A Cleveland man has filed a lawsuit against Tyco International and two healthcare subsidiaries, Tyco Healthcare Group and Mallinckrodt, claiming that the company’s drug Optimark caused him a debilitating skin and joint disease known as nephrogenic systemic fibrosis (NSF).
The suit seeks nine separate causes of action stemming from the effects of Optimark alleged in the suit. Optimark is injected into patients prior to magnetic resonance imaging (MRI) to help diagnosticians distinguish blood vessels from nearby tissues.
According to information released by the firm handling the case, the U.S. Food and Drug Administration (FDA) last year acknowledged that there were 200 reports worldwide of NSF, also sometimes called nephrogenic fibrosing dermopathy. The suit states 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 known, of the risks of Optimark. "During the years that defendants have manufactured, marketed, and sold 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," states the suit.
The firm believes this could be the first such case of its kind in the United States.
Tyco Healthcare/Mallinckrodt said in a released statement that it “has not been served with any litigation related to nephrogenic systemic fibrosis (NSF)” and that the organization does not as a practice comment on pending litigation.
The company added that “Mallinckrodt and other manufacturers of gadolinium-based magnetic resonance agents in the United States have been cooperating with an ongoing FDA investigation to determine the relationship between exposure to these agents and the diagnosis of NSF in certain patients with impaired renal function.”
Further, the company said that “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."