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The Street
The Street
Business
Rob Lenihan

Biogen Makes Big Payout to Settle DOJ Whistleblower Case

In Latin, the phrase "Qui Tam" means "who as well."

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

Qui Tam is perhaps better known as "whistleblower litigation" and it is included in the False Claims Act, which President Abraham Lincoln signed into law in 1863. 

'The Lincoln Law'

The False Claims Reform Act of 1985 changed the so-called "Lincoln Law", making it easier for the government to investigate False Claims Act cases and lowering the required burden of proof, as well as increasing the potential whistleblower’s share to 15-30%, among other items.

Today, Qui Tam can translate into an awful lot of money changing hands .

Biogen (BIIB) is a recent example. The biotech agreed to pay $900 million to charges regarding false claims to Medicare and Medicaid by paying kickbacks to physicians to induce them to prescribe Biogen drugs, the U.S. Department of Justice said on Sept. 26.

The settlement resolves a lawsuit filed and litigated by former Biogen employee Michael Bawduniak against Biogen under the whistleblower provisions of the federal False Claims Act.

This the largest False Claims Act settlement ever secured without government intervention, officials said.

'Intent and Conduct'

Biogen said in a statement that it "believes its intent and conduct was at all times lawful and appropriate" and denies all allegations raised in the case.

The whistleblower provisions allow a private party, known as a relator, to file a lawsuit on behalf of the United States and receive a portion of any recovery. The U.S. may intervene in the action or, as in this case, the relator may proceed with the lawsuit.

Bawduniak, a former sales rep with the company, will receive 29.6% of the federal proceeds from the settlement, or $250 million, along with relator awards from several states for a total of $266.4 million.

Greene LLP, the Boston law firm representing Bawduniak, said the $250 million was the single highest award under any government program, shattering the previous award of $96 million to a single relator in 2010. 

It is also the largest award from a single settlement, surpassing a $170 million award in 2014, Greene LLP said.

In his lawsuit filed in the District of Massachusetts, Bawduniak alleged that Biogen paid kickbacks to physicians to induce them to prescribe the company’s multiple sclerosis drugs. 

'Critical Role' of Whistleblowers

The complaint charges that from Jan. 1, 2009, through March 18, 2014, Biogen offered and paid remuneration to health care professionals who spoke at or attended Biogen’s speaker programs, speaker training meetings or consultant programs to induce them to prescribe the company's Avonex, Tysabri and Tecfidera, a violation of the Anti-Kickback Statute.

The payment included speaker honoraria, speaker training fees, consulting fees and meals, 

“The relator diligently pursued this matter on behalf of the United States for over seven years,” Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, said in a statement.

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

U.S. Attorney Rachael S. Rollins for the District of Massachusetts. said "this matter is an important example of the vital role that whistleblowers and their attorneys can play in protecting our nation’s public health care programs."

'The Right Time to Resolve'

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

"The U.S. and the states did not intervene in the case and the settlement does not include any admission of liability by Biogen," the company said. "Biogen determined that now was the right time to resolve the litigation and allow the Company to remain focused on our patients and strategic priorities."

Biogen won approval for its Alzheimer's treatment known as Aduhelm from the Food & Drug Administration last year, but the drug was mired in controversy as a group of medical experts had advised the FDA against its approval due to efficacy issues.

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

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

The firm said some of the most notable settlements "came from the continued fallout from Covid and a new DOJ initiative around cyber-fraud."

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