TransMedics TMDX
Scorpion petitions the FDA to suspend TransMedics' OCS Liver approval, citing pervasive off-label use, necrotic-organ device failures, and an alleged systematic cover-up of safety issues from regulators.
Thesis
Scorpion Capital files a Citizen Petition asking the FDA to suspend Pre-Market Approval of TransMedics' Organ Care System, particularly OCS Liver, after a six-month investigation spanning 30+ interviews with transplant surgeons at Mass General, Vanderbilt, UCSF and Chicago plus former TransMedics employees. Scorpion alleges the device is overwhelmingly used off-label on donors over 55, with warm ischemic times exceeding 30 minutes, macrosteatosis above 15%, and abnormal anatomy — all explicitly outside the labeled indications and the PROTECT pivotal trial. Ex-employees estimate roughly one-third of perfused livers are specifically contraindicated and that devices frequently malfunction, leaving necrotic organs that are still transplanted, while TransMedics allegedly under-reports failures to FDA's MAUDE database. Scorpion demands suspension of approval, an Advisory Committee, data production, and a new trial — suggesting the FDA may ultimately need to revoke OCS Liver entirely.
SCQA
TransMedics markets the FDA-approved Organ Care System (OCS) for normothermic machine perfusion of donor livers, hearts and lungs, with OCS Liver approved under PMA P200031 for narrowly-defined viability criteria.
Scorpion's investigation finds OCS Liver is overwhelmingly used off-label — older donors, longer ischemic times, fattier and abnormal-anatomy livers — producing necrotic organ failures that TransMedics allegedly conceals from FDA via under-reporting to MAUDE.
FDA should suspend Pre-Market Approval of OCS Liver, convene an Advisory Committee, compel per-organ usage data from TransMedics, and require a new clinical trial reflecting actual real-world usage patterns.
Suspending approval halts ongoing patient harm from contraindicated transplants; because testing safety in high-risk livers may be unethical, Scorpion suggests FDA may have no option but to revoke OCS Liver approval entirely.
The three reasons
- 1
Vast majority of OCS Liver usage is off-label and directly contraindicated by the FDA label
- 2
Device failures cause necrotic 'rotting' livers that get transplanted into patients
- 3
TransMedics allegedly under-reports safety failures to the FDA's MAUDE database
Primary demands
- Suspend FDA Pre-Market Approval of TransMedics OCS devices, particularly OCS Liver
- Convene an FDA Advisory Committee to evaluate off-label usage and device failures
- Require TransMedics to produce per-organ usage data for FDA analysis
- Mandate a new clinical trial reflecting real-world (off-label) usage, or revoke PMA outright
KPIs cited
Pattern membership
Precedents cited
- Scorpion's April 2023 Citizen Petition on Harmony Biosciences pitolisant/Wakix (FDA-2023-P-1273)
- Congressman Paul Gosar (R-Arizona) Feb 21, 2024 letter to TransMedics CEO
Slide gallery ·
Notes
This is the formal FDA Citizen Petition (6 pages) that accompanies Scorpion's underlying 342-page short report on TransMedics published Jan 10, 2024 (linked in Appendix A). Treated here as a regulatory_filing rather than a short_deck because the form is a §10.30 Citizen Petition with statutory boilerplate (Statement of Grounds, Environmental/Economic Impact, Certification). Signed by Kir Kahlon, Founder/CIO of Scorpion Capital, c/o Pugsley Wood LLP. No charts, no branding, no stake disclosed in this filing. Campaign phase tagged follow_up because it post-dates the main short report by 4 days and escalates the same thesis via regulatory channels. References Scorpion's prior Wakix petition (FDA-2023-P-1273) as a procedural precedent. CEO referenced but not named in this petition (only Gosar's letter to him is cited).