Faulty 'pain patch' cited in negligence suits.

The maker and distributor of Duragesic, a medicated skin patch designed to reduce pain in chronic cancer patients, face lawsuits by families of at least four people--including a Florida teenager who had undergone surgery for wisdom teeth extraction--who died or were severely disabled after using the painkiller.

The patch, approved in 1990 by the U.S. Food and Drug Administration for chronic but not acute pain, contains fentanyl, an opioid that is at least 100 times more potent than morphine, said Kalamazoo, Michigan, attorney Frederick Royce, who represents a client injured by the drug.

Fentanyl, when injected into patients, has been used effectively for more than 20 years in hospital operating rooms. But plaintiffs in the suits claim that distributor Janssen Pharmaceutica, Inc., which is a subsidiary of Johnson & Johnson, Inc., and manufacturer Alza Corp. sold fentanyl patches to relieve acute and post-operative pain in outpatients without adequate warnings about potentially dangerous effects.

"Janssen has salespeople out in the field marketing this patch beyond its recommended uses," Royce charged. "Their whole desire and intent was to sell it as an acute pain medication, but the FDA denied that use due to the patch dispensing fentanyl inconsistently."

Royce said many factors, such as a patient's advanced age or even a heat source placed against the body of someone wearing the patch, can change the amount of fentanyl that is delivered into the bloodstream.

In January 1993, 17-year-old Christopher Tyson died at his home in Pensacola, Florida, one day after an oral surgeon extracted his wisdom teeth. The teenager left the surgeon's office with a prescription for Durgesic, but he suffered a massive overdose of fentanyl.

"My son didn't die because he was given a patch that had a drug in it," said his mother, Donna Schilling. "He died because he had the patch and slept on a heated waterbed. The drug was never tested for heat variability, and now the package insert [that comes with the prescription for Duragesic! carries that warning."

Johnson & Johnson spokesman Bob Kniffin said the company considers Duragesic to be a "safe and effective drug when used in accordance with package inserts."

Kniffin acknowledged, however, that since Duragesic's market introduction, Janssen and Alza have changed the package inserts to emphasize the importance of proper dosages and to display more prominent warnings about potential risks of using the drug.

"The whole problem is a poorly worded insert," Schilling said. "[Janssen and Alza! are pointing their finger at a doctor in Pensacola who is a victim, too. This was very sloppy, and I want them punished for it."

Schilling filed a wrongful death suit in November 1993, claiming Janssen and Alza negligently distributed Duragesic to physicians and pharmacists, and ultimately to consumers, who were not adequately warned about its adverse effects. Schilling v. Janssen Pharmaceutica, Inc., No. 93-1729-CA-01 (Fla., Escambia County Cir. Ct. filed Nov. 9,1993).) Discovery is continuing in the case.

Schilling's attorney, Dennis Larry, said the package insert on his client's prescription contained the words "not recommended" rather than "not approved" for acute or post-operative pain--a distinction he contends is significant.

Royce, the Michigan attorney, backed Larry's claim about allegedly unclear or contradictory messages that Janssen and Alza gave to Duragesic users.

"What Janssen did was warn the doctors on the package insert and then had salespeople say it was OK for use after surgery," Royce said. "The salespeople's `out' is that they say they thought the patch would be used in inpatient surgery and that the patient would be under a physician's supervision."

Royce said he represents a 62-year-old Kalamazoo resident who suffered neurological and brain damage as a result of using Duragesic. John Angeletti's doctor prescribed the patch for him after he underwent surgery to correct a snoring problem.

Angeletti and his wife, Audrey, filed their lawsuit in March. (Angeletti V. Raedy, No. A94-0993 NM (Mich., Kalamazoo County Cir. Ct. filed Mar. 31, 1994).

Similar negligence suits have been filed against Jassen and Alza in Arkansas, California, and Florida.