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Boehm v. Eli Lilly & Co.

United States Court of Appeals, Eighth Circuit

March 10, 2014

Timothy Boehm, Plaintiff - Appellant
v.
Eli Lilly & Company, Defendant - Appellee

Submitted September 26, 2013

Appeal from United States District Court for the Eastern District of Arkansas - Little Rock.

For Timothy Boehm, Plaintiff - Appellant: Sidney W. Jackson, III, JACKSON & FOSTER, Mobile, AL; Richard N. Turbeville, Little Rock, AR.

For Eli Lilly & Company, Defendant - Appellee: Samuel J. Abate, Jr., Nina M. Gussack, Andrew E. Kantra, Franklin T. Pyle, III, PEPPER & HAMILTON, New York, NY; Lyn Peoples Pruitt, MITCHELL & WILLIAMS, Little Rock, AR.

Before LOKEN, COLLOTON, and BENTON, Circuit Judges.

OPINION

Page 502

LOKEN, Circuit Judge.

Zyprexa (active ingredient olanzapine) is an " atypical" or " second generation" antipsychotic drug manufactured and sold by Eli Lilly & Company (" Lilly" ). Timothy Boehm's doctors prescribed Zyprexa to treat his bipolar disorder from January 2003 until March 2007, when he developed symptoms later diagnosed as tardive dyskinesia (" TD" ) -- an involuntary movement disorder long recognized as a side effect of antipsychotic drugs. Boehm brought this action, later removed by Lilly, asserting personal injury and product liability claims. The district court[1] granted

Page 503

summary judgment dismissing the failure-to-warn claim, applying the Arkansas learned intermediary doctrine[2] and concluding that Lilly adequately warned Boehm's treating and prescribing physicians of the risk of developing movement disorders like TD. After Boehm dismissed his remaining claims,[3] the district court entered final judgment dismissing the complaint. Boehm appeals the summary judgment order, including the district court's decision to exclude expert testimony that fifteen percent of Zyprexa users will develop TD after three years of use. Reviewing the exclusion of expert evidence for abuse of discretion and the grant of summary judgment de novo, we affirm.

I.

The testimony and medical records of two physicians who prescribed Zyprexa to treat Boehm's bipolar disorder are relevant to the summary judgment issues on appeal. Dr. Forrest Miller, a general practitioner, first prescribed Zyprexa in January 2003, when Boehm complained of sleep problems, overwhelming anxiety, a racing mind, and depression. Dr. Miller's notes record that Boehm had been taking lithium, but it was not effectively controlling these symptoms and was relatively unsafe for a patient like Boehm who was not monitored regularly. Dr. Miller prescribed Zyprexa and an antidepressant. In the following months, Dr. Miller noted that Boehm gained weight (a common Zyprexa side effect). But Boehm liked Zyprexa much better than lithium, and his bipolar disorder was doing " extremely well." Dr. Miller testified that he planned to continue prescribing Zyprexa to Boehm " until it quits working." Though Boehm saw Dr. Miller only sporadically, pharmacy and clinic records show that Dr. Miller refilled Zyprexa prescriptions and provided Boehm Zyprexa samples through June 30, 2006.

In August 2006, Dr. Gregory Kaczenski, a psychiatrist, began treating Boehm when he was hospitalized for increased depression and irritability. After Boehm's discharge, Dr. Kaczenski continued prescribing Zyprexa until late August, when he prescribed a different second-generation antipsychotic, Geodon, because Boehm wasn't sleeping well and his appetite had increased. Dr. Kaczenski again prescribed Zyprexa in October when Boehm reported that he preferred Zyprexa to Geodon. In March 2007, Dr. Kaczenski noted that Boehm had " some difficulty with articulation" and " a repetitive movement of his neck, pulling his head towards the left shoulder." Suspecting either dystonia or TD, Dr. Kaczenski stopped prescribing Zyprexa because it was the most likely cause of these involuntary movements. Another physician subsequently diagnosed Boehm as suffering from TD caused by antipsychotic drug use. Boehm also claims to have torticollis, a type of dystonia.[4]

Page 504

Dr. Miller and Dr. Kaczenski testified that they were well aware of the risks and benefits of antipsychotics. Dr. Miller became familiar with the side effects of older, " first-generation" antipsychotics, including movement disorders, when he attended medical school across the street from a state hospital and observed patients who suffered from these side effects. Dr. Kaczenski's experience with the side effects of first-generation antipsychotics began with his residency at a state hospital, where it was " very, very common" to see patients suffering from movement disorders. Because of these side effects, Dr. Miller does not prescribe first-generation antipsychotics, and Dr. Kaczenski avoids prescribing them. Both doctors instead prescribe atypical second generation antipsychotics like Zyprexa. In their experience, these newer drugs are effective in treating serious psychiatric diseases, such as schizophrenia and bipolar disorder; while they can cause the same movement disorders as the first generation drugs, they do so much less frequently. Both doctors continue to prescribe Zyprexa.

Since Zyprexa first came on the market, Lilly's FDA-approved package insert has expressly warned about the risk of developing TD:

Tardive Dyskinesia -- A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. . . . Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.
The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic ...

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