CHICAGO (CN) – A federal judge in Ohio rejected local governments’ pre-trial request to hold opioid manufacturers and distributors liable for failing to report suspicious pharmacy orders to the Drug Enforcement Agency, finding Monday that the drugmakers presented plenty of evidence justifying their conduct.
Over 2,000 local governments have filed lawsuits against Purdue Pharma, the maker of OxyContin, as well as other opioid manufacturers and distributors, including McKessen and Cardinal, over the nation’s opioid crisis.
Since the late 1990s, the prescription and abuse of opioids has skyrocketed. Opioids were responsible for more than half of all drug overdose deaths in the U.S. in 2017. For Americans under age 50, two-thirds of all drug overdoses are caused by opioids.
The opioid crisis has hit hardest in downtrodden parts of Appalachia where some areas were shipped an average of over 100 pills per person per year.
The lawsuits accuse Purdue Pharma and other drugmakers of pushing the use of opioids for more patients and at higher doses, and say distributors turned a blind eye to pharmacies in small towns ordering massive amounts of these addictive drugs.
U.S. District Judge Dan Polster, who is overseeing the multidistrict litigation in Cleveland, is currently mulling the local governments’ motion for class certification.
Meanwhile, Polster on Monday rejected the local governments’ motion seeking partial adjudication of the opioid manufacturers and distributors’ alleged failure to comply with their responsibility under the Controlled Substances Act, or CSA, with respect to drug orders shipped to Summit and Cuyahoga counties in Ohio.
In 2016, Ohio had the second-highest rate of deaths due to drug overdose after West Virginia.
Under the CSA, pharmaceutical companies have a duty to identify suspicious orders of controlled substances, report these orders to the Drug Enforcement Administration, and decline to ship a suspicious order.
However, “the record is replete with disputes of material fact as to whether each defendant complied with its obligations under the CSA, which preclude summary judgment,” Polster said in Monday’s opinion.
For example, Purdue Pharma asserts that it “routinely” communicated with the DEA about potentially suspicious pharmacy accounts, and even reported dozens of “downstream customers” despite having no duty to do so.
Similarly, McKesson rebuts the plaintiffs’ assertions by claiming that the DEA accepted its reports as compliant, and did not impose a no-ship requirement.
Although McKesson paid the DEA $13 million in 2008 to settle alleged violations of the CSA regarding its distribution of opioids, the company did not admit fault and therefore the settlement does not conclusively prove that it violated its legal duties.
“These facts present issues for a jury determination,” the 32-page opinion concludes.