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HERRING FILES SUIT AGAINST FENTANYL MANUFACTURER TEVA/CEPHALON FOR ILLEGAL MARKETING OF OPIOIDS
~ Lawsuit in Richmond City Circuit Court alleges that Teva/Cephalon engaged in an unlawful, decades-long campaign to deceive the public about the risks of its fentanyl products and boost sales ~
RICHMOND (October 31, 2019)—Attorney General Mark R. Herring today filed suit against opioid manufacturer Teva Pharmaceuticals, USA, Inc. and its predecessor, Cephalon, Inc. for engaging in what he alleges is an unlawful, complex, decades-long campaign to boost sales of fentanyl—the most potent narcotic currently approved for human use—by marketing its rapid acting fentanyl drugs for unapproved and unsafe uses, and by knowingly and intentionally downplaying the risks of its drugs while overselling the benefits.
Since 2007, fatal fentanyl overdoses in Virginia have risen by nearly 1,600%, from just 48 in 2007 to more than 800 in 2018. In the same period, nearly 10,000 Virginians have died of a heroin or opioid overdose, including 5,700 from a prescription overdose, and nearly 3,500 from a fentanyl overdose, all while Teva/Cephalon made huge sums of money from its fentanyl drugs.
"Our complaint alleges a coordinated, decades-long campaign by Teva/Cephalon to turn fentanyl—an incredibly dangerous and powerful drug—into a routine part of pain management in America, which is way beyond the scope of the drug's approved use and commonsense. Teva/Cephalon's own research showed that its products posed alarming risks of abuse, addiction, and even death, but that didn't stop them because they were making hundreds of millions of dollars each and every year. This suit describes the mountain of evidence that the company knew its products were dangerous, continued to push them anyway, and subverted any attempts to control misprescribing,” said Attorney General Herring.
"For decades, opioid manufacturers put profit over people, making as much money as possible no matter how many laws had to be broken or how many people were hurt or killed by their drugs. The roots of the opioid crisis run through American medicine cabinets back to the boardrooms and marketing departments of pharmaceutical companies. I am going to hold these companies accountable, put an end to their lies and illegal conduct, and make sure they shoulder the financial burden for addressing the crisis they created.”
The suit centers around the marketing and promotion of two incredibly powerful rapid-acting opioids: Actiq, which is essentially a raspberry flavored fentanyl lollipop, and Fentora, a rapid-release tablet. The approved use of these drugs has always been tightly restricted and limited only to cancer patients, particularly the terminally ill, whose pain cannot be relieved by any other means. The FDA consistently rejected efforts to expand the approved uses because of serious risks that the drugs will be abused, stolen, or accidentally hurt or kill a patient, family member, or child.
Attorney General Herring's suit alleges that for twenty years Teva/Cephalon successfully but illegally used marketing and promotional efforts to transform these powerful, potentially dangerous fentanyl drugs into commonly prescribed drugs for non-cancer patients, helping to fuel the deadly opioid crisis and harming patients, families, and communities in Virginia and around the country.
"Through the actions of the Defendants and other manufacturers, fentanyl, which was intended to be used only for the most untreatable pain, has now become entrenched in both the legal and illegal market: it is widely prescribed, used, and abused, with Virginians and other Americans bearing the consequences,” the complaint states.
The lawsuit also contains previously unrevealed information that shows Teva/Cephalon engaged in a decades-long cover-up to hide and misrepresent clinical trial data so the company could overstate the benefits and effectiveness of the drugs while downplaying the dangers of abuse and misuse.
Attorney General Herring's lawsuit against Teva/Cephalon alleges violations of the Virginia Consumer Protection Act. He asks the Court to put an end to the company's unlawful sales and marketing practices and to award restitution and civil penalties as it deems appropriate. Portions of the lawsuit have been filed under seal, however the Commonwealth will be moving to unseal and release the full, unredacted complaint as quickly as possible.
The History of Actiq
Actiq was a controversial drug from its very inception. Its "fentanyl lollipop” form was inspired by veterinarians' use of carfentanil sugar cubes to immobilize large wild animals like elk or moose. Because the FDA was worried about Actiq's overdose and addiction risks, the FDA strictly limited its approved use to metastatic cancer patients and required Actiq's manufacturer to abide by a strict risk management program to limit abuse and protect public health. Once the drug was acquired by Cephalon, and later by Teva, the company immediately sought to boost sales by promoting its use in unapproved ways and by subverting the risk management measures that were essential to the FDA's approval.
The result was an explosion of fentanyl use by non-cancer patients. The complaint alleges that Actiq prescriptions increased nine-fold during just a three-year period in the early 2000s, and that Actiq sales rose from $15 million to $600 million in just six years.
When an internal auditor warned that Cephalon was out of compliance with its risk mitigation obligations, the company simply fired the auditor rather than making the changes needed to comply with the law and keep patients safe.
The History of Fentora
In 2006, the patent on Actiq expired and Cephalon then focused on Fentora, a new rapid-release oral fentanyl product that was again intended only to provide relief to those "suffering unbearable pain due to cancer.” The company doubled down on the strategy it had used to turn Actiq into a moneymaker: subverting its risk mitigation obligations, lying about its product, and pushing for as many prescriptions as possible.
Attorney General Herring's lawsuit states that "the predictable, predicted, and alarming result was that Fentora continued to be prescribed widely for non-cancer conditions like back pain, headaches, and migraines – conditions for which it was too risky.”
Prescriptions again exploded, increasing five-fold in just one year. The FDA was quickly forced to issue a "Public Health Advisory” for Fentora based on reports of "death and life threatening side effects.”
Despite all this, Teva/Cephalon nevertheless asked the FDA to expand the approved use of Fentora to include non-cancer patients. As part of its review, the FDA reviewed data submitted by the company and found startlingly high rates of abuse, misuse, and theft, including theft of drugs from clinical trial sites. The FDA ultimately rejected the application to expand Fentora into non-cancer patient use and neither it, nor Actiq, has ever been approved for non-cancer patient use.
Manipulation of Research and False Claims
The Complaint alleges that fentanyl generally and Actiq and Fentora specifically were approved with barely any testing of their risks of addiction or abuse. The few industry-sponsored long-term clinical trials that Teva/Cephalon ran were rife with problems and showed that Fentora's efficacy and risks were not what the companies claimed.
For years Teva/Cephalon has knowingly made false and misleading claims about both the efficacy and safety of Actiq and Fentora based upon shoddy industry-sponsored clinic trials. For example, in long term clinical trials the company simply gave participants 100-150 fentanyl pills with few limits on their usage. Unsurprisingly, patients began abusing and misusing Fentora and engaging in alarming drug-seeking behavior. One study showed that at least 17% of patients who took Fentora for more than four months showed signs of dependence, though the true number was likely much higher, and research showed that patients' average daily dosage increased by nearly 50% over the course of study.
In sum, the lawsuit states that "Fentora increased the risk of addiction while bringing fleeting and diminishing relief, and Defendants both knew this.”
Attorney General Herring's Work to Address the Opioid Crisis
As part of his ongoing efforts to hold pharmaceutical companies accountable for their role in creating and prolonging the opioid crisis, Attorney General Herring has also filed suit against Purdue Pharma and members of the Sackler Family, the owners of Purdue, alleging decades of illegal conduct designed to enrich the company and family by selling the most opioids possible. In his suit against the Sackler family, filed in September 2019, Attorney General Herring also alleges that the family fraudulently extracted billions of dollars from the company in an effort to put the money beyond the reach of investigators and those suing the company.
Attorney General Herring also continues to participate in a bipartisan, multistate effort to investigate and hold opioid manufacturers and distributors accountable for their roles in the opioid crisis.
The heroin and prescription opioid epidemic has been a top priority for Attorney General Herring. He and his team continue to attack the problem with a multifaceted approach that includes enforcement, education, prevention, and legislation to encourage reporting of overdoses in progress, expand the availability of naloxone, and expand access to the Prescription Monitoring Program. He has supported federal efforts to improve the availability of treatment and recovery resources and made prescription drug disposal kits available across the Commonwealth.
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