A woman from Pennsylvania has filed a medical product liability claim, alleging she suffered gadolinium poisoning after undergoing an MRI scan using Omniscan gadolinium contrast dye.

Plaintiff Debra J. alleges that she developed a number of serious reactions soon after Omniscan gadolinium was injected for an MRI scan. According to the MRI contrast dye lawsuit, Debra had developed cognitive impairment, burning sensation of her skin, heart palpitations, and pain throughout her body.

Debra opted to file legal action against manufacturer GE Healthcare Inc. soon after she reportedly developed symptoms of gadolinium deposition disease following her MRI scan.

Reports of Omniscan Gadolinium Toxicity

Gadolinium deposition disease refers to a set of symptoms that occur in patients with previously healthy kidneys after they are exposed to Omniscan or other gadolinium based MRI contrast fluids.

Gadolinium is a common component in intravenous contrast fluids for MRIs, which are meant to make the images easier to examine. Gadolinium is a heavy metal contrast, with its heavy magnetic nature design to improve the images of organs, blood vessels, and tissues in diagnostic images.

However, it has been recently discovered that Omniscan and other gadolinium agents may stay inside the body for months or even years after entering the body. Many patients who have suffered symptoms like pain, spongy or rubbery skin, and unclear thinking or “brain fog” believe their symptoms could be caused by gadolinium retained in their bodies.

The FDA recently issued an alert of this concern in December 2017, which states that long lasting gadolinium can cause a rare condition called nephrogenic system fibrosis (NSF). While this condition has been noted to occur in patients with pre-existing kidney problems, the FDA has noted that patients with normal kidney function have also developed reactions from Omniscan gadolinium.

“We have also received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established,” the FDA stated in a December 2017 communication.

Debra, the plaintiff in the gadolinium deposition disease lawsuit, alleges that GE Healthcare knew about the adverse effects of Omniscan gadolinium but failed to warn patients.

“Pharmacokinetic studies in 1991 indicated that gadolinium retention was occurring in people with normal renal function,” the lawsuit reads. “In 2004, gadolinium was shown to be deposited in the resected femoral heads of people who had undergone gadolinium-chelate enhanced MRI studies. Since then, studies have continued to indicate that gadolinium remains within people’s bodies long after the suggested half-life.”

While GE Healthcare did update the warning label of Omniscan gadolinium label to include that patients with pre-existing kidney complications could face an increased risk of complications in 2012, Debra says the company allegedly failed to warn that patients with normal kidney function could also be at risk.

Other patients who may have suffered gadolinium poisoning may also be able to file legal action, and could be potentially eligible for medical damages.

This Omniscan Gadolinium Lawsuit is Case No. Case 1:18-cv-10877, in the U.S. District Court, District of Massachusetts.