Smith v. Wyeth-Ayerst Laboratories Co., 3:01 CV 355-V.

Page 684

278 F.Supp.2d 684

Rita Fayen SMITH, Plaintiff, v. WYETH-AYERST LABORATORIES COMPANY, Defendant.

No. 3:01 CV 355-V.

United States District Court, W.D. North Carolina, Charlotte Division.

April 17, 2003.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

Gregory M. Martin, Jones, Martin, Parris & Tessener, Raleigh, Janet Ward Black, Donaldson & Black, P.A., Greensboro, for Rita Fayen Smith, plaintiff.

Stacey Stone Bennett, Womble, Carlyle, Sandridge & Rice, Charlotte, David M. Orta, Michael A. Rubin, Arnold & Porter, Washington, DC, Mark J. Spooner, Arnold & Porter, Los Angeles, CA, Michael T. Scott, Reed, Smith LLP, Philadelphia, PA, for Wyeth-Ayerst Laboratories Company, Division of American Home Products Corporation, American Home Products Corporation, both individually & as successor-in-interest to A.H. Robins Company, Inc., defendants.

Memorandum and Order

VOORHEES, District Judge.

THIS MATTER is before the Court on the Defendant's Motions To Exclude Or Limit The Testimony Of Plaintiff's Expert Witnesses, filed August 30, 2002; Plaintiff's Motions To Exclude Expert Testimony of Drs. Steven M. Koenig, Kenneth W. Rictor, and Marta M. Kalinski, filed August 16, 2002 and August 30, 2002; and the parties' responsive memoranda and exhibits. The Court conducted an evidentiary hearing on December 4, 2002 and December 5, 2002, the focus of which was the parties' cross-motions to exclude evidence of causation. On December 10, 2002, Plaintiff conducted a de bene esse deposition of Dr. Carmine Dalto, which has been transcribed and filed with the Court for purposes of supplementing the record.

I. Background

For purposes of the pending Daubert motions, the Court will only recite the relevant facts. Plaintiff suffers from Primary Pulmonary Hypertension ("PPH"), a rare but serious lung disease that exists when there is an elevation of the pressure in the pulmonary artery.¹ Pulmonary hypertension can occur as a result of heart disease, liver disease, sleep apnea, blood clots in the lungs, sickle cell anemia, collagen vascular disease, and other causes. Pulmonary hypertension can occur idiopathically or sporadically, meaning it occurs without an identifiable cause. When there is no known cause, the disease is called "primary pulmonary hypertension" or PPH. PPH occurs in the general population at the rate of 1 to 2 cases per million annually. Women between the ages of twenty (20) and fifty (50) are considered a high risk group for the disease.

The landmark epidemiological study exploring the relationship between diet drugs and PPH is the International Primary Pulmonary Hypertension Study ("IPPHS"), published in the New England Journal of Medicine on August 29, 1996. IPPHS co-authors include Dr. Lucien Abenhaim of McGill University in Montreal, Canada; Dr. Francois Brenot of Antoine Beclere Hospital in Paris, France; and Dr. Stuart Rich of the Rush Heart-Lung Institute in Chicago, Illinois (Plaintiff's expert). The main objective of the IPPHS was to assess the role of several known or suspected risk factors in the development of PPH, including anorectic agents.² The IPPHS, a case-controlled study, considered 95 PPH cases, along with 335 physician-based control cases from France, United Kingdom, Belgium, the Netherlands, and Switzerland.

Although the exact mechanisms of action of the anorexigens in PPH have not been definitively established, the IPPHS confirmed that the use of anorexigens (or appetite suppressants) is, in fact, a risk factor for PPH.³ More specifically, the adjusted odds ratio for those exposed to at least one anorexigen prior to the onset of symptoms was 6.3 (95% CI: 3.0-13.2) if all past exposures were considered and 10.1 (95% CI: 3.4-29.9) for recent users, or those who experienced symptoms within twelve (12) months of the last exposure. For those who used anorexigens for a duration of more than 3 months, the odds ratio was 23.1 (95% CI:6.9-77.7).⁴

Between 1995 and 1997, Plaintiff Rita Smith was prescribed a combination of Pondimin⁵ (name brand for fenfluramine) and Phentermine, commonly known as "Fen-Phen," by two (2) different physicians. Plaintiff used fen-phen intermittently for a total of 8 ½ months, with her last use in April 1997.⁶ According to Plaintiff, she first experienced shortness of breath (or dyspnea), a symptom of PPH, in February of 2000. She also noticed shortness of breath when exercising in November 2000. However, Plaintiff did not seek medical treatment until April 2001. On May 18, 2001, Plaintiff was diagnosed with diet-drug induced Primary Pulmonary Hypertension ("PPH") by Dr. Dalto. At the time of her diagnosis, Plaintiff presented with systolic pulmonary pressures close to 100 mmHg and right ventricular hypertrophy.⁷ Shortly thereafter, Dr. Dalto referred Plaintiff to Duke University's Pulmonary Hypertension Clinic. On June 19, 2001, after the referral to Duke, Dr. Tapson confirmed Plaintiff's diagnosis. Plaintiff's treating physicians assisted in ruling out other potential causes and agree with this diagnosis. Defendant's expert disagrees, and opines that Plaintiff's PPH is `sporadic,' or that the cause is unidentifiable.

II. Discussion of the Law

Expert testimony is admissible under Rule 702 if it concerns (1) scientific, technical, or other specialized knowledge that (2) will aid the jury or other trier of fact to understand or resolve a fact at issue. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 592, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993); FED. R. EVID. 702. The first prong requires an examination of whether the reasoning or methodology underlying the expert's proffered opinion is reliable, while the second prong involves relevance. Id. at 590-92, 113 S.Ct. 2786. In assessing whether an expert's opinion is sufficiently reliable and relevant, the Court, as gatekeeper, conducts a flexible inquiry, focusing on the principles and methodology employed by the expert rather than the conclusions reached. Id. at 594-95, 113 S.Ct. 2786.

In determining reliability, the following factors, if applicable, should be considered: 1) whether the expert's reasoning or methodology has been or could be tested; 2) whether the expert's reasoning or methodology has been subject to peer review and publication; 3) the known or potential rate of error; 4) the level of acceptance of the expert's reasoning or methodology by the relevant professional community. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 149-50, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999); Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786. According to the Fourth Circuit, the court should be conscious of two guiding, and sometimes competing, principles.

On the one hand, the court should be mindful that Rule 702 was intended to liberalize the introduction of relevant expert evidence. Cavallo v. Star Enter., 100 F.3d 1150, 1158-59 (4th Cir.1996). And the court need not determine that the expert testimony a litigant seeks to offer into evidence is irrefutable or certainly correct. Id. As with all other admissible evidence, expert testimony is subject to being tested by "[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof." Daubert, 509 U.S. at 596, 113 S.Ct. 2786. On the other hand, the court must recognize that due to the difficulty of evaluating their testimony, expert witnesses have the potential to "be both powerful and quite misleading." Id. at 595, 113 S.Ct. 2786. And given the potential persuasiveness of expert testimony, proffered evidence that has a greater potential to mislead than to enlighten should be excluded. U.S. v. Dorsey, 45 F.3d 809, 815-16 (4th Cir.1995).

Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th Cir.1999)(emphasis added).

An expert must account for "how and why" he or she reached the challenged opinion. General Electric Co. v. Joiner, 522 U.S. 136, 144, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997). Generally, before an expert opinion on causation is allowed, the expert must be able to "take serious account of other potential causes," and offer an explanation as to why a proffered alternative was not the sole cause. Westberry, 178 F.3d at 265. However, an opinion is not deemed unreliable simply because all other potential causes cannot be excluded. Id.; Cooper v. Smith and Nephew, Inc., 259 F.3d 194, 202 (4th Cir.2001). Instead, the alternative causes suggested by a defendant normally affect the weight that the jury should give the expert's testimony and not the admissibility of that testimony. Id.

Speculation is not a reliable basis for expert opinion. Daubert, 509 U.S. at 590, 113 S.Ct. 2786. In addition, inferences are not allowed unless the inference is derived using scientific or other valid methods. Oglesby v. General Motors Corp., 190 F.3d 244, 250 (4th Cir.1999). Epidemiological data is admissible evidence on the issue of causation. However, the epidemiological data cannot support an inference that a suspected risk factor caused an injury unless:

(i) the analysis of the data is statistically significant⁸ under scientifically accepted statistical norms;

(ii) the statistical relationship is sufficiently strong to support a "more likely than not"⁹ inference; and

(iii) the data being relied upon "fits"¹⁰ the facts of plaintiff's individual case.

The proponent of expert testimony has the burden of establishing its admissibility by a preponderance of proof. Daubert, 509 U.S. at 592 n. 10, 113 S.Ct. 2786. In other words, the proponent must show that there is a reliable basis for concluding that the exposure more likely than not caused the specific harm alleged. Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1320 (9th Cir.), cert denied, 516 U.S. 869, 116 S.Ct. 189, 133 L.Ed.2d 126 (1995)("Daubert II").

III. Analysis

1. Defendant's Motion 1

Plaintiff seeks to present evidence to the jury from which one can infer that Plaintiff's use of fen-phen caused her PPH. The Defendant...