Gadolinium (An MRI contrast) Lawsuit

Gadolinium Lawsuit- Mass tort lawyers investigating plaintiff injuries including brain fog, skin thickening, and bone/joint pain after gadolinium-based contrast agents are used for MRI scans.

Gadolinium-based contrast agents (GBCAs) incorporate a rare earth metal, gadolinium, and are used in magnetic resonance imaging (MRI) and magnetic resonance angiogram (MRA) scans. GBCAs are sometimes referred to as contrast media or dyes, and are injected into the body to enhance or improve the quality of MRI/MRA images.  GBCAs are intended to be eliminated from the body shortly after the MRI/MRAs are completed.

The FDA, however, has released a Drug Safety Communication  that warns gadolinium may remain in the body for months after being administered, with the retention occurring in parts of the body like the brain, bones, joints and skin. The FDA also required this warning be applied to all GBCAs and that the manufacturers of gadolinium-based contrast agents release new medication guides addressing the potential retention of gadolinium. Manufacturers are also required to conduct more studies to assess to the safety of GBCAS and the potential side effects of gadolinium retention in individuals with normal kidney function.  These additional studies are still ongoing.

Gadolinium Retention, Toxicity and Injuries

As noted above, the FDA and manufacturers of gadolinium-based contrast agents have confirmed that gadolinium may be retained in the body. There have been complaints of injuries that patients with normal kidney function have attributed to the retained rare earth metal. Researchers have coined this “Gadolinium Deposition Disease” or GDD.

The injuries being reported by individuals with normal renal function include:

• Brain Fog: Patients may suffer from chronic headaches and experience a clouded memory or a lack mental sharpness resulting in confusion;
• Skin Thickening/Pain: Patients may feel sensations of burning, tingling or numbness in their skin. Patients may also skin rashes or soft-tissue thickening that feels or looks spongy or rubbery.  Damage to the tendons and/or ligaments may also occur with the skin pain; and
• Bone/Joint Pain: Patients report chronic intense pain in the bones or joints without a history of arthritis or other chronic condition that began after undergoing an MRI or MRA with a gadolinium-based contrast agent.

Prior Gadolinium MDL for Nephrogenic Systemic Fibrosis (NSF)

Previously, a multidistrict litigation, MDL 1909 In Re Gadolinium Contrast Dyes Products Liability Litigation, was consolidated in the Northern District of Ohio in 2008. This litigation addressed complaints that gadolinium retained in patients with compromised or impaired renal function caused a serious and life-threatening condition called Nephrogenic Systemic Fibrosis (NSF). NSF is an extremely rare condition and the symptoms include swelling, tightening, thickening and hardening of the skin and internal organs, excess skin pigmentation, and burning or itching of affected areas.

It is important to note that the gadolinium-related injuries being investigated now are only in those patients with normal or near-normal kidney function. Because of the Black Box warnings of NSF for patients with impaired kidneys, patients with impaired renal function would be outside the parameters of the cases our team of experienced mass tort lawyers is investigating at this time.

Linear vs. Macrocyclic Gadolinium-based Contrast Agents

Because gadolinium is intended to be excreted from the body, the rare earth metal is combined with other substances to ensure it passes through a patient’s system. The manner in which gadolinium is combined with these other substances determines which of the two categories that GBCA falls in: linear or macrocyclic.  The FDA and the drug manufacturers are now warning that linear GBCAs result in more gadolinium retention in the body than macrocyclic GBCAs.

The name brand of the GBCA you received is likely to be listed in the TECHNIQUES section of your medical records from the facility that conducted your MRA/MRA.  The chart below details which products are linear GBCAs and which are macrocyclic:

Source: https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm

^*Linear GBCAs result in more gadolinium retention in the body than macrocyclic GBCAs.
^†Gadolinium levels remaining in the body are LOWEST and similar after use of these agents.
^‡Gadolinium levels remaining in the body are HIGHEST after use of these agents

Please contact your healthcare provider if you have any medical concerns or would like more information about determining potential levels of gadolinium in your system.

Free Case Evaluation

We are currently investigating claims of injuries associated with gadolinium retention. If you or a loved one has undergone an MRI or MRA with a gadolinium-based contrast agent and are now experiencing side effects such as brain fog, bone/joint pain, or skin thickening/hardening/burning, contact the team of experienced pharmaceutical products liability attorneys at Zoll & Kranz. Please contact us today for a free case evaluation and to discuss your potential Gadolinium product liability claim.  You can call the office toll-free at 888-841-9623, fill out the form below and all information provided is to remain confidential, or you can use our 24/7 chat service.