Guidant Corporation made a defibrillator that was known to short circuit. They did not inform doctors or current users of this issue, and the protagonist (Joshua Oukrop) of the case dies because of this.
Guidant argues that if they recalled the product, the risk of people making the switch was higher than the chance of harm with the defective product (1.9% chance of complication and 0.08% chance of death in an implantation surgery compared to a 0.11%-0.24% chance of short circuit).
After Oukrop died, there was a article in NYT and Guidant eventually issued warnings to Physicians and offered free new devices and some reimbursement of medical expenses.
As a result of this issue, Guidance was able to command a significantly lower premium when it was acquired by Johnson and Johnson.
Joshua's Doctor's Point
- This isn't about statistics, its about human lives
- The failure percentage is likely higher (but we won't know because many deaths are undiagnosed and unreported)