Thursday, November 21, 2002
ANDRÉ PICARD
PUBLIC HEALTH REPORTER
Canada's tainted blood tragedy has caused untold heartache, thousands of deaths, billions of dollars in lawsuits, an unprecedented public inquiry and much political hand-wringing.
Yesterday. some of the actions and inactions at the heart of the tainted blood tragedy became crimes.
The Royal Canadian Mounted Police opened a new chapter in the decades old saga yesterday when it laid a total of 32 charges against four individuals, a pharmaceutical company and one of the country's most beloved charities.
Those charged include two senior bureaucrats at Health Canada, and the head of the blood program at the Canadian Red Cross Society, as well as the humanitarian agency itself. Armour Pharmaceutical Co. and one of its vice-presidents were also charged.
The charges include criminal negligence causing bodily harm, for which the maximum penalty is 10 years in prison, and common nuisance by endangering the public, which can be punished with up to two yearS in prison. There was also one charge of violating the Food and Drug Act, which is punishable by a fine.
~The Canadian public needs to have confidence in their public institutions," said Superintendent Rod Knecht, head of the RCMP Blood Task Force. ~The Canadian public has the right to expect the safest blood and the safest blood products possible."
The investigation took five years, employing 15 full-time investigators and four Crown Attorneys.
~There has never been an investigation like this one," Supt. Knecht said in an interview. ~The volume of documentation, the complexity of the issues, the multi-jurisdictional aspects and the fact that the events were historical and nature, dating back up to 20 years, all that together is unprecedented."
The victims of tainted blood - including almost 2,000 who contracted HIV-AIDS and an estimated 20,000 more who contracted hepatitis C - as well as their lawyers were elated by the criminal charges, but felt they were only a matter of time.
~We are satisfied that justice has followed its course," said David Page of the Canadian Hemophilia Society. ~They knew the system was inadequate and they chose not to act so it's normal that they be held accountable."
Michael McCarthy, an Ontario hemophiliac who contracted hepatitis C from tainted blood, said it is about time that people and institutions are called to account.
~We can't blame God from what happened here. It was real people who made decisions, based on probably financial aspects of the blood system where they didn't want to spend money to protect people of this country from potentially lethal blood."
Mr. McCarthy said while he was pleased with the charges, he also believes that federal and provincial politicians, who were ultimately responsible for the blood system, should also face criminal charges.
The RCMP would only say that its investigation will continue, and other charges may be laid.
Victims also used the occasion to renew their calls for government compensation. A number of compensation program, paying out roughly $30,000 a year to people who were infected by tainted blood, have been put in place, but some people have been left out, and the money has oftentimes been difficult to access.
~Now is the time to compensate fully and fairly," said Jeremy Beaty, former president of the Hepatitis C Society of Canada. ~There are no more excuses."
Governments had argued that some people infected with hepatitis C, namely those infected prior to 1986 and after 1990, should not be eligible because they have poor legal cases. Mr. Beaty said the charges laid yesterday, in particular one relating to a failure to introduce surrogate testing for hepatitis C, demonstrates this is untrue.
Federal Health Minister Anne McLellan yesterday rejected out-of-hand the call to re-open the compensation plan, saying: ~We're not going to reconsider our position."
The Commission of Inquiry on the Blood System in Canada, led by Mr. Justice Horace Krever, issued a scathing report five years ago, on Nov. 26, 1997. While the Krever report is widely viewed as the most thorough investigation of the tainted blood tragedy done anywhere in the world, Canada has been a laggard in the area of criminal charges.
In France, Germany, Switzerland and Japan, government bureaucrats, blood system administrators and even politicians have faced criminal charges and gone to jail.
But in Canada, the criminal process began only yesterday.
Those charged will appear in court in two groups, in Hamilton, Ont. on Dec. 10 and in Toronto on Dec. 11.
The people and institutions charged include:
* John Furesz, former director of the Bureau of Biologics at Health Canada. Three counts of criminal negligence causing bodily harm and one count of common nuisance by endangering the public.
* Wark Boucher, former chief of the blood products division of the Bureau of Biologics. Three counts of criminal negligence causing bodily harm and one count of common nuisance by endangering the public.
* Roger Perrault, former director of the Red Cross Society Blood Transfusion Service. Three counts of criminal negligence causing bodily harm and seven counts of common nuisance by endangering the public.
* Canadian Red Cross Society, through its former Blood Transfusion and Blood Donor Recruitment Services. Six counts of common nuisance by endangering the public.
* The Armour Pharmaceutical Company, based in Bridgewater, N.J. Three counts of criminal negligence causing bodily harm and one count of common nuisance by endangering the public.
* Michael Rodell, former vice-president of scientific and regulatory affairs at Armour. Three counts of criminal negligence causing bodily harm and one count of common nuisance by endangering the public.
There are 15 counts of criminal negligence in total. The maximum sentence upon conviction is 10 years in prison.
All the charges relate to the distribution of an Armour product called Factorate at a time when the tainted blood problem was supposed to have been resolved. The product, used by hemophiliacs to help their blood clot, was heat-treated to kill the AIDS virus, but the process was inadequate.
In mid-1986, the Canadian Hemophilia Society demanded that the product be withdrawn from distribution in Canada. The Bureau of Biologics and the Red Cross refused. In 1987, at least seven children who were free of
the virus were infected by the ~safe" product. Evidence presented at the
Krever inquiry suggested that Armour knew that its heat-treatment process was inadequate, but distributed the product anyhow.
In the charges filed yesterday by the RCMP it is alleged that three individuals contracted HIV as a result of taking the product, and the failure of government regulators and Red Cross officials to block its distribution.
The RCMP laid 17 charges of common nuisance by endangering the public. These charges relate not to the infection of specific individuals, but placing the public at risk by failing to warn them of potential dangers, and they cover several areas:
* It is alleged that the Red Cross and its officials failed to take adequate measures to screen out individuals who were infected with HIV-AIDS to prevent them from giving blood.
* It is alleged that the Red Cross and its officials failed to ask specific questions in its blood donor questionnaire that might have kept infected blood out of the system.
* It is alleged that there were unreasonable delays in purchasing test kits to screen the blood supply for HIV-AIDS in a timely manner and, as a result, the Red Cross and its officials placed the public at risk.
* It is alleged that the Red Cross and its officials failed to introduce surrogate testing for hepatitis C in a timely manner to locate and remove units of blood.
Armour was charged with violating the Food and Drug Act for failing to disclose to regulators that there were problems with its heat-treatment
process. The man who faces the most charges, Dr. Perrault, moved
quickly, hiring renowned defence lawyer Eddie Greenspan, who said he will plead not guilty.
~The events were obviously one of the great tragedies of Canadian medical history. It is only natural to assign blame, but it is also a tragedy that criminal charges are being laid," he said. ~Dr. Perrault is not a criminal. If his health is up to it, he intends to fight these charges."
Michael Neville, the lawyer for Dr. Boucher, suggested the charges were unwarranted and unfair.
"Essentially, as defined in the criminal code, (criminal negligence) means you do an act or you omit to do an act that you had a duty to do, and thereby show `wanton and reckless disregard for lives or safety of others,'" he said.
"What you're talking about here are otherwise well-respected and long-serving, dedicated professional people, and it's quite an allegation to suggest that people like that showed wanton and reckless disregard for others in carrying out their public duties."
Armour Pharmaceutical also served notice that it will fight the charges vigorously.
"The criminal charges brought today by the RCMP against Armour Pharmaceutical Company and Dr. Michael Rodell are unfair and unjustified, and Armour will now vigorously defend its actions in the Canadian justice system," the company said through James Deeks of Toronto's Primary Counsel Group Inc.
"Armour's actions and those of its employees almost 20 years ago - viewed in the context of the time, rather than with the benefit of 20-20 hindsight - constituted the very best efforts of committed scientists and good, law-abiding people.
"When all facts are considered, and this matter is concluded, Armour is convinced that justice will be done, and that the company and Dr. Rodell will be acquitted on all charges against them.
Analysis
A painful step in Canada's healing process
Thursday, November 21, 2002
ANDRÉ PICARD
PUBLIC HEALTH REPORTER
For years, victims of tainted blood have wondered why, if administrators of the blood system were tried and convicted of criminal wrongdoing in France, the same approach had not been taken in Canada. Now it has. As a result, it is worth looking at the French experience. In France, as in Canada, there was at first an unwillingness to go the criminal route. The general feeling was that while there were many failings
-- bureaucratic, moral, ethical -- it was hard to view the actions and inactions that led to the tragedy as criminal. There was also a fear that speaking of the system's failings publicly would lead to a drop in blood donations, endangering even more lives. But in France, the legal system is quite different. Individuals can, and commonly do, swear out criminal complaints. A pit bull of a man, Edmond-Luc Henry, did so, over the objections of many of his fellow hemophiliacs. "I don't care who or how much it hurts," Mr. Henry said. "I want the world to know the wrong we have suffered. And I want those who betrayed us to be judged for their acts."
The criminal charges did have an impact. The French blood system was revamped, and the government fell, in large part because of the scandal. The criminal process itself was somewhat unsatisfying. Many people were charged -- bureaucrats, blood system administrators, even politicians -- but ultimately only the bureaucrats were convicted, and their sentences were fairly light. Yet it proved cathartic. The trials and convictions forced the world to stand up and take notice. It made the hemophiliacs and transfusion recipients who contracted HIV-AIDS and hepatitis C feel as though they were finally being heard, and believed. The Canadian victims of the tainted-blood tragedy were more patient than their French counterparts. But they have ultimately come around to the same way of thinking. At some point during the inquiry headed by Mr. Justice Horace Krever, the calls for criminal charges began coming, and they have continued unabated. Mark Bulbrook, a Hamilton hemophiliac who contracted HIV and hepatitis C from tainted-blood products, stated the point of view eloquently, arguing that demanding criminal charges was not seeking revenge, but a way of ensuring the tragedy is not repeated. "We believe that the only true act of deterrence at this point in the history of this catastrophic medical injury is to respond with criminal charges," he said. The charges yesterday -- and they are just charges; the presumption of innocence remains -- send a message. Above all, they tell us that public-health officials are responsible for their actions and inaction, and that their failure to protect the public can entail grave consequences. The officials from Health Canada and the Canadian Red Cross Society are facing criminal charges for failing to warn the public adequately that HIV and hepatitis C might be in the blood supply, for failing to act promptly to minimize risks, and for being negligent toward specific individuals. This is unprecedented. It really raises the bar of expectations for those who deliver health services. But it is appropriate. The public entrusted the administrators of the blood system, regulators and corporate suppliers with their lives. Because of failings -- some now considered as criminally negligent failings -- thousands paid with their lives. Laying criminal charges is not a reason to rejoice. Justice has not been done. But another piece has been laid in the puzzle. And, as Mr. Henry warned, it is going to hurt. Yet, Aline Boyer, a lawyer who represented the interests of HIV-positive transfusion recipients at the criminal trials, likened the criminal process to life-saving surgery -- painful, but necessary. "There is only one way to remove a tumour, radical surgery. Without it, the tumour would still be spreading; we would still have a diseased blood system." Let the criminal trials begin. Let the healing begin.