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.

Continue Reading Gadolinium Attorneys Give History of Nephrogenic Systemic Fibrosis In Gadolinium Lawsuit

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.

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

This lawsuit was filed in November of 2008 and alleges that Scott Smiley died after contracting NSF:

8. At all times relevant hereto, Defendants knew or should have known about the significant risk of gadolinium-based contrast agents administered to patients with renal insufficiency, including but not limited to the risk of NSF/NFD in the skin and other body organs.

9. NSF/NFD has been reported in medical literature for at least the last decade.

10. Prior to a decade ago, the group of symptoms now known as NSF/NFD had been variously described as scleromyxedema, scleroderma, or other connective tissue diseases. Regardless of the name ascribed to it, however, it has always been the case that this clinical entity now known as NSF/NFD develops only in patients with renal insufficiency who have been given an injection of gadolinium-type contrast agent.

11. NSF/NFD is predominantly characterized by discoloration, thickening, tightening, and swelling of the skin within days or weeks after receiving a gadolinium-based contrast injection. 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. This scarring can inhibit the ability of body organs to function properly and may lead to death. NSF/NFD is a progressive disease as to which there is no known cure.

12. NSF/NFD has been reported thus far only in people whose kidney function was compromised at the time of injection with gadolinium containing contrast solution.

13. NSF/NFD did not exist until gadolinium containing contrast solutions came into use for enhancing MRI and MRA scans.

14. At all times relevant hereto, Defendants and/or their corporate predecessors knew or should have known about the significant health risk of their gadolinium -based magnetic resonance contrast media being administered to patients with renal insufficiency, including but not limited to the risk of nephrogenic fibrosis in the skin and other body organs.

15. Defendants and/or their corporate predecessors consistently failed to warn consumers and/or their health care providers that NSF/NFD could result when their gadolinium-based magnetic resonance contrast media products were administered to patients with renal insufficiency.

16. During the years that Defendants and/or their corporate predecessors manufactured, marketed, and sold their respective gadolinium-based magnetic resonance contrast media products, there were numerous case reports, studies, assessments, papers, and other clinical data that have described and/or demonstrated NSF/NFD in connection with the use of certain gadolinium-based contrast agents, including Defendants' and/or their corporate predecessors'
gadolinium-based magnetic resonance contrast media products. Despite this, Defendants and/or their corporate predecessors 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.

17. Defendants and/or their corporate predecessors repeatedly and consistently failed to advise consumers and/or their health care providers of the causal relationship between their gadolinium-based magnetic resonance contrast media and NSF/NFD in patients with renal insufficiency.

18. Defendants and/or their corporate predecessors failed to take prompt, reasonable, and effective measures to alert the appropriate members of the health care community and its patients, including but not limited to renal patients, nephrologists and other physicians, radiologists, administrators, technicians, and hospital/radiology supply personnel, to the serious adverse health risks presented by administration of their gadolinium-based magnetic resonance contrast media.

Continue Reading Gadolinium Lawyers File Nephrogenic Systemic Fibrosis (NSF) lawsuit

This Gadolinium lawsuit was filed in October of 2009 in New York.  This lawsuits gives a good background about Gadolinium and its association with Nephrogenic Systemic Fibrosis:

52. Gadolinium is cleared from the body 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 gadolinium administration.

53. Neither Plaintiff, nor her prescribing physician, nor the performing radiologists or technicians were warned or cautioned by Defendants about the serious health risks presented by the administration of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance.

54. Subsequent to being administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, Plaintiff developed NSF/NFD, which was formally diagnosed, and progressed to widespread fibrosis in areas including, but not limited to, her arms, legs, and associated joints.

55. Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD), has been reported in medical literature for at least the last decade.

56. Prior to a decade ago, the group of symptoms now known as NSF/NFD had been variously described as scleromyxedema, scleroderma, or other connective tissue diseases. Regardless of the name ascribed to it, however, it has always been the case that this clinical entity now known as NSF/NFD develops only in patients with renal insufficiency whom have been given an injection of gadolinium-type contrast agent such as Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance.

57. NSF/NFD is predominantly characterized by discoloration, thickening, tightening, and swelling of the skin within days or weeks after receiving an injection of a gadolinium based contrast agent. 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.

58. The Defendants have consistently failed to warn consumers and/or their health care providers that NSF/NSD could result when the Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance is administered to patients with renal insufficiency.

59. As a direct and proximate result of being administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, Plaintiff suffered serious, progressive, incurable, and inevitably fatal injuries.

60. Defendants knew or should have known that the administration of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance to patients with renal insufficiency created an increased risk to those consumers of serious personal injury and even death.

61. Therefore, at the time Plaintiff was administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, Defendants knew or should have known that the use of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance created an increased risk of serious personal injury, or even death to consumers with renal insufficiency.

62. Despite the fact that Defendants knew or should have known of the serious health risks associated with the use of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, Defendants failed to warn Plaintiff and/or her health care providers of those serious risks.

63. Had Plaintiff and/or her health care providers known the risks of damages associated with Omniscan he would not have been administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance and would not have been afflicted with NSF/NFD.

64. As a direct and proximate result Plaintiff being administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, she has suffered significant harm, conscious pain and suffering, physical injury and bodily impairment, including, but not limited to, suffering from NSF/NFD, which may have caused permanent effects, and which may continue in the future to cause her physical effects and damage which lead to her death.

65. Further, as a direct and proximate result of he being administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, Plaintiff suffered significant mental anguish and emotional distress, physical limitations, pain, injury, damages, harm, and mental and emotional distress.

66. Plaintiffs also incurred medical expenses and other economic harm as a result of Plaintiff being administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance.

67. Despite reports of nephrogenic fibrotic changes and other data warranting caution and further evaluation, Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance was marketed and sold without appropriate clinical evaluation of the nephrotoxic effect of this drug on patients with renal insufficiency, without appropriate clinical evaluation of the propensity of this drug to produce nephrogenic fibrosis in humans, and without appropriate and effective warning with respect to either.

68. At all times relevant hereto, Defendants knew or should have known about the significant health risk of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance administration to patients with renal insufficiency, including, but not limited to, the risk of nephrogenic fibrosis in the skin and other body organs.

69. During the years that Defendants have manufactured, marketed, and sold Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, there have been numerous case reports, studies, assessments, papers, and other clinical data that have described and/or demonstrated NSF/NFD in connection with the use of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance. Despite this, Defendants have repeatedly failed to 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.

70. In June 2006, and again in updated form in December 2006, the FDA issued Public Health Advisory Alerts concerning the development of serious, sometimes fatal, NSF/NFD following exposure to gadolinium-based contrast agents, including Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance.

71. The Defendants have repeatedly and consistently failed to advise consumers and/or their health care providers of the causal relationship between Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance and NSF/NFD in patients with renal insufficiency.

72. The Defendants have failed to take prompt, reasonable, and effective measures to alert the appropriate members of the health care community and its patients, including, but not limited to, renal patients, nephrologists and other physicians, radiologists, administrators, technicians, and hospital/radiology supply personnel, to the serious adverse health risks presented by administration of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance.

Continue Reading Gadolinium Lawsuit Filed For Plaintiff Who Contracted Nephrogenic Systemic Fibrosis

There are many lawsuits pending against Merck over its drug Fosamax.  There is evidence that the drug causes necrosis of the jaw.  I’ve seen pictures of people with this disease, and they look like normal people with the jaw of a rotting corpse.  It’s a terrible, horrible disease.  At this time, I don’t know of…