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Ethicon Media Monitoring 12/4/2018
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J&J Driven By Profits To Push Allegedly Faulty Mesh, Jury Told
Dec 3, 2018 | Law 360
By Matt Fair
The latest in a string of trials over injuries linked to a Johnson & Johnson unit’s allegedly defective pelvic mesh products kicked off in Philadelphia as jurors heard arguments Monday that the company’s thirst for profits pushed it to sell the implants... -
Philadelphia Firms Asks Judge Goodwin to Deny Paying MDL Lawyers Millions in Fees and Expenses
Dec 3, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
It had to happen. The hundreds of millions of dollars resulting from the 5% common benefit fund, paid by injured plaintiffs, must be distributed to pelvic mesh litigation lawyers. But how? -
Surgical mesh deemed unsafe for one medical problem is being used for another
Dec 4, 2018 | Noted
By Ruth Nichol
Surgical mesh can no longer be used to treat New Zealand women with pelvic organ prolapse (POP) after Medsafe removed four POP mesh productsfrom the market in January. -
Grieving son demands answers over mum’s tragic mesh implant death
Dec 3, 2018 | Edinburgh Evening News
By Kevan Christie
A grieving son whose mother was the first person in Scotland to have mesh implant surgery listed as an underlying cause of death is demanding answers from the regulator who approved the product. -
Wall & Main: Why did Boston Scientific pay $4.2 billion for a British medical device maker?
Dec 3, 2018 | Worcester Telegram
By Peter Cohan
Last month, Marlboro’s Boston Scientific made its biggest acquisition since 2005.
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J&J Driven By Profits To Push Allegedly Faulty Mesh, Jury Told
Dec 3, 2018 | Law 360
By Matt Fair
The latest in a string of trials over injuries linked to a Johnson & Johnson unit’s allegedly defective pelvic mesh products kicked off in Philadelphia as jurors heard arguments Monday that the company’s thirst for profits pushed it to sell the implants despite serious concerns about patient safety.
Kline & Specter PC attorney Kila Baldwin told the jurors that J&J unit Ethicon knew that its implants were likely to cause women such as plaintiff Suzanne Emmet to experience complications, including the mesh sawing into the vagina, but that it had sold the products anyway as it looked to maintain market dominance.
“They sold these products knowing full well what they would do to women, and had a conscious disregard for it because they were out to make money,” Baldwin said.
Emmet’s is the eighth case over the alleged defects in the Ethicon mesh products to go to trial in the Philadelphia County Court of Common Pleas; juries in five of the previous proceedings have returned verdicts in favor of plaintiffs.
Total damages in the five cases have topped $100 million.
Emmet, who filed suit in July 2013, experienced severe complications after receiving three mesh implants six year earlier to treat urinary stress incontinence, and a condition in which both her bladder and rectum were sagging against her vagina.
But in the weeks after receiving the implants in May 2007, Emmet began to experience complications as a portion of one of the devices eroded into her vagina, according to Baldwin.
Emmet underwent a corrective procedure in August 2007, but Baldwin said the woman’s doctor quickly realized that more of the mesh had made its way through her vaginal wall.
After another erosion two years later, Baldwin said, Emmet submitted to another corrective procedure in which doctors chemically burned a portion of her vagina to try and scar over the exposed mesh.
In total, Emmet underwent nine surgeries and almost a dozen chemical cauterizations to address 14 mesh erosions she experienced after being implanted, according to Baldwin.
The problem with the products was that the tight weave of the mesh caused tissue to grow around the implant — rather than growing through and integrating with it — and encapsulate it in scar plating, Baldwin said.
This caused the flexible organs of the pelvis not to function properly, according to her.
“Scar tissue prevents organs from stretching the way they should,” she said. “It causes organ dysfunction, they don’t work properly because they cant move freely the way they should.”
She said the problem became so pronounced that Ethicon pulled its Prolift mesh — one of the products involved in Emmet’s case — from the market in 2012.
Meanwhile, Baldwin said, Ethicon stopped recommending its Gynemesh product, which is also at issue in Emmet’s case, for use in pelvic surgeries.
The third implant that Emmet received, known as the TVT-O, remains on the market today.
“[Ethicon] still sells TVT-O in the face of mounting evidence about how truly dangerous it is,” Baldwin said.
Butler Snow LLP attorney Anita Modak-Truran, representing Ethicon, countered in her opening argument that the implants had done their job in treating Emmet’s organ prolapse and incontinence.
“The mesh fixed Ms. Emmet’s problems as it was intended to do,” she said.
She also argued that complications such as those experienced by Emmet were well known to her implanting surgeon, and that they had been clearly communicated.
“Mrs. Emmet knew when she agreed to proceed with surgeries that she might need additional surgeries and that there were no guarantees,” Modak-Truran said.
Lastly, she argued that Emmet’s claims were barred by a two-year statute of limitations.
She noted that Emmet began experiencing complications shortly after her original implantation surgery, and that the frequency of the erosions she experienced should have made her realize by 2009 at the latest that there might be a problem with her mesh.
Modak-Truran said that Emmet has maintained that she didn’t realize the possibility that her injuries might have been related to a defective implant until she saw an attorney advertisement in 2012.
But the attorney disputed this in her opening argument.
“The attorney advertisement didn’t tell Ms. Emmet anything she didn’t know already,” Modak-Truran said.
Emmet and her husband, Michael, are represented by Kila Baldwin, Thomas Kline, Elia Robertson and Thomas Bosworth of Kline & Specter PC.
Ethicon is represented by Anita Modak-Truran of Butler Snow LLP, Joseph O’Neil of Lavin O’Neil Cedrone & DiSipio LLP, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP, and Kenneth Murphy, D. Alicia Hickok, Melissa Merk and Molly Flynn of Drinker Biddle & Reath LLP.
The case is Suzanne Emmet et al. v. Ethicon Inc. et al., case number 130701495, before the Court of Common Pleas of Philadelphia County, Pennsylvania.--Editing by Dipti Coorg.
https://www.law360.com/productliability/articles/1053123
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Philadelphia Firms Asks Judge Goodwin to Deny Paying MDL Lawyers Millions in Fees and Expenses
Dec 3, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
It had to happen. The hundreds of millions of dollars resulting from the 5% common benefit fund, paid by injured plaintiffs, must be distributed to pelvic mesh litigation lawyers. But how?
One firm says pay half of the fund back to plaintiffs!
A leading mesh plaintiffs’ law firm is asking Judge Joseph Goodwin to deny paying pelvic mesh lawyers involved in multidistrict litigation (MDL) hundreds of millions of dollars in fees which it calls “excessive and unreasonable given the outcome of this litigation…”
When 104-thousand pelvic mesh defective product cases were consolidated in Charleston, West Virginia, jury verdicts and /or settlements were assessed a 5% fee to be set aside in a Common Benefit Fund.
That fund is supposed to compensate lawyers for their costs and expenses of uncovering evidence working up a case with the discovery to be shared by firms and used at trial.
Lawyers must travel at their own expense, pay for expert witnesses, and in general put out millions of dollars and thousands of hours to get cases ready for trial. The fund is intended to reimburse their expenditure and their hours.
At the present time the Common Benefit Fund has $366 million to be distributed among 94 law firms on a sliding scale depending on hours contributed and the hourly rate. It could swell to an estimated $550 million.
A lawyer for Kline & Specter says return half of it to plaintiffs!
Lee Balefsky says the Plaintiffs’ Steering Committee (PSC) has failed in its job for plaintiffs.
First it failed to achieve a Global Settlement of the litigation therefore “should not be generously rewarded for its failure,” he says in a November 26 filing in the Neomedic MDL.
Thousands of cases remain unresolved. In some cases settlement dollars are less than $40,000 before any 40% in legal fees are taken out and any medical liens or repayment of Medicare and Medicaid. Those settlements should not be rewarded, he writes.
The 5% common benefit fee is too high, writes Balefsky and some firms are being “significantly overcompensated.”
He points out that “a few firms are seeking to grab two-thirds of the fund. Instead they should remit their proportionate share of these saved funds to the injured women. Thus, the proposed allocation is directly relevant to the proposed assessment – and both are wrong.”
Meanwhile the average trial award has been just under $10 million.
A lodestar crosscheck method of calculating attorney fees is typically considered in compensation. The courts multiply the hours of work by the attorneys’ hourly rate resulting in the lodestar. It can be adjusted upward or downward accordingly.
FEE AND COST COMMITTEES
The Common Benefit Fees and Cost Committee (FCC), made up of eight law firms, is headed by Henry Garrard of Blasingame, Burch Garrard & Ashley of Athens, Georgia, which seeks the largest amount of compensation, based on the greatest number of hours contributed to the discovery process.
Those eight have awarded themselves $249 million of or two-thirds of the $374 to be distributed. This averages nearly $29 million per FCC firm, or $739 an hour.
Meanwhile Kline & Specter falls at the other end of the range and is scheduled to collect at an hourly rate of $116, says the motion. The Philadelphia-based law firm has submitted thousands of hours of work done for state litigation in Pennsylvania, which it says are not being considered.
The hourly work should be compensated at the same rate as the FCC law firms, something Garrard had promised to Balefsky as is submitted in an accompanying exhibit e-mail.
Kline & Specter has obtained a number of favorable jury verdicts that contributes to “the overall success of the transvaginal mesh litigation.” It’s cases heard in the Philadelphia Court of Common Pleas have amounted to five verdicts over more than $105 million.
SETTLE EARLY, SETTLE CHEAP
Because of the sheer number of cases in this product liability litigation MDL, many law firms took thousands of cases, too many cases to deal with them individually or adequately, the motion indicates.
As a result, MDL attorneys disadvantaged litigants by settling their inventories way too cheaply, writes Balefsky,
“making it difficult for other attorneys to settle their cases reasonably. They did this despite the huge verdicts in the vast majority of mesh trials. These discounted settlements were driven by the sheer enormity of the number of claims and the inability of lawyers to discover and try hundreds of thousands of cases in their inventory.”
Also to be considered- some mesh makers settled case early with no trials scheduled and no discovery required. American Medical Systems (AMS) closed its mesh division and sold to Endo International. No AMS trials were conducted.
Coloplast and Covidien entered into an early settlement program and no discovery was every conducted in those MDLs. There should be no 5% common benefit fee because there was no common benefit work, Balefsky writes.
He points to Riley Burnett’s law firm which submitted $10 million in expenses and 1,662 hours for compensation in the Coloplast MDL where no true discovery took place.
“This is fundamentally wrong and any proposed distribution of funds regarding Covidien and Coloplast should be returned in full to the clients and the firms who negotiated the settlements.”
Transparency is needed, Balefsky writes.
The FCC will not provide requested documents so others can review the methodology used in determining fees.
Lawyers are not being told the total number of cases settled per manufacturer, the average settlement and/or the hourly rates.
“Discovery on these issues is needed.”
HENRY GARRARD WEIGHS IN TODAY
In a response filed December 3, Monday, Henry Garrard, joined by seven other lawyers on the FCC committee, objects to Kline & Specter’s letter. The firm is the only one objecting and those are “self-serving and unfounded.”
Kline Specter (KS) has benefited from the MDL, including tens of thousands of hours of work product, Garrard says.
“KS was predominantly a consumer rather than a contributor to the common benefit.”
He also objects to the premise that firms took on too many cases that resulted in settlements instead of trials.
KS has 3,000 cases and has only tried a few.
“This after-the-fact claim that any firm’s settlement values were negatively affected by the number of clients represented by that firm is factually groundless and patently unreasonable.
https://www.meshmedicaldevicenewsdesk.com/philadelphia-firms-asks-judge-goodwin-to-deny-paying-mdl-lawyers-millions-in-fees-and-expenses/
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Surgical mesh deemed unsafe for one medical problem is being used for another
Dec 4, 2018 | Noted
By Ruth Nichol
Surgical mesh can no longer be used to treat New Zealand women with pelvic organ prolapse (POP) after Medsafe removed four POP mesh productsfrom the market in January.
That decision, which effectively bans the use of vaginal mesh to treat POP, was made due to safety concerns. The mesh has been associated with serious, long-term complications such as chronic pain, infection, vaginal bleeding and bowel problems.
However, the ban does not apply to vaginal mesh used to treat stress urinary incontinence (SUI) – involuntary urination caused by physical movement or activity such as coughing, sneezing, running or heavy lifting.
This year, up to 1400 Kiwi women with SUI will have what’s known as a mid-urethral sling made of polypropylene mesh implanted through their vagina to support their urethra or bladder neck.
But the growing international controversy about the use of vaginal mesh to treat both POP and SUI – it’s been described as “the new thalidomide” because of its sometimes-devastating consequences – means they face a difficult decision: to have surgery or not?
“Every patient who comes to see me brings it up, and I have to go through the evidence with them,” says Dr Lynsey Hayward, a urogynaecologist at Middlemore Hospital.
As far as she’s concerned, the evidence for mid-urethral slings is convincing. She supports Medsafe’s decision to stop the use of vaginal mesh to treat POP, saying there are much more effective, non-mesh surgical options available. However, she describes mid-urethral slings as a “very different animal” and has no qualms about using them for patients who have not responded to non-surgical treatments for SUI. These include pelvic floor physiotherapy, weight loss and continence pessaries.
“I would use mid-urethral slings as a first-line surgical treatment for my patients and so would my colleagues.”
Hayward recommends using retropubic slings, which are inserted through an incision in the front wall of the vagina, rather than trans-obturator slings, which are inserted through two small cuts at the top of each thigh. She says retropubic slings have fewer complications and are also easier to remove.
“If I had stress urinary incontinence I would absolutely have a retropubic mid-urethral sling.”
Hayward also supports the Ministry of Health’s decision to develop a credentialling system for surgeons inserting the slings; she represents the Royal Australian and New Zealand College of Obstetricians and Gynaecologists on the credentialling committee. In the meantime, the ministry has told district health boards to stop offering the surgery if their surgeons don’t meet Australian credentialling guidelines. These include a requirement to perform at least 10 procedures a year, which is likely to limit the availability of the surgery at smaller regional hospitals.
“It’s clear from studies that high-volume surgeons who are experienced and used to doing the surgery have a much lower complication rate than those who are only doing it occasionally,” says Hayward. “That would apply to any surgery – any surgery at all.”
Mesh Down Under, a support and advocacy group for people injured by mesh, also supports the credentialling process, though – not surprisingly – it takes a more cautious approach to the use of mid-urethral slings to treat SUI. Co-founder Carmel Berry is less convinced by the data than Hayward and says there is not yet much information about the long-term effects of the slings.
“Some people are fine for three or four years, then all kinds of problems start to arise.”
She doesn’t necessarily believe the slings should be banned, but does think they should be used only as a last resort – and only when women are aware of all the possible complications. “The proviso is that the patient must be fully consented.”
She’s helping to write a Ministry of Health information document about the different options for SUI treatment and their possible complications, which will have to be signed by both the patient and the surgeon before surgery goes ahead.
Berry says women who do opt to have a mid-urethral sling inserted should also have a plan in place so that any post-operative problems are fixed as quickly as possible.
“Something I’ve learnt recently is that if you’re in pain at six weeks post-operatively, you’re probably always going to be in pain unless you get it taken out.”
This article was first published in the December 1, 2018 issue of the New Zealand Listener.
https://www.noted.co.nz/health/health/surgical-mesh-unsafe-medical-problem-still-used/
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Grieving son demands answers over mum’s tragic mesh implant death
Dec 3, 2018 | Edinburgh Evening News
By Kevan Christie
Great-grandmother Eileen Baxter died in August from multiple organ failure after being admitted to hospital with internal bleeding, sickness and diarrhoea a week earlier.
The 75-year-old previously underwent sacrocolopexy mesh repair – an implant to fix a pelvic organ prolapse.Her son Mark Baxter, from Loanhead in Midlothian, and his sister Audrey have met health secretary Jeane Freeman to discuss their mother’s death and the implications of the wider use of mesh.
This led to the Scottish Government announcing a halt in the use of transvaginal mesh, with only a limited number of operations to be considered for women already on the waiting list.
Dr Catherine Calderwood, the chief medical officer for Scotland, has again written to the Medicines and Healthcare products Regulatory Agency (MHRA) to seek assurances the safety of mesh products has been properly tested.
An investigation into Eileen Baxter’s death is being carried out by associate medical and nurse directors at NHS Lothian. As part of this process, the Baxter family agreed a list of questions which the health board say they will endeavour to answer.
Mark Baxter said: “The one question I did ask, which I thought was relevant, is there’s a bacteria that comes from this mesh. The surgeon has said that there was a lot of bacteria in my mum’s body, so I’m specifically looking for them to tell me where this bacteria came from.
“I know that the bacteria that comes from the mesh can break down the immune system and then the body can’t cope with any antibiotics. So I’m still waiting on answers to the questions I have surrounding my mother’s death.”Baxter welcomed the decision taken by the Scottish Government to pursue the MHRA for answers regarding the thoroughness of the regulation of the mesh devices on the back of an article ‘What we must learn from mesh’ which appeared published in the British Medical Journal in October.
He said: “The way things are going it looks like the pharmaceutical companies never provided enough information.
“There’s been a lack of transparency and communication between the companies that make the mesh, the NHS and the governments.”
In the letter to the MHRA, Calderwood said: “I remain concerned about a number of issues, in particular in relation to mesh implants, where I do not yet feel the MHRA has satisfactorily evidenced the safety of these products.”https://www.edinburghnews.scotsman.com/news/grieving-son-demands-answers-over-mum-s-tragic-mesh-implant-death-1-4838369
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Wall & Main: Why did Boston Scientific pay $4.2 billion for a British medical device maker?
Dec 3, 2018 | Worcester Telegram
By Peter Cohan
Last month, Marlboro’s Boston Scientific made its biggest acquisition since 2005.
Boston Scientific believes that this deal will help it grow.
But one Wall Street analyst said that the merger — and the debt added to complete the transaction — will boost the chances that Boston Scientific can remain independent.
Boston Scientific is a medical device company best known for its stents that hold open damaged blood vessels. It also makes other products for use in “angioplasty, blood clot filtration, cardiac rhythm management, catheter-directed ultrasound imaging, upper gastrointestinal tract tests, and treatment of incontinence,” according to Morningstar.
Boston Scientific has grown steadily and has generated profits and positive cash flow. Between 2013 and 2017, the company’s revenues grew at a compound annual rate of 4.5 percent to $9.5 billion. During that period, its free cash flow barely budged: It reached $1.1 billion in 2017 while its net income that year was a mere $100 million, according to Morningstar.
Boston Scientific has made many acquisitions over the years. By far the biggest one was its 2005 acquisition of medical device maker Guidant for $25.2 billion, some $9 billion more than the amount Johnson & Johnson offered to acquire Guidant.
Fortune magazine wrote that it was the second worst deal in history. How so? According to The Wall Street Journal, between 2006 and 2012, Boston Scientific took $9 billion in write-downs, mostly related to the Guidant acquisition, and its stock lost nearly 85 percent of its value — from $32.30 before the announcement to about $5 in July 2010. In February 2015, Boston Scientific paid $600 million to J&J, which sued Guidant for $7 billion in damages for allegedly breaching its merger deal with J&J.
And that’s not all. In May 2018, “60 Minutes” reported that Boston Scientific had been sued over alleged problems with its vaginal mesh devices. The company was the target of at least 48,000 lawsuits from more than 100,000 women alleging that the plastic strip can inflict serious pain and injury.
In a statement, Boston Scientific said that nearly 1 million women have been “successfully treated” with the mesh and that the plastic is safe.
The Guidant deal and its fallout hardly deterred Boston Scientific from making other acquisitions. Indeed on Nov. 20, Boston Scientific announced it would pay $4.2 billion to acquire BTG, a British medical device maker.
The deal, which was priced 36.6 percent above BTG’s pre-deal stock market valuation, was touted as giving Boston Scientific new products for the treatment of cancer and other disorders, Bloomberg reported.
BTG, which generated $496 million in revenue in the first half of 2018, makes medical technology for physicians, such as cryoablation products to freeze and destroy diseased cells and radiotherapy that delivers radiation straight to tumors. BTG also makes medicines and antidotes against snake venom for emergency care.
In a statement, Boston Scientific CEO Michael Mahoney said that the acquisition would “augment [Boston Scientific’s] capabilities in important areas of unmet need” such as cancer and harmful blood clots.
A Boston Scientific spokesman offered more details. According to a Nov. 27 interview with Kate Haranis, Boston Scientific’s external communications manager, “BTG has several highly differentiated peripheral interventional (PI) product lines [products that treat clogged arteries]. The interventional oncology franchise includes the Therasphere Y-90 radiotherapy microspheres and the GALIL cryoablation system, used to prolong life and manage pain for patients with liver, kidney and other cancers. The company also has a highly-differentiated vascular portfolio, including filters, crossing catheters, microfoam and the EKOS Endovascular System.”
Boston Scientific believes that BTG will give it more products to treat patients and boost its revenues. “With highly complementary PI portfolios, the acquisition of BTG is expected to further Boston Scientific’s category leadership strategy and advance patient care in ways that could not be realized by either company alone. In addition to its interventional medicine (IM) business, BTG has licensing revenue streams and a pharmaceutical portfolio with acute care antidotes that address unique and lifesaving patient needs,” Ms. Haranis said.
I asked Boston Scientific how it would earn back the 36.6 percent premium it paid for BTG. Based on the company’s response, I am not sure what to conclude.
“BTG has delivered strong recent results and continued growth through [the first half of 2018] across its business and notably its IM business. Transacting the deal now seemed appropriate based on a combination of strategic and financial factors and the fact that they were also amenable and timing was right for them too,” Ms. Haranis said.
As I wrote, in June the Wall Street Journal reported that Boston Scientific had received a takeover approach from Kalamazoo, Michigan-based Stryker, a $65 billion (June 11, 2018 stock market capitalization) maker of hip and knee replacements, endoscopy systems, operating room equipment, embolic coils and spinal devices.
But one analyst thinks that the BTG deal makes it less likely that Boston Scientific will be acquired. Jefferies health-care strategist Jared Holz wrote to clients that the deal, which he called a “strange” move, would take Boston Scientific out of consideration as a takeover target itself. As Mr. Holz wrote, Boston Scientific “has takeout speculation in shares and thus doing a deal will be a perceived negative as far as the stock is concerned.”
Boston Scientific stock fell as much as 11 percent when the deal was announced. By Nov. 28, its shares had recovered 4.4 percent of the loss. And since the beginning of the year, its shares had risen 41 percent.
If the deal boosts Boston Scientific’s revenues and keeps the company from being acquired, perhaps its shares have further to rise.
Peter Cohan of Marlboro heads a management consulting and venture capital firm, and teaches business strategy and entrepreneurship at Babson College.
https://www.telegram.com/news/20181203/wall-amp-main-why-did-boston-scientific-pay-42-billion-for-british-medical-device-maker
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