Cloud v. Pfizer Inc. — (LEAGLE)

United States District Court, D. Arizona.

November 21, 2001

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).

Medical History

According to Plaintiff, in October 1995, Mr. Baskins suffered from some minor depression. In February 1996, Daniel T. Collins, M.D. prescribed him some Zoloft samples. After returning to Dr. Collins, the prescriptions were increased. In a March 15, 1996 report, Dr. Collins noted that Mr. Baskins “had a little bit of agitation but this has settled down.” Pharmacy records indicate that Mr. Baskins refilled his monthly prescription of Zoloft from February 1996 until August 1997. Therefore, it appears that Mr. Baskins took Zoloft for 18 months until his death on August 30, 1997.

In addition to his treatment from Dr. Collins, Mr. Baskins also saw the family’s pastor, Pastor Leslie Maloney, as well as a counselor/therapist Christine Hartzler, M.A., CPC. Mr. Baskins and Plaintiff were having problems with their marriage, and Plaintiff had recently threatened to leave him prior to his hospitalization in August 1997. Furthermore, there is testimonial and documentary evidence that Mr. Baskins consumed alcohol and also smoked marijuana.

Testimony Regarding Mr. Baskins’ Behavior While He Was Taking Zoloft

Regarding Mr. Baskins’ behavior while on Zoloft, the parties have submitted deposition testimony from various witness and answers to interrogatories including the following:

Plaintiff claims that while Mr. Baskins rarely drank prior to taking Zoloft, he had a “strong craving” for alcohol while on the medication.    Plaintiff has also testified that while on Zoloft, Mr. Baskins would pace back and forth, was extremely restless, had difficulty sleeping, and complained that his skin hurt from the inside out.   Ms. Nicolee Shandy, an employee of Plaintiff and Mr. Baskins, testified that she never saw Mr. Baskins pace, wring his hands, shake, in a manic or euphoric state, or complain that his skin hurt from the inside out.   Likewise, his son Michael Baskins did not see any similar actions while Mr. Baskins was on a trip to Kansas that he took not long before his suicide.    Mr. Baskins’ step-son, Jacob, testified that he never saw Mr. Baskins have any trouble sitting still, pacing, or any other restless behavior. He did testify, however, that Mr. Baskins did experience difficulty sleeping.

The Week Leading Up To Mr. Baskins’ Hospitalization & Suicide

In the week leading up to his suicide, Mr. Baskins dropped an air conditioner on his knee on August 25, 1997. On August 26, 1997, he cut off the end of his finger. Plaintiff then took Mr. Baskins to see Ms. Hartzler who diagnosed Mr. Baskins as being suicidal. Ms. Hartzler’s August 27, 1997 note indicates that Mr. Baskins’ mood was flat. From her records, it appears that Ms. Hartzler had seen Mr. Baskins on two prior occasions in January 1997 while she was counseling Plaintiff. In her deposition, Ms. Hartzler testified that she did not see any signs of akathisia in Mr. Baskins on August 27, 1997.

Based upon Ms. Hartzler’s advice, Plaintiff then took Mr. Baskins to St. Mary’  Hospital in Tucson, Arizona on August 27, 1997. The St. Mary’s admitting physician does not believe that Mr. Baskins was suffering from akathisia when he admitted him on August 27, 1997. Some notes in the St. Mary’s records indicate that Mr. Baskins reported problems with insomnia, and span of concentration. Dr. John Ely noted that these symptoms appeared to be psychomotor restlessness. Also St. Mary’s employee Kevin Delmastro testified that Mr. Baskins “had some element of impaired concentration during the interview; that he had complained about difficulty sleeping.” However, he did not observe any pacing or fidgety movements. On August 28, 1997 Mr. Baskins reported that his ability to think and concentrate had improved. Finally, Ms. Adrienne O’Hare testified that during her counseling visits with Mr. Baskins at St. Mary’s Hospital, she did not see any agitation or pacing.

Mr. Baskins’ records from St. Mary’s reveal that he had cannabinoids and amphetamines in his system. The most likely scenario regarding the amphetamines is that they came from some diet medications (Mini Thins) that Mr. Baskins was taking. In his deposition, Plaintiff’s expert, Dr. Edwin Johnstone, testified that he could not be certain that the Mini Thins caused the lab report to be positive for amphetamines but that he would need to check with a toxicologist.

On August 29, 1997, two days after being admitted, the hospital released Mr. Baskins, and Pastor Maloney drove him back to Safford.  Pastor Maloney described Mr. Baskins as “down,” “lethargic,” and “quiet” while he drove him back to Safford. That evening, Plaintiff would not let him stay in their home.  On August 30th, also the birthday of Plaintiff’s daughter from another marriage, Mr. Baskins had various interactions with the family including giving some cards and gifts to the family. After a conversation with Mr. Baskins, Plaintiff left her home and took the children with her. Upon Plaintiff’s request, Pastor Maloney went to the couple’s residence and found Mr. Baskins was dead, having hanged himself in the outbuilding.

Dr. Johnstone’s Deposition Testimony & Affidavit

Regarding the general causal link between Zoloft and suicide, Dr. Johnstone, in his deposition, relied upon a declaration by Dr. Healy’s analysis of a Pfizer clinical trial. In that declaration, Dr. Healy stated that the trial revealed “a relative risk of approximately 1.9 for sertraline versus placebo and a greater risk for sertraline than for comparator antidepressants.” Dr. Johnstone, however, did not have the underlying information or Dr. Healy’s work to verify the conclusions. Regarding the various studies that have been conducted, Dr. Johnstone testified:

• He does not believe that uncontrolled case reports of suicide ideation by patients being treated with SSRIs are a reliable source of scientific information.• He also has not read any placebo controlled clinical trial showing a higher incidence of suicide in depressed patients taking Zoloft than those taking a placebo.
• He claims that the 2000 Donovan naturalistic study cannot establish reliable causal proof but is “strongly suggestive” of a line between Zoloft and suicide.
• He is not aware of any medical or scientific studies that Zoloft increases the risk of suicide in depressed patients or that demonstrate a casual relationship between the use of Zoloft, mixed manic states and suicide.• Regarding the 2000 published study by Healy, Dr. Johnstone notes the study’s importance in demonstrating “a difference between a drug selected because it specifically is a booster of serotonin activity versus equally effective antidepressant that specifically does not boost serotonergic activity, boosts noradrenergic activity.” He also testified that the study is not reliable scientific evidence that Zoloft causes suicide in depressed patients.

Regarding specific causation, Dr. Johnstone does not believe that Mr. Baskins developed akathisia from Zoloft. He stated clearly that “[i]t’s not my opinion that he developed akathisia from Zoloft and that made him—maybe led to the suicide. No. That’s not my opinion.” Rather, his opinion is that the combined effects of Zoloft and the over-the-counter stimulant “together generated in him a dysphoric, manic state, with suicidal desperation and suicidal intent being a feature of that and maybe an additional influence of command hallucinations suggesting that he [commit] suicide.” He has no specific articles, just general medical knowledge, regarding the toxic effects of combining diet pills and Zoloft. Relying upon a St. Mary’s nurse’s note indicating that Mr. Baskins was experiencing auditory hallucinations that he could not understand, Dr. Johnstone has testified that “more likely than not the presence of the auditory hallucinations was related to the Zoloft and very likely related to some kind of toxic effect of the combination of Zoloft and the over-the-counter stimulants.”

No Reasonable Jury Could Conclude that Zoloft Caused Mr. Baskins’ Suicide

Even considering Arizona’s liberal view of causation, Plaintiff has failed to raise a genuine issue of material fact regarding causation. First, Plaintiff has not provided sufficient evidence such that a reasonable jury could conclude that Zoloft causes suicide. As discussed above, the medical articles and diagnostic texts do not support a finding of legal causation. Likewise, individual case reports and retrospective medical articles summarizing individual case reports are not an adequate basis from which a jury could conclude that Zoloft causes suicide. Similarly, Pfizer’s report to the Irish Medicines Board does not constitute an admission of general causation by Pfizer. See Smith v. Pfizer, 2001 WL 968369 (D.Kan.2001).

Furthermore, Plaintiff has failed to produce sufficient evidence such that a reasonable jury could conclude that Zoloft caused Mr. Baskins to commit suicide. In this regard, even assuming that the medical articles support general causation, the literature theorizes the following link: Zoloft causes akathisia that results in a suicidal event. In this case, Plaintiff has not presented any admissible evidence that Mr. Baskins suffered from akathisia. Furthermore, in the absence of Dr. Johnstone’s testimony, Plaintiff cannot prove  causation.

Conclusion

For the reasons set forth above, Dr. Johnstone’s testimony regarding general and specific causation are unreliable and are therefore excluded. Furthermore, Plaintiff has failed to produce sufficient evidence upon which a reasonable jury could agree with her propositions concerning general and specific causation. As a result, summary judgment in favor of Pfizer and against Plaintiff is appropriate.