Petition for Writ of Certiorari — Lundy v. American Cyanamid Co.
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Supreme Cau
031258 war » — 2004
Jn The
Supreme Court of the Anited States
ROY LEE LUNDY et al.,
Petitioners,
V
AMERICAN CYANAMID COMPANY,
Respondent,
and
JOSEPH R. GRAHAM et al.,
Petitioners,
V.
AMERICAN CYANAMID COMPANY,
Respondent.
ON PETITION FOR WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
PETITION FOR WRIT OF CERTIORARI
Marc S. Moller
Counsel of Record
Kreindler & Kreindler LLP
100 Park Avenue
New York, New York 10017
(212) 687-8181
Counsel for Petitioners
QUESTION PRESENTED
Where a circuit court, in a case involving the
violation of a federal statute, 42 U.S.C. § 262(d), and
its implementing regulations, fails to apply and
materially deviates from the controlling United
States Supreme Court decision, Berkovitz v. United
States, 486 U.S. 531 (1988), should not this Court
grant a Writ of Certiorari to enforce the Congres-
sional mandate, the regulatory process, and the rule
of law enunciated by this Court?
PARTIES TO THE PRCCEEDING
IN THE SIXTH CIRCUIT
The parties to Graham v. American Cyanamid
Company (No. C-2-94-423 in the district court and
No. 01-4175 in the Sixth Circuit), were Joseph R.
Graham and Lisa A. Graham, as individuals, and Joseph
R. Graham and Lisa A. Graham, as parents and next
friend of Zachary A. Graham (a minor at the time of filing
the action), as plaintiffs, and American Cyanamid
Company, as defendant.
The parties to Lundy v. American Cyanamid
Company (No. C-2-94-425 in the district court and
No. 01-4176 in the Sixth Circuit), were Roy Lee Lundy
and Janet Lundy, as individuals, and Roy Lee Lundy and
Janet Lundy as parents and next friend of Jason Lundy
(a minor at the time of filing the action), as plaintiffs,-and
American Cyanamid Company, as defendant.
CORPORATE DISCLOSURE STATEMENT
PURSUANT TO RULE 29.6
None of the parties plaintiff in the Graham and
Lundy actions who seek certiorari is a corporate entity.
\
sé
TABLE OF CONTENTS
QUESTIONS PRESENTED.............. i
PARTIES TO THE PROCEEDING IN
Wee CRPRE TE GOPURATED 6 we ec ees ii
CORPORATE DISCLOSURE
STATEMENT PURSUANT TO
eee ii
Rte SI GATEMATA once enwas iii
TABLE OF AUTHORITIES............. vi
TABLE OF CONTENTS TO THE
a ee ere xii
PETITION FOR WRIT OF CERTIORARI .. . 1
Soo 8G 8, | a 2
ar 2
STATUTES INVOLVED IN THE CASE... 2
STATEMENT OF THE CASE.......... 3
I kd vob te eee ea 8s 3
The Roles of the Division of
Biologics Standards and the National
Institutes of Health in Regulating
Oral Poliovirus Vaccine.......... a
ES 7
-ili-
SOTY GUO. 6 ce es 7
PROCEEDINGS BELOW ............0.. 8
REASONS FOR GRANTING THE WRIT... 9
I. UNLESS AND UNTIL BERKOVITZ
IS OVERRULED, THE SIXTH CIRCUIT’S
AFFIRMANCE OF THE LOWER COURT
CREATES AN IRRECONCILABLE
CONFLICT WITH THIS COURT’S
CONTROLLING ARTICULATION
foe 8 Aree errs eee 9
A. Although Oral Polio Vaccine
Is No Longer in Use in the United
States, the Issues Raised by this
Petition Are Not Moot, and the
Issue of the Safety of this Vaccine
Is a Matter of National Concern
to the Public Health....... 19
B. The Regulatory Scheme
And The Amendments Thereto. 20
II. THIS COURT SHOULD
GRANT THE PETITION BECAUSE
THE HOLDING OF THE SIXTH
CIRCUIT DENIGRATES INTO
OBLIVION NEUROVIRULENCE,
THE CENTRAL UNDERPINNING
OF THE ENTIRE FEDERAL
OPV REGULATORY SCHEME. 23
-iV-
III. THE POLIO VACCINE
REGULATIONS HAVE NOT
ERIE ARATE. cee es 27
ee RR 6 ee eee re ee eee 7 30
peg tk rer eee eee eee A thru E
TABLE OF AUTHORITIES
CASES
Baker v. United States, 817 F.2d 560
FOUN Gs BFE os ik dwcko aun evcecn 1C, 20
Berkovitz v. United States,
486 U.S. 531 (1988) .......... Ta a 5
14, 15, 16, 17,
18, 20, 21, 24,
26, 27, 30
Berkovitz v. United States,
822 F.2d 1322 (3d Cir. 1987....... 9,10
Campagna v. American Cyanamid Compan ,
337 N.J. Super. 530,
767 A.2d 996 (2001).............. 13, 14
General Motors Corp. v. Romein,
wus U.S. 191 (1990)... ow ces 28
Griffin v. United States, 351 F. Supp. 10
(E.D. Pa. 1972), affd,
900 F.2d 1059 (3d Cir. 1974)....... 4
Gulla v. Straus, 154 Ohio St. 193,
93 N.E.2d 662 (1950) ............ 12
-vi-
In R in lio Vacci ts Liabili
Litigation, 743 F. Supp. 410 (D. Md. 1990)
("Sabin I"), 763 F. Supp. 811 (D. Md. 1991)
("Sabin II"), and 774 F. Supp. 952 (D. Md. 1991)
("Sabin III"), affd, 984 F.2d 124 (4th Cir.
Picea 6, 8, 16, 20,
21, 22, 23, 25,
26, 27
Kaiser Aluminum & Chemical Corp. v.
Bonjorno, 494 U.S. 827 (1990)..... 28
Loge v. United States, 662 F.2d 1268
(8th Cir. 1981), cert. denied,
So0 U.B. 944 (1SGZ) ow wc 10, 20
Lundy & Graham v. American
Cyanamid Company, 2000 WL
1911431 (E.D. Ohio, Dec. 3, 2003),
affd, 350 F.3d 496 (6th Cir. 2003) passim
STATUTES AND REGULATIONS
yk oe | ren 2
ee as OP I 8 kk oe ke eee 2
Federal Tort Claims Act, 28 U.S.C.
§§ 1346(b) and 2680(a)........... S
ee ee a, 40, 11,
1S, &7
en SS a bode oa he ee 11
-Vli-
21 C.F.R. § 600.3(n) (2000) ...........
eS A eS er er eee
21 C.F.R. § 601.4 (1987) ..............
21 C.F.R. §610.1 ...........005.
Ri CHM. MGM... i
21 C.F.R. § 630.10(b)(2)(1987) .........
21 C.F.R. § 630.10(b)(3), (4). 0.2...
21 C.F.R. § 630.10(b)(4)..............
21 C.F.R. § 630.16 (1987) ............
21 C.F.R. § 630.16(b)(1) (1987).........
21 C.F.R. §§ 630.110(b)(2)(ii) (1987)... ..
21 C.F.R. §§ 630.110(b)(4) (1987).......
AD CPM. Part TS, oo. 05 coke cea es
42 C.F.R. § 73.3 (Supp. 1964) .........
42 C.F.R. § 73.5(a) (Supp. 1964) .......
42 C.F.R. § 73.110(b)(2).............
42 C.F.R. § 73.110(b)(2)(ii) 2... 2...
42 C.F.R. § 73.110(b)(3)............. 5,
-Viii-
3
10, 11, 12
11,19
6,9, 10
11, 24
6
6
6,11, 19
42 C.F.R. 673. 110004)... ww ess 6
J eek 8 oo 2). eer te 6
Ee ee ee BE | eerrarne 8
7 eee fF Oe & © |. ew rer era 6
MCR SPR sic oe 6, 11
73 CPR. SD FRA chi hv ee eee 10
42 C.F .R. § 7S. TEST). oc ie ces 6
42 C.F.R. § 73.114(b)(1)(iili).... 2.2... 6
42 C.F.R. § 73.114(3)(i), (ii), (ili) ...... 6
eee Ae Sees eee eT 10
hat § Ree Bey ee ee ree 10
56 Fed. Reg. 21,418 et seq. (May 18, 1991) 24
Federal Rules of Civil Procedure Rule 56 2
MISCELLANEOUS
Hearing Before the House Energy and
Commerce Subcommittee on Human
Rights and Wellness, Committee on
Government Reform, Serial No. 108-85
a: ee eee eee ee oe 19, 22, 24
-1X-
Hearing Before the House Energy and
Commerce Subcommittee on Human
Rights and Wellness, Committee on
Government Reform, Nov. 13, 2003:
Preventing Another SV40 Tragedy:
Are Today’s Vaccine Safety Protocols
Effective? Serial No. ___ (in press) ...
FDA Docket No. 86N-0027 ...........
L. Fuller, The Morality of Law, 51-62
(Yale U. Press 1977)..............
Munzer, A Theory of Retroactive Le islation,
61Texas L.Rev. 425 (1982).........
Brock, Kelleher and Zlotnick: "Simian
Virus 40 (SV40): A Possible Human
Polyomavirus: Product Quality Control
testing for the Oral Polio Vaccine,"
Developments in Biologic
Standardization, 217-219 (1998)....
Gazdar, A.F., Butel, J., and Carbone, M.:
SV40 virus and human tumours,
Nature Reviews Cancer,
2:957-964 (2002)................
Klein G, Powers A, Croce C., "Association of
SV40 with human tumors," Oncogene,
21:1141-1149 Raat
20
24, 25
29
28
20
20
20
Se *
The Institutes of Medicine Evaluation
of Poliomyelitis Vaccines,
The Nightingale Report, IOM Publication
77-02, re-published as Nightingale, E.O.,
Recommendations for a national policy
on poliomyelitis vaccination, N. Engl J. Med,
1977; 297:249-253 3
Report by Immunization Safety Review
Committee on Health Promotion and Disease
Prevention of the Institute of Medicine,
Immunization Safety Review SV40
Contamination of Polio Vaccine and Cancer,
July 11-12, 2002 (102 pp), available at
www.nap.educatalog/10534.html1/
(accessed Feb. 29, 2004)... 20
«Xi-
TABLE OF CONTENTS TO THE APPENDIX
Opinion of the Court of Appeals, 350 F.3d 496
6" Cir. 2003). cease... App. A
Judgment of the Court of Appeals for
the Sixth Circuit, filed
December 3, 2003............ App. A at 37-38
Opinion of the lower court in Graham /
Lundy v. American Cyanamid
Company, 2000 WL 191 1431
(S.D.Ohio, Dec. 21, ers App. B
Judgment in a Civil Case of the
United States District Court
for the Southern District of Ohio
in Graham v. American Cyanamid
ee aii App. B at 31-32
Judgment in a Civil Case of the
United States District Court
for the Southern District of Ohio
in Lundy v. American Cyanamid
os App. B at 33-34
42 UBS. GIGI oo coc. App. C
Federal regulations governing live oral
poliovirus vaccine, 42 C.F.R. Part
73, later re-numbered as 21 C.F.R.
Part 630 (relevant portions) ....... App. D
American Cyanamid Company
submittals to FDA Docket
No. 86N-0027 (extracts)........\. App. E
-Xll-
PETITION FOR A WRIT OF CERTIORARI
Roy Lundy, his wife Janet Lundy, and his son,
Jason Lundy respectfully seek a Writ of Certiorari to
review the decision of the United States Court of Appeals
for the Sixth Circuit, which, on December 3, 2003,
affirmed a Summary Judgment Order and Judgment
dismissing the action, issued by the United States Dis-
trict Court for the Southern District of Ohio, entered on
December 21, 2001. In this same petition, Zachary
Graham, his mother Lisa Graham, and his father Joseph
Graham respectfully seek a Writ of Certiorari to review
the same decision of the United States Court of Appeals
for the Sixth Circuit, which affirmed a Summary
Judgment Order and Judgment dismissing the action,
issued by the United States District Court for the
Southern District of Ohio, entered on December 21,
2001. The Lundy and Graham actions were decided in
a single decision by the trial court; that decision in turn,
was affirmed by the Sixth Circuit in one decision.
In the Lundy action, plaintiff Roy Lundy claimed
that he contracted Type III paralytic poliomyelitis
through contact with his recently-immunized infant son,
Jason. The oral polio vaccine which was administered to
his infant son had not been licensed, tested, and
manufactured in accordance with the federal oral polio
vaccine regulations. One of the particular batches of
trivalent vaccine Jason may have received contained
rejected and expired vaccine, as well as a monovalent
pool that was more neurovirulent than the entire
neurovirulence safety testing history of the reference
standard as conducted by the manufacturer, Cyanamid.
In the Graham action, plaintiff Zachary Graham’s
parents claimed that their infant son contracted para-
lytic poliomyelitis after ingesting 4 dose of Orimune vac-
cine which was defective. The violations of the same
federal regulatory scheme that was applicable to the
Lundy case was applicable to Zachary Graham’s immu-
nization. In both instances, the vaccine manufacturer
failed to comply with the licensing, testing and
manufacturing requirements for the vaccine at each
stage of manufacture.
OPINIONS BELOW
, The opinion of the Court of Appeals (App. A)! and
Judgment (App. A at 31) is reported at 350 F.3d 496 (6"
Cir, 2003). The unpublished opinion of the lower court
is available at 2000 WL 1911431 (S.D.Ohio 2000, Dec.
21, 2001) (App. B). The Judgment of the District Court
appealed from in Graham (App. B at 31), and in Lundy
(App. B at 33) are unreported.
JURISDICTION
The jurisdiction of this Court is invoked pursuant
to 28 U.S.C. § 1254/1).
STATUTES INVOLVED IN THE CASE
The statutes involved are 28 U.S.C. § 1254(1),
Federal Rules of Civil Procedure Rule 56, and 42 U.S.C.
§ | 262(d) (App. C). The regulations involved are the
federal regulations governing live oral poliovirus vaccine,
42 C.F.R. Part 73, later re-numbered as 21 C.F.R. Part
ye References to the Appendices which are bound in this
volume are preceded with the section designations “App. A,”
App. B.” etc..
a
630. Relevant portions of those regulations are set forth
in Appendix E.
STATEMENT OF THE CASE
Background
Since the introduction of oral polio vaccine in the
United States in 1962 until its removal from sale in
1999, American Cyanamid/Lederle has been America’s
major supplier of Sabin Oral Poliovirus Vaccine.
Beginning in 1962, when it first applied for its license,
until 1977, American Cyanamid/Lederle had approxi-
mately 83% of the United States market. After 1977, it
was the sole oral poliovaccine manufacturer in the
United States until 1999, when Orimune was no longer
recommended for pediatric immunization. At all times
relevant to this petition, a completely safe alternative
vaccine, the Salk vaccine, also known as inactivated
polio vaccine (“IPV”), was available to the American
public.’
2 In 1977, the Institutes of Medicine issued a report
known as the Nightingale Report, which found there was no
benefit to the individual recipient of oral polio vaccine over
immunization with inactivated polio vaccine. Cf. Lundy v.
American Cyanamid Company, 350 F.3d at 499. The Sixth
Circuit’s recitation of the properties of IPV and OPV and their
differences is historically inaccurate and conflicts with both
the Institutes of Medicine Report written in 1977, The
Institutes of Medicine Evaluation of Poliomyelitis Vaccines, The
Nightingale Report, IOM Publication 77-02, and all other
scientifically correct descriptions, as can be found in the
manufacturer’s own package insert beginning in the late
1980's.
Me
On
Between 1979 and 1999, the sole source of
paralytic poliomyelitis cases in the United States was the
oral polio vaccine known as “Orimune,” the vaccine
product manufactured by American Cyanamid Company
/ Lederle Laboratories. Once the nation’s pediatric regi-
men was changed from oral polio vaccine to inactivated
polic vaccine in 2000, not a single child or adult in the
United States was thereafter afflicted with paralytic
poliomyelitis, and no wild cases of polio have occurred.
The Roles of the Division of Biologics Standards
and the National Institutes of Health in Regulat-
ing Oral Poliovirus Vaccine.
Oral poliovirus vaccine, as every other vaccine
utilized to immunize the population in order to protect
the public health of the United States, was initially
regulated not by the Food and Drug Administration
(FDA), but by the Division of Biologics Standards (DBS),
part of the United States Public Health Service. The FDA
did not assume any responsibility for vaccines until
1972, when the DBS was found liable for releasing non-
compliant oral polio vaccine. Griffin v. United States
351 F. Supp. 10 (E.D. Pa. 1972), aff'd, 500 F.2d 1059 (3d
Cir. 1974).
Poliovirus was a scourge to humans because of its
capability to attack the nervous system and permanently
destroy the capacity of particular nerve cells to relay
through the spinal cord the electrical potentials which
activate muscles. Thus, when public health officials
geared up for use of a live virus vaccine in the United
States, they proposed and adopted a set of highly
detailed and stringent regulations which had as their
goal to implement the best methods then known to
science to insure that the neurovirulence of manufac-
-4-
tured vaccine would be at an acceptably safe level. To
accomplish this goal, they specified a particular licen-
sing, manufacture, and safety testing regimen from
which manufacturers could not diverge if they wished to
sell OPV.
Lederle was one of only a handful of biologics
manufacturers that decided to apply for an OPV license.
During the period of American Cyanamid’s licensure, it
and each of the other license applicants were required to
submit to the government the test results demonstrating
-- as a condition precedent to subsequent lawful
manufacture of polio vaccine -- that its master seeds,
production seeds, and/or intermediate seeds passed all
regulatory safety requirements and that the manufac-
turer’s test results for the final product, in the form in
which it distributed it, also demonstrated that that
product fully complied with the regulations.
The record below demonstrated that Cyanamid
did not perform the necessary tests and did not submit
any seed test results with its Orimune license
applications. Moreover, the consistent uncontradicted
record testimony of Cyanamid’s personnel is that the
vaccine manufacturer did not submit the test results.
The vaccine manufacturer did not submit the test
results for two reasons: first, most of the test results,
had they been submitted, would have shown the
applicant’s failure to comply with the regulations then in
effect, such as that all of its seeds were contaminated
with an adventitious agent (i.e., one from an extrinsic
source) known as SV40, which had been shown to cause
cancer in test animals and whose presence in the
vaccine was prohibited explicitly by regulation. 42
C.F.R. § 73.110(b)(3). Cyanamid had not demonstrated
that it had successfully tested for and removed the
SV40, a specific requirement for licensure pursuant to
Si
this Court’s Berkovitz opinion. Second, no tests were
submitted for neurovirulence (see 42 CFR
§§ 73.110(b)(2)(ii), 73.110(b)(4), 73.114(b)(1) (Supp.
1964); 21 CFR §§ 630.110(b)(2)(ii), 630. 110(b)(4),
630.16(b)(1) (1987)) (App. D) or markers (42 C.F.R.
§ 73.114(3)(i), (ii), (iii)), for any of the seeds utilized to
license this oral poliovaccine product. The adventitious
agent test results were not submitted for any of the
seeds utilized to license this product. See 42 C.F.R.
§§ 73.110 (b)(3), and 73.112, 113 and 114.
~
What testing was conducted, and what records do
exist in regard to neurovirulence and markers, proved
that both the licensing lots and the subsequent lots
manufactured for distribution exceeded the neuro-
virulence safety requirements and were more neuro-
virulent than the “reference standard,” a vaccine
provided to manufacturers by which safety testing
results could be calibrated to a standard for maximally
permissible acceptable neurovirulence. 42 C.F.R.
§§ 73.114(b)(1)(iii); In re Sabin, infra, 763 F. Supp. at
815-817, 826-827, 829.
Throughout the years Orimune was produced,
American Cyanamid/Lederle assured the courts, the
public, the medical profession, the state legislatures,
and all others that it warranted that it had fully
complied with each and every regulation in effect at
each relevant time period. This promise and guarantee
of compliance, prominently displayed in each of Cyana-
mid’s Orimune advertisements, package inserts, and
vaccine containers, was false. One of respondent’s
Managers, who was in charge of communications with
physicians, admitted that no physician would use a non-
licensed vaccine and, more importantly, no vaccine
manufacturer could or should be able to sell an unli-
censed product.
-6-
During all times relevant herein, the regulations
that were enacted in 1960 remained in full effect at the
time that Roy Lundy, one of the petitioners herein, was
paralyzed through contact with his recently immunized
infant son, Jason, and when petitioner Zachary Graham,
then a minor, was paralyzed by ingesting Orimune.
Roy Lundy
Roy Lundy is a wheelchair-bound contact polio
victim of Type III poliovirus from Orimune which
contained a neurovirulent component which exceeded
the entire reference history of Lederle’s safety testing in
comparison to the reference standard from 1962 to
1977, and thereafter, until 1999. One of the trivalent
bulks that could have been administered to Roy’s son
Jason came from rejected, expired vaccine, without
knowledge of or permission from the FDA. Sale of such
vaccine was strictly prohibited by the applicable
regulations at the time Jason Lundy was vaccinated.
Zachary Graham
Zachary Graham is a lower-limb paralyzed direct
recipient case of paralytic poliomyelitis. His case was
evaluated by the Centers for Disease Control, and he
was determined to be a vaccine-associated case of polio.
There are no test results showing that the various seeds
utilized in manufacture of Zachary’s final production
seed passed all the required safety tests and, specifi-
cally, neurovirulence and marker tests, which, by regul-
ation, are utilized to judge the safety of the vaccine prior
“to release. It was admitted below that the vaccine was
eB
beyond five tissue culture passages. Pursuant to the In
re Sabin decision (763 F. Supp. at 813, 821 823), this
Court’s Berkovitz decision (486 U.S. at 541, 544, 545
n.11), and the regulations then in effect (42 C.F.R.
§ 73.113(b)), Zachary Graham’s vaccine could not
legally be sold.
PROCEEDINGS BELOW
Following several years of consolidated
pretrial discovery in Graham and Lundy, in 1998
American Cyanamid filed two summary judgment
motions. It sought to dismiss Jason Lundy’s
product defect, negligence, breach of express
warranty, and fraud claims and the dismissal of Roy
Lundy’s fraud and punitive damages claim.
Plaintiffs opposed the motions. The district court
granted summary judgment on both motions on
December 21, 2000, finding that defendant was
entitled to summary judgment. Plaintiffs moved to
amend judgment, which the court denied on
September 28, 2001.
On the same day, Cyanamid filed parallel
motions in Graham. Plaintiffs opposed them. The
district court granted summary judgment on both
motions on December 21, 2000. Plaintiffs moved to
amend judgment, which the court denied on
September 28, 2001.
Plaintiffs in both cases timely appealed. The
Sixth Circuit affirmed the lower court, finding that
-8-
violation of licensing requirements and excessive
vaccine neurovirulence did not cause the plaintiffs’
paralysis. The plaintiffs in each case then peti-
tioned this Court for certiorari.
REASONS FOR GRANTING THE WRIT
i. UNLESS AND UNTIL BERKOVITZIS OVER-
RULED, THE SIXTH CIRCUIT’S AFFIRMANCE OF
THE LOWER COURT CREATES AN IRRECONCIL-
ABLE CONFLICT WITH THIS COURT’S CONTROL-
LING ARTICULATION OF THE LAW.
Berkovitz v. United States, 486 U.S. 531 (1988),
presented to this Court a polio victim’s claims against
the United States, as licensor of the instant defendant,
American Cyanamid Company, for non-compliant
manufacture of Orimune live oral polio vaccine. In the
district court action, the Western District of
Pennsylvania had denied the government's motion to
dismiss on discretionary function exception grounds,
and the government appealed. In Berkovitz v. United
States, 822 F.2d 1322 (3d Cir. 1987), the Court of
Appeals correctly held that "[T]he duty to submit test
data rests with the manufacturer.", (the point of error
which Petitioners address to the Court in Lundy and
Graham), citing 21 C.F.R. §§ 601.2, 610.1, 630.10(b)(4)
(822 F.2d at 1330, n.6), but reversed the lower court's
additional finding that the government was also liable.
The Third Circuit based its reversal upon the discretion-
ary function exception to the Tort Claims Act, 28 U.S.C.
§§ 1346(b) and 2680(a).
The Third Circuit's opinion stated: "It is therefore
evident that looking at the [poliovirus vaccine] regula-
tions as a whole, it is the manufacturer that is required
-9-
to perform the tests [set out in 42 C.F.R. §§ 73.114(b),
73.115, 73.117]." 822 F.2d at 1330 (emphasis supplied).
Judge Higginbotham’s dissent, relying upon
Baker v. United States, 817 F.2d 560 (9th Cir. 1987),
and Loge v. United States, 662 F.2d 1268 (8th Cir.
1981), cert. denied, 456 U.S. 944 (1982), found that an
additional and co-equal liability resided in the govern-
ment. In language which was consistent with what this
Court ultimately held, Judge Higginbotham agreed with
his brethren as to the vaccine manufacturer, stating:
"The regulations in this field place mandatory duties
upon a drug manufacturer, such as Lederle, that seeks
to obtain a federal license to market its drug product."
822 F.2d at 1332 (emphasis supplied). However, citing
to the various regulatory requirements of 21 C.F.R.
§§ 601.2(a), 630.10(b)(2), 630.10(b)(4), and 42 U.S.C.
262(d), he went further than the majority, adopting the
position that the relevant statutes and regulations not
only obligated Lederle, the licensee-applicant, to submit
everything the regulations required, but also obligated
the DBS to require submission of test results and review
the same to measure whether there is full compliance.
Id. at 1333.
Denial of a license when test data failed to prove
that the vaccine conformed with the mandatory require-
ments -- which were the only applicable safety standards
— was what this Court demanded. See 486 U.S. at 544,
n.10, 548. If the manufacturer failed to submit the test
results, the regulatory language imposed a non-discre-
tionary duty on the regulator to insure that that manu-
facturer had to be properly licensed to manufacture its
vaccine. One hundred percent compliance was required.
This Court reversed the Third Circuit and
referenced with approval the broader reading of the
-10-
regulations articulated by the Eighth and Ninth Circuits,
announcing what was assuredly intended to be the rule
of law in regard to licensing and manufacture of all
vaccines. The unanimous Supreme Court in Berkovitz,
supra, stated:
Under federal law, a manufacturer must
receive a product license prior to
marketing a brand of live oral polio
vaccine. See 58 Stat. 702, as amended, 42
U.S.C. § 262(a). In order to become eligible
for such a license, a manufacturer must
first make a sample of the vaccine product.
See 42 CFR § 73.3 (Supp. 1964); 21 CFR
§ 601.2 (1987). [FN7] This process begins
with the selection of an original virus
strain. The manufacturer grows a seed
virus from this strain; the seed virus is
then used to produce monopools, portions
of which are combined to form the
consumer-level product. Federal regula-
tions set forth safety criteria for the
original strain, see 42 CFR § 73.110(B)(2)
(Supp. 1964); 21 CFR § 630. 10(b)(2)(1987),
the seed virus, seed 42 CFR § 73.110(b)(3),
(4) (Supp. 1964); 21 CFR § 630.10(b)(3), (4)
(1987), and the vaccine monopools, see 42
CFR § 73.114 (Supp. 1964); 21 CFR
§ 630.16 (1987).
Berkovitz v. United States, 486 U.S. at 541 (footnote
omitted).
Notwithstanding Berkovitz, the Sixth Circuit in
the within matter found that there had been non-
compliance with the licensing regulatory demands, but
nevertheless, equated its proximate cause significance to
Ry
that of an individual who does not have a driver's license
at the particular moment of an accident leading to
injury, but who had a valid driver's license the day
before the accident, and could get one the day after the
accident.
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, 154 Ohio St.
193, 93 N.E.2d 662, 664 (1950).
What the Sixth Circuit clearly misunderstood and
failed to appreciate was the significance of the licensing
requirements of vaccines in particular, a biological
product which was mandated by many state legislatures
to be administered to children throughout their early
childhood years as a condition precedent to attending
school. No legislator, physician, or public health official
would have permitted the use of non-compliant or non-
licensed vaccine. Stephen A. Szumski, Ph.D., was the
associate director of Cyanamid’s Professional Medical
Service Department from 1965 to 1982. While employed
in that capacity, he chaired a Cyanamid committee
which had the authority over the wording of Orimune’s
$4.
a Pe oa ee Mee a
package inserts and the Physician’s Desk Reference
annual insert. The testimony of this witness was relied
upon by the New Jersey Appellate Division in reversing
a lower court grant of summary judgment for Cyanamid
on theories of failure to warn, strict liability, negligence,
fraud, and punitive damages in Campagna v. American
Cyanamid Company, 337 N.J.Super. 530, 767 A.2d 996
(2001):
Dr. Szumski was also asked if he
was aware that defendant's vaccine had
failed certain safety tests (tests that were
required under the federal regulations),
would he have "notified the medical
profession" if the medical profession had
asked whether the vaccine could be
administered? Dr. Szumski answered,
"Well, I certainly would have told them not
to use it."
The plaintiffs attorney then read to
Dr. Szumski the disputed warning
statement concerning regulatory
compliance from the package insert and
Dr. Szumski testified that he thought
physicians would believe that statement.
When asked if the statement would
constitute a "misrepresentation" or "lie" if
defendant had released vaccine that did
not comply with the regulations, Dr.
Szumski replied, "Well, if they [defendant]
say so and it wasn't so, then certainly I
would believe it's a lie."
On cross-examination by defen-
dant's attorney, Dr. Szumski was asked
"[ijf it was determined by the [FDA] that a
4%.
technical violation of the regulations had
no effect on the safety of the [Orimune
OPV] vaccine, do you think it would be
reasonable for [defendant] to rely on that?"
Dr. Szumski answered, "Yes, [defendant]
would take action and they probably
wouldn't market it." Unsatisfied with this
answer, defendant's attorney repeated the
question and Dr. Szumski again replied:
"([Defendant] would probably act on it [the
FDA's determination] and not use the
vaccine." Still unsatisfied, defendant's
attorney repeated the question again,
whereupon Dr. Szumski answered that
defendant "would use their judgment" in
relying on the FDA's determination.
Finally, on redirect examination by
the plaintiffs attorney, Dr. Szumski was
asked, "Doctor, if in 1978 [Orimune OPV]
did not technically comply with the regula-
tions, if you were aware of that in 1978, |
would you have informed physicians,
hospitals, and other health care providers
of that fact?" Defendant's attorney
objected, and the plaintiffs attorney
rephrased the question, asking "If it
[Orimune OPV] did not technically comply
with the regulations in 1978, would you
have informed health care providers of that
fact?" Dr. Szumski replied that, "[ilf it
didn't comply with the regulations, it
wouldn't have been on the market."
Id. ,767 A.2d at 545-547.
It is evident that this Court's holding in Berkovitz
ata.
was disregarded by the Sixth Circuit when it reviewed
the Graham and Lundy appeals. This Court necessarily
and implicitly ruled that if a vaccine manufacturer fails
to submit any of the requisite safety tests of its license
application, it cannot sell the product. If the manufac-
turer succeeds in obtaining licensure because of the
regulator’s failure to enforce regulatory requirements,
neither the government nor the vaccine manufacturer
can claim that a person injured does not have a valid
damage claim. Any conduct which departs from what
the regulations mandate is squarely prohibited. If the
manufacturer-license applicant fails to submit the
required safety test results, or if the sample of the oral
polio vaccine product intended to be marketed fails the
government’s own safety testing, or if the manufacturer
failed to present proof as to the absence of adventitious
agents, then the license application as presented must
be rejected. Pursuant to the Public Health Service Act,
42 U.S.C. § 262(d), and the regulations enacted
thereunder, neither the government nor the vaccine
maker can permit the product to be sold. The Berkovitz
Court held:
A regulation similarly provides that "[a]
product license shall be issued only upon
examination of the product and upon a
determination that the product complies
with the standards prescribed in the
regulations... ." 42 CFR § 73.5(a)(Supp.
1964); see 21 CFR § 601.4 (1987). In
addition, a regulation states that "[a]n
application for license shall not be
considered as filed" until the DBS receives
the information and data regarding the
product that the manufacturer is required
to submit. 42 CFR § 73.3 (Supp. 1964); 21
CFR § 601.2 (1987). These statutory and
at$.
regulatory provisions require the DBS,
prior to issuing a product license, to
receive all data the manufacturer is
required to submit, to examine the
product, and to make a determination that
the product complies with safety
standards.
Berkovitz, 486 U.S. at 542 (emphasis supplied).
It is unquestionable that from the very earliest
days of Orimune, American Cyanamid fully understood
the importance of compliance with the regulations: in
order to convince physicians, legislators, the parents of
infants, and the public health community that its
vaccine was safe, Lederle stated on each of its package
inserts, and on each container of Orimune that was
shipped from its plant, that it had fully complied with all
of the regulations that were in effect at the time of release.
See Lundy & Graham v. American Cyanamid Company,
2000 WL 1911431 at *5 (App. B). That express and
affirmative warranty statement was false (see In_Re
Sabin Oral Polio Vaccine Products Liability Litigation,
984 F.2d 124 (4th Cir. 1993), affg 743 F. Supp. 410 (D.
Md. 1990) ("Sabin I"), 763 F. Supp. 811 (D. Md. 1991)
("Sabin II"), and 774 F. Supp. 952 (D. Md. 1991) ("Sabin
III")) and flew directly in the face of what the vaccine
manufacturer was required to do under the Public
Health Act and under the regulations which were
enacted pursuant to that Congressional mandate.
Berkovitz v. Unit tates is the law of the land,
and if this Court fails to grant certiorari, the Sixth
Circuit's decision in these cases will conflict
irreconcilably both with this Court's Berkovitz decision
and the decisions of the circuits which have applie
Berkovitz’ holdings and with the applicable era
-16-
tll
statute, 42 U.S.C. § 262(d), not to mention the plain
meaning of the text of the regulations themselves. In
essence, the requirement to be properly licensed in order
to sell a vaccine (or, in a more general sense, a drug) in
the United States, which was the basis for this Court's
discretionary function exception decision in Berkovitz,
will have been abolished by the Sixth Circuit, notwith-
standing the clear language of this Court and the
authorizing statutes.
The possibly unintended but inevitable conse-
quence of allowing the Lundy and Graham decision to
stand will be that in the future, a drug or vaccine
manufacturer will be able to point to the Sixth Circuit
decision and argue that whenever licensing require-
ments may have been overlooked, ignored, omitted,
performed improperly, or even falsified and resulted in
injury or death, the government, and not the manufac-
turer / licensee, is liable in damages for breach of that
duty, and that Berkovitz, supra, does not in any way
speak to liability which can result from failures or
defalcations on the part of the manufacturer.
To the contrary, Berkovitz confirmed that a
regulatory system such as that which governed the oral
polio vaccine involved here created a very calculated and
deliberate additional layer of liability, over and above the
vaccine manufacturer’s direct liability, which has never
been diminished by this Court. Furthermore, in the face
of the oral polio regulatory scheme, that direct liability
was strict and absolute if the regulation was breached at
any time or at any juncture. The failure of experts to cite
peer-viewed studies to support their conclusions where
there are unquestioned violations of the safety tests used
to measure neurovirulence of the vaccine cannot be a
basis to deny relief to paralyzed polio victims exposed to
an unacceptably neurovirulent vaccine.
si?
Cyanamid’s failure to submit the safety test
results can not be as the Sixth Circuit has determined --
that it is “only an issue of licensing” and, therefore, not
important, much as failure to have a driver license is not
a basis for liability in Ohio.
Clearly, from the Pennsylvania District Court and
Third Circuit decisions which were the predicate of what
this Court ruled in Berkovitz, it was a given that the
regulations at issue were addressed to the conduct of
the manufacturer and governed the conduct of the
manufacturer with at least as great consequence in their
breach as attached to the government. This Court in
Berkovitz did not alter in any manner that portion of the
two Berkovitz decisions below which correctly articulated
the law as it applied to the vaccine manufacturer.
Petitioners respectfully submit that if that is the
case, and if Berkovitz v. United States is to have any
substantive meaning at all, this Court must re-affirm
what it cogently proclaimed in Berkovitz , but the Sixth
Circuit declined to accept: the obligation of the vaccine
manufacturer, as well as the government, must fulfill the
duties created and mandated by the duly promulgated
regulatory system in effect at the time of the release of the
product, which system had been subject to extensive
public and industry comment.
For this reason, we respectfully request this Court
to grant the Writ of Certiorari so that this issue involving
the duties of drug and vaccine manufacturers to comply
under the federal regulations can be clarified for all time
in regard to the licensing of this product.
-18-
A. Although Oral Polio Vaccine Is No Longer
in Use in the United States, the Issues Raised by
this Petition Are Not Moot, and the Issue of the
Safety of this Vaccine Is a Matter of National
Concern to the Public Health.
The mootness doctrine does not apply here and is
not an appropriate reason for the Court to deny
certiorari in these cases. To the contrary, the extreme
currency and the high importance of the Court's review
of this matter can easily be ascertained by examining the
Orimune-related public health issues currently being
discussed and debated in the scientific community and
in its peer-reviewed literature as a new public health
issue of substantial concern. That issue is whether
Orimune oral polio vaccine contained the carcinogenic
simian virus adventitious agent, SV40, in violation of
licensing provisions of the regulations which prohibited
American Cyanamid from selling any Orimune which
contained any adventitious agents. 42 C.F.R.
§ 73.110(b)(3) (renumbered as 21 C.F.R. § 630. 10(b)(3))
(App. D). There is presently litigation in the courts of
California, New Jersey, and Texas which questions
whether American Cyanamid truthfully told the world
scientific community that its Orimune product was free
of the cancer-causing agent SV40. The failure to comply
with the licensing requirements mandating demonstra-
tive proof that SV40 was not in any oral polio vaccine
intended to be distributed and sold in the United States
is now before those courts, before the international
scientific community, and before Congress.°
* See Sept. 10, 2003: Hearing Before the House Energy
and Commerce Subcommittee on Human Rights and Wellness,
Com-mittee on Government Reform, Serial No. 108-85, “SV-40
Virus: Has Tainted Polic Vaccine Caused An Increase in Cancer”
(available full text at www.access.gpo.gov/congress/house /
-19-
B. The Regulatory Scheme And The Amend-
ments Thereto.
When Messrs. Lundy and Graham were paralyzed
by the live virus in Orimune, the OPV regulations then
in effect were basically the regulations that had been
enacted in 1960. Those very regulations had been the
subject matter of federal court decisions in Baker v.
United States, 817 F.2d 560, 566 (9th Cir. 1987) (license
may not issue unless vaccine manufacturer has
submitted all the relevant test data), Berkovitz, and Loge
v. United States, 662 F.2d 1268 (8th Cir. 1981), cert.
denied, 456 U.S. 944 (1982), and thereafter, the In Re
Sabin decisions cited supra. In 1991, following the
District Court's decisions in In Re Sabin (“Sabin II”), the
United States, at the behest of American Cyanamid,
immediately changed the regulations to permit the legal
sale of Orimune at a tissue culture passage greater than
the five tissue culture passages the regulations had
house07ch108. html (accessed 02/28/04); Hearing Before the
House Energy and Commerce Subcommittee on Human Rights
and Wellness, Committee on Government Reform, Nov. 13,
2003: “Preventing Another SV40 Tragedy: Are Today’s Vaccine
Safety Protocols Effective?” Serial No. __ (in press); Report by
Immunization Safety Review Committee on Health Promotion
and Disease Prevention of the Institute of Medicine,
Immunization Safety Review SV40 Contamination of Polio
Vaccine and Cancer, Klein G, Powers A, Croce C. “Association
of SV40 with human tumors” Oncogene, 21:1141-1149, 2002;
Gazdar, A.F., Butel, J., and Carbone, M.,SV40 virus and
human tumours, Nature Reviews Cancer, 2:957-964, 2002. Cf.
American Cyanamid’s presentation and paper by Brock,
Kelleher and Zlotnick: Simian Virus 40 (SV40): A Possible
Human Polyomavirus: Product Quality Control testing for the
Oral Polio Vaccine, Developments, Biologic Standardization,
217-219 (1998).
20.
previously permitted.
At Cyanamid's request following Sabin II, supra,
the government re-designated what the "original strain
material" would be considered to be for the Type III
component of the trivalent vaccine. At that time and for
many years before, the only OPV manufacturer in the
United States was American Cyanamid, and the only oral
polio vaccine sold was Orimune. American Cyanamid by
that time realized that it could no longer utilize the seeds
that it had been utilizing to produce its Type III trivalent
component, because they had been shown to be highly
neurovirulent in humans, and the Maryland District
Court and the Fourth Circuit had so held. See In Re
Sabin, supra, 763 F. Supp. at 817, 823 n.11, 827, 828,
citing Berkovitz (at 827). See also Berkovitz, supra, 486
U.S. at 547.
Even after the regulations were changed in 1991,
that change, relating to tissue culture passages,
| pertained solely to the Type III component; the
regulatory agency was not asked to make changes to any
other parts of the regulations, and it did not do so sua
sponte. Accordingly, the Type I and Type II components,
which were combined with the Type III to make the
trivalent Orimune vaccine Jason Lundy and Zachary
Graham received, all had to have passed the require-
ments of the mandatory regulatory system. Not a single
type* of polio vaccine ever satisfied the initial licensing
requirements which were in effect in 1991 and which
4 There are three strains of wild poliovirus and,
therefore, three types of vaccine are needed to confer human
immunity. Shortly after introducing Orimune as three
different monovalent vaccines, Cyanamid applied for and
received permission to market a trivalent product, the only
form of Orimune thereafter sold.
cs
A ine
ilar Bric a wk
remain in effect even today (see POINT III, infra), and the
failure to submit the test results of all seeds continued
with respect to the Type I and Type II vaccines utilized in
the United States from the 1970s to 1999, when the last
oral polio vaccine was distributed in the United States.
American Cyanamid has been forced to admit to the
same, and it is part of the Congressional record. Sept.
10, 2003 Hearing, Report Serial No. 108-85, at 231-232
(Request for Admissions Nos. 9 and 10).
The 1991 change in regulations did no more than
make prospectively permissible and "acceptable" under
the amended regulations a Type III vaccine component
that was at the seventh tissue culture passage from the
original seed. If, forexample, Zachary Graham had been
a plaintiff in the In Re Sabin Multi District Litigation, he
would have been entitled to judgment either against the
United States or against American Cyanamid, just as
were the actual In Re Sabin plaintiffs, in whose favor
judgment was entered and affirmed, because Zachary’s
paralysis had occurred prior to 1991.
The subsequent removal of the regulations in
1996 (see 350 F.3d at 514) pertained to all vaccines, not
merely oral poliovirus vaccine. In any event, it was
unrelated to the initial licensing requirements applicable
to every manufacturer-applicant for a vaccine license.
This change indicated that the regulator, in order to
fulfill the congressional mandate, agreed with this Court
and its holding that the license and the tests conducted
to procure that license was the measuring rod used to
determine the safety of the product. The word standard
was further defined in 1996 to constitute “ .
specifications and procedures applicable to an
establishment or to the manufacture or release of
products, which are prescribed in this subchapter or
established in the biologics license application
7.
Ee
i ne a a a Te ee
EE See A. eee,
designed to insure the continued safety, purity and
potency of such products.” 21 C.F.R § 600.3(n) (2000)
(emphasis supplied). The regulations were still to be
followed, because the license requirements demanded it.
From 1996 until the last day on which it manufactured
Orimune, American Cyanamid continued the identical test
regimen it had used to produce the Lundy and Graham
doses. The requirements remained the same --
notwithstanding what the Sixth Circuit erroneously
stated -- both in the statutory scheme and in actual
practice.
Il. THIS COURT SHOULD GRANT THE
PETITION BECAUSE THE HOLDING OF
THE SIXTH CIRCUIT DENIGRATES INTO
OBLIVION NEUROVIRULENCE, THE
CENTRAL UNDERPINNING OF THE
ENTIRE FEDERAL OPV REGULATORY
SCHEME.
The Sixth Circuit incongruously determined that
notwithstanding American Cyanamid's failure to comply
with the neurovirulence test standards (In re Sabin, 763
F. Supp. at 813, 815, 817 n.7, 818, 820, 822, 826, 827,
828 n.17, 829), and even though the neurovirulence of
the vaccine was higher than the reference standard
allowed, the Sixth Circuit stated that that did not relate
to an increase in the risk to an individual recipient. 350
F.3d at 509-510, 511-512. The Sixth Circuit quoted this
Court in part (350F.3d at 510), but failed to follow and
apply the entire statement of this Court. The Sixth Circuit
quoted the first sentence of this Court’s description of
neurovirulence, but then completely ignored and omitted
the Court’s next statement, which was that
neurovirulence is the barometer by which one can
determine whether administration of the vaccine will
24.
result in vaccinees contracting paralytic poliomyelitis.
This Court stated the following in regard to neuro-
virulence:
Neurovirulence is the capacity of an infec-
tious agent to produce pathologic effects
on the central nervous system. In this
context, it refers to the vaccine's ability to
cause paralytic poliomyelitis. The neuro-
virulence of a vaccine product is tested by
injecting the product into monkeys. The
product meets the neurovirulence criterion
only if a specified number of the animals
survive and a "comparative analysis"
demonstrates that the neurovirulence of
the vaccine product "does not exceed” the
neurovirulence of a reference product
previously selected by the agency. 42 CFR
§73.114(b)(1)(iii) (Supp.1964); 21 CFR
§ 630. 16(b)(1)(iii) (1987).
Berkovitz, supra, 486 U.S. at 542.
Such a position is irreconcilable under the plain
language of the regulations and under the holding of
Berkovitz v. United States, because the inescapable and
anomalous conclusion which the Sixth Circuit's findings
compel is that there was no purpose served by the
regulations. See Report, Serial No. 108-85, supra, at
228-233, 240, 248.
As the record below amply demonstrated from
Cyanamid's own business records (Cyanamid filings in
FDA Docket No. 86N-0027, the public record of a formal
rulemaking), the so-called "change" in the tests that
occurred in 1991 (56 Fed. Reg. 21,418 et seq. (May 8,
-24-
a Nena
1991)), had been fought by American Cyanamid in at
least seven separate submittals to the FDA extending
from 1984 through and after 1991. FDA Docket No.
86N-0027 (pertinent portions reproduced in App. E)
reflects not the support for amendment "relaxing" the
regulatory requirements, as one would anticipate from
the position Cyanamid took in the court below, but
rather the total opposition of the defendant below to any
government attempt to amend the neurovirulence test
protocol to broaden the range of test results which the
regulations would accept as associated with a "safe" lot
of vaccine. Cyanamid adopted this position notwith-
standing that every FDA scientist involved in the rule-
making effort had concluded that the newer method of
calculating the test results was a better method of
insuring public safety. The In Re Sabin Court deter-
mined the following in 1991 in regard to American
Cyanamid’s willingness to utilize the new and safer
method:
In 1986 DBS did seek extensive amend-
ments for the purpose of adopting the
WHO regulatory scheme in the United
States. Under the WHO regulations (of
which, incidentally, Dr. Elisberg is a strong
proponent) only intraspinal need to be
conducted and type 3 lots are to be
compared to a type 3 reference history.
Opposed by Lederle, the proposed amend-
ments failed.
763 F. Supp. at 821 n.10.
In the new test protocol proposed by the FDA and
opposed by Cyanamid, the test performed was identical
to what it had been, as was the degree (scored on a 0 -
4 "grade" scale) of any observed simian test animal
26.
lesion, as was the method by which the calculation was
to be performed. The only difference lay in what
reference standard would be used, how one would
compare the test results, and on what materials the
tests would be conducted.
At the behest of American Cyanamid, however,
the regulations ultimately continued to allow the
vaccine manufacturer (in this instance, American
Cyanamid, which had already assumed OPV monopoly-
supplier status) to utilize none other than the identical
method it had utilized from 1960 up to that point. After
1977, when the last of the OPV licensees competing with
Lederle closed up shop under the intense economic
pressure that Lederle's methods of marketing to
pediatricians and other physicians created, no other
vaccine manufacturer ever again sought licensure in the
United States for the production of oral polio vaccine.
By preserving the regulations to require both the
intrathalamic and intraspinal tests be conducted, as
originally set forth in the regulations, Lederle realized its
goal of excluding other biological firms from OPV market
competition. The only other manufacturer did not per-
form the intrathalamic test. Lederle now had the best
of ali worlds: it would continue to present regulatorily-
unacceptable vaccine lots to the releasing agency, and if
they were approved for release -- whether rightly or
wrongly -- that simply translated into that much more
sellable product and profit for Cyanamid.
It was, in fact, precisely that wrongful approval
under Berkovitz which resulted in the government being
held liable by the Fourth Circuit in the In Re Sabin Multi
District Litigation. See 984 F.2d 124, 128 (4th Cir.
1993).
"=
OR Sei hee Fa Ts wa a DAT Se
teil Ty
By 1991, American Cyanamid knew from its
lengthy production experience history that it could not
comply with the new amendments were the government
to enforce them, and conversely, that its competition,
Connaught Laboratories, could not comply with the
existing regulations, which the government was failing
to enforce against Cyanamid. Therefore, by fighting any
change until 1991, American Cyanamid accomplished its
goal of keeping the competition out, while retaining the
opportunity provided by government non-enforcement to
continue to violate the neurovirulence regulations
through monovalent pool test results that exceeded the
entire history of testing on the reference standard.
Cyanamid had convinced the FDA by that late date in
American production of OPV that if the government
would suddenly begin enforcing the regulations as the
words of the regulation required, the results from the
vaccine production of the nation's only OPV supplier
would constitute an admission that the government had
been violating, and continued to violate, the require-
ments this Court set out in Berkovitz.
III. THE POLIO VACCINE REGULATIONS
HAVE NOT BEEN ABOLISHED.
The Sixth Circuit and the district court both
found that the “removal” of all safety regulations in 1996
proved the contention of American Cyanamid that the
regulations were useless. This Court has in the past
issued opinion after opinion stating the importance of
enforcing the regulations applicable at the time of
operative events which flow from the regulations. There
is no legal precedent in the sefety regulatory system for
the approach the Ohio Southern District court and the
circuit court used to determine the standard of conduct
which would control rights of recipients of drugs and/or
vaccines and questions of the public health.
Eo
American Cyanamid argued successfully below that its
non-compliance with the regulations was excused by the
amendment to the five tissue culture safety rule in 1991
(one of the bases for the Grahams’ claim) -- and
thereafter, as the Sixth Circuit Court of Appeals found at
the behest of American Cyanamid -- the obsolete
regulations were all abolished in 1996. 350 F.3d at 514.
This retroactive application of regulatory amendments to
an operative event giving rise to a cause of action runs
counter to the jurisprudence of this Court and of this
country.
Justice Scalia has stated that the presumption
against retroactive legislation is deeply rooted in our
jurisprudence and embodies a legal doctrine centuries
older than our Republic. Elementary considerations of
fairness dictate that individuals should have an
opportunity to know what the law is and to conform
their conduct accordingly; settled expectations should
not be lightly disrupted. For that reason, the “principle
that the legal effect of conduct should ordinarily be
assessed under the law that existed when the conduct
took place has timeless and universal appeal.” Kaiser
Aluminum & Chemical Corp. v. Bonjorno, 494 U.S. 827,
842-844, 855-856, (1990) (Scalia, J., concurring). Ina
free dynamic society, creativity in both commercial and
artistic endeavors is fostered by a rule of law that gives
people confidence about the legal consequences of their
actions. See, also, General Motors Corp. v. Romein, 503
U.S. 181, 191, (1992) (“Retroactive legislation presents
problems of unfairness that are more serious than those
posed by prospective legislation, because it can deprive
citizens of legitimate expectations and upset settled
transactions”); Munzer, A Theory of Retroactive Legisla-
tion, 61 Texas L.Rev. 425, 471 (1982) (“The rule of law
_. is a defeasible entitlement of persons to have their
behavior governed by rules publicly fixed in advance”);
-28-
a Or A lala ene HOO! Be
Maa LE TID IGA AN BOBO ob
o Vidteear detiint
Beek a ARLEN OM NTR Nha
ee a ee —
L. Fuller, The Morality of Law, 51-62 (Yale U. Press
1977).
Even if it were the case that the regulations were
no longer in effect, we respectfully submit that does not
change the obligation of the vaccine manufacturer at the
time of the occurrences in question. However, the regula-
tions were not amended and were not made obsolete;
as to Orimune, they were the rule of law which every
physician and every parent relied on to insure that their
children were not exposed to an unlicensed or unsafe
product.
This Court should grant the writ so as to put to
rest whether safety regulations can be made “obsolete”
nearly two decades after the individuals exposed to the
product governed by those regulations have suffered
paralysis which the regulations were intended to prevent.
This Court’s grant of certiorari will put an end to Cyana-
mid’s fiction that the OPV regulations were rendered
obsolete. They were not: all that occurred was a
structural streamlining of the existing regulations under
which all vaccines (one of which was the oral polio
vaccine) no longer needed to be regulated through
individually promulgated regulations, because the word
“standards” in the definitions of the Food and Drug Act
was expanded to incorporate the original licensing
process:
(n) The word standards means specifi-
cations and procedures applicable to an
establishment or to the manufacture or
release of products, which are prescribed
in this subchapter or designed to insure
the continued safety, purity and potency of
such products.
-29-
21 C.F.R. § 600.3(n) (2000) (emphasis supplied).
The regulators saw the wisdom of this Court’s
reliance on the licensing requirements in Berkovitz and
once again emphasized as central to the process the same
points which the Sixth Circuit ignored. The regulators
understood that the tests necessary to secure a license
were the best barometer by which to judge the product.
If this Court fails to grant certiorari and allows the
Sixth Circuit’s opinion to stand, every future litigant will
be misled to believe that licensing serves no safety
purpose, that the regulations’ requirements of submis-
sion of safety testing data is optional for licensing a
vaccine, and that even if the data are non-conforming to
the standards (now, the license), it does not matter.
Such an outcome is in direct conflict with the
Congressional mandate, this Court’s opinions, and now,
even the regulator’s own determination to make
licensure the barometer by which to measure safety.
CONCLUSION
For all the reasons stated herein, the Petition for
Writ of Certiorari should be granted.
DATED: March 1, 2004
Marc S. Moller (MM-1231)
Kreindler & Kreindler LLP
100 Park Avenue
New York, New York 10017
(212) 687-8131
Counsel for Petitioners and
Counsel of Record
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mat ta
7 Stanley P. Kops
102 Bala Avenue
7 Bala Cynwyd, Pennsylvania 19004
(610) 949-9999
Counsel for Petitioners
SSA RTP
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——— ——
United States Court of Appeals,
Sixth Circuit.
Joseph R. GRAHAM, et al., Plaintiffs-Appellants,
v.
AMERICAN CYANAMID COMPANY, Defendant-
Appellee.
Roy Lee Lundy, et al., Plaintiffs-Appellants,
v.
American Cyanamid Company, Defendant-
Appellee.
Nos. 01-4175, 01-4176.
Argued: Aug. 1, 2003.
Decided and Filed: Dec. 3, 2003.
Reported at 350 F.3d 496
Before: DAUGHTREY, MOORE, and SUTTON,
Circuit Judges.
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OPINION
SUTTON, Circuit Judge.
he ee nS ee
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 the
exposure to it in another caused a family member to
contract polio.
App. A- 1
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 *499 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 tu 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.
App. A -2
Litig., 743 F.Supp. 410, 412 (D.Md.1¢90) ("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.
App. A - 3
=
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 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 *500 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
App. A-4
OO RR TANTS I A RS on
we RIA ANNs OT aN NS SNR ts iat Neer ow ed ei eddy Sa NE
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 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 II 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
App. A - 5
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.
*501 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
App. A - 6
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 seg. (1977); Public
Health Act, 42 U.S.C. §§ 262. Certain regulations are
addressed solely to manufacturers of OPV. See 21 C.F.R.
§§8§ 630.10-17; Berkovitz ex rel. Berkovitz v. United
States, 486 U.S. 531, 541, 108 S.Ct. 1954, 100 L.Ed.2d
931 (1988). Others are 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)-(ii).
"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, 108 S.Ct. 1954.
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. §§
App. A - 7
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.
*502 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
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
"[vjirus 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
App. A- 8
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), affd, 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., 139 F.3d 890, 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 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.
App. A -9
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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 *503
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
"[vjirus 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.
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.
App. A - 10
At Ae PE at
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
2 relationship exists.
“a dest BA UCR Sipe LEE Mi aA
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 [ JOPV were
App. A - 11
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
*504 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
App. A - 12
—E
(ee) Som be ed cE
practice in the United States. The
responsible adult should be informed cf
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 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 admitt«-d to Grady Memorial Hospital
in Delaware, Ohio, wher oe 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
\
App. A - 13
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. §§ 30Qaa-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) 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.
*505 Roy's doctors advised him that the probable
source of the disease was the Orimune vaccine given to
App. A - 14
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.
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., 54 Ohio App.3d 192, 561 N.E.2d 1027
(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.
App. A - 15
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 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.
*506 E. The District Court's Decision
App. A - 16
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 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
App. A - 17
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, 106
S.Ct. 1348, 89 L.Ed.2d 538 (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.3d 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.
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 *507
District Court that the claims must be summarily
App. A - 18
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.,
59 Ohio St.3d 42, 570 N.E.2d 1076, 1083 (1991). The
elements of the claim are conjunctive, and accordingly
all of them must be shown. See Schwartz v. Capital Sav.
& Loan Co., 56 Ohio App.2d 83, 381 N.E.2d 957, 959
(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?
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
App. A - 19
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, 23 Ohio St.3d 69, 491 N.E.2d 1101,
1105 (1986); Cohen v. Lamko, Inc., 19 Ohio St.3d 167,
462 N.E.2d 407, 409 (1984). See also Picklesimer v.
Baltimore & O.R. Co., 151 Ohio St. 1, 84 N.E.2d 214
(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 Uv.
Preterm-Cleveland, Inc., 33 Ohio St.3d 54, 514 N.E.2d
709, 712 (1987) (holding that misstatement by doctor
could have caused plaintiffs 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 Strother v. Hutchinson, 67 Ohio
St.2d 282, 423 N.E.2d 467, 471 (Ohio 1981); Pfirsch v.
Hall-Omar Baking Co., 6 Ohio App.2d 108, 216 N.E.2d
626, 628 (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, 113 S.Ct.
2786, 125 L.Ed.2d 469 (1993); cf Berdyck v. Shinde, 66
Ohio St.3d 573, 613 N.E.2d 1014, 1022 (1993).
App. A - 20
battens ie omisna nasa
*508 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
App. A - 21
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. 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 996 (2001)). But he did not find a correlation
or any study supporting the existence of such a
correlation. Id.
App. A - 22
*509 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 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:
App. A - 23
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--
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, 9 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., 2000 WL 1911431, 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,
App. A - 24
it expressly recognized the absence *510 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.
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
nencompliance 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
App. A - 25
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 ... | 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).
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.
App. A - 26
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 *511 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 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
App. A - 27
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, 15 Ohio St.3d 316,
473 N.E.2d 827, 828 (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, 82
Ohio St.3d 563, 697 N.E.2d 198, 201 (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.
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.
App. A - 28
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 plaintiffs 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 *512 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 t’:at may not
qualify for use by itself in order to reach F_4-regulated
potency levels and must do so without violating anc*her
FDA regulation. The Lundy (and Graham) experts ain
did not offer a tenable basis for concluding tha. re-
bulking vaccine potency with expired or rejected material
negatively affects product safety.
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
App. A - 29
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.)
Ohio has adopted §§ 402A of the Restatement
(Second) of Torts (1965) as the standard for strict
App. A - 30
liability. See Temple v. Wean United, Inc., 50 Ohio St.2d
317, 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 ail
possible care in the preparation and
sale of his product, and
*513 (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., 37 Ohio St.3d 1, 523 N.E.2d 489,
494 (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
App. A - 31
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 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 rej ected 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, 154 Ohio St. 193,
App. A « 32
93 N.E.2d 662, 664 (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., 40
Ohio St.3d 390, 533 N.E.2d 748, 752 (1988) ("a
manufacturer of an unavoidably unsafe product may not
be held strictly liable for injuries caused 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 Graharns independently bring a negligent
failure-to-warn claim. See*514 Crislip v. TCH Liquidating
Co., 52 Ohio St.3d 251, 556 N.E.2d 1177, 1181-82
(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
App. A - 33
:
:
H
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 toa prescribing physician
is inadequate, the plaintiff must prove his claim through
expert medical testimony. See, e.g., Jones v. Roche Labs.,
84 Ohio App.3d 135, 616 N.E.2d 545, 547 (1992).
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 Cal.App.3d 812, 818-19, 834-36, 218
Cal.Rptr. 453 (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., 67 Ohio St.2d 192, 423 N.E.2d 831, 838
(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),
App. A- 34
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 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 *515 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., 41 Ohio App.3d 392, 536
N.E.2d 25, 36 (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.
Ill, CONCLUSION
App. A «35
For the foregoing reasons, we AFFIRM.
App. A - 36
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
Nos. 01-4175; 014176
FILED
DEC - 3 2003
LEONARD GREEN, Clerk
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,
Vv.
AMERICAN CYANAMID COMPANY,
Defendant - Appellee.
Before: DAUGHTREY, MOORE, and SUTTON,
Circuit Judges.
App. A - 37
JUDGMENT
On Appeal from the United States District Court
for the Southern District of Ohio at Columbus.
THIS CAUSE was heard on the record from the
district court and was argued by counsel.
IN CONSIDERATION WHEREOF, it is ORDERED
that the judgment of the district court is AFFIRMED.
ENTERED BY ORDER OF THE COURT
Leonard Green
Leonard Green, Clerk
~ App. A - 38
United States District Court,
S.D. Ohio, Eastern Division.
Joseph R. GRAHAM, et al., Plaintiffs,
Vv.
AMERICAN CYANAMID COMPANY, Defendant.
Roy Lee LUNDY, et al., Plaintiffs,
AMERICAN CYANAMID COMPANY. Defendant.
Nos. C-2-94-423, C-2-94-425.
Dec. 21, 2000.
[Reported at 2000 WL 1911431]
OPINION AND ORDER
SMITH, District Judge
[*1] Plaintiffs Roy Lee Lundy and Zachary Graham
assert state law claims alleging that they became
permanently disabled by a polio vaccine (named
"Orimune") that was manufactured by defendant
American Cyanamid Co. Jason Lundy, as a child of Roy
Lee Lundy, brings a derivative claim for loss of parental
consortium based on product defect and failure to warn.
This matter is before the Court on defendant's motion for
summary judgment in each case. For the reasons herein,
the Court grants defendant's motion for summary
judgment in both cases. [FN1]
FN1. The Court also denies plaintiffs' motion of
May 18, 1999 that seeks a stay of disposition of
App. B- 1
defendant's summary judgment motion, a
"Bratka" hearing, and an order of the U.S.
Marshall to seize all of defendant's records
concerning the production, manufacture, and
testing of Orimune between 1972 and 1984 (Doc.
188).
I. BACKGROUND
Poliomyelitis and the Orimune Vaccine
Polio is a disease of the central nervous system.
In 1955, Dr. Jonas Salk developed a vaccine against
polio. Dr. Salk's vaccine was an inactivated polio vaccine
("IPV") derived from a dead polio virus. The Salk vaccine
decreased the incidence of polio but did not eradicate it.
While Dr. Salk was developing his IPV, which had to be
injected, Dr. Albert Sabin, among others, was working
on an oral polio vaccine ("OPV"). The OPV, unlike the
IPV, is produced from live polio virus that is weakened,
but not killed.
OPV has advantages over IPV. First, OPV is less
expensive and requires only a single dose, as opposed to
three inoculations of IPV and a follow-up booster shot.
Second, OPV is administered orally, commonly on a
sugar cube, while IPV must be injected by a hypodermic
needle. Third, the interaction of the live virus in OPV
with the immunological system confers lifetime
immunity. IPV, in contrast, requires periodic
readministration. Fourth, the oral administration
stimulates the body's production of antibodies in the
gastrointestinal tract as well as in the bloodstream,
thereby producing bowel immunity which interrupts the
method of transmitting the wild strain of the virus.
Persons vaccinated with OPV shed vaccine viruses
through feces and saliva to nonvaccinated persons,
thereby conferring immunity on them as well.
\
App. B -2
There are, however, inherent risks with the
administration of OPV. The live but weakened viruses of
OPV grow in the intestinal tract of the vaccinated
individual. The growing viruses trigger the vaccinee's
immune system to produce antibodies which makes the
vaccinee immune to the disease after thirty days.
However, on extremely rare occasions, the virus
reproduced in the vaccinee's intestinal tract reverts to
the virulent form. When this occurs, the vaccinee or
persons coming in close contact with the vaccinee
during the thirty day period may contact polio.
Unvaccinated adults can take two precautions to avoid
the risk of "contact 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 1960, the Surgeon General declared that OPV
was suitable for use in the United States. In 1961, the
Division of Biologic Standards of the National Institutes
of Health ("DBS") adopted regulations governing the
issuance of manufacturing licenses and the approval
and release of OPV. Cyanamid purchased strain material
that had been developed by Sabin and allegedly applied
to DBS for a license to manufacture and sell OPV. Since
1963, Cyanamid has distributed an OPV product under
the name Orimune, and since 1977, Cyanamid has been
the sole supplier of OPV in the United States.
[*2] Orimune is composed of all three Sabin strains of
live polio virus corresponding to the three different types
of polio, known as Types I, II, and III. This results in the
designation "trivalent." Because of the inherent risks in
the Sabin strains, the Secretary of the Department of
Health, Education, and Welfare promulgated regulations
to protect susceptible persons form contacting the
disease. 21 C.F.R. §§§§ 630. 10-630. 18 (formerly codified
at 42 C.F.R. §§§§ 73.110-73.118). Drug manufacturers
App. B - 3
had to prove its product's conformity with these
regulations before the Secretary could issue a license
authorizing manufacture. 42 U.S.C. §§ 262(d).
Orimune is not sold directly to patients, but rather is
distributed to physicians, hospitals, and clinics.
Graham, et al., v. American Cyanamid Co
Plaintiff Zachary Graham was born on May 2,
1984. On July 3, 1984, he was taken to one of the offices
of Delaware Family Practice, P.C. for an administration
of Orimune for the immunization from polio. Around
July 26, 1984, Zachary Graham began experiencing
fever, irritability, lethargy, and general lack of interest
and was admitted to Grady Memorial Hospital in
Delaware, Ohio where he remained until July 29, 1984.
Plaintiff was diagnosed by the Centers for Disease
Control in Atlanta as suffering from Type III poliomyelitis
from the Orimune administered to him on July 3, 1984.
As aresult, Zachary Graham is permanently disabled in
his lower extremities.
Graham plaintiffs filed a petition in the United
States Court of Federal Claims, seeking compensation
under the National Vaccine Injury Compensation Act.
Later, they filed a motion to voluntarily dismiss the
petition under the National Vaccine Injury
Compensation Program, which was approved on
December 10, 1993. The present action was filed on May
10, 1994 by plaintiff Zachary Graham, then a minor, by
and through his parents Joseph and Lisa Graham.
Graham plaintiffs bring state law claims for: (1) common
law fraud; (2) strict products liability; (3) negligence;
and, (4) punitive damages. Defendant Cyanamid moves
for summary judgment on each of Graham plaintiffs
claims.
Lundy, et. al., v. American Cyanamid Co.
App. B - 4
ST
Mitte Minin. > —— ee
On March 24, 1977, plaintiff Jason Lundy was
taken by his mother for a routine check-up and given a
dosage of Orimune for immunization from polio by Dr.
Carl Greever, M.D., in an office of the Jackson County
Combined General Health District. On April 19, 1977,
Jason's father, plaintiff Roy Lee Lundy, began to
experience fever, headaches, diarrhea, myalgia, malaise,
and great weakness. He was admitted to Mercy Hospital
in Portsmouth, Ohio. He was transferred to Ohio State
University Hospital in Columbus about a week later
where he was diagnosed as suffering from poliomyelitis.
He was advised that the probable source of the polio
virus was the Orimune given to his son and that it had
likely been transmitted to him through close contact
with his son. Roy Lee Lundy's poliomyelitis is a
permanent condition and has rendered him a paraplegic.
[*3] The package insert that accompanied the
Orimune administered to Jason Lundy in March 1977
included a warning that "paralytic disease following the
ingestion of live poliovirus vaccines has been reported in
individuals receiving the vaccine, and in some instances,
in persons who were in close contact with subjects who
had been given live oral poliovirus vaccine." This
warning mirrored the Orimune entry in the 1977
Physicians’ Desk Reference that warned of the rare
occurrence of paralytic disease "in persons who were in
close contact with subjects who had been given live oral
poliovirus vaccine" and that "those parents of a vaccinee
who have not had previous polio vaccination should
probably be considered among those adults as subject to
increased risk of exposure and in this special situation,
in the judgment of the physician responsible, protection
may be needed for these intimate contacts." Both the
package insert and the Physicians’ Desk Reference entry
for Orimune also contained a statement that Orimune
had been licensed, manufactured, tested, and released
in accordance with FDA regulations.
App. B - 5
Plaintiffs allege that they did not suspect that
defendant had acted wrongfully until they saw a
television program on vaccine-induced cases of polio on
September 27, 1985. After viewing this program, Lundy
plaintiffs attempted to recover for their injuries by filing
an action in state court and a petition in the United
States Court of Federal Claims. Judge David Cain
dismissed each of the Lundys' actions for bodily injury
and loss of spousal consortium as time-barred. Lundy
plaintiffs then filed the present action.
In this action, Lundy-plaintiffs raise six state law
claims for relief: (1) strict product liability; (2) fraud; (3)
negligence; (4) breach of implied warranty of
merchantability; (5) breach of implied warranty of fitness
for a particular purpose; (6) breach of express warranty;
and (7) loss of parental consortium by Jason Lundy.
Each of the Lundys' claims, except the fraud and loss of
parental consortium claims, were dismissed by Judge
Holschuh on September 29, 1995 having been raised
and dismissed with prejudice in the previous state court
action. Defendant now moves for summary judgment on
Roy Lee Lundy's fraud claim and Jason Lundy's loss of
parental consortium claim.
II. SUMMARY JUDGMENT STANDARD
The procedure for granting summary judgment is
found in Fed.R.Civ.P. 56(c), which provides:
The judgment sought shall be rendered
forthwith if the pleadings, depositions,
answers to interrogatories and admissions
on file, together with the affidavits, if any,
show that there is no genuine issue as to
any material fact and that the moving
party is entitled to judgment as a matter of
law.
App. B - 6
The evidence must be viewed in the light most favorable
to the nonmoving party. See Adickes v. Kress & Co., 398
U.S. 144, 158-59, 90 S.Ct. 1598, 26 L.Ed.2d 142 (1970).
Summary judgment will not lie if the dispute about a
material fact is genuine; "that is, if the evidence is such
that a reasonable jury could return a verdict for the
nonmoving party." Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).
Summary judgment is appropriate, however, if the
opposing party fails to make a showing sufficient to
establish the existence of an element essential to that
party's case and on which that party will bear the
burden of proof at trial. See Celotex Corp. v. Catrett, 477
U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986);
see also Matsushita Electric Industrial Co., Ltd. v. Zenith
Radio Corp., 475 U.S. 574, 106 S.Ct. 1348, 89 L.Ed.2d
538 (1986).
[*4] When reviewing a summary judgment motion,
the Court must view all of the evidence in the record. -
See Reeves v. Sanderson Plumbing Products, Inc., 530
U.S. 133, 120 S.Ct. 2097, 2110, 147 L.Ed.2d 105 (2000).
The Court must draw all reasonable inferences in favor
of the nonmoving party, and nust refrain from making
credibility determinations or weighing the evidence. Id.
Although the Court views the entire record, it disregards
all evidence favorable to the moving party that the jury
is not required to believe. Id. Stated otherwise, the Court
must credit evidence favoring the nonmoving party as
well as evidence favorable to the moving party that is
uncontroverted or unimpeached, if it comes from
disinterested witnesses. Id.
The Sixth Circuit Court of Appeals has recognized
that Liberty Lobby, Celotex and Matsushita have effected
"a decided change in summary judgment practice,
ushering in a 'new era’ in summary judgments." Street v.
J.C. Bradford & Co., 886 F.2d 1472, 1476 (6th Cir. 1989).
App. B - 7
The court in Street identified a number of important
principles applicable in new era summary judgment
practice, For example, complex cases and cases
involving state of mind issues are not necessarily
inappropriate for summary judgment, Jd, at 1479, In
addition, in responding to a summary judgment motion,
the nonmoving party "cannot rely on the hope that the
trier of fact will disbelieve the movant's denial of a
disputed fact, but must ‘present affirmative evidence in
order to defeat a properly supported motion for summary
judgment." ' Id. (quoting Liberty Lobby, 477 U.S. at 257),
The nonmoving party must adduce more than a scintilla
of evidence to overcome the summary judgment motion.
Id. It is not sufficient for the nonmoving party to merely
"show that there is some metaphysical doubt as to the
material facts.” Id. (quoting Matsushita, 475 U.S. at 586).
III]. DISCUSSION
1. Fraud
Plaintiffs assert that defendant acted fraudulently
by falsely representing that Orimune was licensed,
manufactured, tested, and released in accordance with
FDA regulations and that defendant made unspecified
false and misleading representations concerning the
degree of risk associated with contracting polio as a
result of ingestion or contact with someone who had
ingested Orimune. [FN2] Plaintiffs also claim defendant
acted fraudulently by failing to disclose that Orimune
had not complied with FDA regulations. Plaintiffs allege
that defendant's misrepresentations and omissions
“were made to induce medical care providers to continue
to use Orimune ... and to induce reliance by medical
care providers on those representations in the care and
treatment of persons receiving Orimune, including
[plaintiffs]" (Complaint, J] 32).
App. B- 8
FN2, The Court will address plaintiffs
contention that the defendant made
unspecified false and misleading statement
in regard to the risk inherent in the
ingestion of Orimune in the Court's
analysis of plaintiff's failure to warn claim
infra,
Under Ohio law, the elements of fraud are: (1) a
representation, or concealment where there is a duty of
disclosure; (2) which is material to the issue at hand; (3)
that is made falsely, with knowledge of its falsity, or with
such reckless or utter disregard as to its truth or falsity
that knowledge may be inferred; (4) with the intent of
misleading another into relying upon such
representation or concealment; (5) where one at whom
the representation or conceaiment was _ directed
justifiably, or reasonably, relied upon the representation
or concealment; and, (6) an injury proximately caused by
the reliance resulted. See Burr v. Bd. of Cty. Comm'rs of
Stark County, 23 Ohio St.3d 69, 491 N.E.2d 1101 (1986).
It is eminently clear under Ohio law that plaintiffs must
prove fraud by a preponderance of the evidence in an
action at law. See Household Finance Corp. v. Altenberg,
S Ohio St.2d 190, 214 N.E.2d 667 (1966); Weiss v.
Kearns, 11 Ohio St.2d 73, 228 N.E.2d 331 (1967). [FN3]
FN3. Counsel for defendant has set forth in its
filings that the proper standard for fraud in this
case where a legal remedy is sought is clear and
convincing evidence (94-425, Doc. 163, pp. 2, 7;
94-423, Doc. 166, pp. 16-18). This is incorrect. It
is basic and widely-regarded Ohio law that a
fraud action that seeks an equitable remedy (i.e.
declaratory judgment, reformation or recission of
~
App. B - 9
a contract) must be proved by clear and
convincing evidence, while a fraud action that
seeks a monetary remedy must be proved by the
lower preponderance standard, The cases that
defendant's counsel has chosen to cite for its
incorrect proposition of law are peculiar (94-425,
Doc, 163, p. 7, §§ 1; 94-423, Doc, 166, p. 17, n.
7), The first case, Zehe v. Caugherty, 1989 WL
7948, is an unpublished appellate decision of the
8 th District. Surely, in researching the law,
counsel would have begun with the Supreme
Court of Ohio and found Household Finance and
other cases citing this proposition. Even if
counsel had mistakenly searched cases of the
Cuyahoga Court of Appeals first, they would have
discovered upon due diligence the more recent
case of Watkins v. Cleveland Clinic Found., 130
Ohio App.3d 162, rendered only two years ago,
that cites correctly the Household Finance
proposition. It appears that defendant's counsel
dug until they were able to find an opinion with a
standard sufficiently vague that it could be used
to attempt to deceive this Court into using an
incorrect legal standard. The second case, Kern v.
Kern, 100 Ohio App. 327, 136 N.E.2d 675 (1955),
is an appellate decision of the 9 th District
wherein the plaintiff is seeking a declaratory
judgment to quiet title in real property in himself-
- an equitable remedy. The third case cited by
defendant's counsel, Jn re Lamberton's Estate, 142
Ohio St. 417, 52 N.E.2d 855 (1944), is an action
by estate beneficiaries to set aside the payment of
an allegedly fraudulent judgment by the estate's
administrator out of the proceeds of the estate--
also an equitable action, While citing these three
cases, defendant's counsel ignored or failed to
disdewerthe endless string of cases citing the law
App. B - 10
of Household Finance and its progeny, The Court
does not have patience with counsel that acts to
willfully mislead it on matters of law, The Court
notes, in fact, that this violates the Ohio,
Pennsylvania, and New York Codes of Professional
Responsibility, The Court will assume in this
matter that defendant's counsel has acted
negligently rather than willfully to mislead the
| Court, However, the Court urges counsel in the
future to perform due diligence and be truthful in
its filings with the Court.
(*5] It appears that Graham plaintiffs have
abandoned their fraud claim. As defendant points out in
its Reply Memorandum (94-423, Doc. 183, p. 19), and as
best this Court can ascertain, Graham plaintiffs have
failed to respond to or present any evidence to defeat
defendant's summary judgment motion on this issue as
required under Fed. R. Civ. Proc. 56©© and subsequent
cases (See 94- 423, Doc. 180) . [FN4] Defendant's
summary judgment motion as to the Graham's fraud
claim is therefore granted.
FN4. Graham plaintiffs title Doc. 180 "Plaintiffs'
Memorandum in Opposition to ... Motion For
Summary Judgment on the Grahams ... Fraud...
Claim." Graham plaintiffs also state on page one
that American Cyanamid engaged in "egregious
fraud on the American medical community and
the public." Graham plaintiffs’ next mention of
fraud is on page33, where they write, "[t]here is
no privilege for fraud." Graham plaintiffs discuss
warnings alleged falsity on page 60. Yet, there is
no presentation of evidence of fraud or discussion
of its elements.
App. B- 11
For a plaintiff to succeed on a claim of fraud, he
must demonstrate that the representation was false, or
that the plaintiff concealed a material issue of fact.
Defendant argues that the assertion made in the
representations accompanying the dosage of Orimune
administered to Jason Lundy were in compliance with
FDA regulations and therefore not false. [FN5] See 42
CFR 73.114 et seg. [FN6] The parties agree that the
vaccine administered to Jason Lundy originated from
either control numbers 483-269 or 480-277. The type III
component of Orimune in 483-269 was manufactured
from monopool 3-437. Plaintiffs’ expert, Dr. Jeffrey
Almond, agreed that monopool 3-437 satisfied FDA
regulations as they existed at that time (Almond Depo.,
p. 106-08). It is also undisputed that the FDA authorized
the release of 3-437 on October 22, 1975 (94-423, Doc.
165, Exh. 3, Exh. C, p. 3).
FNS. Specifically, the statement included in the
vaccine package insert administered to Jason
Lundy read:
DISCLAIMER OF REPRESENTATIONS AND
WARRANTIES
This vaccine has been produced and tested in
accordance with regulations of the United States
Food and Drug Administration for the production
of polio virus vaccine, live, oral. The manufacturer
makes no representation of warranty, expressed
or implied, with respect to the merchantability of
fitness for use of this vaccine other than that the
vaccine has been produced in accordance with
the standards for its production prescribed by the
United States Food and Drug Administration and
applicable thereto at the time of its release by the
manufacturer. While the use of this preparation
and other measures described herein are
App. B - 12
consistent with accepted standards of medical
practice, their use as described cannot be
expected necessarily to assure a specific result.
Doc. 163, Exh. 3A.
FN6. These regulations are cited as they
were originally promulgated and as they
were in effect when plaintiffs in these cases
contracted poliomyelitis. Since that time,
they have been recodified in 21 CFR §§§§
630.10-630.17. On August 1, 1996, the
Food and Drug Administration removed 21
CFR 630, summarizing that the
regulations were “obsolete or no longer
' necessary to achieve public health goals."
See Federal Register, August 1, 1996, Vol.
61, No. 149, p. 40155.
The type III component of Orimune in 480-277
was manufactured from a combination of monopools 3-
427 and 3-436. Dr. Almond testified that monopool 3-
436 satisfied then-existing FDA regulations (Almond
Depo., p. 106). It is also undisputed that the FDA
authorized the release of 3-436 on July 16, 1975 (94-
423, Doc. 165, Exh. 3, Exh. C, p. 2). Monopool 3-427
also was part of control number 480-277. Plaintiffs’
expert, Dr. Lawrence Steinman, testified that the
intraspinal and intrathalamic tests performed on
monkey hosts did not demonstrate a "severity" score that
was different than the reference test scores as performed
by the FDA (Steinman Depo., pp. 83-93; Doc. 163, Exh.
14). Given this information, Dr. Steinman testified that
the FDA's decision to release monopool 3-427 warranted
deference (Steinman Depo., pp. 93-97). This evidence
creates an inference that the type III Orimune in control
numbers 480- 277 and 483-269 was licensed and
manufactured in accordance with FDA regulations, and
therefore, defendant's representation of compliance with
App. B - 13
FDA regulations on the accompanying insert was in fact
true.
The plaintiffs argue at great length that defendant was
not duly licensed ab initio to manufacture any oral polio
vaccine by the FDA, and therefore, the specific vaccine
administered to Jason Lundy, though approved for
release itself, should not have been released based on a
lack of enumerated requirements. It contends that
defendant did not complete each step required in order
to obtain its original license, including submitting a
sample of the vaccine product, measuring the safety of
the product at every stage of the manufacturing process,
and submitting a license and results of each test
performed and a sample of the finished product. See 42
U.S.C. §§ 262(a); 42 C.F.R. §§ 73 (1964); 21 C.F.R. §§
601 (1987); Berkowitz v. United States, 486 U.S. 531,
940-541, 108 S.Ct. 1954, 100 L.Ed.2d 531 (1988). Thus,
plaintiffs contend that defendant's authority to produce
oral polio vaccine never existed. As proof of this,
plaintiffs submit that neither defendant nor the
government can produce the application authorizing
defendant to product oral polio vaccine (94-425; Doc.
207, p. 13). Plaintiffs argue this conclusively evidences
a failure to satisfy the licensing requirements. Yet, the
mere absence of records does not indicate that a license
was never granted. Administrative agencies are afforded
a presumption of regularity in regard to adherence to
their own regulations. See Bowen v. Amer. Hosp. Assoc.,
476 U.S. 610, 626-27, 106 S.Ct. 2101, 90 L.Ed.2d 584
(1986); Motor Vehicles Ass'n of U.S. v. State Farm Mut.
Auto. Ins. Co., 463 U.S. 29, 42-43, 103 S.Ct. 2856, 77
L.Ed.2d 443 (1983), f. 9; Schweiker v. McClure, 456 U.S.
188, 195, 102 S.Ct. 1665, 72 L.Ed.2d 1 (1982); Bd. of
Trustees of Ohio St. Univ. v. U.S. Dept. of Educ., 849 F.2d
1472,*8 (6 th Cir.1988)(unpublished opinion). For
plaintiffs to demonstrate that defendant acted wholly
without authority, they must present some affirmative
App. B - 14
evidence that the National Institute of Health did not
grant a license to defendant. [FN7] For example,
plaintiffs could discover or seek release of DBS records
of all applications received or all licenses issued and
demonstrate that there is an absence of an application
or grant of license to defendant. Fed.R.Evid. 803(6), (7),
(10). Their argument fails as a matter of law because
they have failed to present this affirmative evidence.
FN7. In 1972, the Department of Biologic
Standards was transferred from the
National Institute for Health to the Food
and Drug Administration and renamed the
Bureau of Biologics. See 37 Fed.Reg.
12865 (1972).
[*6] Assuming that the plaintiffs allegations that
defendant was not properly licensed to manufacture OPV
is accurate, the evidence does not demonstrate that this
lack of regulations proximately caused plaintiffs injuries.
See Burr, 23 Ohio St.3d at 73, 491 N.E.2d 1101. Rather,
the evidence indicates that there are risks inherent in
the ingestion of OPV regardless of whether the
manufacturer was licensed. Dr. Steinman testified as
follows:
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 Depo., p. 113). In sum, the Court finds that
plaintiffs have failed to adduce affirmative evidence
showing misrepresentation in the form of a lack of
App. B - 15
license to manufacture polio vaccine.
Reliance is also a necessary element of plaintiffs fraud
claim. See Burr, 23 Ohio St.3d at 73, 491 N.E.2d 1101.
Plaintiff Roy Lundy argues that his reliance should be
presumed (Doc. 207, p. 32). Plaintiff cites Rubin v.
Schottenstein, Zox, & Dunn, 143 F.3d 2632 (6 th
Cir. 1998) as support for this proposition. Yet, as plaintiff
correctly notes, Rubin concerns the presumption of
reliance for fraud in connection with the purchase or
sale of securities under federal Rule 10b-5 and its "fraud
on the market" theory. Conversely, the case at bar
concerns a claim of fraud under Ohio common law. The
Sixth Circuit and other circuits have held that the
presumptions necessarily given to investors because of
the nature of securities and security markets and the
necessary protection of investors, does not apply in
common law fraud. See In re Sofamor Danek Group, Inc.,
123 F.3d 394, 403-04 (6 th Cir.1997); Mergens v.
Dreyfoos, 163 F.3d 1114, 1118, 1999 WL 46751,*4 (11
th Cir.1996), Basham v. Gen. Shale Products Corp., 989
F.2d 491, 1993 WL 65086,*4, fn. 4 (4 th Cir.1993). The
evidence indicates that Roy Lee Lundy was not present
when his son was vaccinated (Roy Lee Lundy Depo., p.
103). The evidence also demonstrates that Roy Lee
Lundy did not speak with anyone, including medical
professionals, about the benefits and risks of oral polio
versus inactivated polio vaccine (Roy Lee Lundy Depo.,
pp. 111-112). Roy Lee Lundy also testified that he was
not aware of an alternative inactivated polio vaccine at
that time and did not know whether his son was offered
the alternative killed vaccine (Roy Lee Lundy Depo., p.
112). Plaintiff has therefore not proven reliance as is
necessary to support a claim for common law fraud. For
this additional reason, Roy Lee Lundy's fraud claim is
accordingly dismissed.
App. B - 16
2. Product Defect
Graham plaintiffs claim that defendant is strictly
liable for defective manufacture of the Orimune dosage
provided to Zachary Graham. A federal court sitting in
diversity must follow the law directed by the Supreme
Court of the state whose law is applicable, and if there is
no direct decision by the highest court of that state, the
federal court should determine what it believes that
state's highest court would find if the issue were before
it. See Meredith v. Winter Haven, 320 U.S. 228, 234-37,
64 S.Ct. 7, 88 L.Ed. 9 (1943). The parties agree that Ohio
law is applicable in this case.
[*7] Ohio has adopted Section 402A of Restatement of
the Law 2d, Torts (1965) with respect to strict products
liability. See Temple v.. Wean United, Inc., 50 Ohio St.2d
317, 40.0.3d 466, 364 N.E.2d 267 (1977). Section 402A
provides:
"(1) One who sells any product in a defective
condition unreasonably dangerous to the user or
consumer or to is property his 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."
App. B - 17
Ohio later adopted Comment k to Section 402A which
provides an exception to the strict liability of
manufacturers for injuries and damages caused by
defective products which are "unavoidably unsafe." See
Seley v. G.D. Searle & Co., 67 Ohio St.3d 192, 21 0.0.3d
121, 423 N.E.2d 831 (1981). Comment k recognizes that
there are products that exist that are incapable of being
made safe for their ordinary and intended use. Yet, their
production, marketing, and use are justified because
they provide great societal benefits that outweigh their
inherent risk.
The seller of a drug is not strictly liable for injury
resulting from use of an unavoidably unsafe product
only if the product has been prepared properly and
adequate warning of all potential adverse reactions
inherent in the use of the drug are included with the
product. See Restatement of Torts 2d, Section 402A,
Comment k; Seley, 67 Ohio St. at 197. Therefore, when
the product is manufactured improperly or when the
drug manufacturer fails to give adequate warning, the
drug may be considered "defective" and unreasonably
dangerous, thereby subjecting the manufacturer to strict
liability for resulting injury. [FN8] See id.
FN8. Courts have had difficulty in
distinguishing negligence and __ strict
liability claums where the defect alleged is
based on a Section 402A inadequate
warning. Strict liability focuses, not on the
conduct of the manufacturer, but rather
on the condition of the product. Yet, the
manufacturer's provision of adequate
warning has been said to sound in
negligence. This, however, overlooks
Section 402A, where the duty is one of
App. B - 18
strict liability where care is irrelevant. The
ultimate issue is whether the product was
unreasonably dangerous, thus defective,
because the warning was inadequate,
rather than how it became inadequate.
Plaintiffs argue that the polio vaccine
administered to Zachary Graham was unreasonably
dangerous because: (1) it was defectively manufactured
under the "tissue culture passages" test; (2) it was
defectively manufactured based upon the "consistency
of manufacture" test; and, (3) it was defectively
manufactured because defendant was not licensed at the
time it manufactured plaintiffs polio vaccine.
Plaintiffs assert that Graham's vaccine was
defectively manufactured because it violated a regulation
that required the type III component of the vaccine to be
no more than five "tissue culture passages" from the
original strain. 21 C.F.R. §§ 630.13(a). Plaintiffs,
however, have offered only conclusory arguments as to
this assertion and have not presented evidence in its
Response Memorandum in Opposition to avoid summary
judgment under Rule 56. Specifically, plaintiffs state
that "American Cyanamid was at the sixth tissue culture
passage as to Type III, and the sixth, seventh, or who
knows what passage as to Type I and Type II. Therefore,
American Cyanamid had no knowledge about this
product." (Doc. 180, p. 40). These conclusory
contentions, in the absence of affirmative evidence, are
not sufficient to demonstrate a triable issue of fact. As
such, plaintiffs argument is not well-taken.
(*8] Plaintiffs also argue that the vaccine administered
to Zachary Graham was defective because it was not one
of five consecutive monopools that passed the monkey
neurovirulence test. The vaccine administered to
Zachary Graham emanated from control number 3-486,
App. B - 19
which was descendant from seed 45B165. In order to
satisfy the monkey neurovirulence test as it then
existed, 3-486 must have been one in a series of at least
five lots that passed the monkey neurovirulence test.
Plaintiffs experts, Drs. Almond and Steinman, both
testified that 3-486 was one of a series of at least five
lots that satisfied this test under the regulations as they
then existed. Dr. Almond testified:
Q: Turning your attention to that same page we were
looking at a moment ago, which is bar code 23914.
MR. KOPS: That's NA2 tests?
Mr. YOERGES: No, 23914 is the 45B165 tests.
THE WITNESS: 488.
BY MR. YOERCES:
Q: Look at the test results for 486 through 490. Just tell
me that based on these results--and I know we did some
of this before--do the monopools satisfy or not satisfy the
regulations in your opinion?
MR. KOPS: Objections.
THE WITNESS: They satisfy.
(Almond Depo., p. 155).
Dr. Steinman testified similarly:
Q: Okay. Looking at Exhibit 7 on I think the last page,
the first of those monopools is 3-486; right?
A: Right.
Q: 3-486, based on the results in this exhibit, satisfies
the requirement both on the IS [intraspinal] and IT
[intrathalamic]; is that correct?
A: 3-486, yes. ;
Q: And 3-487 passes both the IS and IT; correct?
A: Yes.
Q: And 488 passes both IS and IT?
A: Yes.
Q: And 489 passes both?
A: Yes.
Q: And 490 passes both?
A: Right.
App. B - 20
Q: 3-486 both passes the requirements as one of five
consecutive passing lots based on Exhibit 7; correct?
MR. KOPS: Objection.
A: Yes.
(Steinman Depo., p. 115-116).
As can best be drawn from plaintiffs’ briefs,
plaintiff has presented no evidence other than Dr.
Almonds' affidavit executed six months after his
deposition testimony on the eve of the filing of plaintiffs'
Memorandum in Opposition that seeks to modify or alter
his deposition testimony (Doc. 180, Exh. 20.). 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 inadmissable and should not be
considered. See Hughes v. Vanderbilt Univ., 215 F.3d
943, 549 (6 th Cir.2000); Russell v. Ohio River Co., 960
F.2d 149, 1992 WL 78104,*3 (6 th
Cir.1992)(unpublished opinion).
Plaintiffs also argue that the vaccine administered
to Zachary Graham was defective because defendant was
not licensed to manufacture polio vaccine when Zachary
Graham's vaccine was produced. Plaintiff, however, has
presented no evidence to substantiate this allegation
(Doc. 180, p. 40). The Court has already addressed this
argument, supra, and found it to be without merit.
[*9] |The warning accompanying the vaccine must aiso
have been adequate under Comment k for the product to
be unavoidably unsafe. The question of the adequacy of
the warning given in strict liability cases has been
deemed to be perhaps the central issue in determining
whether the product is unreasonably dangerous within
the concept of strict liability as set forth in Section 402A.
See Seley at 197. Where an adequate warning is
App. B - 21
provided, the action must be determined in favor of the
manufacturer irrespective of whether the plaintiffs use
of the drug was, in fact, causally connected to the
plaintiffs injury, and despite the fact that the product is
unavoidably unsafe. See id.
In order to be adequate, the warning must
reasonably disclose to the medical profession all msks
inherent in the use of the drug which the manufacturer
knew or should have known to exist, being held to the
standard of an expert in that field. See Seley, at 197,
198. A warning may be unreasonable in its factual
content, its expression of the facts, or the method or
form in which it is conveyed. See id. at 198, 423 N.E.2d
831. The adequacy of warnings is measured not only by
what is stated, but also by the manner in which it is
stated. A reasonable warning not only conveys a fair
indication of the nature of the dangers involved, but also
warns with the degree of intensity demanded by the
nature of the risk. A warning may be inadequate if it is
unduly delayed, reluctant in tone, or lacks a sense of
urgency. See id.
The plaintiffs argue that the warning provided to
the medical professional who administered Orimune to
Zachary Graham was inadequate. [FN9] The warning provided:
FN9. Under Ohio law, the duty to warn
depends upon the drug manufacturer's
relationship to the user. Where a
prescription drug has been prescribed for
a patient by the patient's physician, the
manufacturer has been held to discharge
its duty to warn if the manufacturer
adequately warns the physician. See Tracy
v. Merrell Dow Pharamaceuticals, Inc., 58
Ohio St.3d 147, 149, 569 N.E.2d 875
(1991). This duty to warn is termed the
App. B - 22
learned intermediary rule. Ohio adopted
the learned intermediary rule in Seley. If
the product is properly labeled with the
apprropriate warnings and instructions to
fully inform the physician of the risks
involved and the procedures for use, the
manufacturer may reasonably assume that
the physician will exercise informed
judgment in the patients best interest. See
Tracy, at 150, 569 N.E.2d 875.
ADVERSE REACTION:
Paralytic disease following the.
ingestion of live poliovirus vaccines has
been, on rare occasion, reported in
individuals receiving the vaccine, (see for
example CONTRAINDICATIONS) and in
persons who were in close contact with
vaccines. 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
App. B - 23
[*10]
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 TOPV were distributed
in the United States. In the same 12 years,
25 "vaccine-associated" cases and 55
"contact vaccine-associated" paralytic
cases were reported.
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