Quality Control Issues Cost Michigan Company $35 Million

Well, now they have $35 million less to spend on corrections and improvements.

Just how fuqqing bright is that???

This is another aspect of the same arrogance that exacerbates the problems with the Japanese nuclear power stations in the recent quake and tsunami.

It seems the Japanese culture has a flow of authority from high to low that must

continue. The higher executives can never admit error, lest they lose that

undefinable face, that must be guarded at all times.

Thus clients can not complain, head office, the head honcho knows best. We saw this in the recent car recalls - refusal to admit a thing, and we saw it in the tsunami and here it is again.

"dealing with defective devices, customer complaints, and product design"

It strikes me as a bit of an unusual precedent to demand a company in a free enterprise economy - employ better Service, Complaints and Design staff.

But it's not 'bad enough' for a recall, like say the car makers?

Nor are 'profits' normally garnisheed without due process of Law.

E.g. damage suits against drug companies

So I guess it's not 'bad enough' to justify suit.

Interesting set of precedents for all American manufacturers

Do not medical device makers approved by the FDA have some degree of shielding? I had heard that at one time, but I was not sure how meritorious it was?

Not quite enough information here to decide. Is the FDA clamping down on Terumo for violating internal procedures listed in their own quality manual, or for killing patients in the field? Many organizations will write a quality manual with the intention of having it look good for an outside agency (their standard's auditor, the FDA, etc.) and then find that they are not able to live up to the lofty standards they claimed they were using.