Thirty-five year old Cliff Cruse was found dead by his minor son near midnight on April 12, 2006. The toxicology report revealed a lethal concentration of fentanyl in his blood. At the time of his death, Cliff was wearing one 75 mg/hr Duragesic fentanyl patch manufactured, distributed and sold by Defendants. Duragesic is a 72 hour transdermal pain medication that is absorbed through the skin. The active ingredient in Duragesic is fentanyl, a powerful opioid narcotic with pain relieving properties. Cliff's Duragesic patch was prescribed by his physician for treatment of his chronic back pain. There was no other source for the fentanyl found in Cliff's blood and there was no evidence that Cliff has misused or abused his Duragesic prescription. "This case was referred to us as a medical negligence matter, but with the unusually high amount of fentanyl in Mr. Cruse's blood upon autopsy, we had to investigate the role of the fentanyl patch. Shortly after we began our work, a jury in Florida awarded a father 5.1 million dollars for the wrongful death of his adult son. Because the pleadings in federal court are all online, we went to work trying to determine whether our case was similar.", says Amy Gunn, lead trial counsel for the Cruse family. She spoke with and hired the same experts and found that there were many similar cases pending around the country.
The family filed a product liability case alleging that the Duragesic patch worn by Cliff on the day of his death was defectively designed and manufactured because, during the manufacturing process, small holes or slits could sometimes occur in the material containing the fentanyl gel. It was believed that the patch worn by Cliff leaked a fatal dose of fentanyl gel, which was then absorbed quickly into his skin while he slept. The concentration was too much for his liver to metabolize and Cliff died of respiratory depression caused by the overdose of fentanyl. This same product had been recalled in February, 2004 because Johnson & Johnson had reports of leaking patches from the field. As a result of the recall, changes were made to the manufacturing process, but the design stayed the same. The family alleged that not 100% of leaks could be ruled out despite the manufacturing changes or despite quality assurance and quality control measures. Recalls continued after Cliff's death and in the summer of 2009, the company changed from the reservoir design to a matrix design, which does not leak.
In November, 2008, a Cook County jury awarded the husband of a woman who
had died while wearing a Duragesic patch, 16.6 million dollars. Shortly
before, another Florida jury awarded a family over 13 million dollars
in a case involving similar allegations against the Duragesic patch. After
two and a half years of litigation, the Cruse family agreed to settle
their claims against the Johnson & Johnson Defendants for a confidential
amount about one month before trial was scheduled to begin. "The
settlement was important to my clients, but they were more satisfied to
learn that the reservoir design had been taken off the market. It is not
everyday that lawsuits can effectuate positive change to an industry,
but I believe these cases have done that.", Amy Gunn added.
Amy Collignon Gunn