J&J To Pay $16.6M For Duragesic Patch Death
4 CommentsBy Ed Silverman // November 18th, 2008 // 7:00 am
A jury in an Illinois state court awarded the money to the family of Janice DiCosolo, 38, who died in February 2004, because the patch she was wearing delivered a fatal dose of the fentanyl narcotice, which is the main ingredient in Duragesic, Bloomberg News reports.
This if J&J’s fourth loss in as many trials over the past two years and it took the jury less than two days to deliberate. The patch, by the way, is made by Alza and distributed by Janssen Pharmaceutica, and generated $1.16 billion in sales last year for J&J, making Duragesic one of its best-selling products, the news service writes.
“We disagree with the jury’s verdict,” a J&J spokesman writes Bloomberg. “We are considering our options for an appeal.”
The lawsuit was filed by DiCosolo’s husband, John, 45, and the couple had three children. The trial began Oct. 29, one day after a jury in Sanford, Florida, awarded more than $13 million to the family of Susan Hodgemire, a 34-year-old mother of five who died after using a Duragesic patch in 2002.
DiCosolo’s husband, a Cicero, Illinois police sergeant, wasn’t in the courtroom when the verdict was read. His lawyer, John Cushing, said his client was relieved to have had the opportunity to tell his wife’s story. “He didn’t do this for money,” Cushing tells Bloomberg.
Defense lawyers, citing an autopsy, said DiCosolo died from the interaction of at least five drugs, including fentanyl, found in her system by a Cook County coroner, Lawrence Cogan.
Fentanyl is a painkiller 100 times more powerful than morphine, plaintiffs’ lawyers said at trial. The patches, prescribed for people combating chronic pain, are to be worn for 72 hours and then discarded. Janice DiCosolo was found wearing one when she died. Each patch contains enough fentanyl to kill 10 men weighing 300 pounds each, according to DiCosolo’s lawyer.
Janssen recalled one lot of Duragesic patches in February 2004, a day after DiCosolo died, because of improper sealing of the adhesive backing of the devices, defense lawyer David Sudzus wrote in a court filing. The patch worn by DiCosolo was from that lot, he said.
“Both an independent expert and a company expert inspected the patch in question and concluded there was no defect,” the J&J spokesman wrote Bloomberg. “We believe that the cause of Ms. DiCosolo’s death was polypharmacy, a mix of multiple and potentially incompatible medications.”
Two jurors said the money they awarded John DiCosolo and the couple’s children was an average of higher and lower amounts suggested by members of the panel. “It was a common ground,” juror Bret Lessard, 22, of Tinley Park, Illinois, said of the panel’s initial verdict for $18 million. The jurors then subtracted 8 percent after finding DiCosolo at least partly liable for her death because of the other meds in her system. “You assume some risk with as many drugs as you’re taking,” Lessard said.
The jury forewoman, Peggy Rounsfull, 51, of Glenview, said, it was the fentanyl that appeared to have killed DiCosolo, who suffered from chronic neck pain. “There was no way of getting around the fact that she had too much fentanyl,” Rounsfull tells Bloomberg.
On Jan. 12, the J&J units face another trial in Chicago, this time in federal court.
Johnson & Johnson in July 2007 agreed to pay the family of a Florida man $2.5 million to resolve claims that Adam Hendelson, 28, had died after using one of the patches, three people with knowledge of the accord said. A jury had awarded the plaintiffs $5.5 million one month earlier.
In July 2006, a state court jury in Houston ordered Janssen and Alza in July to pay $772,500 to the family of a Texas woman who died after her patch leaked. The companies appealed that verdict.
Source: Bloomberg News
An FDA Reviewer
This is exactly the type of problem that FDA reviewers have been detecting while doing reviews during the initial approval of new drugs and during supplemental reviews for manufacturing changes.
This is why companies such as J&J and in particular their Alza division have been pushing Quality by Design (QBD). In effect saying to us we know so much about how to manufacture drugs and change them that we don’t need to do any testing on changes, the quality is already built in.
J&J is definitely in my opinion the strongest advocate of QBD, not only taking the attitude that who are reviewers to question us, but also when a reviewer does question J&J have FDA management retaliate.
An FDA Reviewer
Webb Margaret
My mother died on February 23rd 2008. She had been wearing duragesic patchs for approximately two years. Is it possible that the patch had something to do with her death? She had been to her doctor and her heart specialist within two weeks of her death and everything was fine. They listed the cause of death as cardiogenic encephalopathy. My mom had been doing so well that this taking place so suddenly really confused everyone. My concern is, was her death related to her wearing the duragesic patch?
Jamie Mikle
The 34 yr old mother of 5 that died from the pain patch was my mother and I just want to send sympathy to the families that have lost their loved ones due to the neglectfulness of the company producing these patches. Though these cases disappear for the companies after they are settled it is something that the families will live with forever. In deepest symathy to the loved ones of the ones we lost, stay strong for eachother and hang in there.
Hubdar Ali
In Pakistan J@J importing and marketing the same patches since 2002 and they neither recalled the patches manufactured by ALZA Corp nor publised any information in this regard for the users.
Company like J@J and USFDA should take appropriate action and compensation to avoid discriminative attitude with third world like Pakistan. As none of the company paid any compensation to Pakistani victim. Pfizer, MSD, BMS, Aventis, GSK etc have paid penalty in developed world like US but ignored the same here. They even do not bother to recall the such products from Pakistan voluntrarily while knowing the safety and threat potential associated with certain drug products.
I hope authorities will also consider the same in the spirit of WTO to ensure equal behaviour with people and country too.