Summary
granting summary judgment to the defendant on basis of conflict preemption
Summary of this case from Levine v. WyethOpinion
Civil Action No. 3:03-CV-3074-N.
August 6, 2004
MEMORANDUM OPINION AND ORDER
Before the Court is Defendant Pfizer Inc.'s ("Pfizer") Motion for Summary Judgment, filed February 20, 2004. Pfizer argues that Plaintiffs' attempt to use state tort law to require warnings that indicate a relationship between Zoloft use and suicide conflicts with the Food, Drug, and Cosmetic Act ("FDCA") and the U.S. Food and Drug Administration's ("FDA") determination that the suicide warnings advocated by Plaintiffs are inappropriate and, if given, would be false, misleading, and harmful to patients. Because Plaintiffs' failure to warn claims are preempted by federal law, summary judgment is appropriate. Accordingly, Pfizer's motion is granted.
I. BACKGROUND
According to Plaintiffs' complaint, Mike Needleman ("Needleman") was prescribed Effexor, a member of the class of drugs referred to as "selective serotonin reuptake inhibitors" ("SSRI"), by his family doctor. SSRIs are used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disporder, and social anxiety disorder. During the night of May 23, 2002, Needleman presented to the emergency room, apparently suffering a reaction to Effexor with symptoms including rocking back and forth, a sign of akathisia. Needeman's doctor instructed Needleman to discontinue use of Effexor and prescribed Zoloft, an SSRI manufactured by Defendant Pfizer. According to the complaint, Needleman subsequently suffered severe side effects including akathisia and sleep disturbance, and feared that these symptoms were a direct result of his use of Zoloft. On May 31, 2002, Needleman saw another doctor, who prescribed an immediate drug change. Tragically, Needleman took his own life that evening.
Akathisia, or inability to sit, is a neurological phenomenon with characteristics of intense internal restlessness, agitation, and feelings of unease or discomfort.
Plaintiffs argue that Pfizer is liable for Needleman's death due to its failure to warn consumers and doctors about alleged side effects of Zoloft, including emotional blunting and akathisia, which can cause acts of self harm resulting in death. In effect, Plaintiffs allege that Needleman's death resulted from Pfizer's consistent failure to address the relationship between suicidality and the use of prescribed SSRI's, and from Pfizer's practice of improperly downplaying the grave risks of Zoloft in promotional materials and activities. Pfizer responds that no studies have established a link between SSRI use and suicide, and any warning purporting to address such a link would be false, misleading, and contrary to the public interest. Pfizer moves for summary judgment on the basis of federal preemption, arguing that Plaintiffs' failure to warn claim is barred because it is in direct, actual conflict with the FDA's repeated determination that no explicit causation admonition is scientifically justified.
Since Pfizer filed its "new drug application" to market Zoloft for adult depression in 1988, a number of studies have addressed the possible relationship between SSRI use and suicide. The initial review of Zoloft, completed in 1991, found that "disproportionate numbers of suicide attempts do not occur [in clinical trials]," and concluded that the data was too inconclusive to permit a scientifically-reliable conclusion about a causal relationship between the use of Zoloft and increased rates of suicide. Although the advisory committee voted unanimously that the evidence had shown that Zoloft is "safe and effective when used in the treatment of depression," the FDA required a precaution label which states:
Suicide — The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. Close supervision of high risk patients should accompany initial drug therapy. Prescriptions for Zoloft (sertraline) should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
In addition, the "Adverse Reactions" section of the proposed labeling requires a "Psychiatric Disorders" subsection that listed "suicide attempt" as an "Infrequent" occurrence, explaining that "infrequent adverse events are those occurring in 1/100 to 1/1000 patients." The FDA continues to require that these warnings be included in Zoloft packaging.
Such findings and warning requirements did little to satisfy Zoloft's critics: they contended (and still contend) that the effects of Zoloft on brain chemistry remain largely unknown, and that the drug appears to give some subset of its users increased energy to follow through on suicidal impulses before any mood improvement takes effect. However, repeated attempts by critics to require SSRI manufacturers to include warnings of a link between SSRIs and suicidality have been rejected by the FDA, and the FDA has since approved Zoloft as safe and effective treatment for a number of additional illnesses, each time requiring the exact language concerning suicide that the agency had proposed upon Zoloft's initial approval in 1991. To date, no published study or FDA periodic safety review has concluded that SSRIs such as Prozac, Zoloft, or Paxil, cause suicide.
In 2002, the federal government proffered an amicus curiae brief in Motus v. Pfizer, a "failure to warn" case involving Zoloft. The government noted that the FDA conducted reviews of the issue in 1991, 1992, 1997, and 2002, each time finding no scientific basis for a warning that SSRIs cause suicide. The government concluded that any warning suggesting a link between SSRIs and suicide would be false, misleading, contrary to the public interest, and should not be given. The government explained:
The FDA . . . has a clear interest to ensure that state tort law does not undermine the agency's authority to protect the public health through enforcement of the FDCA's prohibition against false or misleading labeling of drug products. To require a warning of a supposed danger that FDA concludes has no actual scientific basis, no matter the warning's language, would be to require a statement that would be false or misleading, and thus contrary to federal law. In such a case, federal law must prevail. The United States files this amicus curiae brief . . . to make clear the basis for federal preemption. . . .
(Def.'s Mem. Supp. Summ. J. Ex. B at 1-2.) [hereinafter cited as Motus Amicus]
I. PLAINTIFFS' CLAIMS ARE BARRED BY FEDERAL PREEMPTION A. Federal Preemption
The parties devote considerable effort to addressing the safety of Zoloft and other SSRIs for the treatment of depression, and the adequacy of clinical studies that have been conducted to date. However, the Court need not — and may not — determine if the evidence establishes the safety of Zoloft, or whether Pfizer's failure to warn of the effects of Zoloft caused Needleman's death. See, e.g., Motus v. Pfizer Inc., 358 F.3d 659, 660 (9th Cir. 2004) ("We offer no opinion on the existence of purported side-effects associated with Zoloft or on the adequacy of Pfizer's warnings."). The FDA has clearly determined that a warning linking Zoloft and suicide would be false, misleading, and harmful to patients. Plaintiffs' inadequate warning claim would thus conflict with the federal requirements imposed during the regulation of Zoloft; in effect, allowing a state regulation to impose labeling requirements contrary to those required by federal law. Accordingly, Pfizer's summary judgment motion must be granted.
It is a bedrock principle of American federalism that any state law conflicting with the exercise of enumerated federal power is preempted. U.S. CONST. art. VI, Cl. 2; Fidelity Fed. Sav. Loan Ass'n v. de la Cuesta, 458 U.S. 141, 152-53 (1982). Under Supreme Court conflict jurisprudence, preemption occurs when (1) Congress expressly preempts state law; (2) Congressional intent to preempt may be inferred from a federal regulatory scheme; or (3) state law conflicts with federal law or its purposes. English v. Gen. Elec. Co., 496 U.S. 72, 78-79 (1990). Where, as here, conflict preemption is alleged, the Court must determine whether "it is impossible for a private party to comply with both state and federal law or [if] state law `stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.'" Id. (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)). "Federal regulations have no less pre-emptive effect than federal statutes." de la Cuesta, 458 U.S. at 153. The imposition of damages under state law is a form of state action subject to preemption. Geier v. Am. Honda Motor Co., 529 U.S. 861, 881 (2000).
B. FDA Labeling Requirements
Plaintiffs' "failure to warn" claim seeks to impose liability on Pfizer for not including a warning in Zoloft packaging that indicates a relationship between Zoloft and suicide. In response, Pfizer argues that such a statement would be considered "false and misleading" by the FDA, and would directly conflict with the FDCA. See 21 U.S.C. § 355(d) (grounds for refusing new drug application). The Food, Drug and Cosmetic Act requires refusal of any "new drug application" that includes labeling that "is false or misleading in any particular." Id. The FDA's new drug approval process includes a procedure by which warning labels are drafted, approved, and required for inclusion in the packaging of manufactured drugs. The Fifth Circuit has concluded that such federal labeling requirements preempt state warnings. See Hurley v. Lederle Laboratories Div. of Am. Cyanamid Co., 863 F.2d 1173, 1179 (5th Cir. 1988) ("assuming that the FDA has processed all the relevant and available information in arriving at the prescribed warning, its decision as to the proper wording must preempt by implication that of a state"); Martin v. Medtronic, Inc., 254 F.3d 573, 585 (5th Cir. 2001) (holding that inadequate warning, design, and manufacturing claims were expressly preempted by Medical Device Amendments to the FDCA where FDA had mandated the warnings, design, and manufacture of the device).
Plaintiffs argue that their failure to warn claim is not preempted solely by the FDA labeling requirements, since the FDCA permits warnings to be strengthened without prior FDA approval. See 21 C.F.R. § 314.70(c)(6)(iii)(A); 21 Fed. Reg. 37,447 (1979); Osburn v. Anchor Laboratories, Inc., 825 F.2d 908, 912 (5th Cir. 1987). However, such changes must later be approved by the FDA, 21 C.F.R. § 314.70(c), and may not violate the statutory and regulatory prohibition against labeling that "is false or misleading in any particular." 21 U.S.C. § 355(e) (withdrawal of approval); 21 C.F.R. § 201.56(a)(b) (labeling requirements for prescription drugs); see also Dusek v. Pfizer, Inc., No. H-02-3559, at 23 (S.D. Tex. Feb. 20, 2004) (Atlas, J.). In addition, the FDA prohibits the misbranding of drugs. 21 U.S.C. § 331(a), (b), and (k). Accordingly, the Court must determine whether the stronger warning sought by Plaintiffs would be deemed "false or misleading" and therefore prohibited by federal law.
C. The FDA Would Deem Any Warnings Proposed by Plaintiffs as False and Misleading
Pfizer argues that any warning attesting to a link between Zoloft use and increased suicidality would necessarily be "false and misleading," and, accordingly, preempted. In support of such argument, Pfizer cites (1) the FDA's initial approval of Zoloft and other SSRIs as "safe and effective," (2) the rejection of three petitions seeking stronger warnings for SSRI drugs, and (3) the government's 2002 amicus curiae brief in Motus reaffirming its view that no scientific evidence supports a stronger warning on suicidality, and concluding that any that suggestion of causation would have been false, misleading, contrary to the public interest, and should not be given. Initially, the FDA's 1991, 1992, and 1997 reviews of Prozac (an SSRI similar to Zoloft) concluded that "there was no credible evidence to support a conclusion that antidepressant drugs cause the emergence and/or intensification of suicidality." Dusek, supra, at 16 (quoting findings of 1991 investigation of Prozac). In addition, the FDA has approved Zoloft (and other SSRIs) for treatment of at least five additional disorders since 1991, each time requiring the same warning, and omitting any statement attributing SSRI use to increased risk of suicide. Indeed, Plaintiffs point to no studies that have established a connection between Zoloft and increased suicidality. These FDA determinations and clinical studies strongly suggest that any insert attributing such a causal relationship would be contrary to the scientific evidence, and deemed false by the FDA.More compelling is the amicus brief submitted by the government in Motus. There, the United States plainly concluded that " any warning, no matter how worded, that could reasonably have been read as describing or alluding to such a relation [between Zoloft and suicide] would have been false or misleading, and therefore in conflict with federal law because there was no (and still is not) scientific support for such a warning." Motus Amicus, at 21 (emphasis in original). The government stated that the Zoloft warnings proposed by the plaintiffs in Motus would be contrary to the scientific evidence, would result in the misbranding of Zoloft, and would chill the drug's otherwise beneficial use. Id. at 17, 23-24. No subsequent study or statement by the FDA indicates that its determination has changed since Motus. The Court recognizes that "Supreme Court precedent dictates that the FDA's position as stated in its amicus brief is entitled to some deference." Dusek, supra, at 12 n. 7 (citing Barnhard v. Thomas, 540 U.S. ___, ___, 124 S. Ct. 376, 380 (2003) and Houston Police Officers' Union v. City of Houston, Tex., 330 F.3d 298, 302-03 (5th Cir. 2003)). Accordingly, the Court places weight on the FDA's unambiguous statement that it would view any statement describing a relationship between Zoloft use and suicide as "false and misleading," and it would deem any state warning requirement preempted.
This case is quite similar to Dusek. As in this case, Pfizer argued for federal preemption in Dusek. That court found the plaintiffs' proposed warning that "Zoloft can and does cause suicide in some patients," preempted. Dusek, supra, at 10, 27. The Dusek court held that the plaintiffs' failure to warn claim was preempted because of the FDA's labeling requirements, continued rejection of stronger warnings, and express disapproval of warnings attesting to a causal relationship between Zoloft and suicide. Id. at 27-28. In so holding, the court explained:
In the face of numerous contentions from several different sources that SSRI antidepressants should contain a warning that they can cause suicide, the FDA has consistently determined no such explicit causation admonition is justified scientifically. The adoption of Plaintiffs' position under the stipulations presented in this case would result in Texas common law requiring a warning that the FDA has explicitly rejected after significant study. Therefore, on the specific facts of this case and the precise state law failure to warn claim Plaintiffs assert, Plaintiffs' failure to warn claim is preempted because it is in direct, actual conflict with federal law.Id. at 27-28.
Without expressly addressing Dusek, Plaintiffs attempt to distinguish it by arguing that, "a warning falling short of a statement that `Zoloft can and does cause suicide' would have sufficed to save Mr. Needleman's life." However, Plaintiffs propose a distinction without a difference. In Motus, the plaintiff never identified the precise warning she thought Pfizer should have required; however, the government concluded that any warning resulting from the litigation would be preempted as false and misleading since "her case, as it related to failure to warn, entirely depended on Pfizer's failure to provide a warning that in some way called attention to an asserted causal relation between Zoloft and suicide." Motus Amicus, at 20-21 (emphasis in original). Whether Plaintiffs fault Pfizer for failing to warn about the risk of suicide, or, alternatively, the risk of akathisia which leads to suicidal behavior, the FDA has concluded that no scientific evidence supports such warning, and it would be false and misleading. In addition, there is no principled way to distinguish Plaintiffs' claim, that Pfizer failed to warn about side effects "which can cause acts of self harm resulting in death," from the Dusek claim that Zoloft "can and does cause suicide."
This holds true even though Plaintiffs coyly decline to identify the specific warning language they claim would be effective but not preempted.
The undisputed summary judgment evidence, as indicated by the FDA labeling of Zoloft, the studies of SSRI use and suicidality, and the government's unambiguous statement in Motus, is that the FDA would deem any such warning false and misleading. Such a determination would clearly make it "`impossible' for [Pfizer] to comply with both state and federal law." Geier, 529 U.S. at 873; Fla. Lime Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963) ("A holding of federal exclusion of state law is inescapable and requires no inquiry into congressional design where compliance with both federal and state regulations is a physical impossibility for one engaged in interstate commerce."). Accordingly, Plaintiffs' state law failure to warn claim is preempted by the FDCA and the FDA's rulings on the warnings required for Zoloft.
CONCLUSION
Because the Plaintiffs have failed to raise a genuine issue of material fact that their failure to warn claims are not preempted by the FDA's rulings and the FDCA's labeling requirements, summary judgment is granted.