Kammerer et al v. Wyeth et al

Filing 291

MEMORANDUM AND ORDER denying 53 63 68 72 Defendants' Motions to Exclude; denying 74 Plaintiffs' Motions to Exclude; granting 57 Defendants' Motion to Exclude testimony of Drs. Maloney and Hartman; granting 149 Plaintiffs' Motion for Leave to Supplement Responses; granting in part and denying in part 181 Defendants' Motion to Strike. Ordered by Chief Judge Joseph F. Bataillon. (SMS, )

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEBRASKA
SALLY KAMMERER and KARL
KAMMERER,
Plaintiffs,
v.
WYETH, and WYETH
PHARMACEUTICALS,
Defendants.

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8:04CV196

MEMORANDUM AND ORDER

This matter is before the court on the following motions: defendants’ motion to
exclude the testimony of Dr. Suzanne Parisian, Dr. Cheryl Blume and Dr. Donald Austin,
Filing No. 53; defendants’ motion to exclude the testimony of Michael T. Maloney, Ph.D.,
and Raymond S. Hartman, Ph.D., Filing No. 57; defendants’ motion to exclude the
testimony of Matthew Hollon, Dr. Adriane Fugh-Berman, and Dr. Warren Keegan, Filing
No. 63; defendants’ motion to exclude any general and specific causation opinion that
hormone therapy causes estrogen-receptor-positive/progesterone-receptor-negative
(ER+/PR-) breast cancer (hereinafter, “causation Daubert motion),” Filing No. 68;
defendants’ motion to exclude expert testimony that estrogen + progestin hormone therapy
causes estrogen receptor positive / HER2-Positive1 (ER+/HER2+) breast cancer or caused
Ms. Kammerer’s ER+/HER2+ breast cancer (hereinafter, “HER2 Daubert motion”), Filing

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HER2 stands for the Hum an Epiderm al Growth Factor Receptor 2 (“HER2”) which is a receptor found
on the surface of norm al breast cells. Filing No. 73, Defendants’ Brief at 10. The norm al HER2 gene is
considered a “proto-oncogene,” a gene found in healthy cells but which, when m utated, is known to cause
cancer. Id. at 13. Once a proto-oncogene has m utated, it is then referred to as an “oncogene.” Id. at 14-15.
W yeth argues that scientific evidence establishes that if a tum or tests positive for HER2 overexpression, the
tum or can grow in the absence of estrogen. Id. at 44. Ms. Kam m erer’s tum or has tested positive for HER2
overexpression. Id. at 27.

No. 72; plaintiffs’ motion to exclude to the testimony of Dr. Thomas Stovall, Filing No. 74;
plaintiffs’ motion for leave to supplement responses in opposition to Wyeth’s Daubert
motions relating to alleged HER2 and PR- [progesterone receptor negative] status of
plaintiff’s breast cancer, Filing No. 149; and defendants’ motion to strike plaintiffs’
supplemental materials relating to HER2 status of plaintiff’s breast cancer, or, in the
alternative, to supplement the record.
The court notes at the outset that it appears the parties have multiple expert
witnesses retained to testify concerning single elements of negligence, causation and
damages. The parties are on notice that the court will not allow cumulative expert
testimony at trial. Unless an expert brings special expertise to an issue, a party will not be
allowed to provide more than one expert for each such issue. The court will contact the
parties to schedule a hearing to discuss trial logistical and legal issues.
I. LAW
Rule 702 permits a witness to testify in the form of an opinion when that expert
possesses scientific, technical, or other specialized knowledge that will assist the trier of
fact. Fed. R. Evid. 702. The central inquiry under Rule 702 is whether the proffered
expert’s testimony is sufficiently reliable. First Nat’l Bank v. Benham, 423 F.3d 855, 861
(8th Cir. 2005). The burden of establishing reliability rests on the proponent of the expert
testimony. Barrett v. Rhodia, 606 F.3d 975,980 (8th Cir. 2010) (quoting Marmo v. Tyson
Fresh Meats, Inc., 457 F.3d 748, 757 (8th Cir. 2006)). The testimony must be based on
scientific, technical, or other specialized knowledge. United States v. Cawthorn, 429 F.3d
793, 799 (8th Cir. 2005). “Knowledge” requires more than a subjective belief or an

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unsupported speculation; it requires an appropriate level of validation. Id. at 799-800
(quoting Daubert v. Merrell Dow Pharms., 509 U.S. 579, 590 (1993)).
Rule 702 sets out three general standards for determining the reliability and
relevance of proffered expert testimony. First, the proffered testimony must be based on
sufficient facts or data. Fed. R. Evid. 702(1). Second, it must be the product of reliable
principles and methods. Fed. R. Evid. 702(2). Third, the expert must have applied those
principles and methods reliably to the facts of the case. Fed. R. Evid. 702(3). Rule 702
reflects a “relax[ation of] the traditional barriers to opinion testimony,” and the court’s
inquiry is intended to be flexible. In re Prempro Prods. Liab. Litig. (Scroggin), 586 F.3d
547, 565 (8th Cir. 2009); see Daubert, 509 U.S. 579, 588, 594 (1993). The district court
must assess whether the methodology used by the proposed expert is valid and whether
it was properly applied. In re Prempro (Scroggin), 586 F.3d at 565. In Daubert, the
Supreme Court listed four factors for consideration: (1) whether the theory or technique
applied can be tested, (2) whether the theory or technique has been subject to peer review
or publication, (3) the known or potential rate of error, and (4) general acceptance.
Daubert, 509 U.S. at 593-95; In re Prempro (Scroggin), 586 F.3d at 565 n.11 (noting that
those factors do not constitute a definitive checklist or test).
District courts apply a number of nonexclusive factors in performing this role,
including “whether the expertise was developed for litigation or naturally flowed from the
expert’s research;” whether the expert ruled out other alternative explanations; and whether
the expert sufficiently connected the proposed testimony with the facts of the case.
Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686-87 (8th Cir. 2001). “There is no single
requirement for admissibility as long as the proffer indicates that the expert evidence is
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reliable and relevant.” In re Prempro (Scroggin), 586 F.3d at 565 (quoting Unrein v.
Timesavers, Inc., 394 F.3d 1008, 1011 (8th Cir. 2005)). “[N]othing in Rule 702, Daubert,
or its progeny requires ‘that an expert resolve an ultimate issue of fact to a scientific
absolute in order to be admissible.’” Kudabeck v. Kroger Co., 338 F.3d 856, 861(8th Cir.
2003) (quoting Bonner v. ISP Tech., Inc., 259 F.3d 924, 929 (8th Cir. 2001)). Importantly,
any doubts regarding the usefulness of an expert’s testimony are to be resolved in favor
of admissibility. Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748, 757-58 (8th Cir. 2006).
When the analytical gap between the data and proffered opinion is too great, the opinion
must be excluded. Id.
II. DISCUSSION
A. Motions to Supplement and to Strike
As a threshold matter, the court will address the parties’ pending motions to
supplement the record and to strike. Plaintiffs filed two motions to supplement their
response to Wyeth’s HER2 Daubert motion with a district court opinion and an expert
report from another hormone therapy products liability case, Kaufman v. Pfizer Pharms.,
Inc., No. 1:02-CV-22692 (S. D. Fla. July 26, 2011) (Kaufman case). See Filing No. 149 &
Filing No. 177, Motions; Filing No. 150, Index of Evid., Ex. 1, Order; Ex. 2, Expert Report
of Elizabeth Naftalis, M.D., in the Kaufman case. One of the plaintiffs’ motions was
granted by text order, prompting the defendant to move to strike that evidence,
characterizing it as the “new, 24-page expert report by Dr. Elizabeth Naftalis regarding the
HER2 breast cancer of a separate plaintiff from an entirely different case.” See Filing No.
177, Motion to Further Supplement; Filing No. 179, Order; Filing No. 181, Motion to Strike.
The plaintiffs concede that the district court opinion in Kaufman is not controlling, and
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contend only that it is “instructive” in connection with the court’s consideration of the
pending HER2 Daubert motion. Filing No. 149, Motion at 2. In opposition to the plaintiffs’
motion to supplement, Wyeth submits a later order from the Kaufman case, reconsidering
the earlier order and ordering Dr. Naftalis to submit another expert report. Filing No. 164,
Ex. 2, Kaufman case, Order dated Aug. 18, 2011. That expert report is the subject of the
plaintiffs’ motion to further supplement the record. Filing No. 177, Index of Evid., Ex. 2.
Wyeth contends that Dr. Naftalis’s report in the Kaufman case contains “brand new
opinions about the role of the HER2 oncogene and brand new epidemiology that she had
never disclosed before and, to this day, has never been questioned about in a deposition,”
argues that Dr. Naftalis should not be permitted to offer these “new, detailed opinions
about the role of HER2,” and requests that Dr. Naftalis’s Kaufman report be stricken from
the record and the plaintiffs “should not be allowed to rely on the opinions set forth in that
report in the Daubert proceedings in this case or at trial.” See Filing No. 182, Defendants’
Brief at 4.
Wyeth has also submitted evidence in opposition to the plaintiffs’ motions, to
support its contention that Dr. Naftalis has changed the methodology that had been
approved by the Eighth Circuit Court of Appeals in In re Prempro Prods. Liab. Litig., 586
F.3d 547, 565 (8th Cir. 2009). See Filing No. 161, Defendants’ Brief at 4. Wyeth argues
that the additional evidence shows that Dr. Naftalis’s opinions on causation with respect
to HER2 cancers are unsupported and should be excluded under Daubert. Id.
The record in this case shows that on January 7, 2011, Dr. Elizabeth Z. Naftalis,
M.D., submitted a 39-page expert report specific to this case. After one of the defendants’
experts testified concerning HER2 cancers, she supplemented her earlier report with a
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report, stating that the HER2 status of plaintiff Sally Kammerer’s cancer would not change
the opinions she expressed in her earlier report. The supplemental report was filed after
Dr. Naftalis had been deposed in this case on March 30, 2011, and after Wyeth’s experts
prepared and submitted their reports, but before the depositions of some of the
defendants’ experts. Wyeth did not move to strike Dr. Naftalis’s supplemental report and
the evidence it seeks to proffer in its alternative motion to supplement addresses the HER2
causation issue. Wyeth’s Daubert motion is directed at both Dr. Naftalis’s original and
supplementary reports.
Dr. Naftalis’s Kaufman report was submitted to the court as additional support for
the plaintiffs’ argument in opposition to Wyeth’s Daubert motion, and not as substantive
evidence in this case. The evidence is nothing more than additional authority for a legal
argument. The court is capable of disregarding irrelevant evidence, and will afford the
purported “supplemental evidence” the weight it deserves, as this court is not bound by the
decision of another federal district court. Defendants’ attempts to refute the information
in the Kaufman report with an evidence criticizing Dr. Naftalis’s credentials and opinions
present a classic battle of the experts, and goes to the weight, not the admissibility of the
evidence.
The court finds the plaintiffs’ motion to supplement the record should be granted and
the defendants’ motion to strike should be denied, but the court will similarly grant the
defendants’ alternative motion to supplement the record with the evidence submitted in
Filing No. 186. The court has considered that evidence in determination of the parties’
Daubert motions.

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B.

Defendants’ Motion to exclude testimony of Dr. Suzanne Parisian, Dr.
Cheryl Blume, and Dr. Donald Austin

Plaintiffs have designated three experts—Drs. Suzanne Parisian, Dr. Cheryl Blume,
and Dr. Donald Austin—to testify with respect to regulatory matters.2 Essentially, these
witnesses will testify regarding about pharmaceutical companies’ approval processes and
testing practices. Wyeth contends that witnesses’ proposed expert testimony is not expert
in nature because plaintiffs cannot point to the existence of a reasonable standard of care
or a custom and practice established by either industry or governmental standards
regarding a duty to test pharmaceuticals.
Dr. Parisian is regulatory expert with a pathology background. She is a medical
doctor and former Medical Officer at the Food and Drug Administration (“FDA”). Dr. Cheryl
Blume was a longtime executive of a pharmaceutical company and she has a Ph.D. in
pharmacology and toxicology. The plaintiffs have shown that these experts are qualified,
based on their training and experience, to testify with respect to the regulatory approval
process and post-marketing surveillance obligations. The court finds the defendants’
Daubert motion should be denied. These witnesses have specialized knowledge with
respect to regulatory procedures, labeling, industry standards, government regulations,
statutes, internal policies, FDA standards, industry recommendations, customs or practice,
administrative rules, and other factors that can assist the trier of fact in determining the
reasonableness of a corporation’s conduct. The court will allow such testimony only to the
extent it is relevant. The court finds Wyeth’s challenge to these experts’ testimony is more
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Plaintiffs concede that W yeth’s m otion is m oot as to Dr. Donald Austin, plaintiffs’ generic causation
expert, because plaintiffs do not “intend to elicit any testim ony from Dr. Austin about whether or not W yeth
acted ‘reasonably.’” They will not elicit any testim ony regarding what a “reasonable com pany” would have or
should have done with respect to testing from that witness. Filing No. 108, Plaintiffs’ Brief at 1.

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properly a challenge to the weight and not the admissibility of the evidence. Accordingly,
the court finds the Daubert motion should be denied.
C.

Defendants’ Motion to Strike testimony of Dr. Michael T. Maloney,
Ph.D., and Raymond S. Hartman, Ph.D.

Dr. Michael T. Maloney, Ph.D., and Raymond S. Hartman, Ph.D., have been
designated to testify with respect to punitive damages. Dr. Maloney is an economist and
valuation expert. Dr. Hartman is also an economist, and he has conducted a forensic
analysis to quantify and qualify the importance of the hormone therapy business to the
Wyeth. Plaintiffs have shown these witnesses are qualified to testify to issues that may be
relevant to the issue of punitive damages.
Defendants seek exclusion of the experts’ testimony as irrelevant because punitive
damages are not recoverable under Nebraska law. The court’s grant of the defendants’
motion for summary judgment on the punitive damages issue is dispositive of this aspect
of the motion. Accordingly the experts’ testimony is irrelevant and the court will grant the
defendants’ motion.
D.

Defendants’ Motion to Exclude the Testimony of Dr. Matthew Hollon,
Dr. Adriane Fugh-Berman and Dr. Warren Keegan

Dr. Matthew Hollon, Dr. Adriane Fugh-Berman and Dr. Warren Keegan have been
designated to testify about Wyeth’s marketing practices for hormone therapy (“HT”)
medications.3 They plan to testify that Wyeth failed to meet the reasonable standard for
drug promotion. Wyeth argues that the proposed testimony of these witnesses lacks the
requisite nexus to this case, absent evidence that Ms. Kammerer’s doctors, Dr.

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W yeth challenges only the m arketing opinions in Dr. Hollon’s testim ony.
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Anderson-Fowler and Dr. Spencer, relied on Wyeth’s marketing materials. Wyeth also
argues that the testimony of these witnesses is inadmissible under Daubert because it
“improperly attempts to instruct the jury on the wrong legal standard by which to judge
Wyeth’s conduct and because their failure to investigate the factual basis of their opinions
renders their testimony unreliable.”
The plaintiffs have shown that the experts’ opinions are based on the experts’
extensive backgrounds, training, education, and experiences, as well as their own
published, peer-reviewed articles and review of Wyeth internal documents, depositions,
relevant scientific and medical literature on the effects of pharmaceutical promotion, and
Wyeth sales-call notes. These witnesses clearly have knowledge of pharmaceutical
marketing that is beyond a juror’s common understanding. Wyeth has not demonstrated
that Sally Kammerer or her physicians did not rely on Wyeth’s promotional materials.
There is evidence that the prescribing physicians relied on many sources in making the
decision to prescribe, that Wyeth sales representative talked to the doctors, provided
information to them, and may have sponsored continuing medical education seminars for
them. Wyeth has not shown that the marketing-practices evidence is not relevant to issues
presented in this case.
The court finds Wyeth’s objections go to the weight, and not the admissibility, of the
evidence and the experts’ testimony is properly the subject of cross-examination, rather
than exclusion. Accordingly, the court finds the motion should be denied, subject to proper
foundation and a showing of relevance at trial. The court will limit the experts’ testimony
to matters that would be helpful to the jury and are within the expert’s area of expertise.

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E. Defendants’ HER2 Daubert motion
This motion is directed at the plaintiffs’ causation witness, Dr. Elizabeth Naftalis,
M.D. The rejection of a Daubert challenge to Dr. Naftalis’s testimony by the Eighth Circuit
is dispositve of the defendants’ motion. The Eighth Circuit specifically approved Dr.
Naftalis’s methodology. Id. at 566. The court finds that Dr. Naftalis’s qualifications,
opinions and bases for her opinions are sufficient under Fed. R. Evid. 702 and 703. The
parties have had sufficient notice with respect to the experts’ opinions in connection with
HER2 issues and any purported weaknesses can be exposed in cross-examination and
presentation of contrary evidence. Accordingly, the court finds the defendants’ motion to
exclude expert testimony that estrogen and progestin therapy causes estrogen
receptive/HER2 positive breast cancer should be denied, provided she testifies within the
parameters of her original and supplemental expert reports.
F. Defendants’ Causation Daubert Motion
Wyeth moves to exclude any opinion that Prempro hormone therapy causes
Estrogen-Receptor-Positive/Progesterone-Receptor-Negative (ER+/PR-) breast cancer and
to exclude any specific causation opinion that caused plaintiff Sally Kammerer’s ER+/PRbreast cancer, due to its scientific unreliability. In opposition to the motion, plaintiffs
contend that this motion is moot because Ms. Kammerer’s breast cancer is positive for
both estrogen and progesterone receptors (ER+/PR+), as opposed to a different subtype
of breast cancer that is ER+/PR–. Alternatively, they claim that if Wyeth maintains that
Ms. Kammerer’s breast cancer is ER+/PR–, then they will present expert testimony that
Prempro causes both ER+/PR+ and ER+/PR– breast cancers alike. In response, the
defendants argue that plaintiffs have not disclosed any expert on that issue, although they
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acknowledge that several doctors have given opinions on ER+/PR– breast cancer in the
MDL case. They further argue that Dr. Naftalis, who plaintiffs have designated in this case
as a specific causation expert regarding ER+/PR+ and ER+/HER2+ breast cancer, also
has not been disclosed as an expert to offer an opinion regarding ER+/PR– breast cancer
in this case. Wyeth argues that it would be inappropriate for the court to allow Dr. Naftalis
to parrot the opinions of other MDL experts on this issue at trial. Both parties have
submitted voluminous scientific evidence, consisting of journal articles, deposition
testimony, and trial testimony from the MDL litigation, in support of their respective
positions.
This dispute presents the classic “battle of experts” that is an issue for resolution by
the trier of fact. There appears to be no dispute that Ms. Kammerer’s cancer was estrogen
receptor positive (ER+). Regardless of the cancer’s progesterone-receptor status, the
Eighth Circuit Court of Appeals has expressly endorsed expert testimony that hormone
therapy can cause hormone-dependent breast cancer. The plaintiffs’ expert evidence
meets the threshold level of reliability. The defendants can expose any weaknesses in the
plaintiffs’ expert’s opinions or theories through cross-examination.
Wyeth also argues that, because plaintiffs have withdrawn Dr. Colditz as a witness,
they have no expert who has offered an opinion on ER+/PR- breast cancer. Wyeth further
contends that the plaintiffs should not be allowed to rely on their specific causation expert,
Dr. Elizabeth Naftalis, on this issue. Defendants have admitted that the HER2 and PRtheories are not new to the litigation.4 As detailed above in connection with the motions to
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Dr. Colditz was withdrawn following his failure to m ake him self available for a 7-hour deposition, as
ordered by the court. The allegedly “new” HER2 and PR- causation issue was acknowledged by W yeth to
“not be a com pletely ‘new’ issue in the HT litigation, it is ‘new’ com ing from Dr. Colditz.,” in the m aterials
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strike and supplement, Wyeth has had ample notice of the issues in this litigation. The
ER+/PR- theory was first brought up by their own pathology expert. The plaintiffs should
be allowed to rebut that testimony. Moreover, as Wyeth argues in opposition to the
plaintiffs’ Daubert motion directed at Dr. Stovall, discussed below, review of relevant
scientific literature, and the drawing conclusions based on those studies, together with
training, and experience, is a scientifically reliable means of reaching a general causation
opinion, as long as the expert reliably interprets the scientific literature. The plaintiffs are
entitled to present causation evidence based on similar testimony, subject to establishing
proper foundation and relevance. Wyeth’s criticism of the probative value of any such
testimony on this issue is the subject of cross-examination, not exclusion of the evidence.
Accordingly, the court finds the defendants’ motion to exclude causation opinions should
be denied.
G. Plaintiffs’ motion to exclude to the testimony of Dr. Thomas Stovall
Plaintiffs contend that Dr. Stovall has conceded under oath that he: (1) is not an
expert in breast cancer; (2) has no methodology underlying his opinions; and (3) rejects
the notion that this court or any other court could make a judgment on methodology. They
argue that allowing Dr. Stovall to testify runs the risk of misleading the jury. Wyeth argues
that Dr. Stovall reviewed the relevant scientific literature and explained the criteria he used
in analyzing whether there was sufficient reliable evidence that hormone therapy causes
breast cancer.

subm itted in connection with the m otion to com pel Dr. Colditz’s deposition. See Filing No. 147, Defendants’
Brief at 1.
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Again, the Daubert objections go more to the weight than to the admissibility of the
expert’s testimony, subject to a proper showing of foundation and reliability. Plaintiffs have
not shown that Dr. Stovall cannot offer testimony that would be helpful to the jury within his
field of expertise. The record shows that Dr. Stovall’s qualifications meet the threshold
under Daubert. The sufficiency of the opinions and the weight to be accorded them are
matters for the jury to determine. The court will properly limit the expert’s testimony to
matters that would be helpful to the jury and are within the expert’s area of expertise.
Accordingly,
IT IS ORDERED:
1. Defendants’ motion to exclude the testimony of Drs. Parisian, Blume and Austin,
(Filing No. 53) is denied.
2. Defendants’ motion to exclude the testimony of Hollon, Fugh-Berman, Keegan
(Filing No. 63) is denied.
3. Defendants’ motion to exclude any general and specific causation opinion that
hormone therapy causes estrogen-receptor-positive/progesterone-receptor-negative
(ER+/PR-) breast cancer (Filing No. 68) is denied.
4. Defendants’ motion to exclude expert testimony that estrogen + progestin
hormone therapy causes estrogen receptor positive / HER2-Positive (ER+/HER2+) breast
cancer or caused Ms. Kammerer’s ER+/HER2+ breast cancer (Filing No. 72) is denied.
5. Plaintiffs’ motion to exclude to the testimony of Dr. Thomas Stovall (Filing No.
74) is denied.
6. Defendants’ motion to exclude the testimony of Dr. Maloney and Dr. Hartman
(Filing No. 57) is granted.
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7. Plaintiffs’ motion for leave to supplement responses in opposition to Wyeth’s
Daubert motions relating to alleged HER2 and PR- status of plaintiff’s breast cancer (Filing
No. 149) is granted.
8. Defendants’ motion to strike plaintiffs’ supplemental materials relating to HER2
status of plaintiff’s breast cancer (Filing No. 181) is granted in part and denied in part as
set forth in this order.
DATED this 1st day of November, 2011.
BY THE COURT:

s/ Joseph F. Bataillon
Chief District Judge

*This opinion m ay contain hyperlinks to other docum ents or W eb sites. The U.S. District Court for
the District of Nebraska does not endorse, recom m end, approve, or guarantee any third parties or the services
or products they provide on their W eb sites. Likewise, the court has no agreem ents with any of these third
parties or their W eb sites. The court accepts no responsibility for the availability or functionality of any
hyperlink. Thus, the fact that a hyperlink ceases to work or directs the user to som e other site does not affect
the opinion of the court.
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