Preemption Rears Its Ugly Head -- Again.

Imagine if a young mother from Pennsylvania were hit by a car while her child watched. Or a grandfather from Kansas. Maybe a musician from Vermont. Just because the driver of that car had a license wouldn’t mean that he couldn’t be held accountable for the injuries he caused those innocent people, right?

Well, that’s just the kind of argument that medical device and a drug companies are making when it comes to avoiding responsibility when their products injure Americans. Just ask Pennsylvania mom Bridgett Robb, Kansas grandfather Earl Hickey and Vermont musician Diana Levine, all of whom have suffered injuries due to drugs or medical devices.

Robb and Hickey were shocked by an implanted defibrillator made by device manufacturer Medtronic. Unfortunately for them, Medtronic was already cleared from liability by a 2008 Supreme Court decision stating that because the Food and Drug Administration had approved the device, the company could not be sued for injuries caused by defects in the device.

A story in today’s Wall Street Journal reiterated the devastating effects that this decision has had on consumers. A federal judge in Minnesota was forced to throw out a case involving thousands of patients who were hurt by faulty defibrillators. Though the judge recognized the devices’ danger, he said that last year’s Supreme Court decision left him no choice but to dismiss the suit. Clearly uncomfortable with the decision, he wrote that the court was “not unsympathetic to [the plaintiffs’] plight,” but that their only remedy now “lies in Congress.”

A similar case involving drug manufacturers, Wyeth v. Levine, is currently being considered by the Supreme Court. Considering the willingness of the Court to grant immunity to medical device manufacturers, the likelihood of the justices holding drug companies responsible seems frighteningly low.

While those already harmed by these products are left with little recourse, there is still hope for the rest of us. Congress can fix these bad decisions by passing legislation that allows state tort law to act, as it has for hundreds of years, as a supplement to federal product regulation. In fact, a bill has already been introduced in Congress to remedy last years Medtronic decision. The Medical Device Safety Act would ensure that just because the FDA approves these devices, their manufacturers aren’t relieved of responsibility for their safety.