Yesterday, the coalition of activist short sellers who have been nipping at the ankles of medical devices company Penumbra Inc. (NYSE: PEN) got some help from Marcus Aurelius Value, who did the legwork to connect various individuals involved with Penumbra and Penumbra’s clinical trials to rival thrombectomy device maker ev3, which was fined in 2018 for encouraging off-label use of its Onyx liquid embolization system.
Ev3 and parent company Covidian, also fined as part of the 2018 USDOJ action, are presently properties of Medtronic (NYSE: MDT). The fund has raised legitimate questions about Penumbra’s clinical trials process, and suggested that there is a pattern of skid-greasing at Penumbra that is indicative of institutional rot.
Certain key terms are relevant for background in this matter.
Qui Tam Lawsuit
This is a type of suit filed by whistle blowers, usually under seal, alleging fraud has been committed against the US government by a company, usually their employer. Qui tam suits give a whistle blower an opportunity to share in any proceeds recovered by the government in the event it successfully levies fines against the company upon whom they are blowing the proverbial whistle.
A process by which an independent committee, usually armed with a database of relevant material, assesses and classifies the outcomes of the tests being done as part of a clinical trial. It’s a sort of hub that makes sure all of the results being submitted by different doctors doing trials in different clinics are being compared against each-other and against a baseline.
Imaging Core & Imaging Core Lab
A database of relevant medical images used in the process of endpoint adjudication. The imaging core used, for example, in the endpoint adjudication of a neurothrombectomy device trial, would likely include CT scans of clots blocking arteries that feed the brain, and images of those same arteries after efforts had been made to un-block them.
This old English term for a ranking teacher or member of an educational faculty survives in medical jargon as a doctor who monitors and evaluates the operations of another doctor. The device makers in this story employ proctors to oversee and direct the ongoing use of the devices they make.
The Long and the Short of it
According to qui tam lawsuits referenced by Marcus Aurelius, Oculus Imaging, a small Knoxville, Tennessee based research services lab, was the preferred endpoint adjudicator and imaging core lab of ev3. Ev3, the Minnesota-based maker of Onyx, owns the embolization system which drew the fine when it was pushed to be used in ways other than those the FDA had approved by an over-ambitious sales force.
Since ev3 plead guilty (taking a $13 million fine), the allegations of the whistle blowers laid out in the qui tam suits will probably never be tested in court, but these short sellers certainly find them notable. Among them is the maintenance and execution of a proctoring program that may have been instrumental in the pervasion of the un-approved use of Onyx by the founder of Oculus, one Dr. Britton K Woodward.
The program is characterized by Marcus Aurelius, as per the whistle blowers’ qui tam suits, as a “kickback” scheme, but Oculus isn’t particularly ashamed of its assistance with proctoring programs. The company’s website pitches a service in which Oculus uses its imaging library and the camera-enabled devices of doctors in the field to quarterback proctor programs that are vital for new product launches.
Penumbra’s name or logo doesn’t appear on Occulasimaging.com, but Marcus Aurelius alleges that it has been retained by Penumbra in the past, as has Dr. Woodward. The doctor’s spouse, one Jennifer Woodward, was once the principle of AngioSuite, a tech-forum for neurosurgeons that no longer exists, but was sponsored by Penumbra when it did.
Marcus Aurelius’ sources put Oculus as the core lab on five Penumbra clinical trials since 2013, including one that’s ongoing. The firm is calling on Penumbra to release a list of all core labs and consultants, presumably so they can be asked if they are now or have ever been named in a qui tam lawsuit.
Aurelius puts two doctors named by whistle blowers as having significant roles in allegedly shoddy clinical trials conducted by ev3, Dr. Raul Noguiera and Dr. Adnan Siddiqui, at prominent roles in Penumbra’s trial process. Dr. Siddiqui co-authored studies sponsored by Penumbra and has been quoted in their press releases.
Penumbra was off -$11.46 (-6%) yesterday following the report, continuing an extended stay beneath its moving averages. These revelations are too new and complicated to have been fully digested by the market, so we expect it will take a few more trading sessions to ascertain the general consensus.
Information for this briefing was found via Sedar and the companies mentioned. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.