Bill Clinton On The Opioid Crisis “Nobody Gets Out For Free”

“FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

By Mark A. York (April 18, 2018)

 

Former President Bill Clinton Speaks On The Opioid Crisis

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Former President Bill Clinton pulled no punches as he focused directly and commented on how the opioid epidemic “creeps into every nook and cranny of our country” and needs to be addressed as both a huge national problem and a community-by-community tragedy, adding “this can rob our country of the future.”

President Clinton was the keynote speaker at the National Rx Drug Abuse & Heroin Summit, which drew more than 3,000 experts in fields such as addiction treatment, law enforcement and medicine from across the country recently in Atlanta. He shared his own personal experiences as well as voicing his opinions on opioid solutions and strategies that work and the many challenges facing the country in the future.

He was very clear when stating that there’s no room for stigma in the face of such an urgent and widespread problem. Nearly every family is touched by the issue — including his. Not only does he have family members who have struggled with drug abuse, he said at least five close friends have lost children and family members to overdoses, including two native Arkansans, first-generation immigrants from India and Kosovo and African-American preachers. This is the common thread in the opioid crisis fabric, there is no social or demographic group that is exempt from the epidemic.

“Nobody gets out of this for free,” which seems to be where most of the finger pointing and blame game issue of the highest importance. The checkbook to pull the country out of this national opiate epidemic will be in the hundreds of billions of dollars and even then, the costs of social and economic damage to date, will never be recovered.

From 2000 to 2016, government research data shows that more than 600,000 people died from drug overdoses — nearly 64,000 in 2016 alone. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

The former president referred to the work done by his Clinton Foundation, who’ve provided both training and resources to communities fighting addiction and makes the opioid antidote naloxone more available to the public at a low cost.

He discussed programs elsewhere that he believes work well, including a unique medical system in eastern Pennsylvania where no doctors prescribe opioids. When a patient comes in who may legitimately need the painkillers, a panel headed by a highly educated pharmacist looks at that option as well as other alternatives. The panel does all the opioid prescribing, he said, and opioid prescriptions have dropped dramatically.

Clinton praised community health centers, local county health units and faith based community groups who are spearheading efforts in in caring for people struggling with addiction. He said grass roots solutions often work best because each place is different, and its residents know it best.

He also added the United States as a whole faces many challenges, including the rise of the deadly synthetic opioid fentanyl, which is making its way “into the bloodstream of America” from China. He said the United States “ought to get the Chinese to help us” and must also do more to stop the heroin flowing in from Mexico. Many others in government have directed attention to the Chinese government for help, but to date, there has been very limited assistance from China on this.

He further stated that the country must do more to reduce demand for drugs. And that will mean addressing issues at the root of addiction, such as hopelessness and poverty. Many overdose victims, he said, are ultimately “dying of a broken heart.” How treatment programs can be more widely accepted as well as becoming approved as a disease treatment versus a “drug addict” problem, remains to be seen.

“The roots of this are deep in our soul,” Clinton said. “You know it and I know it.”

During the Clinton years in office, he enacted various drug control programs and strategies which primarily focused on drug abuse prevention, drug use education, drug treatment and enforcement. Clinton White House archives, show he elevated the position of “drug czar” to a cabinet-level post, expanded drug courts, provided funding across the country and stepped up drug-related enforcement efforts. To support these programs and efforts, overall funding for anti-drug efforts rose from $12.2 billion in 1993 to $18.5 billion in 2000.

Although there were critics the time, many were determined to be politically motivated and more of a rhetorical attack on Bill Clinton politics as a whole. These included the 1994 report by the conservative Heritage Foundation titled, “How the Clinton Administration is Abandoning the War Against Drugs,” which falsely claimed Clinton’s “new direction will allow more cocaine, heroin and marijuana to reach American streets, and it will cut federal enforcement personnel.” Which simply furthered the now misguided correlation between marijuana use and hard drugs. The group also said one of the first announced goals of then-Attorney General Janet Reno was to reduce mandatory minimum sentences for drug trafficking and other related crimes, sentences the group argued “put teeth in drug enforcement.” This has been proven to be inaccurate and a distortion of the attempts to bring crime and punishment more in line with the times and how criminal sentencing were applied in lower economic areas of the country.

Clinton said today’s fight against drugs must be a bipartisan effort that pulls together Americans from all parts of the political spectrum. Although this would be a sincere effort to bring political parties together to address a problem that is now firmly implanted across the United States.

 “We can do this. And it will be really good for us, because it’s about time we did something together again,” he said. “Last time I checked, anytime we did anything together, we never lost.”  Mr. Clinton’s stance on a joint effort to address the opioid crisis seems genuine, but based on the many views within the current DC political world, beginning with President Trump and his view that the problem is drug users versus taking a step back view that society itself along with Big Pharma are accountable for the current opiate epidemic.

What the solutions are for solving the Opioid Crisis across the country remain to be seen and as stated by President Clinton “nobody gets out for free.”

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More Doctors Charged With Taking Opiate Rx Kickbacks From Insys Therapeutics, Inc.

“MD’s Paid To Write Fentanyl Based Subsys Prescriptions”

Subsys, a fast acting fentanyl spray

 

 

 

 

 

 

 

 

 

 

 

(Mass Tort Nexus Media) Following the indictments of the entire Insys Therapeutics, Inc. Board of Directors in late 2016, and then criminal charges against company founder John Shapoor in October 2017,  the US Attorney’s office in New York has brought federal charges against five New York doctors who accepted kickbacks from Insys in exchange for prescribing the company’s fentanyl-based cancer pain medication.

The multi-count indictment filed last week in Manhattan federal court charged physicians Gordon Freedman, Jeffrey Goldstein, Todd Schlifstein, Dialecti Voudouris and Alexandru Burducea with receiving payment from Insys to participate as speakers, in order to enable illegal fees paid for writing fentanyl based prescriptions. Under the guise of “educational events”, the speaking fees were simply a mechanism to pay the doctors, as Insysy has done across the country since mid 2015.

As far as how this “pay to prescribe Subsys” policy came about, here’s a look at what’s taken place at the Insys Therapeutics, Inc. executive level.

INSYS EXECUTIVES INDICTED

December 2016 saw Insys Therpaeutics CEO Michael Babich and five other senior executives indicted on criminal charges for paying kickbacks and bribes to medical professionals and committing fraud against insurance companies across the country for offering a highly addictive Fentanyl prescription product “Subsys” to the masses. The Insys boardroom was indicted in the US District Court of Massachusetts, where the entire team has engaged a stable of top national law firms to defend the indictments. The “Subsys” sales teams were charged in federal indictments across the country, including Arkansas, Connecticut, Alaska and New York and the indictments will only increase as these cases proceed and “cooperating witnesses” decide that prison isn’t an option.

To compound further harsh scrutiny for Insys, it’s new CEO Saeed Motahari, moved over from Purdue Pharmaceuticals, the Oxycontin maker, who’s also a major target of criminal and civil investigations across the country by local state and federal agencies. Purdue is charged with false marketing, off-label use and ignoring the Oxycontin highly addictive dangers for years, while bringing in literally billions of dollars in profits.

PRIOR DOCTOR INDICTMENTS

Doctors who’ve written massive numbers of Subsys prescription, under the “fee to speak” program have been indicted and they include pain clinics, medical centers and other healthcare facilities who now face federal criminal charges for fraudulent prescription writing, submitting false claims to insurance companies and numerous other federal charges and all face a minimum of 20 to 50 years in federal prison. Two of the busiest “Subsys” prescription writers in the country were Alabama doctors, John Couch and Xiulu Ruan, who earned over $40 million from Insys, and were charged with running a pill mill between 2013 and 2015, have been convicted and sentenced to 20 years each in federal prison.

The top “Subsys” prescriber of all, Dr. Gavin Awerbach, of Saginaw, MI pled guilty to defrauding Medicare and Blue Cross out of $3.1 million in improper Subsys prescriptions, his criminal sentence is pending. To show the far reach of Insys and its corporate plans to saturate the US market with opioids, in Anchorage, Alaska Dr. Mahmood Ahmad, was charged with a massive Subsys prescribing operation, which he denies, but immediately surrendered his Alaska medical license which caused the revocation of his license Arkansas.

THE OFF LABEL CAMPAIGN

The only people who are supposed to be taking Subsys are adult cancer patients, according to the FDA “Subsys” approval files, anything other than that is an “off label” indication. Now you can take a drug to treat something off label if you want to, but you have to get your doctor to get pass a prior authorization.

Anthem alleges that Insys has an entire unit to get around this requirement — it’s titled the “reimbursement unit.” Investigative journalists exposed this fraud initially as far back as 2015 on behalf of the Southern Investigative Reporting Foundation, see Insys Therapeutics “Subsys” Off Label Rx Fraud.

The Reimbursement Unit claim was basically the company’s fraudulent prescription approval factory, which helped participating doctors process claims (the doctors had so many they couldn’t handle them all). The unit falsified records to show patients had cancer and called insurers, pretending to be patients or other medical professionals, to facilitate approval of payment for off-label treatment.

This is the Unit’s script for obtaining off-label approval (taken from the Anthem suit):

The script read: “The physician is aware that the medication is intended for the management of breakthrough pain in cancer patients. The physician is treating the patient for their pain (or breakthrough pain, whichever is applicable).” The script deliberately omitted the word “cancer as applied to the patient treatment under discussion.”

Prosecutors also said that two former Insys employees who were first charged in 2016 in connection with the scheme, Jonathan Roper and Fernando Serrano, had secretly pleaded guilty and become cooperating witnesses. The five doctors were arrested last Friday morning and face charges including that they violated the federal anti-kickback law and conspired to commit fraud.

INSYS RX ABUSES WERE BLATANT

The case is the latest in a series of medical practitioners and former Insys executives and employees facing criminal charges related to Subsys, the company’s potentially addictive fentanyl-based spray.

Federal prosecutors in Boston are moving forward aggressively against the seven former Insys executives and managers as well billionaire founder John Kapoor, all accused of actively designing and participating in the scheme to bribe doctors to prescribe Subsys and to defraud insurers into paying for it. Insys has said it may need to pay at least $150 million towards part of a settlement with the U.S. Justice Department as well as numerous other state investigations around the country, not to mention the civil complaints filed against the company in the Opiate Prescription MDL 2804, see OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION, where the Insys sales and marketing tactics are listed as prime examples of boardroom designed “profits over patients” policies are cited.

 

Insys is joined in the massive Federal Opioid MDL 2804, by other Big Pharma defendants including Purdue Pharmaceuticals, Endo Health, J&J’s Janssen Pharmaceutical and other opioid manufacturers who were allowed to place profits over patients for more than 15 years, while earning billions in profits.

UNETHICAL SALES TACTICS

According to the most recent and prior doctor indictments, the physicians have participated in Insys’ speaker programs, which were in reality social gatherings at high-end restaurants. They earned kickbacks ranging from $68,000 and $308,000 and were among the top 20 prescribers of Subsys nationwide at some point during the marketing campaign. A few doctors indicted as far back as late 2016 have already been sentenced to federal prison terms up to 20 years and forfeit of millions of dollars in assets. The Insys marketing tactics included trips with doctors to strip clubs with Insys sales managers; and often with Insys executives, where they covered lap dances and drinks which on one trip ran up a tab of over $4,100 which was apparently enough to convince physicians to write massive numbers of off-label fentanyl prescriptions.

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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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UNITED STATES DEPARTMENT OF JUSTICE CRACKS DOWN OF OPIOID INDUSTRY AS A WHOLE

US ATTORNEY CREATES NATIONAL TASK FORCE  TO CRACK DOWN ON OPIOID INDUSTRY

By Mark A. York (February 27, 2018)

MASS TORT NEXUS MEDIA

Attorney General Sessions Announces New Prescription Interdiction & Litigation Task Force

Official Press Release: Feb. 27, 2018

Attorney General Jeff Sessions today announced the creation of a new effort, the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force, to fight the prescription opioid crisis.  The PIL Task Force will aggressively deploy and coordinate all available criminal and civil law enforcement tools to reverse the tide of opioid overdoses in the United States, with a particular focus on opioid manufacturers and distributors.

“Over the past year, the Department has vigorously fought the prescription opioid crisis, and we are determined to continue making progress. Today, we are opening a new front in the war on the opioid crisis by bringing all of our anti-opioid efforts under one banner,” said Attorney General Sessions.  “We have no time to waste.  Every day, 180 Americans die from drug overdoses.  This epidemic actually lowered American life expectancy in 2015 and 2016 for the first time in decades, with drug overdose now the leading cause of death for Americans under age 50.  These are not acceptable trends and this new task force will make us more effective in reversing them and saving Americans from the scourge of opioid addiction.”

The PIL Task Force will include senior officials from the offices of the Attorney General, the Deputy Attorney General, and the Associate Attorney General, as well as senior officials from the Executive Office for U.S. Attorneys, the Civil Division, the Criminal Division, and the Drug Enforcement Administration.   The Task Force will coordinate the Department’s many efforts and tools to combat the opioid epidemic.

The PIL Task Force will combat the opioid crisis at every level of the distribution system.  At the manufacturer level, the PIL Task Force will use all available criminal and civil remedies available under federal law to hold opioid manufacturers accountable for unlawful practices.  The PIL Task Force will build on and strengthen existing Department of Justice initiatives to ensure that opioid manufacturers are marketing their products truthfully and in accordance with Food and Drug Administration rules.

The Attorney General has also directed the PIL Task Force to examine existing state and local government lawsuits against opioid manufacturers to determine what assistance, if any, federal law can provide in those lawsuits.  The federal government has borne substantial costs from the opioid crisis, and it must be compensated by any party whose illegal activity contributed to those costs.

The Department will also use all criminal and civil tools at its disposal to hold distributors such as pharmacies, pain management clinics, drug testing facilities, and individual physicians accountable for unlawful actions.

The PIL Task Force will use criminal and civil actions to ensure that distributors and pharmacies are obeying Drug Enforcement Administration rules designed to prevent diversion and improper prescribing.  It will use the False Claims Act and other tools to crack down on pain-management clinics, drug testing facilities, and physicians that make opioid prescriptions.

The PIL Task Force will use the criminal and civil tools available under the Controlled Substances Act against doctors, pharmacies, and others that break the law.  The PIL Task Force will build upon and expand the efforts of the existing Opioid Fraud and Abuse Detection Unit.  Created in August 2017, the Unit uses sophisticated data analysis to identify and prosecute individuals who are contributing to the opioid epidemic, including pill-mill schemes and pharmacies that unlawfully divert or dispense prescription opioids for illegitimate purposes.

The PIL Task Force will also work closely with the Department of Health and Human Services to investigate and hold accountable any parties who engage in illegal activity surrounding prescription opioids.  The Attorney General has directed the PIL Task Force to establish immediately a working group to:  (1) improve coordination and data sharing across the federal government to better identify violations of law and patterns of fraud related to the opioid epidemic; (2) evaluate possible changes to the regulatory regime governing opioid distribution; and (3) recommend changes in laws.

This new Task Force will build on a number of new initiatives begun by Attorney General Sessions over the past year that will help us end the drug crisis, including the following:

  • In July, the Attorney General announced charges against more than 120 defendants, including doctors, for crimes related to prescribing or distributing opioids and other dangerous narcotics.
  • One week later, the Attorney General announced the seizure of AlphaBay, the largest criminal marketplace on the Internet.  This site hosted some 220,000 drug listings – including more than 100 vendors advertising fentanyl – and was responsible for countless synthetic opioid overdoses, including the tragic death of a 13-year old in Utah.
  • In August, the Attorney General created the Opioid Fraud and Abuse Detection Unit, a new data analytics program to help find evidence of overprescribing and opioid-related health care fraud.
  • The Attorney General then assigned 12 experienced Assistant United States Attorneys to opioid “hot-spots” to focus solely on investigating and prosecuting opioid-related health care fraud. By November they had begun issuing indictments.
  • In October, the Department announced the first-ever indictments of Chinese nationals and their North American-based traffickers and distributers for separate conspiracies to distribute fentanyl and other opioids in the United States.
  • Also in October, the DEA announced the establishment of six new enforcement teams focused on combatting the flow of heroin and illicit fentanyl into the U.S. These enforcement teams are based in communities facing some of the most significant challenges with heroin and fentanyl.
  • In 2017, the DEA held two of its National Prescription Drug Takeback Days, when people can dispose of unnecessary and potentially dangerous drugs with no questions asked. In total, DEA took a record 956 tons of drugs out of American communities.
  • In January 2018, the Department announced a new resource to target traffickers who sell drugs online called J-CODE: Joint Criminal Opioid Darknet Enforcement team.  The J-CODE team will coordinate efforts across the FBI’s offices all around the world – bringing together DEA, our Safe Streets Task Forces, drug trafficking task forces, Health Care Fraud Special Agents, and other assets – effectively doubling the FBI’s investment into fighting against online drug trafficking.
  • Also in January 2018, the DEA announced a 45-day surge of Special Agents, Diversion Investigators, and Intelligence Research Specialists to focus on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of drugs.
  • On February 7, 2018, the DEA placed all fentanyl analogues not already regulated by the Controlled Substances Act into Schedule I – the category for substances with no currently accepted medical use – for at least two years.  This makes it harder for people to acquire illicit fentanyl and easier for law enforcement to investigate and prosecute drug traffickers.
  • The Department anticipates filing a statement of interest in the coming days in a multi-district action regarding hundreds of lawsuits against opioid manufacturers and distributors.

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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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This Week In Mass Torts Around The Country: Week of February 19, 2018

By MASS TORT NEXUS MEDIA

 

Opiate MDL 2804 Settlement Talks Start Before Discovery

See also OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION

>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

See also Johnson & Johnson Talcum Powder Litigation Briefcase

>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.

 Xarelto Phila Court Bellwether Plaintiff Argues Trial Evidence Ignored

See Also XARELTO Case No. 2349 in Philadelphia Court of Common Pleas Briefcase – Complex Litigation (PA State Court)

>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.

 Purdue Pharma Initiated Opioid Crisis With Massive Opiate Rx Marketing Push

See also Targeting Big Pharma and Their Opiate Marketing Campaigns

>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

 See also  RISPERDAL – PHILADELPHIA COURT of COMMON PLEAS

 >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.

Pennsylvania Appeals Court Won’t Overturn Plaintiff Risperdal Verdict

See also Punitive Damages Now Allowed in Philadelphia Risperdal Suits Per Superior Court Ruling

>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

See State of Kentucky and Counties vs. Opioid Makers and Distributors

 >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.

Settlement Agreement Reached In Zimmer NexGen Knee MDL 2272

 See also ZIMMER NexGen Knee MDL 2272 Briefcase (USDC ND Illinois)

>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)

 

 

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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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