FDA Approval Fraud

What is FDA Approval Fraud & Why Does it Matter?

Pharmaceutical manufacturers must obtain Food and Drug Administration (FDA) approval before introducing any new drug into the market.  But the process is costly for companies, and approval is far from guaranteed.  Some unscrupulous manufacturers, therefore, opt to forego the process altogether while others lie about whether their drug was approved.  Such fraud against consumers is bold enough, but when unapproved medications are, in turn, submitted to Medicare, Medicaid, Tricare, or other federal programs for reimbursement, the fraud becomes actionable under the False Claims Act.

“Health fraud scams waste money and can lead to delays in getting proper diagnosis and treatment.They can also cause serious or even fatal injuries.”   — Federal Food & Drug Administration

The FDA issues warning letters to manufacturers who are marketing unapproved drugs.  These letters put the corporations on notice of their violations and also serve as warnings to consumers regarding the unsubstantiated claims regarding unapproved drugs.  If you, your loved one, or patients in your nursing home or other healthcare facility are being treated with any of these drugs and reimbursement is made under a federal program, then you may have a potential False Claims Act whistleblower cause of action, please contact Frohsin Barger & Walthall — we have been representing False Claims Act whistleblowers exclusively for nearly a decade.

Recent Warnings From FDA About Unapproved Drugs*

DATE	COMPANY RECEIVING WARNING	REASON FOR WARNING
08/12/2016	Cape Apothecary, Inc.	Unapproved New Drug/Compounding/Misbranding/Adulterated
07/28/2016	Min Ny	New Drug/Labeling/Misbranded
07/22/2016	J&E International Corp	Internet Marketing of Unapproved and Misbranded Drugs
07/22/2016	Hsu’s Ginseng Enterprises, Inc	New Drug/Labeling/Misbranded
07/22/2016	Celloxess LLC	New Drug/Misbranded
07/22/2016	New Horizon Nutraceuticals LLC	CGMP/Dietary Supplement/Adulterated/Misbranded
07/20/2016	Finally Pure, LLC	Internet Marketing of Unapproved and Misbranded Drugs
07/19/2016	Sircuit Skin	New Drug/Labeling/False & Misleading Claims
07/19/2016	Sheryl Gibbs	New Drug/Labeling/False & Misleading Claims
07/18/2016	Michael Todd	New Drugs/Cosmetics Labeling and Marketing with Drug Claims
07/18/2016	Ageless Aesthetics	New Drug/Labeling/False & Misleading Claims
07/15/2016	Annemarie Gianni Skin Care LLC	New Drug/Labeling/Misbranded
07/15/2016	Karen Roche	New Drug/Misbranded
06/30/2016	Mc-Cor, LLC	New Drug/Misbranded
06/20/2016	Vitalife Inc.	CGMP/Dietary Supplement/Adulterated/Misbranded
06/16/2016	Centro Naturista	Unapproved New Drugs/Misbranded
06/03/2016	Focus Laboratories, Inc.	Medical Foods and New Drug Labeling/Internet Claims/Misbranded
06/02/2016	Shop Anabolics	Unapproved New Drugs / Misbranded
06/02/2016	Steroid Bazaar	Unapproved New Drugs / Misbranded
05/13/2016	Rocky Fork Formulas Inc	CGMP/Dietary Supplement/Adulterated/Misbranded
05/10/2016	Reviva Labs Inc	Unapproved New Drugs/Adulterated
05/06/2016	Economax LLC	Unapproved New Drugs/Misbranded
04/28/2016	Macular Health	New Drug/Misbranded
04/20/2016	Crescent Health Center, Inc	Unapproved New Drugs/Misbranded
04/14/2016	Hollywood Skincare International Inc.	Unapproved New Drugs/Misbranded
04/14/2016	Ultimate Weight Loss Co.	Unapproved New Drugs/Misbranded
03/31/2016	Chaotic Labz	Methylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/31/2016	Line One Nutrition, Inc	Methylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/31/2016	m4 Nutrition Companies LLC	Methylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/31/2016	NutraClipse, Inc	Methylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/31/2016	Swagger Supps	Methylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/31/2016	Total Body Nutrition	Methylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/31/2016	Xcel Sports Nutrition, LLC	Methylsynephrine/Labeling/Dietary Supplements/False & Misleading/Misbranded
03/17/2016	Rx Vitamins, Inc	Unapproved New Drugs/Misbranded
03/16/2016	Black Onyx World LLC dba Alikay Naturals	Unapproved New Drugs/Misbranded
03/07/2016	VitaCare Pharma, LLC	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
03/03/2016	Universal Formulas, Inc.	New Drugs/Dietary Supplements/Food Labeling/Misbranded
02/25/2016	Herbal Energetics/In Joy Organics	CGMP/Dietary Supplement/Adulterated
02/25/2016	VitaSea Products Int’l, dba Wachters Organic Sea Products	Unapproved New Drugs/Misbranded
02/17/2016	Lucy’s Weight Loss (dba. Waisted With Lucy)	Unapproved New Drugs/Misbranded
02/05/2016	Beauty & Health International Inc.	CGMP/Dietary Supplement/Adulterated/Misbranded
02/04/2016	ABC Productions	New Drug/Labeling/Misbranded/Cannabidiol
02/04/2016	Dose of Nature	New Drug/Labeling/Misbranded/Cannabidiol
02/04/2016	Green Garden Gold	New Drug/Labeling/Misbranded/Cannabidiol
02/04/2016	HealthyHempOil.com	New Drug/Labeling/Misbranded/Cannabidiol
02/04/2016	Michigan Herbal Remedies	New Drug/Labeling/Misbranded/Cannabidiol
02/04/2016	Morguetorium, LLC	New Drug/Labeling/Misbranded/Cannabidiol
02/04/2016	PainBomb	New Drug/Labeling/Misbranded/Cannabidiol
02/04/2016	Sana Te	New Drug/Labeling/Misbranded/Cannabidiol
02/03/2016	ATS Labs, LLC	CGMP/Dietary Supplement/Adulterated/Misbranded
02/02/2016	Better Rx, LLC	Unapproved New Drugs/Misbranded
02/02/2016	Calwood Nutritionals, LLC	Unapproved New Drugs/Misbranded
01/20/2016	Majopa Industries Corporation	CGMP/Dietary Supplement/Adulterated
01/15/2016	Green Supreme Inc.	New Drug/Labeling/Misbranded
01/15/2016	Nutri-Dyn Midwest, Inc.	New Drugs/Dietary Supplements/Labeling/Misbranded/Adulterated
01/13/2016	Alkebulan International Services, LLC	CGMP/Dietary Supplement/Adulterated
01/04/2016	Tibetan Herbal Balance, Inc.	Unapproved New Drugs/Misbranded

*Data provided by Federal Food & Drug Administration.  For all FDA Warning Letters, click here.

Our Attorneys are National Qui Tam Experts and Trial Lawyers.

“The Accomplishments of Frohsin Barger & Walthall warrant the wealth of accolades that it has received.” — Benchmark Plaintiff”

Jim Barger and Elliott Walthall are the only private attorneys general in the country ever to be tapped as part of a Department of Justice trial team in a Medicare fraud jury trial.  A noted expert on the False Claims Act, Jim Barger teaches upper level courses on the subject as an adjunct professor at the University of Alabama School of Law, which was ranked among the top 15 law schools in the nation by Business Insider in 2016. Barger has appeared on HuffPost Live, Fox 6 Atlanta, and NPR and his opinions regularly are sought by major newspaper outlets on False Claims Act Medicare enforcement, including The New York Times and The Washington Post.

Both Jim Barger and Elliott Walthall have spoken on national panels about Medicare fraud for the American Bar Association, the American Association for Justice, and Taxpayers Against Fraud. In 2015, Barger was a featured symposium speaker on Medicare Fraud and the False Claims Act at the Georgetown Law Center in Washington, DC. and in 2016, Georgetown’s American Criminal Law Review published a new research article by Barger on the public-private partnership of the False Claims Act.

 

Frohsin Barger & Walthall Represents Whistleblowers Nationwide.

Frohsin Barger & Walthall investigates and litigates qui tam actions on behalf of whistleblowers in federal and state actions across the country. Our representation includes evaluating, investigating, and filing qui tam actions as well as assisting prosecutors and investigative agents in pursuing cases and reaching settlements, with a high-percentage of our cases resulting in government intervention. We have sealed cases in every region of the country and regularly travel to meet with United States Attorney’s offices, State Attorney General Offices, and United States Department of Justice attorneys in Washington, DC.

The False Claims Act Offers Protection and Rewards for Whistleblowers.

Blowing the whistle on corporate fraud takes courage, and the law rewards that courage with certain protections. We understand that perhaps the most important aspect of representing corporate whistleblowers is guiding and protecting them through the difficult, stressful process of litigation. The False Claims Act provides for a whistleblower’s case to be filed under seal and for the identity of the whistleblower to be protected during the course of the government’s investigation. Further, federal laws protect against retaliation by mandating the reinstatement of wrongfully fired employees at the same seniority level, and an award of double back pay, interest, and attorneys’ fees. Finally, successful whistleblowers are entitled to substantial rewards, including up to 30% of any False Claims Act recovery which Congress has mandated is three times the amount of fraud that is proven through the whistleblower’s allegations plus substantial civil penalties.