United States Court of Appeals

For the Eighth Circuit

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No. 13-1350

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Timothy Boehm

lllllllllllllllllllll Plaintiff - Appellant

v.

Eli Lilly & Company

lllllllllllllllllllll Defendant - Appellee

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 Appeal from United States District Court 

for the Eastern District of Arkansas - Little Rock

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 Submitted: September 26, 2013

 Filed: March 10, 2014

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Before LOKEN, COLLOTON, and BENTON, Circuit Judges.

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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

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granted summary judgment dismissing the failure-to-warn claim, applying the

Arkansas learned intermediary doctrine and concluding that Lilly adequately warned 2

Boehm’s treating and prescribing physicians of the risk of developing movement

disorders like TD. After Boehm dismissed his remaining claims, the district court

3

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

The Honorable D.P. Marshall, Jr., United States DistrictJudge for the Eastern 1

District of Arkansas.

“This doctrine provides that a drug manufacturer may rely on the prescribing 2

physician to warn the ultimate consumer of the risks of a prescription drug. The

physician acts as the ‘learned intermediary’ between the manufacturer and the

ultimate consumer.” West v. Searle & Co., 806 S.W.2d 608, 613 (Ark. 1991). 

The district court dismissed two claims without prejudice. At oral argument, 3

Boehm agreed to accept dismissal of those claims with prejudice to ensure that we

have a final order to review.

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a patient like Boehm who was not monitored regularly. Dr. Miller prescribed

Zyprexa and an antidepressant. In the following months, Dr. Miller noted thatBoehm

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 Boehmhad “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.

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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

TD involves repetitive involuntary muscle movements. Dystonia involves 4

involuntary sustained muscle contractions. Torticollis is a type of dystonia that

involves twisting of the neck muscles. Boehm alleges that painful involuntary necktwisting motions make him unable to work and cause mental anguish.

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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 patientssuffering frommovement disorders. 

Because of these side effects, Dr. Miller does not prescribe first-generation

antipsychotics, and Dr. Kaczenski avoids prescribing them. Both doctors instead

prescribe atypicalsecond generation antipsychotics likeZyprexa. 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 patientstreated 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 drugs

administered to the patient increase. . . .

There is no known treatment for established cases of tardive

dyskinesia, although the syndrome may remit, partially or completely,

if antipsychotic treatment is withdrawn. . . .

Given these considerations, olanzapine should be prescribed in a

manner that is most likely to minimize the occurrence of tardive

dyskinesia. . . . In patients who do require chronic treatment, the

smallest dose and the shortest duration of treatment producing a

satisfactory clinical response should be sought. The need for continued

treatment should be reassessed periodically.

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If signs and symptoms of tardive dyskinesia appear in a patient on

olanzapine, drug discontinuation should be considered. However, some

patients may require treatment with olanzapine despite the presence of

the syndrome.

(Emphasis added.) The package insert also notes: “There is no body of evidence

available from controlled trials to guide” maintenance treatment of bipolar disorder

with Zyprexa, meaning treatment for longer than a month.

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Dr. Miller testified that his practice is to read a drug’s package insert before

ever prescribing it, and to re-read the insert occasionally to refresh his memory. Dr.

Kaczenski consults the Physicians’ Desk Reference, which contains package insert

information, and re-reads package inserts when they are updated. Dr. Kaczenski

testified that Lilly’s package insert was adequate to warn him of the risk of TD with

Zyprexa use. Independent of the package insert, Dr. Miller and Dr. Kaczenski

learned about Zyprexa’s side effects from their own clinical experience and from

speaking with their colleagues. Both doctors testified that an alternative warning

about the risk of movement disorders would not have changed their decisions to

prescribe Zyprexa to treat Boehm’s bipolar disorder.

Based on the express TD warning it gave all physicians, and the testimony of

Boehm’s prescribing physicians that they read the warning and considered it adequate

in deciding to prescribe Zyprexa, Lilly moved for partial summary judgment on the

failure-to-warn claim, relying on the learned intermediary doctrine.

The package insert also reported that the incidence of dystonia (including

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torticollis) in a Zyprexa clinical trial was not significantly higher than with a placebo. 

On appeal, Boehm asserts that this was far short of an adequate warning. We agree

with the district court that “Boehm has not produced any reliable evidence to show

an increased risk of torticollis and dystonia associated with Zyprexa [and therefore]

has not demonstrated the need for a warning.”

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II. 

In opposing summary judgment, Boehm argued that Lilly failed to adequately

warn physicians of the risk of developing TD after long-term use of Zyprexa. Boehm

focused on additional deposition testimony by Dr. Miller and Dr. Kaczenski. After

Dr. Kaczenski described weight gain and movement disorders astwo side effects that

can occur with long-term Zyprexa use, he was asked:

[Boehm’s counsel]: I’m going to ask you about something that -- a

figure that I have seen here, that 15 percent -- and I will ask you if you

are aware of this. But 15 percent of those who have taken neuroleptics,

such as Zyprexa, for three years, develop tardive dyskinesia?

[Dr. Kaczenski]: Yes, that’s a number I have known for a long time.

Counsel used that answer in cross-examining Dr. Miller at his subsequent deposition:

[Boehm’s Counsel]: Did you receive any information that once a patient

is prescribed Zyprexa for three years, one in six patients will develop

tardive dyskinesia? Were you told that?

* * * * *

[Dr. Miller]: No.

Q: All right. If you had known that, and that is an established fact in

this case pursuant to Doctor Kaczenski’s deposition testimony * * * --

that the inciden[ce] of tardive dyskinesia increases to one in six patients

after three years of use, would you still have prescribed that to Tim

Boehm?

* * * * *

A: Not for that long.

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Q: All right. That’s just too long, isn’t it?

A: That’s too long.

To satisfy its duty to warn, the manufacturer of an “unavoidably unsafe” but

beneficial prescription drug must make “an adequate warning” to prescribing

physicians of the risks of adverse side effects. West, 806 S.W.2d at 613, applying

comment k to § 402A of the Restatement (Second) of Torts and the learned

intermediary doctrine. After initial briefing, the district court concluded “that this

testimony [by Dr. Miller], if supported, could create a triable issue” as to the

adequacy of Lilly’s TD warning. But the court noted that “Dr. Kaczenski did not

offer the 15% risk figure on his own; the percentage was part of a leading question.” 

Accordingly, the court “requested briefing on whether . . . the alleged 15% risk was

supported by [scientific] evidence that would be admissible under Daubert [v. Merrell

Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993)].” 

In response, Boehm relied on the opinion of his expert, psychiatrist Dr. Stefan

Kruszewski. Based on “clinical experience and review of relevant literature,” Dr. 

Kruszewski opined that “Zyprexa is capable of a high rate of incident tardive

dyskinesia/dystonia after three years of use, affecting between 15-20% of those

prescribed the drug.” When Lilly challenged that opinion as lacking scientific

support, Dr. Kruszewski submitted two supplements to his report. The first

supplement cited two additional sources. First was an article by Dr. Patricia Deegan

published on the National Empowerment Center website claiming: “Different studies

quote different rates of tardive dyskinesia ranging from 15%-20% for people using

[antipsychotics] for more than three years.” The article stated that Zyprexa “has been

found to cause TD” but listed no sources for its information. The second new source

was a webpage where Dr. Peter Breggin advertises his work as an expert witness in

TD-related cases. Without citing a source, the webpage claims: “The rates for TD

are astronomical. In otherwise physically healthy adults, 5%-8% per year will

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develop the disorder, with cumulative rates in the range of at least 15%-20% for the

first three years.” Dr. Breggin claims it is “simply untrue” that “the newer or atypical

antipsychotic drugs cause TD at a very low rate.” Again, the only Zyprexa-specific

claim was that it can cause TD.6

Dr. Kruszewski again supplemented his report with a 2010 peer-reviewed study

comparing TD incidence rates for users of first-generation and second-generation

antipsychotic drugs. The study concluded: “[T]he incidence rate ofTD with atypical 7

antipsychotics, while modestly reduced, remains substantial . . . . Despite the feeling

among some clinicians that TD is much less of a problem now in the atypical era,

such a conclusion may unfortunately be premature.” As Lilly pointed out, two

implications of the study data suggest that bipolar patientstaking Zyprexa can expect

better resultsthan other patients. First, the Woodsstudy notes: “Little TD advantage

for atypicals was apparent in schizophrenia subjects, while a relatively strong

advantage was estimated in affective disorder subjects.” Second, based on available

data differentiating specific drugs, the study reported that “olanzapine [Zyprexa]

showed the lowest relative TD rate” in the second-generation group.

The district court concluded that Dr. Kruszewski’s first supplement -- a blog

post and website advertising -- “are a deficient foundation” to support Dr.

The cite for Dr. Deegan’s article is Tardive Dyskinesia and Tardive Dystonia:

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where you can turn for help, National Empowerment Center, http://www.power2u.

org/articles/selfhelp/tardive.html (last visited Dec. 10, 2013). Dr. Breggin’s cite is

Selected Tardive Dyskinesia (TD) cases, Psychiatric Drug Facts with Dr. Peter

Breggin, http://breggin.com/index.php?option=com_content&task=view&id=184

(last visited Dec. 10, 2013). Copies of these internet materials are on file in the

Clerk’s Office.

Woods, S.W., et. al., Incidence of Tardive Dyskinesia with Atypical Versus 7

Conventional Antipsychotic Medications: A Prospective Cohort Study, J. Clin.

Psychiatry 71(4): 463-474 (2010) (the “Woods study”). 

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Kruszewski’s 15% risk figure. Though the second supplement was a peer-reviewed

study in a well respected journal, the court reasoned, the Woods study “was not

designed to establish the risk of a particular drug, only the risk of a class of drugs to

which Zyprexa belongs.” The Woods study “does not even attempt to establish that

Zyprexa is a twin to conventional antipsychotics,” and it “indicates that Zyprexa

carries a lower risk of [TD] than other atypical antipsychotics.” Concluding there “is

too great an analytical gap to extract from the Woods study the 15% incidence rate

Dr. Miller said would have changed his prescribing decisions,” the court excluded all

evidence of that risk percentage under Daubert. The court then granted summary

judgment dismissing Boehm’s failure-to-warn claims because there was no genuine

issue of material fact as to the adequacy of Lilly’s TD warnings.

III.

On appeal, Boehmargues the district court erred in excluding Dr. Kruszewski’s

expert opinion that 15% of Zyprexa users will develop TD after three years of use. 

Because the grant of summary judgment turned on this ruling, we will review it first. 

Junk v. Terminix Int’l Co., 628 F.3d 439, 447 (8th Cir. 2010), cert. denied, 132 S. Ct.

94 and 95 (2011). “We reverse a trial court’s decision on the admissibility of expert

evidence only on the basis of a clear and prejudicial abuse of discretion.” Id. 

In determining whether to admit a qualified expert’s opinion testimony under

Rule 702 of the Federal Rule of Evidence, the district court acts as a gatekeeper to

“ensure that any and all scientific testimony or evidence admitted is not only relevant,

but reliable.” Daubert, 509 U.S. at 589. If “opinion evidence . . . is connected to

existing data only by the ipse dixit of the expert,” a district court “may conclude that

there is simply too great an analytical gap between the data and the opinion

proffered.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997).

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Here, after giving Boehm ample opportunity to supplement Dr. Kruszewski’s

initial, inadequately supported opinion, the district court reasonably concluded that

Boehm had not provided sufficient scientific support for that opinion. The internet

materials in the first supplement provided no supporting data or sources for their

general assertions relating to Zyprexa; the Woods study, while peer-reviewed, was

not designed to establish a TD incidence rate for Zyprexa and in fact contained

findings that undermined Dr.Kruszewski’s opinion thatZyprexa causes TD in bipolar

patients at the same 15-20% rate as first-generation antipsychotics. On this record,

we conclude that it was well within the district court’s substantial discretion to

exclude Dr. Kruszewski’s 15% risk opinion.

IV.

Boehm further argues the district court erred in granting summary judgment

dismissing the failure-to-warn claim, even without Dr. Kruszewski’s 15% risk

opinion. The learned intermediary doctrine does not apply, Boehm argues, because

he presented substantial evidence that Lilly’s warning to physicians as to the risk of

developing TD after long-term use of Zyprexa was inadequate. The district court

carefully summarized “the essential and undisputed materialfacts” that warranted the

grant of summary judgment absent reliable scientific evidence of a known 15% risk

factor for long-term use of Zyprexa:

Lilly’s package insert warned the prescribing doctors that, though [TD]

was an infrequent side effect, the risk that it would occur and become

irreversible . . . was believed to increase as treatment continued over

time and the patient’s total cumulative dose increased. . . . No studies

or other evidence existed to guide prescribers about deploying the drug

for more than one month. . . . Drs. Miller and Kaczenski knew all these

risksfrom reading the Zyprexa package insert and from their experience

with first and second generation anti-psychotic medicines. They

prescribed Zyprexa for Timothy Boehm across many years because,

weighing the risks against the benefits of treating his bipolar disorder,

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in their opinion the drug helped him. These two main prescribers

thought Lilly’s warning adequate. Both are still prescribing Zyprexa to

other patients.

After careful consideration of the extensive summary judgment record, we agree. On

appeal, Boehm places great emphasis on the testimony in which Dr. Miller agreed

that prescribing Zyprexa for three years was “too long” given the 15% risk of

developing TD. But that testimony was based on Boehm’s counsel instructing Dr.

Miller that a 15% risk factor for Zyprexa users had been established by Dr.

Kaczenski’s testimony, which was untrue. On this record, the district court properly

applied the learned intermediary doctrine in dismissing the failure-to-warn claim.

V.

Boehm further argues the district court erred in rejecting his contention that

Lilly’s overpromotion of Zyprexa negated an otherwise adequate warning of the risk

that users will develop movement disorders including TD. A few courts have

recognized an overpromotion “exception” to the learned intermediary doctrine. The

Supreme Court of Arkansas has not addressed the issue. The exception applies in

“unusual cases” where a plaintiff can “establish with individualized proof” that a drug

manufacturer’s excessive promotion of its product “caused the [plaintiff’s] physician

to initiate or maintain the prescription at issue.” In re Zyprexa Prods. Liab. Litig.,

649 F. Supp. 2d 18, 33 (E.D.N.Y. 2009) (emphasis in original). 

Here, the district court expressed doubt that the Supreme Court of Arkansas

would recognize an overpromotion exception to the learned intermediary doctrine. 

But in any event, the court concluded, the exception would not apply in this case

because Boehm presented “no evidence that any representation by a salesperson

affected a prescribing doctor’s decision to continueBoehmon Zyprexa,” and because

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“[t]here is no reliable evidence that Zyprexa had significantly more risk of movement

disorders than the drug reps allegedly said it had.” We agree. 

The summary judgment record includes substantial evidence that Lilly

aggressively marketed Zyprexa to doctors, including Dr. Miller and Dr. Kaczenski,

instructing its marketing representatives to make personal calls to promote Zyprexa

by discussing bipolar symptoms and stressing Zyprexa’s “safety,” “efficacy,” and

“ease of use” for treating bipolar patients. But there is no evidence that any

representative made statements to Dr. Miller or to Dr. Kaczenski that negated the

package insert warning, and there is no evidence their prescribing decisions were

affected by the Lilly representatives’ statementsregarding the risk of TD. Therefore,

even if Arkansas would recognize this exception, Boehm failed to prove that Lilly

overpromoted Zyprexa, that its promotional efforts negated the written warnings, or

that these promotional efforts had any effect on the decisions by Dr. Miller and Dr.

Kaczenski to prescribe Zyprexa for the continued treatment of Boehm’s bipolar

disorder. Accord Dean v. Eli Lilly & Co., 387 Fed. App’x 28, 30 (2d Cir. 2010)

(unpublished); Patteson v. AstraZeneca, L.P., 876 F. Supp. 2d 27, 34-37 (D.D.C.

2012); In re Zyprexa Litigation, 649 F. Supp. 2d at 33.

The judgment of the district court is affirmed.

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