Preview Newsletter
Ethicon Media Monitoring 10/24/16
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Judge halves $4m pelvic mesh verdict against Johnson & Johnson
Oct 21, 2016 | Mass Device
By Fink Densford
A Georgia federal judge yesterday cut a $4 million verdict in a defective pelvic mesh lawsuit against Johnson & Johnson‘s (NYSE:JNJ) Mentor business unit in half, applying a statutory $2 million damages cap. -
Attending a National Patient Training Workshop
Oct 23, 2016 | Mesh Medical Device Newsdesk
By Janet Holt
Two women who are part of the mesh-injured community pushed themselves to become involved in a national patient training workshop. Here’s what they found. -
Report: FDA Rules Allow Device Makers to Hide Adverse Events
Oct 21, 2016 | Drug Watch
By Michelle Llamas
The U.S. Food and Drug Administration created a program that allows medical device makersto hide adverse events and report them years later, the Star Tribune reported. -
Attorney: Ethicon Physiomesh Flexible Composite Mesh Recalled Due to High Revision Rates
Oct 22, 2016 | Lawyers And Settlements
By Heidi Turner
Attorneys are investigating possible lawsuits against Johnson & Johnson subsidiary Ethicon concerning theEthicon Physiomesh Flexible Composite Mesh. The Physiomesh, used in laparoscopic hernia surgeries, has reportedly been linked to higher than normal revision rates.
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Judge halves $4m pelvic mesh verdict against Johnson & Johnson
Oct 21, 2016 | Mass Device
By Fink Densford
A Georgia federal judge yesterday cut a $4 million verdict in a defective pelvic mesh lawsuit against Johnson & Johnson‘s (NYSE:JNJ) Mentor business unit in half, applying a statutory $2 million damages cap.
Chief U.S. District Judge Clay Land rejected a bid to overturn the verdict, but reduced the damages by $2 million. Judge Land also upheld a compensatory damages verdict of $400,000, lifting the total amount awarded to $2.4 million.
The case relates to a suit, filed by Florida resident Tessa Taylor in 2012, which claimed that she had been implanted with J&J’s ObTape Sling to treat her incontinence in 2004. The implant was defective, Taylor alleged, and resulted in serious pain and recurring infections. A jury sided with the plaintiff in the case, and set out $4 million in damages for Taylor.
In a post-trial motion, J&J’s Mentor claimed it was entitled to a new trial or decision, alleging that the jury ruled against the weight of the evidence and that evidentiary errors and violations interfered with their decision.
The judge disagreed, and outside of the reductive cap, upheld the jury’s verdict.
“The law has long recognized that only the jury can do this factfinding and that mischief can be created when judges are lulled into believing that due to their superior training and experience, they can actually second-guess that uniquely juror task of factfinding. Thus, we learn early in law school that these jury verdicts are entitled to great deference,” Judge Land wrote in his decisoin.
http://www.massdevice.com/judge-halves-4m-pelvic-mesh-verdict-johnson-johnson/
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Attending a National Patient Training Workshop
Oct 23, 2016 | Mesh Medical Device Newsdesk
By Janet Holt
Two women who are part of the mesh-injured community pushed themselves to become involved in a national patient training workshop. Here’s what they found.
Jane Pennington and I attended the conference together. We have learned through the years of suffering with mesh complications it is often better if we travel in pairs. One can always help the other.
Diana Zuckerman, the Founder and President of NCHR welcomed all of us patient advocates to the meeting. There were many different areas represented in this group of 31.
Kim Witczack www.Woody matters.com
Kim spoke on the importance of being an advocate. Advocacy matters. She focused on Zoloft given “off label”. My take on her presentation was the importance of “just showing up” – Be part of the conversation for change – Be involved in the conversation.
Diana Zuckerman Ph.D
Diana spoke after Kim on what we needed to know about FDA standards. How do they balance patients wanting new products and drugs with the harm that is caused to patients from devices and drugs? Did you know most hospitals are the buyers of implants not the surgeons? The surgeon normally uses the device the hospital buys. The surgeon may not have even looked at the warnings. Most clinical trials, when used, are paid for by the manufacture. They in turn pay the doctors for the study. Did you know 98% of medical devices are not tested at all?
Miara Jeffress Ph.D.
She gave a quick break down on the different types of clinical trials. There is the “gold standard” double blinded clinical trial where neither the doctor nor the patient know what is being given. The one with the least amount of information gathered would be an uncontrolled study. Here the doctor just follows the patients.
Susan Wood Ph.D
Ms. Wood’s topic was “How to get your voice heard at the FDA”. She reminded us the that the FDA is just made up of people. You also need to understand where they get their money from and what the FDA is allowed to do. They are only allowed to do what Congress allows them to. In order to make change, you must write comments, appear in person with comments and talk to your Congressional representative. After saying all of this you must have patience. Change is difficult. It takes years.
She then moved on to saying medical devices are the hardest to regulate. Much harder than drugs. The FDA almost never rescinds an approval of a medical device. The FDA just waits until the companies take action themselves.
Day Two
Saturday opened up with Stephanie Fox-Rawlings Ph.D
Her topic was the importance of clinic trials and the data within the clinical trial such as sex, race/ethnicity and age when treatments are studied. Your clinical trial may only consist of 10 people. Three women and seven men. Six of the men were white, and one was African American. One man died during the trial. The treatment was not effective for three of the women, nor was it effective for the one African American. The drug was approved for all races, sex, and age. Is your head turning around yet?
Paul Brown, NCHR Government Relation Manager spoke on how patients can engage with the FDA and the NIM. On the FDA’s web site there is a link for patients. You can read on all the upcoming meetings. If you find one that interest you, such as medical devices, you can write or show up to speak.
Later that afternoon we did a mock FDA advisory committee meeting starring all of us. It was not only fun but a great example of what to expect if you ever planned to attend one. They can be rather intimidating.
The NCHR is launching a new website for all patients to use and to learn from. You can go to this exciting new web site by typing in USA Patient Network. You can join
Jane and I both not only had a great time but we learned so much. We met women who had been harmed by different medical devices and drugs. There were women and men who represent other fields but all had an interest in patient safety. It was an awesome group of attendees.
After years of Jane and I traveling to DC for various FDA meetings, congressional hearings, a Capitol Hill Briefing, a town hall meetings and speaking before the advisory panel on mesh, we finally took a taxi to see the white house. Somehow we had never found the time to do so in the past. It was a very short walk from the taxi to the White House and back to the taxi.
Between Jane and myself we have needed 24 surgeries. It has been a very long and painful journey for both of us. Neither one of us dwells on what has past. There is nothing we can do about what happened. We can only move forward in hopes that our daughters and other women will have safer option for SUI and Prolapse treatment.
By showing up change can happen.
We were only two of a large group of injured patients and doctors speaking out on the dangers of mesh implants. It takes years to make change and a whole lot of patience. The only advice we could give other women is to JUST SHOW UP.
It does matter. ##
http://www.meshmedicaldevicenewsdesk.com/attending-national-patient-training-workshop/
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Report: FDA Rules Allow Device Makers to Hide Adverse Events
Oct 21, 2016 | Drug Watch
By Michelle Llamas
The U.S. Food and Drug Administration created a program that allows medical device makersto hide adverse events and report them years later, the Star Tribune reported.
Doctors and patients should be able to use this data to make informed decisions about treatment options, but companies like Johnson & Johnson, Stryker and Zimmerroutinely reported adverse events late, summarized findings or hid them from the public. The Star Tribune’s report uncovered hundreds of thousands of such incidents.
According to law, device makers have 30 days to report adverse events linked to a device to the FDA. These products include drug pumps, pacemakers and hip and knee implants. But many companies report late — in some cases, years after the events happened — and the FDA created a “retrospective summary reporting program” for these offenders. This allows medical device makers to summarize past-due reports without providing details. But no real description of the program exists, and there is no law that authorizes it, the Tribune reported.
Some companies claim reporting the adverse events exposes trade secrets, and the FDA lets them keep these reports confidential. For instance, the agency allowed Baxter International to keep 75,000 malfunction reports of its Colleague drug pump confidential until the Tribune exposed the numbers.
Baxter claimed the hidden reports did not involve injuries or impact patients, but it is difficult for outsiders to truly assess the problems themselves because this data is invisible to the public. The pump in question was later recalled.Summary Reporting May Lead to Manufacturer ‘Bad Behavior’
Critics say this type of reporting gives patients and physicians an incomplete picture of a device and may encourage “bad behavior” on the part of medical device companies.
“Retrospective summary reporting is a mechanism that seems to benefit bad behavior when manufacturers are behind on adverse event reporting,” Madris Tomes, founder and CEO of Device Events, told Drugwatch. “And when the FDA goes on to often redact the number of injuries as a trade secret, physicians have no way of assessing the risk profile of a device, and patients don’t have access to information they need to make critical decisions about their own health.”
Tomes’ software provided Tribune reporters with a means to search FDA databases for reports of adverse events. These reports are difficult to obtain and require specific “marker” reports. Then, the full details are only available through the Freedom of Information Act. It took the Tribune 13 months to get information on Medtronic’s Infuse implant. The company also filed retrospective reports for 27 different devices, the Tribune found. Eric Epperson, a spokesman for Medtronic, told the Tribune the reports do not mean that Infuse caused the problem.
Retrospective summary reporting needs “to be halted in the interest of public safety and transparency,” Tomes told Drugwatch.Devices in Summary Reports Involved in Lawsuits
The FDA defended its practice. Agency spokespeople told the Tribune the summaries involve only well-known issues and requiring more documentation would waste resources.
But devices in many of the reports were involved in recalls or litigation.
For example, Medtronic got permission to summarize adverse events linked to its Infuse Bone Graft. The product racked up hundreds of lawsuits filed by people who say the graft injured them.
J&J’s Ethicon summarized adverse events linked to its TVT transvaginal mesh bladder sling and reported them late. Ethicon currently faces more than 33,500 federal lawsuits for its mesh products. Plaintiffs say the mesh caused them serious injuries like organ perforation, chronic pain and hemorrhaging. About seven companies face mesh lawsuits and the litigation is one of the largest in history.
Two knee and hip implant manufacturers — Stryker and Zimmer — are also among the companies who made the most use of the retrospective program. Stryker filed retrospective summary reports for its Accolade TMZF hip stem, and the company recalled the product on multiple occasions for manufacturer and packaging errors. Lawsuits linked to the product are also beginning to trickle in.
Dr. David Challoner, who led an Institute of Medicine team that studied adverse-event reporting problems in 2011, told the Tribune companies have incentives not to report on popular products.
“Everybody who’s in a position to identify or question an adverse or unexpected clinical event is motivated not to report it, everyone except the patient who has a question about what the hell is going wrong,” Challoner said.
https://www.drugwatch.com/2016/10/21/fda-allows-hidden-adverse-effects/
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Attorney: Ethicon Physiomesh Flexible Composite Mesh Recalled Due to High Revision Rates
Oct 22, 2016 | Lawyers And Settlements
By Heidi Turner
Dallas, TX Attorneys are investigating possible lawsuits against Johnson & Johnson subsidiary Ethicon concerning theEthicon Physiomesh Flexible Composite Mesh. The Physiomesh, used in laparoscopic hernia surgeries, has reportedly been linked to higher than normal revision rates.
In May 2016, the Ethicon Physiomesh Flexible Composite Mesh products were voluntarily recalled by the company after two unpublished studies suggested the medical implants had higher failure rates than other mesh products available on the market. Ethicon gave medical professionals up to September 16, 2016, to return unused products for a full refund. According to the recall issued by Ethicon, "The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries."
The Physiomesh composite mesh was designed for use in laparoscopic hernia surgeries, including ventral and inguinal hernia repair. It is made of polypropylene, which has also been used in transvaginal mesh. According to Dr. Shezad Malik, founder of the Dr. Shezad Malik Law Firm, lawsuits have already been filed by patients who allege they were harmed by Ethicon's Physiomesh composite mesh.
"There were two big studies done, one involving the German Medical Registry and one involving the Danish Medical Registry," Dr. Malik says. "Compared with other available meshes, the Ethicon Physiomesh was shown to fail earlier than the other options on the market. Patients are reportedly experiencing more side effects. Ethicon says it is unclear what is going on, but they're saying it could be because of the patient or the physician or a host of as yet unidentified causes."
At issue is the mesh breaking down too early, which can allow hernias to recur, or can cause bacterial infections, damage to the internal organs, and the need to redo the surgery. Patients who have the Physiomesh implanted are encouraged to follow up with their doctors to ensure there are no problems with their mesh.
Symptoms of mesh failure include recurrence of the hernia, bacterial infection—marked by fever and chills—pain or swelling at the operative site, fluid-filled abscesses in the abdomen and groin, and perforation of the organs or blood vessels. Patients who have had laparoscopic hernia surgery and are not sure what mesh device was used can ask their surgeons for the operative report, request their medical records from the hospital or clinic, or look through billing records to see if the mesh is listed as a line item.
Patients who have suffered a hernia, had the Ethicon Physiomesh implanted, and suffered adverse effects as a result of that Physiomesh may be eligible to file a lawsuit against the medical device company. A few lawsuits have already been filed with the first trial reportedly expected in 2018.
The recall does not involve the Physiomesh Open product, which was approved more recently than the Flexible Composite Mesh.
"In 2014, Johnson & Johnson came out with the Physiomesh Open, went through the controversial 510(k) process, which bypasses rigorous safety data testing, and had it rubber stamped by the FDA," Dr. Malik says. "The company brought the replacement device in and after more problems were reported with the original, they recalled the older model knowing they had a replacement in the wings."https://www.lawyersandsettlements.com/articles/mesh-complications/interview-surgical-mesh-lawsuit-21796.html
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