San Diego, CAThe makers of fentanyl patches and the Duragesic pain patch face lawsuits that their patches are defectively designed, causing serious harm and even death to some patients. One family that filed a lawsuit against a fentanyl patch manufacturer has won a small battle in its lawsuit against the pharmaceutical company—the company has been ordered to make its documents available for the plaintiffs.
The lawsuit was filed by the family of Nicole Bristol, a 37-year-old who died in 2008 after using a fentanyl pain patch. Bristol reportedly died of a fentanyl overdose, and her family filed a wrongful death lawsuit against Watson Pharmaceuticals, the company that manufactures the patch Bristol used.
Now a judge has ordered the pharmaceutical company to hand over documents and e-mails and ensure employees and executives are available for depositions.
The lawsuit argues that Bristol did not abuse the patch, but still received a lethal dose of fentanyl. According to court documents, "The Patch is unsafe for its intended or reasonably foreseeable use because it can and does leak and/or because it otherwise causes lethal levels of fentanyl in patients." Specifically, the lawsuit alleges that the patch was defective because of a problem with the seal and because it did not carry adequate warnings and instructions about the risk of harm.
Furthermore, the lawsuit argues, other companies selling fentanyl patches used a "matrix" design that would have lessened the risk of accidental overdose. Instead, the defendant reportedly used a reservoir design, despite the company's patches being recalled in 2008 due to leakage problems.
Among the allegations against Watson Pharmaceuticals are misleading, inadequate or insufficient warnings; failure to use due care in the design and manufacture of the patch; not performing adequate testing of the patch; and failure to ensure the patch is made without defects. Finally, the lawsuit argues that the defendants represented that the maximum blood concentration of fentanyl that could be achieved using the patch was much lower than the concentration found in Bristol's blood when she died.
In situations where the patient receives too much fentanyl—either through direct contact with the skin or because too much of the medication is released—the patient is at risk of death. According to some reports, Bristol had 15 ng/ml of fentanyl in her system when she should have had 1.7 ng/ml. Fentanyl can reportedly be lethal at 3 ng/ml.
Fentanyl pain patches are the generic versions of the Duragesic pain patch, used to manage chronic pain that is considered severe. Fentanyl, however, is a strong opioid that has been linked to accidental overdoses in patients who receive too much of the medication. There were reportedly some defects in the design of some fentanyl patches, resulting in lethal amounts of the fentanyl reaching the patient's skin and being absorbed into the system.
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