Heygood, Orr & Pearson has filed a wrongful death lawsuit on behalf of a Connecticut woman’s daughter and other beneficiaries alleging that the woman died of fentanyl intoxication because her health care providers failed to heed “black box warnings” clearly providing that she should not have been prescribed the fentanyl patch.
A “black box warning” is an alert that is printed on the package insert for prescription medication that describes potential serious side effects or adverse events linked to the drug. A black box (usually surrounded by a black border) warning appears separately from the usual list of side effects to indicate that the side effect that is described is extremely serious – even life-threatening – and that the link to the drug has been established. It is the strongest warning required by the U.S. Food and Drug Administration (“FDA”).
Companies that make fentanyl patches prepare an FDA-approved “Package Insert” that contains warnings and instructions to doctors and physician assistants who prescribe the Patch. The Package Insert for the Patch contains a “black box” warning stating that the Patch should not be given to patients who are not sufficiently opioid tolerant or given for acute pain because doing so could cause life-threatening hypoventilation. The suit filed by HOP alleges that, despite these warnings, this woman’s health care providers prescribed a 50 mcg fentanyl patch for acute pain even though she was not sufficiently tolerant for that dose of fentanyl and prescribing fentanyl for acute pain was contraindicated.
The woman’s medical records did not reflect any opioid usage during the weeks leading up to the fentanyl prescription. And, a prior oxycodone use (which she was not using when fentanyl patches were prescribed for her), was insufficient to make it safe for her to use even a lower-dosage 25 mcg Patch. Despite Decedent’s insufficient tolerance for the 25 mcg patch, the health care providers prescribed a higher-dosage 50 mcg fentanyl patch. The high initial dose of fentanyl drastically increased the risk of respiratory depression.
The Package Insert for the fentanyl patch also contains a warning to doctors and physician assistants stating that the Patch should be used with caution in patients who are predisposed to hypoventilation. HOP’s client was predisposed to hypoventilation because: (l) she had a documented history of shortness of breath, fatigue, and sleepiness; (2) she was a smoker; (3) she likely had sleep apnea; (4) she likely had COPD; and (5) she had a history of bronchitis, pneumonia, and pleurisy. The lawsuit alleges that, despite the fact that the health care providers knew or should have known that she had these conditions and that the conditions increased her risk of hypoventilation, she was nonetheless prescribed a high dose of fentanyl and other sedating drugs.
The Package Insert for the fentanyl patch also warns doctors that prescribing fentanyl with other central nervous system (“CNS”) depressants can cause respiratory depression. The Package Insert warns doctors that, if a doctor is contemplating combining fentanyl with other CNS-depressing medications, the dose of one or both agents should be significantly reduced.
According to the family’s fentanyl lawsuit, despite this warning, the woman’s health care providers prescribed the fentanyl patch to her without reducing the dose of any of her other CNS-depressing medications. In fact, they actually prescribed oxycodone – a narcotic, CNS-depressing medication that the woman was not currently taking – when prescribing the fentanyl patch. Only two days after being prescribed the fetanyl patch, this woman died from complications associated with the Patch, including hypoventilation.
Heygood, Orr & Pearson is by far the leading law firm in the United States representing family members in lawsuits against fentanyl pain patch manufacturers. The lawyers at Heygood, Orr & Pearson have settled more cases against the manufacturers of defective patches throughout the United States than all other lawyers across the country combined.
In the very first jury trial by the lawyers of Heygood, Orr & Pearson against makers of a fentanyl transdermal pain patch, a Florida jury awarded a $5.5 million verdict to the family of a man who died while wearing a Duragesic pain patch. More recently, Heygood, Orr & Pearson obtained a $16 million verdict for the family of a Cicero, Illinois woman who died while wearing a Duragesic pain patch
If you or a loved one has experienced the tragedy of losing a family member as a result of fentanyl pain patch usage, you and your family deserve answers to your questions. If the loss was as a result of a defective fentanyl patch, we can help you determine the best way to protect your legal rights and interests and hold the drug companies responsible for your preventable and unnecessary loss.
You can reach us by calling our toll-free hotline at 1-877-446-9001, or by completing our free online case evaluation form.