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To diagnose a condition, a doctor may request a patient have an MRI. In a handful of these tests, the patient may be injected with Gadolinium, a non-radioactive contrast agent. Approved by the FDA in 1988, Gadolinium allows imaging technicians and doctors to get a clearer picture of the patient’s organs and tissues from an MRI or magnetic resonance angiography.
However, since Gadolinium’s approval, the substance has been linked with 200 cases of Nephrogenic Systemic Fibrosis (NSF), or Nephrogenic Fibrosing Dermopathy (NFD), a debilitating, man-made disease that has no cure. Patients living with NSF find their mobility compromised to the point of fatality and, in response, their families have come forward to accuse Gadolinium’s several manufacturers of negligence.

Background

Researchers first discovered NSF in 1997 and linked it to patients with kidney failure given Gadolinium. The condition may develop regardless of how many times a patient has been given the contrast agent.

NSF gradually turns into a debilitating and fatal condition characterized by discolored, thickened skin and connective tissue. With time, this change restricts the individual’s movement and may lead to:

  • Broken bones
  • Muscle weakness
  • Difficulty flexing joints
  • Scarred internal organs
  • Restricting organ function

NSF is a progressive disease with no cure. For patients with kidney issues given Gadolinium, the condition may manifest early on as:

  • A burning or itching sensation
  • Swelling
  • Skin hardening, thickening or tightening
  • Red or dark patches on the skin
  • Yellow spots on the white of the eyes
  • Stiff joints
  • Inability to straighten or move limbs
  • Pain in hip bones and ribs

By 2006, the FDA required a black box warning added to Gadolinium. The warning now lists the risks of developing NSF for those with kidney disease, as well as individuals who’ve had liver transplants or live with chronic liver disease.

Lawsuits

While researchers estimate the risk of NSF for individuals suffering from kidney failure remains around four percent, it’s believed that many more living with the condition haven’t been diagnosed.

Since Gadolinium didn’t come with a warning for close to 20 years, many were likely exposed to this risk without being fully informed. While health care professionals now must screen patients before injecting them with Gadolinium, manufacturers who do not disclose the risks should be held accountable.

Several patients and their families have filed suit against Bayer and others making the drug, alleging they weren’t warned about its risks. Further, they claim the company never adequately tested its product for harmful side effects. Although Bayer has reached a settlement, many more individuals continue to come forward with claims against other manufacturers.