The Spin
Narrative A
Medtronic acted responsibly by halting HVAD sales when clinical data showed higher stroke and death rates compared to alternatives. The company prioritized patient safety over profits, working closely with the FDA and developing comprehensive support programs for existing patients, including financial assistance and specialized care teams.
Narrative B
The FDA failed catastrophically by allowing a deadly heart device to remain on the market for years despite knowing about fatal defects. Over 19,000 patients received HVADs after regulators found manufacturing violations in 2014, resulting in over 3,000 reported deaths, while the agency relied on empty promises instead of enforcement.
Narrative C
Leading U.K. transplant centers made complex clinical decisions when using the Medtronic HVAD: they weighed varied evidence, included specialist clinician judgment and argued that the alternative device might not have been clearly superior at the time. Internal reviews weighed risks against benefits for complex cases lacking options, prioritizing individual survival needs over preliminary audit data questioned for reliability.
Narrative D
Leading surgeons at Freeman and Harefield had long-standing, undeclared financial ties to Medtronic. These conflicts clouded judgment, prioritizing industry relationships and data skepticism over clear NHS evidence of excess deaths, and exposing patients like Greg Marshall to preventable harm. Urgent calls rise for mandatory, transparent conflict disclosure and stricter rules to rebuild shattered trust in life-or-death decisions.
Metaculus Prediction
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