Motus v. Pfizer, Inc.

• Citation: 127 F.Supp.2d 1085
• Decision Date: 12 December 2000
• Docket Number: No. CV 00-00298 AHM (SHx).,CV 00-00298 AHM (SHx).
• Parties: Flora MOTUS, Plaintiff, v. PFIZER INC. (Roerig Division), et al., Defendants.
• Court: U.S. District Court — Central District of California

127 F.Supp.2d 1085

Flora MOTUS, Plaintiff, v. PFIZER INC. (Roerig Division), et al., Defendants.

No. CV 00-00298 AHM (SHx).

United States District Court, C.D. California.

December 12, 2000.

George W. Murgatroyd, III, Karen Ann Barth, Baum Hedlund Aristei Guilford & Downey, Los Angeles, CA, for plaintiff.

Pierce O'Donnell, Ann M. Mortimer, Randy R. Merritt, Daniel C. Tepstein, O'Donnell & Shaeffer, Los Angeles, CA, Malcolm E. Wheeler, Amy L. Padden, James E. Hooper, Michael L. O'Donnell, Wheeler Trigg & Kennedy, Denver, CO, for defendants.

ORDER DENYING PFIZER'S MOTION FOR PARTIAL SUMMARY JUDGMENT

MATZ, District Judge.

INTRODUCTION

Victor Motus suffered from depression. To help deal with that illness, sometime in November 1998 he began taking the drug "Zoloft," which is manufactured by defendant Pfizer Inc. ("Pfizer"). Zoloft was prescribed and supplied to Victor Motus by his internist, to whom Pfizer had provided a supply of Zoloft as a sample. For the approximately one week that he took Zoloft, Victor Motus experienced agitation, confusion and suicidal thinking. On November 12, 1998, he took his life by shooting himself.

Plaintiff Flora Motus ("Motus") was married to Victor Motus. She has brought this lawsuit, removed here from state court, seeking recovery on three claims (1) "wrongful death/negligence"; (2) strict liability; and (3) "survival action" for the pain, suffering and losses that Victor Motus sustained while using Zoloft. Her complaint alleges, among other things, that Pfizer "negligently ... fail[ed] to adequately warn the medical community, the general public and plaintiff's decedent, Victor Motus ... of the dangers, contraindications and side effects ... of Zoloft" [Complaint, ¶ 27] and that in the United States "Zoloft was not properly labeled by defendants¹ ... and was not accompanied by proper warnings for safe, informed use ... [T]he labeling ... did not warn physicians in general and Decedent in particular of the dangers inherent in its use, particularly that the drug can cause the user to become violent and suicidal." Complaint, ¶ 58.

Here is the suicide-related precaution that Pfizer gave:

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.

DSUF, ¶ 20.

Now Pfizer has moved for partial summary judgment dismissing plaintiff's "inadequate warning" claims. Pfizer seeks an order that as a matter of law it may not be held liable for its failure to include in the labeling for Zoloft a warning of the risk of suicide. Pfizer argues that under both California law and federal "conflict" preemption doctrine, plaintiff's state law claims based on Pfizer's failure to include a suicide warning in Zoloft's labeling are barred because the Food and Drug Administration ("FDA") has already considered and rejected the inclusion of such a warning in Zoloft's labeling. Motus responds that 1) although FDA did approve Pfizer's proposed labeling for Zoloft without the suicide warning, FDA did not prohibit Pfizer from adding such a warning and 2) Congress has not preempted state tort law claims for failure to warn just because FDA has approved a manufacturer's proposed warnings.

The Court DENIES defendant's motion for partial summary judgment. As set forth in more detail below, Pfizer has failed to establish that a plaintiff is barred from asserting state law tort claims based on failure to warn of a suicide risk.

FACTS²

A. Statutory Background

One aspect of the FDA's mission is to ensure that drugs sold in the United States are "safe and effective." 21 U.S.C. §§ 355(d) and 393(b)(2)(B). To obtain FDA approval of a drug, a manufacturer must submit a New Drug Application ("NDA"). 21 U.S.C. § 355(b). NDAs must include: "full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use ... and specimens of the labeling proposed to be used for such drug." Id. The FDA will disapprove an NDA if:

(1) the investigations ... do not include adequate tests ... to show whether or not such drug is safe for use ... (2) the results of such tests show that such drug is unsafe for use ... or do not show that such drug is safe for use ... (4) ... [there is] insufficient information to determine whether such drug is safe for use ... or (7) based on a fair evaluation of all material facts, [the product's] labeling is false or misleading in any particular...

21 U.S.C. § 355(d).

If FDA approves an NDA, FDA will withdraw that approval if:

clinical or other experience, tests, or other scientific data show that such drug is unsafe ... [or] that new evidence of clinical experience, not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not ... safe for use ... or that the application contains any untrue statement of a material fact.

21 U.S.C. § 355(e).

B. The Zoloft New Drug Application

On April 13, 1988, Pfizer submitted an NDA to the FDA seeking approval to market Zoloft for treatment of depression. Defendant's Statement of Uncontroverted Facts ("DSUF"), ¶ 11. Zoloft is the registered trademark and brand name in the United States for sertraline hydrochloride. DSUF, ¶ 2. Sertraline hydrochloride is one of a class of medicines commonly referred to as "selective serotonin reuptake inhibitors," or "SSRIs." Id.

Pursuant to Title 21 U.S.C. § 355, the statute governing New Drug Applications, Pfizer submitted 117 volumes of safety and efficacy data on Zoloft that Pfizer had developed during the preceding seven years. DSUF, ¶ 12; 21 U.S.C. § 355(b). These submissions included information about suicidality in patients given Zoloft, placebos and other drugs, although plaintiff disputes the completeness and accuracy of the information. DSUF, ¶ 13; Opposition, passim.

On November 19, 1990, FDA convened a committee of experts, the Psycho-pharmacological Drugs Advisory Committee ("PDAC"), to review the Zoloft NDA and to advise FDA regarding the medicine's safety and efficacy. DSUF, ¶ 14. As part of his presentation of safety data, one of the PDAC experts, Dr. James Knudson, addressed suicide attempts in Zoloft, placebo and active-control treated patients during the clinical studies of Zoloft. DSUF, ¶ 17. Dr. Knudson stated that:

Realizing the difficulty in interpreting data where analyses ignore differential exposure time, this table does show that disproportionate numbers of suicides do not occur among the three treatment groups. All suicide attempts appeared in depressed patients, none in the obese.

Id. At the conclusion of the meeting, the PDAC voted unanimously that the evidence Pfizer produced had shown that Zoloft "is safe when used in the treatment of depression." DSUF, ¶ 18.

On September 30, 1991, FDA issued its "approvable" letter for the Zoloft NDA. DSUF, ¶ 18. The letter stated that FDA has "proposed a number of changes to the draft labeling submitted in your July 24, 1990 amendment" and it proposed some different labeling. Id. The precaution section of the proposed labeling included this statement regarding suicide:

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.

DSUF, ¶ 20. The FDA letter instructed Pfizer to "[p]lease use the proposed text verbatim." (As was shown above, Pfizer eventually did so.) DSUF, ¶ 19.³ In addition, FDA stated that final approval required Pfizer's responses to issues raised in the letter. Defendant's Motion for Partial Summary Judgment ("Defendant's Motion") Declaration of Martha Brumfield ("Brumfield Dec."), Exh .3.

FDA granted final approval of the Zoloft NDA on December 30, 1991. DSUF, ¶ 21. Working from a draft submitted by Pfizer, FDA also prepared a final "Summary Basis of Approval" for Zoloft. DSUF, ¶ 22; Plaintiff's Opposition to Defendant's Motion for Partial Summary Judgment ("Opposition"), Declaration of George Murgatroyd ("Murgatroyd Dec."), Exh. A, Response to Request for Admission Nos. 138, 139. Section 5.2.2.4.1 addressed the occurrence of suicide events in the database of tested sertraline users. DSUF, ¶ 22. That section stated that with respect to suicidality in therapeutic depression trials "[r]eview of the rates of events defined by baseline to endpoint shifts in HAMD Item 3 scores [i.e., measurement of suicidal ideation] and baseline to endpoint changes in HAMD Item 3 scores showed results favoring [Zoloft] over placebo and supported the comparability of the [Zoloft] and active control groups." DSUF, ¶ 22.

Following its approval of Zoloft for treatment of depression, FDA also approved Zoloft as safe and effective for treatment of obsessive compulsive disorder (October 25, 1996), pediatric obsessive compulsive disorder (October 10, 1997), panic disorder (July 8, 1997) and post-traumatic stress disorder (December 7, 1999).⁴ DSUF, ¶¶ 45-48. (The latter approval was granted after Victor Motus took his life.)

C. Other SSRI's and Labeling About Suicide⁵

Before and during FDA's consideration of the Zoloft NDA, FDA considered claims that other SSRIs, such as Prozac, cause suicide.

In early 1990, an article was published about Prozac that led to a...