Appeals Court Upholds Ruling, Duragesic Plaintiff Awarded $13.3 Million

Sanford, FLA patient who called her physician's assistant to complain of stomach pains in the middle of the night was told to take some Pepto-Bismol and try to go back to sleep. However, the 34-year-old mother of three grew worse and died later that night. It was determined at the conclusion of a trial in 2008 that Susan Hodgemire died from an overdose of Fentanyl delivered from a faulty transdermal Duragesic patch.

After 17 days of testimony and 6 hours of jury deliberation, the initial trial ended with an award of $13.3 million to the estate of the late Susan Hodgemire. Last month, an appeals court upheld the original verdict returned in the state circuit court in Seminole County, Florida. While the jury found the physician's assistant partly at fault in the wrongful death lawsuit, the court found that a faulty Fentanyl Duragesic patch had flooded the Florida woman's system with the potent and potentially lethal opiate, ultimately causing her death.

During the initial trial, a deposition by a production operator at Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, revealed that he and his colleagues routinely wore two pairs of protective gloves while testing the Fentanyl patches to prevent the robust medication from coming into contact with their skin.

It was also revealed, according to the 9/3/10 issue of Health Law Week, that testimony brought forward at trial showed that a series of two or even three properly functioning tansdermal patches would be incapable of producing a blood level with regard to Fentanyl toxicity higher then 3.4 to 9.3 ng/ml.

In Hodgemire's case, a postmortem revealed that the deceased woman showed a blood Fentanyl level of 22 ng/ml when she died. Noting the level of Fentanyl in her bloodstream, expert witnesses testifying on behalf of the plaintiff concluded the patches were defective, producing Duragesic side effects from which the patient could not survive.

Fentanyl is a particularly potent synthetic opiate which, when administered by way of a Duragesic time-release pain patch, is designed to treat chronic pain. Doctors are usually cautioned to avoid prescribing such a potent pain medication except in cases where patients have already been exposed to opiates.

There have been several instances since the pain patches were approved in 1990 where a Duragesic patch recall was required due to a manufacturing defect.