Factor VIII (FVIII) is a protein essential to blood clotting. It is also called an “anti-hemophilic factor” (AHF). Factor VIII is prescribed for treating hemophilia A, or classic hemophilia. It helps the body form blood clots to stop bleeding.
Hemophilia A is a genetic disorder that afflicts a person when they lack factor VIII in their blood or their factor VIII is defective. It is passed down from parents to children, but about one-third of the cases diagnosed have no previous family history of the condition.
People with hemophilia A bleed longer than others because they lack the factor in blood that causes clots to form so bleeding can stop. This can be damaging because bleeding can occur both internally and externally. How often a person bleeds and the severity of the bleeding depends on how much FIII a person produces naturally.
Not all cases of hemophilia are the same:
- Mild classic hemophilia: With a case of mild hemophilia, a person has from 6% to 49% of FVIII in their blood. These people commonly experience bleeding only after serious injury, trauma, or surgery. People with mild hemophilia sometimes are not diagnosed until they are adults;
- Moderate classic hemophilia: People with moderate hemophilia have from 1% to 5% of FVIII in their blood and usually have episodes of bleeding after injuries;
- Severe hemophilia: People with severe hemophilia have less than 1% of FVIII in the blood. People with severe hemophilia may suffer bleeding after they have been injured and may have other frequent spontaneous episodes of bleeding without a clear cause. Many males with severe hemophilia are diagnosed due to bleeding after circumcision.
Are There Any Negative Side-effects to Factor VIII?
The most common side effects people suffer after taking Factor VIII are fever, nausea, chills, headache, vomiting, dizziness, and weakness.
A more serious issue arose in the 1970s and 1980s concerning hepatitis C and Acquired Immune Deficiency Syndrome (AIDS). In the 1970s and 1980s, people with hemophilia were given blood infected with the human immunodeficiency virus (HIV), which causes AIDS and hepatitis viruses. This was when Factor VIII was first introduced to the market as a treatment for hemophilia. Before Factor VIII came on the market, people with hemophilia had to have a frequent blood transfusions to strengthen their blood clotting response.
In the early years of the AIDS epidemic in the 1980s, Cutter Biological, a division of Bayer, made Factor VIII from the blood plasma donations of about 10,000 people. However, because there was not yet a test for HIV, thousands of hemophiliacs became infected from using Factor VIII because it was contaminated
At some point, the problem was identified as it became understood that AIDS and hepatitis were transmitted in Factor VIII because the blood from which Factor VIII was made had been contaminated with these viruses. Healthcare professionals then figured out that the viruses could be destroyed, and Factor VIII was made safe if it was treated with heat, which killed the viruses.
Meanwhile, however, thousands of people have contracted AIDS, and some of them died from this disease. Then, some people who were citizens of foreign countries filed a class-action lawsuit in a U.S. federal court claiming that certain pharmaceutical companies knowingly sold Factor VIII, which was made with blood contaminated with HIV and hepatitis C in their countries after they had stopped selling it in the U.S. because of the risk that it was contaminated.
The lawsuit alleged that the companies continued to sell the potentially contaminated product overseas after introducing a safer version to the U.S. It was reported that Cutter Biological sold millions of dollars worth of Factor VIII that was possibly contaminated in Asia and Latin America. Meanwhile, it sold heat-treated Factor VIII in the U.S. and other Western countries.
The lawsuit filed by the foreign nationals claims that drug makers could have taken measures to avoid the contamination of Factor VIII, such as screening blood donors.
In addition, in the United Kingdom, the National Health Service imported Factor VIII supplies from the U.S. However, this Factor VIII came from human blood plasma from donors such as prison inmates and people who used intravenous drugs, such as heroin, who sold their blood and were at higher risk for having AIDS and hepatitis C. The risk of contamination was raised further because Factor VIII was made by pooling plasma from up to 40,000 donors and concentrating it.
What Should I Do If I Have Contracted AIDS or Hepatitis C from Tainted Factor VIII?
If a person believes that they have contracted AIDS, hepatitis C, or another type of hepatitis from Factor VIII, they would want to consult a personal injury lawyer. A personal injury lawyer would be able to seek the help of a medical expert to analyze the facts of a person’s case and figure out whether their AIDS or hepatitis could have been caused by Factor VIII.
Depending on the facts of the case, a person might have grounds for a lawsuit for medical malpractice or other healthcare malpractice. This would be the case if a person’s doctor should have known that the source of the Factor VIII used to treat a hemophiliac patient were tainted or created the risk of exposure to the virus that causes AIDS or the virus that causes hepatitis C. Another possibility would be pharmacy malpractice if a pharmacy were the source of tainted Factor VIII administered to a person.
Another option would be a lawsuit against the manufacturer of Factor VIII on a theory of strict product liability. The law of strict product liability makes a manufacturer and the distributors of products liable for the harm caused by any defect in a product. Defects are usually one or more of three types, design defects, manufacturing defects, and warning label defects. Any defects might be the source of contamination or harm caused by contamination in Factor VIII. For example, it could be said that the defect arose when the product was manufactured because potentially tainted blood from questionable sources was used to make Factor VIII.
Or the defect might be a warning defect if Factor VIII was made using blood from suspect sources, but the warning label on the packaging did not alert potential users of this fact.
Or, as one of the class-action lawsuits filed in years past claimed, the drug companies that manufactured Factor VIII could have taken precautions to limit the possibility of contamination by doing such things as screening blood donors or using volunteers rather than accepting blood from people who sold their blood and were likely to be HIV-positive.
A lawsuit for malpractice, another type of negligence or strict product liability, if successful, results in an award of compensatory damages. Compensatory damages should cover the entire economic loss the victim suffers, usually including the cost of all necessary medical care, lost wages, loss of earning capacity,and any other provable economic loss.
An award of compensatory damages would also include an amount to reimburse the victim for their non-economic damages, the pain and suffering that a person experiences when they are significantly injured.
Do I Need the Help of a Lawyer for My Factor VIII Issue?
If you believe that you contracted AIDS, hepatitis C, or another form of hepatitis from treatment with Factor VIII, you want to consult a class action lawyer.
Your lawyer can obtain the help of a medical professional who can determine whether Factor VIII may have played a role in giving you AIDS or hepatitis. The lawyer can advise you on the best way to recover damages in your case.
