GD TX

1. June 12, 2009, I was injured by Bayer Pharmaceutical’s linear Gadolinium-Based-Contrast-Agent (GBCA), Magnevist, prematurely released in 1988. Bayer Pharmaceutical failed to perform research, and later ignored relevant research, newly published in 1989 through 2009. They failed to change its Warning via the FDA’s Changes Being Effected (CBE) regulations until December 2010 to reflect this newly acquired information establishing my susceptibility and the causal association between their drug and my injuries. A revised warning prior to June 2009 would have altered the prescribing physician’s decision to use Magnevist and prevented my injuries.

2. For 30 years, Bayer Pharmaceutical employed manipulative semantics as they were forced by public research and outrage to repeatedly revise their defective black box warnings. Bayer Pharmaceutical continues to deny most of the injuries their drug caused me. The public’s challenges led to Bayer Pharmaceutical’ sputtering admissions that a wider pool of Patient-Victims exists, albeit, too late for me. Meanwhile, Bayer Pharmaceutical used and continue to use Patient-Victims to test their drug while they profit from the inhuman medical experimentation.

3. I suffers from Gadolinium Toxicity (Gd Tx). Gadolinium Toxicity is an incurable, painful disease. I contracted Gd Tx when he received a Magnetic Resonance Arthrogram (MRA) using an intravenous injection of the linear GBCA known as Magnevist.

Manufacturing Bayer Pharmaceutical:

4. Bayer Pharmaceutical Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG, Bayer Corporation, Bayer Healthcare LLC (collectively referred to as the “Manufacturing Bayer Pharmaceutical”), manufacture, market, and sell Magnevist, a gadolinium-based contrast agent (“GBCA”) that was injected into my body.
5. Defendant Bayer Pharma AG is a foreign company domiciled in Germany. Bayer Pharmaceutical Bayer is a global pharmaceutical company and rakes in more than $40 billion dollars per year. The German based company’s parent company is IG Farben.
6. In 2009, the Manufacturing Bayer Pharmaceutical engaged in business to design, license, manufacturer, advertise, distribute, introduce, market, promote, and sold their linear GBCA Magnevist in California and in interstate business, nationwide, either directly or indirectly through third parties or related entities.
7. Bayer Healthcare Pharmaceuticals Inc. is a Delaware corporation with its principal place of business in New Jersey. Defendant Bayer Healthcare Pharmaceuticals Inc. is the United States pharmaceuticals unit of Bayer Healthcare LLC. Bayer Healthcare Pharmaceuticals Inc. is engaged in the business of designing, licensing, manufacturing, distributing, selling, marketing, and/or introducing Magnevist into interstate commerce, either directly or indirectly through third parties or related entities.
8. Bayer Corporation is an Indiana corporation with its headquarters located in Pennsylvania. Defendant Bayer Corporation is engaged in the business of designing, licensing, manufacturing, distributing, selling, marketing, and/or introducing Magnevist into interstate commerce, either directly or indirectly through third parties or related entities. Defendant Bayer Corporation is duly authorized to conduct business in the State of California and does business in Los Angeles County. Said Defendant has elected to establish an agent for service of process in the State of California.
9. Bayer HealthCare LLC is a Delaware LLC with its headquarters located in New Jersey. Bayer HealthCare LLC is engaged in the business of designing, licensing, manufacturing, distributing, selling, marketing, and/or introducing Magnevist into interstate commerce, either directly or indirectly through third parties or related entities. Bayer HealthCare LLC is duly authorized to conduct business in the State of California and does business in Los Angeles County.
10. The Manufacturing Bayer Pharmaceutical advertised, promoted, marketed, distributed, and sold their linear GBCA Magnevist in California and nationwide.

11. Bayer Pharmaceutical conducted clinical trials of Magnevist within California, which became part of an unbroken chain of events leading to my injury. See Dubose v Bristol-Myers Squibb Co., No. 17-cv-00244, 2017 U.S. Dist. LEXIS 99504 (N.D. Cal. June 27, 2017).

Distributor Bayer Pharmaceutical

12. Defendant McKesson Corporation (“McKesson”) distributes Magnevist and other GBCAs in California and elsewhere. I allege that McKesson distributed the Magnevist that was injected into me.
13. Defendant McKesson Corporation is a Delaware corporation with its principal place of business and headquarters at One Post Street, San Francisco, San Francisco County, California.
14. McKesson Corporation is duly authorized to conduct business in the State of California and does business in Los Angeles County.

15. McKesson Corporation sold Magnevist and other GBCAs in California and elsewhere. I allege that McKesson Medical-Surgical, Inc. distributed the Magnevist that was injected into me.
16. McKesson Medical-Surgical, Inc. is a Virginia corporation with its principal place of business and headquarters in San Francisco, San Francisco County, California.
17. McKesson Medical-Surgical, Inc. is duly authorized to conduct business in the State of California and does business in Los Angeles County.
18. Defendant McKesson Medical-Surgical, Inc. sold Magnevist and/or other GBCAs in Los Angeles County and elsewhere.
19. Merry X-Ray Chemical Corporation (“Merry X-Ray”) distributes Magnevist and/or other GBCAs in California and elsewhere. I allege that Merry X-Ray distributed the Magnevist that was injected into I.
20. Defendant Merry X-Ray Chemical Corporation is a California corporation with its principal place of business and headquarters at 4444 Viewridge Avenue, San Diego, California.
21. Merry X-Ray Chemical Corporation is duly authorized to conduct business in the State of California and does business in Los Angeles County.
22. Merry X-Ray sold Magnevist and/or other GBCAs in Los Angeles County.
23. McKesson, McKesson Medical-Surgical, Inc., and Merry X-Ray, are collectively referred to as the Distributor Bayer Pharmaceutical.

24. The Manufacturing Bayer Pharmaceutical and the Distributor Bayer Pharmaceutical are collectively referred to as the Bayer Pharmaceutical.

FACTS:

THE MECHANICS OF A PHARMACOLOGICAL CRISIS:

25. My complaint concerns the FDA-approved linear Gadolinium-Based-Contrast Agent (GBCA) Magnevist administered to patients intravenously by radiologists to enhance the quality of magnetic resonance imaging. When contrast dye is used, the magnetic resonance imaging procedure is referred to as a Magnetic Resonance Arthrogram (MRA).
26. Because Gadolinium is highly paramagnetic, it is effective for use in MRAs. Yet Gadolinium is highly toxic, too. Hence, GBCAs have been developed as a supposedly, “Safe,” means of introducing gadolinium into the body. Yet, for a variety of reasons, GBCAs safety design fails and exposes the patient to raw, highly toxic Gadolinium.
27. The fundamental dynamics of poisoning include: (1) the nature/strength of the toxin; (2) dosage or quantity of the toxin; (3) duration of contact with the toxin; (4) patients’ vulnerability-variables including health status and allergy profile. Any factor that contributes to one of these dynamics of poisoning contributes to the risk posed to the patient by Magnevist.
28. Thereby, the factors causing Magnevist’s pharmacological crisis, include but are not limited to: (1) Bayer Pharmaceutical’ manufacturing process and inconsistencies; (2) properties of Magnevist and Gadolinium; (3) Bayer Pharmaceutical’ history of concealment, denials of the risks posed to consumers, and defective black box warnings; (4) Magnevist’s bio-chemical interplay with the patients’ biological systems; (5) Patients’ medical vulnerabilities including renal insufficiency.
29. Due to Bayer Pharmaceutical’ 35 years of manipulations, just the naming of the toxicities and ensuing diseases that Magnevist causes is controversial. Current terminology is inadequate. Given the range of injuries I sustained due to one injection of Magnevist, and the ensuing 13 years of discrimination I experienced, I title it by the encompassing, scientifically sound term, Gadolinium Toxicity (Gd Tx) and proceed with my complaint, accordingly.

30. Gadolinium is a chemical element that does not naturally occur within the human body. The only known route for Gadolinium to enter the human body is injection of the GBCA. Gadolinium Toxicity (Gd Tx) is a man-made disease. It only occurs in patients who have received a GBCA for an MRA.

Manufacturing Methods and Inconsistencies: Chelation:

31. Because raw Gadolinium is highly toxic, it must be coated. GBCAs are actually a composite, or, “chelated” chemical construct. The Gadolinium is bound to a protective outer shell, not unlike M&M candies’ interior chocolate is bound by an exterior hard-shell candy so not to melt in one’s hands. Yet, everyone knows what happens if they are held onto for too long.
32. Chelation is designed to protect the body by keeping the toxic heavy metal from coming into contact with human tissue. Yet, during the manufacturing, the application of the chelating or caging protecting the raw toxic Gadolinium can be applied in an inconsistent manner. Therefore, manufacturing process can lead to inconsistencies within the chelation between different manufactured, ‘Batches.’

33. There are two types of contrast agents differentiated by their chemical structure: linear and macrocyclic agents. The main difference is that the linear agents do not fully surround the gadolinium ion, whereas the macrocyclic agents form a complete ring around it which creates a much more difficult bond to break. Bayer Pharmaceutical’ Magnevist is a linear agent. Linear GBCAs are far less stable and more prone to separation of the raw Gadolinium from its chelated compound than the macrocyclic GBCAs. Greater safety due to stronger bonds of the macrocyclic contrast agents as compared to their linear contrast counterparts has been well established by scientists. (Huckle, et al. 2016).

GBCAs’ Bio-Chemical Interplay with the Patient’s Biological Systems:

34. When GBCAs are in the human body, chelation may separate from Gadolinium. This process is called “de-chelation.” It occurs because essential metals in the body such as copper, iron and zinc compete for GBCA’s outer “chelate” layer (Huckle, et al. 2016). This bio-chemical transfer process is known as, “Transmetallation.”
35. Furthermore, emerging science demonstrated the bond between toxic gadolinium and its chelate or cage (Gd-DTPA) becomes very weak and separates easily in low pH conditions such as those found in many compartments of the human body including extracellular fluid spaces. Therefore, chelation fails for a variety of reasons.
36. Once the GBCA is de-chelated, the patient is exposed to raw, highly toxic “Free,” Gadolinium, which in turn then binds to tissue or cells in the human biological structure. It even breaches the natural blood-brain-spinal-cord barrier and deposits in the brain and spinal cord.

37. Once de-chelation starts, not even healthy kidneys can clear/excrete the “free” Gadolinium sufficiently to prevent poisoning. Gadolinium Toxicity does not discriminate and extends its reach to all patients exposed to de-chelated linear GBCAs. Consistent with its toxicology, the relative hazard of Gadolinium to an individual is dependent upon the dose and the length of time Therefore, decreased renal performance is not a pre-requisite for contraction of the disease, Gd Tx, though it increases susceptibility.

Kidney Performance:

38. Kidneys play a key role in the clearance/excretion of GBCAs but in themselves do not “cause” the toxicity, which is why the terminology for the deadly end range of Gd Tx, “Nephrogenic Systemic Fibrosis (NSF)” is medically misleading and semantically flawed.
39. NSF’s toxic terminology disassociates its horrors from its causation. [1]
40. Renal function of patients is divided into six classes, “Healthy,” and then five stages of impairment. Impaired renal function has been correspondingly classified into five categories: mildly impaired Chronic Kidney Disease, (CKD) class 1 and 2; moderately impaired CKD, class 3; and severely impaired CKD, class 4 and 5.
41. Consistent with the science of Nephrology, patients with renal insufficiency are at risk of reduced/slower clearance/excretion of GBCAs. This increases its “residency time.” This in turn increases the risk of the process of de-chelation of the poorly-bonded linear GBCA within the patient. Extended retention of the GBCA allows more time for de-chelation through Transmetallation to occur. This results in the new, toxic compound in which the now “free,” Gadolinium bonds with bio-metals in the body. This deposited Gadolinium can be retained within the body for weeks, months and even years, while the Patient-Victim suffers Gd Tx, and/or awaits the release of the time-bomb.

42. GBCAs perform two negative functions: (1) they increase patients’ susceptibility to toxins, and, (2) they deliver the toxin. GBCAs poison patients by delivering a chemical, “Combo-punch.” The first chemical punch, “Stuns the kidneys,” to increase its residency. Then while they are stunned, the GBCA has time to engage the natural biochemical processes of its host to strip its chelation, already prone to decomposition due to its flawed manufacturing process, and not unlike the Greeks’ Trojan Horse, presented as a gift but concealing a defeat, it delivers the second chemical punch: The invading raw toxin poisons its host and also deposits itself for subsequent toxic attacks.

HISTORY OF BAYER PHARMACEUTICAL’ DEFECTIVE WARNINGS:

Black Box Warning in Operation on June 12, 2009:

43. In 1988, the FDA approved Magnevist for public consumption and Bayer Pharmaceutical and the FDA claimed linear GBCA Magnevist was safe for everyone. Yet, Bayer Pharmaceutical did not share all of its research with the FDA at the time of its premature approval and during subsequent revisions of its “Black Box Warnings.”
44. May 2007, almost 20 years later, Bayer Pharmaceutical and the FDA issued a Black Box Warning. It declared only patients with severe renal insufficiency, classified CKD, class 4 and 5, were at risk of contracting only one disease: NSF. Indeed, retained Gadolinium causes NSF, the end range of Gd Tx. Yet, through their false assertions and omissions, they placed the majority of patients at high risk of sustaining the sequela of Gd Tx toxins’ symptomology, major injuries Bayer Pharmaceutical wrongfully omitted and continue to refuse to admit are indeed caused by their drug.
45. This following Black Box Warning was only seen by the physicians and there were and are numerous, “Field conditions,” in most Radiology Departments and MRI rooms that preclude the transfer of this vital warning to patients.

          WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with: Acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73m2), or, Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration (See WARINGS).

CONTRAINDICATIONS: None. [Emphasis added]

46. This warning asserts only those with severe renal insufficiency of GFR < 30, CKD, class 4 or 5, are at risk of contracting only NSF, the end range of Gadolinium Toxicity, omitting me as a patient at risk and excluding me from Bayer Pharmaceutical’ warning service as I was CKD, class 3, prior to the injection of Bayer Pharmaceutical’ linear GBCA, Magnevist.
47. This warning was defective as it acknowledges only one of Gadolinium’s toxicity, fibrotic toxicity and warns of only one disease, NSF.
48. This warning falsely claimed that there were no Contraindications by stating “Contraindications: None.”
49. This warning’s other foundational defect is caused by Bayer Pharmaceutical’s omission of any designation or numerical parameters of risk other than GFR < 30. “Screen all patients for renal dysfunction,” and, “Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests,” sorely fails to define the laboratory tests and their numerical parameters to establish the, “Range of risk.” Without any further designation of risk, a reasonable physician is led to believe laboratory tests are performed only to determine if a patient is CKD, class 4 or 5. This singular warning of GFR < 30, essentially instructs physicians to only screen for CKD, class 4 and 5, and thereby precludes patients with a higher GFR but who are also at risk of injury, including contraction of the omitted toxicities, their ensuing disorders and diseases.
50. On the

    sixth page it warned in addition to the above information:

The extent of risk for NSF following exposure to any specific gadolinium-based contrast agent is unknown and may vary among the agents. Published reports are limited and predominantly estimate NSF risks with gadodiamide. In one retrospective study of 370 patients with severe renal insufficiency who received gadodiamide, the estimated risk for development of NSF was 4% (J Am Soc Nephro12006; 17:2359). The risk, if any, for the development of NSF among patients with mild to moderate renal insufficiency or normal renal function is unknown. [Emphasis added.]

51. Placing this warning on the six page was defective and harmful to me. Here, they obviously associated two contiguous categories, patients with mild renal insufficiency and patients with moderate renal insufficiency. It claimed the risk for NSF among patients with moderate renal insufficiency, my class, is, “Unknown,” and thereby misled physicians and me. Bayer Pharmaceutical further dismissed and undermined the risk to such patients as me with their employed phrase, “if any,” and thereby published a defective warning.

52. On the seventh page, it warned:

Acute renal failure in patients with renal insufficiency, acute renal failure requiring dialysis or worsening renal function have occurred, mostly within 48 hrs of MAGNEVIST Injection. The risk of these events is higher with increasing dose of contrast. Use the lowest possible dose and evaluate renal function in patients with renal insufficiency. [Emphasis added.]

53. Placing this warning on the seventh page was defective and harmful to me. It is defective as it failed to define the level of renal insufficiency of which to be concerned. “Evaluate renal function in patients with renal insufficiency,” is defective in that it does not define the type of laboratory test or the numerical parameters as they did for acute renal insufficiency. The ambiguity presents risk to any patient, including me.
54. This warning acknowledges the second Gadolinium toxicity, namely, the nephrogenic toxicity of Gadolinium, and only one adverse reaction, acute renal failure.
55. I am informed and believe that on the day of my injection, and for about a two-to-three-week period of time, there was no FDA Black Box Warning for Magnevist.

56. I contend this was the first stage of Bayer Pharmaceutical’ “Divide and conquer,” strategy toward their consumers to conceal culpability and maintain their maximum market share. The logic of this warning is bewildering as gadolinium is universally toxic and will poison anyone, given the susceptibility-variables identified above.

Subsequent Black Box Warnings Demonstrate a Pattern of Defects:

57. Though the following warnings were published subsequent to the day of my devastating injection, these revisions illustrate, by contrast, what was lacking in the 2007 operative warning. The subsequent warnings remain defective and demonstrate (1) Bayer Pharmaceutical’ reticence to modify their warning to reflect prevailing research; (2) their reckless indifference to patients’ well-being; and, (3) their manipulation of patient classification.

58. December 20, 2010, three years later, and 1 ½ years too late for I, Bayer Pharmaceutical and the FDA modified their Black Box Warning, stating:

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF):

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

• Do not administer MAGNEVIST to patients with: chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or acute kidney injury (see CONTRAINDICATIONS).

• Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age>60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR)through laboratory testing. [Emphasis added.

59. The first line of its warning fails to define the numerical parameters of, “Impaired elimination of the drugs.” This phrasing is confusing and misleading. The meaning of the word, “Elimination,” is unclear. The typical terms are, “Clearance,” or, “Excretion.” When it is the patient’s first time, s/he cannot know if s/he will have an “impaired elimination of the GBCA,” until it is too late, as it was for me. Hence, the textual temporality/tense of the warning is manipulative and/or poorly stated. These facts render the warning defective.
60. Like 2007, it clearly states only those with severe renal insufficiency of GFR <30, CKD, class 4 or 5, are at risk to contract NSF, the end range of Gadolinium Toxicity, only. Again, it states NSF may result in, “Fatal or debilitating fibrosis effecting the skin, muscles and internal organs,” and omits neuro-and ortho-toxicities and their ensuing sequelae.
61. It advises physicians, “For patients at risk of chronically reduced function (for example, age > 60 years, hypertension or diabetes) estimate the glomerular filtration rate (GFR) through laboratory testing.” This warning is defective because its, “Examples,” are too limited, and, again, it did not provide numerical parameters for the tests by which to assess the risk.
62. Because Bayer Pharmaceutical omitted an alternative numerical range of recipients’ GFR for which to be concerned, “Patients at risk for chronically reduced renal function,” as it did for severe renal insufficiency, i.e., “glomerular filtration rate < 30 mL/min/1.73m2,” the warning is defective and effectively limits its warning value to patients with CKD class 4 and 5, only.

63. On the fourth page it listed:

WARNINGS AND PRECAUTIONS

Nephrogenic Systemic Fibrosis (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities.

The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m2) as well as patients with acute kidney injury. Do not administer MAGNEVIST to these patients. The risk appears lower for patients with chronic, moderate kidney disease (GFR 30- 59 mL/min/1.73m2) and little, if any, for patients with chronic, mild kidney disease (GFR 60- 89 mL/min/1.73m2). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Report any diagnosis of NSF following MAGNEVIST administration to Bayer Healthcare (1-888-842-2937) or FDA (1­-800-FDA-1088 or www.fda.gov/medwatch). [Emphasis added.]

64. Placing this warning on the fourth page was defective and harmful to patients. Bayer Pharmaceutical finally specified an alternative range of patients at risk, namely, those with CKD, class 3, “Moderate kidney disease (GFR 30- 59 mL/min/1.73m2)”—my classification. Yet, Bayer Pharmaceutical’ warning is defective as it is vague. “Appears lower,” conveys no meaningful quantification and does not compare in a meaningful manner the supposedly “lower [risk],” for CKD, class 3 patients to the “Highest [risk],” for CKD, class 4 and 5 patients. Also, they continued to limit their warning to NSF, a disease caused by the fibrotic toxicity of Gadolinium, omitting other inherent toxicities.
65. Another key aspect of Bayer Pharmaceutical’ 2010 warning concerns the fact that they disassociated and distinguished patients in contiguous classifications with moderate CKD, 3, from patients with mild CKD, 1 and 2. They assert the risk for patients with moderate renal insufficiency, is lower than those patients with GFR < 30, but clearly from their warning, greater than those patients with mild CKD 1 and 2, for whom they characterize the risk as “Little,” and use the dismissive term, “if any,” now, only for the latter group.

66. On the fourth page, it warned:

Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (for example, age > 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing.

Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. When administering Magnevist, do not exceed the recommended dose and allow a sufficient period of time for elimination of the drug prior to any re-administration (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). [Emphasis added.]

67. Here, Bayer Pharmaceutical expanded the parameters of the risk for NSF by expanding the “factors,” that may increase the risk for contracting it, namely “Degree of renal impairment at the time of exposure.” Also, they indirectly acknowledged their drug may be the culprit in/cause of the acute kidney injury (AKI), by listing “drug induced kidney toxicity,” as a common “setting,” for acute kidney injury. Yet, once again, they failed to define the numerical parameters of “renal impairment,” that places patients at risk, nor identify their drug as the possible culprit/cause of AKI thereby rendering their warning defective.

68. On the fourth page it warned:

Acute Renal Failure

In patients with renal insufficiency, acute renal failure requiring dialysis or worsening renal function have occurred, mostly within 48 hrs of MAGNEVIST Injection. The risk of these events is higher with increasing dose of contrast. Use the lowest possible dose and evaluate renal function in patients with renal insufficiency. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.)

69. On its fifth page, it advised:

Patient Counseling Information

Patients scheduled to receive MAGNEVIST Injection should be instructed to inform their
physician if they are pregnant, breastfeeding, or have a history of renal insufficiency, asthma or allergic respiratory disorders. Additionally instruct patients to inform their physician if they:

• Have a history of kidney and/or liver disease, or
• Have recently received a GBCA.

GBCAs increase the risk of NSF among patients with impaired elimination of drugs. To counsel patients at risk of NSF:

• Describe the clinical manifestation of NSF
• Describe procedures to screen for the detection of renal impairment

  Instruct the patients to contact their physician if they develop signs or symptoms of NSF following MAGNEVIST administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.

70. From 2007 to 2010, no significant, “New,” research was published during the three years that was not already available before June 2009 about the use of linear GBCAs on patients with moderate renal impairment. Yet, as defective as the warning is for multiple reasons, if any such warnings and advised counseling was included on their May 2007 warning, my injuries would have been avoided.
71. I contend this was the second stage of Bayer Pharmaceutical’s “Divide and conquer,” strategy toward their consumers to conceal culpability and maintain their maximum market share. The logic of this warning is baffling as gadolinium is universally toxic and will poison anyone, given the appropriate susceptibility-variables.

72. June 2014, four years later, Bayer revised its Black Box Warning, even further. This warning contains a key difference in the graphic design and page layout. For the first time, it included Warnings and Precautions on the first page:

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

See full prescribing information for complete boxed warning.
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities.

• Do not administer Magnevist to patients with:

chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
acute kidney injury. (4)

• Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension, or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

Do not exceed the recommended Magnevist dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration. (5.1)

WARNINGS AND PRECAUTIONS ———————-

• Nephrogenic Systemic Fibrosis (NSF) has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeat dosing appears to increase the risk. (5.1)
• Hypersensitivity: Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory, and/or cutaneous manifestations rarely
  resulting in death have occurred. Monitor patients closely for need of emergency cardiorespiratory support. (5.2)
• Renal Failure: In patients with renal insufficiency, acute renal failure requiring dialysis or worsening renal function have occurred, mostly within 48 hours of Magnevist injection. (5.3)

—————————— ADVERSE REACTIONS —————————–
The most common adverse reactions (≥1%) are headache, nausea, injection site coldness/localized coldness, and dizziness. (6) [Emphasis added.]

73. “Nephrogenic Systemic Fibrosis (NSF) has occurred in patients with impaired elimination of GBCAs.” This revision and the elimination of the terms of supposed “Lower,” and, “Highest,” risks, extends the risk of NSF to any patient with any level of impaired renal function, given the appropriate susceptibility-variables. Unfortunately, it was about five years too late for me. Contributing to the denial of risk  to me: Radiologists were still denying the risk of any adverse injury for Patients with CKD, class 3, as late as 2022. Also, again, for patients receiving the GBCA for the first time, s/he cannot know if s/he has an impaired ability to eliminate the GBCA.
74. The “Adverse Reactions,” are minimized and actual substantial injuries that I suffered, such as neurological and orthopedic toxicities, are omitted.

75. On the third and fourth page, it warns:

4 CONTRAINDICATIONS

Magnevist is contraindicated in patients with:

• Chronic, severe kidney disease (glomerular filtration rate, GFR <

30mL/min/1.73m2), or

• Acute kidney injury, or

• History of severe hypersensitivity reactions to Magnevist.

5 WARNINGS AND PRECAUTIONS

5.1 Nephrogenic Systemic Fibrosis (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is
essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m2) as well as patients with acute kidney
injury. Do not administer Magnevist to these patients. The risk appears lower for patients with chronic, moderate kidney disease (GFR 30- 59 mL/min/1.73m2) and little, if any, for patients with chronic, mild kidney disease (GFR 60- 89 mL/min/1.73m2). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Report any diagnosis of NSF following Magnevist administration to Bayer HealthCare (1-888-842-2937) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch).

Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury, or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (for example, age > 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing.

Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. When administering Magnevist, do not exceed the recommended dose and allow a sufficient period of time for elimination of the drug prior to re-administration [see Clinical Pharmacology (12.3) and Dosage and Administration (2)] [Emphasis added.]

76. Bayer Pharmaceutical did not modify their revised distinction of the contiguous classes, patients with CKD, 3, and those with CKD, 1 and 2. Bayer Pharmaceutical’ reference to “drug-induced kidney toxicity,” is riddled with bitter irony as it was Magnevist that poisoned my kidneys. “And degree of renal impairment at time of exposure,” is a step in the right direction but sorely lacks any numerical specification of the, “Risk range,” rendering the warning defective, and implying it is only for the designated GFR < 30 classified patients.
77. I contend this was the third stage of Bayer Pharmaceutical’ “Divide and conquer,” strategy toward their consumers to conceal culpability and maintain their possibly largest market share. The logic of this warning is baffling as gadolinium is highly toxic and will poison anyone, given the presence of susceptibility-variables.
78. December 19, 2017, almost 30 years after Magnevist’s approval, Bayer Pharmaceutical and the FDA recognized the beginning range and fundamental mechanism of Gd Tx, namely Gadolinium Deposition Disease (GDD) and warned patients with normal to mild renal insufficiency, CKD, 1 and 2, were at risk. Yet, made no mention of CKD, 3. Despite the fact that free Gadolinium is highly toxic, Bayer Pharmaceutical and the FDA asserted no causal relationship exists between the notorious toxin, Gadolinium, and GDD Patient-Victims’ injuries, whose symptomology may be milder than the devastating NSF but still debilitating.

79. This is the FDA’s 2017 statement:

The U.S. Food and Drug Administration (FDA) is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and we have concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.

However, after additional review and consultation with the Medical Imaging Drugs Advisory Committee, we are requiring several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA, and actions that can help minimize problems. These include requiring a new patient Medication Guide*, providing educational information that every patient will be asked to read before receiving a GBCA. We are also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.

80. April and July 2018, the first page of the new Black Box Warning revised:

———————– WARNINGS AND PRECAUTIONS ———————-
• Gadolinium is retained for months or years in brain, bone, and other
organs. (5.3)

81. On page 4, Bayer Pharmaceutical list:

5.3 Gadolinium Retention

Gadolinium is retained for months or years in several organs. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (for example, brain, skin, kidney, liver, and spleen). The duration of retention also varies by tissue and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, gadolinium retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)]. [Emphasis added.]

82. Now, patients are reduced to mere, “Organs.” The warning continues:

Consequences of gadolinium retention in the brain have not been established. Pathologic and clinical consequences of GBCA administration and retention in skin and other organs have been established in patients with impaired renal function [see Warnings and Precautions (5.1)]. There are rare reports of pathologic skin changes in patients with normal renal function. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention [see Adverse Reactions (6.2)]. [Emphasis added.]

83. I contest the false allegations that, (1) “Consequences of gadolinium retention in the brain have not been established, and (2) that there were “rare,” reports. In fact, an extensive number of reports of an array of symptoms were building over time, and submitted to the FDA, well before 2017. The warning continues:

While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent when choosing a GBCA for these patients. Minimize repetitive GBCA imaging studies particularly closely spaced studies, when possible. [Emphasis added.]

84. I contend this was the fourth stage of Bayer Pharmaceutical’ “Divide and conquer,” strategy toward their consumers to conceal culpability and maintain their maximum market share. Their logic is absurd as gadolinium is highly toxic and will poison anyone, given the presence of susceptibility-variables; they acknowledged retention in everyone but denied its “Consequences.”
85. Comparison of the warnings for the two contiguous classifications of patients with mild and moderate renal insufficiencies reveals incriminating inconsistencies. In 2007, they combined the two classes and warned the risk was the same for both. In 2010 and 2014, Bayer Pharmaceutical disassociated and distinguished the two contiguous classifications of patients, mild versus moderate renal insufficiencies, and warned that patients with CKD, 3, were at more risk than the patients with mild renal insufficiency who were said to have, “Little [risk], if any.” Yet, in 2017, Bayer Pharmaceutical omitted any reference to the respective class of patients according to their renal insufficiency. They only designated, “Gadolinium remaining in patients’ bodies.”

     

NEW FACTS IN SCIENCE AND COURTS CONFIRM SUSCEPTIBILITY VARIABLES:

86. About September 2019, I learned the following trifecta of facts:
87. In 2010, Bayer Pharmaceutical and the FDA published a revised Black Box Warning revising the classification of patients at risk of contracting NSF to include patients with moderate renal insufficiency, CKD, 3, but claimed they were at “Lower,” risk than CKD 4 and 5, patients.
88. In 2017, Dr. Jeffrey Brent spoke at FDA’s MIDAC’s 2017 conference. He stated, “We know NSF is a disease. It is very clear-cut unambiguous disease caused by gadolinium retention in patients who have renal failure … NSF is unmistakable, easy to diagnose, clear-cut, limited but devastatingly serious clinical condition, limited in the sense of clinical manifestations.” (FDA’s MIDAC 2017 Conf.) [Emphasis added.]
89. In August 2019, Judge David G. Campbell, Senior U. S. District Judge, rejected the experts for the Gadolinium Deposition Disease (GDD) plaintiffs, classified as healthy to mild renal insufficiency, CKD 1 and 2. In his 84-page ruling against them, he stated, “We have a recognized disease of NSF in renally-impaired patients and its accepted link to GBCAs.” (Case 2:18-cv-01159-DGC, Davis v McKesson Corp., Order 08/02/2019, page 14.) [Emphasis added.]
90. Consistent with the 2010 revised Black Box Warning, both Dr. Brent and Judge Campbell exercised a contemporaneous revision of the defective operative 2007

    discriminatory Thirteen years after I was poisoned, professionals of significant and relevant authority finally established deposited Gadolinium is dangerous to Patient-Victims with either renal impairment or renal failure without CKD class-restriction.

OTHERWISE, THE PROFOUND DISINFORMATION CAMPAIGN DOMINATED

91. Bayer Pharmaceutical’ false, dated, defective 2007 warning otherwise dominated and continues to dominate the legal and medical industries, unjustly oppressing me.
92. For example, Schieda, et al. in Gadolinium-Based Contrast Agents in Kidney Disease: A Comprehensive Review and Clinical Practice Guidelines Issued by the Canadian Association of Radiologists, published in the Canadian Journal of Kidney Health and Disease, 2018, stated, “In patients with category G2 or G3 CKD (eGFR ≥ 30 and < 60 mL/min/1.73 m²), administration of standard doses of GBCA is safe and no additional precautions are necessary.”
93. Another example, Erik V. Soloff and Carolyn L Wang, published in Kidney360, February 2020, “Several studies have shown that use of these lower-stability GBCAs in patients with normal kidney function or mild-to-moderate CKD (stage 3; eGFR 30–59 ml/min per 1.73 m²) is without clinically significant risk of NSF. However, they remain absolutely contraindicated in patients with AKI or stage 4 or 5 CKD (eGFR <30 ml/min per 1.73 m²).”
94. Their source is Ledneva E et al. published in Radiology 250:618-628, in 2009.
95. Julie Davies, et al., in Archives of Toxicology, January 2022, stated: “NSF is a rare disease … and found exclusively in patients with end-stage kidney disease. (Grobner 2006; Marckmann et al. 2006)” “Many agencies have banned the use of linear GBCAs in patients with renal disease with GFR … less than 30ml/min/1.73 m2 (Bhave et all. 2008; Tsushima et al. 2010.)”
96. Their omission of the 2010 FDA warning and related studies perpetuates bias. [Emphasis added.]
97. Davies, et al. disclaimer reveals their bias as, “All authors were employees of GE Healthcare at the time of writing and submission.” GE Healthcare manufactures and sells GBCAs. Research performed by the manufactures of GBCA is biased.
98. Their sources are from 2006—a dated, obsolete and therefore deceitful definition.

99. This manipulative research is epidemic in relevant scientific and medical communities and results from bias, reckless indifference and occasional malice.

BAYER PHARMACEUTICAL’ DISCRIMINATORY AND TOXIC SEMANTICS:

100. The terms NSF, GDD, alone, and Bayer Pharmaceutical’ false assertion and omissions constitute the tactic of toxic semantics. NSF is a toxin pathology that omits the known toxin from its terminology—a deception perpetuated to distance GBCAs from the diseases it causes.
101. As with Lead Poisoning, Bayer’s Round-Up’s Glyphosate cancerous herbicide, or Massengill’s famous 1937 Elixir Sulfanilamide—when the FDA was overhauled due to its failings—the entire world, but for the pharma terrorist-culprits, are better served by healthier, transparent semantics and inclusion of properly identified toxin in the name of the toxicological disease as in this catastrophic iatrogenic injury, therefore better known as Gadolinium Toxicity.
102. Bayer Pharmaceutical not only caused my key disability but for the last thirteen years, they discriminated against me because of it. Their restrictive definition and 13-year history of defective warnings denied me a valid warning and obstructed my receipt of an accurate diagnosis by encouraging medical bias against me, which was/is discriminatory. Bayer Pharmaceutical’ animus and denial of valid warning services is based upon and further aggravates my disabilities. Refusal to acknowledge my true diseases and cause of my key disability, in fact caused by their linear GBCA, Magnevist, is a continuing denial of warning services and failure to fully-equally-fairly accommodate me. Their on-going campaign has had deleterious effect on my health and health care.
103. Contrary to Bayer Pharmaceutical’ 2007 operative defective, discriminatory, exclusionary warning of Gd Tx’s semantic predecessor, NSF, as finally confirmed by the FDA in 2010 and 2017 and a Federal Judge in 2019, a patient does not have to be diagnosed with pre-existing, severe renal insufficiency, nor classified as CKD, class 4 or 5, in order to contract NSF. The toxin will readily pummel the kidneys into submission, oppress performance, then poison the Patient-Victim.
104. Now, someone just has to tell the scientific and medical communities.

BAYER PHARMACEUTICAL’ LINEAR GBCA MAGNEVIST IS DEFECTIVE:

105. Bayer Pharmaceutical’ linear GBCA Magnevist was not reasonably fit, suitable or safe for its intended purpose, i.e., use on ill patients receiving MRAs for medical diagnostic purposes. The substantial incidence and severe degree of injury inherently distinguishes this toxicity crisis from a mere rare occurrence or an occasional accident. It is a medical disaster of epic proportions with tragic consequences for the Patient-Victim of the disease, Gadolinium Toxicity. I suspect Bayer Pharmaceutical concealed relevant information during the FDA approval process and subsequent reevaluations and revisions of its Black Box Warning. I suspect Bayer Pharmaceutical’s product deviated from specifications, formulae or performance standards of manufacturing or from otherwise identical units manufactured to the same specifications or formulae (manufacturing defect), failed to contain adequate warning (warning defect), and was designed in a defective manner (design defect).
106. Bayer Pharmaceutical’ linear GBCA was defective, the defect existed when the product left Bayer Pharmaceutical’ control. The defect caused my injury—the reasonably foreseeable user of the defective medical product. Bayer Pharmaceutical had a duty to warn and it rendered its own product defective—in addition to its design defect—by failing to adequately warn all foreseeable users that their drug can cause injury to them. Bayer Pharmaceutical’ failures to warn constitute a breach of duty. They had a duty to warn intended users about any and all risk related to their drug that it knew or ought to have known. Yet, Bayer Pharmaceutical published no such warning—until too late, and then, incomplete.
107. The risk posed by Bayer Pharmaceutical’ linear GBCA Magnevist outweighs its intended utility, and, the product could have been designed in a readily-available safer alternative manner such as the design of macrocyclic GBCAs, so to minimize the risk of harm. Bayer Pharmaceutical’ failure to implement the known, affordable and available changes to its design and manufacturing practice, including the design of macrocyclic GBCA, a feasible and safer alternative design, and its omission by Bayer Pharmaceutical, rendered the linear GBCA Magnevist to be unreasonably unsafe. Bayer Pharmaceutical drug danger and risk to foreseeable consumer’s health are the direct result of its chemical design and active ingredient, Gadolinium. If Bayer Pharmaceutical’ linear GBCA Magnevist had been designed without defect, my injuries would have been avoided.
108. Bayer Pharmaceutical’ linear GBCA Magnevist caused me to contract the disease Gd Tx, known as GDD at the beginning stage of the toxicological spectrum and NSF and the end stage of the continuity of poisoning. I suffered a complex symptomology detailed below because Bayer Pharmaceutical failed to warn me of the health risks associated with their medical drug.
109. In their course of business, Bayer Pharmaceutical breeched their expressed warranty. Bayer Pharmaceutical made an affirmative promise in their description of Magnevist that their product was safe. In the competitive pharmaceutical industry, Bayer Pharmaceutical’ promise was an integral element of their marketing and eventual sale of their product to medical professionals and subsequent use of it in patients during MRAs. Alas, the product fell far short of their promises of utility and safety.
110. In 2007, they represented that their linear GBCA was generally safe to use on all patients; that the linear GBCA is not any less safe than Macrocyclic GBCAs; that linear GBCAs are contraindicated only in patients with pre-existing, severe chronic renal impairment; that retention of de-chelated Gadolinium in patients without severe chronic kidney disease is harmless.
111. Yet, clinical features of Gadolinium Toxicity include persistent headaches, bone and joint pain, clouded mental activity, dermatological disorders, subcutaneous soft-tissue thickening that clinically appears somewhat spongy or rubbery, painful and thickened tendons and ligaments in a comparable distribution; excruciating pain, typically in the distal distribution but may also be in the torso and ribs or generalized, often described as feeling like sharp pins and needles, cutting and burning; and diseases from nephrogenic, neuropathic and orthopedic toxicities. Gd Tx often progresses to painful inhibition of the ability to use the arms, legs, hands, feet and other joints. Gd Tx is a progressive disease for which there is no known cure.
112. Indeed, Gadolinium is a toxic lanthanide heavy metal with the size similar to that of calcium. It causes toxicity through several processes: cell death induction (apoptosis); oxidative stress; exchange of gadolinium with other bio-metals (transmetallation); competition with calcium for cellular processes.
113. Yet, for 35 years and continuing, Bayer Pharmaceutical piecemealed their admissions in an attempt to conceal culpability. They decided who deserved consideration and through false claims and omissions, refused to acknowledge the full, unbroken spectrum or continuity of Gd Tx and corresponding symptomology for the de-chelated, free, raw, highly toxic Gadolinium, be it deposited or transitory, introduced to the Patient-Victim by the linear GBCA Magnevist.
114. Yet, as is typical and consistent with the tenets of toxicology, the full range of toxicity does exist, as does the entire range of susceptibility, including the middle range, to contract the multiple GBCA Magnevist toxicities, all along.
115. I asserts and will demonstrate upon discovery that Bayer Pharmaceutical knew or ought to have known their linear GBCA Magnevist was dangerous and unfit for patients with moderately impaired renal performance, as partially admitted in 2010.
116. Also, published research available during the 21 years prior to my receipt of the linear GBCA Magnevist, and after the 2007 FDA revision, established the risk posed to moderately impaired patients injected with linear GBCA. Yet, Bayer Pharmaceutical elected not to acknowledge it and failed to warn the FDA and the vulnerable patients via their physicians of the risk they faced if they received Magnevist and certainly did not prohibit its use on such patients as they had in 2007 for patients categorized with severe impairment and in CKD, class 4 and 5, (GFR < 30 mL/min/1.73m2).
117. Patient-Victims were placed at high risk and indeed were severely injured by Bayer Pharmaceutical’ premature release of its defective linear GBCA Magnevist. For one hundred years, Bayer Pharmaceutical have used Patient-Victims as lab rats to test their drugs while they made a financial fortune from inhuman medical experimentation and infliction of injury.

118. About 40% of all MRIs include the use of GBCAs. GBCAs are planting time-bombs in its nearly 9,000,000 victims in the U.S., alone, and 30,000,000 victims world-wide. It is prescribed for pediatric patients, 2 years of age and older.

A SUPERIOR, SAFER PRODUCT DESIGN EXISTS:

119. Pharmaceutical, medical and scientific communities’ reticence to acknowledge the absurdity of intravenously injecting a notorious toxin into humans, humans already ill, or else they would not be receiving MRAs to diagnose their medical conditions, informs the tragic origin of Gd Tx. Likewise, there also exists industrial and FDA bias and institutionalized reluctance to acknowledge there exists a safer design option—if it has to be used at all.
120. A superior product design that achieves the same radiological results but places the patient at less health risk is macrocyclic GBCAs. The proposal to modify linear GBCAs into macrocyclic GBCAs is not a call to terminate the production of Bayer Pharmaceutical’ GBCA. Modification from a toxic product to a demonstrably safer product is an enhancement. Though it may require a modification of manufacturing, that modification simply does not constitute a termination of Bayer Pharmaceutical’ GBCA. It is a humane action. Bayer Pharmaceutical clearly demonstrated this fact when they later modified their linear GBCA in a failed attempt to increase its safety.
121. Though the FDA and medical and scientific communities were misled by the manufacturers of linear GBCAs, they grew so individually and collectively complacent and invested in the use of the linear GBCAs, they forfeited their will to protect the public and advocate for use of the safer, readily achievable macrocyclic GBCA design.

122. In 1992, the FDA approved the first macrocyclic GBCA, ProHance; a mere four years after Magnevist was approved. Hence, macrocyclic GBCAs have long been readily available to serve as a model for modification to manufacture a safer drug. They are more stable, less prone to de-chelation, and represent a safer alternative to liner GBCAs—if they must be used at all. Therefore, Bayer Pharmaceutical knew or should have known about the different risks and safety between the two types of GBCA products. Yet, for 35 years and counting, they chose not to warn the FDA and medical community and failed to alter the design of the linear GBCA to comport with that of their macrocyclic competitors. Instead, the nearly four decades of Patient-Victim poisoning is perpetrated for profit—the result of corporate avarice.

OTHER CAMPAIGNS TO ROUST THE TRUTH:

Publications that Revealed the Dangers but Were Apparently Ignored:

123. In 1984—prior to FDA approval—the inventors of linear GBCAs falsely claimed that their product Gd-DTPA was safe and did not cross the blood-brain barrier, and that the bonds between the toxic gadolinium and its protective coating did not break down inside the body, and that there would be no toxic gadolinium residue left behind to cause illness.
124. Yet, since at least 1984, stability differences among GBCAs have been recognized in laboratory (in vitro). Since 1984, deposition of toxic gadolinium in tissues has been described in animal models (in vitro). Peer review articles were published on the deposition of gadolinium in animals with normal renal function, some illustrating deleterious consequences.
125. In 1988, the FDA approved of Magnevist, the first GBCA to reach the market.
126. In 1988, it was recognized that gadolinium was breaking free from the bonds in the linear GBCAs as they grew weak under certain conditions and locations within the human body. (Huckle, et al. 2016)
127. In September 1989, what may have been the first report of toxic gadolinium retention in humans was published, a little over one year after approval of Magnevist. Authors Tien, et al. reported that intercerebral masses, “remained enhanced on MRI images obtained 8-days after injection of gadolinium DTPA dimeglumine—Magnevist. Subsequent chemical analysis revealed a high concentration of gadolinium remained in the tissue.
128. In 1991, Pharmacokinetic studies indicated that gadolinium retention was occurring in people with normal, slightly impaired and moderately impaired renal function. [2]
129. In 1998, the first major study that showed deposition in patients with renal failure was published. (Huckle, et al. 2016)
130. In 2004, the first major study that showed deposition in patients with normal renal function was published. (Huckle, et al. 2016)
131. In 2004, gadolinium was shown to be deposited in patients’ resected femoral heads who had undergone gadolinium-chelate enhanced MRA studies. [3] Since, studies have continued to indicate that gadolinium remains within patients’ bodies long after its suggested half-life.
132. In 2006, the Food and Drug Administration (FDA) voted to issue a Black Box Warning on all gadolinium-based contrast agents. This was prompted by Nephrologists and other scientists connecting the administration of GBCAs, including Magnevist, to the rapidly progressive debilitating and often fatal disease called Nephrogenic Systemic Fibrosis (NSF).
133. Over the next sixteen years, more evidence was forthcoming, and research began to flourish regarding the release of toxic gadolinium from the linear contrast agents such as Magnevist, and its long-term retention in the bodies of animals and humans.
134. The laboratory (in Vitro) studies assessing the stability of each GBCA in human blood were performed and demonstrated that, over time, greater percentages of gadolinium were released from linear agents as compared to the macrocyclic agents which showed superior stability. The lack of stability seen within the linear agents was not considered to be a problem as long as the contrast agent was cleared/excreted out of the body according to the claimed drug’s half-life, before the chelate could release the toxic gadolinium. However, as discussed above, it was later noted that other conditions could cause prolonged retention of the contrast agents, thus allowing more toxic gadolinium to be released in the bodies of Patient-Victims. In addition, a delayed elimination phase of the GBCA would later be discovered.
135. In 2012, patients sent several strongly worded letters with scientifically-supported research data to the FDA, warning about the occurrence of gadolinium toxicity in those with normal renal function following injections of GBCAs. Correspondence was confirmed.
136. Symptomatic patients started to obtain documentation of high levels of gadolinium in their blood and urine several days, weeks, months and even years after their exposure to GBCAs. Many patients even had tissue biopsies of various parts of their body that showed additional evidence of retained gadolinium years after their exposure.
137. Yet, Bayer Pharmaceutical have failed to update their Black Box Warning to reflect the extensive evidence of gadolinium retention in people with normal, slightly impaired and moderately impaired renal function and to warn of the likely probability of the de-chelation that will expose the patient to “free” toxic gadolinium.
138. Because obvious signs of clinical pathology associated with NSF were only “seen,” and “acknowledged,” in patients who had severely impaired renal performance, i.e., CKD, class 4 and 5, it was widely—BUT ERRONEOUSLY—assumed by the public and medical profession alike that people with normal kidney performance or slightly to moderately impaired renal function were not getting sick and there were no other concerns. However, research continued to report evidence that toxic gadolinium was being stored in people with normal, slightly reduced and moderately reduced renal function. Alas, medical and scientific Confirmation Bias kills, as does individual, organization and corporate greed.
139. Although many patients with debilitating symptoms who had normal, slightly impaired and moderately impaired renal function that received injections of GBCA had already been reporting adverse reactions for years to the FDA, manufacturers and poison control, no link between gadolinium and their symptoms were ever officially made public. This is partially because blood and urine testing for gadolinium only became available recently, but it is primarily due to scientific bias. Most physicians would not allow themselves to be aware of any disease that was associated with gadolinium other than NSF, which was said to only occur in patients with pre-existing severe renal impairment and categorized as CKD, class 4 and 5.
140. In 2013, while examining non-contrast enhanced MRI images, Japanese researchers found evidence of retained gadolinium in the brains of patients with normal renal function that had previously received one or more injections of GBCAs up to several years prior. The findings that the brain had hyperintense signals in critical areas of the brain well after the administration of GBCAs was very alarming.
141. In 2014, scientists at the Mayo Clinic confirmed these findings when autopsy studies were performed on thirteen (13) diseased individuals, all of whom had normal or near normal renal function and who had received six or more injections of GBCAs in the years prior. Up to 56mcg of gadolinium per gram of desecrated tissue were found within the patients’ brains.
142. As these new findings emerged, the entire radiology community was put on high alert. With several large universities conducting research to further address this concern.
143. In July 2015, and in direct response to the Mayo Clinic study’s findings, the FDA issued a new public safety alert. The FDA is evaluating the risk of brain deposits from repeated use of GBCAs use in MRAs and they now have their National Center for Toxicological Research team working on determining the consequences of these new findings.
144. In August 2016, the article, “Gadolinium in Humans: A family of Disorders,” was published in volume 207.2 of the American Journal of Roentgenology.
145. In September 2017, the FDA’s medical advisory committee voted 13 to 1 in favor of adding a Black Box Warning that gadolinium can be retained in organs, including the brain, even in patients with healthy kidneys.
146. On December 19, 2017, the FDA required a new class warning and other safety measures for all GBCAs concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Yet, they continue to deny a causal relationship between the Gadolinium Deposition Disease and Patient-Victims’ injuries.
147. By 2017 and 2019, within the scientific community, medical institutions as well as the United States Federal Courts, the original restrictive qualifiers, “Severe renal insufficiency,” and “preexisting CKD, class 4 and 5,” were replaced with more inclusive qualifiers, “We have a recognized disease of NSF in renally-impaired patients and its accepted link to GBCAs,” and, “NSF … is caused by gadolinium retention in patients who have renal failure.” Clearly, the vocabulary-substitute gained wider use but without fanfare, let alone admission of the decades of abuse caused by its linguistically more restrictive terms of NSF, and symbiotic-industries’ biases.

148. Gadolinium Toxicity is underreported and underdiagnosed because of four decades of linguistically restrictive and discriminatory toxic semantics and medical and scientific bias. This is but one example of how the status quo of biased institutional authority harms the American people—all in the name of profit—and, how those who challenge the misinformation campaign get attacked. Over the past fifteen years, patients with normal, slightly impaired and moderately impaired renal performance have been forming advocacy groups and coming forward to create awareness for their condition—a counter-maneuver to their systemic exclusion by the symbiotic medical-pharma-legal defense industries. I am but one Survivor fighting to bring forth the truth and hold the culpable parties accountable.

MY JOURNEY: SURVIVING MEDICAL PREJUDICE

149. June 2009, while Bayer Pharmaceutical and the FDA negotiated the appropriate black box warning for the linear GBCA Magnevist—for about a six-week period—when I received the MRA and was injected with the linear GBCA Magnevist—there was no black box warning or a defective warning. It did not warn me—via my physicians—of the danger their product posed to me, namely, the risk of contracting NSF or Gd Tx for CKD, class 3, patients.
150. Prior to June 12, 2009, I completed and submitted my Kaiser Permanente MRI/MRA Questionnaire; I listed my Chronic Kidney Disease, (CKD) class 3. I had pre-existing moderate renal insufficiency, CKD, class 3, and a history of kidney stones. I also preemptively inquired with the MRI staff and asked if I should receive a blood test to confirm my renal function. Based in the 2007 Black Box Warning, available only to them, they declined and assured me that I faced no health risk from the MRA because my last GFR was well over 30.
151. If my physicians were properly warned, they would not have prescribed Magnevist.
152. I received no counseling, no testing, no warning. The physicians’ failures to convey any warning for my specific health profile and susceptibility variables is the result of the operative 2007 warning’s defectiveness. Thereby, I was denied my medical right to make an informed decision and to consider and decline the GBCA Magnevist, based on my known risks.
153. June 12, 2009, I received the MRA to rule out an acoustical neuroma during a differential diagnosis to ascertain the cause of my tinnitus (ringing in the ear). I was intravenously injected with 30cc of the linear GBCA, Magnevist. Upon the injection, I felt a burning sensation throughout my body. As soon as he stood, my legs buckled; I left, weakened.

154. Less than an hour after the injection, I collapsed and suffered overwhelming, debilitating symptoms. I returned to the same Kaiser medical center.

Kaiser Permanente’s Response: OPPRESS THE PATIENT:

155. Kaiser Permanente immediately initiated an adversarial campaign against me. It initially refused to admit me into the ER and left me to suffer in excruciating pain until a contingency of fellow ER patients advocated on my behalf for admission.
156. The next day, Kaiser insisted my injury was caused by a one-millimeter kidney stone lodged in my urethra and advised surgery to extract it. I received the surgery but my kidneys continued to fail, an unusual renal response to stone extraction—something else was wrong. In contrast, two years earlier, I received surgery to extract kidney stones that were 5mm in size. My renal performance swiftly returned to its baseline after the stones extraction.
157. I had to remain in the hospital for a week. I suffered excruciating pain throughout my body. For a week, I was curled up into a fetal ball, howling in pain. Kaiser drugged me and concealed their fault and did nothing to help me, when dialysis was in order.
158. June 12, 2009 through August 10, 2010, Kaiser conspired against I and lied to me about the chemical they injected into me during the MRA. In the attempt to expire the California one-year statute of limitation for medical negligence, for the fourteen months following the tragic injection, they repeatedly, falsely asserted they administered an iodine-based-contrast-dye on June 12, 2009. They put it in my medical notes.
159. August 2010, I obtained the real Radiology report and learned Kaiser injected me with the linear Gadolinium-Based-Contrast-Agent, Kaiser’s physicians concealed a second critical fact for the same fourteen months: Magnevist remained trapped for at least three days in my bladder—three days after the injection.
160. The GBCA’s chelation began to break-down after only a few hours, poisoning me, promptly. This explained why I was balled up in a fetal position in my hospital bed and howled in pain for seven days.
161. From 2009 through 2013, Kaiser’s Nephrologists, Allergists, Dermatologists, Endocrinologists, Orthopedists, Primary Care Providers and Toxicologists at three separate medical centers refused me testing of gadolinium in either my blood, skin or bone specimens that were extracted from me during my surgeries. Kaiser confirmed they retained the samples but falsely claimed there was no available method of testing for retained gadolinium.
162. When I tried to inform my physicians that I developed signs and symptoms of poisoning following the injection, the physicians told me Magnevist had nothing to do with his symptoms. In response to my complaints, my physician told him to “Knock it off.” These awful acts of hostility demonstrate the catastrophic consequences of Bayer Pharmaceutical’ defective 2007 warning and omissions, namely, encouragement of subsequent reckless indifference by the medical industry toward Patient-Victims with CKD, 3, who suffer poisoning, such as me.
163. In 2011, I was assessed disabled and assigned to Medi-Cal.
164. About 2013, USC Saeid Nosrati, M.D., Nephrology, diagnosed I sustained Contrast Induced Nephropathy (CIN) due to the June 12, 2009 injection of Magnevist, and, USC Dr. James Adams, PhD, Pharmacology, diagnosed I sustained NSF—the only term available at the time for the only disease contributed to retained de-chelated Gadolinium.
165. Yet, during mandatory arbitration for medical negligence, Kaiser medical experts refuted my allegation that I suffered NSF. Kaiser argued that a patient must be diagnosed with “Pre-Existing, severe renal insufficiency, and categorized as CKD, Class 4 or 5, and/or, be on dialysis, in order to sustain NSF. My own lawyer hired a supposed expert with a dubious reputation who falsely testified I did not suffer NSF but instead fabricated my disorders and injuries and suffered Somatization Disorder. Alas, the 2007 definition prevailed and the Kaiser arbitrator dismissed my complaint and ruled in Kaiser’s favor. I was “defensed.”

166. From 2009 to 2013, Kaiser physicians viciously denied any causal link to Magnevist. They continued to cling to the discriminatory 2007 warning and ignore the 2010 revised warnings that patients with CKD, 3, can contract NSF. Worse, they continued to deny my medical facts and refused to address the matter. 2013, Kaiser denied me orthopedic surgeries, despite the CA DSS ruling ordering the shoulder and hip surgeries to be performed.

Transfer of Care Failed Due to the Same Discrimination:

167. 2014 through present, I sought care from UC Medical Centers and Cedars Sinai. Yet, they refuted the de-chelated, retained Gadolinium from the linear GBCA, Magnevist, poisoned me and refused to test me for Gadolinium retention, contrary to the 2010 and 2014 Black Box Warning. Consequently, I was thrust into untenable positions as I needed their medical services including surgeries but suffered from my opponents’ overwhelming contempt for my true medical condition. They refused to test me for Gadolinium Retention and refused to include me in support groups and studies for NSF. This oppressive campaign to silence me manifested in an, “Either/Or,” demand: “Either stop complaining about NSF—because you don’t have it—or you will not receive surgeries!” I encountered injurious, unethical denials of my contraction of NSF at UCI, 2018; Cedars Sinai, 2018; UCSD, 2020 and at UCLA, 2014 to 2022.

Thirteen Years of Medical Discrimination and Obstruction and Counting:

168. From 2009 through the present, thirteen years, the polluters and their protectors, big pharma and the FDA, have yet to acknowledge my full range of risk and injuries from their man-made disease. The self-preserving symbiotic industries perpetrate an overwhelming effort to obstruct Patient-Victims like me. Kaiser, UC Medical Centers and Cedars Sinai refused my requests to test for Gadolinium though there was no other cause for the continuing decline in my health. They capitalized upon the vast difference in their resources to exploit my vulnerability and surgical needs, to thwart my search. They refused to perform prescribed surgeries. They threatened to and ultimately “discharged,” me, when I would not remain silent. Their drive to protect themselves, their profits and status quo had a deleterious impact upon me as it would have upon any Patient-Victim under the same circumstances.
169. Providers denied Magnevist inflicted the horrific injuries I sustained and denied me appropriate, timely surgeries and allowed me to suffer. They exercised their dominance in a cruel manner in order to protect their profits and to avoid acknowledging that their ongoing use of linear GBCAs may pose an unacceptable risk to all of their patients.

170. In an insidious manner, they refused to accept Medi-Cal supposedly due to its reduced reimbursement rate but it felt like coercion to me to capitulate to their demand to remain silent about Magnevist, its de-chelation and my retention of gadolinium—if I wanted the prescribed surgeries and to survive—a demand I could not morally or physically tolerate.

The Tide of Intolerance Ebbed—Almost:

171. Early 2018, I was moved by four new notable developments. First, I learned the actor Mr. Chuck Norris and his wife, Geena, filed suit for Gadolinium Deposition Disease, GDD, and this way learned about pharmaceutical product liability. Second, medical providers began discussing GBCA-induced diseases for patients classified along the entire spectrum of kidney function from normal to impaired renal function and in all classes of Chronic Kidney Disease, CKD, classes 1 through 5. Third, physicians timidly began to suggest that I was “allergic,” to and had an anaphylactic shock to Gadolinium. Fourth, prayer.
172. With the final acknowledgment of GDD, the overwhelming oppression that excluded me from both medical care and justice began to wane. The flawed premise that there is only one restrictively-defined gadolinium-induced disease, NSF, and only patients with pre-existing, severely impaired renal performance could contract NSF, began to crumble.
173. I realized I had to sue the manufacturers of Magnevist.
174. Alas, as recently as 2020, the medical industry and medical centers like UC San Diego continued to abuse, harass, injure, mock and oppress me for my claim that I contracted the disease, NSF, a subset of Gd Tx; they refused to add it to my medical profile.
175. The symbiotic industries oppress the victims of their animus. By the disproportionate power of office, profession and pharmaceutical lobbying and research dollars, they conceal the truth, and thereby render the disempowered Gd Tx Patient-Victims, “Invisible.”

176. Herein, thirteen years later, I pray to be seen and heard.

MY JOURNEY: SURVIVING GADOLINIUM’S ATTACKS:

177. In my case, no preexistent disease or subsequently developed disease of an alternate known process is present to account for my symptoms. I experience symptoms consistent with the known toxic effect of de-chelated and retained linear Gadolinium.

My Multifactorial Susceptibility:

178. I was susceptible due to a convergence of four susceptibility-variables. They include: (1) CKD, 3 (pre-existing); (2) renal and urinary impairment (kidney stone, same day); (3) renal failure (Magnevist-Induced); and (4) GBCA extended residency (at least three days).

My Body Was Under Attack:

179. Gadolinium, as Bayer Pharmaceutical admits, is fibrotoxic and nephrotoxic. I suffered subsequent fibrotic and nephrogenic toxicities. Those toxicities triggered diseases and inflicted injuries. For example, it poisoned and shocked his kidneys into failure. In me, the first chemical, “Sucker-Punch,” hit my kidneys hard. I suffered AKI also known as Contrast Induced Nephropathy (CIN) and Transient Degradation. I dropped from CKD, class 3, to CKD class 4. My GFR 52 dropped to GFR 28. I suffered Renal Failure.
180. The cruel irony: Bayer Pharmaceutical’s Black Box Warnings advise physicians to screen for Acute kidney Injury (AKI). Yet, a physician cannot screen for AKI that has yet to be inflicted. It was Bayer Pharmaceutical’ drug, Magnevist, that inflicted the contraindication after the injection. It caused the renal failure then swiftly exploited it and destroyed its host.
181. Soon thereafter, the GBCA stripped down to its raw toxic state, using the body’s own processes against itself, so the free Gadolinium could deliver the second chemical, “Punch.” It poisoned me as the stunned kidneys and restricted urinary system could not clear/excrete the enemy, the de-chelating Gadolinium for three days. Within hours, the toxin, raw Gadolinium, was released and poisoned its Patient-Victim. Gadolinium is a two-faced terrorist: both suppressant and toxin.

NSF:

182. I suffered fibrotic and nephrotic toxicities and sustained diseases and injuries including renal failure, skin disorders, hair loss, fibrotic accumulation, muscular and joint contractures, movement restrictions, pain and Nephrogenic Systemic Fibrosis (NSF).

Contrarily, I Demonstrates Something Much More: The Unbroken Spectrum of the True Range of Risk, Gadolinium’s Multiple Toxicities and Their Induced Sequelae of Diseases:

183. Almost 35 years since its approval, contrary to ongoing toxic semantics, it is logically and scientifically valid to identify and title those Patient-Victims sandwiched between the two recognized end-points, namely NSF (recognized in 2007) and GDD, (recognized in 2017). It is equally reasonable to assert that Gadolinium contains not just Fibrotic and Nephrotic toxicities, as acknowledged, it contains neurologic and orthopedic toxicities, too, as studies and my medical evidence establish. Yet, Bayer Pharmaceutical refuses to admit it.
184. In addition to fibrotic and nephrotic toxicities, I sustained neurologic and orthopedic toxicity diseases and injuries. Neurotoxicant Gadolinium works through numerous neuro-mechanisms and damages the brain and central and peripheral nerves. Orthotoxicant Gadolinium adversely affects mineralized tissue such as bone and calcium homeostasis and causes orthopedic disorders. Combined, these four toxicities cause a devasting matrix of long-term diseases and injuries. Over the ensuing years, Gadolinium’s fibro-nephro-neuro-ortho-toxicities inflicted profound matrix of diseases and sequelae of injuries and symptoms upon me.
185. Thereby, I contracted something much more than NSF but Bayer Pharmaceutical have failed to acknowledge it and to warn against the neuro or ortho toxicities and their diseases.
186. Hence, I am entitled to title it. In accordance with the science of Toxicology and my medical evidence, as a patient in the middle of two recognized end points, not unlike the middle finger saddled between the two sets of outside fingers, and with moderate renal insufficiency, I retained gadolinium because four susceptibility-variables were present in sufficient degree and I suffered debilitating Gadolinium Toxicity, Gd Tx, which, again, includes fibrotic-nephrotic-neurologic-orthopedic toxicities and their ensuing disease.
187. Patient-Victims with moderately impaired renal function, CKD, class 3, develop a sequela of symptoms that arise at the time of injection and minutes/hours/months/years after administration of linear GBCA Magnevist. These symptoms are not acknowledged by Bayer Pharmaceutical or the FDA. The severe injuries I sustained from neurologic and orthopedic toxicities that destroyed my body were not listed in Bayer Pharmaceutical’ 2007, 2010, 2014 or 2017/2018 warnings. Therefore, their original, their 2007 and their subsequent warnings are defective.
188. Bayer Pharmaceutical and the FDA’s last claim that, “Consequences of gadolinium retention in the brain have not been established,” is false, as per my medical evidence to the contrary. The list of contractible diseases must be expanded from their one singular disease, NSF, to include the neurologic and orthopedic toxicity-caused diseases and symptoms. Bayer Pharmaceutical’ motives for such extensive omissions are obvious. They contend the one of the primary use of their drug is for imaging the nervous system. Yet, their drug is toxic to the nervous system. They have misrepresented Magnevist’s toxicity as long as they can to maximize their profits.

189. Had I and/or my medical provider been warned about the risks associated with the linear GBCA Magnevist, I would not have been administered Magnevist and would not have been inflicted with its life-destroying diseases.

My Sustained Injuries:

190. As a direct and proximate result of being administered GBCA Magnivest, I initially suffered excruciating pain, delirium, debilitation, numbness, sharp, painful tingling sensation throughout my body, severe fatigue, restless leg syndrome, limb and rib pain, memory loss and cognitive impairment and renal failure.
191. As a direct and proximate result of being administered GBCA Magnevist, I have been rendered permanently disabled and has subsequently suffered and continues to suffer:

(1) Brain/Head Neurological Injuries including Cerebral Atrophy; Cranial Nerve Root Damage including Trigeminal and Occipital Neuralgias; Vestibular Disorders, Neuro-Ophthalmological Disorders; Hearing Loss, exacerbated Tinnitus, Atrophied and Scarred Vocal Cords; Oral, dental and jaw injuries; Pituitary Adenoma/Rathe Cyst and sinus polyps;

(2) Spinal Injuries, both Orthopedic and Neurological Injuries including Adhesive Arachnoiditis, Cervical Vertebral and Intervertebral Disc Degradation and Bilateral Peripheral Radiculopathy; Dorsal Arachnoid Web and resulting severe thoracic spinal cord compression; Schmorl’s Nodes; Tarlov Cysts; Hemangioma; Herniated Discs; Sacroiliitis;

(3) Heart Disorders Sick Sinus Syndrome/Chronotropic Incompetence/Sinus Bradycardia;

(4) Vascular Disorders including Deep Venus Reflux Disease, arterial blockage and varicocele;

(5) Pulmonary Disorders including Restricted Breathings and esophageal restrictions;

(6) Orthopedic Disorders and Injuries including Osteoporosis; Osteoarthritis; Bilateral Shoulder and Hip Injuries; Bone and Joint Pain in hips, spine and ribs; joint contracture;

(7) Systemic and Tissue Disorders and Injuries including Ankylosing Spondylitis; calcified tendons; carpal tunnel and cubital ulnar nerve impingement; stenosing tenosynovitis. dermatological/fibrotic disorders with ulcerated rashes, excessive scarring and deformed skin.

192. From 2009 through 2022, as a direct and proximate result of being administered GBCA Magnevist, I has received about forty major surgeries and about sixty minor procedures including two brain surgeries, revision cranioplasty; five neurostimulator surgeries, three vocal cord surgeries; two nasal-polyp surgeries; multiple oral surgeries; two cardiological implant surgeries; four cervical spine surgeries; four pelvic surgeries; three lower abdominal surgeries; bilateral varicocelectomies, bilateral carpal tunnel surgeries.
193. More than 50% of my surgeries are delayed, on average, for 4 years, while providers deny me the appropriate, timely surgeries due to bias, disbelief and Medi-Cal’s abysmally low reduced reimbursement rate, extending my suffering to abhorrent levels of torture.
194. As a direct and proximate result of being administered linear GBCA Magnevist, I have been prescribed about twelve more surgeries, including: (1) cervical spine revision surgery—denied for 3 years, (2) thoracic spinal cord surgery—denied for 6 years, (3/4) bilateral shoulder surgeries—denied for 10 years; (5/6) bilateral elbow surgeries—denied for 9 years, and (7/8) bilateral hip surgeries—denied for 10 years; (9) neurostimulator replacement surgery—denied for 6 years; (10) oral surgeries—denied for 10 years; and (11) bunion surgery—denied for 2 years and (12) hand surgery denied for 3 years. To treat my exacerbated disabilities caused by Gd Tx diseases, I have received and am pending approximately 113 procedures.
195. As a direct and proximate result of being administered GBCA Magnevist, I suffered and continue to suffer significant mental anguish and emotional distress and will continue to suffer significant mental anguish and emotional distress in the future and have also incurred medical expenses and other economic damages and will continue to incur such expenses in the future.

196. As a patient with pre-existing CKD, class 3, who retained, “free,” highly toxic Gadolinium, I suffered fibro-nephro-neuro-ortho toxicities and sustained a complex matrix of diseases with varying levels of disease activity and severity and a profound sequelae of injuries and symptoms. Therefore, based upon my evidence, and due to the dearth of pharmaceutical and medical consideration, I identify as a Patient-Victim of the logical, inclusive, full-spectrum, unbroken-continuity term, Gadolinium Toxicity, and advance this complaint, accordingly.

BAYER PHARMACEUTICAL’ TORTIOUS ACTS AND TOXIC DRUG:

197. Gadolinium is a notorious fibrotic, nephrogenic, neurologic and orthopedic toxin, and begins to poison its victims within hours. Yet, as late as 2017, the FDA forfeited credibility when it argued there was no proof of causation of injury by toxicity from retained de-chelated, toxic Gadolinium deposited in the bodies for GDD Patient-Victims. Yet, one of their own scientists confirmed, “Retained,” gadolinium can cause the “devastatingly serious,” disease, NSF.
198. Reasonably, retained Gadolinium’s four toxicities inflicts various diseases of varying levels of activity, resulting in varying degrees of injury and symptoms sustained by Patient-Victims, according to their varying susceptibility-variables of risk—as do all toxins.
199. Bayer Pharmaceutical’ trick is a mere sleight of hand. After decades of unethically claiming their drug was safe for everyone, slowly and in stages they, “Opened,” their false claim to partial truths, and not willingly, and not completely. First, they admitted only one disease, NSF, and, only the narrowed risk range, CKD, class 4 and 5. Second, they divided contiguous classes of patients and admitted only one of the two classes was at some undesignated, “Lower,” range of risk, but again, only for NSF, omitting equally devastating additional toxic diseases. Third, they finally admitted what the rest of the world established: De-chelated gadolinium indeed deposits within its victims’ bodies and even traverses the blood-brain barrier and deposits within their brain and spinal cord (but oddly omitted CKD, 3, Patient-Victims). Fourth, they talked only about the “Organs’ susceptibility, further de-humanizing the crisis, and falsely assert the causal link of the notorious toxin to Patient-Victims’ documented and reported injuries is “Unknown.”
200. Bayer Pharmaceutical have forfeited their credibility as have medical professionals who continue to protect themselves, the linear GBCA manufacturers and the trillion-dollar market by denying the conspicuous causal relationship between linear GBCAs and sustained injuries.
201. Gd Tx is an all-inclusive term that accommodates the varied degree of injury sustained by Patient-Victims in proportion to the impact the GBCAs’ de-chelated and retained gadolinium has upon them, typically proportional to their susceptibility-variabilities, be they pre-existing, or, “Post-induced” by the GBCA-Injection, itself.
202. Bayer Pharmaceutical’ drug Magnevist can create the adverse circumstances/susceptibility-variables that place their consumers of their drug at risk of contraction of fibrotic, nephrogenic, neurologic and orthopedic toxic injuries and their sequelae of diseases and symptoms, not just NSF.

203. Now, I proceed as a Survivor to fight back. I ask you to hear my plea for justice in order to stop the insidious, inhuman abuse by a company that since world War I has been missioned to profit from the injury of others.

BAYER PHARMACEUTICAL’ KNOWLEDGE AND RESPONSIBILITY TO KNOW AND THE CONSEQUENCES OF THEIR ACTIONS:

204. The linear GBCA Magnevist that was injected into me, was manufactured by the Manufacturing Bayer Pharmaceutical and distributed by the Distributor Bayer Pharmaceutical. Manufacturing Bayer Pharmaceutical knew that their product, Magnevist, did not have very stable bonds and could come apart easily causing significant toxicity in humans.
205. During the years that Bayer Pharmaceutical manufactured, marketed, distributed, sold their linear GBCA Magnevist, there have been numerous case reports, studies, assessment, papers, peer review literature, and other clinical data that have described and/or demonstrated three diseases in connection with the use of GBCAs: NSF, GDD and Gadolinium Toxicity. Also, there have been a significant number of publicized complaints and comments from individual Patient-Victims afflicted with the three diseases and others seeking to help these individuals.
206. This information was all available to Bayer Pharmaceutical several years ago, and put them on notice of the issues that give rise to my complaint as alleged herein.
207. I received an MRA. During the time period when I received the injection of the linear GBCA, Magnevist, Bayer Pharmaceutical knew or ought to have known that the use of GBCAs created a risk of serious bodily injury in patients with all degrees of kidney performance including, normal, slightly impaired, moderately impaired and severely impaired renal function. Yet, Bayer Pharmaceutical failed to warn me and my healthcare providers about the serious health risk associated with GBCA Magnevist, and failed to disclose the fact that there were safer alternatives.
208. As a direct and proximate result of receiving an injection of the linear GBCA Magnevist, manufactured, distributed, marketed and sold by Bayer Pharmaceutical, I developed Gadolinium Toxicity, the gadolinium-induced disease, including its subset, NSF.
209. Bayer Pharmaceutical has repeatedly and consistently failed to advise consumers and/or their medical providers of the causal relationship between linear GBCAs and the disease Gadolinium Toxicity (Gd Tx). Bayer Pharmaceutical knew or ought to have known of the risk of Gd Tx posed by linear GBCA Magnevist, to individuals in all ranges of kidney function from normal renal performance to severely impaired and obviously including the middle range, CKD, class 3.
210. Bayer Pharmaceutical has known about the risks that linear GBCA Magnevist, posed to people with normal, slightly impaired and moderately impaired renal function for many years. Despite the well-documented evidence of gadolinium retention as listed above, Bayer Pharmaceutical have continuously produced a defective black box warning and thereby failed to warn consumers and their medical providers of the multiple toxicities of their defective drug.
211. Bayer Pharmaceutical was also involved in prior litigation (San Francisco Superior Court Complex Civil Litigation and Federal MDL-1909) involving this very product, and made statements about this product denying that it causes the types of injuries alleged in this complaint.

BAYER PHARMACEUTICAL PREDISPOSITION TO EXPLOIT AND HARM THE VULNERABLE:

212. Bayer’s parent company, IG Farben, previously Schering, previously Chemische Werke Essener Steinkohle, was founded in 1851. During World War I, it produced Serin Gas for the German military. During World War II, it had extensive ties to the Nazi Third Reich. It built a plant at Auschwitz, developed the gas used in its gas chambers and used prisoners for slave labor and participated in human experiments on victims of concentration camps, including the famous case of the 10-year-old twins, Eva and Miriam. Bayer resolved that lawsuit with a $5 billion fund for the, “Foundation of Remembrance.” In 1913, Bayer promoted Heroin use in children. In 1980 Bayer’s division Cutter Biological sold HIV-contaminated blood clotting medicines. Cutter made a heat-treated medication for Americans but continued to sell the tainted medication in Argentina and parts of Asia. The medication infected thousands in the U.S. and abroad with HIV and hepatitis-C. Many died. Contemporaneously, Bayer has been repeatedly, successfully sued for defective drugs and products including Yaz/Yasmin, a female hormonal birth control and Essure, the female sterilization device. In 2016, Bayer merged with Monsanto to gain a footing in agriculture or “Crop Science,” and settled the law suits against the defoliant, “Round-Up” for about $11,000,000,000.

213. Bayer continues to experiment upon, harm and kill people world-wide for profit.

[1] NSF is a horrible disease. Victims’ skin and vital organs fibrose, become hardened. It is nick-named the “Rock Disease,” because victims incur such severe limitations in their movement, they grow sedentary likes rocks as their skin hardens and scales, appearing “rock-like,” while their internal organs suffer the same fate. Over five hundred (500) NSF cases were reported and it is estimated to be well over a thousand non-reported cases. Over 500 lawsuits were filed against GBCA manufacturers; most joined MDL-1909; they settled before trial. Contrary to public interest, the Court sealed the results. Decker vs. GE (Omniscan), went solo and resulted in a $5,000,000 verdict but not before Mr. Decker died from NSF.

[2] Schmann-Giampieri G, Krestin G. Pharmacokinetics of Gd-DTPA in patients with chronic renal failure. Invest Radiol., 1991: 26:975-979.

[3] Gibby WA, Gibby KA, Gibby WA. Comparison of GD-DTPA-BMA (Omniscan) versus GD HP-DO3 (ProHance) retention in human bone tissue by inductively coupled plasma atomic emission spectroscropy. Invest Radiol., 2004: 39:138-142.