On March 14, John G. Walker, a retired 71-year-old Cleveland businessman, filed suit against Tyco International, Princeton, NJ, and two health care subsidiaries, Tyco Healthcare Group and Mallinckrodt Inc. His claim: The Tyco MRI contrast agent OptiMark gave him nephrogenic systemic fibrosis (NSF), a rare, debilitating skin and joint disease.

Walker’s lawyer, Peter J. Brodhead—a partner in Cleveland litigation firm Spangenberg, Shibley and Liber—painted a harrowing portrait of the illness. “Within days of his OptiMark injection last year, Mr. Walker experienced excruciating pain and suffered serious, progressive, and incurable injuries,” Brodhead said. “This man-made disease caused his skin to harden and his joints to lock up and to swell. He was sent to a nursing home and confined to bed and a wheel chair. Today, he is at home, but he continues to require regular physical therapy in order to walk.”

The FDA issued an advisory alert in 2006 about NSF, noting that 200 cases had been reported worldwide, all linked to the use of gadolinium-based contrast agents like OptiMark, Omniscan from GE Healthcare Medical Diagnostics, Princeton, NJ, and Magnevist from Bayer HealthCare (formerly Berlex Inc), Montville, NJ. Walker’s suit claims that Tyco either was or should have been aware of the risks, stating, “There have been numerous case reports, studies, assessments, papers, and other clinical data that have described and/or demonstrated NSF/NFD in connection with the use of certain gadolinium-based contrast agents. Despite this, defendants have repeatedly failed to adequately revise their package inserts, material safety data sheets, and other product-related literature, and to conduct appropriate postmarketing communications in order to convey adequate warnings.”

In response to the growing controversy, GE Healthcare issued a white paper on NSF and gadolinium. The report notes that research suggests gadolinium contrast agents could be triggering NSF by releasing free gadolinium ions, a more likely risk in agents with lower stability constants, such as gadodiamide. One idea presented is altering the chemical makeup of Omniscan by adding caldiamide sodium. The paper stresses that NSF has been reported only in patients with serious renal impairment.

The American College of Radiology (ACR), Reston, Va, recently revised its MR practice guidelines to include information about the risk of NSF following gadolinium-based contrast injections. When risk-benefit assessments warrant administration of a gadolinium-based MR contrast agent to patients with moderate to end-stage kidney disease or acute kidney injury, consideration should be given to administering the lowest dose that would provide diagnostic benefit,” the report states. “Clinicians also should consider postponing the examination in patients with acute kidney injury until renal function has recovered.”

Meanwhile, Shawn E. Cowper, MD, assistant professor of dermatology and pathology at Yale University School of Medicine, New Haven, Conn, the first clinician to identify the condition 7 years ago, told AuntMinnie.com that he believes cases of NSF will be identified more frequently now that the word is out about the disease. He founded the International Center for Nephrogenic Fibrosing Dermopathy Research; on May 4, he will help lead the First Annual Scientific Symposium on NSF and MRI Contrast at Yale.