Tuesday, May 14, 2019

State Sues Opioid Maker on Marketing Claims

Posted By on Tue, May 14, 2019 at 1:51 PM

click to enlarge JUSTIN FOX BURKS
  • Justin Fox Burks

The state of Tennessee sued an opioid manufacturing company recently on marketing claims that its products were less addictive and more effective than other products.

Attorney General Herbert Slatery said Tuesday the state sued Endo Pharmaceuticals and Endo Health Solutions Inc. for violating the state’s consumer protection laws and contributing to “a devastating public health crisis in Tennessee.”

“Our office has conducted an extensive investigation into Endo’s unlawful marketing practices, which included targeting vulnerable populations like the elderly,” Slatery said in a statement. “Endo has repeatedly refused to take responsibility for its unconscionable conduct, which is why we are taking this action.”

The state’s 180-page complaint is sealed as Endo said some of the information it contains is confidential. The seal expires in 10 days, unless Endo moves to extend it. Slatery said the complaint should be made available to the public in its entirety and “efforts to keep it confidential will only prolong and diminish Endo’s accountability for its conduct.”
Slatery
  • Slatery
Endo deceptively marketed its opioid products as being less addictive and more effective than others on the market, Slatery said.

“It did this despite evidence to the contrary, including the (U.S. Food & Drug Adminstration’s) explicit rejection of Endo’s claim that Opana (extended release - ER) was resistant to abuse as well as overwhelming evidence that Opana ER was being abused throughout Tennessee,” reads the statement.

Tennessee argues the company knew the dangers of its opioid products, including increased risks of respiratory depression and death in elderly patients. Also, the company did not clearly disclose those risks while it specifically targeted patients in that age group, says Slatery’s office.

In June 2017, the FDA asked Endo to remove Opana ER from the market. It was the first time the agency acted to remove an on-the-market opioid pain medication from sale "due to the public health consequences of abuse.”

"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said at the time. “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market. This action will protect the public from further potential for misuse and abuse of this product.”

The company’s stock slid from $94.46 per share in April 2015 to to $6.69 in Tuesday afternoon trading, according to Google Finance.

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