Eli Lilly 2015 Annual Report Download - page 99

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FINANCIAL REPORT
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actions allege that Actos caused or contributed to their bladder cancer. Almost all of the active cases have
been consolidated in federal multi-district litigation (MDL) in the Western District of Louisiana or are pending
in a coordinated state court proceeding in California or a coordinated state court proceeding in Illinois.
In April 2015, Takeda announced they will pay approximately $2.4 billion to resolve the vast majority of the
U.S. product liability lawsuits involving Actos, including the case of Allen, et al. v. Takeda Pharmaceuticals, et
al., no. 6:12-md-00064, in which a judgment of approximately $28 million was entered against Takeda and a
judgment of approximately $9 million was entered against us. In September 2015, Takeda announced that
more than 96 percent of eligible claimants have opted into the resolution program that was announced in April
2015. Takeda is now evaluating the submissions to determine whether they satisfy various criteria specified
under the terms of the resolution program. Takeda expects the resolution program to become effective upon
completion of that review.
Although the vast majority of U.S. product liability lawsuits involving Actos are included in the resolution
program announced in April 2015, there may be additional cases pending against Takeda and us following
completion of the resolution program. Our agreement with Takeda calls for Takeda to defend and indemnify us
against our losses and expenses with respect to the U.S. litigation arising out of the manufacture, use, or sale
of Actos and other related expenses in accordance with the terms of the agreement. We believe we are
entitled to full indemnification of our losses and expenses in the U.S. cases; however, there can be no
guarantee we will ultimately be successful in obtaining full indemnification.
We are also named along with Takeda as a defendant in four purported product liability class actions in
Canada related to Actos, including two in Ontario (Casseres et al. v. Takeda Pharmaceutical North America,
Inc., et al. and Carrier et al. v. Eli Lilly et al.), one in Quebec (Whyte et al. v. Eli Lilly et al.), and one in Alberta
(Epp v. Takeda Canada et al.). We promoted Actos in Canada until 2009.
We believe these lawsuits are without merit, and we and Takeda are prepared to defend against them
vigorously.
Byetta Product Liability Litigation
We are named as a defendant in approximately 510 Byetta product liability lawsuits in the U.S. involving
approximately 1,035 plaintiffs. Approximately 110 of these lawsuits, covering about 630 plaintiffs, are filed in
California state court and coordinated in a Los Angeles Superior Court. Approximately 395 lawsuits, covering
about 400 plaintiffs, are filed in federal court, the majority of which are coordinated in a MDL in the U.S.
District Court for the Southern District of California. The remaining approximately five lawsuits, representing
about five plaintiffs, are in various state courts. Approximately 450 of the lawsuits, involving approximately 690
plaintiffs, contain allegations that Byetta caused or contributed to the plaintiffs' cancer (primarily pancreatic
cancer or thyroid cancer). The federal and state trial courts granted summary judgment in favor of us and co-
defendants on the claims alleging pancreatic cancer; those rulings are being appealed by the plaintiffs. We
are aware of approximately 10 additional claimants who have not yet filed suit. These additional claims allege
damages for pancreatic cancer or thyroid cancer. We believe these lawsuits and claims are without merit and
are prepared to defend against them vigorously.
Cymbalta® Product Liability Litigation
In October 2012, we were named as a defendant in a purported class-action lawsuit in the U.S. District Court
for the Central District of California (Saavedra et al v. Eli Lilly and Company) involving Cymbalta. The
plaintiffs, purporting to represent a class of all persons within the U.S. who purchased and/or paid for
Cymbalta, asserted claims under the consumer protection statutes of four states, California, Massachusetts,
Missouri, and New York, and sought declaratory, injunctive, and monetary relief for various alleged economic
injuries arising from discontinuing treatment with Cymbalta. In December 2014, the district court denied the
plaintiffs' motion for class certification. Plaintiffs filed a petition with the U.S. Court of Appeals for the Ninth
Circuit requesting permission to file an interlocutory appeal of the denial of class certification, which was
denied. Plaintiffs filed a second motion for certification under the consumer protection acts of New York and
Massachusetts. The district court denied that motion for class certification in July 2015. The district court
dismissed the suit and plaintiffs are appealing to the U.S. Court of Appeals for the Ninth Circuit.
Additionally, we are named in approximately 140 lawsuits involving approximately 1,300 plaintiffs filed in
various federal and state courts alleging injuries arising from discontinuation of treatment with Cymbalta.