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| Fentanyl Pain Patch Recall |
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| | 160 | LEAD PLAINTIFF: Case Filed: 2008-03-17 |
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Case Summary: In lawsuits filed against manufacturers of fentanyl pain patches, injured patients have alleged that they were directly exposed to the powerful drug. Some patches, the lawsuits charge, had a cut in the lining of the internal reservoir where the drug is stored in a gel form. As a result, the powerful opioid if the gel form of fentanyl has leak into the packaging. The patients suffered injuries including respiratory failure, aspiration pneumonia, acute renal failure, rhabdomyolysis, dehydration, and elevated troponin due to volume depletion. The lawsuits allege that the drug’s manufacturers are liable for failing to provide adequate warnings to the medical community and consumers on the safe use of the Fentanyl Transdermal System, and that a safer and more effective methods of pain relief were available. Case Detail: In July 2005, the Food and Drug Administration issued a Public Health Advisory stating that it is "investigating reports of death and other serious side effects from overdoes of fentanyl in patients using fentanyl transdermal (skin) patches for pain control." Fentanyl (sold by PriCara under the brand name Duragesic, and in a generic version by Sabdoz Inc.), is intended for chronic pain in people such as cancer patients, and can cause trouble breathing in people not used to this family of painkillers. Despite this, the FDA found cases where doctors prescribed Duragesic for headaches or post-surgical pain. |
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