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The simple corporate scheme behind massive US Brand Drug Prices

My 7-year whistleblower effort
"People Before Profits"

Whistleblower (Qui Tam) Case Histories

Whistleblower (Qui Tam) Case Timelines:

  • January 2014: filed first FCA (qui tam) case in District Court of Rhode Island (D-RI)
    • Regarding U.S. multiple sclerosis (MS) market
    • Eight (8) major U.S. multiple sclerosis (MS) brand drugs
      • Biogen's Avonex/Pledigry and Tecfidera, Teva's Copaxone, Pfizer/EMD Serono's Rebif, Bayer's Betaseron, Novartis' Gilenya and Extavia
      • 8-10X U.S. price increases past decade-plus
      • Estimated $60+ billion financial harm to date and ongoing 
    • Pharmaceutical Defendants: Bayer, Biogen, EMD Serono, Novartis, Pfizer, Teva 
    • PBM Defendants: UnitedHealth, CVS/Aetna, Cigna/Express Scripts, Humana 

  • October 2015: filed second qui tam case in Southern District of New York (SDNY) 
    • Filed in different federal Court due to rising concerns regarding the DOJ investigation in D-RI 
    • Targeted fourteen (14) major U.S. cancer, insulin, rheumatoid arthritis and other drugs
    • Including AbbVie's Humira, Amgen's Enbrel, Sanofi's Lantus, Eli Lilly's Humulin, Novartis' Gleevec, Pfizer's Lyrica, Premarin and Viagra
    • 5-7X U.S. price increases past decade-plus
    • Estimated $114+ billion financial harm to date and ongoing  
    • Pharmaceutical Defendants: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, Sanofi-Aventis
    • PBM Defendants: UnitedHealth, CVS/Aetna, Cigna/Express Scripts, Humana 

Subsequent Case Developments:

  • Mid-to-late 2017: Due to our rising concerns about DOJ’s failure to investigate, we sought public unsealing of both qui tam cases by the District Courts 
  • March 2018: Government declined to intervene (i.e., to pursue the defendants) regarding both qui tam cases
  • April 2018: Both qui tam cases were publicly unsealed
  • July/August 2018: We served all defendants in both qui tam actions with Amended Complaints 
  • October 2, 2018: SDNY defendants filed Motion to Dismiss the SDNY case
  • November 16, 2018: We received a phone call from DOJ indicating, for the first time, its plans to seek dismissal of both qui tam cases (SDNY and D-RI) over our objection
  • November 19, 2018: We filed an Opposition to the SDNY Defendants’ Motions to Dismiss the case
  • November 19, 2018: D-RI defendants filed Motions to Dismiss the qui tam case
  • December 22, 2018: DOJ filed Motions to Dismiss both the D-RI and SDNY qui tam cases over our objection
  • January 11, 2019: We filed Oppositions to the DOJ motions to dismiss in both the D-RI and SDNY Courts
  • January 13, 2019: John R. Borzilleri, M.D. filed an Affidavit, under oath in both Court cases, in support of opposing the DOJ Motions to Dismiss. The Affidavit discussed DOJ admissions of failing to investigate key aspects of the qui tam cases
  • February 3, 2019: We filed an Opposition to the Defendants’ Motion to Dismiss in the D-RI case
  • February 6, 2019: DOJ filed Replies in both Courts in Support its Motions to Dismiss both qui tam cases
  • July 16, 2019: Order/Opinion by SDNY Court granting DOJ’s Motion to Dismiss the qui tam SDNY Court dismissed the qui tam case against all the pharmaceutical and PBM defendants. The Court dismissed all case documents on file, without apparent review
  • September 13, 2019: We filed a Notice of Appeal of the SDNY District Court decision with the Second Circuit, seeking to reverse the DOJ case dismissal
  • September 26, 2019: D-RI Court hearing regarding the DOJ Motion to Dismiss
  • September 27, 2019: D-RI Court text order granting DOJ Motion to Dismiss. The D-RI Court dismissed the qui tam case against all the pharmaceutical and PBM defendants. The Court dismissed all pending qui tam case documents on file, without apparent review
  • October 21, 2019: The D-RI Court issued its written Opinion regarding the September 27, 2019 text order
  • December 23, 2019: We filed our brief with the Second Circuit Court of Appeals seeking reversal of the SDNY District Court's Granting of DOJ's Motion to Dismiss

 

 

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