United States District Court, N.D. Illinois, Eastern Division
May 9, 2005.
GALE C. ZIKIS, individually and as administrator of the Estate of Donald R. Zikis, deceased, Plaintiff,
PFIZER, INC., a Delaware corporation, Defendant.
The opinion of the court was delivered by: SAMUEL DER-YEGHIAYAN, District Judge
This matter is before the court on Defendant Pfizer, Inc.'s
("Pfizer") motion for summary judgment. For the reasons stated
below, we deny the motion for summary judgment.
Plaintiff Gale C. Zikis ("Zikis") brought the instant action on
behalf of herself and on behalf of the estate of her deceased
husband Donald R. Zikis ("D. Zikis"). Zikis alleges that on
December 16, 2005, D. Zikis died as a result of taking the
prescription drug Zoloft. Zikis alleges that Pfizer has known
about serious side effects associated with Zoloft for a long
time, but has only recently begun to inform physicians and consumers about the side effects. Zikis brought
the instant action and includes in the complaint a negligence
claim (Count I), a strict liability claim (Count II), a breach of
implied warranty claim (Count III), a breach of express warranty
claim (Count IV), and a fraud claim (Count V). Pfizer has now
moved for summary judgment prior to discovery.
Summary judgment is appropriate when the record, viewed in the
light most favorable to the non-moving party, reveals that there
is no genuine issue as to any material fact and the moving party
is entitled to judgment as a matter of law. Fed.R.Civ.P.
56(c). In seeking a grant of summary judgment the moving party
must identify "those portions of `the pleadings, depositions,
answers to interrogatories, and admissions on file, together with
the affidavits, if any,' which it believes demonstrate the
absence of a genuine issue of material fact." Celotex Corp. v.
Catrett, 477 U.S. 317, 323 (1986) (quoting Fed.R.Civ.P.
56(c)). This initial burden may be satisfied by presenting
specific evidence on a particular issue or by pointing out "an
absence of evidence to support the non-moving party's case."
Id. at 325. Once the movant has met this burden, the non-moving
party cannot simply rest on the allegations in the pleadings,
but, "by affidavits or as otherwise provided for in [Rule 56],
must set forth specific facts showing that there is a genuine
issue for trial." Fed.R.Civ.P. 56(e). A "genuine issue" in the
context of a motion for summary judgment is not simply a "metaphysical doubt as to the
material facts." Matsushita Elec. Indus. Co., Ltd. v. Zenith
Radio Corp., 475 U.S. 574, 586 (1986). Rather, a genuine issue
of material fact exists when "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 (1986);
Insolia v. Philip Morris, Inc., 216 F.3d 596, 599 (7th Cir.
2000). The court must consider the record as a whole, in a light
most favorable to the non-moving party, and draw all reasonable
inferences that favor the non-moving party. Anderson,
477 U.S. at 255; Bay v. Cassens Transport Co., 212 F.3d 969, 972 (7th
Pfizer argues that the instant action is preempted by federal
law. The Constitution of the United States provides in part the
following: "This Constitution, and the Laws of the United States
which shall be made in Pursuance thereof; and all Treaties made,
or which shall be made, under the Authority of the United States,
shall be the supreme Law of the Land; and the Judges in every
State shall be bound thereby, any Thing in the Constitution or
Laws of any State to the Contrary notwithstanding." U.S. Const.
Art. VI cl. 2. Unless there is reason to believe that Congress
intended otherwise, a federal law can preempt a state common law
cause of action brought by private citizens. Cipollone v.
Liggett Group, Inc., 505 U.S. 504, 520-21 (1992). The Supreme
Court of the United States has recognized doctrines of express preemption and implied preemption. Geier v.
American Honda Motor Co., Inc., 529 U.S. 861, 869 (2000). Field
preemption is a type of implied preemption, Crosby v. National
Foreign Trade Council, 530 U.S. 363, 372 (2000), and "conflict
preemption" is a type of implied preemption." Geier,
529 U.S. at 869. Conflict preemption is distinguishable from express
preemption in that it requires "the identification of `actual
conflict,' and not on an express statement of preemptive intent."
Under the implied preemption doctrines, "a federal statute
implicitly overrides state law either when the scope of a statute
indicates that Congress intended federal law to occupy a field
exclusively, . . . or when state law is in actual conflict with
federal law." Freightliner Corp. v. Myrick, 514 U.S. 280, 287
(1995). Geier, 529 U.S. at 869 (stating that one type of
implied federal preemption recognized by the Supreme Court of the
United States is preemption that is implied when there is a
conflict with federal law).
Although Congress may not have impliedly "occupied the field"
in a certain area, "state law is naturally preempted to the
extent of any conflict with a federal statute" that either: 1)
makes it "impossible for a private party to comply with both
state and federal law," or 2) makes the state law "an obstacle to
the accomplishment and execution of the full purposes and
objectives of Congress." Crosby, 530 U.S. at 372-73; see also
Freightliner Corp., 514 U.S. at 287 (stating that the Court has
recognized a sufficient implied conflict where: 1) "it is
`impossible for a private party to comply with both state and federal requirements,'" or 2)
"state law `stands as an obstacle to the accomplishment and
execution of the full purposes and objectives of Congress.'");
Geier, 529 U.S. at 884 (stating that "conflict pre-emption is
different in that it turns on the identification of `actual
conflict'"). Under the implied preemption doctrine, "[f]ederal
regulations have no less pre-emptive effect than federal
statutes." Fidelity Federal Sav. and Loan Ass'n v. de la
Cuesta, 458 U.S. 141, 153 (1982). The Supreme Court of the
United States has cautioned that "a court should not find
pre-emption too readily in the absence of clear evidence of a
conflict." Geier, 529 U.S. at 885.
Pfizer argues that since Zikis' action is based upon
insufficient warnings regarding Zoloft, an ultimate finding in
this action regarding the appropriateness of the warnings or the
type of warning that was required would overlap the Federal Drug
Administration's ("FDA") duties and regulations. Pfizer cites
Geier in support of its preemption position and argues that
there is an implied preemption by the FDA due to actual conflicts
between the FDA and state law. However, as Zikis points out,
Pfizer must do more than point to hypothetical potential
conflicts with FDA regulations and overlapping areas in this
action and the FDA's responsibilities. Pfizer argues that it is
required to include the FDA approved language on its labels.
However, pursuant to 21 C.F.R. § 314.70(c)(6)(iii)(A), "[t]he
agency may designate a category of changes for the purpose of
providing that, in the case of a change in such category, the
holder of an approved application may commence distribution of the drug product involved upon receipt by the agency of a
supplement for the change . . . [and] [t]hese changes include,
but are not limited to: . . . (iii) Changes in the labeling to
accomplish any of the following: (A) To add or strengthen a
contraindication, warning, precaution, or adverse
reaction. . . ." 21 C.F.R. § 314.70(c)(6)(iii)(A). Thus, nothing
prevented Pfizer from seeking to amend the language in the
labels to include the known additional side effects.
Pfizer criticizes Zikis' contention that Pfizer should have
included a warning on the label stating that Zoloft causes
suicide. Pfizer argues that such a warning would not be based on
scientific information. Pfizer also argues that such a dire
warning would scare off all potential users and prescribing
physicians regardless of the potential benefits. However, nowhere
in the complaint does Zikis make such an allegation. Zikis
further states in her answer to the motion for summary judgment
that she is "not seeking to require Pfizer to include within its
labeling information which is not scientifically accurate" and
"is not seeking to hold Pfizer liable for failing to provide
scientifically inaccurate warnings." (Ans. 2, 10). She merely
contends that the wanting should have included a warning about
"the association between Zoloft and acts of self-harm." (Ans. 2).
Zikis points as an example to a warning provided by Pfizer to
patients in Canada that reads the following: "potential
association with the occurrence of behavioral and emotional
changes including self-harm." (R SF 2). Zikis emphasizes that it
is not, as Pfizer contends, seeking a
"drug-causes-suicide-warning" (Ans. 9 n. 8). It is Zikis, not
Pfizer that determines the claim that Zikis is pursuing and Zikis states quite plainly
that "Plaintiff is simply alleging that Pfizer should have
included the same type of warning to Donald Zikis' doctor that it
currently provides to doctors in Canada." (Ans. 10).
Pfizer also argues that the same warnings that Pfizer claims
that Zikis advocates were previously rejected by the FDA. Pfizer
points to another case in which it claims that similar warnings
were rejected. In support, Pfizer improperly relies upon an
Amicus brief filed by the United States Government in another
case that contains nothing more that legal argument by counsel.
Pfizer also points to what it perceives as indications by the FDA
in the past that it would not accept such warnings. However,
Pfizer fails to point to evidence that shows any tangible
conflict. Neither does Pfizer point to evidence that shows that
Pfizer's belief that the FDA would reject such warnings is the
result of anything other than Pfizer's own speculation and
imagination. Pfizer also argues that the warning that Pfizer
contends is advocated by Zikis would interfere with the FDA's
"objective of providing only scientifically accurate information
in drug labeling." (SJ Mot. 8). However, again Pfizer does not
provide sufficient evidence of any "actual conflicts" with this
objective of the FDA. Pfizer attempts, through speculation, to
artificially construct conflicts where none actually exist. In
addition, the FDA does not prohibit a manufacturer such as Pfizer
from providing additional warnings along with those required by
the FDA. Geier, 529 U.S. at 884 Caraker v. Sandoz
Pharmaceuticals Corp., 172 F. Supp.2d 1018, 1033 (S.D.Ill.
2001); Eve v. Sandoz Pharmaceutical Corp., 2002 WL 181972, at *3 (S.D. Ind. 2002) (stating that
"[c]ourts have generally found that `FDA regulations as to design
and warning standards are minimum standards which do not preempt
state law defective design and failure to warn claims' and FDA
approval does not shield a manufacturer from liability."). Pfizer
has failed to point to sufficient evidence that it would be
impossible to comply with both the FDA and Illinois common law,
and Pfizer has failed to show that allowing Zikis to proceed with
his Illinois common law claims would be "an obstacle to the
accomplishment and execution of the full purposes and objectives
of Congress." Crosby, 530 U.S. at 372-73. Therefore, based upon
the above analysis and the undisputed facts as determined by the
requirements of Local Rule 56.1, we cannot find that the claims
brought by Zikis are preempted as a matter of law and we deny
Pfizer's motion for summary judgment.
Based on the foregoing analysis, we deny Pfizer's motion for
summary judgment. We deny Zikis' motion to strike Pfizer's
Exhibit B as moot since it does not alter the outcome of our
decision even when considered.
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