In re Viagra Products Liability Litigation
| Decision Date | 19 August 2009 |
| Docket Number | Civil No. 06-1064 (PAM).,MDL No. 06-1724 (PAM).,Civil No. 06-1065(PAM). |
| Citation | 658 F.Supp.2d 950 |
| Parties | In re VIAGRA PRODUCTS LIABILITY LITIGATION. This Order Relates to: Richard Martin, Plaintiff, v. Pfizer, Inc., Defendant. Richard Stanley, Plaintiff, v. Pfizer, Inc., Defendant. |
| Court | U.S. District Court — District of Minnesota |
Robert R. Hopper, Ronald S. Goldser, Zimmerman Reed, PLLP, MPLS, MN, Neil D. Overholtz, R. Jason Richards, Aylstock, Witkin, Kreis & Overholtz, PLLC, Pensacola, FL, for Plaintiff's Liaison Counsel.
Camilo K. Salas, III, Salas & Co., LC, New Orleans, LA, Daniel E. Becnel, Jr., Law Offices of Daniel E. Becnel, Reserve, LA, for Plaintiff's Lead Counsel.
Jeffrey J. Lowe, The Lowe Law Firm, St. Louis, MO, for John Gibbons.
Bert L. Slonim, Lori B. Leskin, Melissa Giordano, Steven Glickstein, Kaye Scholer LLP, New York, NY, for Defendant's Lead Counsel.
David P. Graham, Stacey L. Drentlaw, William P. Studer, Heather N. Hoecke, Oppenheimer Wolff & Donnelly LLP, MPLS, MN, for Defendants Lead Counsel, Defendant's Liaison Counsel.
Jonathan Lee Riches, pro se.
This matter is before the Court on Defendant Pfizer, Inc.'s Motions (1) to Exclude the Testimony of Plaintiffs' Specific Causation Experts, (2) to Exclude the Testimony of Cheryl Blume, Ph.D., and (3) for Summary Judgment. For the reasons that follow, Pfizer's Motion to Exclude the Testimony of Plaintiffs' Specific Causation Experts is granted; Pfizer's Motion to Exclude the Testimony of Dr. Blume is granted in part and denied in part; and Pfizer's Motion for Summary Judgment is granted.
At the outset, the Court notes that in an Order issued simultaneously with this Order, the Court granted Pfizer's motion to exclude the general causation opinion of Dr. Gerald McGwin because it is not sufficiently reliable under Daubert. See Order Granting Pfizer's Motion to Exclude the Testimony of Dr. Gerald McGwin (Docket No. 607), in In re Viagra Prod. Liab. Litig., ___ F.Supp.2d ___ (D.Minn.2009) (Magnuson, J.). That decision effectively ended the current litigation, because, as discussed in more detail below, absent an admissible general causation opinion, Plaintiffs' claims necessarily fail and Pfizer's motion for summary judgment must be granted. However, for the sake of comprehensiveness, the Court will consider Pfizer's additional Daubert motions below.
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"). At issue currently before the Court are the specific cases of Plaintiffs Richard Martin and Richard Stanley against Pfizer. Plaintiffs have offered the opinions of five experts that Viagra specifically caused Martin's NAION. Two of those experts also opine that Viagra specifically caused NAION in Stanley. All five proposed experts offer their opinions to a reasonable degree of medical certainty. Plaintiffs have also offered the opinion of one regulatory expert. Pfizer raises a number of challenges to Plaintiffs' proposed experts. Each expert will be discussed in turn.
The Court discussed in detail in its previous orders the law surrounding the admission of expert testimony. Ultimately, the Court's role as a gatekeeper is to ensure that only relevant and reliable expert testimony is admitted. See Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). "This gatekeeping requirement is to ensure that the proffered expert exercises the same intellectual rigor in the courtroom as does an expert in the relevant field." Bland v. Verizon Wireless, (VAW) LLC, 538 F.3d 893, 896 (8th Cir. 2008) (quotations omitted); see also Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999).
Three of Plaintiffs' proposed specific causation experts used a technique called a differential diagnosis to reach their conclusion that Viagra caused Plaintiffs' NAION.
In performing a differential diagnosis, a physician begins by "ruling in" all scientifically plausible causes of the plaintiff's injury. The physician then "rules out" the least plausible causes of injury until the most likely cause remains. The final result of a differential diagnosis is the expert's conclusion that a defendant's product caused (or did not cause) the plaintiff's injury.
Glastetter v. Novartis Pharm. Corp., 252 F.3d 986, 989 (8th Cir.2001). A temporal relationship between the ingestion of a drug and the onset of particular symptoms, alone, "is not scientifically valid proof of causation." Id. at 990. A general causation opinion is a prerequisite to a proper differential diagnosis; it "assumes that the final, suspected cause remaining after this process of elimination must actually be capable of causing the injury." Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 254 (2d Cir.2005) (quotation omitted) (emphasis in original). "[A] medical opinion about causation, based upon a proper differential diagnosis, is sufficiently reliable to satisfy Daubert." Turner v. Iowa Fire Equipment Co., 229 F.3d 1202, 1208 (8th Cir.2000). However, a differential diagnosis that fails "to consider all the possible causes, or to exclude each potential cause until only one remain[s], or to consider which of two or more non-excludable causes [is] the more likely to have caused the condition" is not a proper differential diagnosis to determine causation, and a causation opinion based on that inadequate methodology is not admissible to show causation. Id. Differential diagnoses are presumptively admissible and a court therefore only excludes scientifically invalid diagnoses. Glastetter, 252 F.3d at 989.
Dr. Williams is an ophthalmologist who most recently has focused on occupational medicine rather than ophthalmology. Dr. Williams offers an opinion that Viagra caused both Martin's and Stanley's NAION. Pfizer challenges the admissibility of Dr. Williams's testimony because (1) his general causation opinion is based on Dr. Hayreh's theory, which this Court already excluded as unreliable; (2) his differential diagnosis is not reliable because he cannot rule out that Plaintiffs' NAION was caused by preexisting risk factors rather than by Viagra use; (3) he does not have a scientifically valid method for choosing Viagra as the most likely cause of Plaintiffs' NAION; (4) he applied a different, lower standard to determine causation in this litigation than what he would use in the medical realm; and (5) his opinion is based solely on temporality, which is insufficient to establish causation. Plaintiffs respond by pointing to Dr. Williams's years of experience as a practicing ophthalmologist and by quoting his statements in his two expert reports and in his deposition that it is his opinion to a reasonable degree of certainty that Viagra provoked NAION in Plaintiffs.
Dr. Williams's specific causation opinion in both Plaintiffs' cases is inadmissible. The Court does not doubt Dr. Williams's credentials as an ophthalmologist. Rather, the Court finds that the methodology that Dr. Williams used in reaching his opinions is not scientifically valid. Plaintiffs argue that Dr. Williams's used a differential diagnosis to reach his conclusions. However, Dr. Williams admitted in his deposition that he could not rule out underlying risk factors as the cause of Plaintiffs' NAION. Plaintiff has not produced any evidence that Dr. Williams used any particular test or methodology for determining that Viagra and not underlying risk factors caused Plaintiffs' NAION. To the extent that Dr. Williams relied on temporality in conducting his differential diagnosis, as noted above, temporality is insufficient alone to establish causation. Further, Dr. Williams admitted that, in reaching his conclusion about causation in Plaintiffs' cases, he employed a lower standard than what would be used in the medical realm. The Eighth Circuit Court of Appeals affirmed a district court's exclusion of an expert that "admitted that the causation standard she employed . . . was a much lower standard than medical causation." Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748, 758 (2006). Finally, based on the record before it, Dr. Williams "ruled in" Viagra as a potential cause of Plaintiffs' NAION based on Dr. Hayreh's theory that the Court previously deemed inadmissibly unreliable. Dr. Williams cannot have an admissible specific causation opinion regarding Viagra without a scientifically valid reason for concluding that Viagra can cause NAION in the first place.
Although Daubert may have done away with Frye's rigid reliance on "general acceptance," it clearly envisioned that as a "gatekeeper," the Court would exclude expert opinions that are unreliable. For the reasons discussed above, the Court finds that Dr. Williams's differential diagnosis was methodologically flawed and that his specific causation opinion is therefore inadmissible under Federal Rule 702.
Dr. Lee is a nuero-ophthalmologist. He only offers a specific causation opinion regarding Martin. Pfizer challenges the admissibility of Dr. Lee's testimony because (1) he discredits the general causation opinion of Dr. Hayreh upon which he relied; (2) he cannot connect Dr. Hayreh's theory with Martin; (3) his differential diagnosis is not reliable because he cannot rule out that Martin's NAION was caused by coincidence or another prescription drug that Martin was taking; (4) he does not have a scientifically valid method for choosing Viagra as the most likely cause of Plaintiffs' NAION; (4) his characterization of Martin as a rechallenge case is not supported by the record; (5) he applied a...
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