Suspicious Orders Shipped By Drug Companies
Drug Companies that suspect there is a problem with orders are legally required to refuse to ship those products. But recently, a drug company in Ohio is accused of making and distributing opioids that were “suspicious,” and according to a lawsuit, this helped to fuel the national addiction and overdose crisis.
Lawyers from Cuyahoga and Summit counties were the first to file lawsuits seeking to hold drug companies accountable for the nation’s opioid crisis.
Until now, plaintiffs were focused on allegations that drug companies made false claims about the safety of opioids and encouraged doctors to prescribe them unnecessarily. But now, as part of several motions filed by both sides in the case, counsel for the counties shifted the focus to whether the companies were in compliance with requirements from the Drug Enforcement Administration (DEA) when they shipped the drugs.
Shipment of Suspicious Orders Violates DEA Policy
According to the motion, from 2003 to 2011, generic drug makers shipped 53 million orders of opioid painkillers. They flagged nearly 40,000 orders as “peculiar,” but withheld a mere 33 of those. DEA policy states that suspicious orders must be reported and not shipped unless they are determined to not likely be diverted.
The motion included an email from one distributor that stated “If you are low, order more. If you are okay, order a little more.” A spokesman from the distributor called that email “outrageously callous” and claimed it had been sent by an individual who has not been employed by the company for many years. He claimed the email went against what the company stands for and what they have done to combat abuse and misuse of the drugs.
The actions – or rather inaction – of Teva, another opioid manufacturer, was also called into question. Plaintiffs said the company still did not have a written system for monitoring suspicious orders as of 2012 and had never filed a suspicious order report as of that year. Teva issued a statement claiming it had never conspired, failed to report suspicious orders, or contributed to the opioid abuse crisis.
Overdose Rate Increase Parallel to Increase in Painkiller Shipments
The latest allegations were levied days after federal government data concerning the opioid crisis went public.
According to analysis by the Washington Post, 76 billion painkiller medications were shipping between 2006 and 2012. This was the period of time in which overdose rates rose. Data showed Vicodin and OxyContin, as well as illicit versions of fentanyl and heroin, were all factors in the spike in numbers.
Ohio is not the only one to take legal action against drug manufacturers. More than 2000 state, local, and tribal governments have filed similar claims, many of which have been consolidated in a Cleveland court. Parties in the case have asked that the judge make a ruling without going to trial.
Motions Seek to Reject Evidence and Alleviate Accountability
The other motions filed recently came from defendants in an effort to have plaintiffs’ claims rejected. According to the drug distributors, there is no evidence of a conspiracy or effort to weaken regulations or increase limits on how much of a drug can be made. They also claim there is no evidence they illegally pushed prescriptions that were unnecessary.
Generic opioid manufacturers claim they cannot be held legally accountable for claims made about the drugs regarding efficacy or safety because they aren’t even the ones making the claims – it’s the brands that are selling the drugs under their names.
Manufacturers also moved to exclude testimony claiming that opioids are a gateway to heroin and illicit fentanyl and that testimony concerning the cost of abating the opioid crisis also not be presented to jurors. That cost is estimated to be more than $450 billion in a 10-year period, the majority of which is to pay for addiction treatment programs.
Other motions included a request from Walmart to be dropped as a defendant, a request to not allow any claims prior to October 2012 due to the statute of limitations, and several requests from pharmacies and small distribution companies that they not be subjected to conspiracy claims against them.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
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