NTRODUCTION..
II. JURISDICTION AND VENUE.
III. PARTIES.
IV. FACTUAL ALLEGATIONS APPLICABLE TO ALL CLAIMS.
A. Hemophilia and Its Treatment
B. Even Before the Discovery of HIV and AIDS, Defendants
Failed to Disclose or Warn of Serious Adverse Effects Associated with Factor
Concentrates.
C. Defendants Recruited Plasma Donors from High Risk
Populations to Manufacture Factor VIII and IX
D. Defendants Failed to Use the Available Hepatitis B
Core (HBc) Test to Exclude Plasma from High Risk Donors.
E. Defendants Also Failed to Implement Available Heat
Treatment and Solvent Detergent to Kill BloodBorne Diseases.
F. Defendants Continued to Ship Non-Heat Treated Factor
Concentrate Products Abroad Even After They Stopped Selling Non-Heat Treated
Product in the United States.
G. Defendants Fraudulently Misrepresented the Safety of
Factor VIII and IX and Concealed the Dangers of the Products.
H. Defendants’ Activities Were Subject to Applicable
Federal Regulations, Which Evidence the Standard of Care With Which Defendants
Should Have Complied.
I. Conspiracy, Concert of Action and Group Liability. 36
V. CLASS ACTION ALLEGATIONS.
VI. TOLLING OF APPLICABLE STATUTES OF LIMITATION..
VII. CLAIMS FOR RELIEF.
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..
VIII. PRAYER FOR RELIEF.
DEMAND
FOR JURY TRIAL.
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Elizabeth
J. Cabraser (State Bar No. 83151)
Robert
J. Nelson (State Bar No. 132797)
Morris
A. Ratner (State Bar No. 157554)
Fabrice N. Vincent (State Bar No. 160780)
Heather
A. Foster (State Bar No. 184353)
Lexi J. Hazam (State Bar No.
224457)
Lieff, Cabraser,
Heimann & Bernstein, LLP
275 Battery Street, 30th Floor
San Francisco, CA 94111-3339
Telephone: (415) 956-1000
Facsimile: (415) 956-1008
Charles Kozak (State Bar
No. 141758)
LAW OFFICES OF CHARLES KOZAK
275 Battery Street, 30th Floor
San Francisco, CA 94111-3339
Telephone: (415) 956-1000
Facsimile: (415) 956-1008
Attorneys for Individual and Representative
Plaintiffs
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|
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF CALIFORNIA
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DOMENICO GULLONE, MARCO
MERCINELLI, ROBERTO MERCINELLI, FRANCA GAI, RICCARDINO GUALTIERO, BASTIAN
GUTZEIT, CHRISTOF BARTH, ADRIAN MELSON, MAXINE MELSON, COLIN POTTS, HAYDN LEWIS,
GAYNOR LEWIS, NORMAN KIDD, GARY WADE, and PAMELA BLACKWELL, on behalf of
themselves and all others similarly situated,
Plaintiffs,
v.
BAYER
CORPORATION, an Indiana corporation, successor to CUTTER BIOLOGICAL, a
California Corporation; BAXTER HEALTHCARE CORPORATION, a Delaware
corporation, and its HYLAND DIVISION; ARMOUR PHARMACEUTICAL COMPANY, INC., a
Delaware corporation, AVENTIS BEHRING LLC, a Delaware corporation, and
AVENTIS INC., a New Jersey corporation; and ALPHA THERAPEUTIC CORPORATION, a
California corporation,
Defendants.
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Case
No.
CLASS ACTION COMPLAINT FOR
DAMAGES AND INJUNCTIVE RELIEF
Jury Trial Demanded
(1) Negligence
(2) Negligence Per Se
(3) Fraudulent Omission and Concealment
(4) Breach of Implied Warranty
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I.
INTRODUCTION
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.
II.
JURISDICTION AND VENUE
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.
III.
PARTIES
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 stop bleeding. The two most prevalent forms of such
treatment are cryoprecipitate, and factor concentrates. Factor concentrates are the product made by
Defendants in this action. Cryoprecipitate is made by freezing plasma, the
fluid component of circulating blood in which various proteins, including
Factor VIII and Factor IX, are contained; thawing the frozen plasma; and
isolating Factor VIII from the plasma through centrifugal concentration.
Cryoprecipitate is an effective therapeutic agent for patients with hemophilia
A. Hemophilia B has been effectively treated with the use of fresh frozen
plasma containing Factor IX. Cryoprecipitate and fresh frozen plasma are made
from small numbers of donors, who are generally unpaid volunteers.
41.
By contrast, Defendants in the late 1960s to early
1970s began to market factor concentrates, or AHF, which contained Factor VIII
and Factor IX in higher concentrations than had been available in either
cryoprecipitate or fresh-frozen plasma. To produce factor concentrates,
Defendants mixed pools of plasma from five to twenty thousand donors at a time,
a substantial percentage of which were paid donors. These large pools were then
subjected to chemical process to concentrate Factors VIII and IX.
B.
Even Before the Discovery of HIV and AIDS,
Defendants Failed to Disclose or Warn of Serious Adverse Effects Associated
with Factor Concentrates
42.
Shortly after the initial commercial marketing of
Factor VIII and IX concentrates in the late 1960s to early 1970s, a wide range
of serious adverse effects were reported in association with these products.
Even before the dissemination of HIV, Defendants knew of serious diseases caused
by unidentified agents transmissible by blood and Factor VIII and IX.
Defendants failed to warn Plaintiffs or the medical community of these adverse
effects, in violation of industry standards and federal regulations.
43.
By 1976, only a few years after Defendants’ factor
concentrate products went on the market, the United States Food and Drug
Administration (“FDA”) Bureau of Biologics held a conference entitled “Unsolved
Therapeutic Problems in Hemophilia.” The research articles compiled from the
conference discussed the high incidence in patients using Defendants’ products
of disorders such as liver dysfunction, enlarged spleen, Hepatitis B, and
Non-A, Non-B Hepatitis (“NANB Hepatitis,” later renamed Hepatitis C). The articles concluded that these disorders were
tied to the patients’ use of factor concentrates, and emphasized the risks
entailed in producing such concentrates using plasma from paid donors. For instance, Robert Gerety
of the FDA Bureau of Biologics, Division of Blood and Blood Products, reported
that the agent or agents of NANB Hepatitis “appear to be blood borne, perhaps
to be associated with a form of chronic hepatitis, and to represent a
considerable risk to recipients who repeatedly require the administration of
blood products.” (Gerety, et al., “Viral Antigens and
Antibodies in Hemophiliacs,” (1)77). Gerety noted
that “[t]he use of large plasma pools from paid donors no doubt contributes to
the risk of HBV [Hepatitis B] infection from these products,” and stated that
“an all voluntary blood donor system is being pursued as a result of the known
increased risk of PTH [post-transfusion hepatitis] from blood derived from
commercial donors.” As described below, however, Defendants not only refused to
implement such a voluntary donor system, but instead recruited paid donors
precisely because their hepatitis exposure resulted in plasma from which
Defendants could make other commercially valuable products as well.
44.
Several of the articles from the 1976 conference also
raised alarm over the unprecedented convergence of immune disorders in the
hemophiliac community, and called for close medical monitoring of the
situation. Dr. Peter Levine stated, “one wonders whether our patients are suffering a sort of
immune complex disease as a result of intensive bombardment with foreign
antigens....” (Levine, “Unsolved Problems with Current Therapeutic Regimens for
Hemophilia,” (1977)). Shapiro warned of the possibility that “a new spectrum of
disease may be seen in this population” and urged that it “behooves us to
follow the suggested findings very closely over the coming years.” (Shapiro,
“Antibody Responses in the Hemophiliac,” (1977)). Seeff
concurred that “it is evident that continued surveillance of the hemophiliac
population is mandatory.” (Seeff, “Acute and Chronic
Liver Disease in Hemophilia,” (1977)).
45.
At all times material to this Complaint, Defendants
failed to adequately warn Plaintiffs or their physicians of these serious
adverse side effects. Several such adverse effects, including immunosuppression
(suppression of the immune system) were not mentioned at all in the Defendants’
package inserts, which were required to disclose adverse reactions pursuant to
federal statutes and regulations and applicable standards of care. Although
Defendants’ inserts mentioned a risk that plasma “may” contain the causative
agent of viral hepatitis, the warning was seriously deficient in that: (a)
Defendants failed to disclose that the risk of hepatitis was essentially a 100%
guarantee due to their practices of using high-risk donors and specifically
recruiting for donors who had previously been exposed to Hepatitis B; (b) while
“hepatitis” simply means inflammation of the liver, and may be a relatively
benign, temporary condition, Defendants failed to warn that some forms of
hepatitis transmitted by their products were believed to present a considerable
risk of severe liver damage, cirrhosis, and significantly elevated risk of
cancer; (c) Defendants misleadingly stated that the source plasma used in
preparation of the product had been found to be non-reactive for Hepatitis B
surface antigen (HBsAg)—implying that no viral
hepatitis was present in the plasma—and falsely stated that available methods
were not sensitive enough to detect all units of potentially infectious plasma,
while failing to disclose that Defendants had refused to implement the more
sophisticated Hepatitis B Core Antibody (HBc) test
which would have excluded essentially all plasma contaminated by Hepatitis B;
and (d) Defendants’ labeling disclosed that the product was made from large
pools of fresh human plasma, but failed to disclose that paid donors increased
the risk of disease, and that the particular groups of paid donors targeted by
Defendants were known to be the highest risk groups available.
C.
Defendants Recruited Plasma Donors from High
Risk Populations to Manufacture Factor VIII and IX
46.
The demand for and supply of anti-hemophilia factor
rapidly increased during the 1970’s, with the commercially-manufactured
concentrate accounting for a large proportion of the increase in supply. In 1977, a federal report projected that the
volume of AHF manufactured would increase substantially by 1980. (“Study to
Evaluate the Supply-Demand Relationships for AHF and PTC Through 1980,”
Division of Blood Diseases and Resources, National Heart, Lung and Blood
Institute (1977), at page 8; hereinafter “NHLBI Report”).
47.
In order to sell more AHF to this growing market,
Defendants turned to the fastest and cheapest way of obtaining sufficient
plasma, paid donors. Defendants
recruited paid donors from those populations most likely to respond to the
financial incentive to donate: poor
inner city residents, drug abusers, prisoners, and even residents of
impoverished developing countries such as Haiti and Nicaragua.
48.
Defendants purposefully sought out paid donors despite
knowing that the risk of diseases transmissible by blood was far greater among
paid donors than among volunteers.
Because no test was available yet for the NANB Hepatitis virus
identified in the early 1970’s, the only means to prevent the virus from
contaminating the plasma supply was to exclude donors with behaviors that were
inconsistent with good health—precisely those populations from which Defendants
were recruiting paid donors. Some
studies indicated that paid donors were up to ten times more infectious than
volunteer donors. For this reason, the
National Blood Policy, adopted by the federal government in July 1973,
advocated conversion to an all-volunteer blood supply. Defendants, however, not
only continued to use paid donors, but also focused their recruiting efforts on
the highest risk populations.
49.
Defendants had an additional financial incentive for
recruiting paid donors. Factor VIII and
Factor IX are only two of many products that can be made for commercial sale
from human plasma. According to the NHLBI Report, by the late 1970s at least 17
different therapeutic components of blood were manufactured by the process of
“fractionating” plasma into its various elements. The NHLBI Report noted that,
“as the costs of fractionation have increased,
fractionators have produced as many products as possible from a liter of
plasma.” (Id. at 65).
50.
Blood derivatives used as vaccines or therapeutics had
particularly high economic value for Defendants. The NHLBI Report noted that
plasma with a very high titer, or antibody level, for a corresponding antigen
is “very expensive.” (Id. at 41). Such products are manufactured from source
plasma drawn from donors who have been sensitized to a particular antigen. (Id.).
The NHLBI Report specifically stated, however, that “plasma collected for high
antibody titer cannot be used for fractionation into therapeutic products,”
such as Defendants’ factor concentrate. (Id., emphasis added).
51.
Defendants targeted donors with high titers to
Hepatitis B antigens in order to manufacture and sell Hepatitis B
immunoglobulin (HBIG), a product that confers temporary immunity to the
Hepatitis B virus. Despite the warning
in the NHLBI report, Defendants’ used the same high titer plasma they obtained
for making HBIG to manufacture the Factor VIII and IX products used by
hemophiliacs. Defendants thus sought to maximize profits by producing “as many
products as possible from a liter of plasma,” while ignoring industry standards
that precluded the use of high-titer plasma for other therapeutic products.
52.
Beginning in about 1978, Defendants BAXTER, CUTTER and
ALPHA began targeting homosexual donors in known urban gay communities. Because urban homosexuals had been reported in the 1970’s to
have exceptionally high prevalence of Hepatitis B infection, Defendants
knew that such donors would provide a reliable source of plasma for the
manufacture of commercially valuable HBIG.
53.
It was also well-known in the
public health community by the 1970’s that urban
homosexuals engaged in promiscuous sexual practices that rapidly transmitted other diseases, including NANB Hepatitis, which were transmitted
by blood, could not be isolated nor identified, and were believed to have
serious adverse consequences. Despite
this knowledge, Defendants used the same plasma pool from urban homosexuals to
manufacture both HBIG and Factor VIII and IX.
54.
Defendants continued this dual use of high risk plasma
even after federal reports warned of the rapid spread of fatal immunosuppressive
disease among the same homosexual population from which Defendants heavily
recruited. On June 5, 1981, the United States Centers for Disease Control
(“CDC”) reported that five homosexual men had unusual and similar
immunosuppressive disorders (Morbidity and Mortality Weekly Report, hereinafter
“MMWR,” June 5, 1981, at p. 250). On July 3, 1981, the CDC reported similar
diseases in 26 homosexuals, noting that all 12 patients tested for
cytomegalovirus (“CMV”) had evidence of “past or present CMV infection,” and
that past infections with hepatitis “were commonly reported.” (MMWR, July 3,
1981, at p. 305). The CDC warned doctors to be alert for “opportunistic
infections associated with immunosuppression in homosexual men.” (Id., at p.
307). By August 28, 1981, less than two months later, the reported figure had
grown to 108 cases and 40% fatalities; 94% of the 101 males were homosexual or
bisexual (MMWR, August 28, 1981, at p. 409). Based on this evidence and the
high prevalence of hepatitis in the same population, Defendants knew or should
have known by no later than the summer of 1981 that urban homosexual males were
not “suitable donors” within the meaning of federal regulations and/or other
applicable standards of care.
55.
By the 1970s, it was also well-established that plasma
from prison populations carried a high risk of hepatitis and other blood-borne
diseases, primarily because of the concentration of intravenous (IV) drug users
in prisons. By 1974, the alanine
aminotransferase (“ALT”) test was available to test for elevated levels of
liver enzymes called SGOT that indicate the presence of hepatitis. Prisoners were associated with SGOT levels of
over 60 IUs per ml, a level that increases the risk
of Hepatitis C transmission by a factor of 6.
Despite knowledge of this risk, Defendants actively recruited prisoners
for plasma used to manufacture Factor VIII and IX, while concealing or failing
to disclose the risk to Plaintiffs, their physicians, or the FDA.
56.
On June 11, 1982, the CDC reported that 281 homosexual
men and 33 IV drug users had been diagnosed with similar immunosuppression and
opportunistic infections, with a 43% fatality rate. Yet Defendants continued to
recruit these high risk donors while concealing the risk from Plaintiffs, their
physicians and the FDA. It is highly significant that only Defendants had
knowledge of this risk; while the spread of disease in homosexuals and IV drug
users became known to the FDA and the public, only Defendants knew that these
very populations were target donors for plasma used to make Factors VIII and
IX.
57.
At a July, 1982 meeting attended by Defendants, the CDC
publicly reported the first three cases of opportunistic infections among
individuals with hemophilia. All three were reported to be heterosexual males.
The CDC reported that the clinical and immunologic features of the three
patients were strikingly similar to those recently observed among homosexual
males and heterosexual IV drug users, while noting that the hemophilia patients
did not share the latter two groups’ risk factors. The CDC stated, “Although
the cause of the severe immune dysfunction is unknown, the occurrence among the
three hemophiliac cases suggests the possible transmission of an agent through
blood products.” (MMWR, July 16, 1982, at p. 366).
58.
In light of Defendants’ special knowledge of the
disease patterns among urban homosexuals and prisoners, and their recruitment
of such donors for Factor VIII and IX manufacture, Defendants had duties to:
(a) promptly investigate the first reports of opportunistic infections among
urban homosexuals in 1981; (b) discontinue the practice of using such high risk
donors; (c) disclose the risk to Plaintiffs, their physicians, and the FDA,
including the ongoing risk of continuing to use Factor VIII and IX previously
manufactured with high risk plasma and still marketed to patients; (d)
implement procedures to kill blood-borne diseases in the products; and (e)
recall existing products from distribution or further use. Instead, Defendants
continued to conceal their recruitment of high risk donors and resist warnings
and recalls, and failed to implement procedures to make their products safe.
D.
Defendants Failed to Use the Available Hepatitis
B Core (HBc)
Test to Exclude Plasma from High Risk Donors
59.
By no later than 1978, Defendants knew of the
availability of a new test to determine whether an individual had a history of
viral Hepatitis, which would have disqualified the donor from providing plasma
for the manufacture of Factor VIII or IX. By testing a person’s serum for the
presence of the core to the Hepatitis B antibody, a history of viral Hepatitis
could be verified. This was known as the “HBc test.”
Published, peer-reviewed literature shows that the HBc
test was in use by researchers to determine that homosexual AIDS victims had a
history of viral Hepatitis by no later than December 1981. (Gottlieb, et al.,
“Pneumocystis Carinii Pneumonia and Mucosal Candidiasis in Previously Healthy
Homosexual Men,” NEW ENGLAND JOURNAL OF MEDICINE 1981; 305:1425-1431).
60.
Use of the HBc test would
have eliminated approximately 75% of homosexual plasma donors and over 90% of
promiscuous urban homosexuals. It would have eliminated almost 100% of
intravenous drug users.
61.
Use of the HBc and ALT tests by
Defendants by 1981 would have eliminated the vast majority of the transmitters
of HIV and HCV from the blood and plasma pools of the nation, before the height
of the AIDS and Hepatitis C epidemics. If Defendants had implemented this test
in a timely manner, Plaintiffs would never have been infected with HIV or HCV
or suffered from AIDS or Hepatitis C as a result of factor concentrate use.
62.
Plaintiffs and thousands of other hemophiliacs
worldwide became infected by the AIDS and Hepatitis C viruses through repeated
exposures from blood products manufactured from large pools of plasma donors
(5,000 to 40,000). If Defendants had used the HBc and
ALT tests to decrease by 70% to 90% the number of HIV and HCV positive donors
who went into a pool, the infectivity of the product would have decreased
substantially. Consequently, the rate of infection of hemophiliacs would have
slowed down enormously, and the medical and scientific community would have
been given more time to react appropriately to the HIV and Hepatitis C
epidemics.
63.
As noted below, federal regulations required plasma
donors to be in good health, and donors with a “history of viral Hepatitis”
were by definition unacceptable as blood or blood plasma donors. Persons with a
history of viral hepatitis were excluded not only because of the risk of
transmitting Hepatitis B, but because such a history indicated a lifestyle or
previous behavior of the prospective donor which carried the risk of
transmitting other viruses in addition to hepatitis. A reasonable and prudent
plasma fractionator would not accept a HBc positive donor and expect to
be in compliance with federal regulations as of 1978.
64.
After public reports of the first hemophilia AIDS cases
in July 1982, government officials urged Defendants to implement the HBc test as a “surrogate” or “marker” to eliminate plasma
contaminated by the transmitter of AIDS or Hepatitis C. HBc testing was
also strongly suggested to Defendants by the CDC at a meeting of the United
States Public Health Service (“PHS”) on January 4, 1983. Despite this urging, Defendants continued to
use contaminated plasma donations that would have been excluded by the HBc test and continued to conceal from Plaintiffs, their
physicians, and the FDA the dangerous practice of targeting donors at highest
risk for the very diseases that disqualified their plasma. At a January 6,
1983 meeting of Defendants’ trade association, the Pharmaceutical
Manufacturer’s Association, Defendants agreed not to implement the
highly effective HBc donor screening, and instead
opted to use ineffective donor questionnaires that did little to screen out
donors at high risk for AIDS and Hepatitis C transmission.
65.
As late as December 13, 1983, years after the HBc test was available, a memorandum from CUTTER’s responsible head Stephen Ojala
to various CUTTER executives, reporting back on a meeting held by all
Defendants, shows that all Defendants conspired to propose a “task force” to
further study the use of HBc as an intentional, bad
faith “delaying tactic for the implementation” of the test.
E.
Defendants Also Failed to Implement Available
Heat Treatment and Solvent Detergent to Kill
BloodBorne
Diseases
66.
In the late 1970s and early 1980s, it was recognized
that viruses were in all AHF products, including Factor VIII and IX. Heat
treatment and solvent detergent was available at that time to eliminate many of
these viruses, including HIV and HCV. Defendants were required to take
reasonable steps to eliminate contamination, but Defendants failed to utilize
these available technologies to eliminate the viruses in a timely manner.
67.
The 1977 NHLBI Report noted that albumin, another
plasma product, was “heat treated to remove almost all danger of hepatitis.”
(Id., at p. 49). Defendant ARMOUR’S memorandum of June 1983 acknowledged that
no cases of AIDS had been reported in heat-treated albumin users, but
misleadingly states that heat treatment of Factor VIII and IX was not yet
feasible. It was clearly known by no later than 1977 that heat treatment was an
effective way to make blood products safer, but Defendants wrongfully refused
to implement such procedures as to Factor VIII and IX. In 1995, the National
Institutes of Health Institute of Medicine (“IOM”) issued a report on the
hemophilia AIDS epidemic which concluded that defendants “did not seriously
consider alternative inactivation processes,” including heat treatment, and
that “heat treatment processes to prevent the transmission of hepatitis could
have been developed before 1980.” Heat treated, HIV-safe factor concentrates
were not introduced by any Defendant until 1983, and were not universally in
use until 1985.
68.
In addition to heat treatment, solvent detergent
treatment was available to Defendants by the late 1970’s as a simple and
effective method of eliminating viruses in their factor concentrate
products. Solvent detergent effectively
kills viruses such as HIV and HCV by destroying the viruses’ lipid envelope. It
is simpler than heat treatment, and unlike heat treatment does not interfere
with the Factor VIII and IX proteins needed for blood clotting.
69.
Solvent detergents were well-known, commercially
available products as of the 1970’s, and studies in which solvent detergent
treatment was used to disrupt viruses were published in the 1970’s in
peer-reviewed journals. In 1980, Dr.
Edward Shanbrom, a former BAXTER scientist, received
a patent for a solvent detergent treatment process for viral inactivation of
factor concentrate. After receiving the
patent, Dr. Shanbrom approached all four Defendants
about implementing the solvent detergent method, but all four Defendants
wrongfully refused to implement the method.
F.
Defendants Continued to Ship Non-Heat Treated
Factor Concentrate Products Abroad Even After They Stopped Selling Non-Heat
Treated Product in the United States
70.
Between 1983 and 1985, Defendants stopped selling
non-heat treated factor concentrate in the United States and introduced a
vastly safer heat-treated version.
However, one or more Defendants continued to ship their remaining stocks
of non-heat treated product abroad after ceasing sales of such product in the
United States, despite knowledge that the non-heat treated product was
contaminated with HIV and/or HCV.
71.
According to a New York Times article entitled
“2 Paths of Bayer Drug in 1980’s: Riskier Type Went Overseas,” published on May
22, 2003, CUTTER, BAYER’s predecessor, sold millions
of dollars of non-heat treated factor concentrate in Asia and Latin America for
over a year after introducing its heat-treated product in the United States in
February, 1984. According to the
article, CUTTER records show that the company sought to maintain its profit
margin on “several large fixed-price contracts” in Latin America and Asia, and
avoid being stuck with old, unmarketable stock, by continuing to sell its
cheaper-to produce non-heat treated factor concentrate. Minutes from a CUTTER meeting in November,
1984 stated that “there is excess nonheated
inventory,” and that the company planned to “review international markets again
to determine if more of this product can be sold.” The company pursued this strategy even
though, according to the Times article, CUTTER’s
manager for plasma procurement had acknowledged in a letter in January, 1983
that “[t]here is strong evidence to suggest that AIDS is passed on to other
people through … plasma products,” and despite its knowledge that the CDC had reported in
October, 1984 that 74 percent of hemophiliacs who used unheated product were
HIV positive. The same CDC report
indicated that a study done with CUTTER showed that heat treatment rendered HIV
“undetectable” in factor concentrate.
72.
According to the Times article, in late 1984
CUTTER told a Hong Kong distributor interested in its new heat-treated product
to “use up stocks” of its old, non-heat treated product first. CUTTER later assured the same distributor
that the non-heat treated product posed “no severe hazard.” In March 1985, a CUTTER report stated that
“the Far East has ordered 400,000 units” and that “in Taiwan, Singapore, Malaysia,
and Indonesia, doctors are primarily dispensing nonheated
Cutter” factor concentrate. CUTTER did
not apply for a license to sell its new heat-treated product in Taiwan until
July 1985, over a year after it began selling the new product in the United
States. According to the Times
article, over 100 hemophiliacs in Hong Kong and Taiwan alone were infected with
HIV by non-heat treated CUTTER product sold after February, 1984.
73.
The March, 1985 CUTTER report additionally states that
“Argentina has been sold 300,000 units,” according to the Times article. A total of 100,000 vials, or $4 million
dollars worth, of non-heated CUTTER concentrate was shipped abroad after the
company began selling its heat-treated product in the United States.
74.
CUTTER’s wrongful conduct in
continuing to ship non-heat treated factor concentrate abroad after ceasing
sales of such product in the United States is typical of all Defendants’
wrongful conduct worldwide. The Times
article reports that upon learning of this conduct in May, 1985, the FDA
requested a meeting with Defendants to order them to comply with their
voluntary agreement to withdraw non-heat treated product from the market. According to the Times article, Dr.
Harry M. Meyer, at that time the FDA’s regulator of blood products, stated in
later legal papers that “[i]t was unconscionable for them to ship that material
overseas.”
G.
Defendants Fraudulently Misrepresented the
Safety of Factor VIII and IX and Concealed the Dangers of the Products
75.
Defendants engaged in a pattern and practice of
fraudulent concealment of their dangerous practices, fraudulent
misrepresentations of the extent of their efforts to assure safety, and
fraudulent misrepresentations that understated the risk of AIDS and Hepatitis
C, in order to maintain profits from both factor concentrates and HBIG. A
summary of Defendants’ fraudulent misrepresentations and concealment is set
forth below.
76.
On July 27, 1982, a meeting of the Public Health
Service was held as the result of the CDC’s report of three hemophiliacs who
contracted AIDS. The responsible heads of ARMOUR, ALPHA, CUTTER and BAXTER were
in attendance, along with officials from the National Hemophilia Foundation,
CDC and FDA. Three of the four Defendants were aware that they had used
cryoprecipitate containing plasma from known, targeted homosexuals in the
manufacture of Factor VIII and IX blood products. These products had a shelf
life of two and three years, respectively, and were
either in production or already on the shelves in pharmacies waiting to be
infused by hemophiliacs who purchased them. The Defendants involved, CUTTER,
BAXTER and ALPHA, failed to disclose these facts at the meeting where CDC
officials Dr. Don Francis and Dr. Jeff Koplin were
present, despite knowledge that the CDC’s primary concern at that meeting was
the infection of Factor VIII and IX by the transmitter of AIDS, which was
already well-known to be epidemic in the targeted homosexual population.
(CUTTER memorandum dated August 3, 1982)
77.
In or about December, 1982, Rodell,
the responsible head for BAXTER, entered into an agreement with officials of
the FDA to the effect that BAXTER would no longer use prison plasma in the
production of factor concentrates. In fact, BAXTER, unbeknownst to the FDA,
continued to use prison plasma in factor concentrate production through October
1983. (BAXTER memorandum dated October 20, 1983.)
78.
On January 5, 1983, an AIDS meeting was held at
Children’s Orthopedic Hospital in Los Angeles, California, the largest
hemophilia treatment center in the United States. Representatives of all four
Defendants were present at the meeting with treaters
and patients. The purpose of the meeting was to have Defendants’
representatives answer patients’ questions about AIDS transmission through
factor concentrates. A patient asked representatives from CUTTER, ALPHA, ARMOUR
and BAXTER the following question: “Is the plasma from homosexuals, prisoners,
Haitians or other high risk persons being used in the manufacture of
concentrates?” No Defendants admitted targeting or using plasma from
homosexuals, prisoners or inner city IV drug abusers. Dr. Goodman from BAXTER
answered regarding BAXTER’S use of known homosexuals as follows: “We are
changing the nature of questions to homosexuals to the best of our ability.”
CUTTER’S responsible head, Stephen Ojala, an ALPHA representative,
and ARMOUR’S Karl Hansen made no response to the question. This partial and
misleading response amounted to concealment of the true risk created by the use
of known homosexuals, IV drug abusers and prisoners in the manufacture of
factor concentrates.
79.
At the January 5, 1983 meeting, and in the presence of
the patients, one of the treating physicians, Dr. Kasper, asked CUTTER’S
Stephen Ojala: “These [plasma] centers seem to be in
rundown centers of town. Is there a move to move them to rural towns?” Ojala answered: “Many of
the centers are in smaller communities and in towns such as Ypsilanti, Seattle,
Clayton, NC., and San Diego. We do not have centers in
L.A. or San Francisco.” This answer was misleading because Ojala
failed to state that CUTTER’S largest and first plasma center was located at
Arizona State Penitentiary. CUTTER also had a center at the Las Vegas Prison. Ojala and CUTTER were well aware of the CDC’s and FDA’s
concern over use of prison plasma, due to homosexual practices and drug abuse
in the prison donor population. Many of CUTTER’S centers were in inner city
areas frequented by IV drug abusers, such as downtown Oakland, California.
CUTTER had also used plasma from centers which targeted known homosexuals. In
August 1982, CUTTER quarantined plasma from the Valley Medical Center, a center
which targeted known homosexuals, because a donor was hospitalized with full
blown AIDS. The plasma was intended for Factor IX and HBIG production, but was
not used because it had thawed on the way to the processing plant. Upon
receiving a report of this incident from CUTTER, the FDA indicated a recall
might have been necessary if the plasma had been incorporated into factor
concentrate final product. Ojala omitted any mention
of these facts and circumstances in his response to Dr. Kasper regarding the
location of their plasma centers. (CUTTER memorandum dated January 5,1983.)
80.
On January 14, 1983, Dr. Michael Rodell
and the other responsible heads from the four Defendants attended a meeting of
the National Hemophilia Foundation (“NHF”). The purpose of the meeting was to
have Defendants explain to the NHF what steps they were prepared to take to
safeguard the plasma supply from potential AIDS transmitters. Defendants were
very concerned that the NHF would insist on a recommendation that HBc testing be implemented, consistent with the CDC
recommendation 10 days earlier. BAXTER, under Rodell’s
supervision, had already conducted a survey of several of their donor centers
to determine how many donors they would lose if the test were implemented.
BAXTER had decided that up to 16% of their donors would not pass the test.
Further, BAXTER’S high titered immunoglobulin donors would be eliminated. In
order to defer an NHF recommendation that HBc testing
be used, Rodell told NHF officials that surrogate
testing was in the “R and D,” or “Research and Development,” stage currently. Rodell concealed the fact that the CDC had strongly
recommended use of the HBc Antibody test as a
screening device for donors at high risk for AIDS transmission. The HBc Antibody test was not in the “R and D” stage, and was
suitable for use as a screening device for high risk AIDS and Hepatitis C
donors. In fact, the HBc test had been approved in
1979 by the FDA as a diagnostic test to be used to ascertain a history of
previous hepatitis B infection, and as a screening device for blood and plasma
donors. The test had the capability of identifying all donors with a history of
viral hepatitis. Donors with a hepatitis history were specifically prohibited
pursuant to the federal regulations (21 C.F.R. § 640.63). Rodell acknowledged that implementation of the HBc test would eliminate high titered immunoglobulin
donors, but failed to disclose that opposition to use of the test was based on
economic rather than safety concerns.
81.
At the January 14, 1983 meeting, ALPHA, CUTTER and
BAXTER concealed their advertising in publications distributed among urban
homosexuals, for the specific purpose of attracting them to plasma centers
which supplied high titered plasma to the Defendants. CUTTER and ALPHA concealed their extensive
use of prison plasma, and BAXTER discussed plans to phase out prison plasma
during the coming year. However, none of the Defendants revealed their
“gentlemen’s agreement” with the FDA to discontinue use of these plasma sources
immediately. (CUTTER Memorandum dated January 17, 1983.)
82.
In response to the growing concern by hemophiliacs
regarding reports in the lay press of AIDS transmission through blood products,
CUTTER issued a press release dated January 28, 1983. The press release stated,
“Cutter has intensively involved its people and resources to contribute to a
resolution of this segment of the AIDS problem.” This statement was false
because CUTTER was, or had been, actively engaged in using the plasma of
prisoners, known homosexuals and inner city IV drug abusers in the manufacture
of factor concentrates. CUTTER had refused to comply with the CDC’s
recommendation to immediately implement the HBc test
to screen out these high risk donors, and was engaged in a conspiracy with the
other Defendants to conceal use of these donors in factor concentrates that
were currently on the market. CUTTER had formed an alliance with the other
three Defendants to avoid timely warnings, effective donor screening, and
immediate recalls of high risk blood products. (ALPHA Memorandum dated January
20, 1983.)
83.
CUTTER published and distributed a magazine called
ECHO, which was intended for patients, treaters and
pharmacies. The May 1983 issue of ECHO Magazine was entitled, “Special AIDS
Issue.” In the introductory statement by CUTTER Medical Director Dr. George
Akin, the following representation appeared: “We at Cutter want you to know
that your welfare is our prime concern. We are doing everything possible to
help researchers diagnose the syndrome as well as implement precautionary
measures designed to minimize the risk for the person with hemophilia.” This
statement was false because:
a.
CUTTER had engaged in concerted actions with the other
three companies to avoid recalls, timely warnings, appropriate HBc testing and screening of donors, and the flow of
accurate information through the NHF. They were engaged in aggressive overpromotion of Factor VIII calculated to understate the
risk of AIDS and Hepatitis C in order to increase sales, which had dropped due
to information reported in the lay press regarding the risks of AIDS
transmission. CUTTER, through its responsible head, Steven Ojala,
was in the process of organizing a coordinated legal defense plan to defend
claims from AIDS victims they anticipated as the result of their sales
increases in 1983-84. In a January 1983
memorandum, CUTTER discussed its plan to “refute links to AIDS.”
b.
CUTTER had failed to conduct any independent investigation
into any hemophiliac AIDS patient. CUTTER had been told by two of the foremost
authorities in the field, Dr. Lou Aledort and Dr.
Peter Levine, that AIDS may be caused in hemophiliacs
by foreign proteins and alloantigens as well as
unidentified viruses in the product, rendering continued use of the products
extremely dangerous. The product had been previously associated with chronic
active hepatitis, splenomegaly, lymphadenopathy, severe thrombocytopenia,
T-cell abnormalities, and high levels of circulating immune complexes. Older
hemophiliacs were at increased risk for full blown AIDS. These facts indicated
that the more product infused, the higher the risk of
contracting AIDS.
c.
Dr. Bruce Evatt of the CDC
had informed CUTTER on March 15, 1983 that based upon the observed T-cell
abnormalities in hemophiliacs, he expected one half of
them to develop full blown AIDS. The four fractionator
Defendants were engaged in meetings with the FDA with a common goal of averting
a complete recall, the only responsible option available to them.
d.
CUTTER’S Dr. Akin did not reveal that CUTTER was using
or had used a substantial amount of prison plasma, plasma from known
homosexuals with a history of Hepatitis B, and inner city dwellers with a high
risk for intravenous drug abuse. These practices exponentially increased the
risk of AIDS and Hepatitis C, in direct contradiction to CUTTER’S
misrepresentation that it was doing everything possible to minimize the risk.
84.
In the May 1983 issue of ECHO, CUTTER published an article
entitled “AIDS, the Unfolding Story,” in which the following statement
appeared: “In addition, NHF is working collaboratively with the CDC on a
nationwide epidemiologic survey of all hemophilia treatment centers and
affiliates, and has obtained special federal funding for AIDS research for the
CDC plus increased funding for NIH.” This statement was misleading because it
did not reveal the fact that the epidemiologic survey by the CDC and the NHF
demonstrated that heavy users of Factor VIII were displaying severe immune
abnormalities and T-Cell imbalances, while cryoprecipitate users were not
displaying these abnormalities. The article does not disclose that the CDC
considered these hemophiliacs to be at increased risk for AIDS because of the
immune abnormalities reported in the survey by December, 1982. The statement
was also misleading because the NHF was presented as an independent authority,
when the NHF was essentially a channel for industry views. In fact, a 1993
report by the U.S. NIH Institute of Medicine concluded that the NHF had serious
“conflicts of interest” precluding objective analysis because of its
“interdependence” with the Defendants.
85.
In the May 1983 ECHO article, CUTTER also understated
the risk of AIDS by presenting the view of Dr. Louis Aledort,
Medical Co-Director of the NHF, and hemophilia treater
from New York’s Mount Sinai Hospital. Dr. Aledort
stated in the article, “Put AIDS Disease in Perspective,” as follows: “AIDS
should not be viewed as a “panic signal” or a reason to change a hemophilia
patient’s therapy.” CUTTER chose to print this statement in enlarged text. The
statement was false and misleading because many physicians had in fact already
changed their patient’s therapy based on scientific evidence of AIDS being
cause by Factor VIII and IX. There was substantial evidence to justify a change
in therapy and a complete recall of unscreened Factor VIII by May 1983.
86.
Dr. Aledort’s article in the
ECHO of May 1983 went on to state: “There is no evidence to support that AIDS
is transmitted in either cryoprecipitate or concentrate, although it is
possible.” This statement was directly contrary to the evidence which led the
Public Health Service (“PHS”) to conclude, following the January 4, 1983 CDC
meeting, that donors at risk for AIDS transmission should be screened to
eliminate them from the blood supply. The statement also ignores the March 24,
1983 PHS recommendations regarding mandatory screening guidelines for blood and
plasma donors to reduce the risk of AIDS transmission, because of the evidence
supporting transmission of AIDS in factor concentrate. It is also contrary to
Dr. Aledort’s repeated assertions, in sworn testimony
at trials and in depositions, that it was his expert opinion that AIDS was
transmitted through factor concentrates by repeated exposure to foreign
proteins and alloantigens in intermediate purity
factor concentrates until 1984, when the AIDS virus was isolated and
identified. (ECHO Magazine, May, 1983 “Special AIDS Edition”)
87.
CUTTER conducted an AIDS Forum in the Summer of 1983 at the World Hemophilia Federation Meeting in
Stockholm, Sweden. CUTTER invited several hemophilia treatment experts to
participate in the forum. CUTTER later published the statements made by some of
the experts in a publication entitled “Cutter Forum: AIDS and Hemophilia
Treatment.” In the publication the following statements were selected by CUTTER
for attribution to the experts: “The physician who wants to test a patient for
AIDS runs the risk of putting the patient into a state of terror.” “Many at the
conference warned colleagues to avoid fueling patients’ fears by giving them
inconclusive data.” “The major concern I have is that physicians or others who
deliver healthcare will magnify the panic by telling patients they have `pre AIDS’
or AIDS, based on the methodology we have used for the last four or five years
in defining T-Cell populations.” Another M.D. added, “With the anxiety our
fellow physicians are causing patients, we’re going to
see more fear of AIDS than actual cases of AIDS.” The statements attributed to
these “experts” are misleading. In fact there was no medical or scientific
support for any of the anonymous conclusions stated by the “M.D.’s”
in the article. By the summer of 1983, T-cell testing was sufficiently reliable
to form the basis of numerous reliable studies and conclusions about AIDS in
hemophiliacs and other risk groups. There was no scientific methodology to
support the statement that the fear of AIDS would outnumber actual AIDS cases.
Instead, CUTTER’S motive was to understate the risk and increase sales, while
continuing to conceal the use of high risk plasma to manufacture Factor VIII
and IX.
88.
The CUTTER 1983 “Forum” article also attributed the
following statement to an “expert” treater: “A
physician who has dealt with AIDS directly also doubted the validity of T-Cell
tests.” This statement was false because by the summer of 1983, T-cell abnormalities over time were a clear
risk factor for AIDS. The article also stated, “Another M.D. added, ‘I have to
sit down individually with all the patients and discuss the AIDS problem with
them. But I stress that I am not very concerned because the majority of our
hemophiliacs are not affected by it.’” This statement was very misleading
because the growing epidemiological evidence regarding AIDS in hemophiliacs
clearly supported a substantial risk due to their extensive use of factor
concentrates, and Defendants knew of CDC projections that half of all
hemophiliacs would develop AIDS.
89.
The CUTTER 1983 “Forum” article went on to state: “One researcher put the
situation into perspective this way: ‘The very essence of our treatment
programs could potentially be threatened by the fear of a disease that has not
even killed ten hemophiliac people since 1982... I had eight patients die of trauma and
cerebral hemorrhage last year, and I didn’t have any die of AIDS. I think we
have to remember that our patients are getting hit on the head or mugged, that
they’re falling down stairs, they’re bleeding to death, and that those problems
are much more immediate than anything having to do with AIDS.’” This statement
was misleading because in the summer of 1983, CUTTER conducted an analysis
which acknowledged the risk of 2,000 to 5,000 hemophiliac deaths in the United
States due to AIDS transmission through factor concentrates.
90.
The above statement is also misleading in that it
perpetuated the false dichotomy between the benefits of factor concentrate
therapy and the risk of AIDS. In fact, the benefits of such therapy could and
should have been provided with little or no AIDS risk by avoiding use of high
risk homosexual and IV drug user donors, treating plasma to kill viruses, and
implementing the HBc test. This statement was also
contrary to the medical, scientific and epidemiological evidence in existence
at the time of the conference seminar on July 1, 1983. The risk of contracting AIDS was
already close to one in 100 for severe type A
hemophiliacs. If T-cell abnormalities were taken into consideration, the risk
was close to one out of two for heavy users of the product. As noted
previously, the CDC had predicted several months before the CUTTER Forum was
published that 50% of hemophiliacs would suffer from full blown AIDS. (CUTTER
document entitled “Cutter Forum, AIDS and Hemophilia Treatment” around July l,
1983)
91.
In late October 1983, CUTTER was notified that a donor had died
of AIDS in Austin, Texas. The donor died within 30 days of his last donation.
Because the donor’s plasma had been used in numerous lots of Factor VIII and IX
over the previous two years, a recall of those lots was ordered by CUTTER. On
November 1, 1983, CUTTER issued a press release regarding the recall. The press
release stated, “No adverse reactions involving these lots have been reported.”
This statement is misleading because it was virtually impossible for CUTTER to
know whether or not any adverse reactions had been experienced or reported to
physicians by patients who infused lots which contained plasma from the AIDS
donor. The withdrawal pertained to several lots and involved the pooling of the
AIDS donor’s plasma in thousands of doses of factor concentrate. In fact,
abnormal T-cell ratios had undoubtedly been reported in some hemophiliacs who
infused lots containing the AIDS donor’s plasma, along with lymphadenopathy and
numerous other side effects associated with a pre-AIDS condition.
92.
CUTTER further stated in the November l, 1983, press release,
“Although medical authorities consider the possibility of AIDS being
transmitted through these products exceedingly remote, CUTTER is taking the
action on its own initiative as a precautionary measure.” This statement is
false because public health authorities from the CDC had advised CUTTER on
March 15, 1983 that they expected one-half of the hemophilia patients who had
infused these products to develop full blown AIDS. CUTTER had been repeatedly
advised by public health officials that the AIDS observed in persons at risk
for AIDS was only the “tip of the iceberg.” CUTTER had conducted its own
in-house investigations entitled “AIDS scenarios” and concluded that a possible
outcome would be full blown AIDS in 5,000 hemophiliacs in the U.S. There was a
public health consensus that hemophiliacs were one of the high risk groups for
contracting AIDS because of their use of Factor VIII. CUTTER was within days of
applying to the FDA for a change to the labeling of Factor VIII that would
include a stronger warning. (CUTTER Press Release dated November 1, 1983)
93.
ALPHA published and distributed a newsletter in the
summer of 1983 entitled “Hemophilia.” The newsletter contains the statement in
an introduction by Thomas Stagnaro, Marketing Head,
that “[n]eedless to say, Alpha has stepped up efforts
to protect hemophilia patients, but new evidence suggests there is no proof
that AIDS is necessarily associated with blood or blood products.” This
statement was misleading because it was contrary to existing and accumulating
scientific evidence demonstrating the associated risk between use of Factor
VIII and AIDS. It was also contrary to the PHS guidelines and recommendations
of January 4 and March 24, 1983 mandating screening of high risk donors for
AIDS.
94.
The ALPHA 1983 newsletter also stated: “There is some
question as to whether use of cryoprecipitate would actually be safer in any
case.” This statement was contrary to the consensus that cryoprecipitate was
safer because it was made from voluntary donors in groups of 8 to 10, while ALPHA’s product was made using pools of plasma from high
risk paid donors, with 5,000 to 40,000 donations in each lot. Immune
abnormalities had been associated with use of factor concentrates but not
cryoprecipitate. Thus, there was no credible evidence upon which to question
the fact that cryoprecipitate was safer than factor concentrates. (Hemophilia
Letter, dated Summer, 1983, Vol. 5, No. 1.)
95.
ALPHA organized a seminar consisting of hemophilia treaters and physicians from the CDC and NIH in connection
with an American Blood Resources Association (“ABRA”) meeting held in Puerto
Rico in March, 1983, called the “ABRA Plasma Form.” All Defendants were members
of ABRA, and ABRA itself held meetings of Defendants for the purpose of
planning strategies to understate the AIDS risk. ALPHA published excerpts from
the 1983 Forum which understated the risk of factor concentrate in comparison
to other therapies, such as the statement attributed to Dr. Lou Aledort of the NHF: “[M]ore recent, unpublished data show
that immune system abnormalities develop in hemophiliacs no matter what sort of
treatment they receive, concentrate or cryo, Factor VIII or IX, high doses or
low, and whether they are young or old, or whether their disease is mild,
moderate or severe.” Dr. Aledort also cautioned that
“measuring T-Cell changes is technically difficult, and that the methodology
used in some studies has been faulty.” This statement was contrary to the
medical and scientific evidence existing at that time. Older, more severe
hemophiliacs who had used more product were
demonstrating more severe immune abnormalities, as well as opportunistic
infections. Factor VIII users, who were exposed to greater quantities of
concentrate, were more immune suppressed than Factor IX users. Cryoprecipitate
users had fewer immune abnormalities than concentrate users.
96.
The 1983 ALPHA/ABRA Forum includes the following statement,
attributed to Dr. Nemo: “It is not at all clear,
Dr. Nemo said, that an infectious AIDS agent, if one
exists, can be spread by blood products. The link between AIDS and its possible
transmission by blood products is very tenuous indeed.” This statement was
demonstrably false by March, 1983, by which time the overwhelming scientific
evidence supported the conclusion that AIDS was transmitted by blood products
such as factor concentrates. (Highlights from the 1983 ABRA Plasma Forum, A
Professional Service of Alpha Therapeutic Corporation, March 1983.)
97.
On or about December 15, 1983, Rodell,
then the head of ARMOUR, told members of the federal Blood Product Advisory
Committee (BPAC) and FDA officials that the Defendants wanted a three month
deferral in implementation of any recommendations by the BPAC or FDA that HBc testing be required for plasma donors. Rodell told the FDA that the purpose of the deferral was to
prepare a response to the proposed recommendation. In fact, all Defendants had
agreed to seek the three month hiatus as a “delaying tactic” against
implementing the test, and the request for a deferral was made in bad faith.
(CUTTER memorandum dated December 13, 1983.)
98.
The September 1985 issue of ECHO magazine also
contained a number of false and misleading statements. In the magazine, CUTTER
stated, “The ability to screen donors was hampered by not knowing what caused
the disease. However, as soon as it became known that there was a possibility
of transmitting AIDS through blood products, Cutter Laboratories began to
screen donors in an effort to exclude any who were in the high risk groups.”
This statement was misleading because there was no need to determine what
actually caused Factor VIII to transmit AIDS in order for CUTTER to screen out
donors who were at high risk for AIDS transmission. It was strongly suggested
by the CDC on July 27, 1982, that AIDS had a viral etiology similar to
Hepatitis B because of the risk groups involved. These risk groups comprised a
substantial portion of CUTTER’S plasma donor sources. CUTTER took no meaningful
action to screen out donors at the highest risk for AIDS and Hepatitis C
transmission at any time during the epidemic. In fact, they continued to market
products containing plasma from these groups throughout 1982, 1983 and 1984
worldwide. Even more egregiously, CUTTER
and other Defendants continued to market high risk non-heat treated factor
concentrate abroad after ceasing sales of such product in the United States in
favor of vastly safer heat treated product.
99.
In the same issue of ECHO, Dr. Margaret Hilgartner, a hemophilia treater
from Cornell Medical Center presented by CUTTER, made the following statement
understating the risk of AIDS and exaggerating the need for factor concentrate
products: “The current risk of persons with hemophilia developing AIDS is
directly related to their need for blood products to stop bleeding. The risk is
extremely low. Although most persons with hemophilia who have been treated with
concentrate and some who have been treated with cryoprecipitate have been
exposed to the virus in the past, less than .1 percent of the 20,000 persons
with hemophilia in the United States have developed AIDS.” This statement was
misleading for several reasons:
a.
The risk was very close to 1% for severe type A
hemophiliacs, who were the heaviest users and most likely to be exposed to HIV
in Factor VIII. The CDC had reported 71 cases in such persons by September
1985. Since there were approximately 8,000 severe, Type A
Hemophiliacs using the product regularly, the risk was close to one in 100. A 1
% risk of contracting AIDS, a fatal disease, is not “low” as stated by Dr. Hilgartner. Dr. George Akin, CUTTER’S medical director,
repeated this misrepresentation in his forward to the Hilgartner
article in the ECHO publication.
b.
The article did not disclose the report made by Dr. Evatt of the CDC to the company at a March 1983 ABRA
meeting, in which he projected that one half of all hemophiliacs would get full
blown AIDS based upon their known T-Cell abnormalities tied to exposure to
Factor VIII. (CUTTER memorandum dated March 14, 1983.)
c.
As they had done throughout, Defendants misleadingly
represented that the benefits of Factor VIII outweighed the risks of AIDS and
Hepatitis C, when in fact the benefits could and should have been provided with
minimal risk through proper safety measures and avoiding high risk donors.
100.
In the same issue of ECHO, Dr. Hilgartner
further stated, “[A] positive test result does not mean that the person will
actually get AIDS.” This statement was misleading because there was no
scientific basis for concluding in September 1985 that a positive ELISA test,
the then-existing test for the presence of HIV antibodies, did not mean
eventual full blown AIDS in the patient. In fact, severe T-Cell abnormalities
and a positive ELISA test were reliable predictors of full blown, and
eventually fatal, AIDS.
101.
Dr. Hilgartner’s article
states, “There is no evidence to warrant changing the current use of Factor
VIII or Factor IX.” This statement was also false. In fact, the evidence was
just the opposite. Non-heat treated, intermediate purity products were known by
September 1985 to be contaminated with HIV by virtue of testing done at the CDC
in the summer of 1984. These tests demonstrated that 70% of type A severe and 40% of type B hemophiliacs were HIV positive.
In addition, Dr. Hilgartner had reported to the New
York Academy of Sciences in 1983 that Factor VIII was associated with extremely
serious side effects, including loss of lymphocytes, thrombocytopenia, liver
damage, renal failure, splenomegaly and abnormally high levels of circulating
immune complexes. Many of these same diseases were reported in hemophiliac AIDS
victims. Thus, there was strong medical and scientific evidence that continued
use of non-heat treated, intermediate purity factor concentrates should be
avoided. (ECHO magazine Vol. 6, No. 3, dated September 1985.)
102.
These facts demonstrate that Defendants, jointly and
individually, fraudulently misrepresented the risk of AIDS and Hepatitis C due
to factor concentrates, failed to disclose accurate warnings of the risk to
Plaintiffs or their physicians, and fraudulently purported to be doing
“everything possible” to improve safety, when in fact Defendants maximized the
risk by recruiting high risk donors and by resisting and obstructing HBc testing, heat treatment, and other measures that would
truly have reduced the risk.
H.
Defendants’ Activities Were Subject to
Applicable Federal Regulations, Which Evidence the Standard of Care With Which
Defendants Should Have Complied
103.
Blood derivatives such as Factor VIII and IX are
prescription biologicals subject to federal regulation as both “biological
products” and “drugs.” Public Health Service Act, “Regulation of Biological
Products,” 42 U.S.C. § 262; Food, Drug & Cosmetic Act (“FDCA”), 21
U.S.C. § 301, et seq.
(a)
21 U.S.C. § 331(b) prohibited [should these be
present tense instead?] “adulteration or misbranding
of any … drug, . . . .”
(b)
21 U.S.C. § 351(a)(2)(B)
provided that “[a] drug . . . shall be deemed to be adulterated
. . . if . . . the methods used in, or the facilities
or controls used for, its manufacture, processing, packing, or holding do not
conform to or are not operated or administered in conformity with current good
manufacturing practice to assure that such drug meets the requirements of this
chapter as to safety. . . .”
(c)
21 U.S.C. § 352 provided that “[a] drug... shall
be deemed to be misbranded. .. if
its labeling is false or misleading in any particular.”
(d)
21 U.S.C. § 352(f)(2)
provided that a drug shall be deemed to be “misbranded” unless its labeling
bears “adequate warnings against use. .. where its use
may be dangerous to health.”
(e)
21 U.S.C. § 352(n) provided that a drug shall be
deemed to be “misbranded” unless the labeling included information concerning
side effects and contraindications as required in federal regulations.
(f)
21 U.S.C. § 321(n) provided that if an article is
alleged to be misbranded because the labeling or advertising is misleading,
then the determination of whether the labeling or advertising is misleading
shall take into account “not only representations made or suggested” by
affirmative statements, “but also the extent to which the labeling or
advertising fails to reveal facts material in the light of such representations
or material with respect to consequences which may result from the use” of the
drug.
104.
At all times material to this Complaint, 21 C.F.R.
§ 201.57(e) provided as follows, with respect to information to be
provided with the sale of Defendants’ products:
Warnings: Under this section heading, the labeling shall
describe serious adverse reactions and potential safety hazards, limitations in
use imposed by them, and steps that should be taken if they occur. The labeling
shall be revised to include a warning as soon as there is reasonable evidence
of an association with a drug; a causal relationship need not have been proved.
105.
At all times material to this Complaint, 21 C.F.R.
§ 200.5 provided as
follows:
Manufacturers and distributors of drugs and the Food and Drug
Administration occasionally are required to mail important information about
drugs to physicians and others responsible for patient care. In the public
interest, such mail shall be distinctive in appearance so that it will be
promptly recognized and read.
106.
At all times material to this Complaint, Part 606 of 21
C.F.R. set forth “Current Good Manufacturing Practices” for biological products
generally, and 21 C.F.R. § 640, et seq.,
set forth additional good manufacturing practices for blood and plasma
biologicals.
107.
At all times material to this Complaint, 21 C.F.R.
§ 606.140(a) provided:
Laboratory control procedures shall include: The establishment
of scientifically sound and appropriate specifications, standards and test
procedures to assure that blood and blood components are safe, pure, potent and
effective.
108.
At all times material to this Complaint, 21 C.F.R.
§ 640.60 defined “Source Plasma (1-luman)” as
the fluid portion of human blood which
has been stabilized against clotting, collected by plasmapheresis, and is
intended as source material for further manufacture into blood derivatives (a
portion of pooled plasma separable by chemical means) intended for injection.
109.
At all times material to this Complaint, 21 C.F.R.
§ 640.63(c), entitled “Qualification of Donor,” provided as follows with
respect to donors of source plasma:
Donors shall be in good health on the day of donation, as
indicated in part by: . . . (9) freedom
from any disease, other than malaria, transmissible by blood transfusion, in so
far as can he determined by history and examination indicated in this section;
(10) freedom of the arms and forearms from skin punctures or scars indicative
of addiction to self-injected narcotics; (11) freedom from a history of viral
hepatitis; (12) freedom from a history of close contact within six months of
donation with an individual having viral hepatitis; ...
.
Further, 21 C.F.R.
§ 640.63(a) provided that the method of determining “suitability of a
donor” included “tests” as well as the taking of a history and physical
examination.
110.
At all times material to this Complaint, 21 C.F.R.
§ 606.140 provided as follows:
Laboratory control procedures shall include: (a) The
establishment of scientifically sound and appropriate specifications, standards
and test procedures to ensure that blood and blood components are safe, pure,
potent and effective.
111.
The foregoing statutes and regulations are evidence of
the standard of care Defendants should have employed in the manufacture and
sale of Factor VIII and Factor IX. Defendants violated the foregoing
regulations and/or failed to comply with applicable standards of care by: (a)
marketing “adulterated” products that were unsafe as a result of failure to
comply with “Current Good Manufacturing Practice”; (b) marketing “misbranded”
products that were misleading and failed to disclose or warn of health dangers;
(c) failing to warn of serious adverse reactions and potential safety hazards
as soon as there was reasonable evidence of an association with the product; (d)
failing to exclude intravenous drug users who were unsuitable donors; (e)
failing to exclude donors with a history of viral Hepatitis who were unsuitable
donors; (f) affirmatively seeking out unsuitable donors known to have viral
Hepatitis antibodies, as well as prison populations known to include
substantial numbers of intravenous drug users, for inclusion of their plasma in
the pools used to make Factor VIII and Factor IX; (g) failing to disclose their
use of dangerous donors; and (h) failing to use appropriate tests and/or
procedures to assure the products were safe.
I.
Conspiracy, Concert of Action and Group
Liability
112.
Defendants, and each of them, acted in concert and
participated in a conscious and deliberate conspiracy to act negligently,
fraudulently and with willful and wanton disregard for the rights and safety of
blood product users, in connection with the manufacture of Factor VIII and IX
blood products and the collection of constituent plasma.
113.
After 1978, there were only four corporations in the
United States engaged in the production of Factor VIII and IX. These four
companies, Defendants herein, tacitly and explicitly agreed to avoid upgrading
industry standards. For example, the technology to virally inactivate factor
concentrates existed in the early 1970s, but was not seriously investigated by
any of the Defendants until the early 1980s, despite its effective use in
Europe. Use of the HBc antibody test to eliminate
Hepatitis B carrier donors, and to identify donors with a history of viral
Hepatitis, was known science by 1978. The HBc test
was reported to be an effective surrogate test for both AIDS transmission and
NANB Hepatitis carriers by 1982, yet no Defendant implemented this test until
April 1984.
114.
Three of the Defendants, ALPHA, BAXTER and CUTTER, used
donors from predominantly homosexual donor centers, prisons, and inner city
areas where the risk of IV drug abuse was high. After July 1982, when the
results of this conduct culminated in reports of fatal immune suppression in
three hemophiliacs who infused the product, this concert of action took on a
more overt, active form.
115.
By December 1982, the FDA demanded that Defendants stop
using prisoners, donors from high risk areas for hepatitis and AIDS transmission,
and known homosexuals. Rather than use good faith efforts to comply with the
FDA requests, Defendants collectively argued for a far less onerous and less
effective donor screening program. They jointly proposed a system comprised of
educating the donor by posting a placard in the donor center stating who the
risk groups for AIDS transmission were, and advising the donor that he would be
deferred if he acknowledged he was a member of one of those groups. Later, he
would be required to fill out a questionnaire in private. If he checked the box
indicating he was in a high risk group, he would be permanently deferred.
116.
At a January 6, 1983 meeting of Defendants’ trade
association, the Biological Section of the Pharmaceutical Manufacturer’s
Association (“PMA”), Defendants agreed not to implement highly effective HBc donor screening, instead selecting ineffective donor
questionnaires that did little to screen out donors at high risk for AIDS
transmission. Defendants further agreed
to keep each other informed as to what the other was doing in order that a low
standard of care was maintained. HBc testing had been strongly suggested by the CDC at the
January 4, 1983 Public Health Service (“PHS”) meeting. On January 14, 1983, Defendants acted jointly
to persuade the National Hemophilia Foundation (“NHF”) not to advocate
surrogate testing for AIDS and Hepatitis C through implementation of the HBc test. Defendants persuaded the NHF that use of the HBc test was in the “R and D” stage and not practical to
implement at that time.
117.
Defendants jointly agreed to oppose recall of the
products beginning at the January 6, 1983 meeting at the Pharmaceutical
Manufacturers’ Association (“PMA”).
Beginning with this meeting and continuing through at least
July 19, 1983, Defendants met at various times to prepare a strategy to
prevent the FDA from advocating a far-reaching recall of factor concentrate
products. Defendants knew that due to
their high risk donor populations, and their combining of these donors in pools
of 5,000 to 40,000, that their products were contaminated with the AIDS
agent. Nevertheless, Defendants acted in
concert to lobby the FDA, to get the FDA to issue recommendations to limit
recalls to circumstances in which an identified donor had died of AIDS within a
specified time after the pooling of that donor’s plasma. Defendants were well aware that plasma from
contaminated asymptomatic donors were mixed in the plasma pools and
contaminated virtually all lots.
Defendants were successful in deferring any FDA Blood Products Advisory
Committee (“BPAC”) recommendation for a general recall of the product at the
July 19, 1983 BPAC meeting. This
joint action allowed the defendants to avoid ever recalling any product except
when a donor died of AIDS.
118.
Defendants conducted a meeting on or about January 6,
1983 at the PMA, a major purpose of which was to decide on a unified strategy
to deal with increasing knowledge of risk of AIDS. At the meeting all four companies agreed to
postpone submitting any request to the FDA for permission to amend their
warning labels or package inserts. They
further agreed not to apply to the FDA for warnings enhancements until the
other three companies agreed to make application for warning enhancements and
to make the warnings similar in content.
At the time of the meeting, Defendants had been informed by various
reliable health authorities, including the PHS, that there was evidence of an
association of risk between factor concentrate use and the transmission of
AIDS.
119.
On December 13, 1983, Stephen Ojala,
CUTTER’s responsible head, documented by written
memorandum that Defendants met and jointly agreed to propose a “study” of the HBc surrogate screening test, as a “delaying tactic” to
avoid implementing the HBc test.
120.
Thereafter, at various times throughout 1983-1985,
Defendants attended meetings or otherwise communicated to assure joint efforts
to avoid recalling product; to avoid warning patients of the true risk; to
market product when sales dropped due to information in the lay press related
to AIDS transmission through factor concentrates; to avoid recall of
non-heat-treated product after heat-treated products were available; to avoid
implementation of the HBc test; and to coordinated a
joint legal defense plan in anticipation of litigation from patients afflicted
by AIDS through use of the products. Defendants also operated through trade
organizations, such as ABRA and PMA, to issue public statements minimizing the
risks of AIDS and Hepatitis C and overpromoting the
benefits of factor concentrate, to carry out the abovementioned goals of all
Defendants.
121.
All of the Defendants likely to have caused the harm to
Plaintiffs are parties to this lawsuit and properly before the court.
122.
The conduct of each and all of the Defendants, with
respect to their Factor VIII and Factor IX products and related plasma
collection methods, was tortious.
123.
The harm which has been caused to the Plaintiffs
resulted from the conduct of one, or various
combinations of the Defendants, and, through no fault of the Plaintiffs, there
may be uncertainty as to which one or combination of Defendants caused the
harm.
124.
The burden of proof should be upon each Defendant to
prove that the Defendant has not caused the harms suffered by the Plaintiffs.
125.
AHF was manufactured using the same fractionation
method by all Defendants. As such, during the relevant years from 1975 until
1985, factor concentrates were a fungible product, and physicians prescribed
the products interchangeably without regards to brand names of the drugs.
126.
The factor concentrates manufactured by Defendants from
1975 until 1985 contained the same design flaws. They were all manufactured
from paid donor plasma, which was at highest risk for Hepatitis B, Hepatitis C,
and HIV viral transmission. In addition, the factor concentrate was made from
large pools consisting of 5,000 to 40,000 paid donors, which further magnified
the risk of viral transmission.
127.
None of the factor concentrate was virally inactivated
during this time period. Therefore, all of the AHF carried a significant risk
of viral transmission. In addition, all of Defendants’ factor concentrate
products were similarly misbranded. All
of the products failed to warn of the known risks enumerated in this complaint.
128.
In large part because of the fungibility
of Defendants’ factor concentrate products, many hemophiliacs infused products
from two or more of the Defendants during the time period when all of the
Defendants’ products were infectious for HCV and HIV. It therefore may not be possible in to determine
which of the Defendants’ products actually caused each Plaintiff’s
infection. By suing the named
Defendants, Plaintiffs have joined all those manufacturers who could have
caused the infection with HCV and HIV.
Plaintiffs allege that Defendants have joint, several, and alternative
liability for Plaintiffs’ injuries.
129.
Plaintiffs in this case will make all reasonable
efforts through discovery and use of experts to make a good faith determination
as to which of the Defendants’ product(s) caused their respective HCV and/or
HIV infections. However, if it is not possible to make such a determination,
Plaintiffs respectfully request that in the event that they prove that one or
more Defendants breached a duty to Plaintiffs that caused their infection with
HIV and/or HCV, but it cannot be proven which Defendants’ product(s) caused
this harm, the court award damages consistent with each Defendant's market
share at the relevant time.
V.
CLASS ACTION ALLEGATIONS
130.
Plaintiffs bring this class action pursuant to Rule 23
of the Federal Rules of Civil Procedure, and seek class certification under the
applicable provisions of Rules 23(a) through (c), on behalf of a class (the
“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.
131.
Excluded from the Class are defendants, including any
parent, subsidiary, affiliate or controlled person of defendants and their
officers, directors, agents, employees and members of their immediate families.
132.
The Class is so numerous that individual joinder of all
members is impracticable. As of 1992,
there were over 30,000 hemophiliacs in Europe alone. The Class is readily identifiable on the
basis of medical records indicating positive test results for HIV and/or HCV
and prior usage of Defendants’ blood factor concentrate during the class
period. Fed. R. Civ. P. 23(a)(1).
133.
In this action, key and significant common issues of
law and fact relating to the defectiveness of Defendants’ blood factor
concentrate, and to Defendants’ knowledge, conduct and duty in its formulation,
manufacturing, research, testing, promotion, marketing, and sales exist, and
these common issues predominate over any issues affecting only individual Class
members. Fed. R. Civ. P. 23(a)(2); (b)(3).
134.
The claims of the representative Plaintiffs are typical
of the claims of the Class in that Plaintiffs and the members of the Class were
infected as a result of their or their spouse’s or parent’s infusion with
Defendants’ contaminated factor concentrate during the class period. The harm to Plaintiffs and members of the
Class was caused directly by Defendants’ wrongful conduct in that factor
concentrate infused by Plaintiffs or their spouses or parents suffers from the same
defect(s) as the factor concentrate manufactured, sold and/or distributed by
Defendants to all Class members during the class period, and Defendants’
misrepresentations regarding the factor concentrate were made to all Class
members. Fed. R. Civ. P. 23(a)(3).
135.
Like other Class members, the named Plaintiffs suffered
injuries and damages as a result of their infusion or their spouse’s or
parent’s infusion of Defendants’ factor concentrate. Fed. R. Civ. P. 23(a)(3);
(a)(4).
136.
Plaintiffs will fairly and adequately represent and
protect the interests of the members of the Class. Plaintiffs have no interests which are
adverse to the interests of the Class.
Fed. R. Civ. P. 23(a)(4).
137.
Plaintiffs have retained counsel competent and
experienced in complex class actions, pharmaceutical products liability
litigation, and international litigation.
Fed. R. Civ. P. 23(a)(4).
138.
Class certification may also be appropriate under Fed.
R. Civ. P. 23(b)(1) or (b)(2) for purposes of
equitable/injunctive relief.
139.
This Court may exercise its discretion to designate
particular claims or issues for class treatment and joint or common trial
pursuant to Fed. R. Civ. P. 23(c)(4)(a) and may
designate one or more subclasses pursuant to Fed. R. Civ. P. 23(c)(4)(b).
140.
A class action is superior to other available methods
for the fair and efficient adjudication of this dispute because common
questions of law and fact predominate over any questions that may affect only
individual members of the Class, and there would be enormous economies to the
courts and the parties litigating the common issues on a class wide basis
instead of through repetitive individual trials. A class action approach would involve fewer
management difficulties because it provides the benefits of unitary
adjudication, judicial economy, economics of scale and comprehensive
supervision by a single court. Fed. R.
Civ. P. 23(b)(3)(A)-(D).
VI.
TOLLING OF APPLICABLE STATUTES OF LIMITATION
141.
Any and all potentially applicable statutes of limitations
have been tolled by Defendants’ affirmative and intentional acts of fraudulent
conduct, concealment, and misrepresentation, alleged above, which estop Defendants from asserting statutes of
limitation. Such acts include but are
not limited to intentionally covering up and refusing to disclose use of high
risk plasma; sale of products abroad known to be contaminated; suppressing and
subverting medical and scientific research; and failing to disclose and
suppressing information concerning the risks of HIV and HCV transmission from
Defendants’ contaminated factor concentrate.
For example, while the spread of AIDS in homosexuals and IV drug users
became known to the FDA and the public, only Defendants knew that these very
populations were the donors Defendants were targeting to obtain plasma for
their factor concentrate products.
142.
Defendants are estopped from
relying on any statutes of limitation because of their fraudulent concealment
and misrepresentation alleged above.
Defendants were under a duty to disclose the risks of HIV and HCV
transmission from their contaminated factor concentrate because this is
nonpublic information over which they had exclusive control, because Defendants
knew this information was not readily available to Plaintiffs, and because this
information was relevant to Plaintiffs in deciding whether to use Defendants’
factor concentrate.
143.
Until very recently, Plaintiffs had no knowledge that
Defendants were engaged in much of the wrongdoing alleged herein. Because of the fraudulent and active
concealment of the wrongdoing by Defendants, including but not limited to
deliberate efforts—which continue to this day—to give Plaintiffs the materially
false impression that Defendants undertook all feasible safety precautions to
reduce the risk of HIV and HCV transmission from their contaminated factor
concentrate, Plaintiffs could not reasonably have discovered the wrongdoing any
time prior to this time, nor could Plaintiffs have, as a practical matter,
taken legally effective action given the unavailability, until very recently,
of internal memoranda and other documents (as generally described herein) as
evidence in support of Plaintiffs’ claims.
Defendants still refuse to admit and continue to conceal their
wrongdoing, and therefore Defendants’ acts of fraudulent concealment and
misrepresentation continue through the present time.
VII.
CLAIMS FOR RELIEF
First CLAIM FOR RELIEF
NEGLIGENCE
144.
Plaintiffs incorporate by reference all previous
paragraphs of this Complaint as if fully set forth here and further allege as
follows:
145.
Defendants marketed their Factor VIII and/or Factor IX
blood products to and for the benefit of Plaintiffs and the Class, and knew or
should have known that Plaintiffs and the Class would use their Factor VIII
and/or Factor IX blood products.
146.
Defendants owed Plaintiffs duties to exercise
reasonable care in light of the generally recognized and prevailing best
scientific knowledge.
147.
Through the conduct described in the foregoing and
subsequent paragraphs of this Complaint, the Defendants breached their duties
to Plaintiffs. The following sub-paragraphs summarize Defendants’ breaches of
duties to Plaintiffs and describe categories of acts or omissions constituting
breaches of duty by Defendants; each and/or any of these acts or omissions
establishes an independent basis for Defendants’ liability in negligence:
a.
Failure to exercise reasonable care in producing Factor
VIII and Factor IX blood products that were free of viruses, including the HIV
virus that causes AIDS and the HCV virus that causes Hepatitis C;
b.
Failure to exercise reasonable care in assuring that
only suitable plasma would be used in manufacturing Factor VIII and Factor IX
blood products;
c.
Failure to exercise reasonable care in testing plasma
used in manufacturing Factor VIII and Factor IX blood products for virus
contamination;
d.
Failure to exercise reasonable care in recruiting and
screening donors of plasma used in manufacturing Factor VIII and Factor IX
blood products;
e.
Failure to employ anti-viral techniques, including heat
treating, in the manufacture of Factor VIII and Factor IX blood products;
f.
Overpromotion of Factor VIII
and Factor IX blood products;
g.
Understating the relative value of hemophilia
treatments that constituted alternatives to Defendants’ Factor VIII and Factor
IX blood products;
h.
Failure to warn physicians, Plaintiffs, and the
hemophiliac community of the dangers associated with Factor VIII and Factor IX
blood products and/or the viruses and foreign bodies contained within the
plasma used in manufacturing Factor VIII and Factor IX blood products;
i.
Failure to exercise reasonable care by complying with
federal regulations then applicable to plasma collection and the manufacture of
Factor VIII and Factor IX blood products.
j.
Failure to exercise reasonable care in disseminating
information about Defendants’ methods of manufacturing Factor VIII and Factor
IX blood products and the risks that were created by said methods; and
k.
Failure to exercise reasonable care in recalling Factor
VIII and Factor IX blood products.
148.
Defendants knew, or should have known, that, due to
their failure to use reasonable care, Plaintiffs and other hemophiliacs, would
use and did use Defendants’ Factor VIII and/or Factor IX products to the
detriment of their health, safety and well-being.
149.
As the direct, producing and legal cause and result of
the Defendants’ negligence, Plaintiffs have been injured and have incurred
damages, including but not limited to permanent physical injuries to their
persons, medical and hospital expenses in the past, past disability, past loss
of use of the body, past physical and mental pain and suffering, and will incur
in the future medical and hospital expenses, permanent disability, future loss
of use of the body, and future physical and mental pain and suffering and loss
of the enjoyment of life.
150.
Plaintiffs are therefore entitled to damages in an
amount to be proven at trial, together with interest thereon and costs.
151.
Defendants’ conduct, as alleged above, was malicious,
intentional and outrageous and constituted willful and wanton disregard for the
rights or safety of others. Such conduct
was directed specifically at Plaintiffs and the Class and was such as warrants
an award of punitive damages.
Second CLAIM FOR RELIEF
NEGLIGENCE PER SE
152.
Plaintiffs incorporate by reference all previous
paragraphs of this Complaint as if fully set forth here and further allege as
follows:
153.
Defendants violated applicable federal statutes and
regulations relating to prescription drugs.
Plaintiffs are persons whom these statutes and regulations were meant to
protect.
154.
Defendants’ violation of these statutes or regulations
constitutes negligence per se.
155.
Defendants’ violation of these statutes or regulations
was the direct, producing and legal cause of Plaintiffs’ injuries and damages.
As the direct, producing and legal cause and result of the Defendants’
negligence, Plaintiffs have been injured and have incurred damages, including
but not limited to permanent physical injuries to their persons, medical and
hospital expenses in the past, past disability, past loss of use of the body,
past physical and mental pain and suffering, and will incur in the future
medical and hospital expenses, permanent disability, fixture loss of use of the
body, and fixture physical and mental pain and suffering and loss of the
enjoyment of life.
156.
Plaintiffs are therefore entitled to damages in an
amount to be proven at trial, together with interest thereon and costs.
157.
Defendants’ conduct, as alleged above, was malicious,
intentional and outrageous and constituted willful and wanton disregard for the
rights or safety of others. Such conduct
was directed specifically at Plaintiffs and the Class and was such as warrants
an award of punitive damages.
Third CLAIM FOR RELIEF
FRAUDULENT OMISSION AND CONCEALMENT
158.
Plaintiffs incorporate by reference all previous
paragraphs of this Complaint as if fully set forth here and further allege as
follows:
159.
Defendants had a confidential and special relationship
with Plaintiffs due to (a) Defendants’ vastly superior knowledge of the
health and safety risks relating to Factor VIII and Factor IX,
(b) Defendants’ sole and/or superior knowledge of their dangerous and
irresponsible plasma collection practices; and (c) Defendants’ direct
communications with the hemophiliac community through newsletters that
purported to accurately convey the risk of AIDS. As a result, Defendants had an
affirmative duty to fully and adequately warn the hemophiliac community,
including Plaintiffs and their physicians, of the true health and safety risks
related to the Factor VIII and Factor IX blood products and constituent plasma
and a duty to disclose their dangerous and irresponsible plasma collection
practices. Independent of any special relationship of confidence or trust,
Defendants had a duty not to conceal the dangers of the products to Plaintiffs
and their physicians.
160.
Misrepresentations made by the Defendants about the
health and safety of their factor concentrate products independently imposed a
duty upon Defendants to fully and accurately disclose to the hemophiliac
community, including Plaintiffs and their physicians, the true health and
safety risks related to Factor VIII and Factor IX and its constituent plasma
and a duty to disclose their dangerous and irresponsible plasma collection
practices.
161.
In connection with their Factor VIII and Factor IX
products, Defendants fraudulently and intentionally concealed important and
material health and safety product risk information from Plaintiffs, the
hemophiliac community, and their physicians, all as alleged in this Complaint.
162.
Any of the following is sufficient to independently
establish Defendants’ liability for fraudulent omission and/or concealment:
a.
Defendants fraudulently concealed the health and safety
hazards, symptoms, constellation of symptoms, diseases and/or health problems
associated with their Factor VIII and Factor IX blood products and related
plasma collection activities;
b.
Defendants fraudulently concealed their practice of
using unsuitable plasma from unsuitable donors in the manufacture of Factor
VIII and Factor IX blood products;
c.
Defendants fraudulently concealed their practice of
avoiding the use of available technology to detect viruses in Defendants’ blood
products and the components thereof;
d.
Defendants fraudulently concealed their practice of
avoiding the use of available technology to destroy viruses in Defendants’
blood products and the components thereof;
e.
Defendants fraudulently concealed information about the
known comparative risks and benefits of the use of Factor VIII and Factor IX
and the relative benefits and availability of alternate products and therapies.
163.
Defendants knew that Plaintiffs, the hemophiliac
community, and their physicians would regard the matters Defendants concealed
to be important in determining their course of treatment, including their
decision whether to use Factor VIII and/or Factor IX.
164.
As a direct and proximate result of Defendants’
fraudulent concealment and suppression of material health and safety risks
relating to Factor VIII and Factor IX and of Defendants’ dangerous and
irresponsible plasma collection practices, Plaintiffs have suffered and will
continue to suffer injury, harm and economic loss. As the direct, producing and
legal cause and result of the Defendants’ fraudulent concealment and
suppression of material health and safety risks relating to Factor VIII and
Factor IX and of Defendants’ dangerous and irresponsible plasma collection
practices, Plaintiffs have been injured and has incurred damages, including but
not limited to permanent physical injuries to their persons, medical and
hospital expenses in the past, past disability, past loss of use of the body,
past physical and mental pain and suffering, and will incur in the future
medical and hospital expenses, permanent disability, future loss of use of the
body, and future physical and mental pain and suffering and loss of the
enjoyment of life.
165.
Plaintiffs are therefore entitled to damages in an
amount to be proven at trial, together with interest thereon and costs.
166.
Defendants’ conduct, as alleged above, was malicious,
intentional and outrageous and constituted willful and wanton disregard for the
rights or safety of others. Such conduct
was directed specifically at the Plaintiffs and was such as warrants an award
of punitive damages.
167.
Plaintiffs are informed and believe that Defendants
utilize retention policies that provide for scheduled destruction of documents
and other items, which may result in the knowing, negligent, or inadvertent
destruction of documents, data, and materials relevant and necessary to
adjudication of this action, including, but not limited to, records identifying
batch or lot numbers of Defendants’ products shipped to particular treatment
facilities abroad, which may facilitate product tracing. This risk warrants an order from this Court
that such evidence (including all documents, data compilations, and tangible
things within the meaning of Rule 26 of the Federal Rules of Civil Procedure)
be preserved and maintained for use in these proceedings.
Fourth CLAIM FOR RELIEF
BREACH OF IMPLIED WARRANTY
168.
Plaintiffs incorporate by reference all previous
paragraphs of this Complaint as if fully set forth here and further allege as
follows:
169.
Defendants’ factor concentrate products were
intentionally designed, manufactured, promoted, distributed and sold to be
introduced into the human body.
170.
Defendants breached the implied warranties of
merchantability and fitness because Defendants’ factor concentrate products
cannot pass without objection in the trade, are unsafe, are not merchantable,
are unfit for their ordinary use when sold, and are not adequately packaged and
labeled.
VIII.
PRAYER FOR RELIEF
WHEREFORE, Plaintiffs, on their own behalf and on behalf
of the Class, pray
for judgment against Defendants, and each of them, as follows:
1.
For an order certifying the Class under the applicable
provisions of Federal Rules of Civil Procedure 23, and appointing Plaintiffs
and their counsel to represent the Class;
2.
For compensatory damages sustained by Plaintiffs and
members of the Class, against all Defendants, jointly and severally, in an
amount to be determined at trial;
3.
For punitive and exemplary damages according to proof
against all Defendants;
4.
For an award of prejudgment interest, costs,
disbursements and reasonable attorneys’ fees;
5.
For injunctive relief in the form of an order requiring
Defendants to preserve all relevant documents; and
6.
For such other and further relief as the Court deems
equitable or appropriate under the circumstances.
|
Dated:
|
Elizabeth J.
Cabraser
Lieff, Cabraser, Heimann
& Bernstein, LLP
Elizabeth J. Cabraser (State Bar No. 83151)
Robert J. Nelson (State Bar No. 132797)
Morris A. Ratner (State Bar No.
157554)
Fabrice N. Vincent (State Bar
No. 160780)
Heather A. Foster (State Bar No. 184353)
Lexi J. Hazam
(State Bar No. 224457)
275 Battery Street, 30th Floor
San Francisco, CA 94111-3339
Telephone: (415)
956-1000
Facsimile: (415)
956-1008
|
|
|
LAW OFFICES OF CHARLES
KOZAK
Charles Kozak (State Bar No.
141758)
275 Battery Street, 30th Floor
San Francisco, CA 94111-3339
Telephone: (415)
956-1000
Facsimile: (415)
956-1008
Attorneys for Individual and
Representative Plaintiffs
|
DEMAND
FOR JURY TRIAL
Plaintiffs demand a trial by jury on all issues stated.
|
Dated:
|
Elizabeth J.
Cabraser
Lieff, Cabraser, Heimann
& Bernstein, LLP
Elizabeth J. Cabraser (State Bar No. 83151)
Robert J. Nelson (State Bar No. 132797)
Morris A. Ratner (State Bar No.
157554)
Fabrice N. Vincent (State Bar
No. 160780)
Heather A. Foster (State Bar No. 184353)
Lexi J. Hazam
(State Bar No. 224457)
275 Battery Street, 30th Floor
San Francisco, CA 94111-3339
Telephone: (415)
956-1000
Facsimile: (415)
956-1008
|
|
|
LAW OFFICES OF CHARLES
KOZAK
Charles Kozak (State Bar No.
141758)
275 Battery Street, 30th Floor
San Francisco, CA 94111-3339
Telephone: (415)
956-1000
Facsimile: (415)
956-1008
Attorneys for Individual and
Representative Plaintiffs
|
