A jury in Houston, TX, has found the makers of the Duragesic patch negligent in the personal injury death of Michaelynn Thompson and have awarded her family $772,500 in compensation. Ms. Thompson, 42, died in 2004 while wearing a Duragesic patch to manage pain after being injured in a car accident. Her personal injury lawyer introduced evidence that Ms. Thompson had ten times the therapeutic dose of fentanyl, the active pain-killing narcotic in the Duragesic patch, in her body when she died.

The jury awarded compensation to the Thompson family after determining that Johnson & Johnson's Janssen Pharmaceutica Inc. and Alza Corp. units, manufacturers of the Duragesic patches, produced a defective product. Four days after Ms. Thompson died, Johnson & Johnson recalled a batch of Duragesic patches after receiving reports of the patches leaking too much fentanyl into patients. The doctor who treated Ms. Thompson alerted her family to the recall of the product, which prompted them to collect blood from the medical examiner and have it tested.

An FDA report introduced as evidence at trial showed that the company eventually recalled a total of 2.5 million Duragesic patches between April 2003 and June 2004 due to customer reports of leakage. That same year, Alza Corp. quadrupled production of the patch because its patent was about to expire. The FDA also found that between January 2003 and June 2004, Alza Corp made 40 lots of Duragesic patches, 35 of which had patches which leaked.

Currently, more than 80 million Duragesic patches are sold in the U.S. each year. While the FDA has not ordered a recall of the Duragesic patch, it is investigating 120 deaths tied to the products, which are also manufactured in a generic version by Mylan Laboratories Inc. Johnson & Johnson added a safety warning to the Duragesic patch's label in July 2005 advising physicians not to prescribe the patch to patients who cannot tolerate similar narcotic drugs or who may be prone to abusing them.

Fentanyl is an opiate that can cause addiction or death if abused, used with heat or given to overdose. Fentanyl can cause death from respiratory depression, which is a drastic shortening of breath, due to its anesthetic properties that can actually "shut off" the respiratory center in the brain. In addition, the application of heat over a fentanyl patch may cause the patch to deliver an excess of medication, leading to overdose.

Sources: Brett Brune, "Daughter wins patch case," Houston Chronicle, July 8, 2006, accessed July 10, 2006; "Pain patch caused woman's death, jury finds," Bloomberg News, July 8, 2006, accessed July 10, 2006.