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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Keeping Defective Duragesic Patches “Not a High on the Priority List” for ALZA

Posted in Duragesic / Fentanyl

In a Duragesic lawsuit filed in December of 2005, the plaintiffs allege that:

Even after being made aware of the numerous defects including those which triggered the
recalls, Defendants still failed to take all reasonable and necessary steps to insure that
their manufacturing and quality control processes were adequate . As stated in the
aforementioned FDA Report, Defendants knew that "classic leakers" in Duragesic
patches were a continuing problem and stated to FDA that they were evaluating an
upgrade to their manufacturing and inspection processes but that "it's not a high on the
priority list." Department of Health and Human Services Food and Drug Administration,
Investigation Report of Jeffrey M . Watson, Investigator, dated June 16, 2004, p . 41 .
Other recommended steps to reduce the number of patches exhibiting leaks were
considered to be "not feasible due to engineering issues and costs ." Id . at 41 .

The lawsuit hopes to hold the makers of Duragesic patches liable for the death of Adam Hendelson, who may have received a Duragesic fentanyl patch from a lot that was later recalled. 

In addition to the usual claims of defective design and defective manufacturing, the lawyers in this lawsuit also allege that the manufacturers violated Florida’s Deceptive and Unfair Trade Practices Act.  Most states have a “deceptive practices act” that lawyers can use to hold companies accountable for selling defective products.  This is another powerful tool in the battle to protect the public from defective drugs.

The entire Duragesic lawsuit is available here in PDF format.