A lawsuit has been filed against Covidien (formerly Tyco Healthcare Group) and its Mallinckrodt subsidiary of Hazelwood, MO, on behalf of a patient who asserts that she developed nephrogenic systemic fibrosis (NSF) after being administered the MRI contrast agent OptiMark.
The suit was filed December 14, 2007, in the Circuit Court of the City of St. Louis by the St. Louis law firm of CofmanTownsley. The litigation alleges that the woman sustained serious and potentially life-threatening injuries.
The complaint states that the woman's physician administered OptiMark three times in October 2004 and once in December 2004, which resulted in "overexposure" to gadolinium. In July 2007, the plaintiff was diagnosed with NSF.
Tyco Healthcare and Mallinckrodt became Covidien last year, when Tyco International of Mansfield, MA, spun off its healthcare division.
Covidien spokesperson JoAnna Schooler said the company "does not comment on pending litigation," adding that "Covidien is fully cooperating with the U.S. Food and Drug Administration and global regulatory bodies as they investigate the relationship between gadolinium-based contrast agents and nephrogenic systemic fibrosis."
As a company policy, Schooler said that Covidien recommends that all customers follow the product's prescribing information and any guidelines that have been issued by their governmental health authority on the use of gadolinium-based contrast agents.
Related Reading
Contrast vendors send gadolinium NSF letter, October 1, 2007
MR experts take issue with FDA gadolinium warning, September 18, 2007
Noncontrast MR: The solution to the NSF problem? July 26, 2007
FDA asks for 'black box' warning for gadolinium contrast, May 23, 2007
Gadolinium: A 'necessary factor' in the development of NSF? March 27, 2007
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