Fentanyl patches are designed to deliver a powerful narcotic, fentanyl, through a patient’s skin and into their bloodstream at a steady, predictable rate. Since fentanyl is 100 times stronger than morphine, it is critical that the patches work right every time. But do they? Juries in several different states have concluded no, awarding millions of dollars to families who have lost a loved one to a defective fentanyl patch. These large verdicts raise several questions. Are these isolated incidents? Just how dangerous are fentanyl patches?
A review of publicly available data provides some startling answers and indicates that fentanyl patches may just be the most dangerous product ever approved by the FDA. In 2005, for example, fentanyl patches were not even among the top 200 most widely dispensed prescription drugs in the United States. [1. Pharmacy Times, May 2006.]
While not frequently prescribed, fentanyl was reported to be the cause of 3,545 fatal outcomes reported to the FDA between 1998 and 2005, making it the second most dangerous drug on the market during that time frame. [2. Thomas J. Moore, AG, et al, Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005, Arch intern Med. 2007;167(16): 1752-1759.]
What could be the cause of this remarkably-high death rate? In July 2005, the FDA issued an alert to healthcare providers indicating that the agency was “investigating reports of death and other serious adverse events related to narcotic overdose in patients using the fentanyl transdermal patch for pain control.” [3. FDA Information for Healthcare Professionals: Fentanyl Transdermal System.]
Although the FDA has not released the final results of that investigation, the agency did indicate that one factor identified as a possible cause of these unintentional overdoses was “suspected transdermal patch malfunction (e.g., leaking patches).” This suspected malfunction has proven to be a reality as several fentanyl patch makers such as ALZA Corporation, Sandoz Inc., Watson Pharmaceuticals, Inc. and Actavis have all recalled patches that were defectively manufactured resulting in dangerous leakage of fentanyl gel. And at Heygood, Orr & Pearson, we have handled dozens of cases where an individual using a fentanyl patch exactly as prescribed died with a lethal level of fentanyl in his or her blood—a level much higher than a properly-working patch should have given.
The evidence is clear. Fentanyl patches are an extremely dangerous product, and when they fail, the results are devastating. If you or a loved one has experienced the tragedy of losing a family member as a result of Fentanyl pain patch usage, you and your family deserve answers to your questions, and if the loss was as a result of a defective Fentanyl patch, to demand that the drug company be held responsible. Contact us for a free consultation so we can help you determine the best way to protect your legal rights and interests and hold the drug companies responsible for your preventable and unnecessary loss.