MRI contrast developer Bayer HealthCare Pharmaceuticals of Wayne, NJ, has settled a lawsuit involving a California man who allegedly contracted nephrogenic systemic fibrosis (NSF) after administration of the company's Magnevist gadolinium-based MRI contrast agent.
The confidential settlement was reached January 14, a week before jury selection was scheduled to begin for the San Francisco trial. The litigation is believed to be one of the first NSF cases scheduled to go to trial.
The lawsuit involved Peter Gerber, a 74-year-old San Rafael resident with a history of kidney disease. He received Bayer's Magnevist MRI contrast agent five times between 1997 and 2003, according to his attorney, Larry Gornick, of the San Francisco law firm Levin, Simes, Kaiser, & Gornick. He has since received a kidney transplant.
Terms of the settlement were not disclosed. Bayer issued this statement regarding the settlement: "Bayer will, at times, consider the option of settling litigation on a case-by-case basis. Without admission of liability, the company can confirm that it has reached agreement with Mr. Gerber."
Sales of Magnevist were approximately $238 million in the first nine months of 2009, and the drug is among the company's best-selling pharmaceutical products, according to a Bayer financial report for stockholders.
Approximately 420 product liability cases are currently pending that have been filed across the country since February 2008 related to gadolinium MRI contrast and its possible connection to NSF. Bayer also settled several NSF lawsuits in April 2009.
In addition to Bayer and its Magnevist product, other lawsuits involve GE Healthcare of Chalfont St. Giles, U.K., with its Omniscan product; Bracco Diagnostics of Princeton, NJ, with its ProHance and MultiHance agents; and Mallinckrodt, a division of Covidien of Dublin, Ireland, which markets Optimark.
The U.S. Food and Drug Administration (FDA) issued a warning about gadolinium MRI contrast and its possible connection to NSF in June 2006, and the agency asked manufacturers to put warning labels on their products in May 2007.
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