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Ethicon Media Monitoring 2/5/2018
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Clear the Decks – Judge Goodwin Pushes 23K Pelvic Mesh Cases to Conclusion!
Feb 5, 2018 | Mesh Medical Device Newsdesk
Its time to clear the decks of the MDL and Judge Goodwin’s orders show he has run out of patience after six years of pelvic mesh litigation that continues to linger in his federal courtroom. -
Phila.'s Mass Tort Inventory Skyrockets as Risperdal Continues to Grow
Feb 2, 2018 | The Legal Intelligencer
By Max Mitchell
... The pelvic mesh mass tort, which saw a $57.1 million verdict and a $20 million verdict last year, shrunk by 27 percent, according to the latest numbers. -
Appeals court made right call in shipping pelvic mesh case from St. Clair Co. to Maryland, lawyer says
Feb 2, 2018 | Cook County Record
By Dee Thompson
A state appeals court's recent decision to ship off to Maryland a lawsuit over allegedly defective pelvic mesh may boost hopes of businesses trying to stave off forum shopping by out-of-state plaintiffs seeking a friendly venue in which to air their claims. -
Is the FDA Doing Enough for Women’s Health in 2018?
Feb 5, 2018 | Drugwatch
By Michelle Llamas
... Transvaginal mesh can lead to serious adverse events such as vaginal erosion, severe pain, inability to have sex and others. -
You can’t make an omelette without breaking a few eggs. Surgeon is criticised for dismissing the scale of women’s suffering in the mesh implant scandal
Feb 2, 2018 | Cambs Times
By Kath Sansom
A warning has been sent to the medical community to pull their heads out of the sand after a surgeon dismissed the mesh implant scandal as a small minority suffering. -
UK government to investigate how many women suffered vaginal mesh complications
Feb 5, 2018 | International Federation of Gynecology and Obstetrics
The UK government has agreed to carry out a review into how many women in England suffered complications resulting from a vaginal mesh implant.
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Clear the Decks – Judge Goodwin Pushes 23K Pelvic Mesh Cases to Conclusion!
Feb 5, 2018 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, February 5, 2018 ~ Its time to clear the decks of the MDL and Judge Goodwin’s orders show he has run out of patience after six years of pelvic mesh litigation that continues to linger in his federal courtroom.
There is a clear sense of urgency in the new orders issued by Judge Joseph Goodwin who is overseeing in excess of 104,000 pelvic mesh cases filed in his Charleston, WV district court.
Judge Goodwin announced at this time last year that it was time to clear the decks of this MDL, multidistrict litigation, which was created in January 20112 by the Judicial Panel on Multidistrict Litigation.
It’s not supposed to go on forever. An MDL is supposed to ease pre-trial proceedings so plaintiffs can have a speedy resolution of their case. In the few bellwether trials, the relative value of a case is supposed to be established.
That hasn’t happened so now its time and the federal judge is giving both sides a strong shove.
The four orders affect 23,202 pelvic mesh cases filed by women implanted with polypropylene mesh to treat incontinence and pelvic organ prolapse.
“These orders are not good for either side,” commented someone with knowledge of the court.
In four of the largest mesh maker actions, thousands of cases have been put into “Waves” or a groupings for pre-trial proceedings. Once discovery is completed they can be transferred to a federal court of proper venue or remanded back to the court from which it was transferred so they can be tried.
The four include Boston Scientific, American Medical Systems, Bard and Ethicon.What’s unclear is how cases future pelvic mesh product liability cases will be handled. Those meshes that remain on the market are still being used by medical societies and called the “gold standard” of care.
ETHICON (Johnson & Johnson)
Ethicon– Wave 8 is created in Pretrial order #280 for 13,200 Ethicon cases! Both sides must be ready for trial this fall! Both sides will meet September 3, 2018 to submit joint venue recommendations, where the trial will take place. Judge Goodwin will set the trial dates.
Cases can transfer out of West Virginia and into a state venue, where it was originally filed or New Jersey where J&J calls home.
Cases in the process of settling may be removed from the list and settled and women with meshes from more than one manufacturer may be relieved of some of the deadlines in that case.
Ethicon has 39,350 cases filed in the MDL with 12,716 listed as closed. That means it has the smallest percentage of closed or resolved pelvic mesh cases.
C.R. BARD
C.R. Bard – Must have its cases ready for trial by the end of October and like Ethicon it is limited as to the number of experts one may call. Treating physician depositions are limited to 4 and depositions must take no longer than three hours. Requests for production of documents is limited to ten. Wave 7 will be the final Wave of the Bard cases and includes 2,876 plaintiffs!
At this time Bard has 15,548 cases filed with 11,047 listed as closed.
AMS
AMS – American Medical Systems (now owned by Endo) has never had a trial so little discovery exists. That has not stopped Judge Goodwin for setting Wave 3 of AMS cases, entered as Pretrial order #249 January 30, 2018. October 26 2018 is the deadline to complete expert motions and both sides should be ready to go to trail. The venues will be decided by September 3, 2018 and 952 women are affected. AMS currently has 21,165 cases filed in the MDL with 19,524 listed as closed.
In its settlement documents, AMS requires lawyers to agree not to bring any more cases against the manufacturer.
Complicating matters, Endo International Plc is facing nightmares of debt and falling generic medicine prices and its opioid painkiller Opana, is the focus of federal litigation. Its stock is perilously low and there is speculation of bankruptcy. As of November, the company agreed to pay $3.5 billion to handle its 46,000 mesh lawsuits but the dollars may not be enough.
Last August, AMS agreed to pay $775 million to close out outstanding pelvic mesh claims in the U.S. and internationally.
BOSTON SCIENTIFIC
Boston Scientific Wave 4 will be formed and ready for trial also at the end of October. 6,174 women fall under this order.
Coloplast Waves 1,2, and 3 are awaiting an update as to which have not been resolved or dismissed.
Cook stopped having cases referred into the West Virginia MDL last September. There are 632 cases filed in the Cook product liability litigation and 137 filed in Neomedic which appear to be resolving since they are talking about dividing common benefit dollars and no discussion of trials
LEARN MORE:
U.S. District Court, Southern District of West Virginia
https://www.wvsd.uscourts.gov/https://www.meshmedicaldevicenewsdesk.com/clear-decks-judge-goodwin-pushes-23k-pelvic-mesh-cases-conclusion/
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Phila.'s Mass Tort Inventory Skyrockets as Risperdal Continues to Grow
Feb 2, 2018 | The Legal Intelligencer
By Max Mitchell
With an inventory of pharmaceutical cases that nearly doubled over the past 12 months, Philadelphia’s pharma-related mass tort programs have reached record heights for the second year in a row.
According to latest statistics from the First Judicial District, the total inventory of the city’s mass tort programs went from 6,196 at the beginning of the year to 10,984 by Dec. 31. That is a 77 percent increase for the Complex Litigation Center’s overall inventory.
And when it comes to the pharmaceutical-specific cases, the numbers are even more striking.
At the beginning of 2017, the court had 5,601 pharmaceutical cases pending, which was a record for the court. The latest statistics, however, say that by the end of December, the pharmaceutical inventory jumped to 10,395, which is an 85.5 percent increase.
According to the numbers, the vast majority of the growth is due to the drug Risperdal, which now accounts for more than 56 percent of the total mass tort inventory.
Since Jan. 2, 2017, the number of Risperdal cases jumped from 1,945 to 6,200 by late December, according to the data. That is a 219 percent increase over the 12-month period.
Kline & Specter attorney Thomas R. Kline, who is a lead attorney in the Risperdal litigation, said the significant increase is due to Janssen Pharmaceutical ending a tolling agreement, which then required the plaintiffs to file their cases in court so their claims would not be lost due to the statute of limitations running out.
Kline said he does not expect another wave of cases to be filed soon, but he added there have been no substantive talks regarding a global settlement. However, he said the increase in cases, which he said mostly involve claims related to an earlier version of the Risperdal label that was later updated, as well as a recent ruling by the state Superior Court allowing plaintiffs to push for punitive damages, should put increased pressure on the defendants.
“The inventory increase has been not only, in my view, one of quantity, but also one of quality,” he said.
A spokeswoman for Janssen, the Johnson & Johnson subsidiary that makes Risperdal, said the company plans to “continue to defend this litigation and will try cases where appropriate.”
The percentage of out-of-state plaintiffs filing cases in Philadelphia in 2017 also reached a new high, according to the latest number.
Last year, the number of plaintiffs coming from outside the Keystone State was at its lowest period in more than 10 years, at 74 percent, but the number of out-of-state plaintiffs filing in 2017 jumped to 90 percent. That is the highest number since the court began measuring the statistic in 2005.
The mass tort program that saw the second-highest level of growth was the program focused on Xarelto litigation. That litigation grew 33 percent over 2017, going from 1,214 to 1,619 cases, according to the court’s statistics.
It has been an active year for the Xarelto docket, with three bellwether trials happening in the federal wing of the litigation, and one trial coming to a $27.8 million verdict in Philadelphia. That award was later overturned, and the case is on appeal to the Superior Court.
Despite the growth, the litigation saw a much smaller increase in 2017 than it did in 2016. In 2016, the total number of Xarelto cases in Philadelphia grew by 121 percent.
Attorney Michael Weinkowitz of Levin Sedran & Berman, who is co-liaison counsel, said there is nothing on the horizon indicating that the program will see an influx of cases.
“I don’t expect it to grow substantially,” Weinkowitz said.
The mass tort program that saw the largest verdicts over the past year also saw a significant decline over 2017. The pelvic mesh mass tort, which saw a $57.1 million verdict and a $20 million verdict last year, shrunk by 27 percent, according to the latest numbers.
Court records said that, although 37 new pelvic mesh cases were filed, 82 were disposed of during 2017, dropping the total number of pelvic mesh cases from 164 in January 2017 to 119 by the end of the year.
Shanin Specter, who is also of Kline & Specter and is a leading attorney in the pelvic mesh litigation, said most of that dip was due to settlements in cases being handled by other firms.
https://www.law.com/thelegalintelligencer/sites/thelegalintelligencer/2018/02/02/phila-s-mass-tort-inventory-skyrockets-as-risperdal-continues-to-grow/?slreturn=20180105020432
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Feb 2, 2018 | Cook County Record
By Dee Thompson
MT. VERNON — A state appeals court's recent decision to ship off to Maryland a lawsuit over allegedly defective pelvic mesh may boost hopes of businesses trying to stave off forum shopping by out-of-state plaintiffs seeking a friendly venue in which to air their claims.
In December, a three-justice panel of the Illinois Fifth District Appellate Court in southern Illinois declared a St. Clair County judge abused his discretion in denying a request by a defendant company to make the plaintiffs, who were from Maryland, try the case in their own home state.
The defendant, American Medical Systems Inc. (AMS), appealed the circuit court’s decision to deny its motion to dismiss on the basis of forum non conveniens, which is a power courts hold to dismiss a case when they believe that another court, or forum, would be more suitable to hear the case.
“I think eventually the court was able to make the right decision because, at the time they rendered the decision in December 2017, most of the plaintiffs had settled their claims, so there were only a couple of plaintiffs left, and the doctrine of forum non conveniens, which means ‘an inconvenient forum,’ was applicable,” Kevin Hara, an attorney at Reed Smith in San Francisco, told the Cook County Record.
The case was originally filed in May 2012 in the St. Clair County Circuit Court. In the beginning, the case included 75 plaintiffs from 23 states, and they filed a joint multi-count product liability suit, alleging the defendants, AMS and Endo Pharmaceuticals, a subsidiary of AMS, manufactured and sold defective pelvic mesh products that caused severe health problems following surgical implantation.
The plaintiffs also alleged the defendants had concealed unreasonably dangerous risks posed by their products. The plaintiffs claimed venue was proper in St. Clair County because the defendants had promoted and sold their products there. Also, one of the plaintiffs had her pelvic mesh implanted at Memorial Hospital in Belleville in St. Clair County.
In June 2012, AMS filed a motion to sever the plaintiffs’ causes of action, maintaining they had been improperly joined. AMS also filed a motion to dismiss or transfer on the basis of wrongful venue.
In its motion, AMS noted the plaintiffs had not alleged either defendant was a resident of St. Clair County. AMS also asserted, if the circuit court granted its motion to sever, all plaintiffs other than the one from St. Clair County would lack a proper legal or factual basis upon which to establish venue in St. Clair County.
Eventually, 73 of the 75 plaintiffs settled. When only two plaintiffs were left, Paula and Earl Conway of Essex, Md., the case was set for trial. Citing forum non conveniens, in July 2016 AMS filed a motion to dismiss. The company argued the Conways had no connection to St. Clair County. The circuit court denied the motion and AMS appealed. The appellate court ruled in the company's favor.
Hara said such forum shopping is common. Attorneys will try to get their cases in the court where they think they will achieve the best result.
Hara thinks the decision is interesting for several reasons, including its winding and difficult procedural history and the appellate court's eventual decision.
"They arrived at the correct decision based on the law and the facts that were applicable,” he said.
Hara doesn’t believe the outcome was negative for any of the parties.
“The court will weigh public and private interest factors, such as the location of witnesses, the location of the evidence, convenience of the parties - and all of those factors weighed in favor of transferring the case to Maryland," he said. "They weren’t saying that they were dismissing the case. They were allowing the case to be transferred to Maryland.”
https://cookcountyrecord.com/stories/511325767-appeals-court-made-right-call-in-shipping-pelvic-mesh-case-from-st-clair-co-to-maryland-lawyer-says
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Is the FDA Doing Enough for Women’s Health in 2018?
Feb 5, 2018 | Drugwatch
By Michelle Llamas
According to the U.S. Food and Drug Administration’s January e-update, the FDA’s Office of Women’s Health is “excited to continue advancing science and innovation to improve the health of women” in 2018.
But, have the FDA and the Office of Women’s Health been doing enough for women? Critics say, “No.”
Although the agency has made a few strides in women’s health recently, critics say the agency’s failures to protect women from faulty medical devices and drugs overshadow these accomplishments.
“I recognize the many advancements coming from the Office of Women’s Health,” Essure Problems group administrator Amanda Dykeman told Drugwatch. But, “it becomes difficult to applaud them when they are also doing a great disservice [to] women who have reported severe complications due to products such as Essure birth control, transvaginal mesh and breast implants.”
The FDA from 2015 to 2018, for example, approved drugs and cleared medical devices to treat breast cancer (a market worth billions in the U.S.), giving more choices to women.
But, in 2015 it also approved Addyi (flibanserin) — a drug called “women’s Viagra” — based on clinical trials done mostly on men.
FDA boasted its commitment to women’s sexual health but approved the drug despite serious side effects such as fainting, low blood pressure and dangerous interactions with a variety of medications.
“If [Addyi] is a victory for women, perhaps I am confused by the rules of the game,” said Rick Harrison of Women’s Health Research at Yale.FDA Fails to Protect Women from Power Morcellators
The FDA took more than 20 years to warn women that gynecological devices called power morcellators could spread cancer, despite having evidence of the risk since the 1990s.
“Power morcellators — despite their severe deadly hazard to women — were not banned even after repeated independent studies demonstrated the mortality risk to be very high, and after the FDA’s own experts testified that morcellation of tumors violated the principles of safe surgery,” cardiac surgeon and women’s health advocate Hooman Noorchashm said.
A black box warning — the FDA’s most severe warning — appears on packaging, but the agency has yet to ban the device. In fact, it allowed a new device on the market.
“The [Office of Women’s Health] is a joke,” Noorchashm said. “It has no real sway, or if does, its only to whitewash some really egregious FDA failures on the women’s health front. We don’t even have to go too far in FDA history to find terrible failures in protecting women.”Harm from Essure ‘Not Justifiable’
Thousands of women and doctors have reported about 18,000 complications linked to Essurebirth control, yet the FDA continues to allow Bayer to sell the device in the U.S., according to an Oct. 30, 2017 letter to FDA Commissioner Scott Gottlieb from members of Congress Rosa L. De Lauro, Jan Schakowsky and Louise M. Slaughter.
“Despite widespread safety concerns, the FDA has allowed Essure to remain on the market while mandating that the manufacturer, Bayer, conduct an additional post-market safety study,” the members wrote. “The FDA cannot continue to let Bayer drag its feet on this post-market study while women are continuing to suffer.”
Bayer pulled Essure from the market in all countries except the U.S. in 2017. The FDA has yet to comment on this development.“Essure is an example of the lax process for testing medical devices.”“Essure is an example of the lax process for testing medical devices.”
– MICHAEL CAROME, DIRECTOR OF PUBLIC CITIZEN’S HEALTH RESEARCH GROUP
“I suppose the Office of Women’s Health is comfortable with the harm Essure imposes on otherwise young and healthy American women,” Noorchashm said. “Remember, Essure is birth control, it does not treat an incurable disease, so the irreversible harm it does to women is not justifiable.”
FDA Silent on Pelvic Mesh Ban in Other CountriesTransvaginal mesh can lead to serious adverse events such as vaginal erosion, severe pain, inability to have sex and others.
The FDA reclassified pelvic mesh for prolapse as high-risk in 2016. Australia, New Zealand and the U.K. recently banned the devices. The FDA has yet to comment on the bans.
“The FDA clearly has been reckless in failing to remove [transvaginal mesh] from the market,” Dr. Michael Carome, director of Public Citizen’s Health Research Group told Drugwatch. “Back in 2001, Public Citizen petitioned the FDA to ban and recall all transvaginal mesh for treating pelvic organ prolapse. The FDA itself found these were causing serious adverse events.”
Deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health William Maisel said the agency would monitor women in postmarket studies, but the FDA has yet to provide any of the data from these studies or an update on their progress.
“Here is another example of incontrovertible harm done by a women’s health product,” Noorchashm said. “[There are thousands] of lawsuits and also undeniable scientific evidence of harm.”
FDA is More Marketing Agency than Public Health AgencyDrug and device companies are paying even more of the FDA’s budget in 2018. So-called user fees account for about two-thirds of the FDA’s funding. As a result, critics say, the FDA treats manufacturers like clients.
“Rather than acting in the interest of public health, the FDA is more concerned about meeting the needs of the industry,” Carome said.
The price medical device manufactures pay in user fees to clear Class II devices for sale has risen from $4,690 in 2017 to $10,566 in 2018. For high-risk devices like Essure, the 2018 fee is $310,764.
“The blind leading the blind to make money and ‘innovate’ spells disaster in the women’s healthspace,” Noorchashm said.
Fast Fact: From 1997-2000, eight of the 10 drugs taken off the market were more dangerous to women than men.
Pullout quote: “Essure is an example of the lax process for testing medical devices.” – Michael Carome, director of Public Citizen’s Health Research Group
Include fast fact in this section: Manufacturers pay user fees for FDA approval and clearance of their products, a practice Congress enacted for drugs in 1992 and for medical devices in 2002.
https://www.drugwatch.com/2018/02/02/is-fda-doing-enough-womens-health-2018/
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Feb 2, 2018 | Cambs Times
By Kath Sansom
A warning has been sent to the medical community to pull their heads out of the sand after a surgeon dismissed the mesh implant scandal as a small minority suffering.
Professor Carl Heneghan, an expert in evidence based medicine, told a Parliamentary think tank that surgeon societies need to: “stop pretending it’s alright.”
The stark warning came as criticism was levelled at medical giant Johnson and Johnson, who flew surgeons to America en masse to train them in mesh insertion in the early days of its use.
The scale of the disaster was measured by MP Owen Smith who told a meeting of the All Party Parliamentary Group into mesh: “We have women coming to us in greater numbers than any other procedure historically we’ve known.”
Surgeons Linda Cardozo and Tim Hillard were invited to represent 6,000 members of the Royal College of Obstetrics and Gynaecology to speak to MPs about the escalating implant scandal.
But after hearing them urge MPs against a mesh ban, Professor Heneghan said: “I feel deeply distressed about the way the conversation is going.
“When the metal hip crisis became apparent the difference was the Orthopaedic Society pulled their head out of the sand and dealt with it, you are not doing that.
“You need to do the right thing. There’s things you need to clarify. How does the Department of health put patient safety first?
“You’re talking about developing evidence, yet for 15 years you’ve had the opportunity to build evidence, yet you haven’t.”
Ms Cardozo, who works for King’s, London, currently in special measures, said you could not make an omelette without breaking a few eggs and said a lot of the problems blamed on mesh were things women would get anyway as they aged.
She added: “I have used a significant number of tapes for high profile women who have never come forward (with problems), they are very famous women.
“There is a skewed view of the women who regard themselves as victims. Much of the fuelling of the fire comes from the press, for example, the Daily Mail saying it’s barbaric.
“Sometimes we do get it wrong but we can’t know who that is going to happen to.
“It’s a very sad state of affairs when doctor practice is being guided by the press.
“I think choice is important. By banning, it will disadvantage others,” she said and added it was only a “small minority who suffer.”
Ms Cardozo said mesh use must continue in the interests of patient choice but women should be logged on a National Register.
When told many women suffering had been given no warning of the risks Ms Cardozo admitted that surgeons have “been guilty of glossing over consent because we were busy.”
More concerning was that she said she would fly in the face of NICE guidelines to use vaginal prolapse mesh if a woman presented to her with particular criteria.
Surgeon John Osborne said: “Large numbers of people were taken to the states to be trained in TVT. That sort of marketing should not be happening.”
Surgeon Wael Agur closed the meeting with a stern message: “If you don’t have mesh you don’t have mesh complications. It’s Russian roulette. No woman has a blue badge on their car because of a native tissue repair. Mesh risks are unacceptable.”
http://www.cambstimes.co.uk/news/professor-carl-heneghan-sling-the-mesh-parliament-appg-1-5380772
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UK government to investigate how many women suffered vaginal mesh complications
Feb 5, 2018 | International Federation of Gynecology and Obstetrics
The UK government has agreed to carry out a review into how many women in England suffered complications resulting from a vaginal mesh implant.
It comes as many women have reported pain from the implant - which is intended to hold pelvic organs up in order to treat incontinence and prolapse - cutting into the surrounding tissue.
The Royal College of Obstetricians and Gynaecologists advises: “If you are considering a procedure using mesh, you should have a detailed discussion with an expert healthcare professional about the benefits and risks of the surgery for you.”
It added that for women deciding to proceed with the operation, it “should only be performed by a specialist with expertise in this technique”.
The National Institute for Health and Clinical Excellence recently said the operation should be banned, saying that the implants should be used only for research, not routine surgery.https://www.figo.org/news/uk-government-investigate-how-many-women-suffered-vaginal-mesh-complications-0015824
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