Preview Newsletter
Ethicon 6/2
-
Ethicon Severs Malpractice Claims From Pelvic Mesh Suit
Jun 1, 2015 | Law 360
By Joe Van Acker
A doctor and his clinic aren’t indispensable to a case bringing product liability claims over transvaginal meshes made byJohnson & Johnson unit Ethicon Inc. and C.R. Bard Inc., a Kentucky federal judge said Thursday as he severed the health care providers from the case. -
Ky. Judge Severs Healthcare Defendants from Bard, Ethicon Transvaginal Mesh Action
Jun 1, 2015 | Harris Martin Publishing
...On May 28, Judge David Bunning of the U.S. District Court for the Eastern District of Kentucky concluded that the healthcare defendants are dispensable parties because the medical malpractice claim “is highly distinct” from the products liability claims against C.R. Bard Inc. and Ethicon Inc... -
Boston Scientific Ordered to Pay $100M to Delaware Woman
Jun 1, 2015 | Insurance Journal
A Delaware jury has ordered a medical device manufacturer to pay $100 million to a woman who, despite two surgeries, still has pieces of transvaginal mesh embedded inside her. -
Round two: the fight over how to treat female pelvic prolapse continues
Jun 2, 2015 | Australian Financial Review
By Jill Margo
The fight over female pelvic prolapse goes on. There are several theories about what causes it and two well-known urogynaecologists have challenged a theory described in The Australian Financial Review last week. -
Lawyers Embracing Facebook in Client Pursuit
Jun 2, 2015 | Australasian Lawyer
By Samantha Woodhill
... The names for which Burd says the lawyers will pay around $3,000 each, were potential plaintiffs for a lawsuit against the pharmaceutical company which made transvaginal mesh implants, resulting in health complications for many women...
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Ethicon Severs Malpractice Claims From Pelvic Mesh Suit
Jun 1, 2015 | Law 360
By Joe Van Acker
A doctor and his clinic aren’t indispensable to a case bringing product liability claims over transvaginal meshes made byJohnson & Johnson unit Ethicon Inc. and C.R. Bard Inc., a Kentucky federal judge said Thursday as he severed the health care providers from the case.
U.S. District Judge David L. Bunning said that Melissa and Robert Mayfield’s medical malpractice claims against Thomas Mechas and London Women’s Care PLLC are “highly distinct” from the product liability claims against Ethicon and Bard, saying they involve not only separate legal issues but also separate factual allegations.
“Just as no one from Ethicon was involved with Mayfield’s surgery, Dr. Mechas had nothing to do with the design, manufacture or sale of a single pelvic mesh implant,” Judge Bunning said.
The plaintiffs had moved to remand their case to a state circuit court, and the judge granted that motion only as it applied to the doctor and clinic. The plaintiffs' claims against Ethicon and Bard remain in the federal court.
Judge Bunning said the case lacked complete diversity since Mechas and the plaintiffs are Kentucky residents and the clinic is in the state.
Since Ethicon had removed the case to federal court, the company had to show that the health care defendants were unrelated to the plaintiffs’ claims that the transvaginal meshes implanted during Melissa Mayfield’s surgery were defective in order to sever the Mechas and London Women’s Care.
The judge agreed with Ethicon’s position that the doctor and the clinic weren’t necessary parties because the Mayfields’ malpractice claims wouldn’t resolve their product liability claims.
Judge Bunning looked to two decisions by an Ohio federal judge in similar cases and concluded that having the health care defendants protect their interests in state court wouldn’t expose Ethicon to inconsistent or double obligations in federal court.
The plaintiffs had argued that they would be unfairly prejudiced by having to litigate two cases, but the judge said they had overstated the struggles that two cases would present, noting that the Mayfields’ federal claims could be transferred into multidistrict litigation against Ethicon.
“The cost and burden of litigating against Ethicon would drop considerably, and plaintiffs’ ability to potentially negotiate a settlement would be greatly enhanced,” Judge Bunning said. “Also, they could proceed with discovery of the medical malpractice claim immediately, and do so more efficiently, as other attorneys will take the lead in the Ethicon MDL.”
The plaintiffs objected after Ethicon had the case conditionally transferred into the MDL in West Virginia federal court, and the U.S. Judicial Panel on Multidistrict Litigation heard the Mayfields’ motion to vacate that transfer on Thursday but has not yet released a decision.
Representatives for the parties didn’t respond to requests for comment on Monday.
According to the plaintiffs, Melissa Mayfield suffered a number of injuries during her January 2014 procedure that required additional surgeries and caused her both physical and emotional pain and suffering.
The Mayfields are represented by John J. Carey, Andrew J. Cross and Jeffrey J. Lowe ofCarey Danis & Lowe and Alice Annette Morgan-White and Yancey L. White of Morgan & White.
C.R. Bard is represented by Richard B. North Jr. of Nelson Mullins Riley & Scarborough LLPand W. Kennedy Simpson of Thompson Miller & Simpson PLC.
Ethicon is represented by Susan J. Pope of Frost Brown Todd LLC.
The case is Mayfield et al. v. London Women's Care PLLC et al, case no. 6:15-cv-00019, in the U.S. District Court for the Eastern District of Kentucky. -
Ky. Judge Severs Healthcare Defendants from Bard, Ethicon Transvaginal Mesh Action
Jun 1, 2015 | Harris Martin Publishing
A Kentucky federal judge has severed nondiverse healthcare defendants in a transvaginal mesh action, ruling that the medical malpractice claims should be tried in state court because those defendants are not indispensable.
On May 28, Judge David Bunning of the U.S. District Court for the Eastern District of Kentucky concluded that the healthcare defendants are dispensable parties because the medical malpractice claim “is highly distinct” from the products liability claims against C.R. Bard Inc. and Ethicon Inc..
Kentucky resident Melissa Mayfield underwent surgery in January 2014 to repair multiple vaginal prolapses and treat her stress urinary incontinence. ...
Subscription required, for full article please see: http://harrismartin.com/article/19541/ky-judge-severs-healthcare-defendants-from-bard-ethicon-transvaginal-mesh-action/
-
Boston Scientific Ordered to Pay $100M to Delaware Woman
Jun 1, 2015 | Insurance Journal
A Delaware jury has ordered a medical device manufacturer to pay $100 million to a woman who, despite two surgeries, still has pieces of transvaginal mesh embedded inside her.
The News Journal of Wilmington reports the 51-year-old Newark woman was awarded damages on May 28 following a two-week trial in Superior Court in Wilmington against Boston Scientific.
Court documents say the woman had transvaginal mesh inserts, a net-like product used to treat incontinence and sagging pelvic organs in women, implanted in May 2009. Since then, she has had complications, including urinary tract infections and pain during sex.
The jury found Boston Scientific failed to warn doctors and patients of the risk of the poorly designed inserts.
Boston Scientific spokeswoman Kelly Leadem says the company dedicates significant resources to ensure products are safe.
-
Round two: the fight over how to treat female pelvic prolapse continues
Jun 2, 2015 | Australian Financial Review
By Jill Margo
The fight over female pelvic prolapse goes on. There are several theories about what causes it and two well-known urogynaecologists have challenged a theory described in The Australian Financial Review last week.
They claim the "integral theory", which is based on strengthening ligaments, has limitations and its implementation is potentially harmful.
Prolapse occurs when structures supporting a woman's pelvic organs weaken, causing them to slump. This exists in epidemic proportions in older Australian women.
Integral theory, now under attack, holds that all components in the pelvis are integrated. When organs slump it recommends the use of a special tape to lift the organs back into their original position.
This tape, known as TFS (tissue fixation system) tape, reinforces the over-stretched suspensory ligaments supporting the organs while maintaining the natural movement and balance between them.
Last week, practitioners of this theory expressed frustration that TFS tape had been cancelled by the Therapeutics Goods Administration on the grounds that it hadn't been proved safe.
The urogynaecologists say TFS tape is unlikely to be reapproved for use.
Andrew Korda, a professor of obstetrics and gynaecology at the University of Western Sydney, says that over the years prolapse has variously been attributed to obesity, aging, defective collagen or chronic conditions such as asthma and constipation.
While he is not certain what causes it, he believes a main driver is childbirth, during which the pelvic floor muscle or "levator ani" is stretched and may not return to normal. This muscle encloses an opening which, once enlarged by muscle tears or over-stretching during childbirth, may over time allow the pelvic organs to descend and prolapse.
He notes that women who haven't had children usually don't get prolapse.'HIGHLY UNORTHODOX'
Korda says TFS tape is a mesh and can cause serious complications. Medical literature shows 10 per cent of mesh surgery results in erosion and "nasty" complications.
"The way they use this tape to lift the vagina makes no sense and the way they use it to treat anorectal symptoms is highly unorthodox," he says. "Many anorectal problems are due to defects with nerve supply, defects in the anal sphincter and laxity of the pelvic floor. The tape is not going to correct all those problems."
He also questions the notion that a hysterectomy can cause prolapse. There is no evidence for this although he says it can unmask existing prolapse. "Once the uterus is removed there is much less support for the top of the vagina and what partially existed gets worse."
While there is no question that sometimes the tapes are successful, Korda says using native tissue as the first line of treatment is better because it won't cause complications.
The effect of childbirth on the pelvic floor is a major academic interest of Peter Dietz, a professor of obstetrics and gynaecology at the University of Sydney's Medical School Nepean.
An international expert on pelvic floor imaging, he says integral theory is a conglomerate of several hypotheses, some of which "make no sense". He regards its use of tapes as experimental and says the concept that most prolapse is due to ligamentous laxity is based on a fundamental misunderstanding of anatomy.
Apart from muscle weakness and muscle torn off the pelvic sidewall during birth, some prolapse is due to deficiencies or defects in the fascia which is the connective tissue surrounding the vaginal wall.
"Weakness in one such fascia allows herniation of part of the back passage and there is no way a ligament placed there could fix it. A fascia is a sheet, not a ligament," he says.RISK OF COMPLICATIONS
Mesh tape is the international gold standard for urinary stress incontinence. Tape used by practitioners of integral theory to repair four other ligaments is stiffer, more densely woven and secured with plastic anchors.
Dietz says incontinence and prolapse are different conditions and because a tape works for incontinence doesn't mean it will work for other problems.
"Anyway," he asserts, "some of the 'ligaments' that are supposed to be replaced by the TFS simply don't exist."
Dietz says tape normally used for stress incontinence worked well because it is elastic, and its open weave makes it self-fixing. He says TFS tape is more likely to erode and the barbs on the anchors can be dangerous when placed in sensitive areas that are rich in nerves and vessels.
He says the main complications from using the stiffer tape with barbs include damage to the urethra, bladder and back passage, pain during intercourse and chronic back, leg and perineal pain.
Dietz holds that there is insufficient evidence for the safety and efficacy of the TFS in prolapse surgery.
Having audited the work of some 30 gynaecological surgeons over the last 16 years, he says he is willing to audit the work done by two Sydney practitioners of integral theory who were featured in the Financial Review last week.'NO NEED' FOR AUDIT
They are urologist David Ende and colorectal surgeon, Darren Gold. They have jointly countered this criticism, saying that integral theory is based on a more advanced and thorough understanding of the female pelvic floor.
Once understood, they say the tissue fixation system repairs the damaged supporting ligaments to restore normal anatomy. "These ligaments are well described in the literature and very much exist," they say.
"The pelvic floor muscles do not act to support the organs and keep them in, but act to control their function. Once the support and anatomy is restored so is the function."
Ende and Gold offer the analogy of a tent, saying the ligaments are like the guy ropes that hold the tent in place rather than the floor on which it sits. They say two main ligaments repaired in almost every case normally support the bladder and bowel through their attachment to the cervix.
"A hysterectomy by dividing these ligaments to remove the uterus can only act to weaken the supports and promote symptoms, as it did in the case of the patient who appeared in the Financial Review last week," they say.
"New ideas in surgery frequently bring paradigm shifts in management. These patients have multi-compartmental symptoms including severe bowel and bladder problems and as such should perhaps now be managed by a team comprising a urologist and proctologist rather than by a gynaecologist alone.
"The tissue fixation system of surgery, which was developed in Australia, is available in many other countries. It is supported by robust data published by other surgeons in peer reviewed journals. Audit is part of the peer review process leading to publication.
"There is no need for Professor Dietz to audit our data. Further audit is only recommended where doubt is expressed as to the integrity of the published data."
"We would, however, welcome an audit by an individual who clearly understands the procedure and is not vehemently opposed to it, inorder to maintain objectivity."
"Is it not ludicrous that an Australian woman cannot have this operation in Australia, but could happily fly over to Japan and have it there?" they ask.
"There is no reason for this operation to be withheld from the women of Australia who deserve the option of the best and most up-to-date treatments available."
-
Lawyers Embracing Facebook in Client Pursuit
Jun 2, 2015 | Australasian Lawyer
By Samantha Woodhill
Tim Burd’s San Francisco company was hired by a firm for a lawsuit in relation to a device used in hysterectomies, allegedly causing the spread of ovarian cancer. According to reports, women over 55 are most likely to contract the cancer, and using Facebook, the company was able to target women within a particular age bracket that ‘like’ and ovarian cancer support group.
Burd’s company provided the names of around 10,000 women to personal injury lawyers in recent years, using CDC data, Facebook and other information. The names for which Burd says the lawyers will pay around $3,000 each, were potential plaintiffs for a lawsuit against the pharmaceutical company which made transvaginal mesh implants, resulting in health complications for many women.
“We use age, gender – its only women that qualify, age typically 40 and up. It’s happened to a lot of parents because after they had a kid, that messed up their insides,” he told Bloomberg Business. “So we cast a wide net, really, and then narrow it down from there, from whatever does well.” Facebook reportedly declined to comment.
Johnson & Johnson is now facing more than 24,000 lawsuits over the vaginal mesh implants.
According to Bloomberg, Bayer has paid out about $1.92 billion in the U.S. to settle some 9,600 claims saying its contraceptives caused blood clots, despite never making an admission of guilt in the settlements
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested