Pfizer 2012 Annual Report Download - page 106

Notes to Consolidated Financial Statements
Pfizer Inc. and Subsidiary Companies
2012 Financial Report 105
of 2012, and we do not expect a substantial change in the rate of new actions being filed. Plaintiffs in these suits allege a variety of personal
injuries, including breast cancer, ovarian cancer, stroke and heart disease. Certain co-defendants in some of these actions have asserted
indemnification rights against Pfizer and its affiliated companies. The cases against Pfizer and its affiliated companies involve one or more of
the following products, all of which remain approved by the FDA: femhrt (which Pfizer divested in 2003); Activella and Vagifem (which are
Novo Nordisk products that were marketed by a Pfizer affiliate from 2000 to 2004); Premarin, Prempro, Aygestin, Cycrin and Premphase
(which are legacy Wyeth products); and Provera, Ogen, Depo-Estradiol, Estring and generic MPA (which are legacy Pharmacia & Upjohn
products). The federal cases have been transferred for consolidated pre-trial proceedings to a Multi--District Litigation (In re Prempro Products
Liability Litigation MDL-1507) in the U.S. District Court for the Eastern District of Arkansas. Certain of the federal cases have been remanded
to their respective District Courts for further proceedings including, if necessary, trial.
This litigation consists of individual actions, a few purported statewide class actions and a purported provincewide class action in Quebec,
Canada, a statewide class action in California and a nationwide class action in Canada. In March 2011, in an action against Wyeth seeking the
refund of the purchase price paid for Wyeth’s hormone-replacement therapy products by individuals in the State of California during the period
from January 1995 to January 2003, the U.S. District Court for the Southern District of California certified a class consisting of all individual
purchasers of such products in California who actually heard or read Wyeth’s alleged misrepresentations regarding such products. This is the
only hormone-replacement therapy action to date against Pfizer and its affiliated companies in the U.S. in which a class has been certified. In
addition, in August 2011, in an action against Wyeth seeking damages for personal injury, the Supreme Court of British Columbia certified a
class consisting of all women who were prescribed Premplus and/or Premarin in combination with progestin in Canada between January 1,
1997 and December 1, 2003 and who thereafter were diagnosed with breast cancer.
Pfizer and its affiliated companies have prevailed in many of the hormone-replacement therapy actions that have been resolved to date,
whether by voluntary dismissal by the plaintiffs, summary judgment, defense verdict or judgment notwithstanding the verdict; a number of
these cases have been appealed by the plaintiffs. Certain other hormone-replacement therapy actions have resulted in verdicts for the
plaintiffs and have included the award of compensatory and, in some instances, punitive damages; each of these cases has been appealed by
Pfizer and/or its affiliated companies. The decisions in a few of the cases that had been appealed by Pfizer and/or its affiliated companies or
by the plaintiffs have been upheld by the appellate courts, while several other cases that had been appealed by Pfizer and/or its affiliated
companies or by the plaintiffs have been remanded by the appellate courts to their respective trial courts for further proceedings. Trials of
additional hormone-replacement therapy actions are underway or scheduled in 2013.
Most of the unresolved actions against Pfizer and/or its affiliated companies have been outstanding for more than five years and could take
many more years to resolve. However, opportunistic settlements could occur at any time. The litigation process is time-consuming, as every
hormone-replacement action being litigated involves contested issues of medical causation and knowledge of risk. Even though the vast
majority of hormone-replacement therapy actions concern breast cancer, the underlying facts (e.g., medical causation, family history, reliance
on warnings, physician/patient interaction, analysis of labels, actual, provable injury and other critical factors) can differ significantly from
action to action, and the process of discovery has not yet begun for a majority of the unresolved actions. In addition, the hormone-replacement
therapy litigation involves fundamental issues of science and medicine that often are uncertain and continue to evolve.
As of February 2013, Pfizer and its affiliated companies had settled, or entered into definitive agreements or agreements-in-principle to settle,
approximately 95% of the hormone-replacement therapy actions pending against us and our affiliated companies. Since the inception of this
litigation, we have recorded aggregate charges with respect to those actions, as well as with respect to the actions that have resulted in
verdicts against us or our affiliated companies, of approximately $1.6 billion. In addition, we have recorded aggregate charges of
approximately $100 million that provide for the expected costs to resolve all remaining hormone-replacement therapy actions against Pfizer
and its affiliated companies, excluding the class actions and purported class actions referred to above. The approximately $100 million
charges are an estimate and, while we cannot reasonably estimate the range of reasonably possible loss in excess of the amounts accrued for
these contingencies given the uncertainties inherent in this product liability litigation, as described above, additional charges may be required
in the future.
•Government Inquiries; Action by the State of Nevada
Pfizer and/or its affiliated companies also have received inquiries from various federal and state agencies and officials relating to the marketing
of their hormone-replacement products. In November 2008, the State of Nevada filed an action against Pfizer, Pharmacia & Upjohn Company
and Wyeth in state court in Nevada alleging that they had engaged in deceptive marketing of their respective hormone-replacement therapy
medications in Nevada in violation of the Nevada Deceptive Trade Practices Act. The action seeks monetary relief, including civil penalties and
treble damages. In February 2010, the action was dismissed by the court on the grounds that the statute of limitations had expired. In July
2011, the Nevada Supreme Court reversed the dismissal and remanded the case to the district court for further proceedings.
Effexor
•Personal Injury Actions
A number of individual lawsuits and multi-plaintiff lawsuits have been filed against us and/or our subsidiaries in various federal and state courts
alleging personal injury as a result of the purported ingestion of Effexor.
•Antitrust Actions
Beginning in May 2011, actions, including purported class actions, were filed in various federal courts against Wyeth and, in certain of the
actions, affiliates of Wyeth and certain other defendants relating to Effexor XR, which is the extended-release formulation of Effexor. The
plaintiffs in each of the class actions seek to represent a class consisting of all persons in the U.S. and its territories who directly purchased,