States Across The Country Are Targeting Big Pharma and Their Opiate Marketing Campaigns

Is Big Pharma The Target of Litigation Modeled After Tobacco Litigation?  

Mark A. York,  October 6, 2017

 

 

 

 

 

 

 

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

Opiate Rx MDL 2804 Parallels State Claims

The state actions are now parallel to the September 25, 2017 filing of a “Motion for Consolidation in “The Opiate Prescription Litigation MDL 2804”, with the Joint Panel for Multidistrict Litigation. MDL 2804, where numerous Midwest counties in Ohio, Kentucky and West Virginia as well as the city of Birmingham, Alabama joined together to file suit against the 3 largest distributors of opiates in the country, McKesson Corp., Cardinal Health and AmerisourceBergen Corporation. Also named in the suit are the primary Big Pharma opiate manufacturers including Purdue Pharma, J&J’s Janssen Pharmaceuticals, Endo, Teva and others as additional defendants.

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

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

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

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

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

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

New Jersey Files Against Insys Therapeutics

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

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

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

Ohio Filed First

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

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

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

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

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“NATIONAL PRESCRIPTION OPIATE LITIGATION MDL No. 2804”

Transfer Motion Accepted by JPML On September 29, 2017

By Mark A. York

Mass Tort Nexus (September 29, 2017)

 

 

 

 

 

 

 

The  Motion to Transfer and Consolidate MDL No. 2804, now known as “National Prescription Opiate Litigation”, was accepted by the JPML on September 29, 2017 see “JPML Motion to Consolidate Prescription Opiate Litigation as MDL 2804”, with the apparent motion hearing date being November 30, 2017 at the Joint Panel on Multidistrict Litigation hearings in St Louis, Missouri. The consolidation motion was filed by Hill, Peterson, Carper, Bee & Dietzler, based in Charleston, WV. The filing is the long expected result of the ongoing “Opioid Crisis” which has seemingly overtaken many aspects of day to day life in America, with a particular emphasis on rural America. The many small towns and counties have seen unheard of increases in overdose deaths and 911 calls for drug overdoses, which have depleted budgets and caused ever mounting levels of grief for stricken families as well as tension in government council meetings everywhere, when attempting to address the crisis.

The consolidation filing is followed in the Mass Tort Nexus briefcase, “National Prescription Opiate Litigation MDL”,as the motion directly cites the nation’s three largest wholesalers of opiod drugs, McKesson Corporation, AmerisourceBergen Corporation and Cardinal Health, Inc. as well as naming primary drug makers Purdue Pharma, Teva, Cephalon, Janssen, Endo, Actavis and Mallinckrodt as defendants in certain actions. Opiate drug makers and their executives are now firmly in the sights of not only mass tort lawyers, but facing the full force of criminal investigation by the US Department of Justice in every state, as indictments have already been handed down in several federal venues. The MDL filing contains complaints that specifically reference RICO claims in many of the 66 federal actions cited in the motion, to be transferred into the JPML venue.

The pharmaceutical industry already faces dozens of lawsuits brought by cities, counties and states — including Ohio, Missouri and Oklahoma. Some are trying to recoup the costs incurred from the surge in emergency response from spikes in opioid-related overdoses. The strategy is reminiscent of the successful litigation brought by states and municipalities three decades ago against tobacco companies.

The opioid drug industry expanded in the 1990s in response to the medical community’s push to better treat pain and chronic pain.

A primary focus is the how and why of , millions of opioid users became addicted to opioids, or heroin, after being prescribed the medication by doctors and the apparent failure of corporate executives to address the ever mounting evidence in light of the enormous profits, year in and year out.

Many doctors, in turn, said they were assured by the drugmakers that the opioids were less addictive or even not addictive, which in the civil matters will be a point of very high contention and potentially a focus of US DOJ investigators.

Some states have obtained consent decrees and financial penalties from drug makers, including Illinois, “My investigations have shown that drug companies pressure physicians into prescribing powerful, addictive drugs without regard for the law or patients’ well-being,” said Illinois Attorney General Lisa Madigan, who is also party to the new investigation.

SHOTS – HEALTH NEWS

Intent On Reversing Its Opioid Epidemic, A State Limits Prescriptions

Now, many state prosecutors say they will examine whether the industry was complicit in creating the epidemic and whether it should now be responsible for helping pay for the damage caused to many communities.

Allergan said it was “working cooperatively” with the attorneys generals on their requests for information. The other companies being investigated did not immediately issue statements, and industry lobbying group PhRMA didn’t respond to a request for comment.

The number of opioid prescriptions has declined in recent years, after federal regulators placed new limits on the drugs. That reduced the amount of opioids prescribed by 18 percent in 2015, from a peak in 2010, according to the Centers for Disease Control and Prevention.

Still, as the state attorneys general and other community leaders note, the slowdown in prescriptions has been offset by greater demand for cheaper alternatives such as heroin.

“For millions of Americans, their personal battle with opioid addiction did not start in a back alley with a tourniquet and syringe,” Schneiderman said. “They got hooked on medicine they were prescribed for pain or that they found in a medicine cabinet.”

“Governmental entities across the country are now joining together and stating “We are taking this action today because our communities and homes have been broken and families torn apart by this epidemic,” and this known danger was ignored by opioid drug makers, “This epidemic has claimed victims from all walks of life, and both the financial and emotional costs to our citizens.”

Primary allegations include “That the manufacturing companies pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction, while the distributors breached their legal duties to monitor, detect, investigate, refuse and report suspicious orders of prescription opioids:, which is applicable to all afflicted communities across the country.

From the extensive research by Mass Tort Nexus to date, it appears that this is just the tip of the litigation iceberg that will be brought against all levels of opiate pharmaceutical manufactures and affiliated distributors in the USA. Based on US Dept. of Justice criminal filings, the executive boardrooms are not exempt from indictments and criminal charges,  as well as the many doctors, sale and marketing professionals and others who helped facilitate the current opioid crisis, which directly results in related civil and mass tort actions against all involved.

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AS EXPECTED A “NATIONAL PRESCRIPTION OPIATE LITIGATION MDL FILING” IS ON THE JPML DOCKET

Transfer Motion Filed To Create New Opioid Rx Multidistrict Litigation

By Mark A. York

Mass Tort nexus (September 28, 2017)

A Motion to Transfer and Consolidate the “National Prescription Opiate Litigation”, was filed on September 25, 2017 see “JPML Motion to Consolidate Prescription Opiate Litigation”, with the Joint Panel on Multidistrict Litigation. An MDL number designation has not been assigned as of Thursday the 28th, but the filing and designation are under JPML review.  The motion was filed by Hill, Peterson, Carper, Bee & Dietzler, based in Charleston, WV. The filing is the long expected result of the ongoing “Opioid Crisis” which has seemingly overtaken many aspects of day to day life in America, with a particular emphasis on rural America. The many small towns and counties have seen unheard of increases in overdose deaths and 911 calls for drug overdoses, which have depleted budgets and caused ever mounting levels of grief for stricken families as well as tension in government council meetings everywhere, when attempting to address the crisis.

The consolidation filing is followed in the Mass Tort Nexus briefcase, “National Prescription Opiate Litigation MDL”,as the motion directly cites the nation’s three largest wholesalers of opioId drugs, McKesson Corporation, AmerisourceBergen Corporation and Cardinal Health, Inc. as well as naming primary drug makers Purdue Pharma, Teva, Cephalon, Janssen, Endo, Actavis and Mallinckrodt as defendants in certain actions. Opiate drug makers and their executives are now firmly in the sights of not only mass tort lawyers, but facing the full force of criminal investigation by the US Department of Justice in every state, as indictments have already been handed down in several federal venues. The MDL filing contains complaints that specifically reference RICO claims in many of the 66 federal actions cited in the motion, to be transferred into the JPML venue.

STATES HAVE FILED SUIT ALREADY

The pharmaceutical industry already faces dozens of lawsuits brought by cities, counties and states — including Ohio, Missouri and Oklahoma. Some are trying to recoup the costs incurred from the surge in emergency response from spikes in opioid-related overdoses. The strategy is reminiscent of the successful litigation brought by states and municipalities three decades ago against tobacco companies.  The common understanding is that the “Opiate Rx Litigation MDL” and related lawsuits across the country, may equal or surpass the tobacco litigation in both scope and financial penalties paid by drug makers.

The opioid drug industry expanded in the 1990s in response to the medical community’s push to better treat pain and chronic pain.

A primary focus is the how and why millions of opioid users became addicted to opioids, or heroin, after being prescribed the medication by doctors and the apparent failure of corporate executives to address the ever mounting evidence in light of the enormous profits, year in and year out.

WARNINGS TO DOCTORS INADEQUATE

Many doctors, in turn, said they were assured by the drugmakers that the opioids were less addictive or even not addictive, which in the civil matters will be a point of very high contention and potentially a focus of US DOJ investigators.

Some states have obtained consent decrees and financial penalties from drug makers, including Illinois, “My investigations have shown that drug companies pressure physicians into prescribing powerful, addictive drugs without regard for the law or patients’ well-being,” said Illinois Attorney General Lisa Madigan, who is also party to the new investigation.

 

 

 

 

 

 

 

 

 

Intent On Reversing Its Opioid Epidemic, A State Limits Prescriptions

Now, many state prosecutors say they will examine whether the industry as a whole, was complicit in creating the epidemic and whether it should now be responsible for helping pay for the damage caused to many communities.

Allergan said it was “working cooperatively” with the attorneys generals on their requests for information. The other companies being investigated did not immediately issue statements, and industry lobbying group PhRMA didn’t respond to a request for comment.

The number of opioid prescriptions has declined in recent years, after federal regulators placed new limits on the drugs. That reduced the amount of opioids prescribed by 18 percent in 2015, from a peak in 2010, according to the Centers for Disease Control and Prevention.

Still, as the state attorneys general and other community leaders note, the slowdown in prescriptions has been offset by greater demand for cheaper alternatives such as heroin, now recognized by medical industry leaders, substance abuse professionals, law enforcement and now mass tort lawyers, as a primary direct result of the massive opioid prescription writing campaign for so many years.

ADDICTIONS STARTED WITH A PRESCRIPTION

“For millions of Americans, their personal battle with opioid addiction did not start in a back alley with a tourniquet and syringe,” industry leaders are stating “They got hooked on medicine they were prescribed for pain or that they found in a medicine cabinet.”

“Governmental entities across the country are now joining together and stating “We are taking this action today because our communities and homes have been broken and families torn apart by this epidemic,” and this known danger was ignored by opioid drug makers, “This epidemic has claimed victims from all walks of life, and both the financial and emotional costs to our citizens.”

Primary allegations include “That the manufacturing companies pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction, while the distributors breached their legal duties to monitor, detect, investigate, refuse and report suspicious orders of prescription opioid, which is applicable to all afflicted communities across the country.

From the extensive research by Mass Tort Nexus to date, it appears that this is just the tip of the litigation iceberg that will be brought against all levels of opiate pharmaceutical manufacturers and affiliated distributors in the USA. Based on US Dept. of Justice criminal filings, the executive suites and boardrooms are not exempt from indictments and criminal charges,  as well as the many doctors, sale and marketing professionals and others who helped facilitate the current opioid crisis, which directly results in related civil and mass tort actions against all involved.

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“THE OPIOID CRISIS IN AMERICA” – How Insys Theraputics, Inc. Sold Stock And Killed Americans At The Same Time With The Help Of Doctors

A REPORT BY MASS TORT NEXUS 

by Mark A. York ( September 26, 2017)

 

 

 

 

 

 

 

 

 

Subsys – an Insys Therapeutics, Inc. Pharmaceutical Opioid Product

      Here’s a perfect example of how corporate greed and licensed medical providers helped create the now rampant US opioid crisis– how payments to doctors and prescribers across the country caused addictive painkillers, like “Subsys” a fentanyl based opioid, to suddenly rip through our country like a flash fire.

Insys Therapeutics,a publicly traded pharmaceutical company based in Arizona, is just one small example of what Big Pharma has been doing for the last 10 years in every city and state in the United States, often increasing corporate earnings right alongside the catastrophic opioid related death rates. For Insys Theraputics executives, the sales team and its nationwide cadre of fraudulent doctors, the results have been felony indictments and long federal prison sentences, with many more to come.

INSYS EXECUTIVES INDICTED

December 2016 saw Insys Therapeutics 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 those 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, but Purdue’s transgressions are in Part 2 of our ongoing reports on big pharma and opioid abuses.

DOCTORS FACING NUMEROUS CHARGES

Doctors and their pain clinics, medical centers and other healthcare facilities have been indicted 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 it’s corporate plans to saturate the US market with opioids, in Anchorage, Alaska Dr. Mahmood Ahmad, was charged with heading a massive Subsys prescribing operation, which he denies, but immediately surrendered his Alaska medical license which the caused the revocation of his medical license in Arkansas.

INSURANCE COMPANIES FILED SUIT

Adding weight to this tragedy is Anthem Insurance — you may recognize them as Blue Cross, one of the largest insurers in the country, now setting their sights on Insys Theraputics and it’s executives.

Anthem is suing Insys Therapeutics, the maker of the powerful opioid Subsys, for allegedly lying, cheating and defrauding its way into the medicine cabinets of Anthem clients across the country. The drug according to Anthem’s complaint, was off market prescribed to thousands of patients for years. Review shows that 54% of patients who are taking Subsys don’t really have cancer — one of the requirements for prescribing the drug, Subsys was FDA approved for “treatment of pain related to cancer” and any other use is unauthorized or off-label use.

Anthem says that’s because Insys devised an elaborate scheme to get around Anthem’s system — by falsifying records and posing as medical professionals, often with the complete knowledge and cooperation of medical doctors across the country who then received thousands of dollars in kickbacks. These doctors chose to exchange high fees from Insys in exchange for writing off-label prescriptions to patients seeking pain relief for non-life threatening conditions.

Anthem claims it ultimately paid $19 million more for Subsys than it should have. “But the harm inflicted by Insys’s conduct is not merely financial in nature,” the complaint states “Insys put Anthem’s members’ health at risk.”

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.”

DO STOCKS RISE AND FALL ON INDICTMENTS

 

 

 

 

 

 

 

In late 2016 the entire top level of Insys executives, including former CEO Michael Babich, and five others were indicted and charged with multiple counts of fraud and conspiracy. Since then a number of sales reps and medical practitioners have pled guilty to charges that they gave or accepted kickbacks in furtherance of the fraudulent prescription scheme. The manager of reimbursement services, Elizabeth Gurrieri, pleaded guilty to wire fraud in June. There have been numerous deaths and related overdoses attributed to the over prescribing of Subsys across the country, which to date, show most parties involved being able to avoid the scrutiny of criminal charges related to off-label marketing and prescribing. Insys has tried to re-shuffle the executive board by bringing in new members, but business as usual in the Big Pharma boardroom goes on, as they simply brought in other more experienced “opioid industry” insiders to help further the continued use of “Subsys” and purportedly the major Insys New Pharma” entry, a line of complex medical marijuana products, that may enable them to shake off the current Insys label as the United States leading “opioid abuse by boardroom design” corporation.

As part of the boardroom strategy to get doctors to prescribe Subsys, Insys spent millions paying them off through a fraudulent “speakers program” meant to educate medical professionals about the drug. The speaking engagements were a veiled attempt to cover-up the direct payment to doctors for writing prescriptions, the more prescriptions you wrote, the higher your “speaking fees” increased. There are e-mails, texts and other Insys communications from all levels of company personnel stating “if they not writing prescription, they’re off the speaking program”, this policy resulted in one Alabama sales rep being paid over $700 thousand in Subsys based Rx commissions for one year, while her base salary was $40 thousand.

“While the exact amount of those kickbacks has yet to be determined, criminal indictments of the recipients indicate that Insys paid “speaker fees” of millions, of dollars, which may result in additional criminal charges against the doctors as well as the doctors facility staff who often worked hand in hand with Insys staff.

SALES REP NATALIE REED PERHAC

In the plea, Perhacs admitted that she was hired to be the personal sales representative for one of Insys’s most important prescribers, Dr. Xiulu Ruan. Ruan is one of two Alabama doctors who picked up over $115,000 in speaker fees from 2012 to 2015, and earned in excess of $40 million in related medical earnings during the same period. Earlier this year they were sentenced to 20 years in jail each for running a “pill mill” and helping Insys sales rep Natalie Reed Perhacs sell Subsys, for which she was paid in excess of $700 thousand in commissions, see Perhac Guilty Plea in Alabama Federal Court.

Perhac Plea Excerpts:

Admision No. 78: . Perhacs admitted that her primary responsibility at Insys was to increase the volume of Subsys® prescribed by Dr. Ruan, and his partner Dr. John Patrick Couch. This… was accomplished by (1) handling prior authorizations for their patients who had been prescribed Subsys®; (2) identifying patients who had been at the same strength of Subsys® for several months and recommending that Dr. Ruan or Dr. Couch increase the patients’ prescription strength; and (3) setting up and attending paid speaker programs.

Admission No. 79:. Ms. Perhac admitted that because of her involvement in the prior authorization process, she knew that the vast majority of Dr. Ruan and Dr. Couch’s patients did not have breakthrough cancer pain.

As you can see by the Perhac admissions, numbers 78 and 79, which reflect the vast number of charges lodged against her, the federal government is cracking down on everyone involved with the “Subsys” fraud. According to confidential sources, the recent June 2017 FDA “Opioid Crisis” Conference and related strategic review of the opioid crisis, will result in many more indictments and charges against drug makers and the medical providers who’ve helped facilitate the opioid epidemic that is currently in place across the United States.

Coming in “The Opioid Crisis In America” Part 2: How Insys Therapeutics, Purdue Pharmaceuticals, Endo Health, J&J’s Janssen Pharmaceutical and other opioid manufacturers were allowed to place profits over patients for more than 15 years…

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