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ethicon oct 16
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Suits Alleging Ethicon Device Spreads Cancer Consolidated
Oct 15, 2015 | Law360
By Emily Field
The Judicial Panel on Multidistrict Litigation on Thursday consolidated in Kansas 15 product liability suits over a gynecological medical device made by Ethicon that may have spread cancer in women’s bodies, saying that the actions against the company involve common factual questions. -
TX Jury Rejects Plaintiff’s Claims Against Ethicon Regarding Gynecare Mesh
Oct 15, 2015 | Surgical Watch
By Katarina Siegfeld
A Texas jury has rejected a plaintiff’s claims that Ethicon should be held responsible for injuries related to the company’s Gynecare Prosima Pelvic Floor Repair System, implanted to treat pelvic organ prolapse. -
J&J Puts The Heat On Medical Funder Over Hip Implant Surgeries
Oct 15, 2015 | Fierce Medical Devices
By Emily Wasserman
Johnson & Johnson ($JNJ) scored a victory in its battle against a surgical funder that allegedly profiteered on personal injury settlements for patients suing over J&J's all-metal hip implants, as a federal judge granted the company's ... -
Incontinence and Prolapse Because of Excess weight troubles – How Kegel and Pelvic Ground Workouts May Aid
Oct 15, 2015 | Pulsarcoxia
Two main difficulties of weight difficulties are incontinence and prolapse. Sporting weight arise in two methods. Subcutaneous physique body fat is deposited underneath the skin and visceral body body fat is laid lower all around your organs. -
Steep Learning Curve for Retropubic Mid-Urethral Sling Surgery
Oct 15, 2015 | Renal & Urology News
By Natasha Persaud
Achieving competence in the retropubic mid-urethral sling (MUS) surgery for stress urinary incontinence takes longer than previously acknowledged, researchers found. Using bladder perforation rates as a proxy for inadequate skill...
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Suits Alleging Ethicon Device Spreads Cancer Consolidated
Oct 15, 2015 | Law360
By Emily Field
The Judicial Panel on Multidistrict Litigation on Thursday consolidated in Kansas 15 product liability suits over a gynecological medical device made by Ethicon that may have spread cancer in women’s bodies, saying that the actions against the company involve common factual questions.
The JPML said that the suits all involve common questions of fact that arise from allegations that the defective design of Johnson & Johnson unit Ethicon’s power morcellators made certain laparoscopic gynecological surgeries more likely to spread cancer and that the company failed to warn patients of these risks, given a recent Food and Drug Administration’s guidance that warned against using the devices in certain conditions.
The panel rejected Ethicon’s argument that unique factual questions about the plaintiffs overshadowed any common factual questions in its decision to centralize the suits in the district of Kansas.
“Though the actions may present individual factual issues, ‘this is usually true of products liability cases and medical device cases, in particular,’” the panel said.
The common factual questions in the suits surround the design, manufacture, and marketing of Ethicon’s power morcellators, including the warnings accompanying those devices and whether they should have included a bag to contain tissue, according to the JPML.
Most also involve questions about the risk that women undergoing hysterectomies and fibroid removal surgeries had cancer of an unknown origin, and what the company knew about that risk and when.
Centralizing these questions will eliminate duplicative discoveries and avoid inconsistent rulings before trial, as well conserve the resources of the parties and the judiciary, the JPML said.
The panel also rejected Ethicon’s contention that there aren’t enough actions pending to warrant consolidation and that the number of new cases will stay low.
“There are now at least 28 actions naming Ethicon as a defendant,” the panel said. “We find this to be a sufficient number of pending actions to warrant centralization, given the complexity of anticipated overlapping fact and expert discovery.”
The panel also noted that 650,000 women in the U.S. each year undergo surgery to manage symptomatic uterine fibroids, and that before the FDA’s safety communication about power morcellation, laparoscopic procedures with power morcellation had increasingly been used rather than conventional methods.
Morcellators break targeted tissue into fragments that can be removed through an incision in the stomach, according to the FDA.
Of the 500,000 hysterectomies performed every year, about 11 percent are done using this method, according to the FDA.
Although uterine fibroids are common and usually benign, about 1 in 350 women undergoing a hysterectomy or fibroid removal have an unsuspected uterine sarcoma, a type of uterine cancer, according to the agency.
In November 2014, the FDA put out a guidance warning that laparoscopic power morcellators may spread cancer and shouldn't be used in gynecological surgery that involves cancer or fibroids.
The communique was a sharp warning against the morcellators, gynecological tools used to perform hysterectomy or uterine fibroid removal. The FDA said that uterine tissue may contain unsuspected cancer and that using the morcellators may spread the cancer and decrease long-term patient survival.
The controversy over the tool's danger prompted Ethicon to execute a worldwide recall of its Morcelex brand devices in July 2014 after suspending sales of the devices that April.
In May 2014, Ethicon was hit with the first suit over the product in New York federal court. Brenda Leuzzi and George Leuzzi claim that Brenda Leuzzi was diagnosed with cancer after undergoing a robot-assisted hysterectomy with morcellation in 2012 and that the company did not adequately test its Morcelex product for potentially dangerous side effects.
“Because Ethicon acted appropriately and responsibly at all times in relation to our morcellation devices, we will defend ourselves in the lawsuits that have been filed against us,” an Ethicon spokesman told Law360 on Thursday.
The panel did agree with Ethicon that an industry-wide MDL wouldn’t be appropriate, as individual issues over differences from each company’s power morcellator would predominate.
Two suits included in the MDL also named manufacturer Karl Storz Endoscopy America Inc. as well as Ethicon as a defendant; the panel noted that during oral argument, certain plaintiffs’ counsel indicated that there would be few suits naming multiple defendants and most of those involved issues of product identification."We are all very pleased and relieved in light of the nearly hour long oral argument," Paul J. Pennock of Weitz & Luxenberg PC told Law360 on Thursday. "These clients' cases have the best chance for rapid prosecution through an MDL before an experienced judge, and we now have that. We are disappointed that the other defendants were not also joined but it is a lesser magnitude litigation problem than no MDL at all would have been."
Ethicon is represented by John D. Winter of Patterson Belknap Webb & Tyler LLP.
The plaintiffs are represented by Paul J. Pennock, Jerry M Kristal, Ellen Relkin, Michael Pederson and Donald A Soutar of Weitz & Luxenberg PC, Charles A. Childers of Childers Schlueter & Smith LLC, among others.
The case is In Re: Power Morcellator Products Liability Litigation, MDL number 2652, in the U.S. Judicial Panel on Multidistrict Litigation.
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TX Jury Rejects Plaintiff’s Claims Against Ethicon Regarding Gynecare Mesh
Oct 15, 2015 | Surgical Watch
By Katarina Siegfeld
A Texas jury has rejected a plaintiff’s claims that Ethicon should be held responsible for injuries related to the company’s Gynecare Prosima Pelvic Floor Repair System, implanted to treat pelvic organ prolapse.
According to her complaint, the plaintiff was implanted with the Gynecare Promisa system on April of 2012 and subsequently experienced multiple complications including pain, difficulty urinating, urinary incontinence, discharge, scarring, infection, and bleeding.
Ethicon, a subsidiary of Johnson & Johnson, has been hit with thousands of lawsuits regarding their transvaginal mesh products, designed to treat such complaints and pelvic organ prolapse and urinary incontinence. The company has thus far agreed to undisclosed settlements for some plaintiffs and has been forced to pay multi-million dollar jury verdicts to others.
They have resisted large scale settlements, however. The recent trial took place in the 95th Judicial District Court of Texas under Judge Ken Molberg; it began on September 21 and came to its conclusion after the jury found in favor of the defense on October 5. Defendant’s pelvic mesh allegedly flawed, fraudulently marketed
The plaintiffs lawyer described Ethicon’s transvaginal mesh products as flawed in design in numerous ways. First, the material from which the mesh is made allegedly causes an immune reaction and tissue breakdown in the surrounding areas. In addition, friction created due to the design of the mesh was said to cause surrounding tissue to degrade. And the placement of the mesh was also likely proximate to major nerve routes. Furthermore, it is argued that the mesh itself is likely to degrade, releasing a toxic substance.
Counsel for the defense argued that Ethicon’s mesh products were also marketed, inaccurately but aggressively, as safe. She characterizes the marketing campaign carefully planned and notes the inclusion of several “cash and no-cash benefits to health care providers” to promote the products in their practices. In her Ethicon mesh lawsuit, the plaintiff sued the defense for negligence; strict liability (including design defect, manufacturing defect, and failure to warn); and breach of implied and express warranties. Jury rejects plaintiff’s claims
The jury rejected the plaintiff’s claims regarding the mesh products, however. Matthew Johnson, Ethicon’s communications direction remarked that “The jury’s decision reflects the facts in this case” and that “Ethicon acted appropriately and responsibly in the research, development and marketing of the product and PROSIMA was not the cause of the plaintiff’s continuing medical problems.”
Johnson added that “We empathize with all women suffering from pelvic organ prolapse, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events.” Pelvic organ prolapse (POP) is a condition wherein the bladder, uterus or rectum sinks into the vagina due to weakened pelvic muscles. It after occurs after childbirth or menopause and can entail a number of uncomfortable symptoms.
While various mesh products were designed to treat POP, thousands of woman have claimed that the devices caused more harm than good, leading to recurrent bouts of bladder incontinence, POP and other health complications.
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J&J Puts The Heat On Medical Funder Over Hip Implant Surgeries
Oct 15, 2015 | Fierce Medical Devices
By Emily Wasserman
Johnson & Johnson ($JNJ) scored a victory in its battle against a surgical funder that allegedly profiteered on personal injury settlements for patients suing over J&J's all-metal hip implants, as a federal judge granted the company's request to see information about the funder's questionable payments for plaintiffs' surgeries.
Back in August, J&J's DePuy Orthopaedics unit asked a federal court to make Texas-based surgical funder MedStar pony up information so it could see whether or not the funder tried to squeeze excessive profits from liens it made against settlements for 11 ASR hip implant plaintiffs. U.S. District Judge David Katz greenlighted DePuy's motion, saying that its "request for billing and payment information is necessary to properly assess the validity of the liens," Katz wrote, as quoted by Reuters.
The way DePuy sees it, MedStar submitted claims for about $1.5 million for medical care that should have totaled no more than $336,000--four times the amount that DePuy considers reasonable, Reuters reports. The company wants to know what MedStar paid healthcare providers to help determine what part of the lien relates to surgeries over plaintiffs' ASR hip devices, and which parts come from unrelated medical c
But MedStar is standing by its practices. MedStar founder Dan Christensen said last month that the company's claims in the DePuy hip implant litigation are "usual, customary and reasonable." Plus, many patients would not be able to afford surgeries without MedStar's help, some funders argue.Medical funding companies like MedStar typically cover underinsured or uninsured individuals involved in mass litigation cases by buying medical bills at steep discounts from providers, then agreeing to pay for patients' surgeries as long as individuals accept a lien on settlements. But liens are often larger than expected, leaving patients or companies paying for corrective surgeries with a large bill.
In August, information surfaced about the medical funding industry's dealings with patients suing over vaginal mesh devices. At least several hundred women with claims against vaginal mesh providers have used funders to pay for surgeries, Reuters reported. In one case, MedStar and its affiliates charged mesh plaintiff Tracy Rizzo more than $60,000--about three times the amount that the company paid to have her implant removed.
"I don't begrudge anybody their share," Rizzo said at the time. "But when businesses are abusing already injured people, it is greedy, it is wrong and it shouldn't be allowed.
Meanwhile, DePuy continues to resolve litigation over its all-metal hip implants. In 2010, the company said it would shell out $2.5 billion to settle thousands of claims of pain and injuries stemming from its all-metal ASR hip implants. But J&J/DePuy still face more than 6,000 lawsuits over its Pinnacle line of hip implants, including some cases consolidated before a district court in Texas. At the end of the day, J&J will likely pay more than $4 billion to lay its implant cases to rest, Carl Tobias, a product-liability law professor at University of Richmond, said earlier this year.
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Oct 15, 2015 | Pulsarcoxia
Two main difficulties of weight difficulties are incontinence and prolapse.
Sporting weight arise in two methods. Subcutaneous physique body fat is deposited underneath the skin and visceral body body fat is laid lower all around your organs. When 1 is chubby, lots of room within the stomach cavity is adopted by extra body fat.
These inner human body fat deposits cause an increase in intra-abdominal stress and, elevated through the results of gravity, almost everything presses downwards, weakening the layer of muscle tissues that kinds the pelvic floor.
Also referred to as the pelvic diaphragm, this may be a hammock of muscle tissue that operates while in the backbone, amongst your legs in direction of the pubic bone and transversely across to each sitting bone.
It surrounds each of the three openings inside of a woman’s decrease pelvis – the anus, the vagina and also the urethra – and it’s principal function can be to carry in placement the bladder, the rectum and also the uterus.
Regions of the vagina, urethra or rectum can bulge out (or herniate) by way of elevated intra-abdominal force, leading to damage to the muscle tissue that manage the excretion or urine and feces. When destabilized, these sphincters open wrongly or continuously major to varied amounts of incontinence or will not open correctly in any way, ensuing in constipation.
An additional side-aftereffect of obesity’s influence on your own body’s pelvic infrastructure could be which the destabilized muscles release or sag top for the womb, bladder or rectum to start to fall from the body. This genuinely is recognized as prolapse and, in many cases, surgical treatment may be the only real reply.
Morbid Bodyweight difficulties is basically a well-recorded danger issue for those these problems and research have demonstrated that, despite the fact that sexual perform is usually unimpacted, obese women are two times as most likely to have a pelvic floor condition as slimmer females.
Moreover to slimming down, Kegel and pelvic ground exercises could possibly be instrumental in safeguarding towards the harmful final results of abdominal pressure simply because they support to restore the dwelling in the pelvic flooring.
Often compressing and providing the pelvic floor prolapse surgery (this is the 1 you use to urinate) exercises the complete pelvic diaphragm assisting it to assistance the proper stress, retaining everything the place it must be.
A big edge of these workout routines is stopping hemarrhoids and urinary technique problems because the elevated circulation helps the and tone of those tissue.
The result through the workout routines could be elevated should you execute the exercises concurrently as using a neuromuscular stimulator. These goods are pre-designed to cope with urge and anxiety incontinence, furthermore to firming in the vaginal and rectal waterways by utilizing vaginal and rectal probes.
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Steep Learning Curve for Retropubic Mid-Urethral Sling Surgery
Oct 15, 2015 | Renal & Urology News
By Natasha Persaud
Achieving competence in the retropubic mid-urethral sling (MUS) surgery for stress urinary incontinence takes longer than previously acknowledged, researchers found.
Using bladder perforation rates as a proxy for inadequate skill, Paul Hilton, MD, and Karen Rose, MD, of Royal Victoria Infirmary in Newcastle, U.K., assessed surgical competence in retropubic MUS (tension-free vaginal tape) at a single institution from 1997 to 2013. Of 1,568 MUS surgeries performed, 20% were secondary procedures and 36% involved additional procedures performed at the same time.
Bladder perforation rates ranged from 0% to 31% for the 16 individual surgeons, according to results published online ahead of print in the International Urogynecology Journal. By professional level, the 6 residents and 7 senior residents averaged 10.3%, the 2 fellows 4.5%, and 1 consultant 1.3%. The rate of bladder perforation during secondary operations did not differ significantly from primary operations.
Previous research has suggested that a 5% or lower bladder perforation rate is a marker of surgical competence. Trainees only attained this target after performing 20 to 80 surgeries – more than many expect. No trainee performing fewer surgeries achieved competency.
“Whilst seductively simple in concept, mid-urethral tape procedures are not without risk; their inherently ‘blind' nature makes them difficult to teach,” the investigators explained. “The ‘learning curve' to independent practice may be longer than previously considered.”
They Royal College of Obstetrics and Gynecology recommends trainees complete a minimum of 20 MUS surgeries before competency assessment. However, this study suggests the number required to obtain proficiency can range higher.
The investigators also examined operating time, post-operative voiding difficulties, tape extrusion, and patient satisfaction but could not determine trends due to inadequate numbers.
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