Family of woman who died from defective fentanyl patch prevails against drugmaker

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March 2009, Volume 52, No. 2

Family of woman who died from defective fentanyl patch prevails against drugmaker 

DiCosolo v. Janssen Pharmaceutica, Ill., Cook Co. Cir., No. 04-L-5351, Nov. 17, 2008.

Anyone who has ever suffered intense pain knows that it can pervade all areas of life, making it impossible to work, take care of children, and enjoy everyday activities. Janice DiCosolo, a 38-year-old mother of three active children, used a fentanyl patch to control her pain. But a malfunction in the patch caused it to release too much of the opioid into her system, killing her. With the help of counsel, her family sought justice against the companies that manufactured and distributed the product.

Janice suffered from reflexive sympathetic dystrophy and was unable to function without pain medication. Her doctor placed her on a common regimen of several pain and nerve medications, combined with patches designed to deliver fentanyl over controlled three-day periods.

Janice and her husband John kept careful track of the medications she was taking, and they marked on a calendar the days when Janice needed to change her fentanyl patch. This regimen worked well and helped her enjoy her life. One afternoon, John came home during a work break to help Janice change her patch and noticed an unusual film on her skin. Janice was very tired, and he encouraged her to go to sleep. That night, when his shift was over, Janice was snoring unusually loud, and John went to their son’s room to sleep. When he checked on her a few hours later, he discovered she had died in her sleep. An autopsy revealed a postmortem fentanyl blood concentration of 28.2 nanograms per milliliter—16 times higher than the 1.7 nanograms the patch is supposed to supply. A few days later, John received a recall notice for the patch in the mail.

Fentanyl is an opioid 100 times stronger than morphine, and the patch was designed for treating only patients with severe pain who have become opioid-tolerant after long-term use of narcotic pain medicine. Several drug companies manufacture versions of the fentanyl patch, which comes in varied sizes depending on the strengths prescribed and is intended to spread out the drug’s delivery over three days. A rate control membrane at the bottom of the patch controls how much of the drug can touch the skin. The size of the patch also limits the amount of skin that comes into contact with the drug, and the skin itself will only absorb a certain amount at a time. In the recalled batch of patches, however, some had a “fold-over defect”—one edge of the backing to the patch folded before the patch was sealed, allegedly allowing fentanyl to leak out.

John contacted attorney F. John Cushing III, of Chicago, for recourse. To help him, Cushing brought into the case AAJ members James C. Orr Jr., Michael E. Heygood, and Charles W. Miller, all of Dallas, who were handling several other cases alleging patients had been injured or killed by defective fentanyl patches. John, individually and on behalf of Janice’s estate, sued the Johnson & Johnson subsidiaries that manufactured and distributed the patch, alleging a defect allowed too much of the drug to enter Janice’s system. The attorneys believe the patch Janice had on before John helped her change it that night is the one that had the leak, as evidenced by the film he had seen on her skin and the time it takes for the drug to enter the bloodstream. But, per the manufacturers’ instructions, John threw the patch out after they changed it.

Orr says fentanyl has a narrow therapeutic index, which means that there is a very small window between receiving enough of the drug to alleviate your pain and taking too much. “There are lots of drugs where you could have a whole bottle without it killing you. If fentanyl was a pill, you could take one and be fine, but a second one would kill you,” Orr explains. “The delivery has to be very accurate because just a little too much of the drug is bad.”

The defendants argued that the postmortem fentanyl levels were falsely elevated after Janice’s death as the drug seeped from her organs and tissues into the area where the blood sample was taken. They also argued that additional fentanyl from the patch Janice was wearing when she died migrated to this same area. The plaintiffs’ experts testified, however, that any amount of fentanyl redistributed after Janice’s death would have been minor and that it travels through dead tissue too slowly for the second patch to elevate levels so quickly.

The defendants further argued that Janice died from a combination of all of the drugs in her system rather than from an overdose of fentanyl. The drug companies noted that the patch’s insert warned not to mix fentanyl with other central nervous system depressants. The plaintiffs countered that it is common for pain sufferers to be on several medications simultaneously, and Janice had been taking that combination of pain and nerve medications for some time. “Once you’re on a drug regimen, and your body is doing fine,” says Orr, “something has to change to make it suddenly become harmful.” Here, counsel argued, that change was that Janice suddenly received an excessive amount of fentanyl.

At trial, the defendants admitted the patch was from the recalled batch but argued the plaintiffs could not prove it was one of the small percentage of patches that was defective. But the plaintiffs argued that fentanyl was the only explanation for Janice’s death. “I called it the elephant in the room,” says Orr. “What else did she die from? She was a healthy woman, and the autopsy showed no disease or heart condition. But she did have a super high fentanyl level.”

A jury awarded the plaintiffs $18 million, reduced to $16.56 million after its finding that Janice was 8 percent at fault for combining the drugs. The parties’ posttrial motions are pending. The FDA is investigating the patches and recently issued a second health advisory, noting that it “continues to receive reports of death and life-threatening side effects in patients who use the fentanyl patch.”

Orr hopes the verdict will spur drugmakers to remove defective products immediately and warn the public about the dangers. “Mrs. DiCosolo passed away needlessly,” he says. “When you’re using a patch like you’re supposed to, it’s not supposed to kill you.”

Courtney L. Davenport, Associate Editor

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