"The defective condition of the [fentanyl patch] was the cause of the decedent's death," the lawsuit states, noting that fentanyl is "an extremely dangerous drugthat is at least 80 times stronger than morphine."
The patch, which is put on by the patient, is designed to release a certain amount of the drug through the patient's skin at a certain rate into the blood, says the lawsuit.
But the family says the reservoir design of the patch was defective, and that it leaked and released a lethal amount of the drug, causing the woman's death.
The patch with the reservoir design was manufactured at ALZA Corporation's facility in Vacaville, Calif. The lawsuit alleges that prior to and at the time of the manufacture of the patch, ALZA and Sandoz Inc., a distributor of the product, knew or should have known they were producing defective patches that leaked.
"In 2004, ALZA recalled numerous lots of patches because of leaking defects," the lawsuit states. That same year, the company's manufacturing practices, quality control, assurance policies and procedures were found to be deficient during a Food and Drug Administration investigation, the lawsuit alleges. It says another recall occurred in 2008.
The lawsuit alleges the defendants were negligent for failing to warn that the patch could release a higher drug level than it was designed to deliver.
The lawsuit also claims the companies failed to provide the FDA information relevant to the safety of the patch; didn't do enough testing to make sure the patch was safe; and failed to list death as an adverse event.
"The patch defendants were aware that their conduct was wrongful, but continued their wrongful actions regardless of the potential consequences," the lawsuit states.
The family seeks an unspecified amount in damages.
Sandoz Inc., had no comment on the lawsuit. Calls to ALZA Corporation were not immediately returned.