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By Jessica Dye
Aug 8 Pharmaceutical giant Pfizer is
facing a mounting wave of lawsuits by women who allege that the
company knew about possible serious side effects of its
blockbuster anti-cholesterol drug Lipitor but never properly
warned the public.
In the past five months, a Reuters review of federal court
filings shows, lawsuits by U.S. women who say that taking
Lipitor gave them type-2 diabetes have shot up from 56 to almost
Lawsuits began to be filed not long after the Food and Drug
Administration in 2012 warned that Lipitor and other statins had
been linked to incidents of memory loss and a "small increased
risk" of diabetes. According to plaintiffs' lawyers, women face
a higher risk than men of developing diabetes from using
Lipitor, and gain fewer benefits.
The recent spike in lawsuits followed a decision by a
federal judicial panel to consolidate all Lipitor diabetes
lawsuits from around the country into a single Federal courtroom
in Charleston, South Carolina. Pfizer opposed the consolidation,
arguing it would prompt copycat filings. The first case is
scheduled to be tried next July.
Pfizer said in a statement that it denied liability and
would fight the lawsuits.
It is not uncommon for a drugmaker to get hit with thousands
of lawsuits over its products after the FDA orders a label
change alerting users to newly found risks. Takeda
Pharmaceutical, for instance, is facing more than 3,500
federal lawsuits since 2011 when the FDA ordered it to update
the label on its diabetes drug Actos to warn about bladder
cancer. Takeda has denied liability.
But several factors set the Lipitor diabetes cases apart
from those against other drug companies. For one, Lipitor is the
best-selling prescription drug of all time, racking up global
sales of more than $130 billion since it went on the market in
1996. More than 29 million patients in the United States have
been prescribed the drug, suggesting there is a vast pool of
On the other hand, potentially complicating matters for
plaintiffs, the FDA emphasized the benefits of statins even as
it warned of the risks.
When the labeling change was released in 2012, a top FDA
official underscored that the agency still stood behind the
drugs: "Clearly, we think that the heart benefit of statins
outweighs this small increased risk (for diabetes)," Amy Egan, a
deputy director for safety at the agency's Division of
Metabolism and Endocrinology, said in a statement at the time.
Statins are a class of drugs that block the liver's
production of cholesterol to reduce the risk of heart disease.
Type 2 diabetes, once known as adult-onset or
noninsulin-dependent diabetes, is a chronic condition that
affects the way the body metabolizes glucose.
RISKS AND BENEFITS
The seemingly mixed message from the FDA suggests that
litigation will focus on two questions: how big a diabetes risk
do women using Lipitor face, and whether that risk is mitigated
by the drug's cardiovascular benefits.
H. Blair Hahn of Mount Pleasant, South Carolina, the lead
lawyer appointed to represent Lipitor plaintiffs in federal
court, said the plaintiffs contracted diabetes as a consequence
of taking Lipitor, and that women with diabetes see the length
and quality of their lives reduced.
"We will ask a jury to decide what it's worth to take five
years of someone's life," Hahn said. He said the nearly 1,000
cases filed so far represent 4,000 women, and that the number of
cases could ultimately reach 10,000 or more.
Pfizer said it believes Lipitor did not cause the
plaintiffs' diabetes. Women who are prescribed Lipitor to
control cholesterol may share other risk factors that make them
vulnerable to the disease, such as high blood pressure or
obesity, the company said.
The Pfizer statement said there is an "overwhelming
consensus" in the medical community about statins' benefits.
The first Lipitor trial, scheduled for next July before U.S.
District Judge Richard Gergel, will be one of several so-called
"bellwethers" used to gauge the strength of other cases. If
Pfizer prevails, it could persuade plaintiffs to accept smaller
settlements or drop cases.
Pfizer could also opt to settle before a single case is
tried to avoid possible negative exposure or to prevent
potentially damaging information from coming to light.
If past settlements are any guide, Pfizer's potential
exposure could be substantial. Bayer, the maker of
one-time rival statin Baycol, paid $1 billion in 2005 to settle
about 3,000 cases alleging the drug caused rhabdomyolysis, a
disease that breaks down muscle tissue. Baycol was pulled from
the market in 2001 after being linked to 31 deaths.
In 2011 AstraZeneca said it would pay $647 million to
resolve most of the 28,000 lawsuits it faced alleging its
antipsychotic Seroquel caused diabetes and other injuries.
Pfizer has not indicated that it has set aside any money
specifically to cover potential future Lipitor judgments,
according to its most recent quarterly filing with the U.S.
Securities and Exchange Commission.
Michael Green, an expert in mass torts at the Wake Forest
University School of Law, said he did not expect Pfizer to
settle at this stage, especially given the major obstacle
plaintiffs still face.
"(They) have to show they were actually harmed by this
agent," he said. "That might be hard."
(Reporting by Jessica Dye in New York; Editing by Ted Botha,
Eric Effron and Amy Stevens and John Pickering)