United States District Court, N.D. California
ORDER DENYING DEFENDANT'S DAUBERT
MOTIONS AND DENYING IN PART AND GRANTING IN PART
DEFENDANT'S MOTION FOR SUMMARY JUDGMENT RE: DKT. NOS. 57,
ILLSTON, UNITED STATES DISTRICT JUDGE.
action is before the Court upon remand from the Southern
District of Illinois, where the Honorable David R. Herndon
for many years oversaw the multi-district litigation
(“MDL”) In re: Yasmin and Yaz (Drospirenone)
Marketing, Sales Practices and Products Liability
Litigation, No. 09-md-02100-DRH-PMF. This case, brought
by plaintiffs Susan Galinis and Richard Galinis, is now here
for disposition of several pending motions and, if needed,
trial. Defendant Bayer HealthCare Pharmaceuticals Inc.
(“Bayer”) has filed two motions for exclusion of
expert testimony and a motion for summary judgment. Docket
Nos. 57 (“Daubert Mot. No. 1”), 58
(“Daubert Mot. No. 2”), 59 (“Mot.
Summ. J.”). Plaintiffs filed opposition briefs. Dkt.
Nos. 101 (“Opp'n to Daubert Mot. No.
1”), 115 (“Summ. J. Opp'n”), 116
(“Opp'n to Daubert Mot. No.
2”). Plaintiffs then filed supplemental
briefing on May 7, 2019, to alert the Court to prior rulings
on Daubert motions in the MDL. Dkt. Nos. 117, 118.
Defendant filed reply briefs on May 31, 2019. Dkt. Nos. 125
(“Reply re: Daubert Mot. No. 1”), 126
(“Reply re: Daubert Mot. No. 2”), 127.
The motions came on for hearing on June 13, 2019. Having
carefully considered the papers filed and the arguments made,
the Court hereby rules as follows.
October 2009, Susan Galinis and Richard Galinis brought this
action against Bayer. Susan had suffered a stroke after she
began taking a birth control pill manufactured by
Bayer. She had gone to see her OB/GYN, Dr. Mary
Ann Co-Asino, on April 30, 2008. Pls.' Ex. 4.1
(“Luciani Rpt.”) at 8. Susan had a history of
endometriosis, which caused severely painful menstrual
periods. She had tried various treatment methods over the
years, including surgical interventions. Since the late
1990's, she had also taken Toradol (or its generic
equivalent, ketorolac) on the days of her period to manage
the pain. Def.'s Ex. 3 (“Galinis Dep.”) at
Susan's April 2008 appointment, Dr. Co-Asino prescribed
Bayer's Yasmin birth control pill. Yasmin is a type of
combined oral contraceptive (“COC”) that contains
the progestin drospirenone (“DRSP”) and ethinyl
estradiol. Pls.' Ex. 7.1 (“Stier Rpt.”) at
2-3. Dr. Co-Asino gave Susan instructions to take one active
tablet of Yasmin daily for 12 weeks followed by a 7 day
tablet free interval, with the goal of suppressing
Susan's menstrual periods, and thereby eliminating the
accompanying pain. Luciani Rpt. at 9; Def.'s Ex. 4
(“Prescription Records”) at 3; Pls.' Ex. 9
(“Co-Asino Dep.”) at 64:21-65:13. Such use of
Yasmin was an “off-label” but standard use of the
Rpt. at 10. Susan filled the prescription for Yasmin that
same day. Prescription Records at 3. The record is unclear as
to precisely how long Susan took Yasmin. She testified that
she took it from the time she filled the prescription on
April 30 up until she had the stroke in June, but she also
testified that she took it for only thirteen days, and that
she had her stroke on the fourteenth day. See
Galinis Dep. at 190:24-191:16. She could not recall whether
her doctor had instructed her to delay taking Yasmin until
after her period was over. Id. at 191:17-22.
7, 2008, Susan suffered a cerebral artery ischemic stroke. ER
Records at 4. In the complaint, plaintiffs allege that
“[a]s a result of using Defendants' product Yaz,
Plaintiff sustained serious side effects including, but not
limited to, a stroke in June of 2008, ongoing physical pain,
diminished cognition, mental anguish, diminished enjoyment of
life, significant lifestyle changes, permanent scarring,
medical, health, incidental and related expenses, medical
monitoring and/or medications, and the fear of developing
additional health consequences.” Dkt. No. 1 ¶ 72.
Plaintiffs bring, among other claims, a claim for strict
product liability failure to warn.
trial judge must ensure that any and all scientific testimony
or evidence admitted is not only relevant, but
reliable.” Daubert v. Merrell Dow Pharm.,
Inc., 509 U.S. 579, 589 (1993). Federal Rule of Evidence
702 permits the introduction of expert testimony only if: (1)
“the expert's scientific, technical, or other
specialized knowledge will help the trier of fact to
understand the evidence or to determine a fact in issue,
” (2) “the testimony is based on sufficient facts
or data, ” (3) “the testimony is the product of
reliable principles and methods, ” and (4) “the
expert has reliably applied the principles and methods to the
facts of the case.” Fed.R.Evid. 702. The proponent of
the expert testimony has the burden of proving the proposed
testimony is admissible. Lust ex rel. Lust v. Merrell Dow
Pharms., Inc., 89 F.3d 594, 598 (9th Cir. 1996).
“Although the district court must perform a gatekeeping
function, a trial court ‘not only has broad latitude in
determining whether an expert's testimony is reliable,
but also in deciding how to determine the
testimony's reliability.'” United States v.
Gadson, 763 F.3d 1189, 1202 (9th Cir. 2014) (citation
omitted); see also Daubert, 509 U.S. at 597.
judgment is proper if the pleadings, the discovery and
disclosure materials on file, and any affidavits show that
there is no genuine dispute as to any material fact and that
the movant is entitled to judgment as a matter of law.
See Fed. R. Civ. P. 56(a). The moving party bears
the initial burden of demonstrating the absence of a genuine
issue of material fact. Celotex Corp. v. Catrett,
477 U.S. 317, 323 (1986). The moving party, however, has no
burden to produce evidence showing the absence of a genuine
issue of material fact. Id. at 325. Rather, the
burden on the moving party may be discharged by pointing out
to the district court that there is an absence of evidence to
support the non-moving party's case. Id.
the moving party has met its burden, the burden shifts to the
non-moving party to “designate ‘specific facts
showing that there is a genuine issue for trial.'”
Id. at 324 (quoting then Fed.R.Civ.P. 56(e)). To
carry this burden, the non-moving party must “do more
than simply show that there is some metaphysical doubt as to
the material facts.” Matsushita Elec. Indus. Co.,
Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986).
“The mere existence of a scintilla of evidence . . .
will be insufficient; there must be evidence on which the
jury could reasonably find for the [non-moving party].”
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252
deciding a summary judgment motion, the evidence of the
non-movant is to be believed, and all justifiable inferences
are to be drawn in his favor. Id. at 255.
“Credibility determinations, the weighing of the
evidence, and the drawing of legitimate inferences from the
facts are jury functions, not those of a judge . . . ruling
on a motion for summary judgment . . . .” Id.
However, conclusory, speculative testimony in affidavits and
moving papers is insufficient to raise genuine issues of fact
and defeat summary judgment. Thornhill Publ'g Co.,
Inc. v. Gen. Tel. & Elec. Corp., 594 F.2d 730, 738
(9th Cir. 1979). The evidence the parties present must be
admissible. Fed.R.Civ.P. 56(c)(4).
parties agree that in this action based on diversity
jurisdiction, the substantive law of the state of California
applies. See Erie R. Co. v. Tompkins, 304 U.S. 64
has filed two motions to exclude expert testimony under
Motion to Exclude Testimony of Dr. Luciani (Dkt. No.
first moves to exclude the rebuttal opinion “proffered
by plaintiffs' OB/GYN expert Richard Luciani regarding
Bayer's supposed withholding of information about adverse
events, which Dr. Luciani admits is supported by no evidence
whatsoever.” Daubert Mot. No. 1 at 1.
Plaintiffs say this motion is moot, as Dr. Luciani will not
testify that Bayer withheld information about adverse events.
Rather, plaintiffs say “Dr. Luciani will testify that
if Bayer did indeed withhold information about adverse
clotting events suffered by Yasmin users, then (i)
Bayer's conduct fell below the standard of care that
OB/GYNs expect of drug manufacturers, and (ii) that
information about adverse clotting events would be material
to OB/GYNs like him, giving them the option of changing their
prescribing habits.” Opp'n to Daubert Mot.
No. 1 at 1. Plaintiffs state that whether Bayer withheld
information “is the province of other experts, such as
Dr. Suzanne Parisian” and that “Dr. Luciani is
permitted . . . to rely on the opinions of other experts that
Bayer has indeed withheld information about adverse clotting
events, and to apply his expertise to those facts.”
Id. at 2. In reply, defendant states Dr. Luciani
should be precluded from offering this opinion because he
“has no basis of his own to opine on Bayer's
conduct” and he “failed to disclose any
reliance on another expert's findings in support of his
rebuttal opinion[.]” Reply re: Daubert Mot.
No. 2 at 1, 4.
Luciani's rebuttal report contains the following:
In reviewing all reports and information presented to me, it
appears that Bayer withheld from the prescribers information
about adverse events with regard to Yasmin. Since the
physician relies on the manufacturer to prescribe their
product, this information regarding any adverse events would
be extremely important to the prescribing physician who would
not have expected this information to be withheld. Had the
adverse information ie. increased risk of Yasmin [sic] been
provided to me as a prescribing Ob/Gyn, it would have given
me the option of either changing my prescribing habits or at
the very least having a detailed discussion with my patients
regarding the safety of this product compared to other oral
contraceptives and/or alternative drugs with less risk.
Dkt. No. 57-1 (“Luciani Rebuttal Rpt.”) at 2-3.
At his deposition, Dr. Luciani testified, “There is no
way of me able to be - actually be able to tell that”
Bayer had any information that it withheld from physicians.
Dkt. No. 57-2 (“Luciani Dep.”) at 41:19-23. Dr.
Luciani also testified, “I would give a generic
opinion, which I've already given, that if in fact Bayer
had the information that there was [sic] questionable side
effects of the pills Yaz and Yasmin, . . . and based on the
internal draft of the VTE Crisis Report, that this would be,
in my mind as a practicing physician, less than a honorable
way for a drug company to deal with physicians based on
questions about products. I think that would be the comment
that I would make and I would go probably no further than
that.” Id. at 41:4-15.
Court will DENY this motion, without prejudice to renewal at
the time of trial. First, plaintiffs have stated that Dr.
Luciani will not present the testimony that originally
prompted defendant to file this motion; that is, Dr. Luciani
will not testify that Bayer withheld information about
adverse events regarding Yasmin. Second, defendant has long
been aware of the basis for Dr. Luciani's rebuttal
opinion. Dr. Luciani testified that he read Dr.
Parisian's report as part of his review,  and he testified
at his deposition that he “would give a generic
opinion” from his perspective as a practicing
physician, “if in fact Bayer had the information . . .
.” See Id. at 41:4-15. At the hearing,
defendant characterized this motion as more a problem of
discovery than anything else, saying Dr. Luciani's
failure to disclose Dr. Parisian's findings as the basis
of his rebuttal opinion precluded defendant from being able
to depose him on this further. However, defendant has long
known that Dr. Parisian's report formed the basis for Dr.
Luciani's rebuttal opinion and has apparently not sought
to re-take his deposition. Finally, defendant has presented no
evidence to show that Dr. Luciani is not qualified as a
medical expert to offer his opinion regarding the standard of
care that OB/GYNs expect of drug manufacturers or regarding
what information is material to OB/GYNs when prescribing
medications. Should the evidence at trial fail to support Dr.
Luciani's testimony, defendant may renew its motion.
Motion to Exclude Expert Testimony on VTE Studies and Expert
Testimony that Yasmin Has a Higher Stroke
Risk Than Other Oral Contraceptives (Dkt. No. 58)
second Daubert motion seeks to exclude two types of
expert testimony: (1) expert testimony on studies regarding
venous thromboembolism (“VTE”), which defendant
says is irrelevant; and (2) expert testimony that Yasmin has
a higher stroke risk than other oral contraceptives, which
defendant says is unreliable.
argues that the Court should exclude expert testimony on VTE
studies because plaintiff suffered from an arterial
thromboembolism (“ATE”), not a VTE, and that
because plaintiff's injury was not a VTE, any testimony
relying on VTE studies is irrelevant under Daubert.
Plaintiffs argue that their expert testimony should not be
excluded. They say that defendant never identifies which VTE
studies it seeks to exclude and that “modern
research” no longer considers ATEs and VTEs to be
separate pathophysiological entities but “that the same
biological trigger is responsible for activating clotting
pathways in veins and arteries.” Opp'n to
Daubert Mot. No. 2 at 3. In essence, what the
parties dispute is how to characterize the injury plaintiff
suffered. Defendant argues for a narrow characterization,
that plaintiff suffered an ATE and not a VTE. Plaintiffs
argue that the injury was a blood clot, which in her case led
to an ATE, but in other cases could lead to a VTE, depending
on whether the clot is located in an artery or a vein.
epidemiology expert, Dr. April Zambelli-Weiner, Ph.D.,
M.P.H., explains the difference between VTEs and ATEs in this
Thrombosis is defined as the formation of a blood clot
(thrombus) within a blood vessel which leads to the
obstruction of blood flow to vital organs and may cause
infarction [or tissue necrosis]. An embolism occurs when the
thrombus breaks away from the blood vessel wall and is
transported to other areas through circulation. Whether the
thrombosis is arterial or venous depends on the location of
the formation of a thrombus, whether it occurs in an artery
or a vein. All thrombotic and thromboembolic events (TTEs)
consist of (1) arterial thromboembolic events (ATEs) or (2)
venous thromboembolic events (VTEs).
Pls.' Ex. 8.1 (“Zambelli-Weiner Rpt.”) at 9.
says the problem is one of “fit, ” citing
Daubert. There, the Supreme Court explained that
expert testimony, among other criteria, must be
“helpful” to be admissible. 509 U.S. at 591
(citing Fed.R.Evid. 702). “This condition goes
primarily to relevance.” Id. “Rule
702's ‘helpfulness' standard requires a valid
scientific connection to the pertinent inquiry as a
precondition to admissibility.” Id. at 591-92.
In other words, in determining whether expert testimony is
admissible under the Federal Rules, the court must, in
addition to assessing “whether the reasoning or
methodology underlying the testimony is ...