Since December 2006, FDA has continued to investigate reports of NSF in patients who received GBCAs. In addition, the FDA requested the manufacturers of all five GBCAs (Magnevist, MultiHance, Omniscan, OptiMARK and ProHance) to add a new boxed warning and a new Warnings section to their labels to describe the risk of developing NSF.
If you or a loved one have been diagnosed with Nephrogenic Systemic Fibrosis and you have recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your injuries. Please click here to contact us for a free confidential case evaluation.
Since December 2006, FDA has continued to investigate reports of NSF in patients who received GBCAs. In addition, the FDA requested the manufacturers of all five GBCAs (Magnevist, MultiHance, Omniscan, OptiMARK and ProHance) to add a new boxed warning and a new Warnings section to their labels to describe the risk of developing NSF.
Gadolinium is a paramagnetic metal ion. Paramagnetic ions, such as gadolinium, move differently within a magnetic field. This trait makes gadolinium useful for magnetic resonance imaging (MRI).
GBCAs are manufactured by a chelating process, a procedure in which large organic molecules form a stable complex around the gadolinium. The chelate reduces the chances of toxicity that could result from exposure to gadolinium. This stable complex is eliminated predominantly via the kidneys.
GBCAs are approved by FDA for use with MRI as a contrast agent to provide an improved image of body organs and tissues.
GBCAs are also used for magnetic resonance angiography (MRA), an imaging procedure used to evaluate blood vessels. FDA has not approved GBCAs for use in MRA.
MRA is a special type of MRI used to study blood vessels. MRA aids the detection of heart disorders, stroke, and vascular diseases.
An MRI or MRA can be performed without contrast. MRI with GBCAs provides additional diagnostic information as compared to MRI without contrast. Although GBCAs are not FDA-approved for MRA, some radiologists believe that these agents help provide detailed images of blood vessels. There are no FDA approved MRA contrast agents.
Patients with acute or chronic renal kidney insufficiency, or renal dysfunction due to hepato-renal syndrome or in the perioperative liver transplantation period, are at an increased risk for developing NSF when administered GBCAs. Many studies and publications support the association between NSF and GBCAs. Researchers have found gadolinium in the tissue of patients with NSF. Accumulating data indicate that GBCAs increase the risk for the development of NSF among patients with severe renal insufficiency or renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplant period.
NSF was first described in the medical literature in 2000. The first case of NSF was purportedly identified in 1997. NSF is reported only in patients with kidney disease. NSF causes fibrosis of the skin and connective tissues throughout the body. Patients develop skin thickening that may prevent bending and extending joints, resulting in decreased mobility in joints. NSF usually starts in the lower extremities. Fibrosis can also develop in the diaphragm, muscles in the thigh and lower abdomen, and lung vessels. Over time, NSF becomes worse and can cause death.
There is no known treatment for NSF.
The reports FDA has received, the published report of gadolinium deposits in the skin of patients with NSF/NFD, and other published reports suggest that GBCAs play a role in the development of NSF in patients with acute or chronic severe kidney insufficiency or kidney dysfunction due to the hepato-renal syndrome in the perioperative liver transplantation period.
FDA has requested that the manufacturers of the 5 GBCAs include a new Boxed Warning and new Warnings section in the labels that describe the risks of developing NSF. Additionally, FDA has requested that all manufacturers prospectively collect data on patients with varying degrees of renal insufficiency who are exposed to GBCA to more accurately estimate the magnitude of the risk for NSF for patients with kidney disease.
If you have severe renal insufficiency (severe kidney disease) and a physician has requested an MRI or MRA study with a contrast agent, ask if the use of the contrast agent is essential. There are situations where an acceptable study can be obtained without the use of contrast.
NSF litigation at a national level is quickly maturing. Unique procedures apply to cases like this where multiple people from around the country suffer injuries from the same source, such as a pharmaceutical drug, medical device, Ford Explorer rollovers…etc. These cases are called “mass torts.”
Generally, as happened in this litigation, cases start by being filed in various federal courts around the country. Appropriate forums could be your hometown federal court, New York federal court as gadolinium manufacturer General Electric is located there, Pennsylvania in some instances because gadolinium manufacturer Bayer is located there, and other courts.
After a handful of cases are filed, the lawyers file a motion before the Judicial Panel of Multidistrict Litigation (a group of federal judges referred to as the J.P.M.L.) to have all federal cases consolidated on one Court’s docket, assigned to one judge for pre-trial proceedings. The pre-trial proceedings that occur on the docket include obtaining all of the defendant’s corporate documents, taking the depositions of the heads of their key departments, such as regulatory matters, marketing, pre-clinical and clinical testing, and adverse event surveillance. This is also the time when we give the defendants the critical information about your case.
The JPML met on January 31, 2008, and issued its order assigning the litigation to the docket of the Honorable Daniel Polster of the United States District Court for the Northern District of Ohio.
Our firm has filed many cases, which are now pending before Judge Polster. It is our intent to steadily file all of our cases, and vigorously pursue them until they are successfully resolved. The pre-trial proceedings are going very well at this stage of the litigation. A protocol for presentation of all tissue samples was established. We wrote to all doctors involved with biopsies of our clients and provided them with the Court order that sets forth their obligations with respect to tissue samples. Additionally, a process was put in place by the Court to facilitate product identification. This protocol will assist Plaintiffs in the difficult task of identifying all GBCA’s to which they were exposed. Additionally, the Court requested that the parties submit scientific and technical information concerning GBCA’s and Nephrogenic Systemic Fibrosis. This submission enables the Court to fully understand NSF and the suffering of the victims.
Plaintiffs anticipate receiving all relevant internal documents from the Defendant manufacturers very soon. This will enable plaintiffs to prove what the Defendants knew, when they knew it, and what steps they should have taken to avoid the public health crises that they caused. Additionally, depositions of all pertinent depositions are being taken.
I will continue to provide updates on NSF litigation as it develops. However, if you would like additional information, please do not hesitate to contact me.
Additionaly, our firm is accepting new Nephrogenic Systemic Fibrosis cases in all 50 states. If you or a loved one have recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your injuries. Please click here to contact us for a free confidential case evaluation.
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