fiercepharmaAugust 20, 2018
Tag: Trump , major lawsuit
Months ago, the Department of Justice backed the hundreds of lawsuits that accuse drugmakers and distributors of their alleged contribution to the nation’s opioid epidemic. Now, President Donald Trump is asking Attorney General Jeff Sessions to take another step, to bring "a major lawsuit" of its own.
During a cabinet meeting on Thursday, Trump asked Sessions to bring "a major lawsuit" against opioid makers "that are really sending opioids at a level that it shouldn’t be happening," according to a conference transcript from the White House.
Trump said that instead of joining existing litigation brought against the companies, he wanted the attorney general to bring a separate federal lawsuit, and that he’d be "very, very firm on that." Sessions, appearing to concur with the president, said his department is "looking at various, different legal avenues to go after abusive companies."
In a statement sent to FiercePharma, Purdue Pharma, which is under scrutiny for its marketing of OxyContin, said it "shares the president’s concern about the opioid crisis," and that it "is committed to working collaboratively with those affected by this public health crisis on meaningful solutions to help stem the tide of opioid-related overdose deaths."
The request coincided with a new proposal the Justice Department and the Drug Enforcement Administration jointly unveiled to fight opioid abuse. The agencies propose to cut production quotas for the six most frequently misused opioids by an average 10% next year. Those six opioids are oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl.
It also came a week after the DOJ reached an agreement in principle to settle a federal probe into Insys Therapeutics’ sales practices of Subsys, an under-the-tongue spray version of fentanyl. The company is paying $150 million to wrap up charges that it engaged in off-label marketing and paid kickbacks to doctors for prescriptions.
After filing a "statement of interest," the DOJ in April decided to participate in settlement talks of lawsuits brought by hundreds of cities and counties now consolidated in a federal court in Cleveland. Plaintiffs in that multidistrict litigation accuse opioid makers of aggressive marketing of their drugs, and claim that distributors failed to properly monitor suspicious orders.
Drugmakers targeted in the litigation include Purdue Pharma, Johnson & Johnson, Teva, Allergan and Endo, along with the Big Three drug distributors, AmerisourceBergen, Cardinal Health and McKesson. The companies have denied the allegations.
U.S. Judge Dan Polster, who is presiding over the litigation, has been championing for a settlement in the case as soon as possible and immediately moved the parties in that direction. However, in a March filing, the judge indicated the efforts had hit a snag earlier after the parties "identified various barriers to a global resolution."
He set a trial date for September 2019.
New York state this week became the latest entity to bring a lawsuit. In its complaint filed to the New York Supreme Court against Purdue, the state alleged that the OxyContin maker intentionally misrepresented the risk of opioids in its marketing while exaggerating the drugs’ benefits.
President Donald Trump declared the opioid crisis a national health emergency back in October. And in March, the administration rolled out a new basket of policies aimed at tackling the opioid crisis. The plan includes using tougher law enforcement to crack down on drug dealing, as well as ideas to cut nationwide opioid prescriptions by one-third over three years. The DOJ and DEA said their new proposal is consistent with that goal.
At the cabinet meeting, Trump also blasted China and Mexico for sending fentanyl to the U.S., calling it "a form of warfare."
"In China, you have some pretty big companies sending that garbage and killing our people," said Trump. "I’d like to do whatever you can do legally to stop it from China and from Mexico."
In response, Sessions said the DOJ has returned indictments against distributors from China.
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