A Medical Device Daily

A federal jury awarded $5.5 million to the father of a man who died while wearing a drug patch made by two subsidiaries of Johnson & Johnson (New Brunswick, New Jersey).

The jury in U.S. District Court in West Palm Beach found that Janssen Pharmaceutica Products and Alza , both New Jersey-base, were liable in the death of Adam Hendelson, 28, who died in 2003 while wearing the companies' Duragesic patch.

The patch delivers controlled doses of the painkiller fentanyl. Hendelson had suffered chronic hip pain after a car accident and wore the patch on his arm, according to Jim Orr, attorney for Hendelson's father, Lee, who filed the suit.

"The evidence was overwhelming that they knew they were manufacturing patches … that were leaking fentanyl gel," Orr said, adding that the drug is 100 times stronger than morphine. "Despite that fact, they were releasing the product out into the marketplace."

A spokesman for Janssen and Alza said the companies were considering an appeal.

"We sympathize with the Hendelson family over their loss," said spokesman Greg Panico. "However, we disagree with the jury's verdict and we're considering our options for an appeal."

Orr said tests showed Hendelson had at least three times the lethal dose of fentanyl in his system when he died.

The verdict was the first in a federal case against the makers of the patch. Orr said he knows of up to 30 others filed around the country.

Last year, a Houston jury awarded $772,500 to the daughter of a woman who died after wearing the patch. At the time, Alza said it was confident in the safety of the product.

The FDA reported in 2005 that it was investigating 120 deaths among users of patches that emit fentanyl and warned patients to be sure to use the powerful narcotic properly to avoid accidental overdose. While at least some of the deaths appeared to have been accidental, the agency at the time said it was probing whether there were also factors related to the product's quality.

In February 2004, Janssen issued a recall of one manufacturing lot of the Duragesic patch after determining that some patches in that lot might leak along one edge. In April of the same year the company expanded the recall to include five lots — about 2.2 million patches.

The patches were first approved under the brand name Duragesic in 1990. A generic version hit the market in 2005. Deaths of users have been reported to the FDA for both versions.

In other court-related news: The Federal Trade Commission reported a consent order settling charges brought in 2003 that the South Carolina State Board of Dentistry unlawfully restrained competition by adopting a rule that required a dentist to examine every child before a dental hygienist could provide preventive care, such as cleanings, in schools.

The board adopted the rule in 2001, after the South Carolina legislature had eliminated a statutory requirement that a dentist examine each child before a hygienist could perform preventive dental care in schools.

The board is a state regulatory agency, composedof practicing dentists, that regulates dentist and dental hygienists. The FTC alleged that the board's anti-competitive conduct led to fewer children receiving preventive dental care in schools, particularly economically disadvantaged children. As a result of legislation enacted by the South Carolina legislature in 2003, the board no longer requires a dentist to examine each child before a hygienist's exam in a public health setting.

The consent order requires the board to publicly announce its support for the current state policy — that hygienists can provide such care in public health settings without a dentist's examination — and to notify the commission before adopting rules or taking other actions related to preventive dental services provided by dental hygienists in public health settings.