The case revolves around the overdose death of 37-year-old Nicole Bristol on Feb. 9, 2008. It asks a simple question: Why did Watson allegedly use an easily damaged "reservoir" structure to hold the fentanyl between the two layers of its patches when other companies used a "matrix" structure that prevented sudden discharge or infusion of the drug if the patch was compromised?
The case claims that the difference between the reservoir and the matrix designs explains why Watson was required to recall its patches in 2009 and 2008, yet matrix patches made by Mylan (MYL) and Nycomed have not been recalled.
If the FDA needs another reason to take a look at whether skin patches should be used to distribute an easily abused, addictive drug, then perhaps it should poke around in North Carolina where a local TV station found 500 fentanyl deaths in that state alone:
We reviewed reports from the NC Office of the Chief Medical Examiner that show more than 500 people have died from Fentanyl poisoning in the past 10 years in North Carolina. Some of those people had a prescription for Fentanyl; others took it illegally or took it in combination with other powerful drugs such as Oxycodone.Fentanyl kills 16 people per month in Wayne County, Mich., according to the Detroit Free Press. Here's an updated list of fentanyl patch recalls. The product has been recalled nine times, by my count:
- Year, company, reason for recall
- 2010, Actavis: "accelerated release"
- 2009, Watson: "leaking"
- 2009, Johnson & Johnson: "a cut along one side of the drug reservoir within the patch."
- 2008, Actavis: "fold-over defect"
- There were five prior patch recalls, according to this report, including:
- 2008, Watson: "leaking"
- 2004, J&J: "seal breach"
- 2004, J&J: "improper seal"
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