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Gadolinium Attorneys Give History of Nephrogenic Systemic Fibrosis In Gadolinium Lawsuit

Posted in Misc. Drugs

This lawsuit was filed in February of 2009 and gives an excellent history of NSF:

26. This is a personal injury claim relating to Eric Jenkins' development of, and subsequent death from, Nephrogenic Systemic Fibrosis ("NSF"), also known as Nephrogenic Fibrosing Dermopathy ("NFD").

27. NSF/NFD develops only in patients with renal insufficiency, such as Eric Jenkins, who have been given an injection of a gadolinium-based contrast agent such as Magnevist, Omniscan, OptiMARK, and/or upon information and belief, MultiHance and/or ProHance.

28. NSF/NFD is predominantly characterized by discoloration, thickening, tightening, and swelling of the skin within weeks after receiving a gadolinium -based contrast injection such as Magnevist, Omiscan, OptiMARK and/or upon information and belief, MultiHance and/or ProHance.

29. These symptoms can occur weeks or months after a person is administered these dyes.

30. These fibrotic and edematous changes produce muscular weakness and inhibit flexion and extension of joints, resulting in painful and disfiguring contractures.

31. NSF/NFD often progresses to painful inhibition of the ability to use the arms, legs, hands, feet, and other joints.

32. The skin changes that begin as darkened patches or plaques progress to a "woody" texture, and are accompanied by burning, itching, or severe pain in the areas of involvement.

33. NSF/NFD also progresses to a fibrotic or scarring condition of other body organs such as the lungs, heart, liver, and musculature, and that can inhibit their ability to function properly and may lead to death.

34. NSF/NFD is a progressive disease for which there is no known cure.

35. NSF/NFD has been reported in medical literature since 2000.

36. It has always been the case that this clinical entity now known as NSF/NFD develops in patients with renal insufficiency, who have been given an injection of gadolinium-based contrast agent such as Omniscan, Magnevist, OptiMARK, MultiHance, and/or ProHance.


United States District Court, D. Colorado.

  Allison JENKINS, as widow and Executor of the Estate of Eric Jenkins, Plaintiff,

v.

  GENERAL ELECTRIC COMPANY; GE Healthcare, Inc.; GE Healthcare As; Bayer Healthcare
  Pharmaceuticals, Inc, f/ka Berlex, Inc., f/k/a Berex Laboratories, Inc. Bayer AG;
 Bayer Schering Pharma AG f/k/a Schering AG; Mallinckrodt, Inc.; Bracco Diagnostics
    Inc.; Bracco Research USA, Inc.; Altana Pharma AG; and Nycomed International
  Management GMBH.

   No. 109CV00312.

February 13, 2009.

  Complaint and Jury Demand

Peter W. Burg, Jeffrey D. Pederson, Burg Simpson, Eldredge Hersh & Jardine, P.C.,
40 Inverness Drive East, Englewood, Colorado, 80112, Telephone: (303) 792-5595,
Facsimile: (303) 708-0527, Attorneys for the Plaintiff

Plaintiff, by and through her counsel, BURG SIMPSON ELDREDGE HERSH & JARDINE,
P.C., and for her Complaint against Defendants, alleges as follows:

   PARTIES

1. Allison Jenkins is the widow and Executor of the Estate of Eric Jenkins, whose
last address was

2. Defendant General Electric Company is a New York Corporation with its principal
place of business at 3135 Easton Turnpike, Fairfield, Connecticut 06431. Defendant
General Electric Company is a resident of both New York and Connecticut. Defendant
General Electric Company is the parent company of Defendant GE Healthcare AS and
GE Healthcare, Inc.

3. Defendant GE Healthcare AS is a Norwegian corporation with its principal place
of business in the Kingdom of Norway. Defendant GE Healthcare AS is a subsidiary
of General Electric Company. Omniscan's package insert/prescribing information
identifies the putative manufacturer of Omniscan as GE Healthcare AS.

4. Defendant GE Healthcare, Inc. is a Delaware corporation with its principal
place of business at 101 Carnegie Center, Princeton, New Jersey 08540.

5. Defendant GE Healthcare, Inc. is a resident and citizen of both Delaware and
New Jersey.

6. Defendant GE Healthcare, Inc. is a subsidiary of General Electric Company.
Omniscan's package insert identifies the putative distributor of Omniscan as GE
Healthcare, Inc.

7. Defendants General Electric Company, GE Healthcare, Inc., and GE Healthcare AS
will be collectively referred to in this Complaint as the "GE Defendants."

8. Defendant Bayer Healthcare Pharmaceuticals, Inc. f/k/a/ Berlex, Inc. f/k/a
Berlex Laboratories, Inc., is a Delaware corporation with its principal place of
business at 6 West Belt, Wayne, New Jersey 07470.

9. Defendant Bayer Healthcare Pharmaceuticals, Inc. is a resident and citizen of
both Delaware and New Jersey. Defendant Bayer Healthcare Pharmaceuticals, Inc.
f/k/a/ Berlex, Inc. f/k/a Berlex Laboratories, Inc. is a division of Bayer AG.

10. Defendant Bayer AG is a company domiciled in Germany and is the parent/holding
company of both Bayer Healthcare Pharmaceuticals, Inc. and Bayer Schering Pharma
AG.

11. On April 4, 2007, Berlex, Inc. f/k/a Berlex Laboratories, Inc. changed its
name to Bayer Healthcare Pharmaceuticals, Inc.

12. Therefore, Defendant Bayer Healthcare Pharmaceuticals, Inc. is a corporate
successor to Berlex, Inc. f/k/a Berlex Laboratories, Inc. and, as such, is
obligated for its predecessor's liabilities.

13. Defendant Bayer Schering Pharma AG is a foreign company domiciled in Germany.
Bayer Schering Pharma AG is a corporate successor to Schering AG. Schering AG was
renamed Bayer Schering Pharma AG effective December 29, 2006.

14. Defendants Bayer Healthcare Pharmaceuticals, Inc., Bayer AG, Bayer Schering
Pharma AG will be collectively referred to in this Complaint as the "Bayer
Defendants."

15. Defendant Mallinckrodt, Inc. ("Defendant Mallinckrodt") is a Delaware
corporation with its principal place of business at 675 McDonnell Blvd., St.
Louis, Missouri 63042. Defendant Mallinckrodt is a resident and citizen of both
Delaware and Missouri. Defendant Mallinckrodt is a subsidiary of Tyco Healthcare
Group LP.

16. Defendant Bracco Diagnostics Inc. is a Delaware corporation with its principal
place of business in Princeton, New Jersey.

17. Defendant Bracco Research USA, Inc. is a Delaware corporation, with its
principal place of business in Princeton, New Jersey.

18. Upon information and belief, Defendant ALTANA Pharma AG is a German company
with its principal place of business in Germany.

19. Defendant ALTANA Pharma AG manufactured MultiHance and/or ProHance for Bracco
Diagnostics Inc.

20. Defendant Nycomed International Management GmbH ("Nycomed") is a Swiss company
domiciled in Switzerland. Defendant Nycomed bought ALTANA Pharma AG in 2006.

21. Defendant Nycomed is corporate successor to ALTANA Pharma AG and, as such, is
obligated for its predecessor's liabilities.

22. Defendants Bracco Diagnostics Inc., Bracco Research USA, Inc., ALTANA Pharma
AG and Nycomed will be collectively referred to in this Complaint and Jury Demand
as the "Bracco Defendants."

   JURISDICTION AND VENUE

23. This Court has jurisdiction over this action pursuant to 28 U.S.C. s 1332
because there is complete diversity of citizenship between the parties, and the
amount in controversy exceeds $75,000.00, exclusive of interest and costs.

24. The Court has personal jurisdiction over Defendants consistent with the laws
of the State of Colorado and the United States Constitution because Defendants
caused tortious injury in the State of Colorado by an act or omission outside the
State of Colorado by virtue of Defendants' regularly conducted business in the
State of Colorado from which they derive substantial revenue.

25. Venue in this district is appropriate under 28 U.S.C. s 1391 because a
substantial part of the events giving rise to this claim occurred in the district
as Eric Jenkins was administered the offending contrast dye at St. Anthony's
Hospital in Denver, Colorado in this district and acts and omissions occurred as
the result of the administration of that contrast dye.

GENERAL ALLEGATIONS

26. This is a personal injury claim relating to Eric Jenkins' development of, and
subsequent death from, Nephrogenic Systemic Fibrosis ("NSF"), also known as
Nephrogenic Fibrosing Dermopathy ("NFD").

27. NSF/NFD develops only in patients with renal insufficiency, such as Eric
Jenkins, who have been given an injection of a gadolinium-based contrast agent
such as Magnevist, Omniscan, OptiMARK, and/or upon information and belief,
MultiHance and/or ProHance.

28. NSF/NFD is predominantly characterized by discoloration, thickening,
tightening, and swelling of the skin within weeks after receiving a gadolinium
-based contrast injection such as Magnevist, Omiscan, OptiMARK and/or upon
information and belief, MultiHance and/or ProHance.

29. These symptoms can occur weeks or months after a person is administered these
dyes.

30. These fibrotic and edematous changes produce muscular weakness and inhibit
flexion and extension of joints, resulting in painful and disfiguring
contractures.

31. NSF/NFD often progresses to painful inhibition of the ability to use the arms,
legs, hands, feet, and other joints.

32. The skin changes that begin as darkened patches or plaques progress to a
"woody" texture, and are accompanied by burning, itching, or severe pain in the
areas of involvement.

33. NSF/NFD also progresses to a fibrotic or scarring condition of other body
organs such as the lungs, heart, liver, and musculature, and that can inhibit
their ability to function properly and may lead to death.

34. NSF/NFD is a progressive disease for which there is no known cure.

35. NSF/NFD has been reported in medical literature since 2000.

36. It has always been the case that this clinical entity now known as NSF/NFD
develops in patients with renal insufficiency, who have been given an injection of
gadolinium-based contrast agent such as Omniscan, Magnevist, OptiMARK, MultiHance,
and/or ProHance.

   Omniscan and the GE Defendants

37. Omniscan is an injectable paramagnetic contrast agent for magnetic resonance
imaging and arteriography.

38. Omniscan contains the metal gadolinium, which is highly toxic in its free
state.

39. Omniscan, the chemical name of which is gadolinium diethylenetriamine
pentaacetic acid bismethylamide (gadodiamide), is represented by the GE Defendants
to be safely and effectively indicated for intravenous administration to
facilitate the visualization of lesions with abnormal vascularity.

40. Omniscan is cleared from the body solely by glomerular filtration in the
kidneys.

41. As a result, Omniscan has a prolonged half-life in patients with renal
insufficiency and who, therefore, are at increased risk for adverse health effects
in connection with Omniscan administration.

42. Omniscan was originally developed by Salutar, Inc. which then conducted
pre-clinical testing with Sterling Winthrop and Daiichi Pharmaceuticals.

43. Salutar was subsequently acquired by Nycomed.

44. In 1994, Nycomed acquired Sterling Winthrop's diagnostic imaging business.

45. In 1997, Nycomed acquired Amersham International plc, and the new company was
named Amersham plc, which then held the rights to Omniscan.

46. In 2004, General Electric Company acquired Amersham plc and the rights to
Omniscan.

47. At the time of the acquisition, Amersham plc was the ultimate parent company
of Amersham Health AS, which manufactured the Omniscan that was distributed and
sold in the United States, and Amersham Health Inc., which distributed and sold
Omniscan in the United States.

48. In 2006, Amersham Health AS was renamed GE Healthcare AS, and Amersham Health,
Inc. was renamed GE Healthcare, Inc.

49. Defendants General Electric Company, GE Healthcare AS, and GE Healthcare, Inc.
are corporate successors to Amersham plc and its related entities, and, as such,
are obligated for their predecessors' liabilities.

50. Amersham plc, either itself or by and through its subsidiaries, was engaged in
the business of designing, licensing, manufacturing, distributing, selling,
marketing, and/or introducing into United States interstate commerce, directly and
indirectly through third parties or related entities, the drug Omniscan.

51. Omniscan is identified by General Electric Company in its packaging that it is
a product of "GE Healthcare," which is a unit/division of General Electric
Company.

52. "GE Healthcare" is prominently identified on the Omniscan
packaging/prescribing information, alongside the "GE" monogram.

53. Omniscan is identified as a trademark of GE Healthcare.

54. "GE" and the GE monogram are trademarks of the General Electric Company.

55. The GE Healthcare website, which includes detailed product information
concerning Omniscan, is copyrighted by General Electric Company.

56. General Electric Company has acknowledged in deposition testimony that GE
Healthcare is not a separate entity from General Electric Company and that GE
Healthcare is a unit of the General Electric Company that is responsible for
Omniscan.

57. Subsidiaries obtaining revenue from the production and sale of Omniscan held
revenue in a "lock box" and passed the revenue on to the General Electric Company.

58. General Electric Company does business as GE Healthcare, including the
business of designing, licensing, manufacturing, distributing, selling, marketing,
and/or introducing into United States interstate commerce the drug Omniscan.

59. General Electric Company does business as GE Healthcare, including the
business of designing, licensing, manufacturing, distributing, selling, marketing,
and/or introducing into United States interstate commerce, the drug Omniscan.

60. At all times relevant, the GE Defendants, and/or their corporate predecessors,
were engaged in the business of designing, licensing, manufacturing, distributing,
selling, marketing, and/or introducing into the stream of commerce, directly and
indirectly through third parties or related entities, the drug Omniscan.

61. Upon information and belief and at the relevant times, Omniscan was
distributed and sold in the United States, and the State of Colorado, by the GE
Defendants.

Magnevist and the Bayer Defendants

62. Magnevist is an injectable paramagnetic contrast agent used for magnetic
resonance imaging and arteriography.

63. Magnevist is a patented, proprietary formulation that contains the metal
gadolinium, which is highly toxic in its free state.

64. Magnevist, the chemical name of which is gadopentetate dimeglumine, is
chemically distinct from other gadolinium-based contrast agents in that it more
easily permits the release of toxic free gadolinium under expected physiologic
conditions in patients with renal insufficiency who received it.

65. Magnevist (gadopentetate dimeglumine) is cleared from the body solely by
glomerular filtration in the kidneys.

66. As a result, Magnevist has a prolonged half-life in patients with renal
insufficiency.

67. Patients with renal insufficiency, therefore, are at increased risk for
adverse health effects in connection with Magnevist (gadopentetate dimeglumine)
administration.

68. Berlex obtained FDA approval of its New Drug Application (App. No. 019596) for
Magnevist (gadopentetate dimeglumine) on June 2, 1988.

69. In 2006, Bayer AG, which has its legal domicile in Berlin, completed its
acquisition of Schering, AG.

70. Berlex was a U.S. affiliate of Schering, AG.

71. Bayer AG is a holding company that owns and operates Defendant Bayer
Healthcare Pharmaceuticals, Inc.

72. At all times relevant hereto, the Bayer Defendants knew or should have known
about the significant health risk of Magnevist (gadopentetate dimeglumine)
administration to patients with renal insufficiency including, but not limited to,
the risk of nephrogenic fibrosis in the skin and other body organs.

73. At all times relevant hereto, the Bayer Defendants knew or should have known
that their product, Magnevist, was not reasonably fit, suitable or safe for its
intended purpose, and specifically, that it was defective and unsafe for use in
patients with renal insufficiency such as Eric Jenkins, and knew or should have
known that the gadolinium contained in its product is highly toxic to humans.

74. Further, at all times relevant hereto, the Bayer Defendants knew or should
have known about the significant health risk of Magnevist administration to
patients with renal insufficiency, including, but not limited to, the risk of
toxic gadolinium being released into the bodies of those patients, causing severe
and permanent physical injury.

75. The Bayer Defendants knew or should have known of the need to prevent the
gadolinium contained in its product from becoming free in the body of humans
injected with Magnevist through the use of, among other things, proper design,
testing, and manufacturing.

76. At all times relevant hereto, the Bayer Defendants knew or should have known
that there were safer, alternative designs for paramagnetic contrast agents that
would prevent or minimize the risk of gadolinium becoming free in the bodies of
humans.

77. Notwithstanding their knowledge of the unreasonable dangers associated with
Magnevist, this product was represented by the Bayer Defendants to be safely and
effectively indicated for intravenous administration to facilitate the
visualization of cranial and spinal anatomy, as well as tumors, lesions, and
immediately adjacent areas.

78. Magnevist was further represented by the Bayer Defendants to be superior to
two of its competitors (Omniscan and OptiMARK) in its thermodynamic and
conditional stability, its low volume of excess chelate, and its ability to
prevent the release of gadolinium.

79. At all times relevant, the Bayer Defendants and/or their corporate
predecessors, were engaged in the business of designing, licensing, manufacturing,
distributing, selling, marketing, and/or introducing into the stream of commerce,
directly and indirectly through third parties or related entities, the
prescription drug Magnevist.

80. At all times relevant, the Bayer Defendants were engaged in the business of
designing, licensing, manufacturing, distributing, selling, marketing, and/or
introducing into interstate commerce, and into the State of Texas, either directly
or indirectly through third parties or related entities, the diagnostic agent
Magnevist.

   OptiMARK and Mallinckrodt, Inc.

81. OptiMARK is an injectable paramagnetic contrast agent used for magnetic
resonance imaging and arteriography.

82. OptiMARK contains the metal gadolinium, which is highly toxic in its free
state.

83. OptiMARK, the chemical name of which is gadolinium diethylenetriamine
pentaacetic acid bismethoxyethylamide (gadoversetamide), is represented by the
Defendant Mallinckrodt to be safely and effectively indicated for intravenous
administration to facilitate the visualization of lesions with abnormal
vascularity.

84. At all times relevant, Defendant Mallinckrodt was engaged in the business of
designing, licensing, manufacturing, distributing, selling, marketing, and/or
introducing into interstate commerce, either directly or indirectly through third
parties or related entities, the diagnostic agent OptiMARK.

   MultiHance, ProHance and the Bracco Defendants

85. MultiHance and ProHance are injectable paramagnetic contrast agents for
magnetic resonance imaging and arteriography.

86. MultiHance and Prohance contain the metal gadolinium, which is highly toxic in
its free state.

87. Upon information and belief, MultiHance and ProHance were represented by the
Bracco Defendants to be safely and effectively indicated for intravenous
administration to facilitate visualization of lesions with abnormal blood brain
barrier or abnormal vascularity of the brain, spine, and associated tissues.

88. At all times relevant, the Bracco Defendants were engaged in the business of
designing, licensing, manufacturing, distributing, selling, marketing, and/or
introducing into interstate commerce, either directly or indirectly through third
parties or related entities, the diagnostic agents MultiHance and ProHance.

89. At all times relevant hereto, the Defendants knew or should have known about
the significant health risk of their products' administration to patients with
renal insufficiency, including, but not limited to, the risk of nephrogenic
fibrosis in the skin and other body organs.

   All Defendants

90. At all times relevant hereto, Defendants knew or should have known that, in
its free state, gadolinium is highly toxic, harmful and dangerous to humans, and
causes severe physical injury and knew or should have known of the need to prevent
the gadolinium contained in its product from becoming free in the body of humans
injected with Omniscan, Magnevist, OptiMARK, and/or, upon information and belief,
MultiHance and/or ProHance, through the use of, among other things, proper design,
testing, and manufacturing.

91. At all relevant times, Defendants knew or should have known that there were
safer, alternative designs for paramagnetic contrast agents that would prevent or
minimize the risk of gadolinium becoming free in the bodies of humans and knew or
should have known of safer, alternative designs for imaging systems, like those
used by other leading MRI systems manufacturers, that do not use gadolinium-based
contrast agents, which would provide a safer imaging alternative for the public,
including Eric Jenkins.

92. At all times relevant hereto, Defendants knew or should have known that their
respective products, Omniscan, Magnevist, OptiMARK and/or upon information and
belief, MultiHance and/or ProHance, were not reasonably fit, suitable or safe for
their intended purpose and, specifically, that they were defective and unsafe for
use in patients with renal insufficiency, such as Eric Jenkins, and knew or should
have known that the gadolinium contained in its product is highly toxic to humans,
and knew or should have known about the significant health risk of administration
of these products to patients with renal insufficiency, including, but not limited
to, the risk of toxic gadolinium being released into the bodies of those patients,
causing severe physical injury.

93. The condition of these products is one that would not be reasonably
contemplated by an ordinary consumer.

94. The GE, Bayer, Mallinckrodt, and upon information and belief, Bracco
Defendants consistently failed to warn consumers and/or their health care
providers that severe, even fatal, injuries could result when their dyes are
administered to patients with renal insufficiency.

95. During the years that the Defendants manufactured, marketed, and sold their
respective products, there were numerous case reports, studies, assessments,
papers, and other relevant experimental and clinical data that have described
and/or demonstrated dissociation and transmetallation in connection with the use
of certain gadolinium-based contrast agents.

96. Despite this, the GE, Bayer, Mallinckrodt and, upon information and belief,
Bracco Defendants repeatedly failed to adequately revise their package inserts,
Material Safety Data Sheets, and other product-related literature, and to conduct
appropriate post-marketing communications in order to convey adequate warnings.

97. The GE, Bayer, Mallinckrodt, and upon information and belief, Bracco
Defendants repeatedly and consistently failed to advise consumers and/or their
health care providers of the propensity of their products to undergo dissociation
and transmetallation in vivo and of the causal relationship between certain
gadolinium contrast dye and the development of NSF/NFD in patients with renal
insufficiency.

98. Eric Jenkins suffered from renal insufficiency at all relevant times herein.

99. Eric Jenkins was exposed to the gadolinium-containing contrast dyes, upon
information and belief, Omniscan, Magnevist, OptiMARK, ProHance and/or MultiHance,
during imaging procedures in 2003 through the time of his death.

100. After being administered, upon information and belief, Omniscan, Magnevist,
OptiMARK, MultiHance and/or ProHance, gadolinium was released into Mr. Jenkins'
body.

101. In November 2005, Eric Jenkins began to experience severe pain from what
would ultimately be known as NSF, and suffered from debilitating and worsening
fibrotic changes to his body as a result of contracting NSF/NFD.

102. Eric Jenkins died on August 31, 2007 in Austin, Texas as the result of
complications from NSF.

103. Eric Jenkins was not diagnosed with NSF/NFD until after his death and no
physician ever informed Eric Jenkins that his illness was the result of exposure
to gadolinium.

104. In fact, the connection was not known by the scientific community, other than
those in the Defendants employ, until the FDA issued a black box warning in May
2007.

105. As a direct and proximate result of being administered Omniscan, Magnevist,
OptiMARK, MultiHance, and/or ProHance in the context of his renal insufficiency,
Eric Jenkins suffered serious, progressive, permanent, incurable, and fatal
injuries.

106. As a direct and proximate result of being administered Omniscan, Magnevist,
OptiMARK, MultiHance, and/or ProHance, Eric Jenkins sustained injuries and damages
including, but not limited to, physical injury, bodily impairment, loss of
enjoyment of life, disfigurement and scarring, severe and debilitating physical
and emotional pain and distress, severely limited mobility, and, ultimately,
death.

107. Eric Jenkins' spouse has also suffered loss of companionship, care and
treatment, consortium, community, support, economic damages and all other damages
recoverable by a spouse in the State of Colorado.

108. The Defendants, upon information and belief, have, or may have, failed to
comply with all federal standards and requirements applicable to the sale of their
prescription drugs, Omniscan, Magnevist, OptiMARK, MultiHance and ProHance,
including, but not limited to, one or more of the following violations:

a. The Defendants' prescription drugs are adulterated pursuant to 21 U.S.C. s 351
because, among other things, they fail to meet established performance standards,
and/or the methods, facilities, or controls used for their manufacture, packing,
storage or installation are not in conformity with federal requirements;

b. The Defendants' prescription drugs are adulterated pursuant to 21 U.S.C. s 351
because, among other things, their strength differs from or their quality or
purity falls below the standard set forth in the official compendium for the
drugs, and such deviation is not plainly stated on their labels;

c. The Defendants' prescription drugs are misbranded pursuant to 21 U.S.C. s352
because, among other things, their labeling is false or misleading;

d. The Defendants' prescription drugs are misbranded pursuant to 21 U.S.C. s352
because words, statements, or other information required by or under authority of
chapter 21 U.S.C. s 352 are not prominently placed thereon with such
conspicuousness and in such terms as to render them likely to be read and
understood by the ordinary individual under customary conditions of purchase and
use;

e. The Defendants' prescription drugs are misbranded pursuant to 21 U.S.C. s352
because the labeling does not bear adequate directions for use, and/or the
labeling does not bear adequate warnings against use in those pathological
conditions or by children where their use may be dangerous to health or against
unsafe dosage or methods or duration of administration or application in such
manner and form as are necessary for the protection of users;

f. The Defendants' prescription drugs are misbranded pursuant to 21 U.S.C. s352
because they are dangerous to health when used in the dosage or manner, or with
the frequency or duration prescribed, recommended, or suggested in the labeling
thereof;

g. The Defendants' prescription drugs do not contain adequate directions for use
pursuant to 21 CFR s 201.5, because, among other reasons, of omission, in whole or
in part, or incorrect specification of (a) statements of all conditions, purposes,
or uses for which they are intended, including conditions, purposes, or uses for
which they are prescribed, recommended or suggested in their oral, written,
printed, or graphic advertising, and conditions, purposes, or uses for which the
drugs are commonly used, (b) quantity of dose, including usual quantities for each
of the uses for which they are intended and usual quantities for persons of
different ages and different physical conditions, (c) frequency of administration
or application, (d) duration or administration or application, and/or (d) route or
method of administration or application;

h. The Defendants violated 21 CFR s 201.56 because the labeling was not
informative and accurate;

i. The Defendants' prescription drugs are misbranded pursuant to 21 CFR s 201.56
because the labeling was not updated as new information became available that
caused the labeling to become inaccurate, false, or misleading;

j. The Defendants violated 21 CFR s 201.57 by failing to provide information that
is important to the safe and effective use of the drugs, including degree and rate
of absorption, pathways of biotransformation, percentage of dosage as unchanged
drug and metabolites, rate or half-time of elimination, concentration in body
fluids associated with therapeutic and/or toxic effects, degree of binding to
plasma proteins, and/or the degree of update by a particular organ;

k. The Defendants violated 21 CFR s 201.57 because evidence was only available to
support the safety and effectiveness of the drugs in selected subgroups of the
larger population with a disease, syndrome, or symptom and the labeling failed to
describe the available evidence and state the limitations of usefulness of the
drugs;

1. The Defendants violated 21 CFR s 201.57 because they failed to identify
specific tests needed for selection or monitoring of patients who took the
prescription drugs;

m. The Defendants violated 21 CFR s 201.57 because the safety considerations
regarding the prescription drugs are such that the drugs should be reserved for
certain situations, and the Defendants failed to state such information;

n. The Defendants' prescription drugs are mislabeled pursuant to 21 CFR s 201.57
because the labeling fails to describe serious adverse reactions and potential
safety hazards, limitations in use imposed by them, and steps that should be taken
if they occur;

o. The Defendants' prescription drugs are mislabeled pursuant to 21 CFR s 201.57
because the labeling was not revised to include a warning as soon as there was
reasonable evidence of an association of a serious hazard with the drug;

p. The Defendants violated 21 CFR s 201.57 because the labeling failed to list the
adverse reactions that occur with the prescription drugs and other drugs in the
same pharmacologically active and chemically related class;

q. The Defendants violated 21 CFR s 201.57 because the possibility that a patient
could develop NSF/NFD is significantly more severe than the other reactions listed
in the adverse reactions, and, yet, the Defendants failed to list the development
of NSF/NFD before the other adverse reactions on the labeling of the prescription
drugs;

r. The Defendants' prescription drugs are mislabeled pursuant to 21 CFR s 201.57
because the labeling does not state the recommended usual dose, the usual dosage
range, and, if appropriate, an upper limit beyond which safety and effectiveness
have not been established;

s. The Defendants' prescription drugs violate 21 CFR s 210.1 because the process
by which they are manufactured, processed, and/or held fails to meet the minimum
current good manufacturing practice of methods to be used in, and the facilities
and controls to be used for, the manufacture, packing, or holding of a drug to
assure that they meet the requirements as to safety and have the identity and
strength and meets the quality and purity characteristic that they purport or are
represented to possess;

t. The Defendants' prescription drugs violate 21 CFR s 210.122 because the
labeling and packaging materials do not meet the appropriate specifications;

u. The Defendants' prescription drugs violate 21 CFR s 211.165 because the test
methods employed by the Defendants are not accurate, sensitive, specific, and/or
reproducible and/or such accuracy, sensitivity, specificity, and/or
reproducibility of test methods have not been properly established and documented;

v. The Defendants' prescription drugs violate 21 CFR s 211.165 in that the
prescription drugs fail to meet established standards or specifications and any
other relevant quality control criteria;

w. The Defendants' prescription drugs violate 21 CFR s 211.198 because the written
procedures describing the handling of all written and oral complaints regarding
the prescription drugs were not followed;

x. The Defendants' prescription drugs violate 21 CFR s 310.303 in that the
prescription drugs are not safe and effective for their intended use;

y. The Defendants violated 21 CFR s 310.303 because the Defendants failed to
establish and maintain records and make reports related to clinical experience or
other data or information necessary to make or facilitate a determination of
whether there are, or may be grounds for, suspending or withdrawing approval of
the application to the FDA;

z. The Defendants violated 21 CFR ss310.305 and 314.80 by failing to report
adverse events associated with the prescription drugs as soon as possible, or at
least within 15 days of the initial receipt by the Defendants, of the adverse drug
experience;

aa. The Defendants violated 21 CFR ss310.305 and 314.80 by failing to conduct an
investigation of each adverse event associated with the prescription drugs and
evaluating the cause of the adverse event;

bb. The Defendants violated 21 CFR ss310.305 and 314.80 by failing to promptly
investigate all serious, unexpected adverse drug experiences and submit follow-up
reports within the prescribed 15 calendar days of receipt of new information, or
as requested by the FDA;

cc. The Defendants violated 21 CFR ss310.305 and 314.80 by failing to keep records
of the unsuccessful steps taken to seek additional information regarding serious,
unexpected adverse drug experiences;

dd. The Defendants violated 21 CFR ss310.305 and 314.80 by failing to identify the
reports they submitted properly, such as by labeling them as "15-day Alert
report," or "15-day Alert report follow-up;"

ee. The Defendants violated 21 CFR s 312.32 because they failed to review all
information relevant to the safety of the prescription drugs or otherwise received
by the Defendants from sources, foreign or domestic, including information derived
from any clinical or epidemiological investigations, animal investigations,
commercial marketing experience, reports in the scientific literature, and
unpublished scientific papers, as well as reports from foreign regulatory
authorities that have not already been previously reported to the agency by the
sponsor;

ff. The Defendants violated 21 CFR s 312.32 because they failed to notify the FDA
in a written IND safety report of the adverse experiences associated with the use
of the prescription drugs that were serious and unexpected;

gg. The Defendants violated 21 CFR s 314.80 by failing to report adverse drug
experiences at quarterly intervals for three (3) years from the date of approval
of the application, and then at annual intervals;

hh. The Defendants violated 21 CFR s 314.80 by failing to provide periodic reports
to the FDA containing (a) a narrative summary and analysis of the information in
the report and an analysis of the 15-day Alert reports submitted during the
reporting interval, (b) an Adverse Reaction Report for each adverse drug
experience not already reported under the post marketing 15-day Alert report,
and/or (c) a history of actions taken since the last report because of adverse
drug experiences (for example, labeling changes or studies initiated); and

ii. The Defendants violated 21 CFR s 314.80 by failing to submit a copy of the
published article from scientific or medical journals along with one or more
15-day Alert reports based on information from the scientific literature.

    FIRST CAUSE OF ACTION Strict Products Liability-Defective Manufacturing: ALL
DEFENDANTS

109. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

110. The GE Defendants are the manufacturers, designers, distributors, sellers,
and/or suppliers of Omniscan.

111. Defendant Mallinckrodt is the manufacturer, designer, distributor, seller,
and/or supplier of OptiMARK.

112. The Bracco Defendants are the manufacturers, designers, distributors,
sellers, and/or suppliers of MultiHance and ProHance.

113. The Bayer Defendants are the manufacturers, designers, distributors, sellers,
and/or suppliers of Magnevist.

114. Omniscan, OptiMARK, Magnevist, and upon information and belief, MultiHance
and ProHance, are diagnostic agents manufactured, designed, sold, distributed,
supplied and/or, placed in the stream of commerce by Defendants, and were
unreasonably dangerous and defective in their manufacture and construction when
they left the hands of Defendants in that they deviated from product
specifications, posing a serious risk of injury and death.

115. As a direct and proximate result of Eric Jenkins being administered Omniscan,
OptiMARK, Magnevist, and/or upon information and belief, MultiHance and ProHance,
as manufactured, designed, sold, supplied and introduced into the stream of
commerce by Defendants, Eric Jenkins suffered serious physical injury, death,
damages and economic loss from the use the contrast in question without the
contrast undergoing substantial change.

   SECOND CAUSE OF ACTION Strict Products Liability-Design Defect: ALL DEFENDANTS

116. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

117. The Omniscan, OptiMARK, Magnevist, and upon information and belief,
MultiHance and ProHance diagnostic agents manufactured and supplied by Defendants
were unreasonably dangerous and defective in design or formulation in that, when
they left the hands of the Defendants, the foreseeable risks of the products
exceeded the benefits associated with their design or formulation, or they were
more dangerous than an ordinary consumer would expect.

118. The foreseeable risks associated with the design or formulation of Omniscan,
OptiMARK, Magnevist, and upon information and belief, MultiHance and ProHance,
include, but are not limited to, the fact that the design or formulation of
Omniscan, OptiMARK, Magnevist, and upon information and belief, MultiHance and
ProHance, are more dangerous than a reasonably prudent consumer would expect when
used in an intended or reasonably foreseeable manner.

119. Defendants knew or should have known that there were safer, alternative
designs for paramagnetic contrast agents, including non linear designs, that would
prevent or minimize the risk of gadolinium becoming free in the bodies of humans
and knew or should have known that there were safer, reasonable alternative
designs for imaging systems, like those used by other leading MRI systems
manufacturers, that do not use gadolinium based contrast agents, which would
provide a safer imaging alternative for the public, including Eric Jenkins.

120. As a direct and proximate result of Eric Jenkins being administered Omniscan,
OptiMARK, Magnevist, and/or, upon information and belief, MultiHance and ProHance,
as manufactured, designed, sold, supplied and introduced into the stream of
commerce by Defendants, Eric Jenkins suffered serious physical injury, death,
damages and economic loss.

 THIRD CAUSE OF ACTION Strict Products Liability– Defect Due to Inadequate Warning
   ALL DEFENDANTS

121. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

122. The Omniscan, OptiMARK, Magnevist, and upon information and belief,
MultiHance and ProHance, manufactured and supplied by the GE Defendants, Defendant
Mallinckrodt, Bayer Defendants, and Bracco Defendants respectively, were defective
due to inadequate warning or instruction because Defendants had a duty to warn of
defects and knew or should have known that their products created significant
risks of serious bodily harm and death to consumers and they failed to adequately
warn persons who were administered these products and/or their health care
providers of such risks.

123. The Omniscan, OptiMARK, Magnevist, and upon information and belief,
MultiHance and ProHance, diagnostic agents manufactured and supplied by Defendants
were defective due to inadequate post-marketing warning or instruction because,
after Defendants knew or should have known of the risk of serious bodily harm and
death from the administration of Omniscan, OptiMARK, Magnevist, and/or, upon
information and belief, MultiHance and ProHance, Defendants failed to provide an
adequate warning to users of these products and/or their health care providers,
knowing the products could cause serious injury and death.

124. As a direct and proximate result of Eric Jenkins being administered Omniscan,
OptiMARK, Magnevist, and/or, upon information and belief, MultiHance and ProHance,
as manufactured, designed, sold, supplied and introduced into the stream of
commerce by the Defendants, Eric Jenkins suffered serious physical injury, death,
damages and economic loss.

   FOURTH CAUSE OF ACTION Strict Products Liability – Defect due to Nonconformance
with Representations ALL DEFENDANTS

125. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

126. The GE Defendants, Defendant Mallinckrodt, Bayer Defendants and Bracco
Defendants made representations regarding the character or quality of Omniscan,
OptiMARK, Magnevist, MultiHance and ProHance, including representations that the
Omniscan, OptiMARK, Magnevist, MultiHance and ProHance diagnostic agents were
safe.

127. The Omniscan, OptiMARK, Magnevist, and upon information and belief,
MultiHance and ProHance, diagnostic agents manufactured and supplied by Defendants
were defective in that, when they left the hands of Defendants, they did not
conform to representations made by Defendants concerning their products.

128. Eric Jenkins, and/or, Eric Jenkins's health care providers justifiably relied
upon Defendants' representations regarding the Omniscan, OptiMARK, Magnevist
and/or, upon information and belief, MultiHance and ProHance, diagnostic agents at
the time those products were administered to him*

129. As a direct and proximate result of Eric Jenkins being administered Omniscan,
OptiMARK, Magnevist, and/or, upon information and belief, MultiHance and ProHance
as manufactured, designed, sold, supplied and introduced into the stream of
commerce by Defendants, Eric Jenkins suffered serious physical injury, death,
damages and economic loss.

  FIFTH CAUSE OF ACTION Strict Products Liability–Defect Due to Failure to
   Adequately Test ALL DEFENDANTS

130. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

131. Defendants advised consumers and the medical community that Omniscan,
OptiMARK, Magnevist, and upon information and belief, MultiHance and ProHance were
safe for use. Defendants failed to adequately test Omniscan, OptiMARK, Magnevist,
and upon information and belief, MultiHance and ProHance, with respect to their
use by consumers with renal insufficiency.

132. Had Defendants adequately tested the safety of Omniscan, OptiMARK, Magnevist,
and upon information and belief, MultiHance and ProHance, for use by consumers
with renal insufficiency and disclosed those results to the medical community or
the public, Eric Jenkins would not have been administered Omniscan, OptiMARK,
Magnevist, and/or, upon information and belief, MultiHance and/or ProHance.

133. As a direct and proximate result of Eric Jenkins being administered Omniscan,
OptiMARK, Magnevist, and/or, upon information and belief, MultiHance and/or
ProHance, as manufactured, designed, sold, supplied and introduced into the stream
of commerce by Defendants, Eric Jenkins suffered serious physical injury, death,
damages and economic loss.

    SIXTH CAUSE OF ACTION Strict Liability in Tort-ALL DEFENDANTS

134. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

135. Defendants used and controlled toxic gadolinium for injection in humans.

136. Gadolinium is highly toxic, inherently dangerous, and ultra-hazardous to
humans.

137. Defendants allowed and directed that toxic gadolinium be used and injected in
humans.

138. As a direct and proximate result of Defendants' use and control of toxic
gadolinium, toxic gadolinium was injected and released into the body of Eric
Jenkins and as a result, he suffered serious physical injury, harm, damages and
economic loss.

139. Defendants are strictly liable for Eric Jenkins's injuries, damages and
losses.

  SEVENTH CAUSE OF ACTION Negligence – Highest Possible Duty of Care ALL DEFENDANTS

140. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

141. Because gadolinium is highly toxic and inherently dangerous and
ultra-hazardous to humans, Defendants had a duty to exercise the highest possible
degree of care in the design, manufacture, sale and/or distribution of Omniscan,
OptiMARK, Magnevist, and upon information and belief, MultiHance and ProHance,
diagnostic agents into the stream of commerce, including the duty to assure that
their products did not pose a significantly increased risk of bodily harm and
adverse events.

142. Defendants failed to exercise the highest possible degree of care in the
design, formulation, manufacture, sale, testing, quality assurance, quality
control, labeling, marketing, and distribution into interstate commerce of
Omniscan, OptiMARK, Magnevist, and upon information and belief, MultiHance and
ProHance, in that Defendants knew, or should have known that their products were
inherently dangerous and ultra-hazardous to humans, and caused such significant
bodily harm or death and were not safe for administration to consumers.

143. Defendants also failed to exercise the highest possible degree of care in the
labeling of Omiscan, OptiMARK, Magnevist, and upon information and belief,
MultiHance and ProHance, and failed to issue to consumers and/or their health care
providers adequate warnings of the risk of serious bodily injury or death due to
the use of Omniscan, OptiMARK, MultiHance, and Magnevist and ProHance.

144. Despite the fact that Defendants knew, or should have known that Omniscan,
OptiMARK, Magnevist, and upon information and belief, MultiHance and ProHance,
posed a serious risk of bodily harm to consumers, and was inherently dangerous and
ultra-hazardous to humans and particularly those with renal insufficiency,
Defendants continued to manufacture and market Omniscan, OptiMARK, Magnevist, and
upon information and belief, MultiHance and ProHance, for administration to
magnetic resonance imaging and arteriography patients with renal insufficiency.

145. Defendants knew or should have known that it was foreseeable that consumers
such as Eric Jenkins would suffer injury as a result of Defendants' failure to
exercise the highest possible degree of care as described above.

146. As a direct and proximate result of Defendants' negligence, Eric Jenkins
suffered serious physical injury, death, damages and economic loss.

EIGHTH CAUSE OF ACTION Negligence – ALL DEFENDANTS

147. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

148. Defendants had a duty to exercise reasonable care in the design, manufacture,
sale and/or distribution of Omniscan, OptiMARK, Magnevist, and upon information
and belief, MultiHance and ProHance, into the stream of commerce, including a duty
to assure that their product did not pose a significantly increased risk of bodily
harm and adverse events.

149. Defendants failed to exercise reasonable care in the design, formulation,
manufacture, sale, testing, quality assurance, quality control, labeling,
marketing, and distribution into interstate commerce of Omniscan, OptiMARK,
Magnevist, and upon information and belief, MultiHance and ProHance, in that
Defendants knew or should have known that the product caused such significant
bodily harm or death and was not safe for administration to consumers.

150. Defendants also failed to exercise ordinary care in the labeling or warning
for Omniscan, OptiMARK, Magnevist, and upon information and belief, MultiHance and
ProHance, and failed to issue to consumers and/or their health care providers
adequate warnings of the risk of serious bodily injury or death due to the use of
Omniscan, OptiMARK, MultiHance, ProHance, and Magnevist.

151. Despite the fact that Defendants knew or should have known that Omniscan,
OptiMARK, Magnevist, and upon information and belief, MultiHance and ProHance,
posed a serious risk of bodily harm to consumers, Defendants continued to
manufacture and market Omniscan, OptiMARK, Magnevist, and upon information and
belief, MultiHance and ProHance, for administration to magnetic resonance imaging
and arteriography patients with renal insufficiency.

152. Defendants knew or should have known that it was foreseeable that consumers
such as Eric Jenkins would suffer injury as a result of Defendants' failure to
exercise ordinary care as described above.

153. As a direct and proximate result of Defendants' negligence, Eric Jenkins
suffered serious physical injury, death, damages and economic loss.

   NINTH CAUSE OF ACTION Breach of Express Warranty-ALL DEFENDANTS

154. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

155. The GE Defendants, Defendant Mallinckrodt, Bracco Defendants and Bayer
Defendants, expressly warranted that their products, Omniscan, OptiMARK,
Magnevist, and upon information and belief, MultiHance and ProHance, respectively,
were safe and effective paramagnetic contrast agents for magnetic resonance
imaging.

156. The Omniscan, OptiMARK, Magnevist, and upon information and belief,
MultiHance and ProHance, manufactured and sold by Defendants did not conform to
these express representations because they caused serious injury when administered
in recommended dosages.

157. As a direct and proximate result of Defendants' breach of warranty, Eric
Jenkins suffered serious physical injury, death, damages and economic loss.

   TENTH CAUSE OF ACTION Breach of Implied Warranty-ALL DEFENDANTS

158. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

159. At the time Defendants designed, manufactured, marketed, sold, and
distributed Omniscan, OptiMARK, MultiHance, ProHance, and Magnevist, Defendants
knew of the use for which Omniscan, OptiMARK, Magnevist, and upon information and
belief, MultiHance and ProHance, were intended and impliedly warranted their
respective products to be of merchantable quality and safe for such use.

160. Eric Jenkins and his healthcare providers reasonably relied upon the skill
and judgment of Defendants as to whether Omniscan, OptiMARK, Magnevist, and upon
information and belief, MultiHance and ProHance, were of merchantable quality and
safe for their intended use and upon Defendants' implied warranty as to such
matters.

161. Contrary to such implied warranty, the Omniscan, OptiMARK, Magnevist, and
upon information and belief, MultiHance and ProHance, diagnostic agents were not
of merchantable quality or safe for their intended use because these products were
unreasonably dangerous as described herein.

162. As a direct and proximate result of Defendants' breach of warranty, Eric
Jenkins suffered serious physical injury, death, damages and economic loss.

  ELEVENTH CAUSE OF ACTION Fraud/Misrepresentation – ALL DEFENDANTS

163. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

164. The GE Defendants, Defendant Mallinckrodt, Bracco Defendants and Bayer
Defendants knowingly and intentionally made material, false and misleading
representations to Eric Jenkins, his physicians, and to the public that their
products, Omniscan, OptiMARK, Magnevist, and upon information and belief,
MultiHance and ProHance, respectively, were safe for use and that Defendants'
labeling, marketing and promotion fully described all known risks of those
products.

165. Specifically, the Defendants concealed or knowingly failed to advise
consumers concerning the risk that highly toxic gadolinium would be released into
the bodies of persons with renal insufficiency who were administered the product
when they knew or should have known of that fact.

166. Defendants' representations were in fact false, as Omniscan, OptiMARK,
Magnevist, and upon information and belief, MultiHance and ProHance, are not safe
for use and their labeling, marketing and promotion did not fully describe all
known risks of those products, including the risk that highly toxic gadolinium
would be released into the bodies of persons with renal insufficiency who were
administered the product.

167. Defendants had actual knowledge based upon studies, published reports and
clinical experience that their products, Omniscan, OptiMARK, MultiHance, ProHance,
and Magnevist, created an unreasonable risk of serious bodily injury and death to
consumers, or should have known such information.

168. Defendants knowingly and intentionally omitted this information in their
products' labeling, marketing, and promotion and instead, labeled, promoted and
marketed their products as safe for use in order to avoid monetary losses and in
order to sustain profits in their sales to consumers.

169. When Defendants made these representations that Omniscan, OptiMARK,
Magnevist, and upon information and belief, MultiHance and ProHance, were safe for
use, they knowingly and intentionally concealed and withheld from Eric Jenkins,
his physicians and the public, the true facts that Omniscan, OptiMARK, Magnevist,
and upon information and belief, MultiHance and ProHance, diagnostic agents are
not safe for use in consumers with renal insufficiency.

170. Defendants had a duty to disclose to Eric Jenkins, his physicians, and the
public that Omniscan, OptiMARK, Magnevist, and upon information and belief,
MultiHance and ProHance, were not safe for use in patients with renal
insufficiency in that they cause NSF/NFD, because they had superior knowledge of
these facts that were material to Eric Jenkins' and his physician's decision to
use Omniscan, OptiMARK, MultiHance, ProHance, and Magnevist.

171. Eric Jenkins and his physicians reasonably and justifiably relied on the
Defendants' concealment of the true facts and reasonably and justifiably relied
upon Defendants' representations to Eric Jenkins and his health care providers,
that the Omniscan, OptiMARK, Magnevist, and upon information and belief,
MultiHance and ProHance, diagnostic agents were safe for human consumption and/or
use, and that Defendants' labeling, marketing and promotion fully described all
known risks of the product.

172. Had Eric Jenkins and his physicians known of Defendants' concealment of the
true facts that Omniscan, OptiMARK, Magnevist, and upon information and belief,
MultiHance and ProHance, were not safe for human use, Eric Jenkins would not have
been administered Omniscan, OptiMARK, Magnevist, and/or, upon information and
belief, MultiHance and ProHance.

173. As a direct and proximate result of Defendants' misrepresentations and
concealment, Eric Jenkins was administered Omniscan, OptiMARK, Magnevist, and/or,
upon information and belief, MultiHance and ProHance, Eric Jenkins suffered
serious physical injury, death, damages and economic loss.

    TWELFTH CAUSE OF ACTION Negligent Misrepresentation – ALL DEFENDANTS

174. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

175. Defendants, in the course of their business profession, supplied Eric Jenkins
and his physicians with false information for guidance in their decision to use
Omniscan, OptiMARK, Magnevist, and/or, upon information and belief, MultiHance and
ProHance.

176. The false information supplied by Defendants to Eric Jenkins and his
physicians was that Omniscan, OptiMARK, Magnevist, and/or, upon information and
belief, MultiHance and ProHance, were safe and would not adversely affect Eric
Jenkins's health, and in particular, the Defendants failed to advise Eric Jenkins
and his physicians of the risk that highly toxic gadolinium would be released into
the bodies of persons with renal insufficiency who were administered the product.

177. In supplying the false information, Defendants failed to exercise reasonable
care or competence in obtaining or communicating information to Eric Jenkins and
his physicians.

178. The false information obtained and communicated by Defendants to Eric Jenkins
and his physicians was material, and they justifiably relied in good faith on the
information given to them.

179. As a result of the negligent misrepresentations of Defendants, Eric Jenkins
suffered serious physical injury, death, damages and economic loss as alleged
herein.

    THIRTEENTH CAUSE OF ACTION Violation of the Colorado Consumer Protection Act
  C.R.S. § 6-1-101 et seq.

180. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further
alleges as follows:

181. Plaintiff is a person within the meaning of the Colorado Consumer Protection
Act (the "Act").

182. Defendants are persons within the meaning of the Act for all purposes
therein.

183. Plaintiff is a person entitled to bring a claim pursuant to the Act.

184. The false, deceptive and misleading statements and representations made by
Defendants alleged above are Deceptive Trade Practices within the meaning of the
Act.

185. Defendants engaged in the Deceptive Trade Practices alleged above, and those
Deceptive Trade Practices occurred or were committed in the course, vocation or
occupation of Defendants' pharmaceutical business.

186. The Deceptive Trade Practices that Defendants committed as alleged above
significantly impacts the public as actual or potential customers of Defendants.

187. As a direct and proximate result of the Deceptive Trade Practices committed
by Defendants as alleged above, Plaintiff suffered injuries, damages and losses as
alleged herein.

188. Plaintiff is entitled to recover all damages permitted by C.R.S. s 6-1-113 of
this Act, including actual damages sustained, civil penalties, attorneys' fees and
costs of this action. Also, the State of Colorado is entitled to statutory
penalties from Defendants for each violation of the Act pursuant to C.R.S. s
6-1-112.

  FOURTEENTH CAUSE OF ACTION Wrongful Death ALL DEFENDANTS

189. Plaintiff hereby incorporates by reference, as if fully set forth herein,
each and every allegation set forth in the preceding paragraphs and further allege
as follows:

190. Eric Jenkins developed NSF as a result of being exposed to gadolimium
contrast dye designed, manufactured and/or put into the stream of commerce by
Defendants.

191. As a direct and proximate result of her NSF, Eric Jenkins suffered severe
health impairment and complications that ultimately led to his death.

192. Plaintiff Allison Jenkins is the widow and Executor of the Estate of Eric
Jenkins.

193. Plaintiff suffered economic and non-economic damages, as described herein, a
loss of companionship and consortium as a direct and proximate result of
Defendants' actions.

WHEREFORE, Plaintiff prays for relief as follows:

1. Compensatory damages in excess of the jurisdictional amount, including, but not
limited to, pain, suffering, emotional distress, loss of enjoyment of life,
emotional distress, disfigurement, permanent physical impairment and other
non-economic damages in an amount to be determined at trial of this action;

2. Expenses, income, and other economic damages in an amount to be determined at
trial of this action;

3. Pre- and post-judgment interest;

4. Damages pursuant to C.R.S. s 6-1-113;

5. Attorneys' fees, expenses, and costs of this action as allowed by law; and Such
further relief as this Court deems necessary, just, and proper.

JURY DEMAND

Plaintiff hereby demands a trial by jury on all issues so triable.

Respectfully submitted this 10th day of February, 2009.