Preview Newsletter
Ethicon Media Monitoring 4/12/2018
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*Breaking* Judge Goodwin to Dismiss Thousands of Non-Revision Ethicon Mesh Cases
Apr 11, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
Judge Joseph Goodwin, overseeing more than 104,000 pelvic mesh product liability cases filed in his West Virginia court, will dismiss more than 13,000 non-revision Ethicon mesh cases, allowing them to be refiled if the woman undergoes an attempted mesh removal within five years. -
FDA’s 510(k) Clearance Does NOT Lead to Safer Gyn Medical Devices
Apr 12, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
The Food and Drug Administration’s 510(k) clearance process for medical devices has been called a fast-track to market clearance process. This study reveals it does not lead to safer gynecologic medical devices. -
Autoimmune Issues to be Added to AU Women Mesh Claim Against J&J
Apr 11, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
The class action lawsuit involving more than 800 women against Johnson & Johnson just expanded in numbers and in mesh claim complaints against the healthcare giant. -
Bard Hustled Defective Meshes To Market, Jury Told In Closing
Apr 11, 2018 | Law 360
By Daniel Siegal
C.R. Bard pushed a pair of pelvic mesh devices to market without proper testing or warning, counsel for a woman alleging harm from those devices told a New Jersey jury during Wednesday closing arguments, and Bard countered there isn’t evidence the devices harmed the woman. -
Allegations of pelvic mesh shrinkage considered in C.R. Bard trial
Apr 12, 2018 | Legal Newsline
By John Sammon
An attorney for Mary McGinnis in her lawsuit against C.R. Bard said during trial that the pelvic mesh McGinnis had installed in her pelvic region in 2009 shrunk and distorted, while the defendant contends it can be tissues attempting to heal that causes mesh shape change, not the mesh. -
Nearly a dozen women in Port Pirie are known to suffer from pelvic mesh complications
Apr 12, 2018 | The Recorder
By Piper Denholm
Living among the Port Pirie population are nearly a dozen women who have been made victim to the under researched and overlooked pelvic mesh surgery.
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*Breaking* Judge Goodwin to Dismiss Thousands of Non-Revision Ethicon Mesh Cases
Apr 11, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
Mesh Medical Device News Desk, April 11, 2018 ~ Judge Joseph Goodwin, overseeing more than 104,000 pelvic mesh product liability cases filed in his West Virginia court, will dismiss more than 13,000 non-revision Ethicon mesh cases, allowing them to be refiled if the woman undergoes an attempted mesh removal within five years.
This agreement was reached with Ethicon, a division of Johnson & Johnson, and allows the statute of limitations to begin again upon her revision date.
JUDGE GOODWIN CLEARS THE DECKS OF NON-REVISION CASES FOR NOW
In Pretrial Order #293, issued Wednesday, April 11, federal Judge Joseph Goodwin, overseeing thousands of defective product pelvic mesh cases amassed in multidistrict litigation (MDL), plans to dismiss more than 13-thousand Ethicon mesh cases where the plaintiff has a mesh-in-placewith no attempted removals, also known as revisions.
There are many reasons a woman may not have her pelvic mesh removed – compromised health, a risk of going under anesthesia, a new complication to her health, a warning from her doctor that the risks of revision outweigh the benefit – all might preclude having a mesh removal. Now that may count against her.
For a woman who may have died from mesh complications or suicide from pain associated with her pelvic mesh, before undergoing mesh removal surgery, her case may be over.
A removal or revision is defined by the court as one that involves general anesthesia, not a removal attempt with a local anesthesia in a doctor’s office, sometimes known asss “trimming the mesh.”Responding to a Motion by Ethicon “regarding disposition of non-revision Gynecare TVT Products Cases” Judge Goodwin has agreed to voluntarily dismiss without prejudice pelvic mesh cases, “with the ability to refile in a federal district court of proper venue and jurisdiction within five (5) years of dismissal of the pending litigation should plaintiff undergo a medically necessary Revision Surgery, be recommended for a medically necessary Revision Surgery, or otherwise undergo multiple qualifying procedures described below, within those five years.”
Ethicon, within 60 days of the order, agrees that if a non-revised plaintiff has a revision surgery within five years of dismissal, that the statute of limitations shall begin on the date of that revision surgery. She may then file a second lawsuit without suffering any limitations imposed by the original statute of limitations.
Ethicon further agrees for plaintiffs who have more than one office revision of the mesh and have trigger point injections, vaginal physical therapy or vaginal Valium, will be treated the same as those plaintiffs who undergo revision surgery within five years.
The meshes made by Gynecare include TVT Retropubic and Obturator and Abdominal System, Gynecare TVT Abbrevo or Exact Continence Systems. Meshes no long on the market but sold by Ethicon include Prolift, Prolift +M, Prosima and TVT-Secur, as well as Gynemesh PS and Prolene are included in this order if they are mesh-in-place with no revisions.
“This court is well aware of the issues in this litigation and believes there is significant value to the plaintiff who has not undergone a revision surgery not being required to go forward with a case at this time when there is a possibility that they could be at risk of a surgery in the future”~ Judge Joseph Goodwin
THE OTHER OPTION
Non-revision women have until June 10, 2018 to accept the offer or continue her case with no waiver.
Those who opt not to dismiss her case must deliver by July 30, 2018, a Plaintiff Fact Sheet, documentation of lost wages, documentation of medial expenses and all medical records on her gynecological history for five years before the date of implantation of an Ethicon Gynecare TVT Product.
Plaintiffs must also submit all medical records relating to the alleged injury and to the mesh implant, revision, and any treatment for prolapse and incontinence. See the complete list on pages 9 and 10.
The other mesh manufacturers in this MDL- CR Bard, Boston Scientific, AMS, Cook and Neomedic are not effected by this order.
ETHICON TRIALS IN WAVES 7 & 8 MOVE FORWARD
Ethicon cases set to be heard in a Charleston, WV trial scheduled for on May 15, 2018 involve Wave 7 cases. Wave 8 cases should be heard in Charleston or another venue in the fall.
The federal court in West Virginia has amassed more than 104,000 transvaginal mesh cases. Ethicon has consistently has the largest case load with in excess of 55-thousand product liability cases facing the healthcare giant, both in the U.S. and abroad according to its SEC filing. ###
https://www.meshmedicaldevicenewsdesk.com/breaking-judge-goodwin-to-dismiss-thousands-of-non-revision-ethicon-mesh-cases/
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FDA’s 510(k) Clearance Does NOT Lead to Safer Gyn Medical Devices
Apr 12, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
Mesh Medical Device News Desk, April 11, 2018 ~ The Food and Drug Administration’s 510(k) clearance process for medical devices has been called a fast-track to market clearance process. This study reveals it does not lead to safer gynecologic medical devices.
FDA Approval of Gynecologic Medical Devices
Image: Desara mesh by Caldera Medical
This study was published this week in the Journal of Minimally Invasive Gynecology, by doctors at Rush University Medical Center in Chicago.
It reports the recall rate for 510(k) cleared gynecologic medical devices is 13.6 times the rate of PMA devices. That results in an increased risk to patients.
In all, 685 medical devices were cleared by the pre-market approval process (PMA), a more stringent clearance that requires proof of patient safety and efficacy through clinical trials, versus the 1,564 medical devices that were cleared through the 510(k) clearance to sell process.
It does not require clinical trials. It does require a manufacturer name a “predicate” devices already on the market that the new device is substantially similar to. MND has reported that the material and construction can be different, but the predicate device can still be named. Also the FDA has no system in place to re-review devices approved when a predicate is recalled from the market for causing patient harm.
Transvaginal mesh, whether TVT, TVT-O or pelvic organ prolapse meshes, made from polypropylene, biologics, or composites, are all cleared through the 510(k) process. Learn more about 510(k) here.
In all, 1.17% of the PMA approved devices and 15.98% of the 510(k) cleared devices were recalled.
The number of recalls with PMA approved devices did not change over time while there was an increase in recalls among the 510(k) cleared medical devices.
While industry often urges lawmakers to allow the FDA to clear more devices faster, researchers here conclude this evidence calls for improvements and increase scrutiny of the 510(k) approval process for gynecologic medical devices. ###
J of Minimally Invasive Gynecologic Surgery, Assessment of Obstetric and Gynecologic FDA Device Approvals and Recalls, April 2018
http://www.jmig.org/article/S1553-4650%2818%2930214-0/fulltextMND, 510(k) approval process
https://www.meshmedicaldevicenewsdesk.com/?s=510%28k%29https://www.meshmedicaldevicenewsdesk.com/fdas-510k-clearance-does-not-lead-to-safer-gyn-medical-devices/
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Autoimmune Issues to be Added to AU Women Mesh Claim Against J&J
Apr 11, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
Mesh Medical Device News Desk, April 11, 2018~ The class action lawsuit involving more than 800 women against Johnson & Johnson just expanded in numbers and in mesh claim complaints against the healthcare giant.
Autoimmune Issues to be Added to AU Women Claim Against J&J
Image: Au Herald
Since July of last year, more than 800 women have been locked in litigation with global healthcare giant, Johnson & Johnson (JNJ) and its Ethicon division. As the transvaginal mesh claim case comes to a conclusion, the women have added numbers and new grounds to their complaint.
Unlike U.S. courts, Australian courts allow many month for both sides to air their grievances. Then it is up to a judge to conclude this class action. The defendant may offer a settlement to end the action at any time.
Being held in a Sydney federal court, Monday Justice Anna Katzmann, agreed to expand the numbers of women who had joined in this class class action up until July of last year. Lawyers for the plaintiffs successfully argued it would be unfair if a large number of women were shut out of the case which began six years ago after complications began emerging among mesh implanted women in that country.
That ruling expanded the class action by more than 100 women.
AUSTRALIAN MESH BAN
Australia already led the U.S. in taking action against permanently implanted transvaginal meshes used in women to treat incontinence and pelvic organ prolapse.
Last November, Australia’s medical device regulator banned all implantable transvaginal meshes, even those called the “gold standard” by J&J and other manufacturers. The risks outweigh the benefitsconcluded the Therapeutic Goods Administration, the Australian version of the U.S. Food and Drug Administration (FDA).
Similar to the US, medical societies largely sided with mesh makers. The Australian Medical Associationeven marketed a mesh as a “medical design breakthrough” despite complication reports coming in, reports The Herald.
The death of Canadian campaigner Christina Brajciclast November, solidified the Australian campaign and push to have mesh banned in that country.
Senator Derryn Hinch has joined forces with thousands of Australian campaigners against mesh calling it “the greatest medical scandal” against Australian women. The mesh issue has been the subject of a Senate inquiry in Australia.
IMMUNE SYSTEM RESPONSE
In another move, Justice Katzmann on Monday gave Ethicon (J&J) until May 31 to respond to the women who claim the company sold its transvaginal meshes without the “proper warning” of alleged consequences and in doing so engaged in misleading and deceptive conduct.
A proper warning might include the chronic inflammatory response to a foreign body implant in the body, as well as “psychiatric injury” to a woman who feels she has been violated by the implant that may be impossible to remove and a medical professional who implanted it.
Discovery, revealed at this trial, has shown doctors suggesting anal intercourse as an alternative for women who can no longer have vaginal intercourse due to chronic pain from their mesh implants.
The Guardian (here) reports a failure to warn would also include that mesh presents a particular risk for patients who might have an autoimmune reaction. That would include women with compromised immune systems.
One biomaterials expert at trial, Prof Paul Santerre, testified that any existing immune problems made it more difficult for polypropylene mesh to integrate with the body.
Immune system response was not included in the original complaint in this class action filed by Shine Lawyers of Australia. Judge Katzmann rejected company claims that expanding the complaint would be unfair to J&J.
Judge Katzmann rejected a request by plaintiffs that more women be able to join until early 2019 when a decision is expected or a settlement is reached. ###
LEARN MORE:
The Guardian, January 30, 2018, Vaginal mesh complications too severe to be infliected on patients, court told
https://www.theguardian.com/society/2018/jan/31/vaginal-mesh-complications-too-severe-to-be-inflicted-on-patients-court-toldMND, October 30, 2017, All Mesh High Risk in Australia
https://www.meshmedicaldevicenewsdesk.com/mesh-high-risk-australia/MND, January 23, 2018, Au Pulls All Mesh Devices from the Market
https://www.meshmedicaldevicenewsdesk.com/australia-pulls-ethicon-tvt-mesh-devices-market/https://www.meshmedicaldevicenewsdesk.com/autoimmune-issues-to-be-added-to-au-women-mesh-claim-against-jj/
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Bard Hustled Defective Meshes To Market, Jury Told In Closing
Apr 11, 2018 | Law 360
By Daniel Siegal
Law360 (April 11, 2018, 9:49 PM EDT) -- C.R. Bard pushed a pair of pelvic mesh devices to market without proper testing or warning, counsel for a woman alleging harm from those devices told a New Jersey jury during Wednesday closing arguments, and Bard countered there isn’t evidence the devices harmed the woman.
Mary McGinnis has alleged that C.R. Bard Inc. knew its Avaulta Solo Support System and the Align Trans-Obturator Urethral Support System were unsafe and failed to warn about the potential risks, and that the products have caused her to suffer debilitating pain.
On Wednesday morning, Adam Slater of Mazie Slater Katz & Freeman LLC, representing McGinnis, reiterated for the Hackensack jury during his closing argument what he had alleged at the outset of the trial — that Bard had blown through “red lights” warning of the dangers of the devices and pushed them onto market anyway.
Slater said that internal documents and emails had revealed that Bard had engaged in an unsafe design process, and said that when asked about this during the trial, Bard representatives had “run away from their emails and their documents.”
“They knew that the problems with this mesh material were causing clinical harm to patients before this was ever put into Mary’s body,” he said. “They knew it was unsafe, and these were among the many red lights.”
Slater said Bard didn’t do clinical trials testing the Avaulta Solo on live patients before bringing it to market, and that their failure to do a real clinical study over time should be held against them, because had they done the study, they might have realized the risks of the mesh outweighed its benefits and would lead to the kind of painful scarring that has affected McGinnis.
Slater said that McGinnis’ doctor wasn't properly warned even of the risks that Bard was aware of, such as permanent pain and permanent sexual pain.
McGinnis, who filed the lawsuit in 2011 along with her husband, Thomas, had the devices implanted in March 2009. She underwent the Avaulta Solo procedure to support her bladder, and the Align system was designed to treat stress urinary incontinence, court documents state.
McGinnis has alleged that before her procedure, however, Bard knew about problems with the devices, and that McGinnis’s surgeon would not have implanted the devices in her if Bard had warned the physician about certain risks.
On Wednesday morning, Lori Cohen of Greenberg Traurig LLP, representing Bard, told the jury during her closing argument that the plaintiffs hadn’t come close to actually proving that Bard’s devices were defective, that Bard didn’t adequately warn of the risks and, most importantly, that McGinnis’ current health complaints were caused by the devices.
Cohen told the jury they should take notice of what the plaintiffs hadn’t told them and that came in through the defense case — like McGinnis’ significant history of medical problems before she had the Bard devices implanted, or that it was a separate surgical procedure that was likely causing her inability to have sex with her husband.
Cohen said Bard met all the industry standards in designing and testing its devices, and that even if it didn’t do a clinical study, it didn’t need to, because of the wealth of medical literature available on the technology they were based on.
Cohen also told the jury to question the credibility of plaintiff expert and doctor Anne Weber, who had testified that Bard’s meshes had caused McGinnis’ health problems, saying that Weber was not licensed to practice medicine and only had one item on her resume — consulting for Slater’s law firm.
The jury began deliberating on Wednesday afternoon, and will return Thursday to resume deliberations.
Mary and Thomas McGinnis are represented by Adam Slater and Cheryll A. Calderon of Mazie Slater Katz & Freeman LLC.
Bard is represented by Lori G. Cohen and Cliff Merrell of Greenberg Traurig LLP and Melissa A. Geist of Reed Smith LLP.
The case is Mary McGinnis et al. v. C.R. Bard Inc. et al., case number L-17543-14, in the Superior Court of New Jersey, County of Bergen.
For additional coverage of this trial, visit Courtroom View Network.
--Additional reporting by Bill Wichert. Editing by Alanna Weissman.https://www.law360.com/lifesciences/articles/1032419/bard-hustled-defective-meshes-to-market-jury-told-in-closing
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Allegations of pelvic mesh shrinkage considered in C.R. Bard trial
Apr 12, 2018 | Legal Newsline
By John Sammon
HACKENSACK, N.J. (Legal Newsline) – An attorney for Mary McGinnis in her lawsuit against C.R. Bard said during trial that the pelvic mesh McGinnis had installed in her pelvic region in 2009 shrunk and distorted, while the defendant contends it can be tissues attempting to heal that causes mesh shape change, not the mesh.
“You don’t disagree that mesh contracts over time do you?” McGinnis’ attorney, Adam Slater of Mazie, Slater, Katz & Freeman of Roseland, New Jersey, asked Dr. Marta Villarraga, a noted biomaterials interaction and biomechanics scientist. "You told the jury you agree that with the concept of mesh contraction - scar tissue contracts and deforms the mesh down with it. You agree that’s a real process, right?”
“I explained to the jury the tissue contracting brings the mesh with it,” Villarraga said.
Streaming video coverage of the trial was provided to Legal Newsline by Courtroom View Network.
McGinnis is suing New Jersey-based C.R. Bard in New Jersey Superior Court in Bergen County for its Avaulta and Align pelvic implant devices that were supposed to support bladder prolapse, but instead allegedly caused inflamed tissue and scarring that caused intense pain, damaged McGinnis' quality of life and had to be surgically removed, causing her more harm.
In addition, the suit contends the company began marketing the products in 2007 and was more interested in selling them than making sure they were safe by doing proper clinical studies beforehand. The devices are made of clear polypropylene.
A sticking point of the trial from the beginning has been the plaintiff’s allegation that the pelvic mesh, in addition to risk from its polypropylene and resin chemical makeup, shrinks and deforms, causing the body to develop unacceptable amounts of scar tissue in an effort to reject it. The attorneys for the defendant maintained it was McGinnis’ arthritic back and hip conditions that pre-dated the implant that caused her pain.
During the April 9 session, Slater sought to minimize the expertise of Villarraga, who was called as a witness for the defendant.
“You’ve never been involved in the development or testing of a mesh product, correct?” he asked.
“No, I have not,” Villarraga answered.
“You’ve never given a lecture or presentation regarding synthetic mesh, correct?”
“That’s correct,” Villarraga said.
“You’re not a physician or expert in gynecology?” Slater asked.
“That’s correct,” Villarraga said.
However under cross-examination by Melissa Geist, an attorney for C.R. Bard, Villarraga said no design of any such implant device is risk-free.
“There is always knowledge of potential complications,” she said. “There is some degree of wound contraction (from implant surgery) in the first few months.”
“Isn’t that consistent with what you testified to?” Geist asked.
“Yes,” Villarraga said.
“Were you objective in reaching your opinions?” Geist asked.
“Absolutely,” Villarraga said.
Geist also attacked Slater’s portrayal that Villarraga lacked expertise in the matter.
“Do you need to have experience in these devices to have an opinion whether they were defective in any way?” she asked.
“No,” Villarraga responded. “I use my training, background and experience to make that assessment.”
Geist asked Villarraga if she had an opinion whether C.R. Bard had met reasonable standards in putting the implant devices on the market starting in 2007.
“Yes, based on my review they (C.R. Bard) acted reasonably to bring this product to market,” Villarraga said.
“C.R. Bard’s conduct was consistent with industry standards?” Geist asked.
“Yes,” Villarraga answered.
Dr. John Heller, an orthopedic surgeon from Atlanta, called as a witness for the defendant said McGinnis suffered from a number of pre-implant arthritic conditions that were progressive in nature.
“She (McGinnis) has a lot going on and has been going on for decades,” Heller said. "There are troubles with the spine and some degree of change between the vertebrae.”
A projected document recounted the alleged conditions including degenerative disc disease, lumbar joint arthritis, femoral impingement and pubic symphysitis (pelvic inflammation).
“I think she had clinically significant stenosis, which is responsible for the symptoms (pain) and that’s been evolving steadily over time,” Heller said.
Lori Cohen, attorney for C.R. Bard with Greenberg Traurig, asked Heller if the implant devices caused the symptoms.
“It has nothing to do with them,” Heller said. “These are treatable conditions.”
https://legalnewsline.com/stories/511386992-allegations-of-pelvic-mesh-shrinkage-considered-in-c-r-bard-trial
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Nearly a dozen women in Port Pirie are known to suffer from pelvic mesh complications
Apr 12, 2018 | The Recorder
By Piper Denholm
Living among the Port Pirie population are nearly a dozen women who have been made victim to the under researched and overlooked pelvic mesh surgery.
The surgery is offered to women who suffer from urinary incontinence, or pelvic organ prolapse which is often a natural cause of child birth, but the mesh can have adverse effects.
The complications include erosion and the mesh poking through the vaginal wall into internal tissue which can cause vaginal scarring, fistula formation, painful sex, and pelvic, back and leg pains.
A survey completed by the Health Issues Centre in 2017 revealed through the 2,410 Australian women they surveyed that 59 per cent of these women returned that the surgery did not help solve the initial problem and 41 per cent of women felt that they were not properly informed prior to the surgery.
With the problems affecting more women due to a lack of proper and informed consent, a senate inquiry has been completed on the plastic implant and on March 28, Pelvic Mesh Support Groups across Australia were informed of the outcomes and for local advocate Kim Blieschke, it is not everything they were hoping for.
“The findings were what we were looking for but probably not exactly what we were looking for. There are recommendations that recommends a mesh registry so that any implants go into a registry so that you can follow up women who have these implants.”
“There was also a recommendation of a mandate to report any adverse events because there is no mandate for that at the moment, so a lot of the complications are going unreported. There was also a recommendation that mesh should only be used as a last resort. That other alternatives should be offered to women before mesh surgery.”
Yet a flaw pointed out to the list of recommendations, is not only the wording of them, the fact that they are not strong enough or wanting to mandate a change in treatment, but also they are simply just recommendations, it does not mean anything will change.
For Kim, this is disappointing.
“Who will actually enforce them”, she asked.
“Given that there is a lot of problems for women in the country who are offered this as a quick fix surgery with no follow up. While the recommendations are great, we are not sure what the follow up is.”
There was a lot of things overlooked in the report, and Kim believes that mesh should be suspended, a registry should be formed, informed consent needs to be made a duty of care and both financial and mental support should be given.
Yet this is so far fetched for something which is only a Senate Report so now women across Australia are now pushing for a Royal Commission into the use of pelvic mesh.
But for the interim, thousands of women are sitting in limbo as they do not know what is next for them.
“There definitely needs to be a mandatory reporting and that needs to be enforced. There needs to be proper informed consent for women because that is still not happening, women are still being implanted with mesh having no idea what the complications are.”
“The financial help whether it be a disability support pension, or some sort of financial recompense needs to happen for them but at this point in time we really don’t know what is going to happen from here.”
The surgery is still performed in Port Pirie and in many other regional hospitals, and Kim has been lobbying and providing women state wide information on what can actually happen if the mesh is implanted or if there are complications.
She knows there is a long journey ahead for the groups Australia wide who are advocating for the mesh to be suspended and doesn’t want to see anymore women come victim to the implants.
“Any woman that is suffering from pelvic organ prolapse or urinary incontinence to research and get all of your options before you even consider surgery.”
“Unfortunately mesh has numerous complications and they are quite devastating and I don’t want one more woman to have to endure what thousands of women in Australia have been through.”
If you or someone you know would like to support Kim and the many other women across South Australia on their fight against pelvic mesh, are encouraged to get in contact with the South Australian Pelvic Mesh support group.
https://www.portpirierecorder.com.au/story/5327727/senate-report-not-what-women-need/
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