Joseph R. Graham v. American Cyanamid Company

1
RECOMMENDED FOR FULL-TEXT PUBLICATION
Pursuant to Sixth Circuit Rule 206
ELECTRONIC CITATION: 2003 FED App. 0423P (6th Cir.)
File Name: 03a0423p.06
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
_________________
No. 01-4175
JOSEPH R. GRAHAM, et al.,
Plaintiffs-Appellants,
v.
AMERICAN CYANAMID
COMPANY,
Defendant-Appellee.
No. 01-4176
ROY LEE LUNDY, et al.,
Plaintiffs-Appellants,
v.
AMERICAN CYANAMID
COMPANY,
Defendant-Appellee.
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Nos. 01-4175/4176
Appeal from the United States District Court
for the Southern District of Ohio at Columbus.
Nos. 94-00423; 94-00425—George C. Smith, District
Judge.
2 Graham, et al. v. American
Cyanamid Co.
Nos. 01-4175/4176
Argued: August 1, 2003
Decided and Filed: December 3, 2003
Before: DAUGHTREY, MOORE, and SUTTON, Circuit
Judges.
_________________
COUNSEL
ARGUED: Marc S. Moller, KREINDLER & KREINDLER,
New York, New York, Stanley P. Kops, Bala Cynwyd,
Pennsylvania, for Appellants. David P. Donovan, WILMER,
CUTLER & PICKERING, McLean, Virginia, for Appellee.
ON BRIEF: Marc S. Moller, KREINDLER &
KREINDLER, New York, New York, Stanley P. Kops, Bala
Cynwyd, Pennsylvania, E. Marianne Gabel, Delaware, Ohio,
Nicholas E. Bunch, WHITE, GETGEY & MEYER CO.,
Cincinnati, Ohio, John F. Berry, Portsmough, Ohio, for
Appellants. David P. Donovan, WILMER, CUTLER &
PICKERING, McLean, Virginia, William G. Porter, II,
VORYS, SATER, SEYMOUR & PEASE, Columbus, Ohio,
Roger Yoerges, WILMER, CUTLER & PICKERING,
Washington, D.C., for Appellee.
_________________
OPINION
_________________
SUTTON, Circuit Judge. Joseph Graham and Roy Lee
Lundy, along with several members of their families,
challenge the district court’s order granting summary
judgment to American Cyanamid Company on a series of
fraud and product liability claims. American Cyanamid
manufactures Orimune, which is an oral polio vaccine.
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
contract polio.
Seeking compensation for these injuries, both sets of
plaintiffs filed fraud claims against American Cyanamid,
asserting that the company publicly represented Orimune as
licensed, manufactured, tested and released in accordance
with FDA regulations, when in fact the Orimune vaccines at
issue (according to plaintiffs) did not comply with FDA
standards. The Graham plaintiffs separately brought strict
liability and negligent failure-to-warn claims against
American Cyanamid. Both sets of plaintiffs also filed
derivative claims for loss of consortium and punitive
damages. The district court granted American Cyanamid’s
motion for summary judgment on all claims. We AFFIRM.
I. BACKGROUND
A. Polio and the Orimune Vaccine.
Poliomyelitis (or polio) is a disease of the central nervous
system that causes illness, paralysis and in some instances
death. It affected thousands of individuals in this country
during the first half of the twentieth century. See Dorothy M.
Horstmann, Poliovirus (Poliomyelitis), in 2 Textbook of
Pediatric Infectious Diseases 1186, 1189–90 (Ralph D.
Feigin & James D. Cherry, eds., 1981). At its height between
1951 and 1955, polio led to 21,000 cases of paralysis per year
in the United States. See id.
That this scourge did not continue through the second half
of the twentieth century is a credit to the work of several
scientists. In 1955, Dr. Jonas Salk developed the first widely
successful vaccine against polio. Derived from a dead polio
virus, the Salk vaccine is known as an inactivated polio
vaccine (“IPV”) and was licensed for production and use in
the United States in 1955. See In re Sabin Oral Polio
Vaccine Prods. Liab. Litig., 743 F. Supp. 410, 412 (D. Md.
4 Graham, et al. v. American
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Nos. 01-4175/4176
1990) (“Sabin I”). The vaccine decreased the incidence of
polio but did not eradicate it. Between 1958 and 1961, for
example, nearly 19,000 cases of the disease were still reported
in the United States. Id. Thirteen thousand people became
paralyzed by the disease, and more than 1,000 people died
from it during this period. Id.
At the same time that Dr. Salk was developing his vaccine,
Dr. Albert Sabin began working on an oral polio vaccine
(“OPV”) made from attenuated strains of the polio virus. The
Sabin OPV, unlike the Salk IPV, is produced from a live
polio virus that has been weakened but not killed. “‘Like all
vaccines cultivated from live viruses,’” such as those used for
smallpox and yellow fever, “‘OPV creates immunity by
inducing a mild infection in the recipient.’” United States v.
St. Louis Univ., 336 F.3d 294, 295 (4th Cir. 2003) (quoting
Stuart v. Am. Cyanamid Co., 158 F.3d 622, 625 (2d Cir.
1998)).
OPV has several advantages over IPV. OPV is less
expensive and requires only a single dosage, while IPV
requires three inoculations and a follow-up booster shot.
OPV is administered orally, commonly on a sugar cube, while
IPV must be injected by a hypodermic needle. The
interaction of the live virus in OPV with the immune system
confers lifetime immunity, while IPV requires periodic re-
administration. See generally Sabin I, 743 F. Supp. at 412.
And OPV creates “herd immunity,” because an individual
who has not received the vaccine can obtain immunity by
contact with someone who has been vaccinated. Id.
Individuals who have been immunized with IPV, by contrast,
may still serve as carriers of the wild polio virus and may pass
it on to others even though they themselves have been
immunized. Id.
OPV, however, also has several inherent risks in view of
the way it—and all vaccines developed from live
viruses—work. The live but weakened viruses of OPV grow

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

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

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

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

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

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

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Cyanamid Co.
17
the basis of these rulings, the court held that the derivative
nature of Jason Lundy’s consortium claim and each claim for
punitive damages required these claims to be dismissed as a
matter of law as well. (While the district court labeled the
entry disposing of all of these claims a “final judgment,”
neither the record nor the docket sheet reveals what happened
to the three warranty claims filed by the Graham plaintiffs in
their complaint. Because the Grahams do not address these
claims on appeal and because the district court purported to
dismiss all claims, we do not address them here.) The district
court denied the Graham and Lundy plaintiffs’ motions for
reconsideration, and these consolidated appeals followed.
II. DISCUSSION
The customary rules for reviewing a summary-judgment
decision apply. We give de novo review to the district court’s
decision. Sperle v. Mich. Dep’t of Corr., 297 F.3d 483, 490
(6th Cir. 2002). A decision granting summary judgment is
proper where no genuine issue of material fact exists and the
moving party is entitled to judgment as a matter of law. Fed.
R. Civ. P. 56(c). And in considering such motions, we give
all reasonable factual inferences to the nonmoving party.
Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S.
574, 587 (1986).
Our jurisdiction over these state-law claims rests on the
diversity of citizenship of the parties. All of the Graham and
Lundy plaintiffs are residents of Ohio. American Cyanamid,
incorporated in Maine, maintains its principal place of
business in New Jersey. See 28 U.S.C. § 1332. In this
setting, we sit in effect as another court of the forum state, in
this case Ohio, and therefore must apply its choice-of-law
rules. See Muncie Power Prods., Inc. v. United Tech Auto.,
Inc., 328 F.2d 870, 873 (6th Cir. 2003). In this instance, the
parties agree that those choice-of-law rules indicate that Ohio
substantive law governs this claim.
18 Graham, et al. v. American
Cyanamid Co.
Nos. 01-4175/4176
All three of the tort claims in this case represent a variation
on a common theme. Whether labeled fraud, strict liability,
or negligent failure to warn, all three claims turn on the theory
that there is a proximate connection between the alleged
violations of the FDA’s neurovirulence rules and the safety of
the Orimune vaccine. Because we conclude that plaintiffs
have failed to establish a triable issue of fact on this central
point and because we conclude that each of these tort claims
otherwise fails as a matter of law, we agree with the District
Court that the claims must be summarily dismissed.
A. FRAUD
We begin by addressing the one claim common to both sets
of plaintiffs. The Grahams and Lundys each allege that
American Cyanamid acted fraudulently by representing that
Orimune was licensed, manufactured, tested and released in
accordance with FDA regulations when in fact it did not
comply with FDA standards. To establish a cognizable claim
of fraud under Ohio law, a claimant must prove the following
six elements: “(a) a representation or, where there is a duty to
disclose, a concealment of fact, (b) which is material to the
transaction at hand, (c) made falsely, with knowledge of its
falsity, or with such utter disregard and recklessness as to
whether it is true or false that knowledge may be inferred, (d)
with the intent of misleading another into relying upon it, (e)
justifiable reliance upon the representation or concealment,
and (f) an injury proximately caused by the reliance.” Russ v.
TRW, Inc., 570 N.E.2d 1076, 1083 (Ohio 1991). The
elements of the claim are conjunctive, and accordingly all of
them must be shown. See Schwartz v. Capital Sav. & Loan
Co., 381 N.E.2d 957, 959 (Ohio 1978).
Both in the district court and here, the parties have
vigorously contested many of these elements. Did the
company in fact violate certain FDA regulations in
manufacturing Orimune—specifically, the “tissue culture
passage” and “consistency of manufacture” regulations?

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

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

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

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

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

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

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

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Nos. 01-4175/4176 Graham, et al. v. American
Cyanamid Co.
33
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.

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