Opioid Makers Challenge Suit -- WSJ

This article is being republished as part of our daily reproduction of WSJ.com articles that also appeared in the U.S. print edition of The Wall Street Journal (September 12, 2017).

A group of opioid painkiller makers has asked an Ohio court to dismiss the state's case alleging the companies misrepresented the addiction risks of their drugs, arguing the lawsuit is "fatally defective."

Ohio's lawsuit, filed in state court in May, targeted parent companies or subsidiaries of Purdue Pharma LP, Johnson & Johnson, Teva Pharmaceutical Industries Ltd., Allergan PLC and Endo International PLC, alleging they fraudulently marketed their drugs by overselling the benefits and playing down the addictive risks of the painkillers, helping create an addiction crisis.

Since then a number of other states have filed similar lawsuits against painkiller makers or distributors, including New Hampshire, South Carolina, Oklahoma, Missouri and New Mexico.

In a joint motion to dismiss, the companies argued that Ohio failed to offer any specifics to its fraud allegations, as required under the law, and that the claims are pre-empted by federal law and Food and Drug Administration regulations.

The companies also took issue with one of Ohio's main claims: that the drug industry engaged in a decadeslong fraud to persuade doctors and patients to use opioids for chronic pain rather than just severe, short-term pain.

The FDA has approved extended release, long-acting versions of some opioids to be used to treat chronic pain, the companies argued, which they said undermines Ohio's allegations.

"At its core, the complaint seeks to substitute the Ohio Attorney General's judgment about how to weigh the risks and benefits of chronic opioid therapy for the FDA's judgment," the companies said.

In addition to the joint request, the manufacturers each filed separate motions to dismiss the case.

The pharmaceutical companies also argued that Ohio failed to support two additional claims: that the defendants deceived the state into reimbursing opioid prescriptions, or that specific doctors relied on the companies' allegedly fraudulent marketing when writing prescriptions.

On Monday, the Ohio Attorney General's office said it was reviewing the companies' filings and would file a response in court "in due course."

Should the court decline to dismiss the case, the defendants requested in a separate joint filing that the court stay, or suspend, the case pending what they described as an FDA review of opioid painkillers. The FDA, the defendants said, has asked opioid companies to conduct additional studies to assess the risks of addiction, overdose and death associated with long-term use of opioid painkillers.

The FDA has "primary jurisdiction" over drug safety and efficacy matters, the defendants argued. The FDA didn't immediately respond to a request for comment.

Write to Jeanne Whalen at jeanne.whalen@wsj.com and Sara Randazzo at sara.randazzo@wsj.com

(END) Dow Jones Newswires

September 12, 2017 02:48 ET (06:48 GMT)