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.
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.
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:
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.
Fluogen is an ethical drug,
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.
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
The case before us falls within the latter description, as the record conclusively demonstrates that Dr. Edmunds' decisions and actions would not have been affected in the least by the communication of an adequate warning. As there is a complete lack of evidence indicating that Parke-Davis' failure to warn her physician was a factor in producing her injury, we conclude that Mrs. Stanback has failed to adduce sufficient proof of causation under any of the theories of liability set forth in her complaint to survive the motion for summary judgment.
Possibly in anticipation of our reaching this conclusion, Mrs. Stanback argues for reversal of the summary judgment primarily on the ground that Parke-Davis had the duty not only to warn physicians but also to warn her directly of the alleged risk of GBS associated with flu vaccines. We agree that, under this theory of the case, the proof presented to the district court would be sufficient on the question of causation to survive the summary judgment motion.
In a small number of cases concerning injuries resulting from live virus polio vaccines, courts have indeed expanded the scope of a drug manufacturer's duty to warn of the risks associated with an ethical drug to require that the public be warned. See, e. g., Givens v. Lederle, 556 F.2d 1341 (5th Cir. 1977); 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). This duty was imposed upon the manufacturer because the vaccines were not dispensed as prescription drugs, that is, they were "dispensed without the sort of individualized medical balancing of the risks of the vaccine that is contemplated by the prescription drug exception." Reyes v. Wyeth Laboratories, 498 F.2d at 1277. The polio cases concerned a special, nationwide immunization program undertaken to profit from a remarkable breakthrough in medical research. Because the manufacturers of the live virus vaccine knew that there was a small risk of contracting polio associated with the vaccine and could also foresee that the vaccine was going to be distributed on a large scale, often by persons other than doctors, and without any individual attention given to the recipients, courts have held them liable
The exception established for the polio cases is quite narrow and highly fact specific. Unlike the polio cases, this case does not concern a massive, nationwide immunization program in which it would have been foreseeable by Parke-Davis that large numbers of flu vaccines would be dispensed without a physician's consideration of individual needs and circumstances.
We are mindful of the tragic human dimensions of this case, but we are persuaded that Mrs. Stanback cannot recover from Parke-Davis unless we hold it to a standard of absolute liability, and this we cannot do under Virginia law. See Turner v. Manning, Maxwell & Moore, Inc., 216 Va. 245, 217 S.E.2d 863 (1975) (manufacturer is not an insurer of its product). Mrs. Stanback's inability to show that Parke-Davis' failure to warn physicians of the alleged risk of GBS associated with its product Fluogen was the cause in fact of her injury leads us therefore to affirm the grant of summary judgment to Parke-Davis.
Because of the nature of the illness, Mrs. Stanback's attempts to show causation have been limited only to the question whether she would have initially received the vaccine had adequate warnings been given.