Court Opinion

ID: 2971000
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Date Created: 2015-09-22 16:26:39.888158+00
Date Added: 2024-06-11T11:43:33.227198
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            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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Nos. 01-4175/4176          Graham, et al. v. American       3    4    Graham, et al. v. American            Nos. 01-4175/4176
                                       Cyanamid Co.                   Cyanamid Co.

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
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                                        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.
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                                        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
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                                         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
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                                       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)
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                                         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.