Chuck and Gena Norris are taking 11 drug companies to court in a lawsuit claiming that gadolinium contrast during MR scans “nearly killed her.”

The companies in the crosshairs of the action star include McKesson and Bracco, according to Norris' attorneys Brooks Cutter and Todd Walburg of Cutter Law in California.

“These companies continue to say that there is no link between gadolinium and adverse events, even though the evidence is overwhelming that this heavy metal stays in the body for years, rather than hours,” they said in a statement.

Gena Norris alleges that after a series of MR scans she ended up developing Gadolinium Deposition Disease. This led to long-term health battle for the couple, including numerous hospitalizations that cost $2 million or more in out-of-pocket costs.

Her symptoms included cognitive impairment, body pain/burning, kidney damage, loss of energy/mobility, and difficulty breathing.

Five-years after her last gadolinium exposure she continues to require treatment, including controversial and unreimbursed chelation therapy, for the damage she suffers.

"My heart breaks for those who don't have the financial means they need," she said in mid-September, at which time there was an FDA panel meeting to address gadolinium safety. "We will continue to use our platform to raise awareness about the dangers of gadolinium," she added.

The suit is part of their effort to “raise awareness” about the condition, and alert potential recipients of the agents.

“Unfortunately, litigation is the only course of action we can take to hold the drug companies accountable for threatening the lives of so many innocent people who undergo MRIs,” says Gena Norris. “These companies continue to say that there is no link between gadolinium and adverse events, even though the evidence is overwhelming that this heavy metal stays in the body for years, rather than hours,” she added.

In mid-September, the FDA's Medical Imaging Drugs Advisory Committee (MIDAC) voted to recommend revisions to the prescribing information for MR contrast agents with the material.

The vote was to add a warning that gadolinium can be retained in some organs and tissues.

According to a response to the meeting by Guerbet, “There are two kinds of gadolinium-based contrast agents [GBCAs], linear and macrocyclic. Although there are many similarities amongst these agents, they differ in their kinetic and thermodynamic stability. Linear GBCAs are generally less stable, and for this reason, more likely than macrocyclic agents to deposit gadolinium in tissue. Guerbet's GBCA, Dotarem [gadoterate meglumine] is a macrocyclic agent. The advisory would also state the risk of retention is slightly greater with linear agents versus macrocyclic ones.”

At the meeting, 13 committee members voted in favor of the proposal. The strongest – and only – dissenting vote came from Alicia Toledano, who is president of Biostatistics Consulting in Kensington, MD. She felt it did not go far enough.

"It is hard to dismiss an anecdotal report when you are the anecdote. A life ruined is a life ruined," she said. "What does a patient do when doctors and everyone she or he turns to for help 'pooh-poohs' his or her concerns and does not order a simple urine test? When a patient finally gets tested and is found to have gadolinium retention, there is no FDA-approved antidote. What does that patient do?"

She called the proposal “insufficient.”

The group was also unanimous in its decision to have contrast manufacturers examine whether more regulation is needed.

"It's clear we need more information," stated Dr. Peter Herscovitch, acting MIDAC chair and director of the PET department at the U.S. National Institutes of Health (NIH).

In fact, gadolinium retention may be more widespread than previously thought. In June, a report published in "Radiology" by Dr. Robert J. McDonald evaluated postmortem neuronal tissue samples from 5 patients who had gotten four or more gadolinium-enhanced MR exams, and compared them with samples from 10 who had MR scans without the agent.

“Our results suggest current thinking with regard to the permeability of the blood-brain barrier is greatly oversimplified, as gadolinium appears to accumulate even among patients with normal brain tissue and no history of intracranial pathology,” McDonald said in a statement.

In March, the European Union's committee that weighs the risks of medicine advised suspending market authorization for some gadolinium agents. It said it had found evidence of brain deposits of the agent in “small amounts” after MR body scans “but no signs of harm.”

Chuck and Gena Norris declined to discuss the issue with HCB News.