Gadolinium Contrast Dye Lawsuit Centralization on JPML’s Agenda

Published on September 26, 2018 by Sandy Liebhard

The U.S. Judicial Panel on Multidistrict Litigation will convene a Hearing Session tomorrow in San Francisco, California.

Matters set for oral arguments include a proposal to centralize all federally-pending Gadolinium Deposition Disease lawsuits in a single U.S. District Court.

Gadolinium Deposition Disease Allegations

Gadolinium Deposition Disease is a disorder allegedly related to the retention of gadolinium contrast dyes following an MRI.

Symptoms of the condition are said to include:

• Intense burning of the skin and skin substrate
• Intense boring pain in bones or joints
• Brain fog or mental confusion
• Muscle vibrations, pins and needles sensation
• Headache
• Thickening, discoloration, pain in the skin or skin substrate of the distal arms and legs

There are currently around 21 Gadolinium Deposition Disease lawsuits pending in federal courts around the country. Plaintiffs claim that the manufacturers of these products have known for years that gadolinium could be retained in the body long after an MRI, even in patients with normal kidney function. They further allege that gadolinium retention can result in severe, debilitating adverse events and accuse the products’ manufacturers of failing to warn doctors and patients of these risks.

Plaintiffs who seek to consolidate the federal docket assert that the creation of a multidistrict litigation in a single U.S. District Court will eliminate duplicative pretrial proceedings and avoid inconsistent rulings across various jurisdictions.

However, gadolinium lawsuit defendants are opposed to consolidation, arguing that plaintiffs’ alleged injuries lack commonality and should not all be grouped under the umbrella of “Gadolinium Deposition Disease”.

FDA Gadolinium MRI Warning

Gadolinium is a rare earth element used in MRI contrast dyes to enhance images that show up on scans. For years, it was widely believed that, for most patients, gadolinium was flushed from the body within hours of an MRI in patients with normally functioning kidneys.

But last December, the U.S. Food & Drug Administration (FDA) warned that gadolinium could actually be retained by the body for weeks, months, or even years following a scan. Among other things, the FDA noted that certain MRI dyes called linear agents – Eovist, Magnevist, Multihance, Omniscan, and OptimMARK – appeared to be associated with a higher risk of retention compared to others called macrocylic agents.

The FDA has advised doctors to consider the characteristics of each agent when choosing an MRI contrast dye for patients most likely to experience gadolinium retention. These patients include:

• Those who will require multiple lifetime doses
• Pregnant women
• Children
• Patients with inflammatory conditions

And while the FDA has not yet linked gadolinium MRI contrast dyes to any adverse events, it has ordered the products’ manufacturers to conduct animal and human studies to help better assess their health risks.