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Ethicon Media Monitoring 5/27/2019
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Two Men Charged in Pelvic Mesh Removal Scheme
May 24, 2019 | The New York Times
By Matthew Goldstein
Federal prosecutors in Brooklyn have charged a physician and the owner of a medical consulting firm over a scheme to persuade women to have their pelvic mesh implants surgically removed to bolster the value of lawsuits against the devices’ manufacturers. -
Doctor, medical funder charged in New York in transvaginal mesh fraud
May 25, 2019 | Reuters (Also in Yahoo News, Medical Dialogues, U.S. News & World Report, ET Healthworld)
By Brendan Pierson
A doctor and a surgical funding consultant were arrested on Friday on charges that they defrauded women into having unnecessary surgeries to remove transvaginal mesh implants in order to profit from settlements paid to the women by mesh manufacturers, U.S. prosecutors in New York said. -
Doctor, Consultant Charged In Pelvic Mesh Removal Scheme
May 24, 2019 | Law 360
By Pete Brush
A Florida doctor and a Detroit medical consultant were arrested Friday for what Brooklyn U.S. Attorney Richard P. Donoghue called a scheme to get New York women to travel out-of-state for transvaginal mesh implant removals based on misrepresentations about health and economic benefits. -
Report: J&J faces uphill battle in $20 million pelvic mesh appeal
May 24, 2019 | Mass Device
By Nancy Crotti
Johnson & Johnson (NYSE:JNJ) is appealing a $20 million verdict in a 2018 Indiana pelvic mesh trial, but a federal appeals court panel pushed back against the device maker’s argument this week, according to a published report. -
Shocking number of medical device malfunctions reports hidden from public
May 25, 2019 | Komando
By Janet Perez
...According to Kaiser Health News, the FDA's exemptions included some common and some controversial devices such as pelvic mesh, surgical staples, balloon pumps for improving circulation, breathing machines and breast implants.
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Two Men Charged in Pelvic Mesh Removal Scheme
May 24, 2019 | The New York Times
By Matthew Goldstein
Federal prosecutors in Brooklyn have charged a physician and the owner of a medical consulting firm over a scheme to persuade women to have their pelvic mesh implants surgically removed to bolster the value of lawsuits against the devices’ manufacturers.
The scheme alleged in the indictment on Friday is one of the more unsavory sides of the mass tort litigation against a half-dozen manufacturers of pelvic mesh, which has led to nearly $8 billion in settlements for roughly 100,000 women.
The six-count indictment outlines a plot in which bribes and kickbacks were paid to get women from across the country referred to the doctor and others for the surgery. The procedures were paid with money from high-interest cash advances arranged by a group of so-called litigation finance firms.
Pelvic mesh, which was used to treat health issues caused by a woman’s bladder pressing against her vagina, has led to severe complications for some women, such as bleeding and pain during sex. Sales of the mesh have been halted over safety concerns.
In the Brooklyn case, prosecutors charged Dr. Christopher Walker and Wesley Blake Barber, the medical consultant, with wire fraud and violations of the federal Travel Act.
The indictment said the two men had been part of plan “to entice the victims” to undergo the surgery while “falsely and fraudulently” describing the health risks associated with pelvic mesh implants and playing down the possible complications from removal surgery.
Dr. Walker was arrested on Friday in Florida, and Mr. Barber was arrested in Dallas, said John Marzulli, a spokesman for Richard P. Donoghue, the United States attorney for the Eastern District of New York.
Fritz Scheller, a lawyer for Dr. Walker, said his client would contest the charges. A lawyer for Mr. Barber was not immediately available for comment.
Prosecutors opened the investigation last year after a report in The New York Times about a network of consultants, doctors, lawyers and financiers that recruited women with mesh implants. The women were sent to medical centers in Florida for the removal surgery without regard to whether they were having problems with the implants.
The financing firms provided cash advances with high interest rates in anticipation of a favorable personal injury settlement for the women. The indictment said some women “were responsible for the medical bills associated with the removal surgeries even if they did not receive a settlement.”
The larger settlements in the mesh litigation have gone to women who had the implant removed. Mr. Barber and Dr. Walker are accused of being involved in a network that sought to take advantage of that fact by persuading woman — some of them having only minor problems with the mesh — to have it removed in an assembly-line surgical procedure in Florida.
“The defendants and their co-conspirators exploited and defrauded women, misrepresenting health risks,” Mr. Donoghue said.
The indictment refers to complaints from three unidentified women who said they had been contacted by representatives from the finance firms and Mr. Barber’s companies, Surgical Assistance and Medical Funding Consultants, to determine whether they were interested in having the mesh removed. The charging document said the women had been unaware that Dr. Walker and others paid kickbacks and bribes to Mr. Barber’s firms for the surgical referrals.
The companies that financed the surgery were not identified by name in the indictment and were not charged with any wrongdoing. The charging document said one of the companies was based in Brooklyn and the other in Boca Raton, Fla.
A person familiar with the matter but who declined to be identified because the matter was not public said the Brooklyn finance firm was LawCash, which provides cash advances against potential legal settlements. LawCash was one of two firms mentioned in the Times article a year ago.
George Arzt, a LawCash spokesman, said the company had no comment.
When complaints about the mesh started arising about a decade ago, lawyers aggressively advertised for women who had received implants, and signed them up by the thousands to file claims against the manufacturers. But some women have complained that money being offered by manufacturers was too low given that the complications from the mesh can get worse over time.
The average settlement in the mesh litigation is less than $60,000 before legal fees are deducted.
In light of the complaints, some manufacturers voluntarily stopped selling mesh implants. The Food and Drug Administration last month ordered the two companies still selling surgical mesh to treat pelvic organ prolapse to stop distributing it in the United States.
https://www.nytimes.com/2019/05/24/business/vaginal-mesh-surgery-arrests.html
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Doctor, medical funder charged in New York in transvaginal mesh fraud
May 25, 2019 | Reuters (Also in Yahoo News, Medical Dialogues, U.S. News & World Report, ET Healthworld)
By Brendan Pierson
A doctor and a surgical funding consultant were arrested on Friday on charges that they defrauded women into having unnecessary surgeries to remove transvaginal mesh implants in order to profit from settlements paid to the women by mesh manufacturers, U.S. prosecutors in New York said.
Urogynecologist Christopher Walker, 49, of Florida, and Wesley Barber, 49, of Michigan, were both charged with wire fraud and conspiracy in an indictment unsealed in federal court in Brooklyn.
Barber, who is the owner of Surgical Assistance Inc and Medical Funding Consultants LLC, was arrested in Texas and Walker in Florida, authorities said.
“Dr. Walker maintains his innocence and is committed to defending his case vigorously,” said Fritz Scheller, a lawyer for Walker, in an email. A lawyer for Barber could not immediately be reached.
Transvaginal mesh implants, which have been pulled from the U.S. market, were commonly implanted in women to repair weakened or damaged tissue and provide support in cases of pelvic organ prolapse. Tens of thousands of lawsuits have been filed in recent years against medical device manufacturers, saying the implants caused pain, perforations, urinary problems, bleeding and other injuries.
Manufacturers, including Boston Scientific and Johnson & Johnson, eventually reached agreements to settle many of those lawsuits.
In the indictment unsealed on Friday, prosecutors said that Walker and Barber sought to profit from women who had their mesh implants removed and were entitled to larger settlement payments under those agreements than women who did not.
Walker, Barber and others persuaded women to have their mesh implants removed by lying to them about the health risks they posed, and told them they would have to travel to have the procedure done by specific doctors, including Walker, prosecutors said.
Barber’s companies funded the surgeries, either by purchasing the women’s medical debts or making direct loans, allowing them to collect money from any settlements received by the women, prosecutors said. Some of the funding agreements included “exorbitant” interest rates and left the women on the hook even if they never received a settlement, according to the indictment.
Walker paid kickbacks and bribes to Barber in exchange for referrals to perform the surgeries, according to prosecutors.
The U.S. Food and Drug Administration last month ordered the two remaining companies selling transvaginal mesh, Boston Scientific and Coloplast A/S, to halt sales of the product, citing safety concerns.
https://www.reuters.com/article/us-usa-crime-surgicalmesh/doctor-medical-funder-charged-in-new-york-in-transvaginal-mesh-fraud-idUSKCN1SU2ES
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Doctor, Consultant Charged In Pelvic Mesh Removal Scheme
May 24, 2019 | Law 360
By Pete Brush
A Florida doctor and a Detroit medical consultant were arrested Friday for what Brooklyn U.S. Attorney Richard P. Donoghue called a scheme to get New York women to travel out-of-state for transvaginal mesh implant removals based on misrepresentations about health and economic benefits.
Christopher Walker, 49, of Orlando, Florida, and Wesley Blake Barber, 49, of Detroit were arrested on charges including fraud and conspiracy. Walker was to appear before Orlando U.S. Magistrate Judge Gregory Kelly, and Barber was to appear before Dallas U.S. Magistrate Judge Rebecca Rutherford.
Details of the court appearances were not available and requests for comment from defense counsel were not immediately returned.
The scheme sought to take advantage of a multidistrict litigation settlement for thousands of plaintiffs injured by defective pelvic mesh implants, prosecutors said.
Walker, a urogynecologist, and Barber enticed women who had the implants — including at least three unnamed women from Brooklyn — to travel out of state and undergo removal procedures by fraudulently misrepresenting both the health risks associated with the TVM implants and the need to travel to use pre-selected doctors, according to the charges.
The women were persuaded to agree to repay the costs of their removal procedures, including "exorbitant" interest rates, to be funded by their MDL settlement payouts, according to the indictment. Some were also put on the hook for their medical costs if they did not receive a settlement, according to the charges.
Barber, who owns and operates Surgical Assistance Inc. and Medical Funding Consultants LLC, also paid "kickbacks and bribes" to Walker, the owner of MedSurg Holdings LLC, for the referrals, the charges say.
Barber's companies allegedly coordinated the removal surgeries and then purchased and resold medical debts incurred by the women, according to the charges.
"The defendants and their co-conspirators exploited and defrauded women, misrepresenting health risks from TVM implants to pressure the women to undergo procedures to the defendants' economic advantage," Donoghue said in a statement.
Walker is represented by Mark E. NeJame of NeJame Law.
Barber is represented by Fritz Scheller PL.
The government is represented by Andrew Estes of the U.S. Attorney's Office for the Eastern District of New York.
The case is USA v. Barber et al., case number 1:19-cr-00239, in the U.S. District Court for the Eastern District of New York.
https://www.law360.com/articles/1163146/doctor-consultant-charged-in-pelvic-mesh-removal-scheme
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Report: J&J faces uphill battle in $20 million pelvic mesh appeal
May 24, 2019 | Mass Device
By Nancy Crotti
Johnson & Johnson (NYSE:JNJ) is appealing a $20 million verdict in a 2018 Indiana pelvic mesh trial, but a federal appeals court panel pushed back against the device maker’s argument this week, according to a published report.
J&J’s Ethicon subsidiary claims it was wrongly barred from presenting evidence from the FDA saying that its Prolift pelvic mesh device was safe and effective, said the report by Law360. The Seventh Circuit judges’ panel was hesitant to agree, given that other federal appellate courts have decided differently.
“We would be running upstream against other circuits reversing on that ground,” Judge Diane Sykes said during oral argument, Law360 reported. “Federal law did not prohibit your client from redesigning this implant to be safer and submitting a request for a safer design.”
Ethicon’s lawyers claimed the trial jury heard “one-sided fiction,” partly because the company wasn’t allowed to present the FDA findings. The jury found that the company negligently designed Prolift and then failed to warn healthcare providers and patients about its problems.
Indiana resident Barbara Kaiser and her husband Anton Kaiser sued Ethicon in March 2012, after learning that the Prolift mesh her doctor implanted in 2009 to treat her pelvic organ prolapse might be causing her low pelvic pain.
The lawsuit accused J&J and Ethicon of concealing the problems with Prolift, which allegedly include high failure, injury, and complication rates and “frequent and often debilitating re-operations,” according to the Kaisers’ complaint. Prolift “caused severe and irreversible injuries, conditions, and damage to a significant number of women, including plaintiff,” the complaint said.
The U.S. District Court for Northern Indiana jury awarded Barbara Kaiser $10 million in damages and $25 million in punitive damages in March 2018 but gave nothing to her husband. The trial court judge reduced the punitive damages award to $10 million.
“Excluding the FDA evidence in this case is equivalent to dropping a soldier in the middle of a battlefield with no weapon or even shoes,” Ethicon attorney Lisa Blatt told the appeals court panel, according to Law360.
Ethicon also claims that the trial judge should have used federal law requiring FDA approval for device designs as the standard for this case rather than Indiana’s design defect law, and therefore should have dismissed Kaiser’s lawsuit. The company also claims that Kaiser did not prove that the mesh was unreasonably dangerous, that a different design would have prevented her injuries, or that her surgeon failed to understand the device’s risks to patients, the report said.
The jury’s verdict “contradicts the evidence that the product was properly designed and that the company appropriately informed surgeons of pertinent complications,” J&J spokeswoman told MassDevice following the 2018 trial.
https://www.massdevice.com/report-jj-faces-uphill-battle-in-20-million-pelvic-mesh-appeal/
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Shocking number of medical device malfunctions reports hidden from public
May 25, 2019 | Komando
By Janet Perez
Imagine if you had a critical medical device implanted only to find out the government had hidden tens of thousands of reports of the product malfunctioning? This isn't a hypothetical situation for 268,000 Americans.
The U.S. Food and Drug Administration (FDA) allowed Medtronic to secretly log 50,000 reports of malfunctions in its Sprint Fidelis heart device, according to investigations by Kaiser Health News.
That's scary stuff. Making it worse is the fact that the FDA allowed many other companies to hide reports of faulty medical products. This is becoming an increasingly critical issue as new tech advances are made in the diagnosis and treatment of various medical conditions.The FDA kept complaints private
The FDA has a database called MAUDE (Manufacturer and User Facility Device Experience) that is open to the public. This allows consumers to investigate whether a product has received reports of malfunctions or injuries, allowing them to make informed decisions about their health and safety.
But for decades, the FDA also operated a shadow site that allowed some companies to submit incident reports not open to the public. The FDA gave some companies this option for a wide variety of medical devices.
According to Kaiser Health News, the FDA's exemptions included some common and some controversial devices such as pelvic mesh, surgical staples, balloon pumps for improving circulation, breathing machines and breast implants.
Since 2016, the FDA’s private site has accumulated around 1.1 million reports of incidents and injuries about malfunctioning medical devices, according to Kaiser Health News.
The FDA said the private site was developed to cut down on paperwork. But the agency kept the existence of the site so quiet that many doctors, consumer advocates and some high-ranking FDA employees had no idea there even was such a thing.
Doctors and health advocates said concealing reports keeps necessary safety data away from patients who are trying to assess important health risks they may face, according to Kaiser Health News.
The FDA said reports in the private site were available to the public, but even if a consumer were aware such documents existed, they would have to file a Freedom of Information Act request that could take as long as 2 years to process.
The FDA has now announced it will be shutting down the so-called “alternative summary reporting” repository, ending exemptions and making reports in the private site open to the public "within weeks."Sprint Fidelis malfunctions put patients at risk
Medtronic recalled the Sprint Fidelis device in 2007. By that time, however, the device had been implanted in about 268,000 patients.
The device consists of a pair of wires and a defibrillator to jolt the heart back into a regular rhythm. But the device was giving some patients random, harmful zaps. Worse, they sometimes failed during actual cardiac emergencies.
Many of the patients who have had such experiences now have to choose whether to just live with the device or have it surgically removed in a procedure that could turn lethal.
https://www.komando.com/happening-now/568959/shocking-number-of-medical-device-malfunctions-reports-hidden-from-public
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