Against GlaxoSmithKline’s objections, former head of the Food and Drug Administration David Kessler will be allowed to testify in front of a jury as an expert for the plaintiffs in a class action suit against the company.

London-based drug giant GSK violated antitrust laws when it filed "sham" petitions to the FDA in an effort to stall generic versions of its popular nasal spray, Flonase, from entering the market, third-party purchasers and generic drugmakers allege.

GSK countered by arguing the citizen petitions it filed with the FDA during the agency’s review process for generic versions of its drug are protected from antitrust liability by the Noerr-Pennington doctrine, which shields the First Amendment right for a party to petition the government, GSK argued.

U.S. District Judge Anita B. Brody of the Eastern District of Pennsylvania dismissed that argument on summary judgment over a year ago because there remained issues of fact regarding whether or not GSK intentionally filed baseless petitions and she ruled last week that the plaintiffs could present Kessler in support of their argument that the company did, thereby triggering the sham exception to Noerr-Pennington immunity.

"GSK claims that its petitions are protected under the First Amendment and thus cannot form the basis of antitrust liability," Brody said in In re Flonase Antitrust Litigation.

"To get around this immunity, plaintiffs will have the burden of proving that the petitions were ‘shams,’ which requires showing that they were both objectively and subjectively baseless. Kessler’s testimony is directly relevant to the question of objective baselessness," she said, rejecting GSK’s Daubert petition aimed at keeping Kessler’s testimony out of the courtroom.

It was one of several Daubert motions filed by each side.

Brody explained that the U.S. Supreme Court established a test for determining whether a party’s conduct can be considered a sham. The first prong, called the objective prong, requires the plaintiff to show that no reasonable actor could have expected its petition to succeed on the merits and the second prong, called the subjective prong, is intended to establish whether the petitioner intended to obstruct a competitor’s business, according to the opinion.

The plaintiffs intended to use Kessler’s testimony to meet their burden of proof, showing that GSK filed "sham" petitions as part of a strategy to maintain market dominance after its patent expired in 2003.

GSK had gotten FDA approval for Flonase, a steroid nasal spray, in 1994 and commanded 38 percent of the market by 2000, according to Brody’s opinion certifying the class. That year, the company made $600 million in sales of the drug and, by its peak year in 2005, it made more than $1.3 billion in sales, Brody said.

Part of GSK’s strategy to maintain its share of the market, the plaintiffs allege, was delaying the entry of generic drugs by stalling the FDA during its review of drugmakers’ applications for generic versions of steroid nasal sprays, according to the opinion.

Until Congress changed the law in 2007, the FDA had to respond to every petition filed by a citizen, according to the class-certification opinion.

"The citizen petition process often was abused by pharmaceutical companies attempting to prolong their monopoly in the market," Brody said in that opinion, from June.

By filing "several frivolous citizen petitions" and interfering with the FDA’s review process, GSK kept generics from entering the market until 2006, when they could have otherwise entered in 2004, the indirect purchasers alleged. Because of that delay, they couldn’t purchase the cheaper drug for that two-year period, according to the opinion.

Kessler, who has a medical degree from Harvard Medical School and a law degree from the University of Chicago Law School, served as the commissioner of the FDA from 1990 to 1997, after having worked on food and drug issues in the Senate.

During a hearing last month, Kessler testified that "there was no reasonable possibility that the FDA would have granted GSK’s requests to refrain from approving new FP generics until the agency had finalized ‘guidances’ on standards and policies," according to the opinion.

GSK objected to Kessler’s testimony at trial "on all three prongs of the Daubert inquiry: qualification, reliability, and fit."

Brody found that Kessler satisfied all three.

GSK argued that Kessler doesn’t have the scientific expertise to interpret whether its petitions lacked "clinically meaningful data," as is required for a petition to have merit sufficient to weigh on the FDA’s ultimate opinion.

Brody, citing Kessler’s lengthy career, held that he is qualified.

Regarding reliability, GSK argued that Kessler didn’t perform an independent analysis of its petitions, but, rather, "parrots" the FDA’s responses to GSK; that Kessler is unfamiliar with the meaning of ‘regulatory merit’; and his "opinions on causation" are too generalized.

"An examination of an expert’s reliability focuses on the methodology behind his opinion," Brody said. "Kessler relied on his own direct experience at the FDA to formulate his opinions about what moves the agency to act," she said, holding that he satisfied the reliability prong.

Similarly, on the question of fit, GSK had argued that Kessler’s opinions would be detached from issues specific to the case and would "encourage the jury to improperly rely on Kessler’s impressive resume," according to the opinion.

However, Brody rejected that argument, holding that, because he won’t be speaking to what actually delayed the generics entry to the market, his opinions about the process as a whole are admissible.

"His testimony is directly related to the question of sham petitioning, and squarely rebuts expert testimony presented by GSK," Brody said.

Steven Asher of Weinstein Kitchenoff & Asher in Philadelphia represented the plaintiffs and couldn’t be reached for comment.

Leslie John of Ballard Spahr in Philadelphia represented GSK and declined to comment.

Saranac Hale Spencer can be contacted at 215-557-2449 or Follow her on Twitter @SSpencerTLI.

(Copies of the 14-page opinion in In re Flonase Antitrust Litigation, PICS No. 12-2094, are available from The Legal Intelligencer. Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information.) •