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Ethicon Media Monitoring 02/11/2015
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District Judge Calls For Transvaginal Mesh Lawsuit Settlements
Feb 10, 2015 | Med Device Online
By Jof Enriquez
U.S. District Judge Joseph Goodwin in Charleston, WV, urged lawyers representing the plaintiffs and the defendant medical device companies — notably C.R. Bard, Johnson & Johnson's (J&J's) Ethicon subsidiary, and Boston Scientific — in court to settle -
Bard May Not Present Evidence of 510(k) Compliance in Upcoming Transvaginal Mesh Trial, Judge Rules
Feb 10, 2015 | Harris Martin Publishing
A West Virginia federal judge has ruled that C.R. Bard may not present evidence in an upcoming transvaginal mesh trial that it complied with the 510(k) clearance process, -
Johnstone mum's agony goes on for years after nightmare mesh operation
Feb 10, 2015 | The Daily Record and Sunday Mail
By Jeff Holmes
A former hospital theatre nurse has spoken of her anguish at the medical scandal surrounding controversial mesh implants. -
Mesh Activist Keeton Accuses J&J, FDA of RICO Violations
Feb 10, 2015 | Mesh Medical Device News Desk
By Jane Akre
Mesh activist Lana Keeton has filed a Pro Se complaint against Johnson & Johnson accusing it of organized corruption. -
The Difference Between Hope and Despair – Same Facts, Different Way of Telling a Story
Feb 10, 2015 | Mesh Medical Device News Desk
By Jane Akre
...Fine, you win, take everything we have and we will close our doors for good.” And just like there is no way possible that Endo/AMS could ever come up with $50 billion, the same is true for Bard, Boston Scientific, and even industry behemoth Johnson & Johnson...
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District Judge Calls For Transvaginal Mesh Lawsuit Settlements
Feb 10, 2015 | Med Device Online
By Jof Enriquez
A judge recently enjoined parties embroiled in tens of thousands of transvaginal mesh cases to forge settlement deals soon to avoid costly and lengthy trials.
U.S. District Judge Joseph Goodwin in Charleston, WV, urged lawyers representing the plaintiffs and the defendant medical device companies — notably C.R. Bard, Johnson & Johnson's (J&J's) Ethicon subsidiary, and Boston Scientific — in court to settle. Otherwise, he would have to send the cases to trial as quickly as necessary.
"I'm going to kick it into high gear and ask that you do the same," he said in court during pre-trial meetings, according to a Reuters report.
Judge Goodwin told parties present in court that trials could drag on for decades and cost billions in penalties for manufacturers of transvaginal mesh, used to treat urinary incontinence and organ prolapse, per Reuters. Goodwin is overseeing the multi-district litigation (MDL), to which some 70,000 cases have been consolidated.
Women across the United States have filed thousands of claims that the implants caused them pain, bleeding, and tissue injuries. Makers of transvaginal devices have defended the devices’ safety. The companies have gone to trial multiple times, winning some cases, though recent verdicts have been unfavorable.
For instance, Boston Scientific lost successive court trials last year, with jurors in West Virginia and Texas ordering the company to pay plaintiffs millions. J&J last year also was ordered to pay a woman millions in damages for injuries caused by mesh made by its Ethicon subsidiary. In January, J&J decided to settle four other mesh cases.
Other manufacturers have also opted to settle. Last year, Endo subsidiary American Medical Systems (AMS) settled 20,000 thousand cases for $830 million. C.R. Bard also last year agreed to settle more than 500 lawsuits for $21 million.
Judge Goodwin had earlier warned C.R. Bard and others that they risk losing billions in dollars in damages, given how jurors are returning verdicts.
“I can’t imagine a corporation facing potentially billions of dollars in verdicts wouldn’t find it advisable to try to achieve a settlement for a much lesser sum,” Goodwin said at a recent hearing of C.R. Bard’s cases, according to a previous Med Device Online article. “I base that billions of dollars business on some of the rather large verdicts that we’ve had.”
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Bard May Not Present Evidence of 510(k) Compliance in Upcoming Transvaginal Mesh Trial, Judge Rules
Feb 10, 2015 | Harris Martin Publishing
A West Virginia federal judge has ruled that C.R. Bard may not present evidence in an upcoming transvaginal mesh trial that it complied with the 510(k) clearance process, explaining that such evidence is irrelevant as to whether the Avaulta system was safe and effective.
However, in the Feb. 6 order, Judge Joseph R. Goodwin of the U.S. District Court for the Southern District of West Virginia ruled that Bard may present evidence of lawsuits the plaintiff has filed against her implanting surgeon or evidence concerning injuries arising out of the surgeon’s care, finding it is relevant ...
Subscription required, for full article please see: http://harrismartin.com/article/19081/bard-may-not-present-evidence-of-510k-compliance-in-upcoming-transvaginal-mesh-trial-judge-rules/
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Johnstone mum's agony goes on for years after nightmare mesh operation
Feb 10, 2015 | The Daily Record and Sunday Mail
By Jeff Holmes
A former hospital theatre nurse has spoken of her anguish at the medical scandal surrounding controversial mesh implants.
Norma Roberts was a regular walker on Gleniffer Braes and visited the gym three times a week, before having the operation in 2011.
Like hundreds of other women in Scotland, Norma had the op to cure incontinence brought on by childbirth.
The mum-of-two was told the “simple procedure” would change her life. And it has done, but not in the way the surgeon had promised.
Norma, 51, told the Paisley Daily Express: “I felt mild pain after my operation at the Royal Alexandra Hospital, but was assured by my surgeon that it would disappear through time.
“It was always there, but not enough to bother me, but two years after the operation, I woke up one morning and could hardly move. The pain in my groin was incredible. I tried to get out of bed but couldn’t walk. At first, I hobbled into work but it soon became clear that I couldn’t get about.”
Norma, from Spateston, in Johnstone, told herself that it was probably hereditary, as her brother had needed a hip replacement while in his 30s.
After visiting an orthopaedic surgeon, she was told that it was probably inflammation of the joint.
It wasn’t. She was admitted to hospital last May to have the tension on her mesh tape released – although it hasn’t made any difference.
She said: “Sometimes the pain is on the right-hand side, sometimes on the left, or even both, but one thing is crystal clear – it’s nerve pain as a result of mesh.
“It’s like a nagging toothache pain and I take tablets every day to try and ease the pain.
“It’s so frustrating, but I also feel angry at the Scottish Government and surgeons for allowing these procedures to be carried out.
“Knowing what they now know, I don’t understand how they can continue to allow operations to happen under the guise of clinical trials – as there is a suspension
in place.”Norma, a theatre nurse at the Southern General for 24 years, added: “I had to give up a job I loved and now I can’t even do a desk job, as I can’t sit down.
“My husband David and I used to love walking up the Braes, and I was a regular at the gym and exercise classes – but that’s all finished.
“And to compound it all, after cheering former Health Secretary Alex Neil’s decision to suspend mesh procedures, it emerges that he had written to surgeons telling them that the suspension would soon be lifted.
“These people are playing with our lives – and those of the unsuspecting victims of the future. It’s not right.”
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Mesh Activist Keeton Accuses J&J, FDA of RICO Violations
Feb 10, 2015 | Mesh Medical Device News Desk
By Jane Akre
Mesh activist Lana Keeton has filed a Pro Se complaint against Johnson & Johnson accusing it of organized corruption.
In the complaint, filed in the U.S. District Court for the Southern District of Florida, Keeton says defendants have engaged in “a fraudulent scheme in violation of the Federal Racketeer Influenced and Corrupt Organizations Act (RICO)”.
Violations include mail fraud, perjury and a worldwide effort to influence doctors to use their products accomplished through professional medical societies such as AUGS (American Urogynecologic Society) and ICS (International Continence Society).
Also named are Ethicon, a wholly owned subsidiary of J&J, Gynecare Worldwide, Dr. Willy Davila of the Cleveland Clinic, the president of the Cleveland Clinic, and the U.S. Food and Drug Administration.
Dr. Davila performed numerous surgeries on Keeton from 2002 through 2009 to remove a bladder sling, according to the complaint. At the time he was under contract with J&J, a fact unknown to her at the time, she says. He even attended her first Truth in Medicine conference in September 2009 as a speaker. Truth in Medicine is a nonprofit organization Keeton founded after she became aware of injuries associated with pelvic mesh after her TVT implant (Ethicon) in December of 2001.
“What Davila did was the worst betrayal of my life,” she tells MND.
Keeton is filing the action as a Pro Se litigation, in other words, filing on her own without legal assistance. Her lawsuit filed in the federal multidistrict litigation was dismissed without prejudice by Judge Goodwin in 2014.
“I will no longer protect people who don’t protect me,” says Keeton referring to the FDA. “It’s not just for me. This could open up the truth for so many injured women worldwide. Accountability is coming.”
Keeton says since the mid 1990’s, Ethicon (J&J) has hid the risks of polypropylene mesh (Prolene is the Ethicon trade name) while heralding its benefits.
Keeton is filing the action as a Pro Se litigation, in other words, filing on her own without legal assistance. Her lawsuit filed in the federal multidistrict litigation was dismissed without prejudice by Judge Goodwin in 2014.
“I will no longer protect people who don’t protect me,” says Keeton referring to the FDA. “It’s not just for me. This could open up the truth for so many injured women worldwide. Accountability is coming.”
Keeton says since the mid 1990’s, Ethicon (J&J) has hidden the risks of polypropylene mesh (Prolene is the Ethicon trade name) while heralding its benefits.
The complaint states:
“Further, David Krause, Branch Chief, General Plastic Surgery Devices at the FDA’s Center for Devices and Radiological Health (CDRH), interacted with Peter Cecchini, Fellow, Regulatory Affairs, Ethicon, Inc. disclosing Keeton’s activities at the FDA in 2010. Krause alerted Cecchini to the existence of damning information in a video, “The Benefits of Light Weight Mesh” funded by Ethicon, Inc. in collaboration with one of Ethicon’s experts, Dr. B. Todd Heniford at the Carolinas Medical Center in 2007. Krause was concerned that it was being shown to Dr. Jeffrey Shuren, Director of the CDRH in a meeting in November 2010.”
Her complaint, filed February 4, asks for compensatory damages in the amount of $7 million and punitive damages of $21 million.
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The Difference Between Hope and Despair – Same Facts, Different Way of Telling a Story
Feb 10, 2015 | Mesh Medical Device News Desk
By Jane Akre
“Life isn’t fair.”
It’s a saying that has probably been around since Adam and Eve were banished from the Garden of Eden, and it’s a feeling that every victim of defective surgical mesh probably experiences on a daily basis. Nobody deserves to suffer innocently as the result of someone else’s fault, which is why many of the juries to date have come down hard on the manufacturers with very large verdicts in favor of the victims. But even those courageous women who have prevailed in trial thus far and been compensated fairly in the eyes of a jury would all still tell you that “life isn’t fair” because they still have to face the rest of their lives with the pain and uncertainty associated with their permanent mesh-related injuries. This is the stark reality of our legal system, so anyone who ever expects to feel like they truly received a fair outcome at the end of their case is only setting themselves up for disappointment – especially if they try to compare their result with the highest reported verdicts on record and not with the least favorable results.
It is human nature to hear about someone else who received millions of dollars for a similar injury and to wish for the same result, yet it is also human nature to hear about someone with a similar injury getting nothing as the result of losing their trial and to block it out by coming up with excuses and reasons for why that wouldn’t happen to them. As humans, we try to always remain optimistic and see ourselves with a positive future, but this can oftentimes lead to unreasonably optimistic expectations in legal matters.
Scales of Justice, WikiCommons
Nobody files a lawsuit expecting to lose, yet it happens hundreds of times a day in courtrooms across America. A lawyer who has not lost a trial that he or she fully expected to win is a lawyer who has not tried a lot of cases. All it takes is a judge or a single juror who has preconceived biases against lawsuits or lawyers and everything is lost. Yes, lawyers try desperately during jury selection to identify and remove these biased jurors from the panel, but jurors with a personal vendetta against lawsuits are savvy enough to know that they need to keep their feelings silent and repeatedly tell the court that they can be “fair.”
So there is one of life’s great ironies: the only time it’s fair is when it’s someone else’s version of what is fair and not your own.
This is a discussion that I have with my clients on a daily basis. They come into my office having heard of someone somewhere who was awarded millions of dollars after having an automobile accident, and they expect to receive the same result. After all, that would only be “fair,” wouldn’t it? I have to compassionately explain to them that just because two people have the exact same injuries, there are several factors that will prevent them from having the same legal outcome. And time after time, the most common factor mentioned is the defendant’s ability to pay the judgment.
There simply is no legal tool for making assets appear where they do not exist, so there is no way for a lawyer to recover the same compensation for someone who was injured by an old pick-up truck with minimal insurance coverage as that lawyer could get for someone who was run over by a Budweiser truck. So every day, thousands of injured victims across the country are left with no choice but to settle their case for the minimal insurance coverage limits and to come to the realization that their case is not the same as that other case that they had heard about… because life isn’t fair. These settlements aren’t newsworthy and nobody wants to talk about them, so all the general public continues to read about are the large verdicts; nobody ever clarifies how extremely rare those verdicts are.
So how does all of this translate into the current surgical mesh MDL situation and the ongoing settlement discussions? After all, these corporate defendants are all billion dollar companies with far more assets than any of us could ever imagine owning. But let’s take a closer look at exactly what that means from a practical standpoint.
Dollar sign, WikiCommons
Billions and Billions
For my example, I will use Endo International (Endo/AMS) and C.R. Bard, Inc. (Bard) as two companies whose value we will try to break down. A quick look at any stock market report tells us that the “Market Capitalization” for both companies is roughly $12 billion. Does this mean that Endo/AMS and Bard both have $12 billion in cash just sitting in a bank somewhere? No. It just means that the total value of their outstanding shares of stock is $12 billion each. But since those shares are mostly held by public investors, their value has no relevance when it comes to settlement purposes. In other words, Bard could not just agree to turn over the $12 billion in stock as part of any settlement because they don’t own them.
Furthermore, if we look at a hypothetical situation where the FDA comes out and prohibits Bard for ever again selling mesh, it would logically cause Bard’s stock price to plummet, thereby turning Bard from a $12 billion company into a $6 billion company overnight. This is why “Market Capitalization” is horribly misleading and totally irrelevant in the context of any ongoing and settlement discussions. It is more important to focus on line items such as net income and cash on hand in order to get a more accurate and realistic picture of how much companies like Endo/AMS and Bard can pay out overall without putting themselves out of business.
And after reading that last sentence you might be asking, “Don’t we want them to go out of business?” The answer — at least from a settlement frame of reference — is absolutely not! Future expected cash flow is going to make up a very large portion of any settlement, so the worst thing possible would be for that income stream to be cut off completely. Just like all of us count on future income when we go out and borrow to buy a house, these companies count on future income when they determine how much they can finance a mass tort settlement. So let’s take a closer look at income and cash flow for Endo/AMS and Bard.
According to the income statements filed with the SEC for the past three reporting years, Endo/AMS has had a net income (exclusive of some accounting write-offs) of approximately $500 million each year. Bard, over that same period of time, has brought in roughly $775 million per year. And at the end of 2013, each company had a little bit more than $1 billion cash-on-hand according to their balance statements. This gives us a much better idea of what is really there and what can really be expected in terms of a final global settlement. (It is true that both companies also carry insurance to cover mesh-related damages, but those confidential amounts are not going to be anywhere near a billion dollars.)
Hopefully now it is starting to become evident as to why these companies cannot just enter into open-ended settlements with numbers large enough to fully satisfy every claim. There are just too many injured victims and not enough money to go around. Even if you use a $2 million figure (which according to the juries thus far is conservative for the most seriously injured victims) and you multiply it by the 25,000 for the number of injury cases that have been filed against Endo/AMS, you get a total of $50 billion! This is why Judge Goodwin is openly telling everyone that there won’t be any multi-million dollar mass settlements; he has the same financial information and he has done the same math.
Judge Joseph Goodwin
Billions and Bankruptcy
Think back for a minute about what I wrote earlier about not wanting these companies to shut down, and use the same analysis for why we do not want them to go into bankruptcy. If Endo/AMS was forced to liquidate through Chapter 7 and put 100% of its assets into a trust for injured mesh victims, what would that look like? The trust would get the $1 billion cash-on-hand, a few office buildings, and several warehouses full of Endo/AMS’s inventory – which is mesh! Can you think of anything more insulting for mesh victims than to have their settlement paid in mesh?
Now, compare that bankruptcy scenario to the current Endo/AMS global settlement of $1.6 billion and it becomes a little clearer as to how the numbers were reached. In reality, the settlement is far better for victims than having Endo/AMS say, “Fine, you win, take everything we have and we will close our doors for good.” And just like there is no way possible that Endo/AMS could ever come up with $50 billion, the same is true for Bard, Boston Scientific, and even industry behemoth Johnson & Johnson. Accordingly, it is unquestionably impossible for any global settlement to fully compensate all of the victims, and hopefully anyone who expected otherwise can now see why that is.
I know firsthand how hard it will be on an individual basis for any mesh victim to say “OK, I will settle and accept much less than I deserve,”… but I also know that this is the only possible outcome that is “fair” to everyone who has ever been injured by this terrible product. Otherwise, the huge group of mesh victims that is now currently bound together in solidarity will be forced to fight against each other in a race to the courthouse to see who gets paid while the companies are still viable and who gets left out when they file bankruptcy.
It would be analogous to opening a box of twelve cookies in a room with 500 children. There is a way for every child to get a taste of cookie, but not without a system in place that treats everyone equally and controls the situation. If the first twelve children rush in and eat a full cookie each, then the remaining 488 children will be out of luck. So is it “fair” that each child will only get a tiny piece of a cookie? No… but it’s a lot better outcome for the large majority of the group than the alternative outcome. In other words, it’s a much “fairer” result when seen from the viewpoint of the group, because everyone is making a sacrifice for the good of the group as a whole. We are all in this together.
The Big Picture
Along those same lines, it is counterproductive and irrational for victims to be blaming their own lawyer for why their case has not yet been resolved. The whole purpose of the MDL is to put a moratorium on mesh trials while the bellwether cases are being tried. So far, given the great successes by the plaintiff lawyers to date, everything is going perfectly for mesh victims as a group. So while it may seem like your individual case is not moving, it isn’t because your lawyer doesn’t want it to. It’s because the rules of MDL are prohibiting your lawyer from doing so. So rather than be angry at what seems like inactivity, one should be pleased with the verdicts thus far, because I can assure you that the positive outcomes are increasing the value of everyone’s settlement in the end. These MDL’s always take time, but they always work out in the end. Things are going great, and real progress is being made.
As a final note, please realize that these manufacturing companies have every incentive to settle these cases for the exact same reasons that I have discussed herein. They can do the math, and they can see that paying out large verdicts every month will land them in bankruptcy. Thus, they are motivated to settle for anything that allows them to stay in business.
So while they are publicly touting the safety of their products and publicly ridiculing the victims and their lawyers, they are privately working furiously to salvage their companies. But just like no reasonable person would go to work every day for ten years if they weren’t going to make a dime of income over that decade, no company is going to agree to a settlement that keeps them in business without being able to turn a profit. There has to be some give and take, because as I explained previously, we need these companies to keep generating income that can be used to pay out our claims.
If everyone can begin to see the big picture and start to understand why mesh victims are never going to be satisfied with a global settlement that seems “fair” to them individually, then we can continue to move forward towards a global settlement that is as close to fair as it can be to the group as a whole. On other hand, if every mesh victim is determined to settle for nothing less than “a full cookie,” then every mesh victim needs to be prepared for the strong possibility of being one of the 95% that gets no cookie at all.
Given those odds, I would be negligent to recommend to any of my clients that they spurn any eventual settlement. Not because I don’t understand their pain, not because I don’t want to work on their case, and not because I think they deserve anything less than full compensation. But as long as the eventual settlement is like all other MDL settlements before it in which the most serious claims get the most compensation, I will spend as much of my time as needed to show my clients why they are coming out ahead in the end. Because the only maxim as proven as “life isn’t fair” is that a “bird in the hand beats two in the bush” every time.
By Halley B. (Hal) Lewis, III, of Fonvielle Lewis Foote & Messer (wrongfullyinjured.com)
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