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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).", "kpisCited": [ { "detail": "Label: ≤55 years; some centers report 100% of donors >55, into 60s and 70s", "metric": "Donor age limit (label vs real-world)" }, { "detail": "Average 45.9 years, well below real-world usage", "metric": "PROTECT pivotal trial donor age" }, { "detail": "Label: ≤30 min; one large user reports ~50% of livers >30 min, often 45 min, up to 2 hours", "metric": "Warm ischemic time (label vs real-world)" }, { "detail": "Label: ≤15%; real-world use pushed to 50%, despite literature flagging risk above 5%", "metric": "Macrosteatosis (label vs real-world)" }, { "detail": "One study cited shows 2-3x higher death rates in patients receiving fatty livers", "metric": "Mortality from fatty livers" }, { "detail": "Surgeons estimate ~1/3 of OCS Liver use is back-to-base, not an approved indication", "metric": "Back-to-base off-label use" }, { "detail": "Ex-employees estimate ~1/3 of livers placed on the pump are specifically contraindicated", "metric": "Contraindicated use" }, { "detail": "10% of regional livers reportedly lost due to back-to-base damage", "metric": "Organs lost in one OPO region" }, { "detail": "Approximately one week of training before managing organs on the pump", "metric": "Device technician training" } ], "closingAsk": "Petition the FDA to suspend Pre-Market Approval of TransMedics OCS Liver and undertake the additional regulatory remedies detailed in Section A.", "extraction": { "at": "2026-04-22 22:20:01+00", "model": "unknown-legacy", "runId": null, "seconds": 96.54947, "promptVersion": null }, "scqaReward": "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.", "thesisTypes": [ "fraud_exposure", "other" ], "top3Reasons": [ "Vast majority of OCS Liver usage is off-label and directly contraindicated by the FDA label", "Device failures cause necrotic 'rotting' livers that get transplanted into patients", "TransMedics allegedly under-reports safety failures to the FDA's MAUDE database" ], "scqaSituation": "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.", "thesisSummary": "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.", "primaryDemands": [ "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" ], "scqaResolution": "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.", "thesisOneLiner": "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.", 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The rampant off-label usage indicates that the device is not being used in the manner for which it was intended...", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Numbered list", "slug": "numbered", "status": "active", "canonId": "019de52c-fcc0-7718-a284-a4250c805df2", "version": 1, "description": null }, "framework": null }, "subkind": "numbered", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:04:46.811+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "752f71dd-da3f-4fa2-829a-b0c5fe7e05c2", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.5, "x": 0.11, "y": 0.58 }, "kind": "paragraph", "text": "This petition requests that the FDA take the following actions:", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:04:46.811+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "778e4129-c9f4-400a-8dff-8eddeb756b3e", "parentComponentId": null }, { "bbox": { "h": 0.04, "w": 0.72, "x": 0.14, "y": 0.09 }, "kind": "paragraph", "text": "of transplant failure at levels >20%; and that livers >30% are simply discarded. One study shows 2-3 fold higher levels of death in patients receiving fatty livers.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:04:46.811+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8228c5f2-84df-4fcf-a6e7-027f0ee60b70", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.11, "y": 0.55 }, "kind": "title", "text": "A. Action Requested", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:04:46.811+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a3b6c813-5984-4d20-8ccb-554ca4fab591", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.55, "x": 0.11, "y": 0.36 }, "kind": "title", "text": "Device failures/necrotic livers (please refer to p326-342, Exhibit A)", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:04:46.811+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e6dad530-efc3-40d0-a709-c83c1fbb0d1a", "parentComponentId": null } ], "metrics": [], "tools": [ { "tool": { "name": "List presentation", "slug": "list-presentation", "status": "active", "bestFor": null, "canonId": "019dd9e1-4ef7-777d-ba68-9074c2b3bcf1", "version": 1, "bodyDocId": null, "description": "Bulleted, numbered, or checklist enumerations.", "familyLabel": null, "categoryName": null, "categorySlug": null }, "agent": null, "layer": "slide", "agents": null, "matchId": "8b1ae4e6-f331-4392-a254-b349ada2bc3a", "evidence": "list/bullet: Ex-employees, surgeons, and organ procurement organizations indicated to us that: a) TransMedics OCS Liver devices are plagued by failures leading to the loss of a significant percentage of organs; b) that l", "pageRefs": null, "priority": null, "whenToUse": null, "confidence": 0.9, "extraction": { "at": "2026-07-16 23:08:05.179777+00", "model": "or:meta-llama/llama-4-scout", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 3, "whyItWorks": null, "antipattern": null, "cardinality": "common", "narrativePurpose": null } ], "frameworks": [], "arcBeats": [ { "to": 3, "arc": { "name": "Problem-Agitate-Solution", "slug": "problem-agitate-solution", "status": "active", "bestFor": "Sales pitches, urgency-driven, competitive displacement", "canonId": "019dd956-5ec6-70f9-9fd8-fdbaaff39acf", "version": 1, "bodyDocId": "019df22a-2356-73eb-8061-d8c81dc0aa49", "structure": "Problem (Identify pain) -> Agitate (Make it worse) -> Solution (Provide relief)", "description": null, "familyLabel": null }, "from": 3, "name": "Complication", "beatId": "662f06c7-150f-4876-8137-c35e54f8ebd5", "matchId": "409916bd-5cae-469e-82e3-24e5049e1e5c", "beatType": { "name": "Complication", "slug": "complication", "status": "active", "canonId": "019dd9b8-0275-7709-b2d6-4f77c3fc7579", "version": 1, "description": "The point in the narrative where the audience should feel discomfort. 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21:04:52.735+00", "seconds": 8.937, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-0a80d2583138/4", "deck": "/decks/019dd923-622c-750b-8b9a-0a80d2583138", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-0a80d2583138#slide-4", "deckJson": "/decks/019dd923-622c-750b-8b9a-0a80d2583138.json" }, "components": [ { "bbox": { "h": 0.07, "w": 0.77, "x": 0.118, "y": 0.265 }, "kind": "paragraph", "text": "In addition to all of the information detailed supra, and incorporated by reference, Petitioner has enclosed with this Citizen Petition...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, 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"paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:04:52.735+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "248da1a9-d808-4e92-aec5-45ad1561f131", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.77, "x": 0.118, "y": 0.705 }, "kind": "paragraph", "text": "Pursuant to 21 C.F.R. § 10.30(b), economic impact information will be submitted by the Petitioner only upon request...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, 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Require a new clinical trial to evaluate the safety and efficacy of OCS Liver for livers that reflect its actual usage pattern...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:04:52.735+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5d4ec80c-4113-4de0-ac33-36d85e50b093", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.2, "x": 0.118, "y": 0.84 }, "kind": "paragraph", "text": "Respectfully submitted, Kir Kahlon", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:04:52.735+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "60114b6d-b8f5-4f72-94e8-884d3f26940f", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.77, "x": 0.118, "y": 0.365 }, "kind": "paragraph", "text": "Scorpion Capital LLC is an investment firm that specializes in investigative due diligence...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:04:52.735+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a4d00645-5b5c-46cf-9470-ad0fea5f171b", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.77, "x": 0.118, "y": 0.625 }, "kind": "paragraph", "text": "Petitioner claims a categorical exclusion under 21 C.F.R. § 25.30 and § 25.31...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:04:52.735+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e621b4dc-75df-4935-8af2-ca4f8d4f18da", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.118, "y": 0.24 }, "kind": "title", "text": "B. Statement Of Grounds", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:04:52.735+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "0f089643-3b0f-4a06-aaf3-5fc18975fd47", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.118, "y": 0.68 }, "kind": "title", "text": "D. 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