At no time has ARC indicated that it disagreed with a letter. She also said that the severity of the issues held the potential for grave impact to patients. She stated, however, that ARC management had not been aware of the seriousness of these problems. Whether Dr. Healy or Elizabeth Dole personally knew of these serious ARC problems is not relevant. They, like all manufacturers of blood products, have a legal obligation to ensure that the necessary systems and controls are in place to make certain that their blood products are safe.
Ignorance is no excuse.
In summary, the ARC, including its regional blood centers, have for at least 15 years been consistently violating the laws and regulations governing the conduct of the blood industry. For the last eight years, there have been flagrant violations of the 1993 Consent Decree with never-ending promises that things will get better. It is time for the FDA to stop playing dangerous, cooperative, polite games with the ARC and ask that the organization be held in contempt of court for recklessly disregarding the 1993 Consent Decree. I look forward to a prompt response to this urgent request. This was included with the FDA court papers.