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FDA Fraud

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How Whistleblowers Can Report Fraud Related to Clinical Trials

Posted  09/4/20
The COVID-19 pandemic has highlighted the importance of government-funded scientific and medical research, including clinical trials of vaccines, treatments, and more.  We are all potentially at risk if there is fraud and abuse in clinical trials and other research. Individuals with knowledge of fraud and misconduct in federal grants and clinical trials may be able to bring a whistleblower action for that research...

Question of the Week — Is DOJ’s Blockbuster $1.4 Billion Opioid Settlement Just the Tip of the Iceberg?

Posted  07/12/19
Pill container spilled over with pills fallen out.
On July 11, DOJ announced a record-breaking $1.4 billion settlement with Reckitt Benckiser Group plc (RB Group) over allegations that its former subsidiary Indivior Inc. inflated prescriptions of its opioid-withdrawal drug Suboxone through numerous unestablished representations about the drug’s safety and addictiveness. The settlement resolves RB Group’s potential civil and criminal liability, but Indivior still...

Catch of the Week — Wound Care Device Manufacturer ACell Inc.

Posted  06/14/19
By Edward Baker
Nurse Wrapping a Wound on Mans Wrist
Our Catch of the Week goes to ACell Inc., a Maryland-based medical device manufacturer that pleaded guilty to violating the Federal Food, Drug, and Cosmetic Act (FDCA) by failing to report that it had partially removed its wound-care product, MicroMatrix, from the market because it was contaminated with endotoxins, placing treated patients in danger of serious infection, even death, without informing the FDA that it...

February 22, 2019

Pharmaceutical manufacturer Lehigh Valley Technologies, Inc. will pay $4 million to resolve claims that it caused the submission of false claims through a scheme to avoid the payment of FDA new drug application (NDA) fees.  The FDA will waive such fees for a small business applicant submitting its first NDA, and had waived fees for Lehigh on an NDA in 2010.  Subsequently, in an effort to avoid $2 million in fees for a later NDA, Lehigh entered into agreements with two other companies to submit the NDAs and claim the fee exemptions, while Lehigh retained undisclosed control. USAO ED PA

October 1, 2018

Pharmaceutical distributor AmerisourceBergen Corporation will pay $625 million to the federal government and 43 states to settle claims that between 2001 and 2014 a pre-filled syringe program at one of its subsidiaries, Medical Initiatives, Inc., violated federal law.  Despite lacking the proper licensing and registration, MII opened FDA-approved sterile vials of oncology drugs, and in a non-sterile environment, pooled the medicine and transfered it into non-FDA approved pre-filled syringes which were then sold to oncology practices and physicians.  This practice allowed Amerisource to capture the "overfill" in the original FDA-approved sterile vials and produce a larger number of pre-filled syringes.  AmerisourceBergen also resolved claims that it provided unlawful kickbacks to physicians to induce them to purchase pre-filled syringes rather than vials.  The settlement resolved three qui tam actions initiated by whistleblowers Michael Mullen, Daniel Sypula, Kelly Hodge, and Omni Healthcare, Inc.; a payment of over $93 million will be made to relators. Previously, in September, 2017, AmerisourceBergen Specialty Group pleaded guilty to illegally distributing misbranded drugs and agreed to pay $260 million in criminal fines and forfeitures. USAO E.D.N.Y.NY

What Would You Do? Disgrace and Conflicts in Medical Clinical Studies

Posted  09/18/18
By Jessica T. Moore
The fall and resignation of the renowned Chief Medical Officer and physician-in-chief of Memorial Sloan Kettering Cancer Center, researcher Dr. Jose Baselga, once again sound the alarm of questionable ethics, conflicts of interest, and integrity in clinical studies. Dr. Baselga is known as one of the world’s top cancer doctors, credited with new, life-saving therapies. Drug companies sponsor interested...

AstraZeneca Settles Seroquel False Claims Action -- Again

Posted  08/9/18
On August 8, 2018, AstraZeneca agreed to pay $110 million to the state of Texas to settle allegations that it promoted two of its drugs without FDA approval resulting in health risks to children, adolescents, and other state hospital patients. This case was brought by two whistleblowers under the qui tam provisions of Texas’s Medicaid Fraud Prevention Act. The whistleblowers, two former AstraZeneca employees, among...

Supreme Court Considers Revisiting Key FCA Decision

Posted  04/17/18
Supreme CourtBy the C|C Whistleblower Lawyer Team Yesterday, the justices asked the Trump Administration’s Office of the Solicitor General’s views on a petition for certiorari in United States ex rel. Campie v. Gilead Scis., a False Claims Act (FCA) suit against pharmaceutical giant Gilead Sciences. The suit, which was brought by two former Gilead employees turned whistleblowers, alleges the company made false statements...

September 22, 2017

Aegerion Pharmaceuticals Inc., the Massachusetts-based subsidiary of Novelion Therapeutics Inc., agreed to plead guilty to charges relating to its prescription drug Juxtapid.  Specifically, Aegerion introduced Juxtapid into interstate commerce that was misbranded because, among other things, Aegerion failed to comply with a Risk Evaluation and Mitigation Strategy.  Aegerion agreed to pay more than $35 million to resolve criminal and civil liability arising out of violations of the False Claims Act and Federal Food, Drug, and Cosmetic Act.  The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Aegerion former employees Michele Clarke, Tricia Mullins, and Kristi Winge.  They will receive a whistleblower award of $4.7 million from the proceeds of the government's recovery. DOJ

September 5, 2017

Novo Nordisk Inc. agreed to pay $58.65 million to settle charges it violated the False Claims Act and Food, Drug, and Cosmetic Act by failing to comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza.  The New Jersey based pharmaceutical manufacturer is a subsidiary of Denmark’s Novo Nordisk A/S.  At the time of Victoza’s FDA approval in 2010, the FDA required a REMS to mitigate the potential risk in humans of a rare form of cancer called Medullary Thyroid Carcinoma (MTC) associated with the drug. Under the REMS, Novo Nordisk was required to disclose to physicians the potential risk. If it failed to comply with these disclosure requirements, including requirements to communicate accurate risk information, the drug would be considered misbranded under the law.  According to the government, Novo Nordisk failed to comply with the REMS requirements, providing information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant.  The allegations originated in several whistleblower lawsuits filed under the qui tam provisions of the False Claims Act. The whistleblowers who brought these actions will receive a yet-to-be-determined whistleblower award from the proceeds of the government’s recovery. Whistleblower Insider
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