Supreme Court Leaves Patients Vulnerable to Medical Device Defects

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Supreme Court Leaves Patients Vulnerable to Medical Device Defects

Written by Tiffany Sanders

Monday, 24 March 2008 23:26

Earlier this month, the United States Supreme Court ruled that federal law pre-empted state lawsuits based on negligent design or manufacture of medical devices that had received pre-market approval from the Food & Drug Administration (FDA).

In theory, pre-emption makes sense. The Medical Device Amendments specify that states can’t add requirements; it’s easy to see the kind of complications that would ensue if each state had different—and possibly conflict--requirements for medical device approval. But in determining that allowing state courts to apply common-law negligence standards would amount to “additional requirements”, the Supreme Court has effectively declared that a medical device manufacturer that secures pre-market approval is in the clear.

Even that, on the surface, might seem logical. After all, the device has already gone through rigorous screening, right? Can’t we assume that it wasn’t negligently designed if the FDA thoroughly reviewed and approved it?

Perhaps, if the FDA conducted its own tests or used outside experts to approve medical devices, there might be some reason to that perspective. In fact, however, the pre-market approval process is based on data submitted by the manufacturer itself, based on its own testing.

So, in essence, the manufacturer says, “We tested it out and it works great. No problems.” The FDA reviews all of the reports that say “we tested it out and it works great” in more detail, and then grants approval. And then, if it turns out that the device DOESN’T actually work great…that, perhaps, it kills people…those people (and their heirs) are barred from filing lawsuits against the manufacturer because it would be “imposing additional requirements” for the state court to say that medical devices should be manufactured in such a way as to not kill people.

Think the FDA has a handle on that in the pre-market approval process? Here are just a few of the drugs and devices that have received FDA approval in recent years and gone on to be recalled and/or formed the basis for nationwide lawsuits:

Vioxx
Seroquel
Risperdal
Baycol
Ortho-Evra
Viagra
Cialis
Certain Cordis Balloon Catheters
Certain Guidant Defibrillators
Certain Medtronic Implantable Infusion Pumps

Somehow, it doesn’t look like that pre-market approval is a sure thing. Just maybe, some “additional requirements” (try not to kill the patient) would be helpful. As it stands, medical device manufacturers have little at risk if their devices fail.

While it might be nice to believe that these corporations will want to avoid killing their customers out of the goodness of their hearts, or concern for public relations, or just because doctors might stop using their devices if they don’t work out, the recent history of drug litigation tells us that isn’t the case at all. Well-documented information in recent trials has made it clear that major corporations are making conscious decisions to sacrifice certain numbers of consumers in the interest of higher profits—civil litigation that might have cut into those profits might have been the last protection standing for patients reliant on their products.

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