A judicial panel has denied a plaintiffs’ motion requesting centralization of all product liability lawsuits filed against the manufacturers of linear gadolinium-based MRI contrast dyes, or GBCAs, in a single U.S. District Court.
There are currently 21 gadolinium toxicity lawsuits pending in 13 U.S. District Courts, all of which were filed on behalf of individuals who claim to be suffering from Gadolinium Deposition Disease, a disorder that purportedly occurs when gadolinium is retained in brain and other organs following an MRI.
Plaintiffs had moved for centralization of the docket in June. However, all six defendants – Bayer, GE Healthcare, Bracco Diagnostics, Mallinckrodt Inc., Guerbet LLC and Liebel-Flarsheim Company, and McKesson Corp. – opposed centralization.
In an October 10th Order, the U.S. Judicial Panel on Multidistrict Litigation did acknowledge that the pending claims involved some common factual issues concerning the manufacture, regulatory approval, labeling, and marketing of GBCAs, as well as the alleged propensity of the agents to cause gadolinium retention in patients with normal kidney function.
However, it remained unconvinced that centralization would improve judicial efficiency or serve the conveniences of the parties and witnesses involved in the litigation.
“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 states. “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.”
Despite the JPML’s denial, all of the pending gadolinium toxicity lawsuits will continue to move forward in the U.S. District Court where they were initially filed. It’s also highly likely that additional claims will be filed in the coming months.
Plaintiffs may also make a new bid for centralization in the future if they are able overcome the Panel’s objections.
Gadolinium is a rare earth element used in MRI contrast dyes to enhance images that show up on scans.
Such products are contraindicated in patients with renal impairment, as the kidney’s inability to eliminate gadolinium from the body can result in a debilitating disease called Nephrogenic Systemic Fibrosis, or NSF. However, it had long been assumed that gadolinium would be quickly flushed from the bodies of patients with healthy kidneys.
Last December, the U.S. Food & Drug Administration (FDA) warned that gadolinium could, in fact, be retained by the body for weeks, months, or even years following a scan. Among other things, the agency noted that linear gadolinium 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 yet to link gadolinium retention to any serious side effects. But it continues to investigate and has asked gadolinium MRI dye manufacturers to conduct additional studies in humans and animals to better assess their products’ risks and benefits.