Federal prosecutors have opened a criminal investigation into whether pharmaceutical companies intentionally allowed opioid painkillers to flood communities, using laws normally used to go after drug dealers, the Wall Street Journal reports.
The investigation could become the largest prosecution yet of drug companies alleged to have contributed to the opioid epidemic, escalating the legal troubles of businesses that face multibillion-dollar civil litigation in various courts. Prosecutors are examining whether the companies violated the federal Controlled Substances Act.
At least six companies have said in regulatory filings that they received grand-jury subpoenas in the Eastern District of New York: manufacturers Teva Pharmaceutical Industries Ltd., Mallinckrodt, Johnson & Johnson and Amneal Pharmaceuticals Inc., and and distributors AmerisourceBergen Corp. and McKesson Corp. A spokesman for Johnson & Johnson said the company believes its policies and procedures to stop opioid medications from being used for nonmedical purposes complied with the law.
The probe is in its early stages and prosecutors are expected to subpoena additional companies in the coming months. Under the Controlled Substances Act, companies are required to monitor commonly abused drugs, reporting suspicious orders, maintaining compliance programs and disclosing suspicious pharmacy customers to authorities.
Companies can face civil charges under the law for not reporting signs, like suspicious orders, that could indicate drugs are being used for nonmedical purposes.
Criminal charges require prosecutors to prove an effort to willfully and intentionally avoid such requirements. At least 400,000 people have died in the U.S. from overdoses of legal and illegal opioids since 1999. This year, federal prosecutors filed major criminal cases in New York City and Ohio that, for the first time, employed criminal statutes that are more commonly applied to drug dealers.
Lawsuits against the companies have been a frustrating tool in combatting the epidemic and making big pharma accountable, say experts.
Many communities have been forced to make their own cases against the drug companies and wind up competing with one another in a protracted legal slog.
Even the most optimistic projection of a long-term settlement — legal experts suggest a range from $50 billion to $100 billion, paid out over many years — will be orders of magnitude smaller than the human cost of the epidemic.
“No matter how much goes in there, it will not be enough,” said Prof. Roger Michalski of the University of Oklahoma College of Law.