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Mylan N.V.

Case Details

Class Period: February 16, 2016 - May 7, 2019
Date Filed: June 26, 2020
Case Number: 2:20cv00955
Jurisdiction: Pennsylvania Western District Court
Days Left to
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11

Case Summary

Mylan is the second largest generic drug manufacturer in the world with roughly 55 manufacturing and R&D facilities globally. During the Class Period, Mylan’s largest U.S. manufacturing facility was located in Morgantown, West Virginia. The claims against Mylan arise from the Company’s misrepresentations and omissions regarding rampant abuses of federal quality control regulations, including at the Morgantown facility. Under a scheme implemented by Mylan’s President, Rajiv Malik, Mylan chemists manipulated quality control test data in order to create the facade that Mylan’s drugs had achieved passing quality control results. In November 2016, a whistleblower reported Mylan’s conduct to the U.S. Food & Drug Administration (“FDA”). The truth began to be revealed on June 27, 2018, when Mylan revealed that the FDA had investigated the Morgantown plant in the Spring of 2018the second FDA investigation of that plant in less than two years. According to the FDA, the Morgantown plant exhibited “significant deficiencies in [its] cleaning process[es],” “numerous instances of a lack of oversight,” and “multiple instances” of Mylan chemists re-cleaning and re-swabbing quality control testing machines “multiple times until passing results were obtained.” As a result of these violations, Mylan was ultimately forced to reveal that it would be dramatically “restructuring” its Morgantown facility, including by terminating hundreds of employees, and reported a surprise quarterly loss on May 7, 2019, which the Company attributed, in part, to the Morgantown “restructuring.” The disclosures concerning Mylan’s misconduct and its impact on the Company’s business and financial condition caused the value of Mylan stock to decline dramatically, resulting in significant damages to investors.

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