Why Are Opiate Prescription Overdoses Still Rising? The Statistics Are Telling The Story

The Emergency Room Statistics Tell The Story

 Why Is The Midwest USA Still Seeing Opioid OD’s Rise Every Year? 

By Mark York (March 9, 2018) 

  

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) 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  

WHY THE HUGE INCREASE IN THE MIDWEST

ER visits for opioid-related emergencies more than doubled in two states. Wisconsin saw the biggest increase, 109 percent and Delaware saw a 105 percent increase. In Pennsylvania, ER visits were up 81 percent. 

“We’re seeing the highest ever death rates in the US,” Schuchat said. She pointed to national statistics that out of 63,000 overdose deaths in 2016, 42,000 of them involved opioids. 

“[This] means 115 people die each day from opioid overdose,” she said. This number has been at are above 100 for most of the last 3 years, with no end in sight and with so many different regions affected it may require more grassroots focus and demands made to elected officials to move faster on a long term solution.  

There were some decreases reported in the East, with the largest being a 15 percent reduction in Kentucky, which could reflect fluctuation in drug supplies or interventions. 

However, hospital visits in cities of all types increased steadily in each quarter by 51 percent. Schuchat emphasized, “Bottom line — no area of the US is exempt from this epidemic.” Looking closer at causation and access to opiates across the country is required. How are unlimited numbers of federally controlled substances still so readily accessible to so many?   

US Surgeon General James Adams was also present during the briefing and mentioned how he witnessed first-hand his own young brother’s struggle with opioid addiction. 

“Science is clear: Addiction is a chronic disease and not a moral failing,” the doctor said. Adams outlined that a coordinated effort is necessary to prevent opioid addiction. “To successfully combat this epidemic, everyone must play a role,” he noted. 

The Surgeon General explained how health departments, along with public safety and law enforcement officials, have to work together to deal with local opioid-related emergencies. 

He stressed the need to make naloxone, a life-saving drug that can reverse the effects of an overdose, more accessible in emergency situations. 

 CHILDREN ARE OPIOID VICTIMS TOO 

Opioid poisonings and overdoses are sending increasing numbers of U.S. children and teens to the hospital, according to additional studies showing a substantial rise in young patients needing critical care. The study included accidental poisonings along with overdoses from intentional use. Prescription painkillers were most commonly involved, but heroin, methadone and other opioid drugs also were used. 

Hospitalizations were most common among kids aged 12-17 and those aged 1 to 5. The youngest kids typically found parents’ medications or illicit drugs and used them out of curiosity, said Dr. Jason Kane, the lead author and an associate pediatrics professor at the University of Chicago and Comer Children’s Hospital. 

Reasons for the increases are unclear but it could be that drugs became more widely available and potent during the study years, Kane said. Finding a solution is something that is often discussed yet there seems to be limited ability to slow or control access to opiates.  

“Opioids can depress your drive to breathe,” Kane said, and they also may cause blood pressure to plummet to dangerously low levels. Treatment for these symptoms includes ventilators and powerful drugs that constrict blood vessels. Naloxone, the “rescue’ drug used that can revive overdose patients who’ve stopped breathing, was used in nearly one-third of cases during the 2004-15 study. 

The study was published March 2018 American Association of Pediatrics, see Pediatrics Journal study results. The study involved 31 children’s hospitals, or about 20 percent of U.S. children’s hospitals. Opioid-related stays increased from almost 800 to 1,500 during the study. The results echo research published last year that found the annual rate of hospitalizations for opioid poisonings in kids nearly doubled from 1997-2012 

The new study found a similar increase in patients requiring intensive treatment, rising from 367 to 643 in the final years.A small fraction of the nearly 4.2 million hospitalizations of children during the study involved opioids, but 43 percent of these opioid-related stays required intensive treatment. Annual deaths dropped from almost 3 percent to just over 1 percent of kids hospitalized for opioid reactions. 

The number of children admitted to peditriac hospital intensive care units for opioid poisoning nearly doubled over a decade, according to a new study. 

“Current efforts to reduce prescription opioid use in adults have not curtailed the incidence of pediatric opioid ingestion, and additional efforts are needed to reduce preventable opioid exposure in children,” authors wrote in the study “Opioid-Related Critical Care Resource Utilization in U.S. Children’s Hospitals” (Kane JM, et al. Pediatrics. March 5, 2018, https://doi.org/10.1542/peds.2017-3335). 

Researchers analyzed 2004-’15 data from the Pediatric Health Information System and found 3,647 opioid-related hospitalizations across 31 children’s hospitals. They rose from 797 in 2004-’07 to 1,504 in 2012-’15 and were highest among children ages 12-17 (61%) followed by ages 1-5 (34.2%) and ages 6-11 (4.8%). With nearly 20% of children in the youngest age group were admitted for methadone ingestion, which tends to show that the drug access is often affiliated with a person undergoing opioid addiction treatment 

THE OFTEN OVERLOOKED VCTIMS

“These kids are really the secondary victims of this adult opioid epidemic,” Kane said. He said the results emphasize how crucial it is to store medications and other drugs locked, hidden and out of children’s reach. 

The Pediatrics Journal editorial notes that several treatment programs for drugs including opioids have been shown to reduce teen and young adult use. The new findings highlight the need for pediatricians to get involved “to combat the ongoing opioid crisis in our country,” the editorial said. Perhaps speaking to and letting young children know the dangers of opiates at an early age would be advisable, just as the “drunk driving” campaigns has been ingrained into our society from a young age, resulting in a net reduction in drunk driving fatalities.   

Treating the opioid crisis and abuse of prescription opiates as a disease or referring to it as a formally recognized medical condition requiring medical professional intervention as an inclusive part of the solution will be a mandatory part of any long term viable solution to the opiate crisis.     

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The Opioid Crisis: Is This A Doctor-Driven Epidemic? Looking At The Cause

“FINDING OUT HOW THE THE OPIOID EPIDEMIC CAME INTO BEING”

By Mark A. York (February 27, 2018)

WHEN WRITING PRESCRIPTION OPIOIDS BECAME MUCH EASIER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The speech of a medical specialty society president at a medical conference doesn’t usually get attention outside the conference center, sometimes a few trade publications might report something. On November 11, 1996, however, something different happened. Standing before a room of medical prescribers, James N. Campbell, MD, president of the American Pain Society (APS), announced a new initiative. “Vital signs are taken seriously,” he said. “If pain were assessed with the same zeal as other vital signs are, it would have a much better chance of being treated properly. It was the kickoff for the APS’s new campaign to convince doctors they should treat “pain as the 5th vital sign.”

And the initiative got instant traction, with the Veterans Health Administration and the Joint Commission on Accreditation of Healthcare Organizations (now the Joint Commission) adopting the slogan and calling on US physicians to manage patients’ pain. But just as quickly, some researchers say, the campaign got off track. Where leaders said, “Manage pain,” doctors and patients seemed to hear “Prescribe opioids.”

Today, governmental and professional groups are frantically trying to hit the rewind button. The American Medical Association has previously issued a “call to action” on opioid over-prescribing, as well as former President Barack Obama, who requested $1.1 billion to address opioid and heroin abuse. Then the Centers for Disease Control and Prevention (CDC) issued new guidelines calling for reduced use of opioids in chronic pain.

Among orthopedists, the calls for action carry particular urgency. By some measures, orthopedists are the third highest prescribers of opioid medications among medical specialties.[6] “In the United States, the current expectation of opioid use as the primary treatment for acute and chronic pain has created an opioid epidemic,” the American Academy of Orthopaedic Surgeons (AAOS) said in a statement .

A look at the statistics explains this tone of urgency. In the decade following Dr. Campbell’s speech, sales of prescription opioids in the United States quadrupled. And rates of overdose, death rates, and substance abuse treatment admissions spiraled in tandem.  In 2013, almost 2 million Americans 12 years of age or older either abused prescription opioids or were hooked on them. Also that year, more than 16,000 people in the United States died of an overdose related to opioid pain relievers. The drugs killed more people than heroin and cocaine combined, more than suicide, and more than car crashes.

The prevalence of pain remained undiminished during this period.

“There’s a fear that we’re going to get in trouble if we don’t control pain appropriately,” says Loree K. Kalliainen, MD, MA, who specializes in wrist and peripheral nerve surgery at the University of North Carolina in Chapel Hill. “But we’re creating people who are habituated to these medications, which is tragic, and we’re not using things that actually do work instead of or in addition” to opioids.

For example, whereas doctors were dramatically increasing their opioid prescriptions, they did not prescribe more nonopioid analgesics, such as nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen.

 Why the Focus on Opioids for Pain Management?

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.”

Strategies for Minimizing Treatment Addiction

So how can orthopedic surgeons avoid contributing to the epidemic?

In its October statement, the AAOS recommended nine strategies. In brief, it said orthopedic surgeons should:

  • Set strict policies about how opioids are used in their practices, perhaps limiting prescriptions to the amount they think a patient will actually use after surgery;
  • Identify patients at risk of abusing opioids, perhaps using an assessment tool, such as the Opioid Risk Tool (ORT) for narcotic abuse.
  • Rehearse empathetic conversations with patients who are in pain or requesting opioids;
  • Establish relationships with hospitals, employers, patient groups, state medical and pharmacy boards, law enforcement, pharmacy benefit manager, insurers, and others with whom they can collaborate on reducing opioid abuse;
  • Use state databases to check patients’ other opioid prescriptions and coordinate with other healthcare providers who can provide alternative pain management strategies;
  • Inform themselves and staff about opioid uses and misuses;
  • Add improved opioid practices to their practice’s quality metrics;
  • Recognize that patients with terminal conditions and other appropriate indications should have access to opioids; and
  • Spread the word that opioids are not the best way to manage pain in most circumstances.

Reducing opioid prescriptions may not only reduce abuse but also improve outcomes, says Dr. Morris. Patients who use opioids before surgery have worse outcomes than patients who don’t, he and his colleagues found in a study of total shoulder arthroplasty. And other researchers have found that patients who continue using opioids for 1 month or more after surgery have more psychological distress, less effective coping strategies, more symptoms, and more disability than patients who do not use opioids.

The information has changed what Dr. Morris says to his patients. “I still do shoulder surgery in patients who are on opioids before surgery, but now I counsel them. I say, ‘We now have data that says you will do very well, but you are not going to do as well as patients who are not using opioids.’ That sets the stage for postoperative liberation from the opioids after surgery. And we have an appropriate schedule for opioid tapering.”

Dr. Morris also relies on screening tools aimed at identifying high-risk patients. “When a patient has an ankle fracture or shoulder arthritis, we may not be aware of all the other things going on that that may be contributing to their response to pain, whether it’s pain catastrophizing, depression, anxiety, or things going on socially for them,” he says. Frequently, patients with chronic pain ask Dr. Morris for opioid medications. It’s hard to say no, he acknowledges. “Certainly, it makes for a challenging discussion if the patient is already on opioids for that arthritic problem,” he says. He responds to this situation by discussing it with the patient’s primary care doctor and the patient, quoting from the literature about the way outcomes can be affected, warning about the long-term risks of opioid use, and referring patients to pain management specialists.

Pain Management Is Still Educated Guesswork

But for postoperative pain management, Morris still writes plenty of prescriptions for opioids. And he acknowledges that all his research has not helped much in figuring out how much of the drugs to prescribe for postoperative pain management. That’s still a matter of educated guesswork, he says, because patients vary tremendously in their response to pain.

Many other orthopedists are struggling with the same question. After reviewing charts in her department at Regions Hospital in St Paul, Minnesota, Dr. Kalliainen found a huge range in the quantity of opioids prescribed for pain management after the same procedures.

Bothered by this, she calculated the average amount of opioids physicians in the department were prescribing for each procedure and listed them on a card. The other side of the card lists alternatives to opioids, such as nerve block, NSAIDs, ice, and elevation. She printed the card on pink paper, laminated it, and distributed it throughout the department. Then she once again surveyed charts. “About half the number of pills was being used, and peoples’ pain was better controlled,” she says.

And Dr. Kallianen has other evidence that patients can survive with fewer opioids. Currently on sabbatical in New Zealand, Kalliainen has noticed far less reliance on opioids in surgery departments there. “Patients are maybe a little bit sturdier,” she says. “They’re not asking for these medications. They understand that with surgery, there will be some discomfort.” New Zealand is not an outlier. The United States uses more opioids than any other country, including virtually all of the hydrocodone and 81% of the oxycodone in the world. One study comparing the United States with The Netherlands found that 85% of patients with hip fractures treated in the United States were prescribed opioids after discharge, compared with none of the Dutch patients.

The American Pain Society is now working to put the genie back in the bottle. In a press release last February, it announced new guidelines for pain management, calling on physicians to avoid relying on any one single class of medication to treat postoperative pain.

 Disclosure: This article contains excerpts from Medscape media releases and other sources – Mass Tort Nexus asserts no rights or ownership to media contents within this article.

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It Was Raining Opiates: How drug companies submerged West Virginia in opioids for years

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

By Mark A. York (February 26, 2016 )

Why West Virginia has the highest rate of overdose deaths in the country

 

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) 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 Kentucy 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.

OPIOID BIG PHARMA INDUSTRY CONSPIRACY

Beside drug distributors, drug manufacturers such as Purdue Pharma and others bare responsibility for the flood of opioids to hard hit areas of West Virginia, Ohio and Kentucky and they are very familiar with the “opiate litigation dance” often paying hundreds of millions in fines without accepting real responsibility or pleading guilty to criminal charges.  They often enter into consent decrees where they pay a huge fines and promise to monitor the bad conduct in the future. This is actually considered a “get out of jail free” card, a very expensive card but a free pass for Opioid Big Pharma, none the less.

Purdue isn’t new to court battles. In 2007, the infamous drug maker and three of its executives pled guilty in federal court and paid out $634.5 million in fines for purposefully misleading regulators, doctors, and patients about the addictiveness of their opioid painkiller. Around the same time, Purdue was also sued by several states, including Washington, over similar allegations. Purdue agreed to a $19.5 million multi-state settlement. And in 2015, Purdue settled a case with Kentucky, agreeing to pay $24 million.

As part of the state settlements, Purdue was supposed to set up monitoring programs to make sure that its opioid drug didn’t wind up in the wrong hands. It was supposed to watch out for shady pharmacies, unusually large orders, or suspiciously frequent orders. But on this front, Everett alleges that Purdue once again put profits over people.

In released letters that were addressed to two regional drug distributors, Ohio-based Miami-Luken and Illinois-based HD Smith, related to both companies having distributed eye-popping numbers of pills to small cities in the state. In the letter, the committee lays out distribution data it has collected and asks questions about the companies’ distribution practices, including why they increased distribution so sharply in some towns and why they didn’t flag suspicious orders.

But Miami-Luken and HD Smith are not the only distributors that have drawn the committee’s attention. The letters are just the latest in the committee’s ongoing probe into what’s referred to as pill dumping amid the opioid crisis. Last year, the committee sent similar letters to three other drug companies, asking about their drug distribution in the state, these included the largest opiate distributors in the country AmerisourceBergen, Cardinal health and McKesson Corp, with all three listed in the top 10 of Fortune 100’s corporate hierarchy.

Miami-Luken followed through by providing some data and requested files, according to the committee. But those new pieces of information “raise a number of additional questions,” according to the committee.

WV FLOODED WITH OPIOIDS

Combining data collected from the Drug Enforcement Administration and Miami-Luken, the House Energy and Commerce Committee dove into the situation in Williamson. Between 2006 and 2016, drug distributors collectively shipped 20.8 million hydrocodone and oxycodone pills to two pharmacies in the small city. Those pharmacies were located roughly four blocks apart from each other, the committee noted. Miami-Luken alone supplied 6.4 million of those pills to just one of the pharmacies between 2008 and 2015. And between 2008 and 2009, the company inexplicably increased the amount of pills it delivered by 350 percent. The committee pressed Miami-Luken to explain how a town of 3,191 people could require such massive supplies and why the increases didn’t raise alarms.

The letter also reveals that in Kermit, West Virginia, a town of just 406 people, the company delivered 6.3 million hydrocodone and oxycodone pills between 2005 and 2011. For just the year of 2008, the numbers work out to Miami-Luken providing 5,624 opioid painkiller pills for every man, woman, and child in the town, the committee notes.

Likewise, Miami-Luken also delivered 4.4 million hydrocodone and oxycodone pills to the 1,394-person town of Oceana, West Virginia, between 2008 and 2015. And in Beckley, West Virginia, the company didn’t hesitate to fulfill a string of orders for tens of thousands of opioid doses placed by one pharmacy in the span of five days.

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.

OPIOID INDUSTRY HAS INFLUENCE

To show the far reaching tentacles of Opioid Big Pharma,  West Virginia Attorney General Patrick Morrisey was a former lobbyist for a trade group that represented Miami-Luken and other drug companies. In 2016, Morrisey ended several state lawsuits with drug companies, including one with Miami-Luken. The lawsuits, filed by the state’s former attorney general, Darrell McGraw, alleged that the companies flooded the state with opioid painkillers.

How this conduct would be viewed outside West Virginia would normally not have become an issue if Morrisey’s halt to the litigation would have been the end of the legal story. But fast forward to December 2018 and the official opening of the “Opiate Prescription MDL 2408”, where hundreds of counties, cities, states, hospitals and others impacted by the opioid crisis across the country, are now able to file lawsuits against all “Opioid Big Pharma” players. The defendants include drug makers, distributors, major pharmacies and others, there may a second long hard look at Patrick Morrisey’ conduct and reasoning for stopping prior legal action against the prescription opioid industry.

 

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Orange County and Santa Clara County Suits Against “Opiate Big Pharma” In California State Court Can Proceed

Ruling Rejects Opioid Manufacturers’ Arguments To Dismiss Deceptive Marketing Litigation

By Mark A. York (February 19, 2018)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) On February 13, 2018, the Orange County Superior Court rejected efforts by opioid manufacturers to dismiss a lawsuit brought by the Santa Clara County Counsel and the Orange County District Attorney on behalf of the People of the State of California. The lawsuit, filed in May 2014, alleges that the defendants—including opioid manufacturers Purdue Pharma L.P., Janssen Pharmaceuticals, Inc., Endo Health Solutions, Inc., and Actavis PLC—engaged in a deceptive marketing scheme that trivialized the risks of opioids, resulted in rampant over-prescribing, and led to a nationwide epidemic of opioid abuse and addiction.

“The court’s ruling puts an end to years of delay tactics by the defendants,” said Santa Clara County Counsel James R. Williams. “Now we will finally be able to move forward with the litigation and obtain key documents demonstrating the manufacturers’ misconduct. This is a critical step in addressing the opioid crisis that plagues California and the nation, and we will fight to hold opioid manufacturers accountable for their actions.”

STATE COURTS AHEAD OF FEDERAL OPIATE LITIGATION

In addition to the California counties suing in state court there are more than 200 counties from across the country as well as 30 major cities that have filed suits against opioid manufacturers in Opiate Prescription Multidistrict Litigation MDL 2804, pending in the US District Court of Northern Ohio in front of Judge Dan Polster, see Prescription Opiates MDL 2804 Briefcase. In addition to governmental entities, Judge Polster has also permitted unions and hospitals to join in the consolidated opioid litigation against Purdue Pharma, et al. The age of “Profits Before Patients” by Big Pharma may finally have started to come to an end, but it will not occur with very aggressive legal tactics and maneuvering by the opioid makers defense teams.

INSURERS ARE FIGHTING BACK

Earlier this year Travelers Insurance and St Paul Fire and Marine Insurance scored a legal victory when they were granted a declaratory judgment win related to defending Watson and it’s parent company Activis, Inc in the Orange County-Santa Clara County litigation, after the California Appellate Court declared the Traveller’s/St Paul  opioid coverage policy void due to the “Watson’s Deliberate Conduct” in relation to sales and marketing of opioid prescription drugs, which was determined to be improper. The decision also voided the Watson-Activis coverage in the City of Chicago vs. Watson et al, in Chicago federal court, see  California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense. This may be a trend for insurance carriers as they’ve filed other legal action to void coverage on behalf of opioid drug makers including Insys Therapeutics, Inc and defense of its Subsys fentanyl fast acting drug.

OPIOID RX DRUG MAKERS CHANGING TACTICS

The ruling comes the same week that Purdue Pharma, maker of the opioid OxyContin, announced that it will cut its salesforce in half and stop promoting opioids to doctors. The lawsuit brought by the Santa Clara County Counsel and the Orange County District Attorney was among the first lawsuits brought by government officials to hold opioid manufacturers responsible for their role in the opioids crisis. Manufacturers like Purdue now face pressure from hundreds of additional lawsuits nationwide.

The lawsuit was filed on May 21, 2014, against major opioid manufacturers. (People of the State of California v. Purdue Pharma, et al., Orange County Superior Court, Case No. 30-2014-00725287-CU-BT-CXC.) In 2015, defendants moved to stay the lawsuit, and the case was stayed until October 2016, when the court partially lifted the stay to consider defendants’ arguments that the case should be dismissed. The court has now lifted the stay entirely, and its ruling allows the lawsuit to go forward.

UP TO $500 BILLION SETTLEMENT

The current “Opiate Prescription Litigation MDL 2804” is being compared to the 1998 Tobacco Litigation settlement where Big Tobacco paid a settlement of $200 billion to cities, states and other governmental entities. The Opioid Litigation is expected to reach settlement figures of 3 to 4 times that amount, projected to be at the $500 billion plus figure, due to the rampant corporate boardroom directed policies that flooded the US marketplace for the last 15 years. Corporate sales and marketing policies and lack of oversight, enabled hundreds of millions of opioid prescription drugs to reach all areas of the country, thereby causing in excess of 100 thousand deaths and unknown catastrophic economic damages in every corner of the United States.

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Gary, Indiana joins litigation against opioid manufacturers 

“Profits Before Patients”

By Mark A. York (February 12, 2018)

Gary City Hall

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Economically hard hit Gary, Indiana is the latest local government to join the hundreds of other cities, counties and states across the country, along with private entities such as hospitals and unions in suing opioid manufacturers and distributors for their roles in the opioid addiction crisis.  Gary joins other Indiana communities including Indianapolis, Hammond, Fort Wayne and more than 10 Indiana counties in filing lawsuits against Bi Pharma drug makers such as Purdue, Endo, Abbott, Watson-Actavis and others, asserting that the marketing campaigns and a boardroom supported corporate philosophy of “profits before patients” would result in records profits from opioid drugs, which it clearly has for more than 10 years.  Many major cities have also filed lawsuits against the same opiod drugmakers and distributors, New York City sue Big Pharma over opioids – joining Chicago, Seattle, Milwaukee and other major cities.

Along with record profits came record overdose deaths, catastrophic increases in emergency response budgets for local communities, major metropolitan areas and most every region of the USA that has been impacted by the opioid crisis.

OPIATE Rx LAWSUITS EXPLODE

In light of escalating costs to combat the city’s opioid epidemic, the city of Gary on Jan. 29 filed a complaint in Lake Superior Court seeking to recover damages for use of public resources to fight the problem. Gary has decided to file the lawsuit in Indiana state court versus joining the fast growing Opiate Prescription Multi-District Litigation known as MDL 2804, (see MDL 2804 OPIATE PRESCRIPTION LITIGATION BRIEFCASE), which according to experts will dwarf the Tobacco Litigation of 1990’s and its $200 billion settlement with governments from 46 states. According to Mass Tort Nexus consultant and opioid expert John Ray, “In a comparative sense, the Opioid Litigation will make the financial and social impact of the Tobacco Litigation appear insignificant, due to the sheer size of the opioid addiction crisis and related treatment, healthcare and social-economic impact that’s occurred over the last decade, which will have to continue for years to come.”

Gary Mayor Karen Freeman-Wilson stated “I have seen addiction as a deputy prosecutor, defense attorney, drug court judge and Indiana Attorney General. We understand the scourge of addiction created by illegal drugs. To think that legal drugs have been manufactured and distributed in a way that increases and risks the harm to citizens of Gary and other communities is unconscionable,” with Gary being a community severely impacted by the residual affect of years of pharmaceutical opioids flooding the market.

LOCAL BUDGETS OVERWHELMED

The complaint which names more than 25 defendants — alleges that manufacturers, distributors and other entities intentionally mislead the public about the dangers of opioids, including marketing campaigns that minimized addiction and overdose risks to the medical and healthcare industry. The claims outline the history of how defendants downplayed the risks associated with OxyContin, Fentanyl and Percocet while aggressively marketing them, often paying huge commission to field sales reps who increased opioid prescriptions written in an assigned area, which was often low income and rural areas across the country.

“This negligent behavior has led to a significant increase in the City’s budgets for law enforcement, emergency care, first responder overtime, Narcan training and prevention and treatment programs. There will be no cost to City taxpayers with this filing,” The increase in the city’s budget to combat the opioid related issues has stressed an already tight budget, as well as the economic and social impact of the addiction and deaths associated with opiate abuses.

Hospitals in the state of Indiana have seen a 60-percent increase in non-fatal drug overdoses from 2011 to 2015, with deadly overdoses rising by an average of 3.5 percent each year, according to a report from the Indiana State Department of Health.

Indiana and other states, including Ohio, West Virginia and Kentucky have also seen a dramatic increase in children placed in foster care because of parents’ addiction, as well as related healthcare and addiction treatment costs.

FORCING OPIOID BIG PHARMA TO TABLE

Filing lawsuits against the Big Pharma opioid drug industry seems to be the only recourse available to cities such as Gary and the hundreds of other economically depresses local governments across the country, to force the opioid prescription drug industry to finally face the crisis that they’ve designed, marketed and placed into the US commerce stream.

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WEEKLY MDL and MASS TORT UPDATE by Mass Tort Nexus (February 2, 2018)

 

Week of January 29, 2018

This Week in Mass Torts Around The Country:

By Mark A. York

 

 

Xarelto MDL 2592: Are Settlement Talks Coming to Xarelto Litigation?

> During the January 30, 2018 monthly status conference hearing in Xarelto products liability MDL No. 2592, US District Court Judge Eldon Fallon stated that this MDL is nearing its end, and “I need to devise an end game,” as he now seems to be pushing both sides toward a resolution. He also referred to selection of cases to remand where 400 cases each will be selected by plaintiff and defense counsel and 400 more by the court, for a total of 1200 cases being designated for remand back to the court of original jurisdiction for trial or settlement.

Full hearing transcript: XARELTO MDL 2592 Judge Fallon January 31, 2018 Hearing Transcript

 Related-Xarelto Docket briefcase: XARELTO MDL 2592 US District Court ED Louisiana Judge Fallon

Opioid Crisis:

See Mass Tort Nexus Briefcase Re: OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION

>  Insys Therapeutics Sued by New York Attorney General for “Opioid Marketing Abuses” Even After MDL Judge Schedules Settlement Conference Inviting State AG’s

How will Opiate MDL 2805 Judge Polster view NY AG’s suit after he requested states attend his January 31, 2018 full day opioid “settlement” meeting in Cleveland? More than 200 attorneys for city and county governments as well as unions and others met all day in closed door meetings. The day included presentations by non-legal “opioid experts” including Dr. Anna Lembke from Stanford, Dr. Aaron Kesselheim from Harvard Medical School who offered views on the who, how and why the opioid drug makers were able to create the opioid crisis, including how Congress hindered attempts at controlling Big Pharma as well as Joseph Rannazzi, former DEA Head of Diversion Control who spoke to restrictions on DEA enforcement against opioid abuses by drug manufacturers and distributors.  

>New York State Attorney General Eric T. Schneiderman on Thursday became the latest attorney general to sue Insys Therapeutics Inc. for allegedly misrepresenting that a spray version of the opioid fentanyl is safe for non-cancer patients and appropriate for mild pain.
Schneiderman alleged in state court that Insys’ marketing of the drug Subsys for unapproved uses caused physicians to overprescribe the treatment, exacerbating the opioid epidemic currently affecting New York and many other states. The MDL judge has stated he wants all parties to come to the settlement table with an open mind, however behind the scenes parties are expressing different views on a quick settlement, since more and more of the suits filed against “Opioid Big Pharma” are RICO claims and some parties want to punish the drug makers for creating the opioid crisis.

 Opioid Indictments:

Pennsylvania Appeals Court Affirms Doctor Conviction For Opioid Prescriptions

 

>A Pennsylvania appeals court panel on Jan. 26 affirmed a doctor’s sentence for illegally prescribing opioid medications and submitting fraudulent bills to insurance companies after finding that the jury was properly instructed about the state’s standards for properly prescribing the drugs (Commonwealth of Pennsylvania v. Lawrence P. Wean, Nos. 1165 EDA 2016, 1167 EDA 2016, Pa. Super., 2018 Pa. Super.

Insys Therapeutics Sales Manager Wants Term “Opioid Crisis” Barred From Trial

>A former Insys Therapeutics Inc employee going to trial for paying kickbacks to doctors to prescribe fentanyl, has requested the court bar U.S. prosecutors from referring to the “opioid crisis” at his trial. Defendant, Jeffrey Pearlman, a former Insys district sales manager , filed a motion asking a Connecticut  federal judge to bar references at his trial to the crisis and evidence the dangers opioids pose. His lawyers cited the “rampant media attention” devoted to opioids, stating  “jurors would likely have strong biases against someone like Pearlman whose company sold and marketed opioids:, even though Pearlman and Insys engaged in rampant illegal sales and marketing of Subsys, the Insys Theraputics, Inc. fast acting fentanyl based opioid drug. . Pearlamn is jusyt one of more than 15 people at Insys to be indicted, including billionaire founder, John Kapoor, and the entire Board of Directors, for marketing off-label prescriptions of Subsys fentanyl spray (United States of America v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).

Rhode Island Doctor Pleads Guilty to Taking Kickbacks from Insys Therapeutics, Inc

>A Rhode Island doctor on Oct. 25 pleaded guilty to health care fraud and taking kickbacks for prescribing the opioid Subsys to unqualified patients (United States of America v. Jerrold N. Rosenberg, No. 17-9, D. R.I.).

Related Mass Tort Nexus Opiod Articles:

>California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense: Will other insurers say no to opioid coverage? Nov 15, 2017

>Targeting Big Pharma and Their Opiate Marketing Campaigns: Across The USA Nov 3, 2017

For more Mass Tort Nexus Opiod Crisis Information See: Mass Tort Nexus Newsletters and MDL Updates

IVC Filters:

See Bard IVC Filter MDL-2641 Briefcase

510(k) Defense Allowed In Bard IVC Bellwether Trial

>An Arizona federal judge overseeing the C.R. Bard Inc. inferior vena cava (IVC) filter multidistrict litigation on Jan. 29 denied a plaintiff motion to preclude evidence about the devices’ 510(k) clearance in an upcoming bellwether trial, but said he will put the evidence in context and will not allow it to be used as evidence that the devices are approved by the Food and Drug Administration (In Re:  Bard IVC Filters Products Liability Litigation, MDL Docket No. 2641, No. 15-2641, Sherr-Una Booker v. C.R. Bard, Inc., et al., No. 16-474, D. Ariz.)

Cordis IVC Filters:

See Cordis IVC Filter Litigation Alameda County, California Superior Court

>California State Court Cordis IVC Plaintiffs Argue “No Mass Action” To US Supreme Court

WASHINGTON, D.C. — Plaintiffs in an inferior vena cava (IVC) filter case on Oct. 18 told the U.S. Supreme Court that their suggestion of individual bellwether trials does not convert their actions into a mass action under the Class Action Fairness Act (CAFA), 119 Stat. 4 (Cordis Corporation v. Jerry Dunson, et al., No. 17-257, U.S. Sup)

Pelvic Mesh:

Boston Scientific TVM Litigation MDL 2362

>Exclusion of 510(k) Defense in Boston Scientific Pelvic Mesh Case:

ATLANTA — The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017 U.S. App. LEXIS 20432).

PLAVIX:

See Mass Tort Nexus Briefcase Re: PLAVIX MDL 2418 USDC NEW JERSEY

>Plaintiff Loses Plavix Case on Summary Judgment Over Late “Learned Intermediary” Declaration

TRENTON, N.J. — The judge overseeing the Plavix multidistrict litigation on Oct. 26 granted summary judgment in a case after ruling that the plaintiff’s “eleventh hour” declaration by one treating physician did not overcome California’s learned intermediary defense for defendants Bristol-Myers Squibb Co. (BMS) and Sanofi-Aventis U.S. Inc. (In Re:  Plavix Products Liability Litigation, MDL Docket No. 2418, No. 13-4518, D. N.J.)

 Hip Implant Litigation

UTAH FEDERAL JUDGE ASK STATE SUPREME COURT “Does Unavoidably Unsafe Apply To Medical Devices”

A Utah federal judge on Jan. 23 asked the Utah Supreme Court whether the state recognizes the unavoidably unsafe product doctrine for medical devices, such as hip implants, as well as drugs  (Dale Burningham, et al. v. Wright Medical Group, Inc., No. 17-92, D. Utah)

Most Wright Profemur Hip Claims Dismissed in Iowa Federal Court Ruling

See: Wright-Medical-Inc-MDL-2329-Conserve-Hip-Implant-Litigation

>An Iowa federal judge on Jan. 26 dismissed most claims in a metal-on-metal hip implant lawsuit and found no personal jurisdiction of Wright Medical Group Inc. (Rebecca Dumler, et al. v. Wright Medical Technology, Inc., et al., No. 17-2033, N.D. Iowa, Eastern Div).

Related Article: Federal Judge Joins Plaintiff Cases in Wright Profemur Hip California Litigation

Diabetes Drugs

Actos Cases Dismissed in California Court: 2014 Global Settlement Applies

>A California federal judge on Jan. 25 dismissed for lack of jurisdiction an Actos class action because the four plaintiffs previously settled their individual claims against the diabetes drug maker Takeda Pharmaceuticals America Inc. (Gary Bernor, et al. v. Takeda Pharmaceuticals America Inc., et al., No. 12-04856, C.D. Calif)

Birth Control

Non-Missouri Plaintiffs Dismissed From Essure Litigation “No Personal Jurisdiction”

>A Missouri federal judge dismissed 92 plaintiffs from a multiplaintiff Essure lawsuit Jan. 24, finding that the court lacked personal jurisdiction over the non-Missouri plaintiffs see Bayer-Essure Missouri Federal Court Order Dismissing All Non- Missouri Plaintiffs Jan 24, 2018 (Nedra Dyson, et al. v. Bayer Corporation, et al., No. 17-2584, E.D. Mo., Eastern Div.)

Mirena IUD:

>2nd Circuit Appeals Court Excludes Mirena MDL Experts—Litigation Terminated

NEW YORK — The Second Circuit U.S. Court of Appeals on Oct. 24 affirmed the exclusion of general causation experts in the Mirena multidistrict litigation and a court order terminating the MDL before any trials were held (In Re:  Mirena IUD Products Liability Litigation, Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals, Inc., Nos. 16-2890 and 16-3012, 2nd Cir)

Related: Federal Court Reopens Mirena IUD Product Liability MDL Nov 3, 2016

Testosterone Replacement Therapy:

See Mass Tort Nexus Briefcase Re: TESTOSTERONE MDL 2545 (AndroGel)

>Seventh Circuit Appeals Court: “Premeption Applies to Thousands of Depo-T Cases”

CHICAGO — The Seventh Circuit U.S. Court of Appeals on Jan. 19 said a regulatory quirk in how the testosterone drug Depo-T is classified means that thousands of product liability claims involving the drug are preempted (Rodney Guilbeau, et al. v. Pfizer Inc., et al., No. 17-2056, 7th Cir., 2018 U).

>Defense Wins 4th AndroGel MDL Bellwether Trial

An Illinois federal jury on Jan. 26 returned a defense verdict for AbbVie Inc. in the fourth AndroGel multidistrict litigation bellwether trial (Robert Nolte v. AbbVie, Inc., et al., No. 14-8135, N.D. Ill.)

Fosamax MDL 1789:

See Mass Tort Nexus Briefcase Re: MDL 1789 Fosamax Products Liability Litigation USDC New Jersey and FOSAMAX MDL 2243 (FEMUR FRACTURE CLAIMS) BRIEFCASE

>Fosamax Plaintiffs Request Supreme Court To Deny Merck Preemption Argument

Counsel for more than 500 Fosamax femur fracture plaintiffs on Oct. 25 urged the U.S. Supreme Court to deny certiorari to Merck Sharp & Dohme Corp., arguing that their claims are not preempted by “clear evidence” that the Food and Drug Administration would have rejected stronger warnings for the osteoporosis drug (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup., 2017 U.S. S. Ct.)

 

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Attorney General Opiate Investigations in New York, Texas, Missouri and Other States Move Forward

Amid Opioid Crisis: Investigations by AG’s in Texas, New York and Other States Demand Drug Company Documents

By Mark A. York (December 19, 2017)

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) As communities nationwide grapple with opioid addiction, Texas and a coalition of 40 other states have served investigative subpoenas and other requests to eight companies that manufacture or distribute prescription painkillers, Texas Attorney General Ken Paxton recently announced. This is just one of at least 14 other states that are conducting investigation into opiate drug companies and their recent business practices.

It’s the latest development in an investigation unveiled in June. Paxton and his counterparts are trying to determine whether opioid manufacturers played a role in creating or prolonging what has become a national epidemic. The attorneys general served investigative subpoenas to drugmakers Endo Pharmaceuticals, Janssen Pharmaceuticals, Teva Pharmaceuticals’ Cephalon, Allergan and their related entities, and they served a supplemental subpoena to Purdue Pharma, Paxton’s office said. The states also sent “information demand letters” to three opioid distributers: AmerisourceBergen, Cardinal Health, and McKesson.  These actions are completely apart from the many civil lawsuits filed against the same opiate drug makers under investigation, the civil suits have been filed by more than 400 counties, cities and states in “Opiate Prescription Litigation MDL 2804” recently consolidated in the United States District Court of Ohio, see NATIONAL PRESCRIPTION OPIATE LITIGATION MDL 2804 BRIEFCASE.

“The goal of this phase of our investigation is to collect enough information so that the multi-state coalition can effectively evaluate whether manufacturers and distributors engaged in unlawful practices in the marketing, sale, and distribution of opioids,” Paxton said in a statement. “We’ll determine an appropriate course of action once it’s determined what role these companies may have played in creating or prolonging the opioid crisis.”

Caitlin Carroll, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, said Tuesday she could not comment on the investigation of individual companies, but she pointed to policies her group supports to “prevent and deter abuse.”

An Allergan spokesman said that company was “working cooperatively with the state attorneys general,” but he downplayed the company’s share of the opioid market and said it didn’t aggressively promote such drugs.

“Allergan’s two branded opioid products — Norco and Kadian — account for less than 0.08 percent of all opioid products prescribed in 2016 in the U.S.,” the spokesman, Mark Marmur, said. “These products came to Allergan through legacy acquisitions and have not been promoted since 2012, in the case of Kadian, and since 2003, in the case of Norco.”

Cardinal Health also released a lengthy statement in which the company said: “We look forward to working with the attorneys general.”

Opioids are a family of drugs including prescription painkillers like hydrocodone, as well as illicit drugs like heroin.

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.

In teaming up to probe drug companies, some experts suggest the states are following a playbook similar to one used during the 1990s to sue tobacco companies for their role in fueling a costly health crisis — an effort that resulted in a settlement yielding more than $15 billion for Texas alone.

 

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FDA Fails to Cite Big Pharma Opioid Drug Makers for False Marketing and Advertisements

“PROFITS BEFORE PATIENTS REIGNS SUPREME AT FDA”

By Mark A. York (December 12, 2017)

Purdue Pharma and OxyContin Never Warned By FDA

 

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA)  In the midst of a national opioid crisis, the federal agency that monitors drug ads has issued a record low number of warning letters to pharmaceutical companies caught lying about their products.

The Food and Drug Administration has sent just three notice letters to drug makers busted for false marketing their medications to unknowing consumers, the lowest ever since the FDA historic decision to ease strict rules for drug ads in 1997. “It certainly raises questions,” said Dr. David Kessler, head of the FDA from late 1990 through 1996, who’s industry credentials would add weight to the issue of why the FDA is not doing more to monitor false marketing campaigns by Big Pharma and Opioid Drug makers in particular.

The FDA’s Office of Prescription Drug Promotion monitors all ads drug companies issue to make sure patients aren’t being scammed by false assertions or misleading marketing campaigns. Which now seems to be the norm, based on the hundreds of lawsuits filed against Opioid Drug Makers in the last 3 months, and recently consolidated into Opiate Prescription MDL 2804 see Opioid Crisis Briefcase-Mass Tort Nexus, where Big Pharma is being sued by states, cities and counties across the country. The primary claim in almost every suit is long term boardroom coordinated false marketing campaigns designed to push opioid drug prescriptions at any cost.

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 years since the push to increase opioid prescriptions in every way possible became an accepted business model Big Pharma boardrooms across the counrty.

FDA PLEADS NO STAFF

But the agency has long struggled to keep track of the thousands of ads published each year, largely due to lack of staff.

There are approximately 60 FDA staffers responsible for keeping track of at least 75,000 ads and other promotional material published each year. Although in the age of electronic monitoring and hi-tech tracking of data it would seem that monitoring drugs such as Schedule 2 – 4 narcotics or other drugs that are considered high risk for abuse, the FDA could create a quarterly e-review or a flagging system when new campaigns are started by Big Pharma.

“It’s a very, very small unit,” a former high-ranking FDA official said. “It’s historically been underfunded.” Which seems to support the contention that Washington D.C lawmakers are in the pockets of Big Pharma and the hundreds of lobbyists they utilize to ensure a true lack of oversight in the pharmaceutical industry as a whole.

Additionally, many of the ads are submitted to the FDA for review at the same time they begin to run. So by the time the assessment is complete the ad has “already had a significant impact,” the FDA insider said. This policy flies in the face of the creation regulatory oversight based on the fact that when a problem or an issue with a product is discovered, the FDA, EPA or other agency should enforce the law and correct the problem. In the case of the FDA, that is not happening and Big Pharma is and has been aware of the lack of oversight for years.

Critics say the FDA needs to do more to stay on top of an industry with a history of trying to maximize profits by at times misleading consumers, which has recently been described as a policy of “patients before patients” which has resulted in the current Opioid Crisis that’s firmly in place across the United States.

The number of public admonishment letters has been at or close to single digits from 2014 until 2016 during the Obama administration, records show. The FDA sent out 11 of those caution missives in 2016, nine in 2015 and 2014, and 24 in 2013.

A SINGLE FDA WARNING IN 2016

This year, one of the warning letters was sent to Canadian drugmaker Cipher Pharmaceuticals, ordering it stop using deceptive promotional material to hawk its extended-release opioid ConZip.

The ad failed to note “any risk information” highlighting the potentially addictive nature of the powerful painkiller, the FDA letter issued Aug. 24 said. The promotional material was also misleading because it asserted other treatment options “are inadequate,” the oversight agency concluded.

“By omitting…serious and potentially fatal risks, the detail aid…creates a misleading impression about the drug’s safety, a concern heightened by the serious public health impacts of opioid addiction, abuse and misuse,” the FDA said.

The agency demanded that Cipher “immediately cease misbranding” the medication. The drug company responded by yanking the promotional material, the firm’s execs said in a statement issued after the warning letter was made public.

But that was the single caution letter issued to an overhyped painkiller by the FDA this year so far, records show. The other caution letters were sent to Amherst Pharmaceuticals for the insomnia drug Zolpimist, and to Orexigen Therapeutics Inc. for its weight loss drug Contrave.

There are many long term FDA and other senior DC officials who have for whatever reasons, chosen to defer reigning in Big Pharma sales and marketing abuses and now it appears the corrective action has been undertaken in federal courts across the country by mass tort lawyers in litigation which will apparently make the “Tobacco Litigation” of the 1980’s pale in financial comparison.

With the primary lawsuits recently consolidated by in the Multidistrict Litigation titled “National Prescription Opiate Litigation” Case No. MDL 2804, recently assigned to the US District Court, Northern District of Ohio.  With the key case heading including “prescription and opiate” which reflects the federal court recognizing that opiate prescriptions have become such a major issue the federal courts will now determine the penalties assessed against Big Pharma. The focus will be on the long term “sales and marketing campaigns” designed in corporate boardrooms of Fortune 100 companies, to increase corporate profits, while ignoring the known catastrophic increases in addictions and other inter-connected healthcare, economic and social upheavels caused by the flood of opioid drugs in the US market.

The FDA maintains that letters to drug companies are merely one tool the agency uses to keep the pharmaceutical industry in line.

“We have many efforts to encourage compliance by industry, including our work on guidance, by providing advice to companies on draft promotional materials, and outreach to our stakeholders,” FDA spokeswoman Stephanie Caccomo said. “The FDA’s priorities regarding prescription drug promotion are policy and guidance development, labeling reviews, core launch and TV ad reviews, training and communications and enforcement.” The key terms referred to by Ms. Caccamo are “guidance and by providing advice” from the FDA, when direct enforcement actions are required, as Big Pharma see the terms “guidance and advice” as harmless and not applicable to their efforts to increase sales and profits. In-house lawyers at Big Pharma have reviewed FDA enforcement failures and offered opinions to the boardrooms for years about the FDA not willing to enforce anything close to restrictions on opioid drug marketing and sale practices, all the while reaping the profits of the opioid crisis.

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.

US CONGRESS IS NOT HELPING

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.

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JPML APPROVES “OPIATE PRESCRIPTION MDL 2804” AGAINST OPIOID MANUFACTURERS AND DISTRIBUTORS

The UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION  has formally approved the“NATIONAL PRESCRIPTION OPIATE LITIGATION, MDL No. 2804″ on December 5, 2017.

     Assigned to Judge Daniel Polster, US District Court Northern District of Ohio, who will oversee the litigation related to manufacturing, marketing, distribution and sales practices of prescription opioid drugs by Big Pharma drug makers and distributors.  

 

 

 

JPML Transfer Order in MDL No. 2804, December 5, 2017

UNITED STATES JUDICIAL PANEL

on

MULTIDISTRICT LITIGATION

IN RE: NATIONAL PRESCRIPTION OPIATE LITIGATION                                                                            MDL No. 2804

TRANSFER ORDER

Before the Panel:* Plaintiffs in 46 actions move under 28 U.S.C. § 1407 to centralize pretrial proceedings in the Southern District of Ohio or the Southern District of Illinois, but plaintiffs do not oppose centralization in the Southern District of West Virginia.  These cases concern the alleged improper marketing of and inappropriate distribution of various prescription opiate medications into cities, states and towns across the country.  Plaintiffs’ motion includes the 64 actions listed on Schedule A,1 which are pending in nine districts.  Since plaintiffs filed this motion, the parties have notified the Panel of 115 potentially related actions.2 

Responding plaintiffs’ positions on centralization vary considerably.  Plaintiffs in over 40 actions or potential tag-along actions support centralization.  Plaintiffs in fifteen actions or potential tag-along actions oppose centralization altogether or oppose transfer of their action.  In addition to opposing transfer, the State of West Virginia suggests that we delay transferring its case until the Southern District of West Virginia court decides its motion to remand to state court.  Third party payor plaintiffs in an Eastern District of Pennsylvania potential tag-along action (Philadelphia Teachers Health and Welfare Fund) oppose centralization of third party payor actions.  Western District of Washington plaintiff City of Everett opposes centralization and, alternatively, requests exclusion of its case.  Northern District of Illinois tagalong plaintiff City of Chicago asks the Panel to defer transfer of its action until document discovery is completed.

Defendants’ positions on centralization also vary considerably. The “Big Three” distributor defendants,3 which reportedly distribute over 80% of the drugs at issue and are defendants in most cases,

__________________________________________

* Judges Lewis A. Kaplan and Ellen Segal Huvelle did not participate in the decision of this matter.

1  Two actions included on plaintiffs’ motion to centralize were remanded to state court during the pendency of the motion.

2 These actions, and any other related actions, are potential tag-along actions.  See Panel Rules 1.1(h), 7.1 and 7.2. 3

3 AmerisourceBergen Drug Corp., AmerisourceBergen Corp., McKesson Corp., Cardinal Health 110, LLC, Cardinal Health, Inc., Cardinal Health 105, Inc., Cardinal Health 108, LLC, Cardinal Health 112, LLC, Cardinal Health 414, LLC, and Cardinal Health subsidiary The Harvard Drug  – 2 –

support centralization in the Southern District of West Virginia.  These defendants request that the Panel either delay issuing its transfer order or delay transfer of their cases until their motions to dismiss are decided.  Defendant distributor Miami-Luken also supports centralization in the Southern District of West Virginia.  Multiple manufacturer defendants4 support centralization in the Southern District of New York or the Northern District of Illinois; defendant Malinckrodt, LLC, takes no position on centralization but supports the same districts.  Teva defendants5 suggest centralization in the Eastern District of Pennsylvania or the manufacturers’ preferred districts.  Physician defendants6 in three Ohio actions, who are alleged to be “key opinion leaders” paid by manufacturing defendants, do not oppose centralization in the Southern District of Ohio. 

Defendants in several Southern District of West Virginia cases oppose centralization.  These defendants include several smaller distributor defendants or “closed” distributors that supply only their own stores.7  Many of these defendants specifically request exclusion of the claims against them from the MDL.  Also, manufacturer Pfizer, Inc., opposes centralization and requests that we exclude any claims against it from this MDL.8

The responding parties suggest a wide range of potential transferee districts, including: the Southern District of West Virginia, the Southern District of Illinois, the Northern District of Illinois, the Eastern

District of Missouri (in a brief submitted after the Panel’s hearing), the District of New Jersey, the Southern District of New York, the Southern District of Ohio, the Northern District of Ohio, the Eastern District of Pennsylvania, the Eastern District of Texas, the Western District of Washington and the Eastern District of Wisconsin.

After considering the argument of counsel, we find that the actions in this litigation involve common questions of fact, and that centralization in the Northern District of Ohio will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. Plaintiffs in the actions before us are cities, counties and states that allege that: (1) manufacturers of prescription opioid medications overstated the benefits and downplayed the risks of the use of their opioids and aggressively marketed  (directly and through key opinion leaders) these drugs to physicians, and/or (2) distributors failed to monitor, detect, investigate, refuse and report suspicious orders of prescription opiates.  All actions involve common factual questions about, inter alia, the manufacturing and distributor defendants’ knowledge of and conduct regarding the alleged diversion of these prescription opiates, as well as the manufacturers’ alleged improper marketing of such drugs.  Both manufacturers and distributors are under an obligation under the Controlled Substances Act and similar state laws to prevent diversion of opiates and other controlled substances into illicit channels.  Plaintiffs assert that defendants have failed to adhere to those standards, which caused the diversion of opiates into their communities.  Plaintiffs variously bring claims for violation of RICO statutes, consumer protection laws, state analogues to the Controlled Substances Act, as well as common law claims such as public nuisance, negligence, negligent misrepresentation, fraud and unjust enrichment. 

______________________________________________________________

Group, L.L.C. 4

4 Actavis LLC, Actavis Pharma, Inc., Allergan PLC, Allergan Finance, LLC, Allergan plc f/k/a Actavis plc, Actavis Pharma Inc. f/k/a Watson Pharma Inc., Watson Pharmaceuticals, Inc. n/k/a Actavis, Inc., and Allergan PLC f/k/a Actavis PLS, Cephalon, Inc., Endo Health Solutions, Inc., Endo Pharmaceuticals, Inc., Janssen Pharmaceutica Inc., Johnson & Johnson, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Purdue Frederick Company Inc., Purdue Pharma Inc., Purdue Pharma L.P., Teva Pharmaceuticals Industries Ltd., Teva Pharmaceuticals USA, Inc., Watson Laboratories, Inc., Watson Pharmaceuticals, Inc., Janssen Pharmaceutica Inc. n/k/a Janssen Pharmaceuticals, Inc. 5

5 Teva Pharmaceutical Industries, Ltd., Teva Pharmaceuticals U.S.A, Inc., Cephalon, Inc., Watson Laboratories, Inc., Actavis LLC, and Actavis Pharma, Inc. 6

6 Scott Fishman, M.D., Perry Fine, M.D., Lynn Webster, M.D., and Russell Portenoy, M.D. 7

7 JM Smith Corp.; CVS Indiana, LLC and Omnicare Distribution Center, LLC; TopRx; Kroger Limited Partnership I, Kroger Limited Partnership II, SAJ Distributors (a Walgreens distributor for two months in 2012), Walgreen Eastern Co., Inc., and Rite Aid of Maryland, Inc.; Masters Pharmaceuticals and KeySource Medical; WalMart Stores East, LP. 8

8 Pfizer specifically requests that we exclude any potential future claims against it because of its minimal involvement in the opioid market.  At oral argument, counsel stated that Pfizer was not named as a defendant in any pending case.  In the absence of a case before us, the Panel will not address Pfizer’s argument.

 

 

The parties opposing transfer stress the uniqueness of the claims they bring (or the claims that are brought against them), and they argue that centralization of so many diverse claims against manufacturers and distributors will lead to inefficiencies that could slow the progress of all cases.  While we appreciate these arguments, we are not persuaded by them.  All of the actions can be expected to implicate common fact questions as to the allegedly improper marketing and widespread diversion of prescription opiates into states, counties and cities across the nation, and discovery likely will be voluminous.  Although individualized factual issues may arise in each action, such issues do not – especially at this early stage of litigation – negate the efficiencies to be gained by centralization.  The transferee judge might find it useful, for example, to establish different tracks for the different types of parties or claims.  The alternative of allowing the various cases to proceed independently across myriad districts raises a significant risk of inconsistent rulings and inefficient pretrial proceedings.  In our opinion, centralization will substantially reduce the risk of duplicative discovery, minimize the possibility of inconsistent pretrial obligations, and prevent conflicting rulings on pretrial motions.  Centralization will also allow a single transferee judge to coordinate with numerous cases pending in state courts.  Finally, we deny the requests to delay transfer pending rulings on various pretrial motions (e.g., motions to dismiss or to remand to state court) or until the completion of document discovery in City of Chicago

Although all of the cases on the motion before us involve claims brought by political subdivisions, we have been notified of potential tag-along actions brought by individuals, consumers, hospitals and third party payors.  As reflected in our questions at oral argument, this litigation might evolve to include  – 4 –

additional categories of plaintiffs and defendants, as well as different types of claims.  We will address whether to include specific actions or claims through the conditional transfer order process.[1]

As this litigation progresses, it may become apparent that certain types of actions or claims could be more efficiently handled in the actions’ respective transferor courts.  Should the transferee judge deem remand of any claims or actions appropriate (or, relatedly, the subsequent exclusion of similar types of claims or actions from the centralized proceedings), then he may accomplish this by filing a suggestion of remand to the Panel.  See Panel Rule 10.1.  As always, we trust such matters to the sound judgment of the transferee judge.

Most parties acknowledge that any number of the proposed transferee districts would be suitable for this litigation that is nationwide in scope.  We are persuaded that the Northern District of Ohio is the appropriate transferee district for this litigation.  Ohio has a strong factual connection to this litigation, given that it has experienced a significant rise in the number of opioid-related overdoses in the past several years and expended significant sums in dealing with the effects of the opioid epidemic.  The Northern District of Ohio presents a geographically central and accessible forum that is relatively close to defendants’ various headquarters in New York, Connecticut, New Jersey and Pennsylvania.  Indeed, one of the Big Three distributor defendants, Cardinal Health, is based in Ohio.  Judge Dan A. Polster is an experienced transferee judge who presides over several opiate cases.  Judge Polster’s previous MDL experience, particularly MDL No. 1909 – In re: Gadolinium Contrast Dyes Products Liability Litigation, which involved several hundred cases, has provided him valuable insight into the management of complex, multidistrict litigation.  We have no doubt that Judge Polster will steer this litigation on a prudent course.

 

IT IS THEREFORE ORDERED that the actions listed on Schedule A and pending outside of the Northern District of Ohio are transferred to the Northern District of Ohio and, with the consent of that court, assigned to the Honorable Dan A. Polster for coordinated or consolidated  pretrial proceedings.

PANEL ON MULTIDISTRICT LITIGATION

  

Sarah S. Vance

Chair

Charles R. Breyer Marjorie O. Rendell
R. David Proctor Catherine D. Perry

__________________________________________________________________________________

IN RE: NATIONAL PRESCRIPTION

OPIATE LITIGATION                                                                            MDL No. 2804

SCHEDULE A

Northern District of Alabama

CITY OF BIRMINGHAM v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL.,

C.A. No. 2:17-01360

Eastern District of California

COUNTY OF SAN JOAQUIN, ET AL. v. PURDUE PHARMA, L.P., ET AL.,

C.A. No. 2:17-01485

Southern District of Illinois

PEOPLE OF THE STATE OF ILLINOIS, ET AL. v. PURDUE PHARMA LP, ET AL.,

C.A. No. 3:17-00616

PEOPLE OF THE STATE OF ILLINOIS, ET AL. v. AMERISOURCEBERGEN

DRUG CORPORATION, ET AL., C.A. No. 3:17-00856

PEOPLE OF STATE OF ILLINOIS, ET AL. v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00876

Eastern District of Kentucky

BOONE COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00157

PENDLETON COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00161

CAMPBELL COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00167

ANDERSON COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00070

FRANKLIN COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00071

SHELBY COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00072

HENRY COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 3:17-00073

BOYLE COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00367

FLEMING COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00368

– A2 –

Eastern District of Kentucky (cont.)

GARRARD COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00369

LINCOLN COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 5:17-00370

MADISON COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00371

NICHOLAS COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00373

BELL COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00246

HARLAN COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00247

KNOX COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00248

LESLIE COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00249

WHITLEY COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00250

CLAY COUNTY FISCAL COURT v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 6:17-00255

Western District of Kentucky

THE FISCAL COURT OF CUMBERLAND COUNTY v. AMERISOURCEBERGEN

DRUG CORPORATION, ET AL., C.A. No. 1:17-00163

LOUISVILLE/JEFFERSON COUNTY METRO GOVERNMENT v.

AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 3:17-00508

THE FISCAL COURT OF SPENCER COUNTY v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 3:17-00557

THE FISCAL COURT OF UNION COUNTY v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 4:17-00120

THE FISCAL COURT OF CARLISLE COUNTY v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-00136

Northern District of Ohio

CITY OF LORAIN v. PURDUE PHARMA L.P., ET AL., C.A. No. 1:17-01639

CITY OF PARMA v. PURDUE PHARMA L.P., ET AL., C.A. No. 1:17-01872

– A3 –

Southern District of Ohio

CLERMONT COUNTY BOARD OF COUNTY COMMISSIONERS v.

AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00662 BELMONT COUNTY BOARD OF COUNTY COMMISSIONERS v.

AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00663

BROWN COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00664

VINTON COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN CORPORATION, ET AL., C.A. No. 2:17-00665

JACKSON COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00680

SCIOTO COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL., C.A. No. 2:17-00682

PIKE COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN

DRUG CORPORATION, ET AL., C.A. No. 2:17-00696

ROSS COUNTY BOARD OF COUNTY COMMISSIONERS v. AMERISOURCEBERGEN

DRUG CORPORATION, ET AL., C.A. No. 2:17-00704

CITY OF CINCINNATI v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL.,

C.A. No. 2:17-00713

CITY OF PORTSMOUTH v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL.,

C.A. No. 2:17-00723

GALLIA COUNTY BOARD OF COMMISSIONERS v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00768

HOCKING COUNTY BOARD OF COMMISSIONERS v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00769

LAWRENCE COUNTY BOARD OF COMMISSIONERS v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 2:17-00770

DAYTON v. PURDUE PHARMA LP, ET AL., C.A. No. 3:17-00229

Western District of Washington

CITY OF EVERETT v. PURDUE PHARMA LP, ET AL., C.A. No. 2:17-00209

CITY OF TACOMA v. PURDUE PHARMA, L.P., ET AL., C.A. No. 3:17-05737

Southern District of West Virginia

THE COUNTY COMMISSION OF MCDOWELL COUNTY v. MCKESSON CORPORATION,

ET AL., C.A. No. 1:17-00946

HONAKER v. WEST VIRGINIA BOARD OF PHARMACY, ET AL., C.A. No. 1:17-03364

THE COUNTY COMMISSION OF MERCER COUNTY v. WEST VIRGINIA BOARD OF

PHARMACY, C.A. No. 1:17-03716

– A4 Southern District of West Virginia (cont.)

KANAWHA COUNTY COMMISSION v. RITE AID OF MARYLAND, INC., ET AL.,

C.A. No. 2:17-01666

FAYETTE COUNTY COMMISSION v. CARDINAL HEALTH, INC., ET AL.,

C.A. No. 2:17-01957

BOONE COUNTY COMMISSION v. AMERISOURCEBERGEN DRUG CORPORATION,

ET AL., C.A. No. 2:17-02028

LOGAN COUNTY COMMISSION v. CARDINAL HEALTH, INC., ET AL.,

C.A. No. 2:17-02296

THE COUNTY COMMISSION OF LINCOLN COUNTY v. WEST VIRGINIA BOARD OF PHARMACY, ET AL., C.A. No. 2:17-03366

LIVINGGOOD v. WEST VIRGINIA BOARD OF PHARMACY, ET AL., C.A. No. 2:17-03369

SPARKS v. WEST VIRGINIA BOARD OF PHARMACY, C.A. No. 2:17-03372

CARLTON, ET AL. v. WEST VIRGINIA BOARD OF PHARMACY, ET AL.,

C.A. No. 2:17-03532

STATE OF WEST VIRGINIA, ET AL. v. MCKESSON CORPORATION, C.A. No. 2:17-03555 BARKER v. WEST VIRGINIA BOARD OF PHARMACY, ET AL., C.A. No. 2:17-03715

THE CITY OF HUNTINGTON v. AMERISOURCEBERGEN DRUG CORPORATION, ET AL.,

C.A. No. 3:17-01362

CABELL COUNTY COMMISSION v. AMERISOURCEBERGEN DRUG CORPORATION, ET

AL., C.A. No. 3:17-01665

WAYNE COUNTY COMMISSION v. RITE AID OF MARYLAND, INC., ET AL.,

C.A. No. 3:17-01962

WYOMING COUNTY COMMISSION v. AMERISOURCEBERGEN DRUG

CORPORATION, ET AL., C.A. No. 5:17-02311

 

[1]  Eastern District of Pennsylvania Philadelphia Teachers Health and Welfare Fund third party payor plaintiff opposed centralization of such claims, stating that it intends to file a motion for centralization of third party payor claims.  We will address that motion, if it is filed, in due course.

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Targeting Big Pharma and Their Opiate Marketing Campaigns

The Major Focus Across The USA is Now Big Pharma and Their Opiate Marketing Campaigns

Mark A. York (November 3, 2017)

(Mass Tort Nexus) A bipartisan group of states and their attorneys general have started massive joint investigations into the marketing and sales practices of drug companies that manufacture opioid painkillers. These drug makers are the largest in the country and are considered at the center of the current national addiction epidemic. This includes the executive suite and boardrooms of all opiate manufacturers, as the policy and direction for the massive growth in opiate prescriptions could not have gone unnoticed by executives at the opiate drug makers, for close to 15 years. Record earnings, bonuses and SEC filings all point to “boardroom knowledge” of ever increasing opiate focused sales efforts.

The state actions are now parallel to the “Motion for Consolidation in “The Opiate Prescription Litigation MDL 2804” , filed with the Joint Panel for Multidistrict Litigation. MDL 2804 is set for a Consolidation Motion Hearing before the JMPL panel in St. Louis,  MO on November 30, 2017, where numerous Midwest counties in Ohio, Kentucky and West Virginia as well as the city of Birmingham, Alabama joined together to file suit against the 3 largest distributors of opiates in the country, McKesson Corp., Cardinal Health and AmerisourceBergen Corporation. Also named in the suit are the primary Big Pharma opiate manufacturers including Purdue Pharma, J&J’s Janssen Pharmaceuticals, Endo, Teva and others as additional defendants.

Attorney Generals from Massachusetts, Tennessee, Texas, Illinois, New Jersey, Missouri and Pennsylvania have launched full investigations, following the lead of Ohio Attorney General Mike DeWine, who sued five drug manufacturers for misrepresenting the risks of opioids. Other states are also beginning the review of opioid manufacturers and will decide if they are joining the others in filing legal claims.

“We are looking into the role of marketing and how related corporate business practices might have played into increasing prescriptions and use of these powerful and addictive drugs,” District of Columbia Attorney General Karl Racine, a Democrat, said in a statement.

Its currently unclear exactly how many states are involved in the probe, though officials said a majority of attorneys general are part of the coalition. Among those leading the probe is Tennessee Attorney General Herbert Slatery, a Republican.

Officials did not specify which companies were under investigation, but suffice it to say, any company that made and marketed opioids products over the last 10 years will be scrutinized.

Opioid drugs, including prescription painkillers and heroin, killed more than 33,000 people in the United States in 2015, more than any year on record, according to the U.S. Centers for Disease Control and Prevention.

Separate lawsuits by attorneys general in Ohio, Tennessee, New Jersey and Mississippi, are pursuing opioid-related cases as of September 2017, with many more following suit very soon. They are have targeting Purdue Pharma LP, Johnson & Johnson(JNJ.N), Endo International Plc(ENDP.O), Teva Pharmaceutical Industries Ltd (TEVA.TA) and Allergan Plc(AGN.N) as well as leaving the door open to add additional defendants, based on the information revealed in the ongoing multi-state investigations.

New Jersey recently filed suit against Insys Therapeutics, Inc over marketing scheme for its Fentanyl product known as “Subsys”, and the massive off-label marketing campaign for uses other than FDA approved “cancer pain” treatments. The entire executive board of Insys was indicted in December 2016, along with many of its sales staff and numerous doctors across the country, with at least to physicians being sentenced to 20 years in prison by the US District Court in Alabama. See Insys Therapeutics, Inc Executives Indicted Over Fentanyl Sales Campaign.

Teva in a statement said on Thursday it is “committed to the appropriate promotion and use of opioids.” Representatives for the other companies did not immediately respond to requests for comment.

The companies have denied wrongdoing, saying the U.S. Food and Drug Administration approved their products as safe and effective and saying that they carried warning labels that disclosed their risks. The specific allegation focus more on “off label” and doctor targeting and marketing practices that repeatedly encouraged over-writing of opiate prescriptions for patients with minimal pain issues.

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.

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