Court Opinion

ID: 9749444
Source: CourtListenerOpinion
Date Created: 2023-08-27 16:43:32.876869+00
Date Added: 2024-06-11T07:25:48.717324
License: Public Domain

*158GARIBALDI, J.,
dissenting.
The majority’s narrow view of this case and the role of the Food and Drug Administration (FDA) prevent it from understanding the untoward implications its decision could have on the health of the many members of our society other than Carol Ann Feldman. The process that allows a prescription drug to be developed, tested, and marketed involves a complex balancing of the medical needs of everyone in our society against the risk that such drugs may present to any one person in that society. The majority’s opinion upsets that balance.
Bad public policy emerges from the majority’s intrusion into the field of prescription drug regulation. Its decision jeopardizes research and development of new drugs. It also will increase the cost of marketed drugs, thus escalating the nation’s already spiraling health-care costs. Pharmaceutical manufacturers will be reluctant to develop and market drugs, in some instances, either withholding or withdrawing them from the market. People who need the drugs will be deprived of them because they are either not available or too expensive. Either way the public suffers. For those reasons, and because I am convinced that the majority introduces an unnecessary and unreasonable degree of confusion in this highly regulated area, I dissent.
I
Congress gave the FDA an explicit mandate “to act as both a public health promoter by facilitating the approval of important new safe and effective therapies, and as a public health protector, by keeping off or taking off the market drugs not shown to meet safety and efficacy standards.” 50 Fed.Reg. 7452 (1985) (emphasis added). The FDA’s mission is to ensure that each drug’s “benefits outweigh its risks.” Id. at 7469. The FDA must balance the “expected therapeutic gains” of each drug against the “risks entailed by its use.” United States v. Rutherford, 442 U.S. 544, 555, 99 S.Ct. 2470, 2477, 61 *159L.Ed.2d 68, 79 (1979). The FDA cannot fulfill its role if state courts are allowed to require certain actions by pharmaceutical manufacturers that are prohibited under federal law and that supplant, rather than supplement, the carefully-considered regulations of a federal government agency. See Rose-Ackerman, Tort Law in the Regulatory State, in P. Schuck, Tort Law and the Public Interest: Competition, Innovation and Consumer Welfare 80, 100 (1991) (hereinafter Ackerman) (“Retaining conventional tort actions in the face of regulatory statutes can undermine the behavioral impact of. [those] statutes.”).
To enable the FDA to make those risk-utility determinations, Congress gave control to the FDA over virtually “every aspect of drug formulation, production, testing and labeling.” Comment, Federal Preemption of Prescription'Drug Labeling, 22 J. Marshall L.Rev., 629, 656 (1989) (hereinafter Comment, Federal Preemption). The FDA promotes and protects health through a pervasive regulatory system that is exacting and time consuming. Even today “[pharmaceutical product development is a long, tedious and expensive process * * * development time now averages twelve years.” Comment, Developing, Testing and Marketing An AIDS Vaccine: Legal Concerns for Manufacturers, 139 U.Pa.L.Rev. 1077, 1083 (1991) (hereinafter Comment, Legal Concerns for Manufacturers).
In making its risk-utility analysis the FDA relies on a greater accumulation of information and expertise about the subject drug than can be found anywhere else. “The FDA has developed the highest level of competence in pharmaceutical investigation in the world.” Comment, Federal Preemption, supra, 22 J. Marshall L.Rev. at 629. As was noted in 1967,
[t]oday, side-effect data from numerous sources feeds into the FDA’s Information Center on Adverse Reactions and Hazards, where it is studied and catalogued. Some 6600 hospitals supply the FDA with drug information. The agency also collaborates with the AMA central registry of adverse reactions, which receives drug news from hospitals not reporting to the FDA and from doctors in private practice. All federal medical services and agencies send side-effect reports to the FDA, and eight countries will exchange information through an international center created by the World Health Organization to *160provide a worldwide early warning system for new drugs. [Ruge, Regulation of Prescription Drug Advertising: Medical Progress and Private Enterprise, 32 Law & Contemp. Probs. 650, 659-60 (1967).]
See also 50 Fed.Reg. 7476-77 (1985) (calling for physicians to provide the FDA with direct information concerning suspected adverse reactions to drugs by means of form called Drug Experience Report (DER) or Form 1639). In addition to reaching out for such information, the FDA investigates and prosecutes violations and publishes “monthly reports on adverse reactions and a weekly journal of literature abstracts, which are sent to competing hospitals and other groups.” Ruge, supra, 32 Law & Contemp. Probs. at 660.
“[Bjecause drug labeling is intended to advise health care professionals about potential hazards in the use of a drug and convey documented statements about its safety,” 44 Fed.Reg. 37,447 (1979), the FDA also makes a risk-utility determination about drug labeling. Because of its importance, drug “labeling” is expansively defined and extensively regulated by the FDA.
“Labeling” is defined to include “all labels or other written, printed, or graphic matter” on the container or “accompanying such article.” 21 U.S. C.A. § 321(m). “ ‘[Accompanying such article” means any information that “supplements or explains’ ” the labeling and “[n]o physical attachment one to the other is necessary.” Kordel v. United States, 335 U.S. 345, 350, 69 S.Ct. 106, 110, 93 L.Ed. 52, 57, reh’gs. denied, 335 U.S. 900, 69 S.Ct. 298, 93 L.Ed. 435 (1948), and 336 U.S. 911, 69 S.Ct. 513, 93 L.Ed. 1075 (1949). The “textual relationship” of the communication to the article is what is significant. . Ibid. Thus, package inserts and all other communications to physicians with respect to the use or safety of the drug are considered to be “labeling” subject to FDA approval.
Even today, the FDA allows “labeling statements with respect to safety [only] if they are supported by scientific evidence,” 44 Fed.Reg. 37,441 .(1979). It demands that the “pharmacological information” in the label be “clinically relevant,” *161id. at 37,442, and warn only of “known hazards and not theoretical possibilities.” 21 C.F.R. § 201.57(d) (1991). The FDA has determined that a warning may not include a “statement of differences of opinion with respect to warnings (including contraindications, precautions, adverse reactions, and other information relating to possible product hazards) required in labeling food, drugs, devices, or cosmetics under this act,” 21 C.F.R. § 1.21(c) (1991) (emphasis added). Simultaneously, following its “long-standing agency policy,” the FDA demands that drug manufacturers continuously report to the FDA any unexpected or new side-effects, adverse reactions, or toxicity, “whether or not considered to be caused by the drug in question.” 50 Fed.Reg. 7476 (1985). The FDA decision that a drug label is “an authoritative document which contains only those indications and usages which are based upon substantial evidence," 40 Fed.Reg. 15,394 (1975) (emphasis added), reflects a conscious policy choice that certain information it gathers not be included in drug labeling.
Despite their portrayal by the majority, today’s prescription drug manufacturers enjoy only a “very limited freedom,” a freedom not enjoyed at all before 1965, to make temporary, conditional labeling changes. Note, Federal Preemption: A Vaccine Manufacturer’s Defense, 56 U.Mo.-K.C.L.Rev. 515, 529 (1988) (hereinafter Note, A Vaccine Manufacturer’s Defense ). Even that freedom evaporates once the FDA has ruled. See ibid. The FDA must enforce its best assessment of the proper risk-benefit balance because of the unique concerns associated with pharmaceuticals.
Prescription drugs are unlike typical consumer goods, on which stringent warnings of possible dangers have no appreciable negative impact on the utility and use of the product and should rarely be omitted. See, e.g., Freund v. Cellofilm Properties, Inc., 87 N.J. 229, 242, 432 A.2d 925 (1981). Pharmaceuticals also differ from some other products, such as cigarettes, for which a negative impact on “utility” or use is not only a tolerated byproduct of a warning but often a targeted goal. *162See, e.g., Dewey v. R.J. Reynolds Tobacco Co., 121 N.J. 69, 100, 577 A.2d 1239 (1990) (noting legislative attempts to discourage smoking); see also Recent Development, Tort Law — Strict Products Liability — New Jersey Supreme Court Preserves Claims Against Tobacco Companies — Dewey v. R.J. Reynolds Co., 121 N.J. 69, 577 A.2d 1239 (1990), 104 Harv.L.Rev. 1723, 1727 (1991) (“A second defense of strict liability * * * argues that forcing the industry to internalize the health costs of smoking will raise cigarette prices and thus encourage smokers to cut back or quit.”) Despite those differences the majority’s analysis proceeds uninfluenced by the conflicting policy considerations this case presents.
The uses and benefits of prescription drugs like Declomycin, and the analysis of those uses and benefits, differ markedly from an appraisal of the social benefits of paint mixers or cigarettes. See Brown v. Superior Court, 44 Cal.3d 1049, 1063, 751 P.2d 470, 478-79, 245 Cal.Rptr. 412, 420 (1988) (decision in any given pharmaceutical case must recognize and reflect broad policy considerations occasioned by “important distinction between prescription drug and other products”). Warning of the possible but not scientifically-verifiable side-effects of prescription drugs can have a significant anti-utilitarian effect, especially if required only in certain states. Cf. ibid. (“broader public interest in availability of drugs at affordable prices must be considered in deciding appropriate standards of liability for injuries resulting from their use” because beneficial drugs are necessary despite fact that “harm to some users is unavoidable”). As the FDA has said, “[t]o permit or require statements of conflicting opinion on all these matters would destroy the present usefulness of prescription drug labeling.” 39 Fed.Reg. 33, 232 (1974). It would also destroy the FDA’s hope of “ ‘bringing consistency and uniformity to the marketplace’ ” or of succeeding in its “ ‘well-established policy of promoting uniformity in the area.’ ” See Comment, Legal Concerns for Manufacturers, supra, 139 U.Pa.L.Rev. at 117 n. *163190 (quoting 51 Fed.Reg. 8181 (1986), and 50 Fed.Reg. 51,403 (1985), respectively).
The FDA has expressed two serious concerns about drug labeling. First, it has an interest in “rational prescribing,” i.e., ensuring that the risks and benefits of a particular drug be fairly presented so that a physician can compare them with other available therapies. That goal is not advanced if a drug is made to appear riskier than other drugs and other therapies due to the over-dramatization of risk information. To allow a warning based on inconclusive evidence or scientific hunches results in doctors not prescribing effective drugs to a patient because of the erroneous belief that a side-effect might occur.
In addition to promoting “rational prescribing,” the FDA must prevent “information overload.” As one court has noted:
The quality of evidence supporting a causal connection between product and injury may change from extremely vague to highly certain. * * * [I]f every report of a possible risk, no matter how speculative, conjectured, or tentative, imposed an affirmative duty to give some warning, a manufacturer would be required to inundate physicians indiscriminately with notice of any and every hint of danger, thereby inevitably diluting the force of any specific warning given. [Finn v. G.D. Searle & Co., 35 Cal.3d 691, 701, 677 P.2d 1147, 1153, 200 Cal.Rptr. 870, 876 (1984).]
The FDA has legitimate concerns that information overload may lead physicians to ignore drug labels or package inserts or to read them without any intention of modifying their prescription practices because substantial parts of what they have found in them in the past had not been useful or had later been disproved. See Note, A Question of Competence: The Judicial Role in the Regulation of Pharmaceuticals, 103 Harv. L.Rev. 773, 783 (1990) (hereinafter Note, Pharmaceutical Regulation ).
The FDA has an interest in promoting health. Ensuring that drug scares do not occur and that unsubstantiated claims, good or bad, do not appear on the label is a way of achieving that goal. Even today, under 21 C.F.R. § 310.303(a) (1991), the FDA receives information regarding every possible side-effect, but issues warnings based only on “substantial evidence,” *164because “statements of conflicting opinion * * * would destroy the present usefulness of prescription drug labeling.” 39 Fed. Reg. 33,232 (1974). That policy balance represents the expert appraisal of how best to maximize aggregate health benefits. The dual function of the FDA ensures that drug companies produce and market medications that “decrease aggregate health risks as safely and inexpensively as possible,” Note, Pharmaceutical Regulation, supra, 103 Harv.L.Rev. at 780, because “Americans insist on the best available medications to treat those suffering from illness.” Comment, Federal Preemption, supra, 22 J. Marshall L.Rev. at 629.
Against that background, we review this case.
II
—A—
I agree with the Appellate Division. Although the comprehensive nature of FDA regulations and the national goal of uniformity in drug labels tempts me to find implied preemption, I need not reach that issue here. The Appellate Division’s narrower holding disposes of this case and addresses those concerns that force me to disagree with my colleagues:
We conclude that the Food and Drug Administration’s (FDA) regulation of the drug industry does not warrant a finding of implied federal preemption of all State tort claims grounded in strict liability failure to warn. However, under certain circumstances, such as presented here, federal law may preempt a discrete issue upon which liability is predicated because compliance with State decisional law would require federal law to be violated. [234 N.J.Super. at 564, 561 A.2d 288.]
“[E]ven in the absence of express language on implied congressional intent to occupy the field, state law may be preempted ‘to the extent that it actually conflicts with federal.’ ” Dewey, supra, 121 N.J. at 78, 577 A.2d 1239 (quoting Brown v. Hotel Employees Int’l Union, 468 U.S. 491, 510, 104 S.Ct. 3179, 3190, 82 L.Ed.2d 373, 383 (1984)). Federal regulations have the same preemptive effect as federal statutes, Hillsborough County v. Automated Medical Laboratories, Inc., 471 *165U.S. 707, 713, 105 S.Ct. 2371, 2375, 85 L.Ed.2d 714, 721 (1984), and state common law and state statutory law stand equally subject to preemption. Chicago N.W. Transp. Co. v. Kalo Brick & Tile Co., 450 U.S. 311, 325-26, 101 S.Ct. 1124, 1134, 67 L.Ed.2d 258, 270 (1981).
I agree with the Appellate Division that the “clear wording” of the regulations in place before 1965 prevented the defendant, Lederle Laboratories, from complying with the common-law duty this Court now imposes on it. 234 N.J. Super, at 588, 561 A.2d 288; see Roginsky v. Richardson-Merrell, Inc., 378 A.2d 832, 835, 848 (2d Cir.1967) (interpreting pre-1965 regulations to require prior FDA approval before a labeling change could be made); Miller v. Upjohn Co., 465 So. 2d 42, 45 (La.Ct.App.1985) (same), cert. denied, 467 No. 2d 533 (1985) (same); see also Hurley v. Lederle Laboratories, 863 F.2d 1173, 1179, modifying 851 F.2d 1536, 1542 (5th Cir.1988) (because it is “[mjost important [that] the manufacturers cannot change the language in the product insert without FDA approval,” court found that direct conflict preempted adequacy of warning issue as long as Lederle had met its duty to disclose all relevant information to FDA).
The plain wording of the two regulations relevant here support that position. The first, 21 C.F.R. § 130.9(a) (1960), states in part:
A supplemental application should be submitted for any change beyond the variations provided for in the application * * * that may alter the conditions of use, the labeling, the safety, identity, strength, quality or purity of the drug * * *. Labeling changes include deviations from the authorized brochure in any mailing or promotional piece used after the drug is placed on the market. When necessary for the safety of the drug, a supplemental application may be required to specify a period of time within which the proposed change will be made; and in such case the distribution of the drug after such time without such change constitutes distribution without an effective new-drug application. If a material change is made in the * * * labeling or advertising[ ] from the representations in an effective application for a new drug, and the drug is marketed before a supplement is effective for such change, the application may be suspended under § 130.27 on the grounds that it contains an untrue statement of a materia! fact.
*166The other regulation of primary relevance, which defined the FDA’s position on the certification of batches of antibiotics, stated:
(b) A certificate shall cease to be effective:
********
(2) With respect to any immediate container * * * when its label or labeling is altered, mutilated, destroyed, obliterated, or removed in whole or in part, or ceases to conform to any labeling requirement prescribed by the regulations in this part, except that:
(i) If the drug in such container is repacked * * *, and certification of the batch thus made is requested, such certificate shall continue to be effective for a reasonable time * * '; [or]
(iii) If its label or labeling is removed in whole or in part for the purpose of relabeling and supplemental certification of the relabeled drug is requested, as provided by § 146.18. [21 C.F.R. § 146.4 (1955).]
Each of those regulations clearly indicates the need to obtain approval before altering labels. See L. Tribe, American Constitutional Law § 6-26 at 482 (1988) (Implication can still amount to direct preemption because “state and federal law need not be contradictory on their face for the latter to super-cede the former. There are more subtle forms of actual conflict.”).
Subsequent history also discloses that Lederle could not alter its label without approval under the FDA regulations governing changes in drug labeling in effect during 1962 and 1963. In January 1965, the FDA amended the form.of the New Drug Application prescribed in 21 C.F.R. § 130.4 (1956), and the requirement of filing a supplemental application set forth in 21 C.F.R. § 130.9 (1960), to allow a manufacturer to incorporate additional warnings of side-effects in its labeling prior to receiving a written notice of approval of the supplemental new drug application from the FDA. See 30 Fed.Reg. 993 (1965). In Feldman v. Lederle Laboratories, 97 N.J. 429, 479 A.2d 374 (1984) (Feldman I) we mistakenly suggested, on an incomplete record, that those amendments might have merely clarified existing procedures. Id. at 459, 479 A.2d 374. We know now *167that that is not so. The former Commissioner of the FDA explained that the regulations were “amended * * * to enable prompt adoption of changes,” and that the amendments were intended to “relax existing requirements.” 30 Fed.Reg. 993-94 (1965) (emphasis added).
History is particularly telling in the case of antibiotics. Although Congress immediately recognized that antibiotics “are spectacularly efficacious in many serious diseases suffered by large numbers of our population,” it was very concerned about the complicated manufacture and safe use of antibiotics. Hearings Before a Subcommittee of the House Committee on Interstate and Foreign Commerce, 81st Cong., 1st Sess. 5 (1940). Accordingly, Congress imposed on antibiotics “even more stringent regulations” than those generally imposed on prescription drugs. See Pfizer, Inc. v. Richardson, 434 A.2d 536, 538 (2d Cir.1970). After the initial approval of an antibiotic, but not other drugs, the manufacturer was required to request certification of each batch before it was marketed. See 21 C.F.R. §§ 146.2 & 146.3 (1963). Thus, before a batch of antibiotic could be certified, the FDA was required to find affirmatively that the labeling did not contain any “untrue statement of a material fact,” that it contained “all words, statements, and other information required by the regulations,” and that it otherwise met all the statutory standards for adequate warnings. See 21 C.F.R. §§ 146.3 & 146.4 (1963).
Moreover, the FDA precluded drug manufacturers from altering approved labeling in any respect without prior authorization. The certification of any batch of antibiotics was immediately void if the “labeling [had been] altered * * * in whole or in part, or [had ceased] to conform to any labeling requirement.” 21 C.F.R. § 146.4(b)(2) (1963). Even the 1965 amendments did not change the batch certification requirements applicable to antibiotics. Only in 1966 did the FDA modify its antibiotic regulations to allow manufacturers to use “mailing and promotional pieces that are essentially the same as the previously approved labeling” without “advance approval” from *168the agency. 31 Fed.Reg. 11,415 (1966). In explaining that change, the then-Commissioner of FDA stated that “heretofore, the regulations have required specific advance approval of each mailing piece.” Ibid, (emphasis added). Except for that minor change, however, the FDA approval procedures for changes in antibiotic labeling remained intact.
The FDA’s intent to prevent pharmaceutical manufacturers from changing drug labels without the FDA’s approval is confirmed by the regulations. See Grove City College v. Bell, 465 U.S. 555, 567, 104 S.Ct. 1211, 1218, 79 L.Ed.2d 516, 528 (1984). The 1965 amendments “relaxe[d]” existing standards and “enable[d]” manufacturers to take previously-prohibited actions. See 30 Fed.Reg. 993-94 (1965). Neither did the FDA then, nor does it now, believe “warning of possible dangerous side effects * * * [to be] consistent with its primary purpose.” Ante at 149-50, 592 A.2d at 1193-94 (emphasis added). Labels should warn only of “known hazards and not theoretical possibilities,” 21 C.F.R. § 201.57(d) (1991) (emphasis added), and these “warnings” should describe only those “adverse reactions” and “safety hazards” that have a demonstrated “association” with the subject drug. 21 C.F.R. § 201.57(e) (1991).
—B—
The facts also support the position that if Lederle had placed on its label for Declomycin the additional warning now required by the majority, it would have been in direct conflict with the FDA’s strict drug-labeling regulations.
I agree with much of the majority’s discussion of the facts, including the observation that the ingestion of Declomycin during the developmental stages of plaintiff’s teeth caused the injury alleged here. However, I highlight those facts that are most salient to the present inquiry.
Tetracyclines, a generic label for a group of antibiotics, of which Dedomycin is one,1 marked a great advance in the fight *169against bacterial infections. See United States v. An Article of Drug, 394 U.S. 784, 785, 89 S.Ct. 1410, 1411, 22 L.Ed. 2d 726, 729 (1969) (describing tetracyclines as “wonder drugs”). “A primary benefit of tetracyclines is that they are effective against a wider variety of organisms than are other antibiotics.” Ante at 122-23, 592 A.2d at 1178-79.
Declomycin “had greater antibiotic potency that made it possible to achieve therapeutic activity with less weight of antibiotic,” * * * it had “a reduced renal clearance rate that produced a prolongation of the antibacterial level in the body,” and * * * it was “therapeutically equally effective as other tetracyclines in infections caused by organisms sensitive to the tetracyclines.” [Ibid. (quoting Feldman I, supra, 97 N.J. at 436, 479 A.2d 374.)]
Those proven qualities made Declomycin a beneficial addition to medical-treatment programs throughout this country when it was introduced in 1959.
In 1962, defendant began to receive anecdotal reports regarding a possible link between the use of tetracycline by children during their developmental years and the subsequent yellowing of some users’ teeth. Lederle quickly notified the FDA of the possible link and proposed a warning label. The FDA responded that it had been “devoting a great deal of attention to the matter” over “the past several months.” Letter from FDA to Lederle (Dec. 3, 1962). The FDA had received reports “of this type from here and abroad,” and, although it was “acutely interested” in the problem and was “fully aware of the importance of the various implications of this problem,” it did not order Lederle to augment or alter its current label. Ibid.
Defendant continued to supply information to the FDA during the agency’s research on Declomycin. In early 1963, the FDA directed that a warning label be placed on certain tetracycline analogues to alert users to a demonstrated link between these drugs and tooth staining. The FDA had removed the generic label “tetracycline” from its proposed warning and *170specifically excluded Declomycin because there was “practically no specific clinical evidence to substantiate such a labeling requirement.” Thus, the FDA refused to approve immediately Lederle’s desired warning for Declomycin’s labeling, and it further forced Lederle to exclude its originally-approved blanket statement from Declomycin labeling because there was insufficient information to “substantiate” the clinical association necessary to support such a labeling requirement.
On April 18, 1963, the FDA issued the following press release to all medical and dental journals, and to the general media, with respect to tooth discoloration and tetracyclines. That release, in pertinent part, said:
'Children’s teeth can be seriously discolored by three types of tetracycline antibiotics,’ the Food & Drug Administration said in a message to physicians and dentists.
‘The three drugs are: tetracycline, ehlortetraeycline, and oxytetracycline. There is no evidence that a fourth drug, [Declomycin] causes the discoloration, ’ FDA said, [emphasis added.]
Thus, if Lederle had issued the warning required by the majority, it would not only have proceeded without the FDA’s approval of its desired warning, it also would have directly contradicted the public position of the FDA. Cf. L. Tribe, supra, § 6-26 at 483 (state law will be preempted “if its effect is to discourage conduct that federal action specifically seeks to encourage”).
Accordingly, this record unambiguously demonstrates a direct conflict. The majority need not search it out. It emerges clearly from the totality of the evidence in this record.
—C—
The majority’s opinion’s assumptions and inferences have no basis in the record. The majority unfairly casts Lederle as a scheming dissembler that provided evasive answers and caused some sort of knowing delay in FDA decisions by suppressing information. Were that true, my position here might be different. Cf. Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 257, 104 S.Ct. 615, 626, 78 L.Ed.2d 443, 458 (1984) (when “federal *171standards have been violated,” paying both federal administrative fines and state tort damages does not “frustrate any purpose” of a pervasive federal scheme). I would not countenance a result that insulated a manufacturer who violated federal standards by delaying or disrupting, through action or inaction, the flow of information to the FDA, by refusing to investigate independently the possibility that its drugs were harmful, or by using administrative delay as an opportunity to unload on the public drugs known to be unsafe. See Hurley, supra, 863 F.2d at 1179-80.
However, nothing like that occurred here. Lederle violated no federal standards — indeed, Lederle went so far beyond mere adherence that it drew praise from the FDA. Although Lederle certainly had information implicating a potential connection between tooth staining and tetracyclines, no one, including the FDA, “could * * * come to any conclusions as to what exactly was going on,” according to one witness. Another witness noted that Declomycin, unlike two other tetracycline analogues, had not been demonstrably linked to tooth discoloration by 1963. Another witness stated that Declomycin had “initially [been] thought to have even less effect on tooth staining than the original tetracyclines.” Moreover, Lederle warned its sales staff not to use the FDA’s exemption of Declomycin from its order for revised warnings to gain market advantage. I see no evasion in the answer “Declomycin has not as yet been officially implicated in tooth staining.” (Lederle memorandum dated April 23, 1963) (emphasis added). Indeed, the modifying language “as yet” and “officially” indicates even to the most unsophisticated physician that that status might change. Despite that evidence, the majority makes the unsupported assumption that evidence that would have demonstrated a known hazard and not a theoretical possibility would “not then have been available to the FDA,” ante at 126, 592 A.2d at 1181, yet existed for Lederle. Indeed, the record shows just the opposite. The FDA’s information-gathering mechanisms were pervasive even in the 1960s — they reached into the experiences of manu*172facturers, hospitals, and doctors’ offices. See Ruge, supra, 32 Law & Contemp. Probs. at 659-60. The evidence had not yet convinced the FDA; that does not mean that it was concealed from the FDA.
Ill
The exclusion of Declomycin from the original list of tetracycline analogues that had to carry a label warning against tooth staining was not merely “an unfortunate turn of events.” Ante at 155, 592 A.2d at 1196. It was a deliberate administrative response by the FDA. Available information did not substantiate such a labeling requirement.
The Court’s single-case focus inevitably diverts any risk-benefit analysis away from the proper medication-market balance to an improper medication-patient one. Unlike cigarette cases, in which the offending substance provides neither society nor the individual with any appreciable medical benefit, pharmaceutical cases demand the most accurate risk assessment possible:
[I]n the event that the tort system fails to assess appropriately the relative risk calculus, and thereby deters the development, forces the removal, or skews the pricing of medications that lower aggregate harm, certain individuals will be unable to receive net beneficial medications. As such, total harm will increase. * * * Although the tort system undeniably provides the only compensation for some individuals, tort law in the pharmaceutical context distorts the availability and price of beneficial medications, thereby harming more individuals in the first instance. [Note, Pharmaceutical Regulation, supra, 103 Harv.L.Rev. at 784-85.]
Announcing such fears is neither crying wolf nor aping Chicken Little. “The histories of Oculinum, Bendectin and DPT vaccine symbolize a developing crisis in health care.” Id. at 775. The manufacturers of Oculinum could not obtain insurance on the drug, and hence it could not be marketed, despite six years of experimental success in treating eye problems. Id. at 774; see also Brown, supra, 44 Cal.3d at 1065, 751 P.2d at 480, 245 Cal.Rptr. at 421 (“a manufacturer was unable to market a new drug for the treatment of vision problems be*173cause it could not obtain adequate liability insurance at a reasonable cost”). The story of Bendectin illustrates how net health benefits can be evaporated by non-expert juries without any demonstrable basis.
Bendectin is a drug effective in remedying the difficulties of morning sickness. The drug continues to enjoy the approval of the FDA, and studies have consistently concluded that the drug is safe. Nonetheless, Bendectin became such a popular target for tort lawsuits alleging that it was responsible for birth defects that the drug’s manufacturer withdrew it — the only available morning sickness medication — and submitted to a $120 million class action settlement. Although the manufacturer had not lost a case on appeal, “[sjince even wins were only adding to the costs of defense, the company * * * decided to settle.” [Note, Pharmaceutical Regulation, supra, 103 Harv.L.Rev. at 774 (quoting “Morning Sickness, Legal Miscarriage,” N.Y. Times, July 30, 1984, at A20, col. !)•]
The diphtheria-pertussis-tetanus (DPT) vaccine saga is a bit more complicated but no less revealing. At one time, pertussis, or whooping cough, “was a major cause of childhood morbidity and mortality in the United States.” Note, A Vaccine Manufacturer’s Defense, supra, 56 U.Mo.-K.C.L.Rev. at 519. It caused 36,013 deaths and over 800,000 cases between 1926 and 1930. Ibid. Because of the development and use of an effective vaccine, no more than 3,000 cases a year, and between five and twenty deaths a year, were reported from 1960 to 1982. However, the disease may ravage our children again — “skyrocketing litigation costs,” id. at 516, prompted seven of the eight DPT vaccine manufacturers to withdraw from the market and caused the price per dose to rise from 11$ to $11 between 1981 and 1986. Note, Pharmaceutical Regulation, supra, 103 Harv.L.Rev. at 775 n. 10; see also Viscusi & Moore, “Rationalizing the Relationship Between Product Liability and Innovation,” P. Schuck, supra, at 111. (“Rising liability costs” caused ten of the thirteen manufacturers of vaccines for five serious childhood diseases to cease production between 1981 and 1990). These are events with which we are familiar. See Schackil v. Lederle Laboratories, 116 N.J. 155, 178-80, 561 A.2d 511 (1989). Drug manufacturers refused to supply a newly discovered vaccine for influenza on the ground that mass innoculation *174would subject them to enormous liability. The government therefore assumed the risk of lawsuits resulting from injuries caused by the vaccine. See Feldman v. Lederle Laboratories, 189 N.J.Super. 424, 435-36, 460 A.2d 203 (App.Div.1983); Franklin & Mais, Tort Law and Mass Immunization Programs, 65 Calif.L.Rev. 754, 769 (1977).
The majority’s view of the issue of “what choices, if any, did Lederle have in 1962 and 1963,” ante at 153, 592 A.2d at 1195, demonstrates its failure to understand the importance of risk-utility analysis in the development and marketing of prescription drugs. It determines that Lederle could have discontinued the production or raised the price to cover its potential liability. Ignored entirely in the majority’s assessment is the effect the drug’s removal from the market or its increased price will have on the numerous people who are helped by the drug. The majority does not consider the good the drug does, the lives it may save, or the suffering and pain it may prevent. The majority’s suggestion that suspending production or raising the price of Declomycin in response to then-unverified possibilities ignores the widespread disutility of such practices, especially if the possibilities proved to be false alarms. Drugs, would go unproduced or produced only at high prices: each prevents many in need from using them.
That is not an unrealistic appraisal. To assume or posit, as the majority does, that tort liability judgments do not have a profound regulatory effect on the prescription drug market is naive. As noted by the California Supreme Court, “the possibility that the cost of insurance and of defending lawsuits will diminish the availability and increase the price of pharmaceuticals is far from theoretical.” Brown, supra, 44 Cal.3d at 1064, 751 P.2d at 479, 245 Cal.Rptr. at 421; see also id. at 1065, 751 P.2d at 480, 245 Cal.Rptr. at 421 (rejecting a failure-to-warn claim for the “same reasons of policy” that led court to reject strict liability). In Shackil v. Lederle Laboratories, we recognized the “important societal goals of maintaining an adequate supply of life-saving vaccines and of developing safer alterna*175tives to current methods of vaccinations.” 116 N.J. at 190, 561 A.2d 511. In finding for the defendant, we stated that “our aim is not to insulate vaccine manufacturers from liability, but to acknowledge a painful reality — that the excessive exposure to liability * * * would inevitably discourage highly useful activity.” Id. at 190-91, 561 A.2d 511. Whatever the validity of the “incidental effects” distinction of Dewey, supra, 121 N.J. at 90-94, 577 A.2d 1239, the examples of Oculinum, Bendectin, and DPT vaccine demonstrate that the prescription-drug market has directly felt the regulatory effect of the threat or payment of court-awarded damages. Brown, supra, 44 Cal. 3d at 1064-65, 751 P.2d at 479, 245 Cal.Rptr. at 421 (noting 300% increase in cost of Bendectin and “hundredfold” increase in price of DPT vaccine that paralleled increase in lawsuits from one in 1979 to 219 in 1985).
[T]he tort system undermines the availability of pharmaceuticals. Even in the absence of liability judgments, the mere fear of astronomical liability may render a drug uninsurable and consequently unmarketable. In the event that a beneficial drug does reach the market, but becomes the target of tort suits, litigation costs alone may force the manufacturer to withdraw its product. Moreover, actual or potential tort liability, even if it does not force the removal of a medication from the market can have marked effects on pricing and production. [Note, Pharmaceutical Regulation, supra, 103 Harv.L.Rev. at 774-75.]
Awarding compensatory damages certainly does have a regulatory effect. See Shackil, supra, 116 N.J. at 190-91, 561 A.2d 511; see also Ackerman, supra, at 93 (if manufacturers surpass “the optimal agency standard” of care because of fear of damage awards, “marginal costs” of production will “exceed marginal benefits,” producing “regulatory effect” from “purely compensatory damages”).
Congress empowered the FDA alone to set that “optimal” level — i.e., to make the necessary risk/benefit analysis involved in the marketing of prescription drugs. Congress understood that “there is no such thing as absolute safety in drugs.” Hearings on Drug Safety Before the Subcomm. on Intergovernmental Relations of the House Comm, on Government Operations, 88th Cong., 2d Sess. 147 (1964) quoted in Note, *176Pharmaceutical Regulation, supra, 103 Harv.L.Rev. at 773. Yet, Congress created and continued to support the FDA’s regulatory approach. That approach calls for extensive premarketing testing and risk/benefit evaluation. It also demands that post-marketing information be gathered. That post-marketing information, however, will warrant a withdrawal or a conditioning of a drug’s continued approval only if there is substantial evidence demonstrating the necessity of such action. That is an administrative decision based on a desire to increase the aggregate health benefits, and on a legitimate ad hoc risk assessment that holds that once an already-approved drug has proven sufficiently safe and efficacious in pre-market studies, the interest in health demands that it not be withdrawn or encumbered until substantial evidence exists.
A system in which we shun expertise, experience, and institutional purpose and instead allow a court to change drug labels after it “arrogates to a single jury the regulatory power explicitly denied to all the fifty states’ legislative bodies” seems strange. Fitzgerald v. Mallinckrodt, Inc., 681 F.Supp. 404, 407 (E.D.Mich.1987). Moreover, jury verdicts discourage the use of important drugs. Through the media, the public becomes aware of jury verdicts that frighten, and focuses its attention on the side-effects of the drug without any appreciation of its beneficial results.
IY
Lederle proposed a change in the labeling of Declomycin to warn of possible tooth staining in November 1962, but the FDA did not believe that the evidence warranted such a change and refused to authorize it. In Feldman I, we wondered if “it would [not] seem anomalous for the FDA to have prevented a drug manufacturer from advising the public immediately of a newly discovered danger while waiting for FDA approval.” 97 N.J. at 459, 479 A.2d 374. However, the more substantial record provided by this case demonstrates that there is nothing *177at all anomalous about the FDA’s position — there was no “newly discovered danger;” there was only a newly-suspected one.
In reviewing Lederle’s November 1962 request to change the labeling of its tetracycline drugs to warn of possible tooth discoloration, the FDA balanced the substantial therapeutic benefits that those drugs had in the treatment of a wide range of bacterial infections against the scientifically-knowable risks of tooth staining in normal, healthy children. The FDA also considered the impact that that warning — if the suspicions about Declomycin proved to be unfounded — would have on rational prescribing and on the credibility of side-effect warnings generally. As stated by Dr. Barzilai of the FDA in his December 3, 1962, letter acknowledging Lederle’s desire to change its Declomycin label, the issue had to be reviewed from a “medical, scientific [and] regulatory” point of view before the FDA could reach “any form of final opinion” on the matter.
What has happened in this case is that a lay jury was instructed by the trial court to second-guess freely those delicate scientific and policy judgments of the FDA from a vantage point twenty-five years later. The logic of giving judicial deference to the medical judgments of the FDA and the agency’s own view of its statutory role in the drug-labeling process is even more compelling when the issue is the liability of an FDA licensee who has strictly complied with the agency’s dictates, as occurred here.
The FDA, not courts, must determine the proper balance of risk and benefit and the necessary extent of any warnings. To make such broad judgments is peculiarly beyond the competence of courts. The FDA, not the courts, has the assets and abilities both to protect and to promote health. Indeed,
[s]ince 1938, Americans have looked to the FDA for assurance of quality in the medicines they take. Pursuant to this task, the FDA has developed the highest level of competence in pharmaceutical investigation in the world. Nevertheless, technically incompetent state court juries are continuing to usurp federal authority by rejecting FDA standards in product liability cases. [Comment, Federal Preemption, supra, 22 J. Marshall L.Rev. at 656.]
*178Many battles remain to be fought — for example, the fight against AIDS. See McKenna, The Impact of Product Liability Law on the Development of a Vaccine Against the AIDS Virus, 55 U.Chi.L.Rev. 943 (1988). “Drug availability and pricing policies may depend on the ability of manufacturers to limit their own liability. The consequences of these issues extend beyond the AIDS epidemic and influence the extent to which the drug development process will be able to respond to disease victims in the future.” Comment, Legal Concerns for Manufacturers, supra, 139 U.Pa.L.Rev. at 1078. Those problems convince me we would be better to trust the decisions made by experts at the FDA rather than by health novices, such as jurors or judges.
“[Ijmplicit in any decision to broaden liability in order to provide compensation is a judgment that the .goals of public policy will likewise be served.” Shackil, supra, 116 N.J. at 177, 561 A.2d 511. By holding Lederle liable despite its strict adherence to federal law, as understood and applied by the FDA at the time and despite Lederle’s efforts quickly to bring to the attention of the FDA, all the information it had, and despite its cooperation in providing the public with all relevant, pharmacologically-significant, and verified information at the earliest possible date, the majority thwarts the important “societal goals [of] encouraging the use and development of needed drugs * * * in order to provide compensation to those injured by [Lederle’s] products.” Id. at 178, 561 A.2d 511.
Conveying useful, important information on drug labeling promotes a vital societal need: the safe and efficacious use of drugs. However, “[t]o permit or require statements of conflicting opinion on all these matters would destroy the present usefulness of prescription drug labeling.” 39 Fed.Reg. 33,232 (1974). That statement shows that the FDA does not establish minimum standards — it establishes uniform ones. Today’s decision requires a warning that the FDA would not permit. In early to mid-1963, available scientific knowledge had not reached a level that allowed Lederle or the FDA to present *179anything other than a “conflicting opinion” regarding the potential effect of Declomycin on developing teeth. Because requiring or permitting such deviation “would destroy the present usefulness of prescription drug labeling,” ibid., I cannot join my colleagues.
V
Based on my analysis, a discussion of N.J.S.A. 2A:58C-4 is not necessary. Nonetheless, I add a few comments to indicate my disagreement with the majority’s analysis of that statute.
The Legislature enacted N.J.S.A. 2A:58C-4 in a regulatory system that allows manufacturers to make conditional label alterations and additions. The effort to create a pro-manufacturer presumption evinces legislative recognition of precisely the concerns I have discussed throughout this opinion. Indeed, the primary motivating force behind N.J.S.A. 2A:58C-4 was an effort to restore some protection to a manufacturer’s decision to conform to FDA labeling decisions, a protection stripped by overly-enthusiastic judicial expansions of the reasonable implication of the FDA’s 1965 regulatory amendments. To carry out the goals of N.J.S.A. 2A:58C-4, the Legislature “establish[ed] clear rules,” Senate Judiciary Committee Statement, L.1987, c. 197, 202nd New Jersey Legislature, 2d. Sess., reprinted in 1987 New Jersey Session Law Service (No. 6) 193, 194, created a strong presumption in favor of FDA decisions, N.J.S.A. 2A:58C-4, and limited the costs of litigation, see N.J.S.A. 2A:58C-5(c) (exempting FDA-approved drugs from punitive damages). All those goals undercut and contradict the majority’s decision.
Moreover, the majority’s analysis of the specific facts of this case is flawed. Preemption in this case presupposes the pre1965 world in which Lederle could not have changed its Declomycin label in any way without prior FDA approval, whereas the statutory presumption presupposes the post-1965 world in which Lederle has a limited freedom to make conditional altera*180tions or additions pending a dispositive FDA ruling. The majority draws from that distinction the conclusion that
under the unique circumstances of this case, compliance with the ‘determination’ of the FDA not to require a warning for Declymycin due to the lack of ‘unequivocal factual evidence of adverse reaction in man,’ although evidence of the adequacy of the labeling, should not be accorded the same presumptive weight now given to warnings approved or prescribed by that agency, and certainly does not create a conclusive presumption that the labeling contained an adequate warning. [Ante at 157, 592 A.2d at 1197.]
I agree — it should be given more.
Today’s manufacturers have the limited freedom to enhance the warning they give. Concomitantly, they can be held accountable for failure to exercise that freedom when it would have been reasonable to do so. Seeking “to establish clear rules with respect to specific matters as to which decisions of the courts in New Jersey have created uncertainty,” Senate Judiciary Committee Statement, Senate No. 2805-L.1987, c. 197,” supra, reprinted in 1987 New Jersey Session Law Service (No. 6) at 194, the Legislature made it presumptively reasonable not to exercise that freedom to enhance a label already approved by the FDA. A pre-1965 manufacturer had no similar freedom. Consequently, it could not be held liable for failure to exercise a then-nonexistent freedom. In that context, the presumption is so strong we call it preemption.
For reversal and remandment — Chief Justice WILENTZ, and Justices CLIFFORD, HANDLER, POLLOCK, O’HERN and STEIN — 6.
Dissenting — Justice GARIBALDI — 1.

Declomycin is the trade name used by Lederle for demethylchlortetracycline, a tetracycline analogue.