Yesterday Johnson & Johnson announced a voluntary recall of a popular version of their Duragesic pain patch. About 32 million patches sold by PriCara, a unit of J & J, are being recalled due to concerns that a defect could expose patients to excess doses of the powerful opioid, fentanyl, leading to respiratory difficulties and even death. The company estimates that defects exist in two out of every one million patches, 64 in all. The recall involves the widely used 25-microgram per hour patch used to treat lower-weight and newer patients suffering from chronic pain.
In 2004 the company issued a recall of some batches of the less popular 75-microgram per hour patch. Johnson & Johnson has been sued by 72 people alleging injury from the Duragesic patch. A case last summer delivered a $5.5 million verdict.
Some plaintiffs’ attorneys have argued that it may be time for the patches to be pulled from the US market, citing the prevalence of safer and more effective alternatives.
“We’re acting responsibly by recalling the defective lot,” says the PriCara spokesman, Mr. Panico, adding that the company can’t comment on pending lawsuits. “Despite the defect, there’s much unaffected product on the market and we think overall the patients have been served by this therapeutic option.”
The company has said that no fatalities have been reported with the defective patches and hopes to avoid the bulk of legal issues associated with this recall by acting in a quick and preventative fashion.