Sims v. Bayer Corporation et al

Filing 257

ORDER denying 81 Motion for summary judgment denied. Motion to exclude expert testimony denied. 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

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3:09-md-02100-DRH-PMF
MDL No. 2100

This Document Relates to: Kerry Sims v. Bayer Corp., et al., No. 3:09-cv10012-DRH-PMF

MEMORANDUM AND ORDER
I.

INTRODUCTION

Defendants Bayer HealthCare Pharmaceuticals Inc. and Bayer Pharma AG
(Bayer) move to exclude certain opinions of plaintiff’s case-specific experts
Mitchell Botney, M.D., Anthony Disciullo, M.D., Henry Rinder, M.D., and Mehrdad
Sehizadeh, M.D. Bayer also moves for summary judgment on plaintiff’s failure to
warn and defective manufacture and construction strict products liability claims
(Doc. 81). 1 Further, in Bayer’s reply (Doc. 171) to plaintiff’s response (Doc. 87), it
moves for summary judgment as to plaintiff’s negligence per se claim brought for
the first time in her third amended complaint (Doc. 165).

For the following

reasons, Bayer’s motion to exclude certain opinions of plaintiff’s case-specific
experts and for summary judgment as to plaintiff’s failure to warn claim is

1

The Court notes plaintiff’s response concedes insufficient evidence to submit a defective
manufacturing claim. Plaintiff agrees to withdraw and dismiss the claim. However, she emphasizes
that dismissal of this claim does not relate in any way to plaintiff’s strict liability design defect
claim (Doc. 88, p. 1 n. 3). Accordingly, Bayer’s motion for summary judgment as to plaintiff’s
defective manufacturing claim is moot.

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DENIED (Doc. 81).

Bayer’s motion for summary judgment as to plaintiff’s

negligence per se claim is also DENIED as untimely (Doc. 187).
II.

BACKGROUND
a. MDL Generally 2

This multidistrict litigation (MDL) relates to the manufacture, marketing,
and sale of the prescription pharmaceuticals known as YAZ and Yasmin. 3 YAZ
and Yasmin, which are manufactured, marketed, and sold by Bayer, are members
of a class of prescription medicines known as combined hormonal oral
contraceptives (COCs), which contain 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) (Doc. 2090, p. 6). 4 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) (Doc. 2090,
p. 6).
DRSP-containing COCs are known as “fourth-generation” COCs (classified
by the type of progestin used) (Doc. 2090, pp. 5-6).

COCs containing earlier

developed progestins are categorized as “first-generation,” “second-generation,”
and “third-generation” (Doc. 2090, p. 6).

First-generation COCs contain the

progestin norethynodrel (Doc. 2090, p. 6). Second-generation COCs contain the
2

The documents cited in this section of the Court’s Order are filed in 09-md-2100-DRH.
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.
4
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.
3

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progestin Levonorgestrel (LNG) and third-generation COCs contain several
progestins, including desogestrel, gestodene, and norgestimate (Doc. 2090, p. 6)
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).
At issue in this litigation, is the safety of DRSP-containing COCs and
whether DRSP use is associated with a higher risk of VTE disease. Specifically,
plaintiffs, including plaintiff Sims currently in issue, contend that Bayer
misrepresented or omitted facts pertaining to the safety and efficacy of YAZ and
Yasmin. With regard 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 threatening thrombosis complications, including deep vein

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thrombosis (DVT) (a blood clot formation in one of the body’s deep veins) and
pulmonary embolism (a clot formation that travels to the lungs).
b. Facts Pertaining to Plaintiff Sims’ Claims
In June 2008, plaintiff requested that her gynecologist switch her current
COC prescription to YAZ. Plaintiff cites to advertisements promoting YAZ’s ability
to treat moderate acne as motivating her request.

Plaintiff’s physician then

prescribed YAZ. Plaintiff used YAZ continuously from June 2008 to July 2008.
In July 2008, plaintiff was diagnosed with a pulmonary embolism (PE) while
taking YAZ (Doc. 87, pp. 2-3). Relevant to the instant dispute, plaintiff contends
Bayer knew or should have known by 2003 that DRSP COCs carry a higher risk
for VTE than other commonly used COCs. Plaintiff cites to numerous reports,
studies, and FDA actions as the basis for this contention (Doc. 87, pp. 5-6).
Based on Bayer’s alleged knowledge, plaintiff claims Bayer’s YAZ label is
misleading and does not adequately warn of YAZ’s increased risk of thrombotic
events, including PE (Doc. 87, pp. 7-8). The Court refers to Bayer’s motion (Doc.
81) and plaintiff’s statement of material facts in response (Doc. 87) for the
remainder of the disputed factual allegations.
III.

BAYER’S MOTION TO EXCLUDE CERTAIN
STATEMENTS OF PLAINTIFF’S EXPERTS
a. Legal Standard
i. Generally

FEDERAL RULE OF EVIDENCE 702, and Daubert v. Merrell Dow Pharms., Inc.,
509 U.S. 579 (1993), govern the admissibility of expert testimony. The Daubert
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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 Rule 702 charges the district court with the
task of ensuring expert testimony is both relevant and reliable. Daubert, 509 U.S.
at 589.
Courts in the Seventh Circuit conduct a three-step analysis under Daubert.
Ervin v. Johnson & Johnson, Inc., 492 F.3d 901, 904 (7th Cir. 2007). 5 First, the
district court must determine whether the person whose testimony is offered is in
fact an expert, as codified in Rule 702 through “knowledge, skill, experience,
training, or education.”

Id. (citing Fed. R. Evid. 702).

Notably, although

“extensive academic and practical expertise” sufficiently qualify a potential witness
as an expert, Bryant v. City of Chicago, 200 F.3d 1092, 1098 (7th Cir. 2000),
“Rule 702 specifically contemplates the admission of testimony by experts whose
5

The Court notes the Seventh Circuit has also described the Daubert analysis as a two-step
process. See Chapman v. Maytag Corp., 297 F.3d 682, 686 (7th Cir. 2002). However, as
Chapman simply combines the first two steps described in Ervin as a single test of reliability,
whether the analysis is described as a three-step or two-step process does not substantively
change the Court’s analysis.

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knowledge is based on experience,” Walker v. Soo Line R.R. Co., 208 F.3d 581,
591 (7th Cir. 2000). Smith, 215 F.3d at 718 (citing Kumho, 526 U.S. at 156
(“[N]o one denies that an expert might draw a conclusion from a set of
observations based on extensive and specialized experience.”)).
Secondly, the district court must determine the expert’s reasoning or
methodology is reliable. Ervin, 492 F.3d at 904; see Mihailovich v. Laatsch, 359
F.3d 892, 918 (7th Cir. 2004) (citing Kumho, 526 U.S. at 147). Specifically, the
testimony must have a reliable basis in the knowledge and experience of the
relevant discipline, Kumho, 526 U.S. at 149 (internal quotations removed),
consisting in more than subjective belief or unsupported speculation. Chapman
v. Maytag Corp., 297 F.3d 682, 687 (7th Cir. 2002); Daubert, 509 U.S. at 590.
Further, as to reliability, Daubert provided the following non-exhaustive list
of relevant factors: “(1) whether the scientific theory can be or has been tested; (2)
whether the theory has been subjected to peer review and publication; (3) whether
the theory has been generally accepted in the scientific community.” Ervin, 492
F.3d 901, 904 (7th Cir. 2007) (citing Daubert, 509 U.S. at 593-94). However,
there is no requirement that courts rely on each factor, as the gatekeeping inquiry
is flexible and must be “tied to the facts” of the particular case. Kumho, 526 U.S.
at 150 (quoting Daubert, 509 U.S. at 591); see also Chapman, 297 F.3d at 687.
Thus, “the role of the court is to determine whether the expert is qualified in the
relevant field and to examine the methodology the expert has used in reaching his
[or her] conclusions.” Smith, 215 F.3d at 718 (citing Kumho, 526 U.S. at 153).

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The district court possesses “great latitude in determining not only how to
measure the reliability of the proposed expert testimony but also whether the
testimony is, in fact, reliable.” United States v. Pansier, 576 F.3d 726, 737 (7th
Cir. 2009) (citing Jenkins v. Bartlett, 487 F.3d 482, 489 (7th Cir. 2007)).
Accordingly, the court’s gatekeeping function requires focus on the expert’s
methodology; “[s]oundness of the factual underpinnings of the expert’s analysis
and the correctness of the expert’s conclusions based on that analysis are factual
matters to be determined by the trier of fact.” Smith, 215 F.3d at 718 (citing
Daubert, 509 U.S. at 595; Walker, 208 F.3d at 587).
Resolution of an expert’s credibility or the correctness of his or her theories
is left to the jury’s determination after opposing counsel has cross-examined the
expert at issue.

Id. (citing Walker, 208 F.3d at 589-90). 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”)). However,
as an expert must explain the methodologies and principles that support his or
her opinion, he or she cannot simply assert a “bottom line” or ipse dixit
conclusion. Metavante Corp. v. Emigrant Sav. Bank, 619 F.3d 748, 761 (7th
Cir. 2010) (quoting Minix v. Canarecci, 597 F.3d 824, 835 (7th Cir. 2010)).

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Lastly, the district court must consider whether the proposed testimony
will assist the trier of fact in its analysis of any issue relevant to the dispute. See
Smith, 215 F.3d at 718; Chapman, 297 F.3d at 687; Daubert, 509 U.S. at 592.
It is crucial that the expert “testify to something more than what is ‘obvious to the
layperson’ in order to be of any particular assistance to the jury.’”

Dhillon v.

Crown Controls Corp., 269 F.3d 865, 871 (7th Cir. 2001) (quoting Ancho v.
Pentek Corp., 157 F.3d 512, 519 (7th Cir. 1998)). However, the expert need not
have an opinion as to the ultimate issue requiring resolution to satisfy this
condition. Smith, 215 F.3d at 718 (citing Walker, 208 F.3d at 587).
ii. Physician Testimony
Indisputably, a medical degree does not qualify a doctor to opine on all
medical subjects. Gayton v. McCoy, 593 F.3d 610, 617 (7th Cir. 2010) (citing
Carroll v. Otis Elevator Co., 896 F.2d 210, 212 (7th Cir. 1990)). However, the
Seventh Circuit recognizes that often a “physician in general practice is competent
to testify about problems that a medical specialist typically treats.” Id. (citing 29
Wright & Gold, Federal Practice and Procedure, § 6265 (1997); Doe v. Cutter
Biological, Inc., 971 F.2d 375, 385 (9th Cir. 1992) (“The fact that the experts
were not licensed hematologists does not mean that they were testifying beyond
their area of expertise. Ordinarily, courts impose no requirement that an expert
be a specialist in a given field, although there may be a requirement that he or she
be of a certain profession, such as a doctor.”); Dickenson v. Cardiac & Thoracic
Surgery of E. Tenn., 388 F.3d 976, 978-79 (6th Cir. 2004); United States v.

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Viglia, 549 F.2d 335, 336 (5th Cir. 1977) (holding that a pediatrician who had
degrees in medicine and pharmacology but no experience in treating patients in
obesity had sufficient knowledge, training, and education to testify regarding
drug’s effect on obese persons)). Thus, courts must individually evaluate each
conclusion drawn to determine whether the purported expert “has the adequate
education, skill, and training to reach them.” Id.
b. Arguments and Analysis
1. Daubert Analysis Generally
The following qualifications and statements concerning the reliability of the
experts’ opinions are applicable to all statements for which Bayer seeks exclusion.
As to the third prong under Fed. R. Evid. 702 and Daubert, whether the proposed
testimony will offer assistance to the trier of fact, the Court finds all of the experts’
opinions as stated in their reports are helpful to the trier of fact’s analysis of
issues relevant to the dispute.

All of the at-issue experts opine from the

perspective of medical doctors. Accordingly, they testify as to something more
than what is obvious to a layperson.

Thus, the Court will only independently

analyze the qualifications of the relevant expert and the reliability of their
opinions.
a. Dr. Mitchell Botney
i. Qualifications
Plaintiff offers Dr. Botney to opine, from a pulmonary perspective, as to
plaintiff’s future damages and prognosis resulting from her PE (Doc. 90, p. 2).

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Dr. Botney received his Bachelor of Science from the University of Michigan in
1974.

In 1984, he received a Doctorate of Medicine from the Ohio State

University College of Medicine.

He completed a fellowship in Respiratory and

Critical Care at the Washington University School of Medicine in 1988. Thus, he
has over twenty years of clinical experience as a pulmonologist. Further, he has
authored numerous articles pertaining to thrombotic events (See Doc. 90-2).
ii. Reliability
In forming his opinions, Dr. Botney consulted numerous publications
concerning acute pulmonary embolism, the relation of recurrent VTE and
pregnancy, the risk of VTE in relation to DRSP COC users, and other related
subjects. Further, he consulted the depositions of plaintiff and Dr. Mark Erwin.
Finally, he consulted all of plaintiff’s relevant medical records (See Doc. 90-4).
b. Dr. Henry Rinder
i. Qualifications
Plaintiff offers Dr. Rinder to opine, from a hematology perspective,
regarding plaintiff’s future damages and prognosis resulting from her PE (Doc.
90, p. 2). Dr. Rinder is a board certified Internal Medicine doctor, specializing in
Hematology. Dr. Rinder received his Bachelor of Science from Yale University in
1979.

In 1984, he received a Doctorate of Medicine from the University Of

Vermont College Of Medicine. In 1988, he completed a fellowship in Hematology
at the Yale University School of Medicine. He is currently an attending physician
at the Yale University School of Medicine. Dr. Rinder has over nineteen years of

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clinical experience diagnosing and treating patients with venous thrombotic
events. Further, Dr. Rinder has authored numerous texts concerning thrombosis
and bleeding, including a text titled, “Hematology in Clinical Practice” (See Doc.
90-5).
ii. Reliability
In forming his opinions, Dr. Rinder consulted plaintiff’s medical and
hospital records.

He further consulted relevant deposition testimonies and

medical summaries submitted in 09-md-2100, the general MDL proceeding (See
Doc. 90-6).

Moreover, he reviewed relevant medical literature concerning the

relationship between VTE and COC users. Lastly, he relied on relevant clinical
study reports, their corresponding clinical reports, and relevant internal Bayer
documents (See Doc. 90-8).
c. Dr. Anthony Disciullo
i. Qualifications
Plaintiff offers Dr. Disciullo to opine, from the perspective of an OB/GYN,
regarding plaintiff’s future damages, prognosis, and his experience with Bayer’s
marketing techniques. He is a board certified OB/GYN who has practiced in the
Boston area since 1975 (Doc. 90-9, p. 2).

He received a Bachelor of Arts in

Biology from Boston College in 1964, and a Doctorate of Medicine from New York
Medical College in 1968.

He has held numerous academic appointments,

including his current position as Assistant Clinical Professor of Obstetrics,
Gynecology, and Reproductive Biology at the Harvard Medical School.

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Dr.

Disciullo is an attending physician at four Boston area hospitals (Doc. 90-9, p. 3).
His practice is limited to gynecology with a focus on laparoscopic and pelvic
reconstructive procedures (See Doc. 90-9).

According to Dr. Disciullo, a

“considerable portion” of his practice requires him to prescribe hormonal
contraception (HC) in addition to COCs (Doc. 90-11, p. 2).

Additionally, Dr.

Disciullo has received several awards, conducted numerous research studies, coauthored various medical journal articles, and authored educational texts (See
Doc. 90-9).
ii. Reliability
Dr. Disciullo states his opinions “are based on the materials referenced
throughout the body of [his] report as well as [his] clinical training, education and
background knowledge of the subject matter” (Doc. 90-11, p. 2).

Specific to

plaintiff, Dr. Disciullo forms his opinions as to her future damages and prognosis
on her medical records and relevant deposition testimony (Doc. 90-10, p. 2).
Additionally, Dr. Disciullo cites to an expansive list of medical literature, clinical
study reports, published studies corresponding to clinical reports, deposition
transcripts and exhibits, and other Yasmin and Yaz-related materials as forming
the basis of his opinions (See Doc. 90-12).
d. Dr. Mehrad Sehizadeh
i. Qualifications
Plaintiff offers Dr. Sehizadeh, from the perspective of a radiologist, to opine
as to plaintiff’s PE diagnosis (Doc. 90, p. 3). He is a board certified radiologist

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with ten years’ experience of interpreting radiologic studies.

He received a

Doctorate of Medicine from the Tehran University of Medical Sciences in 1991.
He received his certification from the American Board of Radiology in 2002. He is
licensed in three states and is currently a Neuroradiologist partner at Midwest
Radiological Associates, PC (See Doc. 90-13).
ii. Reliability
In forming his opinions, Dr. Sehizadeh relied on a publication concerning
the diagnosis of chronic pulmonary thromboembolism, and all of plaintiff’s
relevant medical records. These records include plaintiff’s chest and abdomen
scans relevant to the diagnosis of her PE, all dated from July 16, 2008, to July
31, 2008. Moreover, he relied on his years of experience as a radiologist (See
Doc. 90-14).
2. Daubert Applied to Specific Statements
a. Dr. Sehizadeh’s Opinion as to Age of Plaintiff’s PE
First, Bayer seeks exclusion of certain statements of plaintiff’s expert Dr.
Sehizadeh, a radiologist, opining as to the age of plaintiff’s PE. Bayer argues as
Dr. Sehizadeh is not a thoracic radiologist, he is not qualified to opine in this
manner. As Dr. Sehizadeh does not generally determine the age of a PE “by days
or weeks,” Bayer argues his opinion stating plaintiff’s PE was three to seven days
old at the time of her diagnosis requires exclusion. Bayer states as Dr. Sehizadeh
cannot cite to articles in support of his contention, it is unfounded (Doc. 81, pp.
7-8).

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Plaintiff responds Dr. Sehizadeh’s opinions as to the age of plaintiff’s PE are
admissible as Dr. Sehizadeh is a board-certified radiologist who was on staff at
plaintiff’s hospital during her admission for treatment of her PE. Plaintiff cites
Dr. Sehizadeh’s ten years of experience interpreting more than 80,000 radiologic
studies, including approximately 2,000 CTA chest scans and 12,000 chest
radiographs, as the basis for his status as a qualified expert. Plaintiff states Dr.
Sehizadeh’s methodology of reviewing radiology films to diagnose plaintiff’s acute
PE is reliable as it it identical to the methodology any radiologist would employ
when making this diagnosis. Further, plaintiff states, Dr. Sehizadeh bases his
opinion that plaintiff’s PE was less than three days old at the time of diagnosis on
his years of medical experience and knowledge concerning the difference between
an acute PE and a chronic PE. Thus, plaintiff contends it is admissible under
Daubert (Doc. 90, pp. 17-19).
i. Dr. Sehizadeh’s Opinion as to Age of Plaintiff’s PE Admissible
Under Daubert
1. Qualifications
The Court finds Dr. Sehizadeh’s years of general experience as a radiologist
and specifically his experience related to plaintiff, qualify him to opine in this
manner. Although Dr. Sehizadeh is not a thoracic radiologist, he is indisputably a
radiologist with over ten years of experience. A physician in general practice is
competent to testify about problems that a medical specialist typically treats, due
to his or her relevant medical training and experience.
Sehizadeh is a specialist. He is a radiologist.
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In this instance, Dr.

Although he may not regularly

opine as to the specific age of PEs, he regularly reads CTA chest scans and
radiographs such as those underlying the basis of his opinion.

Thus, he is

qualified to opine in this manner.
2. Reliability
As plaintiff states, Dr. Sehizadeh formed his opinion as to the age of
plaintiff’s PE according to the methodology radiologists employ on a daily basis.
He reviewed her radiology films.

He further explains the bases of his opinion

concerning the age of plaintiff’s PE. In his report Dr. Sehizadeh states,
Considering the pleural effusion and pulmonary consolidation on the
left side after initial diagnosis while on treatment, central position of
embolus in CTA, dilation of the affected left lower lobe pulmonary
arterial branch in CTA and normal appearance of the chest
radiographs on 7/16/2008 and 7/18/2008; I believe that pulmonary
embolism [was] not more than three days old at the time of diagnosis
on 7/18/2008 and [was] definitely less than one week old at that time.
(Doc. 90-14, p. 4). Thus, the Court finds Dr. Sehizadeh adequately explains the
methodology underlying his opinion.

Bayer disagrees with Dr. Sehizadeh’s

conclusions. However, Bayer’s arguments are more properly addressed on crossexamination. As Dr. Sehizadeh is qualified and his opinions are reliably based,
his statements are admissible pursuant to Daubert.
b. Opinions as to Possible Future Harm
Bayer next argues specific opinions of Drs. Botney, Disciullo, and Rinder
require exclusion as speculative and unreliable. Bayer cites to specific statements
opining as to plaintiff’s possible risks concerning post-thrombotic syndrome,
future

VTEs,

pregnancy

complications,

future

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surgery,

flying,

hormone

replacement theory, and psychological damages. As these opinions do not state a
“definitive diagnosis of a medical condition,” Bayer argues they require exclusion.
Bayer also cites to Fed. R. Evid 401, holding evidence is relevant where it has “any
tendency to make the existence of any fact that is of consequence to the
determination of the action more or less probable,” as further requiring the
statements’ exclusion. As the experts in issue cannot opine as to whether these
circumstances are reasonably likely to occur, Bayer argues they are inadmissible.
Further, Bayer states the prejudicial effect of these statements outweighs their
probative value under Fed. R. Evid. 403.
Plaintiff responds that pursuant to Illinois law; specifically, Dillon v.
Evanston Hosp., 771 N.E.2d 357, 370 (Ill. 2002), she need not prove future harm
is “more likely than not” to occur. Rather, plaintiff contends, evidence of future
harm is admissible, and not speculative, so long as the increased risk of future
injury is likely to occur within a reasonable degree of medical certainty. Thus,
plaintiff argues she need only present expert testimony within a reasonable degree
of medical certainty that plaintiff is at an increased risk of a particular future
injury.
i. Post-Thrombotic Syndrome Opinions
Plaintiff states Drs. Rinder and Disciusllos’ opinions as to plaintiff’s
increased risk of developing post-thrombotic syndrome are not speculative as
made within a reasonable degree of medical certainty.

For example, plaintiff

states, Dr. Rinder opines that plaintiff is, “at risk for post-thrombotic syndrome

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which occurs in 20% of patients who have experienced VTE” (Doc. 90-6, p. 4).
Further, as to Dr. Disciullo, plaintiff cites to his opinion that “[p]ost-thrombotic
syndrome may occur in instances of DVT” (Doc. 90-11, p. 6). Plaintiffs argue as
these and similar opinions are stated within a reasonable degree of medical
certainty due to the doctors’ experience and training, they are admissible (Doc.
90, pp. 6-7).
ii. Future VTEs
Plaintiff next contends the statements of Drs. Botney, Disciullo, and Rinder
concerning plaintiff’s increased risk of a future VTE are similarly not speculative
as made within a reasonable degree of medical certainty due to the experts’
medical experience (Doc. 90, pp. 7-9). For example, plaintiff cites to Dr. Botney’s
statement that, “the risk of recurrence [of VTE] varies with time after the incident
event, being highest during the first 6 to 12 months but never falling to zero” (Doc.
90-3, p. 6). Plaintiff states Dr. Disciullo similarly opines to a reasonable degree of
medical certainty that, “[p]atients who develop DVT and/or [PE] are at an
increased risk for clotting events in the future” (Doc. 90-10, p. 4). Lastly, as to
Dr. Rinder, plaintiff states he sufficiently opined to a reasonable degree of medical
certainty that “the likelihood of recurrent VTE is higher throughout their lifetime
in individuals with a previous VTE” (Doc. 90-7, p. 7).
iii. High Risk Pregnancy
As to Bayer’s contention that certain statements of Drs. Botney, Disciullo,
and Rinder concerning plaintiff’s risk of pregnancy complications require

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exclusion as speculative, plaintiff argues it is undisputed that any future
pregnancy of plaintiff will be “high risk.” Further, plaintiff argues, even conceding
it is more likely than not that plaintiff will have a “successful” pregnancy, the
increased risks any pregnancy will incur entitle her to compensation. Concerning
Dr. Botney’s opinion, plaintiff cites to his statement that plaintiff is at an
“increased

risk

for

thrombosis

during

pregnancy,”

noting,

“’official’

recommendations . . . include offering anticoagulation to pregnant women with
previous . . . [PE] secondary to oral contraceptives” (Doc. 90-3, pp. 9, 12). As to
Dr. Disciullo, plaintiff cites his statement that the pregnancy of someone with a
prior VTE will require, “additional office visits, time off from work if she is
employed, the need to visit the laboratory for periodic blood draws, and further
expense and pain/stress of frequent blood draws and daily injections” (Doc. 9011, p. 10).

Lastly, plaintiff cites to Dr. Rinder’s statement that, “[i]f [plaintiff]

becomes pregnant, she is now at further increased risk of VTE during and after
pregnancy and must be prophylactically treated with anticoagulation” (Doc. 90-2,
p. 3). Thus, plaintiff states these statements are admissible as made within a
reasonable degree of medical certainty (Doc. 90, pp. 9-12).
iv. Future Surgery
As similarly argued previously, plaintiff contends Drs. Botney and Rinder
are not required to testify it is more likely than not that plaintiff will require
future surgery. Plaintiff cites to two statements of Drs. Botney and Rinder as
demonstrating the reasonable degree of medical certainty with which they opine

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regarding future surgery complications. As to Dr. Botney, plaintiff cites to his
opinion that, “[n]ow that [plaintiff] has had a DVT/PE, she may require DVT
prophylaxis where none would be required, or require higher levels of prophylaxis
than would have been necessary with future surgeries” (Doc. 90-3, p. 12). Plaintiff
cites to Dr. Rinder’s opinion that if plaintiff, “requires any surgery, especially
orthopedic surgery given her running lifestyle, she will require significant
anticoagulant prophylaxis for VTE, more so than a comparable individual without
VTE history, and with its attendant increased risk of bleeding complications for
such prophylaxis” (Doc. 90-6, p. 4). Plaintiff states these, and similar statements,
are stated with a reasonable degree of medical certainty; thus, admissible (Doc.
90, p. 12).
v. Increased Risk Associated With Flying
Plaintiff contends Dr. Disciullo states his opinion as to the increased risk
associated with flying due to plaintiff’s VTE with a reasonable degree of medical
certainty. For example, plaintiff cites to Dr. Disciullo’s statement that, “to reduce
[her] elevated risk, there are some things that [she] can do, but [she] can never get
rid of the elevated risk over baseline” (Doc. 90-17, p. 5: 11-23). As Dr. Disciullo
opines as to the increased risk associated with flying after diagnosis of a VTE with
a reasonable degree of medical certainty, plaintiff argues his opinion is not
speculative and is admissible (Doc. 90, pp. 12-13).

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vi. Inability to Use Hormone Replacement Therapy
Regarding her experts’ opinions as to her future inability to use hormone
replacement theory, plaintiff states, it is undisputed that she is not a candidate for
estrogen based hormone replacement therapy (HRT) to relieve menopausal
symptoms. Plaintiff argues Drs. Botney and Disciullo are not required to testify
plaintiff is “more likely than not” to require HRT, only that she cannot seek future
treatment for this common medical condition.

Plaintiff cites to Dr. Botney’s

statement that HRT, “is associated with an increased risk of deep vein thrombosis
or pulmonary embolism- even more so now that [plaintiff] has had a prior DVT
and PE” (Doc. 90-3, p. 12). Plaintiff similarly cites to Dr. Disciullo’s statement
that plaintiff will experience, “foreclose[ure] from using HRT containing any form
of estrogen,” so that she, “will be unable to avail herself of hormonal remedies to
ease her through [menopause]” (Doc. 90-10, p. 5).

Plaintiff states as these

opinions are grounded in a reasonable degree of medical certainty, they are
admissible (Doc. 90, pp. 13-14).
vii. Psychological Damages
Lastly, pertaining to Bayer’s arguments seeking exclusion of certain
statements of Dr. Disciullo concerning plaintiff’s possible future psychological
damages as speculative, plaintiff cites to Dr. Disciullo’s report.

Dr. Disciullo

states, “VTE is a potentially life-threatening event and brings with it fear of
possible death that can extend long after the pain and fear from the acute event is
over” (Doc. 90-11, p. 10). Further, plaintiff cites Dr. Disciullo’s statement that,

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“[i]n the event [plaintiff] decides to become pregnant, her pregnancy shall . . . be
classified as a ‘high risk’ pregnancy, which can be frightening to such a young
person, especially one who has never experienced a ‘normal’ pregnancy” (Doc. 9010, p. 4). Thus, plaintiff argues, as she need only submit evidence that she is at
an increased risk of future psychological harm, not that she will experience harm
of a certain degree, Dr. Disciullo’s opinions stated to a reasonable degree of
medical certainty are admissible.
1. Opinions as to Possible Future Harm Admissible
At the outset, the Court notes Bayer’s arguments concerning the admission
of expert testimony opining as to plaintiff’s future harm are more akin to a motion
in limine than a motion seeking exclusion under Daubert. Thus, the Court must
first determine whether evidence of future harm is admissible as a general matter
under Illinois law. 6 Then, it will address whether the statements are admissible
under Fed. R. Evid. 702 and Daubert.
a. Evidence of Future Harm Admissible if Stated
Within a Reasonable Degree of Medical Certainty
Concerning recovery of damages for future harm, the Illinois Supreme
Court has held, “simply that a plaintiff must be permitted to recover for all
demonstrated injuries . . . A plaintiff can obtain compensation for a future injury
that is not reasonably certain to occur, but the compensation would reflect the low
probability of occurrence.”

Dillon, 771 N.E.2d at 504.

6

However, speculative

Plaintiff Sims is a resident of Belleville, Illinois. Thus, Illinois state law applies to the
substantive issues of this diversity action. See Thomas v. H & R Block Eastern Enters., 630 F.3d
659, 663 (7th Cir. 2011).

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damage of future harm is inadmissible. See Kamp v. Preis, 774 N.E.2d 865, 871
(Ill. App. 2002). As to the level of certainty required, Illinois courts have held the
argument that, “future damages must be supported by testimony that the injury is
at least 51% likely to occur—is not acceptable. So long as the increased risk of
future injury is proven within a reasonable degree of [medical] certainty and is
proximately caused by the defendant's negligence, evidence of that possibility is
not speculative.”

Id. at 871-72 (citing Anderson v. Golden, 664 N.E.2d 1137,

1139 (Ill. App. 1996)).

Thus, as an initial matter, the experts’ purported

testimony is admissible, as all of the medical experts opine within a reasonable
degree of medical certainty. Moreover, as to Bayer’s argument seeking exclusion
of evidence of future harm pursuant to Fed. R. Evid. 401, as damages for future
harm are clearly recoverable under Illinois law, the evidence instantly in dispute
is relevant. Finally, the probative value of these statements is not outweighed by
their prejudicial effect.

Therefore, provided the statements satisfy the

requirements of Fed. R. Evid. 702 and Daubert, they are admissible.
b. Expert Opinions Concerning
Admissible Under Daubert

Future

Harm

i. Qualifications
Drs. Botney, Disciullo, and Rinder are all qualified to testify as to plaintiff’s
future harm; specifically, her increased risk of developing post-thrombotic
syndrome, future VTEs, experiencing a high risk pregnancy, requiring future
surgery, experiencing risks associated with flying, and an inability to use HRT. As
stated previously, all three experts are medical doctors with twenty, nineteen, and
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thirty-five years of clinical experience, respectively. Thus, the Court finds they are
qualified to opine, within a reasonable degree of medical certainty, concerning the
future damages associated with plaintiff’s PE.
ii. Reliability
As also stated previously, Drs. Botney, Disciullo, and Rinder base their
opinions concerning plaintiff’s future damages on relevant medical literature,
plaintiff’s medical records, clinical study reports, deposition testimonies, and
their years of experience as clinicians.

Contrary to Bayer’s assertion, these

opinions are not speculative as the expert physicians’ base their opinions on their
experiences with patients who have suffered PEs. The Court finds the experts
have opined within a reasonable degree of medical certainty that plaintiff is at an
increased risk of the particular injuries at issue. As such, their opinions are not
speculative. Thus, as Drs. Botney, Disciullo, and Rinder base their opinions on a
reliable

methodology;

specifically,

their

experience

and

relevant

medical

knowledge, the Court finds their opinions as to plaintiff’s possible future harm
admissible.
c. Miscellaneous Opinions of Dr. Disciullo
i. Marketing and Advertising Opinions
Bayer argues certain statements of Dr. Disciullo concerning Bayer’s
advertising and warnings require exclusion. Specifically, Bayer seeks exclusion of
Dr. Disciullo’s statements commenting on plaintiff’s interest in YAZ’s ability to
treat acne. Dr. Disciullo opines plaintiff’s request to switch her COC prescription

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to YAZ resulted from Bayer’s YAZ marketing campaigns. He also opines that YAZ
is an unsafe method of acne treatment. Bayer states these opinions are beyond
Dr. Disciullo’s expertise as an OB/GYN and are inappropriate as the subject of
expert testimony (Doc. 81, p. 12).
Plaintiff responds that Dr. Disciullo bases his opinion that Bayer’s,
“concerted efforts to expand the [acne treatment] indications through promotional
materials geared towards physicians, as well as direct-to-consumer advertising
aimed at young women,” misled women, “into thinking that these ‘low dose’ pills
were as safe or safer than [older pills],” on his thirty-five years of experience as an
OB/GYN (Doc. 90, p. 15) (citing Doc. 90-11, pp. 5-6). Moreover, plaintiff argues,
Dr. Disciullo consulted Bayer internal documents and relied on his personal
experience interacting with Bayer marketing tactics and prescribing COCs. Thus,
plaintiff contends, his opinions concerning Bayer’s marketing and advertising are
reliable and within his expertise (Doc. 90, pp. 15-16).
As to Dr. Disciullo’s statements opining that YAZ is an unsafe method of
acne treatment, plaintiff argues he bases his opinion on clinical data from clinical
acne trials. Further, plaintiff contends this opinion is consistent with relevant
medical literature. Therefore, plaintiff contends his opinion is admissible (Doc.
90, p. 16).

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1. Marketing and Advertising Opinions Permissible Under
Daubert
a. Qualifications
Dr. Disciullo’s bases his opinion as to the marketing techniques of Bayer on
his experience as a prescriber of COCs.

Similarly, Dr. Disciullo’s bases his

opinion as to the merits of prescribing COCs to treat moderate acne on his years
of experience as a prescriber of COCs.

Although Dr. Disciullo has never

personally conducted an analysis of YAZ or Yasmins’ effectiveness as to acne
treatment, he is qualified to opine, based on relevant experience and literature, in
this manner.

Dr. Disciullo cites to numerous reports, studies, internal Bayer

documents, and his own preference as a prescriber of COCs, as forming the basis
of these opinions. Accordingly, Dr. Disciullo is qualified to opine in this manner.

b. Reliability
Dr. Disciullo thoroughly explains the basis of his opinions in his report.
Dr. Disciullo cites to the availability of other medication that also treat moderate
acne.

Based on this availability, Dr. Disciullo believes the risks of YAZ and

Yasmin outweigh the benefits.

He bases this opinion on his reading of the

relevant available literature concerning the safety of YAZ and Yasmin, in addition
to his own experience. Bayer is free to attack the credibility of this opinion on
cross-examination.

However, as Dr. Disciullo bases his opinion on his own

relevant experience, in addition to medical studies and reports, it is reliable and
admissible.

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ii. Opinions Regarding Knowledge of Plaintiff and her Doctors
Bayer also seeks exclusion of Dr. Disciullo’s opinion that, “as a result of
[the] omission [of clinical study results from the YAZ label] prescribing physicians
are unaware of the substantial increase in risk for clotting events for their
patients, as occurred in the case of [plaintiff]” (Doc. 90-10, p. 4). Bayer argues as
Dr. Disciullo has no knowledge concerning whether plaintiff’s doctor informed her
of YAZ-related risks, his opinion is speculative and improper (Doc. 81, pp. 1213).
Plaintiff responds it is irrelevant whether Dr. Disciullo can comment as to
the influence of Bayer’s promotional materials or alleged lack of information on
any specific prescribing physician. Plaintiff argues Dr. Disciullo bases his opinion
as to the information relevant to a prescriber’s decisions on his thirty-five years of
experience as a prescriber of medication. Thus, plaintiff argues this opinion is
not speculative and is properly admissible (Doc. 90, p. 17).
1. Opinions Regarding Knowledge of Plaintiff and her
Doctors Permissible Under Daubert
a. Qualifications
Once again, Dr. Disciullo is similarly qualified to opine in this manner as he
bases his opinions on his own clinical experience, in addition to his experience as
an educator at Harvard Medical School. Dr. Disciullo is qualified to opine as to
the information physicians deem relevant in making a risk/benefit analysis of
medication.

As he bases his opinions on his own experience, they are not

speculative.

Notably, Dr. Disciullo clarifies he will not testify as to why a
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particular physician prescribed Yasmin or Yaz to a particular plaintiff (See MDL
2100 Doc. 2100-3, pp. 168-69: 25, 1-5). Thus, he is qualified to opine as to his
own personal experience prescribing COCs.
b. Reliability
Dr. Disciullo bases his opinion on his own personal experience concerning
information physicians deem important when making prescription-related
decisions. Specifically, Dr. Disciullo explains the relevant criteria physicians use
when evaluating prescription drugs (See MDL 2100 Doc. 2100-1, p. 4). Thus, Dr.
Disciullo does not state “bottom line” conclusions. He explains the reasoning of
his opinions based on relevant experience and documents. Thus, as Dr. Disciullo
limits his testimony to own personal experience, his opinions are the product of a
reliable methodology and are admissible.
The Court finds Drs. Botney, Disciullo, Rinder, and Sehizadeh are all
qualified to opine as to the statements for which Bayer seeks exclusion. Further,
the methods underlying their opinions are reliable. Accordingly, Bayer’s motion
to exclude certain statements of plaintiff’s experts pursuant to Fed. R. Evid. 702
and Daubert is DENIED.
IV.

BAYER’S MOTION FOR PARTIAL SUMMARY
JUDGMENT ON FAILURE TO WARN CLAIM
i. Legal Standard

Summary judgment is appropriate only when “the pleadings, depositions,
answers to interrogatories, and admissions on file, together with the affidavits, if
any, show that there is no genuine issue as to any material fact and that the
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moving party is entitled to a judgment as a matter of law.” Fed. R. Civ. P. 56(c).
A genuine issue of material fact exists when the evidence is such that a reasonable
jury could find for the nonmovant. Buscaglia v. United States, 25 F.3d 530, 534
(7th Cir. 1994). The movant in a motion for summary judgment bears the burden
of demonstrating the absence of a genuine issue of material fact by specific
citation to the record; if the party succeeds in doing so, the burden shifts to the
nonmovant to set forth specific facts showing that there is a genuine issue of fact
for trial.

Fed. R. Civ. P. 56(e); Celotex Corp. v. Catrett, 477 U.S. 317, 325

(1986). In considering motions for summary judgment, a court construes all facts
and draws all inferences from the record in favor of the nonmoving party.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).
ii. Arguments and Analysis
1. Failure to Warn Claim
Bayer moves for summary judgment as to plaintiff’s claim that Bayer failed
to adequately warn consumers after it knew or should have known of the serious
health risks associated with YAZ and Yasmin (See Doc. 165, p. 13). Bayer argues
that under Illinois law, the learned intermediary doctrine bars plaintiff’s claim, as
adequately warning a physician fulfills a pharmaceutical company manufacturer’s
duty to warn of the potential adverse effects of drugs (Doc. 81, p. 13) (citing Kirk
v. Michael Reese Hosp. & Med. Ctr., 513 N.E.2d 387, 392 (Ill. 1987)). Further,
Bayer argues the Illinois Supreme Court has applied the learned intermediary
doctrine to oral contraceptives (Doc. 81, p. 13) (citing Martin ex rel. Martin v.

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Ortho. Pharm. Corp., 661 N.E.2d 352, 356-57 (Ill. 1996)). Thus, Bayer argues it
is entitled to summary judgment on plaintiff’s claim.
Plaintiff responds that the learned intermediary doctrine only applies if the
manufacturer provides adequate warnings (Doc. 88, p. 5) (citing Hansen v.
Baxter Healthcare Corp., 764 N.E.2d 35, 43 (Ill. 2002)).

Most pertinent to

plaintiff’s claims is the disputed adequacy of Bayer’s consumer warnings
concerning YAZ and Yasmin.

Thus, plaintiff claims the learned intermediary

doctrine does not apply. Moreover, as the bulk of the instant factual disputes
concern the adequacy of Bayer’s warnings, plaintiff argues summary judgment is
improper. The Court agrees.
As

Bayer

states,

the

learned

intermediary

pharmaceutical companies under Illinois law.

doctrine

applies

to

See Kirk, 513 N.E.2d at 393

(stating, “there is no duty on the part of manufacturers of prescription drugs to
directly warn patients”). However, the learned intermediary doctrine only applies
where the manufacturer has adequately warned the prescribing physician. See
Hansen, 764 N.E.2d at 43 (stating, “[d]octors who have not been sufficiently
warned of the harmful effects of a drug cannot be considered ‘learned
intermediaries’ and the adequacy of warnings is a question of fact, not law, for the
jury to determine”) (citing Proctor v. Davis, 682 N.E.2d 1203, 1215 (Ill. App.
1997)); see also McNichols v. Johnson & Johnson, 461 F. Supp. 2d. 736, 749
(S.D. Ill. 2006) (stating, “[u]nder Illinois law, the learned intermediary doctrine is
a shield against liability only where the manufacturer of a prescription drug has

Page 29 of 31

given adequate warning of known dangerous propensities of the drug to
physicians”).
Plaintiff alleges Bayer did not provide adequate warnings of YAZ and
Yasmins’ known dangerous propensities. Thus, construing the alleged facts in
favor of plaintiff, the learned intermediary doctrine does not apply. Moreover, one
need only glance at the expert opinions, depositions, and pleadings relevant to the
instant dispute to determine the adequacy of Bayer’s warnings is a factual dispute
underlying the bulk of plaintiff’s claims. Accordingly, Bayer’s motion for partial
summary judgment is DENIED.
2. Negligence Per Se Claim
In Bayer’s reply to plaintiff’s response (Doc. 171), it moves for summary
judgment as to plaintiff’s negligence per se claim, brought for the first time in her
third amended complaint (Doc. 165). As Bayer’s motion is untimely, plaintiff has
not has a possibility to respond to Bayer’s arguments.

Accordingly, Bayer’s

motion for summary judgment as to plaintiff’s negligence per se claim is DENIED
without prejudice. Accordingly, Bayer is free to renew its argument at the end of
plaintiff’s case-in-chief.
V.

CONCLUSION

The Court finds Drs. Botney, Disciullo, Rinder, and Sehizadeh are all
qualified to opine as to the statements for which Bayer seeks exclusion.
Moreover, the methodology on which the experts base their opinions is reliable.
Further, the Court finds summary judgment on plaintiff’s claim for failure to warn

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is not appropriate. Accordingly, Bayer’s motion to exclude certain statements of
plaintiff’s case-specific expert testimony and for partial summary judgment is
DENIED (Doc. 81).

Further, its untimely motion for summary judgment

presented in its reply to plaintiff’s response is DENIED without prejudice (Doc.
171).

SO ORDERED

David R.
Herndon
2011.12.16
21:41:24 -06'00'
Chief Judge
United States District Court

Date: December 16, 2011

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