A scandal over tainted blood plasma products that made headlines periodically over the past decade has finally been settled. Although Bayer and three other companies, which were blamed for infecting hemophiliacs with HIV in nearly two dozen countries, were rather reluctant to acknowlege any resolution until an activist group in Europe disclosed the deal.
The backdrop: A former Bayer division known as Cutter Biological introduced a new version of its med in 1984, but continued to sell the old one overseas, according to documents filed in federal court in Illinois. By doing so, Cutter avoided a build-up of inventory of its old Factor VIII concentrate, which provided a missing ingredient that allows a hemophiliac’s blood to clot.
Why would a build-up have occurred? A new version, which was more expensive to produce, was heat-treated to reduce HIV to undetectable levels and, in 1984, this was introduced in the US. By then, studies had shown HIV could survive the use of the older product. But the older med was still actively marketed in Asia in 1985. Meanwhile, the FDA was upset that Bayer and other companies still sold older Factor VIII.
As we have noted previously, a Cutter budget estimate for 1985 disclosed later offered a cold calculation. The assumption was that AIDS wouldn’t become a “major issue” among Asian hemophiliacs that year, but if there was “hysteria over AIDS,” the fallout could reduce sales of its older med by $400,000 and gross profits by $110,000 (back stories here and here).
Last week, the Coalition Against Bayer Dangers began circulating a report by Agence France Presse (see here)and media in Italy indicating a settlement was reached. The group characterized the deal as a “late guilty plea" and chastised Bayer for not disclosing its existence or terms (see statement), and allegedly requiring those who settled not to disclose details (although, such practices are not uncommon in settlements).
After pressing Bayer to confirm the settlement, a spokeswoman sent us a note saying a deal was reached with the "vast majority" of plaintiffs in the multidistrict litigation. "Bayer, along with other providers of plasma-derived therapies whe are defendants in this litigation, agreed to settle to move closer to finality and closure and to put regrettable circumstances that occurred more than 20 years ago behind it. The company does not acknowledge any liability," she wrote, adding that Bayer remains "steadfast" about having acted responsibly and ethically.
"It is especially tragic that the HIV virus was transmitted by the very therapies that revolutionized the quality and length of life expectancy for hemophilia patients, at a time when it was unknown that it had entered the blood supply. Bayer has expressed deep sorrow to the infected hemophiliacs regarding the impact of this situation and throughout the decades has participated in efforts to support the hemophilia community."