A 2010 study shows that Medicare is being billed up to a billion dollars
in extra claims as a direct result of Medtronic's recalled
Sprint Fidelis Lead. Combined with the costs of malfunction of other Class III medical devices
the costs to taxpayers could be in the billions. In the 2008 court decision
Riegel v. Medtronic, the Supreme Court said medical device manufacturers
are completely immune from liability for the harm caused by Class III
medical devices even when the device has been recalled or proven to be faulty.
Sprint Fidelis leads model number 6930, 6931, 6948, and 6949 were recalled
by Medtronic in the fall of 2007 because of their large failure rate.
Failures lead to inappropriate shocks to the heart muscle, or a failure
to function at all. The report says this turns the ICD into a "torture
The Medical Device Safety Act of 2009 will restore proper responsibility
to medical device manufacturers. The bill changes the Food Drug and Cosmetic
Act to explicitly say that the FDCA does not preempt state laws that require
medical devices. The bill is currently in committee in both the House and the Senate.
Below are links to an article summarizing the report as well as a link
to the report itself.