Appellate Court Upholds $16.56 Million Duragesic Fentanyl Verdict

Chicago, ILThe verdict in a Duragesic Fentanyl lawsuit that originally favored the plaintiff has been upheld by the First District of the Illinois Court of Appeals, affirming a $16.6 million judgment against the manufacturers of the allegedly problematic pain patch.

With interest, that judgment is now worth about $20 million. The defendants—Janssen Pharmaceutical Inc. and ALZA Corporation—are expected to appeal to the Illinois Supreme Court.

According to the July 7 issue of PR Newswire, Janice DiCosolo had been prescribed a Duragesic patch by her doctor in an effort to combat pain from reflex sympathetic dystrophy, a neurological disorder. However, DiCosolo died on February 15, 2004, allegedly from an overdose of the narcotic fentanyl emerging from an allegedly defective pain patch.

PR Newswire reports that an examination of DiCosolo's remains by the Cook County Medical Examiner's office confirmed the presence of 15 times the level of fentanyl deemed safe.

The Fentanyl pain patch is designed for patients experiencing intense and chronic pain. Fentanyl—a powerful narcotic—is stored in a reservoir within the pain patch. The latter is designed to be worn on the skin and is supposed to release measured amounts of Fentanyl within the safe zone to patients through their skin.

However, a Fentanyl patch recall revealed there were problems with some of the patches, and millions were recalled, according to PR Newswire. Evidence entered into the original trial at Cook County Circuit Court included documents relating to an investigation by the US Food and Drug Administration (FDA) that uncovered a host of manufacturing deficiencies on the part of ALZA relating to the very Fentanyl Duragesic patch that had been prescribed to DiCosolo at the time she died.

A jury of the Cook County Circuit Court awarded $16.56 million to the family of the deceased, and the Court of Appeals upheld that finding, noting "there was overwhelming evidence regarding the defective Duragesic patch causing Mrs. DiCosolo's death."

In an unrelated development, it was announced late last month that the FDA has approved the first Fentanyl product available in a nasal spray. It is not known if a similar misuse of Fentanyl, either deliberately or accidental, could mirror problems encountered with the Fentanyl patches and Duragesic side effects that can result. The nasal spray was approved for Archimedes Pharma Ltd. and its subsidiary, Archimedes Pharma US Inc.