Contaminated haemophilia blood products
Encyclopedia
Contaminated hemophilia blood products were a serious public health problem in the late 1970s through 1985. These products caused large numbers of haemophiliac
s to become infected with HIV
and hepatitis C
. The companies involved included Alpha Therapeutic Corporation, Rhone-Poulenc Rorer Inc., a unit of Rhone-Poulenc S.A., Bayer Corporation and its Cutter Biological
division, Baxter International
and its Hyland Pharmaceutical division . Estimates range from 6,000 to 10,000 haemophiliacs in the United States becoming infected with HIV.
It is believed that these companies recruited and paid donors from high-risk populations including former prisoners, homosexual men, injection-drug users, and plasmapheresis
facilities in prisons (e.g. Arkansas Prison Plasma Scandal) and in cities already having large numbers of these persons to obtain blood plasma
used for the production of Factor VIII
and Factor IX
. These companies allegedly failed to follow United States federal law mandates to exclude donors with a history of viral hepatitis
. The medicine was made using pools of plasma from 10,000 or more donors, and since HIV at that time couldn't be screened out, the plasma carried a high risk of passing along the disease.
Factor VIII essentially provides the missing ingredient without which hemophiliacs' blood cannot clot. By injecting themselves with it, haemophiliacs can stop bleeding or prevent bleeds from starting; some use it as many as three times a week.
was focused on homosexual men and intravenous drug users. On July 16, 1982, the United States
Centers for Disease Control and Prevention
(CDC) reported that three hemophiliacs had acquired HIV. Epidemiologists started to believe that the disease was being spread through blood products, with grave implications for hemophiliacs who had routinely injected themselves with concentrate made from giant pools of donated plasma. Without an AIDS test, health officials had no idea how many plasma donors carried the disease.
In January 1983, the manager of plasma procurement for Bayer's Cutter Biological division acknowledged in a letter that "There is strong evidence to suggest that AIDS is passed on to other people through ... plasma products." In March 1983, the CDC warned that blood products "appear responsible for AIDS among hemophilia patients." By May 1983, a Cutter rival began making a heated concentrate and France
decided to halt all clotting concentrate imports.
Cutter feared losing customers, so according to an internal memo, Cutter "want[ed] to give the impression that [they were] continuously improving our product without telling them [they expected] soon to also have a heat-treated" concentrate. The heat-treatment rendered the virus "undetectable" in the product, according to a government study.
By June, a Cutter letter to distributors in France and 20 other countries said that "AIDS has become the center of irrational response in many countries" and that "This is of particular concern to us because of unsubstantiated speculations that this syndrome may be transmitted by certain blood products." France continued using unheated concentrate through until August.
Bayer officials (responding on behalf of Cutter) issued a statement, stating that Cutter continued to sell the old medicine, "because some customers doubted the new drug's effectiveness", and because some countries were slow to approve its sale. The company also said that a shortage of plasma, used to make the medicine, had kept Cutter from manufacturing more of the new product." Bayer officials also claimed that an overall plasma shortage in 1985 kept Cutter from making more heat treated medicine; however, because Cutter was using some of its limited plasma to continue making the old product, they may have contributed to the shortage. While Bayer said that "procedural requirements" imposed by Taiwan
slowed down their ability to sell the new product, according to The New York Times
, Hsu Chien-wen, an official at Taiwan's health department, said in 2003 that Cutter had not applied for permission to sell the heated medicine until July 1985, a year and a half after doing so in the United States. Dr. Cindy Lai, assistant director of Hong Kong's health department, said that Cutter needed only to get an import license in the 1980s to sell the newer product in which "It normally [takes] one week."
While the new product was selling well for Cutter, a Cutter company meeting notes that "There is excess nonheated inventory", which resulted in the company deciding to "review international markets again to determine if more of this product can be sold." Cutter decided to sell millions of dollars of the older medicine to Asia and Latin America while selling the new, safer product in the West, to avoid being stuck with large stores of a product that was proving increasingly unmarketable.
In late 1984, when a Hong Kong
distributor asked Cutter about the newer product, records show that Cutter asked the distributor to "use up stocks" of the old medicine before switching to its "safer, better" product. Several months later, once haemophiliacs in Hong Kong began testing positive for HIV, some local doctors began to question whether Cutter was dumping "AIDS tainted" medicine into less-developed countries. Cutter denied the allegation, claiming that the unheated product posed "no severe hazard" and was in fact the "same fine product we have supplied for years." By May 1985, when the Hong Kong distributor told of an impending medical emergency, asking for the newer product, Cutter replied that most of the new medicine was going to the US and Europe and there wasn't enough for Hong Kong, except for a small amount for the "most vocal patients."
The United States
Food and Drug Administration
helped to keep the news out of the public. In May 1985, the FDA's regulator of blood products, Dr. Harry M. Meyer Jr., believing the companies had broken a voluntary agreement to withdraw the old medicine from the market, called together officials of the companies and ordered them to comply. Cutter's notes from the meeting indicate that Dr. Meyer asked that the issue be "quietly solved without alerting the Congress, the medical community and the public" while another company noted that the FDA wanted the matter solved "quickly and quietly."
At the same time, a Cutter official wrote that "It appears there are no longer any markets in the Far East where we can expect to sell substantial quantities of nonheat-treated [medicine]" and stopped shipping unheated concentrate in July 1985.
According to The New York Times, doctors and patients contacted overseas said they had not known of the contents of the Cutter documents. The effects are close to impossible to calculate. Since many records are unavailable and because it was a while until an AIDS test was developed, one cannot know when foreign haemophiliacs were infected with HIV - before Cutter began selling its safer medicine or afterward.
The New York Times found these largely unnoticed documents ("internal memorandums, minutes of company marketing meetings and telexes to foreign distributors") as part of the production in connection with the American haemophiliacs lawsuits described below. Dr. Sidney M. Wolfe
, director of the Public Citizen Health Research Group, which has been investigating the industry's practices for three decades called them "the most incriminating internal pharmaceutical industry documents I have ever seen."
On August 22, 2003, MSNBC
's Scarborough Country
had Bayer on their "Rat of the Week" segment. Speaking with Mike Papantonio
, a legal advisor to the show, they discussed the 2003 New York Times article referenced above, saying that the product (known by Bayer to bear the risk of contamination) was "dropped ... in Japan, Spain and France." , the United States Justice Department
has yet to investigate any corporate executives.
, by the time blood tests began in late 1985, about 2,000 people were infected with HIV and up to 60,000 with Hepatitis C
. Three suits were brought against the Canadian Red Cross
by people who had received tainted blood, two of whom subsequently died of AIDS and the third HIV positive. In April 2001, the Supreme Court of Canada
found the Canadian Red Cross
guilty of negligence
for failing to screen blood donors effectively for HIV infection.
, an estimated 4,000 people, many haemophiliacs, were given blood infected with HIV.
A former Health Minister
was convicted for failing to adequately screen the blood, leading to the deaths of five people from AIDS, and the contamination of two others during a key period in 1985. Two other government officials that continued to use the old unheated stock in 1985, when a heated product was available, were sent to prison. Allegedly, all three politicians delayed the introduction of United States blood-screening test in France until a rival French product was ready to be sold on the market.
, as of 2001, the former head of Iran's blood transfusion centre went on trial (a Dr. Farhadi along with two other doctors) facing several charges including negligence for importing HIV-tainted supplies from France after patients contracted HIV. The case followed complaints by families of some 170 people, many of them children, suffering from haemophilia and the blood disease thalassaemia
.
's Health Ministry had determined that at least 115 Iraqi haemophiliacs had contracted AIDS from clotting agents imported from France
and Austria
. According to Dr. Said I. Hakki, the director of the Iraqi Red Crescent Society
, 189 haemophiliacs, from 6 months to 18 years old, contracted HIV from blood products that Institut Mérieux and Immuno sold to Iraq from 1982 to 1986; undetected, the virus later spread to at least another 50 more Iraqis, through sexual intercourse, childbirth or breast-feeding.
In August 2005, the 35 or so survivors, along with the families of the ones who died, and the Iraqi Red Crescent Society have sued the Health Ministry and Institut Mérieux of France and Immuno AG of Austria, two corporations who either acquired or succeeded the companies that sold tainted blood products to Iraq. Institut Mérieux is now part of Sanofi-Aventis
, while Immuno AG was acquired by Baxter International
in 1996.
Several of the infected haemophiliacs spoke with The New York Times
in 2006 about life under Hussein's rule. They were forced to "sign a pledge vowing not to work, marry, attend school, use public swimming pools or barbershops, visit a doctor’s office or tell anyone about their condition", punishable by death. The families' homes had warnings painted on them, telling neighbours to stay away because the house was contaminated with HIV and uninfected siblings were not even allowed to marry. As of 2006, the infected haemophiliacs receive about $35 a month in government assistance, but no HIV medication.
from infected blood infusions since 1985.
An Italian court in Rome ordered the Health Ministry
to pay damages to 351 people who contracted HIV and Hepatitis C through blood transfusions; the court said that the ministry was too slow to introduce measures to prevent the virus being spread by donated blood, and did not establish proper checks on plasma and plasma-derived products. Although almost 100 of the victims had already died, the court ruled that their families were still entitled compensation.
More than 500 Italian haemophiliacs form a part of the worldwide suits in various US Courts starting from July 2003.
, the Health Ministry
did not ban unheated products until December 1985, despite knowing that they were contaminated. As a result, over 1,400 Japanese haemophiliacs were exposed to HIV, and more than 500 were believed to have died by 2001.
In November 1995, a case involving Japanese haemophiliacs settled, resulting in $420,000 for each victim, with $235,000 coming from industry and the rest from the Japanese government. This was much higher than the results being discussed in the United States cases.
In February 2000, three former drug company executives accused of selling blood products tainted with HIV were given prison terms.
However, in March 2001, a Tokyo
court cleared the former top AIDS expert of professional negligence over the scandal.
, more than 100 Portuguese haemophiliacs were infected with the AIDS virus after receiving transfusions of contaminated plasma that had been imported and distributed by the public health service. In 2001, a court indicted Leonor Beleza
, a former health minister, for propagating a contagious disease during her time in office during the 1980s.
, Rhône-Poulenc
and Alpha Therapeutic) met with leaders of the haemophilia community to outline the terms of a $125 million offer. Rejecting the offer, David Shrager, a plaintiffs' lawyer, filed a class action
lawsuit with Jonathan Wadleigh as lead plaintiff on behalf of American haemophiliacs. Shrager had previously negotiated a favourable settlement on behalf of Canadian haemophiliacs and then established a panel of claimants, led by Wadleigh, to advise him and other lawyers. In early 1995, the United States Court of Appeals for the Seventh Circuit
in Chicago
decertified the lawsuit, saying it might bankrupt the industry.
There became a split between Wadleigh and Corey Dubin (another named plaintiff) who favoured appeal
ing the Seventh Circuit decision to the Supreme Court of the United States
, to protect the rights of all affected haemophiliacs, not just those who had already sued, while Shrager wanted to shift gears and pursue the separate federal proceeding that had consolidated hundreds of individual lawsuits that had been filed against the producers. By June 1996, the differing groups reconciled, looking for industry settlement proposals.
Meanwhile, the clotting producers were quietly settling many claims. Individual lawsuits continued to fail because most states had laws shielding blood products from traditional product liability
claims. However, discovery
was producing damaging documents contending that the companies had collected blood from high-risk donors like homosexuals and prisoners, intensifying informal settlement negotiations. James and Matthews, using source plasma clinic address data, and a spatial/demographic model of illicit drug markets, reported data showing that during the period from 1980-1995, US source plasma clinics were over-represented in so-called "underclass" or extreme-poverty census tracts, and simultaneously demonstrate that link these same census tract types to active illicit drug markets.
In 1997, Bayer and the other three makers agreed to pay $660 million to settle cases on behalf of more than 6,000 haemophiliacs infected in United States in the early 1980s, paying an estimated $100,000 net to each infected haemophiliac. The settlement consent decree denied attorney contingent fees and provided a $40 million fund to pay attorneys as ordered by the court.
Soon after the settlement, because the New York
state statute of limitations
required people to file a lawsuit within three years of discovering an illness, New York Governor George Pataki
signed a bill allowing people infected by blood products, or their survivors, two years to bring product liability suits against the manufacturers. While the settled class members are barred from filing suits against the companies, the bill allowed an estimated additional 75 eligible persons to file suits.
The plaintiffs alleged that the companies manufactured and sold blood factor products as beneficial "medicines" that were, in fact, contaminated with HIV and/or HCV and resulted in the mass infection and/or deaths of thousands of haemophiliacs worldwide. The companies' failure to follow US federal law and conduct tests against viral hepatitis increased the risk of plasma containing HIV entering plasma pools.
Haemophilia
Haemophilia is a group of hereditary genetic disorders that impair the body's ability to control blood clotting or coagulation, which is used to stop bleeding when a blood vessel is broken. Haemophilia A is the most common form of the disorder, present in about 1 in 5,000–10,000 male births...
s to become infected with HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
and hepatitis C
Hepatitis C
Hepatitis C is an infectious disease primarily affecting the liver, caused by the hepatitis C virus . The infection is often asymptomatic, but chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years...
. The companies involved included Alpha Therapeutic Corporation, Rhone-Poulenc Rorer Inc., a unit of Rhone-Poulenc S.A., Bayer Corporation and its Cutter Biological
Cutter Laboratories
Cutter Laboratories was a pharmaceutical company located in Berkeley, California. They were bought by the Bayer pharmaceutical company in the 1970s.-The Cutter incident:...
division, Baxter International
Baxter International
Baxter International Inc. , is an American health care company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions...
and its Hyland Pharmaceutical division . Estimates range from 6,000 to 10,000 haemophiliacs in the United States becoming infected with HIV.
It is believed that these companies recruited and paid donors from high-risk populations including former prisoners, homosexual men, injection-drug users, and plasmapheresis
Plasmapheresis
Plasmapheresis is the removal, treatment, and return of blood plasma from blood circulation. It is thus an extracorporeal therapy...
facilities in prisons (e.g. Arkansas Prison Plasma Scandal) and in cities already having large numbers of these persons to obtain blood plasma
Blood plasma
Blood plasma is the straw-colored liquid component of blood in which the blood cells in whole blood are normally suspended. It makes up about 55% of the total blood volume. It is the intravascular fluid part of extracellular fluid...
used for the production of Factor VIII
Factor VIII
Factor VIII is an essential blood clotting factor also known as anti-hemophilic factor . In humans, Factor VIII is encoded by the F8 gene...
and Factor IX
Factor IX
Factor IX is one of the serine proteases of the coagulation system; it belongs to peptidase family S1. Deficiency of this protein causes hemophilia B. It was discovered in 1952 after a young boy named Stephen Christmas was found to be lacking this exact factor, leading to...
. These companies allegedly failed to follow United States federal law mandates to exclude donors with a history of viral hepatitis
Viral hepatitis
Viral hepatitis is liver inflammation due to a viral infection. It may present in acute or chronic forms. The most common causes of viral hepatitis are the five unrelated hepatotropic viruses Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis D, and Hepatitis E...
. The medicine was made using pools of plasma from 10,000 or more donors, and since HIV at that time couldn't be screened out, the plasma carried a high risk of passing along the disease.
Factor VIII essentially provides the missing ingredient without which hemophiliacs' blood cannot clot. By injecting themselves with it, haemophiliacs can stop bleeding or prevent bleeds from starting; some use it as many as three times a week.
Initial concerns
After its discovery in 1981, concern over AIDSAIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...
was focused on homosexual men and intravenous drug users. On July 16, 1982, the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...
(CDC) reported that three hemophiliacs had acquired HIV. Epidemiologists started to believe that the disease was being spread through blood products, with grave implications for hemophiliacs who had routinely injected themselves with concentrate made from giant pools of donated plasma. Without an AIDS test, health officials had no idea how many plasma donors carried the disease.
In January 1983, the manager of plasma procurement for Bayer's Cutter Biological division acknowledged in a letter that "There is strong evidence to suggest that AIDS is passed on to other people through ... plasma products." In March 1983, the CDC warned that blood products "appear responsible for AIDS among hemophilia patients." By May 1983, a Cutter rival began making a heated concentrate and France
France
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
decided to halt all clotting concentrate imports.
Cutter feared losing customers, so according to an internal memo, Cutter "want[ed] to give the impression that [they were] continuously improving our product without telling them [they expected] soon to also have a heat-treated" concentrate. The heat-treatment rendered the virus "undetectable" in the product, according to a government study.
By June, a Cutter letter to distributors in France and 20 other countries said that "AIDS has become the center of irrational response in many countries" and that "This is of particular concern to us because of unsubstantiated speculations that this syndrome may be transmitted by certain blood products." France continued using unheated concentrate through until August.
Sales to Asia and Latin America
On February 29, 1984, Cutter became the last of the four major blood product companies to get US approval to sell heated concentrate. Even after Cutter began selling the new product, for several months, until August 1984, the company continued making the old medicine. One reason was that the company had several fixed-price contracts and believed that the old product would be cheaper to produce.Bayer officials (responding on behalf of Cutter) issued a statement, stating that Cutter continued to sell the old medicine, "because some customers doubted the new drug's effectiveness", and because some countries were slow to approve its sale. The company also said that a shortage of plasma, used to make the medicine, had kept Cutter from manufacturing more of the new product." Bayer officials also claimed that an overall plasma shortage in 1985 kept Cutter from making more heat treated medicine; however, because Cutter was using some of its limited plasma to continue making the old product, they may have contributed to the shortage. While Bayer said that "procedural requirements" imposed by Taiwan
Taiwan
Taiwan , also known, especially in the past, as Formosa , is the largest island of the same-named island group of East Asia in the western Pacific Ocean and located off the southeastern coast of mainland China. The island forms over 99% of the current territory of the Republic of China following...
slowed down their ability to sell the new product, according to The New York Times
The New York Times
The New York Times is an American daily newspaper founded and continuously published in New York City since 1851. The New York Times has won 106 Pulitzer Prizes, the most of any news organization...
, Hsu Chien-wen, an official at Taiwan's health department, said in 2003 that Cutter had not applied for permission to sell the heated medicine until July 1985, a year and a half after doing so in the United States. Dr. Cindy Lai, assistant director of Hong Kong's health department, said that Cutter needed only to get an import license in the 1980s to sell the newer product in which "It normally [takes] one week."
While the new product was selling well for Cutter, a Cutter company meeting notes that "There is excess nonheated inventory", which resulted in the company deciding to "review international markets again to determine if more of this product can be sold." Cutter decided to sell millions of dollars of the older medicine to Asia and Latin America while selling the new, safer product in the West, to avoid being stuck with large stores of a product that was proving increasingly unmarketable.
In late 1984, when a Hong Kong
Hong Kong
Hong Kong is one of two Special Administrative Regions of the People's Republic of China , the other being Macau. A city-state situated on China's south coast and enclosed by the Pearl River Delta and South China Sea, it is renowned for its expansive skyline and deep natural harbour...
distributor asked Cutter about the newer product, records show that Cutter asked the distributor to "use up stocks" of the old medicine before switching to its "safer, better" product. Several months later, once haemophiliacs in Hong Kong began testing positive for HIV, some local doctors began to question whether Cutter was dumping "AIDS tainted" medicine into less-developed countries. Cutter denied the allegation, claiming that the unheated product posed "no severe hazard" and was in fact the "same fine product we have supplied for years." By May 1985, when the Hong Kong distributor told of an impending medical emergency, asking for the newer product, Cutter replied that most of the new medicine was going to the US and Europe and there wasn't enough for Hong Kong, except for a small amount for the "most vocal patients."
The United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
helped to keep the news out of the public. In May 1985, the FDA's regulator of blood products, Dr. Harry M. Meyer Jr., believing the companies had broken a voluntary agreement to withdraw the old medicine from the market, called together officials of the companies and ordered them to comply. Cutter's notes from the meeting indicate that Dr. Meyer asked that the issue be "quietly solved without alerting the Congress, the medical community and the public" while another company noted that the FDA wanted the matter solved "quickly and quietly."
At the same time, a Cutter official wrote that "It appears there are no longer any markets in the Far East where we can expect to sell substantial quantities of nonheat-treated [medicine]" and stopped shipping unheated concentrate in July 1985.
According to The New York Times, doctors and patients contacted overseas said they had not known of the contents of the Cutter documents. The effects are close to impossible to calculate. Since many records are unavailable and because it was a while until an AIDS test was developed, one cannot know when foreign haemophiliacs were infected with HIV - before Cutter began selling its safer medicine or afterward.
The New York Times found these largely unnoticed documents ("internal memorandums, minutes of company marketing meetings and telexes to foreign distributors") as part of the production in connection with the American haemophiliacs lawsuits described below. Dr. Sidney M. Wolfe
Sidney M. Wolfe
Sidney M. Wolfe, MD, is a physician and currently the director of Public Citizen's Health Research Group, a consumer and health advocacy lobbying group.He has publicly crusaded against many pharmaceuticals, which Dr...
, director of the Public Citizen Health Research Group, which has been investigating the industry's practices for three decades called them "the most incriminating internal pharmaceutical industry documents I have ever seen."
On August 22, 2003, MSNBC
MSNBC
MSNBC is a cable news channel based in the United States available in the US, Germany , South Africa, the Middle East and Canada...
's Scarborough Country
Scarborough Country
Scarborough Country was an opinion/analysis show broadcast on MSNBC Monday - Thursday at 9 P.M. ET. It was hosted by former congressman Joe Scarborough....
had Bayer on their "Rat of the Week" segment. Speaking with Mike Papantonio
Mike Papantonio
James Michael Papantonio , popularly known as Mike Papantonio, is an American attorney and radio talk show host. A prominent trial lawyer, he co-hosts Ring of Fire, a nationally-syndicated weekly radio program, with Robert F...
, a legal advisor to the show, they discussed the 2003 New York Times article referenced above, saying that the product (known by Bayer to bear the risk of contamination) was "dropped ... in Japan, Spain and France." , the United States Justice Department
United States Department of Justice
The United States Department of Justice , is the United States federal executive department responsible for the enforcement of the law and administration of justice, equivalent to the justice or interior ministries of other countries.The Department is led by the Attorney General, who is nominated...
has yet to investigate any corporate executives.
Canada
In CanadaCanada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
, by the time blood tests began in late 1985, about 2,000 people were infected with HIV and up to 60,000 with Hepatitis C
Hepatitis C
Hepatitis C is an infectious disease primarily affecting the liver, caused by the hepatitis C virus . The infection is often asymptomatic, but chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years...
. Three suits were brought against the Canadian Red Cross
Canadian Red Cross
The Canadian Red Cross Society is a Canadian humanitarian charitable organization and one of 186 national Red Cross and Red Crescent societies....
by people who had received tainted blood, two of whom subsequently died of AIDS and the third HIV positive. In April 2001, the Supreme Court of Canada
Supreme Court of Canada
The Supreme Court of Canada is the highest court of Canada and is the final court of appeals in the Canadian justice system. The court grants permission to between 40 and 75 litigants each year to appeal decisions rendered by provincial, territorial and federal appellate courts, and its decisions...
found the Canadian Red Cross
Canadian Red Cross
The Canadian Red Cross Society is a Canadian humanitarian charitable organization and one of 186 national Red Cross and Red Crescent societies....
guilty of negligence
Negligence
Negligence is a failure to exercise the care that a reasonably prudent person would exercise in like circumstances. The area of tort law known as negligence involves harm caused by carelessness, not intentional harm.According to Jay M...
for failing to screen blood donors effectively for HIV infection.
France
In FranceFrance
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
, an estimated 4,000 people, many haemophiliacs, were given blood infected with HIV.
A former Health Minister
Minister of Health (France)
Minister of Health and Solidarity is currently a cabinet position in the Government of France. The health portfolio oversees the healthcare public services and the health insurance part of the French Social Security...
was convicted for failing to adequately screen the blood, leading to the deaths of five people from AIDS, and the contamination of two others during a key period in 1985. Two other government officials that continued to use the old unheated stock in 1985, when a heated product was available, were sent to prison. Allegedly, all three politicians delayed the introduction of United States blood-screening test in France until a rival French product was ready to be sold on the market.
Iran
In IranIran
Iran , officially the Islamic Republic of Iran , is a country in Southern and Western Asia. The name "Iran" has been in use natively since the Sassanian era and came into use internationally in 1935, before which the country was known to the Western world as Persia...
, as of 2001, the former head of Iran's blood transfusion centre went on trial (a Dr. Farhadi along with two other doctors) facing several charges including negligence for importing HIV-tainted supplies from France after patients contracted HIV. The case followed complaints by families of some 170 people, many of them children, suffering from haemophilia and the blood disease thalassaemia
Thalassemia
Thalassemia is an inherited autosomal recessive blood disease that originated in the Mediterranean region. In thalassemia the genetic defect, which could be either mutation or deletion, results in reduced rate of synthesis or no synthesis of one of the globin chains that make up hemoglobin...
.
Iraq
In 1986, officials from Saddam HusseinSaddam Hussein
Saddam Hussein Abd al-Majid al-Tikriti was the fifth President of Iraq, serving in this capacity from 16 July 1979 until 9 April 2003...
's Health Ministry had determined that at least 115 Iraqi haemophiliacs had contracted AIDS from clotting agents imported from France
France
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
and Austria
Austria
Austria , officially the Republic of Austria , is a landlocked country of roughly 8.4 million people in Central Europe. It is bordered by the Czech Republic and Germany to the north, Slovakia and Hungary to the east, Slovenia and Italy to the south, and Switzerland and Liechtenstein to the...
. According to Dr. Said I. Hakki, the director of the Iraqi Red Crescent Society
Iraqi Red Crescent Society
Iraqi Red Crescent Society was founded in 1932 and it has its headquarters in Baghdad.-External links:* *...
, 189 haemophiliacs, from 6 months to 18 years old, contracted HIV from blood products that Institut Mérieux and Immuno sold to Iraq from 1982 to 1986; undetected, the virus later spread to at least another 50 more Iraqis, through sexual intercourse, childbirth or breast-feeding.
In August 2005, the 35 or so survivors, along with the families of the ones who died, and the Iraqi Red Crescent Society have sued the Health Ministry and Institut Mérieux of France and Immuno AG of Austria, two corporations who either acquired or succeeded the companies that sold tainted blood products to Iraq. Institut Mérieux is now part of Sanofi-Aventis
Sanofi-Aventis
Sanofi S.A. is a multinational pharmaceutical company headquartered in Paris, France, the world's fourth-largest by prescription sales. Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the...
, while Immuno AG was acquired by Baxter International
Baxter International
Baxter International Inc. , is an American health care company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions...
in 1996.
Several of the infected haemophiliacs spoke with The New York Times
The New York Times
The New York Times is an American daily newspaper founded and continuously published in New York City since 1851. The New York Times has won 106 Pulitzer Prizes, the most of any news organization...
in 2006 about life under Hussein's rule. They were forced to "sign a pledge vowing not to work, marry, attend school, use public swimming pools or barbershops, visit a doctor’s office or tell anyone about their condition", punishable by death. The families' homes had warnings painted on them, telling neighbours to stay away because the house was contaminated with HIV and uninfected siblings were not even allowed to marry. As of 2006, the infected haemophiliacs receive about $35 a month in government assistance, but no HIV medication.
Italy
Angelo Magrini, the head of a haemophiliacs' association, said that as of 2001, 1,300 people, including almost 150 children, had died in ItalyItaly
Italy , officially the Italian Republic languages]] under the European Charter for Regional or Minority Languages. In each of these, Italy's official name is as follows:;;;;;;;;), is a unitary parliamentary republic in South-Central Europe. To the north it borders France, Switzerland, Austria and...
from infected blood infusions since 1985.
An Italian court in Rome ordered the Health Ministry
Italian Minister of Health
This is a list of Italian Ministers of Health...
to pay damages to 351 people who contracted HIV and Hepatitis C through blood transfusions; the court said that the ministry was too slow to introduce measures to prevent the virus being spread by donated blood, and did not establish proper checks on plasma and plasma-derived products. Although almost 100 of the victims had already died, the court ruled that their families were still entitled compensation.
More than 500 Italian haemophiliacs form a part of the worldwide suits in various US Courts starting from July 2003.
Japan
In JapanJapan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
, the Health Ministry
Ministry of Health, Labour and Welfare (Japan)
The ' is a cabinet level ministry of the Japanese government. It is commonly known as Kōrō-shō in Japan. This ministry provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug regulations, standards for foods, food additives, etc.It was formed with...
did not ban unheated products until December 1985, despite knowing that they were contaminated. As a result, over 1,400 Japanese haemophiliacs were exposed to HIV, and more than 500 were believed to have died by 2001.
In November 1995, a case involving Japanese haemophiliacs settled, resulting in $420,000 for each victim, with $235,000 coming from industry and the rest from the Japanese government. This was much higher than the results being discussed in the United States cases.
In February 2000, three former drug company executives accused of selling blood products tainted with HIV were given prison terms.
However, in March 2001, a Tokyo
Tokyo
, ; officially , is one of the 47 prefectures of Japan. Tokyo is the capital of Japan, the center of the Greater Tokyo Area, and the largest metropolitan area of Japan. It is the seat of the Japanese government and the Imperial Palace, and the home of the Japanese Imperial Family...
court cleared the former top AIDS expert of professional negligence over the scandal.
Portugal
In PortugalPortugal
Portugal , officially the Portuguese Republic is a country situated in southwestern Europe on the Iberian Peninsula. Portugal is the westernmost country of Europe, and is bordered by the Atlantic Ocean to the West and South and by Spain to the North and East. The Atlantic archipelagos of the...
, more than 100 Portuguese haemophiliacs were infected with the AIDS virus after receiving transfusions of contaminated plasma that had been imported and distributed by the public health service. In 2001, a court indicted Leonor Beleza
Leonor Beleza
Maria Leonor Couceiro Pizarro Beleza , is a Portuguese politician.-Career:She is daughter of José Júlio Pizarro Beleza and Maria dos Prazeres Lançarote Couceiro da Costa. Her brother is Luís Miguel Beleza....
, a former health minister, for propagating a contagious disease during her time in office during the 1980s.
United States
In 1993, top executives of three companies (Baxter InternationalBaxter International
Baxter International Inc. , is an American health care company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions...
, Rhône-Poulenc
Rhône-Poulenc
-History of the company:The Company was founded in 1928 through the merger of Société des Usines Chimiques du Rhône from Lyon and Établissements Poulenc Frères from Paris founded by Étienne Poulenc, a 19th century Parisian apothecary and brought to prominence by his second and third sons Emile...
and Alpha Therapeutic) met with leaders of the haemophilia community to outline the terms of a $125 million offer. Rejecting the offer, David Shrager, a plaintiffs' lawyer, filed a class action
Class action
In law, a class action, a class suit, or a representative action is a form of lawsuit in which a large group of people collectively bring a claim to court and/or in which a class of defendants is being sued...
lawsuit with Jonathan Wadleigh as lead plaintiff on behalf of American haemophiliacs. Shrager had previously negotiated a favourable settlement on behalf of Canadian haemophiliacs and then established a panel of claimants, led by Wadleigh, to advise him and other lawyers. In early 1995, the United States Court of Appeals for the Seventh Circuit
United States Court of Appeals for the Seventh Circuit
The United States Court of Appeals for the Seventh Circuit is a federal court with appellate jurisdiction over the courts in the following districts:* Central District of Illinois* Northern District of Illinois...
in Chicago
Chicago
Chicago is the largest city in the US state of Illinois. With nearly 2.7 million residents, it is the most populous city in the Midwestern United States and the third most populous in the US, after New York City and Los Angeles...
decertified the lawsuit, saying it might bankrupt the industry.
There became a split between Wadleigh and Corey Dubin (another named plaintiff) who favoured appeal
Appeal
An appeal is a petition for review of a case that has been decided by a court of law. The petition is made to a higher court for the purpose of overturning the lower court's decision....
ing the Seventh Circuit decision to the Supreme Court of the United States
Supreme Court of the United States
The Supreme Court of the United States is the highest court in the United States. It has ultimate appellate jurisdiction over all state and federal courts, and original jurisdiction over a small range of cases...
, to protect the rights of all affected haemophiliacs, not just those who had already sued, while Shrager wanted to shift gears and pursue the separate federal proceeding that had consolidated hundreds of individual lawsuits that had been filed against the producers. By June 1996, the differing groups reconciled, looking for industry settlement proposals.
Meanwhile, the clotting producers were quietly settling many claims. Individual lawsuits continued to fail because most states had laws shielding blood products from traditional product liability
Product liability
Product liability is the area of law in which manufacturers, distributors, suppliers, retailers, and others who make products available to the public are held responsible for the injuries those products cause...
claims. However, discovery
Discovery (law)
In U.S.law, discovery is the pre-trial phase in a lawsuit in which each party, through the law of civil procedure, can obtain evidence from the opposing party by means of discovery devices including requests for answers to interrogatories, requests for production of documents, requests for...
was producing damaging documents contending that the companies had collected blood from high-risk donors like homosexuals and prisoners, intensifying informal settlement negotiations. James and Matthews, using source plasma clinic address data, and a spatial/demographic model of illicit drug markets, reported data showing that during the period from 1980-1995, US source plasma clinics were over-represented in so-called "underclass" or extreme-poverty census tracts, and simultaneously demonstrate that link these same census tract types to active illicit drug markets.
In 1997, Bayer and the other three makers agreed to pay $660 million to settle cases on behalf of more than 6,000 haemophiliacs infected in United States in the early 1980s, paying an estimated $100,000 net to each infected haemophiliac. The settlement consent decree denied attorney contingent fees and provided a $40 million fund to pay attorneys as ordered by the court.
Soon after the settlement, because the New York
New York
New York is a state in the Northeastern region of the United States. It is the nation's third most populous state. New York is bordered by New Jersey and Pennsylvania to the south, and by Connecticut, Massachusetts and Vermont to the east...
state statute of limitations
Statute of limitations
A statute of limitations is an enactment in a common law legal system that sets the maximum time after an event that legal proceedings based on that event may be initiated...
required people to file a lawsuit within three years of discovering an illness, New York Governor George Pataki
George Pataki
George Elmer Pataki is an American politician who was the 53rd Governor of New York. A member of the Republican Party, Pataki served three consecutive four-year terms from January 1, 1995 until December 31, 2006.- Early life :...
signed a bill allowing people infected by blood products, or their survivors, two years to bring product liability suits against the manufacturers. While the settled class members are barred from filing suits against the companies, the bill allowed an estimated additional 75 eligible persons to file suits.
The plaintiffs alleged that the companies manufactured and sold blood factor products as beneficial "medicines" that were, in fact, contaminated with HIV and/or HCV and resulted in the mass infection and/or deaths of thousands of haemophiliacs worldwide. The companies' failure to follow US federal law and conduct tests against viral hepatitis increased the risk of plasma containing HIV entering plasma pools.