Fentanyl Pain Patch Recall Part Two

Actavis Group, just announced they have expanded their recall to include all of its fentanyl pain patches sold in the United States. In mid-February, PriCara, and Actavis Group, both announced that Fentanyl Duragesic Patches were being voluntarily recalled as a precaution from wholesalers and pharmacies.

Fentanyl pain patches are used to treat patients suffering from moderate to severe chronic pain that cannot be treated by short-acting or non-narcotic pain products. Fentanyl is a powerful narcotic gel that if comes in direct contact with a patient’s or caregiver’s skin, it may cause difficulty breathing, produce life-threatening side effects and even death.

I’ve often wondered what really goes on behind closed doors at a pharmaceutical manufacturing plant. Did someone say “Oh No! I messed up these patches, oh well, it’s no big deal”. Do they have quality control procedures in place? Did someone actually take responsibility and notify management that there was a problem? Did management listen? Or, did they choose to wait it out and hope it would go away? Did they figure the cost of a recall (and even a few lawsuits) would be more cost effective than stopping production?

Was it a faulty design? How extensively do they test a product before they allow it go on the market? PLOS Medicine, an online medical journal conducted a study using numbers from 2004 and concluded that pharmaceutical companies spent almost twice as much on marketing than on their research and development for their United States markets. That answers that question.

How many people were either injured or died before this product was recalled. These are all questions I wonder about whenever I come across a new recall.

According to the FDA website, Activis claims they are “unaware of any injuries resulting from this issue” and “as a precaution, is recalling these lots.”

Yet, in June 2007 the family of 28 year old Adam Hendelson was awarded $5.5 million by a Florida jury. Tests confirmed that Hendelson had three times the lethal dose of fentanyl in his system when he died. I’m guessing he wasn’t wearing three patches.

Imagine my surprise, after further research I found that this is not the first recall of Duragesic pain patches. In 2004 fentanyl patches were recalled over a similar issue and in 2005, the Food and Drug Administration issued an alert in response to a number of deaths potentially linked to defective patches.

I’m no brain surgeon, but if this is not the first recall and there was a $5.5 million judgement, then it answers one of my questions…did management know about the problem? Seems like they did.