Friday November 16, 2018
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Beshear Alleges Pharmaceutical Manufacturer’s ‘Off-label’ Marketing Of Cancer Pain Drugs Directly Contributed To Kentucky’s Opioid Epidemic

Attorney General Andy Beshear today filed suit against Pennsylvania-based pharmaceutical manufacturer Teva for allegedly promoting its fentanyl-based cancer drugs for “off-label” use in Kentucky, which directly contributed to the state’s addiction outbreak.

The lawsuit, filed in Fayette Circuit Court, claims Teva persuaded physicians to prescribe its drugs, Actiq and Fentora, to treat chronic pain despite the drugs being approved solely for breakthrough pain in cancer patients.

The lawsuit alleges Teva’s salesforce was instructed to target doctors who were not oncologists, including general practitioners. In one instance, a sales representative alleges that 99 percent of the doctors in her territory were pain specialists not oncologists who wrote prescriptions for off-label use.

Beshear said this allowed the company to grow its market in Kentucky while contributing to the state’s drug epidemic. He said Teva had the largest amount of opioids, per gram, sold in Kentucky over a nearly 10-year period.

“The actions by Teva to deceptively push highly-powerful fentanyl-based opioids into a state like Kentucky that’s ravaged by addiction is probably one of the most egregious acts we have seen from a pharmaceutical company that’s heartlessly focused on profits over our people,” Beshear said. “While Teva is predicting $19 billion in revenues this year, we are seeking to hold them accountable under Kentucky law by making them pay for the damages caused to our state and Kentucky families.”

Fentanyl is 50-100 times more potent than morphine and 50 times more potent than many forms of heroin.

Beshear said in Kentucky and the U.S., overdose deaths related to fentanyl now surpass deaths related to heroin.

According to a July 25, 2018 report released by the Kentucky Office of Drug Control Policy, fatal overdoses in Kentucky totaled 1,565 in 2017, which was an 11.5 percent increase over the previous year. Fentanyl was a factor in approximately 763 deaths and 52 percent of the toxicology cases, which is an increase of about 47 percent compared to 2016.

Beshear’s lawsuit claims Teva took steps to conceal its deceptive marketing and unlawful conduct by funding and working through unbranded marketing, third-party advocates and professional associations to promote opioid use.

According to the lawsuit, Teva sales representatives regularly omitted any discussion of addiction caused by long-term opioid use from their sales conversations with Kentucky prescribers, and despite having knowledge of suspicious prescribing, Teva failed to implement policies and procedures that would enable its sales representatives to report this conduct.

One of Teva’s drugs, Actiq, delivers fentanyl into the bloodstream via a lollipop lozenge. It’s other, Fentora, is an oral tablet that also dissolves in a patient’s mouth.

According to the lawsuit, the FDA expressly prohibited Teva from marketing Actiq for anything but breakthrough cancer pain, which is a sudden flare-up of pain. The FDA refused to approve Fentora for the treatment of chronic pain because of the potential harm, including the high risk of “serious and life-threatening adverse events” and abuse, which the agency said are greatest in non-cancer patients.

In 2008, the Department of Justice accused Cephalon, a Teva subsidiary, of promoting Actiq for uses the FDA had not approved. Cephalon settled the charges for $425 million. The federal government charged that Cephalon promoted Actiq to non-cancer patients for conditions such as “migraines, sickle-cell pain crises, injuries, and in anticipation of changing wound dressings or radiation therapy.”

“Teva has not changed its ways or corrected its past misconduct but instead is continuing to fuel our opioid crisis,” Beshear said.

Beshear said the opioid crisis is having a devastating effect on Kentucky’s workforce. Recent research has demonstrated that the Commonwealth’s high rate of opioid usage has reduced the workforce, created high turnover, increased employers’ costs to train new employees and caused an increase in employee thefts.

Today’s lawsuit is the eighth opioid related lawsuit Beshear has filed.

Beshear has sued three national opioid distributors, Pennsylvania-based AmerisourceBergen, Ohio-based Cardinal Health and San Francisco-based McKesson Corporation, which together are responsible for supplying 85 percent of opioids in Kentucky; distributor and retail pharmacy Walgreens; and pharmaceutical manufacturers Johnson and Johnson, Mallinckrodt, and Endo Pharmaceuticals.

A Franklin Circuit Judge ruled that he would not dismiss Beshear’s 2017 lawsuit against Endo. Beshear recently announced that his office has won fights to keep four of his current opioid lawsuits in Kentucky courts, and that Kentuckians can track the progress of each case by visiting ag.ky.gov.

Beshear is once again calling on lawmakers to create a permanent trust fund to battle addiction in Kentucky. He is working with Rep. Dennis Keene, of Wilder, on legislation that requires funds recovered by the Commonwealth from lawsuits, fines or settlements related to the drug epidemic to only be spent addressing the needs of Kentucky’s drug prevention educators, law enforcement and treatment providers.

Beshear has provided $8 million from a pharmaceutical settlement to 15 substance abuse treatment centers.

And he has launched the state’s first initiative to allow Kentuckians to safely dispose of opioid medications at home. The program has the potential to dispose of more than 2.2 million unused opioids and help to reduce the nearly 80 percent of heroin users who begin their addiction with prescription drugs.

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