Early signs of how each side could fare at trial in hundreds of lawsuits over contrasting agents that allegedly cause nephrogenic systemic fibrosis are expected to come out of a San Francisco courtroom.
On Monday a suit against Bayer Healthcare Pharmaceuticals was assigned to trial, to begin in January, in front of San Francisco Superior Court Judge Curtis Karnow. Plaintiff Peter Gerber's suit, which accuses Bayer of negligently designing, testing and marketing Magnevist, a drug used to help doctors read MRIs, is one of hundreds of suits in California and elsewhere alleging that diagnostic drugs containing gadolinium have caused nephrogenic systemic fibrosis. And according to Gerber's lawyer, his suit is the first to be scheduled for trial.
Gerber contends he contracted NSF, a disease that causes hardening of the skin and connective tissues, after he was injected with Magnevist.
"When you have a case of NSF, it's pretty much a certainty that person was exposed to one of these agents," said Gerber's lawyer, Lawrence Gornick of Levin Simes Kaiser & Gornick in San Francisco.
Rodney Hudson, a Drinker Biddle lawyer representing Bayer, declined to comment. A spokeswoman for Bayer said Monday the company does not comment on pending litigation.
The company had been served with about 350 lawsuits involving Magnevist as of Oct. 15, according to a recent financial report it published for stockholders.
Sales of Magnevist were about $246 million in the first nine months of 2009, according to that report, and the drug is among the company's best-selling pharmaceutical products.
Magnevist is a contrast agent used to improve magnetic resonance imaging. In 2007 the U.S. Food and Drug Administration requested that gadolinium-based agents such as Magnevist carry boxed warnings about the risk of contracting nephrogenic systemic fibrosis for patients with kidney problems.
Roughly 20 to 30 California NSF lawsuits have been consolidated before San Francisco Superior Court Judge Richard Kramer, Gornick said. Most of the lawsuits involving these contrast agents have been filed in federal court, though, and consolidated in the Northern District of Ohio before Judge Dan Polster. Two major defendants are Bayer and General Electric Co., he added, though Gerber's suit names only the former.
Gerber's case was given a preferential trial setting because he is over 70 and in bad health, according to Gornick, who serves on the national gadolinium litigation plaintiffs steering committee. Kramer already had a trial set for the time period Gerber was entitled to, so he assigned the trial to Karnow's department, Gornick added.
A joint meeting of Food and Drug Administration committees on kidney and cardiovascular drugs was set to meet Tuesday to discuss safety considerations with gadolinium-based contrast agents.
Gornick said Bayer has made a motion to exclude all evidence from the committee meeting. "They apparently don't think the evidence coming out of that hearing is good for them, but we'll have to see," he said.
Levin Simes Kaiser & Gornick is handling about 50 lawsuits dealing with nephrogenic systemic fibrosis. Other big players on the plaintiff side, Gornick said, are Steven Skikos of San Francisco's Skikos, Crawford, Skikos, Joseph & Millican and Ramon Lopez of Newport Beach's Lopez McHugh.