Duragesic Pain Patch Lawsuit Results in $16.5 Million Verdict

The family of a 38-year old mother of three, who died in 2004 as a result of a fentanyl overdose, has been awarded $16.56 million by a Chicago jury in the fourth wrongful death verdict against two Johnson & Johnson subsidiaries involving the Duragesic fentanyl patch.
 
The verdict was returned after a three week trial in Cook County Circuit Court over the death of Janice DiCosolo. The plaintiff died on February 15, 2004, after receiving the Duragesic fentanyl patch to reduce pain she was experiencing as a result of a neurological condition.

The verdict was entered against Johnson & Johnson’s Janssen Pharmaceutica, Inc. and ALZO Corporation.

The trial started on October 29, one day after a jury in Florida awarded $13.3 million in a similar Duragesic patch lawsuit involving the death of a 34-year old mother who died in June 2002. In addition, two other trials in 2006 and 2007 resulted in combined verdicts of $6.3 million in favor of the plaintiffs, and Johnson & Johnson still face another 60 Duragesic lawsuits that are pending throughout the United States.

The Duragesic patch contains a powerful fentanyl gel, which is 100-times stronger than morphine. The gel is supposed to be contained within the patch and delivered in a regulated fashion through a membrane placed on the skin.

The FDA has received reports of hundreds of fentanyl overdoses and deaths associated with the use of the Duragesic patch and generic versions which are now available. The deaths have been caused when too much of the medication was delivered through the membrane or as a result of manufacturing defects which allowed the fentanyl gel to leak directly onto the skin.

The DiCosolo family alleged that her death was caused by a group of defective patches which were recalled in 2004 because of improper sealing. The same year as her death, the FDA identified several problems and deficiencies in the manufacturing and quality control procedures at the plant where these Duragesic pain patches were made.

Problems associated with the manufacturing of fentanyl patches have led to a number of different recalls over the past five years, involving both name brand Duragesic pain patches and generic fentanyl patches. The most recent recall involved Watson generic fentanly patches in August 2008, which was issued after it was discovered that many of the patches were leaking.