Most often, we hear of major False Claims Act cases when they settle for millions of dollars.

But what happens when the case hits a bump in the road?

Then the relator’s attorneys need to get in the trenches and do hand to hand combat with corporate defense attorneys to give the whistleblowers a chance.

Timothy Cornell is handling one such case — now entering its tenth year of litigation — against Novartis and Genentech.

Cornell is a partner at Cornell Dolan in Boston, Massachusetts.

“It’s a fairly standard false claims case against pharmaceutical companies,” Cornell told Corporate Crime Reporter in an interview last week. “It alleges that Novartis and Genentech used kickbacks in the form that we very often see them in order to boost the sales of their products, in this case an asthma drug called Xolair. It is still on the market.

The allegations were brought by two insiders. Who are they?

“One was a pharmaceutical rep from Genentech — Frank Garcia — and one was a rep from Novartis — Allison Kelly. Genentech and Novartis were jointly producing and selling this drug Xolair. They met at conferences where they were being coached on how to sell. And they compared notes on what they saw. And they realized that what they were being told to do was illegal.”

What were they being told to do?

“They were being told to give doctors equipment, American Express check cards, computers, mixers. They stepped in and did work for doctor’s offices — kickbacks in the form of labor. They took doctors out for very expensive restaurants — $4,000 dinner bills. They took them to conferences in lavish resorts in the Caribbean and out West — all of which have been found to be kickbacks in other similar cases.”

Why did the companies feel the need to do this? Why couldn’t Xolair sell itself?

“Xolair is a troublesome drug. It’s very expensive. It has to be administered in a doctor’s office because for some patients it can cause anaphylactic shock. It has to be done under a doctor’s supervision. It was not permitted for use in what they hoped to be a blockbuster market — young people. So they had a limited market. They were up against competition that was many times cheaper. They had to have something to give it a competitive boost. And that’s what they found was successful for them.”

What was the government’s response?

“The government investigated for a number of years and in 2011, the government decided to decline the Kelly Garcia case,” Cornell says. “Under the False Claims Act, if the government declines to intervene, the case is unsealed and becomes public. Allison Kelly was still at the time a very successful pharmaceutical representative. And she knew that when the case came to light with her name on it, she would be blackballed in the industry. She was worried about that. She worked it out with the Justice Department, with her attorneys and with the judge to allow her to voluntarily withdraw from the case and redo the case with only one relator — Frank Garcia.”

Cornell is facing off against a phalanx of corporate lawyers.

For Novartis, there is Ronald Dove and Matthew O’Connor of Covington & Burling in Washington. Tracy Miner of Demeo in Boston. Michael Rogoff and Debra E. Schreck of Kaye Scholer in New York. For Genentech, it’s David E. Silbert and Elliott R. Peters of Keker Van Nest in Oakland.

After many twists and turns, the case ended up before a federal judge in Boston — Judge William G. Young.

After many years and many lawyers, Cornell sought to merge the expanded cases of Kelly and Garcia.

“There was a 400-page complaint that contained allegations of named doctors who received specific Medicare and Medicaid money and specifically went on lavish trips, how much those cost, how much government money they were spending and other kickbacks they received. That was in the 400-page complaint that Judge Young denied leave to amend.”

“That was in March 2014 — Judge Young denied leave to amend. Under the False Claims Act there is a first to file provision. It says that only the first complaint relevant allegations will be heard. Subsequent complaints are barred.”

“The defense argues — here is this amended complaint, but we have no idea whose allegations are Garcia’s and whose allegations are Kelly’s. That deprives us of our right to mount a defense. You have to go back to your separate corners. You have to have one Kelly complaint and one Garcia complaint. That’s what the defense counsel argued and the Judge apparently agreed.”

“Judge Young blocked the relators from being able to file their 400-page complaint with these detailed allegations. He then went on to rule on the existing complaint. In the existing complaint, he said that it shows probable fraud, but there is not enough in the allegations. The Judge says — if you could show me one doctor who received government money and what you alleged to be kickbacks, then I would let this pass. But you haven’t done this.”

But he had the 400-page complaint that showed him exactly that.

“That’s the important part of my appeal. He had the complaint. But he denied leave to amend.”

“During oral argument, he said — I think I’m going to give you leave to amend. And my co-counsel Mark Labaton replied — you have a 400-page complaint that will do what you are asking. He didn’t reply to that.”

“Contrary to what he said during oral arguments, he didn’t give us leave to amend.”

Cornell is appealing Judge Young’s ruling to the First Circuit Court of Appeals. He expects a ruling by sometime later this year.

[For the complete q/a format Interview with Timothy Cornell, see 30 Corporate Crime Reporter 2(13), January 11, 2016, print edition only.]