Former DEA officials: Opioid companies exploited gray areas of law - Charleston Gazette-Mail
Pharmaceutical manufacturers followed the letter of the law of the federal Controlled Substances Act, but didn’t act in the spirit of the law when it came to keeping opioid drugs from being illegally diverted from their intended use, attorneys for the state of West Virginia argued Tuesday.
The Controlled Substances Act essentially defines what certified opioid manufacturers and distributors need to do, but it doesn’t tell them how to do it, according to testimony from two former U.S. Drug Enforcement Agency officials during the 22nd day of a bench trial in the state's case against two pharmaceutical manufacturers.
The testimony was part of the state trying to prove that executives and employees with Teva Pharmaceuticals and a group of companies owned by Allergan Finance LLC used deceptive marketing practices to encourage doctors to prescribe opioid medications, ultimately leading to the Mountain State’s substance abuse epidemic.
Joseph Rannazzisi, former head of the Office of Diversion Control for the DEA, testified by way of depositions he sat for in 2019.
Even though the law gave the pharmaceutical manufacturers a broad range to create systems to monitor potentially suspicious orders of opioid medications, pharmaceutical manufacturers and distributors had trouble complying with it.
When they encountered issues complying with the law, the companies “lobbied Congress to get their way,” said Rannazzisi, who called the companies “pretty much out of control.”
“When they decided they just didn’t want to get fined anymore, didn't want to have their registrations revoked or suspended, they went to Congress and rewrote the law,” Rannazzisi said.
Former DEA Diversion Program Supervisor Ruth Carter spent about five hours testifying in the Ceremonial Courtroom in the Kanawha County Courthouse, in Charleston.
She said that, while there never were any formal written standards for how certified opioid distributors made and maintained their systems for tracking suspicious opioid drug activity, the law was very clear as to what their objectives and responsibilities were.
West Virginia alleges the pharmaceutical companies created a public nuisance and violated the state’s Consumer Credit and Protection Act by mischaracterizing and failing to disclose the serious risk of addiction of prescription opioids medications.
The state also alleges the companies overstated the benefits of chronic opioid therapy, and promoted the idea that doctors should prescribe higher dosage amounts without disclosing the greater risk involved.
Attorneys for the pharmaceutical companies have argued that their sales representatives appropriately and legally marketed their opioid medications. They’ve also argued that their respective opioid medications took up so little of West Virginia’s overall opioid market share that they couldn’t be declared a public nuisance.
Attorney General Patrick Morrisey originally filed the lawsuit in Boone County Circuit Court in 2019. It later was moved to West Virginia’s Mass Litigation Panel, where Mercer Circuit Judge Derek Swope became the presiding judge.
The state is seeking an injunction to require the companies to accurately disclose the “significant risk and limited benefits” of opioid drugs, and not to market opioid medications as front-line treatment for chronic pain.
The state additionally wants Swope to assess civil and financial penalties against the companies. Those penalties would be dispersed among 54 of West Virginia’s 55 county governments and other municipal governments.
There originally were three defendants in the lawsuit, but Johnson & Johnson and the state reached a $99 million settlement last month. Johnson & Johnson is the parent company of Janssen Pharmaceuticals Inc., which no longer is a defendant in the case, as per the settlement.
The trial will resume at 8:30 a.m. Wednesday.
source: https://www.wvgazettemail.com/news/legal_affairs/former-dea-officials-opioid-companies-exploited-gray-areas-of-law/article_27a7c53c-358b-5e5e-97a2-b864e300222a.html
Your content is great. However, if any of the content contained herein violates any rights of yours, including those of copyright, please contact us immediately by e-mail at media[@]kissrpr.com.