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Cutter goes to trial J UNITED STATES DISTRICT COURT IV. FACTUAL ALLEGATIONS APPLICABLE TO ALL CLAIMS A. Hemophilia and Its Treatment C. Defendants Recruited Plasma Donors from High Risk Populations to Manufacture Factor VIII and IX
I. Conspiracy, Concert of Action and Group Liability VI. TOLLING OF APPLICABLE STATUTES OF LIMITATION First CLAIM FOR RELIEF: NEGLIGENCE Second CLAIM FOR RELIEF: NEGLIGENCE PER SE Third CLAIM FOR RELIEF: FRAUDULENT OMISSION AND CONCEALMENT Fourth CLAIM FOR RELIEF: BREACH OF IMPLIED WARRANTY
UNITED STATES DISTRICT COURT
1. Plaintiffs’ claims arise out of the most egregious misconduct in the history of the pharmaceutical industry, which resulted in the killing of thousands of hemophiliacs worldwide, with a continuing death rate of hundreds of victims per year. Defendants are American corporations which manufactured blood products known as “Factor VIII” and “Factor IX” for the treatment of hemophilia, and sold these products to hemophiliacs worldwide, despite knowledge that the products were manufactured from sick, high risk donors and/or known to be contaminated with the viruses that cause AIDS and Hepatitis C (now known as HIV and HCV respectively). Defendants continued selling these products to hemophiliacs abroad even after the products were no longer being used in the United States due to the known risk of AIDS and Hepatitis C transmission. Plaintiffs are hemophiliacs from countries outside the United States who contracted HIV and/or Hepatitis C through use of Defendants’ contaminated products. 2. Defendants manufactured HIV and HCV-contaminated blood factor products at plants in the United States using human plasma taken from thousands of paid American donors, including populations then known to be at high risk of carrying blood-borne diseases, such as urban homosexuals, prisoners, and intravenous drug users. Defendants intentionally recruited urban homosexuals who had a history of viral hepatitis as plasma donors, despite regulations prohibiting the use of such donors and despite knowledge that the viruses that cause AIDS and Hepatitis C were blood-borne diseases prevalent in such populations. Defendants continued using plasma taken from high risk prison donors, including from prisoners at the notorious Angola prison in Louisiana, even after promising the FDA that they would cease doing so. Through their trade associations, Defendants actively conspired to conceal these practices and to substantially delay product recalls and implementation of safety measures. 3. Defendants failed to fully and completely disclose the known risks of their products, including the risk of AIDS and Hepatitis C; failed to implement readily available screening tests that would have prevented AIDS and Hepatitis C by excluding contaminated plasma; failed to use available methods of treating plasma to kill viruses, including heat treatment and solvent detergent; and concealed and affirmatively misrepresented the extent of the health dangers of the diseases caused by the products. Perhaps most egregiously, Defendants continued to ship non-heat treated product overseas even after ceasing to sell it in the United States, in order to maintain their profit margin on existing contracts and sell off remaining stock no longer marketable domestically. 4. Defendants’ efforts to maximize profits came at the expense of the health and lives of thousands of hemophiliacs worldwide who were needlessly infected with HIV and/or HCV. AIDS is the leading cause of death for hemophiliacs who were treated with non heat-treated factor concentrate in the 1980’s, and the average life expectancy of hemophiliacs has decreased substantially. As of 1992, Defendants’ contaminated blood products had infected at least 5,000 European hemophiliacs with HIV, of which 2,040 had already developed AIDS and 1,250 had died from the disease. In the United Kingdom, 34% of hemophiliacs tested positive for HIV in 1992. As of the mid-1990’s in Japan, hemophiliacs accounted for the majority of Japan’s 4,000 reported cases of HIV infection, and virtually all infections of Japanese hemophiliacs have been linked to contaminated blood products imported from the United States. In Hong Kong and Taiwan, over one hundred hemophiliacs were infected with HIV by Defendant CUTTER’s products alone. In Latin America, at least 700 HIV cases are linked to use of contaminated blood products by hemophiliacs. Thousands more around the world were infected with Hepatitis C from Defendants’ products. 5. Many surviving hemophiliacs with HIV suffer from AIDS. Some have temporarily postponed AIDS with antiretroviral therapy, which has toxicities and side effects of its own and fades in effectiveness over time. Those with Hepatitis C face cirrhosis and/or liver cancer unless they qualify for and respond to Interfeuron and Ribavirin combination therapy, a chemotherapy-like treatment with severe side effects, including major depression. Coinfection with both HIV and HCV accelerates the advance of each disease and makes treatment of both riskier and more complicated. 6. Defendants’ wrongful conduct has not only damaged and shortened the lives of the hemophiliacs who used their contaminated products, but terribly affected their families and spouses as well. Many infected hemophiliacs unknowingly transmitted HIV and/or HCV to their spouses, and in some cases their infected wives transmitted HIV to their children during pregnancy. Other hemophiliacs have foregone having children, or their wives have aborted pregnancies, for fear of transmitting the disease to their children or of being unable to care for them. 7. Plaintiffs, and each of them, allege an amount in controversy in excess of $75,000, exclusive of interest and costs. This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1332 because there is complete diversity of citizenship between the Plaintiffs and the Defendants. 8. Plaintiffs are informed and believe and upon such information and belief allege that the unlawful, negligent and/or tortious activity alleged herein was carried out predominantly in the United States. Defendants recruited high risk paid donors in the United States and mixed plasma from such donors into the blood pool at their facilities in the United States. Defendants placed misleading labels on their products in the United States and made affirmative misrepresentations regarding their products’ safety in the United States, which were relied upon by Plaintiffs and their doctors worldwide. Defendants’ decisions to recruit paid donors from high risk populations, to refrain from disclosing the known risks of their products, to forego implementing readily available procedures that would have prevented their products from transmitting AIDS, and to ship their products overseas even after they could no longer be used domestically were all made in the United States. Defendants’ acts of conspiracy, including trade association meetings where they agreed to engage in wrongful conduct, also took place in the United States. 9. Plaintiffs are informed and believe and upon such information and belief allege that the vast majority of the evidence of the unlawful activity alleged herein is located in the United States. Documents showing Defendants’ policies, practices, and decisions regarding recruitment of plasma donors, mixing of plasma into the blood pool at their facilities, labeling of their products, advertising and promotion of their products, disclosure or lack thereof of the risks posed by their products, implementation or lack thereof of procedures to prevent their products from transmitting AIDS, and shipment of their products overseas are located almost exclusively in the United States. The vast majority of witnesses who will testify to these policies, practices, and decisions are also located in the United States, and would not be subject to subpoena in other countries. The expert witnesses likely to be presented by both Plaintiffs and Defendants are also located in the United States. 10. The named Plaintiffs’ medical records, as well as those of many class members, have already been brought to the United States and translated into English. In addition, witnesses to Plaintiffs’ damages, such as Plaintiffs’ family members, are willing to travel to the United States to testify. 11. Because the named Plaintiffs and class members in this action reside in many different countries with differing legal systems, litigation in each of their home countries would be costly and inefficient and would pose the risk of inconsistent verdicts. In addition, Plaintiffs’ home countries are inadequate alternative fora because of chronic and lengthy court delays, lack of open discovery, and unavailability of legal theories, procedures, and remedies, and lack of subpoena power over physical evidence in the United States. 12. Plaintiffs are informed and believe and upon such information and belief allege that Defendants’ unlawful activity was carried out, in significant part, in the Northern District of California. Defendant CUTTER BIOLOGICAL (“CUTTER”), the predecessor of Miles, Inc. and Defendant BAYER CORPORATION (“BAYER”), had its headquarters in Berkeley, California at all pertinent times. CUTTER’s Biological Management Committee met at its Berkeley headquarters, and it was at its Berkeley headquarters that the decisions were made to recruit high risk homosexual donors from cities in California, including San Francisco’s drug-ridden Tenderloin neighborhood, and to ship blood products overseas. In addition, at all times pertinent, Defendant BAXTER CORPORATION, and/or its HYLAND DIVISION, had its main manufacturing plant in Glendale, California. HYLAND’s President, Medical Director, and Head of Donor Recruitment all had their offices in the Glendale facility. Defendant BAXTER, and/or its HYLAND DIVISION, also recruited all their homosexual donors from California, particularly from San Francisco and Los Angeles. All Defendants obtained plasma from plasma collection centers located in San Francisco and Oakland. 13. Plaintiffs are informed and believe and upon such information and belief allege that the evidence of Defendants’ unlawful activity is located, in significant part, in the Northern District of California, where much of the unlawful activity was carried out. The majority of documentary evidence on liability is located in a facility in San Jose. 14. This is a class action on behalf of Plaintiffs individually and as representatives of a class consisting of: all persons residing outside the United States who used any non-heat treated blood factor concentrate manufactured, sold, or distributed by Defendants in the period from 1978 to 1990 and who contracted HIV and/or HCV; their infected spouses and children; and the estates of persons in the previous two categories who died on or after May 31, 2002 and/or have surviving children 18 years of age or younger. This action seeks, among other relief, compensatory and punitive damages for class members who suffered the dangerous, severe and often fatal adverse effects of Defendants’ contaminated blood factor concentrate. 15. Plaintiff Domenico Gullone is a citizen and resident of Italy and a hemophiliac who used Defendants’ factor concentrate and was infected with HIV and Hepatitis C and contracted AIDS by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 16. Plaintiff Marco Mercinelli, the brother of Plaintiff Roberto Mercinelli, is a citizen and resident of Italy and a hemophiliac who used Defendants’ factor concentrate and was infected with Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 17. Plaintiff Roberto Mercinelli, the brother of Plaintiff Marco Mercinelli, is a citizen and resident of Italy and a hemophiliac who used Defendants’ factor concentrate and was infected with Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 18. Plaintiff Franca Gai, wife of Plaintiff Riccardino Gualtiero, is a citizen and resident of Italy who suffers from von Willebrand’s disease, a hemorrhagic disease similar to hemophilia, and who used Defendants’ factor concentrate and was infected with Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 19. Plaintiff Riccardino Gualtiero is a citizen and resident of Italy who was infected with Hepatitis C through sexual relations with his wife, Plaintiff Franca Gai, who used Defendants’ factor concentrate and was infected with Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 20. Plaintiff Bastian Gutzeit is a citizen and resident of Germany and a hemophiliac who used Defendants’ factor concentrate and was infected with Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 21. Plaintiff Christof Barth is a citizen and resident of Germany and a hemophiliac who used Defendants’ factor concentrate and was infected with Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 22. Plaintiff Adrian Melson, husband of Plaintiff Maxine Melson, is a citizen and resident of the United Kingdom and a hemophiliac who used Defendants’ factor concentrate and was infected with HIV and Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 23. Plaintiff Maxine Melson is a citizen and resident of the United Kingdon who was infected with HIV through sexual relations with her husband, Plaintiff Adrian Melson, who used Defendants’ factor concentrate and was infected with HIV and Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 24. Plaintiff Colin Potts is a citizen and resident of the United Kingdom and a hemophiliac who used Defendants’ factor concentrate and was infected with HIV and Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 25. Plaintiff Haydn Lewis, husband of Plaintiff Gaynor Lewis, is a citizen and resident of the United Kingdom and a hemophiliac who used Defendants’ factor concentrate and was infected with HIV and Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 26. Plaintiff Gaynor Lewis is a citizen and resident of the United Kingdom who was infected with HIV through sexual relations with her husband, Plaintiff Haydn Lewis, who used Defendants’ factor concentrate and was infected with HIV and Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 27. Plaintiff Gary Wade is a citizen and resident of the United Kingdom and a hemophiliac who used Defendants’ factor concentrate and was infected with HIV and Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 28. Plaintiff Norman Kidd is a citizen and resident of the United Kingdom and a hemophiliac who used Defendants’ factor concentrate and was infected with HIV and Hepatitis C by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy. 29. Plaintiff Pamela Blackwell is a citizen and resident of the United Kingdom who was infected with HIV through sexual relations with her husband, Dennis Blackwell, a hemophiliac who used Defendants’ factor concentrate and was infected with HIV by Defendants’ factor concentrate and/or as a result of Defendants’ conspiracy, and who died of the disease. 30. The named Plaintiffs and class members contracted permanent injuries and diseases, including AIDS and/or Hepatitis C and associated symptoms and diseases, as a direct and proximate result of use of Defendants’ blood products and/or Defendants’ conspiracy. 31. The named Plaintiffs and class members would not have chosen to have be treated with Defendants’ blood products had they known of or been informed by Defendants of the true risks of using those products or the nature of the sources of the blood products. 32. Defendant CUTTER, the predecessor of Miles, Inc., and Defendant BAYER, was a California corporation headquartered in Berkeley, California at all pertinent times. At all pertinent times CUTTER and its successors Miles, Inc. and BAYER regularly and systematically engaged in the harvesting and collection of human plasma and the processing, manufacturing, marketing, sales and distribution of anti-hemophilic factor (hereinafter referred to as “AHF”) produced from such plasma, to which Plaintiffs were exposed and which contributed directly or indirectly to Plaintiffs’ infection with HIV and/or HCV. 33. Defendant BAYER, formerly Miles, Inc., is and was an Indiana corporation, authorized to do business in all 50 states and the District of Columbia. Miles, Inc. had its principal place of business operation in Elkhart, Indiana, while its successor BAYER has its principal place of business in Pennsylvania, with offices located at 100 Bayer Road, Pittsburgh, Pennsylvania 15205. At all pertinent times BAYER and its predecessors Miles, Inc., and CUTTER regularly and systematically engaged in the harvesting and collection of human plasma and the processing, manufacturing, marketing, sales and distribution of anti-hemophilic factor (hereinafter referred to as “AHF”) produced from such plasma, to which Plaintiffs were exposed and which contributed directly or indirectly to Plaintiffs’ infection with HIV and/or HCV. 34. Defendant BAXTER HEALTHCARE CORPORATION (hereinafter “BAXTER”) is a Delaware corporation, authorized to do business in all 50 states and the District of Columbia, with its principal place of business in Illinois, with offices located at One Baxter Parkway, Deerfield, Illinois 60015. At all times pertinent, Defendant BAXTER, and/or its HYLAND DIVISION, had its main manufacturing plant in Glendale, California. In 1997, BAXTER acquired all assets and liabilities of Immuno International A.G., an Austrian company that at all times pertinent sold AHF products worldwide which were produced from human plasma derived from paid donors in the United States. Immuno International A.G. operated in the United States at all times pertinent through its wholly owned American subsidiary Immuno-U.S., located in Rochester, New York. At all times pertinent, Defendant BAXTER, and/or its HYLAND DIVISION, and/or its wholly owned subsidiaries Travenol Laboratories and Fenwal Laboratories, regularly and systematically engaged in the harvesting and collection of human plasma and the processing, manufacturing, marketing, sales and distribution of AHF products produced from such plasma, to which Plaintiffs were exposed and which contributed directly or indirectly to Plaintiffs’ infection with HIV and/or HCV. 35. Defendant ARMOUR PHARMACEUTICAL COMPANY, INC. is a Delaware corporation, authorized to do business in all 50 states and the District of Columbia, with its principal place of business in Pennsylvania, with offices located at 500 Arcola Road, P.O. Box 1200, Collegeville, Pennsylvania 19426-0107. In 1996 Defendant ARMOUR merged with Behringwerke A.G., a German company that at all times pertinent sold AHF products which were produced from human plasma derived from paid donors in the United States, to form Defendant AVENTIS BEHRING LLC, formerly Centeon Bio-Services, Inc., a Delaware company with offices located at 1020 First Avenue, King of Prussia, Pennsylvania, 19406. Defendant AVENTIS BEHRING LLC and its predecessors, Centeon Bio-Services, Inc. and Armour Plasma Alliance, Inc., are wholly owned subsidiaries of Defendant AVENTIS INC., formerly Rhone-Poulenc Rorer International, Inc., formerly Rorer Group, Inc., a Delaware corporation authorized to do business in all 50 states and the District of Columbia, with offices located at 300 Somerset Corporate Boulevard, Bridgewater, New Jersey, 088907. At all times pertinent, Defendants ARMOUR PHARMACEUTICAL COMPANY, INC., AVENTIS BEHRING LLC, and AVENTIS INC., (all of whom are described hereinafter collectively as “ARMOUR”) regularly and systematically engaged in the harvesting and collection of human plasma and the processing, manufacturing, marketing, sales and distribution of AHF products produced from such plasma, to which Plaintiffs were exposed and which contributed directly or indirectly to Plaintiffs’ infection with HIV and/or HCV. 36. Defendant ALPHA THERAPEUTIC CORPORATION (hereinafter “ALPHA”) is a California corporation authorized to do business in all 50 states and the District of Columbia, with its principal place of business in California, with offices at 5555 Valley Boulevard, Los Angeles, California 90032. ALPHA is a wholly owned subsidiary of The Green Cross Corporation (hereinafter “Green Cross”), a Japanese business corporation. At all times pertinent Defendant ALPHA and its parent, Green Cross, have been regularly and systematically engaged in the harvesting and collection of human plasma and the processing, manufacturing, marketing, sales and distribution of AHF products produced from such plasma, to which Plaintiffs were exposed and which contributed directly or indirectly to Plaintiffs’ infection with HIV and/or HCV. 37. Defendants CUTTER, ARMOUR, BAXTER and ALPHA (hereinafter collectively referred to as “MANUFACTURERS”) acting on behalf of themselves and/or their predecessor and/or successor corporations, collected, harvested and/or processed human plasma and/or manufactured, marketed, sold and distributed AHF products worldwide that were contaminated with HIV and/or HCV. In the alternative, one or more of said Defendants participated in the collection, harvesting and/or processing of human plasma and/or the manufacturing, marketing, distribution and sale of AHF products worldwide, or assumed, became or are responsible for the liabilities of the Defendants and their predecessor or successor corporations who did participate in the collection, harvesting and/or processing of human plasma and/or the manufacturing, marketing, distribution or sale of AHF products worldwide, without limitation thereto. 38. At all times herein mentioned, all Defendants and each of them, were fully informed of the actions of their agents and employees, and thereafter no officer, director or managing agent of Defendants repudiated those actions, which failure to repudiate constituted adoption and approval of said actions and that all Defendants and each of them, thereby ratified those actions. IV. FACTUAL ALLEGATIONS APPLICABLE TO ALL CLAIMS A. Hemophilia and Its Treatment 39. Hemophilia is an inherited condition that causes uncontrolled hemorrhaging or bleeding. Hemophilia results from a deficiency of blood components essential for coagulation. The most common form of the disease is hemophilia A, characterized by a lack of a blood protein known as Factor VIII, which affects approximately one in 10,000 males. Factor VIII is commonly called “AHF,” or antihemophilic factor. Hemophilia B is characterized by absence of another blood protein, known as Factor IX, affecting about one in 40,000 males. Von Willebrand’s disease is an inherited hemorrhagic condition similar to hemophilia that affects both men and women. It is characterized by lack of both Factor VIII and another blood protein called von Willebrand’s factor. 40. The treatment of hemophilia and von Willebrand’s disease involves intravenous introduction, called infusion, of the missing blood proteins required to |
