Moore v. Medeva, et al.

2004 DNH 013

• Court: District Court, D. New Hampshire
• Decided: January 13, 2004
• Docket: CV-01-311-M
• Status: Published

Opinion

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

2 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)

5 (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.

6 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.

7 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

9 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.

10 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.