v. Boston Scientific, 2:12-cv-08633).
The jurors decided in each case the Obtryx mesh was defectively designed, the instructions to physicians were insufficient and the company was negligent in its manufacture of the Obtryx. Each woman was awarded an additional $1 million in punitive damages. See Mesh News Desk storyhere.
Last September in a Dallas courtroom, the jury awarded Martha Salazar $73.5 million for the injuries she received from the Obtryx Mid-Urethral Sling. That amount was later reduced by half under state caps. Story here.
Maria Cardenas lost her product liability trial to Boston Scientific last August in the Massachusetts Superior Court of Middlesex County. (No. 12-02912). See the Mesh News Desk story here.
Reportedly, her lawyers were not allowed to introduce to the jury the Material Safety Data Sheet. That is a breakdown of raw materials that is issued by petroleum companies that sell the raw resin used to make a polypropylene pelvic mesh implant, in her case the Obtryx pelvic mesh. It contains a warning the resin is not to be used to make an implantable medical device. See background storyhere.
The Obtryx remains on the market
In July, 2014, the company won its first bellwether case in Albright v. Boston Scientific. Ms. Albright was also implanted with the Pinnacle mesh. See her story here. Mesh News Deskreported August 4, 2014 the problems with the Albright case (Albright v. Boston Scientific No. 12-0909) here.
Since then Judge Diane Kottmyer has retired from the federal bench in Middlesex Co. Mass., the headquarters of Boston Scientific.
The Pinnacle Pelvic Floor Repair Kit is no longer on the market in the U.S.
Boston Scientific used polypropylene mesh known as Marlex to make its pelvic mesh implants to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The Pinnacle Pelvic Floor Repair Kit was the largest among all mesh kits ever made among all manufacturers to treat POP. It was voluntarily recalled from the market by Boston Scientific in 2011.
On May 10, 2011, Boston Scientific sent an “URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED” letter to all affected customers concerning its Class 2 recall for the Pinnacle Pelvic Floor Repair Kit because ‘the device may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.”
There are more than 1,000 pelvic mesh cases filed in Massachusetts naming Boston Scientific and 16,664 filed in federal court in Charleston West Virginia (here)
where 75,000 cases against seven manufacturers have been consolidated.Boston Scientific along with C.R. Bard, Ethicon (Johnson & Johnson) Coloplast and Cook have been called to a status conference before Judge Joseph Goodwin June 2, 2015 to update any efforts to reach settlement in the outstanding product liability actions. See Judge Goodwin’s order here. #
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