Professional Documents
Culture Documents
United States Court of Appeals, Fourth Circuit
United States Court of Appeals, Fourth Circuit
2d 1108
98 A.L.R.Fed. 107, Prod.Liab.Rep.(CCH)P 11,765
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.1. 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
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.
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.
10
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. When preemption by regulation is considered,
courts are reluctant to find preemption by federal regulations when the agency
does not make very clear an intent of preemption since agencies normally
address problems in a detailed manner. Id. at 718, 105 S.Ct. at 2377-78. The
presumption against preemption is even stronger against preemption of state
remedies, like tort recoveries, when no federal remedy exists. Silkwood v.
Kerr-McGee Corp., 464 U.S. 238, 251, 104 S.Ct. 615, 622-23, 78 L.Ed.2d 443
(1984). All of those work against preemption in the present case. We agree with
the majority of courts addressing the issue that Congress has not impliedly
preempted state regulation of vaccine manufacture.1
11
12
The overall goal of the PHSA and FDCA is the safety of drugs and biologic
products. That goal is more enhanced than frustrated by state law. However, the
federal government has favored not only vaccine safety but also availability and
use. Availability and use of vaccines can be frustrated by state tort law. The
issue then is whether the federal interest requires that federal regulation be
viewed as having struck the balance between safety and quantity or whether the
regulations merely establish minimum safety standards and allow state
regulation to establish the balance. See Hillsborough, 471 U.S. at 721, 105
S.Ct. at 2379 (The Court responded to a similar preemption argument and
decided that federal regulation of blood plasma collection did not strike the
balance of safety and quantity, but only provided minimum standards).
13
In deciding the issue of whether federal law should strike the balance or allow
states to, it is appropriate to consider the National Childhood Vaccine Injury
Act of 1986. As indicated earlier, we assume the 1986 Act is of no relevance in
construing the preemptive intent of earlier federal legislation like the PHSA
and FDCA. That conclusion is important when considering whether Congress
expressly or impliedly preempted state law in those statutes.
14
We must decide whether the federal interest in vaccine safety and quantity is
frustrated by coexisting state regulation. Thus, it is appropriate to look at recent
views on federal policies regarding the balance of vaccine availability and
safety especially those enunciated by the Congress. The Childhood Vaccine
Injury Act of 1986 speaks to this balance with clarity. Congress created a "nofault" compensation program as an alternate to state tort and contract
recoveries. The legislative history of the Vaccine Compensation Amendments
of 1987 make even more clear that at the time of passage of the 1986 and 1987
Acts Congress acted with the understanding that state tort and contract
remedies were available and that they continue to be available as modified by
the Acts.
15
Congress, when it addressed vaccines in 1986 and 1987, did not preempt state
law. Further, to the extent that the Acts state congressional views about the
preemptive effect of earlier legislation, the Acts and their legislative history
assume that earlier legislation was of no preemptive effect. Defendant argues
that the 1986 Act did not reject preemption, rather it is neutral on the issue
leaving the preemption issue exactly as it stood before the 1986 Act. Defendant
supports the argument in the only way it can, by noting that the word
"preemption" cannot be found in any of the 1986 Act legislative materials,
therefore, it was not addressed. While the premise is true, the conclusion is not.
The 1986 Act is replete with two powerful assumptions: one, state tort and
contract actions are available without preemption by earlier federal legislation
and two, following the 1986 Act's effect state law actions remain available. The
1987 Act expressly states these assumptions. Defendant's assertion that the
statement, made in the purpose and summary section of the House Report on
the 1986 Act, "[v]accine-injured persons ... [who] reject a judgment and award
made under the compensation program ... may file a civil action for damages
relating to a vaccine injury just as he or she may have done prior to the
enactment of the legislation," is neutral on the issue of preemption strains a
normal reading. H.R.Rep. No. 908, 99th Cong., 2d Sess. 4, reprinted in 1986
U.S. Code Cong. & Admin. News 6287, 6344-45.
16
Since Congress did not believe, in 1986 or 1987, that federal public health
policies require preemption of state tort and contract law regarding vaccines it
is dubious that the court should contemporaneously make the opposite policy
determination. The point of time that is relevant in deciding whether a federal
policy requires preemption, as opposed to point of time when the intent of a
statute to preempt is discerned, is the time of the suit. See Hillsborough, 471
U.S. at 720-722, 722 n. 5, 105 S.Ct. at 2380 n. 5 (the Court considers
contemporaneous policy interests).
17Whether Virginia law and its "learned intermediary" doctrine preclude recovery
2.
from a vaccine manufacturer
18
19
20
The two warranty theories muddle to some extent because plaintiff alleges that
one aspect of the inadequacy of defendant's warning was its failure to disclose
the defective design of the product. That allegation makes every defective
design case a failure to warn case. But plaintiff does allege other defects of the
warning, adequate to state a cause of action.
21
Defendant muddles the two theories in the other direction. It argues that an
adequate warning precludes imposition of liability for a defective product on
any theory. Thus, it argues that its adequate warning precludes the defective
design claim based on warranty. Defendant has a threshold problem in making
the argument here because defendant did not make it below. Defendant's
warning arguments below dealt only with whether the warning was adequate as
a matter of law to foreclose the failure to warn claim. Plaintiff argues that we,
therefore, should not consider the argument. The question is close. The precise
argument was not presented below but it is not a substantial shift in theory.
Plaintiff's claim for breach of warranty alleges two manners in which the
product was unreasonably dangerous. An argument that refutation of one theory
of warranty recovery forecloses the other when the two are so closely related
does not run afoul of fairness or the "sifting of issues" considerations embodied
in the rule not to pass upon contentions not asserted in the district court.
22
When defendant's argument is considered, it fails. The cases it cites are not
directly on point. The argument is based on a dictum in Brockett v. Harrell
Bros., Inc., 206 Va. 457, 143 S.E.2d 897 (1965). Brockett was an adulterated
food case in which the court indicated that while contributory negligence does
not apply to claims for breach of the implied warranty of wholesomeness of
food, plaintiff cannot recover for defects known, visible or obvious to her. Id. at
463, 143 S.E.2d at 902. Defendant's argument extends this dictum to mean that
plaintiff cannot recover in warranty for hazards that were adequately warned of.
Virginia courts have not carried this dictum as to ordinary consumer products,
like food, to all products.
23
The Supreme Court of Virginia in Featherall v. Firestone Tire and Rubber Co.,
219 Va. 949, 252 S.E.2d 358 (1975), considered many products liability issues
including claims for breach of implied warranty of merchantability by
inadequate warning, breach of implied warranty of merchantability by improper
design and tort negligent design of a tank lid. The court found that plaintiff
could not recover on any of these three theories from the manufacturer of the
tank lid. The court considered each claim independently, it did not, after
concluding that no duty to warn arose, foreclose the warranty or tort negligence
defect claims.
24
We have decided that federal law does not preempt plaintiff's state law causes
of action and that under Virginia law, an adequate warning does not foreclose a
design defect claim in either warranty or tort.
25
We now consider each of the state law tort claims: (a) failure to warn, a manner
under which the product would be "unreasonably dangerous" and breach the
implied warranty of merchantability, (b) defective design, a second manner in
which the product would be unreasonably dangerous, and (c) negligent design,
a tort action.
26
a. Failure to warn
26
a. Failure to warn
27
28
The adequacy of a warning is a question of fact for the jury. Pfizer, 221 Va. at
683-84, 272 S.E.2d at 44-45. The issue is whether the warning was reasonable.
Id. Defendant and the trial court make much of the fact that plaintiff's
physician, Dr. Metzger, testified on deposition that the warning was "very
adequate." Defendant argues, and the trial court held, that adequacy was
thereby conclusively established.
29
We disagree on two grounds. First, Virginia law does not support the notion
that the treating physician's subjective view as to adequacy conclusively
determines that issue. In Pfizer, the Supreme Court of Virginia found a warning
adequate as a matter of law in spite of the treating physician's testimony of
inadequacy. Second, plaintiff alleges that the warning should have contained a
statement about a difference, known to defendant at the time, in adverse
reaction rates between different pertussis vaccines. Dr. Metzger testified that
had he known that information he would have used the vaccine with the lowest
reaction rate. Thus, the adequacy of the warning even in Dr. Metzger's view is
in issue.
30
There is then a genuine issue regarding the adequacy of the warning. Summary
judgment on the failure to warn claim was improper.
31
32
c. Negligent Design
33
Va. 949, 961-65, 252 S.E.2d 358, 366-68 (1979). In the former the focus is on
the product and its attributes, in the latter the focus is on the defendant's
conduct.
34
The merits of the design defect claims were not addressed below, the trial court
dismissed any design defect claim as preempted. Since we reverse the
preemption ruling, the design defect claims move back into the case.
35
REVERSED.
WILKINS, Circuit Judge, concurring:
36
I agree with the majority, but for different reasons, that Congress did not intend
to completely preempt state tort actions for DTP vaccine-related injuries. The
majority reaches this conclusion without deciding what congressional intent is
reflected in the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.A.
Secs. 300aa-1, et seq. (West Supp.1987). Prior to the passage of this Act,
federal law appeared to preempt any state action alleging defective design of
the DTP vaccine. But, this Act unmistakably demonstrates that Congress
intended to preempt state law in only limited areas of this field. See Grove City
College v. Bell, 465 U.S. 555, 567, 104 S.Ct. 1211, 1218, 79 L.Ed.2d 516
(1984) (evidence of congressional intent may be gleaned from subsequent
actions).
37
In deciding whether federal law preempts state law, "our sole task is to
ascertain the intent of Congress." California Fed. Sav. & Loan Ass'n v. Guerra,
479 U.S. 272, ----, 107 S.Ct. 683, 689, 93 L.Ed.2d 613, 623 (1987). In the
absence of express congressional intent, preemption may be inferred to the
extent that "the state law stands 'as an obstacle to the accomplishment and
execution of the full purposes and objectives of Congress.' " Id. (quoting Hines
v. Davidowitz, 312 U.S. 52, 67, 61 S.Ct. 399, 404, 85 L.Ed. 581 (1941)).
Although preemption should not be lightly presumed, id., the legislative history
of the Act presents some compelling reasons in support of a finding of
preemption. H.R.Rep. No. 908, 99th Cong., 2d Sess. 1-7, reprinted in 1986
U.S.Code Cong. & Admin.News 6287, 6344-48 (Legislative History).
38
For many years, one of this nation's main public health priorities has been the
prevention of childhood diseases by immunization. Through federal leadership
and state immunization laws, most children are vaccinated against the major
childhood diseases prior to entering school. As a result, polio, diphtheria, and
tetanus have been virtually eliminated in this country. While the immunization
40
41
42
By requiring claimants to exhaust their administrative remedies in a speedy, nofault system prior to filing court actions, Congress hoped to divert a significant
number of potential litigants. Legislative History, supra at 6354. Children
injured from vaccines administered after the effective date of the Act must
proceed through the system as a prerequisite to filing a court action. 42
U.S.C.A. Sec. 300aa-11. Those, such as Tracy Abbot, who were injured prior to
the effective date are eligible to participate in the new system, but are not
required to exhaust its remedies before resorting to the courts. Id. While the
purpose of the system is to reduce litigation, the Act does not entirely preempt
state laws.
43
44
The Act generally provides that "State law shall apply to a civil action brought
for damages for a vaccine-related injury or death." 42 U.S.C.A. Sec. 300aa22(a). However, the Act does expressly preempt state law in several respects
by: (1) adopting comment k of Section 402A of the Restatement of Torts
(Second), precluding liability for damages arising from unavoidable side
effects of a properly prepared vaccine accompanied by proper directions and
warnings; (2) establishing a rebuttable presumption that warnings are adequate
if they comply with federal regulations; and (3) codifying the learnedintermediary doctrine. 42 U.S.C.A. Secs. 300aa-22(b), (c). Significantly, the
Act also preempts state statutes which prohibit civil actions against
manufacturers for vaccine-related injuries. 42 U.S.C.A. Sec. 300aa-22(e); see
also Legislative History, supra at 6368.
Finally, in the Vaccine Compensation Amendments of 1987, which set the
effective date of October 1, 1988, Congress clearly expressed its intent:
45 the time of original enactment and in passing this legislation, the Committee
[A]t
acted with the understanding that tort remedies were and are available....
46
....
47is not the Committee's intention to preclude court actions under applicable law.
It
The Committee's intent at the time of considering the Act and in these amendments
was and is to leave otherwise applicable law unaffected, except as expressly altered
by the Act and Amendments.
48
H.R.Rep. No. 391, 100th Cong., 1st Sess. 691 (1987), U.S.Code Cong. &
Admin.News 1987, pp. 2313-1, 2313-365. Despite our differing analyses, we
have reached the same conclusion: Congress did not intend to completely
preempt state tort law in the area of vaccine-related injuries.
1987); Patten v. Lederle Laboratories, 655 F.Supp. 745 (D. Utah 1987). Only
the court in Hurley v. Lederle Laboratories, 651 F.Supp. 993 (E.D.Tex.1986)
and the district court in the present case have found federal preemption