Brumley v. Pfizer, Inc.

200 F.R.D. 596, 50 Fed. R. Serv. 3d 627, 2001 U.S. Dist. LEXIS 8130, 2001 WL 670057
CourtDistrict Court, S.D. Texas
DecidedJune 7, 2001
DocketNo. CIV. A. C-00-160
StatusPublished
Cited by14 cases

This text of 200 F.R.D. 596 (Brumley v. Pfizer, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Brumley v. Pfizer, Inc., 200 F.R.D. 596, 50 Fed. R. Serv. 3d 627, 2001 U.S. Dist. LEXIS 8130, 2001 WL 670057 (S.D. Tex. 2001).

Opinion

ORDER CONCERNING ADMISSIBILITY OF EXPERT WITNESS OPINIONS

JACK, District Judge.

On May 14, 2001, the Court heard evidence and argument concerning the Defendant’s motion to exclude testimony by the Plaintiffs experts. For the reasons stated below, the Court GRANTS Pfizer’s motion to exclude the expert testimony of Dr. Gerald Polukoff to the extent the testimony goes beyond the opinions stated in his Rule 26 report. The Court also GRANTS Pfizer’s unopposed motion to exclude the expert testimony of Dr. Sanjay Kaul.

I. JURISDICTION

The Court has diversity jurisdiction over this action pursuant to 28 U.S.C. § 1332.

II. FACTUAL BACKGROUND

This is a product liability action involving Viagra (sildenafil citrate), a prescription medication manufactured by Pfizer for the treatment of erectile dysfunction (ED). Dr. Jack Brackin, a medical doctor in Aransas County, Texas, prescribed Viagra to Decedent Earnest Brumley on April 28, 1998. (Brief in Support of Summary Judgment Motion at 5). Upon taking his first dose of Viagra, Mr. Brumley died on May 15,1998 of cardiac complications after having sexual intercourse. (Brief in Support of Summary Judgment Motion at 5; Exhibit A to Summary Judgment Motion at 3).

It is undisputed that at the time of his death, Mr. Brumley suffered from heart disease. He had undergone coronary artery bypass surgery. He suffered from at least twice-weekly angina attacks, for which Dr. Brackin had prescribed nitroglycerin tablets. Mr. Brumley had a history of angina during sexual intercourse. He smoked 1-1/2 to 2 packs of cigarettes daily, suffered from chronic pulmonary obstructive disease, and was obese. He also had a strong family [598]*598history of heart disease. Both Plaintiffs’ and Defendant’s experts agree that Mr. Brumley was at a high risk for a heart attack.

At the time that Dr. Brackin prescribed Viagra for Mr. Brumley, the packet insert for Viagra carried the following language:

CONTRAINDICATIONS
... Consistent with its known effects on the nitric oxide/cGMP pathway (see CLINICAL PHARMACOLOGY), Viagra was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are concurrently using organic nitrates in any form is therefore contraindicated.
PRECAUTION
General
A thorough medical history and physical examination should be undertaken to diagnose erectile dysfunction, determine potential underlying causes, and identify appropriate treatment.
There is a degree of cardiac risk associated with sexual activity; therefore, the physician may wish to consider the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction.

(Emphasis supplied). Sometime later, the wording of the contraindication was changed to specify that taking nitrates intermittently was a contraindication for Viagra.

When Dr. Brackin prescribed Viagra to Mr. Brumley, Pfizer had not yet modified the contraindication. Dr. Brackin instructed Mr. Brumley to avoid using his nitroglycerin tablets within 24 hours of taking Viagra and that if he suffered from angina during or after sexual intercourse, to go directly to the hospital. It is undisputed that angina is a symptom of coronary artery disease that occurs as a result of decreased blood flow in the coronary arteries to the heart muscle. Further, nitrates such as nitroglycerine are used to dilate the coronary arteries to increase the blood flow to the muscle and thereby decreasing the muscle pain exhibited by angina. After his first dose of Viagra, Mr. Brumley engaged in sexual intercourse and died some two hours later. An autopsy found that Mr. Brumley’s death was caused by “cardiac arrhythmia with accompanying severe ischemic cardiomyopathy.”

Plaintiffs now assert claims against Pfizer for strict liability, marketing defects, and negligent marketing. On March 15, 2001, Pfizer moved for summary judgment, arguing first, that there is no evidence that Viagra caused the death of Mr. Brumley, and second, that Pfizer provided adequate warnings as to the proper use of the drug.

In their summary judgment response, Plaintiffs offered the opinion of Dr. Gerald Polukoff that linked Viagra to cardiac risk. Dr. Polukoff had produced a Rule 26 report in February of 2001. That initial report stated that “Viagra (Sildenafil) and sexual intercourse triggered the untimely death of Mr. Earnest Brumley because Viagra (Silde-nafil) enables sexual activity in patients at increased risk to cardiovascular events and death.”

Dr. Polukoff also executed an April 5, 2001 affidavit in response to Defendant’s motion for summary judgment. That affidavit restates the opinion contained in the Rule 26 report that Mr. Brumley’s death resulted from his participation in vigorous sexual activity enabled by Viagra, but the affidavit also adds the following, previously undisclosed, opinion:

Viagra causes a marked increase in sympathetic activation. Increased sympathetic activation is associated with myocardial ischemia, myocardial infarction, malignant and fatal arrhythmias and sudden cardiac death; therefore, Mr. Brumley would have survived sex were it not for his ingestion of Viagra on the night of his death.

Pfizer moved to exclude the second opinion because it was not previously disclosed as required by Rule 26, and because the opinion did not have a valid scientific foundation. The Court held a Daubert hearing on May 14, 2001. At the hearing and during his deposition, Dr. Polukoff testified that he discerned a direct link between the use of Viagra and increased cardiac risk after reading a report authored by Brady Phillips (the “Phillips Report”). See Phillips, B.G., et al., “Sympathetic Activation by Sildenafil”, 102 [599]*599Circulation 3068-3073 (Dec.2000). Dr. Polu-koff theorized that he can “extrapolate [Phillips’] findings and apply them to our findings and our understanding that our patients with coronary artery disease are at risk for death or infarction with sexual activity, and that this risk may actually be exacerbated or heightened with common use of sildenafil.” (Polukoff Deposition at 279).

The Phillips report demonstrated that Viagra produced a rise in catecholamine levels in the volunteers who participated in his study. At the Daubert hearing, Dr. Polukoff asserted that the rise in catecholamine levels in the Phillips report “demonstrates the mechanism by which there’s people dropping dead with Viagra. It’s a sentinel paper.” Dr. Polukoff opined that catecholamines are “clearly known to alter cardiovascular outcome ... adversely.” Although he posited that the catecholamine levels in the report were elevated over levels that would be observed in people at rest, he acknowledged that they were not abnormal for someone engaged in physical activity. Importantly, he could not cite any studies nor could he identify or quantify what are normal or abnormal levels of catecholamines.

Dr.

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200 F.R.D. 596, 50 Fed. R. Serv. 3d 627, 2001 U.S. Dist. LEXIS 8130, 2001 WL 670057, Counsel Stack Legal Research, https://law.counselstack.com/opinion/brumley-v-pfizer-inc-txsd-2001.