A federal judge in the Eastern District of Pennsylvania has denied class certification to wholesalers of the narcolepsy drug Provigil who claimed that its maker, Cephalon, paid off Ranbaxy Laboratories to delay generic versions of the medication from entering the market.
U.S. District Judge Mitchell S. Goldberg of the Eastern District of Pennsylvania’s ruling comes nearly a year after the U.S. Court of Appeals for the Third Circuit revoked class status in the case and sent it back to Goldberg for a second look.
The appeals court did not entirely scrap the idea of a potential class of direct purchasers of the wakefulness drug—rather, it noted that the small number of plaintiffs merited re-examination under a new framework to determine whether numerosity was satisfied by the two dozen plaintiffs.
Upon further review, Goldberg held that there weren’t enough direct-purchaser plaintiffs to grant class status.
“Regardless of whether the class consists of 24 or 25 members, ‘inquiry into impracticability should be particularly rigorous when the putative class consists of fewer than 40 members,’” Goldberg said, citing In re Modafinil Antitrust Litigation.
The ruling came just over a week after the Third Circuit, in a precedential opinion in a pair of consolidated cases, revived suits against drugmakers Pfizer and Ranbaxy over an alleged “reverse settlement” deal concerning cholesterol-reducing drug Lipitor and against Wyeth and Teva relating to antidepressant Effexor XR.
Bruce Gerstein of Garwin Gerstein & Fisher in New York represents the plaintiffs and did not return a call seeking comment.
Christopher K. Diamond of Venable in Washington, D.C., represents Ranbaxy and also did not return a call seeking comment.
Previously, Cephalon settled antitrust claims against it related to Provigil for $125 million.
Under the settlement terms, which was reached with state attorneys general offices, $35 million was devoted to compensation for consumers and $90 million went to state governments across the country.
“The settlement ends a multistate investigation into anticompetitive conduct by Cephalon to protect the monopoly profits it earned from its landmark wakefulness drug, Provigil,” according to a statement released by Georgia Attorney General Sam Olens’ office in August of last year.
“Cephalon was able to delay generic competition for nearly six years by filing patent infringement lawsuits against all potential generic competitors,” the statement continued. “Cephalon settled those lawsuits in 2005 and early 2006 by paying the generic competitors to delay sale of their generic versions of Provigil until at least April 2012. Because of that delayed entry, consumers, states, and others paid hundreds of millions more for Provigil than they would have had generic versions of the drug launched by early 2006, as expected.”
In May 2015, the Federal Trade Commission’s biggest settlement to date—$1.2 billion in a pay-for-delay case—came out of the case against Cephalon.
Cephalon, which is now owned by Teva Pharmaceutical Industries, agreed to settle a suit filed by the FTC over the same reverse-payment arrangements made with the generic drugmakers.