Medical device maker paternalism

When medical device companies recall their products, they typically notify only physicians, not patients in whom the devices have been implanted. That might be fine if physicians were set up to systematically notify their patients, but sadly many are not.

The Boston Globe wrote about this problem recently Doctors see flaw in device recalls

”If your car tires have the potential to malfunction, you as a car owner get a letter,” said William H. Maisel, a cardiologist at Brigham and Women’s Hospital in Boston. “It’s remarkable to me that if you have a [problem] device, you are not notified directly.”

But some in the device industry have a more paternalistic view.

Robert B. Nicholas, who represents some medical-device companies as head of the FDA practice at the law firm of McDermott, Will and Emery in Washington, said companies sometimes negotiate with regulators to avoid the bad publicity associated with recalls. Also, Nicholas said, sending notices to all consumers might needlessly worry some of them because they are not as well informed about the issues as their doctors.

Is there really any reason not to notify both doctors and patients?

June 30, 2005

One thought on “Medical device maker paternalism”

  1. Ideally you’d send separate letters to the physicians and to the patients. And would this mean that the device maker would have a database on where their product is already installed?

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