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60 percent of all prescriptions written.68  Writing such

"off-label" prescriptions exposes doctors to the standards

of common-law negligence principles, by which they can be

found liable for their actions; yet they continue to pre-

scribe "off-label" rather than accept the truncated liabili-

ty offered by the FDA.  There is no reason to believe that

breaking the FDA's approval monopoly would cause radical

changes in the common-law standards doctors already face.

Without the FDA's approval, a physician would be liable only

if the current medical consensus rejected the particular use

of a device or if the doctor prescribed a patently unsafe

device or a device that could not be made safe for the

prescribed usage.  Doctors would then rely on the safety

mark of the certifier, and the usage guidelines from the

manufacturer's information and from medical journals in

writing prescriptions.  Those guidelines and the safety seal

would then be the basis of a doctor's defense in a liability

suit.

Expanding third-party certification to medical devices

may increase the liability exposure of the certifying orga-

nizations.  The potential that certifying organizations may

be held liable for the manufacturer's products may cause

potential certifiers to stay out of the medical device

market.  However, certifying organizations are not sellers,

advertisers, distributors, or manufacturers of products.

They do not offer testimonials or underwrite risk.  Third-

party certification simply states the professional opinion

of the certifiers as to the safety and, perhaps, the effec-

tiveness of the good.  They can still be sued, but the law

does not assign many of the principles of liability to such

certification organizations, and there is no principle to

hold a certifier liable for an unforeseeable error, provided

the certifier was not negligent.

The laws governing fraud and liability protect consum-

ers.  An injured consumer still retains all powers of legal

redress.  Breaking the FDA's legal monopoly on approval of

medical devices in no way implies a change in liability law

or practice.  Currently, the FDA does not especially help or

hinder consumers bringing torts before the court, nor does

it protect the public by filing individual or class actions

on behalf of aggrieved consumers.  If the FDA were no longer

to exercise monopoly authority, such suits would still be

brought, and the relative balance of power between consumers

and corporations or physicians would not have changed.  The

notion that harmed consumers need the FDA to help them col-

lect damages from deep-pocketed medical establishments is

specious.  Manufacturers of medical devices have never been

immune from torts, and removing the FDA blockade to market