Tyco, Mallinckrodt being sued over gadolinium-based MR
The complaint alleges that as a result of being administered OptiMark by her physician three times during October 2004 and once during December 2004, the plaintiff was also overexposed to gadolinium, which can be found in the contrast agents injected into some patients before MRI scans and all patients before MRA scans.
In July 2007, the plaintiff was diagnosed with nephrogenic systemic fibrosis, also known as nephrogenic fibrosing dermopathy (NSF/NSD). Since the time of her diagnosis, her condition has resulted in bodily impairment, disfigurement and scarring, as well as fibrosis and contractures in her extremities, according to her lawyers.
NSF/NFD can occur in patients with kidney disease who undergo an MRI or MRA where a gadolinium-based contrast agent is used.
At RSNA 2007, a panel of experts discussed the mounting evidence that gadolinium-based MR agents can cause NSF in patients with chronic kidney disease. Emanuel Kanal, MD, FACR, director, MR services and professor of radiology and neuroradiology, department of radiology, University of Pittsburgh Medical Center, said that “radiologists may likely imminently have to start grappling with the concept of identifying total, possibly lifetime, prior-administered gadolinium-based MR contrast agent (GBMCA) dosages to patients with significant renal disease prior to deciding on whether or not to administer any GBMCA in the future and, if so, which one and how much to administer.” As of December 2007, more than 450 NSF cases had been reported to the FDA MedWatch reporting system.
The lawsuit also claims that Tyco insufficiently tested OptiMark and disregarded the fact that OptiMark could cause debilitating and potentially lethal side effects. Furthermore, the suit states that Tyco knew of the risk for dangerous side effects, yet withheld evidence from the FDA during OptiMark’s approval process.
The plaintiff asked that a jury compensate for reimbursement of current and future medical expenses, lost future income, loss of earning capacity, out-of-pocket expenses, emotional distress and other damages.
The suit was filed Dec. 14, 2007, in the Circuit Court of the City of St. Louis.