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Timeline: Insulin Market Under Scrutiny

The price of lifesaving diabetes drugs has skyrocketed over the past decade. And patients aren’t the only ones who have noticed. Five states and a federal prosecutor are demanding information from insulin manufacturers and the pharmaceutical industry’s financial middlemen.

Below, we detail when legal action related to insulin drugs began, with links to documents.

March 2016

The U.S. Attorney’s Office for the Southern District of New York launches the first of several civil investigative demands (CIDs), beginning with Sanofi and Novo Nordisk.

[documentcloud url="https://www.documentcloud.org/documents/4113098-Novo-Nordisk-Annual-Report-2016/annotations/384366.html"] The federal prosecutor’s demand of Novo Nordisk specifies information is needed regarding insulins Novolog, Novolin and Levemir, according to the company’s annual report; Sanofi reports the request for information is also in relation to pharmacy benefit managers and regarding top-selling insulin drug Lantus as well as Apidra since 2006, according to the company’s annual 20-F filing. July 2016 Eli Lilly discloses that the U.S. Attorney’s Office for the Southern District of New York issued a CID also for information related to pharmacy benefit managers, according to its July 2016 quarterly filing. August 2016 Express Scripts receives a CID from the U.S. Attorney’s Office for the Southern District of New York. It too notes the federal prosecutor is asking for information about relationships. No specific drugs are named, according to the company’s 2016 annual report. November 2016 Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) ask the Department of Justice and the Federal Trade Commission  to investigate whether insulin makers have colluded or engaged in anti-competitive behavior. January 2017 Minnesota’s attorney general launches what appears to be the first state investigation, issuing civil investigative demands to Sanofi and Novo Nordisk. [documentcloud url="https://www.documentcloud.org/documents/4113097-Sanofi-Form-20-F-2016/annotations/382711.html"] Sanofi specifies information is needed regarding insulin drugs Lantus and Toujeo, according to the company’s 20-F filing. Novo Nordisk reports the state lawmaker wants information relating to “pricing and trade practices” since  January 2008 to present regarding insulins Levemir and Tresiba, according to the company’s annual report. On Jan. 30, attorney Steve Berman of Hagens Berman files initial complaint in the U.S. District Court of Massachusetts against insulin makers Novo Nordisk, Sanofi and Eli Lilly. He alleges an “organized scheme to drive up prices at the expense of patients who need insulin drugs to live.” The case later transfers to New Jersey. February 2017 Berman’s lawsuit is transferred to New Jersey and combined with a related case filed by attorney James Cecchi, representing patients against the insulin makers. March 2017 Washington’s attorney general issues a CID to Sanofi echoing Minnesota’s request and specifying the request is for insulin drugs Lantus, Toujeo, Apidra and Soliqua from 2005 to present, according to the company’s half-year financial report. Frank Barnett and other patients file suit March 8 in the U.S. District Court of New Jersey against the insulin manufacturers, notably adding the nation’s largest pharmacy benefit managers Express Scripts, CVS Health and UnitedHealth Group as defendants. [documentcloud url="https://www.documentcloud.org/documents/4116774-Barnett-Et-Al-v-Novo-Nordisk-Eli-Lilly-Sanofi/annotations/384370.html"] Julia Boss, the Type 1 Diabetes Defense Foundation and other patients file suit on March 17 in the U.S. District Court of New Jersey against the three big insulin manufacturers as well as the pharmacy benefit managers. April 2017 CVS Health receives a CID from Washington’s AG seeking information regarding pricing and rebates for insulin and epinephrine products connected to a pending investigation. Under the bullet item “Insulin Products Investigation,” CVS states that the Washington attorney general’s office will share information with the attorneys general of California, Florida and Minnesota, which filed a CID in July. Scott Christensen and other patients file suit April 20 in the U.S. District Court of New Jersey alleging violations of the Sherman Antitrust Act. Defendants include Novo Nordisk, Eli Lilly, Sanofi, Express Scripts, CVS Health, UnitedHealth Group with its PBM division OptumRx. May 2017 Eli Lilly does not specify drugs but confirms it has a received a CID from Washington’s attorney general about the “pricing of our insulin products and our relationships with pharmacy benefit managers.” It also states New Mexico’s attorney general issued a CID related to “the pricing of our insulin products,” according to its quarterly financial filing. July 2017 CVS Health receives a CID from Minnesota’s AG seeking information regarding pricing and rebates for insulin and epinephrine products connected to a pending investigation, according to a quarterly filing. Eli Lilly says it has received a CID from Minnesota’s AG “relating to the pricing and sale of our insulin products.” California and Florida’s attorneys general requested information related to pricing of insulin products,  according to its quarterly filing. Sen. Amy Klobuchar (D-Minn.) sends letters to insulin manufacturers asking for “an explanation of the extreme price increases” of insulin.  Eli Lilly, Sanofi and Novo Nordisk each respond. September 2017 On Sept. 18, U.S. District Judge Brian Martinotti appoints Steve Berman and James Cecchi as interim lead counsel over a suit that combines the various civil lawsuits filed since the beginning of 2017 into one behemoth potential class-action suit. Martinotti notes that the team of Berman and Cecchi “has successfully tried similar claims against comparable defendants.”