A wrongful death lawsuit has been filed against ALZA Corporation by the family of a Utah woman who died in 2010, after using one of the company’s pain patches.
According to court documents, Janine Ward died May 4, 2010, after using one of the prescription patches. Toxicology reports later showed the woman had a lethal level of fentanyl in her bloodstream at the time of her death, and now plaintiffs say the company should be held strictly liable.
In a complaint entered in Salt Lake City’s 3rd District Court, attorneys for the woman’s husband, Preston Ward, say the ALZA Corporation of Vacaville, Calif., a subsidiary of Johnson & Johnson, knowingly produced transdermal patches that leaked dangerous doses of the painkiller fentanyl – a synthetic drug nearly 100 times more powerful than morphine.
Johnson & Johnson, ALZA’s parent company, first developed the first pain patch as the Duragesic patch in 1994. Since it was introduced, the fentanyl patch has been plagued by manufactured problems and a number of wrongful death lawsuits filed by families of individuals who overdosed on fentanyl.
“Ward(‘s) patch was defective because of the existence of a manufacturing flaw that made the product not reasonably fit or safe for its intended use,” the plaintiff’s attorneys write.
“The manufacturing defect was a proximate cause of decedent’s death (and) her pain and suffering prior to death.”
Also at issue is whether ALZA’s patch construction methods contributed to the unit’s alleged failure. Ward’s legal team says the patches could have been made using a “matrix” design rather than the “reservoir” system that supposedly failed and allowed the drug to leak too rapidly.
The gel in the patch is supposed to be contained and delivered in a regulated fashion through a membrane placed on the skin. However, over the last several years the FDA has received hundreds of reports of fentanyl overdoses and deaths associated with the use of fentanyl pain patches.
“Defendants could have utilized the matrix technology to manufacture the patch instead of the reservoir technology,” they add. “These technologies are safer alternative designs in that they are associated with fewer defects involving seal integrity.”
In many of the cases, too much of the fentanyl was delivered through the skin due to manufacturing defects. There have been a number of fentanyl patch recalls due to defective manufacturing.
“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.
Ward family attorneys demanded a jury trial for the matter and are requesting punitive and exemplary damages for an unspecified amount against the defendant.