Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca8-07-01822/USCOURTS-ca8-07-01822-0/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 

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United States Court of Appeals

FOR THE EIGHTH CIRCUIT

___________

No. 07-1822

___________

In re: Prempro Products Liability *

Litigation, *

____________________ *

*

Helene Rush, *

*

Appellant, *

* Appeal from the United States

 v. * District Court for the

* Eastern District of Arkansas.

Wyeth, doing business as Wyeth, Inc., *

doing business as Wyeth *

Pharmaceuticals, *

*

Appellee. *

___________

Submitted: October 18, 2007

Filed: January 31, 2008

___________

Before RILEY, MELLOY, and COLLOTON, Circuit Judges.

___________

RILEY, Circuit Judge.

Helene Rush (Rush) was prescribed the Wyeth, Inc. (Wyeth) estrogen products

Premarin and Prempro for symptoms related to menopause. Rush took the drugs for

nearly ten years, beginning in August 1989. Rush was diagnosed with breast cancer

in June 1999. Six years later, in March 2005, Rush filed this lawsuit alleging Wyeth’s

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The Honorable William R. Wilson, Jr., United States District Judge for the

Eastern District of Arkansas.

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products caused her breast cancer. Rush’s case is part of the multi-district litigation

(MDL) on Hormone Replacement Therapy (HRT). A jury found Rush failed to prove:

(1) Wyeth inadequately warned about the drugs’ risks, (2) the drugs were defective

in design, and (3) Wyeth was negligent, or (4) any of these claims proximately caused

her breast cancer. Rush moved for a new trial which was denied. 

On appeal, Rush argues the district court1

 erred by (1) giving incorrect

instructions to the jury, (2) allowing undisclosed and improper expert testimony,

(3) disallowing Rush’s expert opinions, and (4) failing to instruct the jury on fraud.

The jury also found against Wyeth on Wyeth’s statute of limitations defense,

finding Wyeth failed to prove Rush either knew, or should have discovered by the

exercise of reasonable diligence, the causal connection between the Wyeth estrogen

products and her breast cancer. Wyeth asserts (1) Rush’s claims are time barred, and

(2) her labeling claim was preempted by federal law. 

We affirm without reaching Wyeth’s issues. 

I. BACKGROUND

In 1989, at age 55, Rush began taking prescribed estrogen products

manufactured by Wyeth for symptoms related to menopause. Rush’s physician, Dr.

Cynthia Frazier (Dr. Frazier), prescribed HRT for the treatment of vaginal atrophy.

Before beginning the therapy, Dr. Frazier discussed with Rush the benefits and risks

of the medications. 

In 1992, an abnormality was discovered in Rush’s breast. At that time, Dr.

Frazier discussed with Rush the association between breast cancer and HRT and that

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Rush “may want to stop hormones.” After another breast abnormality was found the

next year, Rush stopped the HRT treatment for eight months before deciding to

resume HRT. 

Rush took the product Premarin until 1996, when her new gynecologist, Dr.

Karen Kozlowski (Dr. Kozlowski), switched Rush to Prempro. Dr. Kozlowski told

Rush with HRT “there was a slight risk of cancer.” Rush took these drugs for nearly

ten years until, in June 1999, she was diagnosed with breast cancer. 

Rush relied solely on her doctors’ advice in deciding to take HRT. Rush did

not rely on any product advertisements. Rush did receive patient information sheets

with her monthly Premarin and Prempro prescriptions. These information sheets

explicitly warned that some studies suggested breast cancer was a possible danger or

risk of the medications if taken “for prolonged periods of time and especially if higher

doses are used.” While Rush admits receiving the information sheets, she denies ever

reading them. 

During the entire time Rush was taking Premarin and Prempro, and continuing

to this day, these drugs were approved by the Federal Drug Administration (FDA) as

safe and effective. Before the FDA approved Prempro, the FDA specified the

wording and placement of breast cancer warnings on the product labeling. 

On March 18, 2005, Rush filed her lawsuit alleging Wyeth’s hormone drugs

caused her breast cancer. The case filing was nearly six years after Rush was

diagnosed with breast cancer. 

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II. DISCUSSION

A. Jury Instructions

Jury instructions are reviewed for abuse of discretion. Slidell, Inc. v.

Millennium Inorganic Chems., Inc., 460 F.3d 1047, 1054 (8th Cir. 2006). “We afford

the district court broad discretion in choosing the form and language of the

instructions” and “will reverse a jury verdict only if the erroneous instruction affected

a party’s substantial rights.” Id. “[O]ur review is limited to a determination of

whether the instructions, taken as a whole and viewed in the light of the evidence and

applicable law, fairly and accurately submitted the issues to the jury.” Id.

1. Assumption of Ordinary Care Instruction 

Arkansas Model Jury Instruction (AMI) 602 states, “Every person using

ordinary care has a right to assume, until the contrary is or reasonably should be

apparent, that every other person will use ordinary care. To act on that assumption is

not negligence.” Rush asserts the district court erred in giving this instruction because

only a plaintiff—but never a defendant—may assume that others will use ordinary

care based upon the Arkansas Supreme Court’s interpretation in England v. Costa, 216

S.W.3d 585, 590 (Ark. 2005) (“Generally speaking, when the instruction is utilized

in a contributory negligence case, the phrase ‘every person’ in the instruction is

intended to refer to the plaintiff.”). 

Wyeth counters that Justice Imber’s concurring opinion in England specified

“[t]he instruction is not limited to plaintiffs alleging negligence against defendants.”

Id. at 592 (Imber, J., concurring). Further, Wyeth notes the AMI’s commentary states,

“England . . . held that [AMI 602] should only be given where there is evidence of

negligence on the part of a party claiming damages.” Ark. Model Jury Instr., Civil

AMI 602 cmt.

Wyeth asserts evidence of Rush’s negligence was presented, thereby rendering

this instruction proper. Specifically, Wyeth asserts Rush’s admission, that she never

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read the warnings Wyeth included with each prescription, was evidence of negligence.

Furthermore, reading England to restrict the instruction only to a case where a plaintiff

is alleging contributory negligence may be overly restrictive. In any event, England

does not apply directly to the facts of this case and is not controlling.

 

Even if giving the assumption of ordinary care instruction was erroneous under

England’s logic, this instruction did not affect Rush’s substantial rights. The

instruction did not direct the jury to find Wyeth was not negligent if Rush did not read

the warnings. Instead, the instruction only explained Wyeth was not negligent in

assuming Rush would read the warnings. The jury could still have found Wyeth

negligent and Wyeth’s warnings were inadequate. Thus, assuming this instruction

was given in error, the instruction was not unfairly prejudicial and any error was

harmless. The district court’s decision to include this instruction was not an abuse of

discretion. 

2. Failure to Warn Instruction

Rush challenges Instruction 14, regarding the failure to warn, because this

instruction directed the jury that it must find for Wyeth if the jury found Rush was

aware of the dangers posed by using Premarin (with progestin) or Prempro before

Rush’s breast cancer diagnosis. In an action for negligent failure to warn, this court

has held, “if a user is already aware of the dangers, the lack of warning is not the

proximate cause of the injury.” Crook v. Kaneb Pipe Line Operating P’ship, 231 F.3d

1098, 1103 (8th Cir. 2000). As such, the focus is on whether or not Rush was aware

of the dangers posed by the Wyeth drugs, Premarin (with progestin) and Prempro.

Arkansas recognizes the existence of the Learned Intermediary Doctrine. See

Hill v. Searle Labs., 884 F.2d 1064, 1070 (8th Cir. 1989). Under this doctrine, a

physician acts as a learned intermediary between a pharmaceutical manufacturer and

the physician’s patient. As such, “a warning to the physician is deemed a warning to

the patient.” Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1016 (8th Cir. 2004)

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(internal brackets omitted). “[A]dequate warnings to prescribing physicians obviate

the need for manufacturers of prescription products to warn ultimate consumers

directly.” Id.

 

While the Learned Intermediary Doctrine provides that adequate warning to a

patient’s physician can suffice to defeat a patient’s failure to warn claim, this doctrine

does not preclude informing a patient directly. “[I]f a user is already aware of the

dangers, the lack of warning is not the proximate cause of the injury.” Crook, 231

F.3d at 1103. The goal is to assure either the patient or the patient’s physician, as a

proxy for the patient, is aware of the dangers. If the patient is independently aware

of the dangers, then a failure of the manufacturer to warn adequately of the danger is

irrelevant. 

 The district court’s instruction accurately reflects Arkansas law and did not

prejudice Rush. Rush’s assertion, that this portion of the law created “a total bar to

recovery” under the doctrines of assumption of risk and contributory negligence, is

incorrect. Rush’s claim is a negligence claim based upon Wyeth’s failure to warn. The

district court’s jury instruction accurately reflected Arkansas law because the jury was

only directed to find for Wyeth if the jury determined Rush was aware of the dangers

before her diagnosis with breast cancer. The trial court did not abuse its discretion. 

3. Failure to Instruct on Fraud

Wyeth moved for summary judgment on Rush’s fraud claim, which the district

court granted. Rush does not appeal the grant of summary judgment, but instead

asserts the district court erred in failing to instruct the jury on Rush’s fraud claim

because evidence offered in support of other claims was sufficient to warrant this

instruction.

To prove fraud, Rush must show a justifiable reliance on a false representation

of a material fact. Tyson Foods, Inc. v. Davis, 66 S.W.3d 568, 577 (Ark. 2002). Rush

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does not claim she relied upon false statements from Wyeth, but claims that her doctors

so relied. To the contrary, both Dr. Frazier and Dr. Kozlowski testified at trial they

relied “very little,” if at all, upon anything said by Wyeth in making the prescription

decisions for Rush, instead relying on their own knowledge independent of any drug

company. Rush asserts her doctors’ testimony is subject to a credibility determination

so that if her doctors’ testimony is sufficiently discredited, the jury could conclude the

doctors relied upon false representations by Wyeth. “[D]iscredited testimony is not

normally considered a sufficient basis for drawing a contrary conclusion.” Anderson

v. Liberty Lobby, Inc., 477 U.S. 242, 256-57 (1986) (internal brackets omitted).

Instead, there must be some affirmative evidence to support a claim. See id. Here, no

such affirmative fraud evidence exists. 

The district court’s refusal to instruct the jury on fraud was not an abuse of

discretion. 

B. Expert Testimony

We review the district court’s decision to admit or exclude expert testimony for

abuse of discretion. See Torbit v. Ryder Sys., Inc., 416 F.3d 898, 903 (8th Cir. 2005).

In the context of admitting evidence, an abuse of discretion occurs “only where the

error is clear and prejudicial to the outcome of the proceeding.” Id.

1. Expert Testimony Allowed

a. Dr. Lewis Chodosh

Rush asserts the district court erred in allowing a defense expert, Dr. Lewis

Chodosh (Dr. Chodosh), to give case specific testimony. Wyeth asserts Dr. Chodosh’s

testimony was necessarily implied by his testimony as to general causation and, as

such, was properly admitted or harmless.

One of the key opinions set forth in Dr. Chodosh’s report and deposition, and

reiterated at trial, was his opinion that “the lower limit of latency for breast cancer from

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initiation to detection is in the range of twelve years.” Dr. Chodosh’s opinion was

substantially based on extensive studies of radiation exposure and the onset time of

breast cancer for women in Hiroshima and Nagasaki. Dr. Chodosh opined twelve

years was the minimum time period between exposure to a causative element and

detection of breast cancer. At trial, Dr. Chodosh was asked to consider a hypothetical

situation based on Rush’s situation. Specifically, Dr. Chodosh was asked to assume

Rush was diagnosed with breast cancer at age 65, and had been taking hormone

therapy for nine plus years with a seven month period when no HRT occurred. Based

upon those hypothetical facts, Dr. Chodosh was asked his opinion as to whether Rush’s

breast cancer was present before she began her HRT. 

Dr. Chodosh’s “opinion is [Rush’s] breast cancer almost certainly was present

prior to the time when she began to use [HRT].” His opinion was based on knowing

how long it takes for breast cancers to grow and “given that the risks of breast cancer

associated with [HRT] are small, the math alone would suggest that more probably

than not Ms. Rush’s breast cancer was unrelated to her use of hormone therapy.” 

Dr. Chodosh’s trial testimony clearly reflects the application of his opinion, that

it takes a minimum of twelve years from exposure to detection of breast cancer, to

Rush’s situation. Where Rush’s exposure to HRT began less than ten years before she

was diagnosed, Dr. Chodosh’s conclusion that the HRT drugs could not have caused

the breast cancer is an exercise in basic math using simple deductive reasoning. As

such, the admission of this opinion was not an abuse of discretion. 

b. Dr. Lisa Rarick

Rush objects to the defense testimony of Dr. Lisa Rarick (Dr. Rarick) regarding

the correlation of hormonal blood levels with menopausal symptoms. Dr. Rarick was

asked, “[c]an you tell us what hormone therapy taken by a menopausal woman adds

to her circulating blood levels?” Dr. Rarick responded estrone levels “go up to about

the range you would expect in the low range for a premenopausal woman.” This

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testimony went beyond Dr. Rarick’s report, but was elicited in response to an opinion

of Rush’s expert, Dr. Suzanne Klimberg (Dr. Klimberg), an opinion which also had not

previously been disclosed. In answer to a juror’s question, Dr. Klimberg testified HRT

brings estrone levels that are “not quite at the level that you would get premenopausal.” Essentially, Dr. Rarick’s testimony echoed Dr. Klimberg’s earlier

testimony. Rush was not prejudiced, and the district court did not abuse its discretion

in allowing this testimony.

 

c. Dr. Michael Dey

Rush asserts reversible error occurred when Dr. Michael Dey (Dr. Dey) testified

by giving his definition of the word promote. Dr. Dey said, “[m]y definition of

promotion is, they stimulate an existing cancer to grow in some tumors, in some

women, or some tissues. But they do not cause cancer because they do not take a

normal cell and make it a cancerous cell.” There was no objection to this testimony.

Dr. Dey was then asked if he understood “the term ‘promotion’ is used differently by

different scientists.” Dr. Dey agreed. Next, Dr. Dey was asked, “What other meanings

of promotion have you heard in connection with this subject matter?” Only when Dr.

Dey attempted to answer this question was an objection made. The objection was

based solely on hearsay. The district court overruled this objection, telling the jury,

“I’m going to allow the witness to give his understanding of the word ‘promote’ in the

scientific field. I want you to keep in mind, though, that at the end of this trial, I am

going to give you my understanding of the word ‘promote’ as Arkansas law applies,

and that definition will be the one you’ll have to follow.” 

 

In the closing charge, the district court instructed the jury as to the definition of

“promote” under Arkansas law, noting the jury was to consider the evidence in light

of the definition provided by the court. A jury is presumed to follow the instructions

given. See Weeks v. Angelone, 528 U.S. 225, 234 (2000). Thus, we must presume

any confusion that may have existed because of differences between the definitions of

“promote” given by Dr. Dey and the district court was resolved by the jury instruction

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SEER is an acronym for the Surveillance Epidemiology and End Results

program of the National Cancer Institute. The SEER program “is an authoritative

source of information on cancer incidence and survival in the United States.”

Overview of the SEER Program, at http://seer.cancer.gov/about/ (last visited Jan. 4,

2008). 

3

In his deposition, Dr. Austin testified it would be fallacious to use the SEER

database study to prove causation. 

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which defined “promote” for the jury and specified the evidence should be considered

in light of the trial court’s definition of the term. 

2. Expert Opinions Disallowed

Rush asserts the district court abused its discretion when it excluded portions of

the testimony of Rush’s expert, Dr. Donald F. Austin (Dr. Austin). Rush attempted to

have Dr. Austin testify regarding new data garnered from the SEER2

 database. The new

testimony was intended to prove causation and contradicted Dr. Austin’s prior

testimony.3

 Rush cites to Farmland Indus. v. Morrison-Quirk Grain Corp., 54 F.3d 478,

482 (8th Cir. 1995), for the proposition that it is proper for the court to permit testimony

like Dr. Austin’s where Dr. Austin previously gave the same opinions in a prior trial

between the same parties. In Farmland, this court affirmed the district court’s decision

allowing the causation testimony stating, “As with all discovery matters, the district

court maintains broad control over Rule 26(e) issues regarding the disclosure of the

substance of an expert’s testimony. We will not reverse a district court’s decision in this

area absent a gross abuse of discretion resulting in fundamental unfairness in the trial

of the case.” Id. (internal quotations and citations omitted).

Unlike Farmland, where the district court admitted the causation expert

testimony, the district court excluded Rush’s causation expert testimony. Farmland

does not stand for the proposition this testimony must be admitted. Rather, Farmland

simply expresses the unremarkable proposition that the district court’s decision,

whether or not to allow testimony, is reviewed “in this area” for “a gross abuse of

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Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). 

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discretion resulting in fundamental unfairness.” Id. (internal quotations and citations

omitted). The district court did not abuse its broad discretion when it excluded this

testimony, particularly as here, where Dr. Austin previously testified such a study could

not be used to prove causation. 

Rush also asserts the district court erred in excluding the causation testimony of

her expert Dr. Graham Colditz (Dr. Colditz) based upon recent data in the SEER

database. After the district court excluded the testimony of Dr. Austin regarding this

new data, Rush attempted to permit Dr. Colditz to testify to the same data. The district

court excluded Dr. Colditz’s testimony regarding this new data because Dr. Colditz had

never referenced this data in his expert report nor testified about this data before his

December 18, 2006, preservation deposition. The district court found this new

testimony would be subject to Daubert4

 and the deadline for raising Daubert issues was

September 21, 2006. The district court noted, “this specific testimony by Dr. Colditz

was not designated until after I ruled that Dr. Austin could not use the very same

information.” The district court did not abuse its discretion when it excluded Dr.

Colditz’s testimony regarding the new, and previously undisclosed, SEER database

data.

 

C. Wyeth Appeal Issues

Having affirmed the decision of the district court on other grounds, we do not

reach the issues of whether Rush’s claims are barred by the statute of limitations or

whether Rush’s labeling claim is preempted by federal law.

III. CONCLUSION

For the foregoing reasons, we affirm the decision of the district court.

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