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Rush v. Wyeth: EXPERT WITNESSES - no error or abuse regarding expert witness opinion rulingsUnited States Court of Appeals
FOR THE EIGHTH CIRCUIT
In re: Prempro Products Liability *
Helene Rush, *
Appeal from the United States
v. * District Court for the
* Eastern District of Arkansas.
Wyeth, doing business as Wyeth, Inc., *
doing business as Wyeth *
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
1The Honorable William R. Wilson, Jr., United States District Judge for the
Eastern District of Arkansas.
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.
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
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
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
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.
(internal brackets omitted). “[A]dequate warnings to prescribing physicians obviate
the need for manufacturers of prescription products to warn ultimate consumers
While the Learned Intermediary Doctrine provides that adequate warning to a
patient’s physician can suffice to defeat a patient’s fanh
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
2SEER 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,
3In his deposition, Dr. Austin testified it would be fallacious to use the SEER
database study to prove causation.
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
4Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
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
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.
For the foregoing reasons, we affirm the decision of the district court.
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Michael E. Douglas, Attorney at Law, Saint Paul MN. All Rights
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