844 F.2d 1108 (4th Cir. 1988), 87-1578, Abbot by Abbot v. American Cyanamid Co.
|Citation:||844 F.2d 1108|
|Party Name:||Tracy Isabel ABBOT, a minor who sues by her mother and next friend Deborah ABBOT, Plaintiff-Appellant, v. AMERICAN CYANAMID CO., a Maine Corp., Defendant-Appellee, Pharmaceutical Manufacturers Association; American Academy of Family Physicians; United States of America, Amici Curiae.|
|Case Date:||April 20, 1988|
|Court:||United States Courts of Appeals, Court of Appeals for the Fourth Circuit|
Argued Jan. 4, 1988.
[Copyrighted Material Omitted]
Michael Hersch Gottesman (Barbara E. Bergman, David A. Sklansky, Cynthia L. Estlund, Deborah C. Malamud, Bredhoff & Kaiser, Washington, D.C., Anthony M. Colantoni, Martin Preiser; McDowell & Colantoni, Ltd., Chicago, Ill., Robert J. Zelnick; Szabo, McCarthy, Quito, Webb & Zelnick, Woodbridge, Va., on brief), for plaintiff-appellant.
Lloyd Norton Cutler (James Robertson, Ronald J. Greene, Michael Stevenson, Robert C. Longstreth, Wilmer, Cutler & Pickering, Edwin A. Williams, Kellogg, Williams & Lyons, Washington, D.C., on brief), for defendant-appellee.
Ronald E. Robertson, Gen. Counsel, Dept. of Health & Human Services, Catherine C. Lorraine, Associate Chief Counsel, Washington, D.C., for Enforcement, Food & Drug Admin.
Richard K. Willard, Asst. Atty. Gen. (John F. Cordes, Irene M. Solet, Appellate Staff, Civ. Div., Dept. of Justice, Washington, D.C., on brief), for amicus curiae U.S.
Richard F. Kingham, Bruce N. Kuhlik, Covington & Burling (Bruce J. Brennan, Edwin C. Mulcahy, Washington, D.C., Pharmaceutical Mfrs. Ass'n, on brief), for amicus curiae Pharmaceutical Mfrs. Ass'n in support of defendant-appellee.
Gerald W. Gorman, John A. Vering, III (Dietrich, Davis, Dicus, Rowlands, Schmitt & Gorman, Kansas City, Mo., on brief), for amicus curiae American Academy of Family Physicians in support of defendant-appellee.
Before MURNAGHAN, SPROUSE, and WILKINS, Circuit Judges.
MURNAGHAN, Circuit Judge:
Plaintiff, Tracy Abbot, whose name throughout is sometimes inconsistently spelled as "Abbott", is a four year old child suffering neurologic injuries. She alleges that they result from inoculation in August 1983 of Tri-Immunol, a diptheria-tetanus-pertussis (DTP) vaccine manufactured by Lederle Laboratories, a division of defendant American Cyanamid Co. Plaintiff brought suit under three counts: (1) strict liability, (2) breach of implied warranty of merchantability and (3) negligence. In the course of the summary judgment proceedings, plaintiff limited her claims to: (1) breach of warranty in two manners (a) failure to warn and (b) defective design, and (2) the tort of negligent design.
The district court granted summary judgment on all claims to defendant. First, it held that plaintiff's rights under state law were preempted by federal law. Second, the court granted judgment, on an alternate basis, to defendant on plaintiff's failure to warn claim because plaintiff's administering physician, who was a "learned intermediary," testified on deposition that the warnings were adequate.
Whether federal law preempts imposition of state common law liability for defective design or failure to warn upon a manufacturer of a vaccine.
The doctrine of federal preemption of state law arises under the supremacy clause of the United States Constitution, art. VI, cl. 2. Preemption occurs in any of three manners: (1) Congress may pass a statute that by its express terms preempts state law, (2) Congress, though not expressly so stating, may imply that it is preempting state law by occupation of an entire field of regulation, so that no room is left for supplementary state regulation, (3) Congress may speak neither expressly nor impliedly of preemption, nonetheless state law is preempted to the extent it actually conflicts with federal law; such a conflict occurs when (a) compliance with both state and federal law is impossible or (b) when state law stands as an impediment to a federal purpose. Michigan Canners and Freezers Assoc. v. Agricultural Mktg. and Bargaining Bd., 467 U.S. 461, 469, 104 S.Ct. 2518, 2522-23, 81 L.Ed.2d 399 (1984).
Defendant discerns preemption of plaintiff's claims from the Public Health Service Act, 42 U.S.C. Secs. 201-300 (PHSA) and the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Secs. 301-392 (FDCA) of which the enactments both predate the regrettable 1983 incident. Defendant argues for preemption most strongly under manner 3(b), frustration of a federal purpose, its so-called narrow preemption argument, though it alternatively argues that manner 2 is satisfied also, its broad preemption argument. Defendant makes no argument that Congress, in the period relevant to the present case, has expressly displaced state law regarding vaccines. Plaintiff argues the contrary, that Congress has expressly provided the opposite, i.e., that state remedies apply. Plaintiff discerns the argument from the National Childhood Vaccine Injury Act of 1986, Pub. L. 99-660, 100 Stat. 3755 (1986), (1986 Act) and its legislative history.
In the 1986 Act, Congress created an administrative "no-fault" program to compensate children injured by vaccines. The 1986 Act directed that children would have access to state remedies but with certain restrictions for injuries resultant from vaccinations administered after the 1986 Act's effective date. The effective date of the pertinent provisions of the 1986 Act is the date of enactment of a special tax to finance the compensation program. The 1986 Act did not provide a funding tax, but part of the Omnibus Budget Reconciliation Act of 1987 (Budget Act) did. A manufacturers' excise tax was placed on certain vaccines to fund the Vaccine Injury Compensation Trust Fund. The Budget Act also contains the Vaccine Compensation Amendments of 1987 (1987 Act) that establish October 1, 1988 as the effective date for the compensation system and limitation upon state law for vaccinations occurring after that date.
Plaintiff's argument is anachronistic, for it uses subsequent legislation in construing the preemptive effect of the earlier, PHSA and FDCA, statutes. While anachronistic, the approach is not without support; the Supreme Court has on occasion found evidence of Congress' intent concerning a statute at the time of its enactment embodied in subsequent actions regarding the statute. Grove City College v. Bell, 465 U.S. 555, 567, 104 S.Ct. 1211, 1218, 79 L.Ed.2d 516 (1984). Since the 1986 Act is an amendment to the PHSA the exception might apply. We need not decide what effect the 1986 Act has, as plaintiff claims, for determining the preemptive intent of the PHSA and FDCA, for even without consideration of what we should draw from the allowance of state based actions in the 1986 Act, we conclude that, considering the PHSA and FDCA alone, Congress did not intend, either expressly or impliedly, to preempt state law.
Defendant's broad preemption theory is that pervasive federal regulation of vaccines reflects a federal purpose to occupy the field of vaccine design and labeling. Defendant's narrow theory is that the national public health purposes and objectives underlying the PHSA would be frustrated if potentially ruinous liability could be imposed under state law for manufacturing
the only type of pertussis (whooping cough) vaccine approved by the federal government rather than a different type of vaccine that is not now and might never be federally approved. Defendant argues that preemption under its narrow theory is most clear as against design defect and failure to warn claims, as plaintiff alleges in the present case, in contrast to claims of improper manufacture, distribution or testing. We first consider the broad theory, then the narrow.
The FDA's regulation of prescription drugs and biological products is comprehensive. The DPT vaccine is a prescription biological product subject to the provisions of the FDCA, the PHSA, and regulations promulgated thereunder. The FDA regulations encompass the licensing, production, testing, distribution, labeling, review and approval of all drugs and biologicals. Each DPT manufacturer must be licensed, must submit detailed description of and receive FDA approval of its manufacturing process, must permit FDA inspection of its manufacturing facilities, meet personnel qualifications, and conduct and submit results of quality assurance tests to the FDA for each batch of vaccine. 21 C.F.R. Secs. 600.20, 601.1, 601.2, 601.25, 610.1, 620.1-620.7.
The FDA requires that the label or package insert for a biological product contain among others: (1) the composition of the product; (2) the product's administration schedule; (3) indication and contraindication of product usage; and (4) potential adverse reactions associated with the product's use. 21 C.F.R. Secs. 201.50-.57, 610.60-.65. The language of the label is subject to FDA approval, and once approved, cannot be changed without FDA approval. 21 C.F.R. Sec. 601.12.
Preemption does not follow immediately from the comprehensive federal regulation of prescription biological products. Every subject that merits congressional legislation is, by definition, a subject of national concern. That cannot mean, however, that every federal statute ousts all related state law. Hillsborough County v. Automated Med. Labs., 471 U.S. 707, 719, 105 S.Ct. 2371, 2378, 85 L.Ed.2d 714 (1985). Defendant has several canons of interpretation and presumptions set against it. When Congress does not expressly state its intent, there is a presumption against preemption. Maryland v. Louisiana, 451 U.S. 725, 726, 101 S.Ct. 2114, 2118-19, 68 L.Ed.2d 576 (1981). The presumption is even stronger with state or local regulation of matters related to health and safety. Hillsborough, 473 U.S. at 715, 105 S.Ct. at 2376. Courts are more reluctant to infer preemption from the comprehensiveness of regulations than from the comprehensiveness of statutes. Id. at 717, 105 S.Ct. at 2377...
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