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Galinis v. Bayer Corp.

United States District Court, N.D. California

June 28, 2019

SUSAN GALINIS, et al., Plaintiffs,
BAYER CORPORATION, et al., Defendants.



         This 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”).[1] 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.


         In 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.[2] 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 121:9-13.[3]

         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.[4] Such use of Yasmin was an “off-label” but standard use of the drug.[5]

         Luciani 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.

         On June 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.


         I. Daubert Motions

         “[T]he 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.

         II. Summary Judgment

         Summary 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.

         Once 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 (1986).

         In 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).

         The 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 (1938).


         I. Daubert Motions

         Defendant has filed two motions to exclude expert testimony under Daubert.

         A. Motion to Exclude Testimony of Dr. Luciani (Dkt. No. 57)

         Defendant 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.

         Dr. 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.

         The 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, [6] 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.[7] 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.

         B. 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)

         Defendant's 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.

         1. VTE Studies

         Defendant 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.

         Plaintiffs' epidemiology expert, Dr. April Zambelli-Weiner, Ph.D., M.P.H., explains the difference between VTEs and ATEs in this way:

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.

         Defendant 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 ...

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