Gadolinium MRI Contrast Dye Lawsuits Mount, With New Filing in Louisiana

Published on November 8, 2018 by Sandy Liebhard

Gadolinium MRI contrast dye lawsuits continue to mount in court throughout the United States.

One of the most recent cases was filed by a Louisiana resident who suffered adverse health effects allegedly caused by gadolinium retention following the administration of Omniscan and Multihance.

Patient Alleges Symptoms of Gadolinium Deposition Disease

According to a complaint filed in the U.S. District Court, Eastern District of Louisiana, on October 31st, Judy Gomilla was injected with Omniscan, Multihance, and other gadolinium-based dyes prior to undergoing MRIs.  She had normal kidney function when the agents were administered. (Case 2:18-cv-10212-BWA-JCW)

Gomilla subsequently developed debilitating symptoms allegedly characteristic of “Gadolinium Deposition Disease,” including skin patchiness, bone and joint pain, and cognitive impairment.

In December 2017, Gomilla tested positive for gadolinium retention. She alleges that her symptoms were the result of the gadolinium deposits that remain in her body.

Her lawsuit cites numerous studies and reports that suggest gadolinium may be retained in brain, tissue, and organs long after an MRI, even among patients with normal kidney function. Gomilla further alleges that the manufacturers of of these products have long concealed this risk from the public.

“Defendants knowingly and intentionally made materially false and misleading representations to Plaintiff’s healthcare providers and to the public, to the effect that GBCAs, including those administered to Plaintiff, were safe and effective for use and that their labeling, marketing and promotional materials fully described all known risks of the products,” the complaint charges.

FDA Warns of Gadolinium Retention in Patients with Normal Kidney Function

Gadolinium-based MRI agents are contraindicated for use in renal-impaired patients. That’s because the kidneys’ inability to eliminate gadolinium can cause a debilitating disease called Nephrogenic Systemic Fibrosis, or NSF.

In fact, the manufacturers of Omniscan, Multihance, and other gadolinium-based contrast dye were previously involved in litigation over NSF.

Until recently, however, it was thought that gadolinium was quickly flushed from the bodies of patients with normal kidney function. A growing number of studies published over the years now suggests that’s not always the case.

in December 2017, the U.S. Food & Drug Administration (FDA) warned that gadolinium deposits could remain the brain and other organs for months – and even years – even among patients with healthy kidneys. Among other things, the agency noted that linear agents – which include Omniscan and Multihance – were more likely to result in gadolinium retention.

The FDA has not yet linked gadolinium deposits to any adverse events. However, it has required the products’ manufacturers to update their labeling to note the potential for retention in patients with normal kidney function. The agency also ordered drug makers to conduct post-market studies to better assess the safety and effectiveness of their gadolinium agents.

Gadolinium Toxicity Lawsuits Moving Forward in Federal Courts

Plaintiffs have since filed more than a dozen new lawsuits against the manufacturers of gadolinium-based MRI contrast dyes.

Last month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) rejected a plaintiffs’ request seeking to have these claims – as well as any filed in the future – centralized in a single federal court for the purpose of coordinated discovery and other pretrial proceedings.

“We find movants have failed to demonstrate that any common questions of fact and law are sufficiently complex or numerous to justify centralization,” the Panels stated in its October 10^th Order, “In particular, the injuries alleged in each case appear to be highly plaintiff-specific, and the actions involve GBCAs manufactured by one or more of four different defendant groups, involving different formulations.”

As such, all federally-filed gadolinium-based MRI contrast dye lawsuits will continue to proceed individually in their original court of filing. However, as cases continue to mount, plaintiffs may renew their centralization request if they are able to overcome the JPML’s objections.