Purdue defends against opioid lawsuits by pointing to FDA regulations it helped create

Purdue is defending itself against lawsuits around the country alleging it downplayed opioid risks and overstated their benefits. In response, the company is pointing to the FDA's regulations on the painkillers, regulations that it affected through contributions to advocacy groups.

In 2012, the Physicians for Responsible Opioid Prescribing petitioned the FDA to restrict the approval for Purdue's OxyContin and other opioids. In deciding against several proposed restrictions, the agency used input from the American Pain Society and other advocacy groups with financial ties to drugmakers, according to a September 2013 FDA letter (PDF) on the decision.

A report (PDF) from Sen. Claire McCaskill, D-Mo., published earlier this year found that patient foundations, American Pain Society among them, received millions in pharma funding from 2012 to 2017 and "amplified" the industry's message about wide opioid use. The FDA used input from the groups in its decisionmaking, the agency's letter shows. 

Purdue faces hundreds of lawsuits from cities, counties and states alleging it oversold opioid benefits, downplayed risks and ignored warning signs about an abuse epidemic. A recently unsealed lawsuit in Tennessee attempts to shed light on the company's strategy. According to the suit, Purdue "placed profits over people" with its opioid marketing, pushing high doses and targeting "pill mills" to increase sales. Tennessee officials allege the company violated consumer protections laws and that it created a public health nuisance in the state. The state also said Purdue violated a 2007 settlement by not forming an adequate Abuse and Diversion Detection program.

A representative for the company told FiercePharma via email that Purdue is "disappointed" that in "the midst of good faith negotiations with many states, Tennessee has decided to pursue a costly and protracted litigation process." The company denies the allegations and said it's "inappropriate for the state to substitute its judgment for the judgment of the regulatory, scientific and medical experts at FDA."

The Tennessee suit also alleged that Purdue gave the American Pain Society more than $3 million from 1997 to 2012. Tennessee Attorney General Herbert Slatery III argued in the filing that Purdue cited guidance from the foundations in its opioid marketing without disclosing financial ties. The company did so in an effort to make the guidance appear more neutral or authoritative, the state contends.

Facing growing legal scrutiny, Purdue this year has stopped marketing its opioids and laid off about 350 staffers. The company and other drugmakers face claims from cities and countries around the U.S., plus dozens of states, regarding an alleged role in the opioid epidemic. Drugmakers entered into settlement negotiations in a multidistrict grouping of the cases, but those talks hit "barriers" in March and the judge set a few cases on a course for bellwether trials.

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