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Neurontin Class Action Lawsuits Information
Attorneys general from 47 states are currently investigating
if Neurontin maker Pfizer Corp. illegally marketed the epilepsy drug. When
Neurontin was first FDA approved, the drug was intended as an add-on epilepsy
treatment, however off label use became a regular, widespread practice. Soon,
Neurontin became a blockbuster hit, selling over $1.3 billion per year. The high
sales were greatly controversial because the majority of sales were estimated to
have come from off-label use.
For years, the use of Neurontin has been a source for dispute. A March 2002 New
York Times article printed that Pfizer was illegally promoting Neurontin for at
least 11 off-label uses. Then in May 2002, Public Citizen consumer group posted
an article on Neurontin. The article entitled "The Illegal Corporate Creation of
a Blockbuster Drug" discussed how Pfizer was able to use a loophole to expand
the uses of Neurontin.
Without off label use, the consumer group alleges the small corner of the market
that Neurontin was approved for would have never allowed the drug to become such
a financial success for the drug company. Public Citizen continues to oppose
Neurontin's present state on the market, calling it "the most complete and well
document case of off-label promotion to ever come into public view." Pfizer is
currently the target of Neurontin related lawsuits.
Neurontin Side Effects
Neurontin entered the U.S. market in February 1994 as a
powerful epilepsy drug. From mid 1995 to 2001, Neurontin experienced remarkable
growth of off-label sales, a practice that has been beneficial over the years in
sparking medical innovations. While a common practice, the risks of doing so are
becoming more scrutinized. Pfizer Inc. has just pleaded guilty to a two count
criminal information charging the company with violating the FDA with
misbranding Neurontin. The company has been sentenced to pay a $240 million
criminal fine, amounting to the second largest criminal fine in a health care
fraud prosecution.
Up to 40 percent of all prescriptions written every year are for off-label
purposes, but Pfizer 's strategic marketing plans has shown that Neurontin was
aggressively marketed to treat things not FDA approved. This off-label promotion
is illegal and a company must state its intended use of a drug in a new drug
application to the FDA in order to push it for other uses. Over the years,
Neurontin has been promoted by Pfizer as an effective treatment of bipolar
mental disorder, pain disorders, Amyotrophic Lateral Sclerosis, attention
deficit disorder, migraines, drug and alcohol withdrawal seizures, restless leg
syndrome, and as a first line monotherapy treatment for epilepsy.
The FDA had previously rejected Neurontin as an effective monotherapy drug
treatment for epileptic seizures after scientific study had shown it to be
ineffective. Pfizer continued to implement various marketing and sales
approaches to illegally promote Neurontin for off-label uses, including making
misleading statements about the drug. As a result, the popularity of Neurontin
for off-label uses were influenced by Pfizer's unproven and unsubstantiated
claims and doctors and patients may not have appropriately weighed possible
benefits and risks for Neurontin side effects.
Pfizer 's ability to implement a coordinated national effort for an off-label
marketing plan has misled the medical community and may have greatly impacted
the number of adverse effects suffered by Neurontin patients receiving the
prescription based off of false claims. The "illegal and fraudulent promotion
scheme" has been putting Neurontin patients at risks for dangerous Neurontin
side effects. It has been estimated that 90 percent of Neurontin's $2.7 billion
in sales during the first year was because of off-label uses.
More Neurontin Information
Neurontin was FDA approved only as a powerful epilepsy drug
for adjunctive or supplemental use. Under FDA provisions a company must specify
the intended uses of a drug in new drug application to the federal agency. Only
if the FDA approves it can a company then market or promote it. Pfizer pleaded
guilty to criminal charges that its Warner-Lambert subsidiary, which Pfizer
bought in 2000, promoted Neurontin for off-label uses that lacked any type of
scientific support.
Pfizer has been sentenced to pay $240 million, which is the second largest
criminal fine ever imposed in a health care fraud prosecution according to the
Justice Department. Hundreds of thousands of dollars went into Pfizer's efforts
to promote such off-label uses like bipolar mental disorder, pain disorders,
Amyotrophic Lateral Sclerosis, attention deficit disorder, migraines, drug and
alcohol withdrawal seizures, restless leg syndrome, and as a first line
monotherapy treatment for epilepsy. Scientific studies had already shown
Neurontin was not an effective treatment as a monotherapy for epileptic
seizures, and the FDA already rejected its solo use.
Patients are angered by the realization that their Neurontin prescriptions may
have been based on false and misleading information that was part of a financial
scheme. Legal action is expected to occur in response to the sentencing of
criminal health care fraud and whether or not a Neurontin class action emerges
can only be told with time. While a Neurontin class action lawsuit may not
develop because of the wide range of conditions Neurontin was prescribed to
treat, lawyers will investigate individual cases to see if a strong claim
exists.
Pfizer used many different approaches to reach the marketing goals it had set
for off-label promotions. Part of a widespread effort, Pfizer also chose not to
bother seeking FDA approval for any of the new uses because of the company's
concern that it could allow for generic competitors to emerge as competition
just as the patient was expected to soon end.
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