Product News and Recalls

Cedars-Sinai Patients Affected by Disease


CONTACT: Attorney Ramon R. Lopez and/or Attorney Jason E. Ochs
Telephone: 949-737-1501
Fax: 949-737-1504

Los Angeles, California, January 16, 2008 – On Friday, January 11, 2008, 63-year-old Priscilla Geffen and 60-year-old Michael Gleaton filed nearly identical lawsuits alleging that they contracted a rare, terminal disease known as nephrogenic systemic fibrosis after undergoing routine MRI’s with gadolinium-contrast dye at the S. Mark Taper Imaging Center at Cedars-Sinai Medical Center. The lawsuit names General Electric and Mallinckrodt, the makers of the gadolinium-contrast dyes, together with Cedars-Sinai Imaging Group and several radiologists.

Nephrogenic systemic fibrosis “NSF” is a relatively new disease first appearing in the medical literature in 2000. The disease was originally called nephrogenic fibrosing dermopathy as it was believed only to be a skin disorder. Since then, medical experts have discovered that the rare disease is a systemic disease and, thus, changed the name to nephrogenic systemic fibrosis. To date, only 215 cases have been reported to the FDA, but based on the voluntary nature of this kind of reporting to FDA some experts believe the actual numbers could be at least 10 times that amount. There is no known cure for NSF, and there have been a number of deaths attributable to this disease. Sadly, many NSF victims are denied the opportunity for kidney transplants due to the presence of this disease and succumb to their underlying kidney diseases.

In April 2006 a Danish study was the first to hypothesize the causal nexus between the rare disease and the gadolinium used in MRI and MRA imaging studies. However, many medical experts have warned about the possibility of the potential for catastrophic consequences from this known toxic element in certain formulations since the late 1980’s. The U.S. Food and Drug Administration has issued three written warnings (June 2006, December 2006 and May 2007) concerning the risk of NSF with gadolinium-contrast dye. In September of this 2007 the FDA required General Electric and Mallinkrodt, among others, to issue “black box” warnings on their gadolinium contrast dyes regarding the risk of NSF. That warning was first published by GE in their package insert in September, 2007, some 14 months after the first FDA bulletin.

NSF has only been linked to individuals with renal and/or hepatic insufficiency. Gadolinium is excreted through the kidneys and in individuals with compromised kidney function, the gadolinium remains in the body for a prolonged period of time causing the formulation to break down; releasing free gadolinium inside the body. Gadolinium is a metal that is highly toxic in its natural state.

NSF manifests itself initially in the lower legs, feet, arms and hands. The disease hardens the skin to rock-like texture. Over time, the disease will progress throughout the rest of the body, forcing the limbs, toes and fingers to contract. Patients describe NSF as a horrifically painful disease and medical literature has documented individuals who have foregone their dialysis treatments, choosing to die instead, because the pain is unbearable.

“The disease is unlike anything I have ever seen. You cannot imagine what it does to the skin until you have seen and touched an individual who has this disease,” says Jason Edward Ochs, attorney for Mrs. Geffen and Mr. Gleaton. “It is like touching rock.” Attorney Ochs has met with or spoken to more than two dozen individuals with the disease and is actively litigating cases across the country with the firm’s managing senior partner, and veteran pharmaceutical litigator, Ramon Rossi Lopez.

Attorney Lopez has been prosecuting pharmaceutical cases for more than twenty years. “We believe, and intend to prove, that the companies who manufactured the gadolinium-contrast dyes knew their dyes placed individuals with compromised kidney function at great risk. They made no effort to adequately test their product or to warn of these dangers despite clear signs of the potential for this known toxic element to escape from its protected shield should it remain in the body for periods longer than intended, and they knew this drug in the kidney diseased patient extended their exposure of gadolinium from minutes to many hours. It was only a matter of time that this type of epidemic among this class of already very sick patients would develop some devastating and debilitating disease process as a result of that excessive exposure. It’s yet another example of this industry focusing more attention to their bottom line profits than to the bottom line safety and efficacy profiles of their products. As a consequence, our clients have now been forced to endure a very painful, horrific and slow death,” says Attorney Lopez.

The Cedars-Sinai Imaging Group along with several radiologists were named because Mrs. Geffen and Mr. Gleaton continued to receive MRI’s with gadolinium-contrast dye in spite of displaying clinical manifestations of the disease and the FDA warnings.
“It is imperative that the medical community at large recognizes the very real risk of NSF in this small population group. Our healthcare providers need to be absolutely certain of patients’ renal sufficiency prior to injecting gadolinium into anyone,” says Attorney Ochs.

General Electric is the manufacturer of Omniscan™; a gadolinium-contrast dye. Mallinckrodt is the manufacturer of OptiMARK®. Post-marketing reports have identified the development of NSF following single and multiple administrations of gadolinium-based contrast agents. Where a specific agent was identified, the most commonly reported agent was Omniscan™, followed by Magnevist® and OptiMARK®.

Contact Information:
Ramon R. Lopez, Lopez McHugh LLC Mark Davis, Esq., Mark Davis P.C.

Jason E. Ochs, Lopez McHugh LLC Martin Crump, Esq., Mark Davis P.C.
100 Bayview Circle, Suite 5600 1712 15th St., Gulfport, MS
Newport Beach, California 866-857-8500; Fax: 228-864-0907
949-737-1501; Fax: 949-737-1504

For additional information or a sample copy, please contact: Jason Edward Ochs

Lopez McHugh LLC is a national consumer-rights law firm with offices in Newport Beach, Philadelphia and New Jersey. Ramon Rossi Lopez is a nationally recognized litigator who has actively litigated a number of high-profile pharmaceutical cases including Fen-phen, Baycol, Zyprexa and Vioxx. Jason Edward Ochs is an attorney at Lopez McHugh and a former Orange County Deputy District Attorney. He has prosecuted pharmaceutical, medical and criminal cases and, together with Ramon Rossi Lopez, is heading up the gadolinium litigation at Lopez McHugh. Lopez McHugh represents more than sixty individuals across the country who have been diagnosed with, or died from, NSF.

Lopez McHugh and Mark Davis P.C. are co-counsel in the above action and are actively litigating NSF cases all over the country.

Mark Davis P.C. is a national consumer-rights law firm located in Gulfport, Mississippi. Mark Davis P.C. attorneys, Mark Davis and Martin Crump, have extensive experience litigating pharmaceutical actions all over the country including Vioxx, Drug-Eluting Stents, Hormone Replacement Therapy, Baycol, Fen-phen and more.