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In Re: Flonase Antitrust Civil Action Litigation

October 31, 2012

IN RE: FLONASE ANTITRUST CIVIL ACTION LITIGATION


The opinion of the court was delivered by: Anita B. Brody, J.

THIS DOCUMENT RELATES TO: All Actions

MEMORANDUM

I. Background

Direct and Indirect Purchasers of a steroid nasal spray containing the active ingredient fluticasone propionate ("FP"), along with Roxane Laboratories, Inc. ("Roxane"), a generic FP manufacturer, brought actions against Defendant SmithKline Beecham Corporation, doing business as GlaxoSmithKline PLC ("GSK"). GSK manufactures Flonase, the branded version of FP. The various Plaintiffs allege antitrust and state consumer violations that they claim arise from GSK delaying market entry of generic FP. In its defense, GSK asserts, among other things, that its conduct-particularly the filing of citizen petitions with the Federal Drug Administration ("FDA") regarding issues related to Roxane's Abbreviated New Drug Application ("ANDA")-is protected from antitrust liability under the First Amendment and the NoerrPennington doctrine, and, additionally, is not the actual cause of generic delay into the market.*fn1

Under the Noerr-Pennington doctrine, a party that exercises its First Amendment right to "petition[] the government for redress generally is immune from antitrust liability." Cheminor Drugs, Ltd v. Ethyl Corp., 168 F.3d 119, 122 (3d Cir. 1999) (citing E. R.R. Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S. 127 (1961); United Mine Workers of Am. v. Pennington, 381 U.S. 657 (1965)). An exception to the Noerr-Pennington doctrine occurs when the conduct "is a mere sham to cover what is actually nothing more than an attempt to interfere directly with the business relationships of a competitor . . . ." Noerr, 365 U.S. at 144. The Supreme Court has established a two-pronged test to determine whether a party's conduct is a sham, therefore denying Noerr-Pennington immunity. See Prof'l Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc. (hereinafter "PRE"), 508 U.S. 49 (1993). Under the first prong, known as the objective prong, plaintiffs must show that "a reasonable petitioner could not realistically expect that the petition will succeed on its merits." In re Flonase Antitrust Litig., 795 F. Supp. 2d 300, 311 (E.D. Pa. 2011) (citing Cheminor, 168 F.3d at 122--23; Bryant v. Military Dep't of Miss., 597 F.3d 678, 693 (5th Cir. 2010)). If the challenged conduct is deemed objectively meritless, the trier of fact then considers the second prong, known as the subjective prong. The fact-finder must examine the defendant's "subjective motivation" to determine if the conduct "conceals 'an attempt to interfere directly with the business . . . of a competitor.'" PRE, 508 U.S. at 60--61 (quoting Noerr, 365 U.S. at 144).

The parties in these three related actions have retained numerous experts to opine on issues relating to liability, including the Noerr-Pennington doctrine and causation, as well as damages. In 2010, the parties filed several "Daubert"motions to exclude the reports and testimony of certain expert witnesses. See Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579. In June 2011, I denied without prejudice all those Daubert motions that did not relate to Indirect Purchaser Plaintiffs' ("Indirect Purchasers") then-pending motion for class certification. In early 2012, the parties re-filed their respective motions to exclude, but then subsequently withdrew the majority of the motions. In July 2012, I denied two motions to exclude parts of the testimony of Plaintiffs' expert Leslie Benet and GSK's expert Mary Pendergast,*fn2 both of whom will opine on, among other topics, issues related to the objective prong of the PRE test and to causation.

Before me now is GSK's Daubert Motion to Exclude Expert Testimony of David A. Kessler, M.D., the former Commissioner of the FDA. See Def.'s Mot., Sept. 14, 2012, Case No. 08-3149 ECF No. 456 ("GSK Motion"). Direct Purchaser Plaintiffs proffer Kessler to testify about FDA procedures with respect to citizen petitions; specifically to rebut testimony from Pendergast. Kessler discusses what is likely to move the FDA to change policies in accordance with a citizen petition; he then applies that analysis to conclude that GSK could not have reasonably expected its citizen petitions to succeed on the merits. In other words, Plaintiffs plan to use Kessler's opinion to rebut GSK's Noerr-Pennington defense.

II. Legal Standard for Expert Testimony

The party offering an expert must demonstrate, by a preponderance of the evidence, that the expert's qualifications and opinions comply with Federal Rule of Evidence 702. See Daubert 509 U.S. at 592-93 (citation omitted). Rule 702 provides:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.

Fed. R. Evid. 702. Rule 702 has "a liberal policy of admissibility." Pineda v. Ford Motor Co., 520 F.3d 237, 243 (3d Cir. 2008) (citation omitted).

The Third Circuit has explained that to survive a Daubert challenge, an expert must satisfy three "restrictions on expert testimony: qualification, reliability, and fit." Schneider ex rel. Estate of Schneider v. Fried, 320 F.3d 396, 404 (3d Cir. 2003) (citations omitted). The qualification inquiry examines whether a witness possesses specialized expertise. The Third Circuit "has interpreted this requirement liberally, holding that a broad range of knowledge, skills, and training qualify an expert." Id. (citing In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 742 (3d Cir. 1994)). For an expert's testimony to be reliable, it "must be based on [] methods and procedures . . . rather than subjective belief or speculation." In re TMI Litig., 193 F.3d 613, 670 (3d Cir. 1999). "[T]he admissibility inquiry thus focuses on principles and methodology, not on the conclusions generated by principles and methodology." Id. at 665. Furthermore, an "expert's testimony must be accompanied by a sufficient factual foundation before it can be submitted to the jury." Elcock v. Kmart Corp., 233 F.3d 734, 754 (3d Cir. 2000) (citation omitted). Finally, Rule 702 requires that the expert testimony fit the issues in the case. Testimony "fits" a case when it is "relevant for the purposes of the case and . . . assist[s] the trier of fact." Schneider, 320 F.3d at 404.

III. Discussion

At trial, Plaintiffs intend to introduce Kessler as an expert on FDA procedures with respect to citizen petitions. Kessler earned a medical degree from Harvard Medical School and a law degree from the University of Chicago Law School. See Expert Report of David A. Kessler July 10, 2012 ("Kessler Report") ¶1. He worked on food and drug issues for the Labor and Human Resource Committee in the United States Senate during the 1980s. Kessler Report ¶2. In 1990, President George H. W. Bush appointed Kessler Commissioner of the FDA, a position he held until February 1997, serving under both Presidents Bush and Bill Clinton. Id. After he left the FDA, he became the Dean of Yale Medical School, where he taught drug regulation, among other topics. Kessler Hr'g Tr. 27:2-12. He also served as Dean of the medical school at the University of California, San Francisco, where he remains a tenured faculty member. Kessler Hr'g Tr. 27:13-28:13. He has consulted for private firms about ...


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