Stanback v. Parke, Davis and Co.

Decision Date27 August 1981
Docket NumberNo. 80-1749,80-1749
Citation657 F.2d 642
PartiesBeatrice G. STANBACK, Appellant, v. PARKE, DAVIS AND COMPANY, Appellee.
CourtU.S. Court of Appeals — Fourth Circuit

Michael K. Quinn, Roanoke, Va. (Richard E. Viar, Dodson, Pence, Viar, Young & Woodrum, Roanoke, Va., on brief), for appellant.

William B. Poff, Roanoke, Va. (Woods, Rogers, Muse, Walker & Thornton, Roanoke, Va., on brief), for appellee.

Before PHILLIPS and ERVIN, Circuit Judges, and ANDERSON, * District Judge.

ERVIN, Circuit Judge:

Beatrice Stanback appeals the district court's grant of summary judgment to Parke, Davis & Company (Parke-Davis) in her products liability suit against the company for its failure to warn of the risk of injuries allegedly related to an influenza vaccine. For reasons that follow, we affirm.

I.

This case concerns Mrs. Stanback's injuries stemming from a neurological disorder known as Guillain-Barre Syndrome (GBS). After contracting GBS in late 1976, Mrs. Stanback was totally paralyzed and required hospitalization and convalescent treatment for almost a year. Since that time she has regained some, but not all, of her previous physical abilities.

In the spring of 1976, Mrs. Stanback suffered an attack of influenza with bronchitis, which motivated her to visit Dr. Edmunds, whom she had last seen in 1963. Because of that illness she resolved to get a flu shot the following fall. She returned to Dr. Edmunds' office on September 23, 1976, at which time she received from him a half-dose of Fluogen, a Parke-Davis flu vaccine. She visited Dr. Edmunds again on October 27, 1976, for a second half-dose flu vaccination.

Shortly after the second injection, Mrs. Stanback began to experience neurological symptoms. She returned to Dr. Edmunds on November 4, 1976, complaining of aching, numbness in her fingers and hands, dizziness, and insomnia. Dr. Edmunds concluded that she was experiencing acute labyrinthitis and generalized osteoarthritis. Subsequently admitted to the hospital, Mrs. Stanback was eventually diagnosed as having GBS.

In the 1976 package insert accompanying the flu vaccine, Parke-Davis did not warn of a risk of GBS associated with flu vaccines. Mrs. Stanback was unaware of any such risk, moreover, when she received the vaccinations.

Mrs. Stanback filed suit against Parke-Davis in 1978, alleging entitlement to damages under theories of negligence, breach of warranty, and strict liability for Parke-Davis' failure to warn her and her physician of the dangers associated with the use of Fluogen. Parke-Davis answered the complaint, both parties filed and answered interrogatories, and depositions were taken. Parke-Davis then moved for summary judgment on the ground that its failure to warn was not the cause in fact of Mrs. Stanback's illness, even assuming that it had a duty to warn physicians of a risk of GBS associated with the vaccinations and that the second injection caused the onset of the GBS. In so arguing, Parke-Davis relied on deposition testimony of Dr. Edmunds, which established that he had not read the package insert accompanying the vaccine but that he knew of the risk of GBS associated with it, and on an affidavit from Dr. Edmunds, which stated:

It is not my practice, and I do not deem it necessary, to advise patients about the package insert "warning" which accompanies flu vaccines. This was true before the Guillian-Barre Syndrome (sic) warning in 1976 and it is true today.

The district court rejected Parke-Davis' argument, reasoning that Dr. Edmunds' acts or omissions should not exonerate Parke-Davis from liability for failure to warn, and formulated an alternative causation standard, which required Mrs. Stanback to show that a reasonable physician would have treated her in a manner which would have avoided or reduced her injuries. Mrs. Stanback then submitted an additional affidavit and deposition testimony. The district court ultimately concluded, however, that Mrs. Stanback had failed to present adequate proof of causation, and it therefore granted summary judgment to Parke-Davis.

II.

Fluogen is an ethical drug, 1 and the well-settled rule is that the duty an ethical drug manufacturer owes to the consumer is to warn only physicians (or other medical personnel permitted by state law to prescribe drugs) of any risks or contraindications associated with that drug. See 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); Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968); Sterling Drug, Inc. v. Cornish, 370 F.2d 82 (8th Cir. 1966). 2 We sit as a Virginia court in this diversity action and therefore look to Virginia substantive law for authority. Having not been cited to a case on point and finding no direct authority ourselves, we assume that the Virginia Supreme Court would follow the general rule in defining Parke-Davis' duty to warn.

For purposes of summary judgment, Parke-Davis does not contest that, under Virginia law, it had a duty to warn physicians of a risk of GBS associated with Fluogen and that it failed to give such a warning. It also concedes, for purposes of argument, that the second Fluogen injection caused the onset of GBS in Mrs. Stanback. Instead, it argues that summary judgment was appropriate on the singular ground that Mrs. Stanback has, as a matter of law, failed to present sufficient evidence that the failure to warn was the cause in fact of her injury. Because Mrs. Stanback must be able to prove that the failure to warn caused the injury under any of her theories of liability, we accept Parke-Davis' characterization of the causation question as potentially dispositive of all of her claims. 3

Given the peculiar facts of this case, we agree that there is not sufficient evidence of causation to allow the question to be put to a trier of fact. Dr. Edmunds testified in his deposition that he knew of the risk of GBS associated with the flu vaccines such as Fluogen at the time he vaccinated Mrs. Stanback. He also averred that he had not found it necessary and did not make it his practice to advise patients about the risks associated with flu vaccinations. Whatever may be said about Dr. Edmunds' policies and decisions from the standpoint of the patient, it is clear that they precluded Parke-Davis' failure to warn from having any effect whatsoever on Mrs. Stanback's injury. 4 Even if Parke-Davis had fully warned Dr. Edmunds of any risk of GBS associated with flu vaccines at the time Mrs. Stanback received the second vaccination, the uncontradicted evidence establishes that Mrs. Stanback would have nevertheless received the flu vaccinations despite the slight risk, and would not have been informed of the risk. Dr. Edmunds' decisions and actions made in full knowledge of the information which an adequate warning would have contained therefore insulate Parke-Davis from any liability resulting from its failure to warn.

In reaching this conclusion, we are keenly aware of a judicial inclination in certain instances to forbid intervening acts or omissions of a physician from insulating a drug manufacturer from liability. See, e. g., Hamilton v. Hardy, 37 Colo.App. 375, 549 P.2d 1099 (1976) (when ethical drug manufacturer puts drug on market without adequate warning, prescribing physician's conduct may not insulate manufacturer from liability if inadequacy of the warning might have contributed to plaintiff's injury). The policy is a sound one and one which should be followed in a failure to warn case when the evidence suggests that a physician might have heeded an adequate warning. In that case it is clear that the failure to warn could make a difference and would be a cause in fact of an injury.

We recognize an important distinction, however, between a failure to warn case in which the physician might have responded to an adequate warning and one in which it is affirmatively established that he would not have. In the first case, there is evidence of causation; in the latter case there cannot be. See, e. g., Chambers v. G. D. Searle & Co., 441 F.Supp. 377 (D.Md.1975), aff'd, 567 F.2d 269 (4th Cir. 1977) (evidence showed that adequate warnings of risks associated with oral contraceptives would not have made a difference in physician's treatment of plaintiff; plaintiff, therefore, failed to establish causation); Vaughn v. G. D. Searle & Co., 272 Or. 367, 536 P.2d 1247 (1975), cert. denied, 423 U.S. 1054, 96 S.Ct. 784, 46 L.Ed.2d 643 (1976) (there was no evidence that even a properly warned physician would have treated plaintiff differently or removed her from oral contraceptives prior to her injury and, therefore, no proof of causation); McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 528 P.2d 522 (1974) (there was substantial evidence that, if adequate warnings had been given to physicians, those physicians would have recommended that plaintiff cease using oral contraceptives before her injuries became irreversible; therefore, there was sufficient proof of cause in fact).

The case before us falls within the latter...

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