The first jury trial involving General Electric’s <"http://www.yourlawyer.com/topics/overview/omniscan_gadolinium">Omniscan gadolinium contrast dye is scheduled to begin today. The plaintiff in the lawsuit, an elderly Minnesota woman, claims she developed nephrogenic systemic fibrosis (NSF) after being injected with Omniscan as part of MRI procedures.
<"http://www.yourlawyer.com/topics/overview/nsf">NSF is a condition involving the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs that can be fatal. Evidence suggests that NSF is most likely to occur in people with severe kidney disease who have been exposed to a gadolinium contrast dyes.
Gadolinium contrast dyes are sold under the names Ablavar, Eovist, Magnevist, Multihance, Omniscan, Optimark, and Prohance. In 2007, the U.S. Food & Drug Administration (FDA) mandated that all gadolinium agents sold in the U.S. carry a black box warning â€“ the agencyâ€™s strongest safety notice â€“ regarding the risk of NSF. This past September, the FDA ordered the warning be strengthened, and use of Omniscan and other gadolinium contrast dyes are now banned in patients with severe kidney disease.
Loralei Knase, 68, from Coon Rapids, Minnesota, who suffered from kidney disease, was injected with Omniscan several times between 2003 and 2005. According to her lawsuit, her entire body became stiff and swollen. She has since had a kidney transplant, but is now disabled and must rely on a wheelchair. Her lawsuit alleges General Electric and its health care division hid Omniscan’s risks and failed to protect patients after its problems became apparent.
Omniscan was first approved for use in 1993. GE acquired Omniscan with the 2004 purchase of the pharmaceutical company Amersham. According to a report from ProPublica, Omniscan was the first gadolinium contrast dye to be linked with NSF and is named more often in medical reports and lawsuits than similar drugs. General Electric and the other makers of gadolinium contrast dyes have confidentially settled most of the cases involving their drugs, ProPublica said, but around 300 remain unresolved.
According to ProPublica, attorneys for Knase are likely to point to internal concerns voiced by employees working for Omniscan’s owners, dating back to the 1990s, about the chemical stability of the drug and the possibility that patients with impaired kidneys might retain some of its active ingredient, the toxic metal gadolinium. Some of those internal corporate concerns focused on the possibility that Omniscan might be less stable than competitors, according to court and public records.
District Judge Dan Aaron Polster will preside over the Knase case and is overseeing similar cases in federal courts elsewhere, ProPublica said. The Knase lawsuit is a potential bellwether for the similar cases filed against the makers of gadolinium contrast dyes.