Suit Filed Against Tyco and Optimark
A retired 71-year-old suburban Cleveland restaurant supplier, filed a lawsuit in U.S. District Court on March 14 against Tyco International and two healthcare subsidiaries, Tyco Healthcare Group and Mallinckrodt, Inc., claiming that their drug Optimark caused him a debilitating skin and joint disease known as Nephrogenic Systemic Fibrosis (NSF). It may be the first against Tyco stemming from the effects of Optimark, a contrast agent containing the metal gadolinium. Optimark is injected into patients prior to magnetic resonance imaging (MRI) to help diagnosticians distinguish blood vessels from nearby tissues. The suit notes that in 2006 the FDA issued Public Health Advisory alerts about the development of serious, sometimes fatal, NSF/NFD following patient exposure to gadolinium-based contrast agents, including Optimark. The suit claims that Tyco was aware, or should have been aware of the risks of Optimark. 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 according to the suit. Further, the suit alledges that the Defendants have not revised their package inserts, material safety data sheets, and other product-related literature, nor conducted appropriate post-marketing communications in order to convey adequate warnings.
