Biogen makes big payments to settle DOJ whistleblower case

Biogen makes big payments to settle DOJ whistleblower case

In Latin, “Qui Tam” means “who also”.

These words are part of a longer statement dating back to the Middle Ages that translates as “he who sues in this matter for the king as well as for himself.”

Qui Tam is perhaps best known as “whistleblower claims” and is included in the False Claims Act, which President Abraham Lincoln signed into law in 1863.

Lincoln’s Law

The False Claims Reform Act of 1985 changed the so-called “Lincoln Act,” making it easier for the government to investigate False Claims Act cases and reducing the burden of proof required, as well as increasing the share of potential whistleblowers to 15-30%, among other elements.

Today, Qui Tam can be translated into a lot of variable money.

Biogen (Bahrain Islamic Bank) It is a recent example. The US Department of Justice said September 26 that the biotech company agreed to pay $900 million in false claims to Medicare and Medicaid by paying doctors bribes to get them to prescribe Biogen.

The settlement resolves a lawsuit by former Biogen employee Michael Pudoniak that sued Biogen under the whistleblower provisions of the federal False Claims Act.

Officials said it was the largest settlement under the False Claims Act ever secured without government interference.

intent and behavior

Biogen said in a statement that she “believes her intent and conduct was lawful and appropriate at all times” and denies all allegations raised in the case.

The whistleblower provisions allow a private party, known as a relator, to file a claim on behalf of the United States and receive a portion of any refund. The United States may intervene in the lawsuit or, as in this case, the link may pursue the lawsuit.

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Bawduniak, a former salesperson with the company, will receive 29.6% of federal proceeds from the settlement, or $250 million, along with multi-state relator awards for a total of $266.4 million.

Greene LLP, the Boston law firm representing Bawduniak, said the $250 million was the highest single award in any government program, smashing the previous $96 million award for a single reviewer in 2010.

It’s also the largest prize from a single settlement, Greene LLP said, surpassing a $170 million prize in 2014.

In the lawsuit filed in the District of Massachusetts, Podoniak alleged that Biogen paid bribes to doctors to get them to prescribe the company’s multiple sclerosis drugs.

The ‘critical role’ of whistleblowers

The complaint alleges that from January 1, 2009 through March 18, 2014, Biogen offered and paid healthcare professionals who spoke or attended Biogen’s speaker programs, speaker training meetings, or consultant programs to induce them to prescribe the company’s Avonex, Tysabri and Tecfidera, in violation of the Anti-bribery Act.

Payment included speaker fees, speaker training fees, counseling and meals fees,

Principal Deputy Assistant Attorney General Brian M.

“The settlement announced today underscores the critical role whistleblowers play in complementing the United States’ use of the False Claims Act to combat fraud affecting federal health care programs,” he added.

American attorney Rachel S. Rollins, Massachusetts. “This order is an important example of the vital role that whistleblowers and their attorneys can play in protecting our nation’s public health care programs,” he said.

The right time to solve

Under the terms of the settlement, Biogen will pay $843,805,187 to the United States and $56,194,813 to 15 states.

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“The United States and the states did not intervene in the case and the settlement does not include any admission by Bion of responsibility,” the company said. “Biogen has determined that now is the time to resolve the litigation and allow the company to continue to focus on our patients and strategic priorities.”

Biogen won approval for an Alzheimer’s disease treatment known as Aduhelm from the Food and Drug Administration last year, but the drug is mired in controversy as a group of medical experts advised the FDA not to approve it due to efficacy issues.

Since 1986, financial damages under the False Claims Act have totaled more than $70 billion.

During the first half of 2022, the Department of Justice announced False Claims Act decisions totaling more than $500 million, according to law firm Gibson Dunn.

The company said some of the most notable settlements “came from the ongoing fallout from Covid and a new Department of Justice initiative on electronic fraud.”

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