Glastetter v. Novartis Pharmaceuticals Corp.

Decision Date14 August 2000
Docket NumberNo. 1:97CV00131ERW.,1:97CV00131ERW.
Citation107 F.Supp.2d 1015
PartiesTina M. GLASTETTER and Steven J. Glastetter, Plaintiffs, v. NOVARTIS PHARMACEUTICALS CORP., Defendant.
CourtU.S. District Court — Eastern District of Missouri

Ellen Relkin, Richard S. McGowan, Catherine T. Heacox, Jill L. Mandell, Denise M. Dunleavy, Weitz and Luxenberg, New York, NY, Martin L. Perron, Perron Law Firm, St. Louis, MO, for Tina M. Glastetter, Steven J. Glastetter.

Deirdre C. Gallagher, Steven P. Sanders, Sr., Armstrong Teasdale, LLP, St. Louis, MO, Joe G. Hollingsworth, Katharine R. Latimer, Rona Endlich, Gary I. Rubin, C. Robert Manor, Manuel S. Varela, Spriggs and Hollingsworth, Washington, DC, for Novartis Pharmaceuticals Corp.

Steven P. Sanders, Sr., Armstrong Teasdale, LLP, St. Louis, MO, Grant J. Esposito, Mayer and Brown, New York, NY, for Novartis AG.

Richard D. Watters, Judith C. Brostron, Lashly and Baer, P.C., St. Louis, MO, for Southeast Missouri Hosp.

AMENDED MEMORANDUM AND ORDER

WEBBER, District Judge.

This matter is before the Court following a Daubert hearing upon defendant's Motion in Limine to Exclude Plaintiffs' Experts [Document # 170] and defendant's Motion for Summary Judgment [Document # 211]. In both motions, defendant challenges the qualifications of plaintiffs' experts on causation, Dr. Kenneth Kulig and Dr. Denis Petro. Defendant claims that both experts must be excluded, because they do not meet the test of scientific reliability set forth by the Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). If such experts are excluded, defendant claims, plaintiffs' case must fail, because plaintiffs will be unable to present any evidence of causation in this case. In addition, defendant argues that it is entitled to partial summary judgment on plaintiffs' failure to warn claim due to the learned intermediary doctrine. Finally, defendant claims that plaintiffs' claim for punitive damages must fail on the facts of this case. Having considered the arguments advanced by the parties at the hearing, the Court concludes that defendant is entitled to summary judgment, because plaintiffs' evidence of causation fails the test for scientific reliability set forth in Daubert.

I. STANDARDS GOVERNING MOTIONS FOR SUMMARY JUDGMENT.

While defendant styled its initial motion with respect to plaintiffs' experts as a Motion in Limine, defendant seeks summary judgment in the event that its Motion in Limine is granted. Thus, the Court will undertake its analysis in this matter under the standards governing motions for summary judgment. The standards applicable to summary judgment motions are well settled. Pursuant to Federal Rule of Civil Procedure 56(c), a court may grant a motion for summary judgment if all of the information before the court shows "there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law." See Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). The United States Supreme Court has noted that "[s]ummary judgment procedure is properly regarded not as a disfavored procedural shortcut, but rather as an integral part of the federal rules as a whole, which are designed to `secure the just, speedy and inexpensive determination of every action.'" Id. at 327, 106 S.Ct. 2548 (quoting Fed.R.Civ.P. 1).

In order to obtain summary judgment, the moving party must demonstrate "an absence of evidence to support the non-moving party's case." Celotex, 477 U.S. at 325, 106 S.Ct. 2548. Once the moving party carries this burden, the nonmoving party must "do more than simply show there is some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). The non-moving party may not rest on allegations or denials in the pleadings, but "come forward with `specific facts showing that there is a genuine issue for trial.'" Id. at 587, 106 S.Ct. 1348 (quoting Fed. R.Civ.P. 56(3)).

In analyzing summary judgment motions, the Court is required to view the facts in a light most favorable to the nonmoving party, and must give the non-moving party the benefit of any inferences that can logically be drawn from those facts. Matsushita, 475 U.S. at 587, 106 S.Ct. 1348; Buller v. Buechler, 706 F.2d 844, 846 (8th Cir.1983). Moreover, this Court is required to resolve all conflicts in favor of the non-moving party. Robert Johnson Grain Co. v. Chemical Interchange Co., 541 F.2d 207, 210 (8th Cir.1976). The trial court may not consider the credibility of the witnesses or weigh the evidence. White v. Pence, 961 F.2d 776, 779 (8th Cir.1992).

II. DISCUSSION.

This case concerns the use of a drug called Parlodel, which has been utilized in the past by some women, like plaintiff Tina Glastetter (Glastetter), for the prevention of postpartum physiological lactation. The plaintiffs in this action, Glastetter and her husband, Steven Glastetter, bring this product liability action against defendant Novartis Pharmaceuticals Corporation ("NPC"), formerly known as Sandoz Pharmaceuticals Corporation, alleging that Glastetter suffered an intracerebral hemorrhage following her ingestion of Parlodel. Glastetter delivered a child on August 2, 1993. On day 13 of a 14-day course of Parlodel drug therapy, she became symptomatic and on August 17, 1993, she was taken to a hospital where she was diagnosed with an intracerebral hemorrhage. Glastetter was 36 years old at the time of this second cesarian section delivery. Bromocriptine mesylate ("bromocriptine") is Parlodel's active ingredient. Plaintiffs will attempt to establish that Parlodel caused the injury at issue in this case through the testimony of expert witnesses.

At this time, defendant has presented the issue of these witnesses' qualifications to testify under the standards set forth by the Supreme Court in the case of Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Defendant argues in both its motions that plaintiffs have failed to come forward with sufficient reliable evidence to demonstrate that Glastetter's intracerebral hemorrhage ("ICH") could be and was caused by defendant's drug Parlodel. Defendant claims that plaintiffs' experts admit that their hypotheses have not been tested and validated using the scientific method and that there is no epidemiological evidence supporting their theories. In addition, defendant claims that plaintiffs' experts admit that they rely upon evidence such as case reports, temporal proximity, animal studies, and inferences based on other drugs to support their hypotheses. Defendant claims such evidence fails under the requirements of Daubert. Also, defendant argues that plaintiffs' experts have no reliable means of ruling out other possible causes of the ICH at issue in this case.

In Daubert, the United States Supreme Court confronted the issue of the proper standard for evaluation of expert testimony by trial judges in light of Federal Rule of Evidence 702. In Daubert, the Supreme Court began by noting that Rule 702 superceded the Frye test, which required courts to exclude all "expert" evidence that was not derived from generally accepted principles or theories. See Jaurequi v. Carter Manuf. Co., Inc., 173 F.3d 1076, 1081 (8th Cir.1999) (citing Frye v. United States, 293 F. 1013 (D.C.Cir.1923) and Daubert, 509 U.S. at 586, 588-89, 113 S.Ct. 2786). Rule 702 provides as follows:

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.

While the Supreme Court found that Rule 702 altered the Frye test in that "general acceptance" was no longer an "absolute prerequisite to admissibility," the Court "emphasized that trial courts must still screen proffered expert testimony for relevance and reliability." Jaurequi, 173 F.3d at 1081 (citing Daubert, 509 U.S. at 588-89, 113 S.Ct. 2786). The Court noted that the adjective "scientific" in Rule 702 "implies a grounding in the methods and procedures of science" while the word "knowledge" "connotes more than subjective belief or unsupported speculation." Daubert, 509 U.S. at 589-90, 113 S.Ct. 2786.

After setting forth this interpretation of Rule 702, the Supreme Court focused much of the remainder of its opinion in Daubert to the issue of how a trial court should determine the reliability of scientific "expert" testimony. Jaurequi, 173 F.3d at 1081-82.1 The Court noted that in determining whether proposed evidence is valid, trial courts should consider the following factors: (1) whether the underlying theory or technique can or has been tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether the technique has a known or knowable rate of error; and (4) whether the theory or technique is generally accepted in the relevant community. Id. (citing Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786). However, the Court made clear that these four factors are not exclusive, and that the trial court has flexibility in adapting its analysis to the particular facts of the case before it. Id. (citing Daubert, 509 U.S. at 594-95, 113 S.Ct. 2786).2 In General Elec. Co. v. Joiner, 522 U.S. 136, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997), the Supreme Court made clear that rulings on the admissibility of evidence pursuant to Rule 702 under these principles are entrusted to the discretion of the trial court. In addition, in Kumho Tire Co., 526 U.S. at 152, 119 S.Ct. 1167, the Court emphasized the importance of the trial judge's gatekeeping role in analyzing proffered testimony of experts.

The Supreme Court decisions involving Federal Rule of Evidence 702 make clear that in...

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