Duragesic | Fentanyl Pain Patch Recall: 2010 Update
Introduction
Fentanyl is sold by PriCara under the brand name Duragesic and by several companies in generic forms. The drug is intended to alleviate chronic pain in people such as cancer patients. Fentanyl can cause trouble breathing or death in people not used to this family of painkillers. Despite this intended narrow use, the Food and Drug Administration found cases where doctors prescribed Duragesic for headaches or post-surgical pain.
Since July 2005, the FDA has issued several Public Health Advisories regarding "reports of death and other serious side effects from overdoes of fentanyl in patients using fentanyl transdermal (skin) patches for pain control." In addition to the FDA scrutiny, various pain patch manufacturers have had to issue recalls due to defects that allow direct exposure to the fentanyl gel. Direct exposure can lead to extremely serious adverse medical events including respiratory depression and even death.
Fentanyl Recalls
On August 7, 2009 Watson Pharmaceuticals Inc. recalled a lot of its generic Fentanyl Transdermal System painkiller patches after finding that some patches leaked fentanyl gel. The recalled pain patches were shipped to customers between April 2 and May 20, with an expiration date of February 2011. The affected painkiller patches have the Lot Number 145287A, which is located on the box or the foil patch.
On December 31, 2008, PriCara, announced that one lot of its 50 microgram/hour Duragesic (Fentanyl) transdermal patches was being recalled because of a manufacturing cut defect that can potentially expose patients directly to fentanyl gel.
On February 12, 2008, pain patch manufacturers issued a recall on patches containing fentanyl in the 25 micrograms per hour (25mcg/hr) doses. Only patches with an expiration date on or before December 2009 are affected by the 2008 recall.
Duragesic | Fentanyl Pain Patch Lawsuits
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.
Legal Rights of Patients Injured by Prescription Drugs
The law in most states provides several personal injury claims for persons who have been seriously injured due to defective medical devices and treatments. These claims include strict liability for a defective product, failure to warn, and negligence.
Damages sought against drug manufacturers for producing defective products that injure patients can include compensation for:
- Physical pain and suffering, mental anguish and physical impairment;
- Past and future medical expenses;
- Loss of earnings and/or earning capacity; and
- Punitive damages for extreme wrongful conduct.
Submit Your Case
If you have suffered a serious injury while using fentanyl pain patch, please click here to contact a dangerous drug side effects personal injury attorney Lieff Cabraser. There is no charge or obligation for our review of your case.
Alternatively, you may contact Lieff Cabraser personal injury attorneys Kathryn Barnett or Mark Chalos in our Nashville office at 1-866-313-1973 (the call is toll-free).
About Lieff Cabraser
Founded in 1972, Lieff Cabraser Heimann & Bernstein, LLP is a sixty-plus attorney law firm with offices in San Francisco, New York and Nashville. For the last seven years, the National Law Journal has recognized Lieff Cabraser as one of the top plaintiffs' law firms in America.
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