Class Action Lawsuit
Duragesic Side Effect Lawsuit
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Duragesic Side Effect Lawsuit
Duragesic Side Effect Lawsuit
Johnson & Johnson, Watson Pharmaceuticals, and Actavis are facing a large number of Duragesic lawsuits across the United States for life-threatening complications linked to the drug and wrong marketing practices. The FDA approved Duragesic skin patches in 2005 for the treatment of chronic and severe pain. These pain patches release fentanyl, a type of opioid medication, gradually through the skin and provide relief from pain for about 72 hours. However, Duragesic patches can cause life-threatening hypoventilation and withdrawal symptoms in patients who are not opioid tolerant. These skin patches also develop leakages when exposed to external heat sources and release too much fentanyl into the body, which can cause fatal health problems.
Duragesic FDA Warnings and Recalls
The FDA added black box warnings to Duragesic pain patches in 2005 following recommendations by its advisory panels. According to the warning on the label, these fentanyl skin patches can create
potentially dangerous complications, including life-threatening respiratory problems, including breathing difficulty. It should only be prescribed to patients experiencing severe chronic pain. The drug has also been restricted for patients with a history of opioid drug intolerance and children below two years of age. The drug contains fentanyl, a potential substance for abuse. The high doses of Duragesic or its administration for longer duration can cause life-threatening hypoventilation and death.
In July 2005, the FDA warned about the possible fatal consequences of fentanyl overdose and abuse. The warning came after the adverse reporting system of the federal regulator identified 120 deaths linked to various Duragesic side effects. The health alert issued by the FDA warned that, fentanyl, the key element in Duragesic pain patches, is a very strong narcotic and its overdose results in dizziness, breathing problem, and suffocation. The advisory also requested consumers to avoid alcohol while using fentanyl pain patches. In November 2005, the FDA received a report about a Californian woman, who suffered from respiratory distress after using Duragesic pain patches.
In December 2007, the FDA again issued a public health alert highlighting life-threatening Duragesic side effects. It admitted that fentanyl pain patches continued to cause death of users and ordered the drug makers to prepare a medication safety guide. It advised patients and doctors against using Duragesic skin patches for sudden, occasional, less severe, and post-surgery pain relief.
In February 2007, Johnson & Johnson recalled Duragesic pain patches from the U.S. and Canadian markets after it was found that the product could expose users to unsafe fentanyl gel inside. In February 2008, the drug manufacturer issued another recall for the same reason. In February 2011, Johnson & Johnson discontinued production of Duragesic pain patches following detection of unspecified "microscopic crystallization” in certain Duragesic-100 stocks.
Duragesic Side Effects
Nervous System Problems: Duragesic pain patches lead to a number of nervous system side effects, including psychological and respiratory depression in aged patients. The drug has also been linked to stupor, agitation, drowsiness, respiratory myoclonus, seizures, and dysphoria. The FDA has received a report of severe hemiplegic migraine attack following the use of fentanyl pain patches.
Cardiovascular Side Effects: Duragesic cardiovascular side effects include hypotension, bradycardia, and rare reports of abnormal heart muscle contractions. Fentanyl pain patches also cause pulsus alternans and congestive heart failure in patients with cardiac valve stenosis.
Gastrointestinal Side Effects: Duragesic pain patches have been linked to nausea, vomiting, constipation, and gastrointestinal side effects. Post-marketing reports have highlighted cases of gum line erosion, tooth loss, and choledochoduodenal sphincter spasm in patients using fentanyl pain patches.
Respiratory Side Effects: Duragesic respiratory side effects include respiratory depression, breathing problem, acute pulmonary edema, and cough. A number of patients using Duragesic pain patches died due to breathing stoppage.
Other Duragesic Side Effects:
Genitourinary side effects of Duragesic pain patches include urinary retention, painful pennies erection, and problem in sexual arousal.
Hypersensitivity problems due to fentanyl pain patches include injection reaction, skin sensation, and localized rash.
Metabolic side effects include elevated antidiuretic hormone level.
Duragesic pain patches have also been linked to abdominal cramps, blurred vision, and insomnia.
Duragesic Lawsuits
Duragesic lawsuits filed in various U.S. courts have sought compensation against manufacturers for failure to adequately warn consumers about potential risks that resulted in fatal side effects. The first four Duragesic lawsuits resulted in $36 million compensation in favor of plaintiffs who lost their dear ones due to fentanyl side effects. In July 2006, a Huston court held manufacturers responsible for the wrongful death of a Texas woman in a Duragesic lawsuit and awarded $772,500 to the family of the victim. In 2007, Johnson & Johnson paid $5.5 million to settle a Duragesic lawsuit filed by family of Florida man. In October 2008, a Florida jury awarded $13 million compensation in another Duragesic lawsuit. A month later, a jury ordered Johnson & Johnson to pay $16.6 million for the death of an Illinois woman, who died in 2004 after using Duragesic pain patches.
In January 2010, an Illinois woman sued Wal-Mart in a fentanyl lawsuit. Her husband developed toxicity and died after he was administered a fentanyl pain patch at a Wal-Mart store following an accidental slip and fall. In November 2010, a Duragesic wrongful death lawsuit was filed against a Utah nursing home. The plaintiff claimed that her father died after doctors administered three Duragesic pain patches instead of one in every three days.