That's exactly what happened to the husband of Janice DiCosolo, a woman who died after using a Duragesic fentanyl patch to ease her constant pain from a chronic neurological condition. The latest recall of the Duragesic patch, which was first recalled way back in 1994, was out of concern for the possibility of too much fentanyl leaking out of a potentially-defective patch.
In an ironic twist, it was revealed during the course of a lawsuit filed by the DiCosolo family against Duragesic manufacturer Johnson & Johnson and its subsidiaries ALZA and Janssen (J&J et al) that the patch which led to the death of Janice DiCosolo was not defective at all, but was performing properly.
Undeterred, the legal team for the family argued that the basic design of the patch was suspect and that a safer design might have prevented DiCosolo's death. The plaintiffs claimed that a safer design was known to the manufacturers and was available, but the defendants simply decided not to utilize the superior design in an effort to minimize costs and maximize profits.
The Duragesic manufacturers argued that DiCosolo's death was caused by 'polypharmacy,' which has been described as a mix of multiple and potentially incompatible medications.
Undeterred by that argument, the jury eventually found for the plaintiff and lobbed a judgment of $16.5 million against J&J et al.
The Duragesic patch has been recalled several times since 1994 for potential manufacturing defects. The recall that coincided with the death of Janice DiCosolo occurred in 2004.
Most will agree that at the best of times, the fentanyl patch requires handling with kid gloves due to the intense strength and influence of the opioid drug. Fentanyl is a narcotic, and is used for cancer patients and other patients dealing with intense, chronic pain. Patients who have yet to be exposed to medicinal narcotics require conditioning, in order to allow their bodies to adapt.
A fentanyl patch, even properly prescribed, applied and defect-free is at the best of times one heartbeat away from disaster given the potency of the medication. Stories of fentanyl patch use on the very young, or with patients not properly conditioned, are legion. Patients of died, or come very close to death.
The potential for a manufacturing defect in the patch only exacerbates the problem. A patch allowed to leech more fentanyl through the skin than a level considered safe due to a breach, or tear in the reservoir not only puts the patient at risk, but also the caregiver. Fentanyl exposure for the caregiver can occur by handling a defective Duragesic fentanyl patch, with life-threatening results.
A number of lawsuits are still pending, but some have been settled.
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Last fall a jury in Sanford, Florida awarded $13.3 million to the family of Susan Hodgemire. The woman died after undergoing back surgery and used the Duragesic patch afterward for pain management.
The victim was only 34.
In the summer of 2007 a federal jury found in favor of the father to a 28-year-old man who died in 2003 after wearing the Duragesic fentanyl patch. That judgment was worth $5.5 million.
Other manufacturers have recalled other fentanyl patches over the years. The latest recall involving Johnson & Johnson and its PriCara division occurred in February of last year, after lots of fentanyl patches manufactured by ALZA Corp were recalled.
While the recalls have stopped for the time being, the lawsuits go on…