Helene Rush v. Wyeth ( 2008 )

United States Court of Appeals
FOR THE EIGHTH CIRCUIT
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No. 07-1822
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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. *
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Submitted: October 18, 2007
Filed: January 31, 2008
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Before RILEY, MELLOY, and COLLOTON, Circuit Judges.
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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
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
1
The Honorable William R. Wilson, Jr., United States District Judge for the
Eastern District of Arkansas.
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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 pre-
menopausal.” 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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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
2
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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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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4
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
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