Nathaniel C. Simon

Ongoing Cases

• Celgene Corp, Inc.

  CASE CAPTION	In re Celgene Corporation Securities Litigation
  COURT	United States District Court for the District of New Jersey
  CASE NUMBER	2:18-cv-04772-JMV-JBC
  JUDGE	Honorable John Michael Vazquez and Honorable James B. Clark, III
  PLAINTIFF	AMF Pensionsförsäkring AB (“AMF”)
  DEFENDANTS	Celgene Corporation (“Celgene”), Scott A. Smith, Terrie Curran, and Philippe Martin
  CLASS PERIOD	April 27, 2017 through April 27, 2018, inclusive

  This securities fraud case involves Celgene’s misrepresentations and omissions about two billion dollar drugs, Otezla and Ozanimod, that Celgene touted as products that would make up for the anticipated revenue drop following the patent expiration of Celgene’s most profitable drug, Revlimid.

  Celgene launched Otezla, a drug treating psoriasis and psoriatic arthritis, in 2014. Celgene primed the market that Otezla sales were poised to sky-rocket, representing that Otezla net product sales would reach $1.5 billion to $2 billion by 2017. Throughout 2015 and 2016, Defendants represented that Celgene was on-track to meet the 2017 sales projection. As early as mid-2016, however, Defendants received explicit internal warnings that the 2017 projection was unattainable, but continued to reaffirm the 2017 target to investors. By October 2017, however, Celgene announced that the Company had slashed the 2017 guidance by more than $250 million and lowered the 2020 Inflammatory & Immunology (“I&I”) guidance by over $1 billion. Celgene’s stock price plummeted on the news.

  Ozanimod, a drug treating multiple sclerosis, is another product in Celgene’s I&I pipeline, and was initially developed by a different company, Receptos. In July 2015, Celgene purchased Receptos for $7.2 billion and projected annual Ozanimod sales of up to $6 billion despite the fact that Ozanimod was not yet approved by the U.S. Food and Drug Administration (“FDA”).

  Celgene told investors that it would file a New Drug Application (“NDA”) for Ozanimod with the FDA in 2017. Unbeknownst to investors, however, Celgene discovered a metabolite named CC112273 (the “Metabolite”) through Phase I testing that Celgene started in October 2016, which triggered the need for extensive testing that was required before the FDA would approve the drug. Despite the need for this additional Metabolite testing that would extend beyond 2017, Defendants continued to represent that Celgene was on track to submit the NDA before the end of 2017 and concealed all information about the Metabolite.  In December 2017, without obtaining the required Metabolite study results, Celgene submitted the Ozanimod NDA to the FDA. Two months later, the FDA rejected the NDA by issuing a rare “refuse to file,” indicating that the FDA “identifie[d] clear and obvious deficiencies” in the NDA.  When the relevant truth was revealed concerning Ozanimod, Celgene’s stock price fell precipitously, damaging investors.   

  On February 27, 2019, AMF filed a 207-page Second Amended Consolidated Class Action Complaint against Celgene and its executives under Section 10(b) of the Securities Exchange Act. On December 19, 2019, U.S. District Judge John Michael Vasquez issued a 49-page opinion sustaining AMF’s claims as to (1) Celgene’s and Curran’s misstatements regarding Otezla being on track to meet Celgene’s 2017 sales projections, and (2) Celgene’s, Martin’s, and Smith’s misstatements about the state of Ozanimod’s testing and prospects for regulatory approval.

  On November 29, 2020, Judge Vasquez certified a class of “All persons and entities who purchased the common stock of Celgene Corp. between April 27, 2017 through and April 27, 2018, and were damaged thereby” and appointed Kessler Topaz Meltzer & Check as Class Counsel. Discovery is ongoing.

• Mylan N.V.

  CASE CAPTION	In re Mylan N.V. Securities Litigation
  COURT	United States District Court for the Western District of Pennsylvania
  CASE NUMBER	2:20-cv-00955-NR
  JUDGE	Honorable J. Nicholas Ranjan
  PLAINTIFF	Public Employees’ Retirement System of Mississippi (“MPERS”)
  DEFENDANTS	Mylan N.V. (“Mylan” or the “Company”), Heather Bresch, Rajiv Malik, Anthony Mauro, and Kenneth Parks
  CLASS PERIOD	February 16, 2016 through May 7, 2019, inclusive

  This securities fraud class action stems from Defendants’ promotion of Mylan’s unique ability to manufacture quality drugs across a broad product line while concealing that the Company was experiencing widespread product quality issues at its manufacturing facilities, including at its flagship manufacturing plant in Morgantown, West Virginia.

  Mylan is one of the largest drug manufacturers in the world, selling several thousand different drug products.  During the Class Period, Mylan developed and manufactured many of these products at its Morgantown plant.  The Morgantown plant, as with all drug manufacturing facilities, received inspections by the U.S. Food and Drug Administration (“FDA”)  to ensure that its quality and safety testing was complete, consistent, accurate, and free from manipulation.  Mylan publicly acknowledged that complying with FDA regulations was critical to its business and profitability. 

  Yet, despite this acknowledgement, Mylan encountered significant regulatory issues at its manufacturing plants. These issues were largely unknown to the investing public.  In 2016, a surprise FDA inspection of Morgantown substantiated a former Mylan employee’s account that, under the direct leadership of President Rajiv Malik, Mylan employees had been manipulating drug test results to achieve passing quality control results, and deliberately corrupting testing data.  Following this investigation, Malik attended meetings with the FDA where officials told him they were “stunned” by Mylan’s “egregious” violations.   Just two years later, the FDA conducted another surprise investigation into the Morgantown facility. This investigation culminated in the FDA detailing thirteen significant deficiencies in Mylan’s operations and found that, among other violations, Mylan’s attempts to remedy its previous deficiencies identified during the FDA’s 2016 inspection were “inadequate,” and that Mylan exhibited poor quality control oversight, major lapses in equipment cleaning, and ineffective controls. 

  MPERS filed a 137-page complaint in November 2020 on behalf of a putative class of investors alleging that Mylan and its former executives violated Section 10(b) of the Securities Exchange Act.  As alleged, during the Class Period,  Mylan’s CEO Heather Bresch and President Malik stressed Mylan’s ability to produce a significant volume of drugs across product lines while “meeting or exceeding” “stringent” quality standards and that this ability differentiated Mylan from competitors. Unbeknownst to investors, however, its manufacturing facilities, including at its flagship Morgantown facility, were rife with systemic, egregious, and long-standing deficiencies.  As multiple whistleblowers, Mylan employees, and the FDA told Mylan during the Class Period, the company’s quality failures were a by-product of management’s exclusive focus on production volume so as to increase Mylan’s bottom line.  These failures exposed Mylan to serious regulatory penalties, costly production disruptions, and expensive remediation. 

  At the end of the Class Period, Mylan finally admitted that its focus on generating massive volumes of drugs was unsustainable, and it had to halt production at Morgantown and dramatically reduce Mylan’s generics portfolio going forward. When the relevant truth was finally revealed to investors, Mylan’s stock price declined precipitously, materially damaging investors.      

  Defendants’ motion to dismiss is pending.

Representative Outcomes

• Allergan Generic Drug Pricing

  Kessler Topaz represented Lead Plaintiff Sjunde-AP Fonden, one of Sweden’s largest pension funds, in this long-running securities fraud class action before The Honorable Katharine S. Hayden of the United States District Court for the District of New Jersey. The $130 million recovery is the first settlement of a federal securities case arising out of the industrywide generic drug price-fixing scandal which first came to light when Congress launched an investigation into the historic increases in generic drug prices. The price-fixing conspiracy, led by Allergan and several other drug makers, is believed to be the largest domestic pharmaceutical cartel in U.S. history. Shareholders alleged that notwithstanding Allergan’s prominent role in this illicit scheme, the company repeatedly misrepresented to investors that it was not engaged in anticompetitive conduct—even as Allergan became ensnared in an investigation by the U.S. Department of Justice and 46 state attorneys general.

  For four years, a team of Kessler Topaz litigators prosecuted these claims from the initial investigation and drafting of the complaint through full fact discovery and class certification proceedings. On August 6, 2019, Judge Hayden issued a 31-page opinion denying defendants’ motions to dismiss the complaint, sustaining investors’ claims in full, and firmly establishing a shareholder-plaintiff’s ability to pursue securities fraud claims based on the concealment of an underlying antitrust conspiracy. The parties’ settlement was approved by the Court on November 22, 2021, marking a historic recovery for investors and sending a strong message to drug makers engaged in anticompetitive conduct.

• New Jersey Federal Court Approves $130 Million Settlement for Investors in Allergan Generic Drug Price-Fixing Securities Litigation

  November 22, 2021