Summary Judgment Granted
he relies to support his opinion that Zoloftcauses suicide, do not support his conclusion.”
In Zoloft Suicide Case
For Lack Of Causation
“Based upon relevant case law, the Court doesnot believe that Dr. Johnstone can jump fromarticles, that he testified are only suggestive
TUCSON, Ariz. — An Arizona federal judge
of a link between Zoloft and suicide, to a re-
liable conclusion that Zoloft causes suicide,”
Zoloft suicide case for lack of expert testimony
Judge Browning wrote. “Regarding specific
on general or specific causation (Laura Cloud,
causation, Dr. Johnstone’s conclusions are not
et al. v. Pfizer Inc., No. 99-627, D. Ariz.).
supported by the medical literature or anyadmissible evidence. As a result, Dr.
. Document #28-020124-014R.)
Johnstone’s testimony regarding both gener-al and specific causation is excluded as it is
Darrian Baskins was prescribed Pfizer Inc.’s
unreliable and, as a result, would likely mis-
Zoloft brand sertraline hydrochloride in 1996
for treatment of depression. In 1997, whilestill taking the antidepressant, he committed
Judge Browning said he does not believe the
materials cited by Johnstone support his opin-ion that Zoloft causes suicide.
“In particular,” he wrote, “the Court finds that
Baskins’ medical history showed that he coun-
his reliance upon medical articles which he
seled with his pastor and a therapist, was
disavowed as providing evidence of general
having marital problems, drank and smoked
causation particularly disturbing and, in truth,
marijuana. There was deposition testimony
the antithesis of a scientific method.
that while taking Zoloft, Baskins craved al-cohol, paced, was extremely restless, had dif-
“In addition, as Dr. Johnstone has testified,
ficulty sleeping and complained that his skin
case reports are not a recognized method of
proving causation,” Judge Browning contin-ued. “Finally, the lack of significant epide-
The medical record also showed that Baskins
miological studies also undermines the reli-
ability of Dr. Johnstone’s testimony regard-
Baskin’s widow, Laura Cloud, sued Pfizer for
Other Causes Unexplored
alleged failure to warn or provide proper in-structions on the potential side effect of suicide.
As to Johnstone’s opinion on specific causa-tion, Judge Browning said he issued his “psy-
A motion by Pfizer for summary judgment on
chological autopsy” opinion before seeing
the basis of preemption by the Food, Drug and
Baskins’ medical records, didn’t see all the
Cosmetic Act was denied in February 2001.
FDA material on Zoloft, didn’t explore other
Pfizer then moved to exclude the testimony
causes of Baskins’ suicide, relied on medical
of Cloud’s expert witness on causation, Dr.
articles that had analytical and scientific gaps
Edwin E. Johnstone, and for summary judg-
and produced no reports about an interac-
ment on causation and punitive damages.
tion between Zoloft and alcohol and over-the-counter stimulants.
Gerald S. Maltz of Haralson, Miller, Pitt &
Senior Judge William D. Browning of the U.S.
District Court for the District of Arizona on
Richard W. Ewing and Paul F. Waldner III of
Nov. 21 found that Cloud “failed to show that
Vickery & Waldner in Houston represent Cloud.
Dr. Johnstone’s methodology and, therefore,
John D. Everroad of Fennemore Craig in Phoe-
his testimony are reliable. Even assuming he
is qualified to speak about general causation,
Hooper and Amy L. Padden of Wheeler, Trigg
the medical and scientific articles, upon which
& Kennedy in Denver represent Pfizer. ■
Copyright 2002 Mealey Publications, King of Prussia, PA • www.mealeys.com
CONSULTATION WITH TARGET PATIENT GROUPS - MEETING THE REQUIREMENTS OF ARTICLE 59(3) WITHOUT THE NEED FOR A FULL TEST - RECOMMENDATIONS FOR BRIDGING Revision 1, April 2009 1. INTRODUCTION Guidance has already been issued from the CMD(h) which indicates that although all package leaflets (PLs) for medicines must reflect the results of consultation with target patient
UNIVERSIDAD NACIONAL DE CORDOBA Facultad de Filosofía y Humanidades V JORNADAS DE ENCUENTRO INTERDISCIPLINARIO “LAS CIENCIAS SOCIALES Y HUMANAS EN CORDOBA” [Abordaje: clínico-analítico] Equipo de investigación perteneciente a: Seminario electivo: “Psicoanálisis y Mito: La Psiquis entre Eros y Tánatos” [Proyecto colectivo] Eje temático: “Sujetos y subjetivid