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Showing 13 posts in Pharmaceutical Fraud.

False Claims Act and the Opioid Crisis

An Update on the False Claims Act and the Opioid Crisis

In 2018, there were 46,802 deaths attributed to opioid overdoses. That number nearly doubled to 80,816 overdose deaths involving opioids by 2021.  

The Department of Justice (DOJ) has been actively pursuing opioid-related fraud schemes for years, with significant dedication of resources and attention. In 2017, the DOJ formed the Opioid Fraud and Abuse Detection Unit (OFADU) to combat the effects of the opioid epidemic. Despite these efforts and several high-profile prosecutions and civil settlements, the opioid crisis remains a serious issue nationwide.  More

COVID-19 Vaccine Fraud and the False Claims Act

COVID-19 Vaccine Fraud and the False Claims Act

So far, more than 414 million Americans have received a dose of the COVID-19 vaccine. In order to ensure an accessible vaccine rollout, the Center for Disease Control ("CDC") has stated that any COVID-19 vaccine must be administered free of charge to the recipient with no additional “office fees'' if the vaccine was the sole reason for the medical visit. More

Famous Whistleblowers and Their Impact on America

Whistleblowers have played a vital role in American history, bringing to light abuses and scandals in fields as diverse as pharmaceuticals and the military. Law enforcement agencies and government departments depend on whistleblowers to alert them to corporate and government corruption. That doesn’t always mean these entities have welcomed whistleblowers, however, especially when those people are highlighting problems within their organizations.

Fortunately, federal and state legislatures have enacted protections for whistleblowers, understanding the fundamental role they play in a democracy, and whistleblowers continue to come forward with valuable information about government and corporate misdeeds. Let's examine some of the most famous whistleblower cases and the role these courageous men and women have played in our nation's history. More

Pharmaceutical Executive Found Guilty of Racketeering Conspiracy in Landmark Bribery Case Involving False Claims

On May 2, Insys Therapeutics ("Insys") founder, John Kapoor, and four co-defendants were found guilty of a racketeering conspiracy for running a nationwide bribery scheme involving the over-prescription of opioids. Kapoor is among the highest-ranking pharmaceutical executives to be held responsible and face trial for their part in the opioid crisis.  The charges carry up to 20 years in prison. More

Government Takes a Hard Line on Fraudulent Donations to Patient Assistance Programs

Last month, the Department of Justice ("DOJ") announced a settlement with two pharmaceutical companies – Astellas Pharma US, Inc. ("Astellas"), and Amgen Inc. ("Amgen") – resolving allegations that their "donations" to patient assistance programs violated the False Claims Act. The two companies agreed to pay a total of $124.75 million, and both entered into five-year corporate integrity agreements with the Office of Inspector General as part of their respective settlements. United States Attorney Andrew E. Lelling said that according to the allegations, the companies illegally subsidized the high costs of their own drugs at the expense of American taxpayers, and "[w]e will keep pursuing these cases until pharmaceutical companies stop engaging in this kind of behavior.” Multiple settlements related to similar investigations have already brought in hundreds of millions of dollars in only a few years' time. More

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Pharmaceutical Manufacturer US WorldMeds LLC Pays $17.5 Million to Settle False Claims Act Allegations

Pharmaceutical manufacturer US WorldMeds LLC (USWM), headquartered in Louisville, Kentucky, has agreed to pay $17.5 million to settle allegations that it violated the False Claims Act by paying kickbacks to both patients and physicians to induce prescriptions of its drugs Apokyn and Myobloc.  The Department of Justice (DOJ) announced the settlement on April 30, 2019. More

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Drug Maker Actelion Agrees to Pay $360 Million to Settle False Claims Act Investigation Into Kickbacks

The pharmaceutical company Actelion Pharmaceuticals US, Inc. ("Actelion"), based in South San Francisco, California, has agreed to pay $360 million to resolve claims that it illegally funneled kickbacks through a patient-assistance charity.  Federal prosecutors allege in a press release on December 6, 2018 that Actelion "illegally used a foundation as a conduit to pay the copays of thousands of Medicare patients taking Actelion's pulmonary arterial hypertension drugs." These actions are in violation of the False Claims Act.  More

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False Claims Act and the Opioid Crisis: First-ever Civil Injunction Filed by Justice Department to Combat Opioid Over-Prescription

In August 2018, the U.S. Department of Justice announced allegations against an Ohio doctor for violating the False Claims Act (FCA) in addition to violating the Controlled Substances Act (CSA) for prescribing opioid prescriptions in excessive amounts or to those who are not in need of the medication. Although an FCA case is not the most traditional approach to these issues, it is clear that the Justice Department is making the opioid crisis a top priority and therefore potentially invoking the FCA more often in these cases. The government's focus on the opioid crisis has been consistently increasing and expanding from targeting manufacturers of opioids to targeting prescribers and healthcare providers that submit claims to federal health care programs or to the federal government. 


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Department of Justice Announces Mylan Settlements

On August 17, the Department of Justice announced a landmark $465 million settlement in a False Claims Act action against pharmaceutical companies Mylan Inc. and Mylan Specialty L.P., best known as the makers of EpiPen, a critical emergency medication for individuals suffering from life-threatening allergies. More

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Pharmaceutical Fraud: Misleading Off-Label Marketing and the False Claims Act

Pharmaceutical fraud against the government takes many forms, but at the heart of the fraud is an effort to get the government, most commonly Medicare and Medicaid, to pay more for pharmaceutical products than it would have if the government knew the truth.   More

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