Siharath v. Sandoz Pharmaceuticals Corp.

131 F.Supp.2d 1347

Bridget Guthrie SIHARATH, Plaintiff, v. SANDOZ PHARMACEUTICALS CORPORATION, Defendant.

Bonnie Joyce Rider and Walter Anthony Rider, Plaintiffs, v. Sandoz Pharmaceuticals Corporation, a Delaware Corporation, Sandoz Ltd., a Swiss Corporation, and Sandoz Pharma Ltd., a Swiss Corporation, Defendants.

No. CIV.A.195-CV-965TWT.

No. CIV.A.195-CV-3068TWT.

United States District Court, N.D. Georgia, Atlanta Division.

March 1, 2001.

Hubert E. Hamilton, III, The Hamilton Firm, Rossville, GA, Andrew W. Hutton, Hutton & Hutton, Wichita, KS, Edward H. Kellogg, Jr., Steven W. Saccoccia, Daniel Wayne Sigelman, Kellogg Saccoccia & Sigelman, Atlanta, GA, for Plaintiff in No. 1:95cv00965.

Joe G. Hollingsworth, Katharine R. Latimer, William J. Cople III, Scott S. Thomas, Spriggs & Hollingsworth, Washington, DC, for Sandoz Pharmaceuticals Corporation in Nos. 1:95cv00965 and 1:95cv03068.

Lawrence J. Myers, Smith Helms Mulliss & Moore, Atlanta, GA, for Defendants in No. 1:95cv03068.

Lawrence J. Myers, Smith Helms Mulliss & Moore, Atlanta, GA, for Sandoz Pharmaceuticals Corporation in 1:95cv00965.

Andrew W. Hutton, Hutton & Hutton, Wichita, KS, Edward H. Kellogg, Jr., Kellogg Saccoccia & Sigelman, Atlanta, GA, Douglas Richard Powell, Hinton & Powell, Atlanta, GA, Steven W. Saccoccia, Kellogg Saccoccia & Sigelman, Atlanta, GA, Alan Yale Saltzman, Montlick & Associates, Atlanta, GA, Daniel Wayne Sigelman, Kellogg Saccoccia & Sigelman, Atlanta, GA, for Plaintiff in No.1:95cv03068.

Dennis P. Orr, Grant J. Esposito, Mayer Brown & Platt, New York City, for Sandoz

Ltd. and Sandoz Pharma Ltd., No. 1:95cv03068.

ORDER

THRASH, District Judge.

These are two complex products liability actions. In each case, a postpartum woman suffered a stroke after taking a prescription drug manufactured by the Defendant. In its simplest form, the question presented is did the drug cause the strokes? Or, is the temporal association of taking the drug and a subsequent stroke merely coincidental? To begin to answer those questions, the Court must address the recurring issue of what is the quantity and quality of scientific evidence that a plaintiff must present on the issue of medical causation in a world of imperfect scientific knowledge.

Although the cases have not been consolidated, the motions and documentary evidence filed, the expert testimony, and the issues raised are identical in both cases. Consequently, the Court addresses the pending motions of both cases in this single Order. Siharath v. Sandoz Pharmaceuticals Corporation, No. 1:95-CV-965-TWT, ("Siharath") is before the Court on Defendant's Motion to Exclude and for Summary Judgment on Issues of Medical Causation Under Daubert v. Merrell Dow Pharmaceuticals, Inc. [Doc. 68]. Rider v. Sandoz Pharmaceuticals Corporation, No. 1:95-CV-3068-TWT, ("Rider") is likewise before the Court on Defendant's Motion to Exclude and for Summary Judgment on Issues of Medical Causation Under Daubert v. Merrell Dow Pharmaceuticals, Inc. [Doc. 116].

I. BACKGROUND

Parlodel® is manufactured by Defendant Sandoz Pharmaceuticals Corporation —now Novartis Pharmaceuticals Corporation.¹ In 1980, the drug was approved for use to suppress postpartum lactation. Approximately 9 million women in the United States have taken the drug to suppress postpartum lactation. On September 20, 1989, Plaintiff Bridget Guthrie Siharath gave birth by Caesarean section to her second child. At the time, she was 17 years-old. She was unable to breast feed the child because she had taken pain medication. To suppress lactation, her doctor prescribed Parlodel®. Ms. Siharath took regular doses of Parlodel® from the evening of September 20, 1989, until the morning of September 25, 1989. Later in the day on September 25, Ms. Siharath suffered three seizures and a subarachnoid hemorrhagic stroke. Her treating physicians were unable to diagnose the cause of the seizures or the stroke. No unusual trauma resulted from the Caesarean section. There was no indication that she suffered from eclampsia, a toxic blood condition associated with pregnancy that causes seizures and sometimes coma. Ms. Siharath did not smoke. Although she did have a history of suffering migraine headaches, no evidence existed that her migraine history was related to the stroke. Her treating physicians also could not say that Ms. Siharath's stroke was caused by the spasm or constriction of the arteries and veins ("vasospasm" and "vasoconstriction" respectively). While taking Parlodel®, Ms. Siharath regularly ingested pseudoephedrine, a nasal decongestant. It is possible that pseudoephedrine can react with ergot alkaloids, the class of drugs of which Parlodel® is a member. Pseudoephedrine taken at minimal doses, however, is unlikely alone to cause hemorrhagic strokes. Ms. Siharath was hospitalized from September 25 to October 7, 1989. On March 10, 1995, she filed this pharmaceutical products liability action in negligence and strict liability, alleging that Parlodel® caused her seizures and stroke. She seeks compensatory and punitive damages.²

Plaintiff Bonnie Joyce Rider gave birth to a daughter on December 2, 1993. The child was delivered by Caesarean section. At the time, Ms. Rider was 39 years old. On December 5, she was prescribed Parlodel® to suppress lactation. She took the medicine from then until December 8, 1993. On December 9, 1993, Ms. Rider began having difficulty moving her right leg and arm. She was admitted to the hospital with complaints of abrupt onset of headache and weakness of the right leg and arm. During her hospitalization, Ms. Rider intermittently complained of involuntary jerking movements of the right leg. Ms. Rider was given a computerized tomography ("CT") scan, which revealed that she had suffered an acute intracranial hemorrhagic stroke. A magnetic resonance imaging ("MRI") performed the following day confirmed that she had suffered a left parietal hemorrhage. No unusual trauma occurred as a result of the Caesarean section, and there was no indication that Ms. Rider suffered from eclampsia. Ms. Rider had smoked at various times, but no evidence suggested that smoking alone had caused the stroke. Her doctor concluded that her stroke was caused by vasospasm. On November 28, 1995, she and her husband, Walter Anthony Rider, filed this pharmaceutical products liability action in negligence and strict liability, alleging that Parlodel® caused her seizures and stroke. The Riders seek compensatory and punitive damages.³

After a preliminary review of the voluminous record, the Court held a status conference on August 2, 2000, and at that time granted Defendant's request for an evidentiary hearing on its Daubert objections to Plaintiffs' expert testimony on medical causation. Each side was given five hours for direct and cross examination of witnesses and one hour for argument.⁴ The Court on December 18-20, 2000, held a three-day Daubert hearing at which it heard evidence and argument from both sides regarding medical causation. At the hearing, Plaintiffs presented testimony from two of their experts, Dr. Maurice N.G. Dukes and Dr. Kenneth Kulig. Defendant presented testimony from three of its experts, Dr. James Martin, Dr. Karl Engelman and Dr. David Buchholz. Both sides took full advantage of the opportunity to cross examine the other side's experts. In addition to the Daubert hearing, the Court has reviewed the massive volume of documentary evidence (in all, about 575 exhibits, depositions and affidavits) that relates to Plaintiffs' expert testimony on medical causation. The Court's ruling is based on both the testimony from the Daubert hearing and the substantial documentary evidence in the record.

II. SUMMARY JUDGMENT STANDARD

Summary judgment is appropriate only when the pleadings, depositions, and affidavits submitted by the parties show that no genuine issue of material fact exists and that the movant is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c). The court should view the evidence and any inferences that may be drawn in light most favorable to the nonmovant. Adickes v. S.H. Kress and Co., 398 U.S. 144, 158-159, 90 S.Ct. 1598, 26 L.Ed.2d 142 (1970). The party seeking summary judgment must first identify grounds that show the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323-24, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). The burden then shifts to the nonmovant, who must go beyond the pleadings and present affirmative evidence to show that a genuine issue of material fact does exist. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 257, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

III. DISCUSSION

A. INTRODUCTION

Defendant contends that Plaintiffs' experts must be excluded from testifying in this case on the grounds that their expert testimony on medical causation is inadmissible. Expert testimony is admissible only if it satisfies the standards that the United States Supreme Court articulated in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 594, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993); accord General Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997); Kumho Tire Co. v. Carmichael, 526 U.S. 137, 141, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999). The Supreme Court in Daubert explained that Federal Rule of Evidence 702 allows the admission of expert testimony only if: (1) the expert is competent and qualified to testify regarding the matters that he intends to address; (2) the methodology by which the expert reaches his conclusions is sufficiently reliable; and (3) the expert, through scientific, technical or specialized expertise, provides testimony that assists the trier of fact to understand the evidence or determine a fact in issue. Daubert, 509 U.S. at 590-91, 113 S.Ct. 2786; accord Allison v. McGhan Med. Corp., 184 F.3d 1300, 1309 (11th Cir.1999); City of Tuscaloosa v. Harcros Chemicals, Inc., 158 F.3d 548, 562 (11th Cir.1998).

The first element...