Johnson & Johnson has agreed to settle wrongful death claims involving its Duragesic pain-killing patch for more than $2.5 million, according to Bloomberg.com. The settlement, paid to the family of a Florida man who overdosed on the opiod painkiller fentanyl while wearing the patch in 2003, was the first awarded by Johnson & Johnson in a case involving the Duragesic patch. Hundreds more wrongful death suits are still in the works.
“The settlement indicates that Johnson & Johnson realizes the seriousness of these cases and that they have to pay serious money to resolve them,” Alex MacDonald, a lawyer based in Boston, told Bloomberg.com. MacDonald has four cases involving Duragesic overdoses set to go to trial next year, while as many as 300 to 400 more similar suits have been filed, according to Bloomberg.
Johnson & Johnson may now have to consider an all-inclusive settlement for the many pending wrongful death suits, as it has lost both cases that have gone to trial. A jury awarded $772,500 in damages in a suit involving a Texas woman overdosed when her Duragesic patch leaked fentanyl onto her skin instead of administering it in a controlled dose. That case is still under appeal, Bloomberg.com reported.
In July 2005, the federal Food and Drug Administration (FDA) issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. Mylan Pharmaceuticals, a manufacturer based in Morgantown, West Virginia, has sold a fentanyl transdermal patch since it received FDA approval in January 2005. The results of the FDA probe are still pending. The agency is “continuing to investigate the safety of these patches to assure they remain safe and effective,” FDA spokeswoman Kimberley Rawlings told Bloomberg.
The Duragesic painkilling patch, which disperses fentanyl directly through the skin, uses so-called “transdermal” technology developed by California-based Alza Corporation. Janssen Pharmaceutica, the defendant named in the recently settled Florida suit, marketed the Duragesic patch in the United States, but does not currently have the product listed on its Web site. Both Alza and Janssen are part of the Johnson & Johnson “family of companies.”
The jury in the Florida case found that officials employed by Johnson & Johnson were aware of the defects in the Duragesic product, but neglected to inform doctors and consumers about the potential risks. Jurors awarded $5.5 million to the family of Adam Hendelson in June, and Johnson & Johnson agreed to drop its appeal of the case as part of the settlement.
In 2004, the (FDA) recalled all 75 mch/h Duragesic patches, the line of the product that dispenses 75 micrograms of medicine per hour. That recall has since been expanded to include four more versions of the Duragesic patch. Recalled patches could potentially leak fentanyl if their edges are not properly sealed, leading to an excess of the prescription painkiller, a medicine stronger than morphine, and being absorbed into the body.
Signs of fentanyl overdose include trouble breathing or shallow breathing; tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused, according to the FDA’s Web site.
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