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||Michigan Herbal Remedies||New Drug/Labeling/Misbranded/Cannabidiol|
|02/04/2016||Morguetorium, LLC||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.