When the heat from the pad and the blanket came into contact with the patch, the amount of Fentanyl released into Mr Hophan's bloodstream was estimated to be about 100 times greater than the amount prescribed, according to a judge's opinion in a lawsuit filed by Mr Hophan's mother, Elaine Hophan, against the drug's maker.
In 2001, a jury awarded Ms Hophan $5 million in damages but after an appeal, the case was settled under a confidential settlement agreement.
Fentanyl patches are sold under a variety of brand and generic names. Johnson and Johnson's Duragesic was the first on the market arriving in the early 1990s. It's the most popular patch with four million prescriptions filled at US pharmacies last year.
Worldwide sales of Duragesic in 2005 were $1.59 billion, according to J& J's earnings reports. The cost of a 30-day supply ranges from $348 at Target to $408 at Wal-Mart, according to FDA documents.
On July 15, 2005, the FDA issued a public health advisory about the proper way to use the Fentanyl patches to avoid overdose, in response to reports of deaths in patients using the narcotic patch for pain management.
The Los Angeles County Coroners Office reports a growing number of accidental over-doses by patients misusing the patch: 127 deaths over the last six years, according to a CBS News report on December 20, 2005.
"They're not getting the relief that they want. Therefore they're slapping more patches on trying to get that instantaneous relief," says toxicologist Daniel Anderson. "What they don't realize is that most of these patches are to be applied over a three-day period."
Utah statistics according to the latest mortality data from the state Health Department show Fentanyl was related to 29 accidental deaths in 2005, up from nine in 2004, and 13 in 2002, according to the March 14, 2006 Salt Lake Tribune.
Lawsuit are being filed as a result of the high accidental overdose rate. Robert Debry & Associates, in Salt Lake City has taken about a dozen cases involving deaths allegedly from Fentanyl. One lawsuit is filed on behalf of the family of Marilyn Titus who died December 14, 2003, at age 72 and alleges Ms Titus, was suffering from severe back pain, and was sold defective and leaking patches.
In December 2005, surviving family members of two more Utah women filed wrongful death lawsuits, alleging the patches leaked and caused the deaths of both women.
Autopsy reports said the women died from drug poisoning after using pain patches. Both lawsuits claim the women were prescribed the patch and were found dead in their homes within one or two days of using the patch.
Both lawsuits claim negligence for failing to research and design the patch and allege the companies misrepresented the safety of the patch for human use.
Overall, US emergency room doctors saw overdoses of Fentanyl grow from 28 in 1994 to 1,506 in 2002, according to the most recent statistics available from the US Substance Abuse and Mental Health Administration.
In March 2006, the FDA announced it would conduct a review of all medication patches beginning with Fentanyl and the Ortho Evra birth control patch, also made by J& J.
The following month, an April 10, 2006, Long Island Newsday report said that "hundreds" of women had filed lawsuits against Ortho-McNeil, the J&J division that manufactures the Ortho Evra patch.
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