Company / PEN

We believe that Penumbra’s defective Jet 7 Xtra Flex catheter, which caused at least 18 patient deaths before the FDA announced an urgent recall on December 15th, is not just a matter of “bad luck” but instead symptomatic of more pervasive rot.  This report reveals, for example, how Penumbra has repeatedly engaged a small Tennessee entity as the “independent” core lab used to adjudicate many of Penumbra’s clinical studies since at least 2013 even though it is registered to the wife of a Penumbra scientific author and site investigator, a former school vaccine coordinator.  We believe Penumbra’s clinical trials are contaminated by the involvement of other actors accused of accepting large bribes and participating in sham clinical trials orchestrated by EV3, a company that pled guilty in 2018 to a federal criminal charge related to selling defective medical devices that harmed patients.  Lead investigators and authors for Penumbra trials have previously been accused of receiving kickbacks through bogus consulting agreements with EV3 or working as investigators for sham clinical trials in the past. Read More