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Ethicon 8/20
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Reuters: Medical funding industry gets boost from vaginal mesh litigation
Aug 19, 2015 | Fierce Medical Devices
By Emily Wasserman
As companies such as Boston Scientific ($BSX), Johnson & Johnson ($JNJ) and C.R. Bard ($BCR) continue to face claims over allegedly defective vaginal meshdevices, new evidence is mounting against an industry that profits off women undergoing surgeries to remove the implants. -
No retrial for Ethicon in $3m pelvic mesh loss
Aug 19, 2015 | Mass Device
By Brad Perriello
A federal judge today shot down a bid by Johnson & Johnson(NYSE:JNJ) subsidiary Ethicon to overturn a $3.3 million judgment in a pelvic mesh product liability lawsuit and denied the company’s move for a new trial. -
Ethicon Denied Retrial After $3M Bellwether Mesh Verdict
Aug 19, 2015 | Law360
By Jody Godoy
A West Virginia federal judge refused to throw out a $3.27 million jury verdict against Johnson & Johnson unit Ethicon Inc. in a bellwether pelvic mesh implant suit on Wednesday, saying the evidence at trial was sufficient to support the verdict. -
Team 10: Woman says caller asked her to lie about controversial surgery
Aug 19, 2015 | ABC 10 News
By Melissa Mecija
Commercials advertising those lawsuits over transvaginal mesh surgeries air regularly on television. The surgeries are supposed to fix internal female organs when they become weak. -
Newlywed and Yate estate agent Kimberley Vallis joins Sling the Mesh campaign urging other mums not to have TVT bladder sling operation
Aug 19, 2015 | Gazette Series
By Alexandra Womack
BRIDE Kimberley Vallis looks a picture of happiness at her Rangeworthy wedding on Saturday but her smile hides the agony she was in. -
Dr. Walker Answers Your Questions About Pelvic Mesh
Aug 19, 2015 | Mesh Medical Device News Desk
By Jane Akre
Mesh News Desk, August 19, 2015~ MND editor, Jane Akre asked many of you on our Facebook page to pose questions to Dr. Christopher Walker, a urogynecologist located in Orlando, Florida.
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Reuters: Medical funding industry gets boost from vaginal mesh litigation
Aug 19, 2015 | Fierce Medical Devices
By Emily Wasserman
As companies such as Boston Scientific ($BSX), Johnson & Johnson ($JNJ) and C.R. Bard ($BCR) continue to face claims over allegedly defective vaginal meshdevices, new evidence is mounting against an industry that profits off women undergoing surgeries to remove the implants.
The medical funding industry, which traditionally covers underinsured or uninsured patients involved in workers' compensation or slip-and-fall cases, has gotten a boost as mass litigation rages on over vaginal mesh devices, Reutersreports. At least several hundred women with claims against vaginal mesh manufacturers have used medical funders to finance surgeries, according to court records and interviews seen by the news outlet. But the system often works to a patient's disadvantage.
Funders typically purchase medical bills at steep discounts from doctors, hospitals or other providers who offered care during mesh suits. The funders then agree to front patients some money to get their implants removed, as long as individuals accept a medical lien on any settlement they receive.[
Even though medical lenders say patients are made aware of the lien before they accept a loan, the final lien is often larger than anticipated, according to theReuters story. For example, medical funding company MedStar paid a surgeon $17,000 to remove an implant from a mesh plaintiff, Tracy Rizzo. But the company and its affiliates then charged Rizzo more than $60,000 for its services--an amount well above what she expected to pay, she told the news outlet.
"I don't begrudge anybody their share," Rizzo said, as quoted by Reuters. "But when businesses are abusing already injured people, it is greedy, it is wrong and it shouldn't be allowed."
MedStar eventually agreed to cut down Rizzo's claim from $60,000 to $32,500. But Rizzo said the amount is still too high--especially in light of continuing medical problems after she received the surgery, Reuters reports. MedStar owner Daniel Christensen did not respond to the news outlet's requests for comment.
Still, medical lenders are standing by their business. The system allows underserved patients to get treatment and provides access to top surgeons, lenders told Reuters. And the profits that companies make are fair payment for settlements that might never materialize, they argue. "Where else is the patient going to go?" Otto Fisher, a broker who connects lenders with physicians and medical centers, told the news outlet. "The only way to get surgery with top doctors is medical funding."
Plus, devicemakers are not paying for removal procedures after their products are found defective, leaving many women with few alternatives, James Lee, an attorney for mesh plaintiffs including Rizzo, told Reuters in an email. "Even today, with multiple verdicts finding these mesh products defective and the manufacturers liable, not one of the mesh defendants have helped any of the women absent a lawsuit and a settlement," Lee said.
But devicemakers and other industry advocates are striking back, saying that funders may push unnecessary surgeries or take advantage of desperate or ill-informed patients. "The plaintiff is the only one who cares" about the size of the lien, "and by the time she finds out, it's too late," Mark Fischer, a Kentucky lawyer who represents insurers, told the news outlet. "It's outrageous."
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No retrial for Ethicon in $3m pelvic mesh loss
Aug 19, 2015 | Mass Device
By Brad Perriello
A federal judge today shot down a bid by Johnson & Johnson(NYSE:JNJ) subsidiary Ethicon to overturn a $3.3 million judgment in a pelvic mesh product liability lawsuit and denied the company’s move for a new trial.
A jury in the U.S. District Court for Southern West Virginia awarded Jo Huskey and her husband damages of $3.2 million, finding in September 2014 that Ethicon’s TVT-O transvaginal sling caused her injuries and that the company failed to warn about the stress urinary incontinence treatment’s risks.
Ethicon asked Judge Joseph Goodwin, who’s overseeing 10s of thousands of product liability lawsuits brought over pelvic mesh products, to overturn the verdict or, alternatively, to grant a new trial.
But Goodwin today declined to disturb the jury’s verdict, finding that “[t]he evidence on the defective design claim is particularly strong and is capable of upholding the verdict on its own.”
A reasonable jury, Goodwin ruled, could conclude that the risks of the TVT-O product “are not justified by the benefits, and as a result, the TVT-O cannot, as a matter of law, qualify as an unavoidably unsafe product.”
“In short, while Ethicon produced evidence of the TVT-O’s usefulness and benefits, the plaintiffs countered with evidence of the TVT-O’s high risks of injury and how Ethicon could have mitigated those risks through alternative designs,” Goodwin wrote, according to court documents. “Taking the evidence as a whole and viewing it in the light most favorable to the plaintiffs, it is clear that reasonable persons could balance the risks and benefits against Ethicon. As a result, I cannot displace the jury’s verdict on these grounds.”
Goodwin also cited evidence produced at trial that Huskey’s physician would not have used the TVT-O device had she been warned that it was contra-indicated for active patients like Huskey. The doctor was also unaware of other risk factors from the product, the judge ruled, including that the mesh itself could cause infection and that the amount of mesh material in the product could cause more complications.
“The plaintiffs presented sufficient evidence on Ethicon’s knowledge of dangerous propensities of the TVT-O and failure to warn about those propensities such that a reasonable jury could conclude that Ethicon was negligent,” Goodwin wrote.
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Ethicon Denied Retrial After $3M Bellwether Mesh Verdict
Aug 19, 2015 | Law360
By Jody Godoy
A West Virginia federal judge refused to throw out a $3.27 million jury verdict against Johnson & Johnson unit Ethicon Inc. in a bellwether pelvic mesh implant suit on Wednesday, saying the evidence at trial was sufficient to support the verdict.
U.S. District Judge Joseph R. Goodwin picked apart Ethicon's arguments in its motion for judgment as a matter of law, or alternately for a new trial. The judge found the plaintiffs had brought sufficient evidence that Ethicon failed to warn Jo Huskey’s doctor of certain risks implicit in implanting the company's TVT-O polypropylene mesh product, and even stronger evidence that there were defects in the product's design.
“I decline to disturb the jury’s verdict in this case because, as explained below, a reasonable jury could find in favor of the plaintiffs on each of their claims,” Judge Goodwin said. “The evidence on the defective design claim is particularly strong and is capable of upholding the verdict on its own.”
Huskey sued Ethicon in 2012, claiming the polypropylene mesh in her TVT-O sling eroded, causing her severe, ongoing pain as the mesh could not be entirely removed through surgery. Her husband, Allen, also sued for loss of consortium.
The suit was the first bellwether case to go to trial in the massive multidistrict litigation against Ethicon over its mesh implants. The trial concluded on Sept. 5, with the jury deliberating for about three hours before returning its compensatory damages verdict.
In its renewed motion for judgment as a matter of law, which the judge said he had deferred ruling on during the trial, Ethicon argued against the failure to warn claim, saying Huskey's doctor testified she would use the TVT-O again.
But the judge shot that argument down, pointing to the doctor's testimony that she would not have implanted the device in Huskey had she known it carried a higher risk of causing pain in physically active women.
The judge also ruled that Huskey had presented “significant evidence” of the risks of the device, such that a reasonable jury could find that the risks outweighed the device's benefits, a major pillar of the design defect claim.
Ethicon argued that the design defect claims were barred by a product liability doctrine known as “comment k,” which holds some products, such as vaccines, are unavoidably unsafe though not unreasonably dangerous given the harm they are meant to abate. The company also argued that the jury should have been instructed to use the criteria in its consideration.
Pointing to his earlier consideration of the doctrine in another mesh case, the judge said that comment K is redundant under Illinois law, which was applied in the case because Huskey is an Illinois resident. Like West Virginia, the state has adopted a risk-utility standard for weighing whether a product was defective. That standard was incorporated into the jury instructions, the judge said.
Knives, gasoline and even fondue pots carry some level of risk, the judge said. These products can be found defective by balancing their intended utility against the inherent risks of using them, and medical products are no different, the judge said.
“The TVT-O is not unique simply because it is a prescription medical device,” Judge Goodwin held. “Rather, the medical benefits and side effects are factors for the jury to consider in weighing the product’s risks against its utility”
Judge Goodwin was not swayed by Ethicon's argument that it should get a new trial because the weight of the evidence was in its favor and the court had undermined the company's success by allowing prejudicial evidence. Ethicon had not shown there were “exceptional circumstances” or “grievous error” that warranted overruling the jury, the judge said.
Edward Wallace of Wexler Wallace LLP, who represents the Huskeys, told Law360 plaintiffs counsel are “very happy” for the couple and hope the ruling drives home the importance of the verdict.
“The bellwether process is designed to give the parties an understanding of the value of their claims. That should mean something to Ethicon,” Wallace said.
Matthew Johnson, director of communications at Ethicon, said the company now plans to appeal the judgement.
“The evidence showed the TVT-O midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research, development and marketing of the product,” Johnson said. “We empathize with all women suffering from stress urinary incontinence, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events.”
Huskey is represented by Edward A. Wallace and Mark R. Miller of Wexler Wallace LLP, Fidelma L. Fitzpatrick of Motley Rice LLC, and Thomas P. Cartmell and Jeffrey M. Kuntz of Wagstaff & Cartmell LLP.
Ethicon and J&J are represented by Christy D. Jones of Butler Snow O'Mara Stevens & Cannada PLLC and David B. Thomas of Thomas Combs & Spann PLLC.
The case is Huskey et al. v. Ethicon Inc. et al., case number 2:12-cv-05201, in the U.S. District Court for the Southern District of West Virginia. -
Team 10: Woman says caller asked her to lie about controversial surgery
Aug 19, 2015 | ABC 10 News
By Melissa Mecija
A controversial medical procedure is at the center of thousands of lawsuits.
Commercials advertising those lawsuits over transvaginal mesh surgeries air regularly on television. The surgeries are supposed to fix internal female organs when they become weak.
Karen Rasmussen is familiar with those commercials. Recently, she received a call from someone who said she worked for the U.S. Medical Agency.
"She asked me if I had any bladder mesh surgeries, and I said, 'No … I've had surgeries before, but nothing like that,'" Rasmussen said.
That did not stop the caller, who transferred her to a supervisor.
Rasmussen said that person asked if she would be "willing to say that you've had a bladder mesh surgery."
"I'm like, 'Excuse me? You want me to say that I had one?' And she said, 'Yes,'" Rasmussen said, appalled that the caller was asking her to lie.
The California Department of Public Health reported similar calls made last year. A warning by the agency said callers identified themselves as working for the health department. They then "hint at offers of compensation" to get "private information" from their targets -- primarily women.
But it could also be something else.
Court documents show an attorney representing Johnson & Johnson, a maker of the medical device for the surgery, claimed women are being solicited to join these lawsuits. The company said callers "try to entice each woman into filing a lawsuit" even if they never had "an injury or ... mesh implant at all."
For Rasmussen, lying just wasn't going to happen.
"I work here at Holy Cross Lutheran Church," Rasmussen said.
"I was very upset," she told Team 10, when asked to lie by the caller.
Rasmussen was not able to get the name of the caller. She said she knew the caller was a fake, since the U.S. Medical Agency does not exist.
If you receive a similar call, you can file a complaint with the Office of the Attorney General.
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Aug 19, 2015 | Gazette Series
By Alexandra Womack
BRIDE Kimberley Vallis looks a picture of happiness at her Rangeworthy wedding on Saturday but her smile hides the agony she was in.
Mother-of-one Kimberley, who married her partner Tony at Holy Trinity Church, is in constant excruciating pain after undergoing an operation to have a TVT bladder sling fitted in January last year.
The slight of build 29-year-old suffered incontinence after having her son Hayden, who weighed 8lb 6oz at birth and is now aged five.
“It is a subject that not many people talk about,” said Kimberley, who used to work at Edison Ford estate agents in Yate but is due to start a new job at the Bristol Royal Infirmary.
“It is a bit of a taboo that people get embarrassed to discuss, but the truth of the matter is so many women suffer after giving birth. Especially if they are small like me and have had a big baby.
“Also I suffered SPD which means relaxing weakens muscles which makes it more likely for a woman to have weakened pelvic floor muscles.
“I would have accidents doing simple stuff like putting the kids into the car. I wanted to be like a regular mum and be able to jump about and play and not worry so after two years, under the care of the incontinence nurse and then physiotherapy treatment which didn’t work, I was offered the TVT mesh bladder sling.”
She said the operation had offered her real hope but had given her nothing but more problems.
“Six months after the operation I had a check up, by which time I had a really painful lump in my groin and in May 2015 they took out the lump. The pain however has got so much worse.
“ It is shooting electric pains, lifting heavy objects is impossible, I have to sit on a cushion to ease the pain, I struggle to drive as my clutch foot sends pain into my leg and hips.”
She said she had been so worried about getting through her wedding day in so much pain she had a steroid injection and took other painkillers.
“I had the best day,” she told the Gazette this week. “I didn’t limp and hurt from too much dancing and walking but hey ho.”
Kimberley, who is also now stepmother to her husband’s two-year-old son Edward, is calling on other women not to have a bladder sling fitted and has joined a national Sling the Mesh campaign which opposes the procedure.
“I had this operation as I wanted to be a mother and be able to run around and play without the worry of stress urinary incontinence,” she added.
“It seemed like the perfect solution. I was warned that if I wanted another child then I would have to have a Caesarean, but I was not warned of the pain that might happen.
“I would say to anybody considering it please don’t have it done as it is not worth this much pain.”
For more information on the campaign search Sling the Mesh on Facebook.
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Dr. Walker Answers Your Questions About Pelvic Mesh
Aug 19, 2015 | Mesh Medical Device News Desk
By Jane Akre
Mesh News Desk, August 19, 2015~ MND editor, Jane Akre asked many of you on our Facebook page to pose questions to Dr. Christopher Walker, a urogynecologist located in Orlando, Florida. He is one of the new doctors around the country who is capable of addressing mesh explants (removals) with a minimum of harm to the women. Dr. Walker is also a sponsor of MND.Dr. Walker also has a kind and caring nature and relates the ethics of mesh use to what he would do for the people he loves. Please read his profile on Mesh News Desk here.
The following are your questions and his answers. The women will remain anonymous as many are still represented by legal counsel.
S. asks:” First of all do you often recommend a full mesh removal? If a woman wants a full mesh removal, what issues do you weigh and how often are you able to do a full removal?
Dr. Walker: “Each patient will require an individualized treatment plan.. many variables have to be taken into consideration when deciding if a partial vs. full mesh implant removal is required such as the patients presenting complaint, presence of a fulminant mesh infection etc…; With the above said, most patients do not require a full mesh implant removal.”
Statue, WikiCommons
T. asks: “I’d love to know if after partials, then finally full removal of my mesh if there is ever hope for pain relief in the pudendal, and obturator nerves. I have severe scarring, and have seen little if any improvement.”
Dr. Walker: “Due to the process of scarring and nerve entrapment, some patients have permanent lifelong nerve injuries and the sequelae thereof, which includes pain and dysesthesia.”
S. asks: “What causes stabbing, like a knife in the vagina five years later?”Dr. Walker: “This symptoms is most likely due to nerve injury which is manifesting as sensory neuropathy.”
J. asks: “As far as surgical questions does mesh removal from a TVT-O do more harm than good? Why does a partial removal cause more pain?
Dr. Walker: “A partial mesh implant removal should not cause more pain. In fact most patients (>80%) have a resolution of their pelvic pain with this procedure.”TVT-O from IFU
E. asks: “Yes, I had 3 partial removals and each was worse plus 4 fistulas and infections. The pain never stopped and I still have pain. Wonder what made the bladder stop working?
Dr. Walker: “The process of scarring and tissue fibrosis which will occur after each surgical repair in addition to the severe tissue inflammation in response to a fistula can result in nerve entrapment and permanent pelvic pain. The location of the fistulas to the bladder neck can affect the continence mechanism and thus result in a permanent voiding dysfunction.”
S. asks: “How do we get a Dr to listen to us?? What can we say that would make a difference in the way we are treated?? Getting really tired of hearing; “ITS ALL IN YOUR HEAD, YOUR JUST DEPRESSED”!! I’m thinking anyone would be depressed if they put on our shoes!!!!
Dr. Walker: “Firstly, pelvic pain and the many complications that can result from a mesh implant are not imaginary!!!. I suggest seeking the assistance of a Board Certified Urogynecologist.”L. asks: “Does Dr Walker believe that the ingredients that Mesh is made of have a long term effect in a person’s body? And the more years you have it in, the more distributed it goes in body and filters into organs?”Dr. Walker: “The Polypropylene mesh usually has an impact locally versus general side effects. It is, however, known that some patients demonstrate an allergic reaction to Polypropylene and thus may have IgE-mediated-like reactions such as contact urticaria and a possible systemic reaction.”
Prolene mesh and particles
D. asks: “What can we do to rid our bodies of the toxic substance that mesh leaves behind in our cells?”
Dr. Walker: “Unfortunately the scientific literature is sparse in this arena and thus we truthfully do not know what possible systemic effects may arise in the future from polypropylene mesh implants.”
S. asks:
“Is it possible to be allergic to the mesh implant?Dr. Walker: “There have been cases reported to suggest an IgE-mediated-like reaction such as contact urticaria and a possible systemic reaction. To confirm if one has an allergy to the Polypropylene mesh a Patch test could be performed by an Allergist.”
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