J&J Recalls Pain Patches For Fatal Overdose Risk

Portfolio Media

02/13/2008 - Johnson & Johnson voluntarily recalled 32 million of its Duragesic pain patches on Tuesday after discovering a defect in them that could cause a fatal overdose on fentanyl, the opioid contained in the patches.

Duragesic patches, which are prescribed to treat moderate to severe chronic pain, have been the subject of more than 300 wrongful death lawsuits filed on behalf of patients who died of overdoses while using the patch.

Two cases last year resulted in settlements, one for $2.5 million, the other for $700,000. The rest are still pending.

According to a statement by the company, the defective patches recalled this week may have a cut along one side of the drug reservoir within the patch, which could allow the fentanyl gel to leak out.

Direct exposure to fentanyl, a highly addictive class II narcotic, can cause “serious adverse events, including respiratory depression and possible overdose, which may be fatal,” Johnson & Johnson said.

The company's statement advises customers not to use the broken patches or even handle them. Customers who come in contact with the fentanyl gel should “rinse exposed skin with large amounts of water only; do not use soap.”

The recall includes all 25-mcg-per-hour patches sold in the U.S. by Johnson & Johnson subsidiaries PriCara and Sandoz. The patches are made by another subsidiary, Alza Corp. The company estimates that of the millions recalled, a few dozen of the patches are defective.

J&J was alerted to the problem by people who returned the product in January, and no fatalities were reported, Johnson & Johnson spokesman Greg Panicotold told the Wall Street Journal.

“Despite the defect, there's much unaffected product on the market, and we think overall the patients have been served by this therapeutic option,” he said.

According to the Journal, Duragesic had $1.16 billion in sales in 2007.

Jerry Parker, a managing partner at Parker Waichman Alonso LLP, which represents plaintiffs injured by Duragesic patches, said in a statement that the recall shows how dangerous they can be.

The patches “have caused serious injuries to users because of defects that allow the patches to deliver far more medication than is safe,” he said. “This recall just points to the continuing problems Johnson & Johnson is having with its patch technology.”

The U.S. Food and Drug Administration issued two separate safety warnings about fentanyl patches, one in 2005 and one in December.

Both advise consumers to follow directions on the patches exactly to avoid overdose. The warnings mention that the agency has received numerous reports of deaths and life-threatening side effects resulting from incorrect use.

An FDA spokeswoman told the Journal that the agency “continues to engage with the company in its voluntary recall and is investigating the situation.”

The more potent 75-mcg Duragesic patch was subject to recalls in 2004.

If you or a loved one have experienced Duragesic side effects you may be entitled to compensation. Contact the Duragesic attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Duragesic side effects, a possible Duragesic class action lawsuit, or any other type of Duragesic litigation.