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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The Immigrant Doctor Who’s Solving West Virginia’s Opioid Crisis

 

A data-driven commissioner of public health figured out a way to slow overdose deaths. But treating addiction is a much harder problem.

Politico Magazine, May 2, 2018

By Brianna Ehley

Dr. Rahul Gupta, West Virginia Commissioner of Public Health

 

 

 

 

 

 

 

 

CHARLESTON, W.Va.—Last fall, after watching the death toll from opioids climb unchecked for years, Dr. Rahul Gupta, the man in charge of combating one of the worst health crises in America, decided to do something no one had ever tried. He ordered staff to do an in-depth analysis of every person in his state who had died of a drug overdose over the preceding year—all 887 of them.

Since 2014, West Virginia has held the grim distinction of having the highest overdose death rate in the country, according to Centers for Disease Control figures. In 2016, West Virginia’s death rate, according to the most recent federal data, was 52 per 100,000 people—nearly three times the national average. The next highest state, neighboring Ohio, had 39 deaths per 100,000. What West Virginia lacked, though, were the hard numbers that might point officials to a way out of a disaster that showed no signs of abating.

“We wanted to know who each person was and what we could have done to help them,” Gupta, West Virginia’s public health commissioner, told me when I interviewed him in his Charleston office recently. Doctors, he said, know the risk factors for heart disease and use them to screen patients and prescribe treatment. “We didn’t have something like that for opioids. We’re all sort of trying to address a problem without a lot of data to know how to approach it from a prevention aspect. So we wanted to develop those risk factors.”

Over the next 10 weeks, Gupta’s staff combed through public databases, Medicaid rolls, medical examiner reports, birth certificates, death certificates and criminal records. They wanted to find out who was at highest risk of an overdose in West Virginia so they could produce a report for the state legislature before its session began in January. The idea was to give policymakers a data-driven road map of how to get the death rate down, who to focus resources on, and what programs and policies might help them achieve it.

The findings ultimately would show a depressing pattern of vulnerability: Men were twice as likely as women to die of an overdose. And those with jobs in blue-collar industries like construction had a higher risk of overdosing than the general population, likely because they take prescription opioids or illicit substances to deal with chronic pain from injuries. “If you’re a male between the ages of 35 to 54, with less than a high school education, you’re single and you’ve worked in a blue-collar industry,” Gupta said, “you pretty much are at a very, very high risk of overdosing.”

Top left and top right: The Health Right Clinic in Charleston, West Virginia. Bottom left: Dr. Rahul Gupta has a laugh with clinical coordinator Rhonda Francis. Bottom right: Dr. Rahul Gupta passes a large mobile healthcare station on his way into the clinic. | Craig Hudson for POLITICO Magazine

The report included recommendations ranging from limiting initial prescriptions for acute pain to seven days to expanding access to medication-assisted therapies by exempting doctors from federal licensing to administer the treatment. Those recommendations were absorbed into legislation that was signed into law by Governor Jim Justice in March.

But there was another finding, one so obvious and urgent Gupta felt his agency had to act on it immediately. In November, Gupta’s team realized that about 71 percent of people who had fatally overdosed had received emergency medical treatment sometime before they died. But only about half of that group had been administered naloxone, a medicine that when injected can reverse the effects of opioids within minutes.

“We saw this was clearly a missed opportunity where we could have saved people … so it’s critical that whenever these individuals do come into contact with one of the health systems, we take advantage of that opportunity and we do not let that slide.”

Over the past three months, the state has also engaged in a full-court press to get naloxone into the hands of as many people as possible. That includes a recent mandate passed by the state legislature (price tag: $1 million) requiring all first responders to carry the overdose antidote and encouraging libraries and public schools—elementary through high school—to stock up on the lifesaving drug. In January, Gupta issued a standing order for naloxone so that individuals don’t have to pay out of pocket for the drug, which can cost around $40 per dose. In Cabell County, which surrounds Huntington, the city considered to be the epicenter of the West Virginia epidemic, the number of EMS overdose responses declined 36 percent between the first quarter of 2017 and the first quarter of 2018, according to county figures.

The emergency distribution of naloxone may finally be having an effect on the seemingly unstoppable death toll in West Virginia. Although overdose fatalities in 2017 increased 2 percent to 909 from the year before, deaths slowed by about 25 percent in the second half of the year. Officials caution that number could change as there is often a lag in data. Death reports from 2016 are still trickling in. But federal data also shows a slowdown of overdoses in West Virginia. A CDC snapshot of 2017 hospital data showed that hospitalizations for drug overdoses were slightly down in West Virginia, even at a time when most other states across the country saw a dramatic increase.

“We are expecting improvements in overdose deaths this year with all of these things we’re putting into place,” Gupta told POLITICO Magazine. “We’re thrilled about it, but we still feel that we have a long way to go.”

West Virginia’s work to get a handle on the drug abuse epidemic comes as Congress and the Trump administration continue to debate the best ways to tackle the crisis nationwide. Congress recently appropriated an additional $4 billion to help address drug abuse, including for programs to help states expand access to treatment and prevention programs as well as law enforcement activities. Surgeon General Jerome Adams recently issued a rare public advisory encouraging more people across the country to carry naloxone.

But as Gupta and most public health experts warn, naloxone isn’t going to end the opioid crisis. It’s a temporary bandage that saves people but does not treat them. Often many of the same patients who get revived from an overdose end up overdosing again. “We’re doing a good job of saving lives,” said Jack Luikart, the director of correctional substance abuse control under West Virginia’s Military Affairs and Public Safety Department, “but treating addiction, that’s where we need to step up our game.”

Gupta, the son of an Indian diplomat, was born in India but grew up in a Maryland suburb of Washington. He came to West Virginia in 2009 to lead the Kanawha-Charleston Health Department after doing stints as a local health official in Tennessee and Alabama. He was appointed state public health commissioner by former Democratic Governor Earl Ray Tomblin in December 2014, following his work overseeing the response to the massive chemical spill near Charleston in January 2014.

While leading the local health department, Gupta, 47, watched the opioid crisis develop and then explode. He lobbied the state legislature to require special opioid prescribing training for physicians and pushed measures to crack down on “pill dumping,” in which opioid manufacturers send mass quantities of pills to one area, far outpacing demand. Most of the focus then was on limiting prescription opioids, but by the time he took over as state public health commissioner, the opioid crisis had evolved from prescription drug abuse to illicit drug use like heroin and the powerful synthetic opioid fentanyl.

In his first two years as state public health commissioner, the state approved guidelines for opioid prescribers and passed Good Samaritan laws, but, Gupta said, the overdose death data revealed that their work wasn’t saving lives. Despite those efforts, the overdose death rate continued to climb. In 2015, 735 West Virginians died of an overdose, according to state figures. The next year that number climbed to 887.

“For me, it was the second year in a row that I was seeing the numbers continue to incline,” he said. “That’s when I said we have to do something different.”

The state in 2017 applied for, and received, a number of federal grants that officials used to buy naloxone kits to distribute to communities. The federal government also approved a waiver for West Virginia last fall to allow Medicaid to pay for inpatient substance abuse treatment at certain facilities as part of a push to expand access to care.

But Gupta wanted a more immediate way to get a handle on the deaths, and that’s where his overdose analysis project came in. “We were in a rush for time because if there was an opportunity to have legislation passed this year, this was it,” he said. His team turned the report around in three months, partnering with Johns Hopkins University, West Virginia University and Marshall University to come up with a set of 12 policy recommendations. “We didn’t want it to sit on the shelf. We wanted to present practical steps that we could put into place immediately,” Gupta said.

“We often don’t get data-driven policy making in times of an epidemic or a crisis,” Gupta said. “We were using this social autopsy of West Virginians who had died to create policy … and that’s very hard to push back against.”

Roughly 91 percent of all overdose victims had a documented history within the state’s prescription drug monitoring program, meaning they had previously filled a prescription for an opioid. About half of all female victims had filled an opioid prescription within 30 days of their death. From this finding, lawmakers crafted, and approved, legislation that limited initial opioid prescribing and cracked down on providers found to be inappropriately prescribing opioids to patients.

“The problem is there is so much of it in circulation,” Gupta said of prescription opioids.

West Virginia, in the past few years, has taken action to prevent pill dumping, after mass quantities of prescription painkillers flooded into small towns far surpassing necessary amounts. According to a congressional probe by the House Energy and Commerce Committee, over the past 10 years, drug manufacturers have shipped 20 million prescription painkillers to two pharmacies in Williamson, Virginia, a town of about 3,000 people. The Drug Enforcement Administration last month released a proposed rule that would limit how many opioids drug makers can manufacture in an effort to prevent pill dumping.

Gupta said the state is trying to be cautious not to restrict opioids so much that people who actually need them can’t access them. “It’s very important that we don’t forget about those people with legitimate pain. We want minimum disruptors for them,” he said, adding that “there’s still a role for opioids to play.”

Four out of five West Virginians who died from an overdose in 2016 had come into contact with the health system, whether it was during a visit to the emergency room from a prior overdose, or a visit to a clinic for a routine checkup. About 71 percent had or were eligible for Medicaid coverage.

More than half of West Virginians who died of an overdose in 2016 had been incarcerated at some point. That told policy makers that there needed to be more policies built around the incarcerated population.

After that finding, Gupta partnered with the Department of Corrections to develop a number of programs aimed at helping prison and jail inmates who are struggling with addiction. One pilot program, which will be expanded statewide in the summer, gives assisted treatment to inmates with an opioid medication upon their release and then helps connect them to longer term care in the community.

“First, we were like, why do we want to get involved in treatment? That’s not our thing … but when we took a look at this, one of the reasons we have contraband in our facilities is because of inmates with addiction,” said Luikart, of West Virginia’s Military Affairs and Public Safety Department. “So, if we can provide treatment in our prisons and jails, there will be less demand for contraband.” He added that by treating addiction, they also hope to cut recidivism, which is high among people with addiction. “That will help with prison overcrowding.”

Gupta is data-driven, but he also knows the value of gathering anecdotal evidence. Once a month, Gupta works on the front lines of the epidemic, treating patients with drug addiction at West Virginia Health Right, a charity clinic in Charleston that is also one of the city’s two needle exchanges. He treats patients with chronic pain, who became hooked on prescription painkillers and are now self-medicating with illicit drugs that are cheap and easy to find. He tries to direct them into longer-term treatment. “These are mainstream individuals that got entangled into the grips of addiction, and the data shows us that,” Gupta said.

He sees patients who have overdosed a half dozen times and who are still not given any kind of follow through or long-term help. On a recent visit to the clinic, he spoke with a woman who had been resuscitated nine times by paramedics.

Michelle Spencer, 37, has been in and out of treatment for several years. After she was rescued from her latest overdose, she was told by paramedics that they wouldn’t use the antidote on her again. “They narcanned me so much that they said they aren’t willing to do it anymore,” Spencer told Gupta during one of his volunteer shifts at West Virginia Health Right. She came to the clinic with her teenage daughter, who is encouraging her to get into, and stick with, treatment. “It’s so easy to go and do more,” she says.

Spencer’s addiction started like many, with prescription drugs, which she stole or bought from friends. Then she switched to methamphetamine, which was easier to find. She says she has bipolar disorder and has been self-medicating for at least a decade. She went to prison for drug possession and was released about three years ago. That’s when she started using heroin. Like meth, it was cheap and easy to find. She says she uses several times a day.

The treatment program Gupta has recommended for Spencer, who is on Medicaid, takes several days to get into. Because she was suffering extreme withdrawal symptoms, she begged him to get her into more immediate treatment, fearful that she might use again if she didn’t get help immediately.

Spencer was in a common predicament. Out of the more than 2.1 million Americans with opioid use disorder, just 20 percent receive specialty addiction treatment, according to the Substance Abuse and Mental Health Services Administration. It can be particularly challenging to find medication-assisted treatment, which has a proven track record of treating addiction, in rural areas. One of the challenges West Virginia and many other states across the country are facing is how to expand access to that treatment, which is not widely available across the country for a variety of reasons.

Doctors who administer medication-assisted treatment like buprenorphine are required to have federal licensing and waivers that some say are burdensome and deter doctors from getting them. West Virginia recently passed a measure that allows primary care doctors with smaller practices to administer medication-assisted treatment without having to be licensed federally.

West Virginia state Sen. Ron Stollings, who is also a primary care doctor in Madison, West Virginia, said the waiver allows physicians like him, who don’t specialize in substance use treatment but come across many patients struggling with addiction.

“You need to realize that if you don’t treat them right away, they’re more likely to become a statistic—dead from overdose,” Stollings said. “The idea is to get someone on medication-assisted treatment early on.” He added that he isn’t sure how many fellow primary care providers will want to take part in the program, but “it’s a tool in the toolbox.”

On a recent Tuesday, Chris Rauhecker, a recovering heroin addict who now counsels people with drug addiction, and Lindsey Harmon, a Cabell County paramedic, jumped into an old, unmarked police car and drove into downtown Huntington on a mission to find a homeless man who had overdosed in the public library the day before.

They knew nothing more about him than his name and the county paramedic’s report that detailed the overdose incident. He was discovered unconscious on the library’s second floor and was revived by paramedics with naloxone. When he woke up, he walked out of the library and back onto the streets.

The scenario is all too common in Huntington, the rural, Appalachian community that’s become the epicenter for the opioid abuse epidemic: A person overdoses, paramedics rush to the scene to revive him, and once he’s awake, he’s free to walk away with an untreated drug addiction and a high chance of overdosing again, with the next time even more likely to be fatal.

Rauhecker and Harmon are part of a small but persistent team that is working to break that cycle. With federal funding and assistance from Gupta’s office, Cabell County’s Quick Response Team was launched last December to be the link to care for people who suffer from drug overdoses.

The team follows up with drug overdose victims within 72 hours of the incident and helps connect them to long-term treatment. If a patient has a home address, they’ll make house visits. If not, they’ll check the local shelters and drive around town until they find them. Gupta said Charleston is in the stages of developing its own “QRT” and thinks Huntington’s program could serve as a model for other communities nationally that are looking to get a handle on drug overdose deaths.

Rauhecker and Harmon eventually located the man about five blocks from the library near a Sheetz convenience store—known as a local hangout for drug users and dealers. They approached him, introduced themselves as the Cabell County’s Quick Response Team and assured him they were there to help, not implicate him. After some convincing, he agreed to go to an inpatient detox facility. They called a local treatment center, secured a bed for him and drove him there.

“By the end of the week, hopefully, if he’s still receptive, we’ll try to get him into long-term care,” Rauhecker says, cautioning that not everyone the team encounters is ready to be helped, and they know there is a process to gaining a patient’s trust. Word is catching on about the Quick Response Team. He said more and more often people are expecting them to show up, “sometimes they’re even relieved.”

Since December 4, the Huntington QRT has connected with 179 patients who had previously suffered a drug overdose. Of that group, 61 people are now in a form of long-term treatment including medication-assisted therapies, residential treatment centers and sober living homes. That’s about a 34 percent success rate, which county officials are pleased with since the program is only four months old.

The key to QRT, Larrecsa Cox, a paramedic on the team, explained, is that they treat each patient they meet differently, based on their needs. They spend time talking to the individuals to learn what kind of treatment, if any, they are interested in pursuing. This often means either medication-assisted treatment or an abstinence-based program like a recovery home.

People aren’t always receptive. “I wouldn’t say they’re always glad to see us. Some people don’t want us there,” Cox said. That doesn’t deter the team, which often makes multiple trips a week to a patient’s home to follow up and make sure he’s sticking to his appointments. QRT members also stay in touch with patients by texting and talking on the phone.

Top: The QRT make a home visit in Huntington. Bottom: Cox and Prestera counselor Sue Howland, center, make a home visit to two clients. Howland is a recovering alcoholic now seven years without a drink, and is often a familiar face to new clients. Frequently during QRT visits, other users living in the same household will reach out for help. | Craig Hudson for POLITICO Magazine

“If they aren’t interested, we come back later,” Cox said.

Harmon, another paramedic, said she once knocked on the door of a patient’s home every day for a month before finally the woman agreed to hear her out. Her persistence paid off: The woman is now in an inpatient facility in another town, and Harmon still texts her to check in.

“Some of these people, you deal with them so much, you kind of get attached to them,” Harmon said. She added that many of the people they visit don’t have family support systems to help them cope. “In some cases, we become their friends and their family,” she said.

“I wish there would have been someone that would have done this for me,” said Rauhecker, who has been clean from heroin for 26 months and now works as a recovery coach at Recovery Point, a sober living home in Huntington. He said he is certain he would have gotten help earlier if a team of people had knocked on his door and dedicated their time to getting him treatment.

Rauhecker rides along with the group and uses his own experiences recovering from heroin addiction to relate to patients and help them get connected to longer term care. The QRT also employs someone from a clinic that provides medication-assisted treatment to represent that option.

“What works for one person isn’t always going to work for someone else,” he said, adding that sometimes patients want to go to a sober living home, while others prefer medication-assisted treatment. Either way, “the biggest thing is that they have to be ready and want to get help; otherwise it’s not going to work.”

 

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Zinbryta Emerging Litigation

Emerging Zinbryta Litigation

 

 

 

 

 

 

 

 

Zinbryta (daclizumab) is made and marketed by Biogen and AbbVie. Zinbryta first received FDA approval pursuant to Biologic License Application (BLA: 761029) in May of 2016.  Zinbryta is a humanized monoclonal antibody that is self-administered as an injection for the treatment of Multiple Sclerosis.

In March of 2018 Biogen published a letter directed towards physicians and surgeons giving notice that Zinbryta would be withdrawn from the market and would no longer be available as of April 30, 2018.

Biogen Withdrawal Letter link: Biogen – AbbVie Notice of Withdrawal of Zinbryta in USA – March 12, 2018

Additional media related to withdrawal of Zinbryta:

https://www.zinbryta.com/content/dam/commercial/multiple-sclerosis/zinbryta/pat/en_us/pdfs/zinbryta-withdrawal-patient-letter.pdf

Adverse events potentially associated with Zinbryta include:

Serious Liver Damage

Inflammatory Brain Disease

Encephalitis

Onset of Seizures secondary to adverse reactions.

Death secondary to adverse reactions.

To Learn More About the Emerging Zinbryta Litigation:

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

 

 

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

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

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course, including James Onder, of The Onder Firm in St. Louis, MO>

 

 

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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Ocaliva Emerging Litigation

Emerging Ocaliva Litigation

Ocaliva: An Emerging Litigation

 

 

 

 

 

 

 

 

 

 

Ocaliva (obeticholic acid) made by Intercept Pharmaceuticals, Inc. was first approved by the FDA subsequent to New Drug Application (NDA: 207999) in May 2016.

Ocaliva is “indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA.

Recent FDA Communications Excerpts:

September 21, 2017, The FDA is notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we believe should be included in the labeling for OCALIVA (obeticholic acid). This information pertains to the risk of liver injury, liver decompensation, liver failure and death in primary biliary cholangitis (PBC) patients withmoderate to severe hepatic impairment.

Additionally, we refer to our letter dated October 26, and December 7, 2017, notifying you, under Section 505(o)(4) of the FDCA, extension of discussion period warranted for new safety information that we believe should be included in the labeling for OCALIVA (obeticholic acid) Tablets. This information pertains to the risks liver injury, liver decompensation, liver failure and possibly death in primary biliary cholangitis (PBC) patients with moderate to severe hepatic impairment.

FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease:  (see link below)

FDA Warning of September 21, 2017:   https://www.fda.gov/Drugs/DrugSafety/ucm576656.htm

  >To Learn More About the Emerging Ocaliva Litigation:

The emerging Ocaliva 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 Ocaliva Litigaton, using these primary metrics:

 

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course, including Jerry Parker, Founder of the Parker-Waichman Firm>

 

 

 

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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Viberzi Emerging Litigation   

 Emerging Viberzi Litigation  

Viberzi Litigation

   

 

 

 

 

 

 

 

 

 

Viberzi made by Allergan received FDA approval subsequent to New Drug Application (NDA:206940) in May of 2015.

Since its approval the makers of Viberzi have flooded the media with advertisements, primarily directed toward women, featuring a now familiar female character wearing a jumpsuit featuring print depicting a portion of the human gastro-intestinal system.

 

FDA Communication Excerpt on Viberzi:

“FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. As a result, FDA is working with the Viberzi manufacturer, Allergan, to address these safety concerns.

Health care professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients. Hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder. Symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol.”

Viberzi Emerging Litigation

Gallstone disease is one of the most common of all digestive diseases. The U.S. Centers for Disease Control and Prevention estimates that 6.3 million men and 14.2 million women in the United States have gallbladder disease. There is marked variation in the prevalence between ethnic groups

Approximately 700,000 individuals in the U.S.  have their gallbladder removed each year.

How to Learn More About the Emerging Viberzi Litigation

The emerging Viberzi Litigation will be used as a case study in the May 18 – 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.

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 Viberzi

Litigation, using these primary metrics:

 

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

 

 

See endorsements below of some of the top mass tort trial lawyers in the country who’ve attended the Mass Tort Nexus Immersion Course>

 

 

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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Uloric Emerging Litigation

Emerging Uloric Litigation

 

 

Uloric Litigation

 

 

 

 

 

 

 

 

 

 

Uloric made by Takeda Pharmaceuticals gained FDA approval subsequent to New Drug Application (NDA: 021856) in February 2009.

Takeda Pharmaceuticals is facing multiple Qui Tam lawsuits filed by a former safety consultant for the company.  These suits that the company withheld information about dangerous side effects related to Uloric, including kidney problems, liver damage, bone marrow failure, drug interactions and more.

Gout, a type of arthritis that occurs when uric acid crystals build up in the joints. Gout has been found to be more common in men than in women Gout is believed affects about 8.3 million people, or 4% of the U.S. population.

Uloric was the first new drug approved to treat Gout in 40 years. Unfortunately, this new treatment which promised relief for those who suffer from Gout, appears to have numerous significant and potentially life threatening side effects that Takeda never warned the public about.

Learn More About the Emerging Uloric Litigation

The emerging Uloric Litigation will be used as a case study in the May 18-21, 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 Uloric

Litigation, using these primary metrics:

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

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

 

 

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

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Varubi Emerging Litigation

 Emerging  Varubi Litigation

 

 

 

 

 

 

 

 

 

 

 

VARUBI®(rolapitant) was originally developed by Schering-Plough Corp. and after the merger with Merck & Company they began marketing in November 2009. Tesaro Inc. has since licensed Varubi.

January 2018 FDA Communication Excerpt: 

“Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Most reactions have occurred within the first few minutes of administration. Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock. Anaphylaxis or anaphylactic shock are serious medical conditions which if not promptly treated can result in death”

Where to Learn More About the Emerging Varubi Litigation

The emerging Varubi Litigation will be used as a case study in the May 18 – 21, 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 Varubi 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>

 

 

 

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12 Judges Will Try 20 AndroGel Trials In MDL 2545 Starting In Fall of 2018

“US District Court of Illinois Enacts A Real Rocket Docket In AndroGel MDL”

By Mark A. York (April 26, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Judge Matthew F. Kennelly, the Illinois federal judge overseeing AndroGel MDL 2545 also known as the Testosterone Replacement Therapy Multidistrict Litigation, has decided to go along with the 11 fellow district court judges who volunteered to try 20 bellwether trials involving AbbVie Inc.’s AndroGel between Oct. 2, 2018 and March 2019, see AndroGel MDL 2545 CMO No. 114 Re: Setting 20 Trials In Front of 12 Federal Judges, in the  Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ilinois.

Judge Kennelly ordered the cases to be trial-ready by September 2018 and a second group by December.  He also told counsel that other judges in the district volunteered to assist him by trying cases throughout the fall and winter of 2018 and into the spring of 2019, with both sides agreeing to have the cases tried before different judges.  The judge said he will rule on all pretrial matters in the 20 cases, including summary judgments and in-limine motions, jury instructions and Daubert expert witness rulings, with each judge being given a trial-ready package of his rulings.

The judges who have agreed to hear trials in support of Judge Kennelly will be Chief Judge Ruben Castillo and Judges Virginia Kendall, Manish Shah, Rebecca Pallmeyer, Sara Ellis, John Lee, John Blakey, Robert Dow, Edmond Chang, Gary Feinerman and Jay Tharp.
Judge Kennelly said further trial dates after March 4 may be set by a future order.

AbbVie is facing more than 3,770 MDL Cases, see Mass Tort Nexus Briefcase Re: ANDROGEL-TESTOSTERONE-MDL-2545, which to date have resulted in plaintiffs bellwether trial verdicts in amounts ranging from $3 million up to $140 million with a single defense win. One main defendant, Eli Lilly chose to settle all their cases related the Axiron product line, see Eli-Lilly-Announces-Settlement-Of-All-Testosterone-Cases-in-MDL-2545. The Lilly action may have been a smart legal move, as the stacked up trials would be not only financially burdensome but would put major pressure on defense trial teams.

AbbVie declared 3,770 AndroGel claims in the MDL in its Nov. 11, 2017 10-Q report, and about 205 claims in various state courts, including more than 200 additional testosterone drug cases await judgment in Cook County Circuit Court, many involving Illinois plaintiffs. In one trial in the Cook County court,  involving a 66-year-old man who suffered a heart attack while taking AndroGel, resulted in a verdict in favor of AbbVie, but the man’s attorneys are seeking a new trial that will allow them to present evidence on the internal decision-making behind the company’s sales tactics. That evidence was not permitted in the initial trial.

PLAINTIFFS ARE AHEAD IN TRIAL VERDICTS

The first federal AndroGel case to go to trial in 2017 resulted in just a punitive damages award of $150 million, which was later vacated and a new trial ordered.  The retrial resulted in a $3.2 million verdict with compensatory and punitive damages. The second bellwether trial resulted in a $140.1 million verdict in 2017, with the third bellwether trial resulting in a verdict for the defense.

In the fall of 2017 Konrad bellwether trial, resulting in the punitive damage verdict of $150 million, which was the first case in the series of bellwether trials aimed at helping plaintiffs and manufacturers of AndroGel gauge the range of damages and define a legal strategy and settlement options, even though the large verdict was vacated, it sent a clear message to the parties.

With defense losing both of the initial bellwether trials doesn’t look good for the defense, see “ANDROGEL” JURY RETURNS $150 MILLION VERDICT IN 1st TESTOSTERONE TRIAL.  That jury’s decision to award punitive damages without granting compensatory damages was unusual and both sides continue to fight over the verdict’s validity in court, but shows that the plaintiffs seem to have viable claims at trial.

Plaintiffs across the country allege AndroGel has caused heart attacks, strokes and other injuries, and the company was aware of the increase in adverse events while marketing “off-label” use. AbbVie has defended the drug and responded that its marketing of AndroGel adhered strictly to uses approved by the Food and Drug Administration and they have remained in full compliance with all FDA standards.

Konrad, 56, had been using AndroGel for two months in 2010 when he suffered a heart attack, from which he has since recovered. In court pleadings, the company contended that Konrad’s heart attack was caused by other factors, which are are not related to being prescribed AndroGel, such as obesity and high blood pressure. It also said it made no misrepresentations about AndroGel’s safety, which now two juries have disagreed with to the tune of $290 million.

ANDROGEL WAS A BLOCKBUSTER FROM FIRST RELEASE

AbbVie’s AndroGel is one of the more dominant testosterone treatments In the ever growing Low-T market, with sales of $675 million in 2016, and was declared a blockbuster drug and moved earnings and shares higher as soon as AndroGel hit the market. However, there were concerns about the drug safety as far back as 2012 and the FDA took notice not long thereafter. In 2014, the FDA convened an advisory committee to consider the adverse cardiovascular outcomes associated with testosterone replacement therapy, and the committee recommended changing the product warning labels, the FDA then required AbbVie to add a warning about cardiovascular risk to AndroGel’s label in May 2015.

HEART ATTACK AND STROKE RISK

Testosterone replacement drugs are approved to treat certain low-testosterone conditions in men. Plaintiffs allege that manufacturers invented a condition called “low-t” and marketed it for the treatment of the normal aging process and to restore strength and virility. Instead, the plaintiffs say testosterone drugs cause heart attacks and strokes.

AbbVie and predecessor Abbott Laboratories Inc. make AndroGel, a topical gel, AbbVie has owned AndroGel for only part of the drug’s history. Abbott Laboratories acquired AndroGel in 2010, and AbbVie was spun off from the company three years later.

Other defendants included Eli Lilly and Co. which makes Axiron, also a topical gel, and as previously mentioned has chosen to settle all claims in the litigation.. Endo Pharmaceuticals Inc. makes Aveed and Delatestryl, both injection drugs, and Fortesta, a topical gel. Actavis plc makes AndroDerm, an adhesive skin patch. Auxilium Pharmaceuticals Inc. makes Testim, a gel. Pfizer Inc. and Pharmacia Inc. make Depo-Testosterone, an injection drug.

FDA ISSUED A WARNING

As listed in the Chicago Tribune article of March 4, 2015, see Testosterone drugs overused per FDA warning. Testosterone injections were first approved in the 1950s for men who had been diagnosed with hypogonadism, a form of abnormally low testosterone caused by disorders of the testicles, brain and other hormone-related organs. The But current labeling on the drugs is vague enough that companies have been able to promote them to millions of otherwise healthy men who simply have lower-than-normal levels of testosterone.

The FDA began reviewing the safety of testosterone drugs in January 2014 after two federal studies associated them with increased rates of heart attack, stroke and other serious problems. But other studies associated testosterone replacement with longevity.”The benefits and safety of this use have not been established,” the FDA said in a statement released in March 2015.

While men’s testosterone levels naturally decline after age 40, experts disagree on whether that drop actually leads to the issues like decreased energy and lower bone density. Additionally, testosterone levels change by the hour and are affected by a range of environmental factors, such as stress and sexual arousal.

How this unusual judicial move goes over at the trialsl remains to be seen, but there is a distinct message being sent by the courts, that failure to engage in serious settlement talks will result in cases being set for trial. Perhaps other courts across the country should try accelerating MDL case dockets to trial via such unexpected rulings, thereby resulting in more years long case dockets being cleaned up. Who this may benefit remains to be seen, as there will be 20 trial verdicts coming sooner as opposed to later , to answer questions such as this.

 

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