Judge Recommends Ranbaxy Motion to Dismiss RICO and Antitrust Claims be Denied

06/16/2016

BOSTON – Today, Magistrate Judge Kelley recommended that Ranbaxy and Sun’s motion to dismiss the purchasers’ RICO and antitrust claims largely be denied. It dismissed claims against two entities that no longer exist.

The complaint alleges that Ranbaxy, one of the largest generic drug makers in the world, misled the FDA as to the state of its manufacturing plants in India and compliance with good manufacturing procedures, affecting least two products (generic Valcyte and generic Diovan) it produced at those facilities. This deceit, the complaint alleges, enabled Ranbaxy to wrongfully obtain tentative FDA approval, locking in very valuable regulatory exclusivities, and delaying the availability of safe, affordable medications. Only after years of delay did the FDA discover the extent of Ranbaxy’s deceit and revoke Ranbaxy’s approvals, allowing other generic drugs to reach the market.

In permitting these claims to proceed, Judge Kelley referred to Ranbaxy’s manufacturing practices as “abysmal” and noted that, “had Defendants admitted their compliance issues with regard to generic Valcyte, they would likely have forfeited their TA and first-filer status earlier than they actually did. By continuing to pursue their meritless regulatory goal, Defendants allegedly delayed the launch of competitors’ products.”

Judge Kelley held that the purchasers sufficiently alleged a RICO enterprise – between Ranbaxy, its auditor (Parexel) and its law firm (Buc & Beardsley LLP) – that sought to protect and profit from Ranbaxy’s first-to-file status for generic Diovan and Valcyte by misleading the FDA about its compliance status, the truthfulness of its ANDAs and the completeness of its ANDAs.

Judge Kelley also held that the purchasers’ antitrust claims “comfortably coexist” with the FDA’s authority to enforce the Food Drug and Cosmetic Act. 

Ranbaxy has 14 days to object.

# # #

About Hagens Berman
Hagens Berman Sobol Shapiro LLP is a consumer-rights class-action law firm with offices in 10 cities. The firm has been named to the National Law Journal’s Plaintiffs’ Hot List eight times. More about the law firm and its successes can be found at www.hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.

Media Contact
Ashley Klann
ashleyk@hbsslaw.com
206-268-9363


Hagens Berman purchases advertisements on search engines, social media sites and other websites. Transmission of the information contained or available through this website is not intended to create, and receipt does not constitute, an attorney-client relationship. If you seek legal advice or representation by Hagens Berman, you must first enter a formal agreement. All information contained in any transmission is confidential and Hagens Berman agrees to protect information against unauthorized use, publication or disclosure. This site is regulated by the Washington Rules of Professional Conduct.

Back to all cases

Case videos

Case Gallery

Case Timeline

06/16/16: MTD Recommendations

Magistrate Judge Kelley recommended that Ranbaxy and Sun’s motion to dismiss the purchasers’ RICO and antitrust claims be denied. more »

Read the recommendations »

04/14/16: CASE UPDATE

The court held argument on the motion to dismiss. Supplemental briefs are due on Apr. 11, 2016.

Related News