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Every major medical product safety disaster has a predictable anatomy. From thalidomide in the 1960s to Vioxx in the 2000s, from Avandia to recent issues with JAK inhibitors, ranitidine, and opioids, the pattern is the same. It’s not that the science was missing – often the safety signals were there – but the system refused to be accountable to the science. In each case, warning signs existed, yet no one owned the obligation to act on them. This uncomfortable truth underpins why simply getting “better data” isn’t enough: safety advice only matters when someone is accountable to enforce it.

Every major medical device safety disaster has a predictable anatomy — and it's the same anatomy as drug safety disasters. From the Dalkon Shield in the 1970s to metal-on-metal hips in the 2000s, from Therac-25's lethal radiation overdoses to Philips' contaminated CPAP machines, the pattern repeats: warning signs existed, the science was available, and no one with authority was accountable to act on it. The device world just has its own particularly insidious ways of letting danger through.