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# Court Nixes Fraud on FDA in False Claims Case
- URL: https://www.fdaweb.com/court-nixes-fraud-on-fda-in-false-claims-case/
- Published: 2017-01-05T12:00:00.000Z
- Updated: 2026-09-14T21:58:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137645

The 1st Circuit Court of Appeals has affirmed a lower court ruling dismissing a suit that sought to argue fraud on FDA in a False Claims Act (FCA) case. Attorney **James Beck** (Reed Smith) writes in an online [post](http://www.mondaq.com/article.asp?articleid=556564&email%5Faccess=on&chk=1458984&q=902420&ref=fdaweb.com) that the decision in *United States ex rel D’Agostino v EV3, Inc.* effectively eliminates the possibility of alleging fraud on FDA in a false claims case.

In *D’agostino*, a whistleblower said that EV3 defrauded FDA on approvals and supplement approvals for two medical devices, Onyx and Axium. The whistleblower said the company **(1)** sought approval of Onyx for a narrow indication but intended to promote it more broadly off-label; **(2)** failed to meet promises made to FDA about extensive surgeon training for using Onyx; **(3)** hid the failure of Onyx’s active ingredient in another device; and **(4)** failed to recall earlier versions of Axium after obtaining FDA approval.

Beck says that the court found that fraud on FDA claims don’t fit well under the False Claims Act because FDA never actually makes claims or seeks reimbursement of medical costs. Although the whistleblower argued that the company’s misrepresentations could have influenced FDA approval, the court said that wasn’t good enough, according to Beck. “Could have falls short of pleading a causal link between the representations made to FDA and the payments made by” other government entities, it ruled.

The court also noted the lack of FDA enforcement action against the company over the alleged misrepresentations and said that the agency’s failure to withdraw its approval of Onyx in the face of the whistleblower’s allegations precludes the whistleblower from resting his claims on a contention that the FDA approval was fraudulently obtained.

“Without FDA enforcement action,” Beck explains, “causation falls as a matter of law. Further, even if FDA initiated enforcement action, then the administrative proceeding, not the False Claims Act, is the proper forum to examine allegations of fraud on FDA.”