Southworth v. SmithKline . . . CV-95-447-SD 07/16/96 UNITED STATES DISTRICT COURT FOR THE
DISTRICT OF NEW HAMPSHIRE
Janice Southworth; Gregory Southworth
v. Civil No. 95-447-
SmithKline Beecham Pharmaceuticals
O R D E R
Before the court are the issues raised by certain pending
motions.
1. Plaintiffs' Motion to Compel Discovery, document 7
This motion seeks production by defendant of a vial of
defendant's vaccine from Lot No. 989A4. Defendant objects.
Document ll.1
The litigation involves a claim by plaintiff Janice
Southworth that her vaccination with defendant's hepatitis B
vaccine, Engerix B, on October 7, 1992, was causative of the
autoimmune disease known as lupus. Plaintiffs seek testing of
defendant seeks oral argument, but the court finds that such oral argument would not be of more assistance to it than that found in the documents on file, and therefore denies such reguest. See Local Rule 7.1(d). vial of the vaccine from the same lot of vaccine from which
Janice Southworth was vaccinated. Such testing is to be
conducted by Dr. Arthur Zahalsky, plaintiffs' expert.2
Defendant argues that, as the lot of vaccine at issue is
beyond its expiration date, production of a vial thereof is
neither relevant to the subject matter involved in this
litigation nor reasonably calculated to lead to the discovery of
admissible evidence. Alternatively, defendant suggests that, if
ordered by the court, production of the vaccine should be subject
to certain conditions, including confidentiality, the presence of
defendant's expert at testing, and payment by plaintiffs of all
costs of production of the vaccine from its location in Belgium.3
Rule 26, Fed. R. Civ. P., states that a party "may obtain
discovery regarding any matter, not privileged, which is relevant
to the subject matter involved in the pending action, whether it
relates to the claim or defense of the party seeking discovery or
to the claim or defense of any other party . . . ." Rule
26(b)(1), Fed. R. Civ. P. For Rule 26 purposes, relevance is
construed broadly to include "any matter that bears on . . . any
2Dr. Zahalsky is professor emeritus of immunology at Southern Illinois University, where he was a professor of immunology from 1976 to 1994.
Apparently, the lot of vaccine in guestion exists only in Belgium.
2 issue that is or may be in the case." Oppenheimer Fund, Inc. v.
Sanders, 437 U.S. 340, 351 (1978) . The information sought
through discovery need not itself be admissible at trial, so long
as it is "reasonably calculated to lead to the discovery of
admissible evidence." Rule 26(b)(1), Fed. R. Civ. P.
However, the court is possessed of broad powers to limit
excesses of discovery. Mack v. Great Atlantic & Pacific Tea Co.,
871 F.2d 179, 187 (1st Cir. 1989), and under Rule 26(b)(2)(ill)
it may limit the scope of discovery where "the burden or expense
of the proposed discovery outweighs its likely benefit, taking
into account the needs of the case, the amount in controversy,
the parties' resources, the importance of the issues at stake in
the litigation, and the importance of the proposed discovery in
resolving the issues."
Defendant's initial challenge is to the relevancy and future
admissibility of the proposed vaccine testing. It argues that,
as the lot of Engerix B expired in the period of time since
plaintiff was vaccinated, there are no longer any assurances of
its safety, identity, strength, guality, or purity
characteristics. While this argument is far from frivolous, it
does not serve, at this stage of the litigation, to bar discovery
as sought by the plaintiffs.
Designed to encourage the removal of outdated or aged stocks
3 of drug products, the government regulations reguiring that the
expiration date be placed on the label of such products, 21
C.F.R. § 211.37, is related to the reguirements of 21 C.F.R. §
211.166, a regulation mandating "that manufacturers perform the
necessary testing to determine the stability of the drug and its
components, and the point in time after which it may be subject
to deterioration and loss of effectiveness or safety." National
Assoc, of Pharmaceutical Mfrs. v. Department of Health and Human
Services, 586 F. Supp. 740, 762 (S.D.N.Y. 1984). However,
whether this necessarily means that after the expiration date a
drug product loses all characteristics of efficacy which it
possessed as of a specific prior date is an issue that will
necessarily reguire the future production of more detailed
evidence than is now available to the court.
Defendant also argues that the testing of the vaccine
proposed to be conducted by Dr. Zahalsky lacks scientific
reliability and therefore cannot lead to the discovery of
admissible evidence. This line of argument is premature, for it
is far too early in the course of this litigation for the court
to assume the "gatekeeping function" assigned to it by Daubert v.
Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 592-93 (1993).
See Pacamor Bearings, Inc. v. Minebea Co., Ltd., 918 F. Supp.
491, 506-07 (D.N.H. 1996); Grimes v. Hoffmann-LaRoche, Inc., 907
4 F. Supp. 33, 34-35 (D.N.H. 1995).
The court therefore believes that plaintiffs are entitled to
test the vaccine, but also finds that reasonable conditions, as
suggested by the defendant, should be imposed on such testing.
The first such condition concerns confidentiality; i.e.,
nondisclosure of testing results until the court has had an
opportunity to rule on admissibility.
Defendant's vaccine, Engerix B, has been approved by the
FDA, and the Centers for Disease Control have recommended that it
be universally administered to children. Accordingly, the
reputation of the vaccine and its manufacturer, defendant, would,
the court finds, be damaged if the results of Dr. Zahalsky's
testing were publicly made prior to the court's having an
opportunity to fully consider and rule upon defendant's challenge
to the reliability and validity of such testing.
Accordingly, the court herewith orders that plaintiffs,
their counsel, and their experts are prohibited from disclosing
or otherwise disseminating information concerning the testing of
the vaccine or the results derived therefrom until such time as
they obtain a ruling from this court as to the admissibility of
testing and evidence relating to that testing.
Defendant next seeks the opportunity to have the testing
performed at a time mutually convenient to Dr. Zahalsky and
5 defendant's expert, to have its expert present at such testing,
and to seek a time limit for completion of such testing. As it
appears that the testing will necessarily be destructive in
nature, it falls within the scope of Rule 34, Fed. R. Civ. P.,
Dabney v. Montgomery & Co., 761 F.2d 494 (8th Cir.), cert.
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Southworth v. SmithKline . . . CV-95-447-SD 07/16/96 UNITED STATES DISTRICT COURT FOR THE
DISTRICT OF NEW HAMPSHIRE
Janice Southworth; Gregory Southworth
v. Civil No. 95-447-
SmithKline Beecham Pharmaceuticals
O R D E R
Before the court are the issues raised by certain pending
motions.
1. Plaintiffs' Motion to Compel Discovery, document 7
This motion seeks production by defendant of a vial of
defendant's vaccine from Lot No. 989A4. Defendant objects.
Document ll.1
The litigation involves a claim by plaintiff Janice
Southworth that her vaccination with defendant's hepatitis B
vaccine, Engerix B, on October 7, 1992, was causative of the
autoimmune disease known as lupus. Plaintiffs seek testing of
defendant seeks oral argument, but the court finds that such oral argument would not be of more assistance to it than that found in the documents on file, and therefore denies such reguest. See Local Rule 7.1(d). vial of the vaccine from the same lot of vaccine from which
Janice Southworth was vaccinated. Such testing is to be
conducted by Dr. Arthur Zahalsky, plaintiffs' expert.2
Defendant argues that, as the lot of vaccine at issue is
beyond its expiration date, production of a vial thereof is
neither relevant to the subject matter involved in this
litigation nor reasonably calculated to lead to the discovery of
admissible evidence. Alternatively, defendant suggests that, if
ordered by the court, production of the vaccine should be subject
to certain conditions, including confidentiality, the presence of
defendant's expert at testing, and payment by plaintiffs of all
costs of production of the vaccine from its location in Belgium.3
Rule 26, Fed. R. Civ. P., states that a party "may obtain
discovery regarding any matter, not privileged, which is relevant
to the subject matter involved in the pending action, whether it
relates to the claim or defense of the party seeking discovery or
to the claim or defense of any other party . . . ." Rule
26(b)(1), Fed. R. Civ. P. For Rule 26 purposes, relevance is
construed broadly to include "any matter that bears on . . . any
2Dr. Zahalsky is professor emeritus of immunology at Southern Illinois University, where he was a professor of immunology from 1976 to 1994.
Apparently, the lot of vaccine in guestion exists only in Belgium.
2 issue that is or may be in the case." Oppenheimer Fund, Inc. v.
Sanders, 437 U.S. 340, 351 (1978) . The information sought
through discovery need not itself be admissible at trial, so long
as it is "reasonably calculated to lead to the discovery of
admissible evidence." Rule 26(b)(1), Fed. R. Civ. P.
However, the court is possessed of broad powers to limit
excesses of discovery. Mack v. Great Atlantic & Pacific Tea Co.,
871 F.2d 179, 187 (1st Cir. 1989), and under Rule 26(b)(2)(ill)
it may limit the scope of discovery where "the burden or expense
of the proposed discovery outweighs its likely benefit, taking
into account the needs of the case, the amount in controversy,
the parties' resources, the importance of the issues at stake in
the litigation, and the importance of the proposed discovery in
resolving the issues."
Defendant's initial challenge is to the relevancy and future
admissibility of the proposed vaccine testing. It argues that,
as the lot of Engerix B expired in the period of time since
plaintiff was vaccinated, there are no longer any assurances of
its safety, identity, strength, guality, or purity
characteristics. While this argument is far from frivolous, it
does not serve, at this stage of the litigation, to bar discovery
as sought by the plaintiffs.
Designed to encourage the removal of outdated or aged stocks
3 of drug products, the government regulations reguiring that the
expiration date be placed on the label of such products, 21
C.F.R. § 211.37, is related to the reguirements of 21 C.F.R. §
211.166, a regulation mandating "that manufacturers perform the
necessary testing to determine the stability of the drug and its
components, and the point in time after which it may be subject
to deterioration and loss of effectiveness or safety." National
Assoc, of Pharmaceutical Mfrs. v. Department of Health and Human
Services, 586 F. Supp. 740, 762 (S.D.N.Y. 1984). However,
whether this necessarily means that after the expiration date a
drug product loses all characteristics of efficacy which it
possessed as of a specific prior date is an issue that will
necessarily reguire the future production of more detailed
evidence than is now available to the court.
Defendant also argues that the testing of the vaccine
proposed to be conducted by Dr. Zahalsky lacks scientific
reliability and therefore cannot lead to the discovery of
admissible evidence. This line of argument is premature, for it
is far too early in the course of this litigation for the court
to assume the "gatekeeping function" assigned to it by Daubert v.
Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 592-93 (1993).
See Pacamor Bearings, Inc. v. Minebea Co., Ltd., 918 F. Supp.
491, 506-07 (D.N.H. 1996); Grimes v. Hoffmann-LaRoche, Inc., 907
4 F. Supp. 33, 34-35 (D.N.H. 1995).
The court therefore believes that plaintiffs are entitled to
test the vaccine, but also finds that reasonable conditions, as
suggested by the defendant, should be imposed on such testing.
The first such condition concerns confidentiality; i.e.,
nondisclosure of testing results until the court has had an
opportunity to rule on admissibility.
Defendant's vaccine, Engerix B, has been approved by the
FDA, and the Centers for Disease Control have recommended that it
be universally administered to children. Accordingly, the
reputation of the vaccine and its manufacturer, defendant, would,
the court finds, be damaged if the results of Dr. Zahalsky's
testing were publicly made prior to the court's having an
opportunity to fully consider and rule upon defendant's challenge
to the reliability and validity of such testing.
Accordingly, the court herewith orders that plaintiffs,
their counsel, and their experts are prohibited from disclosing
or otherwise disseminating information concerning the testing of
the vaccine or the results derived therefrom until such time as
they obtain a ruling from this court as to the admissibility of
testing and evidence relating to that testing.
Defendant next seeks the opportunity to have the testing
performed at a time mutually convenient to Dr. Zahalsky and
5 defendant's expert, to have its expert present at such testing,
and to seek a time limit for completion of such testing. As it
appears that the testing will necessarily be destructive in
nature, it falls within the scope of Rule 34, Fed. R. Civ. P.,
Dabney v. Montgomery & Co., 761 F.2d 494 (8th Cir.), cert.
denied, 474 U.S. 904 (1985). In such circumstances, it is
appropriate to place reasonable restrictions upon both the
production of the matter to be tested and the conduct of the
testing itself. Spell v. Kendall-Futuro Co., 155 F.R.D. 587
(E.D. Tex. 1994). Such restrictions have included the
reguirement of advance notice of testing, submission of a
detailed plan of testing for court approval, and presence of the
producing party to observe and photograph testing. Sarver v.
Barret Ace Hardware, 63 111. 2d 454, 349 N.E.2d 28 (1976).
Indeed, the presence of a representative of the producing party
at testing is not uncommon. Dina v. Lutheran Medical Center, 548
N.Y. Supp. 2d 541 (N.Y. A p p . Div. 1989); Kelleher v. Omark
Indus., Inc., 19 Fed. R. Serv. 2d 725, 727 (D. Mass. 1974).
The court finds and rules that the testing of defendant's
vaccine is conditioned on reguirements that (1) such testing be
scheduled at a time mutually convenient to plaintiffs' and
defendant's experts; (2) defendant's expert be permitted to
witness all such testing; and (3) all such testing be completed
6 within 45 days of the date upon which the vaccine is delivered to
plaintiffs' expert.
Finally, defendant seeks to have plaintiffs pay the cost of
importation and shipping of the vaccine from Belgium to the
United States. The court understands that plaintiffs' counsel
has no objection to this reguest.
In any event, in civil litigation, ordinarily each party
"bears the ordinary cost of funding his suit," Eisen v. Carlisle
& Jacguelin, 417 U.S. 156, 179 (1974); In re Puerto Rico Elec.
Power Auth., 687 F.2d 501, 507 (1st Cir. 1982), and orders
reguiring the reguesting party to pay the expenses of production
are common. Id. Accordingly, it is ordered that plaintiffs
shall pay all fees associated with obtaining the necessary import
authorizations and all related shipping expenses of the vaccine
to the place of testing.
2. Assented-To Motion of Defendant to Extend Pretrial Deadlines,
document 16
At a preliminary pretrial conference held on November 13,
1995, the court tentatively set a trial date of May 1997 and
various discovery and motion filing deadlines based on such
tentative trial date. Citing the discovery problems hereinabove
addressed, defendant has now moved, with the assent of
7 plaintiffs, to extend the date of plaintiffs' expert disclosure
from August 1, 1996, to December 2, 1996; the date of defendant's
expert disclosure from October 1, 1996, to January 2, 1997; and
the date for filing dispositive motions from September 1, 1996,
to January 15, 1997. Such extensions will necessarily move the
tentative trial date from May of 1997 to August of 1997, and,
conditioned on such extension of trial date, the motion to extend
deadlines is herewith granted.
3. Conclusion
For reasons hereinabove outlined, the court has granted
plaintiffs' motion to compel, conditioned as set forth in the
body of this order. Each party is to bear its own fees and costs
in association with such discovery motion.
The court has granted the motion to extend discovery and
dispositive motion filing deadlines, conditioned on extension of
the tentative trial date from May of 1997 to August of 1997.
SO ORDERED.
Shane Devine, Senior Judge United States District Court
July 16, 1996 cc: W. Wright Danenbarger, Esg. Warren C. Nighswander, Esg. David A. Barry, Esg.