Word around Capitol Hill is that the Medical Device Safety Act will be reintroduced in Congress soon. The bill stalled in the face of strident Republican opposition in the last Congress. Now, we hope the newly energized Democratic majority will be able to pass this important legislation.
The bill responds to last year’s disastrous decision in Riegel v. Medtronic, in which the Supreme Court said that Medtronic could not be sued for injury caused by its faulty implanted defibrillators because the Food and Drug Administration had approved the devices. That left thousands of Americans victims of a corporate “hit and run,” with no ability to sue the manufacturer of these dangerous devices.
Yesterday, a New York Times article stated that the recalled defibrillators are failing at a much higher rate than Medtronic had claimed. A study by Dr. Robert Hauser of the Minneapolis Heart Institute and Dr. David Hayes of the Mayo Clinic found that the devices were failing at a rate more than twice that which Medtronic released. Medtronic claimed that 1 out of 20 defibrillators could be expected to fail after three years. This new study suggested that almost 1 out of every 8 devices have failed in that same time period.
What’s more, patients who received implants of these faulty defibrillators face a difficult decision. As the New York Times previously reported, removing the devices can be dangerous too. The Times told the story of a 33-year-old father, Mark Turnidge, who died after surgery to remove his Medtronic device.
Last year’s Supreme Court decision led to the dismissal of hundreds of lawsuits against Medtronic. By enacting the Medical Devices Safety Act, Congress and President Obama can stop corporations from overturning a hundred years of consumer protection.