Qui Tam Action Targeting Siemens’ Medical Device Shipping Dismissed For Now
September 18, 2023
NEW YORK — A New York federal judge has allowed a relator to amend her complaint in a qui tam action accusing Siemens of knowingly shipping temperature sensitive in vitro diagnostic (IVD) medical devices well outside their FDA-approved or -cleared temperature ranges.
In a Sept. 14 order, Judge Margo K. Brodie of the U.S. District Court for the Eastern District of New York dismissed the original complaint without prejudice, ruling it did not satisfy Rule 9(b)’s particularity requirement because it did not allege Siemens’ shipping practices compromised any IVDs for which claims to governments were actually submitted.
IVDs, also …