Life Science Compliance Update

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June 20, 2017

Ohio Sues Drugmakers Over Opioid Crisis

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Ohio Attorney General Mike DeWine filed a lawsuit against five drug companies on May 31, 2017, alleging that they fueled the opioid addiction crisis by misrepresenting the addictive risks of the painkillers they manufacture. The lawsuit, filed against Purdue Pharma L.P., Johnson & Johnson, Teva Pharmaceutical Industries Ltd., Allergan PLC, and Endo International PLC’s Endo Health Solutions Unit, says the companies violated the Ohio Consumer Sales Practices Act and created a “public nuisance.”

DeWine believes that the companies have been dishonest with both doctors and the general public about the risk of the painkillers. In an interview, he said opioid addiction has “taken an extraordinary human and financial toll on Ohio,” and that the “addiction crisis has placed great financial burdens on the state.”

“You have so many people today who can’t pass a drug test, who can’t work in a factory, who can’t be employed to drive a car or work around machinery or be store manager at McDonald’s because they can’t pass a drug test,” DeWine said.

The Allegations

The Ohio complaint alleges the drug companies violated the Ohio Consumer Sales Practices Act through marketing programs that “falsely deny or trivialize the risks of opioids while overstating the benefits of using them for chronic pain.” The state says the false marketing included medical journal advertising and sales representative statements.

It also alleges the companies engaged in misleading marketing by funding outside groups that have advocated for wider treatment of pain. These groups were “seemingly unbiased and independent patient and professional organizations” but disseminated information that played down the risks of opioids, the complaint alleges.

Ohio is seeking an injunction to prevent the companies from making “misrepresentations” of drug risks, as well as civil penalties to compensate the state for additional costs incurred, associated with the opioid addiction crisis.

Company Response

In a statement about the Ohio case, Johnson & Johnson, parent of Janssen Pharmaceuticals, which sells Duragesic, said: “We firmly believe the allegations in this lawsuit are both legally and factually unfounded. Janssen has acted appropriately, responsibly and in the best interests of patients regarding our opioid pain medications, which are FDA-approved and carry FDA-mandated warnings about the known risks of the medications on every product label,” said the company, referring to the U.S. Food and Drug Administration.

Purdue said, “We share the attorney general’s concerns about the opioid crisis and we are committed to working collaboratively to find solutions.” Allergan and Endo declined to comment.

State Actions Are Becoming More Prevalent

This is not the first action filed against pharmaceutical manufacturers alleging improper marketing of painkillers. However, DeWine said Ohio’s lawsuit is among the most comprehensive taken by any state against a broad group of opioid painkiller makers. He believes there is only one similar lawsuit, filed by Mississippi in state court in December 2015, alleging similar wrongdoing against the same five companies. That suit is pending.

Elizabeth Burch, a law professor at the University of Georgia, expressed sentiments that may sound familiar to some in the industry. The Ohio lawsuit is unsurprising to Burch, considering that Purdue has paid settlements in the past.

“A lot of states are looking for money to subsidize substance-abuse programs. As they do that and as previous states reach settlements, there is blood in the water at this point,” she said.

Whether Burch’s assessment is accurate or not, it is a valid point. As this case was filed in state court, no other states will be joining as plaintiffs, but we will keep an eye on this case, as well as any other state actions taken against industry companies.

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