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.
“FINDING OUT HOW THE THE OPIOID EPIDEMIC CAME INTO BEING”
By Mark A. York (February 27, 2018)
(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. “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.
“A small West Virginia town of 3,000 people got 21 million pills”
By Mark A. York (February 26, 2016 )
(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.
>Federal Judge Dan Polster has ordered the start of formal settlement talks as the way to begin the Opiate Rx MDL 2804, he’s entered a settlement gag order and strongly suggesting the parties move ahead in this area or he will be forced “let both sides loose on each other and the government via wide open discovery” including access to the FDA and DEA files. The fate of multidistrict litigation over the opioid crisis now rests heavily with 18 plaintiff and defense counsel who’ve been tasked with negotiating a settlement in the historic case. The negotiators, chosen earlier this month, are from two camps: seven attorneys representing local governments that assert grievous financial harm from the opioid crisis, and 11 attorneys representing opioid manufacturers and distributors. Their assignment is daunting: broker a quick and meaningful deal that earmarks money for all parties who’ve been affected by the flood of opioids into the US marketplace over the last 15 years.
Johnson & Johnson Talc Use Will Kill Plaintiff Eventually Per Experts in NJ Talc Trial
>An occupational medicine expert told a New Jersey state court jury this week that a man alleging Johnson & Johnson’s baby powder contains asbestos faces a painful death from mesothelioma, and that the disease was caused by his daily use of J&J’s products. According to plaintiff expert occupational health M.D. Jacqueline Moline, of the Feinstein Institute of Medical Research testified on behalf of plaintiff Stephen Lanzo, to support his claim that J&J’s products, including its baby powder, contained the asbestos that caused his mesothelioma. Earlier this week, another plaintiff expert, William Longo, an electron microscopist told jurors Tuesday that he found asbestos in more than half of the 32 samples of Johnson & Johnson talcum powder products he had examined during a trial alleging that using J&J talc caused him to develop mesothelioma, In the trials fourth week, Mr. Longo was called to the stand as a materials science and electron microscopy expert to support plaintiff Stephen Longo’s claim that J&J is responsible for his mesothelioma, an asbestos-related disease that is fatal.
>Lynn Hartman, the woman who won a $28 million verdict in December 2017, in the first Philadelphia bellwether trial over injuries linked to the blood thinner Xarelto has argued the Pennsylvania judge Michael Erdos, who threw out her damages award ignored evidence that additional warnings would not have changed her doctor’s decision to prescribe the medication. In a January 9th hearing Judge Erdos ruled for defense on their Motion to Vacate the Judgment on various grounds, and during the same hearing the judge also ruled on plaintiff trial counsel trial misconduct matters, which resulted in various sanctions against certain members of Ms. Hartman’s trial team.
>Several New Jersey counties and unions have filed suits against OxyContin maker Purdue Pharma and other opioid manufacturers, distributors and retailers in New Jersey state courts, which is outside of the Federal MDL Opiate Prescription MDL 280, in the last 30 days, accusing Purdue of sparking the opioid epidemic with deceptive marketing practices that the others eventually adopted. The claims in NJ sate court appear to be a strategic move to provide local governmental entities with a home court advantage versus jumping into the every growing MDL 2804, where Judge Polster has already moved the parties into settlement talks. There are now many other counties and states that have decided to litigate opioid claims in their own state courts versus joining the masses in the federal MDL, how this plays out in the long run remains to be seen. Several county and state court suits originally placed in the Opiate MDL have already been remanded back to state courts by the federal court.
Pennsylvania Supreme Court Hears Risperdal SOL Dismissal Arguments
>A Johnson & Johnson unit on Tuesday urged the Pennsylvania Supreme Court to leave standing a recent decision jeopardizing thousands of pending lawsuits by rolling back the clock on when claims of abnormal breast growth allegedly linked to the antipsychotic drug Risperdal began to expire. The justices are weighing whether to hear an appeal of a November ruling from the state’s Superior Court finding that a two-year statute of limitations of Risperdal-related lawsuits, more than 6,600 of which are pending in Philadelphia County, should have started the Statute of Limitations clock, which if upholds the decisions, will cause the dismissal of many of the cases in the Phila court Risperdal docket. J&J has not fared well to date in the Risperdal cases, with verdicts against now reaching the hundreds of millions of dollars and a recent ruling that Punitive damages are now permitted for many cases. J&J’s Janssen R&D division is also facing thousands of suit in the Xarelto litigation also filed in the Phila Court of Common Pleas docket.
>A Pennsylvania appeals court on Tuesday rejected efforts by a Johnson & Johnson unit to challenge expert testimony relied on by jurors in finding that the antipsychotic drug Risperdal had caused a Maryland boy to grow female breast tissue. A three-judge Superior Court panel shot down arguments from Janssen Pharmaceuticals Inc. that Dr. Francesco DeLuca had improperly relied on an 8-year-old photograph to conclude that Nicholas Murray had been suffering from gynecomastia, or the abnormal growth of female breast tissue in males, at the time the drug was prescribed. However the Superior Court panel did rule that the Murray v. Janssen Pharmaceuticals, case would go back to the trial court for further determination as to the jury award cap based on Maryland law, wher the plaintiff resides, and taking into account the recent Superior Court ruling that permits punitive damages in the Risperdal litigation. The Murray trial which was the third case to go to trial in the Risperdal mass tort docket in the Philadelphia Court of Common Pleas. The plaintiff was initially awarded a $1.75 million verdict, which was later reduced by the trial court to $680,000, pursuant to the Maryland statute capping damages. The unanimous panel rejected defendant Janssen Pharmaceutical’s attempt to overturn the verdict and affirmed the trial judge’s decision to limit the jury award based on a Maryland law that caps noneconomic damages. However, citing its decision in a case last month that opened the doors for Risperdal plaintiffs to seek recovery of punitive damages, Judge John Bender remanded the case to the trial court to determine whether plaintiff Nicholas Murray, a Maryland resident, should be allowed to seek punitive damages in the case.
State of Kentucky Files Opioid Suit in State Court
>Drug distributor Cardinal Health has exacerbated the opioid epidemic by filling suspicious drug orders and neglecting to alert the authorities about them, Kentucky’s attorney general claimed in a suit filed Monday in state court. Andy Beshear, lead plaintiff counsel claims Cardinal shipped massive opioid orders throughout Kentucky for years, that were unusually large, frequent and deviated from a past pattern, shunning its own data and “common sense” in favor of profits and market share. Beshear had previously sued McKesson Corp., who along with Cardinal and AmerisourceBergen, distributes 85 percent of the country’s prescription opiates, and are alleged to have engaged in an organized and boardroom acknowledged policy of not reporting massive opiate order increases or failing to accurately track the millions of opiate pills that made their way into so many small towns in the region of Kentucky, West Virginia and Ohio. How the drug distribution monitors at these companies couldn’t recognize that often 2 million plus opioid tablets were being shipped to towns that had populations of less than 2,000 remains as the big question, that nobody at these Fortune 50 companies will admit to or acknowledge was an issue. The lack of oversight and re[porting took place during the last 15 years of record breaking profits where billions of dollars in revenue were collected year in and year out by drug distribution companies.
>Federal Judge Rebecca Pallmeyer enterd CMO No. 13 on February 12, 2018 placing a stay on proceeding in MDL 2272, pending the outcome of the finalization of the settlement discussion and a full resolution of the Zimmer NexGen Knee litigation. Lead counsel in the Zimmer NexGen litigation on Feb. 6 told Judge Pallmeyer, that they have reached an agreement in principle that will potentially resolve all MDL cases and similar cases filed in state court as of Jan. 15, 2018. If approved, the settlement will end seven years of litigation, during which some 300 plaintiffs alleged the engineering changes that Zimmer made to allow a greater degree of flexibility in its NexGen components in fact caused greater stress on the knee implants. The NexGen high-flex components theoretically allow patients to bend their knees by 155 degrees, while standard NexGen components provide for up to 125 degrees of bending, according to the plaintiffs.
The Zimmer NexGen knee replacement system has been on the market, almost half a million people in the US alone have had Zimmer knee implants. However, the Zimmer knee replacement, namely the NexGen CR-Flex Porous Femoral component, has been linked to a variety of problems, from loosening of the implant to failure of the replacement knee, requiring revision surgery, as the plaintiffs in the MDL also allege.
The case is MDL 2272 Re: Zimmer NexGen Knee Implant Products Liability Litigation, (MDL Docket No. 2272, U.S. District Court for the Northern District of Illinois)
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.
(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.
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.
> 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.
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.).
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.)
>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)
>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).
>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
>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).
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)
Non-Missouri Plaintiffs Dismissed From Essure Litigation “No Personal Jurisdiction”
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)
>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 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.)
To see how Fentanyl is made in China drug labs, marketed online, shipped to North America, processed upon arrival and how it makes its way to your area! Click on the link below for a video outline of how simple it’s been to smuggle Fentanyl.
(MASS TORT NEXUS MEDIA) Fentanyl: Manufactured in China, it easily crosses porous borders, triggering a heroin-like bliss in users – and, all too often, death. It’s as easy as ordering a book online: Sign up for an account, choose a method of payment, and receive the package in three to four business days.
But first, there are some choices to make. The fentanyl hydrochloride comes in a variety of quantities, ranging from a half-gram sample for $35 (U.S) to a kilogram for $21,000. It also comes in different strengths – purchasers are warned to “be careful” and do their research on the product, described as 99-per-cent pure. And of course, there are the related pharmaceutical products: the fentanyl patches, tablets and even lollipops.
Buyers are assured their package won’t get seized at the Canadian border. To avoid the risk of detection, says a supplier from China, he conceals the purchase alongside urine test strips. Not that there’s reason to worry: Canadian border guards cannot open packages weighing less than 30 grams without the consent of the recipient. (A Globe and Mail reporter corresponded with sellers and suppliers using a pseudonym and did not disclose himself as a journalist, in order to obtain accurate information from the seller.)
The supplier, who identified himself only as Alan, says he has two customers in Canada. He e-mails photos of fentanyl hidden inside silica-desiccant packets – the type normally used when shipping goods such as electronics – and a screen shot of a recent order from Canada, including a shipping address for a clothing store in British Columbia’s picturesque Okanagan Valley.
Alan says he is based in the southern metropolis of Guangzhou, the trading crossroads for manufacturing in China – a country that is, in turn, at the centre of the vast underground world of synthetic-drug manufacturers. Enforcement is fragmented, and companies operate with impunity.
Fentanyl is an opioid, a class of painkillers that also includes oxycodone and morphine. Prescription-grade fentanyl is up to 100 times more toxic than morphine. Developed in 1959 by a Belgian chemist, it was quickly adopted as a pain reliever and anesthetic in medical settings. It came into widespread use in the mid-1990s with the introduction of the transdermal patch that releases the drug into the patient’s bloodstream over two or three days. When the drug is processed in a clandestine lab with no quality controls, it is difficult to get the dosage right, making it potentially much more dangerous.
Chemical companies in China custom-design variants of pharmaceutical-grade fentanyl by tweaking a molecule ever so slightly. A few hundred micrograms – the weight of a single grain of salt – are enough to trigger heroin-like bliss. But the line between euphoria and fatal overdose is frighteningly thin: An amount the size of two grains of salt can kill a healthy adult.
The supply chain for illicit fentanyl begins in China, but the problems Canada is experiencing start right here at home: No other country in the world consumes more prescription opioids on a per-capita basis, according to a recent United Nations report. The widespread use of prescription opioids is behind the rise of a new class of drug addicts, many of whom are turning to the black market to feed their habit. In British Columbia and Alberta, the two hardest-hit provinces, fatal overdoses linked to fentanyl soared from 42 in 2012 to 418 in 2015.
Among the investigation’s findings from interviews with nearly three dozen medical experts, public-health doctors, police and family members of overdose victims: Federal and provincial rejection of harm-reduction measures hindered the response to the fentanyl crisis in Alberta. Neither Ottawa nor the provinces are taking adequate steps to stop doctors from indiscriminately prescribing highly addictive opioids to treat chronic pain – in 2015 alone, doctors wrote enough prescriptions for one in every two Canadians. And addiction-treatment programs are few and far between – a legacy of the former Conservative government’s tough-on-crime policies.
The investigation also found that online suppliers are exploiting gaps at the border. Fentanyl and many chemically similar drugs are classified as controlled substances in Canada, making them illegal to import without a licence or permit. But, for online suppliers, the borders may as well not exist; they devise clever ways to conceal the drugs and skirt inspection rules. Suppliers often ship drugs in packages under the 30-gram threshold, ensuring border agents won’t open them. One supplier with whom a Globe reporter corresponded promised to ship fentanyl inside a gift-wrapped package. Another pledged, “No problem of police coming to you,” as the package would be labelled household detergent, complete with a certificate of analysis. Many suppliers will even offer guaranteed reshipment to customers in the event their package gets intercepted.
Because illicit fentanyl is so potent, once it arrives here, the white crystalline powder gets diluted with powdered sugar, baby powder or antihistamines before it can be sold on the street and consumed. It is also mixed into other drugs, and sold as heroin or OxyContin.
As Canada wakes up to a mounting public-health crisis, it is left playing catch-up with the United States, which is confronting its own epidemic of illicit and prescription drug abuse. Policymakers in Canada do not even have the basic tools to monitor this leading cause of accidental deaths – in contrast to the situation in the United States, there is no national system tracking fatal opioid overdoses.
The arrival of illicit fentanyl in Canada is a “game changer,” says Benedikt Fischer, a senior scientist at Toronto’s Centre for Addiction and Mental Health. When Canada’s opioid problem involved only the abuse of prescription drugs, he says, policymakers squandered an opportunity to address it. Now that many addicts are turning to a drug that is manufactured without government oversight – and in countries beyond our borders, to boot – it is nearly impossible to get a grip on the problem. “Even if we wanted to now suddenly take action, there’s nothing we can do,” he says. “We have no way of controlling thousands of illegal drug labs in China.”
The First Major Canadian Fentanyl Bust
It was the winter of 2012 when a Montreal police detective heard about a drug-dealing operation run by Patrick Provencher, at the time, unknown to police. But it would take another year for Det. Yves Rousseau to confirm the seemingly innocuous tip about the low-level drug dealer that would lead to the first big bust of a Canadian operation dedicated to producing and selling industrial quantities of bootleg fentanyl.
The case was uncharted territory for Canadian law enforcement – three investigators became ill after kicking in the door of the illicit lab and handling the toxic drug, including one who spent a night in hospital. The police drug lab, to which hundreds of kilograms of drug-making substances were hauled, was placed under quarantine. The fire department’s hazardous-material unit had to decontaminate the drugs before they could be examined.
“All of these products were in residential neighborhoods, next to people living their lives,” Det. Rousseau testified in court proceedings, after Mr. Provencher’s 2013 arrest, as he told an astonished judge about the turn of events. “This was very dangerous to public security.”
A year after police were tipped off about Mr. Provencher, a 40-year-old computer engineer trained at Montreal’s École Polytechnique, a second source confirmed the information. Mr. Provencher had recruited Jason Berry, a 33-year-old who had just served time for producing and selling drugs, as his business partner. The two men had set up a lab in a garage in the hardscrabble Pointe-Saint-Charles neighborhood, rented several storage units, and were running the business out of the downtown gym where Mr. Provencher worked.
They received raw material from China, cut the drug with fillers, put the mixture through a pill-press machine to produce tablets, and then shipped them by courier all over North America, often in hollowed-out appliances. In fact, police arrested the two men on their way to a UPS store to ship a microwave oven containing 10,180 fentanyl tablets to New Jersey.
Police found nearly 200,000 pills in various storage units along with pill presses, pulverizers and dryers capable of churning out thousands of tablets an hour. The two men pleaded guilty, and were each sentenced to about eight years in prison in 2014, minus credit for time served. “The quality of the pills was unbelievable and the quantity was unheard of,” Det. Rousseau said.
An Opioid Addicted Nation
The raid of the Montreal lab in April, 2013, shows how fentanyl has revolutionized the illegal drug trade. Unlike the massive infrastructure and cartels required to manufacture and transport heroin or cocaine, just about anyone can buy and sell fentanyl. Because it is so powerful, a little goes a long way. A kilogram ordered over the Internet – an amount equal in weight to a medium-sized cantaloupe – sells on the street in Calgary for $20-million, making it a drug dealer’s dream.
The collective inaction of government leaders, doctors, police and border officials leaves Canada dealing with the fallout from a drug that wouldn’t even be on the streets were it not for a decision made two decades ago. Until the mid-1990s, opioids were primarily prescribed to cancer patients and others suffering debilitating pain. But in 1996, Health Canada approved OxyContin, a brand-name version of oxycodone, to relieve moderate-to-severe pain, heralding a sea change in the treatment of pain.
Purdue Pharmaceutical, the maker of OxyContin, launched sales campaigns promoting the benefits of the drug. Doctors started prescribing it for everything from backaches to fibromyalgia. OxyContin quickly became the top-selling long-acting opioid in Canada. But it also became a lightning rod in the early 2000s, as reports of addiction and overdoses exploded.
The Office of the Chief Coroner of Ontario raised concerns, noting in a 2004 report that deaths linked to oxycodone climbed steadily between 1999 and 2003, according to documents obtained by The Globe through an access-to-information request. The report says that although no attempt was made to determine whether the detected oxycodone was due to “the ingestion of OxyContin or any other oxycodone-containing formulation, it is noteworthy that the increase in the prevalence of oxycodone findings in death investigations coincides with the introduction of Oxycontin [sic] to the Canadian market.”
OxyContin was popular not only with people who became addicted after receiving prescriptions, but also with heroin users, because they could easily snort it like cocaine or inject it like heroin for a quick high.
In 2012, Purdue pulled OxyContin from the market and replaced it with OxyNEO, a tamper-resistant alternative that is difficult to crush, snort or inject. That same year, the provinces stopped paying for either opioid through their public drug plans. But by focusing specifically on those two drugs, medical experts say, policy makers missed the larger picture. Prescriptions for alternative painkillers, including hydromorphone and fentanyl, rose sharply: The crackdown pushed drug abusers and legitimate patients towards other, potentially addictive painkillers.
The removal of OxyContin left a void that organized crime exploited, says Sgt. Luc Chicoine, the RCMP’s National Drug Program Co-ordinator. Responding to an e-mail from The Globe, Purdue spokeswoman Aimee Sulliman said that the increase in fentanyl-related deaths across Canada is “tragic and a significant public-health concern,” but that it is unfair to blame OxyContin for the rise of the illicit drug. “This is a complex issue and the simplistic causality assertion of the question is misleading.”
Demand for a replacement for OxyContin also gave rise to another problem – a counterfeit version of the drug laced with illicit fentanyl smuggled into Canada and processed for street sale in labs. The labs would typically dye their pills green to mimic the 80-milligram OxyContin pills favored by opioid abusers, and sell them as “greenies” or “shady eighties.”
In comparison to Europeans, North Americans rely heavily on pharmacological solutions to medical woes. In a culture whose citizens pop over-the-counter pills to treat every minor ailment, says Sgt. Darin Sheppard, of the RCMP’s Federal Serious and Organized Crime Synthetic Drug Operations, many drug users view the “greenies” as deceptively harmless.
“It’s just a pill to many people,” Sgt. Sheppard says. “Now, we’re starting to realize the true aspect of what harm can be realized as a result of this.”
Police across Canada have shut down 20 fentanyl labs since that first major bust in April, 2013, mostly operated by organized-crime groups, according to a Globe review. The biggest raids were in B.C., Alberta and Saskatchewan. Police have also made dozens of busts involving illicit fentanyl and the prescription-grade patches. This week, police charged a doctor and a pharmacist from the Toronto area with participating in a fentanyl trafficking ring.
The Canada Border Services Agency (CBSA), the first line of defence in preventing illicit goods from entering the country, is responsible for clearing international mail. In 2015, the agency made just under 11,000 illicit-drug seizures, half of which came through the postal system. And yet, even as the volume of all commercial goods cleared at the border increases, including international mail, the number of front-line officers continues to shrink.
As long as fentanyl continues to arrive in Canada undetected, municipal police cannot arrest themselves out of the problem, says Calgary Police Staff Sgt. Martin Schiavetta. He wants to know how serious the federal government is about fentanyl. “Are they aware of the scope of the problem?” he asks. “What strategies does the RCMP have to deal with these Chinese imports? Does CBSA have enough capacity to deal with all the packages?”
The problem is compounded by the fact that the illicit drug is highly profitable for traffickers. Hakique Virani, an Edmonton physician and former deputy medical officer at Health Canada, described the “whack-tastic” profits for traffickers during a conference last November for the Canadian Society of Addiction Medicine. The raw materials and equipment, including a kilogram of pure fentanyl powder and an industrial-grade pill press, cost under $100,000, he said in his presentation. A kilo of powder is enough to produce one million tablets, which sell for $20 each in Calgary. Police chiefs in Alberta asked the federal government last November to make it illegal to import and operate industrial pill presses, but have had no response.
Deadly Denial of Crisis
Many medical experts say that the former Conservative government did not devote enough resources to harm-reduction measures (such as the provision of overdose antidotes) to address the side effects of drug abuse; Ottawa fought a war on drugs instead, primarily by prosecuting low-level offenders.
Any mention of harm reduction was banished from Health Canada’s website in 2007, when the federal department changed the name of its National Drug Strategy to the National Anti-Drug Strategy.
The Conservatives quietly spread the word that not-for-profit groups would have difficulty getting federal funding if they continued to provide harm-reduction programs. Margaret Ormond, project director of Sunshine House, a harm-reduction centre in Winnipeg, says she was told that if she wanted to continue receiving funding from Ottawa, she should not “go on and on about harm reduction” in her application. Sunshine House stopped seeking federal funding six years ago.
Stephen Harper’s Conservatives also attempted to shut down Insite, North America’s only supervised-injection site, in Vancouver’s impoverished Downtown Eastside, which allows addicts to safely inject illegal drugs under a nurse’s supervision. The Conservatives eventually lost that battle at the Supreme Court of Canada, which in 2011 ordered the government to allow Insite to remain open. The government responded to the ruling by introducing legislation making it difficult, if not impossible, for other sites to open, even though Insite has demonstrated that it has reduced overdose deaths.
“Under the previous government, Health Canada did virtually nothing of consequence to address this epidemic,” says David Juurlink, head of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre in Toronto. “In some ways, their actions have made it worse.”
Health Canada did not reply to The Globe’s request for comment on how opioids are managed. In a statement, the spokesman for Alberta’s health minister said that the province is actively looking for ways to improve physician education and prescription monitoring, but could not provide specifics on when any results are expected.
In an interview, federal Health Minister Jane Philpott says she is committed to addressing the problem and to making sure people struggling with opioid abuse have access to harm-reduction programs. “I have talked to families who have lost loved ones, whose lives could have been saved if they had either the opportunity to access a supervised-injection site or if the family had known about the availability of naloxone,” Ms. Philpott says, referring to an antidote that reverses the symptoms of an overdose in minutes. “Nothing is more heartbreaking than hearing the stories of these families.”
Rupa Patel, a family physician in Kingston – who, like a lot of her colleagues, has many patients asking for prescription opioids – sees an additional way the government could help mitigate the crisis: by introducing mandatory prescribing limits.
Unlike the United States, which released new guidelines last month advising doctors not to prescribe opioids for chronic pain in most situations, Canada has not revised its guidelines since 2010. Opioid prescriptions totalled 19.1 million in 2015, up from 18.7 million the year before, according to figures compiled for The Globe by IMS Brogan, which tracks pharmaceutical sales.
Dr. Patel sets her own limits with her patients, often refusing to prescribe painkillers, because the risks are substantial and the benefits uncertain. But saying no is difficult, she says, because patients are often in distress. “People expect a pill to fix their problems.”
Even if new guidelines were introduced, there are still not enough resources, nationally, to treat addiction. More beds are needed for those going through withdrawal as well as treatment programs for people addicted to painkillers, especially for aboriginals and those living in remote areas.
And as the pipeline for black-market drugs leads to an unprecedented surge in deaths, Canada has been slow to make naloxone more widely available. Last month, Health Canada changed the status of naloxone to a non-prescription drug. But before it can be sold without a prescription, each province and territory needs to approve the loosened restrictions – something that is not expected to happen until June or July in several regions.
No province has been hit as hard as Alberta, where fentanyl was found in the blood and urine of 392 fatal-overdose victims over the past two years.
During those early days of the crisis, both federal and provincial health officials were slow to grasp the enormity of the problem, The Globe investigation found. The Alberta government did not issue a province-wide warning to doctors about illicit fentanyl until December, 2014. And it was not until a year later that Alberta’s health minister allowed all first responders across the province to treat overdose victims with naloxone.
The southwestern community of Stand Off, on the Blood Tribe reserve (also known as Kainai Nation), has endured a disproportionate number of Alberta’s deaths. Dr. Esther Tailfeathers, a family physician from Blood Tribe, responded to her first fentanyl overdose in July, 2014. She had just pulled her car into the parking lot of a shopping centre in Lethbridge when she saw a man in a white minivan slumped over the steering wheel. Only minutes earlier he had taken a pill. In the back seat, four children were crying for help as he lost consciousness.
The young man would survive that day. But within months, the reserve in a socially conservative corner of Alberta, where neighbouring communities enforce prohibition and cherish abstinence, would become ground zero for an emerging public-health crisis.
Within days of her first brush with fentanyl, Dr. Tailfeathers began seeing other overdose victims in her hometown of 12,800. At first, she treated one or two overdose cases a week. But that quickly escalated to two or three a shift. “We’ve never seen anything like this,” she says.
Patients soon began sharing stories about illicit pills circulating in the streets of their sprawling reserve near the Montana border. Drug dealers from Calgary and the small First Nations community of Maskwacis travelled there with backpacks full of fentanyl, selling each pill for $80. One girl collapsed at a party after snorting fentanyl, Dr. Tailfeathers says. “We put a tube in her nose, and while she and I were talking I pulled the tube out. There was a green pill stuck in the end.”
By August of 2014, reports of mounting deaths in Blood Tribe began arriving in the Edmonton office of Dr. James Talbot, the province’s chief medical officer at the time. Dr. Talbot quickly set up a working group and invited Dr. Michael Trew, then the province’s chief addictions and mental health officer, to join.
The first thing the two doctors tried to do was distribute naloxone kits to first responders. But they ran into roadblocks: While specialized paramedics were allowed to administer the drug, the majority of first responders in Alberta could not.
The Blood Tribe ended up reaching out to Dr. Virani, who was then still a deputy medical officer at Health Canada, for its first batch of naloxone kits. Dr. Virani remembers his employees going to discount stores to buy the plastic containers that would hold the first 90 doses of the antidote. “At the time that I sent naloxone to Blood Tribe, Health Canada made every effort not to talk publicly about it,” he says.
Meanwhile, crime rates began to soar in Blood Tribe. The community was already struggling with poverty, income inequality and substance abuse. Addicts were breaking into homes looking for valuables. People sold everything they owned to buy another pill, says Dr. Tailfeathers, with some nursing a habit that cost as much as $300 a day. She visited homes where there was no food, no heat and no blankets. The four walls of one house were covered with writings about suicide. “It’s like a natural disaster on the reserve,” she says.
In March of 2015, the local band council declared a state of emergency, making it the first community in the country to sound the alarm because of fentanyl. Despite that, Dr. Virani says that Health Canada told him to stop speaking publicly about First Nations health in Alberta. He resigned from the department last month. While he declined to comment about his departure, he accused the bureaucracy of being slow to respond to the fentanyl crisis and being out of step with the minister, Dr. Philpott. “I think she’s a public-health champion on this,” he says.
The naloxone program that Dr. Virani started in Blood Tribe, where the federal government has jurisdiction, helped reduce the number of people overdosing. But once the epicentre of the fentanyl crisis shifted to Calgary, it was up to the provincial government to take action.
In the final months of the former Conservative government’s time in power, the health minister mobilized the first resources to combat fentanyl. Shortly before the government was defeated last May, Alberta sent a notice to hospitals and clinics warning about the risks associated with illicit fentanyl and recommending naloxone to reverse the effects of an overdose. The end-of-government decision may explain what happened next. During the first chaotic week of New Democratic rule in Alberta, both Dr. Trew and Dr. Talbot were told by senior members of the civil service that they were being let go when their contracts expired. A new chief medical officer has yet to replace Dr. Talbot.
The strain was clear on Staff Sgt. Schiavetta’s face during an interview in February. He took over Calgary Police’s drug unit in early 2015, just as fentanyl use began to skyrocket in the city – 81 people in Calgary died from fentanyl overdoses last year, including residents of all genders, ages and socioeconomic groups. Complicating matters, his officers seized three pills last August that were later identified as W-18, an experimental drug 100 times more potent than fentanyl.
But fentanyl remains the drug that takes up most of Staff Sgt. Schiavetta’s time. “Calgary is flooded with fentanyl,” he says.
While Alberta has borne the brunt of the fallout from the arrival of bootleg fentanyl from China, no one saw it coming, Dr. Trew says. “It hit us between the eyes.”
The scourge of illicit fentanyl is now rapidly expanding east. Deaths linked to fentanyl more than doubled to 29 in Manitoba last year, according to a Globe tally of provincial coroners’ figures. In Ontario, fentanyl was the leading cause of opioid deaths for the first time in 2014 – the most recent figures available – and several communities (including Toronto, Kingston and the Niagara region) have been hit with a spike in fatal overdoses in recent weeks.
Back to the Source in China
Little is known about the companies in China that make fentanyl, including whether the substance is the product of backyard laboratories or professional chemists concocting it on the side. Or, more likely, both.
For most potential buyers, fentanyl manufacturers appear to exist in plain view, openly advertising the drugs they make. On the Chinese Internet – where no trace of them can be found – and on the ground, it’s a different story altogether.
A Globe reporter travelled to Wuhan to search for the addresses posted online by a series of drug sellers and laboratories. One address pointed to a massive apartment-construction project. Several others were for street numbers of buildings that have either been demolished or were never there.
One clue lies in photographs sent to Rodney Bridge, an Australian man who became an expert on Chinese drug manufacturing after his 16-year-old son died from taking a lab-made drug similar to LSD. His son jumped off a balcony, thinking he could fly.
Mr. Bridge travelled twice to China in search of the person who sold the $2 pill to his son. Vendors sent him pictures of their labs. One showed a cobbled-together arrangement resembling a high-school chemistry lab. Another showed a large industrial operation in a warehouse, complete with a forklift.
Chinese officials have taken steps to crack down on the illicit drug business. Last October, the country banned 116 substances, including a half-dozen types of fentanyl. Hu Minglang, a director of China’s National Narcotics Control Commission, told The Globe the ban has been “very effective.”
But the ban appears only to have succeeded in placing chemicals slightly under the radar. Dharma Chemicals, a supplier named by the World Health Organization as a seller of acetylfentanyl, one of the 116 illegal chemicals, has struck the drug from its catalogue. But in response to e-mailed queries, a Dharma representative promised quick delivery of the drug, writing, “stock is available.”
China remains in some ways the ideal country to produce synthetic drugs, something no rules are likely to change. As the world’s biggest trading nation, China already sends huge volumes of goods to countries such as Canada, providing “numerous ways to disguise your drugs,” says John Coyne, a former Australian Federal Police intelligence agent who is now head of border security at the Australian Strategic Policy Institute.
It’s a problem the Mexican government has combatted for years. Mexican drug cartels have long imported chemical ingredients from China, which fuel the Latin American country’s manufacture of meth and finance its crime syndicates. “China was never willing to help. They didn’t see it as their problem,” says Jorge Guajardo, the Mexican ambassador to China from 2007 to 2013.
As long as Chinese officials do not crack down more aggressively on exporters, medical experts say, the responsibility for change falls squarely on those in power at the end of the supply chain. “It’s a national tragedy,” says Meldon Kahan, medical director of the Substance Use Service at Women’s College Hospital in Toronto, “and a health-care tragedy where most groups don’t come out looking very good.”
Coming next: How Fentanyl Made it Into the USA for Years
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.
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.