An Arizona woman recently filed a gadolinium retention lawsuit claiming that the MRI contrast agent caused her to sustain long term health issued including tissue damage.

Plaintiff Amelia P. lodged the gadolinium retention lawsuit against Bayer, alleging that their MRI contrast agent caused her to suffer from long term health issues.

Amelia says she was administered gadolinium contrast agents during MRIs in November 2004, January 2005, December 2014, and April 2015. Amelia has allegedly retained the gadolinium from the contrast agents in her brain and body, resulting in fibrosis in her organs, skin, and bones.

Gadolinium based contrast agents are commonly used in MRI imaging procedures to enhance the images of internal structures. Gadolinium is injected through an IV during an MRI imaging process. Manufacturers have allegedly claimed that gadolinium based contrast agents are completely safe in individuals without kidney problems.

For many years, the healthcare industry believed that these contrasting agents were safe. In 2007, the U.S. Food and Drug Administration (FDA) included a black box warning on gadolinium contrast agents, warning against use in individuals with renal failure. However, research later showed that this was allegedly not enough.

In 2013, Japanese researchers found evidence of gadolinium retention in patients with healthy kidneys who had received gadolinium based contrast agents. The Mayo Clinic confirmed these findings in 2014. Study results prompted the FDA to issue a new safety alert, warning consumers that they were investigating the potential issues for gadolinium retention. In May 2018, following a committee decision to add a black boxed warning for gadolinium retention, the FDA issued a warning to medical providers regarding the potential risks.

Until the warning was released, Amelia says she had no knowledge of the potential risks and could not make an informed decision regarding using gadolinium contrast agents. She says she relied on Bayer’s representations that their gadolinium contrast agents were safe, when in reality they allegedly caused long term health issues.

“The gadolinium from Defendants’ GBCA does not wash out of the patient’s body as readily as promised, and instead can be retained indefinitely or permanently in multiple organs and soft tissues (e.g., brain, heart, liver, kidney, bones, and skin) in patients with normal renal function,” the gadolinium retention lawsuit claims.

“This gadolinium, a toxic heavy metal, causes fibrosis in organs, bone, and skin, other adverse reactions, and crosses the blood-brain barrier and deposits in the neuronal nuclei of the brain.”

Amelia also claims that Bayer knew or should have know that their product caused gadolinium retention. She also claim that the company should have warned herself and other consumers as soon as research was available which suggested a risk for gadolinium retention in patients with normal kidney function.

Amelia accuses Bayer of inadequate warning, defective design, negligence, breach of warranties, negligent misrepresentation, fraudulent misrepresentation, fraud by suppression and concealment, and violation of consumer protection laws. Her gadolinium retention lawsuit seeks general damages, economic damages, compensatory damages, consequential damages, punitive damages, court costs, and attorneys’ fees.

The Gadolinium Retention Lawsuit is Case No. 2:18-cv-02739-GMS in the United States District Court for the District of Arizona.