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Ethicon Media Monitoring 09/28/2015
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Hip implant maker claims surgical funder inflated patients' bills
Sep 28, 2015 | Reuters
By Alison Frankel and Jessica Dye
A unit of Johnson & Johnson that makes artificial hips has accused a surgical funding company of seeking excessive profits from financing surgery for patients suing over the devices. -
Trial Day 5 – Doctor Would Not Use Prosima Pelvic Mesh Again
Sep 26, 2015 | Mesh Medical Device News Desk
By Jane Akre
Carol Cavness sued Ethicon in 2014 after having a Prosima polypropylene mesh device implanted transvaginally two years earlier to treat pelvic organ prolapse (POP). -
J&J’s Prosima Pelvic Mesh – A Game Changer?
Sep 25, 2015 | Mesh Medical Device News Desk
By Jane Akre
Dr. Pence is often called into testify for the injured in these cases because her expertise is in how to bring drugs and devices to market, and presumably, how not to. -
Sling Complications
Sep 25, 2015 | Bella Online
By Denise Howard
Stress urinary incontinence is a common problem in women after childbearing and worsens with age. -
Amidst Stryker Lawsuits, Calls to End FDA Fast-Track Loophole
Sep 27, 2015 | LawyersandSettlements.com
By Gordon Gibb
When one considers that a full premarket approval (PMA) process for a new medical device is measured in years, the mere two months it took to get the Stryker Rejuvenate Modular Hip System approved for market seems remarkably short.
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Hip implant maker claims surgical funder inflated patients' bills
Sep 28, 2015 | Reuters
By Alison Frankel and Jessica Dye
A unit of Johnson & Johnson that makes artificial hips has accused a surgical funding company of seeking excessive profits from financing surgery for patients suing over the devices.
The claim by DePuy Orthopaedics marks the first time that a device maker in the multibillion-dollar litigation over faulty hip replacements has publicly raised concerns about the controversial business of surgical funding, which has increasingly become a part of mass litigation over medical devices.
Surgical funders essentially invest in operations on injured plaintiffs. If a litigant can't afford surgery to correct problems allegedly caused by medical devices, the funders will step in to purchase medical bills at a deep discount from physicians, hospitals and others who have provided care to the patient. When the patient's lawsuit settles, the funder reaps a profit by placing a lien on the settlement for the full amount of the patient's surgical bill.
Following a Reuters report about the role of Texas-based medical funder Medstar in pelvic mesh litigation, DePuy Orthopaedics has raised new questions about Medstar in litigation over its all-metal ASR hip implants.
In an Aug. 31 filing in federal court in Toledo, Ohio, the defendant asked the court to compel MedStar to turn over more information about the liens, so it can investigate whether the funder schemed to "artificially inflate damages claims."
According to DePuy, MedStar submitted claims for nearly $1.5 million for 11 surgeries that should have cost no more than $336,000. DePuy contends MedStar is attempting to collect twice as much as it paid to acquire the medical bills and four times what DePuy considers a reasonable cost for the patients' care.
DePuy's filing cites the Reuters report on MedStar's actions in the mesh litigation.
Because of an unusual feature of DePuy's settlement, MedStar is seeking payment directly from DePuy, rather than from the 11 patients whose hip-replacement surgery it funded. DePuy says it needs access to the funder's records before it will pay. If the claims are ultimately determined to be improper, DePuy might refuse to pay, possibly leaving plaintiffs on the hook for the full cost of their medical care.
MedStar founder Dan Christensen said his claims in the DePuy hip implant litigation are "usual, customary and reasonable." According to Christensen, a medical pricing expert retained by MedStar deemed the bills it submitted to DePuy to be within four percent of typical hip replacement charges. He also said medical providers, and not MedStar, determine such charges.
Last month Reuters reported that in cases involving pelvic mesh, another medical device that is the target of mass litigation, funders' liens on patients' settlements sometimes spiraled to as much as 10 times what private insurers or government programs like Medicaid would pay for the same procedures [ID: nL3N10S54U]
In such cases, patients wind up recovering much less from settlements than they might have if funders weren't involved. Patients who rely on medical funders tend to be uninsured or unable to afford cash deductibles or out-of-network fees charged by their doctors.
In the pelvic mesh litigation, manufacturers American Medical Systems, Johnson & Johnson's Ethicon subsidiary, Boston Scientific and C.R. Bard obtained records and deposition testimony on the Texas-based surgical funder MedStar after learning a MedStar representative was soliciting physicians to perform mesh removal surgery.
DePuy agreed in 2013 to pay about $2.5 billion to settle approximately 8,000 personal injury suits over ASR hip implants. The company had previously recalled the metal-on-metal devices in 2010, after patients alleged they caused pain and joint dislocation and could even damage the central nervous system, thyroid and heart. The average base payment per case was about $250,000.
DePuy also agreed to pay health insurers' liens for hip implant revision surgery directly so the costs would not come out of plaintiffs' recoveries. That provision explains why MedStar submitted its liens to the defendant.
Texas attorney Tom Rhodes, whose law firm represents seven of the hip patients whose surgery was funded by MedStar, said his clients turned to MedStar because their preferred surgeons would not accept their insurance and would not operate at the reimbursement rate DePuy offered. All of the MedStar-funded plaintiffs received treatment from the same San Antonio medical providers.
The surgeon, Dennis Gutzman, did not respond to a request for comment faxed to his office. The other four plaintiffs who used MedStar funding are represented by Watts Guerra. That firm did not respond to multiple requests for comment.
Christensen said that if DePuy does not pay MedStar's liens, he will have "no other choice" but to demand payment from the patients whose surgery his company funded, an outcome he described as "extremely unfair." A spokesman for DePuy's parent company, Johnson & Johnson, declined to comment.
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Trial Day 5 – Doctor Would Not Use Prosima Pelvic Mesh Again
Sep 26, 2015 | Mesh Medical Device News Desk
By Jane Akre
Carol Cavness sued Ethicon in 2014 after having a Prosima polypropylene mesh device implanted transvaginally two years earlier to treat pelvic organ prolapse (POP).
The Cavness case is the sixth product liability case filed against Ethicon over its pelvic mesh. Three of those cases have yielded jury awards ranging from $1.2 to $11.1 million. Other cases filed against Ethicon, a division of Johnson & Johnson, have quietly settled, though the healthcare giant has offered no large settlements in this mass tort. J&J is facing about 35,000 product liability filings over pelvic mesh, more than any of the other six manufacturers.
So far, two juries have found the TVT-O, mesh used for incontinence, and made of the same mesh as the Prosima, to have been defectively designed and manufactured.
Cavness is seeking compensatory damages for disfigurement, impairment, past and future medical expenses and mental anguish. Punitive damages will also be allowed, reports CVN, after Judge Ken Molberg denied Ethicon’s motion to deny punitive damages against the company.
The Plaintiff’s complaint says Dr. Teresa Kowalczyk was negligent in the care and treatment of her patient and failed to disclose the risks associated with the medical device. But what did the doctor actually know about the risks?
THE IMPLANT PHYSICIAN
Dr Teresa Kowalczyk was the Ob/Gyn who implanted Carol Cavness with the Prosima mesh on April 24, 2012. Jurors will have to decide if her failure to care for the patient was due to being ill-informed about the dangers of mesh or whether she practiced poorly.
Originally from Poland, she works in the underserved area of Greenville, Texas about 50 miles northeast of Dallas. Both Dr. Kowalczyk and her hospital, Hunt Regional Medical Center are being sued by the Plaintiff for the care she received.
Dr. Kowalczyk began using the Prosima mesh in 2010. Previously she had used some mesh for pelvic organ repair made by American Medical Systems but generally she had rejected most meshes, instead relying on native tissue repair.
She appeared nervous. Her answers were precise and complete and spoken with a slight accent.
Prosima prototype
Sometime in 2010, the doctor met the sales rep for Ethicon products, Paul Quartz. She trusted him. They met once or twice a week. Sometimes he would bring lunch to the office. He got to know her staff. He seemed to know about the Prosima Pelvic Floor Repair System. Dr. Kowalczyk liked what she heard. Prosima didn’t have the long arms of the Prolift Pelvic mesh used for POP, it didn’t use trocars, stainless steel tubes to pass the mesh into place, and it was a much smaller mesh.
Dr. Kowalczyk liked to read all of the materials herself, she said and she didn’t remember if the sales rep was in the operating room when she implanted Ms. Cavness.
Sales rep Quartz wanted to get the word out in Greenville so he prepared the invitations sent out to the community for a meet-and-greet luncheon to learn about the Prosima and other gynecological issues with Dr. Kowalczyk hosting the get-together.
“All surgical procedures involve risks,” said the brochure.
To encourage her acceptance of the Prosima, Paul Quartz gave Dr. K a study authored by Halina Zyczynski, at the University of Pittsburgh. One-Year Clinical outcomes After Prolapse Surgery with nonanchored mesh and vaginal support devices, Here, which concluded “vaginal support, pelvic symptoms and sexual function improved at one year….” but the co-authors included David Robinson, and others working for Ethicon, directly or indirectly as part of the Prosima Study Investigators.
The study says under “Performance” the inflammation is transient and that the mesh remained soft and pliable.
That was not what the FDA had concluded a year earlier. In a Safety Communication, the agency said a posterior repair with mesh did not represent added benefit to native tissue repair, and complications with POP (pelvic organ prolapse) mesh were “not rare.” Dr. Kowalczyk did not know that.
“Would that be important for you to know,” asked Matthews. She acknowledged it would. The IFU (Instructions for Use) contained nothing under adverse reaction that would lead a surgeon to believe chronic permanent pain could result from a Prosima implant, or that it should not be used for a Grade 3 or 4 rectocele. She admitted the IFU admitted none of those things.
Was she adequately warned about the risks of Prosima? No, she said.
SURGERY SCHEDULED
Ms. Cavness had first gone to Dr. Kowalczyk on April 23, 2012 after a trip to the emergency room with abdominal cramps two days earlier. The symptoms were abrupt and had been constant for about one week. She had a Grade 3 rectocele, one step away from the most serious, where the vaginal wall next to the rectum bulges out of the vagina. It was difficult to walk, Dr. Kowalczyk noted in a follow-up visit note.
The surgeon said Ms. Cavness was in so much pain and she wanted to go back to work. Surgery was suggested, but Dr. Kowalczyk said she always encourages patients ultimately to make their own decision. The Plaintiff was a smoker and the doctor warned her that tissues have poorer healing due to smoking. Lifting heavy items as an aircraft mechanic represented a risk of a recurrence.
Surgery done by Dr. Kowalczyk on April 24, 2012 included a Prosima mesh to reinforce a native tissue repair for added security. Things improved for a few weeks but by June, Ms. Cavness returned crying with lower abdominal pain worse than before surgery, she said.
The doctor suspected the symptoms could indicate interstitial cystitis, or painful bladder syndrome. She never had the testing.
Eventually Dr. Kowalczyk referred Ms. Cavness to a pain doctor.
Today, what does Dr. Kowalczyk do for a Grade 3 rectocele, she was asked under direct examination.
“I do a native tissue repair,” she said.
LIFE CARE PLAN AND MEDICAL NEEDS
Absent from most of these pelvic mesh product liability trials has been an economic forecast of what the Plaintiff will need financially and medical to live the rest of her life. The Linda Gross case against Ethicon’s Prolift mesh by Linda Gross yielded $11.1 million, still the highest jury award against Ethicon. It had a life care plan.
An economist was brought into Cavness v. Ethicon. Dr. Thomas Meyer, an economist, projected her job as an aircraft mechanic would result in wages of upward of $935,460 which would be lost if she can no longer work. The Plaintiff has been trying to return to work but her pay stubs show months of lost wages due to the pain of her medical condition.
Medically, the plaintiff has had two mesh removal surgeries and has incurred medical expenses. She would need $573,383 worth of medical care over a 25-year period with adjusted growth of 1.25% a year, plus inflation, the economist said. That does not account for any further deterioration of her condition.
A DAUGHTER’S CONCERN
The day ended with Ms. Cavness’ daughter, Brandy. Married with three children she lives nearby in Campbell, Texas. Brandy had witnessed her mother change from a happy, vibrant, outgoing personality who loved her work as an airline mechanic to someone who watches TV. Ms. Cavness no longer does yard work, remodeling or go on family outings and play with her grandchildren. The family bought her an iPad to entertain her at home.
Vaginal spotting, discharge, UTI’s and pain are part of her life today. Two mesh removal surgeries with a Dr. Carley did not resolve the issue. Neither did a surgical repair with Dr. Phillippe Zimmern of Dallas.
“It’s a struggle for her to go to work every day. To be honest I don’t know how she does it,” said Brandy who described her pain like labor.
“She’s sad and lonely. She has to ask for help in a lot of different things… She’s a strong woman (she starts tearing up her voice breaks up). She has to ask for help,” said Brandy.
Her mom moved in with Brandy’s family last February. Ms. Cavness and her husband have subsequently divorced. There was not a lot for them to do together anymore, said Brandy.
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J&J’s Prosima Pelvic Mesh – A Game Changer?
Sep 25, 2015 | Mesh Medical Device News Desk
By Jane Akre
Dr. Pence is often called into testify for the injured in these cases because her expertise is in how to bring drugs and devices to market, and presumably, how not to.
Dr. Pence was calm, pleasant and concise in her language, often speaking to the jury directly to further dissect a point about U.S. Food and Drug Administration (FDA) regulations.
One day earlier, (See Day Three) Dr. Pence had outlined how there were two “no-go” points in bringing the Prosima to the market. Dr Marcus Carey, an Australian doctor, had sold the intellectual property rights to the company for millions if his study met certain benchmarks for safety and efficacy. It did not.
THE MARCUS STUDY
Under cross examination by attorney William Gage, for Defendant J&J, documents from the day earlier were revisited. Mr Gage would attempt to tell the rest of the story on the successes of Prosima.
In the Carey study, conducted by the doctor who would benefit from a positive outcome, after examining 95 patients who had been implanted with a prototype Prosima, its objective success rate (exam of the women to determine an anatomic fix) was 92 or 86 percent at 6 and 12 months, Mr. Gage pointed out.
Dr. Pence interjected that is correct but does not take into account the many patients were lost in follow-up. Gage moved to strike that comment as nonresponsive. Sustained, said Judge Molberg. (One has to wonder if jurors make a special mental note to remember the nugget of any objection).
Dr Pence had told jurors the day earlier that when a woman does not follow-up in a study, it generally indicates she is not having a good outcome. Gage continued.
The subjective success rate (filling out a questionnaire) was 91 and 86% at 6 and 12 months, he stated. Doctors in the study were concerned the “procedure would not provide enough support even with the vaginal support device,” was one of the key comments within the study among doctors who used the Prosima prototype.
That wasn’t an issue was it, asked and stated Mr. Gage at the same time. Can you answer that?
I can’t answer yes or no, Dr. Pence said.
(In sort of a mixed message to the jury, Mr. Gage told jurors Ms Cavness had a posterior colporrhaphy or native tissue repair in addition to the Prosima.)
Dr. Carey made some changes to the prototype Prosima during the course of the study. He made alterations in shape and to the procedure as he was moving toward completion of his study “Vaginal surgery for pelvic organ prolapse using mesh and a vaginal support device,” M. Carey, M. Slack, P. Higgs, Feb. 2008. See it here.
You weren’t critical of that, asked Mr. Gage referring to the alterations made to the Prosima.“All accurate data is good data,” Dr. Pence reminded Gage with a smile.
Mr. Gage continued with the good news about the Prosima prototype outcomes.
Sexual dysfunction was reported by 58% of the women before the Prosima. After the implant was in the body for 12-months, that number declined to 23%. That’s more than a 100 percent improvement in sexual dysfunction! he asked and stated at the same time.
Going deep into the data, Mr. Gage questioned Dr. Pence’s statement that a lack of follow-up in study participants indicates a failure. Remember the Prosima data showed 15 women not examined last 12 months were considered objective failures creating a failure rate at 28.4%. If they had returned the failure rate would be 12.6%, insisted Mr. Gage.
“Don’t you think the jury should have heard that,” Gage asked rather aggressively.
Dr. Pence would not be shaken. She exudes confidence without being arrogant.
“The key when you are doing clinical trials, you have to look at the overall and include those who are lost to follow up,” she replied calmly turning to the jury. “As I said yesterday, the data speaks for itself.”
Mr. Gage reminded the jury Ethicon could have marketed Prosima once it got FDA clearance in 2007. You can market it the next day, he said. Ethicon chose not to market it once it got FDA 510(k) approval. In fact, Prosima was held back from launch after it received FDA clearance. ( It was finally marketed in January 2010).
Didn’t that show the company was being careful, he the expert witness Pence.
Gage: “Ethicon went above and beyond the standard of the industry by conducting a study on live woman and waiting for a couple of years before marketing, wouldn’t you agree with that?”
Pence: “I’d say they complied with the standard at the time and it was a good thing to require study.”
Clearly, Pence said, they had disappointing results in the Marcus study and as a result, bad results would impact its acceptance in the market. That’s why they didn’t launch, she said firmly.
Mr. Gage showed company emails that showed the Prosima was being well received in the medical community. “Some preliminaruy results from doctors that have used Prosima have been very favorable and the results have looked good,” said an inner office email. Dr. Ahmet Bedestani, board certified female pelvic medicine surgeon from Louisiana, who was glowing in his praise.
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Sep 25, 2015 | Bella Online
By Denise Howard
Stress urinary incontinence is a common problem in women after childbearing and worsens with age. Effective conservative therapy is available however in severe cases surgery is the only option for a cure. The mid-urethra sling has become the standard for surgical correct of stress urinary incontinence. The majority of women who undergo the sling procedure are satisfied with their outcomes but complications can occur and if managed appropriately can have minimal long-term effects.
The retropubic mid-urethra sling, also called the tension free tape (TVT) was the first in this class. They all use a polypropylene mesh strip which is incorporated into the peri-urethra tissue. In theory, this should provide a permanent fix of the problem. The cure rates for this sling is reported at 85-92% at 5 years and this is excellent. Issues associated with this sling include a 34% urinary tract infection rate at 3 months, a reported voiding dysfunction (incomplete or difficult voiding) rate of 20-47%, and 25% risk of urinary urgency. Other more severe complications include bladder injury up to 7%, mesh erosion as high as 2.5% and inability to void at 3 months at 3%. Rare but serious complications also occur and include intestinal and vascular injury requiring blood transfusion, additional surgery, and even death.
The transobturator mid-urethra sling was developed in an attempt to avoid the more serious complications seen in the retropubic mid-urethra sling. Its insertion site is farther away from the bladder and the vital organs of the pelvis. The cure rates are reported 73-81% while the risk of voiding dysfunction is significantly lower at less than 11%. The urinary tract infection (6.4%) and bladder injury rates (less 1%) are also much less. The mesh erosion rate is about the same while there is a much higher rate of groin/leg pain which occurs in 12-16% of the cases. As with the retropubic sling the incidence of vascular and intestinal injuries are rare.
The single incision slings, also called mini-slings were developed in an attempt to make the procedure even easier and with less complications. The amount of mesh used is less and only a single incision is required to insert the sling. The procedure can even be performed in the office setting with local anesthesia. This is a relatively new procedure so long term data about effectiveness is limited. The 12 month data suggests a cure rate of about 76% with voiding dysfunction occurring less than 10% of the time. The rate of mesh extrusion/exposure is about the same as the other slings.
Each sling has its pros and cons. The ideal situation is to select the most appropriate procedure which will minimize the risk of complications but maximize the chance of success. This is where an experienced surgeon comes in handy. It is easy to decide to do the surgery and it is just as easy to perform any of these procedures. The key is to have a provider who selects the right procedure the first time and who is able to manage any complication that may arise. Sling outcomes can be unpredictable and it is best to choose a surgeon who has the proper training and experience.
I hope this article has provided you with information that will help you make wise choices, so you may:
Live healthy, live well and live long! -
Amidst Stryker Lawsuits, Calls to End FDA Fast-Track Loophole
Sep 27, 2015 | LawyersandSettlements.com
By Gordon Gibb
When one considers that a full premarket approval (PMA) process for a new medical device is measured in years, the mere two months it took to get the Stryker Rejuvenate Modular Hip System approved for market seems remarkably short. This is especially true considering the relatively high failure rate and the subsequent voluntary recall of the Rejuvenate system by the manufacturer just a few short years after bringing the hip replacement system to market.
The issue is not unique to Stryker, in that other manufacturers have faced similar setbacks after modern hip replacements expected to outlast more traditional devices by decades are instead failing after just a few years and negatively impacting patients. Failures have been characterized by the unexpected loosening of components, fostering bone fractures and other issues related to bone health and stability.
The widespread adoption of metal-on-metal devices, again thought to foster longer wear for younger recipients, in reality resulted in metal toxicity, as minute metal particles were released into the bloodstream and caused inflammation of surrounding tissue.
According to most reports, it can take anywhere from three to seven years to bring a medical device from conceptualization to the market through a normal PMA that would also cost manufacturers millions in testing and clinical trials.
In contrast, the Stryker Rejuvenate Modular Hip System was approved by the US Food and Drug Administration (FDA) on June 3, 2008, less than two months after Stryker submitted the Rejuvenate Modular Hip under the now-controversial 510(k) Clearance, given that the Rejuvenate system was substantially similar to other devices currently on the market. This allowed Stryker - like all manufacturers granted a 510(k) Clearance for their medical devices - to skip the costly and time-consuming PMA process, including clinical and observational trials on volunteers before the products were released to the wider market.
“Most case studies show a hip implant is good for 27 to 44 months,” said attorney Ben Gordon, of the law firm Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A. in Florida, in comments to Online Legal Media’s Brenda Craig in April of this year. “Certainly there are people whose devices last five to seven years, but it is rare for these devices to last anywhere close to the 15 years that their predecessors got, much less the 20 to 40 years doctors were led to believe.”
Two years and two months after Stryker began marketing the Rejuvenate Modular Hip, the manufacturer found it necessary to issue an “Urgent Safety Alert” in April 2012. Stryker would issue a voluntary recall of the device some three months later.
“As it turns out, the metal-on-metal hip implant does not last longer,” says Gordon. “I have been representing clients for many years and what they have gone through is unnecessary,” he says.To that end, there have been increasing calls from ethicists and the medical community to end the fast-track 510(k) Clearance, which was originally intended to serve the consumer by bringing promising products to market sooner. However, it seems the opposite has been true, given that products such as the Stryker Rejuvenate Modular Hip was not adequately tested through a full PMA before release to the market, thereby introducing unproven devices without a documented failure rate or history to the unsuspecting consumer. In July 2011, the Institute of Medicine called for the elimination of the 510(k) Clearance altogether.
In the meantime, thousands of Stryker Rejuvenate Modular Hip systems were implanted into patients during the two years it was on the market. With allegedly high failure rates, many patients will be facing needed revision surgery, which is usually more complex than the original procedure - and is not always 100 percent successful.
With a recalled hip implant that may have lasted a fraction of the expected lifespan, a consumer would have little choice but to pursue compensation through a Stryker Rejuvenate Modular Hip System lawsuit.
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