Buckner v. Allergan Pharmaceuticals, Inc.

• Decision Date: 01 July 1981
• Docket Number: No. 80-654,80-654
• Citation: Buckner v. Allergan Pharmaceuticals, Inc., 400 So.2d 820 (Fla. App. 1981)
• Parties: Laura N. BUCKNER, Appellant/Cross-Appellee, v. ALLERGAN PHARMACEUTICALS, INC., a foreign corporation, et al, Appellees, and Philips Roxanne Laboratories, Inc., et al, Cross-Appellants.
• Court: Florida District Court of Appeals

Page 820

400 So.2d 820

Laura N. BUCKNER, Appellant/Cross-Appellee, v. ALLERGAN PHARMACEUTICALS, INC., a foreign corporation, et al, Appellees and Philips Roxanne Laboratories, Inc., et al, Cross-Appellants.

No. 80-654.

District Court of Appeal of Florida, Fifth District.

July 1, 1981.

Larry Sands, P. A., Daytona Beach, for appellant/cross-appellee.

Carey N. Bos, of Rogers & Dowling, P. A., Orlando, for appellee Allergan Pharmaceuticals, Inc.

Dudley D. Allen, of Milam & Wilbur, Jacksonville, for appellee/cross-appellant Armour Pharmaceutical Company.

Sutton G. Hilyard, Jr., and D. Andrew DeBevoise, of Pitts, Eubanks & Ross, P. A., Orlando, for appellee/cross-appellant Philips Roxanne Laboratories, Inc.

A. Craig Cameron, of Gosney, Cameron, Parsons & Marriott, P. A., Daytona Beach, for appellee Smith, Miller & Patch, a Division of Cooper Laboratories.

Ronald L. Harrop, of Gurney, Gurney & Handley, P. A., Orlando, for appellee E. R. Squibb & Sons, Inc.

Ted R. Manry, III, and David J. Kadyk, of MacFarlane, Ferguson, Allison & Kelly, Tampa, for appellee Upjohn Company.

COWART, Judge.

Appellant filed a complaint based upon strict liability in tort for bodily injuries resulting from alleged defective products against many manufacturers of prescription steroid drugs. Appellant, in her complaint, alleged various doctors prescribed corticosteroids for eye disorders without warning her of known dangerous side effects; that she took the drugs without knowledge of their danger and that as a result she developed aseptic necrosis of her femoral heads which was one of the known harmful side effects. Additionally, it was alleged that the defendant manufacturers knew of the numerous dangerous effects of such drugs and gave adequate warnings to the medical profession but also knew or should have known that the medical profession was not adequately relaying those warnings to the consuming public. This appeal results from a trial court dismissal of the complaint for failure to state a cause of action. We affirm.

Appellant argues that the doctrine of strict liability ¹ requires the manufacturer of an inherently dangerous product to convey a fair and adequate warning of its dangerous potentialities to the ultimate consumer, as was applied to a distributor of carbon tetrachloride in Tampa Drug Company v. Wait, 103 So.2d 603 (Fla.1958), and to a manufacturer of a lead arsenic insecticide spray in Edwards v. California Chemical Company, 245 So.2d 259 (Fla.4th DCA), cert. denied, 247 So.2d 440 (Fla.1971).

Appellant cites Lake v. Konstantinu, 189 So.2d 171 (Fla.2d DCA 1966), as authority for the proposition that allegations that the manufacturer of a prescription drug failed to adequately warn the ultimate consumer raises a question of fact for jury determination. It does appear from the opinion in Lake that the plaintiff sued both the prescribing physician and the drug manufacturer and that the trial court did deny the manufacturer's motion to dismiss for failure to state a cause of action. However, the manufacturer did not appeal that ruling but filed an answer and moved for summary judgment which was granted. When the plaintiff appealed the summary judgment the manufacturer apparently did not cross-assign as error the trial court's denial of its motion to dismiss. For this reason the appellate court considered the manufacturer's brief as to the liability of the manufacturer to the ultimate patient to be "utterly irrelevant" to the issue on appeal which it considered to be whether an issue of material fact existed which precluded the granting of the summary judgment. Lake therefore relates only to summary judgments and does not consider the question raised by this appeal.

A manufacturer of a dangerous commodity, such as a drug, does have a duty to warn but when the commodity is a prescription drug ² we hold that this duty to warn is fulfilled by an adequate warning given to those members of the medical community lawfully authorized to prescribe, dispense and administer prescription drugs. ³ Although we find no Florida case directly in point, this view is in accord with numerous decisions from other jurisdictions. See, e. g., Chambers v. G.D. Searle and Company, 567 F.2d 269 (4th Cir. 1977) (applying Maryland law); Givens v. Lederle, 556 F.2d 1341 (5th Cir. 1977) (applying Florida law); Dalke v. Upjohn Company, 555 F.2d 245 (9th Cir. 1977) (applying Washington law); Salmon v. Park Davis and Company, 520 F.2d 1359 (4th Cir. 1975) (applying North Carolina law); McCue v. Norwich Pharmacal Company, 453 F.2d 1033 (1st Cir. 1972) (applying New Hampshire law); Sterling Drug, Inc. v. Cornish, 370 F.2d 82 (8th Cir. 1966) (applying Missouri law); Terhune v. A.H. Robbins Company, 90 Wash.2d 9, 577 P.2d 975 (1978); 28 C.J.S. Drugs and Narcotics Supplement § 57 (1974). Compare Terhune, (characterizing the philosophy as a well established rule) with Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir.), cert. denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974) (characterizing the special standard as an exception to the restatement general rule). The rationale is explained in Reyes as follows

Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a "learned intermediary" between manufacturer and consumer.

Id. at 1276. This reasoning applies even in an action based upon the doctrine of strict liability as set out in section 402A of the Restatement (Second) of Torts (1959). In Terhune, the Supreme Court of Washington reiterated acceptance of the doctrine of strict liability as embodied in section 402A and held that Comment k ⁴ governed the case before them. The court noted

(T)he comment does not purport to state what is 'proper warning' where such a product is involved. However, it has become a well-established rule that in such cases, the duty of the manufacturer to warn of dangers involved in use of a product is satisfied if he gives adequate warning to the physician who prescribes it (citations omitted). 577 P.2d at 977.

The court went on to explain,

(w)here a product is available only on prescription or through the services of a physician, the physician acts as a 'learned intermediary' between the manufacturer or seller and the patient. It is his duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise an independent judgment, taking into account his knowledge of the patient as well as the product. The patient is expected to and, it can be presumed, does place primary reliance upon that judgment. The physician decides what facts should be told to the patient. Thus if the product is properly labeled and carries the necessary instructions and warnings to fully apprise the physician of the proper procedures for use and the dangers involved, the manufacturer may reasonably assume that the physician will exercise the informed judgment thereby gained in conjunction with his own independent learning, in the best interest of the patient. Id. at 978.

In the instant case, appellant argues that the general rule should not apply because of the additional allegation that the manufacturers knew or should have known that the medical profession was not warning patients of potential side effects. A doctor's duty is to

inform his patient what a reasonable prudent medical specialist would tell a person of ordinary understanding of the serious risks and the possibility of serious harm which may occur from a supposed course of therapy so that the patient's choice will be an intelligent one, based upon sufficient knowledge to enable him to balance the possible risks against the possible benefits. (citations omitted) The extent of disclosure is a matter of medical judgment. ZeBarth v. Swedish Hospital Medical Center, 81 Wash.2d 12, 499 P.2d 1, 11 (1972).

Therefore the doctor's duty to warn patients of possible side effects is not absolute. See Annot., 79 A.L.R. 1028 (1977) (Physician's duty to inform patient of nature and hazards of disease or treatment ), and cases cited therein. In Florida this issue has been addressed along with the question of informed consent and the duty of the physician to inform with the extent of the information which may be required depending upon the particular circumstances. In ...