Opioid Painkiller Makers Seek to Dismiss State Lawsuit
September 11 2017 - 7:14PM
Dow Jones News
By Jeanne Whalen and Sara Randazzo
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 11, 2017 18:59 ET (22:59 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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