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Firms Battle in Court Over Safety of Vaccine

BOSTON—The company that agreed to market the world's first genetically engineered pseudorabies livestock vaccine has charged the vaccine's developer with "fraudulent misrepresentation" of the vaccine's safety and efficacy. According to a claim filed November 13 in U.S. District Court in Houston, TechAmerica Group Inc. would not have entered into its agreement with Novagene Ltd. "had it known the truth with regard to such statements, representations and omissions" in the data presented on t

By | February 23, 1987

BOSTON—The company that agreed to market the world's first genetically engineered pseudorabies livestock vaccine has charged the vaccine's developer with "fraudulent misrepresentation" of the vaccine's safety and efficacy.

According to a claim filed November 13 in U.S. District Court in Houston, TechAmerica Group Inc. would not have entered into its agreement with Novagene Ltd. "had it known the truth with regard to such statements, representations and omissions" in the data presented on the product by Novagene in 1984.

TechAmerica's claims are a response to a suit brought against it October 31 by the Houston-based Novagene. Novagene has sued TechAmerica for breach of contract, claiming that the Elwood, Kan., company failed to advertise and market the product, even though the pseudorabies vaccine had been licensed by the U.S. Department of Agriculture (USDA) and made available for sale.

TechAmerica alleges that three key safety issues were initially misrepresented by Novagene: the vaccine's, capacity for reversion to virulence, its degree of safety for pregnant sows, and the extent to which the animals can shed the vaccine virus, potentially passing it into the environment.

Jon Hazard, general counsel for TechAmerica, stated in an interview that "the safety issues have now been resolved. Unfortunately, much more work had to be done to satisfy ourselves and the USDA of the safety of this product than Novagene led us to believe."

Charles Huber, an attorney representing Novagene, claims that TechAmerica's failure to market the pseudorabies vaccine is an attempt to persuade Novagene to renegotiate the profit-sharing agreement in the contract the firms signed in 1984. But observers say that a company that has invested so much in a product and surely needs the revenue from it would be unlikely to do such a thing.

Hazard said TechAmerica's failure to market the product vigorously is a combination of timing and the "uncertain climate" of acceptance. "Until those issues were settled," Hazard said, "we felt we had little chance to successfully market our product." Hazard added that the product was pulled temporarily from the market early last year, only three months after being licensed for sale.

The pseudorabies livestock vaccine has attracted considerable attention as the first genetically engineered vaccine to reach the market. A congressional hearing last spring explored the USDA's handling of the licensing procedure.

The safety questions raised in TechAmerica's counterclaim against Novagene have prompted Jeremy Rilkin's public interest group, the Foundation on Economic Trends, to reopen its suit against the USDA. The Foundation last month asked that the product's license be enjoined in light of this new controversy raised about the product's safety data.

Shulman is a freelance science writer in Cambridge, Mass.

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