San Francisco, CAAt the nation's first Nephrogenic Systemic Fibrosis (NSF) trial in January, attorney Larry Gornick intends to prove that Bayer Healthcare Pharmaceuticals, Inc., the maker of Magnevist, could have made a safer and more stable product but chose not to bring it the US purely for financial reasons.
Magnevist is a gadolinium-based contrast agent (GBCA) used by radiologists during magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) procedures. The gadolinium in Magnevist and other contrast agents such is known to cause NSF.
"One of the reasons why this lawsuit is so compelling is because Bayer knew—for at least 15 years—how to make a GBCA that was less likely to release free gadolinium (a toxic heavy metal) into people's bodies," says Gornick.
Bayer made a safe contrast agent called Gadovist and started selling it in Canada and Europe in 2000, but they didn't sell it in the US. Adds Gornick: "Not only did Bayer know how to make a safer product, they actually made it and sold it."
"We have clear evidence that shows why Bayer chose not to bring Gadovist here," he says. Magnevist was the first contrast agent on the market, with greater than a 50 percent market share, so Bayer didn't want to do anything that might jeopardize Magnevist's sales. Competitive pressures were fierce in the US by the mid-1990s, so Bayer knew it couldn't charge more for Gadovist, which costs more to make than Magnevist.
"If Bayer brought Gadovist to the US and cannibalized Magnevist, their profit margin would decrease," says Gornick. "So they chose not to bring a safer, more stable product to the US purely for financial reasons.
"We also intend to prove that Bayer targeted patients with severe renal impairment for MRI and MRA procedures with Magnevist without having done any studies that actually showed that their contrast agent is safe in people with severe renal/kidney impairment."
Levin Simes Kaiser and Gornick LLP currently represents about 50 people with NSF. The law firm has filed cases in the California state courts and federal court. All California cases are coordinated before Judge Richard Kramer in San Francisco. All federal cases are consolidated before Judge Aaron Polster in the Northern District of Ohio. (Judge Polster has the MDL.) Attorney Larry Gornick has been appointed to the plaintiffs' steering committee for the federal litigation. On December 7, 2009, one of his first California cases was assigned to a trial judge, and jury selection will start on January 25 in San Francisco.
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