Court Opinion

ID: 9714602
Source: CourtListenerOpinion
Date Created: 2023-08-26 05:41:01.433504+00
Date Added: 2024-06-11T18:23:23.142728
License: Public Domain

STEIN, J.,
dissenting.
Underlying this appeal are the allegations of plaintiffs concerning R.F.’s receipt in September 1986 of a transfusion of a unit of blood that was infected with the human immunodeficiency virus (HIV) causing her subsequently to test positive for the presence of that virus. Prior to R.F.’s hip-replacement surgery in 1986 she expressed concern to her surgeon about the safety of donated blood, but was assured by him that blood donated to the Bergen County Blood Center (Blood Center) would be tested and could safely be used in the event she required a blood transfusion during surgery. The blood unit received by plaintiff was supplied by a donor to the Blood Center and was tested for HIV antibodies on August 26, 1986 using defendant Abbott Laboratories’ (Abbott) HTLV III test kit. When that unit of blood was tested, it tested negative for the HIV virus with a test result of 0.121. The Abbott Test Kit instructed users that the cut-off value for a negative unit was 0.128, and that units of blood with readings below that cut-off level should be used and not retested.
The essence of plaintiffs’ contentions in this litigation is that Abbott knew, on the date the infected unit of blood was tested at the Blood Center and for several months prior thereto, that its test tended to report HIV positive samples of blood as false negatives to a substantially greater extent than did the tests of its *638two primary competitors; that prior to the date the infected unit of blood was tested Abbott had submitted to the FDA a product license amendment to obtain approval for a revised test that “would be better able to detect positive samples that were ‘borderline or negative’ by the First Generation Test,” ante at 613, 745 A.2d at 1184; and that Abbott failed to warn users of its test concerning its tendency to record false negative readings and failed to request authorization from the FDA to issue such a warning to users.
Notwithstanding those contentions, the Court today holds that plaintiffs’ state law failure-to-warn claim is impliedly preempted— not expressly preempted pursuant to the Medical Device Amendments of 1976, 21 U.S.C.A. § 360k, to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 301 to § 397 (FDCA), as the Appellate Division held — because of the comprehensiveness of the regulatory control over the Abbott Test exercised by the FDA Because in my view the Court’s preemption analysis exaggerates the legal significance of the FDA’s regulatory role, understates the materiality of the factual dispute concerning information about the test’s deficiencies allegedly acquired by Abbott after licensing of its test in March 1985, and diminishes the precedential effect of this Court’s federal preemption jurisprudence, I am compelled to dissent.
I
A
Because this case was tried to a jury on the basis of the trial court’s conclusion that plaintiffs failure-to-warn claim was not preempted, and the jury returned a verdict for Abbott, the relevance of the majority’s holding that federal preemption bars plaintiffs’ claim is understood only in the context of the Appellate Division’s determination that — absent preemption — plaintiffs would be entitled to a new trial because of reversible error in the trial court’s charge and in the jury verdict sheet. As the Appellate Division noted, both that portion of the trial court’s instruction to the jury and the first jury interrogatory that focused on *639the statutory defense to product liability actions, N.J.S.A. 2A:58C-3a(3), precluding liability if the harm “was caused by an unavoidably unsafe aspect of the product and the product was accompanied by an adequate warning,” misdirected the jury’s attention to whether the “blood supply,” rather than Abbott’s HTLV Test Kit, was unavoidably unsafe. The language of the first interrogatory on the jury Verdict Form illuminates the issue:
Has Abbott Laboratories demonstrated by a preponderance of the evidence that the blood supply was unavoidably unsafe at the time of plaintiff E.F.’s transfusion and that the risk of HIV infection could not be completely eliminated through testing?
[ (Emphasis added).]
As the Appellate Division observed, “the issues before the jury included whether the defendant’s product was ‘unavoidably unsafe’ ... and the adequacy of the warning ..., not whether the blood supply was unsafe irrespective of defendant’s test.” (emphasis added). The interrogatories on the verdict sheet addressed to the two other statutory defenses, N.J.S.A 2A:58C-3a(1) and (2), also incorrectly directed the jury to consider whether the blood supply was unavoidably unsafe, rather than requiring the jury to focus on the alleged deficiency in Abbott’s test.
Moreover, interrogatory number six on the verdict sheet, addressing the failure-to-warn claim, incorrectly enhances the plaintiffs’ burden by requiring the jury to find not only that the warnings accompanying Abbott’s test were inadequate to warn the Blood Center of the limitations of the test, but also that the test was not reasonably fit, suitable or safe when it left Abbott’s control. That interrogatory stated:
Taking into consideration your answer to question no. 5, have the plaintiffs demonstrated by a preponderance of the evidence that the warnings and instructions that accompanied the Abbott Laboratories test were inadequate to warn the Bergen Community Blood Center of the limitations of the test, and that the test was not reasonably fit, suitable or safe when it left the control of Abbott Laboratories?
The appropriate burden of proof for a plaintiff to sustain a failure-to-warn claim is that “the product causing the harm was not reasonably fit, suitable or safe for its intended purpose because it *640... failed to contain adequate warnings or instructions.” (emphasis added). N.J.S.A. 2A:58C-2. Interrogatory number six, however, required the plaintiffs to prove not only that Abbott’s warnings were inadequate, but in addition, that the Abbott test also was not reasonably fit, suitable or safe. See Feldman v. Lederle Labs., 125 N.J. 117, 144, 592 A.2d 1176 (1991) (Feldman II); Freund v. Cellofilm Properties, Inc., 87 N.J. 229, 242, 432 A.2d 925 (1981). I am fully in accord with the Appellate Division’s conclusion that “the lengthy charge as a whole and the [jury] interrogatory were prejudicially confusing in light of the focus of the inquiry on the blood supply, not the defendant’s test.”
B
The Court’s opinion, which meticulously recites the facts concerning the FDA’s supervisory role in reviewing the Abbott blood test prior to licensing in March-1985, ante at 600 -18, 745 A.2d at 1176-86, attempts to diminish the significance of the trial testimony elicited by plaintiffs to demonstrate that after licensure, and specifically between September 1985 and July 1986, — the crucial period before plaintiffs transfusion — Abbott acquired information suggesting that its test frequently failed to detect blood that was confirmed to be HIV positive, and that in two scientific studies its test was shown to be substantially less capable of detecting HIV positive blood than were the blood tests of its primary competitors.
Dr. Robert Nowinski, plaintiffs’ expert witness (who had been employed by a competitor of Abbott), offered the following detailed evidence of reports and studies suggestive of deficiencies in the Abbott blood test that were known to Abbott subsequent to licensure and prior to R.F.’s transfusion:
(a) A September 15, 1985 report by the Canadian Red Cross concerning seven blood samples that were verified as positive by the Western Blot test but were not detected by the Abbott test;
(b) The Syracuse Red Cross correspondence of May 20, 1986, in which blood confirmed to be HIV positive by the Western Blot test was tested three separate times by the Abbott test, and that test recorded negative results on all three occasions;
*641(c) The Ascher study conducted at the University of California Laboratory at Berkeley involved twelve blood samples of blood known to be HIV positive. The Abbott test recorded negative results on all twelve samples. Two other commercial tests using the same blood sample reported positive results for all twelve samples;
(d) The study conducted by Dr. Saah, which Dr. Nowinski described as the “Mac Study” involving 5,000 homosexual individuals monitored for HIV antibodies. Within that study entitled “The Multi-Center AIDS Cohort Study” presented at the National Institute of Health Consensus Conference on July 7, 1986, the data focused on thirty homosexual males who had been tested every six months in order to determine when “sero” conversion occurs, described by plaintiffs expert as the stage in the development of disease when the blood sample converted from HIV negative to HIV positive. The thirty blood samples were tested by test kits of five manufacturers all approved by the FDA. The manufacturers were Litton, Electronucleonic, Abbott, DuPont, and Genetic. The rate of detection of various manufacturers in the Saah study was as follows; Litton 2/30; Electro-nucleonic 4/30, Abbott 13/30, DuPont 25/30, Genetic Systems 25/30. Abbott’s detection rate was 43% whereas DuPont and Genetic Systems detection rates were 83%.
Dr. Nowinski also supported Ms conclusion that Abbott knew that its original test recorded false negative results close to the cutoff by referring to Abbott’s letter to the FDA dated July 28, 1986 proposing a modification of Abbott’s blood test. That letter stated that “the addition of affinity purified p41 derived from HTLV III viral lysate into the current bead coatmg antigen solution enhanced the detection of samples containing anti-HTLV III that are borderline or negative by the current assay.” (emphasis added). To the same effect, Dr. NowinsM quoted from the mailgram sent by Abbott to its customers on January 19, 1987 to announce the approval to its modified blood test:
The improved assay significantly enhances the detection of early sero conversion and low level antibody positive specimens. In clinical comparisons between the improved assay and other licensed assays, it demonstrated significantly higher signals on borderline low-level positive specimens. This increased signal pushes low-level samples farther above the cutoff and assures their detection.
[ (Emphasis added).]
Plamtiffs’ allegations concerning Abbott’s knowledge that its blood test frequently produced false negative results and was less sensitive in detecting HIV contaminated blood than were the tests of its primary competitors was corroborated by other sources. The trial court, in twice denying Abbott’s motions for summary judgment, referred to a June 28, 1998 Wall Street Journal article *642included in plaintiffs’ certifications that discussed a pending congressional investigation concerning the “sensitivity problem with the original Abbott test.” Similarly in Genetic Systems Corporation v. Abbott Laboratories, 691 F.Supp. 407 (D.D.C.1988), the United States District Court for the District of Columbia, in an opinion granting summary judgment to the American National Red Cross (Red Cross) anj partial summary judgment to Abbott on plaintiffs’ anti-trust claims, made factual findings that took note of the substantial dissatisfaction within the Red Cross in the summer and fall of 1986 over the lack of sensitivity of the Abbott blood test.
In July 1986, studies presented at the National Institutes of Health Conference on AIDS indicated that the Abbott AIDS test then in use by the Red Cross was less sensitive to detecting contaminated blood than the test of Genetic Systems. That same month, Victor W. Schmitt, Vice President of Medical Operations of the Red Cross, inquired of Genetic Systems how long it would take for it to supply all Red Cross Regions with then- requirements for AIDS tests. Genetic Systems advised the Red Cross that it could do so within four weeks. In the meantime, the Red Cross continued to use the Abbott test and Abbott sought FDA approval of a new, “improved” AIDS test.
By November 1986, the Red Cross was aware that the new Abbott test would not be available until December 1986; that availability date was later delayed to January 1987. The Red Cross became frustrated at the regulatory delays, however, and developed various strategies in response to the problem. Initially, the Red Cross adopted a “contingency plan” under which it would become a “co-investigator” with Abbott to facilitate licensure by the Food and Drug Administration. This contingency plan was never put into effect, however, and the Red Cross adopted a second contingency plan to purchase blood test equipment from alternative suppliers. This second plan was also never implemented because Abbott’s new test received FDA approval in January 1987.
One month after Abbott received approval for its new test, the Red Cross received proposals from Genetic Systems, Abbott, and DuPont to supply the Red Cross’ requirements for AIDS and the two hepatitis tests for a multi-year period commencing July 1,1987.
The record clearly reflects, and defendants do not deny, that a variety of views, some “strongly held and sharply conflicting,” emerged within the Red Cross as to the desirability of contracting with the various test equipment suppliers for the next contract period. For example, in March 1987, the Red Cross Task Force found that the test kits of Genetic Systems, DuPont, and Abbott “all appear to perform with comparable sensitivity and specificity at this time” and would be “acceptable” but recommended that Genetic Systems continue to have a “signifi-
*643cant part” of the Red Cross’ AIDS test business in light of the dissatisfaction with the Abbott test in 1986.
[id. at 411-12 (footnotes omitted) (emphasis added).]
The Court responds to plaintiffs’ trial testimony indicating that the Abbott blood test had a tendency to produce false negative results by asserting that the testimony was “discredited at trial.” The Court supports that assertion by citations to the direct testimony of three scientists, Harry Meyer, Director of the FDA’s Center for Drugs and Biologies until September 1986 and the official with primary responsibility in the FDA for licensing and implementation of the Abbott test; John Heller, an executive at Abbott since 1983 who was Abbott’s “lead scientist” in the development of the Abbott test; and Thomas Zuck, Director of the FDA Division of Blood and Blood Products during the period of licensure of the Abbott test and, after leaving the FDA in 1987, a consultant for Abbott Laboratories for the past “four or five years” prior to 1996 when he testified. Putting to one side the fact that defendant’s experts were no more impartial than was plaintiffs’ expert, the thrust of their testimony was to suggest, but not conclude, that the blood samples used in the Canadian, Saah and Ascher studies may not have been HIV positive after all. The witnesses testified that at the time the Canadian, Saah and Ascher studies were conducted many scientists believed that a protein called “p24” was the earliest and clearest indicator of infected blood, although subsequently Abbott and other scientists concluded that a different protein, “p41,” found in the outer membrane of the HIV virus was a more reliable indicator. Accordingly, Meyer, Heller and Zuck implied, without ever challenging the statistical results of the Canadian, Saah and Ascher studies, that some of the Abbott test’s “false-negative” results in those studies may have been correct in that all of the blood samples may not have been positive. Ante at 630-35, 745 A.2d at 1194-97.
Far from repudiating the results of those studies, Abbott’s witnesses instead acknowledged that the studies created doubt and uncertainty. Dr. Zuck, responding to questions concerning the Saah study, observed that “we weren’t exactly sure what p24 only meant at that point ... and so we were having growing *644concern about how the knowledge was evolving,” and concerning the Ascher study he noted that “we were again left with the quandary what does this really mean, who among these people is infected and who isn’t.” Dr. Meyer, the FDA official with direct responsibility for the quality of licensed blood tests, states that “[m]y reaction [to the studies] was one of interest, but recognizing some of the potential flaws and [not] racing off to over interpret the data____ Those were very preliminary data. I was interested in knowing more about it, and we did generate more data about it.” Even Dr. Heller, the Abbott scientist in charge of developing the Abbott test, grudgingly acknowledged concern and the need for further inquiry about the Saah and Ascher studies: “Oh, exactly, that’s the responsible thing to do scientifically, to try and investigate and understand what is being presented.”
The obvious point is that, however persuasive or unpersuasive a jury might find the testimony of each side’s experts on the issue of the Abbott test’s propensity to record false negatives, a material question of fact on that issue is presented by the proofs as the Law Division judge twice concluded. The appropriate mechanism for resolving that factual issue is by a remand for a new trial. The Court, however, forecloses plaintiffs’ opportunity to prove their case by implying preemption of their cause of action even in the absence of any statutory foundation or promulgated regulatory basis for that conclusion.
II

Preemption

The Court’s implied preemption analysis and rationale differs markedly from that of the Appellate Division. That court assumed, consistent with the parties’ presentations, that the Abbott blood test was licensed as a medical device pursuant to the Medical Device Amendments of 1976, 21 U.S.C.A §§ 360e-360ee (MDA), to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A §§ 301-397. Before this Court, however, plaintiffs persuasively asserted that although Abbott’s blood test kit met the definition of *645a “device” pursuant to the MDA, the FDA regarded the test kit’s virus as its primary component. Plaintiffs submitted incontrovertible documentary evidence to the Court that the product license authorizing the use of that virus in Abbott’s test kit was issued not under the MDA, but rather by the Office of Biologies Research and Review pursuant to the Public Health Service Act, 42 U.S.C.A. § 262. The Court offhandedly observes, without any explanation, that plaintiffs’ assertion that the test kit was approved as a “biologic,” not as a “device,” is “unsupported by the record” and “irrelevant” to the Court’s conclusion. Ante at 619 n. 14, 745 A.2d at 1187 n.14. Nevertheless, the Court abandons all reliance on the MDA’s express preemption provision, 21 U.S.C.A. § 360k, and rests its preemption holding on the doctrine of implied preemption. One can reasonably infer that the Court would not have eschewed all reliance on the MDA’s express preemption provision unless it concluded that it was compelled to do so.
The broad basic principles that govern federal preemption of state law are well settled, but their proper application to specific cases can be elusive. We recently restated the controlling general principles in Franklin Tower One, L.L.C. v. N.M., 157 N.J. 602, 615-16, 725 A.2d 1104 (1999):
There are several theories under which federal law will preempt a state statute. We begin by noting that “pre-emption is not to be lightly presumed,” and that “the historic police powers of the States [are] not to be superseded by [federal law] unless that was the clear and manifest purpose of Congress.” The party claiming preemption bears the burden of supporting that claim by “clear and manifest evidence.”
Congress explicitly may express its intent to preempt state law. Alternatively, preemption may be inferred where the federal legislation is so comprehensive that it creates the inference that Congress intended to leave no room for state regulation in the area.
Preemption also may be found where state law actually conflicts with federal law. Conflict preemption occurs in two instances: where “compliance with both federal and state regulations is a physical impossibility,” or where a state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Under conflict preemption analysis, a court first must consider the *646purposes of the federal law, and then evaluate the effect of the state law on those purposes.
[ (citations omitted.) ]
The Court primarily rests its implied preemption analysis on “field” preemption, relying on the comprehensive FDA regulation of the Abbott HTLV III Test Kit, ante at 625, 745 A.2d at 1191. But the Court also finds both variants of implied conflict preemption to exist, apparently concluding that Abbott could not provide any additional warnings pursuant to state law without violating the FDA’s labeling requirements, and that added warnings would serve as an obstacle to the FDA’s regulatory goals. Ibid.

Field Preemption

The Court’s preemption discussion relies most heavily on the doctrine of “field” preemption, and assumes that the FDA’s unique regulation and supervision of all aspects of Abbott’s blood test during the licensing process necessarily excludes any exposure of Abbott to state product liability claims based on inadequate warnings.
The United States Supreme Court precedent applying field preemption appears to emphasize a Congressional purpose to occupy a specific area of regulation to the exclusion of state law. In Schneidewind v. ANR Pipeline Company, 485 U.S. 293, 108 S.Ct. 1145, 99 L.Ed.2d 316 (1988), two natural gas companies challenged the authority of the Michigan Public Service Commission to regulate their issuance of long-term securities, contending that the Federal Energy Regulatory Commission (FERC), the regulatory body charged with implementation of the Natural Gas Act of 1938 (NGA), 15 U.S.C.A. § 717, possessed exclusive jurisdiction to regulate all aspects of operations and financing of natural gas companies. The Court observed that the NGA consistently has been recognized as a comprehensive scheme of federal regulation over natural gas in interstate commerce, id. at 300,108 S.Ct. at 1151, 99 L.Ed.2d at 325, that in exercising its rate-making authority FERC possesses the power to control indirectly the capital structure of gas companies, id. at 302,108 S.Ct. at 1151, 99 *647L.Ed.2d at 326, and that FERC authority over the issuance of certificates of public convenience and necessity empowers FERC to approve the manner in which capital construction undertaken by gas companies will be financed. Id. at 302-03, 108 S.Ct. at 1152, 99 L.Ed.2d at 326-27. The Court observed that the Michigan statute addressed issues concerning rates and capitalization of gas companies that Congress delegated exclusively to FERC:
In this ease we are presented with a state law whose central purpose is to regulate matters that Congress intended FERC to regulate. Not only is such regulation the function of the federal regulatory scheme, but the NGA has equipped FERC adequately to address the precise concerns Act 144 purports to manage.
[Id. at 308-09,108 S.Ct. at 1155, 99 L.Ed.2d at 330-31.]
Similarly, in City of Burbank v. Lockheed Air Terminal, Inc., 411 U.S. 624, 93 S.Ct. 1854, 36 L.Ed.2d 547 (1973), an action was brought by the owner and operator of an airport and an interstate air carrier to invalidate a city ordinance prohibiting jet aircraft from taking off from the airport between 11:00 p.m. and 7:00 a.m. The plaintiffs contended that the ordinance was invalid because it was preempted by the provisions of the Federal Aviation Act of 1958, 49 U.S.C.A. § 1301, as amended by the Noise Control Act of 1972, 42 U.S.C.A § 4901. By a 5-4 vote, the Court determined that although the federal legislation contained no express preemption provisions, Congress unmistakably intended to occupy the entire field of aircraft noise regulations:
Our prior eases on pre-emption, are not precise “guide-lines” in the present controversy, for each case turns on the peculiarities and special features of the federal regulatory scheme in question. Control of noise is of course deepseated in the police power of the States. Yet the pervasive control vested in EPA and in FAA under the 1972 Act seems to us to leave no room for local curfews or other local controls. What the ultimate remedy may be for aircraft noise which plagues many communities and tens of thousands of people is not known. The procedures under the 1972 Act are under way. In addition, the Administrator has imposed a variety of regulations relating to takeoff and landing procedures and runway preferences. The Federal Aviation Act requires a delicate balance between safety and efficiency, and the protection of persons on the ground. Any regulations adopted by the Administrator to control noise pollution must be consistent with the “highest degree of safety.” The interdependence of these factors requires a *648uniform and exclusive system of federal regulation if the congressional objectives underlying the Federal Aviation Act are to be fulfilled.
[Burbank, supra 411 U.S. at 638-39, 93 S.Ct. at 1862, 36 L.Ed.2d at 556-57 (citations and footnote omitted).]
In contrast, in Silkwood v. Kerr-McGee Corporation, 464 U.S. 238, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984), the issue was whether a state-authorized award of punitive damages based on the discharge of plutonium from a federally-licensed nuclear facility was preempted on the basis of the Atomic Energy Act’s comprehensive authority over all safety aspects of nuclear energy. The Court noted that it recently had held, based on an examination of the legislative history of the Atomic Energy Act, that Congress intended the federal government to “occup[y] the entire field of nuclear safety concerns, except the limited powers expressly ceded to the states.” Id. at 249, 104 S.Ct. at 621-22, 78 L.Ed.2d at 453 (quoting Pacific Gas & Elec. Co. v. State Energy Resources Conservation & Dev. Comm’n., 461 U.S. 190, 212, 103 S.Ct. 1713, 1726, 75 L.Ed.2d 752, 770 (1983)). Nevertheless, after examining the relevant legislative history and related federal statutes, the Court concluded that Congress did not intend to override traditional state tort law:
In sum, it is clear that in enacting and amending the Price-Anderson Act, Congress assumed that state-law remedies, in whatever form they might take, were available to those injured by nuclear incidents. This was so even though it was well aware of the NRC’s exclusive authority to regulate safety matters. No doubt there is tension between the conclusion that safety regulation is the exclusive concern of the federal law and the conclusion that a state may nevertheless award damages based on its own law of liability. But as we understand what was done over the years in the legislation concerning nuclear energy, Congress intended to stand by both concepts and to tolerate whatever tension there was between them. We can do no less. It may be that the award of damages based on the state law of negligence or strict liability is regulatory in the sense that a nuclear plant will be threatened with damages liability if it does not conform to state standards, but that regulatory consequence was something that Congress was quite willing to accept.
[Id. at 256, 104 S.Ct. at 625, 78 L.Ed.2d at 457.]
The “field preemption” case most analogous to the issues presented by this appeal is Hillsborough County, Florida v. Automated Medical Laboratories, Inc., 471 U.S. 707, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985). In Hillsborough an operator of blood plasma centers throughout the country challenged on preemption grounds the validity of an ordinance adopted by Hillsborough County that *649regulated blood plasma centers and their donors. The ordinance was challenged on the ground that Congress, pursuant to the Public Health Service Act, 42 U.S.C.A. § 262(a), had provided for the licensing of all blood plasma vendors and, pursuant to comprehensive regulations adopted by the Food and Drug Administration, had established detailed and specific standards governing the collection of blood plasma. Id. at 709-10, 105 S.Ct. at 2373, 85 L.Ed.2d at 718-19. Plaintiff argued, relying primarily on the pervasiveness of the FDA’s regulatory scheme, that all state and local regulation of plasma collection was preempted. The Court rejected plaintiffs reliance on the “field” preemption doctrine, noting its concern that to rest federal preemption on the comprehensiveness of agency regulation could jeopardize the Court’s Supremacy Clause jurisprudence:
We are even more reluctant to infer pre-emption from the comprehensiveness of regulations than from the comprehensiveness of statutes. As a result of then-specialized functions, agencies normally deal with problems in far more detail than does Congress. To infer pre-emption whenever an agency deals with a problem comprehensively is virtually tantamount to saying that whenever a federal agency decides to step into a field, its regulations will be exclusive. Such a rule, of course, would be inconsistent with the federal-state balance embodied in our Supremacy Clause jurisprudence.
Moreover, because agencies normally address problems in a detailed manner and can speak through a variety of means, including regulations, preambles, interpretive statements, and responses to comments, we can expect that they will make their intentions clear if they intend for their regulations to be exclusive. Thus, if an agency does not speak to the question of pre-emption, we wül pause before saying that the mere volume and complexity of its regulations indicate that the agency did in fact intend to pre-empt. Given the presumption that state and local regulation related to matters of health and safety can normally coexist with federal regulations, we will seldom infer, solely from the comprehensiveness of federal regulations, an intent to pre-empt in its entirety a field related to health and safety.
[Id. at 717-18, 105 S.Ct. at 2377, 85 L.Ed.2d at 724 (emphasis added) (citations omitted).]
The majority’s answer to the Supreme Court’s warning in Hillsborough that the comprehensiveness of an agency’s regulatory efforts is a weak reed on which to rest preemption completely misses the mark. The Court responds by noting that the Supreme Court has held “repeatedly that state laws can be preempt*650ed by federal regulations as well as by statutes.” Ante at 619, 745 A.2d at 1187. That statement is accurate but inapposite, because the FDA promulgated no preemptive regulations in dealing with HIV blood tests. As the Supreme Court cautioned in Hillsborough, “if an agency does not speak to the question of preemption, we will pause before saying that the mere volume and complexity of its regulations indicate that the agency did in fact intend to preempt.” Id. at 718, 105 S.Ct. at 2377, 85 L.Ed.2d at 724 (emphasis added).
This Court’s willingness to rest its “field” preemption analysis solely on the basis of the comprehensiveness of the FDA’s regulation of Abbott’s test prior to licensure is suspect on two grounds. First, it disregards the Supreme Court’s admonition in Hillsborough that “we will seldom infer, solely from the comprehensiveness of federal regulations, an intent to pre-empt in its entirety a field related to health and safety,” Ibid. The Court’s cautionary language in Hillsborough is consistent with the basic principle that “the historic police powers of the States were not to be superseded by [federal law] unless that was the clear and manifest purpose of Congress.” Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447, 1459 (1947) (citations omitted). Although the Court’s opinion attempts to justify federal preemption not on the basis of Congressional action but rather on the basis of a national health emergency concerning a safe blood supply, ante at 620 - 21, 745 A.2d at 1188, experience informs us that Congress knows how to mandate federal preemption in the context of a national health emergency. During the crisis that arose over the swine flu epidemic in the mid-seventies, Congress enacted federal legislation that immunized from liability the manufacturer of the swine flu vaccine and imposed liability on the federal government for state tort claims arising out of use of the vaccine. See National Sivine Flu Immunization Program of 1976, Pub.L. No. 94-380, 90 Stat. 1113 (1976); Petty v. United States, 740 F.2d 1428 (8th Cir.1984). In contrast, although Congress obviously was aware of the blood supply concerns associated with the AIDS epidemic, it took no action to preempt state law *651tort claims. The Court skates on thin jurisprudential ice when it implies such preemption solely on the basis of an administrative agency’s understandably cautious and thorough procedure for licensing blood tests.
Second, the Court either overlooks or disregards that the plaintiffs’ focus is not on the FDA’s regulation prior to licensure, but on Abbott’s after-acquired knowledge in the summer of 1986 that its test’s tendency to record false negatives around the cutoff required prompt remediation. The record demonstrates that during this post-licensure period Abbott was concerned about its test, not only because of safety concerns, but because the blood tests of competitors appeared, according to some research reports, to be more sensitive in detecting HIV contaminated blood. Abbott knew enough about its test’s deficiencies to propose to the FDA in July 1986 a modified test that “would be better able to detect positive samples that were ‘borderline or negative’ by the First Generation Test.” Thus, the focus of plaintiffs’ argument shifts from the FDA’s comprehensive regulation prior to licensure, to Abbott’s state of knowledge in the summer of 1986 about apparent deficiencies in its own test, and its duty to warn users of those deficiencies. Accordingly, the Court’s application of the doctrine of “field preemption” to Abbott’s duty to warn in the summer and fall of 1986 is unsupported by federal preemption jurisprudence and, as well, by the record that suggests the FDA’s regulatory efforts peaked when the Abbott blood test was licensed in 1985, and that after licensure the FDA impatiently awaited Abbott’s submission of a modified and unproved test.

Conflict Preemption

The majority opinion asserts that, in addition to finding implied “field” preemption of plaintiffs’ claims based on the comprehensiveness of FDA regulation, a state failure-to-warn claim would be subject to implied conflict preemption because the FDA designed the label on the Abbott test and at the time of licensure precluded any change in the label without prior FDA approval. The Court’s *652conflict preemption analysis, authored by the sole dissenting Justice in Feldman v. Lederle Laboratories, 125 N.J. 117, 158, 592 A.2d 1176 (1991) (Garibaldi, J. dissenting), overstates the preemptive effect of the FDA-designed label and resurrects conflict preemption obstacles to state tort law that were definitively addressed and rejected in Lederle.
The federal courts clearly have recognized that the preemptive effect of a warning designed or approved by a federal agency depends on whether the regulated entity has disclosed all relevant information to the agency. See, e.g., Hurley v. Lederle Laboratories, 863 F.2d 1173, 1179-80 (5th Cir.1988) (holding that notwithstanding FDA approval of warning on DPT vaccine, preemptive effect of FDA action depends on jury’s determination whether manufacturer withheld from FDA information that might have affected FDA’s decision on content of warning); Roberson v. E.I. Dupont De Nemours & Co., 863 F.Supp. 929, 933 (W.D.Ark.1994) (holding that manufacturer could be estopped from asserting federal preemption of failure-to-warn claim if manufacturer withheld material facts from Environmental Protection Agency).
The Court also relies on the applicable regulation promulgated pursuant to the Public Health Service Act, 21 C.F.R. 601.12(b), that precluded changes in the labeling of biologies prior to “acceptance” of the changes from the Director, Office of Biologies Research and Review. This Court addressed and rejected precisely that contention in Lederle:
The assertion that Lederle would have been subject to punishment for “misbranding” or would have had its product barred from the market if it had added an unapproved warning is based merely on Lederle’s interpretation of the regulations then in effect. Lederle presents no evidence indicating that the FDA ever took such action for adding a warning suggesting a limitation on use rather than an unapproved representation of a benefit, nor does the record reflect any statement by the FDA to the effect that it would have taken action had a manufacturer attempted to warn without prior approval.
[ 125 N.J. at 148, 592 A.2d 1176.]
Just as did Lederle, the Court cites to subsequent modifications of FDA regulations relating both to medical devices and biologies that, after the critical events here, would permit manufacturers to *653augment their labels with additional warnings without prior FDA approval, asserting that those revised regulations demonstrate that in 1986 Abbott was prohibited from revising its warning without prior approval. Ante at 621-22, 745 A.2d at 1188-89. We also considered and rejected an analogous argument in Lederle:
Although we recognize that subsequent actions of an agency are relevant to determining prior intent, we do not agree that the conclusion that Lederle asserts necessarily follows. It contends that the modification shows that independent action was not permitted under the former regulations. An equally-compelling conclusion, however, is that the FDA had not addressed itself to the issue before. (“One could argue that the changes made in § 130.9 in 1965 * * * indicate that FDA approval of precautionary information was required prior thereto. One could also argue that the change in language was meant to clear up a misconception.”). Arguably, then, on squarely considering the issue, the FDA determined that warning of possible dangerous side effects “at the earliest possible time,” was consistent with its primary purpose to protect the public health.
[Id. at 149, 592 A.2d 1176 (citations omitted).]
Despite persuasive evidence in this record about the deficiencies in Abbott’s blood test and its propensity for recording false negatives, and the evidence revealed in the Genetic Systems litigation, supra, at 642, 745 A.2d at 1200-01, that Abbott was in jeopardy of losing Red Cross contracts because of the unreliability of its test, no evidence in the record reveals or suggests that Abbott ever attempted to persuade the FDA to modify the test’s label to warn users to retest in the event of negative readings close to the cutoff. The Court concludes, however, that Abbott was helpless, and that no matter what it knew about the deficiencies in its test, it was absolutely barred by the FDA from taking any action to warn users. This Court evaluated and rebuffed similar protestations in Lederle:
We also note that Lederle is not faced with the Hobson’s choice of either complying with federal regulations and continuing to be subject to damages in state tort actions or providing additional warnings and thereby violating federal law. The regulations in question have long since been changed expressly to allow pharmaceutical companies to implement necessary changes in labeling while a supplemental new-drug application is pending. Furthermore, the present regulations governing labeling of prescription drags require that the labeling “describe serious adverse reactions and potential safety hazards, [and] limitations in use imposed by them.” Interestingly, that provision states that “labeling shall be *654revised to include [such] a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.”
The issue then is what choices, if any, did Lederle have in 1962 and 1963. Even if we assume Lederle could not have provided a warning, an assumption we find unsupported by the evidence, it could have suspended production of Declomycin for what it termed the “probably * * * short period of time” before which Lederle anticipated that that drug too would be “officially implicated with tooth staining.” Alternatively, Lederle could have quite reasonably and responsibly removed from the market those forms and methods of packaging of Declomycin that were geared toward pediatric use. It could have raised the price as a form of loss-spreading insurance against claims. Lederle also could have continued to press for FDA approval of a warning for Declomycin after the administration’s initial response declining to change its official position. (The record is conspicuously silent on any continuing efforts by Lederle to confirm the association of Declomycin with tooth staining or to gain FDA sanction of a warning for Declomycin. (“at least in some fields, such as those impacting on public health, a manufacturer may be expected to be informed and affirmatively to seek out information concerning the public’s use of its own product”).) The suggestion that Lederle was in some way compelled to continue distributing a drug without warning of the strong likelihood of serious side effects for some child users and that Congress and the FDA intended that it would be immune- from liability for doing so cannot be reconciled with the primary purpose of the FDA to promote and protect the health of the citizens of the United States.
[Id at 153-54, 592 A.2d 1176 (citations omitted).]
In finding that plaintiffs’ state law claims are preempted no matter what the evidence at a retrial may disclose about Abbott’s knowledge of deficiencies in its blood test — deficiencies alleged to pose a severe threat to human life — this Court’s holding threatens the “federal-state balance embodied in our Supremacy Clause jurisprudence.” Hillsborough, supra, 471 U.S. at 717, 105 S.Ct. at 2377, 85 L.Ed.2d at 724. The Court also disregards Justice Frankfurter’s admonition that “[a]ny indulgence in construction should be in favor of the States, because Congress can speak with drastic clarity whenever it chooses to assure full federal authority.” Bethlehem Steel Co. v. New York State Labor Relations Bd., 330 U.S. 767, 780, 67 S.Ct. 1026, 1033, 91 L.Ed. 1234, 1249 (1947). Finally, the majority disregards or ignores this Court’s forceful holding in Lederle, supra, rejecting contentions that mirror Abbott’s assertions in this appeal, and declining to imply federal preemption of plaintiffs state law tort claim:
*655The presence of the following factors reinforces the traditional presumption against preemption: that there was no explicit provision for preemption of state tort claims; that the subject matter infringes on the State’s inherent powers to protect and promote the health and safety of its citizens; and that preemption would effectively eliminate all means of recourse for the plaintiff. If there had been a need to immunize prescription drug and antibiotic manufacturers from tort liability, the determination of that need should have been “made by Congress in an unambiguous mandate and not by the courts.” To date Congress has not seen fit to express such a mandate. We will not do so in its stead.
[Lederle, supra, 125 N.J. at 156, 592. A.2d 1176 (citations omitted).]
Ill
In Lederle, the consequence of defendant’s failure to warn was permanently stained teeth. In Abbott’s case, the consequences are a matter of life and death. In the absence of express congressional action, this Court should deny Abbott’s claim that it is immunized from state tort law liability for failure to warn users of its blood test of the devastating consequences that could result from a false-negative test reading of HIV contaminated blood. Because of those consequences, the Court’s implied preemption analysis simply is too flimsy to support preemption of plaintiffs’ state law tort claim.
I would remand this matter for retrial of plaintiffs’ state law failure-to-warn claim.
Justice O’HERN and Justice COLEMAN join in the dissent.
For modification and affirmance — Chief Justice PORITZ and Justices GARIBALDI, VERNIERO and KING — 4.
For remandment — Justices O’HERN, STEIN and COLEMAN — 3.