Tribe files lawsuit against opioid distributors, manufacturers

by Jan 11, 2018Front Page, NEWS ka-no-he-da0 comments





Last summer, the Eastern Band of Cherokee Indians declared the opioid crisis a public nuisance.  Now, the Tribe has filed a civil lawsuit against a list of manufacturers and wholesale distributors of prescription opioids.

The 161-page lawsuit, filed in U.S. District Court in Asheville on Thursday, Jan. 4, fulfills a resolution, submitted by Principal Chief Richard G. Sneed, that was passed by Tribal Council on Oct. 16, 2017 that directs a Special Counsel to take action “against all manufacturers and wholesale distributors legally responsible for causing or contributing to the opioid epidemic plaguing our Tribe”.

Listed as defendants in the lawsuit are: Amerisourcebergen Drug Corporation; Cardinal Health, Inc.; McKesson Corporation; Purdue Pharma L.P.; Purdue Pharma, Inc.; The Purdue Frederick Company, Inc.; Teva Pharmaceutical Industries, Ltd.; Teva Pharmaceuticals USA, Inc.; Cephaon, Inc.; Johnson & Johnson; Janssen Pharmaceutical, Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc. n/k/a Janssen Pharmaceuticals, Inc.; Janssen Pharmaceutica Inc. n/k/a Janssen Pharmaceuticals, Inc.; Noramco Inc.; Endo Health Solutions, Inc.; Endo Pharmaceuticals, Inc.; Allergan PLC f/k/a Actavis PLS: Watson Pharmaceuticals, Inc. n/k/a Actavis, Inc.; Watson Laboratories, Inc.; Actavis LLC; Actavis Pharma, Inc. f/k/a Watson Pharma, Inc.; Mallinckrodt PLC and Mallinckrodt LLC.

The suit lists several complaints including: Complaint for Public Nuisance, Violations of Racketeer Influenced and Corrupt Organizations Act, Negligence and Negligent Misrepresentations, Negligence Per Se, Civil Conspiracy, and Fraud and Fraudulent Misrepresentations.

The lawsuit states, “Plaintiff brings this civil action to eliminate the hazard to public health and safety caused by the opioid epidemic, to abate the nuisance caused thereby, and to recoup monies spent because of Defendants’ false, deceptive, and unfair marketing and/or unlawful diversion of prescription opioids.  Such economic damages were foreseeable to Defendants and were sustained because of Defendants’ intentional and/or unlawful actions and omissions.”

It goes on to allege, “The manufacturers aggressively pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction.  These pharmaceutical companies aggressively advertised to and persuaded doctors to prescribe highly addictive, dangerous opioids and turned patients into drug addicts for their own corporate profit.”

The suit also alleges that both the distributors and manufacturers “intentionally and/or unlawfully breached their legal duties under federal and EBCI law to monitor, detect, investigate, refuse, and report suspicious orders of prescription opiates.”

An amount is not listed in the suit, but the Tribe is seeking various damages including, “(A) costs for providing medical care, additional therapeutic and prescription drug purchases, and other treatments for patients suffering from opioid-related addiction or disease, including overdoses and deaths; (B) costs for providing treatment, counseling, and rehabilitation services; (C) costs for providing treatment of infants born with opioid-related medical conditions; (D) costs for providing care for children whose parents suffer from opioid-related disability or incapacitation; and (E) costs associated with law enforcement and public safety relating to the opioid epidemic.”

When the resolution was passed by Tribal Council in October, Chief Sneed commented, “Should we prevail in court, any settlement funds would be designated for rehabilitation, education, and law enforcement.”

He went on to state, “This is a manufactured crisis.”

The Eastern Band of Cherokee Indians is one of the first few federally-recognized tribes in the country to file litigation on this crisis.

The Cherokee Nation filed a lawsuit against six companies (McKesson Corporation; Cardinal Health, Inc.; Amerisource Bergen; CVS Health; Walgreens Boot Alliance, Inc.; and Wal-Mart) in April 2017 “charting the companies with failing to prevent the flow of illegally prescribed opioids to men, women, and children in the Cherokee Nation.”

Cherokee Nation Principal Chief Bill John Baker said at the time, “Tribal nations have survived disease, removal from our homelands, termination and other adversities, and still we prospered.  However, I fear the opioid epidemic is emerging as the next great challenge of our modern era.  As we fight this epidemic in our hospitals, our schools, and our Cherokee homes, we will also use our legal system to make sure the companies, who put profits over people while our society is crippled by this epidemic, are held responsible for their actions.”

Three tribes in South Dakota including the Rosebud Sioux Tribe, the Flandreau Santee Sioux Tribe, and the Sisseton-Wahpeton Oyate filed a lawsuit, through trial firm Robins Kaplan LLP, on Monday, Jan. 8 against 24 distributors and manufacturers of opioids.

“The effects of opioids on South Dakota tribes has been horrific,” said Brendan Johnson, former U.S. Attorney for South Dakota who is now a part of the Robins Kaplan LLP team.  “This epidemic has overwhelmed our public health and law enforcement services, drained resources for addiction therapy, and sent the cost of caring for children of opioid-addicted parents skyrocketing.  This is a crisis that affects virtually every tribal member in the state.”

The One Feather contacted each defendant in the EBCI lawsuit seeking comment.  Following are statements from those we heard back from by press time.

John Puskar, Purdue Pharma L.P. public affairs director, commented, “We are deeply troubled by the prescription and illicit opioid abuse crisis and are dedicated to being part of the solution. As a company grounded in science, we must balance patient access to FDA-approved medicines, while working collaboratively to solve this public health challenge. Although our products account for approximately 2 percent of the total opioid prescriptions, as a company, we’ve distributed the CDC Guideline for Prescribing Opioids for Chronic Pain, developed three of the first four FDA-approved opioid medications with abuse-deterrent properties and partner with law enforcement to ensure access to naloxone. We vigorously deny these allegations and look forward to the opportunity to present our defense.”

Puskar went on to note, “Unlike the past tobacco litigation, our medicines are approved by FDA, prescribed by doctors, and dispensed by pharmacists, as treatments for patients suffering from severe pain.”

John Parker, spokesperson for the Healthcare Distribution Alliance, a national trade group that represents wholesale distributors including AmerisourceBergen, Cardinal Health, and McKesson, said in a statement to the One Feather, “As distributors, we understand the tragic impact the opioid epidemic has on communities across the country.  We are deeply engaged in the issue and are taking our own steps to be part of the solution – but we aren’t willing to be scapegoats.  Distributors are logistics companies that arrange for the safe and secure storage, transport, and delivery of medicines from manufacturers to pharmacies, hospital, long-term care facilities, and others based on prescriptions from licensed physicians.  We don’t make medicines, market medicines, prescribe medicines, or dispense them to consumers.”

He continued, “Given our role, the idea that distributors are solely responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and how it is regulated.  We are ready to have a serious conversation about solving a complex problem and are eager to work with political leaders and all stakeholders in finding forward-looking solutions.”

Sarah Freeman, spokesperson for Janssen Pharmaceuticals, Inc., commented, “Responsibly used opioid-based pain medicines give doctors and patients important choices to help manage the debilitating effects of chronic pain. At the same time, we recognize opioid abuse and addiction is a serious public health issue that must be addressed.”

On the suit itself, she noted, “We believe the allegations in the lawsuits against our company are both legally and factually unfounded. Janssen has acted in the best interests of patients and physicians with regard to its opioid pain medicines, which are FDA-approved and carry FDA-mandated warnings about possible risks on every product label. According to independent surveillance data, Janssen opioid pain medicines consistently have some of the lowest rates of abuse among these medications, and since 2008 the volume of Janssen opioid products always has amounted to less than 1 percent of the total prescriptions written per year for opioid medications, including generics. Addressing opioid abuse will require collaboration among many stakeholders and we will continue to work with federal, state and local officials to support solutions.”

Heather Zoumas Lubeski, Endo senior director of corporate affairs, said, “Endo is dedicated to providing safe, quality products to patients in need and we share the public concern regarding opioid abuse and misuse. We are committed to working collaboratively to develop and implement a comprehensive solution to the opioid crisis, which is a complex problem with several causes that are difficult to disentangle. Any serious solution must therefore be multifaceted and consider, among other things, the legitimate access needs of the millions of patients suffering from acute or chronic pain who rely on opioids to improve their quality of life.”

She added, “Toward that goal, Endo has taken meaningful action during the past year by voluntarily ceasing opioid promotion and eliminating its entire product salesforce. Endo also voluntarily withdrew Opana® ER from the market following FDA’s request despite having a statutory right to challenge that request, implemented additional anti-diversion measures and terminated its new opioid product development programs.”

She concluded with, “It is Endo’s policy not to comment on current litigation. That said, we deny the allegations contained in this lawsuit and intend to vigorously defend the Company.”