Opioid maker cites FDA decisions in defense against Ohio lawsuit
Ohio is among several states suing opioid makers, and says the companies falsely marketed the drugs and downplayed the addictive effects of opioid painkillers that drove an epidemic still ravaging the United States. Purdue Pharma, maker of popular painkiller Oxycontin, argues that it marketed the drugs according to FDA guidelines.
Ohio argued in its lawsuit that Purdue Pharma marketed the drugs to treat chronic pain. Ohio defines chronic pain as noncancer pain lasting three or more months. However, Purdue Pharma says that the FDA approved Purdue’s long-acting products to treat chronic pain that includes noncancer pain.
Purdue also said the lawsuit is pre-empted by federal law and prior decisions made by the FDA.
For instance, in 2013 the advocacy group Physicians for Responsible Opioid Prescribing issued a petition asking the FDA to strip the chronic pain indication from opioids’ label. The FDA declined to strip the indication or add any warning that there isn’t enough evidence to show that the benefits outweigh the risks of long-term use in treating non-cancer pain.
Purdue argues that any statements that the painkillers shouldn’t be used for noncancer pain would go against FDA labeling and conflict with its obligations under federal law.
Purdue also faces lawsuits from Oklahoma, Missouri, Mississippi, New Hampshire and South Carolina. Several counties in New York and California, as well as the city of Chicago, have sued opioid makers, too.
The attorney for the eight New York counties that sued Purdue Pharma blasted the defense.
“We find Purdue’s motion to be interesting but fatally flawed,” said attorney Paul Hanly in a statement to the Washington Examiner. “Interesting because the argument that FDA regulation of opioids means there can be no lawsuits has been around for decades, yet just months ago, in nearly identical litigation filed against it by Suffolk County, New York, Purdue submitted hundreds of pages of legal argument to the Court but omitted this argument. Why? There can be but one answer: Purdue knew the argument has no sound basis in the law. To assert it in the Ohio case is a desperate but doomed attempt to confuse the pertinent issues.”
Filed under: General Problems
THE SMELL OF BLOOD AND EASY MONEY BRINGS OUT ALL THE IGNORANT LAWYERS WHOSE SUITS SHOW THAT THEY HAVE NO KNOWLEDGE AND ARE ONLY TRYING TO CONVINCE THAT THEY ARE FIGHTING THE OPIOID CRISIS, WHICH DOES NOT EXIST, THERE IS HOWEVER A FENTYNAL PROBLEM, THAT IS THE ILLEGAL DRUG KILLING ADDICTS, OUR CORRUPT FEDERAL GOV’T HAS DONE A VERY GOOD JOB BRAINWASHING THE AMERICAN PEOPLE, DOCTORS DID NOT START THE ADDICTION PROBLEM NOR ARE THEY OR PAIN PATIENTS TO BLAME, YET WE ARE NO LONGER RECEIVING MEDICAL CARE AND OUR SUFFERING IS DISMISSED AS NOT IMPORTANT, THE “WAR ON DRUGS IS THE ONLY IMPORTANT THING, TO CONTINUE LYING TO THE AMERICAN PEOPLE IS A PRIORITY, WHILE DOING NOTHING TO SOLVE THE ADDICTION OR THE SEVERE CHRONIC PAIN ISSUES FACING INNOCENT AMERICANS TODAY THESE MONEY HUNGRY PEOPLE MAKE ME SICK.