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4th Circ. Upholds J&J Win In Vaginal Mesh Bellwether Case
Mar 2, 2015 | Law360
By Kurt Orzeck
The Fourth Circuit on Monday refused to undo Johnson & Johnson subsidiary Ethicon Inc.’s win in the first bellwether case in multidistrict litigation over alleged transvaginal mesh injuries... -
4th Circuit upholds Ethicon win in federal mesh bellwether
Mar 2, 2015 | Jessica Dye
By Jessica Dye
A U.S. appeals court has affirmed a win for Johnson & Johnson's Ethicon Inc in its first federal trial over transvaginal mesh -
Call to Halt Mesh Implant Ops
Mar 2, 2015 | The Scotsman
Ms Robison will write to NHS boards after it emerged that some are continuing to perform the procedure despite a call for a moratorium by her predecessor Alex Neil in June last year.S -
Week Ahead in Products Liability: March 2, 2015
Mar 2, 2015 | Reuters
By Jessica Dye
A bellwether trial is scheduled to begin today in the U.S. District Court for the Southern District of West Virginia for multidistrict litigation against Johnson & Johnson's Ethicon Inc over transvaginal mesh -
Press Release: Support for Mesh Implant Survivors
Mar 1, 2015 | The Scottish Government
Health Secretary Shona Robison has confirmed the Scottish Government will provide specialist support via NHS 24 for women affected by mesh implants. -
Defense Closing and Rebuttal in Perry v. Ethicon Pelvic Mesh Trial in Hands of Jury
Mar 2, 2015 | Mesh Medical Device News Desk
By Jane Akre
On Thursday, February 26, Perry v. Ethicon went to the jury. After a five-week trial, jurors will decide if the Abbrevo mini-sling, used to treat incontinence was defectively designed and whether the instructions to doctors were adequate. -
Boston Scientific To Pay $1.6B For Endo Urology Portfolio
Mar 2, 2015 | Law 360
By Linda Chiem
...The deal, however, does not include AMS’ women’s health business, which develops products for treating pelvic organ prolapse and female stress urinary incontinence... -
Boston Sci to acquire Endo's men's health devices for $1.6B
Mar 2, 2015 | Fierce Medical Devices
By Varun Saxena
...Crucially, it won't include Endo's women's health devices, such as transvaginal mesh. The mesh (including Boston Scientific's) turned out to have dangerous side effects. Endo agreed to set aside about $1.6 billion to resolve the claims related to its vaginal mesh implants...
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Online Sources
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4th Circ. Upholds J&J Win In Vaginal Mesh Bellwether Case
Mar 2, 2015 | Law360
By Kurt Orzeck
The Fourth Circuit on Monday refused to undo Johnson & Johnson subsidiary Ethicon Inc.’s win in the first bellwether case in multidistrict litigation over alleged transvaginal mesh injuries, saying there wasn’t enough evidence linking them to Ethicon’s TVT pelvic mesh product.
In a per curiam opinion, the appeals judges said plaintiff Carolyn Lewis didn’t sufficiently show that a different warning by Ethicon as to the TVT’s alleged risks would have changed her doctor’s decision to prescribe the device. It thus denied Lewis’ appeal of a lower court’s ruling that granted summary judgment to Ethicon on her failure-to-warn claim.
After a lower court judge in January of last year tossed the failure-to-warn claim, the plaintiff argued on appeal in August that, if Ethicon had provided stronger warnings, her physician would have passed them on to Lewis, who would have chosen not to have the device implanted.
But the Fourth Circuit said Monday that the physician had testified that she didn’t rely on Ethicon’s instructions for use in prescribing the TVT.
“When a physician relies on her own experience and examination of a patient in deciding to prescribe a device, and not on the device’s warning, the warning is not the cause of the patient’s injury,” the appeals judges said.
In 2009, Lewis’ urogynecologist diagnosed her with stress urinary incontinence, which causes urine leakage during physical exertion, according to court papers. In October of that year, the doctor implanted the TVT to correct the incontinence.
After the plaintiff allegedly suffered pain during sexual activity and developed intermittent pelvic pain, she had parts of the TVT removed, court filings said. Lewis’ pain allegedly decreased but didn’t completely go away.
After a district court granted summary judgment to Ethicon on Lewis’ failure-to-warn claim, the case went to trial on her remaining claims, court documents said.
In addition to affirming the lower court’s granting of summary judgment on plaintiff’s failure-to-warn claim, the Fourth Circuit on Monday upheld the court’s judgment as a matter of law on her claim that a design defect in the TVT caused her chronic pelvis pain. The appeals judges determined that Lewis didn’t offer any expert testimony to back the doomed claim.
Ethicon spokesman Matthew Johnson told Law360 on Monday that the Fourth Circuit’s decision was consistent with the law and the facts of the case.
“While we are always concerned when a patient experiences an adverse medical condition, TVT continues to be a safe and effective option for women suffering from the debilitating effects of stress urinary incontinence,” he said.
An attorney for the plaintiffs declined immediate comment Monday.
Circuit Judges Diana Gribbon Motz, Albert Diaz and Andre M. Davis sat on the panel for the Fourth Circuit.
The plaintiffs are represented by Adam Steffen Davis of Wagstaff & Cartmell LLP and Julie L. Rhoades of Matthews & Associates.
Ethicon is represented by David B. Thomas and Philip J. Combs of Thomas Combs & Spann PLLC, Charles C. Lifland, Stephen D. Brody and David K. Roberts of O’Melveny & Myers LLP, and Christy D. Jones of Butler Snow LLP.
The case is Carolyn Lewis et al. v. Johnson & Johnson et al., case number 14-1244, in the U.S. Court of Appeals for the Fourth Circuit.
--Additional reporting by Sindhu Sundar. Editing by Jeremy Barker. -
4th Circuit upholds Ethicon win in federal mesh bellwether
Mar 2, 2015 | Jessica Dye
By Jessica Dye
A U.S. appeals court has affirmed a win for Johnson & Johnson's Ethicon Inc in its first federal trial over transvaginal mesh, ruling that the plaintiff had not shown a direct link between the company's product and her alleged injuries.
The 4th U.S. Circuit Court of Appeals on Monday upheld a ruling from U.S. District Judge Joseph Goodwin in the Southern District of West Virginia granting Ethicon summary judgment on Carolyn Lewis' failure-to-warn claim. The three-judge panel also unanimously affirmed a mid-trial ruling from Goodwin awarding the company a directed verdict on Lewis' design-defect claim.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/1EHnAGH
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Mar 2, 2015 | The Scotsman
Ms Robison will write to NHS boards after it emerged that some are continuing to perform the procedure despite a call for a moratorium by her predecessor Alex Neil in June last year.
She also confirmed that women who have experienced complications as a result of mesh implants will be able to access specialist support through the NHS inform hotline, run by NHS 24.
The Health Secretary met members of the Scottish Mesh Survivors campaign group earlier this week.
Mesh implants are aimed at treating prolapse and bladder problems, but some women have experienced painful complications.
Ms Robison said the Scottish Government will work with patient groups and NHS inform to develop the practical support service for women experiencing complications or who have concerns regarding their condition.
She said: "I had a very constructive meeting with members of the Scottish Mesh Survivors campaign group.
"I recognise the impact the procedure has had on these women and was keen to discuss with them ways in which the Scottish Government can offer support.
"As part of our discussions I was pleased to confirm that the Scottish Government will be able to arrange additional support for those affected by the procedure through the NHS inform hotline.
"We will be working closely with patient groups and NHS inform to develop this role.
"I am extremely concerned that women have suffered complications following their surgery. This is why we have set up an independent review, which is currently considering these issues and will make recommendations in the spring.
"Until then we have requested that all health boards continue to suspend the use of mesh implants, except where clinically advisable and provided the woman, aware of the risks, has fully consented.
"I will be writing again to all medical directors asking them to consider suspension while the independent review is carried out. This is the right thing to do and will allow a thorough assessment of the evidence before next steps are agreed."
The Medicine and Healthcare Products Regulatory Agency (MHRA), which regulates mesh products, published a report in October stating that ''whilst some women have experienced distressing and severe effects, the current evidence shows that when these products are used correctly they can help alleviate the very distressing symptoms of SUI (stress urinary incontinence) and (pelvic organ prolapse), and as such the benefits still outweigh the risks''.
It continued: ''In line with other medical device regulators worldwide we are not aware of a robust body of evidence to suggest that these devices are unsafe if used properly as intended and therefore should be removed from the market.''
Copyright (c) Press Association Ltd. 2015, All Rights Reserved.
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Week Ahead in Products Liability: March 2, 2015
Mar 2, 2015 | Reuters
By Jessica Dye
A bellwether trial is scheduled to begin today in the U.S. District Court for the Southern District of West Virginia for multidistrict litigation against Johnson & Johnson's Ethicon Inc over transvaginal mesh. The plaintiff, Dianne Bellew, was implanted in 2009 with Ethicon's Prolift device to treat pelvic organ prolapse and said she was never warned that the device could contract and erode, causing pain and scarring. It will be Ethicon's third federal trial in the MDL, having previously won one and lost another. The case is Bellew v. Ethicon, No. 13-22473. For Bellew: Bryan Aylstock of Aylstock Witkin Kreis & Overholtz; Adam Slater of Mazie Slater Katz & Freeman; and Benjamin Anderson of Anderson Law Offices. For Ethicon: Christy Jones of Butler Snow O'Mara Stevens & Cannada; and David Thomas of Thomas Combs & Spann.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/1zRZF1V
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Press Release: Support for Mesh Implant Survivors
Mar 1, 2015 | The Scottish Government
Health Secretary meets with campaign group.
Health Secretary Shona Robison has confirmed the Scottish Government will provide specialist support via NHS 24 for women affected by mesh implants.
Ms Robison met with members of the Scottish Mesh Survivors campaign group earlier this week.
During the meeting the Health Secretary confirmed the Government is to pilot additional support for mesh implant survivors.
Those affected by the implants will be directed to specialist support via the NHS inform hotline, run by NHS 24. The specialist will be available to offer practical support for women experiencing complications and how to manage their symptoms.
The Scottish Government will work with patient groups and NHS inform to develop the practical support service for women currently experiencing complications or who may have concerns regarding their condition.
Ms Robison also confirmed during the meeting that she will be writing again to all medical directors to reiterate the request that boards should consider suspending transvaginal mesh implants until the independent review has reported.
The Scottish Mesh Survivors campaign group will also have input in the development of a protocol for health boards to follow when managing patients with stress urinary incontinence.
Ms Robison said:
“I had a very constructive meeting with members of the Scottish Mesh Survivors campaign group.
“I recognise the impact the procedure has had on these women and was keen to discuss with them ways in which the Scottish Government can offer support.
“As part of our discussions I was pleased to confirm that the Scottish Government will be able to arrange additional support for those affected by the procedure through the NHS inform hotline.
“We will be working closely with patient groups and NHS inform to develop this role.
“I am extremely concerned that women have suffered complications following their surgery. This is why we have set up an Independent Review, which is currently considering these issues and will make recommendations in the spring.
“Until then we have requested that all health boards continue to suspend the use of mesh implants, except where clinically advisable and provided the woman, aware of the risks, has fully consented.
“I will be writing again to all medical directors asking them to consider suspension while the independent review is carried out. This is the right thing to do and will allow a thorough assessment of the evidence before next steps are agreed.”
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Defense Closing and Rebuttal in Perry v. Ethicon Pelvic Mesh Trial in Hands of Jury
Mar 2, 2015 | Mesh Medical Device News Desk
By Jane Akre
On Thursday, February 26, Perry v. Ethicon went to the jury. After a five-week trial, jurors will decide if the Abbrevo mini-sling, used to treat incontinence was defectively designed and whether the instructions to doctors were adequate. That same day, attorneys for Ms. Perry asked for $17.2 million in their closing arguments, an attorney representing Ethicon, a division of Johnson & Johnson, presented his closing remarks to the jury gathered in a Bakersfield, California courtroom.
Thanks to Courtroom View Network to access to a live feed during this trial. The conditions imposed by the court are that the Mesh News not quote directly or show any images from the trial.
Ethicon attorney William Gage (of Butler Snow, same law firm as Christy Jones), is animated and incredulous – how can the jury not see through what the plaintiffs have presented in Perry v. Ethicon?
He proceeded for two hours to outline what he says are holes in the plaintiffs’ product liability case – their accusations about the degradation of the Prolene mesh used to make the Abbrevo, for example. We showed you the sutures goes back to 1969, said Mr. Gage, comparing a single strand of suture to a woven mesh implant made up of many strands. He told the jurors he is still trying to understand how it is safe for a suture and not the Abbrevo?
In chronological order, the TVT (transvaginal tape) came out in 1998, the TVT-O (transvaginal tape obturator) was launched in 2003-2004; then came the TVT Abbrevo, all made with the same ingredient – Prolene. The TVT revolutionized surgery, he said. Before this was out, there was nothing to treat the condition of prolapse. Since 1998 there have been more than 1,000 studies of TVT, over 100 randomized clinical trials (RTC) since 1998. TVT-O was cleared by the FDA in 2003 and there have been over 60 RCT on the TVT-O, Gage told the jurors. Abbrevo, made of Prolene, was cleared by the FDA in 2010, and it was found it to be as safe and effective as the TVT-O. Mr. Gage said he’s having trouble understanding the theory that Prolene degrades. It cannot co-exist with the long successful history of Prolene as they’ve laid it out.
Dr. Grier has been a practicing surgery for 30 years and he relies on Prolene sutures, said Mr. Gage. If they degrade, patients will die! It doesn’t degrade, said Mr. Gage. He said we saw things at the molecular level; they said it’s got to be degrading. If it degrades, there should have been wheelbarrows of evidence to show it degrades! They didn’t do it because it doesn’t degrade, he says. Was there any evidence the material was degrading? Was it degrading where you can measure molecules coming off it? No, it’s not there, he said. They have the burden to show you how it degrades. They have Ms. Perry’s mesh and they didn’t analyze it. Dr. Scott Guelcher is professor of polymer science they brought him here. He didn’t do it.
When I heard this I almost fell out of my chair, said Mr. Gage referring to Dr. Guelcher saying he had no evidence of degradation in Ms. Perry’s mesh. Dr. Margolis had testified the mesh was under the skin and he never saw it. Mr. Gage referred repeatedly to Dr. Margolis as “Plan B,” in other words, he was there to deliver the goods that Dr. Gulelcher could not. The tissue reaction causes the mesh to shrink, said Dr. Margolis. There is no wording of mesh degradation in her medical report, Mr. Gage told jurors.
Why did the word “lightweight” mesh disappear from the Ethicon product description on the website during this trial? (much of the trial has focused on light v. heavyweight mesh) A corporate representative said a website revamp had been underway for two months, explaining it away. It is what it is, said Mr. Gage.
We talked a lot about pore size. Is there anything about our mesh that they accept? Nothing, he said. It’s too heavy, it degrades, nothing! TVT has the largest pore size. Folks, there is no evidence, we are the largest pore size, said Mr. Gage referring to Prolene. In 2010, Dr. Klinge said the gold standard is the mid-urethral vaginal sling, the TVT. The whole purpose of lighter weight larger pore mesh is to eliminate erosion and there is a .4 percent erosion rate with Abbrevo. Laser cut mesh the surgeons overwhelmingly preferred, said Mr. Gage, contrary to what was presented in court. In the real world, laser and mechanical cut are identical, he said. Details matter. Gage is apparently agitated now. He admits TVT Secur is not on the market. The Abbrevo is within the standard of care, he says.
Mr. and Mrs. Perry zip lining in Hawaii, 2012
Blame the Victim
Ms. Perry had cryoablation in 2010 because of painful periods. She had stress urinary incontinence. Her doctor, Dr. Luu didn’t even do the burch procedures. March 23 she has four vaginal surgeries for anterior colporrhaphy, to treat a cystocele, she got an Abbrevo and had a posterior colporrhapy. The known complications of those three surgeries carry those risks.
While in San Francisco visiting with Dr. M. Tom Margolis, Ms. Perry picks up the phone to Dr. Allen telling him she forgot to mention she was having pain with intercourse. You gotta be with me, she’s in San Francisco, she picks up the phone to see Dr. Allen who she saw four days earlier, said Mr. Gage exasparated. She said she forgot to tell him she was having pain with intercourse. She forgot to tell the pain specialist she is having pain with sex. In October 2014 penile abrasion was reported by her and her husband. Dr. Allen found no exposed mesh, neither did Dr. Margolis or Dr. Flynn. You have to have exposed mesh to have an abrasion, Mr. Gage says.
Ms. Perry saw a TV ad on mesh litigation and that’s what got things going, according to the defense. After that she went to Kauai, the big island, she is zip lining, hiking and snorkeling. After trips to Las Vegas, Grand Canyon, Sedona and San Diego. After her pelvic surgery Ms. Perry writes her energy levels are through the roof and the pain is gone and she’s been walking 4.5 miles a day, sleeping through the night and life is good, she wrote, said Mr. Gage. What comes after that? A lawsuit, he said.
After her car accident in Las Vegas she has as team of lawyers dealing with that, he says. Is her mesh about to erode in the future, Mr. Gage asked. Dr. Margolis told you only 5 percent of his patients need more surgery after a mesh erosion. He told you there were an unknown number of surgeries ahead. Does it cost $4,000 or $65,000 to have a surgery, asked Gage highlighting the difference estimates between Dr. Allen and Dr. Margolis. She signed an informed consent by Dr. Luu, she was specifically warned synthetic mesh may cause erosion. She was warned of the need of additional surgery, of pain, of scar tissue or poor healing. Dr. Luu knew this and warned her of this. She signed it. The informed consent warns of everything that happened to her, said Mr. Gage.
The case has shown the mesh is heavyweight, small pore, subject to degradation and shrinkage. When Dr. Luu was a defendant, he sat on the stand and said if he had known he would not have implanted the mesh in her. Dr. Luu is no longer a defendant in this case, said Mr. Gage.
If we can’t rely on the ink on the document, our institutions will fail, warned Mr. Gage referring to a signed informed consent agreement.
Mr. Gage appears tightly wound on this day. He recounts 27 days in court, 12 live witnesses who never brought you evidence on why Abbrevo, when compared to other pelvic mesh, is bad, he recounted. You’ve got to get through informed consent, the smoking (Ms. Perry), the erosion. When it comes to erosion, they had to bring in Dr. Margolis when there was a hole in the testimony. Ten-thousand dollars a day. Even Ms. Perry and Dr. Luu can’t see eye-to-eye whether they had a risk consultation. You’ve got to get through all of that, he says, to reach a conclusion for the plaintiffs. And on punitive damages, you’ve got to be kidding, you’ve got to be kidding, repeats Mr. Gage. Like lady justice with the blindfold on, you have to put the blindfold on, you have to weigh the evidence in the courtroom, not outside the courtroom.
Rebuttal – The Last Word Before the Jury
Richard Freese, Freese & Goss
Then there is a break and a rebuttal by Richard Freese who is also incredulous.
Thank you for being here said Mr. Freese. The good news is I’m the last person you will hear from in this trial. He first shows an exhibit and highlights the first document. A credo from the Johnson & Johnson. Every employee of J&J is commanded to abiding to this credo.
The first sentence, ‘We believe our first responsibility is to doctors, nurses and patients who use our services.’ Please keep that sentence in mind, says Mr. Freese. Remember Dr. Luu said he did not know it was heavyweight mesh and it was stiff mesh and there was an alternative. I did not know it degraded. If you had known those facts would you use the product? He said no. That evidence is uncontradicted.
Once it is put in a woman it cannot be removed. If it goes wrong it cannot be removed. The industry did not tell doctors how to get it out. Nobody told you they ever had any training on how to get the product out. If J&J had provided that information we would not be having this case now, said Mr. Freese. She made the assumption that a reasonable manufacturer could be relied on, that her doctor could be relied on. I recognize they have experts and we have experts. Freese said Dr. Rosenzweig is not on an island, he was picked by Ethicon to go to Sweden and train with Dr. Ulmsten; he was part of their team. (countering what Mr. Gage had said that Dr. Rosenzweig was on an island somewhere in his singular opinion).
They did not find a single doctor outside of their payroll to come here and defend the product, they bring in their paid consultants. They did laser cut mesh because it was cheaper and faster. They did not have a single witness tell you laser cut mesh was safe because, said Mr. Freese, it isn’t. Why aren’t the Ethicon engineers here to tell you it’s safer? As to Dr. Flynn, half of his patients are men and he doesn’t even use Abbrevo. You realize Dr. Flynn is the only doctor in the case who blames her obesity, smoking and her calorie restricted diet had something to do with her wound healing.
For Ms. Perry, her life has been on display. She’s had to be in this courtroom to listen to the most personal details of her life. While she was here every day at trial, not one person from Ethicon sat and watched this trial, said Mr. Freese. Instead they go after her personally. Patients are first unless you make us defend the safety of our product, he said referring to the J&J creed. In that case we will attack you and go into your medical records back in time and see whether we can pick out something to pick on you, said Mr. Freese. She must be making it up, he said, and what does that have to do with whether something is negligently designed, he asked. Nothing.
Pain and suffering noneconomic damages
Lawyers have struggled forever – how do you explain noneconomic damages to jurors. How do you put a dollar value on something you can’t see, he asked. On punitive damages, Mr. Gage said ‘Are you kidding me?’ He asked you to ignore the judges directions which are you must look at their financial condition if you decide to award punitive damages ($70 billion a year). The judge has said punitive damages are intended to discourage this kind of behavior, said Mr. Freese. (Mr. Freese is not allowed to mention the number of punitive damages because the defendant did not in its closing.) Mr. Freese said remember this is a company that did not do a single test on laser-cut TVT Abbrevo. They lied to the FDA and didn’t listen to their own scientists, said Mr. Freese.
If it’s the gold standard to ignore your scientists, and the real world of women’s bodies, don’t tell your sales reps and the FDA the full story; don’t tell doctors the full story. You cannot take a piece of plastic mesh and put it in a woman’s pelvis, you’ can’t do that, he said. If you believe they didn’t put Ms. Perry first, make them pay for that mistake. Thank you very much, Mr. Freese concluded. #
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Boston Scientific To Pay $1.6B For Endo Urology Portfolio
Mar 2, 2015 | Law 360
By Linda Chiem
Boston Scientific Corp. has agreed to drop $1.6 billion to buy American Medical Systems Inc.’s urology portfolio, including its men's health and prostate health businesses, from Dublin-based Endo International PLC, the companies said Monday.
Massachusetts-based Boston Scientific will pay $1.6 billion in cash upfront to pick up Minnetonka, Minnesota-based AMS’ men’s health and prostate health businesses, which includes a product portfolio that treats urologic conditions including benign prostatic hyperplasia, male stress urinary incontinence and erectile dysfunction, the company said in a statement.
Boston Scientific may also pay Endo another $50 million in cash if it hits certain product revenue milestones in the men's health and prostate health businesses in 2016.
The deal allows Boston Scientific to pick up a pair of businesses — which it will weave into its urology and women’s health division — that generated $400 million in sales in 2014 and boasts a lineup of devices and products that include the AMS 800 Urinary Control System for treating stress urinary incontinence and the AMS 700 Inflatable Penile Prosthesis for treating erectile dysfunction.
The transaction gives the company a more comprehensive urology, urogynecology and gynecologic surgery portfolio, Boston Scientific said.
"We believe this strategic acquisition will strengthen Boston Scientific's global leadership in the urology device category while delivering a strong return to our investors," Boston Scientific President and CEO Mike Mahoney said in a statement. "The combination of Boston Scientific's Urology and Women's Health and AMS' urology portfolios will create a business with nearly $1 billion in annual sales and enable significant synergies and strong future growth prospects through portfolio innovation and international market expansion."
For Endo, the deal gives it a fresh capital boost and frees it up to continue implementing an ongoing business strategy to streamline assets and focus on its core specialty pharmaceuticals business.
The deal, however, does not include AMS’ women’s health business, which develops products for treating pelvic organ prolapse and female stress urinary incontinence. Endo says it is currently evaluating strategic alternatives for that business.
"This transaction provides us with greater financial flexibility and better positions the company to take advantage of value-creating M&A opportunities for our pharmaceuticals businesses,” Endo President and CEO Rajiv De Silva said in a statement. “As a result of the divestiture, we expect to realize an increase in our revenue growth rate, an improvement in our operating margin profile and a decrease in our overall effective tax rate.”
Boston Scientific says it plans to finance the asset purchase through a combination of existing and newly committed credit facilities. The deal is expected to close in the third quarter.
"This acquisition is intended to bring together the global talent, expertise and product portfolios of both companies to drive continued health care advancements and value for our customers,” Karen Prange, senior vice president and president of urology and women's health at Boston Scientific, said in a statement. “Together, our strong leadership and innovative solutions can help physicians provide relief, restore bodily functions and enable millions of patients worldwide to regain control of their lives."
Boston Scientific is represented by a Shearman & Sterling LLP team that includes Clare O’Brien, Larry Bambino, Ethan Harris, John Cannon, Chris Smith, Danielle Carbone, Maura O’Sullivan, Tania Mattei, Richard Alsop, Jordan Altman, Barbara Edwards, Jason Pratt, Adam Samarillo, Rob Bucella, Carlos Soto, Jennifer Stadler, Laura Mulry, Minsoo Kwon, Matthew Wochok, Katie Butler, Mark Pereira and Emmeline Widjaja.
Boston Scientific’s financial adviser is J.P. Morgan Securities LLC.
Endo is represented by a Skadden Arps Slate Meagher & Flom LLP team that includes Eileen Nugent, Brandon Van Dyke, Katherine Ashley, Maxim Mayer-Cesiano, Jeffrey Goldfarb, Colleen Lee, Cara McGarian, Matthew Zisk, Ingrid Vandenborre and Erica Schohn.
Endo’s financial adviser is Bank of America Merrill Lynch. -
Boston Sci to acquire Endo's men's health devices for $1.6B
Mar 2, 2015 | Fierce Medical Devices
By Varun Saxena
During the continued wave of life science M&A, companies are seeking to focus on core competencies. Once again, this trend has resulted in Boston Scientific ($BSX) snatching the medical device assets of a pharma company, this time from Endo International ($ENDP).
Last year, Boston Scientific snagged Bayer's devices to treat peripheral vascular disease for $415 million. Today it announced an agreement to acquire a good chunk of Endo's American Medical Systems (AMS) device unit for $1.6 billion. The transaction is expected to close in the third quarter of this year.
Crucially, it won't include Endo's women's health devices, such as transvaginal mesh. The mesh (including Boston Scientific's) turned out to have dangerous side effects. Endo agreed to set aside about $1.6 billion to resolve the claims related to its vaginal mesh implants, while Boston Scientific was hammered last year by unfavorable verdicts resulting in payouts as high as $26.7 million.
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Sign up for our FREE newsletter for more news like this sent to your inbox!AMS 700 Inflatable Penile Prosthesis--Courtesy of Endo
Instead, the new devices in the Boston Scientific portfolio will be in the men's health and prostate health arena. Specifically, they include the GreenLight Laser Therapy Systems for benign prostatic hyperplasia (known as BPH), the AMS 800 Urinary Control System for stress urinary incontinence, and the AMS 700 Inflatable Penile Prosthesis for erectile dysfunction. AMS is the market leader in treating all three segments.
The to-be-acquired unit had sales of about $400 million last year and operating income of about $60 million. It will give Boston Scientific a market-leading or co-leading position in 5 therapeutic categories in urology (the three aforementioned ones plus kidney stones and pelvic floor disorders), the company said during a conference call with investors.
Meanwhile, Boston Scientific's urology and women's health device unit produced $500 million in revenue last year.
Boston Scientific CEO Mike Mahoney said in a statement that the deal will "create a business with nearly $1 billion in annual sales and enable significant synergies and strong future growth prospects through portfolio innovation and international market expansion. We look forward to serving customers and impacting patient care in ways that could not be realized by either company alone." Cost savings are expected to exceed $50 million by the end of 2018.
For Endo, the deal marks its shift to the pharma world. The sale represents a loss on its $2.9 billion acquisition of AMS about three years ago. Most of what remains with Endo on the women's health side is tarred by lawsuits and safety concerns.
"The divestiture of AMS marks the continued execution of our business strategy and furthers the transformation of Endo into a leading global specialty pharmaceutical company," said company CEO Rajiv De Silva in a statement.
The announcement comes on the heels of a $600 million settlement with Johnson & Johnson ($JNJ) over a dispute related to Boston Scientific's disastrous acquisition of cardiology player Guidant. J&J had originally requested $7.2 billion.
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