Supreme Court Protects Medical Device Makers

Yesterday, a Supreme Court ruling granted immunity from personal injury lawsuits to the makers of medical devices that cause harm to patients, provided the device originally obtained legitimate FDA approval. This means that, despite the FDA’s continuing incompetence in protecting public safety, if the FDA green lights a medical device that injures you, you have no legal recourse against the company who made it.

Another case is slated to be argued on Monday at the Supreme Court, one that will specify if patients can still sue medical device makers if FDA guidelines are not followed. Unfortunately, analysts believe this recent decision means that case will probably fall on the side of industry as well.

The medical device industry, of course, is ecstatic about the decision. In a piece by the New York Times’ Gardiner Harris (the second link above), he writes:

A result [of the decision], said David Vladeck, a professor at Georgetown University Law Center, is that the public is facing the worst of both worlds: a government health agency that cannot protect them and rules that block them from winning compensation when injured.

Vladeck is absolutely right – the FDA cannot protect us. Worse yet, a similar case that will probably be argued in October will decide whether the makers of prescription drugs will be shielded from these types of lawsuits.

There’s an excellent audio interview with NYT reporter Gardiner Harris, which can be found midway down the first article’s Web page on the left. Check it out.

-- Dylan Blaylock