If you prescribe opioids, be forewarned: The Department of Justice (DOJ) has launched a new salvo in its efforts to stem the opioid crisis, announcing February 27 that it planned to file a “statement of interest” in a multi-district class action lawsuit against opioid manufacturers and distributors.
The Ohio-based lawsuit, brought by states, municipalities, hospitals and others, claims in large part that the manufacturers misrepresented to physicians the safety of opioids, encouraged off-label use of the drugs and downplayed the risk of addiction, causing overprescribing. As a result, the plaintiffs incurred substantial costs dealing with opioid misuse and addiction. They are seeking reimbursement.
In addition to joining this large lawsuit, the DOJ will examine the many other similar lawsuits filed around the country against manufacturers to determine what assistance federal law can provide.
The DOJ’s involvement in these lawsuits raises the ante and will give the plaintiffs more clout. The DOJ stated in its press release that it will use “every lawful tool at our disposal to turn the tide. We will seek to hold accountable those whose illegality has cost us billions of taxpayer dollars.”
The DOJ also announced the creation of a new Prescription Interdiction & Litigation (PIL) task force to coordinate the DOJ’s many efforts and tools to combat the opioid epidemic.
According to the DOJ, 180 Americans die every day from drug overdoses. It is now the leading cause of death for Americans under the age of 50.
These are just the latest moves in the DOJ’s stepped-up efforts to deal with opioids in recent months. It has also created a new opioid fraud and abuse detection unit, assembled new enforcement teams dedicated to dealing with opioids, and led crackdowns against both Americans and foreign nationals engaged in unlawful opioid-related activity.
Prescribers should be wary
While the lawsuits are focused against opioid manufacturers and distributors, prescribers will invariably also face increased scrutiny. The DOJ reiterated in its announcement that it will enforce the law against individuals, including prescribers.
For instance, Galena Biopharma recently agreed to pay the government more than $7.55 million to resolve allegations under the False Claims Act and other law that it paid physicians kickbacks – such as free meals and payments to attend “advisory boards” – to prescribe Galena’s fentanyl-based drug Abstral. Two physicians involved have been convicted and sentenced to prison; Galena cooperated in those prosecutions. The DOJ has also charged other physicians in its crackdowns.
As a result, physicians should take steps to protect themselves:
- Pay increased attention to what drug representatives are saying about the drugs they’re marketing to ensure that the information is accurate and not misleading.
- Be particularly careful about any financial relationship you may have with opioid manufacturers, such as consulting arrangements or free dinners. Make sure that any such relationship is not a payment for referrals and otherwise passes legal muster.
- And take a hard look at your opioid prescribing habits. You don’t want to be found prescribing more than your peers, beyond state-imposed limits, or against CDC guidelines.