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ERONY v. ALZA CORP.

December 21, 1995

ROGER ERONY and NOREEN DELLACORTE as Administrators of the Estate of ALEXANDER ERONY, and ROGER ERONY, individually, Plaintiffs, against ALZA CORPORATION and JANSSEN PHARMACEUTICA, INC., Defendants.


The opinion of the court was delivered by: CHIN

 CHIN, D.J.

 This products liability action arises from the tragic accidental death of a fourteen year-old boy, Alexander Erony ("Alex"). Alex died from sucking on used patches of Duragesic, a transdermal delivery system that contains a potent narcotic analgesic, fentanyl. His parents Roger Erony ("Mr. Erony") and Noreen Dellacorte ("Ms. Dellacorte") bring this action against the manufacturer and distributor of Duragesic, Alza Corporation ("Alza") and Janseen Pharmaceutica, Inc. ("Janseen"), respectively, seeking damages on two theories: (1) failure to warn and (2) negligent infliction of emotional distress.

 Defendants now move for summary judgment, arguing that the warnings were adequate as a matter of law. Defendants also argue that any inadequacy in their warnings was not the proximate cause of Alex's death. Finally, defendants move for summary judgment on plaintiffs' negligent infliction of emotion distress claim.

 Because I find that material issues of fact remain as to both the adequacy of the warnings and the proximate cause of Alex's death, defendants' motion for summary judgment is denied as to the failure to warn claim. The motion is granted, however, as to the negligent infliction of emotional distress claim.

 BACKGROUND

 A. Duragesic

 Defendants' product, Duragesic, is a patch containing fentanyl, a potent narcotic analgesic. Duragesic is a transdermal system--the medicine is absorbed through the patient's skin. Because of its strength, Duragesic is prescribed to relieve chronic pain only in people who have developed a tolerance to narcotics, such as morphine and demerol.

 Two instruction sheets accompany each package of Duragesic: the package insert for prescribing physicians (the "package insert") and the Patient Instructions for Use pamphlet (the "instruction pamphlet"). Both the package insert and the instruction pamphlet contain warnings for use of Duragesic. In one section, the package insert warns that "Patients should be instructed to keep both used and unused systems out of the reach of children." In another section the package insert describes the proper method of disposal: "Used systems should be folded so that the adhesive side of the system adheres to itself and flushed down the toilet immediately upon removal."

 The instruction pamphlet contains similar warnings. The first item on the instruction pamphlet is a boxed warning that states as follows:

 
"Your doctor has prescribed DURAGESIC for your use only. Do not let anyone else use it. Keep this and all other drugs out of the reach of children. When you remove a DURAGESIC you have worn, fold it with the sticky side inside and flush it down the toilet immediately."

 Finally, the package insert warns that Duragesic can cause severe hypoventilation, i.e., depressed respiration, requiring medical treatment. Specifically, the package insert warns that "For management of hypoventilation immediate countermeasures include removing the DURAGESIC system and physically or verbally stimulating the patient. These actions can be followed by administration of a specific narcotic antagonist such as naloxone." The warnings do not state, however, that used patches can cause hypoventilation. Nor do the warnings indicate that hypoventilation can cause death.

 In 1992, three adults died after sucking or chewing on Duragesic patches, in an apparent effort to get "high." Defendants were aware of this fact at the time Duragesic was prescribed for Mr. Erony.

 B. Mr. Erony's Use of Duragesic

 Mr. Erony suffers from several medical ailments, including Crohn's disease, pancreatitis, a partially removed stomach, and ulcer disease. As a result of these conditions, Mr. Erony suffers from severe, chronic pain. In search of an adequate painkiller, in March 1993 Dr. Maurice Beer, Mr. Erony's internist, referred Mr. Erony to Dr. Marcus at the New York pain Clinic. Dr. Marcus prescribed Duragesic.

 Because of Mr. Erony's dependency on narcotics, his dosage of Duragesic increased rapidly. From March until May 1993, Mr. Erony's dosage increased from 50 micrograms per hour to 275 micrograms per hour. To obtain his required dosage, Mr. Erony wore three Duragesic patches at ...


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