A Pennsylvania woman has filed a new MRI contrast dye lawsuit against the manufacturer of Omniscan, after she developed debilitating symptoms allegedly associated with Gadolinium Deposition Disease.
According to a complaint filed in the U.S. District Court, District of Massachusetts, on May 3rd, Debra Javen’s of Erie, Pennsylvania, has undergone one or more MRIs with Omniscan, a gadolinium-based contrast agent marketed by GE Healthcare, Inc. (Case No. Case 1:18-cv-10877)
Shortly thereafter, she developed Gadolinium Deposition Disease, a man-made disorder that allegedly occurs in patients with normal kidney function who have been administered Omniscan or other gadolinium-based MRI agents. Javen’s symptoms include cognitive impairment, burning sensation on her skin, heart palpitations, and pain throughout her body.
Gadolinium is a highly toxic heavy metal that does not occur naturally in the human body. According to the lawsuit, the only way gadolinium can enter the body is via the injection of a gadolinium-based MRI contrast dye.
“Defendants have known about the risks that gadolinium-based contrast agents (including Omniscan) pose to people with normal kidney function for years,” the lawsuit asserts. “Pharmacokinetic studies in 1991 indicated that gadolinium retention was occurring in people with normal renal function. 1 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 peoplrt5e’s bodies long after the suggested half-life.”
While the defendants did update the Omniscan label in 2012 to include contraindications for use in people with kidney disease or acute kidney injury, the complaint notes that GE Healthcare has failed to update the label to reflect the extensive evidence of gadolinium retention in people with normal renal function.
In December 2017, the U.S. Food & Drug Administration (FDA) announced a new class warning for Omniscan and similar contrast dyes, reflecting growing concerns that gadolinium could be retained in a patient’s body, including the brain, for weeks, months, or even years, following an MRI.
“To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure,” the FDA said. “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.”
Among other things, the FDA has directed the manufacturers of these products to conduct further studies to help better assess the side effects potentially associated with gadolinium retention.
Patients at higher risk for gadolinium retention include:
Patents who are undergoing an MRI should be sure to tell their doctor: