Court weighs what US must prove in Regeneron kickback case
By Nate Raymond
July 22 (Reuters) -The U.S. Department of Justice on Monday urged a federal appeals court to overturn a judge's ruling that made it tougher for the government to win a lawsuit against Regeneron Pharmaceuticals REGN.O and prove the drugmaker engaged in an illegal kickback scheme.
Justice Department attorney Daniel Winik urged the Boston-based 1st U.S. Circuit Court of Appeals to overturn a ruling that would make it harder for the government to hold companies that pay kickbacks accountable under the False Claims Act.
He said that ruling was based on an interpretation of anti-kickback law that ran contrary to the goals of lawmakers who when amending the law in 2010 sought to strengthen the government's ability to pursue such claims, not weaken it.
"It really just defies logic," he said.
But some members of the three-judge panel appeared skeptical of his argument including U.S. Circuit Judge William Kayatta, who said the Justice Department was asking his court to look beyond the statute's plain text to what a few lawmakers said.
"What license do we have to delve into the statutory history on this?" he asked.
The False Claims Act allows the department and whistleblowers bringing cases on the government's behalf to sue companies to recover taxpayer funds paid out by government programs including Medicare and Medicaid based on false claims.
A separate law, the Anti-Kickback Statute, forbids paying kickbacks to generate healthcare business.
The Justice Department sued Regeneron in 2020 and accused it of using a charity that helps cover Medicare patients' drug costs as a means to pay kickbacks for using its expensive macular degeneration drug Eylea.
It alleged Regeneron funneled tens of millions of dollars through a patient assistance foundation to ensure virtually no one on Medicare had to pay co-pays, allowing it to boost sales of a drug that typically costs over $10,000 per year.
The lawsuit was filed as part of an industry-wide probe of drugmakers' financial support of patient assistance charities that has resulted in more than $1 billion in settlements with 12 drugmakers, four charities and one pharmacy.
But last year, Chief U.S. District Court Judge F. Dennis Saylor dealt the government a setback in agreeing with Regeneron that at trial the government would need to prove Medicare would not have paid for Eylea but-for any kickbacks patients received.
Saylor based his decision on a 2010 amendment to Anti-Kickback Statute that stated that any claim for services "resulting from" a violation of the kickback law constituted a false claim under the False Claims Act.
Winik during Monday's arguments acknowledged courts regularly read a phrase like "resulting from" as imposing a but-for standard to prove causation and that two other federal appeals courts have interpreted the law that way.
Paul Clement, Regeneron's lawyer, during Monday's arguments said that if Congress wanted to adopt a looser standard of legal liability, "the last words it would have used are 'resulting from."
Regeneron denies that its payments were kickbacks, and Clement said the government's case was based on "a pretty extravagant False Claims Act theory."
The case is United States v. Regeneron Pharmaceuticals, 1st U.S. Circuit Court of Appeals, No. 23-2086.
For the United States: Daniel Winik of the U.S. Department of Justice
For Regeneron: Paul Clement of Clement & Murphy
Read more:
Teva in talks to settle US lawsuit alleging MS drug kickbacks
U.S. claims Regeneron paid kickbacks via charity to boost expensive drug
Reporting by Nate Raymond in Boston
免責聲明: XM Group提供線上交易平台的登入和執行服務，允許個人查看和/或使用網站所提供的內容，但不進行任何更改或擴展其服務和訪問權限，並受以下條款與條例約束：（i）條款與條例；（ii）風險提示；（iii）完全免責聲明。網站內部所提供的所有資訊，僅限於一般資訊用途。請注意，我們所有的線上交易平台內容並不構成，也不被視為進入金融市場交易的邀約或邀請 。金融市場交易會對您的投資帶來重大風險。
所有缐上交易平台所發佈的資料，僅適用於教育/資訊類用途，不包含也不應被視爲適用於金融、投資稅或交易相關諮詢和建議，或是交易價格紀錄，或是任何金融商品或非應邀途徑的金融相關優惠的交易邀約或邀請。
本網站的所有XM和第三方所提供的内容，包括意見、新聞、研究、分析、價格其他資訊和第三方網站鏈接，皆爲‘按原狀’，並作爲一般市場評論所提供，而非投資建議。請理解和接受，所有被歸類為投資研究範圍的相關内容，並非爲了促進投資研究獨立性，而根據法律要求所編寫，而是被視爲符合營銷傳播相關法律與法規所編寫的内容。請確保您已詳讀並完全理解我們的非獨立投資研究提示和風險提示資訊，相關詳情請點擊 這裡查看。
