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Last Updated: April 4, 2025

Litigation Details for In Re: MYLAN N v. SECURITIES LITIGATION (S.D.N.Y. 2016)


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Small Molecule Drugs cited in In Re: MYLAN N v. SECURITIES LITIGATION
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Details for In Re: MYLAN N v. SECURITIES LITIGATION (S.D.N.Y. 2016)

Date FiledDocument No.DescriptionSnippetLink To Document
2016-10-11 39 Amended Complaint expiration of U.S. Patent Nos. 7,449,012 B2 (the “‘012 patent”) and 7,794,432 B2 (the “‘432 patent”), which expire…Numbers 7,449,012, 7,794,432, 8,048,035, and 8,870,827 (the “EpiPen Patents”). These four patents have a …settling its patent infringement suit against Teva Pharmaceuticals (“Teva”) relating to the patents covering…additional patents for features that were subsequently integrated into the EpiPen: U.S. Patent Numbers…The issuance of the EpiPen Patents, and Mylan’s designation of these patents as covering the EpiPen, External link to document
2016-10-11 45 Consolidated Amended Complaint expiration of U.S. Patent Nos. 7,449,012 B2 (the “‘012 patent”) and 7,794,432 B2 (the “‘432 patent”), which expire…Numbers 7,449,012, 7,794,432, 8,048,035, and 8,870,827 (the “EpiPen Patents”). These four patents have a …settling its patent infringement suit against Teva Pharmaceuticals (“Teva”) relating to the patents covering…additional patents for features that were subsequently integrated into the EpiPen: U.S. Patent Numbers…The issuance of the EpiPen Patents, and Mylan’s designation of these patents as covering the EpiPen, External link to document
>Date Filed>Document No.>Description>Snippet>Link To Document
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In Re: Mylan N.V. Securities Litigation: A Comprehensive Analysis

Background of the Case

The In Re: Mylan N.V. Securities Litigation case, filed in the United States District Court for the Southern District of New York (Case No. 1:16-CV-07926), involves a securities class action against Mylan N.V., a global pharmaceutical company, and several of its current and former officers. The litigation centers around allegations that Mylan knowingly misclassified its EpiPen Auto-Injector under the Medicaid Drug Rebate Program (MDRP), leading to misleading financial statements and violations of securities laws[3][4].

Allegations of Misclassification and Securities Fraud

The plaintiffs allege that Mylan misclassified the EpiPen as a generic drug under the MDRP, which allowed the company to pay significantly lower rebates to Medicaid. This misclassification was claimed to be intentional and aimed at boosting Mylan’s financial results. The complaint asserts that Mylan’s executives were aware of the misclassification and the associated risks but failed to disclose this information to investors. Instead, Mylan reported inflated income and revenue figures, misleading investors about the company’s true financial health and the risks associated with its business practices[1][3][4].

Court’s Analysis of Securities Fraud Claims

To establish a claim under Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5, the plaintiffs must demonstrate that Mylan made material misrepresentations or omissions, acted with scienter (a wrongful state of mind), and that these actions directly caused the plaintiffs’ economic losses.

The court examined several categories of statements made by Mylan, including:

  • Statements of Income: Mylan’s financial disclosures in its Annual Reports (Form 10-K) and Quarterly Reports (Form 10-Q).
  • Statements Explaining Income: Descriptions of the sources of Mylan’s income in its Current Reports (Form 8-K) and quarterly earnings calls.
  • Statements Explaining the Market: Descriptions of the competitive nature of the pharmaceutical market in Mylan’s Annual Reports.
  • Statements of Rebate Rates: Reporting of rebate rates for the EpiPen under the MDRP.
  • Statements of Rebate Complexity and Regulatory Risk: Discussions on the complexity and regulatory risks associated with calculating Medicaid rebate rates[3][4].

The court found that Mylan’s statements about its income and the competitive market, when combined with the undisclosed Medicaid misclassification, could have misled investors. The court determined that the plaintiffs had sufficiently alleged that Mylan’s omissions were materially misleading and that the executives had acted with the requisite scienter[1][3].

Misrepresentation of Medicaid Rebates

A critical aspect of the case is Mylan’s reporting of rebate rates for the EpiPen. The plaintiffs alleged that Mylan’s failure to properly classify the EpiPen and its subsequent reporting of lower rebate rates allowed the company to save over $700 million. This misrepresentation was not disclosed to investors, who were led to believe that Mylan's financial performance was stronger than it actually was. The court agreed that these rebate misrepresentations could be considered materially misleading[1][3].

Anticompetitive Agreements

In addition to the misclassification allegations, the plaintiffs also claimed that Mylan entered into anticompetitive agreements to inflate drug prices. These agreements were alleged to have contributed to Mylan’s inflated financial results, which were not disclosed to investors. The court required the plaintiffs to demonstrate that Mylan actually violated the Sherman Act as a necessary step to establishing their securities fraud claims[3][4].

Court’s Ruling

The court ultimately decided to allow the securities fraud claims against Mylan to proceed. It found that the plaintiffs had sufficiently alleged that Mylan’s misclassification of the EpiPen under Medicaid, along with the company’s misleading statements to investors, could constitute a violation of securities laws. The court denied Mylan's motion to dismiss, allowing the case to move forward to further litigation[1][3].

Class Action Notice

The litigation involves a class action that includes all purchasers and acquirers of Mylan N.V. or Mylan Inc. common stock during the period from February 21, 2012, through and including May 24, 2019. The notice of pendency of the class action informs potential class members of their rights and the ongoing proceedings in the case[2].

Key Takeaways

  • Misclassification and Financial Impact: Mylan’s alleged misclassification of the EpiPen under the MDRP led to significant financial savings but also exposed the company to legal and financial risks not disclosed to investors.
  • Material Misrepresentations: The court found that Mylan’s statements about its income, market conditions, and rebate rates were materially misleading due to the undisclosed misclassification and anticompetitive agreements.
  • Scienter and Intent: The plaintiffs successfully alleged that Mylan’s executives acted with scienter, knowing about the misclassification and its implications.
  • Securities Law Violations: The case highlights the importance of accurate and transparent financial reporting to avoid violations of securities laws.

FAQs

Q: What was the central allegation against Mylan in the securities litigation? A: The central allegation was that Mylan knowingly misclassified the EpiPen under the Medicaid Drug Rebate Program (MDRP), leading to misleading financial statements and violations of securities laws.

Q: How did the misclassification affect Mylan’s financial reporting? A: The misclassification allowed Mylan to pay lower rebates to Medicaid, resulting in inflated income and revenue figures that were not accurately reflected in its financial reports.

Q: What categories of statements were examined by the court? A: The court examined statements of income, statements explaining income, statements describing the market, statements of rebate rates, and statements of rebate complexity and regulatory risk.

Q: Did the court find that Mylan’s statements were materially misleading? A: Yes, the court found that Mylan’s statements, when combined with the undisclosed misclassification, could have misled investors and were therefore materially misleading.

Q: What is the status of the class action litigation? A: The class action litigation is ongoing, with the court allowing the securities fraud claims against Mylan to proceed after denying the company’s motion to dismiss.

Sources

  1. Whitcomb Law PC: Mylan Securities Fraud Claims Over Medicaid Misclassification[1].
  2. PR Newswire: Summary Notice of Pendency of Class Action for All Purchasers and Acquirers of Mylan N.V. or Mylan Inc. Common Stock[2].
  3. Casetext: In re Mylan N.V. Sec. Litig., 16-CV-7926 (JPO)[3].
  4. Casetext: In re Mylan N.V. Sec. Litig., 666 F. Supp. 3d 266[4].

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