A California engineer, allegedlyfired for blowing the whistle on his employer, a medical molder, has been granted a January hearing to determine if he should be protected under federal law. Steven E. Balog, of Encinitas, Calif., was a quality-control engineer for Med-Safe Systems Inc., of Oceanside, Calif., when he re-ported that a faulty, two-cavity Portuguese-made mold was producing medical sharps containers that were as much as 45 percent thinner than required by U.S. Food and Drug Administration specifications.
Fearing that too-thin walls of the polypropylene containers could allow easier accidental penetration by contaminated needles, Balog went to Med-Safe's customer, Becton Dickinson and Co. of Franklin Lakes, N.J., with his findings. Becton Dickinson immediately told Med-Safe it had been alerted to problems with sharps collectors by a whistle-blower, then later recalled 125,000 of the 500,000 collectors manufactured at the Med-Safe plant between Augustand December 1994.
Samuel J. Smith, a Department of Labor administrative law judge, ruled Nov. 8 in Long Beach, Calif., that both the Environmental Protection Agency and the FDA have jurisdiction over the manufacture and use of the collectors, which are devices used by hospitals to dispose of used needles, syringes and blades.
Smith determined that sharpscollectors are designed to hold contaminated medical waste, and as such fall under the jurisdiction of the Toxic Substances Control Act, or Tosca, which is administered by EPA. Tosca is one of seven federal laws that provide whistle-blower protections.
No such FDA-administered law provides the same employee whistle-blower protections.
Smith overruled an objection by Med-Safe that only FDA has jurisdiction over the manufacture of sharps collectors, as a section of Tosca ``expressly provides that the definition of `toxic substances' under the TSCA does not include drugs or medical devices as defined by the federal Food, Drug and Cosmetic Act.''
Unless Med-Safe challenges Smith's finding of law, it means the federal government could play a significantly greater role in the manufacture and use of some medical industry products.
Med-Safe Chief Executive Officer Richard A. Shillington declined to comment on the continuing litigation.
Although Balog's lawyers are seeking protected ``whistle-blower'' status for their client through a complicated legal process, they note that no injury has been reported as a result of a discarded medical needle penetrating one of the alleged too-thin containers.
San Diego lawyer Marie A. Backes, who represents Balog, said Smith's call for a hearing settles a question of law over the EPA's additional jurisdictional role. What remains at issue is whether Balog is actually a whistle-blower under federal law.
If Balog is proven to be a whistle-blower, then his job at Med-Safe is supposed to be pro-tected.
According to Backes, Balog was relieved of his position at Med-Safe after alerting Becton Dickinson of Med-Safe's alleged actions.
According to Balog in a Nov. 14 telephone interview, in late 1994 Med-Safe employees were adding paper label shims to the faulty mold ``every 15-30 minutes'' in order to achieve the FDA-mandated thickness of 5 thousandths of an inch. At times, he said, the faulty mold produced container thicknesses of only 28 thousandths of an inch, 45 percent thinner than FDA regulations.
The mold was faulty from the time it was installed a year earlier, Balog said.
Balog, with Med-Safe until January of this year, was in charge of ``oversight of the calibration system for the company's testing equipment and interpretation of test protocols for regulatory compliance,'' according to Smith's ruling.
Balog lost another engineering position after leaving Med-Safe, allegedly because that company learned of his whistle-blowing effort, Backes said.
``The FDA is not as strong an enforcement agency as EPA,'' Backes said.
Sharps collectors, which previously were treated as medical devices under FDA rules, will be more stringently monitored by federal authorities as hazardous materials containers, according to Backes.
``FDA is still in charge of actual manufacture. As soon as it leaves the manufacturer and contains toxic waste, then the EPA can determine the correctness of the product's use,'' she said.