Ruling over chemo drug questionable, attorney says

By Carrie Salls | Feb 24, 2017

PHILADELPHIA – A Saul Ewing LLP partner believes a ruling made in a 15-year-old False Claims Act (FCA) whistleblower lawsuit by the U.S. District Court for the Eastern District of Pennsylvania may not have been entirely fair to the defendants, given the nature of the case.

In the case, United States ex. rel. Gohil v. Aventis, former Aventis salesman Yoash Gohil claimed that the company and its predecessors instructed its employees for an eight-year period beginning in 1996 to make false claims about the safety and effectiveness of its Taxotere chemotherapy drug.

The company allegedly offered money and other perks to salesmen who helped boost the off-label use of the drug.

Gohil’s original whistleblower claim was filed under seal in 2002. However, he filed an amended complaint in 2007 that specified the period during which the FCA violations allegedly occurred and provided other details. The final version of the amended complaint was unsealed in 2008.

After the complaint was unsealed and Aventis was made aware of the specific claims, the company asked the court to dismiss the amended complaint, arguing that the six-year statute of limitations imposed by the FCA had passed. In addition, the company said it did not receive proper notice of the claims for misconduct that occurred before 2000, when the plaintiff worked for its predecessor.

In its Jan. 10 opinion, the district court ruled that the statute of limitations did not apply because the plaintiff filed new claims years after the original complaint was filed. The court deemed those new claims to be a “natural offshoot” of the original ones.

Saul Ewing partner Alexander “Sandy” R. Bilus said this may have not been fair because the defendant never had the opportunity to see the original sealed lawsuit.

“It does seem somewhat unfair to me to change up claims decades after,” Bilus told the Pennsylvania Record.

Bilus said a False Claims Act proceeding begins when a private citizen brings a complaint, which is filed under seal. The defendants do not get to see this complaint. The government, however, does get to review the claim to decide whether to intervene with the plaintiff and investigate the matter further.

“It’s basically outrageous to not have that fair notice,” Bilus said. “If the defendant didn’t know about the original complaint, how does this relate to timeliness?”

If he were representing Aventis, Bilus said he would push that very point on appeal.

However, the court held that “the defendant had fair notice,” according to Bilus, because the original claims and those filed later were connected.

“It comes down to a fairness issue,” Bilus said.

Bilus said he did get a sense from the opinion that the court also thought that the plaintiffs were “looking for a second bite of the apple.”

According to Bilus, the defendants were trying to get just the amended complaint thrown out, but the timeliness issues did not work in their favor.

“If it didn’t relate back, it would have been untimely,” he said.

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