Woman awarded record $57m damages over implant launched with no clinical trial and marketed despite higher failure rate
A vaginal mesh implant made by Johnson & Johnson (J&J) was launched without a clinical trial, and then marketed for five years after the company learned that it had a higher failure rate than their two earlier devices.
Internal company emails disclosed in a US court case, in which a 51-year-old woman was awarded a record $57m in damages this month, also show that senior executives even briefly considered suppressing unfavourable data that “could compromise the future” of the device.
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