Globetti v. Sandoz Pharmaceuticals, Corp., CV-98-TMP-2649-S.

• Decision Date: 06 September 2000
• Docket Number: No. CV-98-TMP-2649-S.,CV-98-TMP-2649-S.
• Citation: 111 F.Supp.2d 1174
• Parties: Melissa GLOBETTI and, Mark Globetti, Plaintiffs, v. SANDOZ PHARMACEUTICALS, CORPORATION, Defendant.
• Court: U.S. District Court — Northern District of Alabama

111 F.Supp.2d 1174

Melissa GLOBETTI and, Mark Globetti, Plaintiffs, v. SANDOZ PHARMACEUTICALS, CORPORATION, Defendant.

No. CV-98-TMP-2649-S.

United States District Court, N.D. Alabama, Southern Division.

September 6, 2000.

Richard R. Rosenthal, Garrison Scott Gamble & Rosenthal PC, Birmingham, AL, Denise M. Dunleavy, Ellen Relkin, Richard S. McGowan, Catherine T. Heacox, Paul J. Pennock, Jerry M. Kristal, Jill L. Mandell, Weitz & Luxenberg PC, New York City, for Plaintiffs.

Joe G. Hollingsworth, Katherine Latimer, Bruce J. Berger, William J. Cople Serena Viswanathan, Scott S. Thomas, Spriggs & Hollingsworth, Washington, DC, Edward S. Sledge, III, Archibald T. Reeves, IV, McDowell Knight Roedder & Sledge LLC, Mobile, AL, Jeffrey A. Peck, Shanley & Fisher, Morristown, NJ, for Defendants.

ORDER DENYING SUMMARY JUDGMENT

PUTNAM, Chief United States Magistrate Judge.

Before the court is the defendant's¹ motion for summary judgment on medical causation, filed July 15, 1999, on which the court conducted a Daubert hearing in December 1999.² The parties have filed extensive briefs and voluminous exhibits dealing with whether the proposed opinions of plaintiffs' expert witnesses that Melissa Globetti's myocardial infarction was caused by ingestion of Parlodel are scientifically reliable under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), and cases following it. After hearing the testimony of many imminent experts and after having struggled through much of the scientific literature offered by the parties, the court concludes that the expert opinions are scientifically reliable and, consequently, defendant's motion for summary judgment on the ground that plaintiffs cannot establish the necessary causal link between the acute myocardial infarction (AMI) and Parlodel is due to be denied.

Factual and Procedural Background

The court does not aim to write extensively about the mounds of scientific evidence presented by the parties, but a clear picture emerges from the briefs, evidence, and testimony considered by the court. In 1993, Melissa Globetti was 33 years old and pregnant with her sixth child. Her health was good. She had no known risk factors for coronary disease; she had no family history of heart disease, was not a smoker, was not overweight, was relatively young, and had very low (indeed, "protective") cholesterol levels.³ Neither during the pregnancy nor the delivery did she experience any hypertension, and she had no history of high blood pressure. After giving birth, she decided not to breast feed, so, pursuant to a standing order of her obstetrician for non-breast feeding mothers, she was given 2.5 mg of Parlodel,⁴ twice daily for fourteen days, to suppress lactation. Mrs. Globetti had taken Parlodel before in connection with some or all of her five prior deliveries.

On the fifth or sixth day after delivery, Mrs. Globetti began to experience chest pain and was rushed to the emergency room of the local hospital in Talladega. Ultimately it was found that she had suffered an acute myocardial infarction of the anterior wall of her left ventricle. Angiography failed to reveal any thrombus, dissection, or occlusion of the coronary artery that could explain the AMI, and her initial cardiologist, Dr, Watford, concluded that it had been caused by a spasm of the coronary artery. Although Dr. Watford noted the possible association between Parlodel and the AMI and advised her to avoid it and other medications known to have vasoconstrictive effects, he expressed the opinion that the spasm was simply spontaneous. Mrs. Globetti's current treating cardiologists, Drs. Finney and Cox, as well as plaintiffs' retained experts, Drs. Waller and Kulig, all now express the opinion that the Parlodel caused or contributed to the arterial spasm that caused her AMI. It is this basic causation opinion that is at the center of the Daubert challenge underlying the motion for summary judgment.

The defendant argues in support of the motion that the plaintiffs' experts' opinion on causation is scientifically unreliable under Daubert and, therefore, must be stricken. In the absence of testimony establishing a causal link between Mrs. Globetti's AMI and the use of Parlodel, plaintiffs' cause of action would fail and defendant would be entitled to summary judgment. Sandoz contends that, absent a scientifically appropriate epidemiological study showing an increased risk of AMI associated with Parlodel use, plaintiffs' experts' opinion is nothing more than their unscientific speculation. Plaintiffs counter that, although there is no epidemiological study dealing with the effects of Parlodel on AMIs, there is an abundance of other scientifically reliable evidence from which a well-reasoned opinion that Parlodel can cause vasoconstriction severe enough to cause an AMI can be drawn. This evidence includes animal studies, case reports, Adverse Drug Reaction reports (ADRs) to the Food and Drug Administration, and the generally accepted notion in the medical community that Parlodel is a risk factor for AMI because of its vasoconstrictive effects.

The Law of Daubert

In Daubert the United Supreme Court rejected the argument that the standard for determining the admissibility of scientific opinion testimony was the "generally accepted in the relevant scientific community" test originating in Frye v. United States, 54 App. D.C. 46, 293 F. 1013 (1923). Rather, the Court held that Federal Rule of Evidence 702, promulgated in 1976, supplanted the Frye standard with a more "flexible" approach. The Court described the old Frye test as "austere," "rigid," and "uncompromising" and signaled with Daubert (later reiterated in Kumho Tire Company, Ltd. v. Carmichael, 526 U.S. 137, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999)) a more practical and flexible approach to assessing whether a proposed expert opinion has sufficient evidentiary reliability⁵ that the fact-finder should be allowed to consider it. While it is true that the Court listed four "factors" for measuring reliability,⁶ it made clear, both in Daubert and Kumho Tire, that these were neither exclusive nor exhaustive and that it remains for the trial court to determine what procedures and tools are necessary for it to analyze the "trustworthiness" of the expert's opinion. The "gatekeeping" role of the trial court requires flexibility and a practical recognition of what can be known and how it is known. If scientific methodologies can validate certain facts, scientifically reasonable inferences drawn from those facts are admissible.⁷ Daubert did not erect insurmountable obstacles to the admissibility of expert opinion evidence; rather, it simply holds that before expert-opinion evidence should be allowed, the opinion should be based on "good grounds," that is, "supported by appropriate validation — i.e `good grounds,' based on what is known." Daubert, 509 U.S. at 590, 113 S.Ct. 2786. The point of the gatekeeping role is to separate opinion evidence based on "good grounds" from simple subjective speculation masquerading as scientific knowledge.

The assessment process, that is, the process of examining whether "good grounds" exist, focuses on the methodologies the witness used to reach the opinion he or she will express, not the scientific correctness of the opinion. It is not part of the trial judge's gatekeeping role to determine whether the proffered opinion is scientifically correct or certain in the way one might think of the law of gravity. The gatekeeping role is addressed to mere evidentiary admissibility; it is the fact-finder's role (usually a jury) to determine whether the opinion is correct or worthy of credence. For the trial court to overreach in the gatekeeping function and determine whether the opinion evidence is correct or worthy of credence is to usurp the jury's right to decide the facts of the case. All the trial judge is asked to decide is whether the proffered evidence is based on "good grounds" tied to the scientific method.

Application of Daubert in this Case

The court is satisfied that the proffered opinion — that Melissa Globetti's AMI was caused by an arterial spasm arising from the vasoconstrictive effects of the Parlodel she was taking — is based on "good grounds" tied to the scientific method and that it possesses sufficient evidentiary reliability (that is, trustworthiness) that a jury should be allowed to consider it in the determination of the facts of this case.⁸ In the words of Daubert, that opinion is an idea inferred from such facts as are scientifically known and established through appropriate scientific methodologies.

In the case of at least Drs. Finney, Cox, and Waller, the methodology used to lead them to this conclusion is the differential diagnosis, a well-recognized and widely-used technique relied upon by medical clinicians worldwide to identify and isolate the causes of disease so that they may be treated. The differential diagnosis calls for the physician to list the known possible causes of a disease or condition, usually from most likely to least likely. Then, utilizing diagnostic tests, the physician attempts to eliminate causes from the list until he is left with the most likely cause. These diagnostic tests may include physical examination, medical history, testing of blood and other bodily fluids, X-rays, CT scans, MRIs, and any of a host of generally accepted techniques for eliminating or "falsifying" a hypothesis that the disease arose from a particular listed cause. In Mrs. Globetti's case these testing techniques included physical examination, family and medical history, coronary enzyme tests, X-ray, angiography, and an echocardiagram. All of the tests performed on Mrs. Globetti are well-recognized and scientifically accepted techniques for confirming or eliminating particular causes for her AMI. Ultimately, following the protocol of a differential diagnosis, her physicians were able to...