Dyer v. Best Pharmacal

577 P.2d 1084, 118 Ariz. 465, 1978 Ariz. App. LEXIS 446
CourtCourt of Appeals of Arizona
DecidedMarch 2, 1978
Docket1 CA-CIV 3510
StatusPublished
Cited by22 cases

This text of 577 P.2d 1084 (Dyer v. Best Pharmacal) is published on Counsel Stack Legal Research, covering Court of Appeals of Arizona primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Dyer v. Best Pharmacal, 577 P.2d 1084, 118 Ariz. 465, 1978 Ariz. App. LEXIS 446 (Ark. Ct. App. 1978).

Opinions

OPINION

EUBANK, Presiding Judge.

Roosevelt and Betty Dyer brought an action against Best Pharmacal and D-M Pharmaceutical to recover for injuries sustained when Betty Dyer received an injection of NOL-L.A., a drug manufactured by D-M and distributed by Best. The Dyers appeal from the summary judgment entered in favor of Best and D-M. Since the record supports the trial court’s determination that no action by Best or D-M proximately caused Mrs. Dyer’s injuries, we affirm the summary judgment.

In March of 1974, Betty Dyer consulted Dr. Augustus Stewart, D. 0., to obtain assistance in weight control. Dr. Stewart administered, by intermuscular injection, a quantity of NOL-L.A., an anorexiant drug. Mrs. Dyer left Dr. Stewart’s office shortly after the injection, and by the time she reached her car she began to experience a “tingling sensation” in her head, accompanied by a loss of orientation. This condition continued during the late afternoon, the early evening, and lasted into the night. The next morning, Mrs. Dyer entered St. Joseph’s Hospital in Phoenix with a primary diagnosis of subarachnoid hemorrhage. She lapsed into a coma for several weeks, and developed cardiovascular complications.

Dr. Stewart obtained his supply of NOL-L.A. directly from Best Pharmacal. Each vial of the drug arrived in a cardboard box, which also contained a package insert bearing the name of Best Pharmacal and information regarding the use and contraindications for the drug. The insert recommends the drug’s use for many purposes, among them being its use as “an anorexant [sic] for control of short term obesity.” The insert also instructs the doctor to administer the drug by injection. Among the contraindications listed for the drug are hypertension and cardiovascular disease. The record shows that Mrs. Dyer was suffering from hypertension.

The Dyers filed this action against Dr. Stewart, Best Pharmacal, and D-M Pharmaceutical.1 Their action against the drug companies is founded on the theories of strict liability in tort and negligence in manufacturing and distributing an unsafe product.

Best and D-M answered the complaint, denying liability and subsequently moved for summary judgment. In opposition to the appellees’ motions for summary judgment, the appellants submitted two affidavits. One was the affidavit of Dr. Carl Leventhal, M.D., Deputy Director of the Bureau of Drugs of the United States Food and Drug Administration. Dr. Leventhal testified that the drug NOL-L.A. is a “new drug,” within the meaning of 21 U.S.C. § 321(p), a part of the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq.; that Section 505 of the FDCA, 21 U.S.C. § 355, requires all new drugs be given the approval of the FDA before they are marketed; that he is thé custodian of the Bureau records, including the New Drug Applications; and that there was no New Drug Application or approval on file for NOL-L.A. The second affidavit was that of Dr. Philip Walson, M.D., a Professor of Medicine at the University of Arizona School of Medicine. It sets forth Dr. Walson’s qualifications, and contains several statements of Dr. Walson’s opinion regarding the safety of NOL-L.A. for various uses. Dr. Walson maintains that it is unsafe to inject NOL-L.A., and that “under no circumstances should the package insert recommend that this drug be used for [467]*467weight control because the dangers far outweigh any medically known benefit to the user.”

The appellants argue that Dr. Leventhal’s affidavit establishes a violation of the FDCA, which constitutes negligence per se. They further contend that the affidavit of Dr. Walson supports recovery against the appellees on a theory of strict liability in tort. The appellees dispute the legal sufficiency of both affidavits, and assert that their actions could not have been the proximate cause of Mrs. Dyer’s injuries. Since we agree with appellees’ latter argument, we have no need to consider the sufficiency of the affidavits. For the purpose of this decision, we will accept the affidavits as sufficient.

We must admit having some difficulty in piecing together appellants’ negligence per se argument. It is true that a person who violates a statute enacted for the protection and safety of the public is guilty of negligence per se. Even assuming for the purposes of review that Mrs. Dyer is one of the class that can raise the effect of non-compliance with the FDCA, appellants still have failed to explain exactly how the appellees’ alleged violation of the FDCA by their failure to file a New Drug Application resulted in Mrs. Dyer’s injuries. Dr. Leventhal’s affidavit offers no enlightenment in this regard. From Dr. Walson’s affidavit, we can only infer that, based on Dr. Walson’s medical opinion, the appellants allege that the FDA might have refused to" approve NOL-L.A. for use as an anorexiant in injectable form. We assume this to be appellants’ argument, since Mrs. Dyer’s injuries were unquestionably caused by the injection of NOL-L.A. for anorexiant purposes. Thus, the appellees’ alleged negligence would be their recommendation that NOL-L.A. be injected for anorexiant purposes, and their sale and distribution of NOL-L.A. without FDA approval of that recommendation. No claim is made that NOL-L.A. was impure or defectively manufactured.

A claim of negligence per se does not obviate the need for the plaintiff to show that the defendant’s actions were the proximate cause of her injuries. Orlando v. Northcutt, 103 Ariz. 298, 299-300, 441 P.2d 58, 59-60 (1968); Valley Transp. System v. Reinartz, 67 Ariz. 380, 382, 197 P.2d 269, 271 (1948); Christy v. Baker, 7 Ariz.App. 354, 355-56, 439 P.2d 517, 518-19 (1968). See also Toole v. Richardson-Merrell, Inc., 251 Cal.App.2d 689, 705, 60 Cal.Rptr. 398, 410 (1967). The ultimate question here thus becomes whether the appellees’ alleged negligence proximately caused Mrs. Dyer’s injuries.

Our Supreme Court has broadly defined proximate cause as follows:

The proximate cause of an event is that which, in a natural and continuous sequence unbroken by any new, independent cause, produces the event, and without which the event would not have occurred. This connection is broken when a new or subsequent cause intervenes so as to become the sole factor producing the injurious result to the exclusion of the negligence of the first wrongdoer in its operation as an efficient factor therein, but it is not broken by the addition of another factor or cause which merely contributes to the result without superseding the efficient operation of the first cause.

City of Douglas v. Burden, 24 Ariz. 95, 101-02, 206 P. 1085, 1087 (1922). When two forces combine to produce an injury, they are labeled either concurrent or successive causes. If the forces are concurrent, both or either may be the proximate cause of the injury. If the two forces are successive, only the most immediate is the proximate cause of the injury. Our Supreme Court has stated the rule as follows:

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Dyer v. Best Pharmacal
577 P.2d 1084 (Court of Appeals of Arizona, 1978)

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Bluebook (online)
577 P.2d 1084, 118 Ariz. 465, 1978 Ariz. App. LEXIS 446, Counsel Stack Legal Research, https://law.counselstack.com/opinion/dyer-v-best-pharmacal-arizctapp-1978.