Companies knowingly sold virus-tainted blood products abroad, class action claims.

Bayer Corp. and three other companies have been named in a class action that could include "tens of thousands" of hemophiliacs worldwide who have been infected with HIV or hepatitis C from contaminated blood products. The other defendants are Armour Pharmaceutical Co., Baxter Healthcare Corp., and Alpha Therapeutic Corp. (Gullone v. Bayer Corp., No. CO3-2572WHA (N.D. Cal. filed June 2, 2003).)

The suit, filed in federal court in San Francisco on behalf of class members in Asia, Latin America, and Europe, claims that the companies continued to sell blood-clotting agents to foreign countries even after they knew that the products could be tainted with HIV or hepatitis C.

"In 1982 there was evidence that HIV was being transmitted through blood," said Robert Nelson, the San Francisco lawyer who filed the suit. "These companies should reasonably have known that their products were infecting hemophiliacs with HIV and hepatitis C, and they literally did nothing to prevent it for several years."

By 1984, the companies had developed a heat-treatment process that killed off any viruses in the product, and stopped selling the untreated version in this country. However, rather than destroying existing stocks of the older product, they sold them outside the United States, predominantly in Asia and Latin America. The companies recently paid around $600 million to about 7,000 Americans, Nelson estimated, to settle years of litigation over use of the product in the United States.

The product, known as Factor VIII concentrate, was derived from the mingled blood of donors, whom the suit claims the companies drew from high-risk populations in prisons and inner cities and continued to do so even after there was medical evidence that HIV was transmitted by blood.

"They were more interested in having a steady supply than a safe supply," Nelson said. "The result is that thousands of people contracted AIDS and hepatitis C." Not only was there a well-established connection between blood and the transmission of HIV, according to Nelson, but screening methods already existed that would have eliminated infected donors. "If they had screened out those with HIV or hepatitis C, it would have demonstrably limited their blood source."

A New York Times article published in May brought the companies' activities to light. It focused on the documents of a former U.S. subsidiary of Bayer, Cutter Biological, which was one of the largest producers of the clotting agent during the mid-1980s. The documents outlined the company's plans to dispose of excess stocks of Factor VIII.

Bayer issued a statement denying the allegations in the article. The company claimed that Cutter, like all other producers at the time, had based its decisions on the best scientific evidence available. According to Bayer, Cutter continued to market untreated Factor VIII in the United States--even after the heat treatment that killed the HIV virus was developed--because of "great skepticism ... among scientists, physicians, hemophilia societies and patients" over the efficacy of the new product. Despite the risks involved, Cutter could not stop producing the untreated clotting agent because it was "vitally important for the patients' well-being," Bayer stated.

The company claimed that Cutter continued to sell Factor VIII overseas once it had stopped marketing the product in the United States because the approval process was slow in some countries.

"Bayer was unable to market the treated product before approval [from foreign governments] had been granted, yet nonetheless had to ensure an uninterrupted supply of medicine to hemophilia patients," the company stated in its official response to the Times article.

Besides basic issues of travel and translation in dealing with plaintiffs from all over the world, the case is no different from any other he has handled, Nelson said. "I would assume that we would have to consider a motion on forum non conveniens," he said, "but we haven't heard from the industry on the motions they intend to file."

Nelson plans a case-management conference in September to schedule various motions that will follow, including one for class certification.