In re Viagra Products Liability Litigation

658 F. Supp. 2d 936, 2009 WL 2899889
District Court, D. Minnesota·Decided August 19, 2009·No. MDL No. 06-1724(PAM)·Published·Cited by 6 cases

Opinion

ORDER

PAUL A. MAGNUSON, District Judge.

This matter is before the Court on Defendant Pfizer, Inc.’s Motion to Exclude the Testimony of Gerald McGwin, Ph.D. and on Plaintiffs’ Motion for Leave to File a Supplemental Expert Report of Gerald McGwin, Ph.D. For the reasons that follow, Pfizer’s Motion is GRANTED and Plaintiffs’ Motion is DENIED.

BACKGROUND

Plaintiffs are suing Pfizer because they allege that one of Pfizer’s drugs, Viagra, caused them to suffer vision loss from a disorder known as non-arteritic anterior ischemic optic neuropathy (“NAION”). Plaintiffs’ sole remaining general causation expert is Dr. Gerald McGwin. Dr. McGwin was the principle author of a study published by the British Journal of Ophthalmology (the “Journal”) in February 2006, entitled Non-Arteric Ischaemic Optic Neuropathy and the Treatment of Erectile Dysfunction (the “McGwin Study”).1

In order to conduct the McGwin Study, 38 patients from the University of Alabama at Birmingham (“UAB”) ophthalmology clinic that had been diagnosed with NAION were age-matched with 38 patients who had not been diagnosed with NAION. Trained UAB researchers asked via telephone the 76 patients a series of questions regarding the patients’ medical history, personal background, and health information. The patients were asked whether they ever taken Viagra or Cialis,2 and if so, when they first took the drug. The telephone survey conductors wrote the patients’ responses to the questions on survey forms. The information from the telephone surveys was consolidated into an electronic dataset. Dr. McGwin used the electronic dataset to conduct the study. Prior to publishing his study, Dr. McGwin did not compare the information from the [940]*940original survey forms to the electronic dataset.

The McGwin Study found that men with a history of myocardial infarction and Viagra/Cialis use had a statistically significant increased risk of suffering from NAION, and that men with hypertension and Viagra/Cialis use had a non-statistically significant increased risk of suffering NAION. Dr. McGwin submitted an expert report in this litigation offering his opinion that Viagra use could cause NAION. In May 2007 Pfizer subpoenaed the underlying documents and data for the McGwin Study. After deposing Dr. McGwin about his opinion in June 2007, Pfizer filed a motion challenging the reliability of Dr. McGwin’s general causation opinion. While that Motion was under advisement with the Court, Plaintiffs filed a new affidavit by Dr. McGwin without asking leave of the Court to do so. Over Pfizer’s objection, the Court considered Dr. McGwin’s untimely affidavit, but granted Pfizer permission to conduct further discovery of Dr. McGwin regarding the affidavit. The Court denied Pfizer’s Dauberb challenge to Dr. McGwin, largely because “the McGwin et al. and Margo et al. studies were peer-reviewed, published, contain[ed] known rates of error, and resulted] from generally accepted epidemiologic research.” In re Viagra Products Liab. Litig., 572 F.Supp.2d 1071, 1081 (2008). The Court further found that “[t]he fact that the data appear not to result from post-litigation research further establishes its reliability for general-causation purposes on a Daubert Motion.” Id. at 1081-82.

In May 2008 Pfizer again subpoenaed all of the underlying documents and data for the McGwin Study. It is undisputed that Dr. McGwin was one of the parties responsible for gathering and producing those documents in response to Pfizer’s request. The deadline for filing a supplement to Dr. McGwin’s expert report passed in November 2008 without Plaintiffs filing a supplement. Pfizer deposed Dr. McGwin for the second time in December 2008. At that deposition Pfizer raised issues with the McGwin Study as published, including discrepancies it found between information on the original survey forms and the electronic dataset that Dr. McGwin used to conduct the study. For example, Pfizer pointed to a number of patients that reported their first use of Viagra or Cialis as occurring after their diagnosis for NAION. However, in the electronic dataset that Dr. McGwin used, those patients were coded as “exposed,” meaning they were coded as having taken Viagra or Cialis prior to their NAION diagnoses. At the same deposition, Plaintiffs raised the possibility that someone from UAB may have recontacted study participants and updated some of the information that was originally provided, specifically the dates of first use.

Shortly after the second deposition of Dr. McGwin, Pfizer requested to conduct additional discovery of Dr. McGwin and UAB. Pfizer also moved for a further Daubert hearing regarding Dr. McGwin. The Court granted Pfizer’s motion for additional discovery. In March 2009 Pfizer subpoenaed from Dr. McGwin any reanalysis he had conducted of the data or statistics in the McGwin Study, but Dr. McGwin did not produce anything. UAB did produce some documents that were found in the files of Irene Xie, the statistician in charge of the McGwin Study. Later that month, Pfizer conducted its third deposition of Dr. McGwin. At the time of his third deposition, Dr. McGwin still had not conducted a reanalysis of any of the data or statistics in the McGwin Study. Dr. McGwin said that he had not done so at least in part at the direction of Plaintiffs’ counsel:

A. [A]t the time after I realized that having run age, I should likely check to see whether I should be [941]*941checking all the numbers in this paper, I was told that I should not do that at the present time — or at that time.
Q. Who told you not to do that?
A. It was in consultation with Mr. Overholtz and Jason Richards.

(McGwin 3/24/09 Dep. at 627.)

Just one week after this deposition, Dr. McGwin requested UAB’s permission to conduct a reanalysis of the data from his study. A month and a half later, UAB produced to Pfizer a copy of a letter that Dr. McGwin sent to the Journal detailing his reanalysis (the “Letter”). The Letter noted that “several aspects of [the] manuscript require[d] modification.” (Pis.’ Opp’n Mem., Ex. B at 1.) Ultimately, Dr. McGwin concluded in the Letter that “the results presented [in the Letter] are consistent with those in our original manuscript with the exception that any increased risk appears to be limited to Viagra.” (Id. at 2.) More than one month after UAB produced the Letter to Pfizer and just three weeks prior to the hearing on Pfizer’s multitude of Motions,3 Plaintiffs provided a copy of the Letter to Pfizer at the same time they moved to file a supplement to Dr. McGwin’s expert report based on Dr. McGwin’s reanalysis. The Journal has referred the Letter and questions about Dr. McGwin’s reanalysis of the data to the Committee on Publication Ethics. As of the writing of this Order, the Journal has not taken any further action regarding Dr. McGwin’s Letter.

This Order resolves Pfizer’s renewed Daubert challenge to Dr. McGwin and Plaintiffs’ motion for leave to supplement the expert report of Dr. McGwin.

DISCUSSION

A. Rule 702 and Daubert Standard

The Court discussed in detail in its previous Order the law surrounding the admission of expert testimony. Ultimately, the Court’s role is to ensure that expert testimony is reliable. See Daubert v. Merrell Dow Pharm., Inc.,

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