Jury awards nearly $16.6M in Ill. skin patch case

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Posted on 17th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/18/2008

By MEGAN REICHGOTT
Associated Press Writer

CHICAGO (AP) _ Two Johnson & Johnson subsidiaries that make and distribute a painkilling skin patch must pay nearly $16.6 million to the family of a suburban woman who died from a drug overdose while using the product, a jury ruled Monday.

Janice DiCosolo, 38, of Cicero died on Feb. 15, 2004, while using a Duragesic patch that her doctor prescribed to reduce pain caused by a neurological condition called reflex sympathetic dystrophy, her attorneys said.

The mother of three died because the patch delivered a fatal dose of its main ingredient, the powerful narcotic pain reliever fentanyl, jurors ruled Monday in Cook County Circuit Court following a three-week trial.

The defendants, Titusville, N.J.-based Janssen Pharmaceutica Inc. and Mountain View, Calif.-based ALZA Corp., knew about problems with the Duragesic patch that allowed it to leak fentanyl in doses large enough to kill patients, the lawsuit claimed. Both companies are subsidiaries of New Brunswick, N.J.-based Johnson & Johnson.

“They knew this patch was dangerous and defective but they continued to sell it and make money, and that’s the only reason Janice DiCosolo is dead,” Jim Orr, an attorney for DiCosolo’s family, said in a statement.

Greg Panico, a spokesman for Janssen and ALZA, said Monday that the companies sympathize with DiCosolo’s family but disagree with the jury’s verdict.

The companies are considering options for an appeal, Panico said in a statement.

“This is a very unfortunate case for everyone, but we maintain that the patch was not defective,” he said.

An independent expert and company expert inspected the patch that DiCosolo used and concluded there was no defect, Panico said. The companies believe DiCosolo’s cause of death was polypharmacy, “a mix of multiple and potentially incompatible medications,” he said.

Duragesic is a prescription-only product that is intended for cancer patients and others with chronic pain and is designed to dispense the medicine slowly through the skin.

The verdict is the fourth trial loss for the companies since 2006, DiCosolo’s attorneys said.

A Sanford, Fla., jury last month awarded $13.3 million to the family of Susan Hodgemire, 34, who died after undergoing back surgery and using the Duragesic patch. In June 2007 a federal jury awarded $5.5 million to the father of a 28-year-old man who died in 2003 while wearing the patch.

The Food and Drug Administration issued two warnings in two years about improper use of fentanyl patches.

Some of the deaths came after doctors prescribed the patches to the wrong patients, the FDA said in December 2007. Patients could also accidentally overdose by using the patches wrong, the FDA said.

Some patches containing fentanyl were recalled in February 2008 because of a flaw that could cause them to leak. Those patches were sold in the United States by Actavis South Atlantic LLC and had both that name and the company’s former name, Abrika Pharmaceuticals Inc., on the packaging.

Also in February, PriCara, another Johnson & Johnson division announced a recall of fentanyl patches manufactured by ALZA Corp.

The patches were first approved under the brand name Duragesic in 1990. A generic version hit the market in 2005.

Copyright 2008 The Associated Press.
Summary

Court hears amputee's case on limits of drug suits

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Posted on 3rd November 2008 by Gordon Johnson in Uncategorized

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Date: 11/3/2008

By MARK SHERMAN
Associated Press Writer

WASHINGTON (AP) — The Bush administration and a drug maker urged the Supreme Court on Monday to throw out a multimillion dollar verdict to a Vermont musician who lost her arm because of a botched injection to relieve nausea.

The case is being watched closely by the pharmaceutical industry and consumer groups because of its potential for broad limits on lawsuits by people, such as Diana Levine, who were harmed by prescription drugs.

But the justices seemed more likely on Monday to be headed toward a narrow ruling that might be confined to the facts of Levine’s case.

A Vermont jury awarded Levine $6.7 million after the improper injection of Phenergan, an anti-nausea drug made by Wyeth Pharmaceuticals, caused gangrene that led to the amputation of her right arm.

The jury agreed with Levine that Wyeth should have included a stronger warning about the risks of a method of intravenous injection known as IV push.

But lawyers for Wyeth and the government said Levine’s case should have been thrown out of court because Phenergan has been approved by the federal Food and Drug Administration and its label adequately warned about its risks. FDA approval serves as a shield against liability lawsuits under state law in such cases, they said.

“The labeling plainly comprehended and warned about the specific risks of IV administration,” Seth Waxman, representing Wyeth, told the justices.

In recent years, the administration and business groups have aggressively pushed limits on lawsuits through the doctrine of pre-emption — asserting the primacy of federal regulation over rules that might differ from state to state.

But Justice Samuel Alito, among others, had a more basic question for Waxman.

“How could the FDA have concluded that IV push was safe and effective,” Alito asked, given that Phenergan is not a lifesaving drug and gangrene can result from improper administration?

Justice Ruth Bader Ginsburg chimed in, “How could the benefit outweigh the substantial risk?”

Waxman responded that testimony in this case was clear that there are circumstances in which IV push is “medically warranted.”

David Frederick, representing Levine, argued that Wyeth never made clear to the FDA how dangerous IV push could be. He noted that Pfizer, Inc., stopped making IV push an acceptable method of injecting its anti-nausea drug after two amputations were reported.

A ruling probably will not come before early next year.

Copyright 2008 The Associated Press.