A Cleveland man who claims he developed nephrogenic systemic fibrosis (NSF) from an injection of gadolinium MRI contrast has filed a lawsuit against Tyco International of Pembroke, Bermuda, and two of its subsidiaries, Tyco Healthcare Group and Mallinckrodt of Hazelwood, MO.
John G. Walker, a 71-year-old retired restaurant supplier, claims that he developed NSF after an injection of Optimark, which he received after being admitted to University Hospitals in Cleveland in January 2006 for dialysis and other treatment. Within days of receiving the injection, Walker developed NSF, "experienced excruciating pain and suffered serious, progressive, and incurable injuries," according to his attorneys. His skin hardened and his joints began to lock up and swell, they said.
Walker was sent to a nursing home and confined to a bed and wheelchair. He is now living at home, but continues to require regular physical therapy in order to walk, his attorneys said.
The lawsuit was filed in a U.S. District Court in Cleveland and seeks damages for nine separate causes of action, according to the plaintiffs. It claims that Tyco was aware or should have been aware of the risks of Optimark, and claims that during the years that the defendants manufactured the agent, "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, including Optimark."
The lawsuit also notes the public health advisories issued by the U.S. Food and Drug Administration (FDA) and academic societies regarding the apparent link between gadolinium contrast and NSF in patients with kidney disease.
In response to press inquiries, Tyco Healthcare/Mallinckrodt said that the company has not been served with any litigation related to NSF, and it does not generally comment on pending litigation. The company noted that it and other manufacturers of gadolinium-based MRI contrast agents have been cooperating with the FDA in its investigation into the relationship between the products and NSF.
"Mallinckrodt is fully committed to the timely dissemination of safety information about its products to the healthcare community and has encouraged its customers to exercise caution and follow the guidelines published in the FDA Public Health Advisory when using any gadolinium-based agents in patients with renal impairment," the company said in a statement.
By AuntMinnie.com staff writers
March 19, 2007
Related Reading
Health Canada issues gadolinium advisory, March 15, 2007
Scottish study shows potential gadolinium-NSF link, March 9, 2007
Gadolinium-based contrast may cause nephrogenic systemic fibrosis, March 6, 2007
ACR releases new MR safety guidelines, March 1, 2007
FDA learns of more cases of gadolinium-related disease, December 26, 2006
Copyright © 2007 AuntMinnie.com
