Pfizer 2009 Annual Report Download - page 97

Notes to Consolidated Financial Statements
Pfizer Inc. and Subsidiary Companies
the anti-retaliation provisions of the Federal Civil False Claims Act, the Civil Rights Act of 1964 and applicable New York law, for
raising concerns about the alleged off-label promotion of Lipitor and about alleged instances of sexual harassment in the workplace,
and he seeks damages and the reinstatement of his employment. In May 2009, the court dismissed without prejudice the claims
alleging violations of the Federal Civil False Claims Act and the false claims acts of certain states. In February 2010, plaintiff filed an
amended complaint containing allegations concerning violations of the Federal Civil False Claims Act and false claims acts of
certain states that are substantially similar to the allegations in the original complaint.
Chantix/Champix
A number of individual lawsuits have been filed against us in various federal and state courts alleging suicide, attempted suicide and
other personal injuries as a result of the purported ingesting of Chantix, as well as economic loss. Plaintiffs in these actions seek
compensatory and punitive damages and the disgorgement of profits resulting from the sale of Chantix. In October 2009, the federal
cases were transferred for consolidated pre-trial proceedings to a Multi-District Litigation (In re Chantix (Varenicline) Products
Liability Litigation MDL-2092) in the U.S. District Court for the Northern District of Alabama.
In December 2008, a purported class action was filed against us in the Ontario Superior Court of Justice (Toronto Region) on behalf
of all individuals and third-party payers in Canada who have purchased and ingested Champix or reimbursed patients for the
purchase of Champix. This action asserts claims under Canadian product liability law, including with respect to the safety and
efficacy of Champix, and, on behalf of the putative class, seeks monetary relief, including punitive damages. In April and October
2009 and February 2010, respectively, substantially similar purported class actions were filed against us in the Superior Court of
Quebec (District of Montreal), the Court of Queen’s Bench of Alberta, Judicial District of Calgary, and the Superior Court of British
Columbia (Vancouver Registry).
Zosyn
In April 2006, Wyeth filed a citizen petition with the FDA asking it to refrain from approving any application for a generic product that
references Zosyn (piperacillin and tazobactam) unless the generic product complies with the U.S. Pharmacopeia standards on
particulate matter in injectable drugs and exhibits the same compatibility profile as Zosyn. Wyeth further requested that, in the event
the FDA chose to approve a generic product that did not exhibit the same compatibility profile as Zosyn, the FDA condition such
approval upon the applicant’s implementation of a risk-minimization action plan to address the confusion that would necessarily
arise as a result of such difference.
In September 2009, the FDA denied the principal requests in Wyeth’s citizen petition and approved applications by Orchid
Healthcare for a generic piperacillin/tazobactam product that does not exhibit the same compatibility profile as Zosyn. Following the
FDA’s decision, in September 2009, Wyeth brought suit in the U.S. District Court for the District of Columbia against the FDA and its
parent agency, the U.S. Department of Health and Human Services, seeking to overturn the FDA’s ruling on Wyeth’s citizen petition
and to have the generic approvals suspended and/or withdrawn. Orchid Healthcare and its U.S. marketing partner, Apotex Corp.,
intervened in the case. In September 2009, the court denied Wyeth’s motion for a temporary restraining order. Pending action by the
courts, the generic approvals granted by the FDA in September remain in effect. Wyeth understands that generic piperacillin/
tazobactam is currently being marketed in the U.S. pursuant to those approvals.
Thimerosal
Wyeth is a defendant in a number of suits by or on behalf of vaccine recipients alleging that exposure through vaccines to
cumulative doses of thimerosal, a preservative used in certain childhood vaccines formerly manufactured and distributed by Wyeth
and other vaccine manufacturers, causes severe neurological damage and/or autism in children. While several suits were filed as
purported nationwide or statewide class actions, all but one of the purported class actions have been dismissed, either by the courts
or voluntarily by plaintiffs. In the one remaining purported class action, the U.S. District Court for the Eastern District of Kentucky
dismissed all claims except plaintiffs’ fraud claim, which has been stayed. In addition to the suits alleging injury from exposure to
thimerosal, certain of the cases were brought by parents in their individual capacities for, among other things, loss of services and
loss of consortium of the injured child.
The National Childhood Vaccine Injury Act (the Vaccine Act) requires that plaintiffs alleging injury from childhood vaccines first bring
a claim under the Vaccine Act in the U.S. Court of Federal Claims. At the conclusion of that proceeding, plaintiffs may bring a lawsuit
against the manufacturer in federal or state court, provided that they have satisfied certain procedural requirements. Also under the
terms of the Vaccine Act, if a claim has not been adjudicated by the U.S. Court of Federal Claims within a specified time period after
filing, the claimant may opt out of the proceeding and pursue a lawsuit against the manufacturer by following certain procedures.
Some of the vaccine recipients who have sued Wyeth to date may not have satisfied the conditions to filing a lawsuit that are
mandated by the Vaccine Act. The claims brought by parents for, among other things, loss of services and loss of consortium of the
injured child are not covered by the Vaccine Act.
In July 2002, the U.S. Court of Federal Claims established an Omnibus Autism Proceeding with jurisdiction over petitions in which
vaccine recipients claim to suffer from autism or autism spectrum disorder as a result of receiving thimerosal-containing childhood
vaccines or the measles, mumps and rubella (MMR) vaccine. There currently are several thousand petitions pending in the Omnibus
Autism Proceeding. The court heard six test cases on claimants’ theories that either thimerosal-containing vaccines in combination
with the MMR vaccine or thimerosal-containing vaccines alone can cause autism or autism spectrum disorder. In February 2009, the
court rejected the three cases brought on the theory that a combination of MMR and thimerosal-containing vaccines caused
claimants’ conditions. The court in each case found that the scientific evidence against a connection between the vaccines and
autism was significantly stronger than the evidence presented by the claimants. Two of these cases have been appealed by the
plaintiffs to the U.S. Court of Appeals for the Federal Circuit. Decisions on the three test cases involving thimerosal-containing
vaccines alone are pending.
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