Justinian C. Lane, Esq.
Let Justice Be Done, Though the Heavens May Fall

Justinian Lane's Blog

Justinian's Blog

228 more reasons preemption is a bad idea

This is just scary:

WASHINGTON -- Some medical devices for sensitive uses, from certain hip joints to a type of defibrillator, have won government approval without a close scientific review, congressional investigators said Thursday.

Although Congress ordered the Food and Drug Administration years ago to resolve the issue, the agency approved 228 medical devices without a full scale review from 2003-2007, the Government Accountability Office said in a report.

Source: High risk medical devices escaped close review - washingtonpost.com

This is the main reason I oppose the idea of preemption – the FDA simply doesn’t do the job it’s been assigned to do.  I understand the need to get these devices to people quickly.  Fine.  But it’s just plain wrong to rush these devices to market and then prevent lawsuits on the ground that the FDA thoroughly evaluated them.