Lawsuits prompt drug company to report opioid deaths to FDA

The opioid epidemic has hit Kentucky and several neighboring states hard, and between civil lawsuits and criminal arrests of executives, both the citizenry and the government are taking steps to hold pharmaceutical manufacturers responsible for the role they have played in the crisis.

Even with the increased awareness, however, a senior scientist with the Institute for Safe Medication Practices says that when it comes to monitoring deaths related to therapeutic drugs, the United States does a poor job. The law does not require drug manufacturers to actively check for adverse effects related to medications, although it does require them to report any adverse effects that they do become aware of to the Food and Drug Administration.

Prior to 2017, Endo Pharmaceuticals, which produces an opioid known by the brand name Opana, reported only 250 deaths possibly related to the drug over a 10-year span. However, in response to government investigations into opioid marketing, as well as an increase in lawsuits, Endo took steps beginning in 2017 to report to the FDA approximately 20,000 deaths related to opioid use that took place over a span of roughly two decades.

The company provided the reports over an approximately nine-month period from November 2017 to August 2018. They include deaths connected with Opana as well as opioid products from other manufacturers. A spokesperson for the company says that it released the reports out of an abundance of caution despite the difficulty in determining which product caused the harm, as well as the fact that a report alone is not enough to establish a link between the product and the adverse outcome.

Concerns about abuse of Opana ER prompted the FDA to request that Endo pull it from the market, which the company did voluntarily. Two months later, it began submitting the thousands of reports about opioid deaths to the FDA.

In light of the ongoing crisis, Endo has also taken additional steps to halt research and development on opioids and dismiss its sales force for pain products in the U.S. Those who believe they have suffered harm due to dangerous pharmaceuticals, either directly or due to the death of a loved one, may find it helpful to consult an attorney.