Starr Teachers

Think independent counsels use dirty tricks? Check out the Justice Department's regular prosecutors.

Harvey Silverglate from the May 1999 issue

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The C.R. Bard Company manufactured and marketed a catheter used to improve blood flow through arteries clogged by heart disease. The FDA approved the catheter as "safe and effective" even though the manufacturer disclosed a small (1.7 percent) risk that the device could fail and injure patients if the warnings against unsafe use were not followed by physicians. Sure enough, although with less frequency than predicted, the device failed when physicians ignored the warnings against unsafe use. To better protect patients, C.R. Bard made changes to the catheter which had no effect on its safety or effectiveness under the approved conditions of use but which made it more resistant to failure when the instructions were not followed.

FDA regulations required approval of any change that affected safety or effectiveness. In the absence of notice to the contrary, C.R. Bard had every reason to believe that the phrase safety and effectiveness referred to "the conditions of use and warnings against unsafe use in the approved labeling." Since the changes had no effect when conditions and warnings were heeded, the company thought it could make the beneficial changes without waiting for agency approval.

The FDA and the Justice Department nevertheless indicted C.R. Bard and several of its executives, one of whom we represent, for making the changes without approval. As publicly traded companies frequently do even in dubious cases, the manufacturer pleaded guilty and paid a huge fine. Threatened with imprisonment, the executives all went to trial. Contrary to the position that the FDA had taken in several prior cases, the government argued that the law forbids any unapproved change that affects safety and effectiveness, even if the effect is relevant only when the conditions of use are ignored. Three of the executives were convicted and sentenced to 18 months in prison. They are free during their appeal, which is based partly on their claim that it is fundamentally unfair to punish them for violating a law that meant one thing before the fact and another after.

A basic insight at the heart of our republic is that injustice inevitably flows from conferring uncontrolled power upon any agency of government and, even more so, upon any individual in government. The public is awakening to the fact that independent counsels exercise such power. Although run-of-the-mill federal prosecutors have to answer more directly to superiors in the Justice Department and are not quite as free to spend whatever it takes to convict their targets, they use the same tactics as the independent counsels with even less public accountability, since they are not subject to as much scrutiny. Amending or eliminating the independent counsel statute might make life fairer for Cabinet secretaries and presidents, but it will not redress the gross imbalance that has been created between the power of federal prosecutors and the rights of ordinary citizens.