- Kentucky Attorney General Andy Beshear on Monday filed a lawsuit against Endo Pharmaceuticals plc, claiming the opioid manufacturer violated the state's Consumer Protection Act through deceptive marketing of its drug Opana ER.
- In the 72-page complaint, Beshear asserts Endo misled prescribers by hyping Opana ER's benefits without adequately detailing the drug's risk for addiction. More than 190 people from Kentucky have died from overdosing on the prescription painkiller, according to a statement from Beshear's office.
- "The vast market for opioids was created and sustained in significant part by Endo’s deceptive marketing in establishing opioids as a first-line treatment for chronic pain," the lawsuit alleges. "Endo's deceptive marketing caused patients to believe they would not become addicted, addicted patients to seek out more drugs, and health care providers to make and refill opioid prescriptions that maintain dependence and addiction."
Endo finds itself at the center of controversy as U.S. lawmakers, healthcare providers and families attempt to get an ongoing opioid epidemic under control
Earlier this year, the Food and Drug Administration took an uncommon step and asked Endo to pull Opana ER (oxymorphone hydrochloride) from the market due to the products risks outweighed its benefits.
"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market," Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a June 8 statement.
Pulling the drug from market, however, hasn't stopped Endo from promoting it on the internet, Beshear contended. Additionally, the company still actively sells other prescription painkillers, including Percocet (acetaminophen and oxycodone), which earned $31 million for the three months between April and June.
"Endo failed to disclose or misrepresented clinically significant risks of Opana, Opana ER, Percocet, Percodan, and opioid therapy to Kentucky consumers and their doctors," the lawsuit states, going on to detail how Endo used key opinion leaders and additional third party sources to promote its opioids, practices that were "unconscionable, offend public policy; are immoral, unethical, oppressive, or unscrupulous."
In an emailed statement to BioPharma Dive, Endo's Chief Legal Officer Matthew Maletta fired back at Beshear's characterization of his company's actions. "[T]he public statement made by Kentucky Attorney General Andy Beshear today in connection with filing suit against Endo that this organization and its dedicated employees seek to 'line their pockets at the expense of communities' is patently offensive. We intend to vigorously defend the Company against the claims set forth in this lawsuit."
Endo's shares fell about 2% on Monday to close at $6.24 apiece. The company's stock has slipped over the course of 2017 amid mounting litigation and increased regulator pushback against opioid-based painkiller.