BioZorb Plaintiffs Ask Judge to Take Judicial Notice of Jan. FDA Warning Letter

BOSTON — Plaintiffs in two cases alleging injuries caused by Hologic Inc.’s radiographic marker BioZorb have asked a Massachusetts federal judge to take judicial notice of a January FDA Warning Letter detailing violations revealed during an inspection of the company’s facilities.

In a Jan. 21 motion filed before Judge Allison Burroughs of the U.S. District Court for the District of Massachusetts, plaintiffs say the FDA Warning Letter undermines defendants’ argument that their implanting surgeons were adequately warned of the device’s risks and would not have changed their prescribing decisions had they been presented with a different warning.

Defendants, in a …