WYETH LABORATORIES, INC.
v.
Billy Joe FORTENBERRY.
Supreme Court of Mississippi.
*689 Thomas A. Bell, Roy A. Smith, Jr., Trudy D. Fisher, Daniel, Coker, Horton & Bell, Jackson, for appellant.
Ralph E. Chapman, Chapman & Heaton, Clarksdale, for appellee.
EN BANC
ANDERSON, Justice, for the Court:
This appeal comes from the Circuit Court of Pike County. Billy Joe Fortenberry, appellee, became seriously ill after receiving a non-swine influenza vaccine, [Influenza Virus Vaccine, Trivalent, Types A & B (1982-83 formula)], manufactured by Wyeth Laboratories, Inc., and administered at the direction of Dr. T.L. Moore, Jr. Fortenberry brought suit against both Dr. Moore and Wyeth for failure to warn. The jury returned a verdict for Dr. Moore and against Wyeth in the amount of $200,000. As explained below, we have no alternative but to reverse and render.
On September 21, 1982, Fortenberry took his wife and two children to Dr. Moore, their family physician of seventeen years, and requested flu shots. Fortenberry, who had not had the shot before, was in good health and had never suffered from any previous allergic reactions.
Dr. Moore, after asking each of the Fortenberrys if they had a cold or any other physical problems and receiving answers in the negative, warned them they might have a sore arm and run a slight fever after receiving the shot. At Dr. Moore's direction, his nurse administered the vaccine to each member of the family.
The vaccine package contained an insert for the prescribing physician warning of possible adverse reactions.[1] One of these was Guillain-Barre syndrome (GBS). Dr. Moore testified that he had received and read the package insert and kept abreast of recent medical literature. He also testified that he believed the risk to be minimal and remote and therefore a warning, which would scare his patients, was not required.
Approximately five days after receiving the shot, Fortenberry began experiencing a burning sensation and weakness in his lower extremities. His condition progressively worsened and resulted in paralysis of the lower extremities, bowel and bladder dysfunction and impotence. He was subsequently diagnosed as having transverse myelitis which "is closely related, in etiology and pathology, to GBS." Unthank v. United States,
At trial, a biochemist testifying on behalf of Fortenberry stated with medical certainty that there existed a causal relationship between the vaccine and Fortenberry's illness. Several medical doctors testifying on behalf of Wyeth denied the existence of *690 any causal relationship.[2]
I.
Wyeth raises the question of whether Dr. E.H. Eylar, a biochemist, was competent to render an opinion as to medical causation although not a medical doctor. It was recognized recently by this Court in a workers' compensation proceeding that "`medical causation' is no more than causation in fact." Sonford Products Corp. v. Freels,
"A witness may qualify as an expert based on his knowledge, skill, experience, training, education or a combination thereof. Qualification as an expert does not necessarily rest upon the educational or professional degree a witness possesses." Thompson,
Once the trial judge has determined that expert testimony will be of assistance to the trier of fact the determination of whether a particular witness is qualified as an expert is a matter within his discretion. Mississippi Farm Bureau Mutual Ins. Co. v. Garrett,
II.
Wyeth also argues that Fortenberry failed to prove causation.
It was proven that the swine flu vaccine given during the 1976-77 flu season caused a much higher incidence of GBS and related disorders. Numerous suits brought against the government arose out of that mass immunization. The vaccine in the case at bar is a non-swine vaccine made with a different formula. Its causal relationship to GBS was seriously disputed.
Dr. Eylar testified that his studies and research indicated the presence of a common link between the swine and non-swine flu vaccines; to-wit the presence of chicken P-2 protein in the blood of persons who contracted GBS. Both vaccines are grown in chicken egg embryos and then extracted.
At trial no fewer than five experts rejected or refuted Eylar's study and testified regarding current medical literature and studies which, in their opinion, disproved any causal connection between the vaccine and these diseases. According to these experts, the incidence of GBS (1.7 out of 100,000) is no higher in persons who have had the vaccine than in persons who have not.
*691 While there was considerably more expert testimony against a causal connection, that the jury chose to believe expert testimony to the contrary is not sufficient ground for relief on appeal. Mississippi Farm Bureau Mutual Ins. Co.,
Causation is more than just cause-in-fact. Proximate, or legal cause, must be proven. W. Keeton, Prosser and Keeton on The Law of Torts, sec. 41 (5th ed. 1984). "[T]he primary function of the jury is the determination of questions of fact upon which reasonable persons might differ." W. Keeton, Prosser and Keeton on The Law of Torts, sec. 45 at 319-20 (5th ed. 1984). Assuming arguendo that the warning was inadequate, Fortenberry still had the burden of showing that an adequate warning would have altered Dr. Moore's conduct. Plummer v. Lederle Laboratories,
III.
We hold that the drug manufacturer has a duty to adequately warn the prescribing physician of any known adverse effects which might result from use of its prescription drugs. Swayze v. McNeil Laboratories, Inc.,
The general rule is "that where prescription drugs are concerned, a manufacturer's duty to warn only extends to physicians and not to laymen." Swayze,
We cannot quarrel with the general proposition that where prescription drugs are concerned, the manufacturer's duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the drug's use... . As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient... . 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 the manufacturer and consumer.498 F.2d at 1276 (emphasis in original). This rule has been reaffirmed in Timm v. Upjohn Co.,624 F.2d 536 , 638 (5th Cir.1980), cert. denied,449 U.S. 1112 , 101 *692 S.Ct. 921,66 L.Ed.2d 840 (1981), and Mauldin v. Upjohn Co.,697 F.2d 644 , 647 (5th Cir.), cert. denied,464 U.S. 848 ,104 S.Ct. 155 ,78 L.Ed.2d 143 (1983).
If there is no physician in the role of "learned intermediary" then the drug manufacturer has a duty to adequately warn the consumer. Swayze,
The issue of a warning's adequacy is factual and usually will be resolved by the trier of fact. Graham v. Wyeth Laboratories, Inc.,
The adequacy of a warning addressed to the medical community may fall into the category of issues requiring expert testimony. "Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect." Reyes,
An adequate warning is one reasonable under the circumstances. Swayze v. McNeil Laboratories, Inc.,
The package insert involved has been thoroughly examined and the most relevant passages have been reproduced in a footnote in this opinion. It is clear from the record that Fortenberry was in that group of "healthy adults" for whom the vaccine was not recommended. It was recommended for those "who are at increased *693 risk of adverse consequences from infections of the lower respiratory tract." The insert went on to warn physicians that although the connection between the vaccine and GBS was not clear, persons considering the vaccine "should be made aware of the benefits and possible risks, including GBS, of administration."
Dr. Moore testified that he kept abreast of the medical literature and did not believe there was a sufficient connection between the vaccine and GBS to warrant a warning. He decided to give no warning to the Fortenberrys.
It is the holding of this Court that the warning was adequate as a matter of law and that Dr. Moore functioned as a learned intermediary. Application of the learned intermediary doctrine, adopted in this opinion, prevents liability from being found against Wyeth. We reverse the decision of the lower court and render a verdict for Wyeth. The jury verdict for Dr. Moore is not before this Court as part of this appeal.
REVERSED AND RENDERED.
ROY NOBLE LEE, C.J., HAWKINS and DAN M. LEE, P.JJ., and PRATHER, ROBERTSON, SULLIVAN, GRIFFIN and ZUCCARO, JJ., concur.
NOTES
Notes
[1] Some of the language in the package insert supporting the determination that the warning to Dr. Moore was adequate as a matter of law follows:
"INDICATIONS AND USAGE
* * * * * *
Annual routine influenza immunization is NOT recommended for healthy adults, infants, or children but is strongly recommended for all persons, children and adults, who are at increased risk of adverse consequences from infections of the lower respiratory tract.
* * * * * *
ADVERSE REACTIONS
* * * * * *
3. Guillain-Barre syndrome (GBS). This is an uncommon illness characterized by ascending paralysis which is usually self-limiting and reversible... . Before 1976, no association of GBS with influenza use was recognized... . A statistically significant excess risk of contracting GBS after receipt of the 1978-79 or 1979-80 Influenza Virus Vaccine could not be demonstrated... . Nevertheless, candidates for Influenza Virus Vaccine should be made aware of the benefits and possible risks, including GBS, of administration.
Other neurologic disorders, including encephalopathies, not defined as GBS, have been temporally associated with influenza vaccination.
[2] Unthank v. United States,