Painkiller Patch Recall
Duragesic painkiller patches contain the active ingredient fentanyl and provide users with up to three days of potent pain relief. Patients experiencing chronic pain, including cancer patients, may be prescribed a pain patch so the powerful opioid medication can provide relief. Fentanyl is actually a more powerful drug than morphine, and an overdose of the drug can be deadly.
Unfortunately, studies revealed that the Duragesic pain patches have a problem: the fentanyl gel could leak from the lining inside of the patch. This could result in direct contact between the patient and the opioid inside, which can have potentially fatal consequences. If you or a loved one has been harmed by pain patches, Michigan Injury Lawyers can file a lawsuit and pursue compensation on your behalf. Call us now for a free consultation.
The Food and Drug Administration first approved products with the active ingredient fentanyl in 1990. The Duragesic patch was the first containing fentanyl to be released on the market, although other manufacturers subsequently followed with variations on the transdermal patch.
When a patient wears a Duragesic pain patch, it is supposed to result in the slow release of the drug into the bloodstream, usually over 48 to 72 hours. When the patches malfunction and too much of the drug is released into the bloodstream at once, the result is a potentially fatal overdose.
Patients who overdose on the drug can experience dizziness, confusion, difficulty walking, impaired cognitive function and fainting. The drug can cause breathing impairment and extreme sleepiness and it is possible someone who overdoses will never wake up.
Unfortunately, overdoses can occur involuntarily and unexpectedly if the pain patch malfunctions. By July 2005, an estimated 120 deaths had already been reported to and investigated by the FDA and a safety alert was sent out. Reports continued to come in and the FDA issued another warning in December 2007. Manufacturers have also recalled several different pain patches over the course of the past decade, and The New York Times reports that past lawsuits have resulted in compensation for plaintiffs who sued after fatal overdoses.
Pain Patch Recalls
Amidst FDA concerns and reports of deaths, various manufacturers of pain patches have recalled their products over the past decade. For example:
- In 2004, Janssen Pharmaceuticals and the FDA announced a Class I recall of certain Duragesic 75 microgram/hour patches because of a potential seal breach that could result in leakage of fentanyl.
- In 2008, PriCara recalled certain 25 mcg/hr Duragesic® CII pain patches because of a cut along one side of the patch that could result in an overdose.
- In 2012, Johnson & Johnson recalled more than 53,000 Duragesic pain-relief patches after small crystals of the potent active ingredient appeared on the patches.
Patients were put at risk by these dangerous products before each recall took the respective patches off the shelves. Manufacturers are held strictly liable for all injuries resulting from defective products that are released to the public, but plaintiffs must prove the patches were the direct cause of harm. The recalls go a long way toward showing that the painkiller patches were injuring patients.
If you or a loved one suffered complications from fentanyl overdose, a painkiller patch lawsuit can make it possible to recover compensation. Contact Michigan Injury Lawyers today to request a free consultation with a member of our legal team. Our attorneys are here to help you take action against the drug manufacturer so you can be compensated for losses.