Patients who say they suffered side effects from the contrasting agent used during MRI scans, including gadolinium toxicity are asking for their cases to be consolidated against the drug makers.

There are reportedly 21 current gadolinium toxicity lawsuits currently pending in federal court.

Gadolinium is used in magnetic resonance imaging (MRI) scans to help enhance fine detail, making it more visible to the trained eye of the reviewing physician. It is a rare earth element—chemically similar elements that occur together in nature and are difficult to separate and tease apart.

For as long as the MRI procedure has been around, it was believed by medical professionals and laypeople that gadolinium would be easily removed through the urine output of the body within a few hours of a scan.

In December 2017, however, the U.S. Food and Drug Administration (FDA) announced that gadolinium retention could last much longer than that. The FDA sent out a warning that month that the element could potentially stay in the body for a number of days, weeks, months, or even years.

The FDA noted in this alert that some very specific types of contrast dyes have been associated with lengthier body retention times, such as Eovist, Magnevist, MultiHance, Omniscan, and OptimMARK. These are considered linear agents rather than macrocyclic agents.

According to the plaintiffs filing gadolinium toxicity lawsuits, retention of the dye in the body can lead to a collection of symptoms called gadolinium deposition disease (GDD). GDD allegedly exists when gadolinium toxicity levels are such that a patient experiences part or all of the following:

• Frequent and persistent headaches
• Troubling recalling details, other memory issues—sometimes referred to as “brain fog”
• Pain in the trunk or extremities, experienced like pins and needles
• High levels of unexplained pain in the joints and bones
• Changes in texture and color of skin, also known as thickening

The plaintiffs associated with these 21 gadolinium toxicity lawsuits filed a petition this summer with the U.S. Judicial Panel on Multidistrict Litigation (JPML). According to petition, they believe that the cases have core questions of law that are very similar.

The plaintiffs also point out that the discovery necessary prior to going to trial in each of these gadolinium toxicity lawsuits involves many of the same witnesses and much of the same documentation. They argue these efforts would be a drain on the federal court system if the lawsuits are not centralized.

Given that a quarter of the registered federal complaints originate in California, the U.S. District Court, Northern District of California is being considered as the most viable option.

Meanwhile, six named defendants in these cases are fighting these efforts to centralize the litigation. Among them are the Bayer Co., GE Healthcare, Bracco Diagnostics, McKesson Corp., Mallinckrodt Inc., Guerbet LLC, and Liebel-Flarsheim Co.

These defendants allege that, in addition to having too few lawsuits pending to warrant consolidation, the term “GDD” is a misnomer. The defendants argue that the plaintiffs’ injuries appear to have symptoms which run the gamut and are not cohesive or held in common.

One of the defendant companies has said that the formulations between gadolinium-based contrasts dyes vary based on which active and inactive ingredients are included. This fact makes it difficult to draw up one statement concerning product defect.

The FDA hasn’t publicly linked any reports of adverse medical events to retention and gadolinium toxicity. They are requiring the manufacturers to run new studies on animals and humans to make better health risk assessments.