Fender v. Bayer Corporation et al

Filing 57

ORDER deferringin part and denying in part 47 Motion to exclude expert testimony is denied. Motion for summary judgment is deferred. Signed by Chief Judge David R. Herndon on 12/16/2011. (dsw)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF ILLINOIS

IN RE: YASMIN AND YAZ
(DROSPIRENONE) MARKETING, SALES
PRACTICES AND PRODUCTS LIABILITY
LITIGATION

This Document Relates to:

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3:09-md-02100-DRHPMF
MDL No. 2100

Jill Fender, as Special Administrator and
Surviving Parent of the Estate of Melissa A.
Fender, Deceased v. Bayer Healthcare
Pharmaceuticals, et al. Case No. 09-CV-20036DRH

MEMORANDUMUM AND ORDER
Regarding That part of the Motion which seeks to Exclude Testimony of
Plaintiffs’ Expert Witnesses David Green, M.D., Ph.D. and Mitchell Botney,
M.D.
(Partial Ruling on Document No. 47)

I.

INTRODUCTION
Defendants Bayer HealthCare Pharmaceuticals Inc. and Bayer Pharma AG

(“Bayer”) move, in part, to exclude the testimony David Green, M.D., Ph.D. and
Mitchell Botney, M.D. as part of plaintiff’s evidence. (Doc. 47).1 Familiarity with

1

Bayer also seeks summary judgment in this motion. The Court is deferring
ruling on that part of the motion seeking summary judgment until a later date,
but will determine the issues raised under Daubert v. Merrell Dow Pharm.,
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the underlying proceeding is presumed.

For the reasons that follow, Bayer’s

motion is DENIED on all grounds raised.

II.

BACKGROUND
This Order is part of the Court’s consideration of one of the bellwether

cases in a multidistrict litigation (MDL) action relating to the manufacture,
marketing, and sale of the prescription pharmaceuticals known as YAZ and
Yasmin.2 Jill Fender, as Special Administrator and Surviving Parent of the
Estate of Melissa A. Fender, Deceased v. Bayer Healthcare Pharmaceuticals, et
al. Case No. 09-CV-20036-DRH.
YAZ and Yasmin, are manufactured, marketed, and sold by Bayer, and are
members of a class of prescription medicines known as combined hormonal oral
contraceptives (“COCs”), which contain both an estrogen and a progestin
component (Doc. 2090 p. 6).

The vast majority of COC’s, including YAZ and

Yasmin, contain the same type of estrogen–ethinyl estradiol (EE). Id.3 In contrast
to estrogen, the progestins in COCs are of many types. The progestin in YAZ and
Yasmin is a newer type of progestin known as drospirenone (“DRSP”). Id.

2

This MDL relates to other oral contraceptives that, like YAZ and Yasmin, contain drospirenone.
However, YAZ and Yasmin are the subject drugs involved in the pending bellwether trials.

3

YAZ and Yasmin differ in their dosing schedule and the amount of estrogen they contain. The
Food and Drug Administration (FDA) approved YAZ and Yasmin as oral contraceptives in 2006.
The FDA subsequently approved YAZ and Yasmin as a treatment for moderate acne vulgaris in
women who choose to use an oral contraceptive and as a treatment for premenstrual dysphoric
disorder (PMDD) in women who choose to use an oral contraceptive .

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DRSP-containing COCs are known as “fourth-generation” COCs (classified
by the type of progestin used). Id. at pp. 6-5. COCs containing earlier developed
progestins are categorized as “first-generation,” “second-generation,” and “thirdgeneration.”

Id. at p. 6. First-generation COCs contain the progestin

norethynodrel. Id. Second-generation COCs contain the progestin Levonorgestrel
(“LNG”) and third-generation COCs contain several progestins, including
desogestrel, gestodene, and norgestimate (“NGM”). Id.
It is generally accepted that there is an increased risk of venous
thromboembolic (VTE) disease (disease relating to blood clotting in the veins) in
COC users (Doc. 2102-14 p. 5; Doc. 2090-2 p. 2). It is also generally accepted
that second-generation COCs (LNG-containing COCs) are considered to have a low
risk for VTE disease (Doc. 2102-14 p. 6). Because the VTE risk associated with
second-generation COCs is relatively low, LNG-containing COCs are often selected
as a reference treatment in comparative studies evaluating whether there is an
association between third-generation COCs and an increased risk of VTE disease
(See e.g., Doc. 2102-4) and in comparative studies evaluating whether there is an
association between DRSP-containing COCs and an increased risk of VTE disease
(See e.g., Doc. 2102-14 pp. 5-6). In the mid-1990s, various reports indicated
that users of third-generation COCs were at higher risk of VTE disease than users
of second-generation COCs (Doc. 2090-2 p. 2).4

4

Plaintiffs note that the third-generation COCs include labels advising doctors that “[s]everal
epidemiologic studies indicate that third generation oral contraceptives . . .are associated with a
higher risk of venous thromboembolism than certain second generation oral contraceptives.”

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At issue in this litigation is the safety of DRSP-containing COCs and
whether the use of DRSP is associated with a higher risk of VTE disease.
Specifically, plaintiffs contend that Bayer misrepresented or omitted facts
pertaining to the safety and efficacy of YAZ and Yasmin. With respect to the safety
of YAZ and Yasmin, plaintiffs contend that the DRSP component of the drugs is
associated with an increased risk of VTE disease and of potentially life-threating
thrombosis complications, including deep vein thrombosis (DVT) (a blood clot
formation in one of the body’s deep veins) and pulmonary embolism (“PE”) (a clot
formation that travels to the lungs).5
In this bellwether case, the plaintiff, Jill Fender, alleges that her daughter,
Melissa A. Fender, suffered a fatal PE in July of 2007, as a result of taking YAZ
for a period of approximately seven months. Melissa Fender was prescribed YAZ
by a nurse practitioner after suffering break-through bleeding and diagnosis of
ovarian cysts while taking other COCs. Before her death in July of 2007, Melissa
Fender had taken other oral contraception medicines without experiencing any
symptoms of PE. Melissa fender, shortly after a long road trip to and from New
Jersey to her home in Iowa, experienced intermittent shortness of breath and
chest pain. She was evaluated for these symptoms on July 21, 2007 and then
collapsed during a walk on July 27, 2007, and was pronounced dead a short time
later. The coroner later determined the cause of death was a PE.
5

Plaintiff’s

Plaintiffs also contend that Bayer misrepresented the benefits of YAZ and Yasmin with respect to
treatment of premenstrual syndrome (“PMS”), acne and premenstrual dysphoric disorder
(“PMDD”) and that YAZ and Yasmin are defectively designed because safer alternative designs
exist. These contentions are not addressed by Dr. Green’s proffered opinions.

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experts, Dr. Green, and Dr. Botney, have each prepared reports with respect to
the death of Melissa Fender (See Botney Report at Doc. 51, Ex.1 and Green
Report at Doc. 51, Ex. 8). Based upon deposition testimony and their reports,
Bayer seeks to exclude their testimony as experts. In particular, Bayer objects to
each expert’s opinion testimony that Melissa Fender’s use of YAZ was a
substantial factor in causing her fatal PE, and that if she had been using a
different COC she would not have suffered the PE. In addition, Bayer seeks to
exclude Dr. Botney’s testimony that Melissa Fender experienced pain and
suffering.

III.

Legal Standard
FEDERAL RULE

OF

EVIDENCE 702, and Daubert, govern the admissibility of

expert testimony. The Daubert standard applies to all expert testimony, whether
based on scientific competence or other specialized or technical expertise. Smith
v. Ford Motor Co., 215 F.3d 713, 719 (7th Cir. 2000) (citing Kumho Tire Co., Ltd.
v. Carmichael, 526 U.S.137, 141 (1999)). Rule 702 provides:
If scientific, technical, or other specialized knowledge will assist the
trier of fact to understand the evidence or to determine a fact in
issue, a witness qualified as an expert by knowledge, skill,
experience, training, or education, may testify thereto in the form of
an opinion or otherwise, if (1) the testimony is based upon sufficient
facts or data, (2) the testimony is the product of reliable principles
and methods, and (3) the witness has applied the principles and
methods reliably to the facts of the case.
Fed. R. Evid. 702. Daubert clarified that Rule 702 charges the district court with
the task of ensuring that expert testimony is both relevant and reliable. Daubert,
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509 U.S. at 589. This is commonly referred to as the “gatekeeper” role of the
court. See, e.g. Banister v. Burton, 636 F.3d 828, 831 (7th Cir. 2011)(where the
court stated that “it is the district court’s role to act as gatekeeper before
admitting expert scientific testimony in order to ‘ensure that any and all scientific
testimony or evidence admitted is not only relevant, but reliable.’”)
Resolution of an expert’s credibility or the correctness of his or her
theories under the particular circumstances of a given case is a factual inquiry,
left to the jury’s determination after opposing counsel has cross-examined the
expert at issue as to the conclusions and facts underlying his or her opinion. See,
Walker v. Soo Line R.Co., 208 F.3d 581 589-90 (2000). Thus, “[i]t is not the trial
court’s role to decide whether an expert’s opinion is correct. The trial court is
limited to determining whether expert testimony is pertinent to an issue in the
case and whether the methodology underlying that testimony is sound.” Id. (citing
Kumho, 526 U.S. at 159 (Scalia, J., concurring) (stating that the trial court’s
function under Daubert is to exercise its discretion “to choose among reasonable
means of excluding expertise that is fausse and science that is junky”)).

IV.

ANALYSIS
The Court has previously determined that both Dr. Botney and Dr. Green

are qualified to render expert opinions in this multidistrict litigation. Therefore,
to the extent that Bayer again challenges their qualifications, that part of the
motion to exclude is DENIED. The crux of Bayer’s objection to these witnesses is

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to their opinions that Melissa Fender would not likely have suffered a fatal PE if
on a COC other than YAZ and that she suffered pain and suffering before her
death. Bayer argues, in part, that because these opinions were not part of their
respective reports, they cannot be the subject of testimony by the experts.
Unfortunately for Bayer’s argument, the matters that they object to were
opinions given by each witness in response to hypothetical questions posed by the
defendant during the witnesses’ depositions. Specifically, Dr. Botney was asked
the following:
Q.
If Ms. Fender was [sic] taking a different estrogencontaining oral contraceptive at the time
of her
pulmonary embolism, do you have an opinion as to
whether or not she would have had the pulmonary
embolism?
A.
Now, you’re asking about relative risk, and I’m
not—I’m not prepared—I can’t answer that question. I—
I’m not competent to get into the topic of relative risks
between various types of oral contraceptives.
(Botney Depo at 33-34). When asked the question later in his deposition, Dr.
Botney stated:
Q.
. . .if Ms. Fender of [sic] not been switched to Yaz
that she would have continued the rest of her life on this
other birth control pill without a VTE—
A.
. . .More likely than not she would not have had a
pulmonary embolism in the future.
Id. at 46-47. On re-direct, when asked if the use of YAZ, within a reasonable
degree of medical certainty, caused her fatal PE, Dr. Botney replied, “I have no
doubt about it.” Id. at 48-49.
Similarly, Dr. Green’s deposition included the following:

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Q.
Do you recall earlier today that you were asked
some hypothetical questions about a fictitious situation,
asking you to speculate as to Ms. Fender being on a
different contraceptive other than YAZ at the time of her
death? Do you recall that series of questions?
A.
Yes, I do.
Q.
And in answering those questions, were you
required to speculate?
A.
Yes.
(Green Depo. at 119). Unfortunately for Bayer’s position, both of these “opinions”
by Drs. Botney and Green were in direct response to hypothetical questions posed
by counsel. The witnesses are permitted to respond to hypothetical scenarios.
The defendant’s challenge actually goes to the weight, not the admissibility of their
testimony in the Fender case. The defendant is welcome to cross examine the
witnesses and challenge the bases for their conclusions as part of the
hypotheticals.

In addition, defendant may tender experts of its own in

contradiction to the position that Plaintiff’s experts may take.
In addition, Bayer’s challenge to the statement by Dr. Botney that the
plaintiff suffered pain and suffering is likewise subject to challenge on crossexamination. As the Court previously noted: resolution of an expert’s credibility or
the correctness of his theories under the particular circumstances of a given case
is a factual inquiry, left to the jury’s determination. Walker, 208 F.3d at 589-90.
Defendant may attempt to challenge that testimony, and those conclusion through
the normal process of cross examination and the presentation of its own evidence.
This is not, however, grounds for excluding a witness.

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V.

CONCLUSION
Accordingly, the Court DENIES, on all grounds raised, Bayer’s motion to

exclude the testimony of Plaintiff’s experts, Mitchell Botney, M.D. and David
Green, M.D., Ph.D. (Doc. 47) as set forth above.
IT IS SO ORDERED.
David R. Herndon
2011.12.16 17:38:34
-06'00'
Chief Judge
United States District Court
DATE: December 16, 2011

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