Bickel v. Pfizer, Inc.

• Decision Date: 19 May 2006
• Docket Number: No. 1:03-CV-372-TS.,1:03-CV-372-TS.
• Citation: 431 F.Supp.2d 918
• Parties: Janet BICKEL and Joseph Bickel, Plaintiffs, v. PFIZER, INC., Warner — Lambert Co., Parke — Davis, Defendants.
• Court: U.S. District Court — Northern District of Indiana

Page 918

431 F.Supp.2d 918

Janet BICKEL and Joseph Bickel, Plaintiffs, v. PFIZER, INC., Warner — Lambert Co., Parke — Davis, Defendants.

No. 1:03-CV-372-TS.

United States District Court, N.D. Indiana, Fort Wayne Division.

May 19, 2006.

Beverly H. Pace, PHV, Calvin S. Tregre, PIIV, Janet G. Abaray, PHV, Lopez Hodes Restaino Milman & Skikos, Cincinnati, OH, Richard Delaney, Bendall Delaney Hartburg Mcneely & Roth LLP, Huntington, IN, for Plaintiffs.

Mark S. Cheffo, PHV, Skadden Arps Slate Meagher & Flom LLP, New York City, J. Stephen Bennett, Baker & Daniels, Fort Wayne, IN, Thomas G. Stayton, Baker & Daniels, Indianapolis, IN, for Defendants.

OPINION AND ORDER

SPRINGMANN, District Judge.

Plaintiff Janet Bickel alleges in this product liability case that she suffered strokes of the optic nerves and partial vision impairment as a direct result of ingesting Lipitor, a cholesterol lowering statin drug. She designated Dr. Valerie A. Purvin, a neuro-ophthalmologist and one of her treating physicians, as her expert witness on medical causation. The Defendants, Pfizer, Inc., Warner-Lambert Company LLC, and Parke-Davis, have challenged the admissibility of Dr. Purvin's opinion testimony. The Defendants contend that Dr. Purvin's testimony is inadmissible under Federal Rule of Evidence 702, as interpreted by Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), and Fuesting v. Zimmer, Inc., 421 F.3d 528 (7th Cir.2005). They argue that without admissible evidence of causation, the Plaintiffs claims fail as a matter of law.

PROCEDURAL BACKGROUND

On October 3, 2003, the Plaintiffs filed their Complaint against the Defendants asserting claims for strict product liability, negligence, breach of express and implied warranty, negligent misrepresentation and fraud, negligent infliction of emotional distress, loss of consortium, and punitive damages, arising out of injuries allegedly caused by the prescription drug Lipitor. The Plaintiffs invoked the Court's federal diversity jurisdiction. On December 12, 2003, the Defendants filed their Answer.

On October 26, 2005, the Defendants moved to exclude the opinions of Dr. Valerie A. Purvin, the Plaintiffs' designated expert. On November 21, the Plaintiffs filed their memorandum in opposition to the Defendants' motion to exclude and, on December 2, the Defendants replied.

On February 1, 2006, the Defendants moved for summary judgment on all the Plaintiffs' claims, in accordance with the parties' joint scheduling order deadline for dispositive motions. The Defendants argued that summary judgment was appropriate on all the Plaintiffs' claims because they had no admissible evidence of causation. They also argued an independent basis for dismissal: the Plaintiffs could not satisfy the elements of failure to warn under the Indiana Products Liability Act (IPLA). On March 13, the Plaintiffs filed their response and on March 31 the Defendants replied.

FACTUAL BACKGROUND

Janet Bickel's primary care physician, Dr. William Webb, prescribed Lipitor to her in October 2001 for treatment of hyperlipidemia after he determined that she was not reaching her cholesterol goal on Zocor, another statin drug. Shortly after using Lipitor, the Plaintiff began experiencing body and joint pain and swelling of the eyes. In early February 2002, she called to report these symptoms to Dr. Webb, and he advised her to stop taking Lipitor.

The Plaintiff did so and her symptoms subsided. However, on March 1, 2002, she awoke from her sleep with blurriness and partial vision loss in her right eye. Dr. Harman and Dr. Walker treated her, as did Dr. Dykstra, who diagnosed her on March 19 with anterior ischemic optic neuropathy (AION). On April 4, 2002, the Plaintiff was diagnosed with bilateral AION, or AION in both eyes, after she complained of fuzziness and a strange sensation in her left eye. Dr. Dykstra referred the Plaintiff to Dr. Purvin for further examination and treatment.

Dr. Purvin saw the Plaintiff on April 16, 2002, and twice thereafter. After her first examination, Dr. Purvin wrote to Dr. Dykstra wondering if the Plaintiff had some immune complex disease or other form of vasculitis that was induced by the Lipitor and which "could perhaps have contributed to her ischemic optic neuropathy." She indicated that she would look into it further.

On May 23, 2003, Dr. Purvin provided her expert Report regarding causation. The opinions provided in this Report are the subject of the motion to exclude testimony under Federal Rule of Evidence 702.

DISCUSSION

A. Standard for Admitting Expert Testimony

For expert testimony to be admissible, it must be relevant and reliable, as required by Federal Rule of Evidence 702:

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, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.

Fed.R.Evid. 702. The Supreme Court in Daubert stated that Rule 702 required the district court to perform a "gate-keeping function" before admitting expert scientific testimony, to ensure that it is not only relevant, but reliable. 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469. The purpose of the rule in Daubert "was to make sure that when scientists testify in court they adhere to the same standards of intellectual rigor that are demanded in their professional work." Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 318 (7th Cir. 1996).

Daubert listed four factors to be considered when determining whether scientific evidence is reliable: 1) whether the theory or technique can be or has been tested; 2) whether the theory or technique has been subjected to peer review and publication; 3) whether there are standards controlling the technique's operation and its known or potential rate of error; and 4) whether the theory or technique has gained widespread acceptance in the relevant scientific community. 509 U.S. at 593-94, 113 S.Ct. 2786. Also, the 2000 Advisory Committee's Notes to Rule 702 suggest other factors to determine expert reliability, including:

(5) whether "maintenance standards and controls" exist; (6) whether the testimony relates to "matters growing naturally and directly out of research they have conducted independent of the litigation," or developed "expressly for purposes of testifying"; (7) "[w]hether the expert has unjustifiably extrapolated from an accepted premise to an unfounded conclusion"; (8) "[w]hether the expert has adequately accounted for obvious alternative explanations"; (9) "[w]hether the expert is being as careful as he would be in his regular professional work outside his paid litigation consulting"; and (10) "[w]hether the field of expertise claimed by the expert is known to reach reliable results for the type of opinion the expert would give."

Fuesting v. Zimmer, Inc., 421 F.3d 528, 534-35 (7th Cir.2005) (quoting Fed.R.Evid. 702 advisory committee's notes (2000 amendments)). The list is not exclusive, and the Supreme Court emphasized the inquiry 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. The focus, of course, must be solely on principles and methodology, not on the conclusions that they generate." Daubert, 509 U.S. at 594-95, 113 S.Ct. 2786. A witness's own training and experience may be the foundation for an expert opinion, but "the witness must explain how that experience leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and how that experience is reliably applied to the facts." Fed. R.Evid. 702 (advisory committee's notes (2000 amendments)). The burden of showing an expert's testimony to be relevant and reliable is with the proponent of the evidence. Bradley v. Brown, 852 F.Supp. 690, 697 (N.D.Ind.1994).

B. Dr. Purvin's Opinion

Dr. Purvin's expert opinion is that Lipitor, a member of the class of cholesterol lowering drugs known as statins, most likely caused the Plaintiff's AION, commonly known as a stroke of the optic nerve. She based her opinion and her May 23, 2005, Report on her review of the Plaintiff's medical records, adverse event reports from Pfizer, FDA approval package for Lipitor, Adverse Ocular Side-effects of Commonly Prescribed Systematic Medications, WHO Pharmaceuticals Newsletter No. 2, 2002, and results of a Med Line search regarding vasculitis related to the use of statin drugs.

In her Report, Dr. Purvin noted that she had diagnosed the Plaintiff with bilateral sequential non-arteritic anterior ischemic optic neuropathy (NAION) on the basis of the Plaintiff's clinical features. She stated in her Report that AION is "a relatively common condition in which the optic nerve suffers damage due to insufficient blood supply." (Report at 1.) She explained the difference, both in causes and clinical features, between arteritic and non-arteritic forms of MON. Arteritic AION is typically caused by Giant Cell Arteritis (GCA), an autoimmune disease that effects elderly people. NAION usually affects middle aged people with risk factors for hardening of the arteries. Other risk factors for NAION include a small crowded disk and a transient drop in blood pressure.

Dr. Purvin explained that it was highly atypical for patients with NAION to experience visual loss in the fellow eye in just one month, as the Plaintiff had. Usually this occurs months to years later. Therefore, Dr. Purvin considered whether the Plaintiff might have had some form of underlying vasculitis. During the months before her visual loss, the...