Endo Hit with Securities Lawsuit Over Opana ER Product

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Endo International PLC (formerly known as Endo Health Solutions Inc.) and its board of directors are facing a proposed class action lawsuit alleging they misinformed the investing public about their reformulated opioid product that was purportedly resistant to abuse. The suit concerns Opana ER, a pill the case says the company reformulated to resist crushing by possible abusers. According to the complaint, Endo fought to include abuse-deterrent information on the product's labels and to prohibit generic, non-abuse-deterrent versions from entering the market, but was denied by the FDA. Despite this, the defendants allegedly continued to promote the product, relying on claims of its supposed safety advantages.

Beginning in 2016, however, information began to leak into public view that Opana ER was not, in fact, resistant to crushing and still presented a risk of abuse, the suit claims. On March 3, 2016, a settlement between Endo and the Attorney General of New York was released, revealing tests that reportedly contradicted Opana’s abuse-deterrent claims.

Finally, on June 8, 2017, the FDA issued a press release requesting that Endo remove the reformulated product from the market due to concerns that the product’s benefits “no longer outweighed its risks,” the complaint says. Upon this news, Endo’s stock prices allegedly fell over 19.4 percent and dropped an additional two percent when the company announced on July 6, 2017 that it would remove Opana from the market, according to the suit.

The plaintiff argues that Endo hid the truth about Opana’s risks from the investing public while falsely promoting its benefits. As a result, stockholders who purchased or acquired Endo stock between November 30, 2012 and July 6, 2017 were unjustly injured, the suit says.