The unredacted Complaint also reveals for the first time the scope of Cephalon's illegal sales practices at this time. It shows Cephalon aggressively targeted non-cancer prescribers and doctors with sales and promotional visits, including doctors specializing in "primary care, family medicine, physical medicine, and neurology,” even though the drugs were only FDA approved to treat cancer patients. Below is a breakdown of Cephalon's sales calls in the first seven months of 2004:

The unredacted Complaint also reveals Cephalon's "ride ‘em up ride ‘em down policy,” which encouraged salespeople to repeatedly target high prescribers up until the point authorities stepped in and stopped the prescriber. As the Complaint explains: "as a high-performing Florida salesperson put it about a high prescribing doctor…‘i[f] I knew that this physician was in town practicing medicine, I would've been in there three times a week pushing him to write more Actiq'”. Cephalon even "affirmatively told salespeople not to report or flag doctors who salespeople knew were prescribing Fentora off-label for the wrong conditions”.

Cephalon Ignored FDA Warnings

The unredacted Complaint reveals a previously unknown series of meetings between the FDA and Cephalon in 2004, in which top FDA officials warned Cephalon that the use of Actiq by non-cancer patients was "staggering…the Agency is very concerned that the situation that occurred with Oxycontin may happen again.” The FDA told Cephalon its sales practices were creating a "significant public health” problem, by providing non-cancer patients with a product so powerful it put them at risk of an immediate overdose.

The unredacted Complaint also reveals that Cephalon did not substantially change its practices with the introduction of Actiq's successor Fentora, in 2006, a rapid-release fentanyl tablet. The company kept targeting providers who were prescribing Fentora for back pain, and other non-cancer conditions, and it kept turning a blind eye to the resulting problems.

Below is an egregious example of a company-approved response to a Q&A produced for their salespeople:

Knowingly Downplaying Risks of Abuse and Overdose While Overselling Benefits and Efficacy

The unredacted Complaint discloses clinical trial data showing that Cephalon and then Teva, which acquired Cephalon in 2011, knew Actiq and Fentora were widely abused and misused by clinical trial patients and knew the drugs were showing potentially alarming diminution in pain relief the longer the patients used them.

The unredacted Complaint reveals that data from clinical trials of Fentora showed that the drug "increased the risk of addiction while bringing fleeting and diminishing relief” and that "patients taking Actiq or Fentora for months or longer exposed themselves to extremely high risks and diminishing pain relief.” According to the unredacted Complaint, in one 18 month clinical trial patients had a:

• 31% increase in pain episodes per day, from 3.5 to 4.6 episodes/day;
• Took 26% more Fentora tablets per day, from 3.5 to 4.4 tablets/day; and
• Had a 42% increase in their average daily Fentora dosage, from 2,162 mcg/day to 3,088 mcg/day.

The companies ghostwrote publications in prominent academic journals, like Cancer, that deliberately misled prescribers and patients about these potential declines in the opioids' pain relieving properties over time. As the unredacted Complaint notes of the Cancer publication about a long-term study of Fentora use by cancer patients, "the actual study data…suggested the opposite of what Cephalon claimed: that the patients who were in study for 12 months or more actually experienced a decline in analgesic efficacy, suggesting an increase in incremental tolerance to Fentora because they were taking more and more doses per day of Fentora and other opioids.” The unredacted Complaint shows that Teva made efficacy claims a "key pillar” of its marketing campaigns for Fentora from 2008 to the present, all while relying on misleading data.

Additionally, the companies were well aware of, but largely did not disclose, alarming clinical trial data about misuse, abuse, and addiction involving Fentora. The unredacted Complaint details how clinical trial patients in long-term cancer and non-cancer trials, none of whom had a history of substance abuse, started exhibiting alarming drug seeking behaviors, what the companies called "aberrant drug related behavior.”

For example, in one non-cancer long-term clinical trial there were frequent incidents of abuse and misuse:

• 11 patients overdosed;
• One patient's husband overdosed;
• 35 patients reported their Fentora stolen;
• Dozens of patients dropped out of the trial without accounting for the 100-plus Fentora tablets they had been given; and
• Five study centers reported Fentora stolen from supposedly secured lockers.

The company claimed in limited disclosures to regulators like the FDA and its European Union counterpart, that the rates of aberrant drug related behavior in study patients were around 17%. Both the FDA and the EU thought this was alarming, and Cephalon's internal discussions showed that medical staff believed this 17% rate could rise to "more than 41%” if patients took Fentora and other opioids for a year or more.

The unredacted Complaint also alleges that in marketing materials and publications disseminated to healthcare providers, academics, and the public, Teva and Cephalon knowingly omitted this data, failing to list these serious cases of misuse and abuse in its tables of adverse events, all while claiming its products were "generally safe” and "well tolerated.”

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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