Gadolinium Lawsuit Filed Over Allergic Reaction, Disfiguring Injuries from MRI Contrast Dye

A Louisiana woman has filed a product liability lawsuit alleging that side effects of gadolinium contained in MRI contrast dyes caused her to suffer a severe allergic reaction and disfiguring injuries, joining a growing number of similar cases brought in recent weeks over the widely used contrast agents. 

The complaint (PDF) was filed on behalf of Cindy Dwyer in the U.S. District Court for the Eastern District of Louisiana on January 12, against various manufacturers of gadolinium-based contrast agents (GBCAs) used to enhance magnetic resonance imaging (MRI) scans, including GE Healthcare, Bayer, Tyco Healthcare, Mallinckrodt, Inc. and Bracco Diagnostics, Inc.

According to the lawsuit, Dwyer was given a gadolinium contrast dye in January 2017, before she was slated to undergo a coronary angiography stent placement. However, after being given the dye, as well as other medications, intravenously, Dwyer began suffering health problems.

“After being administered the IV, plaintiff began suffering from an allergic reaction. Plaintiff has been re-admitted to the hospital several times due to ongoing complications from the IV dye,” Dwyer states in the complaint. “Petitioner, Cindy Dwyer, alleges that GBCAs caused her severe, disabling, and disfiguring injuries to her entire body.”

Dwyer is seeking damages for medical expenses, mental anguish and emotional distress, loss of enjoyment of life, loss of earnings, the need for future medical monitoring and other expenses.

The lawsuit comes about a month after the FDA issued new label requirements for gadolinium contrast agents such as Magnevist, Gadavist and Omniscan, which called for warnings that alert patients and medical professionals to the risk of gadolinium retention and possible side effects. The agency is also planning to require all gadolinium-based contrast agent manufacturers to conduct new human and animal studies to determine their safety.

The FDA is also recommending that health care professionals consider the fact that the body retains gadolinium when deciding whether to give it to patients that may be at higher risk of health problems. These include women who are pregnant or think they may be pregnant, patients with kidney problems, children, and patients when inflammatory conditions. The recommendations also suggest that repeated use of the contrast agents be minimized where possible, particularly when MRIs are scheduled closely together.

Patients are urged to tell their health care professionals whether they are pregnant or may be pregnant, whether they have kidney problems, and the date of their last MRI with gadolinium, or whether they have had repeated MRI scans that involved the use of gadolinium contrast agents.

Dwyer’s lawsuit also joins a growing number of MRI toxicity lawsuits filed in recent months. The complaints allege that use of MRI dyes to enhance imaging tests have left users with a condition known as gadolinium deposition disease (GDD), which involves various symptoms, including reduced cognitive function, headaches, bone and joint pain, tendon and ligament pain, thickening of soft tissues and other problems. The condition is considered incurable and progressive, meaning that it worsens over time, raising concerns about the safety of gadolinium contrast agents.

Recently, there have also been growing concerns over signs of gadolinium build-up in the body. In September, the FDA’s Medical Imaging Drugs Advisory Committee voted to recommend the FDA require new MRI contrast agent warnings about the risk of gadolinium build up in the brain. However, in May the FDA concluded that gadolinium in the brain appeared to carry no threat of health effects.

The FDA is continuing to assess their safety, and its National Center for Toxicological Research is currently conducting a study on gadolinium brain retention in rats.