A Medical Device Daily

A Chicago jury has ordered two Johnson & Johnson (J&J; New Brunswick, New Jersey) subsidiaries to pay $16.6 million to the family of a 38-year-old Illinois woman who died while using a Duragesic patch, after a three-week trial in Cook County.

Janice DiCosolo died Feb. 15, 2004, while using Duragesic, a patch containing a gel form of the drug fentanyl, according to her lawyers. The patch that she was using was part of a larger group of patches that the company recalled that year.

In the lawsuit, DiCosolo's family argued that the defendants, Janssen Pharmaceutica (Titusville, New Jersey) and ALZA (Mountain View, California) – both J&J subsidiaries – knew about the Duragesic patch's problems, which allowed the patches to leak fentanyl in amounts large enough to kill the patients using it.

According to an Associated Press report, Greg Panico, a spokesman for Janssen and ALZA, said the companies sympathize with DiCosolo's family but disagree with the jury's verdict. The companies are considering options for an appeal, he said.

"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," said attorney Jim Orr of Heygood, Orr, Reyes, Pearson & Bartolomei (HORP&B; Dallas), counsel for the DiCosolo family. "They even knew there was a safer design, one that would prevent the fentanyl from leaking, but they chose not to use it," added Orr's partner, Michael Heygood, who also represented the DiCosolo family at trial.

The same year DiCosolo died, an FDA investigator found deficiencies in ALZA's manufacturing practices and quality control assurance policies and procedures.

"The drugstore that sold this patch sent Mr. DiCosolo a letter days after his wife's death to tell him about the recall," says attorney John Cushing of Chicago, who also represented the DiCosolo family. "This was a tragic death that didn't have to happen."

HORP&B said this is the second Duragesic case where HORP&B has prevailed on behalf of a client who lost a family member due to a defective fentanyl patch. Last year, a federal court jury in Florida awarded $5.5 million to the family of 28-year-old Adam Hendleson, who died while using a Duragesic patch that was prescribed for hip pain, the law firm noted.

In other legalities, Candela (Wayland, Massachusetts) and Palomar (Burlington, Massachusetts) reported that the U.S. District Court for the District of Massachusetts agreed to stay the patent litigation that Palomar brought against Candela in August 2006.

In the lawsuit, Palomar asserts that Candela infringed upon its hair removal patents, specifically U.S. patent Nos. 5,735,844 and 5,595,568.

Candela said it filed a motion requesting a stay of the lawsuit on Oct. 31 after learning of a third party's re-examination request that was filed with the U.S. Patent and Trademark Office on July 10, which was granted by the USPTO on Aug. 29.

"We are pleased with the court's ruling to stay the litigation while the PTO re-examines the validity of the patents at issue. While every re-examination has varying timeframes for resolution, according to the PTO statistics reported as of June 30, 2008, average pendency of re-examination is 24.3 months. We remain resolute in our belief that, not only do we not infringe these patents, but that the patents themselves are invalid." Said Gerard Puorro, Candela president/CEO. "While the re-examination is pending, we expect a precipitous drop in our legal expenses while we work to restore profitability to the company."

Palomar says reexaminations of patents are common and granted by the patent office 92% of the time. "The granting of a request for reexamination does not indicate that the claims of the patents will be cancelled or altered in any way," the company noted.

In this particular instance, an anonymous third party filed the request for reexamination and cited only a single prior art reference, which Palomar says was previously cited during the prosecution of the '844 patent. Palomar said it believes the arguments regarding invalidity in the request for reexamination are "baseless as well as factually and legally incorrect." The company said it would respond to the reexamination, including by citing all prior art, which Candela and others have relied upon.

The lawsuit will be delayed until the reexamination is complete.

Candela's products are designed to treat selected cosmetic and medical conditions using lasers, aesthetic laser systems, and other advanced technologies.

Palomar develops light-based systems for cosmetic treatments.