Marketing non-approved medical devices in the United States is a crime,
as Stryker and every device manufacturer know. In a public announcement
in May, 2012, Stryker told shareholders it was taking a $33 million charge
which reflected the minimum amount they may eventually pay the Department
of Justice to settle allegations about its OtisKnee device. The details
of the federal subpoena and specific allegations are not known at this
time. Medical device manufacturers can get approval through a full blown
"pre-market approval" process, or a "510k" fast-track
process. The latter requires that the device is similar to another already
on the market. What is defined as "similar" can be quite stretched,
and many 510k products, such as the DePuy ASR metal-on-metal hip implant
and various
Medtronic defibrillators
have been pulled from the market. A recent Supreme Court decision allows
suits against 510k devices but pre-empts, also known as barring, lawsuits
if the product got premarket approval. PMA device makers are always certain
they won't be sued, even if their approval was allegedly done fraudulently.
