Lundy v. Amer Cyanamid Co

• Court: Court of Appeals for the Sixth Circuit
• Decided: December 3, 2003
• Docket: 01-4176
• Status: Published

Opinion

RECOMMENDED FOR FULL-TEXT PUBLICATION Pursuant to Sixth Circuit Rule 206 2 Graham, et al. v. American Nos. 01-4175/4176 ELECTRONIC CITATION: 2003 FED App. 0423P (6th Cir.) Cyanamid Co. File Name: 03a0423p.06 Argued: August 1, 2003 UNITED STATES COURT OF APPEALS Decided and Filed: December 3, 2003 FOR THE SIXTH CIRCUIT _________________ Before: DAUGHTREY, MOORE, and SUTTON, Circuit Judges. No. 01-4175 X _________________ JOSEPH R. GRAHAM, et al., - Plaintiffs-Appellants, - COUNSEL - Nos. 01-4175/4176 - ARGUED: Marc S. Moller, KREINDLER & KREINDLER, v. > New York, New York, Stanley P. Kops, Bala Cynwyd, , Pennsylvania, for Appellants. David P. Donovan, WILMER, - AMERICAN CYANAMID CUTLER & PICKERING, McLean, Virginia, for Appellee. - ON BRIEF: Marc S. Moller, KREINDLER & COMPANY , - KREINDLER, New York, New York, Stanley P. Kops, Bala Defendant-Appellee. - Cynwyd, Pennsylvania, E. Marianne Gabel, Delaware, Ohio, - Nicholas E. Bunch, WHITE, GETGEY & MEYER CO., - No. 01-4176 Cincinnati, Ohio, John F. Berry, Portsmough, Ohio, for - ROY LEE LUNDY , et al., Appellants. David P. Donovan, WILMER, CUTLER & - Plaintiffs-Appellants, - PICKERING, McLean, Virginia, William G. Porter, II, VORYS, SATER, SEYMOUR & PEASE, Columbus, Ohio, - Roger Yoerges, WILMER, CUTLER & PICKERING, v. - Washington, D.C., for Appellee. - - _________________ AMERICAN CYANAMID - COMPANY , - OPINION Defendant-Appellee. - _________________ - - SUTTON, Circuit Judge. Joseph Graham and Roy Lee N Lundy, along with several members of their families, challenge the district court’s order granting summary Appeal from the United States District Court judgment to American Cyanamid Company on a series of for the Southern District of Ohio at Columbus. fraud and product liability claims. American Cyanamid Nos. 94-00423; 94-00425—George C. Smith, District manufactures Orimune, which is an oral polio vaccine. Judge. Plaintiffs allege that the use of Orimune in one instance and

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the exposure to it in another caused a family member to 1990) (“Sabin I”). The vaccine decreased the incidence of contract polio. polio but did not eradicate it. Between 1958 and 1961, for example, nearly 19,000 cases of the disease were still reported Seeking compensation for these injuries, both sets of in the United States. Id. Thirteen thousand people became plaintiffs filed fraud claims against American Cyanamid, paralyzed by the disease, and more than 1,000 people died asserting that the company publicly represented Orimune as from it during this period. Id. licensed, manufactured, tested and released in accordance with FDA regulations, when in fact the Orimune vaccines at At the same time that Dr. Salk was developing his vaccine, issue (according to plaintiffs) did not comply with FDA Dr. Albert Sabin began working on an oral polio vaccine standards. The Graham plaintiffs separately brought strict (“OPV”) made from attenuated strains of the polio virus. The liability and negligent failure-to-warn claims against Sabin OPV, unlike the Salk IPV, is produced from a live American Cyanamid. Both sets of plaintiffs also filed polio virus that has been weakened but not killed. “‘Like all derivative claims for loss of consortium and punitive vaccines cultivated from live viruses,’” such as those used for damages. The district court granted American Cyanamid’s smallpox and yellow fever, “‘OPV creates immunity by motion for summary judgment on all claims. We AFFIRM. inducing a mild infection in the recipient.’” United States v. St. Louis Univ., 336 F.3d 294, 295 (4th Cir. 2003) (quoting I. BACKGROUND Stuart v. Am. Cyanamid Co., 158 F.3d 622, 625 (2d Cir. 1998)). A. Polio and the Orimune Vaccine. OPV has several advantages over IPV. OPV is less Poliomyelitis (or polio) is a disease of the central nervous expensive and requires only a single dosage, while IPV system that causes illness, paralysis and in some instances requires three inoculations and a follow-up booster shot. death. It affected thousands of individuals in this country OPV is administered orally, commonly on a sugar cube, while during the first half of the twentieth century. See Dorothy M. IPV must be injected by a hypodermic needle. The Horstmann, Poliovirus (Poliomyelitis), in 2 Textbook of interaction of the live virus in OPV with the immune system Pediatric Infectious Diseases 1186, 1189–90 (Ralph D. confers lifetime immunity, while IPV requires periodic re- Feigin & James D. Cherry, eds., 1981). At its height between administration. See generally Sabin I, 743 F. Supp. at 412. 1951 and 1955, polio led to 21,000 cases of paralysis per year And OPV creates “herd immunity,” because an individual in the United States. See id. who has not received the vaccine can obtain immunity by contact with someone who has been vaccinated. Id. That this scourge did not continue through the second half Individuals who have been immunized with IPV, by contrast, of the twentieth century is a credit to the work of several may still serve as carriers of the wild polio virus and may pass scientists. In 1955, Dr. Jonas Salk developed the first widely it on to others even though they themselves have been successful vaccine against polio. Derived from a dead polio immunized. Id. virus, the Salk vaccine is known as an inactivated polio vaccine (“IPV”) and was licensed for production and use in OPV, however, also has several inherent risks in view of the United States in 1955. See In re Sabin Oral Polio the way it—and all vaccines developed from live Vaccine Prods. Liab. Litig., 743 F. Supp. 410, 412 (D. Md. viruses—work. The live but weakened viruses of OPV grow Nos. 01-4175/4176 Graham, et al. v. American 5 6 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

in the intestinal tract of the vaccinated individual. They Cyanamid has distributed a trivalent OPV product under the eventually trigger the production of antibodies, which in turn name Orimune. make the individual immune to the disease after thirty days. On rare occasions, however, the virus reproduced in the The production of Orimune proceeds in several stages. vaccinee’s intestinal tract reverts to the virulent form. When Manufacturers initially obtain wild polio virus and attenuate this occurs, vaccinated individuals or persons coming in close its neurovirulent properties by passing it through animal contact with them during the thirty-day period may contract hosts. What results is a “strain,” which in small portions is polio. Unvaccinated adults may take two precautions to avoid then injected into monkey kidney cell cultures. This process, the risk of contracting polio: (1) alternative vaccination with known as a “tissue culture passage,” leads to the growth of IPV prior to contact with the vaccinee; or (2) avoidance of more virus and the creation of vaccine “seeds.” Small contact with the vaccinee for one month, during which time portions of this seed material are frozen periodically and live polio viruses are being shed from the intestinal tract of again injected into monkey kidney cell cultures to create the vaccinee. “pools” of vaccine for each of the three types of polio manufactured. Each monopool contains a single type of In 1958 and 1959, epidemiologists conducted a series of vaccine and is given a designation indicating the type of field trials on the use of OPV. See Sabin I, 743 F. Supp. at vaccine and the number of the pool (e.g., 3-442 is a type III 412–13. On the basis of these tests, the Surgeon General in vaccine from monopool 442). Monopools for each of the 1960 determined that OPV was suitable for use in the United vaccine types are then blended together to make a trivalent States, and it soon became the most widely used of the polio bulk “lot” that is used to fill vials. The trivalent bulk lot is vaccines. Id. given a seven-digit number and letter, such as 2054-532A. The prefix (2054) designates Orimune dosage, and the suffix The Federal Government granted licenses to three (532) represents the sequential number for the trivalent bulk manufacturers to make live polio vaccines from the strains of that dose. The final letter (A) designates the particular developed by Dr. Sabin. American Cyanamid purchased filling of the final product from its trivalent bulk lot. After strain material that Sabin had developed, and its Lederle packaging, the manufacturer gives each lot of final containers Laboratories division received one of the three authorized a six-digit control number, then ships the lots to physicians, licenses from the Division of Biologic Standards (“DBS”) of pharmacies, hospitals and clinics for use. The product is not the National Institutes of Health to manufacture and sell OPV. sold directly to patients. The polio virus has three types—types I, II and III—and In the late 1970s, American Cyanamid explored the different vaccines address each of them. Some vaccines possibility of obtaining a new type III seed to replace the seed address just one type of polio, and one vaccine is designed to it had been using to make most of the type III component of prevent all three types of polio. American Cyanamid first Orimune since the mid-1960s. At the time, another produced “monovalent” vaccines, which contain just one of manufacturer, Pfizer, Ltd., had taken one of the “Sabin the three types of polio virus vaccine. In 1963, however, the Original” strains and cloned it to create a seed known as Federal Government granted American Cyanamid a license to “Sabin Original Rederived.” In 1981, American Cyanamid make and distribute a “trivalent” vaccine, which contains all obtained some of the Sabin Original Rederived type III seed three types of polio virus vaccine. Since then, American and started using it in Orimune production. Nos. 01-4175/4176 Graham, et al. v. American 7 8 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

Since 1977, American Cyanamid has been the sole supplier addressed specifically to the Federal Government. See, e.g., of OPV in the United States. The annual number of cases of 21 C.F.R. §§ 600.3 et seq., 630.17(e). To distribute any dose polio in this country has steadily declined since the of Orimune, American Cyanamid thus had to obtain a license widespread use of OPV. By the 1980s, fewer than twenty- from the government and allow the government to test each five vaccine-associated cases of paralytic polio in the United batch of vaccine before releasing it for use. States were being reported yearly, a number that dropped to an average of ten per year in the 1990s. The ten-per-year The regulations in effect in the 1970s required that vaccine figure represents one case for every 2.6 million doses of monopools be tested in monkeys for neurovirulence before vaccine distributed. Sabin I, 743 F. Supp. at 412 n.3. they could be used for production of vaccine. See 21 C.F.R. § 630.16(b)(i)–(iii). “Neurovirulence is the capacity of an B. Federal Regulation of Polio Vaccine Production and infectious agent to produce pathologic effects on the central Testing in the United States. nervous system.” Berkovitz, 486 U.S. at 543 n.9. In performing tests for neurovirulence, samples of each In view of the health and safety risks of polio vaccines, the monopool are injected at different dilutions into the brain Federal Government regulates the manufacture and stems of thirty monkeys and into the spinal cords of at least distribution of them in a variety of ways. In 1961, the DBS fifteen other monkeys. After these injections, the monkeys adopted regulations governing the issuance of manufacturing are sacrificed and their spinal and brain tissues are licenses and the approval and release of OPV. See 21 C.F.R. microscopically examined by qualified pathologists who §§ 630.10–.18 (1974) (formerly codified at 42 C.F.R. conduct a “comparative evaluation” of the monopool being §§ 73.110–.118 (Supp. 1964)). To obtain a license tested relative to identical tests performed on samples of a authorizing manufacture from the Secretary of the “Reference Attenuated Poliovirus” provided by the FDA. See Department of Health, Education and Welfare under these 21 C.F.R. § 630.16(b)(iii). The evaluation examines: regulations, drug manufacturers must prove that their product conforms to regulations covering all phases of the (a) the number of animals showing lesions characteristic manufacturing process—beginning with the original Sabin of poliovirus infection, (b) the number of animals strains of vaccine (the only strains approved in the United showing lesions other than those characteristic of States) and ending with the doses administered to patients. poliovirus infection, (c) the severity of the lesions, (d) the See generally 42 U.S.C. § 262. degree of dissemination of the lesions, and (e) the rate of occurrence of paralysis not attributable to the mechanical Under these regulations, tests must be performed on the injury resulting from inoculation trauma. vaccine during various stages of production as a condition not only for licensing but also for the release of each monopool Id. A given monopool passes the neurovirulence test “if a and the filling of the product. See Federal Food, Drug and comparative analysis of the test results demonstrates that the Cosmetic Act, 21 U.S.C. §§ 301 et seq.; 21 C.F.R. §§ 200 et neurovirulence of the test virus pool does not exceed that of seq. (1977); Public Health Act, 42 U.S.C. § 262. Certain the Reference Attenuated Poliovirus.” Id. regulations are addressed solely to manufacturers of OPV. See 21 C.F.R. §§ 630.10–17; Berkovitz ex rel. Berkovitz v. Among the FDA regulations governing these United States, 486 U.S. 531, 541 (1988). Others are neurovirulence tests at this time were a “consistency of Nos. 01-4175/4176 Graham, et al. v. American 9 10 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

manufacture” regulation and a “tissue culture passage” that the FDA had violated 21 C.F.R. § 630.13(a) by approving regulation. The “consistency of manufacture” regulation that seed for use. See Sabin II, 763 F. Supp. at 813. The required that no lot of vaccine be released “unless each same district court, however, expressly found that Orimune monovalent pool contained therein is one of a series of five made from this seed was both safe and effective: consecutive pools of the same type, each having been manufactured by the same procedures, and each having met [M]y finding that regulatory violations occurred does not the criteria of neurovirulence for monkeys prescribed in imply that the public health is or has been endangered in § 630.16(b)(1) . . . .” Id. § 630.17(b). The “tissue culture any respect. According to the undisputed record, the passage” regulation required that all polio “[v]irus in the final OPV used in the United States has always been ‘state of vaccine shall represent no more than five tissue culture the art’ vaccine and the OPV program has resulted in the passages from the original strain . . . .” Id. § 630.13(a). virtual eradication of wild poliovirus in the Western Hemisphere. Over time, the FDA modified its regulations governing the manufacture, testing and release of OPV, prompting Id. After characterizing the country’s OPV program as disagreements over how the regulations should be interpreted. “perhaps the most successful public health program in Some of these disagreements resulted in lawsuits under the history,” id., the court held that the FDA’s only error with Federal Tort Claims Act (“FTCA”) between the Federal respect to seed 45B165 was in not “amend[ing] . . . the Government and individuals allegedly injured by the vaccine. regulations” to allow the Pfizer seed to be the “starting point” In 1981, the FDA’s Bureau of Biologics assured American for counting tissue culture passages—something that “would Cyanamid that the vaccine produced from the Pfizer seed, clearly be proper and in the public interest.” Id. at 825. The though rederived from the Sabin Original, did not violate the Fourth Circuit affirmed this judgment. See In re Sabin Oral “tissue culture passage” regulation. However, several FTCA Polio Vaccine Prods. Liab. Litig., 984 F.2d 124 (4th Cir. plaintiffs argued generally that the Federal Government had 1993). failed to interpret its regulations correctly and as a result had released an excessively neurovirulent Orimune vaccine, As a result of the Sabin decisions, the FDA amended its which violated the “tissue culture passage” regulation. See polio vaccine regulations. See Additional Standards for Viral Sabin I, 743 F. Supp. at 410; In re Sabin Oral Polio Vaccine Vaccines; Poliovirus Vaccine Live Oral, 56 Fed. Reg. 21,418, Prods. Liab. Litig., 763 F. Supp. 811 (D. Md. 1991), aff’d, 21,422 (May 8, 1991). It amended 21 C.F.R. § 630.13(a) to 984 F.2d 124 (4th Cir. 1993) (“Sabin II”); Griffin v. United provide that “[v]irus in the final vaccine shall represent no States, 500 F.2d 1059 (3d Cir. 1974). Similar claims were more than five tissue culture passages from the original strain brought against vaccine manufacturers. See Jones v. Am. or no more than five tissue culture passages from a virus Cyanamid Co., Nos. 97-1519, 97-1607, 1998 WL 116171 clone derived from one of the first five tissue culture passages (4th Cir. Mar. 17, 1998); Am. Cyanamid Co. v. St. Louis of the original strain.” Id. at 21,433. At the same time, the Univ., 336 F.3d 307 (4th Cir. 2003). agency repealed and amended several other regulations, including the “consistency of manufacture” regulation. In In 1991, a federal district court judge in Maryland ruled doing so, the FDA determined that, based on extensive that vaccine from seed 45B165 was, in fact, more than five experience with the vaccine in the field, the repealed tissue culture passages beyond the Sabin original strain and regulations did not impact vaccine safety. See id. at 21,431. Nos. 01-4175/4176 Graham, et al. v. American 11 12 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

C. Graham v. American Cyanamid Co. were distributed in the United States. In the same 12 years, 25 “vaccine-associated” and 55 “contact vaccine- Zachary Graham was born on May 2, 1984. On July 3, associated” paralytic cases were reported. Twelve other 1984, his mother, Lisa Graham, took him to one of the offices “vaccine-associated” cases have been reported in persons of Delaware Family Practice, P.C. to receive an Orimune (recipients and contacts) with immune deficiency polio vaccine. The vaccine dose came from lot 739-472, conditions. These statistics do not provide a satisfactory which was derived from seed 45B165. The type III basis for estimating these risks on a per person basis. component of this lot was manufactured from monopool 3- 486. When the attenuated vaccine strains are to be introduced into a household with adults who have not been The dose of Orimune that Zachary Graham received adequately vaccinated or whose immune status cannot be contained the following warning from American Cyanamid: determined, the risk of vaccine-associated paralysis can be minimized by giving these adults three doses of IPV ADVERSE REACTIONS: a month apart before the children receive ORIMUNE. The CDC reports that no paralytic reactions to IPV are Paralytic disease following the ingesting of live known to have occurred since the 1955 cluster of poliovirus vaccines has been, on rare occasion, reported poliomyelitis cases caused by vaccine that contained live in individuals receiving the vaccine . . . and in persons polioviruses that had escaped inactivation. who were in close contact with vaccinees. The vaccine viruses are shed in the vaccinee’s stools for at least 6 to The Immunization Practices Advisory Committee of the 8 weeks as well as via the pharyngeal route. Most U.S. Public Health Service states: “Because of the reports of paralytic disease following ingestion of the overriding importance of ensuring prompt and complete vaccine or contact with a recent vaccinee are based on immunization of the child and the extreme rarity of OPV- epidemiological analysis and temporal association associated disease in contacts, the Committee between vaccination or contact and the onset of recommends the administration of OPV to a child symptoms. Most authorities believe that a causal regardless of the poliovirus-vaccine status of adult relationship exists. household contacts. This is the usual practice in the United States. The responsible adult should be informed The risk of vaccine-associated paralysis is extremely of the small risk involved. An acceptable alternative, if small for vaccinees, susceptible family members and there is strong assurance that ultimate, full immunization other close personal contacts. However, prior to of the child will not be jeopardized or unduly delayed, is administration of the vaccine, the attending physician to immunize adults according to the schedule outlined should warn or specifically direct personnel acting under above before giving OPV to the child.” his authority to convey the warnings to the vaccinee, parent, guardian, or other responsible person of the In addition to this warning, Lisa Graham signed an possibility of vaccine-associated paralysis. The Centers “Important Information” consent form provided by the Ohio for Disease Control report that during the years 1969 Department of Health. It stated that she understood the risks through 1980 approximately 290 million doses of []OPV and benefits associated with OPV and had been given an Nos. 01-4175/4176 Graham, et al. v. American 13 14 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

opportunity to ask questions about OPV that were answered negligence; (4) breach of implied warranty of to her satisfaction. The form also stated: “[O]nce in about merchantability; (5) breach of implied warranty of fitness; every 4 million vaccinations, persons who have been and (6) breach of express warranty. vaccinated or who come in close contact with those who have recently been vaccinated are permanently crippled and may D. Lundy v. American Cyanamid Co. die. Even though these risks are low, they should be recognized.” And the form made known the availability of On March 24, 1977, Janet Lundy took her young son, IPV as an alternative polio vaccine with “no known risk of Jason, to an office of the Jackson County Combined General causing paralysis.” Health District for a routine check-up. There, Dr. Carl Greever gave Jason a dosage of Orimune for immunization On July 26, 1984, Zachary Graham began experiencing from polio. On April 19, 1977, Jason’s father, Roy Lee fever, irritability, lethargy and general weakness. He was Lundy, began experiencing fever, headaches, diarrhea, admitted to Grady Memorial Hospital in Delaware, Ohio, myalgia, malaise and general weakness. After a brief stay at where he remained until July 29, 1984. The Centers for Mercy Hospital in Portsmouth, Ohio, Roy’s doctors Disease Control in Atlanta diagnosed Zachary with Type III transferred him to The Ohio State University Hospital in poliomyelitis caused by the Orimune vaccine that he had Columbus. About a week later, he was diagnosed with type received earlier in the month. As a result of the illness, III poliomyelitis, which led to permanent paralysis. Zachary Graham became permanently disabled in his lower extremities. Roy’s doctors advised him that the probable source of the disease was the Orimune vaccine given to Jason, which likely The Grahams initially filed a petition in the United States had been transmitted to him through close contact with his Court of Federal Claims on September 27, 1990, seeking son. Jason Lundy’s vaccine came from lot 480-277 or lot compensation under the “no fault” provisions of the National 483-269. The type III component of Orimune in lot 480-277 Vaccine Injury Compensation Act, 42 U.S.C. §§ 300aa-10 et was manufactured from a mixture of monopools 3-427 and 3- seq. (Supp. 1990). Because his paralysis occurred before the 436. The type III component in lot 483-269 was Act’s effective date of October 1, 1988, however, it limited manufactured from a single monopool—3-437. The evidence the amount of compensation Zachary could receive for his does not establish which lot was responsible for the Orimune injuries to $30,000. 42 U.S.C. § 300aa-15(b). Graham’s vaccine that Jason ingested. family thereafter filed a motion to dismiss their petition voluntarily, which the United States Court of Federal Claims The Lundys allege that they did not suspect that American granted on December 10, 1993. Cyanamid had acted wrongfully until they saw a television program on vaccine-induced cases of polio on September 27, On May 10, 1994, Zachary’s parents, Joseph and Lisa 1985. After viewing this program, the family initially Graham, filed this action against American Cyanamid in the attempted to recover for their injuries in state court. Southern District of Ohio (Eastern Division) on behalf of Zachary, who was then a minor. Their complaint sought compensatory and punitive relief under a variety of state-law theories: (1) strict products liability; (2) fraud; (3) Nos. 01-4175/4176 Graham, et al. v. American 15 16 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

1. State Court Action warranty of fitness; and (6) breach of express warranty. Janet and Jason Lundy each filed independent loss-of-consortium On March 13, 1987, Lisa and Roy Lee Lundy filed an claims. American Cyanamid filed a motion for judgment on action in the Franklin County Court of Common Pleas against the pleadings, arguing that all of the claims were barred by (1) Lederle Laboratories, a Division of American Cyanamid, res judicata (due to the prior state-court action) and the (2) the Board of Health of the Jackson Combined General statute of limitations. With the exception of Roy’s fraud Health District and (3) Dr. Carl Greever. See Lundy v. claim and Jason’s loss-of-parental-consortium claim, the Lederle Laboratories, Div. of Am. Cyanamid Co., 561 N.E.2d district court dismissed each of the other claims as barred by 1027 (Ohio Ct. App. 1988). Roy Lee Lundy sought res judicata on September 29, 1995. compensatory and punitive relief under a variety of theories: (1) negligence; (2) failure to obtain informed consent from the The two remaining Lundy claims were consolidated with plaintiffs; (3) failure to warn; (4) breach of implied warranties the Graham plaintiffs’ claims. On July 15, 1998, after of merchantability and fitness; (5) strict liability; and (6) considerable discovery, American Cyanamid filed separate breach of express warranties. Janet Lundy separately filed a motions for summary judgment against the Lundy plaintiffs claim for loss of consortium. and the Graham plaintiffs. The Franklin County Court of Common Pleas eventually E. The District Court’s Decision granted motions to dismiss on behalf of all defendants. The Ohio Court of Appeals for the Tenth District affirmed these On December 21, 2000, the district court granted American decisions. Cyanamid’s motions for summary judgment against the Grahams and Lundys. As to the Lundys, the court held that In November 1990, the Lundy plaintiffs filed a petition in they had failed to submit sufficient evidence to raise a triable the United States Court of Federal Claims seeking issue that the alleged fraudulent representations made by compensation under the National Vaccine Injury American Cyanamid in the package insert regarding Compensation Act, 42 U.S.C. §§ 300aa-10 et seq. On compliance were in fact false. It further concluded that the March 11, 1994, the Lundys voluntarily withdrew their plaintiffs had failed to submit any admissible evidence that petition in view of the limited size of the award authorized by the alleged violations had any impact on the safety of the the Act. See 42 U.S.C. § 300aa-15(b). Orimune dose that Jason Lundy received. 2. Federal Court Action As to the Grahams, the court concluded that they had abandoned their fraud claim by failing to respond to On May 10, 1994, Roy, Janet and Jason Lundy filed this American Cyanamid’s summary judgment motion on the action in federal court in the Southern District of Ohio claim. It dismissed the Grahams’ strict liability claim, (Eastern Division), naming American Cyanamid as the only concluding that Orimune was unavoidably unsafe. And it defendant. They sought compensatory and punitive relief dismissed the Grahams’ negligent failure-to-warn claim, under the following state-law theories of liability: (1) strict concluding that the Orimune warnings and “Important products liability; (2) fraud; (3) negligence; (4) breach of Information” sheet provided to Zachary Graham and his implied warranty of merchantability; (5) breach of implied mother were adequate and reasonable as a matter of law. On Nos. 01-4175/4176 Graham, et al. v. American 17 18 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

the basis of these rulings, the court held that the derivative All three of the tort claims in this case represent a variation nature of Jason Lundy’s consortium claim and each claim for on a common theme. Whether labeled fraud, strict liability, punitive damages required these claims to be dismissed as a or negligent failure to warn, all three claims turn on the theory matter of law as well. (While the district court labeled the that there is a proximate connection between the alleged entry disposing of all of these claims a “final judgment,” violations of the FDA’s neurovirulence rules and the safety of neither the record nor the docket sheet reveals what happened the Orimune vaccine. Because we conclude that plaintiffs to the three warranty claims filed by the Graham plaintiffs in have failed to establish a triable issue of fact on this central their complaint. Because the Grahams do not address these point and because we conclude that each of these tort claims claims on appeal and because the district court purported to otherwise fails as a matter of law, we agree with the District dismiss all claims, we do not address them here.) The district Court that the claims must be summarily dismissed. court denied the Graham and Lundy plaintiffs’ motions for reconsideration, and these consolidated appeals followed. A. FRAUD

II. DISCUSSION We begin by addressing the one claim common to both sets of plaintiffs. The Grahams and Lundys each allege that The customary rules for reviewing a summary-judgment American Cyanamid acted fraudulently by representing that decision apply. We give de novo review to the district court’s Orimune was licensed, manufactured, tested and released in decision. Sperle v. Mich. Dep’t of Corr., 297 F.3d 483, 490 accordance with FDA regulations when in fact it did not (6th Cir. 2002). A decision granting summary judgment is comply with FDA standards. To establish a cognizable claim proper where no genuine issue of material fact exists and the of fraud under Ohio law, a claimant must prove the following moving party is entitled to judgment as a matter of law. Fed. six elements: “(a) a representation or, where there is a duty to R. Civ. P. 56(c). And in considering such motions, we give disclose, a concealment of fact, (b) which is material to the all reasonable factual inferences to the nonmoving party. transaction at hand, (c) made falsely, with knowledge of its Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. falsity, or with such utter disregard and recklessness as to 574, 587 (1986). whether it is true or false that knowledge may be inferred, (d) with the intent of misleading another into relying upon it, (e) Our jurisdiction over these state-law claims rests on the justifiable reliance upon the representation or concealment, diversity of citizenship of the parties. All of the Graham and and (f) an injury proximately caused by the reliance.” Russ v. Lundy plaintiffs are residents of Ohio. American Cyanamid, TRW, Inc., 570 N.E.2d 1076, 1083 (Ohio 1991). The incorporated in Maine, maintains its principal place of elements of the claim are conjunctive, and accordingly all of business in New Jersey. See 28 U.S.C. § 1332. In this them must be shown. See Schwartz v. Capital Sav. & Loan setting, we sit in effect as another court of the forum state, in Co., 381 N.E.2d 957, 959 (Ohio 1978). this case Ohio, and therefore must apply its choice-of-law rules. See Muncie Power Prods., Inc. v. United Tech Auto., Both in the district court and here, the parties have Inc., 328 F.2d 870, 873 (6th Cir. 2003). In this instance, the vigorously contested many of these elements. Did the parties agree that those choice-of-law rules indicate that Ohio company in fact violate certain FDA regulations in substantive law governs this claim. manufacturing Orimune—specifically, the “tissue culture passage” and “consistency of manufacture” regulations? Nos. 01-4175/4176 Graham, et al. v. American 19 20 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

Were American Cyanamid’s regulatory representations The Fourth Circuit recently addressed the issue of inaccurate? Did plaintiffs justifiably rely upon any of these proximate cause in a similar context in American Cyanamid representations? Were the representations material to product Co. v. St. Louis University, 336 F.3d 307 (4th Cir. 2003). In safety? And, even if all of plaintiffs’ allegations are true, did that case, St. Louis University sued American Cyanamid, the alleged regulatory violations proximately cause these seeking contribution for a state-court judgment arising from injuries? Because we conclude that the plaintiffs have failed vaccine-related injuries suffered by one of its patients. St. as a matter of law to present admissible evidence of Louis University claimed that the Orimune vaccine violated proximate cause, we address this issue and this issue (with the FDA “tissue culture passage” and “consistency of one minor exception) alone. manufacture” neurovirulence regulations. In doing so, however, the university failed to produce expert testimony Under Ohio law, plaintiffs bear the burden of establishing establishing that a polio vaccine violating these FDA that American Cyanamid’s alleged misrepresentation of regulations was any more likely to cause injury than a fully Orimune’s regulatory compliance proximately caused their compliant vaccine. “[I]n analyzing the element of proximate injuries. See Burr v. Bd. of County Comm’rs, 491 N.E.2d cause in claims against Cyanamid,” the district court initially 1101, 1105 (Ohio 1986); Cohen v. Lamko, Inc., 462 N.E.2d explained, “the focus must be on whether the plaintiff can 407, 409 (Ohio 1984). See also Picklesimer v. Baltimore & prove that it was a defect in the OPV that resulted in his O.R. Co., 84 N.E.2d 214 (Ohio 1949) (noting that ordinary injury, not simply . . . whether he had been exposed to OPV element of proximate cause applies where plaintiff has derived from a seed that had been improperly approved in alleged fraud); Restatement (Second) of Torts § 557A cmt. a violation of the regulatory process.” St. Louis Univ. v. United (noting that ordinary rules of legal cause govern fraudulent States, 182 F. Supp. 2d 494, 500 (D. Md. 2002). Applying misrepresentation cases involving physical harm). To show Missouri law, the district court held that a “violation of the proximate cause, the Grahams and Lundys must demonstrate OPV regulations is not sufficient to prove the element of that the fact allegedly misrepresented—compliance with the proximate cause in a context . . . where a plaintiff must prove FDA regulations—caused their harm. See Gaines v. Preterm- that it is more likely than not that it was excessive Cleveland, Inc., 514 N.E.2d 709, 712 (Ohio 1987) (holding neurovirulence in a dose of vaccine that caused him to that misstatement by doctor could have caused plaintiff’s contract polio.” Id. at 501. The Fourth Circuit affirmed, physical injuries in action for fraud). That is to say, was the holding that St. Louis University “presented no expert plaintiffs’ contraction of polio a “natural and probable” (i.e. testimony showing that [the patient] would not have reasonably foreseeable) consequence of the alleged contracted polio or would have contracted a less severe case noncompliance with the regulations? See Strothers v. of polio had he been given a vaccine complying with the Hutchinson, 423 N.E.2d 467, 471 (Ohio 1981); Pfirsch v. neurovirulence regulations.” 336 F.3d at 310. Hal-Omar Baking Co., 216 N.E.2d 626, 628 (Ohio Ct. App. 1966). In view of the technical and scientifically complex Today’s case parallels St. Louis University in many ways. nature of this inquiry, only Daubert-qualifying expert It involves the same defendant, the same Orimune vaccine, testimony may satisfy it. See Daubert v. Merrell Dow the same FDA regulations, the same allegations of non- Pharms., 509 U.S. 579 (1993); cf. Berdyck v. Shinde, 613 compliance and the testimony of two of the same N.E.2d 1014, 1022 (Ohio 1993). experts—Drs. Almond and Steinman. A different state’s law applies, to be sure—here Ohio law, there Missouri law. Nos. 01-4175/4176 Graham, et al. v. American 21 22 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

St. Louis University of course comes from a different Circuit. Lundys cite a single article, published in 1961, to support And some differences in the evidence and apparently in the their claim of a causal connection between monkey nature of the tort claims exist as well. But in the end we see neurovirulence and the likelihood of vaccine-associated the issue in much the same way St. Louis University did. paralytic polio. See R. Murray, Standardization, Licensing, Under Ohio law, as under Missouri law, plaintiffs must show and Availability of Live Polio Vaccine, 175 J.A.M.A 843 that American Cyanamid’s alleged misrepresentation of (1961). While the article states that “[n]eurovirulence for Orimune’s regulatory compliance proximately caused their monkeys . . . has some correlation with safety in man,” it injuries. Because the Grahams and Lundys have not made out equivocates on the extent of that relationship, noting that a tenable claim of proximate cause in this respect (and more “many strains exist which, while causing evidence of specifically because they have not produced expert testimony infection in monkeys, apparently cause no discernible disease that supports this claim), their claims must be dismissed as a in man.” Id. at 845. In the end, the article fails to address matter of law. whether a causal connection between monkey neurovirulence and paralytic polio exists and indeed never references tissue As in St. Louis University, Drs. Almond and Steinman did culture passage. No less importantly, the Lundys offer no not satisfy the proximate cause requirement in either a general studies, data or expert testimony establishing any such or a specific manner. They did not show as a general matter connection. that American Cyanamid’s alleged regulatory noncompliance increased the risk that the Orimune vaccine would cause polio When questioned about compliance with the 1984 “tissue in recipients or those in close contact with recipients, beyond culture passage” regulation, it is true, Dr. Almond opined that the inherent risk long known to be associated with OPV. Orimune exceeded the permissible tissue culture passage Plaintiffs’ statistician, Dr. Krieger, attempted to perform a limits. At the same time, however, he called the regulation statistical analysis to determine if one could “predict based on “daft” and in need of change, and did not opine that failure to the [neurovirulence test] results of the lot whether somebody comply with the regulation would lead to a more dangerous [i]s more likely or less likely to get polio from that particular vaccine. More specifically, Dr. Almond testified as follows lot, if it were released.” Krieger Dep. at 18 (testifying in about the regulation: Campagna v. Am. Cyanamid Co., 767 A.2d 1996 (N.J. Super. Ct. App. Div. 2001)). But he did not find a correlation or any A. [T]he move to Pfizer seed was a sensible study supporting the existence of such a correlation. Id. development and a desirable development. But in light of that development and in light of the decision to do it, Plaintiffs and their experts do not fare any better in the maintaining of a regulation which said you couldn’t discussing the alleged violation of specific neurovirulence be more than five passages away from [the original regulations. They initially claim, for example, that the strain] was daft. It should have been changed. vaccines at issue violate the “tissue culture passage” regulation. At the time of manufacture, this regulation Q. They should have amended the regulation? required the vaccines to be no more than five tissue culture passages from the Sabin original strain, see 21 C.F.R. A. They should have amended the regulation. § 630.13(a), on the theory that more than five tissue culture passages would increase monkey neurovirulence. The Q. Now, if they had amended the regulation – Nos. 01-4175/4176 Graham, et al. v. American 23 24 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

A. Before giving it to Zachary? 56 Fed. Reg. at 21,420. With respect to the now-repealed “tissue culture passage” regulation, in short, plaintiffs have Q. Yes. not established that this alleged regulatory noncompliance increased the risk that the Orimune vaccine would cause polio A. That would have been fine. in recipients or those in close contact with recipients. Almond Dep., June 9, 1998, at 171–72. Plaintiffs also contend that the vaccines at issue, and more specifically the relevant monopools comprising Orimune’s Some seven months after this deposition and six months type III component of the vaccine, did not meet the after American Cyanamid filed its motion for summary “consistency of manufacture” regulation. As noted, this judgment, Dr. Almond executed a new affidavit to “explain” regulation required manufacturers (at the time of production) his previous references to the “daft” regulation. Almond Aff., to demonstrate the genetic stability of the seed and the Jan. 14, 1999, ¶ 7. In that affidavit, he claims that American regularity of its manufacturing processes through the Cyanamid was “daft” in not seeking to have the regulation production of five consecutively and properly manufactured amended before producing Orimune from the Pfizer seed. Id. monovalent pools. See 21 C.F.R. § 630.17(b) (“each As the district court noted, however, “a party cannot create a monovalent pool . . . [must be] one of a series of five factual issue by filing an affidavit which contradicts earlier consecutive pools of the same type, each pool having been deposition testimony after a motion for summary judgment manufactured by the same procedures, and each having met has been made. If an affidavit is untimely and inconsistent the criteria of neurovirulence for monkeys. . . .”). with prior discovery responses, it is inadmissible and should not be considered.” Graham v. Am. Cyanamid Co., Nos. C-2- Again, however, plaintiffs have not produced evidence 94-423, C-2-94-425, slip op. at 18 (S.D. Ohio Dec. 21, 2000). showing that a monopool that failed to satisfy the 1984 See Hughes v. Vanderbilt Univ., 215 F.3d 543, 549 (6th Cir. “consistency of manufacture” regulation would be more likely 2000). No less importantly, Dr. Almond’s affidavit never to cause vaccine-associated polio than one that satisfied the contradicts his deposition testimony that the FDA should requirement. When asked whether there was a scientific basis have changed its regulation. for concluding that the “consistency of manufacture” requirement was linked with product safety, Dr. Almond In 1991, when the FDA did amend this regulation, it testified that “there is a scientific argument that you can make expressly recognized the absence of any correlation between which would support such a conclusion . . . I am not saying observed monkey neurovirulence and the risk of vaccine- that is the right conclusion.” Almond Dep., April 20, 1998, at associated paralytic polio. 144–45. Almond added that he was not aware of any study supporting this theory. Id. This testimony does not suffice to No single vaccine lot has been associated with an create a material dispute of fact. An admissible expert’s increased incidence of poliomyelitis. The lots that have opinion, it is clear, “must be supported by more than been identified as associated with a case of paralytic subjective belief and unsupported speculation . . . .” McLean poliomyelitis have had typically low scores when tested v. 988011 Ontario Ltd., 224 F.3d 797, 800–01 (6th Cir. 2000) by FDA and the manufacturer for neurovirulence in (quotations and citations omitted). monkeys. Nos. 01-4175/4176 Graham, et al. v. American 25 26 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

Nor did Dr. Steinman fill this gap. He testified that he was providing a statistical means for monitoring the “not aware of any data one way or the other” showing that a continued qualification of a seed virus by evaluating its violation of this regulation poses a higher risk of causing ability to consistently produce monovalent pools of vaccine-associated paralytic polio than one satisfying the acceptable neurovirulence. . . . [T]hese requirements requirement. He testified: provide assurances of consistency . . . while actually reducing the likelihood that a seed virus will be rejected MR. DONOVAN: Q: You understand and acknowledge on the basis of test variability unrelated to genetic that live oral polio vaccine poses a risk of vaccine- stability. associated polio? 56 Fed. Reg. at 21,430–31. On this record, plaintiffs have not MR. KOPS: Objection. shown a connection between this regulation and product safety. THE WITNESS: Yes. Attempting to fill this evidentiary gap, the Grahams and MR. DONOVAN: Q: Whether it complies with the Lundys make a series of arguments to the effect that the regulations in your view or it does not comply? alleged violations of these regulations establish negligence per se and to the apparent effect that proximate cause on this THE WITNESS: A: Absolutely, yes. fraud claim accordingly need not be shown. But the invocation of this tort doctrine by itself, whether in the Steinman Dep., June 23, 1998, at 113. The FDA’s view of context of a negligence claim or a fraud claim, does not the former “consistency of manufacture” regulation echoes excuse the claimant from showing that the regulation at issue this view. In 1991, it amended and expanded the regulation has a tenable and provable connection to public safety. See, in an attempt to make it more applicable to product safety. e.g., Merchants Mutual Ins. Co. v. Baker, 473 N.E.2d 827, The former consistency requirements were based on the 828 (Ohio 1984) (“Negligence per se does not equal liability premise that the failure of a monovalent virus pool to per se. Simply because the law may presume negligence meet neurovirulence requirements could be the result of from a person’s violation of a statute or rule does not mean a manufacturing deficiency. . . . [N]o criteria were that the law presumes that such negligence was the proximate provided to link the history of performance of cause of the harm inflicted.”); see also Chambers v. St. monovalent virus pools with the continued qualification Mary’s School, 697 N.E.2d 198, 201 (Ohio 1998) (noting that of the seed virus. Long experience has shown that the negligence per se requires a showing of proximate cause). In failure of a monovalent virus pool, produced from an this instance, the alleged violations relate to regulations that acceptable seed virus, is usually unrelated to deficiencies no longer are in existence, that the FDA believes did not in the manufacturing process, but is usually due instead affect public safety and that plaintiffs’ experts have not been to test variability. . . . The revised methodology is at least able to show affected public safety. Plaintiffs offer no as stringent as the former consistency requirements in example of a court (in Ohio or elsewhere) that has concluded detecting neurovirulence problems related to that the invocation of “negligence per se” may fill this manufacturing defects, while having the added benefit of evidentiary gap. We doubt such a case exists, and at all events reject this argument as a matter of law. Nos. 01-4175/4176 Graham, et al. v. American 27 28 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

Plaintiffs do not gain any more traction by turning to the In the end, as in St. Louis University, plaintiffs have not 1991 Sabin case and other cases arising from challenges to met their burden of proximately linking their allegations of the 1984 neurovirulence regulations. These decisions did not regulatory non-compliance with these undisputed and involve the liability of private manufacturers for regulatory indisputably-severe injuries. That evidentiary gap is violations, but rather concerned the actions of the FDA in particularly significant in this medical setting. All vaccines interpreting and applying its regulations. Sabin itself, produced from live viruses, as this one is, carry the moreover, concludes that the regulatory violations did not paradoxical risk of inducing the very disease that the vaccine affect product safety: “[T]he scientists who established and strives to prevent. In the absence of expert testimony implemented the OPV program . . . consistently acted in the showing that these alleged regulatory violations made public interest as they reasonably perceived it to be. They Orimune more unsafe than it otherwise would have been, a made judgments on extremely difficult questions which, rational trier of fact could rule for plaintiffs only on the basis strictly from the standpoint of public health, appear to be of conjecture, not a legitimate set of inferences drawn from entirely proper. . . . [M]y finding that regulatory violations admissible evidence. On this record, it remains unknowable occurred does not imply that the public health is or has been whether plaintiffs’ injuries stemmed from an avoidable defect endangered in any respect.” Sabin II, 763 F. Supp. at 813. in the product or unavoidable bad luck. That the 1984 What is more, Judge Motz, who presided over Sabin II, regulations upon which these claims rest have since been presided over the recent case between St. Louis University repealed and that the FDA has concluded that compliance and American Cyanamid. See St. Louis Univ., 182 F. Supp. with these regulations did not decrease the incidence of 2d at 494. There, Judge Motz concluded that the plaintiff’s vaccine-associated paralytic polio cement this conclusion. failure to prove, via expert testimony, that a regulatory violation increased the risk of paralysis meant that it could not Unable to establish a connection between these regulations prove any such violation by American Cyanamid proximately and product safety, plaintiffs also necessarily come up short caused the vaccinee’s paralysis. See id. at 500–03. A similar in showing that the representations at issue were material. flaw exists here. For if plaintiffs cannot show that the alleged misrepresentations affected product safety, they cannot show The Lundys further allege that expired and rejected that they were material. All things considered, the fraud materials were included in Jason’s vaccine. American claims in both cases must be summarily dismissed. Cyanamid’s experts confirmed that when a trivalent product’s potency is not sufficient to reach the FDA criteria for potency, B. STRICT LIABILITY it must be re-bulked. That is to say, the manufacturer combines vaccine that may not qualify for use by itself in The Grahams separately claim that they have presented a order to reach FDA-regulated potency levels and must do so triable issue of fact on their strict-liability claim. For many of without violating another FDA regulation. The Lundy (and the same reasons that their fraud claim fails, however, this Graham) experts again did not offer a tenable basis for claim fails as well. (The Lundys, recall, brought strict- concluding that re-bulking vaccine potency with expired or liability and failure-to-warn claims in state court and lost; rejected material negatively affects product safety. when they filed the same claims here, the district court rejected them on res judicata grounds; those decisions have not been appealed.) Nos. 01-4175/4176 Graham, et al. v. American 29 30 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

Ohio has adopted § 402A of the Restatement (Second) of warning accompanying the Orimune dose Zachary received Torts (1965) as the standard for strict liability. See Temple v. was inadequate. Wean United, Inc., 364 N.E.2d 267, 271 (1977). It says: The Grahams’ strict-liability claim fails for the same reason (1) One who sells any product in a defective condition that their fraud claim fails and for the same reason that the unreasonably dangerous to the user or consumer or to his Fourth Circuit recently rejected identical claims in American property is subject to liability for physical harm thereby Cyanamid Co. v. St. Louis University, 336 F.3d at 307. They caused to the ultimate user or consumer, or to his have not been able to show that the alleged regulatory property, if violations—non-compliance with the “tissue passage culture” and “consistency of manufacture” regulations—proximately (a) the seller is engaged in the business of selling such a caused Zachary Graham’s illness. Just as the expert product, and testimony relied upon by the Grahams and Lundys did not show proximate cause in support of their fraud claims, the (b) it is expected to and does reach the user or consumer same expert testimony fails to do so here. In the absence of without substantial change in the condition in which it is admissible evidence of proximate cause, the Grahams’ sold. product defect claim under the 1984 “tissue culture passage” and “consistency of manufacture” regulations fails as a matter (2) The rule stated in Subsection (1) applies although of law. (a) the seller has exercised all possible care in the The Grahams also claim that the Orimune vaccine Zachary preparation and sale of his product, and received was defective because American Cyanamid was not properly licensed to manufacture it. While they question (b) the user or consumer has not bought the product from whether certain testing procedures necessary for licensing or entered into any contractual relation with the seller. occurred, they offer no evidence that the company did not in Restatement (Second) of Torts § 402A. To establish strict fact have a valid license to manufacture Orimune. As with liability under Ohio law, plaintiffs must produce expert their other claims, they also offer no evidence that any testimony that the defect at issue “proximately caused the[ir] anomalies in American Cyanamid’s license proximately claimed injuries.” State Farm Fire & Cas. Co. v. Chrysler caused Zachary’s injuries. In Ohio, the absence of a valid or Corp., 523 N.E.2d 489, 494 (Ohio 1988). See Ohio Rev. properly issued license does not by itself establish the Code Ann. § 2307.73(A)(2). proximate cause of an injury. Cf. Gulla v. Straus, 93 N.E.2d 662, 664 (Ohio 1950). Against this legal backdrop, the Grahams argue that American Cyanamid is strictly liable for Zachary’s injuries. Plaintiffs also argue that the defense under Ohio law for Specifically, they claim that Orimune was defective because “unavoidably unsafe” drugs is not available to American it violated several FDA regulations: (1) the “tissue culture Cyanamid because the company allegedly violated FDA test”; (2) the “consistency of manufacture test”; and (3) the regulations. See White v. Wyeth Labs., 533 N.E.2d 748, 752 FDA’s licensing requirements. They further argue that the (Ohio 1988) (“a manufacturer of an unavoidably unsafe product may not be held strictly liable for injuries caused Nos. 01-4175/4176 Graham, et al. v. American 31 32 Graham, et al. v. American Nos. 01-4175/4176 Cyanamid Co. Cyanamid Co.

thereby, provided that the product was ‘. . . properly prepared, Cal. App. 3d 812, 818–19, 834–36 1985) (holding that an and accompanied by proper directions and warning . . .’”) “Important Information” statement identical to the one Lisa (quotation omitted); Restatement (Second) of Torts § 402A, Graham signed adequately informed the plaintiff of the cmt. k (recognizing that certain products exist that cannot be reasonably foreseeable risks associated with OPV as a matter made completely safe for their intended use and, when of law), the Grahams have not shown that this inadequacy properly prepared, and accompanied by proper directions and proximately caused Zachary’s injuries. See Seley v. G.D. warnings, are not defective, nor unreasonably dangerous). Searle & Co., 423 N.E.2d 831, 838 (Ohio 1981). To the The availability of this defense, however, does not come into extent plaintiffs complain that the warning failed to play in this instance, because plaintiffs have failed to establish acknowledge the alleged regulatory violations, they again their affirmative case by showing a causal relationship have not shown that regulatory non-compliance in this between the asserted defect—alleged regulatory instance had a bearing on product safety. violations—and Zachary’s injury. See St. Louis Univ., 336 F.3d at 311 n.4. To the extent plaintiffs mean to complain that the warning should have noted that IPV is the preferred polio vaccine, the C. NEGLIGENT FAILURE TO WARN record contradicts that claim. The scientific community agreed long ago that “IPV and OPV are both effective in The Grahams independently bring a negligent failure-to- preventing poliomyelitis, [but] OPV is the vaccine of choice warn claim. See Crislip v. TCH Liquidating Co., 556 N.E.2d for primary immunization of children in the United States 1177, 1181–82 (Ohio 1990). The claim has three elements, when the benefits and risks for the entire population are each of which must be satisfied: (1) a duty to warn against considered.” Recommendation of the Advisory Committee on reasonably foreseeable risks; (2) breach of this duty; and (3) Immunization Practices 2 (1982). This was largely because an injury that is proximately caused by the breach. See of “its ease of administration (oral instead of injected), Briney v. Sears, Roebuck & Co., 782 F.2d 585, 587 (6th Cir. expected long lasting immunity, and the production of bowel 1986). Under Ohio law, the manufacturer of a prescription immunity.” E.O. Nightingale, Recommendations for a drug discharges its duty to warn about risks regarding National Policy on Poliomyelitis Vaccination, 287 N.E. J. prescription drugs if the manufacturer adequately warns the Med. 249–53 (1977). See also Report of Committee on patient’s doctor of those risks. See Ohio Rev. Code Ann. Infectious Diseases 208, 209 (1982); Institute of Medicine, An § 2307.76(C). When a plaintiff alleges that the warning given Evaluation of Poliomyelitis Vaccine Policy Options 28 to a prescribing physician is inadequate, the plaintiff must (1988). Mass vaccination with IPV also has had little impact prove his claim through expert medical testimony. See, e.g., on polio outbreaks. In contrast, wide use of OPV brought an Jones v. Roche Labs., 616 N.E.2d 545, 547 (Ohio Ct. App. end to any cases of paralytic polio caused by naturally 1987). circulating polio virus in the United States in 1979 and in the Western Hemisphere in 1991. Centers for Disease Control, As with the Grahams’ other claims, this one too founders Poliomyelitis Prevention in the United States: Updated on the shoal of proximate cause. Even if we grant that the Recommendations of the Advisory Committee on warning American Cyanamid offered was in some way Immunization Practices (ACIP), Morbidity & Mortality inadequate, which appears not to be the case, see supra Weekly Report, May 19, 2000, at 1, 5. In 1996, the FDA (reprinting warnings); see also Kearl v. Lederle Labs., 172 recognized the wide use of OPV as so successful that it Nos. 01-4175/4176 Graham, et al. v. American 33 Cyanamid Co.

officially revoked OPV regulations on the express ground that they were now “obsolete or no longer necessary to achieve public health goals.” Revocation of Certain Regulations, Biological Products, 61 Fed. Reg. 40,153, 40,153 (Aug. 1, 1996). D. DERIVATIVE CLAIMS Jason Lundy’s claim for loss of parental consortium and the Grahams’ and Lundys’ claims for punitive damages are derivative in nature. A derivative cause of action may not provide greater relief than that available under the primary cause of action. See Lynn v. Allied Corp., 536 N.E.2d 25, 36 (Ohio Ct. App. 1987). Having dismissed plaintiffs’ respective causes of action for fraud, strict liability, and negligent failure-to-warn as a matter of law, we must dismiss these derivative claims as well. III. CONCLUSION For the foregoing reasons, we AFFIRM.