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Ethicon Media Monitoring 4/25/2019
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Philly Jury Slams J&J With $120M Award In Mesh Injury Case
Apr 24, 2019 | Law 360
By Matt Fair
A Philadelphia jury hammered a Johnson & Johnson unit with $120 million in damages Wednesday after agreeing that a negligently designed pelvic mesh implant left a woman all but incontinent and suffering from chronic pain that prevented her from having sex. -
Johnson & Johnson filed nearly $10 million for failing to disclose dangers of surgical mesh
Apr 25, 2019 | Seattle Post-Intelligencer
By Rita R. Robison
Johnson & Johnson will pay $9.9 million to avoid going to trial for misrepresentations and failure to include serious risks in the instructions and marketing materials for surgical mesh devices. -
Pa. Woman Awarded $120 Million in Ethicon Transvaginal Mesh Case
Apr 25, 2019 | HarrisMartin Publishing
A jury has awarded a Pennsylvania woman $120 million on claims that Ethicon Inc. negligently designed its Gynecare TVT-O transvaginal mesh device, causing her to undergo revision surgery and suffer multiple injuries. -
Johnson & Johnson To Pay $9.9 Million For Failing To Disclose Risks Of Surgical Mesh Devices
Apr 24, 2019 | Seattle Medium
In Monday, Washington State Attorney General Bob Ferguson announced that Johnson & Johnson will pay $9.9 million to avoid going to trial, which was schedule to being earlier this week, for misrepresentations and failure to include serious risks in the instructions... -
Boston Scientific trims 2019 sales growth forecast on weak first quarter, shares fall
Apr 24, 2019 | Reuters
By Manas Mishra and Tamara Mathias
Boston Scientific Corp on Wednesday posted a rare first-quarter profit and revenue miss and lowered the top end of its 2019 sales growth forecast as the medical device maker faces regulatory scrutiny for some of its products. -
Investor Sues Boston Scientific Over FDA's Mesh Product Pull
Apr 24, 2019 | Law 360
By Dean Seal
An investor sued Boston Scientific on Wednesday over the 7.7% drop in share price that followed the U.S. Food and Drug Administration's decision last week to pull the company's surgical mesh products from the U.S. market. -
Boston Scientific misses targets despite earnings growth, while the FDA hands down green lights and red lights
Apr 24, 2019 | Fierce Biotech
By Conor Hale
What the FDA gives, it can also take away—and in the past week, Boston Scientific has seen both. -
Boston Scientific Q1 hit by woes over mesh, paclitaxel, sterilization
Apr 24, 2019 | Medtech Dive
By Maria Rachal
Boston Scientific said Wednesday morning its first quarter earnings grew 4.8% to roughly $2.5 billion, falling short of prior company guidance and consensus analyst estimates. -
Boston Scientific dials back sales target for Eluvia stent
Apr 24, 2019 | Minneapolis Star-Tribune
By Joe Carlson
A clash of financial forces, both good and bad, largely offset one another Wednesday as executives at medical device maker Boston Scientific sought to emphasize a positive new product approval and downplay impacts of negative regulatory actions. -
APRIL 24, 2019 Boston Scientific's Q1 earnings miss estimates as banned products impact profit
Apr 24, 2019 | Worcester Business Journal
By Zachary Comeau
Shares of Marlborough medical device maker Boston Scientific opened Wednesday trading down 2% as the company's first quarter financials came in under expectations. -
9 recent lawsuits involving pharma companies, PBMs, distributors, pharmacists
Apr 24, 2019 | Becker's Hospital Review
By Alia Paavola
Below are nine legal actions involving members of the drug supply chain, including pharmaceutical companies, pharmacy benefit managers, pharmacies, pharmacists and distributors, reported by Becker's Hospital Review in the last two weeks.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Philly Jury Slams J&J With $120M Award In Mesh Injury Case
Apr 24, 2019 | Law 360
By Matt Fair
A Philadelphia jury hammered a Johnson & Johnson unit with $120 million in damages Wednesday after agreeing that a negligently designed pelvic mesh implant left a woman all but incontinent and suffering from chronic pain that prevented her from having sex.
The verdict is the latest, and easily the largest, in a string of damages awards handed down by Philadelphia juries against J&J subsidiary Ethicon Inc. over injuries related to mesh implants intended to treat urinary stress incontinence in women.
Before Wednesday, the largest of the six plaintiffs’ verdicts to come out of Philadelphia reached $57.1 million.
After Wednesday’s verdict, which included $100 million in punitive damages, the total amount awarded in seven separate mesh cases in Philadelphia now tops $270 million.
Jurors credited claims from Susan McFarland that the negligent design of a mesh implant she received in 2008 caused the product to saw through the soft tissue in her pelvis and become exposed in her vagina. She was eventually forced to undergo a second surgery to remove a portion of the implant.
The pain she’s been left with as a result of the complications, she says, has prevented her from having sex with her husband for the last 10 years.
This is the second time jurors have been asked to determine whether McFarland and her husband should be awarded damages for injuries she attributes to alleged defects in a so-called TVT-O implant she received to treat urinary stress incontinence.
Ethicon managed to dodge liability in an initial trial in the case in September as a jury deadlocked over whether the device, which the panel agreed had been negligently designed, had been the cause of McFarland’s injuries.
A retrial kicked off in mid-March and wrapped up on Wednesday, following a nearly monthlong hiatus called by the presiding judge to accommodate an expert witness’ recovery from a recent heart attack.
The verdict came after Tracie Palmer, an attorney with Kline & Specter PC representing McFarland, encouraged jurors during closing arguments Wednesday morning to send a clear message to Ethicon and J&J, which are valued at some $60 billion, about their conduct in developing and selling the mesh implants.
“I can’t tell you how much money to award to stop Johnson & Johnson from hurting other women, that’s your decision to make, but I’d ask you to make it count, and not let Johnson & Johnson and Ethicon brush Susan off their shoulder like a piece of lint,” she said.
Palmer told Law360 after the verdict was returned that she believed the jury had done its job.
“We hope that Ethicon and Johnson & Johnson start to listen,” she said. “Verdict after verdict have sent the message that their behavior is unacceptable, but that message has continued to fall on deaf ears.”
Palmer had told jurors that the type of complication that McFarland experienced — a result of what she said was the heavyweight mesh used in the product — was endemic with Ethicon’s mesh.
“When the mesh shrinks, it becomes tense and rigid, and then this rigid mesh can cut through the vaginal wall,” she said. “It’s like a saw.”
Palmer added that Ethicon had allowed the product to go to market in only nine months without conducting any clinical studies to determine its safety and efficacy.
Adam Spicer, an attorney with Butler Snow LLP representing Ethicon, told jurors during his closing argument Wednesday that there were other probable causes for McFarland’s pain, including the natural atrophying of vaginal tissue with age.
“I’m not blaming Ms. McFarland, but the evidence — the testimony and the medical records — shows that TVT-O is not the cause of her problems,” he said.
He said the TVT-O used the same mesh as a previous product that had been on the market since the 1990s, and which was considered the “gold standard” for treatment of urinary stress incontinence.
“It’s the same mesh that had been used for years,” he said.
But Palmer told Law360 that the jury had seen right through that argument.
“This is a product that’s on the market today and has been sold for a long time, and the jury simply wasn’t buying that that fact alone means that this is safe for women,” she said. “They saw clearly that it hasn’t been the case for Susan McFarland and that she suffered grievously as a result of defendants’ irresponsible behavior.”
Ethicon spokeswoman Mindy Tinsley told Law360 that the verdict was out of line both with prior precedent in mesh cases and with what the company believes is the accepted science around their products.
"While we empathize with women who experience medical complications, this verdict and the damages awarded are inconsistent with the science, Ethicon’s actions, and previous verdicts related to our TVT-O product, which continues to be the gold standard of treatment for stress urinary incontinence," she said. "We believe the evidence showed Ethicon’s TVT-O device was properly designed and that Ethicon acted appropriately and responsibly in the research, development and marketing of the product. We respect the legal process, but we want to reiterate that jury verdicts are not medical, scientific or regulatory conclusions about a product and Ethicon will appeal this verdict."
McFarland and her husband are represented by Tracie Palmer, Braden Lepisto, Shanin Specter and Lee Balefsky of Kline & Specter PC.
Ethicon is represented by Kate Skagerberg of Beck Redden LLP, Adam Spicer, Paul Rosenblatt and Jordan Walker of Butler Snow LLP, and D. Alicia Hickok, Kenneth Murphy and Melissa Merk of Drinker Biddle & Reath LLP.
The case is Susan McFarland et al. v. Ethicon Inc. et al., case number 130701577, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Editing by Aaron Pelc.
Update: This story has been updated with comments on the verdict.
https://www.law360.com/trials/articles/1153027
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Johnson & Johnson filed nearly $10 million for failing to disclose dangers of surgical mesh
Apr 25, 2019 | Seattle Post-Intelligencer
By Rita R. Robison
Johnson & Johnson will pay $9.9 million to avoid going to trial for misrepresentations and failure to include serious risks in the instructions and marketing materials for surgical mesh devices. The Washington State Attorney General’s Office is the first state to file a lawsuit against Johnson & Johnson on surgical mesh devices.
About 14,000 Washington women had these devices implanted. Although Attorney General Bob Ferguson said precise information isn’t available, his office believes hundreds of those have been adversely impacted, ranging from having to go back for another procedure, to having their quality of life impacted dramatically.
The trial was scheduled to begin Monday.
In May 2016, the agency filed a lawsuit against Johnson & Johnson asserting that it violated Washington’s Consumer Protection Act by failing to include several serious, life-altering risks associated with its surgical mesh devices in materials for patients and doctors. Washington women experienced pain, suffering, and life-altering complications that Johnson & Johnson knew were associated with its devices, including chronic pain, pain with sexual intercourse, and numerous urinary issues. In addition, the mesh is difficult and sometimes impossible to remove.
“Johnson & Johnson’s knowing deception caused Washington women to suffer in deeply personal ways,” said Ferguson. “I’m proud of my team for holding a powerful interest accountable for its egregious conduct – and look forward to providing millions of dollars in relief to assist those who were harmed.”
To avoid a trial, Johnson & Johnson will pay $9.9 million. Ferguson said the payment will be used to assist women who received pelvic mesh implants. This is in addition to any money they receive in a personal injury lawsuit. Many lawsuits have been filed across the country on these devices.
The Attorney General’s Office will announce a formal claims process in the future. Due to privacy protections in law, the agency doesn’t know the names of the women implanted with surgical mesh in Washington state. So, the Attorney General’s can’t reach out to affected women directly. If you would like a claims administrator to contact you, provide your contact information here.
In addition to paying $9.9 million, the resolution prohibits Johnson & Johnson from making unfair or deceptive statements regarding surgical mesh, including statements about risks associated with the devices. If the company learns about new, significant risks associated with its surgical mesh, it must disclose those risks.
Johnson & Johnson’s promotional material need to be truthful, accurate, and presented in a balanced way. In addition, if Johnson & Johnson sponsors a study or research and cites that study or research in promotional materials, it must disclose its sponsorship.
Johnson & Johnson knew of the risks of its surgical mesh devices
The surgical mesh devices manufactured and sold by Johnson & Johnson and its subsidiaries are implanted through the vagina and used to treat two conditions in women – pelvic organ prolapse, when organs shift from their normal position, and urinary issues, including incontinence. These conditions are non-life-threatening and can be treated by surgical and non-surgical methods.
The mesh devices are made of polypropylene.
Johnson & Johnson knew that some of the most serious risks it failed to include – chronic pain, pain with sexual intercourse, and more – were associated with the use of its mesh devices, the Attorney General’s Office said. It also knew that the impact of these reactions would greatly increase due to the difficulty of removing the mesh after it was implanted.
During a deposition, Johnson & Johnson Global Head of Medical Affairs Piet Hinoul said that the company knew about the serious risks “from day 1,” but didn’t inform patients of the risks.
Johnson & Johnson is one of the largest manufacturers and sellers of surgical mesh devices in the United States. It had continued to sell four of the devices in Washington state.
Some Washington women have suffered lifelong pain as a result of Johnson & Johnson’s devices. One doctor wrote to Johnson & Johnson in 2009 that their patient would have “a permanently destroyed vagina” due to complications from her surgical mesh devices.
For more information for boomer consumers, see my blog The Survive and Thrive Boomer Guide.
https://blog.seattlepi.com/boomerconsumer/2019/04/24/johnson-johnson-filed-nearly-10-million-for-failing-to-disclose-dangers-of-surgical-mesh/
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Pa. Woman Awarded $120 Million in Ethicon Transvaginal Mesh Case
Apr 25, 2019 | HarrisMartin Publishing
A jury has awarded a Pennsylvania woman $120 million on claims that Ethicon Inc. negligently designed its Gynecare TVT-O transvaginal mesh device, causing her to undergo revision surgery and suffer multiple injuries.
The verdict, which consists of $20 million in compensatory damages and $100 million in punitive damages, was handed down on April 24 following a retrial that began last month.
The trial was presided over by Judge Kenneth Powell Jr. of the Philadelphia County Court of Common Pleas.
In 2008, Susan McFarland was implanted with Ethicon’s Gynecare TVT-O device by Dr. Liang Bartkowiak to treat pelvic floor ...
§ Access to full text unavailable – subscription required. Story can be found here:
https://harrismartin.com/article/24514/pa-woman-awarded-120-million-in-ethicon-transvaginal-mesh-case/
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Johnson & Johnson To Pay $9.9 Million For Failing To Disclose Risks Of Surgical Mesh Devices
Apr 24, 2019 | Seattle Medium
In Monday, Washington State Attorney General Bob Ferguson announced that Johnson & Johnson will pay $9.9 million to avoid going to trial, which was schedule to being earlier this week, for misrepresentations and failure to include serious risks in the instructions and marketing materials for surgical mesh devices. Ferguson is the first state attorney general to file a lawsuit against Johnson & Johnson, one of the largest manufacturers and sellers of surgical mesh devices in the U.S., regarding surgical mesh devices.
The surgical mesh devices manufactured and sold by Johnson & Johnson and its subsidiaries are implanted through the vagina and used to treat two conditions in women — pelvic organ prolapse, when organs shift from their normal position, and various urinary issues, including incontinence. These conditions are non-life-threatening and can be treated via multiple, surgical and non-surgical methods.
According to the Attorney General’s Office (AGO), approximately 14,000 Washington women had these devices implanted. While precise information is not available, the AGO believes hundreds of those have been adversely impacted so far, ranging from having to go back for another procedure, to having their quality of life impacted dramatically.
In May 2016, Ferguson filed a lawsuit against Johnson & Johnson asserting that the multi-billion dollar corporation violated Washington’s Consumer Protection Act by failing to include several serious, life-altering risks associated with its surgical mesh devices in materials for patients and doctors.
Washington women experienced pain, suffering, and life-altering complications that Johnson & Johnson that the AGO claims the company knew were associated with its devices, including chronic pain, pain with sexual intercourse, and numerous urinary issues. Furthermore, the mesh is very difficult and sometimes impossible to remove. During a deposition, according to the AGO, Johnson & Johnson Global Head of Medical Affairs Piet Hinoul admitted that the company knew about the serious risks “from day 1”, but did not inform patients of the risks. In addition, one woman shared that her consultant “likened the mesh removal as to ‘trying to remove chewing gum from hair.’”
Some Washington women have suffered lifelong pain as a result of Johnson & Johnson’s devices. One Washington woman has suffered chronic urinary tract infections, constant lower back pain and cramps in the back of her leg. After years of these conditions, she is now largely homebound and suffers from depression and loneliness. She has described her complications as a “nightmare.”
Another Washington woman endured three separate surgeries to only partially remove the mesh and treat her incontinence and frequent pain. One doctor wrote to Johnson & Johnson in 2009 that their patient would have “a permanently destroyed vagina” due to complications from her surgical mesh devices.
“Johnson & Johnson’s knowing deception caused Washington women to suffer in deeply personal ways,” said Ferguson. “I’m proud of my team for holding a powerful interest accountable for its egregious conduct — and look forward to providing millions of dollars in relief to assist those who were harmed.”
To avoid trial, Johnson & Johnson will pay $9.9 million. Ferguson announced the payment will be used to assist women who received pelvic mesh implants. This is in addition to any recovery they receive in a personal injury lawsuit. Many lawsuits have been filed across the country regarding these devices.
In addition to paying $9.9 million, the resolution prohibits Johnson & Johnson from making unfair or deceptive statements regarding surgical mesh, including statements about risks associated with the devices. If the company learns about new, significant risks associated with its surgical mesh, it must disclose those risks. Johnson & Johnson’s promotional material must be truthful, accurate, and presented in a balanced way. Further, if Johnson & Johnson sponsors a study or research and cites that study or research in promotional materials, it must disclose its sponsorship.
Due to privacy protections in law, the Attorney General’s Office does not know the names of the women implanted with surgical mesh in Washington state. Consequently, the Attorney General’s cannot reach out to affected women directly.
The Attorney General’s Office will announce a formal claims process in the future. If you would like a claims administrator to contact you, you can make your request online at https://fortress.wa.gov/atg/formhandler/ago/MeshContactForm.aspx.and marketing materials for surgical mesh devices. Ferguson is the first state attorney general to file a lawsuit against Johnson & Johnson, one of the largest manufacturers and sellers of surgical mesh devices in the U.S., regarding surgical mesh devices.
The surgical mesh devices manufactured and sold by Johnson & Johnson and its subsidiaries are implanted through the vagina and used to treat two conditions in women — pelvic organ prolapse, when organs shift from their normal position, and various urinary issues, including incontinence. These conditions are non-life-threatening and can be treated via multiple, surgical and non-surgical methods.
According to the Attorney General’s Office (AGO), approximately 14,000 Washington women had these devices implanted. While precise information is not available, the AGO believes hundreds of those have been adversely impacted so far, ranging from having to go back for another procedure, to having their quality of life impacted dramatically.
In May 2016, Ferguson filed a lawsuit against Johnson & Johnson asserting that the multi-billion dollar corporation violated Washington’s Consumer Protection Act by failing to include several serious, life-altering risks associated with its surgical mesh devices in materials for patients and doctors.
Washington women experienced pain, suffering, and life-altering complications that Johnson & Johnson that the AGO claims the company knew were associated with its devices, including chronic pain, pain with sexual intercourse, and numerous urinary issues. Furthermore, the mesh is very difficult and sometimes impossible to remove. During a deposition, according to the AGO, Johnson & Johnson Global Head of Medical Affairs Piet Hinoul admitted that the company knew about the serious risks “from day 1”, but did not inform patients of the risks. In addition, one woman shared that her consultant “likened the mesh removal as to ‘trying to remove chewing gum from hair.’”
Some Washington women have suffered lifelong pain as a result of Johnson & Johnson’s devices. One Washington woman has suffered chronic urinary tract infections, constant lower back pain and cramps in the back of her leg. After years of these conditions, she is now largely homebound and suffers from depression and loneliness. She has described her complications as a “nightmare.”
Another Washington woman endured three separate surgeries to only partially remove the mesh and treat her incontinence and frequent pain. One doctor wrote to Johnson & Johnson in 2009 that their patient would have “a permanently destroyed vagina” due to complications from her surgical mesh devices.
“Johnson & Johnson’s knowing deception caused Washington women to suffer in deeply personal ways,” said Ferguson. “I’m proud of my team for holding a powerful interest accountable for its egregious conduct — and look forward to providing millions of dollars in relief to assist those who were harmed.”
To avoid trial, Johnson & Johnson will pay $9.9 million. Ferguson announced the payment will be used to assist women who received pelvic mesh implants. This is in addition to any recovery they receive in a personal injury lawsuit. Many lawsuits have been filed across the country regarding these devices.
In addition to paying $9.9 million, the resolution prohibits Johnson & Johnson from making unfair or deceptive statements regarding surgical mesh, including statements about risks associated with the devices. If the company learns about new, significant risks associated with its surgical mesh, it must disclose those risks. Johnson & Johnson’s promotional material must be truthful, accurate, and presented in a balanced way. Further, if Johnson & Johnson sponsors a study or research and cites that study or research in promotional materials, it must disclose its sponsorship.
Due to privacy protections in law, the Attorney General’s Office does not know the names of the women implanted with surgical mesh in Washington state. Consequently, the Attorney General’s cannot reach out to affected women directly.
The Attorney General’s Office will announce a formal claims process in the future. If you would like a claims administrator to contact you, you can make your request online at https://fortress.wa.gov/atg/formhandler/ago/MeshContactForm.aspx.
https://seattlemedium.com/johnson-johnson-pay-9-9-million-failing-disclose-risks-surgical-mesh-devices/
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Boston Scientific trims 2019 sales growth forecast on weak first quarter, shares fall
Apr 24, 2019 | Reuters
By Manas Mishra and Tamara Mathias
Boston Scientific Corp on Wednesday posted a rare first-quarter profit and revenue miss and lowered the top end of its 2019 sales growth forecast as the medical device maker faces regulatory scrutiny for some of its products.
Shares of the company were down 3 percent at $34.78 in early trading.
Last week, the U.S. health regulator ordered makers of transvaginal surgical mesh implants, including Boston Scientific, to immediately stop selling the products, citing safety and effectiveness concerns.
Tens of thousands of lawsuits have been filed in recent years against medical device manufacturers, including Boston Scientific, claiming their transvaginal mesh implants caused pain, urinary problems, bleeding and other injuries.
Adding to its woes, the U.S. Food and Drug Administration recently raised safety concerns about balloons and stents coated with a paclitaxel drug in treating peripheral arterial disease, affecting sales of Boston Scientific’s drug-eluting stent system, Eluvia.
“While the Eluvia launch in Japan remains on track, we do expect slower adoption of Eluvia to persist in the U.S. and Europe in second quarter and potentially throughout the second half,” Chief Executive Officer Michael Mahoney said on a conference call with analysts.
The Marlborough, Massachusetts-based company had cut its expectations for Eluvia revenue this year by half to reflect the changing landscape, Mahoney said, but did not reveal the revenue figure.
The company said it expected revenue growth for this year to be in a range of about 7 percent to 8 percent on a reported basis, compared to an earlier forecast of 7 percent to 9 percent.
Boston Scientific said the mesh withdrawal would result in a $30 million impact to global revenue this year and a $0.02 charge to adjusted earnings per share.
Excluding items, the company reported earnings of 35 cents per share, compared with IBES Refinitiv estimates of 36 cents per share, breaking a seven-quarter streak of meeting or beating the average analyst estimate for profit.
Net income rose 42.3 percent to $424 million in the first quarter ended March 31, while net sales were $2.49 billion, falling short of estimates of $2.53 billion.
“This was a rare off color performance from BSX,” Evercore ISI analyst Vijay Kumar wrote in a note.
“We suspect that investors hoping for Q1 to be a clearing event might be disappointed,” he added.
https://www.reuters.com/article/us-boston-results/boston-scientific-trims-2019-sales-growth-forecast-on-weak-first-quarter-shares-fall-idUSKCN1S01PV
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Investor Sues Boston Scientific Over FDA's Mesh Product Pull
Apr 24, 2019 | Law 360
By Dean Seal
An investor sued Boston Scientific on Wednesday over the 7.7% drop in share price that followed the U.S. Food and Drug Administration's decision last week to pull the company's surgical mesh products from the U.S. market.
The FDA said on April 16 that the medical device manufacturer's premarket approval applications for its Uphold Lite Vaginal Support System and Xenform Soft Tissue Repair System lacked evidence guaranteeing the safety and long-term effectiveness of those products.
News that the products would be pulled from shelves in the U.S. caused Boston Scientific's share price to drop by $2.90, according to investor Steve Klein, who said the FDA's order was the tipping point in a series of product liability and racketeering suits that belie the company's representations about the safety of its surgical mesh products.
"Despite years of denials by Boston Scientific in response to questions concerning the safety of its vaginal mesh products, the apparent full extent of the company's misstatements was revealed on April 16," Klein said.
The putative securities class action in New York federal court claims Boston Scientific misled investors, in press releases and regulatory filings, about the safety of surgical mesh products intended for the transvaginal repair of pelvic organ prolapse. Klein hopes to represent a class of investors who purchased the company's shares between Feb. 26, 2015, and the FDA's order last week.
That proposed class period starts the day after Boston Scientific filed an annual report noting that it was facing more than 25,000 product liability cases or claims related to the company's transvaginal surgical mesh products. A West Virginia federal judge said in January that Boston Scientific has paid more than $7 billion to resolve thousands of those cases; the company's most recent annual report pegs the number of settlements at roughly 50,000.
One year later, Boston Scientific disclosed in its subsequent annual report that it was facing a putative racketeering class action accusing it of using counterfeit or adulterated products from China in its vaginal mesh implants. That case was quickly stayed and sent to the FDA for consideration; court records indicate the stay has not yet been lifted.
But through all of these challenges to the safety of its mesh products, Boston Scientific has "skirted any admissions of liability or guilt," Klein said Wednesday.
The FDA cleared the market of most of these types of surgical mesh devices after reclassifying them in 2016 as high-risk and requiring manufacturers to submit premarket approval applications if they wanted to keep their products in the U.S. market.
Boston Scientific and Coloplast were the only manufacturers to file applications, but an agency director said last week that neither company gave an "adequate assessment" of its devices' long-term safety or showed they had an "acceptable long-term benefit" compared to mesh-less, native tissue repair.
The company is now liable for hits its shareholders took when the FDA's announcement caused a stock drop, Klein claimed Wednesday, as it misled investors about the sustainability of sales for an unsafe product, its sale of products that used cheap knockoff resin and the heightened regulatory risks it faced as a result.
Counsel for Klein and a representative for Boston Scientific did not immediately respond to requests for comment Wednesday.
Klein is represented by Jeremy A. Lieberman, J. Alexander Hood II, Jonathan Lindenfeld and Patrick V. Dahlstrom of Pomerantz LLP.
Counsel information for Boston Scientific is not yet available.
The case is Klein v. Boston Scientific Corp. et al., case number 1:19-cv-03642, in the U.S. District Court for the Southern District of New York.
--Additional reporting by Danielle Nicole Smith and Kat Greene. Editing by Marygrace Murphy.
https://www.law360.com/articles/1153164/investor-sues-boston-scientific-over-fda-s-mesh-product-pull
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Apr 24, 2019 | Fierce Biotech
By Conor Hale
What the FDA gives, it can also take away—and in the past week, Boston Scientific has seen both.
The agency has approved the company’s long-awaited Lotus Edge aortic valve system for high-risk patients; the transcatheter replacement system is now the only FDA-approved heart valve that allows surgeons to reposition or recapture the valve after it has been fully deployed.
But this month the FDA also ordered Boston Scientific, alongside devicemaker Coloplast, to immediately halt their sales of transvaginal mesh used to repair pelvic organ prolapse following years of safety reports, lawsuits and settlements related to the procedure.
Those highs and lows coincided with the release of the company’s first-quarter earnings report, in which Boston Scientific just missed analysts’ expectations, sending its shares down by as much as 4% in premarket trading.
The company brought in $2.493 billion in sales, a growth of 4.8% on a reported basis—or 6.3% when excluding currency fluctuations and sales from Boston Scientific’s 2018 acquisition spree of NxThera, Claret Medical and Augmenix, which had no comparable sales for the previous year.
Adjusted earnings per share for the quarter reached $0.35, up from last year’s $0.33, but below Wall Street’s expectations by one cent. In addition, Boston Scientific narrowed and lowered its guidance for the year, to 7% to 8% growth, compared to the 7% to 9% it predicted last quarter. After the markets opened, the company’s stock had climbed back to just within a percentage point of the previous close, at around $35.55.
"Our global team and differentiated portfolio enabled us to deliver good sales and earnings growth this quarter, despite some revenue softness compared to our estimates," Boston Scientific Chairman and CEO Mike Mahoney said in a statement.
"With our strong pipeline and category leadership strategy, we are confident in our top tier 2019 outlook and how we can help improve outcomes for patients around the world for years to come," Mahoney added.
With growth in all segments compared to last year’s first quarter, the company’s MedSurg division led the pack with a 7.7% increase, compared to 2.8% in rhythm and neuromodulation devices and 4.2% in cardiovascular products.
But that could change with the addition of the newly approved Lotus Edge heart valve, with its approval announced in the 24 hours before the earnings release. The device features a braided frame and an adaptive seal that aims to minimize leaks by conforming to the patient’s native valve.
"Bringing the much-anticipated Lotus Edge valve system to market allows us to provide patients who aren't good candidates for traditional surgery a safe and effective treatment alternative to restore proper function to their severely narrowed aortic valve," said Kevin Ballinger, global president of interventional cardiology. Boston Scientific began a controlled launch of the device in Europe in March, and said it plans to do the same in the U.S. in the coming weeks.
Regarding its transvaginal mesh products—including its Uphold Lite Vaginal Support System, Xenform Soft Tissue Repair Matrix, Pinnacle Lite Posterior and Polyform devices—the company said it was “deeply disappointed” by the FDA’s decision, and that it would halt not just U.S. sales, but international ones as well.
However, Boston Scientific also made it clear the agency’s order did not apply to surgical mesh used to treat stress urinary incontinence or transabdominal repair.
As a result, the company said it expects to lose about $30 million globally over the course of 2019, including about $5 million in a sales return reserve recorded in the first quarter. Its adjusted net income dropped $11 million in the first quarter, as well.
https://www.fiercebiotech.com/medtech/boston-scientific-misses-targets-despite-earnings-growth-while-fda-hands-down-greenlights
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Boston Scientific Q1 hit by woes over mesh, paclitaxel, sterilization
Apr 24, 2019 | Medtech Dive
By Maria Rachal
Boston Scientific said Wednesday morning its first quarter earnings grew 4.8% to roughly $2.5 billion, falling short of prior company guidance and consensus analyst estimates.
Executives attributed revenue softness to headwinds from an FDA letterto healthcare providers cautioning against use of paclitaxel-coated devices, the shutdown of a sterilization facility that impacted Boston Scientific's supply of men's health products and an FDA order that the company cease sales and distribution of surgical mesh products for repair of pelvic organ prolapse.
Amid the disappointing results, Boston Scientific expressed confidence in its structural heart portfolio, which it expects to contribute up to $725 million on the year, buoyed by Tuesday's FDA approval for its Lotus transcatheter aortic valve replacement (TAVR) device, and planned expansion of its Sentinel cerebral protection system in TAVR procedures and Watchman device in patients with atrial fibrillation.Dive Insight:
Among the challenges during the quarter, growing distrust in paclitaxel devices was one of the most serious for Boston Scientific, with its Eluvia drug-eluting stent caught in the fray. Executives slashed 2019 revenue targets for the device by 50%.
CEO Mike Mahoney said Boston Scientific expects slower Eluvia adoption in U.S. and European markets to continue in the second quarter and potentially into the second half of 2019, calling FDA's planned advisory committee meeting June 19-20 on the subject a "key next dialogue point."
Global Chief Medical Officer Ian Meredith called impact of the meta-analysis to the entire paclitaxel product family "disappointing," saying Boston Scientific still has "considerable confidence in paclitaxel as an anti-restenotic agent" in patients with peripheral artery disease.
On FDA's recent decision to reject the company's PMA application for certain surgical mesh products for repair of pelvic organ prolapse, Boston Scientific reported it has ceased global sales and distribution of the products and now expects a roughly $30 million negative impact globally to 2019 full year revenue. That includes an approximate $5 million sales return reserve recorded in the first quarter and roughly $18 million charge to net income.
CFO Dan Brennan also said that about 95% of all known claims on mesh have been settled.
The company's urology and pelvic health unit was dragged down by the unanticipated shutdown of Illinois sterilization facility Sterigenics, which disrupted supply of some of its men's health products, Mahoney said. He added that the situation has since been resolved, with FDA approving Boston Scientific for in-house sterilization of the products. Full supply is expected to be restored by the end of the second quarter.
Still, the company said the unit was bolstered by the integration of its NxThera and Augmenix acquisitions, which added technologies for patients with benign prostatic hyperplasia or who have received prostate cancer radiotherapy.
Among Boston Scientific's forthcoming product rollouts is a single-use duodenoscope model, as the company looks to capitalize in its endoscopy unit on another safety issue flagged by FDA: contamination problems with reprocessed duodenoscopes.
The company said it will begin a controlled U.S. launch of its Lotus TAVR device immediately, seeking to take market share from Medtronic and Edwards Lifesciences. It's also looking to expand existing site use rates of its Sentinel platform, which it acquired through last year's purchase of Claret Medical, calling protected TAVR the emerging standard of care.
Executives reduced full year guidance to 7% to 8% reported growth, down from 9% on the higher end. It also expects 5% to 7% growth in the second quarter.
The company said it will update guidance upon completion of the more than $4.2 billion acquisition of BTG, the largest of Boston Scientific's many 2018 buyouts expected to close in June or July, following BTG shareholder approval in February.
https://www.medtechdive.com/news/boston-scientific-q1-hit-by-woes-over-mesh-paclitaxel-sterilization/553325/
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Boston Scientific dials back sales target for Eluvia stent
Apr 24, 2019 | Minneapolis Star-Tribune
By Joe Carlson
A clash of financial forces, both good and bad, largely offset one another Wednesday as executives at medical device maker Boston Scientific sought to emphasize a positive new product approval and downplay impacts of negative regulatory actions.
The stock closed the day down a little more than 1%, at $35.44, after recovering from a 3% dive shortly after the market opened Wednesday.
The stock initially tumbled after the device maker reported lower-than-expected adjusted quarterly earnings and revenue and dialed back sales expectations for one of its key future growth drivers — the Minnesota-designed Eluvia drug-eluting stent for the legs.
That was among a combination of factors that caused the company to inch down its revenue guidance for the rest of the year, while acknowledging that meeting those targets will require an acceleration of growth in the second half of the year.
“We obviously don’t take this slight revenue miss in the first quarter lightly,” Chief Executive Mike Mahoney told investors during an earnings call Wednesday morning. “I think it’s the first time we’ve missed in close to a decade. And we pride ourselves on delivering on our commitments and we are very excited about the future.”
Other setbacks included the unexpected closure of a plant that sterilizes men’s health devices, an order from the U.S. Food and Drug Administration to stop selling surgical mesh kits for pelvic organ prolapse, and soft sales of neuromodulation devices that are seen as an alternative to opioid medications.
But executives on Wednesday pumped the news that the FDA has finally approved Boston Scientific’s Lotus Edge replacement heart valve, giving the U.S. market its third transcatheter aortic valve — one whose design features have been highly refined to address shortcomings in earlier versions of TAVR valves, Global Chief Medical Officer Ian Meredith said.
Meredith called the Lotus Edge a “competitive valve that has a number of design features that I think will be very attractive to physicians to use the product,” including a deployment system that gives an interventional cardiologist a degree of control as the device gradually unfurls inside the heart and pushes aside the diseased natural aortic valve. The result is lower rates of stroke and pacemaker implantation and less risk of needing a second valve to correct a misplaced first valve, he said in an interview.
“You have complete and utter control over the expansion in a very uniform way,” Meredith said.
The Lotus Edge, which is approved only for the treatment of high-risk aortic stenosis patients at the moment, is expected to be introduced into the general U.S. market gradually.
Despite securing the key product approval, Boston Scientific ended up lowering the top end of its revenue outlook for the rest of the year. That comes after its first-quarter revenue of $2.49 billion fell short of the $2.54 billion that analysts expected. Adjusted earnings of 35 cents for the quarter came up a penny short of projections.
Expectations for organic revenue growth are now in a range of 7% to 8% (the company previously said it expected up to 8.5% growth). Adjusted full-year EPS guidance is in a range of $1.54 to $1.58 (previously, the lower EPS boundary was $1.53).
Executives confirmed Wednesday that “some” hospital systems have stopped using their new high-margin Eluvia stent for the legs because of concern over the anti-inflammation drug paclitaxel that the device slowly gives off after being implanted to open vessels above the knee.
No study has shown that the low dose of paclitaxel on the Eluvia stent is associated with worse outcomes than the same device without the drug coating. However, the FDA has warned doctors that it is investigating a finding in a recent study of past clinical trials of paclitaxel-eluting devices for the legs that show the devices are associated with a greatly increased long-term mortality risk. On June 19-20, the FDA will be asking for advice on future regulatory action when an expert panel gathers to hear more about the evidence and potential theories on the increased mortality.
Regarding vaginal mesh, Boston Scientific was one of two companies that sought to continue selling kits for transvaginal mesh insertion for treatment of pelvic organ prolapse (POP), along with Coloplast. The products have been targeted by thousands of lawsuits from women who say the plastic devices led to more pain and other problems. The companies stand behind the devices’ safety and performance.
However, on April 16 the FDA announced that makers of transvaginal pelvic mesh products for POP would have to stop selling the products in the U.S. because they couldn’t meet enhanced safety standards with data from ongoing clinical trials. The move affected Boston Scientific’s Uphold Lite Vaginal Support System, Xenform Soft Tissue Repair Matrix, Pinnacle Lite Posterior and Polyform devices.
Boston Scientific said the decision would limit an important treatment option for women with POP. Meanwhile, more than 2,300 urogynecology specialists have signed a change.org petition urging the FDA to delay any final action until after the conclusion of an ongoing three-year clinical trial and consider evidence from other “highly relevant” clinical trials.
Finally, Boston Scientific is one of the companies whose product supplies were affected by the closure of the Sterigenics medical-device sterilization plant in Willowbrook, Ill.
Public health concerns prompted Illinois environmental officials to order the plant to seal all its containers of a carcinogenic chemical called ethylene oxide, used to sterilize medical devices that are too sensitive to be cleaned with heat or radiation. The seal order effectively closed the plant; litigation to overturn the order is pending.
The FDA said the closure continues to affect hundreds of different medical devices, and shortages of some devices may begin to happen, though Boston Scientific has moved its affected products to its own internal sterilization facilities.
“That issue has been resolved, that supply issue, so we will be back to full supply … in mid-June. So that will be strong for the second half of the year,” Mahoney said Wednesday.
http://www.startribune.com/boston-scientific-misses-revenue-eps-targets/508996192/
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APRIL 24, 2019 Boston Scientific's Q1 earnings miss estimates as banned products impact profit
Apr 24, 2019 | Worcester Business Journal
By Zachary Comeau
Shares of Marlborough medical device maker Boston Scientific opened Wednesday trading down 2% as the company's first quarter financials came in under expectations.
The company said its first quarter revenue of $2.5 billion rose 4% percent from the prior year period compared to the company's expectations of at least 6% growth.
Per-share earnings of $0.30 was under the company's guidance range low of $0.32 despite profit of $424 million representing a 42% increase from the first quarter of 2018 net income of $298 million.
That figure might have been higher if not for the U.S. Food & Drug Administration pulling two of the company's pelvic mesh products from the market due to safety and health concerns.
Boston Scientific said the removal of those products would result in a $25-million hit, but the company updated that full-year impact Wednesday to $30 million.
For the first quarter, that included a $5-million sales return reserve in the first quarter and an $18-million charge to net income.
In a statement, Chairman and CEO Mike Mahoney noted the revenue softness compared to company estimates, but noted the company's strong and growing portfolio.
"With our strong pipeline and category leadership strategy, we are confident in our top tier 2019 outlook and how we can help improve outcomes for patients around the world for years to come," Mahoney said.
The earnings report came the morning after the company won FDA approval for its much-anticipated Lotus Edge Aortic Valve System for patients with aortic stenosis, a heart valve disease that leads to narrowing of the aortic valve.
The device was specifically made for patients considered high risk for open heart surgery.
http://www.wbjournal.com/article/20190424/NEWS01/190429982/boston-scientifics-q1-earnings-miss-estimates-as-banned-products-impact-profit
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9 recent lawsuits involving pharma companies, PBMs, distributors, pharmacists
Apr 24, 2019 | Becker's Hospital Review
By Alia Paavola
Below are nine legal actions involving members of the drug supply chain, including pharmaceutical companies, pharmacy benefit managers, pharmacies, pharmacists and distributors, reported by Becker's Hospital Review in the last two weeks.
1. Drug distributor, ex-CEO + COO indicted in connection with opioid conspiracy
Prosecutors criminally charged a prescription drug distributor and two of its former top executives in New York April 23, marking a first in the nation's fight against the opioid epidemic.2. BCBS of Louisiana sues J&J subsidiary, alleges it filed sham lawsuits to thwart competition
Blue Cross Blue Shield of Louisiana is suing a Johnson & Johnson subsidiary, accusing it of filing "sham" patent litigation to keep generic forms of Zytiga off shelves to maintain a monopoly on its best-selling prostate cancer drug.3. J&J to pay $9.9M to settle Washington state surgical mesh case
Just before a trial was set to begin April 22 in Seattle, Johnson & Johnson agreed to pay $9.9 million to resolve a lawsuit claiming the company failed to warn patients about the risks of its pelvic mesh devices.4. 53 medical professionals charged in sweeping opioid takedown
Dozens of medical professionals in seven states, including 31 physicians, eight nurse practitioners, seven pharmacists and seven other medical workers, are charged with participating in the unlawful prescribing of more than 32 million pain pills.5. CVS to pay $535K to settle claims of filling forged prescriptions
CVS Health will pay $535,000 to resolve allegations that some of its pharmacies in Rhode Island filled dozens of forged prescriptions.6. Vermont pharmacy sues insurer over prescriptions steered to mail order
Rutland Pharmacy, an independent pharmacy in Vermont, is suing a New York insurer, MVP Health Care, for pushing its customers to use a mail order pharmacy to fill prescriptions.7. Martin Shkreli must face antitrust suit, judge rules
A federal judge has declined to dismiss an antitrust suit against "Pharma Bro" Martin Shkreli and Retrophin, the biotech he founded.8. Jury orders Dignity Health to pay $3.4M to former pharmacy manager
A jury has decided that San Francisco-based Dignity Health must pay $3.4 million to a former outpatient pharmacy manager who claimed she was wrongly fired in 2015 for not fudging documents ahead of a federal probe.9. 3 drugmakers pay nearly $123M to settle kickback claims
Three drugmakers — Jazz Pharmaceuticals, Lundbeck and Alexion Pharmaceuticals — have agreed to pay $122.6 million to resolve allegations of violating the Anti-Kickback Statute by illegal use of copay assistance programs.https://www.beckershospitalreview.com/pharmacy/9-recent-lawsuits-involving-pharma-companies-pbms-distributors-pharmacists.html
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