Moore v . Medeva, et a l . CV-01-311-M 01/13/04
UNITED STATES DISTRICT COURT
DISTRICT OF NEW HAMPSHIRE
Linda E . Moore and
Wallace Moore,
Plaintiffs
v. Civil N o . 01-311-M
Opinion N o . 2004 DNH 013
Medeva Pharmaceuticals, Inc.,
a/k/a Celltech Pharmaceuticals, Inc.
and Celltech Pharmaceuticals Ltd.,
Defendants
O R D E R
Linda Moore says that in October of 1998, after receiving a
flu vaccine allegedly manufactured, distributed, and/or sold by
defendants (and their predecessors), she contracted a “paralytic
ailment known as Guillain-Barre Syndrome and other consequential
and incidental ailments.” Amended complaint (document n o . 2 8 ) ,
para. 8 . Defendant Celltech Pharmaceuticals, Inc. (“CPI”) moves
for summary judgment, claiming it did not manufacture,
distribute, or sell the vaccine in question. Nor, says C P I , did
it develop or supply the package information or other warnings
included with the vaccine. Plaintiffs object, asserting that
there are genuinely disputed material facts with regard to CPI’s
involvement in the vaccine’s chain of distribution.
Standard of Review
When ruling on a party’s motion for summary judgment, the
court must “view the entire record in the light most hospitable
to the party opposing summary judgment, indulging all reasonable
inferences in that party’s favor.” Griggs-Ryan v . Smith, 904
F.2d 1 1 2 , 115 (1st Cir. 1990). Summary judgment is appropriate
when the record reveals “no genuine issue as to any material fact
and . . . the moving party is entitled to a judgment as a matter
of law.” Fed. R. Civ. P. 56(c). In this context, “a fact is
‘material’ if it potentially affects the outcome of the suit and
a dispute over it is ‘genuine’ if the parties’ positions on the
issue are supported by conflicting evidence.” Intern’l Ass’n of
Machinists and Aerospace Workers v . Winship Green Nursing Center,
103 F.3d 196, 199-200 (1st Cir. 1996) (citations omitted).
Discussion
I. Background.
Complicating the resolution of CPI’s pending motion for
summary judgment is the fact that the relationships between the
entities responsible for manufacturing, distributing, and selling
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the vaccine i s , to say the least, complex. In a prior
memorandum, CPI described some of the relevant relationships as
follows:
The influenza flu vaccine (the “Vaccine”) referenced
[in plaintiffs’] interrogatories for the year 1998 was
manufactured in the United Kingdom by Medeva Pharma
Limited, a corporation organized under the laws of the
United Kingdom. Medeva Pharma Limited was formerly
known as Evans Medical Limited. The name change to
Medeva Pharma Limited occurred on July 6, 1998. Medeva
Pharma Limited merged into Celltech Pharmaceuticals,
Ltd. on April 2 , 2001. Medeva Pharma Limited has since
sold the assets related to the manufacture of the
Vaccine to Evans Vaccines Ltd. in October, 2000. Evans
Vaccines Ltd. is an unrelated company to Medeva Pharma
Limited and [CPI].
CPI’s Answers to Plaintiffs’ Interrogatories, Exhibit 2 to CPI’s
memorandum in support of its motion in limine (document n o . 3 6 ) .
See also CPI’s memorandum at 9 n . 3 (“Medeva Pharma Limited
[formerly known as Evans Medical Limited] merged into Celltech
Pharmaceuticals, Ltd. on April 2 , 2001. On September 9, 2002,
this Court granted Plaintiffs’ Motion to Amend their Complaint to
add Celltech Pharmaceuticals, Ltd. as a defendant in this case.
As such, Evans is now essentially a defendant in this case.”).
3
Based upon CPI’s statement of the relationships between the
various parties, it would appear that defendant Celltech
Pharmaceuticals, Ltd. (“Celltech”) is the successor-in-interest
to the entity that manufactured the vaccine in question. In
fact, in its answer to plaintiffs’ amended complaint, Celltech
admitted that “prior to October 2 , 1998, it manufactured Fluvirin
Lot N o . E20228KA” - the vaccine at issue in this case.
Celltech’s Answer (document n o . 55) at para. 6. And, in response
to plaintiffs’ requests for admissions, Celltech admitted that:
it manufactured the influenza vaccine, Fluvirin, used
during the 1998-1999 vaccine season and was responsible
for its sale, including the development and provision
of package labeling and other warnings approved by the
Food and Drug Administration and/or other governmental
entities. During the 1998-99 influenza vaccine season,
Celltech Pharmaceuticals, Ltd. shipped packages of
Fluvirin, including its approved package labeling
directly t o , and only t o , General Injectables and
Vaccines, Inc. (“GIV”), a Virginia corporation. The
vaccine was then distributed by GIV. Defendant,
Celltech Pharmaceuticals, Ltd. has no knowledge of
GIV’s distribution methods.
Exhibit 3 to CPI’s memorandum (document n o . 6 8 ) , Celltech’s
Response to Plaintiffs’ Request for Admissions at 1-2.
4
Notwithstanding Celltech’s admitted (and, at least according
to it and C P I , its exclusive) role in manufacturing the vaccine
at issue in this case, preparing and shipping the package inserts
approved by the FDA, and contracting for the vaccine’s
distribution in the United States through General Injectables and
Vaccines, Inc., plaintiffs assert that CPI might still be liable
to them, based upon the following three factors. First,
plaintiffs point out that CPI’s “Medical Information department
. . . fielded questions from the medical community and its
patients regarding medical questions concerning the flu vaccine
generally, and Fluvirin, specifically.” Exhibit 1 to plaintiffs’
memorandum, CPI’s Amended Answer to Plaintiffs’ Interrogatory N o .
10 at 2 . Second, CPI was listed in the Physicians’ Desk
Reference as an American affiliate of the vaccine’s foreign
manufacturer. Exhibit 2 to plaintiffs’ memorandum, 1999
Physicians’ Desk Reference at 3456. And, finally, CPI was
registered with the Food and Drug Administration as the United
States agent for the vaccine’s foreign manufacturer. See
Plaintiffs’ memorandum at 5 . See also 21 C.F.R. § 207.40(c)
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(each foreign drug manufacturer required to register with the FDA
must provide the name and address of its United States agent). 1
II. Plaintiffs’ Claims Against CPI.
Plaintiffs’ complaint advances three substantive claims
against C P I , as well as three derivative claims by M r . Moore for
loss of consortium. Unfortunately, in opposing CPI’s motion for
1
Section 207.40(c) of Title 21 of the Code of Federal
Regulations provides, in pertinent, part:
Each foreign drug establishment required to register
under paragraph (a) of this section shall submit the
name, address, and phone number of its United States
agent as part of its initial and updated registration
information in accordance with subpart C of this part.
Each foreign drug establishment shall designate only
one United States agent.
(1) The United States agent shall reside or maintain a
place of business in the United States.
(2) Upon request from the FDA, the United States agent
shall assist FDA in communications with the foreign
drug establishment, respond to questions concerning the
foreign drug establishment’s products that are imported
or offered for import into the United States, and
assist FDA in scheduling inspections of the foreign
drug establishment. If the agency is unable to contact
the foreign drug establishment directly or
expeditiously, FDA may provide information or documents
to the United States agent, and such an action shall be
considered to be equivalent to providing the same
information or documents to the foreign drug
establishment.
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summary judgment, plaintiffs do not describe how the three
factors listed above, even if proved at trial, might possibly
give rise to liability on the part of CPI - an entity that did
not manufacture, distribute, promote, sell, administer, or
provide the package warnings or inserts with regard to the
vaccine at issue in this case.2
In count one of their amended complaint, plaintiffs allege
that CPI was negligent insofar as it failed to warn Mrs. Moore of
the risks associated with taking the vaccine and that it was
“otherwise negligent in manufacturing, selling, and administering
the Vaccine to Plaintiff Linda Moore.” Amended complaint at
para. 1 4 . First, since plaintiffs have failed to point to any
evidence that might suggest CPI had a role in “manufacturing,
selling, [or] administering” the vaccine, their negligence claim,
to the extent it is based upon such conduct, necessarily fails.
2
While it appears that CPI did distribute an influenza
vaccine during the 1996-1997 flu season, that was the only year
during which it did s o ; CPI did not distribute a vaccine during
the 1998-1999 flu season and, perhaps more importantly, it did
not distribute the particular vaccine at issue in this case:
Fluvirin, Lot N o . E20228KA.
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Beyond that shortcoming in their amended complaint,
plaintiffs have failed to articulate precisely how (or why) CPI
had a duty, independent of those borne by the manufacturer and
distributor, to warn Mrs. Moore of the potential risks associated
with the vaccine. CPI’s role as United States agent for the
vaccine’s manufacturer obligated it only to act as an
intermediary between the manufacturer and the FDA; the
regulations upon which plaintiffs rely do not purport to impose
any further obligations on a United States agent of a foreign
drug manufacturer. And, plaintiffs have failed to point to any
case law (binding or persuasive) supporting their assertion that,
as a result of its status as the United States agent for the
manufacturer (or because it fielded questions about the vaccine,
or because of its status as an “affiliate” of the vaccine’s
manufacturer), CPI assumed the obligation to warn potential
recipients of the vaccine of the risks associated with its use.
Consequently, in light of the undisputed facts of record, CPI is
entitled to judgment as a matter of law with regard to count one
(negligence) of plaintiffs’ amended complaint.
8
In count three of their amended complaint, plaintiffs allege
that the vaccine was defective and unreasonably dangerous.
Amended complaint, para. 2 2 . Accordingly, they say CPI is
strictly liable to them for damages. As noted above, however,
the undisputed material facts demonstrate that CPI did not
manufacture, sell, distribute, or administer the vaccine in
question. And, plaintiffs have failed to articulate how CPI’s
status as the manufacturer’s United States agent, or its listing
in the Physicians’ Desk Reference as an “affiliate” of the
manufacturer, might give rise to strict liability for an
(allegedly) unreasonably dangerous product. Nor have plaintiffs
cited any judicial opinions that are supportive of their strict
liability claim against CPI. CPI i s , therefore, entitled to
summary judgment as to count three of plaintiffs’ complaint.
Count five of plaintiffs’ amended complaint alleges that CPI
“warranted to Plaintiff Linda Moore that the Vaccine would be
free from defects and free from unreasonably dangerous or unsafe
qualities,” but that CPI breached that warranty. Amended
complaint at para. 28-29. Again, however, plaintiffs’ objection
to CPI’s motion for summary judgment provides little insight into
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the precise nature of their claims. Plaintiffs do not, for
example, identify whether the “warranties” referenced in count
five were express or implied. Nor do they identify any case law
supportive of their theory of the case.
In their pre-trial memorandum, plaintiffs do say that their
claims are governed by “New Hampshire products liability law and
the New Hampshire Uniform Commercial Code.” Plaintiffs’ Pre-
trial Memorandum (document n o . 29) at 6. Importantly, however,
New Hampshire’s Uniform Commercial Code imposes warranties (both
express and implied) only upon manufacturers, sellers, and
suppliers of goods. See N.H. Rev. Stat. Ann. (“RSA”) 382-A:2-
318. See also RSA 382-A:2-313, 2-314, and 2-315. Since
plaintiffs have failed to point to any evidence suggesting that
CPI manufactured, sold, or supplied the vaccine in question, and
because plaintiffs have not identified any other legal theory
under which CPI might be liable to them for breach of warranty,
CPI is entitled to judgment as a matter of law as to plaintiffs’
breach of warranty claim.
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Finally, since CPI is entitled to summary judgment on all of
Mrs. Moore’s claims against i t , it is also entitled to summary
judgment on all of the derivative claims for loss of consortium
advanced by M r . Moore (counts two, four, and s i x ) .
Conclusion
For the foregoing reasons, plaintiffs have failed to
demonstrate that there are any genuinely disputed material facts.
Given the undisputed material facts, Defendant CPI is entitled to
judgment as a matter of law. Accordingly, Celltech
Pharmaceuticals, Inc.’s motion for summary judgment (document n o .
68) is hereby granted.
SO ORDERED.
Steven J. McAuliffe
United States District Judge
January 1 3 , 2004
cc: David M . Cohen, Esq.
Daniel P. Gibson, Esq.
Jennifer Humphreys, Esq.
Peter C . Neger, Esq.
John H . O’Neil, Jr., Esq.
Kevin H . O’Neill, Esq.
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