The makers of the Duragesic Pain Patch have been held liable for the death of an Illinois woman. According to the Associated Press, a jury has ordered Johnson & Johnson subsidiaries, Janssen Pharmaceutica Inc. and ALZA Corp, to pay the woman’s family $16.6 million.
Fentanyl-containing Duragesic Pain Patches and similar products are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.
Over the past several years, problems with Duragesic patches have resulted in several recalls. Last February, about 32 million Duragesic Pain Patches were recalled because of concerns that they could be defective. According to the recall notice, there was a chance that some 25-microgram-per-hour patches might have had a sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking. It was estimated that the defect could have affected 2 out of every one million patches.
In 2004, 75 microgram-per-hour patches where recalled by Janssen Pharmaceutica Products for a similar leakage issue. In December, the Food & Drug Administration (FDA) issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.
The December warning marked the second time the FDA had cautioned the public about overdose dangers associated with the Duragesic Pain Patch. In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches. Between the 2005 and 2006 warnings, the FDA apparently received many more reports of accidental overdoses associated with the Duragesic Pain Patch, but declined to say how many.
According to the Associated Press, 38-year-old Jerry DiCosolo died in 2004 while using a Duragesic Pain Patch to treat pain she suffered as a result of a neurological problem. The lawsuit filed by DiCosolo’s family claimed that Janssen and ALZA knew about problems with the Duragesic patch that allowed it to leak fentanyl in doses large enough to kill patients.
According to Bloomberg.com, this is the fourth Duragesic case that Johnson & Johnson has lost in the past two years. Last month, a Florida jury awarded more than $13 million to the family of a 34-year-old woman who died after using a Duragesic patch in 2002. Bloomberg.com also reports that in July 2006, a state court jury in Houston ordered Janssen and ALZA in July to pay $772,500 to the family of a Texas woman who died after her patch leaked.
Johnson & Johnson also agreed to pay the family of a Florida man $2.5 million in 2007 to resolve claims that he died as a result of a defective Duragesic patch, Bloomberg.com said. That settlement was reached after a jury had awarded the victims family $5.5 million at trial a month early.