The original complaint charges Amgen and certain of its officers and directors with violations of the Securities Exchange Act of 1934. Amgen, the largest biotechnology company in the world, makes and sells Epogen and Aranesp, erythropoiesis-stimulating agents, a type of drug which encourages the creation of oxygen carrying red blood cells.
The complaint alleges that during the Class Period, defendants marketed Aranesp and Epogen to doctors for off-label uses. As a result, Amgen sold several hundred million dollars worth of drugs each year for these off-label uses. In October 2006, a group of researchers halted a clinical study of head and neck cancer patients treated with Aranesp because more deaths occurred in patients taking Aranesp than in those taking a placebo. Defendants did not disclose these results to investors. On February 16, 2007, a publication called The Cancer Letter published an article about the results of the study and on March 9, 2007, the FDA mandated a "black box" warning regarding the off-label use of Aranesp and Epogen. These revelations caused Amgen's stock price to decline.
On August 1, 2007, the Court consolidated several related actions and granted the Connecticut Retirement Plans and Trust Funds motion for appointment of lead plaintiff and for approval of lead plaintiff selection of lead counsel. On October 1, 2007, a Consolidated Amended Class Action Complaint was filed and the defendants responded by filing a motion to dismiss the complaint on November 8, 2007.
According to a press release dated February 6, 2008, Judge Philip S. Gutierrez of the U.S. District Court for the Central District of California on Friday denied Amgen's motion to dismiss claims by lead shareholder Connecticut Retirement Plans and Trust Funds that positive statements made by company officials regarding the safety of Aranesp and Epogen were knowingly at odds with clinical studies that had raised concerns. The securities class action accuses Amgen and certain of its officers and directors of engaging in a scheme to deceive the investing public about the true value of the company's stock. Judge Gutierrez granted Amgen's motion to toss charges against five of the nine individual Amgen officers and directors named in the suit, dismissing without prejudice outside directors… However, he did allow the plaintiffs 30 days to file an amended complaint in order to include those defendants.
The remaining defendants answered the complaint on April 2, 2008 and the parties soon after engaged in discovery proceedings. On March 3, 2009, the plaintiff filed a motion to certify the class. On August 12, 2009, Judge Philip S. Gutierrez granted the motion for class certification. The defendants filed an appeal to that order granting certification. The defendants filed a motion to stay the case, which was granted on February 2, 2010.
According to a news article dated November 8, 2011, a U.S. appeals panel upheld the certification of a securities class action accusing biotech company Amgen of failing to disclose safety information about two products used to treat anemia. Amgen allegedly exaggerated the safety of its products for Food and Drug Administration-approved uses, according to court documents. The plaintiff, a state pension fund, also alleged Amgen misrepresented its marketing practices, claiming it promoted its products solely for on-label uses when it in fact promoted significant off-label usage. The 9th U.S. Circuit Court of Appeals ruled on Tuesday that a lower court did not abuse its discretion in certifying the class. In order to win class certification, the plaintiff must plausibly allege -- but need not prove -- that Amgen's misrepresentations are material, the three-judge appeals panel ruled.
On April 3, 2013, the 9th U.S. Circuit Court of Appeals issued a Mandate affirming the Judgment of the District Court.
On July 20, 2016, the parties filed a Stipulation of Settlement. The Settlement was preliminarily approved on August 9. The Settlement was granted final approval and this case was dismissed on October 25.