MultiHance MRI Lawsuit Filed Over Alleged Gadolinium Side Effects

Published on September 21, 2018 by Sandy Liebhard

A man from California has gone to court in an effort to obtain compensation for gadolinium side effects he claims were caused by Multihance, an MRI contrast dye marketed by Bracco Diagnostics.

Plaintiff: Bracco Diagnostics Failed to Adequately Warn of Gadolinium Retention Risks

According to a complaint filed in the U.S. District Court, Northern District of California, on August 28^th, Reginald Brown was injected with linear gadolinium-based agents, including Multihance, prior to receiving MRIs on or around January 20, 2017 and February 28, 2018.  (Case 5:18-cv-05277-VKD)

The lawsuit alleges that 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. Brown further claims that gadolinium deposits from his MRIs have remained in his body, resulting in serious and permanent injuries.

“At the time of Plaintiff’s use of the linear GBCAs at issue, Plaintiff did not have chronic/severe kidney disease or acute kidney injury, and the GBCA manufacturers chose to only provide warnings to patients with these types of reduced renal function,” the complaint states. “Defendant failed to appropriately and adequately inform or warn Plaintiff and his healthcare providers about the risks of gadolinium retention in patients with normal renal function.”

FDA Orders New Gadolinium Retention Warnings for MRI Contrast Dyes

Gadolinium-based contrast dyes are used in MRIs to improve the visibility of images on a scan. Currently, more than a half-dozen such agents are approved for use in the United States:

• Dotarem
• Eovist
• Gadavist
• Magnevist
• Multihance
• Omniscan
• OptimMARK
• Prohance

These products are contraindicated in patients with impaired kidney function because of their potential to cause a serious and debilitating disorder called nephrogenic systemic fibrosis, or NFS. However, until recently it was thought gadolinium was quickly flushed from the body when administered to patients with normal kidney function.

In December 2017, the U.S. Food & Drug Administration (FDA) ordered the manufacturers of gadolinium- based MRI contrast dyes to update their prescribing information and medication guides with information regarding the potential for gadolinium retention in patients without renal impairment.

The agency acted after several studies found gadolinium deposits in the brains, bones, and other organs of patients with healthy kidneys who had undergone MRIs with gadolinium-based agents.

Among other things, the FDA noted that linear agents (Eovist, Magnevist, Multihance, Omniscan, and OptimMARK) were associated with the highest risk of retention.

While the FDA has not linked gadolinium retention to any adverse events, the agency has advised health care providers to carefully consider the risks and benefits of these agents in patients at higher risk for retention, including pregnant women and individuals who have undergone multiple scans.

The FDA has also ordered Bracco diagnostics and other manufacturers to conduct animal and human studies to help it better understand the risks potentially associated their products.

Federal Plaintiffs Seek MDL for Gadolinium Contrast Dye Lawsuits

A growing number of gadolinium contrast dye lawsuits have been filed in U.S. courts on behalf of individuals who experienced adverse events allegedly related to gadolinium retention, despite having normal kidney function.

In July, a group of plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to centralize all such federal claims before a single judge in one U.S. District Court, so as to improve judicial efficiency through coordinated discovery and other pretrial proceedings.

The JPML will hear oral arguments on the matter during its September 27^th Hearing Session in San Francisco, California.