On appeal from the Superior Court of New Jersey, Law Division, Ocean County.
Bischoff, King and Polow. The opinion of the court was delivered by Bischoff, P.J.A.D.
In this pharmaceutical products liability case the chief issue presented is whether the manufacturer of a drug which is dispensed only on a physician's renewable prescription has a duty to warn the consumer of potential adverse effects which may occur from extended use of the drug. We hold no such duty exists.
Plaintiff Antone Bacardi suffered from glaucoma since 1969. For a significant portion of those years he had been taking the drug Diamox to control that condition. This drug had been prescribed for him by a series of doctors and the prescriptions were renewable, one being renewed by plaintiff 13 times over a period of 17 months. In October 1975 plaintiff developed a a pain in his right flank and was hospitalized for diagnosis and treatment. After examination it was determined plaintiff had
developed kidney stones. The stones were passed spontaneously. In 1977 plaintiff developed additional urinary tract problems. He was again hospitalized and again kidney stones were diagnosed as the source of his trouble. They were surgically removed. At this time the doctors suspected Diamox as a cause of the recurring kidney stones and recommended the use of the drug Neptazane in place of Diamox. Plaintiff discontinued the use of Diamox and has ever since been symptom-free insofar as his urinary tract is concerned. The drug Diamox is manufactured by defendant Lederle Laboratories, Inc. That company recognized the occurrence of "renal calculus" as a common adverse reaction to the use of the drug, and this information was published in the Physician's Desk Reference and provided in package circulars. Lederle further provided brochures to physicians to supplement the package circulars upon request.
Plaintiff instituted this action against the doctor who prescribed Diamox and also Lederle. Plaintiff thereafter settled with the doctor. In the action against Lederle plaintiff alleged that (1) Lederle had a duty to warn all users of Diamox of its potential adverse effects, which duty it negligently breached, and (2) Lederle was strictly liable in tort.
Plaintiff contended that despite the printed material available, he had never been furnished with a package insert or with information concerning possible adverse consequences following his use of Diamox.
Defendant's motion for summary judgment was granted, the judge holding that while it is the general rule that an ethical drug manufacturer has "a duty to warn the intended or foreseeable consumer of a product of its dangerous aspects," this duty does not exist where there is an intermediary who "is not a mere conduit of the product, but rather administers it on an individual basis or recommends it in some way implying an independent duty to evaluate the risk and transmit relevant warnings to the user."
Plaintiff appeals and argues that (1) defendant is strictly liable to plaintiff in tort and (2) his injuries were proximately caused by defendant's defective product.
Plaintiff explains that in the context of this case the alleged defect upon which his allegation of strict liability is predicated consists of the failure of the manufacturer to warn plaintiff of potential adverse consequences following the use of the drug, and also that the "renal and ureteral calculi" which he developed was the result of "the very condition that the defendant failed to warn him about." See Torsiello v. Whitehall Laboratories , 165 N.J. Super. 311, 320, n.2 (App.Div.1979), certif. den. 81 N.J. 50 (1979).
It is the general rule that in the case of prescription drugs warnings of potential adverse effects to the prescribing physician is sufficient. Torsiello, supra 165 N.J. Super. at 322-323; Davis v. Wyeth Laboratories, Inc. , 399 F.2d 121, 130 (9 Cir. 1968); Reyes v. Wyeth Laboratories , 498 F.2d 1264 (5 Cir. 1974), cert. den. 419 U.S. 1096, 95 S. Ct. 687, 42 L. Ed. 2d 688 (1974); Products Liability, "The Ethical Drug Manufacturer's Liability," 18 Rutg.L.Rev. 947, 985-986 (1964), 3 Frumer and ...