Cloud v. Pfizer Inc.

• Decision Date: 21 November 2001
• Docket Number: No. Civ 99-627-TUC-WDB.,Civ 99-627-TUC-WDB.
• Citation: 198 F.Supp.2d 1118
• Parties: Laura CLOUD, individually and as statutory representative of the Estate of Darren Baskins, Deceased, and on behalf of Elizabeth Cloud, her minor daughter and statutory beneficiary, Plaintiff, v. PFIZER INC., Defendant.
• Court: U.S. District Court — District of Arizona

Page 1118

198 F.Supp.2d 1118

Laura CLOUD, individually and as statutory representative of the Estate of Darren Baskins, Deceased, and on behalf of Elizabeth Cloud, her minor daughter and statutory beneficiary, Plaintiff, v. PFIZER INC., Defendant.

No. Civ 99-627-TUC-WDB.

United States District Court, D. Arizona.

November 21, 2001.

COPYRIGHT MATERIAL OMITTED

Gerald S. Maltz, Haralson Miller Pitt & McAnally PC, Tucson, AZ, Andy Vickery, Richard W. Ewing, Paul F. Waldner, III, Vickery & Waldner LLP, Houston, TX, for plaintiff.

John D. Everroad, John D. Everroad, Fennemore Craig PC, Phoenix, AZ, Malcolm E. Wheeler, James Ernest Hooper, Amy L. Padden, Wheeler Trigg & Kennedy PC, Denver, CO, for defendant.

ORDER

WILLIAM D. BROWNING, Senior District Judge.

Pending before the Court are the following motions filed by Defendant Pfizer:

1. Motion to Strike Declaration of Edwin Johnstone, M.D. (Doc. # 164),

2. Motion to Exclude Testimony of Dr. Edwin E. Johnstone (Doc. # 122),

3. Motion for Summary Judgment re: Causation (Doc. # 136), and

4. Motion for Partial Summary Judgment re: Punitive Damages (Doc. # 129).

For the reasons set forth below, the Motion to Strike (Doc. # 164) is DENIED, the Motion to Exclude (Doc. # 122) is GRANTED, the Motion for Summary Judgment (Doc. # 136) is GRANTED, and the Motion for Partial Summary Judgment is DENIED AS MOOT. Accordingly, the Clerk of the Court is ordered to enter judgment in favor of Defendant Pfizer and against Plaintiff Laura Cloud.

I. Brief Factual & Procedural History

In February 1996, Mr. Darren Baskins was originally prescribed Zoloft for treatment of his depression. In August 1997, Mr. Baskins committed suicide in Safford, Arizona. Mr. Baskins' widow, Laura Cloud, now brings this product liability and negligence action against Zoloft's manufacturer Pfizer Inc. for Pfizer's alleged failure to warn and/or provide proper instructions regarding the potential side-effect of suicide. She essentially claims that Zoloft caused Mr. Baskins to experience side-effects that resulted in his committing suicide, and that Pfizer knew of these side-effects yet failed to warn about the potential risks. On a previous motion for summary judgment, this Court rejected Pfizer's arguments that Plaintiff's claims were preempted by the federal Food, Drug, and Cosmetic Act (FDCA).

A. Brief History of Zoloft Before the Food and Drug Administration

On April 13, 1998, Pfizer submitted a New Drug Application to the Food and Drug Administration (FDA) seeking approval to market Zoloft for the treatment of depression. Zoloft is the registered trademark and brand name in the United States for sertraline hydrocloride. Sertraline hydrocloride is one of a class of medicines commonly referred to as "selective serotonin reuptake inhibitors" or "SSRIs." Prozac, Paxil, and Celexa are other popular SSRIs. In conjunction with its application, Pfizer submitted 117 volumes of safety data and later submitted a report on suicide attempts by patient who were prescribed Zoloft. After changes to Pfizer's proposed label, the FDA finally approved Zoloft on December 30, 1991.

FDA approved labeling must contain a number of specific sections. The sections relevant to Plaintiff's claim include: (1) contradindications, (2) warnings, (3) precautions, and (4) adverse reactions. See 21 C.F.R. § 201.56. Particular to this matter, the final approved label for Zoloft contained the following "precaution:"

Suicide—The possibility of a suicide attempt is inherent in depression. Close supervision of high risk patients should accompany initial drug therapy. Prescriptions for Zoloft should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Under the "adverse reactions" section, Pfizer disclosed on its label as follows:

Psychiatric disorders—Infrequent: abnormal dreams, aggressive reaction, amnesia, apathy, delusion, depersonalization, depression, aggravated depression, emotional liability, euphoria, hallucination, neurosis, paranoid reaction, suicide ideation and attempt, teeth-grinding, abnormal thinking; Rare: hysteria, somnambulism, withdrawal syndrome.

Subsequent to its approving Zoloft to treat depression, the FDA also approved Zoloft as safe and effective for the treatment of obsessive compulsive disorder (October 25, 1996), panic disorder (July 8, 1997), pediatric obsessive compulsive disorder (October 10, 1997), and post-traumatic stress disorder (December 7, 1999). In each of these approvals, the FDA ordered Pfizer to include the same notice about suicide in the "adverse reactions" section of the label.

B. Brief History of Other SSRIs Before the Food and Drug Administration

Before and after the FDA's approval of Zoloft, the FDA considered applications concerning other SSRIs, and claims that the SSRIs cause suicide.

In October 1990, the Church of Scientology filed a petition with the FDA claiming that Prozac caused suicide and asking the FDA to withdraw its approval. In May 1991, the Public Citizen Health Research Group requested that the FDA require the makers of Prozac to label the drug with a boxed warning indicating that Prozac may be associated with suicide in a small number of patients.

In July 1991, the FDA denied the Scientology petition noting that "[t]he data and information available at this time do not indicate that Prozac causes suicidality or violent behavior."

In September 1991, the FDA convened the Psychopharmacological Drugs Advisory Committee (PDAC) to investigate any link between pharmacological treatment of depression and suicidality. The PDAC unanimously found that there was no credible evidence to support a conclusion that antidepressant drugs cause the emergence or intensification of suicidality or other violent behaviors. The PDAC also unanimously found that there was no evidence to indicate that a particular drug or drug class poses a greater risk for the intensification of suicidal thoughts and/or violent behaviors. The PDAC also voted 6-3 not to recommend changing the labeling of anti-depression drugs.

In June 1992, the FDA denied the Public Citizen petition finding that the evidence was "not sufficient to reasonably conclude that the use of Prozac is possibly associated with suicidal ideation and behavior."

In 1997, the FDA denied a petition to expand the suicidality warning on Prozac noting that it had continued to monitor any links between Prozac and suicidality.

C. Brief History of Research Regarding the Link Between SSRIs and Suicide

Both parties have submitted volumes of medical research articles and cases studies to the Court. While not totally exhaustive, the following summaries are offered as a synopsis of the medical community's thoughts regarding the alleged causal link between SSRIs, particularly Zoloft, and suicide:

Pre-August 1997 Research¹

• In September 1989, Joseph F. Lipinski, Jr., M.D., et.al., published a study, based upon case reports, possibly linking akathisia² with fluoxetine (Prozac).

• In February 1990, Harvard psychiatrists Teicher and Cole published an article concerning SSRIs and drug-induced suicidal ideation. The article described six patients who, during treatment with Prozac, experienced either the onset or intensification of suicidal ideation.

• In 1991, Robert A. King, M.D., et.al., published a study in which self-injurious ideation appeared de novo or intensified during fluoxetine (Prozac) treatment of obsessive-compulsive disorder. Because of the nature of the study, King was not able to link fluoxetine with the self-injurious ideation but encouraged increased studies and vigilance.

• In 1991, W. Creaney, et.al., published an article including two case reports of patients developing akathisia and suicidal ideation while taking fluoxetine.

• In 1991, Anthony J. Rothschild, M.D., et.al., published an article listing their findings of three patients. The three patients had previously made serious suicide attempts while taking fluoxetine. When being reintroduced to the drug, they began to develop akathisia. Again, these researchers urged clinicians to monitor the development of akathisia in their patients.

• In November 1991, Dr. John Mann and Dr. Kapur issued an article indicating that clinicians should warn patients of the possible occurrences of suicide while on antidepressants, but was unable to state whether such drugs could precipitate or worsen suicidality.

• In 1991, Roger M. Lane, M.D. of Pfizer linked the administration of SSRI to rare cases of drug-induced akathisia in some patients.

• An internal Pfizer 1992 study indicated no correlation between Zoloft and suicide attempts and suicidal ideation. Those results were published in May 1992 and presented at the Collegium International Neuro-Psychopharmnacologicum in June 1992.

• In July 1992, Wirshing, et.al. reported the occurrence of suicidal ideation in five patients with fluoxentine (Prozac) —induced akathisia and suggested a link between akathisia and suicidal ruminations.

• In November 1992, Margaret S. Hamilton, et.al., published a report entitled "Akathisia, Suicidality, and Fluoxetine." They suggested that "`suicidal ideation' reported in the patients taking fluoxetine described in this article as well as in our own patient is really a reaction to the side effect of akathisia and not true suicidal ideation as is typically described by depressed patients experiencing suicidal ideation."

• In February 1993, the American College of Neuropsychopharmacology's Council and Task Force issued a consensus statement in which it found that "[t]here is no evidence that anti-depressants such as the selective serotonin reuptake inhibitors ... trigger emergent suicidal ideation over and above rates that may be associated with depression and other antidepressants." However, the consensus statement also indicated that "patients should be warned that suicidal ideation may occasionally worsen in the...