Preview Newsletter
Ethicon 12/4
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Defect claims beat preemption in Ethicon pelvic mesh cases
Dec 4, 2015 | Mass Device
By Brad Perriello
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon must face design defect claims in 37 of the 23,000 lawsuits filed against it over its pelvic mesh products, a federal judge in West Virginia ruled yesterday. -
A New Approach to Revolutionize Clinical Trials
Dec 3, 2015 | Insider Sources
By Llewellyn King
It may be the biggest thing in medicine in a long time. It’s not a new drug, or therapy or discovery. Instead it’s a new way of doing clinical trials that could have a dramatic effect, particularly on those diseases that get less attention. -
Dr. Raz Contributed to Plaintiffs’ Injuries, Not Defective Mesh
Dec 3, 2015 | Mesh Medical Device News Desk
By Jane Akre
It’s not surprising that the defense team in Sherrer v Boston Scientific said that two pelvic meshes on trial in this case – the Boston Scientific Solyx mesh and the C.R Bard Align mesh – are safe and effective and have been cleared by the U.S. Food and Drug Administration (FDA).
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Defect claims beat preemption in Ethicon pelvic mesh cases
Dec 4, 2015 | Mass Device
By Brad Perriello
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon must face design defect claims in 37 of the 23,000 lawsuits filed against it over its pelvic mesh products, a federal judge in West Virginia ruled yesterday.
Ethicon asked Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia to grant summary judgment, arguing that the plaintiffs’ state design defect claims about its Tension-Free vaginal tape are preempted by federal law.
It’s the 4th time Goodwin has considered a preemption argument from Ethicon; in each of the prior instances the judge ruled against the company.
Yesterday Goodwin did it again, ruling that there is no conflict between state and federal law in the cases, which are part of the 70,000 cases spanning 3 multi-district litigations concerning pelvic mesh products from several manufacturers.
“Unlike the law imposing the duty of sameness for generics, there is no federal law prohibiting design changes to medical devices, particularly changes representing advances in safety. To the contrary, 1 of the purposes of the 510(k) exemption was ‘to ensure that improvements to existing devices can be rapidly introduced into the market.’ The law simply requires that manufacturers making a ‘significant change’ submit another 510(k) notification, which the FDA will clear if it determines the device is substantially equivalent to a device already on the market,” Goodwin wrote. “Again, this substantial equivalence determination does not directly conflict with the state law requirement that a product be reasonably safe.”
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A New Approach to Revolutionize Clinical Trials
Dec 3, 2015 | Insider Sources
By Llewellyn King
It may be the biggest thing in medicine in a long time. It’s not a new drug, or therapy or discovery. Instead it’s a new way of doing clinical trials that could have a dramatic effect, particularly on those diseases that get less attention.
Initially it is aimed at the deadliest brain cancer, glioblastoma multiforme, known as GBM. From diagnosis, it can kill in about six months.
Traditionally, clinical trials test one drug or a therapy on a lot of patients, sometimes thousands, against a control group that is treated with a placebo, or not treated at all. Trials drag on for years.
The aim in clinical trials, which are certified by the Food and Drug Administration and reviewed by FDA-appointed panels of experts, is to make sure that a drug, medical device or procedure is safe and effective. This system costs a huge amount of money — hundreds of millions of dollars — and takes years. It produces no collateral knowledge; and it doesn’t alleviate the suffering.
Also, it’s an imperfect system. When a drug or medical device is certified for sale by the FDA, it may be less effective than the manufacturer claims, or not safe. Witness the recalls and lawsuits against drugs and medical devices — such as the ones against Avandia, the diabetes drug, and transvaginal mesh.
This form of testing is totally inappropriate for virulent diseases, where the cohort being tested is unlikely to live long enough to find the results.
That stark truth has driven a global fraternity of specialists in brain cancer to set up a new concept in clinical trials. These doctors, neurosurgeons, neuro-oncologists, biostaticians and genetic researchers are out to make trials a present-tense matter.
Members of this fraternity of researchers and clinicians come from around the globe with a heavy emphasis on the United States, China and Australia. They gathered in Washington last month to launch their trial, known as GBM AGILE, an acronym for Adaptive Global Innovative Learning Environment.
They are driven by the knowledge, as Anna Barker, GBM AGILE project director, put it, that the present treatments for GBM “are unacceptable.”
She told me that there has been little progress over the years. Other doctors told me that the three treatments used at present — surgery, chemotherapy and radiotherapy — aren’t saving patients. Few survive, or have their lives appreciably extended.
“It is not acceptable, not acceptable,” Barker said over and over.
Barker is a professor at Arizona State University, a former deputy director for strategic initiatives at the National Cancer Institute, part of the National Institutes of Health, and a crusading force for improvement in brain cancer treatment, as well as how clinical trials are conducted.
Webster Cavenee, a professor at the University of California at San Diego, said the drug that is used for treating this aggressive cancer doesn’t work because the cancer, which doesn’t metastasize, becomes resistant to it in a short time, rendering the procedure useless. “We need a cocktail of drugs,” he said, “so that the cancer is deceived.”
The FDA, often seen as a barrier to new treatments, is on board with GBM AGILE and has promised to approve new procedures within days, according to Barker.
The work to get the trials set up is already well under way. More than 100 cancer specialists, divided into 10 major committees, are working on the structure.
As I understand it, GBM AGILE will establish a global pool of patients whose physicians will report on therapies, drugs and environments that succeed or fail, building a huge database of clinical knowledge. Patients will cycle out, it is hoped because they are cured, but sadly, more likely, because they have succumbed. The organizers call it “crowd-sourcing knowledge.”
It is hoped that major funding will come from big foundations and charities. But initially the institutions that will participate have been defraying expenses, with an important assist from the small but energetic group National Foundation for Cancer Research, whose president, Sujuan Ba, has played a role in bringing in Chinese research institutions.
In the lay language of today, there won’t be any stovepiping, less repetitive prescribing of doubtful treatments, and a greater sharing of the patient experience.
Vice President Joe Biden is an enthusiastic supporter. His beloved son Beau died from GBM. Biden told the gathering of BMG AGILE founders in Washington that if Beau hadn’t contracted the disease, he would’ve run for the presidency.
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Dr. Raz Contributed to Plaintiffs’ Injuries, Not Defective Mesh
Dec 3, 2015 | Mesh Medical Device News Desk
By Jane Akre
It’s not surprising that the defense team in Sherrer v Boston Scientific said that two pelvic meshes on trial in this case – the Boston Scientific Solyx mesh and the C.R Bard Align mesh – are safe and effective and have been cleared by the U.S. Food and Drug Administration (FDA).
That assurance has been said of every other type of polypropylene pelvic mesh that has gone before a jury, no matter which product made by seven pelvic mesh manufacturers facing litigation, even those found to be defectively designed.
What was unique in the first day of this trial in state court in Kansas City, MO is who was blamed for the pelvic injuries to the plaintiff, registered nurse, Eve Sherrer.
Ms. Sherrer, 62, had a Solyx mesh implanted in October 2010 and a Bard Align implanted about five weeks later when the first mesh malfunctioned. After continuing pain – groin, back, pelvic area pain, she decided to have the mesh removed by the world-renowned mesh expert, Dr. Shlomo Raz, a urologist at UCLA. Women come from around the globe to have a removal surgery with Dr. Raz, who comes closer than most any other doctor in the world, to a full mesh excision.
But there was no love lost for Dr. Raz from the defense team – Robert Adams representing Boston Scientific (Shook Hardy) and Lori Cohen representing C.R. Bard (Greenberg Traurig).
Appearing for Boston Scientific, Mr. Adams said Dr. Raz had attempted to remove the pelvic mesh from Ms. Sherrer in April 2014 and that caused more harm than good.
Going one step further, Adams said Dr. Raz, who was a proponent of polypropylene pelvic mesh, made a 180 degree turnabout when he discovered he could make more money by removing it. Adams said when word got out that Dr. Raz could remove a woman’s troubling pelvic mesh, more and more women came to him from around the globe to have him fix their complications. Now, not surprisingly, he’s a big advocate of removing mesh.
Dr. Raz and patient, Facebook
Never mind, that Dr. Raz is not in private practice but is on the staff at UCLA where he heads the urology department. Salaried employees are rarely compensated based on the number of surgeries they perform. Never mind that women swear Dr. Raz gave them back their life when they had no hope.
Representing Bard, Lori Cohen presented the jury with the same premise but went one step further. Not only did Dr. Raz go from mesh proponent to opponent, but the plaintiff’s current complaints are partially due to Dr. Raz’s surgical procedures. Ms. Sherrer was not properly evaluated by him before he decided to remove the Align, a TVT, and the Solyx, a TVT-O, and Dr. Raz never investigated the cause of her pain.
It was an unnecessary surgery, Cohen said. The Align was working and there was no reason to remove it. Dr Raz did more harm than good to Ms. Sherrer, she said.
She characterized him as one of the few “outliers” who doesn’t believe in pelvic mesh implants to correct incontinence and prolapse in women
PREEXISTING CONDITIONS
Eve Sherrer is an attractive, blonde woman who looks a decade younger than her 60s’s. She likely will testify in her own behalf in this three-week trial.
To deflect blame for the medical devices, both defense attorneys pointed to the medical condition of Ms. Sherrer prior to her mesh implants. Eight days before the Solyx mesh implant, she had bursitis on right side of the hip diagnosed along with a mild degenerative joint disease of the right hip and muscle spasms in the low back. She had a three-year history of right hip pain.
Today she has severe osteoarthritis on the top of the femur. Since it’s bone-on-bone pain, a hip replacement is recommended. Osteoarthritis, degenerative disc disease, spine issues and multiple other pelvic surgeries account for her hip, leg and groin pain as well as a gait disturbance, a shortened vagina, urge incontinence, pelvic floor spasms and lower back pain.
According to the defense, none of that can be blamed on her polypropylene mesh implants.
Solyx is not risk- free, there are no devices that are risk free, said Adams who added it comes down to balancing risk with benefits of any product. With half of women over the age of 50 who’ve had a vaginal delivery, approximately 300,000 women in the U.S. will need surgery ever year.
Adams did not add that many of those are Burch Procedures or use of a woman’s own fascia to hold up sagging pelvic organs. That’s the same surgery Dr. Raz eventually performed on Ms. Sherrer in 2014, without mesh.
BURDEN OF PROOF
The plaintiffs in this case must prove, by the preponderance of the evidence, that the Solyx and Align are both defective and caused physical damages to Ms. Sherrer. They must also prove that the alleged failure to warn her physicians about the risks, caused her damages. They won’t be able to do that, said Cohen.
The defense team told jurors they will present experienced experts during the trial who all believe in polypropylene mesh, Cohen called “The Gold Standard.”
Other things to consider jurors were told – that professional medical societies support the use of mesh; and that the treating physicians of Ms. Sherrer all still use mesh. Even Dr. Hill who removed the failed Solyx mesh in October 2010, turned around and put in another mesh, the Bard Align.
Dr Hill is an expert at mesh, added Ms. Cohen. He taught other doctors and was a preceptor for Bard. A preceptor is hired by a company as a consultant and compensated for convincing other doctors to use the medical device. Almost all of the mesh manufacturer who are facing thousands of product liability cases employed the preceptor model to increase sales. Some publications require that relationship be disclosed because of the potential conflict-of-interest.
Dr. Vladimir Iakovlov, Pathologist
Cohen then took a swipe at the experts the plaintiffs plan to bring to trial. Dr. Peggy Pence never worked at the FDA and is not a medical doctor, said Cohen; Dr. Michael Margolis disagrees with the medical community regarding mesh; Dr. Bruce Rosenzweig never implanted an Align; Vladimir Iakovlev, a pathologist who will show the jury the degradation of mesh under a microscope, never practiced medicine in the U.S.
Cohen went on to praise the expertise of the experts the defense plans to call during the trial.
PROUD TO REPRESENT BARD AND WOMEN
During his opening, Ms. Cohn said she was proud to be representing Bard and especially honored because it involves women’s issues adding that the polypropylene sling has improved the quality of life for millions of women.
Cohen went on saying the medical device industry is heavy regulated by the FDA and to suggest the Align is not safe is ludicrous. A few minutes in her presentation, the jury may have noticed a power point document that said the FDA Guidance does not require any clinical testing.
To defend this company is really rewarding, she said. #
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