May 14, 2021

A Massachusetts federal court on Friday certified classes for two groups of buyers accusing Ranbaxy Pharmaceuticals of delaying generic versions of three different drugs by manipulating the regulatory approval system.

U.S. District Judge Nathaniel M. Gorton issued an order granting class certification requests from direct purchasers, including drug wholesalers, and from end-payors, such as health care plans that indirectly paid for the treatments. The order certified separate classes for both groups of buyers covering each drug involved in the case — anti-AIDS drug Valcyte, high blood pressure drug Diovan and reflux medication Nexium.

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Proposed class actions from the two groups of buyers were consolidated in Massachusetts federal court in April 2019. The case accuses Ranbaxy of filing new drug applications with the Food and Drug Administration in the early 2000s for generic versions of Valcyte, Diovan and Nexium that contained missing, incorrect or fraudulent information.

Ranbaxy allegedly filed the applications in order to secure valuable exclusivity periods, meaning it would be the only generics competitor to each of the branded drugs for a set period of time. But the company ultimately failed to gain approval for its generics because of the faulty information supplied to the FDA.

The buyers contend Ranbaxy wrongly obtained the exclusivity periods and that this delayed the eventual launch of generic versions of all three drugs by other manufacturers, resulting in higher prices. The suit includes claims for violation of the Racketeer Influenced and Corrupt Organizations Act, federal and state antitrust laws and state consumer protection laws.

The litigation followed investigations into Ranbaxy by the FDA and U.S. Department of Justice that resulted in guilty pleas and a $500 million fine against the drugmaker for lying to regulators and selling drugs that fell short of federal safety standards.

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The direct buyers are represented by Hagens Berman Sobol Shapiro LLP, Hilliard & Shadowen LLP, Radice Law Firm, Sperling & Slater PC, Kessler Topaz Meltzer & Check LLP, Wexler Wallace LLP, Cohen Milstein Sellers & Toll PLLC and Nussbaum Law Group PC.

The complete article can be viewed here.