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BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION

 

 

IN RE: CHILDREN BORN                       MDL – _________

OPIOID-DEPENDENT

 

BRIEF IN SUPPORT OF PLAINTIFFS’ MOTION FOR TRANSFER OF

ACTIONS PURSUANT TO 28 U.S.C. § 1407 FOR COORDINATED OR

CONSOLIDATED PRETRIAL PROCEEDINGS

Plaintiffs[1] respectfully move that the Judicial Panel on Multidistrict Litigation (“Panel”), pursuant to 28 U.S.C. § 1407 and Rule 6.2 of the Rules of Procedure of the Panel, transfer the actions on behalf of children born opioid-dependent listed in the attached Schedule of Actions and subsequent tag-along actions to a separate MDL before the Southern District of West Virginia.; alternatively, Plaintiffs request transfer to the Southern District of Illinois.

I.        Children Born Opioid-Dependent Need A Separate MDL From MDL 2804

Movants seek transfer and coordination or consolidation of all cases filed on behalf of opioiddependent infants into a new MDL for the reasons laid out

[1] Movants are: Deric Rees and Ceonda Rees, individually and as next friend and guardian of Baby T.W.B. on behalf of themselves and all others similarly situated (Illinois Class); Darren and Elena Flanagan, individually and as adoptive parents and next friends of Baby K.L.F., on behalf of themselves and all others similarly situated (Tennessee Class); Rachel Wood, individually and as next friend and adopted mother of Baby O.W., on behalf of themselves and all others similarly situated (Missouri Class); Melissa Ambrosio, individually and as next friend of Baby G.A., and on behalf of themselves and all others similarly situated (California Class); Shannon Hunt, individually and as next friend of Baby S.J., on behalf of themselves and all others similarly situated (Maryland Class); Bobbi Lou Moore on behalf of Baby R.R.C., and all other similarly situated (West Virginia Class); Walter and Virginia Salmons, individually and as the next friend or guardian of Minor W.D. and on behalf of all others similarly situated (National Class).

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Why Isn’t Medical Cannabis Used to Treat Opioid and Substance Abuse Disorders More Often, Since It Works?

IS MEDICAL CANNABIS AN ALTERNATIVE TREATMENT FOR OPIOID ADDICTION?

By Mark A. York (September 20, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) More and more medical treatment professionals, politicians and others have joined in the quickly emerging role of medical marijuana to help in treatment by patients struggling with opioid addiction. Now, two studies are reflecting this emerging treatment to be viable.

Recent studies, published journal JAMA Internal Medicine, compared opioid prescription patterns in states that have enacted medical cannabis laws with those that have not. One of the studies looked at opioid prescriptions covered by Medicare Part D between 2010 and 2015, while the other looked at opioid prescriptions covered by Medicaid between 2011 and 2016.

Additionally, three states have approved Medical Cannabis for alternative treatments related to both pain management and substance abuse disorders, where cannabis has been determined as an appropriate treatment. Pennsylvania, New Jersey and Illinois are at the forefront of using changes to state laws regarding medical cannabis in the most effective clinical settings when possible.

PENNSYLVANIA CANNABIS BASED OPIOID ADDICTION TREATMENT

The Pennsylvania Department of Health approved major changes to the state’s medical marijuana program, when the  health department added opioid addiction to the list of conditions eligible for treatment with medicinal cannabis. With that decision, Pennsylvania joins New Jersey and Illinois as the only states that have done so.

Pennsylvania Secretary of Health Dr. Rachel Levine told local media that marijuana won’t be the first treatment for addiction to opioids. Instead, doctors will try more traditional therapies first.

“It’s important to note that medical marijuana is not a substitute for proven treatments for opioid use disorder,” Dr. Levine said. “In Pennsylvania, medical marijuana will be available to patients if all other treatment fails, or if a physician recommends that it be used in conjunction with traditional therapies.”

A related positive note by Pennsylvania is the Department of Health has approved cannabis research licenses for five Philadelphia area medical schools on Monday. With one topic of research at the institutions being the potential role of cannabis in addiction treatment as a normal treatment protocol.

The schools that received approval to study cannabis are Drexel University College of Medicine, Lewis Katz School of Medicine at Temple University, Sidney Kimmel Medical College at Thomas Jefferson University, Perelman School of Medicine at the University of Pennsylvania, and Philadelphia College of Osteopathic Medicine.

JAMA STUDY RESULTS

The researchers found that states that allow the use of cannabis for medical purposes had 2.21 million fewer daily doses of opioids prescribed per year under Medicare Part D, compared with those states without medical cannabis laws. Opioid prescriptions under Medicaid also dropped by 5.88% in states with medical cannabis laws compared with states without such laws, according to the studies.

“This study adds one more brick in the wall in the argument that cannabis clearly has medical applications,” said David Bradford, professor of public administration and policy at the University of Georgia and a lead author of the Medicare study.

“And for pain patients in particular, our work adds to the argument that cannabis can be effective.”

Medicare Part D, the optional prescription drug benefit plan for those enrolled in Medicare, covers more than 42 million Americans, including those 65 or older. Medicaid provides health coverage to more than 73 million low-income individuals in the US, according to the program’s website.

“Medicare and Medicaid publishes this data, and we’re free to use it, and anyone who’s interested can download the data,” Bradford said. “But that means that we don’t know what’s going on with the privately insured and the uninsured population, and for that, I’m afraid the data sets are proprietary and expensive.”

Republicans Support Legalizing Medical Cannabis

Earlier this year, the National Academy of Sciences, in a 395-page report, refuted the official US Department of Justice position that cannabis is a “gateway drug” and that using marijuana can lead to opioid addiction and instead found evidence of cannabis having therapeutic and health benefits. Joe Schrank, a social worker who worked at various detox centers and clean houses, is now practicing the report’s findings at High Sobriety treatment center in Los Angeles, where he offers clients medical and therapeutic sessions, and daily doses of marijuana to treat a variety of addictions.

The Opioid Crisis Is Here

The new research comes as the United States remains entangled in the worst opioid epidemic the world has ever seen. Opioid overdose has risen dramatically over the past 15 years and has been implicated in over 500,000 deaths since 2000 — more than the number of Americans killed in World War II.

“As somebody who treats patients with opioid use disorders, this crisis is very real. These patients die every day, and it’s quite shocking in many ways,” said Dr. Kevin Hill, an addiction psychiatrist at Beth Israel Deaconess Medical Center and an assistant professor of psychiatry at Harvard Medical School, who was not involved in the new studies.

“We have had overuse of certain prescription opioids over the years, and it’s certainly contributed to the opioid crisis that we’re feeling,” he added. “I don’t think that’s the only reason, but certainly, it was too easy at many points to get prescriptions for opioids.”

Today, more than 90 Americans a day die from opioid overdose, resulting in more than 42,000 deaths per year, according to the US Centers for Disease Control and Prevention. Opioid overdose recently overtook vehicular accidents and shooting deaths as the most common cause of accidental death in the United States, the CDC says.

 

 

 

 

 

 

 

Doctors must lead us out of our opioid abuse epidemic

Like opioids, marijuana has been shown to be effective in treating chronic pain as well as other conditions such as seizures, multiple sclerosis and certain mental disorders, according to the National Institute on Drug Abuse. Research suggests that the cannabinoid and opioid receptor systems rely on common signaling pathways in the brain, including the dopamine reward system that is central to drug tolerance, dependence and addiction.

“All drugs of abuse operate using some shared pathways. For example, cannabinoid receptors and opioid receptors coincidentally happen to be located very close by in many places in the brain,” Hill said. “So it stands to reason that a medication that affects one system might affect the other.”

But unlike opioids, marijuana has little addiction potential, and virtually no deaths from marijuana overdose have been reported in the United States, according to Bradford.

“No one has ever died of cannabis, so it has many safety advantages over opiates,” Bradford said. “And to the extent that we’re trying to manage the opiate crisis, cannabis is a potential tool.”

Comparing states with and without medical marijuana laws

  • Researchers compared prescription patterns in states with and without medical cannabis laws
  • States with medical marijuana had 2.21 million fewer daily doses of opioids prescribed per year
  • Opioid prescriptions under Medicaid dropped by 5.88% in states with medical cannabis laws

In order to evaluate whether medical marijuana could function as an effective and safe alternative to opioids, the two teams of researchers looked at whether opioid prescriptions were lower in states that had active medical cannabis laws and whether those states that enacted these laws during the study period saw reductions in opioid prescriptions.

Both teams, in fact, did find that opioid prescriptions were significantly lower in states that had enacted medical cannabis laws. The team that looked at Medicaid patients also found that the four states that switched from medical use only to recreational use — Alaska, Colorado, Oregon and Washington — saw further reductions in opioid prescriptions, according to Hefei Wen, assistant professor of health management and policy at the University of Kentucky and a lead author on the Medicaid study.

“We saw a 9% or 10% reduction (in opioid prescriptions) in Colorado and Oregon,” Wen said. “And in Alaska and Washington, the magnitude was a little bit smaller but still significant.”

Cannabis legalization by the numbers

The first state in the United States to legalize marijuana for medicinal use was California, in 1996. Since then, 29 states and the District of Columbia have approved some form of legalized cannabis. All of these states include chronic pain — either directly or indirectly — in the list of approved medical conditions for marijuana use, according to Bradford.

The details of the medical cannabis laws were found to have a significant impact on opioid prescription patterns, the researchers found. States that permitted recreational use, for example, saw an additional 6.38% reduction in opioid prescriptions under Medicaid compared with those states that permitted marijuana only for medical use, according to Wen.

The method of procurement also had a significant impact on opioid prescription patterns. States that permitted medical dispensaries — regulated shops that people can visit to purchase cannabis products — had 3.742 million fewer opioid prescriptions filled per year under Medicare Part D, while those that allowed only home cultivation had 1.792 million fewer opioid prescriptions per year.

“We found that there was about a 14.5% reduction in any opiate use when dispensaries were turned on — and that was statistically significant — and about a 7% reduction in any opiate use when home cultivation only was turned on,” Bradford said. “So dispensaries are much more powerful in terms of shifting people away from the use of opiates.”

The impact of these laws also differed based on the class of opioid prescribed. Specifically, states with medical cannabis laws saw 20.7% fewer morphine prescriptions and 17.4% fewer hydrocodone prescriptions compared with states that did not have these laws, according to Bradford.

 

 

 

 

 

 

This is fentanyl: A visual guide

Fentanyl prescriptions under Medicare Part D also dropped by 8.5% in states that had enacted medical cannabis laws, though the difference was not statistically significant, Bradford said. Fentanyl is a synthetic opioid, like heroin, that can be prescribed legally by physicians. It is 50 to 100 times more potent than morphine, and even a small amount can be fatal, according to the National Institute on Drug Abuse.

“I know that many people, including the attorney general, Jeff Sessions, are skeptical of cannabis,” Bradford said. “But, you know, the attorney general needs to be terrified of fentanyl.”

MAKING CANNABIS AVAILABLE

This is not the first time researchers have found a link between marijuana legalization and decreased opioid use. A 2014 study showed that states with medical cannabis laws had 24.8% fewer opioid overdose deaths between 1999 and 2010. A study in 2017 also found that the legalization of recreational marijuana in Colorado in 2012 reversed the state’s upward trend in opioid-related deaths.

“There is a growing body of scientific literature suggesting that legal access to marijuana can reduce the use of opioids as well as opioid-related overdose deaths,” said Melissa Moore, New York deputy state director for the Drug Policy Alliance. “In states with medical marijuana laws, we have already seen decreased admissions for opioid-related treatment and dramatically reduced rates of opioid overdoses.”

Sessions: DOJ looking at ‘rational’ marijuana policy

Some skeptics, though, argue that marijuana legalization could actually worsen the opioid epidemic. Another 2017 study, for example, showed a positive association between illicit cannabis use and opioid use disorders in the United States. But there may be an important difference between illicit cannabis use and legalized cannabis use, according to Hill.

“As we have all of these states implementing these policies, it’s imperative that we do more research,” Hill said. “We need to study the effects of these policies, and we really haven’t done it to the degree that we should.”

The two recent studies looked only at patients enrolled in Medicaid and Medicare Part D, meaning the results may not be generalizable to the entire US population.

But both Hill and Moore agree that as more states debate the merits of legalizing marijuana in the coming months and years, more research will be needed to create consistency between cannabis science and cannabis policy.

“There is a great deal of movement in the Northeast, with New Hampshire and New Jersey being well-positioned to legalize adult use,” Moore said. “I believe there are also ballot measures to legalize marijuana in Arizona, Florida, Missouri, Nebraska and South Dakota as well that voters will decide on in Fall 2018.”

Hill called the new research “a call to action” and added, “we should be studying these policies. But unfortunately, the policies have far outpaced the science at this point.”

There are no U.S. Food and Drug Administration (FDA)-approved painkillers derived from marijuana, but companies such as Axim Biotechnologies Inc, Nemus Bioscience Inc and Intec Pharma Ltd have drugs in various stages of development.

The companies are targeting the more than 100 million Americans who suffer from chronic pain, and are dependent on opioid painkillers such as Vicodin, or addicted to street opiates including heroin.

Opioid overdose, which claimed celebrities including Prince and Heath Ledger as victims, contributed to more than 33,000 deaths in 2015, according to the Centers for Disease Control and Prevention.

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VERDICT FOR PLAINTIFF! Monsanto Loses First “Roundup” Cancer Trial in San Francisco Courtroom

 Verdict of $288 Million Against Monsanto: “Trial Loss Shows There Was Collusion to Stop Release of Cancer Link For Years”

Regular Damages: $38,819,000 (million)

Punitive Damages: $250 million

Claims Proven by Plaintiffs: Design Defect, Failure to Perform, Design Factor Caused Cancer, Monsnato Failed to Warn of Cancer Risks, “NEGLIGENT FAILURE TO WARN” and others

By Mark A. York (August 10, 2018)

 

 

 

 

 

 

 

DeWayne Johnson vs. Monsanto Is The First Lymphoma Cancer Trial

A verdict in favor of plaintiff DeWayne Johnson was reached earlier today in the first trial versus Monsanto and claims that the weed-killer Roundup causes cancer.

On Thursday, afternoon, the jury requested additional data on the various studies referenced by expert witness in expert witness testimony.

Case is DeWayne Johnson vs. Monsanto Company Case No. CGC-16-550128 in the  SUPERIOR COURT OF CALIFORNIA, SAN FRANCISCO COUNTY, Judge Bolanos.

Johnson Trial Transcripts: Monsanto-roundup-lawsuit/dewayne-johnson-v-monsanto-transcripts(baum-hedlund)

Here is the day one opening statement by Brent Wisner, plaintiff trial counsel with Baum Hedlund Aristei & Goldman.

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(MASS TORT NEXUS MEDIA) Glyphosate is the most widely used agricultural based chemical product in history, starting when Monsanto introduced it in 1974, and worldwide use exploded after 1996 when Monsanto began selling “Roundup-ready” seeds- engineered to resist the herbicide, with now possibly catastrophic consequences in the United States.

More than 2.6 billion pounds of the chemical has been spread on U.S. farmlands and yards between 1992 and 2012, according to the U.S. Geological Survey. Roundup traces have been detected in over 50% of the food products being consumed in the US marketplace in numerous independent studies.

Monsanto earns $1.9 billion a year from Roundup and $10.2 billion from “seeds and genomics,” most of that category being Roundup-ready seeds.

In June, German pharmaceutical giant Bayer completed its $63 billion acquisition of Monsanto after approval by U.S. and European regulators, even though the Monsanto name may disappear, the link between cancer and glyphosate will remain long after the merger. Will Bayer decide to settle or take the thousands of lawsuits to trial that are pending in federal and state courts across the country? Although U.S. and European regulators have concluded Roundup’s active ingredient glyphosate is safe, the World Health Organization’s International Agency for Research on Cancer classified it in 2015 as a probable human carcinogen, triggering over 5,000 lawsuits against Monsanto in the United States.

Plaintiff DeWayne Johnson’s skin-based non-Hodgkin lymphoma, was caused by his use of Monsanto’s “Roundup Weed Killer” and Monsanto has gone to great lengths to suppress any links between Roundup and cancer.

The current state court trial in California has shown the extraordinary lengths that Monsanto has gone to in order to suppress and manipulate hard core science and research results around the world that showed clear links between Glyphosate and Cancer, specifically non-hodgkins lymphoma.

To show the high level of interest in the Monsanto “Roundup” abuses, last week musician Neil young and actress Darryl Hannah were in the DeWayne Johnson courtroom, which reflects Young’s ongoing campaign against the many abuses of Monsanto placed upon the US farmers and others around the world. He even released a 2015 album titled “The Monsanto Years” along with a documentary “Seeding Fear” of which Young co-produced related to Monsanto legal action against Alabama farmer Michael White, over its GMO patented seeds. Link to “Seeding Fear can be found here.

In addition to the Johnson state court case, there is the Monsanto Roundup Multidistrict Litigation No. 2741 in the US District Court of California, Northern District where the same cancer links are claimed. Documents released in the Johnson trial and in the MDL ( see Roundup (Monsanto) MDL 2741 USDC ND California) have raised many new questions about the company’s efforts to influence the public opinion by collusion and steering of data published by the media, authors and scientific research publications, and revealed internal debate over the safety of the Monsanto’s weed killer Roundup.

The active ingredient is glyphosate, the most common weed killer in the world and is used around the world on farm crops and by home gardeners, with the largest market being the USA. While Roundup’s relative safety has been upheld by most regulators, the thelitigation against Monsanto and Roundup, pending in US District Court in San Francisco continues to raise questions about the company’s practices and the product itself. Thousands of plaintiffs from across the USA have filed suit against Monsanto-Roundup and as details of Monsanto’s attempt to suppress and influence the release of damaging scientific data are released the number of cases will only increase. There has been documented evidence introduced that shows Monsanto influenced high level US Environmental Protection Agency (EPA) executives to suppress data and the release of reports that showed Roundup (glyphosate) was dangerous and suspected of causing cancer. Jess Rowland, EPA Regulatory Affairs Manager, stopped the release of a government study that was key in the investigation into the carcinogenic effects of Roundup’s primary ingredient glyphosate by the Agency for Toxic Substances and Disease Registry, see EPA’s Jess Rowland Stops Release of Report on Glyphosate as Cancer Agent. Rowland left the EPA in early 2017 and went on to become a highly paid consultant for Monsanto.

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup.  Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research. An academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

Monsanto said it was outraged by the documents’ release by a law firm involved in the litigation, although the documents are now public court records, which Monsanto attempted to suppress being introduced into the litigation again and again since the start of the Roundup lawsuits.

  1. Brent Wisner, a partner at Baum, Hedlund, Aristei & Goldman, the firm that released the documents, said Monsanto had erred by not filing a required motion seeking continued protection of the documents. Monsanto said no such filing was necessary.

“Now the world gets to see these documents that would otherwise remain secret”, per Mr. Wisner.

To reflect “official corporate collusion and influence”  see Mr. Miller’s 2015 article on Forbes’s website which was an attack on the findings of the International Agency for Research on Cancer, a branch of the World Health Organization that had labeled glyphosate a probable carcinogen, a finding disputed by other regulatory bodies. In the email traffic, Monsanto asked Mr. Miller if he would be interested in writing an article on the topic, and he said, “I would be if I could start from a high-quality draft.”

The article was authored by Mr. Miller and with the assertion that “opinions expressed by Forbes Contributors are their own.” The magazine did not mention any involvement by Monsanto in preparing the article, as most co-authored articles provide.

“That was a collaborative effort, a function of the outrage we were hearing from many people on the attacks on glyphosate,” Mr. Partridge of Monsanto said. “This is not a scientific, peer-reviewed journal. It’s an op-ed we collaborated with him on.”

After disclosure of the stories origin, Forbes removed the story from its website and said that it ended its relationship with Mr. Miller amid the revelations.

“All contributors to Forbes sign an agreement requiring them to disclose any potential conflicts of interest and only publish content that is their own original writing,” stated a Forbes representative. “When it came to our attention that Mr. Miller violated these terms, we removed his blog from Forbes.com and ended our relationship with him.”

Mr. Miller’s work has also appeared in the opinion pages of The New York Times, which reflects the long reach of Monsanto’s attempts to influence public opinion.

“We have never paid Dr. Miller,” said Sam Murphey, a spokesman for Monsanto. “Our scientists have never collaborated with Dr. Miller on his submissions to The New York Times. Our scientists have on occasion collaborated with Dr. Miller on other pieces.” This statement alone reflects the formal relationship between Miller and Monsanto.

James Dao, the Op-Ed editor of The Times, said in a statement, “Op-Ed contributors to The Times must sign a contract requiring them to avoid any conflict of interest, and to disclose any financial interest in the subject matter of their piece.” Miller and Monsanto did not comment on the apparent violation of this Times policy.

The documents also show that the ongoing debate outside Monsanto about glyphosate safety and Roundup, was also taking place within the company.

In a 2002 email, a Monsanto executive said, “What I’ve been hearing from you is that this continues to be the case with these studies — Glyphosate is O.K. but the formulated product (and thus the surfactant) does the damage.”

As to the internal Monsanto views of a causation relationship between cancer and Roundup, where a different Monsanto executive tells others via e-mail see 2003 Monsanto email, “You cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement.”

She adds, however, that “we can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Mr. Hayes made a statement that he wasn’t under contract with Monsanto at the time of the retraction,  however he was compensated by Monsanto for the article after he left the journal. This seems to be a very indirect method of exerting influence on the public opinion via a direct method of paying for favorable treatment and influence by Monsanto.

“Monsanto played no role whatsoever in the decision that was made to retract,” he said. “It was based on input that I got from some very well-respected people, and also my own evaluation.” If this statement is accurate, why would Monsanto pay Mr. Hayes for an article determined to be inaccurate or misleading other than the retraction was of some benefit to Monsanto.

Monsanto has been proven time and time again to be directly responsible for corporate sponsored  collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

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BARD HERNIA MESH MDL 2846 JPML HEARING JULY 26, 2018 SANTA FE, NM

In re: MDL 2846 Davol, Inc./C.R. Bard, Inc. Polypropylene Hernia Mesh Products Liability Litigation

By Mark A. York (July 18, 2018)

BARD POLYPROPYLENE HERNIA MESH MDL 2846

 

 

 

 

 

 

 

 

 

 

 

MASS TORT NEXUS MEDIA) In what may become one of the largest single-defendant multidistrict litigation cases ever consolidated, the U.S. Judicial Panel on Multidistrict Litigation (JPML) hearing on consolidation is set for July 26, 2018 when the JPML will be requested to consolidate cases filed against C.R. Bard/Davol, alleging injuries related to their polypropylene hernia mesh products. See JPML Hearing Order July 26, 2018 (In re: Davol, Inc./C.R. Bard, Inc. Polypropylene Hernia Mesh Products Liability Litigation)

Lead counsel on the consolidation are Fleming, Nolen & Jez, L.L.P., Houston, Texas; Brenes Law Group, P.C., Aliso Viejo, California; Chapin Legal Group, LLC, Columbus, Ohio; and Hollis Law Firm, P.A., Prairie Village, Kansas who jointly filed the motion to consolidate on April 10, 2018.

The hernia mesh products at issue were manufactured by C.R. Bard, Inc. and its subsidiary, Davol, Inc., which control close to 70 percent of the U.S. hernia mesh implant market.  There are close to 100 hernia mesh lawsuits currently pending against C.R. Bard and Davol in federal courts around the country, which is expected to increase drastically upon formal consolidation into MDL 2846..  All claims involve injuries allegedly related to the companies’ polypropylene hernia mesh implants, including the Ventralex and Perfix devices and several others, the product pool encompasses almost all Bard/Davol polypropylene hernia mesh products. Plaintiffs allege that the devices were defectively designed and caused extensive long term complications, debilitating post-surgery injuries and adverse reactions.

The motion, also supported by Bard/Davol, has proposed the U.S. District Court Southern District of Ohio, or alternatively, the Western District of Missouri, as possible venues for the multidistrict litigation. Bard alternatively requested the MDL be transferred to U.S. District Court in New Jersey or the Southern District of New York.

Discussions on Bard MDL 2846 took place with co-lead counsel Kelsey L. Stokes of Fleming, Nolen & Jez, L.L.P., Houston, Texas and Adam Evans of Hollis Law Firm, P.A., Prairie Village, Kansas.

Ms. Stokes commented: “We represent hundreds of clients that have been seriously injured by hernia mesh products manufactured by Davol/C.R. Bard.  We have observed that these devastating injuries are occurring all across the United States.   Because of this widespread harm, we moved for coordination and consolidation under Section 1407.  We believe the suggested venues offer convenience to all parties and have docket conditions that are conducive to the most efficient path to a fair and just resolution for our clients.”

Ms. Stokes added, “Considering Davol/CR Bard is the market leader for products used in the most commonly performed surgery in the United States, this MDL has the potential to be one of the largest medical device MDLs ever.  The number of cases could very well reach into the hundreds of thousands.”

Adam Evans clarified the role of revision surgeries in determining eligibility to file a claim: “Having undergone a revision surgery is not a precondition to filing a case. Nor does a revision surgery, in itself, give rise to a viable case.  The question of whether or not a person has undergone a revision surgery presents a sort of false dichotomy as we evaluate these cases. All that is necessary to file a case is that a plaintiff has suffered an injury, which evidence indicates was caused by a defect in the product.  A revision surgery often provides us with the evidence with which we can connect the injury with the product defect, but there are oftentimes other sources of evidence that a defective product has caused an injury.

For example, treating physicians can conduct imaging studies, nerve conduction studies, and other types of tests, the results of which would permit them to conclude that the product is causing the symptoms of which the plaintiff complains.  On the other hand, regarding revision surgeries, a second surgical prodedure may result in findings that rule out the product defects as a cause of the patient’s symptoms.  In the end, a medical determination that the plaintiff has been injured by the mesh in some way is generally necessary in order to justify filing.”

Both Ms. Stokes and Mr. Evans are available to discuss the Bard MDL, as well as any other questions or concerns you may have regarding hernia mesh issues in general.  The list of Bard/Davol products sought to be included in MDL 2846 is fairly significant and covers almost all of the Bard polypropylene hernia mesh products.

 BARD MDL 2846 POLYPROPYLENE HERNIA MESH PRODUCTS

  • Composix
  • Composix E/X
  • Composix L/P
  • Ventralight
  • Spermatex
  • Sepramesh
  • Ventralex
  • Ventralex ST
  • Kugel Patch
  • Composix Kugel
  • Ventrio
  • Visilex
  • Ventrio ST
  • Marlex (AKA Flat Mesh; Bard Mesh)
  • Perfix Plug
  • Perfix Light Plug
  • 3D Max Light
  • 3D Max

 COMMON INJURIES

Many of the complications associated with hernia repair involving mesh are multi-factorial, and any case must undergo in-depth analysis to ascertain whether the defects of a hernia mesh played a role in the complications.  Here are some of the injuries which patients throughout the country are reporting following implantation of one of these hernia mesh products:

  • Mesh infection
  • Chronic, debilitating pain
  • Mesh migration
  • Mesh contracture
  • Hernia recurrence (as a result of migration and/or contracture)
  • Mesh rupture (aka “mechanical failure”)
  • Wound dehiscence
  • Fistula or sinus tract formation
  • Adhesions of mesh to bowel
  • Bowel perforation
  • Bowel obstruction (as a result of adhesions)

There are many other types of adverse health effects which can stem from these complications, and research is ongoing as to the direct relationship between polypropylene mesh implants and other conditions such as auto-immune disorders.

Joshua S. Kincannon, Lomurro Law Firm in Freehold, New Jersey is counsel in another emerging hernia mesh litigation, the Ethicon “Multi-Layered Hernia Mesh” Litigation, which is the subject of a pending MCL application in New Jersey State Court. Mr. Kincannon stated in support of the Bard MDL 2846: “For decades, medical device manufacturers have utilized polymers that are not safe or effective for permanent implantation in the human body.  The hernia mesh litigation is just another example of what happens when there is little to no oversight into how these products are designed, manufactured and sold to the public.”

 The moving plaintiffs are represented by Kelsey L. Stokes and George M. Fleming of Fleming, Nolen & Jez in Houston; Adam M. Evans and C. Brett Vaughn of the Hollis Law Firm in Prairie Village, Kansas; Troy A. Brenes of the Brenes Law Group in Aliso Viejo, Calif.; and Steven C. Babin Jr. of the Chapin Legal Group in Columbus, Ohio.

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Big Pharma’s Litigation War Chest: The 10 best-selling U.S.prescription drugs for the last 25 years are also all in pharmaceutical litigation

Mark A. York (May 25, 2018)

BIG PHARMA’S TOP 10 DRUGS HAVE BANKED $635 BILLION IN Rx SALES SINCE 1993

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) How many of these drugs have also been or will become involved in litigation related to the dangers of the drugs?  Shareholders see amazing investment returns, Big Pharma see earnings based bonuses for everyone and for the millions of unsuspecting consumers, WHAT’S THEIR RETURN? It’s a trail of Adverse Events, Medical Complications, Extreme Medical Bills and for thousand of patients who were prescribed these drugs, it equates to a death sentence and/or long term critical healthcare problems.

As you will see below of the Top 10 best selling drugs of the last 25 years, more than half have pharmaceutical litigation associated with the prescribing practices, failure to warn and numerous other major issues affiliated with these billion dollar drugs.

Next to each of these blockbuster drugs, you will find information regarding the legal issues and ongoing litigation if that drug is involved in current or historical litigation.

For more information on these drugs and many other pharmaceutical products putting consumers at risk see www.masstortnexus.com

BLOCKBUSTER DRUGS IN THE UNITED STATES SINCE 1993 AND THEIR PROFITS

  1. Lipitor http://www.scd.uscourts.gov/mdlipitor/index.asp

U.S. sales 1992-2017: $94.67 billion
Company: Pfizer
Indications: Treat high cholesterol and reduce the risk of heart disease

  1. Humira https://www.drugwatch.com/humira/lawsuits/

U.S. sales 1992-2017: $75.72 billion
Company: AbbVie
Indications: Inflammatory diseases

  1. Nexium http://www.mad.uscourts.gov/worcester/MDL2409/MDL2409.htm

 U.S. sales 1992-2017: $72.45 billion
Company: AstraZeneca
Indications: Stomach acid reflux, peptic and duodenal ulcers

     4. Advair http://cca.hawaii.gov/ocp/news-release-states-reach-105-million-settlement-with-glaxosmithkline-concerning-asthma-drug-advair/

U.S. sales 1992-2017: $69.08 billion
Company: GlaxoSmithKline
Indications: Asthma and COPD

  1. Enbrel https://www.statnews.com/2017/06/05/actemra-rheumatoid-arthritis-fda/

U.S. sales 1992-2017: $67.78 billion
Company: Amgen
Indications: Autoimmune diseases

  1. Epogen
    U.S. sales until 1992-2017:$55.63 billion
    Companies: Amgen
    Indication: Anemia
  1. Remicade https://www.aboutlawsuits.com/remicade-178/

U.S. sales 1992-2017: $54.67 billion
Company: Johnson & Johnson
Indications: Autoimmune diseases

 

U.S. sales 1992-2017: $54.67 billion
Company: Johnson & Johnson
Indications: Autoimmune diseases

  1. Abilify http://www.flnd.uscourts.gov/master-docket-316-md-2734

U.S. sales 1992-2017: $51.34 billion
Companies: Otsuka/Bristol-Myers Squibb
Indications: Schizophrenia, bipolar disorder, and other CNS indications. https://www.masstortnexus.com/mass-torts-news/abilify-bellwethers-settle-right-before-trial-over-impulsive-gambling-sexual-activity-claims/

     9. Neulasta https://www.drugdangers.com/neulasta/investigation

U.S. sales 1992-2017: $47.40 billion
Company: Amgen
Indication: Boost white blood cells in patients undergoing chemotherapy

  1. Plavix http://www.njd.uscourts.gov/plavix-product-liability-and-marketing-litigation

U.S. sales 1992-2017: $46.48 billion
Companies: Sanofi/Bristol-Myers Squibb
Indication: Prevent heart attack and stroke

When taking a look at 25 years’ worth of drug sales you will see some very familiar names popping up, including the megablockbuster cholesterol drug Lipitor and others that are very common across America.  But you’ll also find some drugs that aren’t the mass-market successes

Amgen’s staple anemia treatment Epogen, for one, even though its sales are in the multi-billions of dollars.

Beyond the drugs themselves, we gleaned some tried-and-true advice for drugs looking to make the top 10 two and a half decades from now. Launch timing, medical need, scientific improvement and marketing efforts all factor into a drug’s success. Often part of the business of Big Pharma are the cost of litigation. This means defending products, paying billion dollar settlements and the increased cost of marketing, damage control, placating the FDA and the American consumer to blindly accept these drugs as “good for you and in your best interests” all the while Big Pharma is concealing the litigation, fines, trial verdicts and governmental investigation into the failings of the pharmaceutical industry as a whole.

Ranked below are the 10 best-selling drugs in the U.S. by the revenue they accumulated from 1992 to 2017. In addition to Lipitor and Epogen, they include the blood thinner Plavix—long a cash cow for Bristol-Myers Squibb and Sanofi and still a big seller as a generic. And the big 3 immunology mainstays led by AbbVie’s Humira, which is predicted to become the first drug ever to pass $20 billion in annual sales.

THE R&D HISTORY OF BLOCKBUSTER DRUGS IN AMERICA

  1. Lipitor
    U.S. sales 1992-2017:$94.67 billion
    Company:Pfizer
    Indications: Treat high cholesterol and reduce the risk of heart disease

Pfizer’s cholesterol-lowering drug Lipitor is by far the best-selling drug of all time. But it wasn’t a sure thing in the megablockbuster races. Originally developed by Warner-Lambert—bought by Pfizer in 2000 for a whopping $90 billion—and approved by the FDA in late 1996, Lipitor wasn’t even the first statin on the market.

But in a historic trial run by trailblazer Merck & Co., statins showed they could not only lower cholesterol but also lower heart attack incidents. Pfizer then padded its Lipitor case with some massive clinical studies proving its own worth. Meanwhile, increased public awareness of the potential link between bad cholesterol and the risks of heart disease, plus Pfizer’s marketing clout and the FDA’s relaxation of consumer advertising rules in 1997, together boosted Lipitor to the throne. Though sales declined dramatically after its patent expired in late 2011, even today, Lipitor is still a force to be reckoned with, with 2017 sales of $1.92 billion.     

  1. Humira
    U.S. sales 1992-2017:$75.72 billion
    Company:AbbVie
    Indications: Inflammatory diseases

Humira, first approved as a rheumatoid arthritis treatment, is the heir apparent, thanks to astronomical growth of its own and Lipitor sales declining post-patent cliff. On the last day of 2002, the anti-inflammatory therapy became the first fully human monoclonal antibody to reach the market. At that time, two TNF-alpha inhibitors, Enbrel and Remicade, had already been sold for more than four years.

But Humira’s convenience in administration—as a self-injection rather than IV—and AbbVie’s (then Abbott Laboratories) quick work at adding indications in other inflammatory diseases such as psoriatic arthritis, Crohn’s disease and juvenile idiopathic arthritis, helped it surpass the other two. Price hikes have also played a part in keeping Humira at the top. Just over the past five years, its price has more than doubled, according to Wells Fargo analyst David Maris. Thanks to a patent settlement, AbbVie will continue to rake in megablockbuster sales from Humira in the U.S. until 2023.       

  1. Nexium
    U.S. sales 1992-2017:$72.45 billion
    Company:AstraZeneca
    Indications: Stomach acid reflux, peptic and duodenal ulcers

Nexium, known as “the purple pill,” was AstraZeneca’s follow-up to its first reflux remedy, Prilosec (omeprazole). Approved in the U.S. in 2001, Nexium showed in clinical trials that it was better at treating gastroesophageal reflux disease, with higher healing rates compared to omeprazole. But some other studies didn’t find much difference among proton pump inhibitors, the class that includes both Nexium and Prilosec.

Because of the similarity in the two drugs, AZ was criticized for pushing for the new, more expensive Nexium. The drug was previously also at the center of a pay-for-delay lawsuit, where AZ allegedly paid Ranbaxy Laboratories to abandon its patent challenge. But Nexium kept on bringing in cash: Before Teva’s generic version and Pfizer’s OTC version hit in 2015, Nexium was returning around $3 billion in annual sales.

  1. Advair
    U.S. sales 1992-2017:$69.08 billion
    Company:GlaxoSmithKline
    Indications: Asthma and COPD

GlaxoSmithKline’s Advair, a combination of fluticasone and salmeterol, is meant to treat asthma and COPD, two chronic respiratory diseases with high prevalence in the U.S. Delays in generic competition due to the hard-to-copy Diskus inhaler technology are a key reason why it still racked up £3.48 billion in 2016 sales.

Though it lost patent protection back in 2010, Teva only launched AirDuo RespiClick and its authorized generic last April. They come at a huge discount to Advair but aren’t readily substitutable for the GSK behemoth at the pharmacy. A long list of generic drugmakers, including Novartis’ Sandoz, Hikma and Mylan, are still struggling to get their versions past the FDA. Mylan said in early May that it’s expecting a generic approval in 2018.

  1. Enbrel
    U.S. sales 1992-2017:$67.78 billion
    Company:Amgen
    Indications: Autoimmune diseases

Enbrel was the first TNF-alpha inhibitor, approved by the FDA in 1998 to treat rheumatoid arthritis and later expanded into other autoimmune diseases. Like latecomer Humira, Enbrel also comes with a big price tag. Even though it doesn’t boast as many FDA-approved indications as Humira, it’s still among doctors’ favorites. In 2017, the drug racked up $5.21 billion in U.S. sales, and Amgen has been able to stall the launch of a biosim from Sandoz with a patent suit.

  1. Epogen
    U.S. sales until 1992-2017:$55.63 billion
    Companies:Amgen
    Indication: Anemia

Approved in 1989, Epogen soon moved to dominate the kidney disease-related anemia market. With orphan drug status, it enjoyed a long exclusivity period, and it has contributed billions of dollars year after year to Amgen and Johnson & Johnson, which sells the drug under the Procrit brand (sales not included here). It could have faced direct competition from Roche’s Mircera as early as 2007, but an injunction prevented the Swiss drugmaker’s competitor from launching in the U.S. until 2014. Even after Medicare instituted new rules for use of anemia drugs in some patients, Epogen prevailed; for 2017, Epoetin alfa brought in $1.77 billion in U.S. sales. And it’s set for more despite expired patents. Efforts to bring biosimilars to the U.S. market have suffered several setbacks.

  1. Remicade
    U.S. sales 1992-2017:$54.67 billion
    Company: Johnson & Johnson
    Indications: Autoimmune diseases

Remicade emerged almost at the same time as Enbrel, but it was first approved as a treatment for Crohn’s disease, only later expanding into other inflammatory diseases such as rheumatoid arthritis and psoriatic arthritis. The requirement for intravenous infusion—which means inconvenience for patients and the additional cost of outpatient administration—marked a key disadvantage for Remicade against its TNF counterparts. Pfizer launched a biosim version in the U.S. back in 2016, but it hasn’t been able to steal much share from J&J, thanks to the branded drugmaker’s aggressive deals with payers.

  1. Abilify
    U.S. sales 1992-2017:$51.34 billion
    Companies:Otsuka/Bristol-Myers Squibb
    Indications: Schizophrenia, bipolar disorder, and other CNS indications.

Discovered by scientists at Otsuka, Abilify was greenlighted by the FDA in 2002 to treat acute episodes of schizophrenia and as a maintenance therapy in the same group of patients. More indications followed; the drug racked up approvals for bipolar disorder, add-on treatment of major depression, and autism. The antipsychotic later acquired a long-lasting sister called Abilify Maintena, an injectable that freed patients from daily pill-taking. The drug caught the industry’s attention last November when Otsuka won an FDA approval for Abilify MyCite, a digital version of the drug that has a sensor that digitally tracks patients’ dosing.

  1. Neulasta
    U.S. sales 1992-2017:$47.40 billion
    Company:Amgen
    Indication: Boost white blood cells in patients undergoing chemotherapy

Approved in the U.S. in 2001, Neulasta is designed to help chemotherapy patients fight infection by boosting their white blood cell counts. Each year, about 650,000 cancer patients undergo chemotherapy in an outpatient setting in the U.S., according to the CDC. To help patients self-manage injections, Amgen rolled out the Neulasta Onpro kit in 2014. In 2017, Neulasta returned $4.53 billion in sales, and about 87% of that came from the U.S.

Though Neulasta’s shorter-acting predecessor Neupogen now faces biosimilar competition from Sandoz’s Zarxio, Neulasta doesn’t yet have a rival. Would-be biosim makers fell short with their FDA applications last year. But 2018 could well change that. Mylan says it’s on track for a Neulasta copy this year; the FDA is set to decide by June.

  1. Plavix
    U.S. sales 1992-2017:$46.48 billion
    Companies:Sanofi/Bristol-Myers Squibb
    Indication: Prevent heart attack and stroke

Plavix was approved in 1998 and became the standard-of-care blood thinner, earning a place on the WHO’s list of essential medicines. Plavix and Lipitor were the mainstays of the drug industry in the 1990s, so when Plavix’s patent expired in 2012—about half a year after Lipitor’s—it marked a major shift away from the mass-market megablockbuster era. With an influx of multiple generics from the get-go, Bristol-Myers Squibb and Sanofi were hit hard, as Plavix’s $7.1 billion in 2011 sales accounted for a third of BMS’ revenue for the year. But its legacy remains. Even today, new drugs like AZ’s Brilinta still use it as a comparator to demonstrate their products’ safety and efficacy.

For more information on these drugs and emerging pharmaceutical litigation across the country see the Mass Tort Nexus Emerging Litigation Briefcase: Emerging-Phase-Litigation www.masstortnexus.com/briefcases/emerging

(images reposted from original content of fiercepharma.com)

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Abilify Bellwethers Settle Right Before Trial Over Impulsive Gambling-Sexual Activity Claims

“With global settlement talks now in place less than a week later”

By Mark A. York (May 3, 2018)

Will Abilify MDL Settle By September 15, 2018?

(Mass Tort Nexus Media) The first pool of three bellwether trial plaintiffs have settled just before trials started in the Abilify MDL 2734 in front of Judge Casey Rodgers earlier this week, see Abilify Settlement Order Re First Bellwether Trial Pool Cases Entered April 28, 2018 (www.masstortnexus.com), related to the antipsychotic drug Abilify. The plaintiffs claimed after being prescribed the drug, Abilify made them gamble compulsively. All three cases were settled against the drug makers  Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, for undisclosed amounts. The three Florida residents’ cases were scheduled for trial starting in June as bellwether trials, for case information see the Mass Tort Nexus Abilify briefcase, ABILIFY-MDL-2734-USDC-MDL-Florida (Briefcases/Drugs).

The Abilify multidistrict litigation includes 808 cases, as of April 16, and as of May 2, 2018 there is a Global Settllement Order in place, see Abilify MDL 2734 Global Settlement Order No. 1 Entered May 2, 2018, where Judge Rodgers gave the parties 120 days to finalize a framework of a global settlement, including a first phase outline of what will be classified as “no pay” cases, with these cases to be identified within 14 days of the global order or by May 16, 2018. Upon identification of the no pay cases, they will be removed from the MDL.

Also of note is language in the April 28th settlement order for the three bellwether trials, is a requirement that defendants must pay the settlement proceeds to plaintiffs, who in turn must execute full release and then, within 10 days, parties must file a stipulation of dismissal. Judge Casey has ordered the three cases to remain on the trial docket until the stipulated dismissals are filed. This appears to be another federal judge asserting direct control over the often lengthy and drawn out settlement talks  in MDL’s across the country. Judges are now moving cases toward settlement or setting them for trial, pursuant to the JPML rules of civil procedure outline.

ABILIFY BACKGROUND

The Abilify litigation is against defendants Japanese drugmaker Otsuka and Britsol-Myers Squibb, which marketed the drug in the U.S. until 2013 and related to plaintiffs being prescribed Abilify, an anti-psychotic medication commonly prescribed to treat a variety of mental disorders, which caused impulse control problems in users. The two primary impulse control claims are “impulsive gambling” and “uncontrollable sexual urges” with several plaintiffs claiming to have lost millions of dollars in gambling sprees brought on after consuming Abilify, while never having gambled before. The other control issue is “inability to control sexual urges or engaging in sexual promiscuity” resulting in ruined personal relationships and adverse health conditions, as well as related financial consequences.

 

 

 

 

 

 

 

 

 

 

Aripiprazole is available under the brand names Abilify, Abilify Maintena, Aristada, and also as generics. A search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature in the 13 years since the approval of the first aripiprazole product (Abilify) in November 2002 identified a total of 184 case reports in which there was an association between aripiprazole use and impulse-control problems.

May 5, 2016 FDA Drug Safety Notice: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)

ABILIFY (aripiprazole) – FDA: Adverse Reactions

https://www.accessdata.fda.gov/…/021436s038,021713s030,021729s022,021866s023…

Seizures/Convulsions. 5.10 Potential for Cognitive and Motor Impairment. 5.11 Body Temperature Regulation. 5.12 Suicide. 5.13 Dysphagia. 6. ADVERSE REACTIONS. 6.1. Clinical Trials Experience. 6.2. Postmarketing Experience. 7. DRUG INTERACTIONS. 7.1. Drugs Having Clinically Important Interactions with Abilify.

THE ABILIFY MDL

On October 3, 2016, the JPML consolidated pretrial proceedings for In Re: Abilify (Aripiprazole) Products Liability Litigation, MDL No. 2734, in the US district Court Northern district of Florida. The transferred actions share factual issues arising from allegations that Abilify (aripirazole), an atypical anti-psychotic medication commonly prescribed to treat a variety of mental disorders, can cause impulse control problems in users. All the actions involve factual questions of whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.

These cases were  assigned to the Honorable M. Casey Rodgers for coordinated discovery and pretrial matters.

Abilify Linked to Compulsive Behaviors

Details of the three Abilify settlements were not made public. But include payment by the defendants to the plaintiffs, as well as apparently opening the door for a full global settlement of the remaining 800 plus cases.

Introduced in 2002, Abilify became a blockbuster drug, generating nearly $8 billion a year by 2013. The following year, it was the top-selling drug in the U.S. Sales fell in 2015 when the first generic versions of the drug were approved.

The drug is prescribed to treat psychiatric conditions including bipolar disorder, schizophrenia and major depression.

Off-label uses include anxiety disorders, dementia and post-traumatic stress disorder. The drug has been linked to severe, compulsive behaviors, mainly gambling, sex and shopping.

Gambling Warning Added in 2016

About a week before the settlement was reached, the plaintiffs sought a court order allowing them to secure documents from Otsuka regarding Rexulti, the drug that was introduced when Abilify’s patent expired.

Plaintiffs argued in court filings that Rexulti had the same mechanism of action. The company didn’t begin to warn that Rexulti could cause compulsive gambling until January of this year. That warning was added to the Abilify label in the U.S. in August 2016.

The cases that settled are plaintiffs, Jennifer Lilly, David Viechec and Fanny Lyons.

Lyons’ lawsuit was scheduled to start trial June 18. According to court filings, she began taking Abilify around January 2009 and soon began compulsive gambling. She stopped taking the drug in January 2014 and stopped gambling soon after that. She claims to have lost more than $75,000.

Viechec was scheduled to have his case heard by a jury beginning Aug. 6. According to court filings, he was prescribed Abilify for bipolar symptoms from 2012 until late 2016. He also claimed to have lost more than $75,000 from gambling, which stopped after he stopped taking the drug.

Lilly’s case was scheduled to start trial on Aug. 27. According to her lawsuit, she took Abilify from 2003 to 2016. Her lawsuit claims unspecified gambling and other losses, including the loss of the ability to earn money.

The settlement of the three initial trials and entry of a global settlement order less than a week later seems to point to a decision by Bristol Myers and Otsuka that perhaps settling now versus waiting until adverse material and testimony come out at trial is the prudent legal strategy at this point.

Congratulations to Judge Casey for putting a timer on the settlement discussions and directing legal traffic in his MDL docket.

 

 

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HeartStart MRx Defibrillator Emerging Litigation

Emerging HeartStart MRx Defibrillator Litigation

 

 

 

 

 

 

 

 

 

 

HeartStart MRx Defibrillator by Philips Electronics: Class I Recall –

Defects in Gas Discharge Tubes May Cause Device Failure

2018 FDA Communication Excerpt:

ISSUE: Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device’s Gas Discharge Tube (GDT). The GDT has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected. This also permits an electrical current surge to cross the device’s designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED) mode.

As a result of this GDT defect, the HeartStart MRx may fail at any time, including when delivering repeated shocks in AED mode, or during the periodic Operational Check outlined in the device’s Instructions for Use. If the device is used in AED mode after failure, the device will not deliver patient therapy. Continued use of the device in AED mode after failure may lead to serious patient injury or death.

To Learn More About the HeartStart MRx Defibrillator Emerging Litigation:

The Emerging  HeartStart MRx Defibrillator Emerging Litigation will be used as a case study in the May 18th to 21st 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Couse, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494. 

For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”

Course attendees will receive the benefit of a step by step analysis of the Emerging HeartStart MRx Defibrillator Litigation using these primary metrics:

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course, including Michael Brady Lynch>

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively.  Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

 

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Kayexalate Emerging Litigation

Emerging Kayexalate Litigation

Kayexalate: An emerging litigation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Kayexalate, made by Concordia Pharmaceuticals, Inc. was first approved by the FDA subsequent to New Drug Application 011287.

September 2017 : FDA is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as other medicines taken by mouth. A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medicines, decreasing the absorption and therefore effectiveness of those oral medicines.

A study was conducted in the laboratory, called an in vitro study, to evaluate the binding potential for certain administered medicines commonly taken together with sodium polystyrene sulfonate. These medicines included certain:

Blood pressure medicines

Antibiotics

Seizure Medications

Blood Thinner Medication

Furosemide

By reducing or eliminating the effectiveness of other drugs, patients may be more likely to suffer adverse events intended to be controlled by the effected drugs.

Prior to the September 2017 FDA action, the Kayexalate label included warnings related to the concomitant use of several drugs however, these warnings did not include a significant number of drugs now found to be potentially harmful when used in combination with Kayexalate.

To Learn More About the Emerging Kayexalate Litigation:

The emerging Kayexalate Litigation will be used as a case study in the May 18th to 21st 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Course, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”

 

Course attendees will receive the benefit of a step by step analysis of the emerging Kayexalate Litigaton, using these primary metrics:

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

 

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course, including Michael Brady Lynch>

 

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively.  Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

 

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Absorb GT1 Bioresorbable Vascular Scaffold Potential Litigation

Absorb GT1 Bioresorbable Vascular Scaffold Potential Litigation     

 

  

 

Absorb GT1 Bioresorbable Vascular Scaffold made by Abbot Vascular gained FDA Approval in July of 2016 subsequent to Premarket Approval Application (PMA: P150023)

Intended Use: The Absorb GT1 Bioresorbable Vascular Scaffold (BVS) is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

FDA Communication Excerpt:

October 31, 2017 : The FDA is issuing this update to our March 18, 2017 letter to health care providers to inform the health care community that interim study results through three years from the pivotal clinical trial (ABSORB III) continue to show an increased rate of major adverse cardiac events and BVS scaffold thrombosis in patients receiving the Absorb GT1 Bioresorbable Vascular Scaffold (BVS), when compared to patients treated with the approved metallic XIENCE drug-eluting stent.

 

To Learn More About the Emerging Absorb GT1 Bioresorbable Vascular Scaffold Potential Litigation:   

The emerging GT1 Bioresorbable Vascular Scaffold Potential Litigation  will be used as a case study in the May 18th to 21st 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Couse, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

 

 

For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”

Course attendees will receive the benefit of a step by step analysis of the emerging GT1 Bioresorbable Vascular Scaffold Potential using these primary metrics:

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

 

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course, including Annesley DeGaris>

 

 

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively.  Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

 

 

 

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New Breast Implant Emerging Litigation

Emerging New Breast Implant Litigation     

 

 

 

 

 

 

 

 A recent study published in JAMA Oncology concluded that  found that silicone breast implants with a textured surface are 400-times more likely to cause a rare type of cancer compared to silicone breast implants with a smooth surface.

Approximately 1 out of every 26 women in the United States have breast implants.

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC

Sientra, Inc.

To Learn More About the newest Emerging Breast Implant Litigation

The emerging New Breast Implant Litigation will be used as a case study in the May 18th to 21st 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Course, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

 

 

For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”

Course attendees will receive the benefit of a step by step analysis of the emerging New Breast Implant Litigation using these primary metrics:

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course, including CNN Legal Analyst Mark O’Mara>

 

 

 

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively.  Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

 

 

 

 

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