Jon Campisi Nov. 5, 2012, 7:39am

The federal judge overseeing the Flonase antitrust litigation against drugmaker

GlaxoSmithKline has ruled that a former commissioner of the Food and Drug Administration can offer expert witness testimony at trial.

U.S. District Judge Anita B. Brody, sitting in the Eastern District of Pennsylvania, denied in an Oct. 31 order GlaxoSmithKline’s motion to exclude the expert testimony of David A. Kessler, who is expected to describe how a citizen petitioner could influence the FDA to change its policies; opine on whether GSK could have reasonably expected the FDA to accept the positions it advocated in its own petitions; and to respond to a GSK expert’s testimony regarding the use of the term “regulatory merit” at the FDA.

Direct and indirect purchasers of the steroid nasal spray containing the active ingredient fluticasone propionate, along with generic manufacturer Roxane Laboratories Inc., are suing GlaxoSmithKline and parent corporation SmithKline Beecham, over allegations of antitrust and state consumer violations that the plaintiffs claim arise from the defendants’ delaying marketing of entry of the generic version of the Flonase nasal spray.

In defense, the defendants are asserting, among other things, that its conduct, particularly the filing of citizen petitions with the FDA regarding issues relating to Roxane’s Abbreviated New Drug Application, is shielded from antitrust liability under the First Amendment and the Noerr-Pennington doctrine, which states that a party exercising its First Amendment right to petition the government for redress is generally immune from antitrust liability.

An exception to the doctrine, however, 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,” according to the court order.

The plaintiffs in this case have retained numerous experts to give opinions on issues relating to liability, including the Noerr-Pennington doctrine and causation, as well as damages, the ruling states.

In 2010, the parties in the litigation filed several Daubert motions to exclude the reports and testimony of certain expert witnesses.

The following year, Judge Brody denied without prejudice all those motions that did not relate to the Indirect Purchaser Plaintiffs’ then-pending motion for class certification.

Earlier this year, the parties re-filed their motions to exclude, although soon after they withdrew most of the motions.

This summer, Brody denied motions to exclude parts of the testimony of plaintiffs’ expert Leslie Benet and GSK’s expert, Mary Pendergast, both of whom would talk about issues relating to causation and an objective prong that says a plaintiff must show that a “reasonable petitioner could not realistically expect that the petition will succeed on its merits.”

In GSK’s motion to exclude the testimony of former FDA head Kessler, the defendant argued that the witness’s testimony fails all three prongs of the Daubert inquiry: qualification, reliability and fit.

On the first point, “qualification,” Brody disagreed with GSK, writing that as former FDA commissioner charged with overseeing the agency’s response to all citizen petitions, Kessler is “qualified to opine on what moves the FDA to adopt positions espoused in a citizen petition.”

During an Oct. 15 hearing, the judge wrote, Kessler testified that the approval of generic drugs occupied a considerable amount of attention.

“Kessler’s lifelong experience in the field of food and drug regulation demonstrates that he is well-equipped to discuss the FDA’s processes for responding to citizen petitions, and that he is qualified to opine on whether a sophisticated petitioner like GSK could have reasonably expected to succeed in changing FDA policy with its petitions,” Brody wrote.

On the second prong, “reliability,” GSK raised three objections with regard to Kessler’s potential testimony, one of which was that Kessler’s opinions about the citizen petition review process are based on neither independent analysis nor reliable methodology.

Again, Brody disputed the defense assertions.

“An examination of an expert’s reliability focuses on the methodology behind his opinion,” Brody wrote. “Kessler relied on his own direct experience at the FDA to formulate his opinions about what moves the Agency to act. For these reasons, Kessler’s testimony satisfies the ‘reliability’ prong of Daubert.”

Finally, on the question of “fit,” GSK argued that Kessler’s opinions regarding how the FDA handles citizen petitions fail the fit requirement because they are detached from the specific issues of the case, and encourage the jury to improperly rely on Kessler’s “impressive resume.”

“Fit” examines the relevance of expert witness testimony as to the issues at trial.

Brody determined that despite GSK’s objections, Kessler’s testimony has a tight “fit” in this litigation.

“Kessler’s testimony is directly relevant to the question of objective baselessness,” Brody wrote. “By opining on what moves the FDA to adopt policies from a citizen petition, Kessler’s testimony will assist the jury in determining whether GSK could reasonably expect to succeed in its petitions.”

In conclusion, Brody wrote that Kessler’s testimony will assist the jury in understanding federal regulations relating to Abbreviated New Drug Applications and how the FDA implemented those regulations to deal with ANDA-related citizen petitions.

“His testimony is directly related to the question of sham petitioning, and squarely rebuts expert testimony presented by GSK,” Brody wrote. “He is a credible witness with an indisputably impressive background.”

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