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Pfizer – Can It Weather the Current Storm?

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A
review of Pfizer’s most recent 10-K filings with the Securities & Exchange
Commission leads to concerns about whether Pfizer’s legal woes are quickly
growing out of control.  The list of
drugs that are currently subject to litigation appears to be growing longer and
longer.  The filings note some of the old
problems for the pharmaceutical giant – such as the horrific story of the harm
inflicted on Nigerian children in connection with the controversial antibiotic
Trovan, a drug that Pfizer pulled from the market in the United States several
years ago after reports of drug-induced liver failure and death and Rezulin,
the diabetes drug removed from the market long ago (also due to liver
toxicity).

Pfizer
is also facing thousands of lawsuits filed by women who developed breast cancer
after ingesting various hormone replacement therapy drugs.  These HRT drugs include various products
manufactured by Upjohn, Pfizer, and Novo Nordisk including Provera, Activella,
Vagifem, Ogen, Estring, Depo-Estradiol, and generic medroxyprogesterone. More
than five thousands lawsuits have been pending in multi-district proceedings in
federal court in Little Rock. There are also more than 1,000 cases pending in
state courts in Pennsylvania, New Jersey, New York, and Nevada.  It has now been nearly six years since
publication of the Women’s Health Initiative (WHI) study, which confirmed that
the HRT drugs are promoters of hormone-positive cancers and are also associated
with an increased risk of heart attacks, strokes, and ovarian cancer. The WHI
Study and other recent publications have also provided further proof that many
of the long-touted benefits of HRT were false. 
Hopefully, the courts will continue the process of scheduling additional
trials for these cases as well as establishing an orderly process for transfer
of the thousands of cases pending in federal court, especially in light of the
amount of time that has passed since diagnosis and the fact that many of the
plaintiffs are elderly.

The
10-K filing also lists a number of additional drugs that are still presenting
problems for the company. Lipitor, one of Pfizer’s shining stars, has mired the
company in lots of adverse publicity recently, including questions about
ethics, a Congressional inquiry, and various class action and whistleblower
claims have been filed in the court system.  
Litigation also persists over Neurontin and improper marketing; Mirapex,
a Parkinson’s drug that has been linked to addictive behavior and heart valve
damage; Zoloft, an anti-depressant subject to litigation over an increased rate
of suicides; and Viagra, an impotence drug linked to blindness. 

Pfizer
is also facing more than 1,000 lawsuits over Celebrex and Bextra.  While Celebrex remains on the market, the
arthritis drug has been linked to serious cardiovascular risks such as heart
attacks and strokes.  Bextra was pulled
from the market in 2005 due to an increased risk of heart attacks and strokes
as well, but also was pulled from the market due to reports of serious skin
reactions including Stevens Johnson syndrome and erythema multiforme. Those
cases are coordinated in federal court through MDL proceedings in San
Francisco, and there are also coordinated proceedings in state courts as well.  The first Bextra trials will occur later this
year. 

Pfizer’s
latest headache has come from Exubera, its inhaled insulin product.  Pfizer announced last fall that it intended
to discontinue wide-scale sale of the drug due to economic reasons.  Recent studies have indicated that the drug
may be causing lung cancer.  The entire
Exubera saga will cost Pfizer nearly $3 billion in write-offs and charges for
the once-promising new product and is a significant loss to a weak pipeline
(the lifeblood for any pharmaceutical company). 
Only time will tell whether Exubera also becomes the most recent entry
on the vast list of fallen drugs that are now causing headaches for Pfizer’s
legal department and its bottom line.