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Gadolinium Lawyers Sue Makers of Omniscan and Magnevist, Alleging They Cause NSF

Posted in Misc. Drugs

This Gadolinium lawsuit was filed in December of 2008 against the makers of a variety of MRI contrast dies that contain the paramagnetic metal Gadolinium:

47. Omniscan is an injectable paramagnetic contrast agent for magnetic resonance imaging and arteriography. It contains the metal gadolinium, which is highly toxic in its free state. 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.

48. Omniscan is cleared from the body solely by glomerular filtration in the kidneys. As a result, it 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.

49. Omniscan was originally developed by Salutar, Inc., which then conducted pre-clinical testing with Sterling Winthrop and Daiichi Pharmaceuticals. Salutar was subsequently acquired by Nycomed. In 1994, Nycomed acquired Sterling Winthrop's diagnostic imaging business.

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

51. In 2004, General Electric Company acquired Amersham plc and the rights to Omniscan. 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. In 2006, Amersham Health AS was renamed GE Healthcare AS, and Amersham Health, Inc. was renamed GE Healthcare Inc.

52. Defendants General Electric Company, GE Healthcare AS, and GE Healthcare, Inc. re corporate successors to Amersham plc and its related entities and, as such, are obligated for heir predecessor's liabilities. Amersham plc, either itself or by and through its subsidiaries, was ngaged in the business of designing, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling,
and/or selling directly and indirectly through third parties or related entities, the drug Omniscan.

53. Magnevist is an injectable paramagnetic contrast agent used for magnetic resonance imaging and arteriography. It contains the metal gadolinium, which is highly toxic in its free state. Magnevist, the chemical name of which is gadopentetate dimeglumine, 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. Magnevist was further represented by the Bayer Defendants to be superior to two of their 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.

54. Optimark is an injectable paramagnetic contrast agent used for magnetic resonance imaging and arteriography. It contains the metal gadolinium, which is highly toxic in its free state. Optimark, the chemical name of which is gadolinium diethylenetriamine pentaacetic acid bismethoxyethylamide (gadoversetamide), is represented by Defendant Mallinckrodt to be safely and effectively indicated for
intravenous administration to facilitate the visualization of lesions with abnormal vascularity.

55. Upon information and belief, ProHance is an injectable paramagnetic contrast agent for magnetic resonance imaging and arteriography. It contains the metal gadolinium, which is highly toxic in its free state. Upon information and belief, ProHance was 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.

56. 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. 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, ProHance and/or MultiHance, through the use of, among other things, proper design, testing, and
manufacturing.

  United States District Court, E.D. Pennsylvania.

   Tamara E. MARTIN, Individually and as Heir and Administratrix of the Estate of
   Stephen L. Stott, Deceased, Plaintiff,

v.

  GENERAL ELECTRIC COMPANY; GE Healthcare, Inc.; GE Healthcare as; Bayer Healthcare
   Pharmaceuticals, Inc.; Bayer AG; Bayer Schering Pharma, AG; Mallinckrodt, Inc.;
  Bracco Diagnostics Inc.; Bracco Research USA, Inc.; Altana Pharma AG; and Nycomed
International Management GmbH, Defendants.

   No. 208CV05950.

December 23, 2008.

  Complaint and Jury Demand

Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley, PC, Thomas R. Anapol, Esquire,
Sol H. Weiss, Esquire, 1710 Spruce Street, Philadelphia, PA 19103, (215) 735-1130,
(215) 875-7707 (Facsimile), Attorneys for Plaintiff.Of Counsel:, Peter W. Burg,
Burg Simpson Eldredge Hersh & Jardine, 40 Inverness Drive East, Englewood, CO
80112, Telephone: (303) 792-5595, Facsimile: (303) 708-0527,
pburg@burgsimpson.com.

   CIVIL ACTION COMPLAINT

Plaintiff, Tamara E. Martin, Individually and as Administratrix of the Estate of
her father, Stephen L. Stott, Deceased, by way of this Complaint against
Defendants, states as follows:

   PARTIES, JURISDICTION AND VENUE

1. Plaintiff, Tamara E. Martin, is an adult individual residing in Pennsylvania.

2. Plaintiff's father, Decedent Stephen L. Stott, died on September 5, 2008 as a
result of the factual events that form the basis of this Complaint.

3. At the time of his death, Decedent was a resident and citizen of Charleston,
Maryland.

4. Tamara E. Martin was appointed Administratrix of the Estate of Stephen L. Stott
by the Register of Wills of Chester County on September 30, 2008.

5. 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.

6. Omniscan, one of the products in question in this suit, 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. "GE Healthcare" is
prominently identified on the Omniscan packaging/prescribing information,
alongside the "GE" monogram. Omniscan is identified as a trademark of GE
Healthcare. "GE" and the GE monogram are trademarks of the General Electric
Company. The GE Healthcare website, which includes detailed product information
concerning Omniscan, is copyrighted by General Electric Company. 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. 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. 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.

7. At all times relevant, Defendant General Electric Company, and/or its corporate
predecessors, were engaged in the business of designing, developing,
manufacturing, testing, packaging, promoting, marketing, distributing, labeling,
and/or selling directly and indirectly through third parties or related entities,
the drug Omniscan.

8. 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.

9. At all times relevant, Defendant GE Healthcare AS, and/or its corporate
predecessors, were engaged in the business of designing, developing,
manufacturing, testing, packaging, promoting, marketing, distributing, labeling,
and/or selling directly and indirectly through third parties or related entities,
the drug Omnisca

10. Defendant GE Healthcare, Inc. is a Delaware corporation with its principal
place of business at 101 Carnegie Center, Princeton, New Jersey. Defendant GE
Healthcare, Inc. is a resident and citizen of both Delaware and New Jersey.
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.

11. At all times relevant, Defendant GE Healthcare, Inc., and/or its corporate
predecessors, were engaged in the business of designing, developing,
manufacturing, testing, packaging, promoting, marketing, distributing, labeling,
and/or selling directly and indirectly through third parties or related entities,
the drug Omniscan.

12. Upon information and belief and at the relevant times, Omniscan was
distributed and sold in the United States by GE Healthcare, Inc. and was
manufactured by GE Healthcare AS.

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

14. Upon information and belief, at all relevant times, the GE Defendants were
present and doing business in the State of Pennsylvania and in the Eastern
District of Pennsylvania in particular.

15. At all relevant times, the GE Defendants transacted, solicited, and conducted
business in the State of Pennsylvania and derived substantial revenue from such
business.

16. At all relevant times, the GE Defendants expected or should have expected that
their acts would have consequences within the United States of America, the State
of Pennsylvania, and the Eastern District of Pennsylvania in particular.

17. 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. 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.

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

19. At all times relevant, Defendant Bayer Healthcare Pharmaceuticals, Inc.,
and/or its corporate predecessors, was 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 (gadopentetate dimeglumine).

20. Bayer Schering Pharma AG is a foreign company domiciled in Germany.

21. Bayer Schering Pharma AG is a corporate successor to Schering AG. Schering AG
was renamed Bayer Schering Pharma AG effective December 29, 2006. At all times
relevant, Defendant Bayer Schering Pharma AG f/k/a/ Schering AG and/or its
corporate predecessors, was 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 (gadopentetate dimeglumine).

22. 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.

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

24. 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 Pennsylvania, either
directly or indirectly through third parties or related entities, the diagnostic
agent Magnevist (gadopentetate dimeglumine).

25. Upon information and belief, at all relevant times, the Bayer Defendants were
present and doing business in the State of Pennsylvania and in the Eastern
District of Pennsylvania in particular.

26. At all relevant times, the Bayer Defendants transacted, solicited, and
conducted business in the State of Pennsylvania and derived substantial revenue
from such business.

27. At all relevant times, the Bayer Defendants expected or should have expected
that their acts would have consequences within the United States of America, the
State of Pennsylvania, and the Eastern District of Pennsylvania in particular.

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

29. At all relevant times, Defendant Mallinckrodt was engaged in the business of
designing, developing, manufacturing, testing, packaging, promoting, marketing,
distributing, labeling, and/or selling directly or indirectly through third
parties or related entities the prescription drug Optimark.

30. Upon information and belief, at all relevant times, Defendant Mallinckrodt was
present and doing business in the State of Pennsylvania and in the Eastern
District of Pennsylvania in particular.

31. At all relevant times, Defendant Mallinckrodt transacted, solicited, and
conducted business in the State of Pennsylvania and derived substantial revenue
from such business.

32. At all relevant times, Defendant Mallinckrodt expected or should have expected
that its acts would have consequences within the United States of America, the
State of Pennsylvania, and the Eastern District of Pennsylvania in particular.

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

34. Upon information and belief, at all times relevant, Defendant Bracco
Diagnostics Inc. was engaged in the business of designing, developing,
manufacturing, testing, packaging, promoting, marketing, distributing, labeling,
and/or selling directly or indirectly through third parties or related entities,
the drugs MultiHance and ProHance.

35. Upon information and belief, Defendant Bracco Research USA, Inc. is a Delaware
corporation, with its principal place of business in Princeton, New Jersey.

36. Upon information and belief, at all times relevant, Defendant Bracco Research
USA, Inc. was engaged in the business of designing, developing, manufacturing,
testing, packaging, promoting, marketing, distributing, labeling, and/or selling
directly and indirectly through third parties or related entities, the drugs
MultiHance and ProHance.

37. Upon information and belief, Defendant ALTANA Pharma AG is a German company
with its principal place of business in Germany. Defendant ALTANA Pharma AG
manufactured MultiHance and/or ProHance for Bracco Diagnostics Inc.

38. Upon information and belief, at all times relevant, Defendant ALTANA Pharma AG
was engaged in the business of designing, developing, manufacturing, testing,
packaging, promoting, marketing, distributing, labeling, and/or selling directly
and indirectly through third parties or related entities, the drugs MultiHance and
ProHance.

39. Defendant Nycomed International Management GmbH ("Nycomed") is a Swiss company
domiciled in Switzerland. Defendant Nycomed bought ALTANA Pharma AG in 2006.
Defendant Nycomed is the corporate successor to ALTANA Pharma AG and, as such, is
obligated for its predecessor's liabilities.

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

41. At all times relevant, the Bracco Defendants were engaged in the business of
designing, developing, manufacturing, testing, packaging, promoting, marketing,
distributing, labeling, and/or selling directly or indirectly through third
parties or related entities, the drugs MultiHance and ProHance.

42. Upon information and belief, at all relevant times, the Bracco Defendants were
present and doing business in the State of Pennsylvania and in the Eastern
District of Pennsylvania in particular.

43. At all relevant times, the Bracco Defendants transacted, solicited, and
conducted business in the State of Pennsylvania and derived substantial revenue
from such business.

44. At all relevant times, the Bracco Defendants expected or should have expected
that their acts would have consequences within the United States of America, the
State of Pennsylvania, and the Eastern District of Pennsylvania in particular.

45. 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.

46. 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 Plaintiff Tamara Martin is a resident of this district, Decedent Stephen L.
Stott was administered gadolinium in this district, was diagnosed with NSF in this
district, and suffered injury in this district, and Decedent Stephen L. Stott
resided in this judicial district at relevant times.

GENERAL ALLEGATIONS

47. Omniscan is an injectable paramagnetic contrast agent for magnetic resonance
imaging and arteriography. It contains the metal gadolinium, which is highly toxic
in its free state. 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.

48. Omniscan is cleared from the body solely by glomerular filtration in the
kidneys. As a result, it 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.

49. Omniscan was originally developed by Salutar, Inc., which then conducted
pre-clinical testing with Sterling Winthrop and Daiichi Pharmaceuticals. Salutar
was subsequently acquired by Nycomed. In 1994, Nycomed acquired Sterling
Winthrop's diagnostic imaging business.

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

51. In 2004, General Electric Company acquired Amersham plc and the rights to
Omniscan. 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. In 2006, Amersham Health AS
was renamed GE Healthcare AS, and Amersham Health, Inc. was renamed GE Healthcare
Inc.

52. Defendants General Electric Company, GE Healthcare AS, and GE Healthcare, Inc.
re corporate successors to Amersham plc and its related entities and, as such, are
obligated for heir predecessor's liabilities. Amersham plc, either itself or by
and through its subsidiaries, was ngaged in the business of designing, developing,
manufacturing, testing, packaging, promoting, marketing, distributing, labeling,
and/or selling directly and indirectly through third parties or related entities,
the drug Omniscan.

53. Magnevist is an injectable paramagnetic contrast agent used for magnetic
resonance imaging and arteriography. It contains the metal gadolinium, which is
highly toxic in its free state. Magnevist, the chemical name of which is
gadopentetate dimeglumine, 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. Magnevist was further represented by the Bayer
Defendants to be superior to two of their 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.

54. Optimark is an injectable paramagnetic contrast agent used for magnetic
resonance imaging and arteriography. It contains the metal gadolinium, which is
highly toxic in its free state. Optimark, the chemical name of which is gadolinium
diethylenetriamine pentaacetic acid bismethoxyethylamide (gadoversetamide), is
represented by Defendant Mallinckrodt to be safely and effectively indicated for
intravenous administration to facilitate the visualization of lesions with
abnormal vascularity.

55. Upon information and belief, ProHance is an injectable paramagnetic contrast
agent for magnetic resonance imaging and arteriography. It contains the metal
gadolinium, which is highly toxic in its free state. Upon information and belief,
ProHance was 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.

56. 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. 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, ProHance and/or
MultiHance, through the use of, among other things, proper design, testing, and
manufacturing.

57. 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 Stephen L. Stott.

58. At all times relevant hereto, Defendants knew, or should have known, that
their respective products, Omniscan, Magnevist, OptiMark, and/or, upon information
and belief, ProHance and/or MultiHance, 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 Stephen L. Stott, and knew,
or should have known, that the gadolinium contained in their products 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.

59. After being administered Omniscan, Magnevist and, upon information and belief,
OptiMark, ProHance and/or MultiHance, gadolinium was released into his body.
Stephen L. Stott began experiencing symptoms of Nephrogenic Systemic Fibrosis
(NSF) also known as Nephrogenic Fibrosing Dermopathy (hereinafter "NFD), after and
because of these administrations.

60. Specifically, Decedent Stephen L. Stott was administered Magnevist in
connection with an imaging study performed at Paoli Hospital in Paoli,
Pennsylvania on or about March 7, 2006.

61. Additionally, Decedent Stephen L. Stott may have been administered Omniscan,
Magnevist, OptiMark, ProHance, and/or MultiHance in connection with imaging
studies performed at Paoli Hospital in Paoli, Pennsylvania on various dates
including, but not limited to, September 20, 2005, December 23, 2005, March 29,
2006, and May 24, 2007.

62. Decedent Stephen L. Stott was administered Magnevist or ProHance in connection
with imaging studies performed at Hahnemann Hospital in Philadelphia, Pennsylvania
on various dates including, but not limited to, July 25, 2006 and July 26, 2006.

63. Decedent Stephen L. Stott was administered Omniscan in connection with imaging
studies performed at Chester County Hospital in West Chester, Pennsylvania on
March 4, 2007.

64. Additionally, Decedent Stephen L. Stott may have been administered Omniscan,
Magnevist, OptiMark, ProHance, and/or MultiHance in connection with imaging
studies performed at Chester County Hospital in West Chester, Pennsylvania on
various dates including, but not limited to, December 8, 2005.

65. Decedent Stephen L. Stott was diagnosed with NSF through a biopsy in April of
2007.

66. Decedent Stephen L. Stott, died on September 5, 2008 as a result his
administration of Omniscan, Magnevist, and, upon information and belief, OptiMark,
ProHance and/or MultiHance and his resulting development of NSF.

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

68. 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 Omniscan, Magnevist, and, upon information and
belief, OptiMark ProHance and/or MultiHance. These symptoms can occur weeks or
months after a person is administered these dyes. These fibrotic and edematous
changes produce muscular weakness and inhibit flexion and extension of joints,
resulting in contractures. NSF/NFD often progresses to painful inhibition of the
ability to use the arms, legs, hands, feet, and other joints. 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.
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. NSF/NFD is a progressive
disease as to which there is no known cure.

69. 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.

70. 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. 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.

71. 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.

72. Stephen L. Stott suffered from debilitating and worsening fibrotic changes to
his body as a result of contracting NSF/NFD until he ultimately died.

73. Had the Defendants properly disclosed the risks associated with their
respective products to Decedent Stephen L. Stott and/or his health care providers,
Decedent Stephen L. Stott would not have been administered gadolinium.

74. As alleged herein, as a direct and proximate result of the Defendants'
negligence and wrongful conduct, the Defendants' failure to comply with federal
requirements, and the unreasonably dangerous and defective characteristics of the
subject product, the Decedent suffered severe and permanent physical injuries,
including but not limited to the development of NSF and the Decedent's subsequent
death. The Decedent endured substantial conscious pain and suffering, both
physical and emotional in nature. The Decedent incurred significant expenses for
medical care and treatment, suffered lost wages and earnings, and was otherwise
physically, emotionally, and economically injured. The Decedent and his heirs
suffered severe pecuniary loss. The Plaintiff seeks actual and punitive damages
from the Defendants as alleged herein. The injuries and damages alleged herein are
permanent and will continue into the future.

FEDERAL STANDARDS AND REQUIREMENTS

75. 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, and/or, upon information and
belief, MultiHance and/or 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. See, 21
U.S.C. s351;

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 it 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/or

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.

COUNT I NEGLIGENCE

76. 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:

A. DUTIES AND OBLIGATIONS OF THE DEFENDANTS

77. The Defendants owed to the Decedent, Stephen L. Stott, or his health care
providers, a duty of care:

a. To ensure that Omniscan, Magnevist and, upon information and belief, OptiMark,
ProHance and/or MultiHance were appropriately tested to determine whether there
were any potentially adverse effects due to the use them;

b. To ensure that Omniscan, Magnevist and, upon information and belief, OptiMark,
ProHance and/or MultiHance were fit for their intended and/or reasonably
foreseeable uses;

c. To warn that use of Omniscan, Magnevist and, upon information and belief,
OptiMark, ProHance and/or MultiHance carried a significant risk of causing NSF/NFD
when administered to patients with renal insufficiency;

d. To conduct adequate tests and clinical trials to determine the degree of risk
associated with the use of Omniscan, Magnevist and, upon information and belief,
OptiMark, ProHance and/or MultiHance;

e. To conduct ongoing tests and clinical trials with long-term follow-up to
determine the long-term effects and risks of continued use of Omniscan, Magnevist
and, upon information and belief, OptiMark, ProHance and/or MultiHance;

f. To ensure that prescribing physicians were kept fully and completely informed
of all risks associated with Omniscan, Magnevist and, upon information and belief,
OptiMark, ProHance and/or MultiHance;

g. To monitor, investigate, evaluate, and follow-up on adverse reactions to the
use of Omniscan, Magnevist and, upon information and belief, OptiMark, ProHance
and/or MultiHance; and

h. To properly inform the FDA and other regulatory agencies of the risk of the
development of NSF/NFD associated with the administration of Omniscan, Magnevist
and, upon information and belief, OptiMark, ProHance and/or MultiHance to patients
with renal insufficiency.

78. NSF/NFD is a permanent and debilitating condition that is ultimately fatal.
The Defendants knew or should have known that recovery from NSF may not be
complete and that patients afflicted with NSF will not recover.

   B. THE RISKS OF OMNISCAN, MAGNEVIST, OPTIMARK AND, UPON INFORMATION AND BELIEF,
MULTIHANCE AND/OR PROHANCE INFORMATION TO PATIENTS

79. The risks associated with the administration of Omniscan, Magnevist and, upon
information and belief, OptiMark, ProHance and/or MultiHance to patients with
renal insufficiency were in the exclusive knowledge and control of the Defendants.
The extent of the risks was not known and could not have been known to the
Decedent, Stephen L. Stott. Mr. Stott's injuries would not have occurred but for
the negligence of the Defendants in failing to ensure that Omniscan, Magnevist
and, upon information and belief, OptiMark, ProHance and/or MultiHance were safe
for use or, in the alternative, for failing to provide an adequate warning of the
risks associated with Omniscan, Magnevist and, upon information and belief,
OptiMark, ProHance and/or MultiHance to patients with renal insufficiency.

    C. DEFENDANTS NEGLIGENTLY BREACHED THEIR DUTY OF CARE

80. The Defendants breached their duty of care to Mr. Stott as described above in
the following respects:

a. The Defendants failed to conduct adequate tests and clinical trials initially
and on an ongoing basis to determine the risks associated with the administration
of Omniscan, Magnevist and, upon information and belief, OptiMark, ProHance and/or
MultiHance to patients with renal insufficiency;

b. The Defendants failed to conduct ongoing studies on the risks and efficacy of
Omniscan, Magnevist and, upon information and belief, OptiMark, ProHance and/or
MultiHance;

c. The Defendants failed to provide adequate warnings of the inherent risks
associated with the administration of Omniscan, Magnevist and, upon information
and belief, OptiMark, ProHance and/or MultiHance to patients with renal
insufficiency;

d. The Defendants failed to warn Mr. Stott and his physicians about the potential
for NSF/NFD associated with the administration of Omniscan, Magnevist and, upon
information and belief, OptiMark, ProHance and/or MultiHance to patients with
renal insufficiency;

e. The Defendants failed, after notice of dangers with Omniscan, Magnevist and,
upon information and belief, OptiMark, ProHance and/or MultiHance, to issue
adequate warnings, recall the drugs, publicize their problem and/or otherwise act
properly and in a timely manner to alert the public, Mr. Stott, and his physicians
of the inherent dangers;

f. The Defendants manufactured, marketed, distributed, and sold their respective
gadolinium based contrast dyes without adequately disclosing the significantly
increased risk of renal dysfunction;

g. The Defendants failed to give the FDA complete and accurate information
Omniscan, Magnevist and, upon information and belief, OptiMark, ProHance and/or
MultiHance by failing to disclose the risks on a timely basis;

h. The Defendants failed to adequately warn Mr. Stott and his physicians of the
risks then known or which were reasonably foreseeable with the use of their
respective gadolinium based contrast dyes;

i. The Defendants, with full knowledge that Omniscan, Magnevist and, upon
information and belief, OptiMark, ProHance and/or MultiHance could cause NSF/NFD
when administered to patients with renal insufficiency, failed to warn Mr. Stott
of the same and instead continued to sell, market, and distribute Omniscan,
Magnevist and, upon information and belief, OptiMark, ProHance and/or MultiHance
throughout the United States and elsewhere;

j. The Defendants failed to establish adequate procedures to educate their sales
reresentatives and rescribin phsicians with resect to the correct use of Omniscan,
Magnevist and, upon information and belief, OptiMark, ProHance and/or MultiHance
and the risks associated therewith;

k. The Defendants failed to provide proper long term investigations of the effects
and risks of Omniscan, Magnevist and, upon information and belief, OptiMark,
ProHance and/or MultiHance;

1. The Defendants failed to provide proper long term studies and investigations of
the risks and benefits of Omniscan, Magnevist and, upon information and belief,
OptiMark, ProHance and/or MultiHance as compared to their competitors;

m. The Defendants failed to adequately monitor, evaluate, and act upon adverse
reactions to Omniscan, Magnevist and, upon information and belief, OptiMark,
ProHance and/or MultiHance;

n. The Defendants falsely stated that Omniscan, Magnevist and, upon information
and belief, OptiMark, ProHance and/or MultiHance were safe and fit for their
intended purposes and were of merchantable quality when they knew or should have
known that such representations were false;

o. The Defendants misstated the state of research, opinion, and medical literature
pertaining to the purported benefits of Omniscan, Magnevist and, upon information
and belief, OptiMark, ProHance and/or MultiHance and their associated risks;

p. The Defendants failed to accurately, candidly, promptly, and truthfully
disclose all consumer complaints and adverse effects of Omniscan, Magnevist and,
upon information and belief, OptiMark, ProHance and/or MultiHance to the FDA;

q. The Defendants failed to conform with applicable disclosure and reporting
requirements pursuant to the Food and Drug Act and the regulations contained
therein; and

r. The Defendants encouraged their employees to increase sales volumes while
neglecting to inform consumers, retailers, hospitals, and physicians of the side
effects of Omniscan, Magnevist and, upon information and belief, OptiMark,
ProHance and/or MultiHance.

81. As a direct result of the Defendants' acts and omissions as described herein,
and the Defendants' failure to comply with federal standards and requirements,
Decedent Stephen L. Stott was caused to suffer severe personal injuries, pain and
suffering, severe emotional distress and harm, financial or economic loss, and
death.

PRODUCTS LIABILITY

82. At all times herein relevant, the Defendants were engaged in some manner in
the business of designing, testing, manufacturing, selling, marketing, labeling,
advertising, and/or supplying their respective gadolinium based contrast dyes.

83. Defendants knew that Omniscan, Magnevist and, upon information and belief,
OptiMark, ProHance and/or MultiHance would reach the ultimate users or consumers
such as the Decedent in the same condition as they were at the time of supply or
sale.

84. At the time of supply or sale, Omniscan, Magnevist and, upon information and
belief, OptiMark, ProHance and/or MultiHance were not merchantable or reasonably
suited to the use intended, and their condition when sold proximately caused the
death of Mr. Stott.

85. At the time of supply or sale, Omniscan, Magnevist and, upon information and
belief, OptiMark, ProHance and/or MultiHance were unreasonably dangerous,
defective, or not reasonably fit, suitable, or safe for their intended use, and
failed to perform in a manner reasonably expected in light of their nature and
intended function, and the defects subjected Mr. Stott to an unreasonable risk of
harm as set forth in this Complaint and including, but not limited to, the
following:

a. Failing to supply adequate warnings with the products;

b. Selling products defective in their design in that the risks inherent in their
design outweighed the utility of the products;

c. Failing to provide accurate and truthful instructions with regard to the
prescribing of these products;

d. Selling products which were not safe for their intended use;

e. Selling products which were lacking one or more elements necessary to make them
safe for their intended use;

f. Manufacturing products which were defective and which could cause injury to the
user;

g. Designing products which were defective and which could cause injury to the
user;

h. Distributing products which were defective and could cause injuries to a user;

i. Failing to assure that ultimate users were advised of the dangers of said
products;

j. Failing to exercise reasonable care in the design of the products;

k. Failing to exercise reasonable care in the marketing of these products;

1. Failing to adequately and properly test said products;

m. Delivering products which were defective and could cause injury to the users;

n. Producing products which were defective and could cause injury to the users;

o. Producing products with component parts that the Defendants knew or should have
known increased the risk of harm to the user;

p. Supplying products which were defective and could cause injury to the user;
and/or

q. Engaging in other acts regarding the manufacturing, designing, preparing,
testing, producing, distributing, advising, and selling of Omniscan, Magnevist
and, upon information and belief, OptiMark, ProHance and/or MultiHance as will be
learned in discovery.

86. Defendants made representations regarding the safety, efficacy, and usefulness
of Omniscan, Magnevist and, upon information and belief, OptiMark, ProHance and/or
MultiHance without reasonable grounds for believing the representations to be
true. At all times relevant, Defendants' representations were made with the intent
to induce the Decedent, Decedent's health care providers, and the general public
to rely on them. At all times, Mr. Stott and his health care providers were
unaware of the false or misleading nature of the Defendants' representations,
acted in reliance on the truth of the representations, and were justified in doing
so.

87. Defendants' acts and omissions breached implied warranties of fitness and
merchantability of the product supplied to and administered to the Decedent.

88. As a direct result of the Defendants' actions and omissions, and the
Defendants' failure to comply with federal standards and regulations, the
Decedent, Stephen L. Stott, suffered the injuries as described herein that
resulted in his death.

89. As a direct result of the Defendants' acts and omissions as described herein,
and the Defendants' failure to comply with federal standards and regulations,
Decedent, Stephen L. Stott, was caused severe personal injuries, pain and
suffering, severe emotional distress and harm, and death.

NEGLIGENT MISREPRESENTATION

90. Defendants made the misrepresentations described above regarding the safety of
Omniscan, Magnevist and, upon information and belief, OptiMark, ProHance and/or
MultiHance without sufficiently reasonable grounds for believing the
representations to be true.

91. At all times relevant, the Defendants' representations were made with the
intent to induce Mr. Stott, Mr. Stott's health care providers, and the general
public, to rely upon them.

92. At all times relevant, Mr. Stott and his health care providers were unaware of
the falsity or misleading nature of the Defendants' representations, acted in
reliance on the truth of the representations, and were justified in doing so.

93. As a direct result of the Defendants' acts and omissions as described herein,
as well as the Defendants' failure to comply with federal standards and
requirements, the Decedent, Stephen L. Stott, suffered severe personal injuries,
pain and suffering, severe emotional distress and harm, and death.

    INTENTIONAL MISREPRESENTATION

94. Defendants, all or certain of them, made numerous false, misleading, and
fraudulent misrepresentations to the general public and to Mr. Stott's health care
providers, leading Mr. Stott's health care providers, among others, to believe
that Defendants' products were safe.

95. These representations by the Defendants, all or certain of them, were false.
Omniscan, Magnevist and, upon information and belief, OptiMark, ProHance and/or
MultiHance were not safe and had dangerous effects and consequences.

96. These representations by Defendants were material, in that if the Decedent and
his health care providers had known the truth, Decedent may not have accepted the
products into his body.

97. Defendants, all or certain of them, made these representations knowing them to
be false and misleading, and with the intent to defraud, mislead, and deceive Mr.
Stott and his health care providers, and with the intent to induce Mr. Stott's
health care providers, Mr. Stott, and the general public, to use the Defendants'
respective products.

98. Decedent, Decedent's health care providers, and the general public, used
Defendants' products. If the Decedent and the Decedent's health care providers had
known the truth about the facts and dangers posed by Defendants' product, they
would not have used Defendants' product in the same manner as they were used.

99. Mr. Stott and his health care providers acted in reliance on Defendants'
misrepresentation.

100. As a direct and proximate result of the fraudulent and misleading conduct
described herein, Mr. Stott suffered severe personal injuries, pain and suffering,
severe emotional stress and harm, and death.

101. In performing the described acts or omissions, Defendants, all or certain of
them, acted fraudulently, maliciously, or oppressively toward Mr. Stott and others
by compromising their safety for the benefit of profit. Defendants, all or certain
of them, had actual knowledge, or should have had actual knowledge, of the serious
dangers posed to Mr. Stott and others. Defendants, all or certain of them,
intentionally or in a willful or conscious disregard for the safety of Mr. Stott
and others using its products, misled Mr. Stott and health care professionals,
including doctors, and hospitals, regarding the danger posed to Mr. Stott and
other patients from Omniscan, Magnevist and, upon information and belief,
OptiMark, ProHance and/or MultiHance so that Defendants, all or certain of them,
could increase their financial profit.

102. As a direct and proximate result of Defendants' misrepresentations, as well
as the Defendants' failure to comply with federal standards and requirements, Mr.
Stott was suffered severe personal injuries, pain and suffering, severe emotional
distress and harm, and death.

BREACH OF EXPRESS WARRANTY

103. Defendants placed Omniscan, Magnevist and, upon information and belief,
OptiMark, ProHance and/or MultiHance into the stream of commerce for sale and
recommended their use to physicians and consumers without adequately warning
physicians, the FDA, and consumers including the Decedent, of the risks associated
with the use of those respective products.

104. Defendants had a duty to exercise reasonable care in selling, promoting,
marketing, labeling, testing, designing, manufacturing, or distributing Omniscan,
Magnevist and, upon information and belief, OptiMark, ProHance and/or MultiHance
including a duty to:

a. Ensure that the products did not cause the user unreasonably dangerous
consequences;

b. Warn of risks associated with the products; and

c. Disclose adverse material facts when making representations to physicians, the
FDA, and the public at large, including Decedent.

105. The Decedent and his physicians reasonably relied on the Defendants and their
agents to disclose known defects, risks, and dangers of Omniscan, Magnevist and,
upon information and belief, OptiMark, ProHance and/or MultiHance.

106. The Decedent's physicians, the FDA, and the Decedent had no knowledge of the
falsity or incompleteness of the Defendants' statements and representations
concerning the products at issue. Decedent justifiably and detrimentally relied on
the warranties and representations of Defendants regarding the products at issue.

107. Defendants were under a duty to disclose the defective and unsafe nature of
the products at issue to physicians, the FDA, consumers, and users, such as the
Decedent, Mr. Stott. Defendants had sole access to material facts concerning the
defects, and Defendants knew that physicians, the FDA, and users, such as Mr.
Stott, could not reasonably have discovered such defects.

108. By their acts and omissions, Defendants, their agents and employees expressly
warranted to Mr. Stott and his physicians that the products were merchantable and
fit for the purpose intended.

109. This warranty was breached because the products at issue were not safe and
effective as Defendants presented, and Mr. Stott was injured.

110. As a direct result of Defendants' acts and omissions, as described herein, as
well as the Defendants' failure to comply with federal standards and requirements,
Mr. Stott suffered severe personal injuries, pain and suffering, severe emotional
distress and harm, and death.

BREACH OF IMPLIED WARRANTY

111. Omniscan, Magnevist and, upon information and belief, OptiMark, ProHance
and/or MultiHance carried with them an implied warranty of merchantability.
Plaintiff alleges that such implied warranties include that Omniscan, Magnevist
and, upon information and belief, OptiMark, ProHance and/or MultiHance are safe
and non-defective for their intended use. As averred above, Omniscan, Magnevist
and, upon information and belief, OptiMark, ProHance and/or MultiHance were not
safe for their intended use and were not safe at all for certain individuals at
risk.

112. None of the above referenced warranties have been effectively disclaimed by
any Defendant in this action.

113. Defendants are liable for breach of implied warranty of merchantability as
set forth above.

  COUNT II SURVIVAL ACTION

114. 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:

115. Plaintiff, Tamara E. Martin, has the right to bring the following survival
action on behalf of the Estate of Decedent under the Pennsylvania Survival
Statute, 42 Pa.C.S.A. s 8302, and pursuant to 20 Pa.C.S.A. s 3373.

116. Due to the aforementioned conduct of the Defendants, Stephen L. Stott, during
his life, suffered severe injuries resulting in the development of NSF/NFD and his
ultimate death.

117. As a result of aforementioned conduct of the Defendants, Stephen L. Stott has
suffered a substantial increase in the risk of early death and a substantial
shortening of his life.

118. As a result of the aforementioned conduct of the Defendants, Stephen L. Stott
was not able to perform any activities of daily living and was permanently
impaired in his ability to earn a living.

119. As a result of the aforementioned conduct of the Defendants, the Plaintiff
and the Estate have incurred substantial medical expenses for Stephen L. Stott's
medical treatment.

120. As a result of the aforementioned conduct of the Defendants which caused the
above impairments and increased risk of death, Stephen L. Stott had a substantial
loss of earnings and earning capacity during his life and his Estate continues to
suffer a loss of earnings and earning capacity.

121. As a direct and proximate result of the negligence of the Defendants, Stephen
L. Stott suffered a permanent diminution of his ability to enjoy life and life's
pleasures, and suffered severe pain and emotional distress.

122. The untimely death of Stephen L. Stott on October 3, 2007 was caused by the
intentional and negligent conduct of the Defendants.

123. Plaintiff claims damages for the additional medical expenses incurred for the
treatment of the Decedent prior to his death along with the loss of Decedent's net
earnings from the date of death until the respective remainder of his work life
and further claims all damages recoverable under the Pennsylvania Survival
Statute.

124. Plaintiff claims on behalf of the Estate of Stephen L. Stott all damages
suffered by the Estate by reason of the death of the Decedent, as well as for pain
and suffering and fear of impending death the Decedent experienced prior to his
death.

125. In addition, Plaintiff claims all other damages recoverable under the
Pennsylvania Survival Statute.

   COUNT III WRONGFUL DEATH ACTION

126. 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:

127. Plaintiff, Tamara E. Martin, has the right to bring the following Wrongful
Death Action on behalf of the wrongful death beneficiaries under the Pennsylvania
Wrongful Death Statute, 42 Pa.C.S.A. s 8301, and pursuant to Pa.R.C.P. 2202(a).

128. The persons entitled by law to recover wrongful death damages as a result of
the death of Decedent, are:

a.Deborah Stott, Decedent's surviving spouse;

b.Tamara E. Martin, Decedent's daughter; and

c. David A. Stott; Decedents son.

129. Plaintiff claims damages of Defendants under and by virtue of the
Pennsylvania Wrongful Death Statute for the pecuniary value of future services,
support, society, comfort, and contribution of the Decedent that would have been
rendered to the wrongful death beneficiaries for the expected remainder of their
lives.

130. Plaintiff further demands payment for funeral and burial expenses.

131. In addition, Plaintiff demands payment for all economic losses suffered by
the Decedent's survivors including costs of administration and other expenses
reasonably associated with the Decedent's death.

WHEREFORE, the Plaintiff, Tamara E. Martin, Administratrix of the Estate of
Stephen L. Stott, Deceased, demands compensatory damages against Defendants in an
amount in excess of the statutory limit for arbitration together with punitive
damages, attorneys' fees and costs, and pre-judgment and post-judgment interest.

    DEMAND FOR JURY TRIAL

Plaintiff hereby demands a trial by jury on all Counts and as to all issues.