Final Appeal Briefing Issued in $16 Million Illinois Fentanyl Patch Lawsuit

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by Heygood Orr and Pearson

CHICAGO – The First District of the Illinois Court of Appeals has received final briefing in the appeal of a $16.56 million judgment entered more than two years ago against Johnson & Johnson (NYSE: JNJ) subsidiaries Janssen Pharmaceutica Inc. and ALZA Corp.

The appeal stems from a Nov. 17, 2008, jury verdict in Judge Thomas Flanagan’s Cook County Circuit Court.  Jurors found Janssen and ALZA liable in the death of a 38-year-old wife and mother of three in DiCosolo v. ALZA Corp, et al.

Janice DiCosolo died on Feb. 15, 2004, while using a Duragesic® fentanyl patch prescribed by her doctor to reduce pain from the neurological condition reflex sympathetic dystrophy. Duragesic patches contain a gel form of the pain medication fentanyl.

At trial, attorneys for Mrs. DiCosolo’s family argued that well before issuing a recall, the defendants were already aware of the long history of manufacturing defects in the Duragesic® fentanyl patch, which can allow lethal amounts of fentanyl to leak into the user’s bloodstream.

Janssen and ALZA ultimately recalled millions of Duragesic® fentanyl patches, including the patch used by Ms. DiCosolo. A subsequent FDA investigation found numerous deficiencies in ALZA’s manufacturing practices and quality control assurance policies and procedures. The patch has since been redesigned so that it can no longer leak.

“They knew this patch was dangerous and defective, but they continued to sell it knowing it could leak dangerous fentanyl gel to its patients, which is exactly what happened. It’s the only reason Janice DiCosolo isn’t here today,” says attorney Jim Orr of Heygood, Orr & Pearson (HOP), counsel for the DiCosolo family.

“There was an alternative design for fentanyl patches that prevented leaks, but they chose not to use it,” says Michael Heygood, who also represented the DiCosolo family at trial.

Dr. Lawrence Cogan, the Cook County Medical Examiner who performed the autopsy, testified during the trial that the excessive fentanyl level found in Ms. DiCosolo’s blood was the cause of her death. Toxicological testing showed her bloodstream had 15 times more fentanyl than a properly functioning Duragesic® patch was designed and intended to provide.

“The drugstore sent Mr. DiCosolo a letter about the recall days after his wife’s death,” says attorney John Cushing of The Law Offices of John Cushing in Chicago, who also represented the DiCosolo family. “This was a tragedy that didn’t have to happen.”

“The Defendants’ causation arguments on appeal simply ignore the facts heard by the jury,” says Eric Pearson of Heygood, Orr & Pearson, lead appellate counsel for the DiCosolo family. “The facts are that there was an extensive history of selling leaking Duragesic® fentanyl patches to the public; Janice DiCosolo’s fentanyl patch was recalled shortly after her death; the FDA found numerous deficiencies in the Duragesic® manufacturing process; she died with 15 times the amount of fentanyl the patch was intended to deliver in her blood; and the Cook County medical examiner said fentanyl killed her.”

The Illinois Court of Appeals is expected to hear related oral arguments in the fall of 2011.

Heygood, Orr & Pearson is a business litigation and personal injury law firm based in Dallas. The firm prides itself on having the highest of credentials, experience and ability and has tried more than 200 cases to a jury verdict on behalf of both corporations and individuals. These cases include lawsuits involving business disputes, life-altering personal injury, defective products, dangerous prescription drugs and more.