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Family sues over Rx drug

Did pharmaceutical patch lead to death of the Utah woman?

Dec 15, 2005 | Deseret Morning News The family of a Salt Lake area woman who died two years ago of multiple organ failure has filed a lawsuit against the maker of a pharmaceutical skin patch she was using to control pain.

Duragesic distributor, ALZA Corp., is being sued by the family of Marilyn Titus, who died Dec. 14, 2003, at age 72, two months after she began having serious side-effects from the pain medication fentanyl she was receiving through a skin patch, the lawsuit states.
She had sought help managing her chronic pain from two doctors, one of whom prescribed 50 micrograms of fentanyl dispensed timed-release through the patch, according to the suit.
Titus' first prescription 10 patches was filled at a local pharmacy in October 2003. On Nov. 22, she began to have difficulty breathing and lost consciousness while talking to a 911 dispatcher. She was taken to Pioneer Valley Hospital and airlifted to University Hospital, the lawsuit contends.

 The Food and Drug Administration said earlier this year that it is investigating the patch, which it said is linked to deaths and poses risks that users might not understand.

In a suit filed in 3rd District Court on Tuesday, the family alleges that ALZA and a partner company, Janssen Pharmaceutica Products, sold defective and leaking patches to Titus and others in Utah and elsewhere. Officials with those companies could not be reached for comment late Wednesday.

Titus was diagnosed with Paget's disease, which caused her to experience episodes of extreme back pain, the complaint states.

The complaint against the two companies states they negligently and carelessly researched, tested and distributed the patches and failed to warn users of the patch's risks.

The FDA on its Web site issued a public health advisory in July stating the patches may cause death from overdose. "Patients who are using the fentanyl skin patch and their caregivers should be told about the directions for safe use of the patch and should follow the directions exactly," the advisory states.

Symptoms of fentanyl overdose are troubled or shallow breathing, tiredness, extreme sleepiness or sedation, inability to think, talk or walk normally and feeling faint, dizzy or confused.

A Los Angeles Times story in November stated that the county coroner's office there had investigated more than 230 deaths involving fentanyl in the past six years. More than 100 of those deaths were classified as accidental. From 2000 to 2004, sales of Duragesic more than tripled and the number of prescriptions more than doubled, the paper reported. In 2004 alone, 4.1 million prescriptions for Duragesic were filled. While initially developed for cancer patients, the patch has become increasingly common for sufferers of other types of pain that may not be as closely monitored.

The complaint states package labeling lacked adequate information about the use of fentanyl patches and warnings of potential side effects.

The suit alleges the companies knew of injuries and deaths the patches caused and failed to recall them.

Marilyn Titus' husband, Robert, and daughter, Robyn Hastings, are suing the two companies and any others that may be found linked to the sale and marketing of Duragesic for damages that include medical expenses, funeral costs, out-of-pocket expenses, loss of love, companionship and economic support, punitive damages and attorney fees all to be determined at trial.

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