Skip to main content

Black Listed News
Trending Articles:
Trending Articles:

Pfizer Paid the Largest Criminal Fine in U.S. History—Lawsuit Details

Published: September 8, 2021 | Print Friendly and PDF
  Gab
 

Getting full approval from the FDA for its COVID-19 vaccine is a big deal for Pfizer. The FDA-stamp of approval is a critical step in getting a drug to the market. If a pharmaceutical company starts promoting a drug for something that the FDA hasn’t okayed, it can get in big trouble.

In 2009, Pfizer agreed to pay $2.3 billion in a criminal and civil liability lawsuit stemming from the illegal promotion of certain drugs. At the time, it was the largest healthcare fraud settlement in history.

In 2012, healthcare giant GlaxoSmithKline (GSK) agreed to pay $3 billion in criminal and civil charges for the unlawful promotion of drugs likePaxil and Wellbutrin for uses that weren’t FDA approved. However, Pfizer still holds the record for receiving the largest criminal fine in history.

How FDA approval works for pharmaceutical companies

Under provisions of the Food, Drug and Cosmetic Act enacted in 1938, the FDA approves pharmaceuticals for specific uses that a company identifies on its application. After the FDA approves the product as safe and effective for a specified use, a company’s marketing of its drugs must be limited to the FDA-approved use. Uses other than FDA-approved are considered “off-label uses,” and the FDA considers these “misbranded.”

GlaxoSmithKline’s $3 billion settlement was the largest in history.

In the GlaxoSmithKline case, the company got in trouble for promoting the anti-depressant Paxil for use with patients under age 18, even though it hadn’t received FDA approval for pediatric use.

GSK also got in trouble for promoting Wellbutrin for weight loss and treatment for sexual dysfunction, substance addictions, and Attention Deficit Hyperactivity Disorder even though the FDA had only approved it to treat Major Depressive Disorder.

Besides pleading guilty to five criminal counts and getting a criminal fine of about $1 billion, GSK was also found liable for civil charges for:

  • Promoting the drugs Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label, non-covered uses
  • Paying kickbacks to physicians to prescribe those drugs as well as the drugs Imitrex, Lotronex, Flovent, and Valtrex
  • Making false and misleading statements concerning the safety of diabetes drug Avandia
  • Reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program

Pfizer received the largest criminal fine in history.

In Pfizer’s 2009 settlement, the company had to pay a criminal fine of $1.195 billion and its subsidiary Pharmacia & Upjohn Company Inc. had to forfeit $105 million, for a grand total of $1.3 billion. It’s still the largest criminal fine ever imposed in the U.S.

The company pled guilty to felony charges or violating the Food, Drug and Cosmetic Act by misbranding the anti-inflammatory drug Bextra and promoting it for uses that the FDA “specifically declined to approved due to safety concerns,” the Department of Justice stated.

Pfizer also paid $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs—Bextra, anti-psychotic drug Geodon, antibiotic Zyvox, and anti-epileptic drug Lyrica. The settlement claims that Pfizer paid kickbacks to healthcare providers to entice them to prescribe the drugs.

Read More...

Share This Article...




Image result for patreon


PLEASE DISABLE AD BLOCKER TO VIEW DISQUS COMMENTS

Ad Blocking software disables some of the functionality of our website, including our comments section for some browsers.


Gab Social Gettr Twitter Youtube Facebook RSS

Image result for patreon

Support Blacklisted News
and Kill The ADS!!!

Become our Patreon and get access to the ad free version of the website and other insider exclusives for $1.00

Login with patreon to gain access to perks!

10th Amendment Center
Aaron Mate
Activist Post
AIER
Aletho News
Alliance for Natural Health, The
Alt-Market
Antiwar
AUTOMATIC EARTH, The
Ben Bartee
Big League Politics
Black Vault, The
BOMBTHROWER
Brandon Turbeville
Breaking Defense
Breitbart
Brownstone Institute
Burning Platform, The
Business Insider
Business Week
Caitlin Johnstone
Campus Reform
CAPITALIST EXPLOITS
Charles Hugh Smith
Children's Health Defense
CHRISTOPHE BARRAUD
Citizen Free Press
Citizens for Legit Gov.
CNN Money
Collective Evolution
Common Dreams
Conscious Resistance Network
Corbett Report
Cryptogon
Cryptome
Daily Bell, The
Daily Economist, The
Daily Reckoning, The
Daily Veracity
DANERIC'S ELLIOTT WAVES
Dark Journalist
Defense Industry Daily
Defense Link
Defense One
Dennis Broe
DOLLAR COLLAPSE
DR. HOUSING BUBBLE
Dr. Robert Malone
Drs. Wolfson
Drudge Report
Economic Collapse, The
ECONOMIC POPULIST, The
Electronic Frontier Foundation
Ellen Brown
Emerald Robinson
Energy Business Review
Expose, The
F. William Engdahl
FAIR
Farm Wars
Faux Capitalist
FINANCIAL REVOLUTIONIST
Forbes
Foreign Policy Journal
FOREXLIVE
Foundation For Economic Freedom
Free Thought Project, The
From Behind Enemy Lines
From The Trenches
FUNDIST
Future of Freedom Foundation
Futurism
GAINS PAINS & CAPITAL
GEFIRA
Geopolitical Monitor
Glenn Greenwald
Global Research
Global Security
GMG RESEARCH
GOLD CORE
Grayzone, The
Great Game India
Guadalajara Geopolitics
Helen Caldicott
Homeland Sec. Newswire
Human Events
I bank Coin
IEEE
IMPLODE-EXPLODE
Information Clearing House
Information Liberation
Infowars
Insider Paper
Intel News
Intercept, The
Jane's
Jay's Analysis
John Adams
John Pilger
John W. Whitehead
Jon Rappoport
Jordan Schachtel
Just The News
Last American Vagabond, The
Lew Rockwell
Le·gal In·sur·rec·tion
LIBERTY BLITZKRIEG
Market Oracle
Market Watch
Matt Taibbi
Max Keiser
Medical Express
Mercola
Michael Snyder
Michael Tracey
Middle East Monitor
Mike "Mish" Shedlock
Military Info Tech
Mind Unleashed, The
Mint Press
MISES INSTITUTE
Mises Wire
MISH TALK
Money News
Moon of Alabama
Motherboard
My Budget 360
Naked Capitalism
Natural Blaze
Natural News
Natural Society
New American, The
New Eastern Outlook
News Deck
NEWSQUAWK
OF TWO MINDS
Off-Guardian
Oil Price
OPEN THE BOOKS
Organic Prepper, The
PANDEMIC: WAR ROOM
PETER SCHIFF
Phantom Report
Pierre Kory
Political Vigilante
Prevent Disease
Public Intelligence
QUOTH THE RAVEN RSRCH
Reclaim The Net
Revolver
Richard Dolan
Rokfin
RTT News
Rutherford Institute
SAFEHAVEN
SAKER, The
Shadow Stats
Shadowproof
Slog, The
SLOPE OF HOPE
Solari
South Front
Sovereign Man
Spacewar
spiked
SPOTGAMMA
Steve Kirsch
Strike The Root
Summit News
Tech Dirt
Technocracy News
Terry Wahls, M.D.
TF METALS REPORT
THEMIS TRADING
True Activist
unlimited hangout
UNREDACTED
Unreported Truths
Unz Review, The
VALUE WALK
Vigilant Citizen
Waking Times
Wall Street Journal
Wallstreet on Parade
Wayne Madsen
What Really Happened
Whitney Webb
winter oak
WOLF STREET
Wolf Street
Zero Hedge






BlackListed News 2006-2019
Privacy Policy
Terms of Service