Preview Newsletter
Ethicon Media Monitoring 3/27/2018
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Pelvic mesh implants: How tracking vehicle parts is easier than medical devices
Mar 27, 2018 | ABC News
By Sophie Scott and Alison Branley
When Takata airbags were recalled globally in 2017, the manufacturers were able to tell motorists the make, model and year of the cars with the faulty safety device. -
J&J To Pay Record $35 Million in Product Liability Case
Mar 26, 2018 | Legal Reader
By Sara E. Teller
Ethicon, a subsidiary of Johnson & Johnson, will pay $35 million in a product liability case concerning its Prolift pelvic mesh, used to treat pelvic organ prolapse, a debilitating condition with few options for treatment. Plaintiffs Barbara Kaiser and her husband Anton Kaiser sued the company in March 2012 after Barbara began experiencing pelvic pain allegedly associated with the mesh her physician implanted three years earlier. -
Jury trial in C.R. Bard pelvic mesh injury suit underway in New Jersey
Mar 26, 2018 | Legal News Line
By John Sammon
jury trial has begun in the lawsuit of a woman suing the manufacturer of a medical pelvic mesh device that was implanted in her transvaginal region to support a sinking bladder but instead allegedly caused her chronic pain. -
McGinnis Defective Mesh Trial Naming CR Bard Continues in New Jersey Court
Mar 26, 2018 | Mesh Medical Device Newsdesk
In the product liability trial, Mary McGinnis v. CR Bard, the plaintiff blames two pelvic meshes, made by Bard, for her injuries.
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Pelvic mesh implants: How tracking vehicle parts is easier than medical devices
Mar 27, 2018 | ABC News
By Sophie Scott and Alison Branley
When Takata airbags were recalled globally in 2017, the manufacturers were able to tell motorists the make, model and year of the cars with the faulty safety device.
Such is the regulation and monitoring of the car industry where items are meticulously identified and tracked.
If there's a recall, getting word out to consumers is efficient and effective.
But when it comes to "spare parts" for humans it appears to be a different matter.
When problems began to emerge globally with surgical mesh devices used to treat pelvic floor problems in women, a larger issue in the medical industry began to surface.
In many cases, doctors and specialists had no idea which women had what device. To this day, many women don't know what product was used in their surgery.No clear picture of the damage
The apparent inability of physicians and regulators to identify women with specific devices and the failure to track patients and outcomes meant there were massive delays in identifying problems with the products.
There are regulations which mean device makers do have to provide annual reports on devices to the Therapeutic Goods Administration (TGA), but only for high-risk devices and only for the first three years.
The remainder of regulations rely on device manufacturers self-reporting to the TGA if they identify a problem or run into trouble with overseas regulators.
Even the TGA's adverse events database is a self-reporting log with well-documented low reporting rates.
It is often also skewed towards negative outcomes and newer devices, because they're the ones doctors and patients tend to report.
What it all means is there's no clear picture of the number of women with horrible side effects from the devices.
There's also no clear picture of the number of women with good outcomes.
It has taken a Senate inquiry, which is due to hand down its findings today, to get to the bottom of the issue.National approach needed
What's worse is it's not the first time this issue has emerged.
Australia has already dealt with scandals over faulty hip implants, breast implants and cardiac devices.
Those scandals prompted the creation of device-specific registries.
But what doesn't exist is a national register of all devices.
The medical profession says these registries are incredibly expensive to maintain long-term and that's why there isn't one.
But it could be argued this cost would be offset by the cost to the health system of patients with defective devices not being detected.
Earlier in 2018, closing arguments were delivered in a six-month long class action between surgical mesh victims and Johnson and Johnson. In the US similar actions led to multimillion-dollar payouts.
Every day advances are being made in medical devices, such as pacemakers that can access the internet and limb prostheses that can be controlled by brain signals.
Given the speed with which medical technology is advancing, the industry and the government cannot afford to ignore this issue.
It's a parlous state-of-affairs when it's easier to track car parts than body parts.
http://www.abc.net.au/news/2018-03-27/pelvic-mesh-implants-tracking-medical-devices/9588070
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J&J To Pay Record $35 Million in Product Liability Case
Mar 26, 2018 | Legal Reader
By Sara E. Teller
Ethicon, a subsidiary of Johnson & Johnson, will pay $35 million in a product liability case concerning its Prolift pelvic mesh, used to treat pelvic organ prolapse, a debilitating condition with few options for treatment. Plaintiffs Barbara Kaiser and her husband Anton Kaiser sued the company in March 2012 after Barbara began experiencing pelvic pain allegedly associated with the mesh her physician implanted three years earlier.
The lawsuit accused Johnson & Johnson and Ethicon of concealing commonly known problems with the product, including risk of failure, injury, and high complication rates, as well as “frequent and often debilitating re-operations,” according to the couple’s complaint. Prolift “caused severe and irreversible injuries, conditions, and damage to a significant number of women, including plaintiff.”
The Kaisers claimed, “Defendants have consistently underreported and withheld information about their Prolift’s propensity to fail and cause injury and complications and have misrepresented the efficacy and safety of the products through various means and media, actively and intentionally misleading the medical community, patients, and the public at large. Defendants actively and intentionally misled and continue to mislead the public, including the medical community, health care providers, and patients, into believing their Prolift is safe and effective, leading to the prescription for, and implantation of, their Prolift into plaintiff, Barbara Kaiser, and numerous other women.”
A nine-person jury panel in the U.S. District Court for Northern Indiana awarded Barbara $10 million in damages and $25 million in punitive damages. According to court documents, Anton Kaiser was not compensated. In its verdict, the jury found there to be substantial evidence the Defendants were negligent in the design of Prolift and Ethicon deliberately failed to warn patients of the risks to prior to consenting to implant surgery. They found further that Prolift was sold in a defective and unreasonably dangerous condition, placing unnecessary risk on mesh recipients.
The $35 million reward was notably substantial. “This is one of the largest transvaginal mesh verdicts in the country…Ethicon defended an indefensible product and the jury stood up for Barbara Kaiser,” said the couple’s attorney, Thomas Plouff, of Plouff Law, a Chicago-based law firm specializing in medical malpractice, motor vehicle accidents, personal injury cases, product liability, and civil rights violations. “They were asked to send a message to Ethicon to deter future wrongdoing, and they did…We are elated to have won a settlement for a very deserving individual who suffered at the hands of corporate neglect. We look forward to taking on tougher cases in the future through our Plouff Law Offices team.”
Johnson & Johnson has stated it plans to appeal the verdict. Spokesperson Mindy Tinsley said in response to the jury’s decision, “We believe [the verdict] contradicts the evidence that the product was properly designed and that the company appropriately informed surgeons of pertinent complications.” She added, “While we empathize with those who have experienced complications, many women with pelvic mesh see an improvement in their day to day lives. Ethicon stands by, and will continue to defend, our pelvic mesh products in litigation.”
https://www.legalreader.com/jj-pay-record-35-million-pelvic-mesh-case/
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Jury trial in C.R. Bard pelvic mesh injury suit underway in New Jersey
Mar 26, 2018 | Legal News Line
By John Sammon
HACKENSACK, N.J. (Legal Newsline) – A jury trial has begun in the lawsuit of a woman suing the manufacturer of a medical pelvic mesh device that was implanted in her transvaginal region to support a sinking bladder but instead allegedly caused her chronic pain.
Plaintiff Mary McGinnis, 62, a resident of North Carolina, alleged in her suit in New Jersey Superior Court in Bergen County that C.R. Bard, a Murray Hill, New Jersey-based manufacturer and marketer of medical implant devices, sold the Avaulta and Align products used in her implant, knowingly ignoring the dangers the devices would cause.
During the trial, which opened on March 19, McGinnis’ attorney Adam Slater of the New Jersey law firm of Mazie, Slater, Katz & Freeman of Roseland, New Jersey, told the jury that patient safety in the case should have come first.
“A medical business is in business to make money, but profit should not come before safety,” Slater told the jury, according to video provided by Courtroom View Network. “They (C.R. Bard) came to a lot of stop lights but went through them.”
The Avaulta device is clear plastic in appearance and looks somewhat like a jelly fish with long, thin arms. It was alleged during the proceeding that chemicals in the polypropylene-made device caused the vaginal tissue to become inflamed, that the device was too large and the body's cells launched protective attacks to try and expel the device, resulting in damaged and scarred tissue.
“The body reacts to it,” Slater said. “Cells attack the foreign invader. Scar tissue forms and the reaction is permanent.”
In addition, Slater alleged that the device constricted, becoming taut after the implant operation on McGinnis in March of 2009, causing chronic vaginal and rectum pain. He stated the device is very difficult to remove. McGinnis had surgeries after the implant to remove it and eventually journeyed to California, Slater said, at her own expense to have needed vaginal reconstruction.
He alleged that officials at C.R Bard were more interested in promoting and selling the implant to patients and doctors than they were in recognizing the dangers and failed to warn patients properly. He added that adequate studies of the device beforehand had not been done.
“C.R. Bard knew in September of 2008 the mesh was dangerous,” Slater said. “They needed to do a clinical study. That’s another reason not to sell this stupid thing.”
On March 22, Dr. William R. Welch, a surgical pathologist who evaluates tissue specimens called as a witness for the plaintiff, described a projected slide photo demonstrating McGinnis’ type of tissue injury as a “severe inflammation” during testimony.
Welch was asked if this is this normal tissue.
“Not at all,” he responded. “It’s very hard and brittle. A certain amount of fibrous tissue is acceptable. But not to this degree.”
Under cross-examination by Cliff Merrell, defense attorney with Greenberg Traurig LLP of Miami representing C.R. Bard, Welch agreed there was usually some sort of complication with implanting any mesh device.
“You’ve never done any academic work concerning mesh?” Merrill asked.
“That’s correct,” Welch responded.
“You’ve never done any surgery concerning mesh correct?”
“That is correct,” Welch said.
Jonathan Conta, former senior products manager at C.R. Bard who left the company in 2008 and whose testimony was projected on a screen in the courtroom, said he was responsible from a marketing standpoint for selling the pelvic products including what was called the Avaulta Classic device.
He stated he was aware of the possibility of side effects, including chronic pain and vaginal erosion, from the product.
Questioned about a lack of clinical data on the product Conta said, “Any product marketer would want as much clinical data as they could get, and I always wanted more.”
Dr. Elizabeth Barbee, a Raleigh, North Carolina, gynecologist who performed the implant on McGinnis, said the training she received from C.R. Bard in April of 2007 and March of 2008 to implant the devices included practice on a human cadaver.
She said she took into account the risks associated with the procedure and believed that C.R. Bard had data that the procedure was a long-lasting solution to McGinnis’ condition.
“Did you think the potential adverse reaction would lead to a catastrophic condition that couldn’t be safely and effectively treated?” Barbee was asked.
“No,” she said.
Barbee testified she advised patients that any company literature advertising a product was bound to have some bias minimizing potential side effects and that it was very important for patients to know the potential side effects and the worst-case scenario.
Under cross-examination from Lori Cohen, also a defense attorney with Greenberg Traurig, Barbee denied the device had improperly rolled or curled into the wrong position during the implant procedure.
“Do you agree there are risks associated with any medical device or surgery?” Cohen asked.
“Yes,” Barbee answered.
Barbee also agreed that such mesh devices were recognized worldwide as treatment for urinary incontinence and were referred to as the "gold standard" for such treatments in 2009.
Additional medical testimony from physicians was taken on March 23.
Streaming video coverage of the trial was provided to Legal Newsline by Courtroom View Network.
https://legalnewsline.com/stories/511369742-jury-trial-in-c-r-bard-pelvic-mesh-injury-suit-underway-in-new-jersey
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McGinnis Defective Mesh Trial Naming CR Bard Continues in New Jersey Court
Mar 26, 2018 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, March 26, 2018 ~ In the product liability trial, Mary McGinnis v. CR Bard, the plaintiff blames two pelvic meshes, made by Bard, for her injuries.
Monday, it enters its second week in a New Jersey courtroom.
This is the first allegedly defective mesh product trial naming CR Bard to be held in New Jersey.
Mary McGinnis and Thomas Walsh McGinnis v. C.R. Bard Inc., et al., case number BER-L-17543-14 is underway in New Jersey Superior Court, Bergen Co. before Judge James DeLuca.
Jury selection took place March 15th in the first New Jersey lawsuit involving C.R. Bard, manufacturer of allegedly defective pelvic mesh implants.
Courtroom View Network is covering the trial gavel-to-gavel and is available for purchase. Mesh News Desk does not have access to that trial and is compiling evidence from the court appearances on the CVN website here.
Mary McGinnis was implanted with two meshes made by the Murray Hill, New Jersey company – the Avaulta and Align. The polypropylene implants were used to treat pelvic organ prolapse and stress urinary incontinence.
See McGinnis Complaint, Avaulta Jan 2018
Soon afterward she suffered erosion, scar tissue, dyspareunia, loss of bladder functioning, and severe pudendal neuralgia injury and has undergone three separate mesh removal surgeries, the third by Dr. Shlomo Raz of UCLA in June 2016.
That surgery involved extensive groin dissections to remove the transobturator arms of both devices.
She claims she lives in chronic pain from them and that Bard failed to warn the end user doctors.
Bard claims Ms. McGinnis is in pain from previously existing medical conditions.
Witnesses
Adam Slater, representing Ms. McGinnis called plaintiff witness Adam Silver to the stand March 20th.
Silver is a Vice President of Marketing, Bard Medical Division from Atlanta.
In the 2013 Debra Wise case, Adam Silver was not allowed to testify about Chevron Phillip’s state of mind or intent associated with the Material Safety Data Sheet (MSDS).
The MSDS warned manufacturers, such as Bard, from using any raw polypropylene resin from making implantable medical devices.
Read more on MND here.
That was the first evidence presented in the Cisson v. CR Bard trial in West Virginia in 2013.
Ronald Bracken was a plaintiff witness the same day and appeared in a video recording.
Bracken researches and develops medical devices for market.
His area of expertise, according to Linked In, is design controls, failure investigations, 510(k) clearances, test methods and polymer science.
He served as a VP for Strategic Initiatives for CR Bard from 2011 to 2013 in Covington, Georgia, which many mesh medical devices are produced. He also served as a VP of Research and Development for Bard’s medical division from 2006 to 2011 where he was responsible for research and development functions.
He has a Bachelor of Science degree in polymer science from the University of Southern Mississippi.
Jonathan Conta appeared by video recording and was a plaintiff witness March 22. According to LinkedIn, Conta was the key marketing representative on a project team that developed medical devices for the treatment of pelvic organ prolapse.
His bio says he held positions in Corporate Development and Marketing and worked on knee and spine mechanics at Beth Israel Deaconess Medical Center in Boston. Mr. Conta holds a Bachelor of Science Degree in Biomechanical Engineering from Brown University and an MBA from Northwestern’s Kellogg School of Management.
Attorney Adam Slater will try to convince the jury that the company knew its devices were unsafe and failed to warn the end user doctors about potential risks.
Bard representatives counter that their pelvic mesh products were safe and the warnings were adequate.
C.R. Bard
Avaulta was removed from the market by Bard in 2012 after the U.S. Food and Drug Administration announced it would require manufacturers to launch three year post-approval monitoring studies, potentially costing millions of dollars.
Align was taken off in 2016.
In past pelvic mesh product liability trials, jurors have not been allowed to hear that the products are off the market.
State court in Bergen Co. has a list of 155 similar pending cases against C.R. Bard and 9,091 cases against Gynecare or Ethicon, a subsidiary of Johnson & Johnson, also located in New Jersey.
See Bard case list here. See Gynecare Ethicon case list here.
Meanwhile there are 15,558 cases listed in multidistrict litigation consolidated in federal court in Charleston, WV with 11,047 listed as closed cases. They may mean they are in the process or being settled or remanded back to their original jurisdiction.Since January 2018, 10 new cases have been added to the C.R. Bard MDL case list.
While this is the first defective product case against Bard in this venue, it is the fourth product liability trial over pelvic meshes made by C.R. Bard.
The Scott case ended in a $5.5 million verdict for the plaintiff in a California state court.
The Cisson case ended in a $2 million verdict for the plaintiff in federal court in West Virginia in 2013. A trial in Missouri state court ended in a defense verdict in 2016.
The same lawyer who tried that case, Lori Cohen, of Greenberg Traurig, is representing Bard in the McGinnis trial. ###
LEARN MORE:
MND, March 13, 2018, McGinnis Trial to Start Monday
https://www.meshmedicaldevicenewsdesk.com/mcginnis-pelvic-mesh-trial-bard-start-monday/MND, March 21, 2018, What we Know from Past TVM Trials (MSDS)
https://www.meshmedicaldevicenewsdesk.com/mcginnis-v-c-r-bard-know-past-tvm-trials/CafePharma, August 24, 2013, Bard Ignored Internal Memos
http://www.cafepharma.com/boards/threads/bard-ignored-internal-memos-and-doctors%E2%80%99-concerns-over-avaulta-vaginal-mesh.538035/Debra Wise v C.R. Bard Inc, February 7, 2015
https://www.leagle.com/decision/infdco20150210c43MND, Bard Opening Arguments in Federal Transvaginal Mesh case, July 9, 2013
https://www.meshmedicaldevicenewsdesk.com/bard-opening-arguments-in-federal-transvaginal-mesh-case/MND, May 23, 2013, C.R. Bard Lawsuits: Rulings Reveal Company Secrets
https://www.meshmedicaldevicenewsdesk.com/c-r-bard-lawsuits-rulings-reveal-company-secrets/MND, June 13, 2017, C.R. Bard’s Pelvic Mesh Removed from the Market
https://www.meshmedicaldevicenewsdesk.com/c-r-bards-pelvic-mesh-removed-market/Materials Safety Data Sheet
Bard Exhibit #200-1 Marlex Mesh MSDSMND, July 29, 2013, Bard Faces Plaintiff After Mistrial in First Federal Case Against Transvaginal Mesh
https://www.meshmedicaldevicenewsdesk.com/bard-faces-plaintiff-after-mistrial-in-first-federal-case-against-transvaginal-mesh/https://www.meshmedicaldevicenewsdesk.com/mcginnis-defective-mesh-trial-naming-cr-bard-continues-in-new-jersey-court/
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