A Supreme Court ruling last year has begun to show its true colors, as many federal cases against Medical Technology Corporations will go unheard. In February of 2008, the high court decided to restrict the legal options for patients who claim they have been injured by a defective device. If the Food and Drug Administration has approved the device after, “rigorous review,” than a suit cannot be filed under state laws.
This unjust ruling will prevent many individuals who have been subject to hard due to faulty design from collecting the compensation they need to maintain a reasonable quality of life.
Devices that are not properly engineered can have catastrophic effects when implanted in a patient. Janet Moore, of the Star Tribune, provides us with an example:
“Make it stop,” Liz Fossum remembers thinking.
For about an hour early that November morning two years ago, Fossum’s implanted defibrillator repeatedly shocked her heart — 54 times all told. It felt like a horse was kicking her in the chest.
The 68-year-old grandmother from Golden Valley now knows that part of her heart device, an insulated wire made by Medtronic Inc., had been recalled by federal regulators because a small number had malfunctioned, occasionally causing unnecessary shocks.
Unfortunately for people like Ms. Fossum, there is little she can now do under the new law. Several Hundred cases had been filed against Sprint Fidelis, all of which were subsequently dismissed as a result of the Supreme Court decision. Obviously, all those affected by the faulty product were outraged by the Supreme Court’s decision to protect corporate interests over the interests of the public.
This new decision has left consumers without any means to remedy the harmful situation they were put in by a lack of vigilance on the part of the FDA. Henry Waxman, a Representative from California, believes that the Supreme Court puts too much faith in the FDA testing process. He stated that, “The Supreme Court assumed that FDA approval ensures medical devices are safe, but many recent stories of patients harmed by faulty devices have proven those assumptions false.”
Waxman along with New Jersey Representative Frank Pallone plan to introduce legislation that would circumvent the Supreme Court ruling and protect Americans from dangerous medical devices. Until that time however, citizens must remain vigilant. If you are in need of or considering the possible use of a medical device, please research all companies and available options fully. Until the government decides to protect consumers again, self-education is the best defense.
If you have been subject to a faulty medical device, please contact an attorney immediately. There are several possible options, which may allow you the compensation you deserve.