The Norrises are seeking more than $10 million in damages from companies they say should have warned them of risks.
“Over the past several years, my focus has been on Gena’s health,” Chuck Norris said in a statement Tuesday to The Washington Post. “And now we are working together to speak out about the dangers of MRI contrast agents.”
Experts say that MRI scans are still considered safe and that the contrast agent is used when the information needed outweighs the small risk of harm.
Gadolinium-based contrast agents “have been used for diagnosis and treatment guidance in more than 300 million patients worldwide,” according to a statement last year from the American Society of Neuroradiology and American College of Radiology. The chemicals enhance the visibility of organs, blood vessels and other tissues in the body during imaging tests, helping doctors see abnormalities such as a tumor.
The Norrises’ attorney, Todd Walburg, said in a statement Tuesday that the couple’s lawsuit is “one of many cases” that his law firm, Cutter Law, is filing against MRI contrast manufacturers.
Walburg said that Gena Norris was initially being tested for rheumatoid arthritis, which, he said, turned out not to be a problem.
But the Norrises argue in the lawsuit that after several MRI exams, Gena Norris developed a burning pain throughout her body and experienced violent shaking, numbness and tingling, and weakness. She said she has since suffered cognitive deficits and kidney damage and has had trouble breathing, according to the complaint.
The couple argued that had they known about the risks, Gena Norris would not have been given the gadolinium-based contrast agent.
Now, they say, they want to raise awareness to help others who have experienced similar medical issues. They are suing pharmaceutical distributor McKesson Corp. and the diagnostics, research and imaging arms of the Italian health-care company Bracco S.p.A., among others, saying the companies knew of the risks and failed to warn them.
“We are pursuing this litigation to shine a light on a problem that has not been addressed by the pharmaceutical companies that make MRI contrast agents. And we are trying to give a voice to the thousands of other victims who have been ignored,” Gena Norris said in the statement through her attorney.
Bracco said in a statement that the company does not comment on pending litigation, though it “takes patient safety very seriously and stands behind the safety of all of its products.”
McKesson said in a statement that it is “aware of the lawsuit and is currently reviewing the complaint. We will respond in a timely matter.”
Research has shown that gadolinium-based contrast agents can be retained in the brain and other body tissues. In 2006, some patients with severe chronic kidney disease were found to have deposits in connective tissues, resulting in a rare but serious syndrome involving the skin and joints known as nephrogenic systemic fibrosis.
More recently, gadolinium retention was reported in brain tissue of patients who had repeated doses, prompting the U.S. Food and Drug Administration to issue an alert in 2015 saying it was investigating the risks. But the FDA, which approved gadolinium as a contrast agent in the 1980s, said in May that it has discovered no evidence that such deposits in the brain caused any health issues.
The FDA held an advisory committee meeting in September, hearing from medical experts, patient advocates and drug companies regarding the risk of gadolinium retention in the brain and other organs. The committee voted to change the warning on drug labels to say that there does seem to be some risk of retention in the brain, particularly with one type of gadolinium-based contrast agents, and recommended “risk minimization steps for certain patient populations,” according to meeting minutes.
However, Lauren Smith Dyer, an FDA spokeswoman, said in a statement that although advisory committees contribute to the agency’s decision-making processes, decisions on medical products are “science-based,” involve “the careful evaluation of risks and benefits for the product at issue,” and are informed “by science, medicine, policy and judgment.”
Smith Dyer said the FDA will continue to assess the potential health effects.
Jacqueline Bello, a radiologist and chair of the American College of Radiology Quality and Safety Commission, said the decision to use gadolinium-based contrast agents in MRI exams is a risk-benefit equation that doctors often need to solve to determine what is best for the patient.
“Nobody should think that individual patient concerns are unimportant,” said Bello, who teaches at Montefiore Medical Center and Albert Einstein College of Medicine in New York. “That said, in order to build a body of evidence and develop good science behind good patient care, we need to do more research. And in the meantime, we’re left with our best medical judgment in individual care of each patient.”