CHICAGO (CN) - A jury should decide whether a prescription skin patch is to blame for the fatal amount of pain medication in a man's bloodstream, a federal judge ruled.
Suffering chronic back after a car accident in 2005, William Acree had a prescription for 125 micrograms an hour of the fentanyl.
Acree used a generic version of the Duragesic patch, an FDA-approved product that emits a consistent dosage of the opiod over 72 hours.
One day in January 2009, Acree put a new patch on his arm in the morning and went to bed around 7:30 p.m.
The next morning, his son went to wake his father, and found him dead. Paramedics trying to resuscitate Acree stripped off the fentanyl patches and lost them.
An autopsy concluded that Acree died of fentanyl intoxication, or an overdose. There was a concentration of 23.6 nanograms per milliliter of fentanyl in Acree's bloodstream, instead of the expected concentration of 3.1 nanograms per milliliter.
The widowed Debra Acree sued Watson Pharmaceuticals, but the drugmaker argued that "postmortem redistribution" caused the high fentanyl concentration in Acree's blood. In other words, it said that the autopsy measured the drugs in the peripheral blood, rather than the central blood.
A Watson expert also questioned the cause of death, noting that Acree suffered from heart problems, asthma and gout.
U.S. District Judge Matthew Kennelly refused Friday to grant the drugmaker summary judgment, finding that there is enough circumstantial evidence to warrant a trial.
"The patches that Mr. Acree was wearing are long since gone," Kennelly wrote. "Watson contends that because Acree cannot point to any specific defect in the actual patches that were used, she must show that but for a defect in the patches, Mr. Acree would not have died. To the contrary, 'Illinois courts have acknowledged that the unavailability of the product does not preclude a plaintiff from proving that a product was defective through circumstantial evidence.'"
The judge also found that "Acree has presented evidence from present and former Watson employees, who testified that there have been other occurrences of reservoir patches that improperly leaked fentanyl gel."
"Viewing the evidence in the light most favorable to Acree, the Court finds that she has presented sufficient circumstantial evidence to permit an 'inference of probability' that the Watson patches were defective and caused Mr. Acree's death," the decision states. "Watson's evidence about "postmortem redistribution" may make Acree's evidence less persuasive to a jury, but it does not prevent her from surviving summary judgment. The issues of defect and causation thus involve genuine factual disputes that must be resolved by a jury."
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