Opinion ID: 1189000
Heading Depth: 1
Heading Rank: 6

Heading: contractual delegation of the duty to warn

Text: Justice Springer states that a manufacturer cannot be relieved of ultimate responsibility for assuring that its product is dispensed with a proper warning. I agree. However, I believe that a manufacturer must be judged using a reasonableness standard as to whether it reasonably relied on the ultimate dispenser of the drug to warn recipients. Accordingly, the issue in this case is whether Merck reasonably relied upon the CDC to provide adequate warnings to the recipients of the MMR II vaccine. Merck points out that the Important Information sheet given to Mrs. Allison was prepared by the CDC in conjunction with the CDC's Immunization Practices Advisory Committee. Merck maintains that since the CDC possessed the most comprehensive information on the subject, having monitored over 131 million measles vaccinations from 1963 to 1981, Merck can hardly be considered unreasonable in having relied upon the CDC to formulate the Important Information sheet. I am inclined to agree with Merck. The contract provision at issue provided in part: DUTY TO WARN: A. The Department of Health, Education, and Welfare, Public Health Service, Center for Disease Control, represents and agrees that it will (1) take all appropriate steps to assure that all vaccine supplied ... pursuant to the terms of this contract, shall be administered to each patient on the basis of an individualized medical judgment by a physician, or (2) take all appropriate steps to provide to such patient (or the patient's parent or guardian) meaningful warnings relating to the risks and benefits of vaccination, in form and language understandable to such patient, parent, or guardian. It was not merely Merck's decision to have the CDC provide the warning that Mrs. Allison ultimately received. Retired CDC physician Harold B. Dull stated in his affidavit that the CDC requires state health departments to use the CDC's Important Information sheet whenever federally funded vaccines are administered. The MMR II vaccine that Thomas received was administered at no charge by CCHD under a program funded by state and federal grants. Dull stated that this requirement has been in effect since 1976 due to CDC concerns that vaccine manufacturers would overwarn potential vaccinees and thus discourage the use of vaccines. In Boruski v. United States, 803 F.2d 1421, 1429 (7th Cir.1986), the court held that because the government had contractually agreed with Merck to take all appropriate steps to provide vaccinees with meaningful warnings as to the risks associated with swine flu vaccine, the duty to warn had been assumed by the government and Merck [had] the benefit of this additional defense. However, this finding was mentioned in dicta. The court had already ruled that the duty to warn rested with the government pursuant to § 317(j)(1)(F) of the Swine Flu Act. Id. In a similar case, a federal court in Georgia ruled that the manufacturer of a polio vaccine, Merck, could fulfill its duty to warn by `obligating the purchaser [of the drug] to give warning.' Walker v. Merck and Company, 648 F.Supp. 931, 935 (M.D.Ga.1986), aff'd, 831 F.2d 1069 (11th Cir.1987) (quoting Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir.1974)). Reyes borrowed this language from what it termed the leading federal case in the area, Davis v. Wyeth Laboratories, 399 F.2d 121 (9th Cir.1968), cert. denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974). In Davis, the court ruled that Wyeth Laboratories had failed to adequately warn of the newly-discovered risks associated with the Sabin oral polio vaccine. The court held that it is the responsibility of the manufacturer to see that warnings reach the consumer, either by giving warning itself or obligating the purchaser to give warning. Davis, 399 F.2d at 131. The Mazur court also followed this reasoning in affirming summary judgment in favor of defendant Merck. There, the court held that a manufacturer may be relieved of its duty to warn provided that it gave the CDC all relevant information and in no way misinformed the CDC. Mazur, 964 F.2d at 1368. The court concluded as a matter of law that Merck acted reasonably in relying on the CDC to issue proper warnings, noting that Merck had carefully researched the CDC before agreeing to sell the MMR II vaccine, as well as monitored the CDC's performance after it made its decision to rely on the CDC. Id. In view of the foregoing authorities, which all involved failure to warn claims, it is clear that a pharmaceutical manufacturer may fulfill its duty to warn the ultimate consumer by obligating the purchaser of the vaccine to warn. Therefore, Merck could fulfill this duty by obligating the CDC to give warnings to recipients of the MMR II vaccine. Merck contends that at the time Thomas was vaccinated, it had apprised the Food and Drug Administration (FDA) and the CDC of all adverse reaction reports which it had received associated with the MMR II vaccine. I find nothing in the record to refute this contention. The CDC monitors the use of vaccines on a nationwide basis and has the most comprehensive and up-to-date information regarding adverse reactions. Therefore, I must conclude that Merck did not act unreasonably in relying on the CDC to formulate a proper warning for all recipients of the MMR II vaccine.