Eli Lilly 2012 Annual Report Download - page 32

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Item 3. Legal Proceedings
We are a party to various currently pending legal actions, government investigations, and environmental
proceedings, and we anticipate that such actions could be brought against us in the future. The most
significant of these matters are described below or, as noted, in Item 8, "Financial Statements and
Supplementary Data—Note 15, Contingencies." While it is not possible to determine the outcome of the legal
actions, investigations and proceedings brought against us, we believe that, except as otherwise specifically
noted in Item 8—Note 15, the resolution of all such matters will not have a material adverse effect on our
consolidated financial position or liquidity, but could be material to our consolidated results of operations in
any one accounting period.
Legal Proceedings Described in Note 15 to the Consolidated Financial Statements
See Item 8, "Financial Statements and Supplementary Data—Note 15, Contingencies," for information on
various legal proceedings, including but not limited to:
• The U.S. patent litigation involving Alimta
• The U.S. product liability litigation involving Byetta, DES, and Zyprexa.
That information is incorporated into this Item by reference.
Other Product Liability Litigation
We are currently a defendant in a variety of other product liability lawsuits in the U.S. involving primarily
Prozac, Darvon, Actos®, and Cymbalta.
We have been named as a defendant in seven U.S. lawsuits involving claimants alleging that the
antidepressant Prozac caused or contributed to birth defects in the children of women who ingested the drug
during pregnancy. We are aware of approximately 340 additional claims related to birth defects, which have
not yet been filed. We believe these claims are without merit and are prepared to defend against them
vigorously.
Along with several other manufacturers, we have been named as a defendant in approximately 125 cases in
the U.S. involving approximately 1,890 claimants related to the analgesic Darvon and related formulations of
propoxyphene. These cases generally allege various cardiac injuries. Almost all of these cases have been
consolidated in a federal multi-district litigation in the Eastern District of Kentucky or are pending in state and
federal courts in California. Two lawsuits have been filed as putative class actions in the U.S. District Court for
the Eastern District of Louisiana (Ballard, et al. v. Eli Lilly and Company et al. and Lewis v. Eli Lilly and
Company and Xanodyne Pharmaceuticals, Inc.) against Lilly and other manufacturers seeking to assert
product liability claims on behalf of U.S. residents who ingested propoxyphene pain products and allegedly
sustained personal injuries. In Lewis, Lilly was voluntarily dismissed with prejudice and the dismissal cannot
be appealed. In Ballard, Lilly was dismissed with prejudice following a dispositive motion; however, the case
remains open as other defendants have not been dismissed and there is currently no final appealable order.
We transferred the U.S. regulatory approvals and all marketing rights to our propoxyphene products in 2002 to
AAi Pharma, which subsequently transferred all such approvals and marketing rights to Xanodyne
Pharmaceuticals, Inc. We believe these claims are without merit and are prepared to defend against them
vigorously.
We have been named along with Takeda Chemical Industries, Ltd., and Takeda affiliates as a defendant in
product liability cases in the U.S. related to the diabetes medication Actos, which we co-promoted with Takeda
in the U.S. from 1999 until September 2006. In addition, we have been 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 Brewer et al. v. Takeda Canada et
al.), one in Quebec (Whyte et al. v. Eli Lilly et al.), and one in Alberta (Epp v. Takeda Canada et al.). We have
also been named along with Takeda in an individual action for damages in Ontario, Canada (Antonacci v.
Takeda Pharmaceutical Company Ltd, et al.). We promoted Actos in Canada until 2009. In general, plaintiffs
in these actions allege that Actos caused or contributed to their bladder cancer. Under our agreement with
Takeda, we will be indemnified by Takeda for our losses and expenses with respect to the U.S. litigation and