Drug Makers Oppose MDL for Gadolinium-Based MRI Contrast Dye Lawsuits

Published on August 29, 2018 by Sandy Liebhard

The manufacturers of gadolinium-based MRI contrast dyes are resisting efforts to create a multidistrict litigation (MDL) for product liability claims filed over  ill health effects allegedly associated with gadolinium retention.

So far, a half-dozen drug maker defendants have filed responses with the U.S. Judicial Panel on Multidistrict Litigation (JPML) opposing a plaintiffs’ motion to centralize all federally-filed gadolinium toxicity lawsuits before a single judge in one U.S. District Court. Those defendants include:

• Bayer
• GE Healthcare
• Bracco Diagnostics
• Mallinckrodt Inc.
• Guerbet LLC and Liebel-Flarsheim Company
• McKesson Corp.

Among other things, the companies assert that there are too few filings to justify the creation of an MDL, that plaintiffs’ alleged injuries lack commonality, and that those injuries should not all be grouped under the umbrella of “Gadolinium Deposition Disease”.

“Each of the gadolinium-based contrast agents at issue utilizes different active and inactive chemical components. Plaintiffs’ theories of product defect are presently entirely unknown to BDI,” Bracco Diagnostics stated in a response filed on August 23^rd. “However, the differences in formulation of each product are likely to be substantially relevant to questions of alleged defective design and both general and specific causation.”

Gadolinium Retention After an MRI

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. 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.

Why are Plaintiffs Filing Gadolinium Toxicity Lawsuits?

There are currently around 21 gadolinium toxicity lawsuits pending in federal courts around the country.

Plaintiffs who have filed these claims allege that gadolinium retention can result in Gadolinium Deposition Disease, a disorder allegedly characterized by a range of debilitating symptoms, including:

• Persistent headaches
• “Brain fog” and memory problems
• Severe bone and joint pain
• Skin thickening or discoloration
• Burning pain (pins and needles) in arms, legs and/or torso

Plaintiffs further allege that defendants were aware of the potential for gadolinium retention and associated adverse events, yet failed to provide proper warnings to doctors and patients.

“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,” plaintiffs’ stated in a petition for centralization filed with the JPML on July 31^st. “In addition, pretrial discovery in all cases will be substantially similar and will involve the same liability and general causation documents and witnesses.”

Among other things, the petition suggests that the U.S. District Court, Northern District of California – where 5 gadolinium toxicity lawsuits are pending – would be the most appropriate venue for the proposed multidistrict litigation.