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*

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 Wins $75 Million Medicare Fraud Settlement”

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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.

Frohsin Barger & Walthall hospice fraud cases have been featured in the following media outlets, among others:

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