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1-Hormones: On the GE insulin class action suit in the U.S.
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TITLE: A) COMMENT by Natural Law Party Wessex
B) New Mexico diabetic sues over insulin
C) Text of class-action suit
SOURCE: A) NLP Wessex, UK, nlpwessex@bigfoot.com
B) Albuquerque Journal, USA
http://members.tripod.com/diabetics_world/Class_Action_suit.htm
C) Associated Press
DATE: A) October 12, 2000
B) April 8, 2000
C) sent by NLP, October 12, 2000
------------------ archive: http://www.gene.ch/genet.html ------------------
A) COMMENT by NLP Wessex
Remember how safe GE foods are and how great GE in medicine is? Well this
is what some diabetics in the US are now claiming GE (rDNA) insulin is
doing to them (see Associated Press report and court filing below).
Given that GE drugs have to go through tougher testing procedures than GE
foods there will be considerable concern that amongst other things one or
both of the two defendant biotechnology companies stand accused in this
'class action' of having:
- failed to conduct appropriate and adequate clinical trials 'such that the
long-term effects of these drugs are not known nor documented'.
- paid for, arranged for and caused rapid approval' from the Federal Drug
Administration 'despite having knowledge of the potential life-
threatening side effects from these drugs and despite that the long-term
effects of these drugs have not been determined'.
- given rise through such products to personal injuries including
disfigurement, loss of consortium and death'.
- failing to provide adequate warnings to doctors that 'such products could
result in antibody production, arthritic syndromes and other potentially
injurious, life-threatening symptoms in diabetic patients.'
- intentionally, recklessly and maliciously suppressed information which
would inform the diabetic public as to potential injurious side effects'.
- intentionally, recklessly and maliciously failed to provide other, less
risky alternatives for treatment in full knowledge of the potentially
injurious, life-threatening side effects to diabetics'.
It has taken nearly 20 years for this situation to come to full public
attention. Meanwhile the less rigorously tested GE foods are being given to
entire populations especially in the US. The allegations of adverse effects
from GE insulin are arising despite the fact that at least one of these
products (according to its manufacturers) is: "structurally identical to
the insulin produced by your body's pancreas". By contrast genetically
'modified' or 'engineered' foods do not have to be 'structurally identical'
to their natural counterparts but only 'substantially equivalent'. For more
on the structural characteristics of such insulin products see: http://
members.tripod.com/diabetics_world/Diabetics_World_Insulin_Structure.htm
According to its manufacturer one of these rDNA insulin products: "is
synthesized in a non-disease-producing special laboratory strain of
Escherichia coli [E.coli] bacteria that has been genetically altered by the
addition of the human gene for insulin production." and another: "is made
by a special non-disease-producing laboratory strain of Escherichia coli
[E.coli] bacteria that has been genetically altered by the addition of the
gene for this human insulin analog."
In addition to the defendant companies in the New Mexico court case another
corporation manufacturing GE insulin is Aventis, the company whose GE crops
are currently featuring in UK farm-scale trials. Aventis has recently
refused to call expert witnesses to defend their product against biosafety
concerns being raised in a public hearing relating to GM maize in the UK (
see http://www.connectotel.com/gmfood/ti031000.txt). More information on
the effects of their GE insulin is available at: http://members.tripod.com/
diabetics_world/aventis_human_worsens_retinopathy.htm and http://
www.webtribe.net/d/diabetic/avent.htm. Aventis is also engaged in an
insulin patent dispute with one of the GE insulin manufacturers cited in
the New Mexico case (http://www.novo.dk/press/nowuk/91.asp).
Private Eye reports that at last month's Labour Party Conference UK Health
Secretary, Alan Milburn, spoke for the 'Fabians' (a group perceived by the
media as being at the cutting edge of Labour modernisation: see http://
www.fabian-society.org.uk/yf/) on "modernising the NHS" at an event
sponsored by Aventis. Apparently Alan Milburn considers drug firms are
"important not just for the health, but also for the wealth" of the nation
and does not subscribe to the argument about "getting the drugs bill down".
Meanwhile at another event at the party conference Labour Health Minister
John Hutton spoke for the Zito Trust sponsored by Eli Lilly (makers of
Prozac and one of the GE insulin defendant manufacturers in the New Mexico
class-action detailed in the Associated Press report below).
Also featuring at the Labour Conference was party funder Paul Adamson, of
Adamson BSMG Worldwide, whose involvement in forcing GM 'standards' on the
EU parliament has included advising the European and American
pharmaceutical industries "in securing the adoption of key legislation in
the field of biotechnology".
More information on GE insulins is available at: http://members.tripod.com/
diabetics_world/BDA_Human_Animal_Coverup.htm http://www.netlink.de/gen/
Zeitung/2000/000414a.html
http://www.diabetes-ernaehrung.ch/fis/news-e.shtml http://
members.tripod.com/diabetics_world/Australians_at_Risk_Human.htm
See also correlation between increasing use of synthetic insulin and
diabetic road accidents in Switzerland: http://members.tripod.com/
diabetics_world/Synthetics_and_Accidents.htm
Also see Fox TV report on current class action law suit in New Mexico at:
http://members.tripod.com/diabetics_world/Movies/fox13-suit.ram
Given their track record of cover up (including negative biosafety
experiences with genetically engineered rBGH used for milk production in US
dairy cows, but banned in the EU: see http://www.foxBGHsuit.com) are we
happy to place the future of the world's food supply in the hands of the
genetic engineering industry?
It has taken nearly 20 years after its official approval to reveal this
situation with GE insulin (first licensed in USA, UK, Switzerland and other
countries in 1982) despite tests carried out at Guy's Hospital in London
reported as early as 1980 which suggested "further continuous careful
surveillance of unexpected side-effects". Over ten years later one
manufacturer was still willing to go on record as claiming that its GE
insulin product "is one hundred percent a safe drug".
Similar safety claims are currently being made by biotechnology companies
in relation to genetically engineered foods despite their much lower
standards of testing than for GE drugs. Do we wish to wait 20 years to find
out how reliable those claims are too? Do we have to wait 20 years for
Professor Pusztai's concerns about the safety of GM foods to be proved
right all along? From the GE insulin law suit in New Mexico it seems there
may be nothing new about the suppression of data which reveals the damaging
effects of products created by the biotechnology industry and the failure
of the regulatory system to identify such effects. "There is still no
positive proof of a causal relation between the use of thalidomide during
pregnancy and malformations in the new-born." Frank Getman, President
Merrill Company, Feb 2nd 1961.
"Almost everything we grow, everything we eat is the root result of human
intervention, human breeding and so on. But this [genetic modification
through recombinant DNA technology] is unnatural in a different sort of way
from the kinds of breeding programs that have characterized humanity for
ten thousand years.... So the question which people have, I believe, not
only a right but a duty to ask, is how wisely will we use these
unprecedented new powers? What are the risks associated with doing
something this new and this profound at the very wellsprings of life?...
Certainly, humanity's record for using technology wisely, sensitive to its
potential effects on society, on people, on environment is, at best, mixed
and hardly encouraging.... We have not yet identified, yet alone cloned,
the gene for wisdom, and some skepticism about our ability to manage
powerful new technologies is appropriate." Robert Shapiro, Chief Executive
of Monsanto - speech on genetically modified food, State of the World
Forum, San Francisco, October 27, 1998 (emphasis added).
"We're in a crisis position where we know the weaknesses of the genetic
concept, but we don't know how to incorporate it into a more complete
understanding. Monsanto knows this. DuPont knows this. Novartis knows this.
They all know what I know. But they don't want to look at it because it's
too complicated and it's going to cost too much to figure it out." Richard
Strohman, Professor Emeritus, Department of Molecular and Cell Biology,
University of California, Berkeley (Safe Food News, Mothers for Natural Law
of the US Natural Law Party www.safe-food.org).
For more on the NLP's global campaign for an immediate ban on GM foods see:
http://www.natural-law-party.org/key_issues/
immediate_global_ban_of_gm_food.htm
For more on the relationship between politicians and the 'bioscience'
industries see: www.btinternet.com/~nlpwessex/Documents/compliance.htm
NATURAL LAW PARTY WESSEX
nlpwessex@bigfoot.com
www.btinternet.com/~nlpwessex
*****
B) New Mexico diabetic sues over insulin
A class-action lawsuit against Eli Lilly and Co. and Novo Nordisk alleges
the drug makersÕ biosynthetic insulin products can hurt diabetics. The
lawsuit, filed last week in Federal court in New Mexico, also contends the
two companies have recklessly reduced the production alternative
medications. Rene Ostrochovsky, a lawyer handling the lawsuit for Roehl Law
firm in Albuquerque, said Thursday it was too early to discuss the lawsuit.
The lawsuit was filed on behalf of Suzan Kawulok, a diabetic from New
Mexico. She wrote on a diabetes Web site that she took Lilly biosynthetic
insulin, called Humulin, in 1987, and it caused "unbearable pain and loss
of most use (of) my arms." She went back to animal insulin - then tried the
biosynthetic version again in 1998 and experienced the same problems, she
said.
"It was the human insulin causing these horrible symptoms," said Kawulok,
who now takes pork insulin. Both types of insulin - the biosynthetic
versions made from human DNA and the animal-based versions made from the
pancreas glands of cows and pigs - help control blood sugar levels for
diabetics.
The Indianapolis based Lilly and Novo Nordisk began marketing the
biosynthetic versions of the drug in the 1980s. Since then, human insulins
have gradually replaced animal-based insulins. Novo Nordisk is based in
Bagsvaerd, Denmark, just north of Copenhagen. In the past five years, Novo
Nordisk stopped selling all its animal insulins in the United States and
Lilly dropped its beef-pork mix, which was once the nationÔs most-used
insulin. The only animal insulin left on the U.S. market is a pure pork
product sold by Lilly.
The 18-page lawsuit says Lilly and Novo Nordisk "recklessly and maliciously
discontinued or significantly reduced the manufacture of animal-based
insulins knowing that diabetics had serious adverse symptoms" from the
biosynthetic products. The lawsuit also alleges the two companies failed to
warn patients that human insulin can cause injurious, life-threatening
symptoms," including arthritic syndromes and a lack of awareness of low
blood sugar. It also accuses Lilly and Novo Nordisk of trying to prevent
other companies from making animal-based insulins, and asks that the firms
be ordered to release their formulas for animal-based insulins to another
manufacturer.
"We stand behind the safety of our drug," said Lilly spokeswoman Doyla
Chadwick. She said more than 3 million people rely on human insulin
injections to live, and "the safety of human insulin has been proven by
regulatory authorities almost 20 years ago. Human insulin is identical to
the insulin produced naturally by the body. ... and is less allergenic than
animal insulin."
David Groves, a Birmingham, Ala., business consultant who runs an Internet
discussion board on animal insulins, blames Novo NordiskÔs human insulin
for his near-death in a car crash years ago. He called the lawsuit a good
thing, but questioned how the law firm will identify plaintiffs who can
point to human insulin as the cause of their health problems.
"The affected class has no way of knowing theyÔre affected. It took me
years and years and two additional auto accidents to make me aware human
insulin was the cause of my accident, and IÔm no dummy." "It was the human
Insulin causing these horrible symptoms," said Kawulok. Who said she now
takes pork insulin.
*****
C) Text of class-action suit
UNITED STATES D1STRICT COURT
STATE OF NEW MEXICO
SUZAN KAWULOK, INDIVIDUALLY AND
AS REPRESENTATIVE TO THE CLASS;
VARIOUS UNNAMED JOHN DOES AND
VARIOUS UNNAMED JANE DOES INDIV
AND ON BEHALF OF THE CLASS,
Plaintiffs,
vs. NO. CIV 00 0459 BB / LFG
ELI LILLY AND COMPANY; and NOVO NORDISK,
Defendants.
FIRST AMENDED COMPLAINT FOR NEGLIGENCE,
PRODUCTS LIABILITY AND PUNITIVE DAMAGES
Plaintiffs complain against The Defendants as follows:
1. Suzan Kawulok is a resident of Bernalillo County, New Mexico and is the
named representative of this multidistrict class action
2. Defendant Eli Lilly and Company ("Lilly") is a corporation doing
business In the State of New Mexico.
3. Novo Nordisk is a corporation doing business in the State of New Mexico.
4. For purposes of Federal Rule of Civil Procedure 23 and federal diversity
jurisdiction, each plaintiff in this national class action is bringing a
claim for damages in excess of $80,000.00.
5. In accordance with Federal Rule of Civil Procedure 23, the nation-wide
class will be properly expanded during the pre-trial stages of this action.
GENERAL ALLEGATIONS
6. All of the Plaintiffs in this class have bean injected with Humulin¨ or
Humalog¨ manufactured by Defendant Lilly, or insulin prepared with
recombinant DNA (rDNA), or synthetic human insulin manufactured by Novo
Nordisk within the last three years. Upon information and belief,
recombinant DNA or rDNA is made from a sample of human DNA by cloning a
synthetic product from the human DNA.
7. All of the Plaintiffs in this class have expedience harmful or painful
side effects as a direct result of injecting Humulin¨ or Humalog¨
manuf9ctured by Defendant Lilly, or insulin prepared with recombinant DNA
(rDNA), or synthetic human insulin manufactured by Defendant Novo Nordisk
8. Defendant Lilly designed, manufactured, produced, packaged and
distributed both Humulin¨ end Humalog¨, without adequate warnings about
possible side effects of these drugs.
9. Novo Nordisk designed, manufactured, produced, packaged and distributed
rDNA human-based Insulin and synthetic human insulin without adequate
warnings about potential side effects of these drugs.
10. All defendants knew or should have known that Humulin¨, Humalog¨, rDNA
human-based insulin or synthetic insulin would carry with its injection n
potential for Injurious side effects.
11. All Defendants failed to adequately warn Plaintiffs in this class of
the potential Injurious side effects which Could result from Injecting
Humulin¨, Humalog¨, other rDNA human-based insulin or synthetic human
insulin,
12. All Defendants intentionally and maliciously suppressed information
which would inform the diabetic public at potentially Injurious side
effects which could result from Injecting Humulin¨, Humalog¨, other rDNA
human-based insulin or synthetic human insulin.
13. Upon information and belief, all Defendants intentionally discontinued
or significantly reduced the manufacture of animal-based insulins, knowing
that diabetics had serious adverse symptoms from injecting Humulin¨,
Humalog¨, other rDNA insulin or synthetic human insulin.
14. Upon information and belief, all Defendants have intentionally
prevented companies from manufacturing animal-based insulins, knowing that
diabetics adverse symptoms from injecting Humulin¨, Humalog¨, other rDNA
insulin or other have synthetic human insulin.
15. Humulin¨, Humalog¨, other rDNA insulin and synthetic human insulin has
the potential to cause antibody production in the human body and can cause
inter alia, a syndrome which results in arthralgia, arthritis and myalgia-
like symptoms in diabetics. Upon information and belief, human-based or
synthetic human insulin also prevents diabetics from having proper warning
signs of hypoglycemic symptoms until blood sugar ranges are dangerously low
resulting in confusion, distress, Coma and even death.
16. Upon information and belief, Humulin¨ Humalog¨, other rDNA insulin and
synthetic human insulins have the potential to produce a variety of serious
side effects which could be and have been potentially life-threatening to
diabetic individuals who inject these products. Those products are
designed, manufactured, packaged and distributed by Defendants.
17. Upon information and belief, Defendants have repressed the flow of
relevant medical information to medical practitioners prescribing Humulin¨,
Humalog¨, other rDNA human-based Insulin and synthetic human insulin
resulting in prescriptions without proper warnings to patients about
possible antibody production, arthritic syndromes and other injurious, life-
threatening symptoms.
18. Upon information and belief, Defendants have repressed the flaw of
relevant medical information to pharmacists tilling prescriptions for
Humulin¨, Humalog¨, other rDNA human-based insulin and synthetic human
insulin resulting in prescriptions without proper warnings to patients
about possible antibody production, arthritic syndromes and other
potentially injurious, life-threatening symptoms.
19. Upon information and belief, Defendants have repressed the flow of
relevant medical information such that medical practitioners and
pharmacists are failing to adequately train their employees as to
communicate to diabetics the possible side effects of antibody production,
arthritic syndromes and other potentially injurious, life-threatening
symptoms in diabetic patients who are taking Humulin¨, Humalog¨, other
rDNA
human-based insulin or synthetic human insulin.
20. Upon Information and belief, Defendants have repressed the flow of
relevant medical information resulting in a nationwide administration of
the potentially dangerous and life-threatening substances of Humulin¨,
Humalog¨, other rDNA human-based insulin or synthetic human Insulin to
diabetic patients.
21. Upon information and belief, Defendants have repressed the flow of
relevant medical information such that medical practitioners have tailed to
diagnose and treat the injuries and &de effects which Plaintiffs in this
class sustained as a result of injecting Humulin¨, Humalog¨, other rDNA
human-based insulin or synthetic human insulin.
22. Upon information and belief, Defendants have failed to Implement and
supervise adequate protocols for supervising patients who were prescribed
Humulin¨, Humalog¨, other rDNA human-based insulin or synthetic human
insulin for the first time.
23. Upon information and belief. Defendants have failed to inform medical
practitioners such that they would be aware of relevant medical information
to implement and supervise adequate protocols for supervising patients who
were prescribed Humulin¨. Humalog¨, other rDNA human-based insulin or
synthetic human insulin for the first time,
24. Upon information and belief, Defendants have failed to provide other,
less risky alternatives for treatment in full knowledge of the potentially
injurious, life-threatening side effects to diabetics.
25. Upon Information and belief, Defendant Lilly paid for, arranged for and
caused rapid approval of Humulin¨ or Humalog¨ from the Federal Drug
Administration despite having knowledge of the potential life-threatening
side effects from those drugs and despite that the long-term effects of
these drugs have not been determined.
26. All Plaintiffs in this class have suffered personal injuries due to
their injection of Humulin@, Humalog¨, other rDNA human-based insulin or
synthetic insulin and have claims for damages which may include pain and
suffering, medical expenses, lost wages, lost range-of-motion, loss of
opportunity, emotional distress, disfigurement, loss of consortium and
death.
27. PlaintiffsÕ injuries have been directly and proximately caused by
DefendantsÕ actions and omissions regarding Humulin¨, Humulin¨
Humalog¨,
and other rDNA human-based insulin or synthetic Insulin.
COUNT 1 - NEGLIGENCE - ELI LILLY
28. The Plaintiffs incorporate the prior allegations of this Complaint.
29. Defendant Lily was negligent in failing to provide adequate warnings in
its packaging that Humulin¨, Humalog¨, other rDNA human-based insulin or
synthetic human insulin could result in antibody production, arthritic
syndromes end other potentially injurious, life-threatening symptoms in
diabetic patients.
30. Defendant Lilly was negligent in falling to provide adequate warnings
to medical facilities and doctors that Humulin¨, Humalog¨, other rDNA
human-
based insulin or synthetic human insulin could result in antibody
production, arthritic syndromes and other potentially injurious, life-
threatening symptoms in diabetic patients.
31. Defendant Lilly was negligent in reducing or aborting its production of
animal-based insulins which are required for Humulin¨, Humalog¨ other rDNA
human-based or synthetic human insulin-5ensitive diabetic patients in
maintaining quality of life.
32. Defendant Lilly was negligent in failing to advise about other, less
risky alternatives for treatment because of the potentially injurious, life
threatening side effects to diabetics.
33. Defendant Lilly was negligent in the design of Humulin¨ and Humalog¨
such that its defective design causes side effects which are potentially
injurious and life threatening to diabetics.
34. Upon information and belief, Defendant Eli Lilly was negligent in
conducting adequate clinical trials with Humulin¨ and Humalog¨ such that
the long-term effects of these drugs are not known nor documented,
35. The negligent actions and omissions of Lily were a direct and proximate
cause of Plaintiff& injuries.
WHEREFORE, Plaintiffs seek judgment against Defendant Lilly for
compensatory damages, punitive damages, attorneys fees, costs and all other
appropriate relief as the Court may deem proper. Additionally, Plaintiffs
seek an Injunction from the Court requiring Defendant Lilly to release its
formula for animal based insulin to a domestic drug manufacturer so that it
may produce animal insulin under United States FDA guidelines.
COUNT II - NEGLIGENCE - NOVO NORDISK
36. The Plaintiffs incorporate the prior allegations of this Complaint.
37. Defendant Novo Nordisk was negligent in failing to provide adequate
warnings in Its packaging that its rDNA human-based Insulin or synthetic
human Insulins now marketed to the public could result In antibody
production, arthritic syndromes and other potentially injurious, life-
threatening symptoms in diabetic patients.
38. Defendant Novo Nordisk was negligent in failing to provide adequate
warnings to medical facilities and doctors that its rDNA human-based
insulin or synthetic human insulins now marketed to the public could result
in antibody production, arthritic syndromes end other potentially
Injurious, life-threatening symptoms in diabetic patients.
39. Defendant Novo Nordisk was negligent in reducing or aborting its
production of animal-based insulins, which are required for diabetics who
cannot tolerate rDNA human-based or synthetic human insulins because of the
potentially injurious, life-threatening effects.
40. Defendant Novo Nordisk was negligent in falling to advise the public
and medical practitioners about other, less risky alternatives for
treatment than rDNA human-based or synthetic human insulins because of the
potentially injurious, life threatening side effects to diabetics.
41. Defendant Novo Nordisk was negligent in the design of its rDNA human-
based or human insulin drugs such that the defective design of these drugs
causes side effects which are potentially life-threatening to diabetics
injecting these drugs.
42. Upon information end belief, Defendant Novo Nordisk was negligent in
conducting appropriate and adequate clinical trials with its rDNA human-
based or human insulin drugs such that the long-term effects of these drugs
are not known nor documented.
43. The negligent actions and omissions of Novo Nordisk wore a direct and
proximate cause of PlaintiffsÕ injuries.
WHEREFORE, Plaintiffs seek judgment against Novo Nordisk for compensatory
damages, punitive damages, attorneysÕ tees, costs and all other appropriate
relief the Court deems proper. Additionally, Plaintiffs seek an injunction
from the Court requiring Defendant Novo Nordisk to release its formula for
animal based insulin to 2 domestic drug manufacturer so that It may produce
animal insulin under United States FDA guidelines.
COUNT III - PRODUCTS LIABILITY - ELI LILLY
44. Defendant Lilly was negligent in failing to provide adequate warnings
in its packaging that Humulin¨ and Humalog¨ or other rDNA human-based
insulin or synthetic human insulins marketed to the public could result in
antibody production, arthritic syndromes and other potentially injurious,
life-threatening symptoms in diabetic patients.
45. Defendant Lilly was negligent in failing to provide adequate warnings
to medical facilities and doctors that Humulin¨ and Humalog¨ or other rDNA
human-based insulin or synthetic human insulins marketed to the public
could result in antibody production, arthritic syndromes and oilier
potentially injurious, life-threatening symptoms in diabetic patients.
46. Defendant Lilly was negligent in failing to advise the public, medical
practitioners and pharmacists about other, less risky alternatives for
treatment than Humulin¨ and Humalog¨ or other rDNA human-based insulin or
synthetic human insulins now marketed to the public, because of their
potentially injurious, life threatening side effects to diabetics.
47. Defendant Lilly defectively designed Humulin¨ and Humalog¨ such that
its defective design causes harmful side effects which are potentially life-
threatening to diabetics injecting these drugs.
48. Upon information and belief, Defendant Lilly was negligent in
conducting adequate clinical trials with Humulin¨ or Humalog¨ such that
the
long-term effects of these drugs are not known nor documented
49. The negligent actions and omissions of Lilly were a direct and
proximate cause of PlaintiffsÕ injuries,
WHEREFORE, Plaintiffs seek judgment against defendant Lilly for
compensatory damages, punitive damages, attorneysÕ fees, costs and all
other appropriate relief vs. the Court may deem proper. Additionally,
Plaintiffs seek an injunction from the Court requiring Defendant Lilly to
release its formula for animal based insulin to a domestic drug
manufacturer so that it may produce animal insulin under United States FDA
guidelines.
COUNT IV - PRODUCTS LIABILITY - NOVO NORDISK
50. The Plaintiffs incorporate the prior allegations of this Complaint.
51. Defendant Novo Nordisk was negligent in failing to provide adequate
warnings in its packaging that its rDNA human-based insulin or synthetic
human insulins marketed to the public could result in antibody production,
arthritic syndromes and other potentially injurious, life-threatening
symptoms in diabetic patients.
52. Defendant Novo Nordisk was negligent in failing to provide adequate
warnings to medical facilities and doctors that its rDNA human-based
Insulin or synthetic human insulins marketed to the public could result in
antibody production, arthritic syndromes and other potentially injurious,
life-threatening symptoms In diabetic patients
53. Defendant Novo Nordisk was negligent in falling to advise the public,
medical practitioners and pharmacists about less risky alternatives for
treatment than human based insulins because of the potentially injurious,
life-threatening side effects to diabetics.
54. Defendant Novo Nordisk defectively designed its rDNA human-based
insulin or synthetic human insulin drugs marketed to the public such that
their defective design causes side effects which are potentially life-
threatening to diabetics injecting these drugs.
55. Upon information and belief, Defendant Novo Nordisk was negligent in
conducting adequate clinical trials with its rDNA human-based insulin or
synthetic human insulin drugs now being marketed to the public such that
the Long-term effects of these drugs are not known nor documented.
56. The negligent actions and omissions of Novo Nordisk were a direct and
proximate cause of PlaintiffsÕ injuries.
WHEREFORE, Plaintiffs seek judgment against Novo Nordisk for compensatory
damages, punitive damages, attorneyÕs fees, Costs and all other appropriate
relief the Court deems proper. Additionally, Plaintiffs seek injunction
from the Court requiring Defendant Novo Nordisk to release its formula for
animal based insulin to a domestic drug manufacturer so that it may produce
animal insulin under United States FDA guidelines.
COUNT V - PUNITIVE DAMAGES. - ELI LILLY
57. The Plaintiffs incorporate the prior allegations of this Complaint.
58. Defendant Lilly knew or should have known that Humulin¨, Humalog¨, n-
based insulin or synthetic Insulin would carry with its injection a
potential side effects.
59. Upon information and belief, Defendant Lilly intentionally, recklessly
end suppressed information which would Inform the diabetic public as to
potential injurious side effects which could result from injecting
Humu1in¨, Humalog¨, other rDNA human-based insulin or synthetic human
insulin.
60. Upon information and belief, Defendant Lilly intentionally, recklessly
and maliciously discontinued or significantly reduced the manufacture of
animal-based insulins knowing that diabetics had serious adverse symptoms
from injecting Humulin¨, Humalog¨, other rDNA insulin or synthetic human
Insulin.
61. Upon information and belief, Defendant Lilly has intentionally,
recklessly and maliciously prevented other companies from manufacturing
animal-based insulins knowing that diabetics have adverse symptoms from
injecting Humulin¨, Humalog¨, other rDNA insulin or synthetic human
insulin.
62. Upon information and belief, Defendant Lilly has intentionally,
recklessly and maliciously repressed the flow of relevant medical
information to medical practitioners prescribing Humulin¨, Humalog¨, other
rDNA human-based insulin and synthetic: human Insulin resulting in
prescriptions without proper warnings to patients about possible antibody
production, arthritic syndromes and other injurious, life threatening
symptoms.
63. Upon information and belief, Defendant Lilly has intentionally,
recklessly and maliciously repressed the flow of relevant medical
information to pharmacists filling prescriptions for 1-lumulin¨. Humalog¨,
other rDNA human-based insulin and synthetic human insulin resulting in
prescriptions without proper warnings to patients about possible antibody
production, arthritic syndromes and other potentially injurious, life
threatening symptoms.
64. Upon information and belief, Defendant Lilly has intentionally,
recklessly and maliciously
repressed the flow of relevant medical information such that medical
practitioners and pharmacists are failing to adequately train their
employees as to communicate to diabetics the possible side effects of
antibody production, arthritic syndromes and other potentially injurious,
life-threatening symptoms in diabetic patients who are taking Humulin¨,
Humalog¨, other rDNA human-based insulin or synthetic human insulin.
65. Upon information and belief, Defendant Lilly has intentionally,
recklessly and maliciously repressed the flow of relevant medical
information resulting in a nationwide administration of the potentially
dangerous and life-threatening substances of Humulin¨, Humalog¨, other
rDNA
human-based insulin or synthetic human insulin to diabetic patients.
66. Upon information and belief, Defendant Lilly has intentionally,
recklessly and maliciously repressed the flow of relevant medical
information such that medical practitioners have failed to diagnose and
treat the injuries and side effects which Plaintiffs in this class
sustained as a result of injecting Humulin¨, Humalog¨, other rDNA human-
based insulin or synthetic human insulin.
67. Upon information and belief, Defendant Lilly has intentionally,
recklessly and maliciously failed to implement and supervise adequate
protocols for supervising patients who were prescribed Humulin¨, Humalog¨,
other rDNA human-based insulin or synthetic human insulin for the first
time.
68. Upon information and belief, Defendant Lilly has intentionally,
recklessly and maliciously failed to inform medical practitioners such
relevant medical information to implement and supervise adequate protocols
for supervising patients who were prescribed Humulin¨, Humalog¨, other
rDNA
human-based insulin or synthetic human insulin for the first time.
69. Upon information and belief, Defendant Lilly has intentionally,
recklessly and maliciously failed to provide other, less risky alternatives
tar treatment in full knowledge of the potentially injurious, life-
threatening side effects to diabetics.
70. Upon information and belief, Defendant Lilly paid for, arranged for and
caused a rapid approval from the Federal Drug Administration of Humulin¨ or
Humalog¨ despite having knowledge of tile potential life-threatening side
effects from Humulin¨ and Humalog¨ and despite that long-term effects of
these drugs have not been determined.
71. Upon information and belief, Defendant Lilly conducted inadequate
clinical trials of Humulin¨ and Humalog¨ such the long-term effects of
these drugs are not known nor documented.
72. Upon Information and belief, Defendant Lilly conducted clinical trials
of Humulin¨ and Humalog¨ on human subjects who were known to be chronic
alcohol abusers or chronic drug users, which had the effect of distorting
trial results of these drugs.
73. All Plaintiffs in this class have suffered personal injuries due to the
injections of Humulin¨ Humalog¨, other rDNA human-based insulin or
synthetic insulin and have claims for damages which include hut may not be
limited to pain and suffering, medical expanses, lost wages, loss of range-
or-motion, loss of opportunity, emotional distress, disfigurement, loss of
consortium and death.
74. PlaintiffsÕ injuries have been directly and proximately caused by
Defendant LillyÕs actions and Omissions regarding Humulin¨, Humalog¨
other
rDNA human-based insulin or synthetic insulin.
WHEREFORE, Plaintiffs seek Judgment against Defendant Lilly for
compensatory damages, punitive damages, attorneysÕ fees, costs and all
other appropriate relief as the Court may deem proper. Additionally,
Plaintiffs seek an injunction from the Court requiring Defendant Lilly to
release its formula for animal based Insulin to a domestic drug
manufacturer so that It may produce animal irI3uIin under United States FDA
guidelines.
COUNT VI - PUNITIVE DAMAGES - NOVO NORDISK
75. The Plaintiffs incorporate the prior allegations of this Complaint.
76. Defendant Novo Nordisk knew or should have known that Humulin¨,
Humalog¨, rDNA human-based insulin or synthetic insulins marketed to the
public would carry with its injection a potential for injurious side
effects.
77. Upon information and belief, Defendant Novo Nordisk intentionally,
recklessly and maliciously suppressed information which would inform the
diabetic public as to potential injurious side effects which could result
from injecting Its rDNA human-based insulin or synthetic human insulins
marketed to the pubic.
78. Upon information and belief, Defendant Novo Nordisk intentionally,
recklessly and maliciously discontinued or significantly reduced the
manufacture of animal-based insulins knowing that diabetics had serious
adverse symptoms from injecting its rDNA insulin or synthetic human
insulins marketed to the public.
79. Upon information and belief, Defendant Novo Nordisk has intentionally,
recklessly and maliciously prevented other companies from manufacturing
animal based insulins knowing that diabetics have adverse symptoms from
injecting Its rDNA insulin or synthetic human insulins marketed to the
public.
80. Upon information and belief, Defendant Novo Nordisk has intentionally,
recklessly and maliciously repressed the flow of relevant medical
information to medical practitioners prescribing Humulin¨, Humalog¨, other
rDNA human-based insulin and synthetic human insulins now being marketed to
the Public resulting In prescriptions without proper warnings to patients
about possible antibody production, arthritic syndromes and other
injurious, life-threatening symptoms.
81. Upon information and belief, Defendant Novo Nordisk has intentionally,
recklessly and maliciously repressed the flow of relevant medical
information to pharmacists filling prescriptions for Humulin¨, Humalog¨,
other rDNA human-based insulin and synthetic human insulins marketed to the
pubic resulting in prescriptions; without proper warnings to patients about
possible antibody production, arthritic syndromes and ether potentially
injurious, life-threatening symptoms.
82. Upon information and belief, Defendant Novo Nordisk has intentionally,
recklessly and maliciously repressed the flow of relevant medical
information such that medical practitioners and pharmacists are failing to
adequately train theft employees to communicate to diabetics the possible
side effects of antibody production, arthritic syndromes and other
potentially injurious, tile÷threatening symptoms in diabetic patients who
are taking Humulin¨, Humalog¨ or Novo NordiskÕs rDNA human-based insulin
or
synthetic human insulins.
83. Upon information and belief, defendant Novo Nordisk has intentionally,
recklessly and maliciously repressed the flow of relevant medical
information resulting in n nationwide administration to diabetic patients,
the potentially dangerous and life threatening substances of Humulin¨,
Humalog¨, or Novo NordiskÕs rDNA human-based insulin or synthetic human
insulins.
84. Upon Information and belief, Defendant Novo Nordisk has intentionally,
recklessly and maliciously repressed the flow of relevant medical
information such that medical practitioners have failed to diagnose and
treat the injuries and side effects which Plaintiffs in this class
sustained as a result of injecting Humulin¨, Humalog¨, or Novo NordiskÕs
rDNA human-based insulin or synthetic human insulins.
85. Upon information and belief, Defendant Novo Nordisk has intentionally,
recklessly and maliciously failed to implement and supervise adequate
protocols for supervising patients who for the first time were prescribed
Humulin¨, Humalog¨, or Novo NordiskÕs rDNA human-based insulin or
synthetic
human insulins.
86. Upon Information and belief, Defendant Novo Nordisk has intentionally,
recklessly and maliciously failed to inform medical practitioners such that
they would be aware of relevant medical Information to Implement and
supervise adequate protocols for supervising patients who for the first
time were prescribed Humulin¨, Humalog¨, or Novo NordiskÕs rDNA human-
based
Insulin or synthetic human insulins,
87. Upon information and belief, Defendant Novo Nordisk has intentionally,
recklessly and maliciously failed to provide other, less risky alternatives
for treatment In full knowledge of the potentially injurious, life-
threatening side effects to diabetics from its rDNA human÷based or
synthetic human Insulins.
88. Upon information and belief, Defendant Novo Nordisk has manufactured
produced and distributed us rDNA human-based insulin or synthetic insulin
drugs without knowing the long-term effects of such drugs on diabetic
patients.
89. All Plaintiffs in this class have suffered personal injuries due to
their injecting Humulin¨, Humalog¨ or Novo NordiskÕs rDNA human based
insulin or synthetic insulins and have claims for damages which include but
may not he limited to pain and suffering, medical expenses, lost wages,
loss of range-of-motion, loss of opportunity, emotional distress,
disfigurement, loss of consortium and death.
90. PlaintiffsÕ injuries have been directly and proximately caused by
defendant Novo NordiskÕs actions and omissions regarding Humulin¨,
Humalog¨, other rDNA human-based Insulin or synthetic insulins marketed to
the public.
WHEREFORE, Plaintiffs seek judgment against Defendant Novo Nordisk for
compensatory damages, punitive damages, attorneysÕ fees, costs and all
other appropriate relief as the Court may deem proper. Additionally,
Plaintiffs seek an injunction from the Court requiring Defendant Novo
Nordisk to release Its formula for animal based insulin to a domestic drug
manufacturer so that it may produce animal insulin under United States FDA
guidelines.
Respectfully submitted THE ROEHL LAW FIRM, P.C.
/s/ J. J. Roehl
Jerrald J. Roehl
RenŽ Ostrochovsky
Attorneys for Plaintiffs
300 Central Avenue SWS
Suite 2500
East Albuquerque, New Mexico 87102
Voice: (505) 242-6900
FAX: (505) 242-5903
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| GENET |
| European NGO Network on Genetic Engineering |
| |
| Hartmut MEYER (Mr) |
| Kleine Wiese 6 |
| D - 38116 Braunschweig |
| Germany |
| |
| phone: +49-531-5168746 |
| fax: +49-531-5168747 |
| email: genetnl@xs4all.be |
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