Medical Device:

Gadolinium Dye Brand Names

Gadolinium is used in contrast dyes during magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). Patients with pre-existing kidney conditions who receive a gadolinium-containing contrast agent during these scans are at risk for developing nephrogenic systemic fibrosis, a potentially life-threatening disease. Brand names for gadolinium contrast agents include Magnevist which is manufactured by Bayer-Schering; MultiHance developed by Bracco Diagnositcs; Omniscan created by GE Healthcare; OptiMARK manufactured by Mallinckrodt Inc.; and ProHance also manufactured by Bracco Diagnostics. If you have been injected with any of these gadolinium contrast agents and have developed nephrogenic systemic fibrosis, contact a gadolinium attorney immediately.

Omniscan

Omniscan is a gadolinium based MRI contrast dye manufactured by GE Healthcare. Omniscan is injected into patients undergoing MRIs in order to enhance images of tissue abnormalities, such as tumors. In most patients, the gadolinium contrast dye passes through the body in a relatively short time.

Although Omniscan is safe for use in most patients, it poses a serious risk for patients with renal problems. These patients may be unable to eliminate the gadolinium, which puts them at risk for developing a potentially fatal health condition known as Nephrogenic Systemic Fibrosis (NSF). Omniscan was introduced in 1993, but no warnings were given that Omniscan put kidney patients in danger until June 2006. At this time, GE Healthcare issued a safety advisory for Omniscan warning physicians that the use of the Omniscan contrast agent in an MRI or MRA on a patient with pre-existing renal issues may lead to that patient developing NSF. This condition is also known as  Nephrogenic Fibrosing Dermopathy (NFD). The FDA has issued its strongest warning (the Black Box warning) for gadolinium MRI injections because of the serious symptoms linked to the drug.

To date, GE Healthcare has been advised of 96 cases of NSF / NFD following use of MRI contrast agents such as Omniscan throughout the United States, Europe and Asia. In addition, several gadolinium lawsuits have been directed at GE Healthcare. In one case, Greta Carolus filed a suit in the U.S. District Court against General Electric Company, GE Healthcare, Inc., and GE Healthcare Bio-Sciences Corporation alleging that she developed NSF just days after being injected with Omniscan contrast agent for an MRI.

If you have been injected with Omniscan for an MRI or MRA, you may be at risk for developing NSF or NFD. Fill out the form on this page for a free legal consultation and information about your legal rights.

ProHance

ProHance (gadoteridol) is a gadolinium based contrast dye manufactured by Bracco Diagnostics. ProHance was approved by the FDA in 1999 and is used in performing MRIs and MRAs. ProHance is injected into the bloodstream of patients and helps to highlight abnormalities in tissue so that doctors can diagnose any medical problems that are present.

The primary ingredient in Prohance is gadolinium, which has been linked to Nephrogenic Systemic Fibrosis (NSF), or Nephrogenic Fibrosing Dermopathy (NFD) in patients with kidney problems. While healthy kidneys are able to expel the gadolinium quickly following the MRI procedure, patients with compromised kidneys are unable to do so, leaving them at risk for this serious condition. NSF is an incurable disease, which can lead to permanent disability and death in severe cases. It  is characterized by a tightening of the skin, which can occur within days of a ProHance injection for patients with kidney problems.

On May 23, 2007, the U.S. Food and Drug Administration (FDA) asked manufacturers of all gadolinium based contrast agents used in MRIs to include a black-box warning on the products’ labeling. The warning came after reports of patients developing NSF. New black-boxed warnings state that patients with severe renal problems who receive a gadolinium contrast agent are at risk for developing NSF. As of September 2007, the FDA had received reports of more than 250 cases of NSF in patients who were given gadolinium based contrast agents, such as Prohance.

Lawsuits have been filed against gadolinium contrast agent manufacturers by individuals who have developed NSF. If you feel that you may be eligible to participate in a gadolinium lawsuit, fill out the form on this page for a free case evaluation.

OptiMARK

OptiMARK (gadoversetamide) is the name of gadolinium based contrast agent that is manufactured by Mallinckrodt Inc. OptiMARK was approved in December 1999 and is used in medical imaging scans in order to help doctors see abnormalities in tissue and make diagnoses. On May 23, 2007, the U.S. Food & Drug Administration requested that the manufacturers of OptiMARK add a new boxed warning on the product labeling because of reports linking gadolinium contrast agents to Nephrogenic Systemic Fibrosis.

Nephrogenic Systemic Fibrosis (NSF) is a relatively rare condition that causes a hardening and tightening of the skin. In severe cases, it can be fatal. Patients with kidney problems are at risk for NSF because their kidneys are unable to safely flush gadolinium out of the body following an MRI or MRA. Some patients report early symptoms of NSF within days of being injected with a gadolinium based contrast agent, such as OptiMARK.

If you have been diagnosed with NSF following the use of OptiMARK contrast agent in an MRI, it is important to consult with a gadolinium lawyer in order to ensure that your rights are protected.

Magnevist

Magnevist (gadopentetate dimeglumine) is a gadolinium based MRI contrast dye manufactured by Bayer-Schering and its subsidiary Berlex Laboratories. Like other gadolinium contast dyes, Magnevist is used by medical professionals to improve the visibility of organs during MRIs. In most patients, gadolinium is rapidly cleared from the body by the kidneys following the procedure. However, patients with kidney problems may be unable to eliminate gadolinium from their bodies, leaving them at risk for developing serious complications.

On May 23, 2007, the Food and Drug Administration (FDA) requested that Bayer-Schering add a new boxed warning on Magnevist because it had been linked to Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy in MRI patients with renal problems. NSF / NFD is a disease that causes fibrosis of body organs, resulting in the inability of the organs to work properly. NSF can be fatal and there is no known cure.

Magnevist has also been the subject of legal action. In June 2008, a gadolinium lawsuit was filed against Bayer-Schering and Berlex Laboratories by a Minnesota woman who claims that she developed NSF after an imaging scan using Magnevist gadolinium contrast dye. She has suffered from permanent disability and severe disfigurement caused by NSF. The lawsuit alleges that Magnevist is defective, that the defendants failed to adequately test it, and that the defendants failed to warn patients about its potential to cause NSF.

If you or a loved one has been diagnosed with Nephrogenic Systemic Fibrosis following an MRI or MRA in which Magnevist was used as a contrast agent, you may be eligible to participate in a gadolinium lawsuit. In order to ensure that your legal rights are protected, fill out the form on this page for a free case evaluation.

MultiHance

MultiHance (gadobenate dimeglumine) is a gadolinium based contrast agent manufactured by Bracco Diagnostics. The FDA approved Multihance in 2004 for use in magnetic resonance imaging (MRI) of the central nervous system in adults. It helps provide doctors with clear pictures of organs and tissue abnormalities in the body during MRI imaging scans. Healthcare professionals often inject MultiHance into a patient’s bloodstream before an imaging scan in order to enhance the images.

The active ingredient in Multihance is gadolinium. In most healthy patients, gadolinium is quickly flushed out of the body by the kidneys. However, in patients with kidney problems, the gadolinium may remain in the body, resulting in the patient developing Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD). This is a potentially fatal disease that causes skin to swell and tighten, leaving patients unable to extend their limbs.

Due to the risk of NSF, the FDA now requires all gadolinium contrast agents to have warning labels. In addition, gadolinium lawsuits have been filed by patients with NSF naming Bracco Diagnostics and other gadolinium contrast agent manufacturers as the defendants. MultiHance lawsuits are being investigated and reviewed for individuals with kidney disease who were injected with the MultiHhance contrast agent during an MRI or MRA and subsequently developed Nephrogenic Systemic Fibrosis.

If you were injected with Multihance contrast agent for an MRI and have been diagnosed with NSF, you may have a legal right to compensation. Fill out the form on the right side of this page for a free case evaluation and information about your legal rights.

 

Do you think you might have a Medical Device case?
Contact our experienced Medical Device lawyers right now.

Please fill out the form below
and receive a free case evaluation
at no cost or obligation.
6327