Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
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Wall Street Journal - August 11, 2003
Jason Dean, Staff Reporter of The Wall Street Journal
The suit, filed Thursday in California Superior Court in Los Angeles, alleges that a Bayer Corp. unit, Cutter Biological, and four other U.S. and U.S.-registered companies sold a blood-clotting injection called Factor VIII in Taiwan in the mid-1980s that they knew could be tainted with HIV. The other companies are Baxter Healthcare Corp.; Armour Pharmaceutical Co.; the Aventis Behring unit of Aventis SA of France; and Alpha Therapeutic Corp. of California, a unit of Japan's Mitsubishi Pharma Corp. whose assets are in the process of being sold off to Baxter and other companies.
The seven plaintiffs include one person who contracted AIDS, allegedly after using the clotting-factor, and his family members, as well as the family members of another person who died of AIDS, allegedly contracted through Factor VIII.
The Factor VIII product was made from donated blood plasma. With the spread of AIDS in the early 1980s, U.S. regulators approved in February 1984 a version of the medication that was heat-treated to kill the HIV virus. The suit alleges that Cutter and the other defendants continued to sell stockpiles of the untreated drug in Taiwan and other overseas markets for more than a year afterward.
Bayer spokesman Michael Diehl said in an e-mail that his company hadn't been formally notified of the Taiwan lawsuit. But he said, "Bayer emphatically denies misconduct in the marketing of these products in the mid-1980s. Decisions made nearly two decades ago were based on the best scientific and medical information of the time and were consistent with the regulations in place at the time."
In 1996 Bayer, Baxter, Armour and Alpha reached a US$600 million ((Euros)531 million) settlement of a class-action suit involving about 6,000 U.S. hemophiliacs, or their family members. The suit alleged that the hemophiliacs had been infected with AIDS after using untreated Factor VIII or a similar product. Bayer, which paid $290 million of the total, and the other companies admitted no wrongdoing in the settlement. The infections occurred before the medicines were replaced with heat-treated versions on the U.S. market.
The Taiwan suit differs in that it alleges that Cutter executives knew the untreated Factor VIII was potentially tainted, and contends that the company sold it in foreign markets after the treated version was available to avoid wasting existing stockpiles. John P. McNicholas, an attorney for the seven Taiwan plaintiffs, says the allegations are based in part on Cutter internal documents filed in the U.S. class-action suit.
The Bayer spokesman said that at the time in question, "it was unknown and unknowable if HIV was in the plasma supply. Once the [U.S. Food and Drug Administration] accepted data indicating that heat treatment offered a new level of patient safety without compromising the therapeutic protein integrity, Bayer acted swiftly and sought regulatory approval of our heat-treated product in other countries around the world. Bound by law and regulatory policy in all countries where we market product, Bayer could only ship heat-treated product to countries where approvals had been granted, and the demand for life-saving Factor VIII continued in countries where registrations weren't yet available." The spokesman added, "There also continued to be a demand for non-heat-treated product, both in the United States and internationally, even after a heat-treated product came on the market."
Mr. Diehl, the Bayer spokesman, said a separate class-action lawsuit related to Factor VIII was recently filed against Bayer in San Francisco, naming 15 plaintiffs from Germany, Italy and the U.K. and claiming to represent other individuals world-wide.
In Taiwan, 53 people contracted AIDS after taking the untreated Factor VIII medication. Between 1998 and 2002, Bayer reached settlements with 49 of them, or their families, without acknowledging wrongdoing, according to a Bayer spokeswoman. The company paid them each NT$2 million ($58,000 or (Euros)51,380). The spokeswoman said the company had been unable to reach the others.
Write to Jason Dean at jason.dean@wsj.com
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