Pfizer 2008 Annual Report Download - page 89

Notes to Consolidated Financial Statements
Pfizer Inc and Subsidiary Companies
All of these actions arise out of a 1996 pediatric clinical study of Trovan, an antibiotic then in late-stage development, that was
conducted during a severe meningitis epidemic in Kano. The actions allege, among other things, that the study was conducted
without proper government authorization and without the informed consent of the parents or guardians of the study participants and
that it resulted in injury or death to a number of study participants. In the civil actions, the federal government is seeking more than
$6 billion in damages and the Kano state government is seeking $2.075 billion in damages for, among other things, the costs
incurred to provide treatment, compensation and support for the alleged victims and their families; the costs of unrelated health
initiatives that failed, allegedly due to societal misgivings attributable to the Trovan study; and general damages. We believe that we
have strong defenses in these actions.
The 1996 Trovan clinical study also has been the subject of two civil lawsuits filed against Pfizer in the U.S. District Court for the
Southern District of New York on behalf of the study participants. Both of these actions assert that Pfizer violated the federal Alien
Tort Statute, and one of the actions also asserts that Pfizer violated the Connecticut Unfair Trade Practices Act and the Connecticut
Products Liability Act, in connection with the 1996 Trovan clinical study. The District Court dismissed both cases in 2005, and the
plaintiffs appealed the decisions to the U.S. Court of Appeals for the Second Circuit. In January 2009, the Second Circuit reversed
the District Court’s dismissal of both actions, and remanded them to the District Court for further proceedings, on the ground that the
District Court erred in holding that it did not have subject matter jurisdiction over the plaintiffs’ claims under the Alien Tort Statute.
Hormone-Replacement Therapy
Pfizer and certain wholly owned subsidiaries and limited liability companies, along with several other pharmaceutical manufacturers,
have been named as defendants in a number of lawsuits in various federal and state courts alleging personal injury resulting from
the use of certain estrogen and progestin medications prescribed for women to treat the symptoms of menopause. Plaintiffs in these
suits allege a variety of personal injuries, including breast 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 the products 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), and Provera, Ogen, Depo-Estradiol, Estring and generic MPA, all of which
remain approved by the FDA for use in the treatment of menopause. 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.
This litigation originally included both individual actions as well as various purported nationwide and statewide class actions.
However, as a result of the voluntary dismissal of certain purported class actions and the withdrawal of the class action allegations
by the plaintiffs in certain other actions, this litigation now consists of individual actions and a few purported statewide class actions.
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. In January 2009, the action was removed to the U.S. District
Court for the District of Nevada. The action seeks monetary relief, including civil penalties and treble damages.
Viagra
A number of lawsuits, including purported class actions, have been filed against us in various federal and state courts alleging that
Viagra causes certain types of visual injuries. The plaintiffs in the purported class actions seek to represent nationwide and certain
statewide classes of Viagra users. All of the actions seek damages for personal injury, and the purported class actions also seek
medical monitoring. In January 2006, the federal cases were transferred for consolidated pre-trial proceedings to a Multi-District
Litigation (In re Viagra Products Liability Litigation MDL-1724) in the U.S. District Court for the District of Minnesota.
Zoloft
A number of individual lawsuits have been filed against us in various federal and state courts alleging personal injury as a result of
the purported ingesting of Zoloft.
Mirapex
A number of individual lawsuits seeking damages have been filed against us and Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI)
in various U.S. federal and state courts and one purported class action has been filed in Canada alleging that Mirapex, a treatment
for Parkinson’s disease, causes certain impulse-control disorders. We co-promoted Mirapex with BIPI until May 2005 but, as a result
of the sale of our interests in this product to BIPI, we no longer manufacture or sell Mirapex. In June 2007, all of the U.S. federal
cases were transferred for consolidated pre-trial proceedings to a Multi-District Litigation (In re Mirapex Products Liability Litigation
MDL -1836) in the U.S. District Court for the District of Minnesota. We and BIPI have agreed to indemnify each other with respect to
portions of certain of the claims in these actions. We and BIPI have resolved or are in the process of resolving a majority of the
lawsuits pending in the U.S. on terms we consider favorable to the Company.
Neurontin
A number of lawsuits, including purported class actions, have been filed against us in various federal and state courts alleging
claims arising from the promotion and sale of Neurontin. The plaintiffs in the purported class actions seek to represent nationwide
and certain statewide classes consisting of persons, including individuals, health insurers, employee benefit plans and other third-
party payers, who purchased or reimbursed patients for the purchase of Neurontin that allegedly was used for indications other than
those included in the product labeling approved by the FDA. In October 2004, many of the suits pending in federal courts, including
individual actions as well as purported class actions, were transferred for consolidated pre-trial proceedings to a Multi-District
Litigation (In re Neurontin Marketing, Sales Practices and Product Liability Litigation MDL-1629) in the U.S. District Court for the
District of Massachusetts. Purported class actions also have been filed against us in various Canadian provincial courts alleging
claims arising from the promotion and sale of Neurontin and generic gabapentin.
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