FDA Consumer

Still on the hook – unsafe X-ray units

Still on the hook – unsafe X-ray units – column

Annabel Hecht

An equipment manufacturer who produced unsafe X-ray units has been told by a federal judge that he cannot escape responsibility by selling his firm and its assets. Neither can he excuse himself by saying he did not personally make the units.

FDA had charged the defendants, Hodges X-Ray Inc. of Louisville and James J. Hodges, the firm’s president, with introducing the company’s Traceray III diagnostic equipment into interstate commerce when it did not meet the standards of the Radiation Control for Health and Safety Act of 1968.

Evidence indicated that, although the units were unsafe, the firm certified to purchasers that they met federal standards. FDA inspections revealed that some units did not turn off at the preselected time and did not indicate to the operator the exposure time in seconds or pulses. This meant that patients and perhaps operators could be receiving unnecessary radiation from the units.

Because of this hazard, FDA in early 1980 located and seized some 150 Traceray units, all that could be found in the United States. The seizures were necessary because Hodges X-Ray had gone out of business and no longer existed to correct the deficiencies.

FDA sought civil penalties against the firm and its president in the U.S. District Court for the Western district of Kentucky. At a hearing before Judge Charles allen, the firm claimed that the new holder of the assets was responsible for correcting any deficiencies. The firm’s president claimed that he was not accountable for the firm’s past misdeeds.

But Judge allen disagreed and granted a summary judgment for the government. He ruled that the defendants were guilty of the stated violations involving the 41 units introduced in evidence. Separate penalties of $20,500 were levied against the firm and its president.

Beyond resolving this particular case, the court ruling is the first judicial statement that corporate officials can be held personally liable for civil penalties under the 1968 radiation health and safety laws.

COPYRIGHT 1984 U.S. Government Printing Office

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