Allergan Inc., the manufacturer of the popular drug Botox, settled civil and criminal charges and will be paying over $600 million in fines relating to the off-label use causing personal injury during the period between 2000 and 2005 of their latest cosmetic wonderdrug. The Irvine, CA-based company was accused of failing to fully inform users of the potential side-effects of Botox including migraine headaches, spasticity, pain and the potential of juvenile cerebral palsy.
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Makers of Botox Settle Personal Injury Case for Over $600 Million
1. Makers of Botox Settle Case for $600 Million
Allergan Inc., the manufacturer of the popular drug Botox, settled civil and criminal
charges and will be paying over $600 million in fines relating to the off-label use during
the period between 2000 and 2005 of their latest cosmetic wonderdrug.
The Irvine, CA-based company was accused of failing to fully inform users of the
potential side-effects of Botox including migraine headaches, spasticity, pain and the
potential of juvenile cerebral palsy.
Although during this timeframe the drug was only approved by the FDA to be used
therapeutically for treating muscle contractions, overactive sweat glands and correcting
cross-eyes, Allergen pushed the drug for the off-label use of preventing wrinkles
between the years 2000 and 2005. This is why the company was accused of a
misdemeanor misbranding charge before eventually pleading guilty and agreeing to
settle both criminal and civil claims.
Tony West, the Assistant Attorney General of the Department of Justice, gave a
statement to ABC News saying, "For nearly a decade Allergan illegally promoted Botox
for uses that were not approved as safe and effective by the FDA.”
The Department of Justice also accused Allergan of instructing doctors on how to bill for
the off-label use as well as paying unlawful kickbacks to physicians who used Botox for
cosmetic purposes. The breakdown of fines incurred by the manufacturers is $375
million for criminal fines and $225 million in civil fines. Part of the settlement also
requires Allergan to submit to monitoring, auditing, reporting and mandatory disclosure
to the Department of Justice for five years.
The fact that Allergan knowingly allowed their product to be used for purposes other
than what it received FDA approval for gave products liability attorneys all of the
ammunition they needed to make their case. Trail lawyers knew they could make solid
cases for their clients against Allergan for products liability and the threat of one
personal injury attorney after the other filing suit was definitely a contributing factor
towards the company setting the civil claims for such a large amount.
Even though the company was forced to pay such astronomical fines, Botox remains on
the market and is such a profitable product for Allergan that the company continues to
sell the drug for cosmetic purposes despite the risks.
Hornberger & Brewer are California personal injury lawyers who have had extensive
experience in major personal injury litigation and proving negligence in products liability
cases. If you are looking for a reliable personal injury lawyer you won’t need to look any
further than the Law Firm of Hornberger&Brewer. Years of trial experience has given the
2. Los Angeles trail lawyers the ability to utilize both medical and technical knowledge to
create persuasive legal strategies that often obtain successful results for their clients.
www.hgblaw.com