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Perhaps they knew the design was flawed, or perhaps they made a very foolish decision (since they would have profited handsomely if the design could be fixed).

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Any potential profit must be balanced against the highly political question of whether the fix (assuming one was needed) would get thru the FDA, and at what cost, how many bribes, or more politically correctly put, campaign contributions would be needed and whether even doing so would be sufficient to make it onto the market with a revised version.

It's not like these decisions are being made purely on a scientific basis.

I have just as many problems with an overly restrictive FDA as the next free market guy, but there isn't really a lot of evidence that the issues are due to political corruption.

In reality the FDA is too conservative due to the incentive structure: people getting hurt from a drug approved too fast are very visible. People that get hurt due to a drug being approved too slowly are not. This is the core issue.

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