In a major victory for plaintiffs in the National Prescription Opiate Litigation (MDL #2804) this past week, the court ordered that defendants must provide records dating back to 1995.
This ruling concerns a major bone of contention between the litigants in three bellwether cases filed by the Ohio cities of Cleveland, Lorain and Parma. It was “...the most difficult of the issues addressed in this discovery ruling,” according to Special Master David Cohen, who issued the ruling. Cohen was appointed to the position by Judge Aaron Polster.
Plaintiffs' request for records dating back over two decades were met with considerable resistance from the defense. The drug manufacturers, which include Actavis Phama, Johnson & Johnson subsidiary Janssen Pharmaceuticals, Purdue and Teva, disagreed over how far back the records should go. Meanwhile, the “Big Three” drug distributors – Amerisouce Bergen, Cardinal Health and McKesson – agreed to produce records going back to 2013.
This was unacceptable to the plaintiffs, who wanted to establish a baseline for evaluating the scope of the opioid addiction crisis. For this purpose, the year 1995 was chosen. This was the year before oxycodone won FDA approval. At the time, the medical profession acknowledged the addiction dangers of oxycodone, which had been in clinical trials for two years.
Nonetheless, Purdue Pharma (also a named defendant in the current MDL) proceeded to market oxycodone as a “safe alternative” to combination opioid medications such as Percocet and Vicodin. Within a year of oxycodone's arrival on pharmacy shelves, the number of opioid prescriptions written in the U.S. rose by 11 million.
Although opioid addiction has been a problem for over 150 years, it is generally agreed that the current crisis began in the mid-1990s, with aggressive promotions by pharmaceutical companies and easy availability through distributors and physician-run “pill mills.” In his ruling, Cohen wrote, “The scope of the opioid crisis can only be assessed against pre-crisis conditions.”
This ruling comes as the MDL, being heard in U.S. District Court for the District of Northern Ohio, enters its active litigation phase.
Under the ruling, the drug manufacturers must provide records going back to the year prior to the launch of a specific opioid-based medication, including marketing and promotion activities and informational materials given to physicians.
Both manufacturers and distributors will be required to provide records of all transactions and reports of suspicious orders. Cohen's ruling also applies to the sales of generic versions, which defense counsel argued were not significant enough to be entered into evidence – an argument that Cohen writes is “simply untenable,” as “the allegations clearly also support claims premised on the manufacture, sale and distribution of generic drugs.”
The ruling does ease the burden on the defense by limiting the geographical scope of the information required. Initially, the plaintiffs wanted data for the entire country. Cohen's ruling limits it to Florida, Georgia, Illinois, Kentucky, Ohio, Pennsylvania and West Virginia. This also will enable plaintiffs to test theories about the migration of the epidemic.
In a related story, Judge Polster issued an order on June 27 requiring the Drug Enforcement Administration to provide additional data on opioid distribution between 2006 and 2014. The DEA, pharmaceutical companies and distributors argued strongly against it, claiming such an action could compromise the relationship between drug companies and the DEA , and may reveal information that could be used by criminals to steal large opioid orders.
The bellwether trials are scheduled to begin in March of 2019.