Militrano v. Lederle Labs.

Orrick, Herrington & Sutcliffe, LLP, New York City (David J. Thomasch and Holly M. Dellenbaugh of counsel), for Lederle Laboratories and others, defendants. Kaufman, Borgeest & Ryan, New York City (Elizabeth O'Brien Totten of counsel), for St. Mary's Hospital and Catholic Medical Center, defendant. Michael R. Hugo and Samuel Pollack, of the Massachusetts Bar, admitted pro hac vice, and Goldsmith, Richman & Harz, LLP, New York City (Howard S. Richman of counsel), for plaintiffs.

OPINION OF THE COURT

ALLEN HURKIN-TORRES, J. In this action, it is alleged that plaintiff, Bruce Militrano,^[1] was injured when a vaccine, manufactured by defendant Lederle Laboratories, was administered to him by his doctor in 1994. At its core, it is plaintiff's principal contention that, although a fractionated cell vaccine marketed by Eli Lilly & Company under the name TriSolgen from 1967 to 1975 and an acellular vaccine developed by the Japanese during the 1970's and used for all vaccinations there since 1980. The side effects associated with the whole cell pertussis vaccine and those associated with other vaccines led to a spate of lawsuits against vaccine manufacturers. While there was only one lawsuit filed against a DTP manufacturer in 1978, by 1985 the DTP manufacturers faced 219 lawsuits. The costs associated with defending these lawsuits and maintaining adequate insurance was a factor in the dramatic increase in cost of the vaccine, which went from 11¢ a dose in 1984 to $11.40 a dose in 1986, with $8 of the increased price going to cover insurance costs alone. These insurance costs were also a factor in the decrease in the number of manufacturers producing DTP, which went from five in 1972 to two by 1984 (see Shackil v Lederle Labs., Div. of Am. Cyanamid Co., 116 NJ 155, 179, 561 A2d 511, 523 [1989]; Brown v Superior Ct., 44 Cal 3d 1049, 1060-1065, 751 P2d 470, 481-483 [1988]). It was against this historical backdrop that in 1986 Congress enacted the National Childhood Vaccine Injury Act of 1986 (see 42 USC §§ 300aa-1-300aa-34). As stated in Schafer v American Cyanamid Co. (20 F3d 1 [1994]):

"The [act] represents an effort to provide compensation to those harmed by childhood vaccines outside the framework of traditional tort law. Congress passed the law after hearing testimony 1) describing the critical need for vaccines to protect children from disease, 2) pointing out that vaccines inevitably harm a very small number of the many millions of the people who are vaccinated, and 3) expressing dissatisfaction with traditional tort law as a way of compensating those few victims. Injured persons (potential tort plaintiffs) complained about the tort law system's uncertain recoveries, the high cost of litigation, and the delays in compensation. They argued that government had, for all practical purposes, made vaccination obligatory, and thus it had a responsibility to ensure that those injured by vaccines were compensated. Vaccine manufacturers (potential tort defendants) complained about litigation expenses and occasional large recoveries, which caused insurance premiums and vaccine prices to rise, and which ultimately threatened the stability of the vaccine supply" ( id. at 2).

Under the act, a person injured by a vaccine may file a claim with the Court of Federal Claims to obtain compensation from a fund that is financed by a tax on vaccines (42 USC §§ 300aa-11, 300aa-12). The petitioner need not prove fault or causation as long as he or she received the vaccine and suffered symptoms contained on the vaccine injury table within a certain time period (42 USC §§ 300aa-13, 300aa-14). The act, however, requires that a person injured directly by a vaccine must first initiate a proceeding in the Court of Federal Claims before he or she may bring a state court tort action against the manufacturer (42 USC § 300aa-11 [a] [2] [A]). For the most part, the injured person may only initiate a state court tort proceeding if he or she rejects the judgment of the Court of Federal Claims (42 USC § 300aa-11 [a] [2] [A] [i], [ii]; § 300aa-21 [a], [b]). At issue here is the impact of the act on a state court tort action initiated after the injured person has elected to reject the judgment of the Court of Federal Claims. The act specifically provides that, with certain exceptions to be discussed, once a claimant opts out of a Court of Federal Claims proceeding, "State law shall apply to a civil action brought for damages for a vaccine-related injury or death" (42 USC § 300aa-22 [a]). Relevant here is an exception that provides:

"No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings" (42 USC § 300aa-22 [b] [1]). ^[6]

Although this section preempts state law to the extent stated, the act, by expressly reserving state courts a role with respect to claims made under the act, does not preclude state courts from adjudicating issues raised regarding it (see Shadie v Aventis Pasteur, Inc., 254 F Supp 2d 509, 517-518 [MD Pa 2003]). With respect to section 300aa-22 (b) (1), on its face its meaning is not entirely clear. Under one plausible reading of the section, any injury caused by a covered vaccine is deemed "unavoidable" as a matter of law provided that the vaccine was properly prepared and accompanied by proper warnings. Such a reading, which is advocated by Lederle, would bar state tort suits premised upon a design defect theory. On the other hand, the section could be read as barring defective design claims only where the injury was unavoidable, with a finding of unavoidability being determined on a case-by-case basis. This reading, which is advocated by plaintiff, would permit a jury to determine whether a covered vaccine could have been designed better so as to avoid the injury suffered by plaintiff. Resolution of these competing interpretations requires a tripartite analysis of the legislative history of the act, the Restatement (Second) of Torts, and the case law that existed at the time the act was enacted (see Oklahoma v New Mexico, 501 US 221, 235 n 5 [1991]). The House Committee report relating to section 300aa-22 (b) (1) states that Congress intended to adopt Comment k of Restatement (Second) of Torts § 402A (see Abbot v American Cyanamid Co., 844 F2d 1108, 1117 [1988] [Wilkins, J., concurring]; HR Rep No. 908, 99th Cong, 2d Sess, at 25-26, reprinted in 1986 US Code Cong & Admin News, at 6366-6367). Section 402A is a general section providing for strict products liability. Comment k states:

"Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk."

The committee's reference to Comment k, however, provides no clear guidance since the Comment itself suffers from the same ambiguity as section 300aa-22 (b) (1). As to the relevant case law at the time the act was adopted, in 1986 courts had not yet reached a consensus on the meaning of Comment k, or the proper treatment of prescription drugs in design defect litigation. Thus, while some courts concluded that a case-by-case analysis was necessary to determine whether a prescription drug was unavoidably unsafe, i.e., that it could have been made safer by a better design (see e.g., Kearl v Lederle Labs., 172 Cal App 3d 812, 829-831, 218 Cal Rptr 453, 463-465 [1985], disapproved by Brown v Superior Ct., 44 Cal 3d 1049, 1060-1065, 751 P2d 470, 481-483 [1988]; Feldman v Lederle Labs., 97 NJ 429, 446-447, 479 A2d 374, 383 [1984]), others concluded that prescription drug manufacturers were generally not liable for design defect claims (see e.g. Davis v Wyeth Labs., Inc., 399 F2d 121, 128 [1968]; Christofferson v Kaiser Found. Hosps., 15 Cal App 3d 75, 79, 92 Cal Rptr 825, 827 [1971]; Mc-Daniel v McNeil Labs., Inc., 196 Neb 190, 200-202, 241 NW2d 822, 828-829 [1976], overruled by Freeman v Hoffman-LaRoche, Inc., 260 Neb 552, 618 NW2d 827 [2000]; Lewis v Baker, 243 Or 317, 324, 413 P2d 400, 404 [1966]). Congress, of course, is presumed to have been aware of the debate concerning Comment k in this genre of litigation (see Miles v Apex Mar. Corp., 498 US 19, 32 [1990]; Goodyear Atomic Corp. v Miller, 486 US 174, 184 [1988]). This being so, the language in the House Committee report supports the conclusion that Congress intended to view Comment k and the act as immunizing vaccines from liability for design defects (see Garcia v United States, 469 US 70, 76-78 [1984] [in surveying legislative history, the authoritative source lies in the committee reports on the bill]; cf. Bank One Chicago, N.A. v Midwest Bank & Trust Co., 516 US 264, 276-279, 279-283 [1996] [Stevens, J., concurring]). Thus, for example, the committee report states: "The Committee has set forth Comment K in this bill because it intends that the principle in Comment K regarding `unavoidably unsafe' products ... apply to the vaccines covered in the bill and that such products not be the subject of liability in the tort system" (emphasis added). The report also states:

"Given the existence of the compensation system in this bill, the Committee strongly believes that Comment k is appropriate and necessary as the policy for civil actions seeking damages in tort. Vaccine-injured persons will now have an appealing alternative to the tort system. Accordingly, if they cannot demonstrate under applicable law either that a vaccine was improperly prepared or that it was accompanied by improper directions or inadequate warnings [they] should pursue recompense in the compensation system, not the tort system" (HR Rep No. 99-908, 99th Cong, 2d Sess, at 26, reprinted in 1986 US Code Cong & Admin News, at 6367 [emphasis added]).

What therefore emerges from a juxtaposition of the various authorities and sources is that the overall purpose of the act was to provide a means of compensation for those harmed by childhood vaccinations while at the same time limiting the insurance and litigation costs of vaccine manufacturers (see Terran ex rel. Terran v Secretary of Health & Human Servs., 195 F3d 1302, 1306-1307 [1999]; Schafer, 20 F3d at 2). Given the clear intent to limit manufacturer liability, and the forceful statements in the committee reports, I conclude that Congress did not intend that national vaccine policy be determined by the vagaries of a jury's determination on a case-by-case basis. Accordingly, I conclude that 42 USC § 300aa-22 (b) (2) bars any design defect claim brought by plaintiff,^[7] and Lederle is entitled to summary judgment dismissing such claims. In any event, even assuming Congress did not intend to preclude design defect claims, I would still find that Lederle is entitled to summary prescription drugs that warrants a blanket exception to liability (see Hill, 884 F2d at 1069), especially where there is a reasonable alternative design (see Freeman, 260 Neb at 566-567, 618 NW2d at 839). They further emphasize that blanket immunity from tort liability would remove an incentive for developing safer designs (see Toner, 112 Idaho at 341, 732 P2d at 310). As to the New York approach, in Martin v Hacker (83 NY2d 1, 8 [1993]), the Court of Appeals stated that

"Although a prescription drug is by its nature an inherently unsafe product and would in the usual case impute strict liability to its manufacturer, a defense is provided against such liability when the drug is `"properly prepared, and accompanied by proper directions and warning"' ( Wolfgruber v Upjohn Co., 72 AD2d 59, 61, affd 52 NY2d 768 [quoting Restatement (Second) of Torts § 402 A, Comment k]; see generally, Reingold, Products Liability— The Ethical Drug Manufacturer's Liability, 18 Rutgers L Rev 947 [1964]; 2 Frumer and Friedman, Products Liability § 12.14, at 12-147 to 12-149 [1993 revision and July 1993 Cum Supp]). Therefore, even though its side effects may cause injury, a prescribed drug, accompanied by adequate warnings, is `"not defective, nor is it unreasonably dangerous"' ( Wolfgruber, supra at 61)." (Emphasis added.)

This language, of course, strongly suggests that the Court of Appeals has adopted the more restrictive minority approach, an approach that would preclude design defect liability in this case. However, what makes this conclusion problematic is that this statement in Martin is dicta, since the Court was addressing a failure to warn claim, and no design defect claim was before the court.^[8] The Appellate Division decision in Wolfgruber, which is quoted in Martin, likewise only involved a failure to warn claim (see also Enright v Eli Lilly & Co., 77 NY2d 377, 388 [1991] [the Court's favorable citation to Brown v Superior Ct. (44 Cal 3d 1049, 751 P2d 470) suggests that the New York Court of Appeals has adopted a restrictive approach to prescription drug liability as a matter of public policy]). While Martin, Wolfgruber, and Enright lead me to believe that our courts should follow the minority view in this genre of it, fails to demonstrate that a viable alternative to the whole cell pertussis component of the DTP-HIB vaccine could have been marketed at the time the vaccine was administered to the plaintiff here. While the FDA is a passive agency that decides whether or not to approve vaccine designs when a manufacturer submits a proposal (see Hurley v Lederle Labs., Div. of Am. Cyanamid Co., 863 F2d 1173, 1177 [1988]), the record demonstrates that the FDA and the scientific community in this country had concerns regarding the efficacy of the acellular vaccine that precluded its earlier approval. While each case must rest upon the facts before the court, this conclusion is also supported by a majority of the decisions that have considered the availability of the acellular vaccine when faced with a similar evidentiary record (see Ackley, 919 F2d 397 [1990]; Miller, 1995 WL 579969, 1995 US Dist LEXIS 14470; Pease, 795 F Supp 755 [1992]; Jones v Lederle Labs., Div. of Am. Cyanamid Co., 785 F Supp 1123, 1127 [ED NY 1992] [in granting defendants judgment as a matter of law, the court stated that "even today (1992), years of further development and testing will be required before a more advanced vaccine for two-month-old infants will be available in this country"], affd 982 F2d 63, 63-64 [1992]; Koehler v Wyeth Labs., 1987 WL 47831, 1987 US Dist LEXIS 16861 [SD Ind, Sept. 8, 1987]; White, 40 Ohio St 3d at 396, 533 NE2d at 753; but see Graham, 666 F Supp at 1497, affd in part and revd on other grounds 906 F2d 1399 [1990]; Foyle v Lederle Labs., 674 F Supp 530 [1987] [ED NC]). In the absence of a viable alternative to the whole cell vaccine, plaintiff's strict liability design defect claim must fail because the whole cell pertussis vaccine is not an unreasonably dangerous product (see Felix v Akzo Nobel Coatings, 262 AD2d 447, 448 [1999]; Jones, 785 F Supp at 1127) and if it must be so deemed, it is an unavoidably unsafe product for purposes of 42 USC § 300aa-22 (b) (1) and Comment k under New York law. One final observation is warranted concerning plaintiff's argument that a safer drug could have been designed and approved by the FDA. According to section 6 (c) of the Restatement (Third) of Torts, a plaintiff may not prove defectiveness by showing that the defendant manufacturer could have designed and marketed a safer prescription product that has not received FDA approval and is therefore not on the market. As explained by the former reporters of the American Law Institute's Restatement (Third):

"Such refusal rests not on deference to the FDA but on an understandable reluctance to allow courts to determine whether a proposed alternative drug would have received FDA approval. Development by a manufacturer of a safer alternative drug does not, by itself, help anyone. For physicians to prescribe such a safer drug, it must reach the market. To reach the market, a prescription drug must be approved by the FDA. Thus, the question of whether a new alternative drug should have been developed by the defendant must be recast as whether the proposed alternative drug would have won FDA approval in time to help the plaintiff. No court can answer that question without seeking, in some manner, to replicate the FDA approval process. A brief description of the FDA approval process reveals why courts could never hope successfully to undertake such an inquiry.

"To obtain FDA permission to market a prescription drug, a manufacturer must develop extensive information about the safety and efficacy of the proposed drug through human clinical trials. The formal approval process begins with the manufacturer's submission of an investigational new drug application (IND) to conduct such clinical trials. Before the FDA will consider an IND, biologically active agents of the proposed drug must have been subjected to comprehensive animal and human tissue testing. Protocols for human testing must be detailed. Only if the FDA does not object to the IND application, either by requesting more information or by seeking modifications to the protocols for clinical testing, may the manufacturer commence with human clinical trials. On average, the investigation and testing necessary for the preparation and approval of an IND application take eighteen months.

"Human clinical trials take place in three phases and typically take five years or more to complete. The clinical trials are staggered not only to maximize information, but also to protect the well-being of the participants. Phase I clinical trials require that tests be performed on a limited group of healthy adults. These tests are designed to provide information about `the metabolism and pharmacologic action of the drug in humans [and] the side effects associated with increasing doses.' This initial stage is designed primarily to discover dangers related to ingestion of the drug and does not focus on the drug's efficacy. If Phase I is completed successfully, the manufacturer proceeds to Phase II in which the efficacy of the drug is evaluated in a controlled study. Researchers dispense the drug to several hundred patients suffering from a condition to determine whether the drug ameliorates the condition. If the second phase is successful, the drug is then provided to several thousand patients under the direction of many physicians who report to the drug manufacturer in Phase III. The FDA may at any stage require additional testing or studies before allowing the manufacturer to proceed with further clinical trials. As Professor Michael Green observes, `the winnowing of potential new drugs during the IND process is in significant part responsible for the fact that it takes, on average, twelve years and costs more than $200 million to develop and obtain approval for a new drug.' Only upon completion of IND testing does the manufacturer submit a New Drug Application (NDA) to the FDA. Three-fourths of all drugs that are subjected to human clinical trials never reach the NDA stage. An NDA record frequently runs in the hundreds of thousands of pages, cataloguing the entire history of the drug's development and reporting on all the premarketing studies. Negotiations between the FDA and the manufacturer regarding whether a drug should be approved for marketing can continue indefinitely even after the filing of the NDA and throughout its review.

"In light of these realities, the insistence by our critics that the Restatement should apply the same RAD-based standard to prescription products as it applies generally to all other products is manifestly improvident. Given that a drug manufacturer cannot market a drug in the United States without FDA approval, for a court to find that an alternative drug should have been developed would require it to predict with confidence that the alternative drug would have actually been approved. No expert could honestly opine that approval would have been granted without engaging in rank speculation. The approval process is accompanied by countless opportunities to decline or delay further progress. The data required to be developed for drug approval are beyond the capabilities of the litigants to replicate in a trial setting. Trials are compressed in time and scope; they do not allow for the expansive multiyear analysis and interaction between the manufacturer and the FDA that characterize the American drug regulatory process. Even if comparing a defendant's drugs with drugs that might have been developed made sense substantively (it does not), from the standpoint of legal process it could never be accomplished fairly or sensibly." (Henderson and Twerski, Drug Designs are Different, 111 Yale LJ 151, 163-167 [2001].)

The argument proffered by the reporters, it seems to me, are so compelling that plaintiff's claim should be rejected on this basis alone. Turning to plaintiff's remaining claims, they too are without merit. Thus, with respect to plaintiff's negligent design defect claim, that claim must be dismissed for the same reasons as the strict liability claim (see Ackley, 919 F2d at 403-404; cf. Giunta v Delta Intl. Mach., 300 AD2d 350, 353 [2002]). While a breach of an implied warranty claim retains a theoretical underpinning distinct from a strict liability design defect claim under New York law (see Denny v Ford Motor Co., 87 NY2d 248, 254-264 [1995]), here there is no difference in the evidence submitted with respect to a defect in terms of strict products liability and a defect in terms of a breach of implied warranty that would warrant a different finding under plaintiff's breach of implied warranty claim (see Fritz v White Consol. Indus., 306 AD2d 896, 897-898 [2003]; Castrignano, 546 A2d at 783 [Comment k applied to breach of implied warranty claim]). In any event, even if the theoretical difference would not preclude an implied warranty claim under New York law, since Lederle has shown that the vaccine is unavoidably unsafe under 42 USC § 300aa-22 (b) (1), that section—which does not differentiate between causes of action based upon theories of recovery—bars plaintiff from recovering under an implied warranty theory. With respect to plaintiff's express warranty claim, there is no evidence that Lederle expressly warrantied that injuries such as those suffered by the plaintiff would not occur. Finally, while the warnings submitted along with Lederle's vaccine stated that a causal connection between injuries such as those suffered by plaintiff and the administration of a whole cell pertussis vaccine had not been shown, they clearly stated that there is a temporal association between conditions like that suffered by the plaintiff and the administration of the vaccine. Given that the causal connection between the administration of the whole cell vaccine and the more serious side effects that may be temporally related to it is still an issue of debate in the scientific community (see Barlow, The Risk of Seizures After Receipt of Whole-Cell Pertussis or Measles, Mumps, and Rubella Vaccine, 345 New England J Med 656 [2001]; Donnelly, Whole-Cell but Not Acellular Pertussis Vaccines Induce Convulsive Activity in Mice: Evidence of a Role for Toxin-Induced Interleukin-β in a New Murine Model for Analysis of Neuronal Side Effects of Vaccination, 69 Infection & Immunity 4217 [2001] [Geier affidavit, exhibits 32, 36]; see also DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis [report prepared by the Institute of Medicine, attached as exhibit 2 to plaintiff's mem in opposition]), plaintiff has not shown a factual issue with respect to the accuracy of that aspect of the warning. Moreover, nothing plaintiff has submitted shows that the warnings misstate the frequency of these temporally related side effects. When read as a whole, the warnings supplied by Lederle sufficiently detail the risks of the vaccine that it is entitled to summary judgment dismissing the warning claim, whether premised on negligence or strict liability (see White, 40 Ohio St 3d at 397-398, 533 NE2d at 754-755; see also Martin, 83 NY2d at 8 n 1, 10-16). Lederle is thus entitled to dismissal of the warning claim regardless of whether it made the initial showing required for application of the presumption set forth in section 300aa-22 (b) (2) of the act (42 USC § 300aa-22 [b] [2])—a presumption which deems warnings to be sufficient under certain circumstances. In the end, the issue in this action should not be whether there was some speculative, theoretical possibility that Lederle could have designed and brought to market a safer vaccine. Rather, the issue is whether fundamental issues of national vaccine policy should be left to the vagaries of a jury's determination on a case-by-case basis. Since I believe, among other things, that the National Childhood Vaccine Injury Act precludes such an outcome, this action should be dismissed. [1] All references to plaintiff are to the infant plaintiff. [2] It is unclear from the record whether the first DTP and HIB conjugate vaccines were administered in the combination form at the time of the initial vaccination. [3] Plaintiff does not particularize whether his strict products liability claims encompass claims premised on defective design, defective manufacture and/or inadequate warnings and plaintiff did not clarify his claims against Lederle in his bill of particulars. Given the arguments made in the instant motion, plaintiff has effectively waived any manufacturing defect claim. [4] For the purposes of this motion, Lederle does not dispute the issue of causation or that whole cell pertussis vaccination may very rarely cause serious side effects. [5] Except for a fractionated cell pertussis vaccine approved by the FDA in 1967 and marketed until 1975, the whole cell pertussis vaccine was the only pertussis vaccine approved by the FDA until the acellular vaccine was approved for the last two shots in the five shot series in 1991 and for all five shots in 1996. [6] Another exemption limits a manufacturer's liability with respect to warnings (42 USC § 300aa-22 [b] [2]). [7] Plaintiff does not assert that there was any defect with the preparation or manufacture of the vaccine and, as is discussed infra, the warnings supplied were adequate. [8] While the Appellate Division and Court of Appeals addressed a defective product claim in Bichler v Eli Lilly & Co. (79 AD2d 317 [1981], affd 55 NY2d 571 [1982]), application of Comment k to such a claim was not before either Court. [9] This conclusion is also supported by the deposition testimony of Dr. Mary Richard, supplied by Lederle in support of its motion. [10] Whether Dr. Geier's advocacy of TriSolgen is deemed credible is also open to question because he has apparently testified at a deposition that TriSolgen itself is an unreasonably dangerous product (see Pease v American Cyanamid Co., 795 F Supp 755, 760 n 5 [D Md 1992]). [11] In reply, Lederle has submitted additional portions of Dr. Ritchey's deposition in which she states that the reason why FDA approval was not sought earlier for the acellular vaccine was because the science was not there. In general, obtaining FDA approval involved convincing it that the low incidence of pertussis disease in the United States would not be jeopardized by the introduction of an alternative vaccine. One thing Lederle had to demonstrate in particular was that the "mouse potency test" that was required by the FDA was an inappropriate test to assess the potency of the acellular vaccine.