95 F.Supp.2d 1230 (W.D.Okl. 2000), Civ. 96-756, Hollander v. Sandoz Pharmaceuticals Corp.

Docket Nº:Civ. 96-756-T.
Citation:95 F.Supp.2d 1230
Party Name:Dee HOLLANDER and Don Hollander, Plaintiffs, v. SANDOZ PHARMACEUTICALS CORP., a New Jersey corporation, Defendant.
Case Date:March 21, 2000
Court:United States District Courts, 10th Circuit, Western District of Oklahoma
 
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95 F.Supp.2d 1230 (W.D.Okl. 2000)

Dee HOLLANDER and Don Hollander, Plaintiffs,

v.

SANDOZ PHARMACEUTICALS CORP., a New Jersey corporation, Defendant.

No. Civ. 96-756-T.

United States District Court, W.D. Oklahoma.

March 21, 2000

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James E. Frasier, James T. Price, Frasier & Frasier, Tulsa, OK, Glenn J. Shrader, Jr., Walker & Walker, Oklahoma City, OK, for plaintiffs.

Richard M. Eldridge, Thomas E. Steichen, Rhodes Hieronymus Jones Tucker & Gable, Tulsa, OK, Joe Hollingsworth, Katharine R. Latimer, Kirby T. Griffis, Spriggs & Hollingsworth, Washington, DC, for defendant.

ORDER

RALPH G. THOMPSON, District Judge.

Plaintiffs Dee Hollander and Don Hollander instituted this manufacturers products liability action against Novartis Pharmaceuticals Corporation ("NPC"), formerly know as Sandoz Pharmaceuticals Corporation, alleging that Dee Hollander suffered a stroke caused by the ingestion of Parlodel, a prescription drug formulated and sold by the defendant to prevent postpartum physiological lactation. 1 Bromocriptine mesylate ("bromocriptine") is Parlodel's active ingredient. 2

NPC has filed a motion for summary judgment on the ground the plaintiffs fail to present sufficiently reliable evidence to prove that Mrs. Hollanders stroke could be, and in fact was, caused by Parlodel. 3 The plaintiffs' evidence of causation fails the test for scientific reliability set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), the defendant contends, because their experts admit their causal hypotheses have not been tested and validated using the scientific method and they do not rule out other causes of Mrs. Hollander's stroke.

"In Daubert, the Supreme Court held district judges must act as gatekeepers in admitting expert testimony, thereby ensuring that such evidence is both relevant and reliable." Kinser v. Gehl Co., 184 F.3d 1259, 1270 (10th Cir.1999) cert. denied, 528 U.S. 1139, 120 S.Ct. 985, 145 L.Ed.2d 934 (2000). 4 Prior to Daubert, the "general acceptance" test formulated in Frye v. United States, 293 F. 1013 (D.C.Cir.1923), was the dominant standard for determining the admissibility of novel scientific evidence at trial. In Daubert the Supreme Court held that the Frye test was superseded by the adoption of the Federal Rules of Evidence. 5

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[U]nder the Rules the trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable ... The subject of an expert's testimony must be 'scientific ... knowledge.' The adjective 'scientific' implies a grounding in the methods and procedures of science. Similarly, the word 'knowledge' connotes more than subjective belief or unsupported speculation.

Daubert, 509 U.S. at 589-90, 113 S.Ct. 2786.

"Under Daubert, when faced with a proffer of expert scientific testimony, a district court 'must determine at the outset, pursuant to [Fed.R.Evid.] 104(a), whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue.' " Summers v. Missouri Pacific R.R. System, 132 F.3d 599, 603 (10th Cir.1997) (quoting Daubert, 509 U.S. at 592, 113 S.Ct. 2786). This standard ensures that the proffered evidence is not only relevant, but reliable. Scientific knowledge tests reliability, which is "verified by assessing 'whether the reasoning or methodology underlying the testimony is scientifically valid.' " Summers, 132 F.3d at 603 (quoting Daubert 509 U.S. at 592-93, 113 S.Ct. 2786). "Several nondispositive factors should be considered when measuring the reliability of a particular scientific theory or technique: whether it (1) can be and has been tested; (2) has been subjected to peer review and publication; (3) has a known or potential rate of error; and (4) has attained general acceptance in the pertinent scientific community. In considering these factors, '[t]he focus, of course, must be solely on principles and methodology, not on the conclusions that they generate.' " Id. at n. 4 (quoting Daubert, 509 U.S. at 595, 113 S.Ct. 2786) (internal citations omitted).

Relevancy is evaluated by the second element, helpfulness to the trier of fact. "Relevance is determined by ascertaining 'whether [that] reasoning or methodology properly can be applied to the facts in issue.' " Summers, 132 F.3d at 603 (quoting Daubert, 509 U.S. at 593, 113 S.Ct. 2786). "With respect to assessing relevance, 'the district court must determine whether the methodology or reasoning underlying the expert opinion relates to the issue at hand, i.e., whether it assists the trier of fact in understanding the evidence or a fact in issue. In this regard, the Daubert Court discusses the concept of "fitness," that is, whether expert testimony proffered in the case is sufficiently tied to the facts of the case that it will aid the jury in resolving a factual dispute.' " Id. at n. 5 (quoting Joiner v. General Elec. Co., 78 F.3d 524, 530 (11th Cir.1996) (internal quotation and citations omitted)). "The inquiry envisioned by Rule 702 is ... a flexible one. Its overarching subject is the scientific validity--and thus the evidentiary relevance and reliability--of the principles that underlie a proposed submission." Daubert, 509 U.S. at 594-95, 113 S.Ct. 2786.

A Daubert hearing was held to evaluate the reliability and relevance of the plaintiffs' experts' proposed testimony. Having considered the testimony and evidence introduced at the hearing, combined with that submitted by both parties in conjunction with the defendant's motion, 6

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the court concludes that the opinions of plaintiffs' expert witnesses do not meet the reliability requirements of Rule 702 as interpreted by the Supreme Court in Daubert. 7 Because the plaintiffs' expert testimony is inadmissible 8 and the requisite causation cannot be established without it, the defendant's motion for summary judgment is granted. The bases for the court's decision follow.

In their response brief, the plaintiffs summarize the evidence supporting their position that Parlodel causes strokes as: determinations by the Food and Drug Administration ("FDA") that the safety of Parlodel has not been demonstrated; 9 a finding of causation by a Kentucky jury; incidents of challenge/de-challenge/re-challenge; 10 case reports; the effects of othe ergotsr; animal studies;11

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and epidemiology studies. 12 The defendants have challenged the plaintiffs' evidence of medical causation, contending that their experts, Drs. Kulig, Iffy and Jose, (1) cannot explain how Parlodel causes vasoconstriction, which then causes hypertension and strokes; (2) improperly rely on anecdotal case reports and temporal proximity, 13 which do not constitute scientifically reliable bases for their opinions; (3) improperly reason that because some ergot alkaloids, which are in the same class as bromocriptine, cause hypertension, then bromocriptine may also cause hypertension; and (4) improperly rely on animal studies that are too different from the facts presented by this case to be reliable. Both parties cite decisions by other courts, which have either admitted or excluded expert testimony on the issue of whether Parlodel can cause strokes in postpartum women.

The court concurs with the defendant's analysis of the plaintiffs' proof. Dr. Kulig could only list "possible" mechanisms 14 for Parlodel causing hypertension, Defendant's Exhibit 1A, pp. 88-96. Dr. Jose could not cite any studies or tests that proved his hypothesis that bromocriptine might cause high blood pressure, defendant's Exhibit 3B pp. 251-252, and admitted that his opinion about the potential

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mechanism or potential effect was still only a hypothesis, as opposed to scientific knowledge. Id. p. 253. 15 Dr. Iffy also classified his opinion that Parlodel caused Mrs. Hollander's stroke as being a hypothesis, which "is not held by a medical degree of certainty." Defendant's exhibit 2A pp. 17-19. The doctor's responses, when asked what evidence he was relying on for his opinion, further undermined the reliability of his testimony. Id. at pp. 20-31. For example, he stated that some animal studies bolstered his opinion that Parlodel causes vasospasm, "[b]ecause I noted that there was some demonstration of such an effect." He admitted, however, that the study did not conclude that Parlodel causes vasospasm, but merely "presented some suggestive evidence." Id. p. 27. 16

Contrary to the plaintiffs' assertion, their experts do not rely on epidemiological studies 17 to support their position that Parlodel causes strokes. Although several studies have been conducted regarding the relationship between Parlodel and stroke, 18 none has shown a statistically significant link between them. Dr. Kulig testified that in his opinion the ERI study is the only epidemiology study on Parlodel use in the postpartum period, and he concurred with Drs. Iffy and Jose that, standing alone, it does not establish that Parlodel causes stroke. Defendant's exhibits 1A, p. 108-109; 2A, pp. 146-47. See defendant's exhibit 3A, p. 53-54. The ERI Report was based on two simultaneous case-control studies...

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