Eli Lilly 2012 Annual Report Download - page 92

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80
manufacturers have opposed the European Patent Office's decision to grant a vitamin dosage regimen patent,
and are seeking revocation of that patent.
We believe the challenges to the Alimta patents are without merit and expect to prevail in this litigation.
However, it is not possible to determine the outcome of this litigation, and accordingly, we can provide no
assurance that we will prevail. An unfavorable outcome could have a material adverse impact on our future
consolidated results of operations, liquidity, and financial position. We expect a loss of exclusivity for Alimta
would result in a rapid and severe decline in future revenues in the relevant market.
Byetta Product Liability Litigation
We have been named as a defendant in approximately 140 Byetta product liability lawsuits involving
approximately 520 plaintiffs. Approximately 100 of these lawsuits, covering about 485 plaintiffs, are filed in
California and coordinated in a Los Angeles Superior Court. We are aware of approximately 465 additional
claimants who have not yet filed suit. The majority of the claims allege damages for pancreatitis. A smaller
number of claimants allege that Byetta caused or contributed to their pancreatic cancer. We believe these
claims are without merit and are prepared to defend against them vigorously.
Diethylstilbestrol Product Liability Litigation
In approximately 90 U.S. lawsuits against us involving approximately 90 claimants, plaintiffs seek to recover
damages on behalf of children or grandchildren of women who were prescribed diethylstilbestrol (DES)
during pregnancy in the 1950s and 1960s. Approximately 80 of these claimants allege that they were indirectly
exposed in utero to the medicine and later developed breast cancer as a consequence. We believe these
claims are without merit and are prepared to defend against them vigorously.
Zyprexa Product Liability Litigation
We are a defendant in approximately 10 Zyprexa product liability lawsuits in the U.S. covering approximately
10 plaintiffs. The lawsuits allege a variety of injuries from the use of Zyprexa. The claims seek substantial
compensatory and punitive damages and typically accuse us of inadequately testing for and warning about
side effects of Zyprexa. Many of the claims also allege that we improperly promoted the drug. We believe
these claims are without merit and are prepared to defend against them vigorously.
Product Liability Insurance
Because of the nature of pharmaceutical products, it is possible that we could become subject to large
numbers of product liability and related claims in the future. In the past several years, we have been unable to
obtain product liability insurance due to a very restrictive insurance market. Therefore, for substantially all of
our currently marketed products, we have been and expect that we will continue to be completely self-insured
for product liability losses. The DES claims are covered by insurance, subject to deductibles and coverage
limits. There is no assurance that we will be able to fully collect from our insurance carriers in the future.