Dorsett v. Sandoz Inc

• Decision Date: 26 March 2010
• Docket Number: No. CV 06-7821AHM (AJWAx).,CV 06-7821AHM (AJWAx).
• Citation: 699 F.Supp.2d 1142
• Court: U.S. District Court — Central District of California
• Parties: Rosemary DORSETTv.SANDOZ, INC.

699 F.Supp.2d 1142

Rosemary DORSETTv.SANDOZ, INC.

No. CV 06-7821AHM (AJWAx).

United States District Court,

C.D. California.

March 26, 2010.

COPYRIGHT MATERIAL OMITTED

Bijan Esfandiari, Kate Elizabeth Gillespie, Michael Lin Baum, Baum Heldlund Aristei and Goldman, Los Angeles, CA, Arnold A. Vickery, Paul Waldner, Vickery Waldner And Mallia, Houston, TX, for Rosemary Dorsett.

Eric G. Lasker, Joe G. Hollingsworth, Kirby T. Griffis, Stephen A. Klein, Hollingsworth LLP, Washington, DC, Richard Alden Clark, Natasha N. Dawood, Parker Milliken Clark O'Hara & Samuelian, Los Angeles, CA, for Sandoz, Inc.

Proceedings: IN CHAMBERS (No Proceedings Held)

A. HOWARD MATZ, District Judge.

I. INTRODUCTION

This is a products liability case arising from the suicide death of Noe Carrasco, the son of Plaintiff Rosemary Dorsett. Defendant Sandoz, Inc. (“Sandoz”) originally filed this motion on March 27, 2007, as a motion to dismiss on the ground that federal law preempted Plaintiff's claims. On April 2, 2007, the Court granted Plaintiff's ex parte application to convert the motion into a motion for summary judgment and gave Plaintiff additional time to respond. On February 14, 2008, the Court granted Sandoz's unopposed motion to stay this case pending the Supreme Court's decision in Wyeth v. Levine, ---U.S. ----, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009). While the case was stayed, the Court granted Plaintiff's motion to temporarily lift the stay to substitute Eli Lilly and Company (“Lilly”) in place of one of the Doe defendants. Plaintiff then filed her operative pleading, the Second Amended Complaint (“SAC”), on January 6, 2009. Wyeth was decided on March 4, 2009 and the Court reopened the case on March 24, 2009. Thereafter, Lilly filed a motion for judgment on the pleadings on statute of limitations grounds, which the Court denied on October 28, 2009, 2009 WL 3633874. Lilly has also filed a motion for summary judgment on the ground of federal preemption, presenting similar, though not identical, arguments to those of Sandoz. The Court will refer to Lilly and Sandoz collectively as “Defendants” when appropriate. For the following reasons, the Court DENIES Defendants' motions for summary judgment and finds that Plaintiff's claims are not preempted.¹

II. BACKGROUND ²

A. Crux of This Case

On August 20, 2004, Carrasco committed suicide by shooting himself in the garage of his friend's home. Second Amended Complaint (“SAC”) ¶ 5. Carrasco was 26 years old. He had been taking fluoxetine, the generic version of the drug Prozac, for approximately 36 days before his death. SAC ¶ 55.

Carrasco began taking fluoxetine on or about July 15, 2004. SAC ¶ 55; Mem. at 3. Fluoxetine, like Prozac, is a selective seratonin reuptake inhibitor (“SSRI”). Mem. at 3. SSRIs are a class of antidepressants used to treat depression, anxiety disorders, and some personality disorders.

Defendant Sandoz manufactures and markets generic fluoxetine. Its warning label for fluoxetine was identical to the label on its brand name equivalent, Prozac, manufactured by Lilly. At the time of Carrasco's death, the Sandoz label contained the following language, which was standard for all SSRIs:

Suicide: The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. Prescriptions for Drug Z should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

As for Lilly, it asserts that its label was changed at some point in July 2004 (shortly before Carrasco's death) to include an enhanced warning, which stated, in part:

Clinical worsening and suicide risk-Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a longstanding concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

Lilly's Exs. X & Z; SUF ¶¶ 24, 27 (emphasis in original). The warning went on to state that “[a]lthough there has been a long-standing concern that antidepressants may have a role in inducing or worsening of depressions and emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established.” Id. Sometime afterward-at the hearing, the parties represented that it was in December 2004-Sandoz placed this language in its label.

Plaintiff Rosemary Dorsett (“Dorsett”) is Carrasco's mother. She alleges that Defendants failed to provide any warning through any medium about the association between fluoxetine and suicidality; ³ and that based upon the state of knowledge as it existed at the time, Defendants knew or should have known that fluoxetine was a substance associated with producing preoccupation about and acts of self-harm and could be dangerous and unsafe. SAC ¶¶ 55-57. According to Dorsett, Defendants should have provided “a stronger warning regarding the association between fluoxetine and suicidality through a variety of mediums, including but not limited to labeling, continuing education, symposiums, posters, advertisements....” SAC ¶ 53. See also SAC ¶¶ 56-57. Dorsett has not provided a specific warning about a causal relationship between SSRIs and suicidality in adults that she says should have been placed on the label. See infra, p. 1159-60.

Dorsett is suing for common law negligence, strict liability, breach of express warranty, and for survival. SAC ¶¶ 54-85. Defendants have moved for partial summary judgment of Plaintiff's failure-to-warn claims on the grounds that Plaintiff's state product-liability claims are preempted by the Federal Food, Drug and Cosmetic Act (“FDCA”) and by regulations promulgated by the Food and Drug Administration (“FDA”). Defendants seek an order that as a matter of law they may not be held liable for their failure, as of July 2004, to include in the labeling for fluoxetine any warning regarding the risk of suicide beyond that which was approved by the FDA.

B. Statutory and Regulatory Background

The “essential purpose” of the FDCA is “to ensure that any product regulated by the FDA is ‘safe’ and ‘effective’ for its intended use.” Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000). The FDA's mission is to “promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner” and to “protect the public health by ensuring that ... human and veterinary drugs are safe and effective.” 21 U.S.C. § 393(b)(1), (2). The FDA fulfills its mission, in part, by overseeing the approval process for new drug products, regulating drug labeling content, and issuing public health advisories if the safety of a drug product comes into question.

In 1962, Congress amended the FDCA to require all drug manufacturers to submit a new drug application (“NDA”) to the FDA for permission to market a new drug product. See generally 21 U.S.C. § 355; Public Law 87-781 (1962). Applications for new drugs must include scientific data showing the drug's safety as well as its effectiveness for its intended use. 21 U.S.C. § 355(b); 21 C.F.R. pt. 314.

In 1984, pursuant to the Hatch-Waxman Act, the FDA implemented an abbreviated new drug application procedure (“ANDA”) for manufacturers of generic drug products. 21 U.S.C. § 355(j). By using the “innovator” drug as the basis for the generic drug's approval, ANDA applicants are not required to include clinical data to demonstrate the drug's safety and effectiveness. Id. Instead, ANDA applicants must demonstrate that their product is bioequivalent to (that is, performs in the same manner as) the innovator drug. See generally 21 C.F.R. pt. 320.

The statutory provision governing the ANDA procedure provides:

An abbreviated application for a new drug shall contain ... information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug referred to in clause (i) except for changes required because of differences approved under a petition filed under subparagraph (C) or because the new drug and the listed drug are produced or distributed by different manufacturers.

21 U.S.C. § 355(j)(2)(A)(v). Thus, the ANDA procedure is only available for those generic drug products that are “the same as” an already-approved FDA drug. See 21 C.F.R. § 314.92(a)(1). “[T]he term ‘same as' means identical in active ingredient(s), dosage form, strength, route of administration, and conditions of use....” See 21 C.F.R. § 314.92(a)(1). This means that the packaging and labeling of the innovator drug and generic drug must-with limited exceptions-be identical at the time the ANDA application is submitted.

In January 2006 the FDA issued a new final rule on the content and format of labeling, which went into effect in June 2006. Under both the new and old rule, the labeling “must contain a summary of the essential scientific information needed for the safe and effective use of the drug.” 21 C.F.R. § 201.56(a)(1). Also, it “must be informative and accurate and neither promotional in tone nor false or misleading in any particular.” 21 C.F.R. § 201.56(a)(2).

The FDA must withdraw approval if, after notice and hearing, subsequent evidence shows that...