Relator Alleged Company Conned the Government by Shipping Compromised Medical Devices. Why Did the Court Dismiss the Suit?

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A relator alleged her employer violated the FCA by shipping compromised medical devices. The court dismissed. The relator hadn’t alleged any specific devices were compromised. She had merely presumed they were compromised, which doesn’t cut it in an FCA case.

United States ex rel. Mary Bixler Wood v. Siemens Medical Solutions USA, E.D.N.Y, No. 21-194
  • Alleged Fraud – A relator brought a qui tam action, alleging her former employer had shipped compromised medical devices. Specifically, the devices were temperature-sensitive and had to be shipped in a certain temperature range. The relator contended the company shipped the devices outside the approved range. The relator alleged the company had made misrepresentations to the FDA about shipping temperatures and also caused others to submit false claims to the government.
  • Court Dismisses Suit – The court dismissed for failure to plead fraud with particularity. The court found the relator had not alleged the devices were actually compromised. She had simply presumed the devices were compromised.

–Case summary by Craig LaChace, Senior Editor