Gadolinium Contrast Dye Lawsuits Could be Centralized in Single Federal Court

Published on August 20, 2018 by Laurie Villanueva

The growing number of lawsuits filed over Gadolinium Deposition Disease, a complication allegedly caused by certain MRI contrast dyes, could soon be consolidated in a single federal court.

20+ Gadolinium MRI Lawsuits Pending, But Plaintiffs Predict Hundreds More Will be Filed

Court records indicate that plaintiffs petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) last month to establish a centralized litigation for at least 21 gadolinium toxicity lawsuits currently pending in roughly a dozen separate U.S. District Courts.

According to the July 31st filing, all of the lawsuits were brought on behalf of individuals who suffered debilitating symptoms allegedly associated with the retention of linear gadolinium-based contrast dyes following an MRI. Among other things, the petition noted the widespread use of such agents and predicted that hundreds of similar cases would eventually be filed in courts throughout the country.

“Transfer and centralization is proper because each of these actions and future tag-along cases arise out of the same or similar nucleus of operative facts and the same or similar wrongful conduct, and will involve the same or similar questions of fact and law,” the petition stated. “In addition, pretrial discovery in all cases will be substantially similar and will involve the same liability and general causation documents and witnesses.”

The petition further suggests that the proposed multidistrict litigation be housed in the U.S. District Court, Northern District of California, where 5 of the currently-pending gadolinium MRI lawsuits are pending.

According to an Order issued by the JPML on August 16th, Oral Arguments on the matter will be convened at the Panel’s next Hearing Session, which is scheduled for September 27th in San Francisco, California.

Gadolinium Retention Warning

Gadolinium-based contrast dyes are injected just prior to an MRI to improve the visibility of organs, tumors, and blood vessels on imaging scans.

The following linear agents have been approved for use in the United States:

  • Eovist
  • Magnevist
  • Multihance
  • Omniscan
  • OptimMARK

The U.S. Food & Drug Administration (FDA) has also cleared several macrocylic gadolinium dyes, including:

  • Dotarem
  • Gadavist
  • Prohance

In December 2017, the FDA warned that gadolinium could be retained in the brain and other organs long-after an MRI. While the agency has not yet linked gadolinium retention to any adverse events, it has asked the drugs’ manufacturers to conduct additional studies to better understand the health consequences potentially associated with this occurrence.

The FDA’s warning applied to all gadolinium-based contrast dyes currently marketed in the United States. However, the agency did note that linear agents appeared to be associated with a higher risk of retention compared to their macrocylic counterparts.

Among other things, the FDA has advised health care professionals to consider the retention characteristics of each agent when choosing a gadolinium MRI contrast dye for patients who may be at higher risk for retention, including:

  • Patients requiring multiple lifetime doses
  • Pregnant women
  • Children
  • Patients with inflammatory conditions

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