HOW CAN WE SOLVE THE OPIOID CRISIS STARTING NOW? With An Opioid Crisis Summit Like No Other

A Definitive Opioid Crisis Solutions Event

By Mark A. York (May 29, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) It’s been called the most perilous drug crisis ever in the United States, the epicenter of the opioid epidemic, overdose deaths have quadrupled since 1999, killing more than 100 people every day. Pharmaceutical opiate pain relief is an essential clinical tool, but with physicians writing over 240 million opioid prescriptions to Americans every year, the potential for catastrophe is enormous. Now it seems to be coming into realization that the opioid crisis is here and the damage is catastrophic, gauged against the devastating impact on families and communities across the United States.  How can we get the message out that addiction is now  recognized as a medical, not a criminal problem, and new treatments are on the horizon. How do we protect the population from misusing opioids? An Opioid Crisis Summit featuring national leaders who are involved in the day to day efforts to fight this opiate crisis on all levels, including Ohio Lieutenant Governor Mary Taylor, Dr. Rahul Gupta, West Virginia Director of Public Health and others who are involved in providing real time solutions to the opiate epidemic as well as treating physicians and legal professionals who are active in offering solutions.

The Definitive Opioid Crisis Summit For All of America:

July 21-22, 2018

www.opioidcrisissummit.com

OPIOD CRISIS SUMMIT

By Mass Tort Nexus

Fort Lauderdale, FL

 How did the opioid crisis happen?

In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive. Opioid overdose rates began to increase. In 2015, more than 33,000 Americans died as a result of an opioid overdose, including prescription opioids, heroin, and illicitly manufactured fentanyl, a powerful synthetic opioid.1That same year, an estimated 2 million people in the United States suffered from substance use disorders related to prescription opioid pain relievers, and 591,000 suffered from a heroin use disorder (not mutually exclusive).

 What do we know about the opioid crisis?

  • Roughly 21 to 29 percent of patients prescribed opioids for chronic pain misuse them.
  • Between 8 and 12 percent develop an opioid use disorder.
  • An estimated 4 to 6 percent who misuse prescription opioids transition to heroin.
  • About 80 percent of people who use heroin first misused prescription opioids.
  • Opioid overdoses increased 30 percent from July 2016 through September 2017 in 52 areas in 45 states.
  • The Midwestern region saw opioid overdoses increase 70 percent from July 2016 through September 2017.
  • Opioid overdoses in large cities increase by 54 percent in 16 states.

Quarterly rate of suspected opioid overdose, by US region
Source: Centers for Disease Control and Prevention.

This issue has become a public health crisis with devastating consequences including increases in opioid misuse and related overdoses, as well as the rising incidence of neonatal abstinence syndrome due to opioid use and misuse during pregnancy. The increase in injection drug use has also contributed to the spread of infectious diseases including HIV and hepatitis C. As seen throughout the history of medicine, science can be an important part of the solution in resolving such a public health crisis.

 The Opioid Crisis Summit Agenda

An unprecedented group of elected officials, political and medical experts, and academic leaders from around the country are set to examine the crisis and offer insight and solutions.

On July 21-22, 2018, the definitive Opioid Crisis Summit presented by Mass Tort Nexus will convene a symposium to present a firsthand account as to the depth and severity of the crisis. The research team at Mass Tort Nexus has brought together influential speakers including the Lieutenant Governor of Ohio, Mary Taylor; State Attorney for Palm Beach County Florida, Dave Aronberg, Esq.; Director of Public Health, State of West Virginia, Rahul Gupta, MD; Executive Director, Novus Medical Detox Centers, Kent Runyon; The Amy Winehouse Project Addiction Recovery Center, Susan Anderson and Blades Williamson; Opioid Crisis Advocate, Stephen Gelfand, MD and Opioid Crisis Expert, John Ray.  These speakers are coming together to give our attendees a firsthand look at just how dramatic the impact of the opioid crisis is within our communities.

Summit attendees including attorneys, elected officials and healthcare officials will be giving specific information regarding the legal aspects of the Opioid Crisis as well. This relates to the Opiate Prescription MDL 2804, where hundreds of counties, states and cities across the country have filed lawsuits against the opiate pharmaceutical industry as a whole. This includes key MDL 2804 leadership counsel who will discuss signing of both entity and individual cases, regarding case criteria, damage models and estimated timeframes for settlement. See MDL 2804 Opiate Prescription Litigation US District Court of Ohio, for the National Prescription Opiate Litigation docket information.

This level of professional expertise and real time awareness of the issues regarding the opioid crisis in the United States has never been assembled on a scale such as this and if you are wanting to get the most critical and complete information, please contact someone at Mass Tort Nexus before all seats are taken.

Media Contact: media@masstortnexus.com 954.870.7323, Mark A. York

Event Contact:

Barbara Capasso

Jenny Levine

954.530.9892

barbara@masstortnexus.com

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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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Johnson & Johnson Liable For Talc Mesothelioma Verdict Of $21.7 Million In Actual And $4 Million In Punitive Damages

Will Industrial Talc Litigation Become Another Asbestos? The Litigation Is Moving That Way!

By Mark A. York (May 24, 2018)

 

 

 

 

 

 

 

 

Is Industrial Talc Litigation The Next Major Mass Tort?

(MASS TORT NEXUS MEDIA) Johnson & Johnson lost another talcum powder cancer trial, when a California jury awarded $4 million in punitive damages on top of $21.7 million in compensatory damages on Wednesday May 23, 2018 to Joanne Anderson and her husband, Ms. Anderson is a 68-year-old woman who sued J&J alleging that he cancer was caused by asbestos in the company’s baby powder. The case is Anderson v. Borg Warner Corp., BC 666513, California Superior Court, Los Angeles County (West Covina).

The jury found that J&J (JNJ.N), was 67 percent responsible for her mesothelioma, a cancer linked to asbestos exposure. Anderson’s lawyers said she was exposed to baby powder laced with the carcinogen when she used it on her children and while bowling.

The verdict against J&J was linked to company documents produced in the trial, “When jurors are given the opportunity to see internal documents and conduct of J&J — things the FDA and government haven’t seen — there is only one choice in how to rule.” According to Chris Panatier, plaintiffs’ lawyer.

Anderson and her husband had sued J&J, a unit of Imerys SA (IMTP.PA), Cyprus Amax Minerals, a unit of Brenntag (BNRGn.DE), Honeywell International (HON.N) and other local talc suppliers, which are now becoming targets more and more in the emerging talc litigation exploding across the country.

J&J’s lawyers have stated that Anderson’s mesothelioma may not have been caused by asbestos in talc, but could have occurred “spontaneously.’’ They also said the woman had a family history of lung and breast cancer. Even though there has been ample evidence shown in court after court, both state and federal that J&J’s talcum powder products are known to be cancer causing. J&J and others have been diligent in suppressing the research and scientific studies showing the cancer links, going so far as to pay “ghost writers” to submit company sponsored “talc is a good product” papers as legitimate scientific materials to recognize medical journals. This conduct dates back to at least the mid-10970’2 when internal J&J consultants working on Talc R&D projects raised red flags on the dangers of talc and the link to cancer.

Hiding Data That Showed Potential Dangers: The standard complaints utilized in the prior trial allege that J&J knew about the risks of ovarian cancer as early as 1971. The complaints allege that “nearly all” of 23 known epidemiologic studies on cosmetic talc reported an associated risk with ovarian cancer, and assert alleged instances in which J&J “knowingly released false information” about the safety of talc in coordination with the Cosmetic Toiletry and Fragrance Association. Media reports suggest that, in post-trial interviews, jurors indicated that these allegations were part of the motivation for the large punitive damages award.

This is the second jury in less than two months to conclude J&J sold its iconic baby powder knowing it contained at least trace amounts of asbestos and posed a cancer risk to users. In April, jurors in J&J’s hometown of New Brunswick, New Jersey, ordered the company and a unit of Imerys SA, a talc supplier, to pay a total of $117 million to a banker who showed his cancer was tied to baby powder use. See For J&J $37 Million Talcum Powder Mesothelioma Verdict—Add $80 Million In Punitive Damages.

Litigation over J&J’s baby powder is accelerating. The company is facing claims by more than 9,000 plaintiffs, primarily connecting talc to ovarian cancer, according to a May 1 securities filing. J&J didn’t break out the number of ovarian cancer cases versus the number of mesothelioma cases allegedly tied to talc. See Johnson & Johnson Talcum Powder Litigation MDL 2738 (USDC New Jersey).

In MDL 2738 J&J is facing more than 6,000 cases claiming its baby powder caused ovarian cancer, but the talc litigation has taken a new focus in recent months with plaintiffs claiming the widely used product causes mesothelioma due to alleged asbestos contamination.  These casese are being in in US District Court of New Jersey, in front of Judge Freda Wolfson, who has not been perceived as a plaintiff friendly judge so far. But science is science and as more of the data is released and becomes accepted, J&J’s home court advantage in New Jersey courts will continue to

J&J, talc supplier Imerys  and retail seller incuding Rite-Aid pharmacy (RAD.N) are currently facing similar claims in a trial underway in South Carolina over asbestos talc allegations.

Anderson argued she used J&J’s talc products on her children in the 1970s and on herself in the 1980s and 1990s when she would powder her hands and feet while bowling. She claimed at one point, she went through two bottles a month.

Notable Cosmetic Talc/Asbestos Contamination Verdicts

Two recent verdicts for asbestos contamination demonstrate the risk to cosmetic talc defendants. In October 2016, a Los Angeles County jury awarded $18M to Philip Depolian against Whittaker, Clark & Daniels finding it 30% responsible for his mesothelioma due to his alleged exposure to various cosmetic talc products used at his father’s barbershops that contained asbestos. The jury apportioned liability against various cosmetic talc defendants that had settled and several other cosmetic talc product defendants that sold products including Old Spice, Clubman, Kings Men and Mennen Shave Talc.

In 2015, another Los Angeles jury awarded Judith Winkel $13M against Colgate-Palmolive for mesothelioma allegedly caused by exposure to talc in its baby powder. The jury rejected Colgate and its experts’ claims that the cosmetic talc at issue was not contaminated by asbestos and that the talc in question were non-fibrous “cleavage fragments” unlikely to be inhaled or embedded in the lungs. Although details of the trial are not readily verified, at least one report indicated that evidence presented at trial showed that the talc contained 20% asbestos fibers.

These cases are particularly important because the defendants were held responsible for cosmetic talc containing asbestos and for having caused mesothelioma and not ovarian cancer as in the J & J cases. Further, both juries found that the defendants acted with malice. However, the cases were confidentially settled before the respective punitive damage phases.

 Talc History

There are two types of talc: industrial talc which is used most frequently in rubber, plastics and ceramics; and cosmetic talc which is of a higher grade and is used in conjunction with products that involve direct human exposures such as cosmetics, pharmaceuticals and food additives.

Talc manufacturers and companies that have incorporated talc into their products have been, and continue to be, sued. Industrial talc defendants have been involved in litigation for decades. In lawsuits involving industrial talc, plaintiffs generally allege that the talc is contaminated with asbestos. The injuries alleged are mesothelioma, lung cancer and asbestosis. To date, there have been no claims against industrial talc defendants alleging that asbestos in the talc caused ovarian cancer. Industrial talc defendants have aggressively defended the cases and, although suffering some adverse verdicts, they won more cases than they have lost. However, will thousands of new industrial talc claims result in acceptance of litigation and pressure to settle as a suddenly arising “cost of doing business’, such as the view taken by pharmaceutical and medical device manufacturers who incorporate “litigation costs” into corporate filings and simply classify it as an expense of doing business?

Cosmetic talc cases fall into two distinct categories: 1) cosmetic talc alleged to cause ovarian cancer; and 2) cosmetic talc alleged to cause mesothelioma. The J & J verdicts were ovarian cancer cases. There was no claim that the talc was contaminated with asbestos.

While the J & J St. Louis verdicts received significant attention in the national media, cases alleging that asbestos-containing cosmetic talc caused an asbestos-related disease such mesothelioma have been percolating, and some recent notable verdicts have been obtained. In 2015, a Los Angeles jury awarded $13M to a woman who alleged talcum powder sold by Colgate-Palmolive was contaminated with asbestos causing her to contract mesothelioma.  These cases, if they emerge as viable litigation, could make cosmetic talc defendants targets by substituting them for insolvent asbestos defendants and anyone else who may be named, which would present an extreme and unforeseen threat to cosmetic talc defendants and affiliated industry.

Cosmetic Talc Litigation – Ovarian Cancer

Cases alleging injury from cosmetic talc are relatively new, as best exemplified by the recent high-profile J & J verdicts. These cases did not depend on asbestos contamination, nor did they allege mesothelioma. Instead, they alleged that talc itself causes ovarian cancer. The ovarian cancer talc cases indeed represent an entirely new class of toxic product liability litigation. The approximately 14,000 ovarian cancer deaths a year, in conjunction with the widespread use of talc in everyday products such as baby powder, renders these cases a serious threat to certain defendants and their insurers.
According to the National Institute of Health, there are 22,280 new ovarian cancer diagnoses each year in the U.S. and 14,240 women die of the disease every year. This is seven times the number of annual mesothelioma diagnoses.

The American Cancer Society estimates that there are only 3,000 new mesothelioma diagnoses a year,  with mesothelioma lawsuit filings being stable and not increasing. Like any other business, plaintiffs’ firms are always looking to maintain and grow revenue. Litigation against cosmetic talc defendants alleging ovarian cancer offers a way to substantially increase their bottom line. Indeed, “do you have ovarian cancer?” and “did you use talcum powder?” ads are commonplace on television.

Because everyone can credibly claim exposure to cosmetic talc, the primary issue that will be litigated is the science underlying the causal connection between talc exposure and ovarian cancer. While plaintiffs prevailed in the St. Louis actions, Imerys Talc and J & J persuaded a New Jersey trial court in 2016 to dismiss with prejudice two ovarian cancer cases after granting their motions to bar expert testimony due to inadequate science supporting their opinions. Apparently pressing their advantage, the defendants persuaded the federal talc MDL in New Jersey to conduct a “science day” in which the litigants would attempt to generally demonstrate that cosmetic talc does or does not cause ovarian cancer. The plaintiffs’ bar quickly responded with their own proposed “science day” in California state court, presumably where they perceive a jurisdictional advantage. The “science” of whether cosmetic talc causes ovarian cancer will be the field of battle on which the sustainability of these claims will live or die.

The sustainability of ovarian cancer talc cases will depend on how the courts resolve the science questions surrounding causation. This will depend in large part on the plaintiffs’ bar’s ability to persuade courts outside jurisdictions traditionally favorable to asbestos claimants of the merit of their claims.

Cosmetic Talc Cases Alleging Asbestos Contamination

In addition to the emergence of ovarian cancer cases, cosmetic talc defendants are also at risk of becoming responsible for mesothelioma cases alleging that their products were contaminated with asbestos. If plaintiffs can meet their burden of proving asbestos contamination in their products, the issue of product identification will largely be moot due to the ubiquitous use of talc in everyday products to which any plaintiff can presumably credibly claim exposure.

Allegations of asbestos contamination in talc have a long and disputed history. The FDA launched an investigation in 2010 based on reports that talc from South Korea and China contained asbestos. After extensive testing of various U.S. consumer products, the FDA found no asbestos contamination in the products. However, it described its results as inconclusive and only “informative” because it was unable to secure samples from all of the common talc suppliers.

The issue of whether cosmetic talc is contaminated by asbestos is disputed by the plaintiffs’ bar. The cosmetic talc defendants present an attractive target, especially given the declining pool of solvent asbestos defendants. In addition, while mesothelioma case filings have been relatively flat, the expected decline of mesothelioma claims has failed to emerge.

If mesothelioma cases do trend upward, plaintiffs’ lawyers will have additional incentive to identify new solvent defendants to satisfy the potential liabilities. Cosmetic talc defendants, generally not burdened by years of asbestos liabilities, make attractive defendants. In addition, because the traditional asbestos defendants that used and sold asbestos products have gone bankrupt, plaintiffs’ lawyers have increasingly struggled to demonstrate proximate cause against individual defendants and have been forced to make ever-more tenuous arguments that even de minimus exposures to asbestos caused their clients’ mesothelioma. The widespread use of cosmetic talc overcomes most traditional product identification, proximate cause defenses. Instead, the principal issue becomes only whether a particular product was contaminated with asbestos.
The plaintiffs’ bar will attempt to meet its burden of demonstrating asbestos contamination in cosmetic talc by arguing that traditional testing methods are not precise enough to detect it at low levels and that there is no safe level of asbestos exposure. In previous cases, plaintiffs have employed experts to challenge defendants that maintained talc samples. As these cases are being litigated in the same jurisdictions that handle most asbestos cases, these allegations will  be difficult for defendants to rebut.

Question: Will industrial and cosmetic “personal care” products made with talcum powder and the emerging confirmed links to “asbestos” and “mesothelioma” become the new long term mass tort resulting in thousands of complaints against nontraditional and unsuspecting defendants? Such as the Los Angeles County, California Superior Court lawsuits where a 2015 “cosmetic talc” trial resulted in an $18 million verdict award based on “cosmetic talc exposure in a barbershop” against Old Spice, Clubman, Kings Men and Mennen Shave Talc, as well as a prior 2015 trial verdict of $13 million against Colgate-Palmolive for exposure to talc in its baby powder.

 

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First State Court Opioid Crisis Trial Set In Oklahoma With May 2019 Start Date

By Mark A. York (May 24, 2018)

 

 

 

 

 

 

 

May 28, 2019 trial date set in the first opioid litigation case to go to trial where a  state filed suit versus the opioid pharmaceutical companies

(MASS TORT NEXUS MEDIA) The first of many opioid litigation trials where states, counties and cities have filed lawsuits against the Opioid Big Pharma industry and it’s affiliates, is now set in Oklahoma where Cleveland County District Judge Thad Balkman set May 28, 2019 for the start of the trial.  The trial date date has been anticipated in the lawsuit by the State of Oklahoma against pharmaceutical companies over the opioid epidemic, according to Oklahoma‘s attorney general Mike Hunter. See Original Complaint – State of Oklahoma vs. Purdue Pharma et al, June 30, 2017 (Cleveland County, OK District Court)

To summarize the view in Oklahoma and other states who are pursuing the Opioid prescription drugmakers in courts all across the country, Oklahoma Attorney General Mike Hunter stated in his filings  “Defendants created the worst public health crisis in modern history. Families destroyed,”adding “Children killed. Babies addicted. Morgues overflowing. Prisons full.” This is a common view across the entire United States at this point.

Oklahoma, one of at least 13 states that have filed lawsuits against drugmakers, alleges fraudulent marketing of drugs that fueled the opioid epidemic in the lawsuit filed in June 2017, and seeks unspecified damages from Purdue Pharma, Allergan, Janssen Pharmaceuticals, Teva Pharmaceuticals and several of their subsidiaries.

“We appreciate the urgency Judge (Thad) Balkman saw in getting the case to trial,” Attorney General Mike Hunter said. “Oklahomans who have suffered immeasurably from the years of fraudulent marketing campaigns will see this case resolved sooner rather than later.” Hunter said Balkman scheduled the trial to begin May 28, 2019.

For up to date information on the Opioid Litigation across the country see, OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION (https://www.masstortnexus.com/Briefcases/Drugs/254/)

Within the last 2 weeks, state attorneys general of Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee lawsuits have now joined many other states who have filed lawsuits asserting that Purdue Pharma violated state consumer protection laws by falsely denying or downplaying the addiction risk while overstating the benefits of opioids. The lawsuits also names pharmaceutical manufacturers Endo Pharmaceuticals, Allergan, Teva Pharmaceutical Industries and Mallinckrodt, as well as drug distributors AmerisourceBergen, Cardinal Health and McKesson Corporation.

“It’s time the defendants pay for the pain and the destruction they’ve caused,” Florida State Attorney General Pam Bondi told a press conference.

Joining, Oklahoma are states who’ve previously filed claims against opiate drugmakers are Ohio, AlaskaKentuckyLouisianaMississippiMissouriMontanaNew HampshireNew JerseyNew MexicoSouth Carolina and Washington state. West Virginia has been catastrophically affected by the opioid crisis and has previously attempted to stop Opioid Big Pharma from pushing opiates into their communities, without much success.  See How drug companies submerged West Virginia in opioids for years: “A small West Virginia town of 3,000 people got 21 million pills”

Medical professionals say a shift in the 1990s to “institutionalize” pain management opened the doors for pharmaceutical companies to encourage doctors to massively increase painkiller prescriptions, and Purdue Pharma led that effort. Which is now directly linked to the massive increase in drug overdoses, now see as the leading cause of accidental death for Americans under age 50, killing more than 64,000 people in 2016, according to the Centers for Disease Control and Prevention.

OxyContin was launched in the mid-90s by Purdue Pharma and aggressively marketed as a safe way to treat chronic pain. But it created dependency in many even as prescribed, and the pills were easy to abuse. Mass overprescribing has led to an addiction and overdose catastrophe across the US, more recently rippling out into rising heroin and fentanyl deaths.

Opioid overdoses made up a staggering 66 percent of all drug overdose deaths in 2016, surpassing the annual number of lives lost to breast cancer.

Florida and the other states also, named drug makers Endo Pharmaceuticals Inc., Allergan, units of Johnson & Johnson and Teva Pharmaceutical Industries, and Mallinckrodt, as well as drug distributors AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

The companies deny wrongdoing and say they complied with Federal Drug Administration requirements that include warning labels showing potential risks that come with using their drugs. “We are deeply troubled by the prescription and illicit opioid abuse crisis, and are dedicated to being part of the solution,” Purdue Pharma said in a statement Friday. “We vigorously deny these allegations and look forward to the opportunity to present our defense.”

Ohio Filed First

In announcing his office’s lawsuit in May 2017, Ohio Attorney General DeWine said the drug companies helped unleash the crisis by spending millions of dollars marketing and promoting such drugs as Purdue’s OxyContin, without consideration of the long term effects of the related addiction, which Purdue was absolutely aware of throughout the years of profits that now total billions of dollars.

The lawsuit said the drug companies disseminated misleading statements about the risks and benefits of opioids as part of a marketing scheme aimed at persuading doctors and patients that drugs should be used for chronic rather than short-term pain.  Pain centers and medical practices across the country started writing an ever increasing number of high dose opioid prescriptions for what would be considered low to mid-level pain treatment.

Similar lawsuits have been filed by local governments, including those in several California counties, as well as the cities of Chicago, Illinois and Dayton, Ohio, three Tennessee district attorneys, and nine New York counties have also filed individual suits.

It is unknown at this time, if all of the legal actions filed by governmental entities across the country will be consolidated into MDL 2804, which may be the most effective way to manage the soon to be massive number of legal claims against Big Pharma and their long term opiate profit centers. Municipalities across the country seeking to recoup the enormous financial losses brought on by the opioid crisis.

The state lawsuits are separate from pending lawsuits in Ohio by dozens of local governments, and lawsuits by Native American tribes in the Dakotas and Oklahoma.

In South Dakota, the Rosebud Sioux Tribe, Flandreau Santee Sioux Tribe and the Sisseton Wahpeton Oyate filed a federal lawsuit in January against 24 opioid industry groups. See https://www.indianz.com/News/2018/04/11/navajonationopioid.pdf.  n Oklahoma, a federal judge has ruled that another similar lawsuit by the Cherokee Nation cannot be tried in tribal court, and Cherokee Nation Attorney General Todd Hembree told the Tulsa World that the tribe will re-file the lawsuit in state court.

Lawsuits have already been filed by 16 other U.S. states and Puerto Rico against Purdue and the related opioid drug companies and distributors. Purdue, which is a privately held company, owned by the Sackler brothers and family, in February said it stopped promoting opioids to physicians after widespread criticism of the ways drugmakers market highly addictive painkillers.

Purdue Pharma is owned by the Sackler family, listed at 19th on the annual Forbes list of wealthiest families in the country at a worth of $13 billion. The family’s fortune largely comes from OxyContin sales, which its company branded and introduced as an extended release painkiller in 1995.

Two branches of the Sackler family control Purdue, which developed and continues to make OxyContin, the narcotic prescription painkiller regarded as the “ground zero” of America’s opioids crisis.

Bondi said state attorneys general from New York, California and Massachusetts were preparing similar lawsuits, with Massachusetts last week sending a letter to Purdue notifying the company of its intention to sue. The California and New York attorney general offices did not immediately respond to a request for comment.

Stamford, Connecticut-based Purdue, in a statement, denied the accusations, saying its drugs were approved by the U.S. Food and Drug Administration and accounted for only 2 percent of all opioid prescriptions, seemingly ignoring the 600 lawsuits filed against them in the last year, as well as the minimum of 15 federal and state criminal investigations that are underway across the country.  At the forefront of the criminal investigations is the U.S. Attorney, John H. Durham, District of Connecticut, U.S. Department of Justice, Criminal Division, based in New Haven, CT the state which is also where Purdue Pharma is headquartered, who is leading a multi-group task force looking into the potential criminal conduct of not only Purdue, but the entire Opiate Big Pharma industry as a whole.

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help these states address the opioid crisis, this group of attorneys general have unilaterally decided to pursue a costly and protracted litigation process,” Purdue said.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

Separate litigation involving at least 433 lawsuits by U.S. cities and counties were consolidated in a federal court in Cleveland, Ohio. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The federal lawsuits which accuse drugmakers and the opioid industry as a whole, of deceptively marketing opioids and the distributors of ignoring indications that the painkillers were being diverted for improper uses.

U.S. District Judge Dan Polster, who is overseeing the consolidated litigation, has been pushing for a global settlement. He had previously invited state attorneys general with cases not before him to participate in those talks, from the start of the MDL 2804 litigation being assigned to his courtroom.

Despite filing separate lawsuits, the six attorneys general on Tuesday said they would continue to engage in settlement discussions with Purdue and other companies. “You always want to settle and prevent a prolonged litigation,” said Florida’s Bondi. “But we’re sending a message that we’re fully prepared to go to war.”

Will litigation in most every state in the union paired with the National Opiate Prescription MDL 2804 reign in the Opioid industry that’s earned billions and billions of dollars over the last 20 years, all at the expense of the people of the United States and their families?  If history is a gauge of how things will end up, chances are a big “NO” as money and greed at the corporate levels have traditionally overruled anything affiliated with long term public health concerns in our for-profit healthcare system currently entrenched in the United States.

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More States Are Now Filing Lawsuits Against Big Pharma’s Opioid Rx Cash Cow Industry

Florida, Texas, Nevada, North Carolina, North Dakota and Tennessee Join Opioid Litigation

 

 

 

 

 

 

(Mass Tort Nexus Media) Litigation against OxyContin maker Purdue Pharma LP and the rest of the Opioid Big Pharma industry just jumped significantly, as six more states have filed lawsuits against Purdue Pharma, et al. The ongoing allegations against the opioid pharmaceutical industry as a whole, where numerous governmental entities from across the country have asserted that the opiate makers have fueled a national opioid crisis. This is primarily based on corporate boardroom designed deceptive opioid marketing campaigns, designed to sell prescription opioids, and minimize the previously well-known medical risks, including addiction and overdose, while generating billions of dollars in sales.

For up to date information on the Opioid Litigation across the country see, OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION (https://www.masstortnexus.com/Briefcases/Drugs/254/)

Prescription and illegal opioids account for more than 60 percent of overdose deaths in the United States, a toll that has quadrupled over the past two decades, according to the U.S. Centers for Disease Control. Drug overdose deaths in 2015 far outnumbered deaths from auto accidents or guns.

Texas saw 1,186 opioid-related deaths in 2015, while the nation as a whole had 33,000 such deaths that year. Researchers have flagged opioids as one possible factor in Texas’ staggering rise in women’s deaths during and shortly after pregnancy.

State attorneys general of Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee assert that Purdue Pharma violated state consumer protection laws by falsely denying or downplaying the addiction risk while overstating the benefits of opioids. The lawsuits also names pharmaceutical manufacturers Endo Pharmaceuticals, Allergan, Teva Pharmaceutical Industries and Mallinckrodt, as well as drug distributors AmerisourceBergen, Cardinal Health and McKesson Corporation.

“It’s time the defendants pay for the pain and the destruction they’ve caused,” Florida State Attorney General Pam Bondi told a press conference.

Medical professionals say a shift in the 1990s to “institutionalize” pain management opened the doors for pharmaceutical companies to encourage doctors to massively increase painkiller prescriptions, and Purdue Pharma led that effort. Which is now directly linked to the massive increase in drug overdoses, now see as the leading cause of accidental death for Americans under age 50, killing more than 64,000 people in 2016, according to the Centers for Disease Control and Prevention.

OxyContin was launched in the mid-90s by Purdue Pharma and aggressively marketed as a safe way to treat chronic pain. But it created dependency in many even as prescribed, and the pills were easy to abuse. Mass overprescribing has led to an addiction and overdose catastrophe across the US, more recently rippling out into rising heroin and fentanyl deaths.

Opioid overdoses made up a staggering 66 percent of all drug overdose deaths in 2016, surpassing the annual number of lives lost to breast cancer.

Florida and the other states also, named drug makers Endo Pharmaceuticals Inc., Allergan, units of Johnson & Johnson and Teva Pharmaceutical Industries, and Mallinckrodt, as well as drug distributors AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

Teva, in a statement, emphasized the importance of safely using opioids, while AmerisourceBergen said it was committed to collaborating with all stakeholders to combat opioid abuse.

The Healthcare Distribution Alliance, an umbrella group for drug distributors, said in a statement that accusations that distributors were responsible for the abuse of opioid prescriptions defied common sense and lacked understanding of the pharmaceutical supply chain.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

THE SACKLERS AND PURDUE

Lawsuits have already been filed by 16 other U.S. states and Puerto Rico against Purdue and the related opioid drug companies and distributors. Purdue, which is a privately held company, owned by the Sackler brothers and family, in February said it stopped promoting opioids to physicians after widespread criticism of the ways drugmakers market highly addictive painkillers.

Purdue Pharma is owned by the Sackler family, listed at 19th on the annual Forbes list of wealthiest families in the country at a worth of $13 billion. The family’s fortune largely comes from OxyContin sales, which its company branded and introduced as an extended release painkiller in 1995.

Two branches of the Sackler family control Purdue, which developed and continues to make OxyContin, the narcotic prescription painkiller regarded as the “ground zero” of America’s opioids crisis.

Bondi said state attorneys general from New York, California and Massachusetts were preparing similar lawsuits, with Massachusetts last week sending a letter to Purdue notifying the company of its intention to sue. The California and New York attorney general offices did not immediately respond to a request for comment.

Stamford, Connecticut-based Purdue, in a statement, denied the accusations, saying its drugs were approved by the U.S. Food and Drug Administration and accounted for only 2 percent of all opioid prescriptions, seemingly ignoring the 600 lawsuits filed against them in the last year, as well as the minimum of 15 federal and state criminal investigations that are underway across the country.  At the forefront of the criminal investigations is the U.S. Attorney, John H. Durham, District of Connecticut, U.S. Department of Justice, Criminal Division, based in New Haven, CT the state which is also where Purdue Pharma is headquartered, who is leading a multi-group task force looking into the potential criminal conduct of not only Purdue, but the entire Opiate Big Pharma industry as a whole.

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help these states address the opioid crisis, this group of attorneys general have unilaterally decided to pursue a costly and protracted litigation process,” Purdue said.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

Separate litigation involving at least 433 lawsuits by U.S. cities and counties were consolidated in a federal court in Cleveland, Ohio. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The federal lawsuits which accuse drugmakers and the opioid industry as a whole, of deceptively marketing opioids and the distributors of ignoring indications that the painkillers were being diverted for improper uses.

U.S. District Judge Dan Polster, who is overseeing the consolidated litigation, has been pushing for a global settlement. He had previously invited state attorneys general with cases not before him to participate in those talks, from the start of the MDL 2804 litigation being assigned to his courtroom.

Despite filing separate lawsuits, the six attorneys general on Tuesday said they would continue to engage in settlement discussions with Purdue and other companies. “You always want to settle and prevent a prolonged litigation,” said Florida’s Bondi. “But we’re sending a message that we’re fully prepared to go to war.”

PURDUE-OXYCONTIN HISTORY

On December 12, 1995, the Food and Drug Administration approved the opioid analgesic OxyContin. It hit the market in 1996. In its first year, OxyContin accounted for $45 million in sales for its manufacturer, Stamford, Connecticut-based pharmaceutical company Purdue Pharma. By 2000 that number would balloon to $1.1 billion, an increase of well over 2,000 percent in a span of just four years. Ten years later, the profits would inflate still further, to $3.1 billion. By then the potent opioid accounted for about 30 percent of the painkiller market. What’s more, Purdue Pharma’s patent for the original OxyContin formula didn’t expire until 2013. This meant that a single private, family-owned pharmaceutical company with non-descript headquarters in the Northeast controlled nearly a third of the entire United States market for pain pills.

OxyContin’s ball-of-lightning emergence in the health care marketplace was close to unprecedented for a new painkiller in an age where synthetic opiates like Vicodin, Percocet, and Fentanyl had already been competing for decades in doctors’ offices and pharmacies for their piece of the market share of pain-relieving drugs. In retrospect, it almost didn’t make sense. Why was OxyContin so much more popular? Had it been approved for a wider range of ailments than its opioid cousins? Did doctors prefer prescribing it to their patients?

During its rise in popularity, there was a suspicious undercurrent to the drug’s spectrum of approved uses and Purdue Pharma’s relationship to the physicians that were suddenly privileging OxyContin over other meds to combat everything from back pain to arthritis to post-operative discomfort. It would take years to discover that there was much more to the story than the benign introduction of a new, highly effective painkiller.

US DEPT OF JUSTICE INDICTMENTS

While the FDA has failed, the US Department of Justice has launched a massive crackdown on opiate drug makers including indictments of company executives, sales & marketing personnel as well as the doctors and pharmacies that have enabled the flood of easy access narcotics into the US market for over 15 years. The question is “how and why” did the FDA drop the ball or was this an intentional lack of enforcement and oversight by the FDA and other agencies due to Big Pharma influence over Congressional members who would blunt any true oversight of drug companies.

For criminal opioid cases see: Federal Venues and Courts Where Opioid Indictments Are Pending As Of July 2017

FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

Former President Bill Clinton pulled no punches as he focused directly on the opiate issues “Nobody gets out of this for free,” which seems to be where most of the finger pointing and blame game rests, which is one of the prime issues of the highest importance. The checkbook to pull the country out of this national opiate epidemic will be in the hundreds of billions of dollars and even then, the costs of social and economic damage to date, will never be recovered. Clinton further commented on how the opioid epidemic “creeps into every nook and cranny of our country” and needs to be addressed as both a huge national problem and a community-by-community tragedy, adding “this can rob our country of the future.”

RURAL vs. BIG CITY OPIATES

Almost 2.75 million opioid prescriptions were filled in New York City each year from 2014 to 2016. Which is a very high number for a major city, but not nearly the millions of opiate prescriptions written in the more rural regions of Ohio, West Virginia and Kentucky, where the number of opiates prescribed equaled 100 plus pills per month for every resident in these states, with West Virginia numbers being, 780 million painkillers prescribed in six years.

As more and more cities, states and counties files suits against the opiate drug industry as a whole, there will be a point where Opiate Big Pharm will have to decide whether to admit it’s fault in the opioid crisis, or simply continue to evade responsibility and leave the process up to lawyers and the courts to assign a financial penalty for the alleged corporate opioid abuses.

FDA Failed to Cite Opioid Big Pharma

Perhaps a look at former US Representative Tom Price, will provide insight into how our lawmakers work within the healthcare industry. Rep. Price was appointed by President Trump to head the Department of Health and Human Services, which the FDA reports to, was forced to resign as HHS head due to various transgression within 6 months of being appointed, as well as leaks that while a sitting congressman he enacted a bill favoring a medical device makers extension of a multi-year government contract. Not only did Price enact the bill, he purchased stock in the company prior to the bill introduction and secured a massive profit on the stock price increase after the contract extension was announced. In normal business circles this is considered “insider trading” and is illegal, but when you’re one of those people in charge of creating the rules and regulations, there’s an apparent “get out of jail card” that comes with your congressional seat.

As long as the US Congress fails to correct the lack of oversight by the FDA and other regulatory agencies into what and how dangerous drugs and products are placed into the US marketplace, there will always be bad drugs entering the healthcare pipeline in the United States, with the now enduring default misnomer of “Profits Before Patients” firmly in place in boardrooms and within our government.

As the Opioid litigation expands across the country in both state and federal courtrooms, it remains to be seen if the anticipated payouts will surpass the $200 billion payday for governments in the 1998 Big Tobacco Litigation settlement.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, remains to be seen.

Who will be the advocate to make sure that these individuals as well as their children, families and communities as a whole are placed on the road to recovery. Historically, Big Pharma is not an industry to put the best interests of the paying consumer at the forefront of their agendas.

 

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Opiate Prescribing and Use Keeps Rising While Research Data Shows A Diminishing Return

Opiate Use Has Increased While Realtime Data Shows There’s A Diminishing Return

By Mark A. York (May 11, 2018)

Why was there a 30% rise  in opioid overdoses in 2017 

 

 

 

 

 

 

 

 

 

 

 

 

  • (MASS TORT NEXUS MEDIA) From 2000 to 2016, government research data shows that more than 600,000 people died from drug overdoses — nearly 64,000 in 2016 alone.

  • See the data on the 30% rise in opioid overdoses between 2016 and  2017, click CDC link here.

MIDWEST AMERICA WAS TARGETED

According to sources at all levels from police and fire first responders to emergency room physicians across the country and analysts at the CDC, there’s been no slowdown in opiate based medical emergencies in the US over the last 2 years. Emergency response and ER visits for opioid overdoses went way up, with a 30 percent increase in the single year period of June of 2016 to June of 2017, according to the Centers for Disease Control and Prevention. 

The increased emergency room visits also include more young children aged three to fourteen years old, which truly reflects on the unknown number still available opiates that are readily accessible to anyone who has an interest in getting them, and often with an inadvertent and tragic risk to younger victims who somehow are exposed and now being swept up in the opioid crisis.

Center for Disease Control’s Acting Director Dr. Anne Schuchat said overall the most dramatic increases were in the Midwest, where emergency visits went up 70 percent in all ages over 25. This is a figure that’s is comparative to prior medical emergency spikes during pandemic healthcare  

Recently two important medical reports on opiate abuse have emerged indicating that the opioid crisis may be at its worst point ever.

The first study comes from the Centers for Disease Control and Prevention (CDC), a federal agency tasked with studying – and stopping – the spread of diseases, including everything from viral infections like the flu to mental health issues including drug addiction. Published in the agency’s monthly Vital Signs report, the study demonstrates that the number of opioid overdoses increased by 30% in a little more than one year from July 2016 to September 2017.

The second study comes from a group of VA medical personnel and public health researchers publishing in the Journal of the American Medical Association (JAMA), who wanted to learn how effective opioid prescription drugs were at managing long-term and chronic pain. As it turns out, opioid drugs showed less efficacy than non-opioid pain medications over a 12-month period – and in fact, over time opioids became worse for patients who had to deal with side effects that patients taking non-opioid medications did not have to deal with. Taken together, these two studies show that current opioid drug policies, procedures, prescription practices and standards of patient care clearly need to be rethought.

“A small West Virginia town of 3,000 people got 21 million pills”

Drug companies deluged tiny towns in West Virginia with a monsoon of addictive and deadly opioid pills over the last decade, according to ongoing investigations by various public and private entities. After Opioid Big Pharma has reaped billions in profits over the last 15 years at the expense of US citizens, often those in the most rural and distressed areas of the country, it now appears that the time has come for Big Pharma to be called to answer for its conduct.

For instance, drug companies collectively poured 20.8 million hydrocodone and oxycodone pills into the small city of Williamson, West Virginia, between 2006 and 2016, according to a set of letters the committee released Tuesday. Williamson’s population was just 3,191 in 2010, according to US Census data.  These numbers are outrageous, and we will get to the bottom of how this destruction was able to be unleashed across West Virginia,” committee Chairman Greg Walden (R-Ore.) and ranking member Frank Pallone Jr. (D-N.J.) said in a joint statement to the Charleston Gazette-Mail.

The nation is currently grappling with an epidemic of opioid addiction and overdose deaths. The Centers for Disease Control and Prevention estimate that, on average, 115 Americans die each day from opioid overdoses. West Virginia currently has the highest rate of drug overdose deaths in the country. Hardest hit have been the regions of West Virginia, Ohio and Kentucky where for some reason the opioid industry chose to focus on, the how and why will be address in the federal and state courts across the country, as the opioid crisis has caused the “Opiate Prescription Multidistrict Litigation MDL 2804”, to be created and heard in the US District Court-Northern District of Ohio, in front of Judge Dan Polster, see Opiate Prescription MDL 2804 Briefcase.

WHERE WAS THE OFFICIAL OVERSIGHT?

The House committee repeatedly asked if the company thought these orders were appropriate and what limits—if any—it would set on such small towns.  Miami-Luken would not respond to a request for comment. The committee had similar questions for HD Smith, who delivered 1.3 million hydrocodone and oxycodone pills to a pharmacy in Kermit—the 406-person town—in 2008.

“If these figures are accurate, HD Smith supplied this pharmacy with nearly five times the amount a rural pharmacy would be expected to receive,” the committee wrote. It noted that the owner of that Kermit pharmacy later spent time in federal prison for violations of the Controlled Substance Act. Still, the committee pressed the question of whether HD Smith thought its distribution practices were appropriate.

“We will continue to investigate these distributors’ shipments of large quantities of powerful opioids across West Virginia, including what seems to be a shocking lack of oversight over their distribution, all the while collecting record breaking profits and paying sale reps in the field enormous bonuses.  This is the pattern that all Opioid Big Pharma has followed across the United states for the last 20 years, pay field sales rep many thousands of dollars on bonuses, to push opiates on doctors, hospitals and anyone else who can move drugs into the healthcare treatment assembly line.

 OPIOIDS FOR CASUAL PAIN MANAGEMENT PUSHED BY BIG PHARMA

Why did the emphasis on pain management in the 1990s result in a focus on opioid prescriptions? One reason may have been aggressive marketing efforts by opioid drug makers. For example, from 1996 to 2001, Purdue Pharma held more than 40 pain management conferences for healthcare providers to promote the use of its new OxyContin® extended-release formula of oxycodone. Sales surged from $45 million in 1996 to $1.1 billion a year in 2000—an increase of well over 2000%.

“We were told way back in the ’90s that these drugs were safe, that they wouldn’t hurt people, and that it was imperative to control pain,” Dr. Kalliainen recalls. Then, in 2007, Purdue admitted it had misled doctors into thinking OxyContin was less easily abused than other drugs in its class. It agreed to pay $600 million in fines and other fees to the Justice Department. Something else has changed in the culture as well, says Dr. Kalliainen. Patients seem to be in as much emotional pain as physical pain. “I’ve been in practice for 16 years now, and there’s been a huge increase in free-floating anxiety in patients,” she says.

US physicians often that find writing a prescription for an opioid is the most convenient way to respond to their patients’ demands, Dr. Kallianen says. As a resident in the 1990s, she remembers being told by the attending physician to write prescriptions for 60 or 70 opioid tablets for nearly every surgery patient. “You started a whole generation of physicians who are out there saying, ‘Write them for 60 [tablets] so they don’t call in.’”

One reason the practice has persisted is that surgeons often don’t know what effect their prescriptions are having, says Dr. Kalliainen. “We don’t see somebody dying of an overdose or becoming addicted. We don’t know if somebody is coming in and stealing their medications from their medicine cabinet and then having a problem. All the negative effects are away from our direct vision. So we’re not taking as much responsibility.” But research shows that once they have received opioid drugs, many patients can’t stop using them. One study found that 8.2% of patients who took opioids for the first time after total knee arthroplasty were still using them 6 months later, despite weak evidence that the drugs are effective for chronic pain management.

Among people already abusing drugs, some studies suggest that the opioids serve as a bridge between other substances and heroin.] Even when patients don’t abuse the opioids themselves, the drugs prescribed to them may end up in the hands of people who do. Surveys of people who abuse opioids show that as many as 23.8% obtained the drugs from clinicians, and 53% obtained them from friends or relatives, most of whom obtained them from clinicians.

“It’s not like these are stolen off the truck,” says Brent J. Morris, MD, a shoulder and elbow surgeon at the Shoulder Center of Kentucky in Lexington, who has published extensively on opioid prescribing patterns. “Certainly, physicians play a role in this.”

RECENT FDA COMMENTS ON OPIOIDS

Opana ER: June 2017  U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks.

Codeine and Tramadol Can Cause Breathing Problems for Children

FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women issued on April 20, 2017.

These medicines can cause life-threatening breathing problems in children. Some children and adults break down codeine and tramadol into their active forms faster than other people. That can cause the level of opioids in these people to rise too high and too quickly.

January 2018 FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older

The U.S. Food and Drug Administration (FDA) is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18.

FIGHTING THE OPIOiD FIGHT

In the United States, has been fighting a losing opioid battle for a long time now. With one study reporting that Americans consume approximately 80% of the world’s opioid drug supply. Given that painkillers make up the one of the largest classes of drugs manufactured around the globe, second only to cancer drugs, this is a rather staggering statistic: According to the CDC, more than a quarter of a billion prescriptions for opioid painkillers were written in 2013, the latest year for which data is available, and that number has almost certainly risen in recent years.

As these two latest studies show, not only are we losing the battle against opioid use – and, more importantly, abuse – but the battle itself is largely one that we should never have had to wage in the first place. A large portion of people who become addicted to opioids do so after receiving a prescription for long-term pain management. But as the JAMA study shows, it appears opioids are actually worse at managing chronic pain than non-opioid medications.

The primary reason for addiction and the correlating social problems is the casual acceptance by so many that opioids prescribed by a doctor are well intended and okay to use, not realizing that over time people tend to build up a tolerance for them. This means that patients have to take larger and larger doses in order to receive the same benefit as they did previously with smaller doses. This has been long known by doctors and researchers, including the Big Pharma Opioid marketing and sales teams, which was reinforced in the JAMA study. Participants reported that opioids were more effective than non-opioids early in the study, but at around six months they started to report that opioids the same or even less effective at managing pain than their non-opioid counterparts.

Other side effects include nausea and vomiting, mental health problems (including everything from confusion to depression), and full-blown chemical dependence. Then, there are the problems associated with opioid withdrawal. The upshot of all these side effects is that, even when opioids are working, they well may wind up causing the patient harm in other ways.

Combined with the increase in overdoses, the fact that opioids are less effective than presumed creates a substantial public health problem. We are throwing large sums of public and private money at treating opioid addiction and related issues caused by a problem that could have been completely avoided by using more effective (and less habit-forming) medications.

IS THERE A SOLUTION FOR THE OPIOID CRISIS?

People in many different professional areas are looking for ways to address the addiction problem that has arisen while simultaneously working to prevent future addictions. The concern is having the crisis split along political lines where conservative push for draconian solutions and liberals push for free treatment for everyone. Both solution are untenable and misdirected, but there are proponents for both strategies forming in camps across the country. .

Given the reduced effectiveness of opioid painkillers over time, doctors must look at finding newer and better ways to treat long-term and chronic pain, with a more fully evolved treatment protocol. This includes research and developing into safer medications, more active lifestyle review and changes by patients and a wider acceptance by the medical community of complementary therapies, such as meditation, yoga, tai chi, and massage – including the use of medical marijhuana.  Awareness about these alternative pain relief methods need to be be included as part of any sincere program that provides solutions to the opioid crisis.

THE PRESCRIPTION OPIATES BEING PRESCRIBED

  • oxycodone (OxyContin, Percodan, Percocet)

  • hydrocodone (Vicodin, Lortab, Lorcet)

  • diphenoxylate (Lomotil)

  • morphine (Kadian, Avinza, MS Contin)

  • codeine

  • fentanyl (Duragesic)

  • propoxyphene (Darvon)

  • hydromorphone (Dilaudid)

  • meperidine (Demerol)

  • methadone

For another thing, public policy on illegal drugs needs to be significantly reconsidered, especially for less-addictive drugs like marijuana.  A study published last year in the American Journal of Public Health showed that legalizing marijuana for recreational use can significantly reduce the number of opioid deaths. Considering there have been no known reports of a marijuana overdose ever according to the U.S. Drug Enforcement Administration (DEA), that seems like a pretty good tradeoff from a simple public health policy perspective.

Another way to fight the problem is to increase the availability of opioid agonist drugs, such as naloxone, not only to health care providers and emergency department staff but to trained first responders and others as well. Naloxone reverses the effects of both prescription opioids and illegal drugs, such as heroin, and it can be an important first step toward helping those with substance use disorders become well.

Finally, IN the emerging MDL 2804 (Opiate Prescription Litigation) the opioid drugmakers, distributors and pharmacies are being held accountable for marketing tactics and self-funded studies that may have overblown the effectiveness of their drugs.  Many state, county, and local governments are bringing lawsuits, including RICO claims, against pharmaceutical companies in an attempt to offset costs for public health services that have been used to treat addictions and other medical conditions caused by opioid abuse. The DEA and the Department of Justice recently agreed to provide its data on prescription opioid sales to states and municipalities that are pursuing lawsuits.

The comparison is made to the Tobacco Litigation of the 1990’s which settled in 1998 for $200 billion, WITH he Opiate MDL 2804 litigation being expected to easily surpass that figure with conservative estimates reaching between $750 and $900 billion dollars.

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Abilify, Taxotere and Ethicon Multi-Layered Hernia Mesh Lawsuits Being Consolidated in New Jersey State Court

New Jersey State Court MCL Designations: Is NJ the emerging state court mass tort venue for lawsuits against Big Pharma?

By Mark A. York (May 11, 2018)

(Mass Tort Nexus Media) In late 2017 plaintiffs and defendants in the Abilify litigation in New Jersey state court moved to have the litigation designated as a multicounty litigation (MCL) on December 27, 2017 and which was approved as an MCL on May 9, 2018, see links below for both court filings.

Abilify New Jersey State Court MCL Notice to the Bar December 27, 2017

Abilify New Jersey MCL Designation – Atlantic County May 9, 2018

 

 

 

 

 

 

 

The  New Jersey judiciary site provides multicounty litigation docket information where you will see there are more MCL dockets that parallel existing federal MDL’s being brought in Big Pharma’s backyard. These multicounty litigations involve large numbers of claims that are associated with pharmaceuticals and medical devices based in New Jersey, and there appears to be an emerging consensus that confronting J&J, Sanofi and others in their home state venue is now a very viable litigation option for mass tort firms across the country. The recently consolidated Abilify MCL is a prime example, as is the pending Taxotere MCL application.

There were nearly 50 Abilify cases filed in Bergen County in New Jersey Superior Court, with that number expected to rise over the next few months, with Superior Court Judge James DeLuca having been the initial judge handling the docket, both plaintiff and defense had agreed that the cases should remain with Judge DeLuca. However, the May 7, 2018 order designated Superior court Judge Nelson C. Johnson and the Atlantic county court as the Abilify New Jersey MCL venue, Abilify New Jersey MCL Designation Atlantic County May 7, 2018.

The motion for MCL designation was filed to ensure that any Abilify case filed in New Jersey will be transferred into the designated state court venue and remain there. There is already a multidistrict litigation (MDL) designation in the Abilify federal litigation, which is consolidated in Northern District of Florida, where the three upcoming bellwether trial were just settled, as well as pending “global settlement order, see Abilify MDL 2734 Global Settlement Order, where Judge Casey Rodgers ordered the parties to reach an agreement within 120 days of the May 1, 2018 order entry date.  The MDL for Abilify was consolidated in October 2016, before U.S. District Judge M. Casey Rodgers.

NEW JERSEY STATE COURT ETHICON MESH CONSOLIDATION

Ethicon now faces a home state hernia mesh legal battle as the New Jersey Supreme Court posted the Application for Multicounty Litigation (MCL) status on April 11, 2018 regarding the emerging Ethicon/J&J multi-layered hernia mesh products litigation pending in New Jersey state courts, Ethicon Hernia Mesh Litigation MCL Notice – New Jersey State Court April 11, 2018. The filing requests the Ethicon hernia mesh cases be consolidated in Bergen County in front of Judge Rachell Harz, over litigation related to Ethicon’s Proceed, Physiomesh and Prolene synthetic hernia mesh products. For information regarding the New Jersey Ethicon Hernia Mesh Litigation see Mass Tort Nexus Briefcase Re: Ethicon Hernia Mesh New Jersey State Court Consolidation, adding another docket of mesh cases to the ever growing J&J/Ethicon defense of its synthetic surgical mesh products.

 

 

 

 

 

As a growing number of hernia mesh lawsuits continue to be filed against Johnson & Johnson and it’s Ethicon subsidiary in New Jersey state court, each involving complications allegedly caused by the design of multi-layered patch products sold in recent years, a request has been filed to centralize the litigation before one judge for coordinated pretrial proceedings.

On April 11, Glenn A. Grant, acting administrative director of New Jersey state courts, issued a Notice To The Bar (PDF), indicating that the state Supreme Court has received an application to create a multicounty litigation (MCL) for all product liability lawsuits over Ethicon multi-layered hernia mesh.

TAXOTERE EMERGING MCL

The most recent MCL application to be filed and listed by the New Jersey Courts is the Taxotere (docetaxel) cancer chemotherapy drug litigation against Sanofi-Aventis US, Sandoz, Inc. and Actavis, Inc with the MCL Notice posted on April 11, 2018 see Taxotere New Jersey MCL Notice To The Bar April 11, 2018.

There is already an existing Taxotere MDL 2740 in the US District Court ED Louisiana see Mass Tort Nexus Briefcase TAXOTERE-MDL-2740-(US-District-Court-Eastern-District-of-Louisiana, where there are more than 5,000 claims pending in front of the very soon to depart Chief Judge Kurt D. Englehardt, who recently received full US Senate approval to move up to the Forth Circuit Court of Appeals, replaced by sitting US District Court Judge, Jane Triche Milazzo.

 

 

 

 

 

How the New Jersey state court Taxotere MCL compares to the Taxotere MDL 2740 remains to be seen, but the New Jersey based pharmaceutical giants are now being forced to address mass torts more and more often in their home state courts, which previously was perceived as a venue of last resort for many plaintiff firms across the country.

With these three newest mass torts emerging in New Jersey state courts, along with the many pre-existing MCL’s that have been very successful there, will New Jersey now be considered the “go to” venue for filing litigation against Big PharMa?

 

 

 

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Lamictal (lamotrigine) Emerging Litigation – By GlaxoSmithKline plc

Lamictal Emerging Litigation a Drug Made By GlaxoSmithKline plc

By Mark A. York (May 8, 2018)

Emerging Litigation: Lamictal (lamotrigine)

(MASS TORT NEXUS MEDIA) Lamotrigine was approved in 1994 and is available under the brand name Lamictal (GlaxoSmithKline) and in generic forms. Since approval 24 years years ago, the FDA has identified eight cases (two in the United States and six abroad) of confirmed or suspected HLH associated with lamotrigine in children and adults. The FDA has stated “there are likely many more additional cases” that they are unaware of, based on lack of information and awareness of the adverse events.

The anticonvulsant medication lamotrigine can cause the rare but serious immune system reaction hemophagocytic lymphohistiocytosis (HLH), the US and Food and Drug Administration said today in a safety communication.  

The FDA said a warning about the risk for HLH will be added to the prescribing information on lamotrigine drug labels.

Lamotrigine is used alone or with other medicines to treat seizures in patients age 2 years and older. It is also indicated for maintenance treatment in patients with bipolar disorder to help stave off mood episodes (depression, mania or hypomania, and mixed episodes).

HLH is a hyperinflammatory syndrome that can lead to hospitalization and death, especially if not diagnosed and treated quickly. Diagnosis is often complicated because early signs and symptoms, such as fever and rash, are not specific, the FDA notes.  HLH may also be confused with other serious immune-related adverse reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS).

To Learn More About the Emerging Lamictal Litigation:

The emerging Lamictal Litigation will be used as a case study in the May 18 to 21, 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.

FDA LAMICTAL DRUG SAFETY COMMUNICATION

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm605628.htm

Lamictal (lamotrigine): Drug Safety Communication – Serious Immune System Reaction

Posted April 25, 2018

AUDIENCE: Health Professional, Patient, Pharmacy

ISSUE: The FDA is warning that the medicine Lamictal (lamotrigine) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels.

BACKGROUND: The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled response by the immune system. HLH typically presents as a persistent fever, usually greater than 101°F, and it can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs.

Lamotrigine is used alone or with other medicines to treat seizures in patients two years and older. It may also be used as maintenance treatment in patients with bipolar disorder to help delay the occurrence of mood episodes such as depression, mania, or hypomania. Stopping lamotrigine without first talking to a prescriber can lead to uncontrolled seizures, or new or worsening mental health problems. Lamotrigine has been approved and on the market for 24 years, and is available under the brand name Lamictal and as generics.

RECOMMENDATION: Healthcare professionals should be aware that prompt recognition and early treatment is important for improving HLH outcomes and decreasing mortality. Diagnosis is often complicated because early signs and symptoms such as fever and rash are not specific. HLH may also be confused with other serious immune-related adverse reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

Evaluate patients who develop fever or rash promptly, and discontinue lamotrigine if HLH or another serious immune-related adverse reaction is suspected and an alternative etiology for the signs and symptoms cannot be established. Advise patients to seek immediate medical attention if they experience symptoms of HLH during lamotrigine treatment. A diagnosis of HLH can be established if a patient has at least five of the following eight signs or symptoms:

  • fever and rash
  • enlarged spleen
  • cytopenias
  • elevated levels of triglycerides or low blood levels of fibrinogen
  • high levels of blood ferritin
  • hemophagocytosis identified through bone marrow, spleen, or lymph node biopsy
  • decreased or absent Natural Killer (NK) Cell activity
  • elevated blood levels of CD25 showing prolonged immune cell activation

Patients or their caregivers should contact their health care professionals right away if they experience any symptom of HLH while taking lamotrigine. HLH can occur within days to weeks after starting treatment. A physical examination and specific laboratory blood tests and other evaluations are used to diagnose HLH. Signs and symptoms of HLH include but are not limited to:

  • fever
  • enlarged liver; symptoms may include pain, tenderness, or unusual swelling over the liver area in the upper right belly
  • swollen lymph nodes
  • skin rashes
  • yellow skin or eyes
  • unusual bleeding
  • nervous system problems, including seizures, trouble walking, difficulty seeing, or other visual disturbances

FDA LAMICTAL WARNING PODCAST

FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)

https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm606094.htm

Lamictal Podcast Transcript:

Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On April 25, 2018, FDA warned that the medicine lamotrigine (brand name Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels.

The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled response by the immune system and typically presents as a persistent fever, usually greater than 101°F. HLH can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs.

Lamotrigine is used alone or with other medicines to treat seizures in patients two years and older. It may also be used as maintenance treatment in patients with bipolar disorder.

Health care professionals should be aware that prompt recognition and early treatment is important for improving HLH outcomes and decreasing mortality. Diagnosis is often complicated as early signs and symptoms such as fever and rash are not specific. HLH may also be confused with other serious immune-related adverse reactions. Evaluate patients who develop fever or rash promptly, and discontinue lamotrigine if HLH or another serious immune-related adverse reaction is suspected and an alternative etiology for the signs and symptoms cannot be established.

Since lamotrigine’s 1994 approval, FDA identified eight cases worldwide of confirmed or suspected HLH associated with the medicine in children and adults. This number includes only reports submitted to FDA and found in the medical literature, so there are likely additional cases about which we are unaware. We determined there was reasonable evidence that lamotrigine was the cause of HLH in these eight cases based on the timing of events and order in which they occurred. These patients required hospitalization and received drug and other medical treatments, with one dying.

Side effects involving lamotrigine should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications.

If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

 

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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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