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Herring files suit against fentanyl manufacturer Teva/Cephalon

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Attorney General Mark Herring filed suit this week 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 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.

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.

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.

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