Ninth Circuit Allows Whistleblower Allegation Against Medtronic to Go Forward
The U.S. Ninth Circuit Court of Appeals has ruled that a whistleblower suit claiming Medtronic fraudulently obtained a 510(k) clearance from the FDA can proceed.
The plaintiffs in the case include Dan Abrams Co., the U.S. and 28 states. The company, which formerly sold Medtronic products, alleged that Medtronic misled the FDA by claiming that its VerteStack vertebral body replacement device was designed for use in the lower spine, when in fact it was designed for the neck area.
The complaint alleged that the devices “were not properly cleared for any use” and “they cannot be used for their labeled intended use (and are thus not substantially similar to the predicate device).”
Medtronic said it intends to defend itself vigorously against the “baseless allegations."