Nephrogenic Systemic Fibrosis has been identified with exposure to gadolinium-containing contrasting agents used in MRI and patients suffering renal failure and under kidney dialysis. Due to the nature of the disease and its swift and progressive attack that hardens and thickens skin and other tissues throughout the body, the Court has pushed for an aggressive trial schedule since many of the plaintiffs are very ill and may not survive lengthy litigation. The federal gadolinium litigation has been consolidated before Judge Dan Polster in the United States District Court for the Northern District of Ohio for purposes of pretrial litigation. According to Judge Polster, Bayer Healthcare, one of the 5 manufacturers of the gadolinium contrasting agents, has initiated settlement negotiations with a number of plaintiffs. About 400 gadolinium lawsuits have been filed in state or federal courts against Bayer and the makers of four other types of MRI contrast agents, including GE Healthcare’s Omniscan, Bracco Diagnostics’ MultiHance and ProHance, and Mallinckrodt’s OptiMARK. Details of gadolinium settlement negotiations have not been publicly released, during a recent status conference held on March 6, 2009, Judge Polster confirmed that discussions have taken place and suggested that several cases may settle in the near future.

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In Copenhagen, Denmark the health minister has promised compensation to kidney patients who contracted Nephrogenic Systemic Fibrosis after being administered Omniscan, a contrast agent used in MRI to enhance tissue images. Here in the states there are also a number of lawsuits against the 5 manufacturers of gadolinium contrasting agents including the makers of Omniscan. NSF is characterized by the progressive hardening of skin and joints and sometimes internal organs that often result in the inability to move about without a wheelchair. Currently there is no treatment for the condition. Attorneys for the victims in the United States have asked for the suits to be prioritized because some of their plaintiffs are in dire circumstances while others have already perished from the debilitating disorder. As for Jakob Axel Nielson, the health minister in Denmark he says,

“The least we can do for these deeply ill people, who unfortunately became more sick after being administered Omniscan, is to identify them and offer compensation.”

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In the February issue of Radiology researchers raised awareness of the risk factors between gadolinium based contrast agents and the onset of Nephrogenic Systemic Fibrosis. Javier Perez-Rodriguez, of the Johns Hopkins University School of Medicine in Baltimore, and colleagues describe 33 patients diagnosed with NSF from 2003 to 2008. All the patients had advanced renal failure at the time they were given gadolinium contrasting agents prior to an MRI. The time between exposure to gadolinium and the presentation of NSF was an average of 29 days. Researchers reported before the U.S. Food and Drug Administration issued warnings about the association between gadolinium exposure and NSF, the overall incidence of the disease was 36.5 cases in 100,000 patients. After the FDA pressed for a “black box” warning on the contrasting products the amount of NSF cases dropped to 4 per 100,000 patients.

In conclusion the authors write, “In January 2007, our institution implemented policies regarding the use of GBCA in patients with severe renal dysfunction, with the aim being to reduce the incidence of NSF. These policies were associated with a significant reduction in the incidence of NSF. Besides the previously reported epidemiologic considerations of NSF associations, the success of such a policy in the reduction of NSF due to GBCA exposure strengthens the belief that there is a causal relationship between GBCA and NSF.”

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Victims of the debilitating condition Nephrogenic Systemic Fibrosis will have to wait an additional 90 days in seeking retribution. NSF is a progressive disorder characterized by the hardening and thickening of skin that severely restricts movement and in many cases leads to immobility. The U.S. District Judge Dan Polster who is overseeing the lawsuits in the U.S. District Court for the Northern District of Ohio postponed the litigation to give more time in the bellwether selection of 10 cases as a result of the number of gadolinium contrasting agents responsible for the disorder. Approximately 300 lawsuits have been filed against the manufacturers of the five different types of gadolinium based contrast agents identified as responsible for NSF by multiple researchers and medical doctors. Lawyers representing individuals who have filed NSF lawsuits have been pushing for an aggressive t rial s chedule, as many of the plaintiffs are very sick and may not survive lengthy litigation. It is likely that the first NSF lawsuits will not reach a jury until Fall 2009.

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In an effort to notify doctors of the risks of acquiring nephrogenic systemic fibrosis following an MRI in patients with insufficient kidney function, UroToday published an article encouraging physicians to take notice. Nephrogenic systemic fibrosis develops following exposure to MRI imaging products containing gadolinium. Its long term effects devastate the patient leaving them wheelchair bound and can sometimes lead to death. A recent study linked the contrasting agent to the disorder. The symptoms of NSF usually develop within weeks to months after exposure to gadolinium. The study also revealed algorithms to follow when determining the safety in the use of gadolinium, indicating that those with severe renal impairment are not to be exposed to any level of the agent. They conceded that further research needs to be directed in finding agents that will stabilize gadolinium and make MRI imaging safe for all patients.

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On October 21, 2008 lawyers met with the Court to discuss the process for selecting the first Nephrogenic Systemic Fibrosis lawsuits for trial and which of the five gadolinium contrast agents the plaintiffs’ were exposed to during MRIs. The use of gadolinium based contrast agents used in MRIs has been linked to NSF in patients with moderate to severe kidney dysfunction. As of now almost 400 NSF lawsuits have been filed against the 5 manufacturers of the contrasting dye. In an effort to centralize and coordinate pretrial litigation the U.S. Judicial Panel of Multidistrict Litigation transferred all the NSF federal cases to Judge Dan Polster in the U.S. District Court for the Northern District of Ohio in February 2008. Judge Polster has been assigned to nearly 300 of the lawsuits. Lawyers representing the individuals and families whose lives have been affected by NSF are pushing the court to begin trial quickly because many of their clients are sick and may not survive a lengthy litigation.

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A new study undergone by researchers at Vanderbilt University has again shown a strong link between the use of gadolinium dyes and the disease Nephrogenic Systemic Fibrosis found in patients with renal failure. The team of researchers concluded with the warning that gadolinium contrast dyes should be used “judiciously” in patients with kidney disease opining that the benefits should be carefully weighed against the risks. In the study researchers at Vanderbilt analyzed data from case reports submitted to the U.S. Food and Drug Administration. The study found the occurrence of NSF after gadolinium contrast agent exposure depended on the degree of renal dysfunction, amount of contrast agent administered, gadolinium contrast agent stability and the severity of a patient’s kidney disease. NSF has devastated the lives of hundreds of individuals and their families. NSF is characterized by high blood pressure, burning, itching, swelling and hardening of the skin to the point of immobility. Other symptoms include deep pain in the hips and ribs and muscle weakness. In September 2007 the FDA ordered a “black box” warning, the most severe used, to be added to the labels of the manufacturers products including, Bayer HealthCare Pharmaceuticals, Bracco Diagnostics, GE Healthcare and Mallinckrodt. Since then lawsuits have been filed in state and federal courts against the companies for the injuries incurred after the exposure to the gadolinium contrast dyes. As of September 24, there were 287 NSF lawsuits pending in the Multidistrict Litigation. Another 104 lawsuits have been filed in various state courts throughout the U.S.

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Another lawsuit has been filed against the manufacturers of the gadolinium contrasting dye Omniscan on behalf of a 38-year-old Georgia man who contracted the disease Nephrogenic Systemic Fibrosis. General Electric Company’s Omniscan is a dye used to better define soft tissue in MRIs. The lawsuit includes GE’s subsidiaries GE Healthcare Inc., GE Healthcare Medical Diagnostics, GE Healthcare AS and Novation LLC. Nephrogenic Systemic Fibrosis is a condition that affects patients with kidney dysfunction who have been exposed to gadolinium dye. It is debilitating, progressive and can be fatal. The lawsuit alleges that Omniscan is defective, and that the defendants failed to adequately test Omniscan and failed to warn patients about its potential to cause NSF. Finally in September 2007, the Food & Drug Administration asked the manufacturers of gadolinium contrast dyes to add a “black box” warning, the most severe, to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents. NSF is a devastating condition characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include eye discoloration, red or dark patches on the skin, pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints. There is no known cure for NSF, however an experimental treatment called extracorporeal photopheresis has shown progress in three known cases of NSF. Extracorporeal photopheresis is a form of dialysis that involves treating the blood with photoactive drugs that are then activated when the blood is exposed to ultraviolet light. The blood is then reintroduced to the body effectively helping the body’s immune system fight the disease

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In the wake of a number of injuries occurring after the use of gadolinium contrast agents before an MRI, the U.S. Food and Drug Administration has approved a Fast Track Designation for a new type of contrast agent, ferumoxytol. Gadolinium contrast agents have been strongly linked to the debilitating and sometimes deadly disease Nephrogenic Systemic Fibrosis. Those who have suffered from this disease have previous renal failure in their kidneys. The gadolinium contrast agent is unable to evacuate from the body of an impaired renal system as quickly as those without. The FDA reserves the Fast Track Designation for products intended in the treatment of serious or adverse conditions or have the potential for use in previously unmet needs. This designation helps to accelerate the process of development and review of these products. The quicker approval process of ferumoxytol is driven by the potential that this newer diagnostic agent will be a safe alternative for individuals with chronic kidney disease.

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On a website as a service of the U.S. National Library of Medicine and the National Institutes of Health is a report on the clinical findings of three individuals treated with extracorporeal photopheresis who were afflicted with Nephrogenic Systemic Fibrosis. NSF has been strongly linked to the use of gadolinium contrasting dyes used in MRIs and those experiencing renal or kidney dysfunction. Up until this report no known treatment was available. NSF is characterized by the severe stiffening of joints and skin often causing the victim to be handicap-chair bound and can even cause death. The experimental treatment has shown that in each of the three cases mobility improved. Extracorporeal photpheresis treatment is a form of dialysis that involves treating the blood with photoactive drugs that are then activated when the blood is exposed to ultraviolet light. The blood is then reintroduced to the body effectively helping the body’s immune system fight the disease. At the end of four cycles of ECP all three patients showed a clinical response with the softening of the skin. At the completion of the treatments all experienced improved range of motion in all four limbs. The researchers are confident this may well prove to be an effective treatment of a previously untreatable and sometimes terminal condition.

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In the June issue of the American Journal of Kidney Diseases, gadolinium-based contrasting agents used in MRIs was reported to increase the risk for Nephrogenic Systemic Fibrosis. It has been known for some months that there was a link between gadolinium exposure and NSF presenting itself in those with kidney failure. In fact, the U.S. Food and Drug Administration late 2007 issued a “black box”, the most severe warning, for any MRI contrasting products containing the agent. Dr. Alexander J. Kallen from the Centers for Disease Control and Prevention, Atlanta, and colleagues conducted a case-control study of 19 patients with NSF treated at a St. Louis hospital dialysis unit and 57 matched controls from the same unit. The authors reported that 14 patients with NSF had undergone an MRI with a gadolinium injection in the previous year that showed a median interval of 123 days from the gadolinium use in the MRI and the time the disease was detected. Four of the remaining five patients had gadolinium exposure between 16 and 68 months before diagnosis. The risk for NSF increased in steps from one MRI, two to three MRIs, or four or more MRIs, compared with controls. “Providers should carefully weigh both the benefits and potential harms of contrast MRI in their clinical decision making and avoid the use of gadolinium contrast agents if possible in patients with renal failure,” the authors concluded. “If gadolinium contrast is needed, clinicians should use the lowest possible dose and limit the number of future contrast administrations. The mechanism by which gadolinium contrast might cause NSF is unknown,” the researchers add.

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A lawsuit has been filed on behalf of a Minnesota woman who developed the debilitating and sometimes deadly disease, Nephrogenic Systemic Fibrosis. The woman contracted the disease following an injection of Magnevist Gadolinium contrasting dye manufactured by Bayer-Schering and its subsidiary Berlex Laboratories prior to an MRI (Magnetic Resonance Imaging). Nephrogenic Systemic Fibrosis is the consequence of gadolinium contrasting dye use in those with an impaired renal system such as kidney disease. Those with kidney dysfunction cannot eliminate the toxic dye as quickly and efficiently as those without, causing abhorrent side effects including the thickening and hardening of the skin, joint problems, deep pain in the ribs and hips leaving many wheelchair bound experiencing extreme pain. Death has also been known to occur once the disease reaches the internal organs. The woman received a gadolinium injection in March 2001 and in February 2007 was finally diagnosed with NSF by doctors at the Mayo Foundation. She continues to experience a progressive fibrotic debilitation causing severe impairment. Her lawsuit was filed with the Multidistrict Legislation, Northern District of Ohio alleging that Magnevist is defective and that the creators failed to adequately test and ultimately warn patients about its potential to cause NSF. In September 2007, the Food & Drug Administration (FDA) asked all manufacturers of gadolinium contrast dyes to add a “black box” warning to the product labels about its association with NSF in addition to warning patients with kidney disease who should avoid gadolinium contrast agents. Numerous cases have been filed in many federal districts against gadolinium contrast dye manufacturers. On February 29, 2008 the U.S. Judicial Panel on Multidistrict Litigation designated the U.S. District Court for the Northern District of Ohio as the venue for all the lawsuits that have been filed, and that will be filed in federal district court, against the makers of gadolinium contrast dyes.

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A new technology may be released soon that goes further to protect patients with renal failure while undergoing an MRI. Luna nanoWorks and the Washington University School of Medicine co-authored a paper that was published in the Journal of Medicinal Chemistry. The paper introduces a new avenue of gadolinium delivery that could protect patients with insufficient kidney elimination from the debilitating and sometimes deadly disease Nephrogenic Systemic Fibrosis after undergoing and MRI. The paper describes the new contrast agent as encapsulating the gadolinium metal within an extremely stable carbon nanosphere, thus allowing for extended existence in the body. Patients with kidney insufficiency eliminate toxins slower than those with normal renal function. Luna's HYDROCHALARONE™ molecules have initially proven to be more effective at enhancing images and are potentially safer than current gadolinium-containing contrast agents, which have been associated with Nephrogenic Systemic Fibrosis. Currently gadolinium contrast agents are formulated in a chelate to prevent toxicity, but the chelate agent is designed to be in the body for a short period of time. In those with renal failure their slow elimination process allows the gadolinium to separate from the chelate, thus exposing the patient to the toxic metal. The new delivery process of gadolinium may be a boon to those who need to undergo and MRI, but suffer from kidney failure. The U.S. Food and Drug Administration continues to review reports of patients who have developed NSF after receiving the chelate-based gadolinium agent. In response to reports of patient exposure, the FDA issued a black-box warning, the highest available, to warn the medical community of the possible consequences of using the chelate-based gadolinium in patients with renal insufficiency.

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Tennessee resident, Jeanie Deason, has won a two year battle in getting an experimental treatment approved for Nephrogenic Systemic Fibrosis (NSF) covered by TennCare, the state’s insurance plan for the poor and disabled. It's a ruling that a legal expert on health coverage says could potentially assist thousands of others with rare diseases across the country. Patients with rare disorders often face the same predicament as Deason. Insurance companies typically will not cover a treatment unless the FDA has approved it for that particular disease. In regards to NSF, there is no FDA approved treatment. During the two year battle Jeanie Deason’s condition worsened. Dr. John Zic, Deason's physician and an assistant professor of dermatology at Vanderbilt, has treated four of the 200 plus patients worldwide who have NSF. The treatment, extracorporeal photopheresis, involves removing blood from the patient’s body, exposing it to ultraviolet light and then re-infusing it back into the body. Dr. Zic has used the procedure in 3 out of four successful outcomes. One patient who was initially unable to close her hand could use a pen to sign documents after three months of treatment. Another patient had significant joint stiffness and difficulty walking, but nearly seven months later, was walking without a significant limp. The therapy will cost several thousand dollars per month. Deason will undergo two treatments a month for one to two years, according to Zic. It's something that Deason could never afford with the $695 in Social Security she collects each month.

Posted by Peter W. Burg at 08:38 AM | Permalink | Comments (0) | TrackBacks (0)

Patients with renal dysfunction or kidney failure need to be aware of side effects they could experience while undergoing an MRI after being administered Gadolinium. Gadolinium has been linked to the debilitating and potentially deadly disease Nephrogenic Systemic Fibrosis. NSF presents itself with symptoms of hard, shiny, darkened skin that tightens and becomes extremely painful, joint inflexibility, loss of movement, yellow-colored eyes, painful joints, and lung, heart and organ damage. Those who are at risk of NSF are unable to properly evacuate the gadolinium, thus causing the side effects. If a patient, who has undergone an MRI but does not know whether they have renal dysfunction, has presented with any of the symptoms they should immediately check their medical records to see if Gadolinium was administered. Late last year the U.S Food and Drug Administration warned doctors about the use of gadolinium based contrast agents in patients with renal failure and encouraged the doctors to screen all patients for kidney health if they are to undergo an MRI.

Posted by Peter W. Burg at 08:35 AM | Permalink | Comments (0) | TrackBacks (0)

Patients at risk of renal failure or kidney disease have a new tool that can help radiologists determine the safety in use of Gadolinium in Magnetic Resonance Images. Gadolinium is a contrast agent used to highlight soft tissue in patients before an MRI. Gadolinium has been found to be linked to the devastating and sometimes deadly disease Nephrogenic Systemic Fibrosis in patients with renal failure or kidney disease. MEDRAD, Inc. has developed a handheld device called the i-STAT System that can be used to analyze patients’ blood on the spot and deliver results of a variety of diagnostics in less than 3 minutes. Test cartridges in the unit provide an array of nine metabolic tests in the measurement of renal function for those with diabetes, kidney insufficiency and advanced age. The i-STAT is expected to successfully predict patients’ risk for gadolinium induced Contrast Induced Nephropathy (CIN) and Nephrogenic Systemic Fibrosis (NSF). The device can thus help radiology departments more efficiently maximize safety and care.

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In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add black box warnings to their product labels about its association with pre-existing kidney disease patients and the onset Nephrogenic Systemic Fibrosis. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents. NSF is a devastating condition characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin, pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and even possibly death. There is currently no cure for NSF, but those who have received kidney transplants have shown improvement. On February 29, the U.S. Judicial Panel on Multidistrict Litigation designated the U.S. District Court for the Northern District of Ohio as the venue for any lawsuits that have been filed or will be filed in against the makers of gadolinium contrast dyes. An estimated 68 cases have been filed in more than a dozen different federal districts against gadolinium contrast dye manufacturers. The U.S. Judicial Panel indicated that the Northern District of Ohio provides a relatively central forum for the consolidation of this nationwide litigation.

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A class-action lawsuit has been filed on behalf of a Philadelphia resident and patient with pre-existing kidney disease against the makers of a Gadolinium contrasting MRI agent. Zbigniew Marcinczyk contracted Nephrogenic Systemic Fibrosis after being injected twice with the contrasting dye Omniscan, manufactured by General Electric Company, before being administered an MRI. The two hospitals he received the injections at both confirmed the use of Omniscan. Shortly after the administration of Omniscan, Marcinczyk developed and continues to suffer from the severe, debilitating and progressive changes associated with NSF that has permanently disabled, disfigured and severely impaired him. The lawsuit further alleges that Omniscan is defective, that the manufacturers failed to adequately test Omniscan and failed to warn patients about its potential to cause NSF.

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In a study conducted by researchers at the University of Michigan Health Systems, Jonathan R. Dillman, MD, lead author reports on allergic type reactions patients are experiencing when being administered gadolinium. Gadolinium has been linked to the debilitating and sometimes terminal disease Nephrogenic Systemic Fibrosis. The study reports that even when patients have been given corticosteroids and antihistamines before injected with gadolinium, some can still present with allergic-like reactions. For the study, researchers reviewed data from the institution’s department of radiology over a five-year period. They found that eight patients experienced nine allergic-like reactions after being gadolinium despite being pre-medicated. Out of these reactions, six were mild and three were moderate. There were no severe reactions. In response to the findings Dr. Dillman says, “Radiologists, therefore, must be available to treat an allergic-like reaction following gadolinium-containing contrast material administration.”

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Denver Channel 7 News reported recently on the little known disease Nephrogenic Systemic Fibrosis. In an interview attorney Peter Burg informed the news station that the medical profession believes the disease is caused by a contrasting dye used in Magnetic Resonance Imaging (MRI) procedures on people with kidney disease. "It is the most awful disease that I have ever seen in my life," said Burg, who is representing close to 100 clients who are suing the manufacturers of gadolinium. "And what makes it doubly awful is that it was manmade." Greta Carolus of Loveland, Colorado is one of his clients. In August 2006 while preparing for a kidney transplant, Carolus underwent an MRI using the contrasting dye, gadolinium. Gadolinium is used to improve the quality of the picture in an MRI. Four days later she was hospitalized and learned she had contracted NSF. The lesions and hardening of her skin was caused by gadolinium exposure and put Carolus in a wheelchair. "I am a registered nurse, but I have not worked since the day this happened," said Carolus. "I wouldn’t wish this on anybody; my worst enemy I wouldn’t wish it on. This is just a terrible disease." In people with healthy kidneys, gadolinium has been proven safe. It is believed that the chemicals surrounding the gadolinium make it safe for use in the human body, but sometimes breakdown. In patients with ill-functioning kidneys, the gadolinium cannot be expelled properly thus exposing the patients to the dye for an extended period of time. “When I found out it was the dye it was devastating because it was something that didn't need to happen,” said Carolus. According to Carolus’ attorney, Peter Burg, the 5 companies that manufacture gadolinium contrast knew they were toxic to patients with kidney insufficiency. “They knew how toxic it was, they may not have known the specific harm that was going to be caused but they knew the results were likely to be catastrophic,” said Burg.

Continue reading "Peter Burg interviewed by Denver News channel about NSF" »

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George Lipscomb of West Virginia and his wife Ruth Ann have filed a medical malpractice lawsuit against Bayer Corporation and Bayer Healthcare Pharmaceuticals after he contracted Nephrogenic Systemic Fibrosis following MRIs that used a gadolinium containing contrast agent. According to the suit, George Lipscomb received five MRIs from May 2, 2005 to May 29, 2007. NSF causes muscle weakness and inhibits flexing and extending of joints resulting in contractures. It can also progress enough to cause total loss of use in arms, legs, hands and feet. Lipscomb claims he was suffering from chronic renal insufficiency at the time of the first MRI. He was later diagnosed with NSF on Sept. 25, 2007. The lawsuit claims that Lipscomb did not know or have reason to know that his insufficient renal condition would cause him to be harmed by the contrasting agent and as a result, he developed excruciating pain in his leg, hip and foot. He is also experiencing tightening, swelling and stiffening of his skin, muscles and joints, has had difficulty walking and is in jeopardy of having his heart and lungs impaired. The Lipscombs feel Bayer was irresponsible toward the safety and health of those receiving the contrast solution. They seek compensatory and punitive damages. Attorney Barry Hill is representing the Lipscombs.

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A lawsuit has been filed in the Circuit Court of the City of St. Louis in Missouri on behalf of a woman who alleges she developed nephrogenic systemic fibrosis after being exposed to the contrast dye gadolinium. She was given OptiMARK® during an MRI scan and sustained the devastating and potentially deadly tissue disease, NSF. The complaint has been filed against Tyco Healthcare Group, LP and Mallinckrodt, Inc., (subsidiary of Tyco). The complaint states that as a result of being administered OptiMARK® by her physician three times during October 2004 and once during December 2004, the plaintiff was also overexposed to gadolinium. In July 2007, the plaintiff was diagnosed with NSF. Since then, her condition has resulted in bodily impairment, disfigurement, and scarring, as well as fibrosis and contractures in her extremities. NSF/NFD only occurs in patients with kidney disease who undergo an MRI or MRA where a gadolinium-based dye is used. Its symptoms include the skin’s texture changing to a wood-like consistency or feeling like orange peel. Accompanying these symptoms are sensations of burning, itching, and severe sharp pains in specific areas. The lawsuit also claims that Tyco Healthcare insufficiently tested OptiMARK® and disregarded the fact that it could cause debilitating and potentially lethal side effects. Furthermore, the suit states that Tyco Healthcare knew of the risk for dangerous side effects, yet withheld evidence from the Food and Drug Administration during the approval process. The number assigned to the case is Case No. 0722CC09411.

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According to the American Journal of Roentgenology, published by the American Roentgen Ray Society, adverse allergic reactions to gadolinium are minimal in patients without renal failure. Their study is in response to the recent concerns associated with the disease Nephrogenic Systemic Fibrosis and the use of Gadolinium contrasting dyes. “Over the past few years, the utilization of contrast-enhanced MRI has markedly increased; it’s increased by 65% at our institution over the previous five years,” said Dr. Dillman. This is due in large part to a variety of new applications, such as magnetic resonance angiography (MRA) and abdominopelvic MR imaging,” he said. “Consequently, the number of intravenously administered gadolinium-containing contrast material doses over the same time period has significantly increased. Based on the extensive use these intravascular contrast agents, we felt that it was once again time to study their safety profile,” he said.

Posted by Kerry N. Jardine at 06:44 AM | Permalink | Comments (0) | TrackBacks (0)

Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD) is rare, but so far has only affected people with pre-existing kidney problems. The link between Gadolinium MRI dyes and NSF is gaining ground and quickly becoming irrefutable as the cause of the debilitating and sometimes deadly disease. In 2006, researchers discovered a direct association between NSF and the use of Gadolinium MRI contrast dyes. Since then, several other studies have reinforced the link between NSF and Gadolinium. The FDA in 2006 first warned doctors of the side effect. In 2007 the FDA ordered the manufactures of Gadolinium to add a black box warning, the strictest type of FDA warning, to their product labels advising of the risk of NSF to people with kidney problems. NSF leads to excessive formation of connective tissue in the skin and internal organs and is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin, pain deep in the hip bones or ribs and muscle weakness. Researchers at Yale University have reported that 95-percent of those with NSF had an MRI that involved Gadolinium two to three months before their symptoms appeared. Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with Gadolinium were 10 times more likely to develop NSF than patient who had not been exposed to such agents. Unfortunately, there are no effective treatments for NSF, although some patients have improved following a kidney transplant and there are no other alternatives to gadolinium based MRI contrast agents.

Posted by Kerry N. Jardine at 12:34 PM | Permalink | Comments (0) | TrackBacks (0)

Chinese agencies have become aware of complications associated with the use of gadolinium contrast agents used in MRIs. They are warning doctors of the link between gadolinium and the disease nephrogenic systemic fibrosis. The population at risk is those with serious kidney problems such as kidney failure. The kidneys of the people are incapable of eliminating the dye through normal body functions. Gadolinium attaches to specific tissue types highlighting them from other tissues so they can be viewed better by MRI technicians. What remains troublesome is that gadolinium is the only contrasting agent approved for use in most MRIs. The alternatives are Feridex I.V. and Teslascan, but they are limited in use for only examinations of specific liver problems. The NSF symptoms identified is the severe thickening of the skin leading to immobility and can affect the liver lungs and heart. NSF has been confirmed in children and the elderly, but tends to affect the middle-aged most commonly, according to the International Center for Nephrogenic Fibrosing Dermopathy Research. Men and women are affected equally.

Posted by Kerry N. Jardine at 06:21 PM | Permalink | Comments (0) | TrackBacks (0)

Luna Innovations Incorporated has been awarded a grant from the National Heart, Lung and Blood Institute to develop a new agent used in MRI. The carbon nano-material based contrast agent does not contain gadolinium, the dye linked to the devastating disease Nephrogenic Systemic Fibrosis. Although it is being developed at this time for the diagnosis of coronary artery disease (CAD), the expanded significance can assist in MRIs used on individuals with kidney failure and halt the risks of gadolinium exposure. Luna’s contrast agent is anticipated to give a physician not only improved diagnostics, but safety in the non-gadolinium product when exposing the dye to at risk individuals. The product, Trimetasphere® encloses the metallic signal molecule so that it cannot escape and cause harm to a patient. Through this mechanism the Trimetasphere®-based agent may help in preventing Nephrogenic Systemic Fibrosis. In May, the FDA issued a black box warning for the current gadolinium-based contrast agents used in MRI to increase awareness of the risks of NSF in patients with kidney problems.

Posted by Kerry N. Jardine at 12:03 PM | Permalink | Comments (0) | TrackBacks (0)

In a separate and new study researchers in Scotland have once again linked Gadolinium containing contrast agents used in MRIs to the devastating and sometimes deadly disorder nephrogenic systemic fibrosis. Their findings have added to the growing quantity of evidence that strongly associates the onset of NSF with people receiving MRIs who have pre-existing kidney disease. The Scottish study looked at 1,826 patients who underwent renal replacement therapy at two Glasgow hospitals between January 1, 2000 and July 1, 2006. Of those patients, 421 underwent an MRI that involved the use of a Gadolinium based contrast agent. Fourteen were diagnosed with NSF, and of those, 13 had been exposed to Gadolinium during an MRI. The researchers also found that the patients with NSF had received far higher doses of Gadolinium than those patients who were exposed to it but did not develop the disorder. The Scottish study was the second published this month that confirmed the link between NSF and Gadolinium. In their report they suggested that Gadolinium contrast agents be avoided altogether or at the very least in patients with pre-existing kidney issues. Also, in cases where Gadolinium is the only alternative the lowest dose possible should be used.

Posted by Kerry N. Jardine at 06:32 PM | Permalink | Comments (0) | TrackBacks (0)

In a separate and new study researchers in Scotland have once again linked Gadolinium containing contrast agents used in MRIs to the devastating and sometimes deadly disorder nephrogenic systemic fibrosis. Their findings have added to the growing quantity of evidence that strongly associates the onset of NSF with people receiving MRIs who have pre-existing kidney disease. The Scottish study looked at 1,826 patients who underwent renal replacement therapy at two Glasgow hospitals between January 1, 2000 and July 1, 2006. Of those patients, 421 underwent an MRI that involved the use of a Gadolinium based contrast agent. Fourteen were diagnosed with NSF, and of those, 13 had been exposed to Gadolinium during an MRI. The researchers also found that the patients with NSF had received far higher doses of Gadolinium than those patients who were exposed to it but did not develop the disorder. The Scottish study was the second published this month that confirmed the link between NSF and Gadolinium. In their report they suggested that Gadolinium contrast agents be avoided altogether or at the very least in patients with pre-existing kidney issues. Also, in cases where Gadolinium is the only alternative the lowest dose possible should be used.

Posted by Kerry N. Jardine at 06:32 PM | Permalink | Comments (0) | TrackBacks (0)

72-year-old Peter Gerber of San Rafael, Calif. has joined a growing collection of people suing several major health companies for causing him to suffer the painful, incurable and sometimes deadly disease, Nephrogenic Systemic Fibrosis. The gadolinium dyes used to scan his failing kidneys with MRI have been linked to the disease. Peter Gerber’s suit claims people with kidney failure cannot eliminate the gadolinium dyes from their system, ultimately causing them to develop NSF. Last year, the FDA issued an advisory that patients with moderate to end-stage kidney disease should avoid having medical scans that use gadolinium-based contrast dyes. If the imaging is done, “prompt dialysis” should be considered immediately following the procedure. Mr. Gerber had an MRI prior to undergoing a kidney transplant. His lawsuit, filed in San Francisco Superior Court, names medical centers and companies involved in making, distributing and using the dyes, including Bayer Healthcare Pharmaceuticals Inc. and GE Healthcare Inc. Both companies have since added “black box” warning labels to their dyes. “Mr. Gerber was never warned that there was any kind of risk associated with gadolinium, let alone NSF,” said Gerber's attorney. “Because of that, he developed a life-threatening disease that will most likely take his life in a horrible way.” He further indicates, “There is only one identified cause of NSF, and that's gadolinium and there is only one way gadolinium gets into the human body, and that's through these contrasting agents.”

Posted by Kerry N. Jardine at 03:01 PM | Permalink | Comments (0) | TrackBacks (0)

Bayer HealthCare Pharmaceuticals, in the midst of product safety issues concerning their MRI imaging contrasting agent Magnevist, announced that they have been awarded a three-year contract renewal by HealthTrust Purchasing Group to make the injection available to their HealthTrust network. Bayer holds more that 50 percent of the U.S. market share for gadolinium containing contrasting agents and has the broadest range of FDA approved usage than any other MRI agent for adult and pediatric patients. However, a cloud is over the company due to a link between their product and the debilitating, painful and sometimes deadly disease Nephrogenic Systemic Fibrosis. In fact, in their news release they initiate a warning to readers about who the agent should not be used on, such as those with acute renal insufficiency or perioperative liver transplantation. They further caution for all patients to undergo a screening for renal dysfunction as well as not to exceed the recommended dose and to allow a sufficient period of time for the agent to eliminate itself from the system. What they fail to elucidate is that there are other options available to technicians that do not use the sometimes toxic gadolinium. Toshiba recently announced its fourth generation contrast-free imaging technique known as Time and Space Angiography (TSA). TSA creates images that show dynamic blood flow without using contrast agents. In contrast, Bayer’s press release warns of possible serious and life threatening anaphylactic reactions, as well as cardiovascular and respiratory manifestations when using Magnevist. It makes one wonder what these health groups are thinking to allow their patients access to such a controversial treatment.

Posted by Kerry N. Jardine at 12:54 PM | Permalink | Comments (0) | TrackBacks (0)

LegalView.com announced that it will launch an informative and detailed Nephrogenic Systemic Fibrosis blog on its website to inform victims of further findings regarding this debilitating and often deadly disease. Nephrogenic Systemic Fibrosis has been linked to the use of Gadolinium, a chemical dye used in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) tests. The blog offers resources, jury verdicts and information about attorneys for those who need help from a staff knowledgeable in the area of NSF

Posted by Kerry N. Jardine at 06:37 AM | Permalink | Comments (0) | TrackBacks (0)

MSNBC recently reported the case of a woman who is suffering from the after affects of an MRI using a gadolinium contrasting agent. Gadolinium-based dyes are injected into a patient to highlight specific tissue types making them easy to differentiate from other tissues on an MRI. The MRIs can be administered without a contrasting agent, but they are considered to be significantly less useful. To complicate matters, gadolinium is the only contrasting agent approved for use in most MRIs.

Continue reading "MSNBC report of woman afflicted with NSF" »

Posted by Kerry N. Jardine at 09:40 PM | Permalink | Comments (0) | TrackBacks (0)

MSNBC recently reported the case of a woman who is suffering from the after affects of an MRI using a gadolinium contrasting agent. Gadolinium-based dyes are injected into a patient to highlight specific tissue types making them easy to differentiate from other tissues on an MRI. The MRIs can be administered without a contrasting agent, but they are considered to be significantly less useful. To complicate matters, gadolinium is the only contrasting agent approved for use in most MRIs.

Continue reading "MSNBC report of woman afflicted with NSF" »

Posted by Kerry N. Jardine at 09:40 PM | Permalink | Comments (0) | TrackBacks (0)

LegalView.com is a complete online resource for anything legal and they recently re-launched their portal on the painful, debilitating and sometimes lethal disease Nephrogenic Systemic Fibrosis. Burg Simpson is a member and partner in this informative website on this disorder. The site can be found at http://nephrogenic-systemic-fibrosis.legalview.com. Visitors who would like to learn more about NSF and its related health issues are encouraged to visit this site. LegalView.com recognizes that NSF will be a public health problem for decades. The new website provides additional information on treatment resources and can help victims and their families find an attorney in their state.

Posted by Kerry N. Jardine at 12:54 PM | Permalink | Comments (0) | TrackBacks (0)

Peter Gerber is suing several major pharmaceutical companies after contracting the incurable disease nephrogenic systemic fibrosis. The rare disorder is linked to dyes used in MRI scans for patients with kidney failure. The dyes contain a heavy metal known as gadolinium. The disorder is characterized by the stiffening of skin and joints thus restricting movement and has been know to lead to death in some cases because of possible affects on internal organs. No cures have been reported but some patients have seen improvement after treatment to improve their kidney function, according to the International Center for Nephrogenic Fibrosing Dermopathy Research. Mr. Gerber's suit claims that people with impaired kidney function are unable to properly eliminate the gadolinium from their system. Last year, the U.S. Food and Drug Administration issued an advisory that patients with moderate to end-stage kidney disease should avoid having medical scans that use gadolinium-based contrast dyes, such as magnetic resonance images and magnetic resonance angiographies. If the imaging is done, "prompt dialysis" following the procedure should be considered, the FDA said. Mr. Gerber had an MRI before he underwent a kidney transplant. The lawsuit filed in the San Francisco Superior Court names medical centers and the pharmaceutical companies known to develop the gadolinium contrasting dyes. After the advisory from the FDA, the companies put warnings on the gadolinium products.

Posted by Kerry N. Jardine at 12:46 PM | Permalink | Comments (0) | TrackBacks (0)

http://www.burgsimpson.com/nsf.htmlNephrogenic systemic fibrosis (NSF), a new fibrotic skin disease was first recognized in 1997 in 15 patients receiving hemodialysis for kidney failure. The early reports noted that it closely resembled scleromyxedema, but was different enough for further study. People with end-stage renal disease (ESRD), account for 90% of the patients. Peritoneal dialysis appears to be associated with a greater risk for NSF compared to hemodialysis. The age range is from 8 years to 87 years old and does not discriminate against gender or race. Many countries have reported cases of NSF. NSF has been linked to gadolinium exposure which is contained in contrast agents used in MRIs. The initial observation that vascular surgery and thrombotic episodes were common before symptoms occurred prompted speculation that NSF may be triggered by an imaging contrast agent. The time it takes for symptoms to appear is anywhere from 2 to 75 days of which 25 days is the median. As NSF progresses, patients may experience significant decrease in the function of their hands and feet, with the development of joint contracting and stiffening. Some ultimately are confined to a wheelchair and need assistance with daily activities. Severe disability and even death mortality have been reported in patients with NSF. In May of this year the manufacturers of gadolinium contrast agents issued a “Dear Healthcare Professional” letter to inform them of the newly added “Black Box” warning added in the prescribing information for patients with renal failure.

Posted by Kerry N. Jardine at 11:05 AM | Permalink | Comments (0) | TrackBacks (0)

A complaint has been filed in the San Francisco Superior Court against Bayer Corp., General Electric Co., McKesson Corp. and other companies involved in the manufacturing and distribution of the contrast agent gadolinium used in MRIs. In this circumstance however, the firm is taking a case by case approach rather than a federal multi-district litigation (MDL) one. The plaintiff is a man with kidney disease who had the agent injected prior to an MRI and contracted the incurable disease Nephrogenic System Fibrosis. The victims’ lawyer says his client doesn’t have the kind of time it would take to fight in the MDL process and in fact hopes to invoke a California rule that puts cases involving a severely ill plaintiff on a track faster than normal. Further saying, that if his client is able to stay alive for the next 10 years, his treatment for NSF can be upwards of $10M in medical expenses.

Posted by Kerry N. Jardine at 06:56 AM | Permalink | Comments (0) | TrackBacks (0)

Activation of transglutaminase-2 (TG2) may trigger the debilitating fibrosis that affects some end-stage renal patients, researchers believe. In a pilot study using stored tissue, an enzyme involved in wound healing was markedly increased in the skin of patients who suffered nephrogenic systemic fibrosis (NSF), according to David Sane, M.D., of Wake Forest University Baptist Medical Center, and colleagues. While the cause of Nephrogenic Systemic Fibrosis is officially unknown, research has shown that gadolinium accumulates in the tissues of people with the condition. It's also known that gadolinium activates a class of enzymes known as tissue transglutaminases.

Continue reading "Healing Enzyme Implicated in Nephrogenic Systemic Fibrosis" »

Posted by Kerry N. Jardine at 04:53 PM | Permalink | Comments (0) | TrackBacks (0)

General Electric Co., Bayer AG and two other companies have alerted doctors to new warnings about side effects of their chemicals which are used in imaging procedures. The letter dated Sept. 12 cautions that chemicals with gadolinium, which are used in magnetic resonance imaging procedures, can raise the risk of a sometimes fatal disease that causes excessive tissue to grow between internal organs. The new warning appears in a black box on the packaging for the chemicals, which are injected into the body to improve quality of images. The Food and Drug Administration requested the black box, which is the most serious type of warning a medical product can carry, in the spring. The language warns that patients with kidney failure are more likely to develop a very rare disease called nephrogenic systemic fibrosis when treated with the imaging chemicals. The other companies co-signing the letter were Italian firm, Bracco Diagnostics Inc. and St. Louis, Missouri-based Mallinckrodt Inc.

Posted by Kerry N. Jardine at 02:52 PM | Permalink | Comments (0) | TrackBacks (0)

The newly identified Nephrogenic Systemic Fibrosis (NSF) is the debilitating and painful condition that affects patients with kidney failure and is characterized by a thickening and hardening of the skin. It can progress so rapidly that patients can be immobilized and wheelchair-bound within a few weeks. The condition has been linked to gadolinium, a contrast agent used in MRI scans. A new study published in the October issue of Arthritis & Rheumatism on the prevalence of NSF and its risk factors found that the disease is associated with an increased risk of dying and that gadolinium exposure is the significant factor for developing it. The study was conducted on patients undergoing dialysis at six outpatient centers in the Boston area. They used a simple three-part skin examination to check for the three skin changes associated with NSF: hyperpigmentation (darkening of the skin), hardening and tethering (thickening). Patients with two out of the three findings were considered to have a positive examination for NSF and their death rates were followed for two years following the exam.

Continue reading "Higher death rates in kidney patients with NSF" »

Posted by Kerry N. Jardine at 10:49 AM | Permalink | Comments (0) | TrackBacks (0)

Researchers at Wake Forest University Baptist Medical Center, working with colleagues at other institutions have released findings of their research into why some patients who are in kidney failure also develop a condition known as nephrogenic systemic fibrosis (NSF). NSF has caused tightening and swelling in the skin and other organs, among them the lungs and the heart. They have known that 2 to 4% of patients on dialysis and injected with a contrast agent, gadolinium, prior to an MRI have developed the disease. While they know that the gadolinium causes the problem, until now, it has not been known how. This study suggests that an enzyme named transglutaminase-2, TG2, may play a part.

Continue reading "Research suggests cause and possible treatment of NSF " »

Posted by Kerry N. Jardine at 09:48 PM | Permalink | Comments (0) | TrackBacks (0)

Kidney disease patients with nephrogenic systemic fibrosis (NSF) are at increased risk of death, U.S. researchers report. The researchers also concluded that exposure to gadolinium during MRI scans are a significant risk factor for developing NSF. The disease can progress so rapidly that some patients are immobilized and confined to a wheelchair within weeks. The study, led by Jonathan Kay of Massachusetts General Hospital in Boston, conducted skin examination of 186 kidney dialysis patients. They found that 25 had skin changes consistent with NSF. Within two years, 25 of the 186 patients (24 percent) had died. The death rate for those with NSF was 48 percent, compared to 20 percent for patients without the illness. The researchers also found that 30 percent of patients exposed to gadolinium developed NSF compared to one percent of those who had not been exposed to the contrast agent. The findings are published in the October issue of the journal Arthritis & Rheumatism. This is the first study to examine the prevalence of NSF in dialysis patients and the first to quantify the association between NSF and gadolinium exposure. Contrast agents containing gadolinium should only be used with extreme caution in patients with chronic kidney disease, the researchers concluded. If they are exposed to gadolinium, these patients should subsequently receive regular skin examinations. In an accompanying editorial, experts at Yale University School of Medicine noted that a U.S. federal Public Health Advisory urges caution in the use of MRI scans for kidney disease patients and prompt dialysis for those who've had scans involving gadolinium.

Posted by Kerry N. Jardine at 12:42 PM | Permalink | Comments (0) | TrackBacks (0)

Gadolinium products used in MRIs will now carry the U.S. Food and Drug Administration's strongest, "black box" warning. The FDA's decision Friday Sep 28th finalizes its announcement made in May that it would add the labeling warning to the MRI contrast agents. The warning notes that gadolinium increases risk of a potentially fatal side effect in patients with kidney and liver conditions such as renal failure. The skin disease called nephrogenic systemic fibrosis, or NSF, can occur in some patients, the companies said in a joint letter to health-care professionals, posted on the FDA's Web site on Friday. The imaging agents are made by Bayer AG's Bayer Schering Pharma, General Electric Co's GE Healthcare, Tyco International Ltd.'s Mallinckrodt unit, and Bracco Diagnostics Inc. Agency officials first alerted doctors to the potential risk in 2006, following reports that patients who received the injectable agents developed NSF. Although the risk of NSF from any one agent is unknown, the letter cited a study that found an estimated risk in patients with severe renal insufficiency at 4 percent. Patients should be screened for kidney problems before use of such agents, the letter said, further adding that the recommended dose should not be exceeded.

Posted by Kerry N. Jardine at 12:31 PM | Permalink | Comments (0) | TrackBacks (0)

A 61-year-old nurse who claims her left leg was amputated two years ago because of improperly treated complications from spinal surgery at New Milford Hospital has filed a http://burgsimpson.com/malpractice.htmlmalpractice lawsuit against the hospital and the now-retired surgeon. In the lawsuit, Eileen Kelleher, accuses the hospital and its former chief of surgery, Dr. Ramon Mabasa, with failing to properly care for and treat Kelleher after her surgery, during which Mabasa performed an "anterior transabdominal approach to the lumbosacral spine." The lawsuit is a companion to
one the attorneys filed a year ago against Dr. Ramon Mabasa, who Kelleher blames for her disability. The new lawsuit says that during her post-operative recovery in the intensive care unit, she suffered intra-abdominal hemorrhaging, post-operative bleeding, abdominal wounds, and other severe complications that the medical staff d id not appropriately diagnose or treat, resulting in a gangrenous lower leg condition that required an above-the-knee amputation. The lawsuit suggests that the nursing staff did not properly supervise or monitor Kelleher's care, and when complications arose her physicians were not notified promptly so adequate medical interventions could be made. In the legal argument against Mabasa, the lawyer notes that in 2004 the surgeon was disciplined by the state Department of Public Health in relation to an accusation that in November 2002 Mabasa scheduled the repair of a hernia in a woman who had just undergone a caesarean section but mistakenly performed a minor surgical operation on the wrong side. In that case, Mabasa opted against a full hearing and signed a consent order related to the facts in the case. He was required to pay a civil penalty of $5,000. At the time of her planned back
surgery, Kellher was unaware Mabasa was to be involv ed in her surgery until just before the procedure was to take place. He said that denied her an opportunity to check on his credentials, which would have indicated prior m
edical malpractice complaints. Her lawyer said he will seek whatever a financial reward "a jury feels would be appropriate compensation for a woman who needlessly lost her leg."

Posted by Scott J. Eldredge at 08:48 AM | Permalink | Comments (0) | TrackBacks (0)

Another law firm in Dallas, Texas is investigating possible Gadolinium litigation in light of recent public health advisories by the Food and Drug Administration. The FDA published an alert showing a possible link between Gadolinium, a heavy metal used in MRI and MRA, with the disease Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD). According to the FDA, the problem has so far been found only in instances of "off-label" use of the Gadolinium agents for MRA, or Magnetic Resonance Angiography. "Off-label" means the drug has not been approved by the FDA for a particular use, which might be dangerous given that often 3 times the FDA approved dose is used during an MRA. "Gadolinium is supposed to secrete out of the body quickly", says t he lawyer, "but, according to preliminary FDA reports, it looks like people with impaired kidney function might not be able to secrete the toxic substance out of the body quickly enough to avoid suffering lifelong impairment from Gadolinium". The products possibly responsible are Omniscan, OptiMARK, Magnevist, ProHance and MultiHance

Posted by Kerry N. Jardine at 02:19 PM | Permalink | Comments (0) | TrackBacks (0)

A case report published July 12 in the New England Journal of Medicine tells the story of a 70-year-old man with kidney failure who developed the classic symptoms of having been exposed to gadolinium during one or more MRIs. Over the course of four years following a kidney transplant operation, he became seriously disabled by Nephrogenic Systemic Fibrosis (also known as nephrogenic fibrosing dermopathy or NFD). The NEJM report states that the patient had developed skin thickening on one arm, on his legs and on his lower abdomen. He had limited mobility in one elbow and significant skin hardening around the elbow. The overall skin thickening had progressed to the point that he had become increasingly immobile. Where four years earlier he had undergone a successful kidney transplant, he was now back on routine dialysis, and wheel-chair bound.

Continue reading "Kidney failure patients warned of health risk in MRIs News" »

Posted by Kerry N. Jardine at 10:52 AM | Permalink | Comments (0) | TrackBacks (0)

Since 1997, the medical community has been trying to determine the cause of Nephrogenic Systemic Fibrosis (NSF). NSF is also known as Nephrogenic Fibrosing Dermopathy. It is a rare and little understood disease that affects people with kidney problems. Since the first cases were documented, research into NSF has provided few clues into its cause, and even fewer as to its treatment. Most patients eventually diagnosed with NSF are first found to have high blood pressure, which is followed by burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and can eventually lead to death. The progression of the disease can be slow and can take several years for all of the symptoms to appear. However, some patients have a form that progresses so quickly that they often die of complications brought on by the disease.

Continue reading "NSF Research Yields Few Clues into Disease" »

Posted by Kerry N. Jardine at 02:39 PM | Permalink | Comments (0) | TrackBacks (0)

A rare and painful disease, known as Nephrogenic Systemic Fibrosis, has caused Jeanie Deason legs and right arm to become frozen in a bent position. She fears that the condition will soon leave her an invalid. A Vanderbilt University Medical Center doctor says there is a therapy that may improve Deason's condition. However, TennCare, the state's insurance plan for the poor and disabled, will not pay for it because it's considered to be experimental.

Continue reading "Those with rare diseases face non coverage" »

Posted by Kerry N. Jardine at 06:10 PM | Permalink | Comments (0) | TrackBacks (0)

A retired 71-year-old suburban Cleveland restaurant supplier, filed a lawsuit in U.S. District Court on March 14 against Tyco International and two healthcare subsidiaries, Tyco Healthcare Group and Mallinckrodt, Inc., claiming that their drug Optimark caused him a debilitating skin and joint disease known as Nephrogenic Systemic Fibrosis (NSF). It may be the first against Tyco stemming from the effects of Optimark, a contrast agent containing the metal gadolinium. Optimark is injected into patients prior to magnetic resonance imaging (MRI) to help diagnosticians distinguish blood vessels from nearby tissues. The suit notes that in 2006 the FDA issued Public Health Advisory alerts about the development of serious, sometimes fatal, NSF/NFD following patient exposure to gadolinium-based contrast agents, including Optimark. The suit claims that Tyco was aware, or should have been aware of the risks of Optimark. There have been numerous case reports, studies, assessments, papers, and other clinical data that have described and/or demonstrated NSF/NFD in connection with the use of certain gadolinium-based contrast agents, including Optimark according to the suit. Further, the suit alledges that the Defendants have not revised their package inserts, material safety data sheets, and other product-related literature, nor conducted appropriate post-marketing communications in order to convey adequate warnings.

Continue reading "Suit Filed Against Tyco and Optimark" »

Posted by Kerry N. Jardine at 04:56 PM | Permalink | Comments (0) | TrackBacks (0)

Evaluating a patient's kidney function can help determine their ability to safely receive IV contrast including gadolinium prior to CT and MR imaging procedures. This is an important precaution especially for patients with risk factors such as diabetes, known kidney impairment, and advanced age especially in the wake of nephrogenic systemic fibrosis. Currently, such blood tests must be sent to a lab before the patient can undergo a CT or MRI procedure, a time-consuming step that can cause delays in busy radiology departments. E-Z-EM, Inc. a leading manufacturer of contrast agents for gastrointestinal radiology announced the release of the company's new EZ CHEMTM blood analyzer. The blood analyzer is a convenient device used in detecting blood creatinine levels in patients prior to CT and MRI. The FDA cleared the technology in May 2007. EZ CHEMTM performs a simple test for assessing kidney function in the imaging room and produces results in as little as 30 seconds. The device analyzes a finger prick sample of blood for levels of creatinine which is an important indicator of a patient's renal function. Such blood values are often required to determine a patient's kidney function before IV contrast agents are administered. This new technology may not help current victims of nephrogenic systemic fibrosis, but for radiologists the release is welcome news

Continue reading "EZ CHEMTM on site blood analyzer of kidney function" »

Posted by Kerry N. Jardine at 02:23 PM | Permalink | Comments (0) | TrackBacks (0)

A study published by the Journal of the American Society of Nephrology written by researches at Copenhagen University Hospital in Denmark reports on its findings back in 2006. They found that Nephrogenic Systemic Fibrosis was a new, rare disease that affects patients with renal failure. Single cases led to the suspicion of the role of gadodiamide being used for magnetic resonance imaging. A study reviewed all of the confirmed cases of Nephrogenic Systemic Fibrosis with respect to clinical characteristics, gadodiamide exposure, and subsequent clinical course. It was found that all had been exposed to gadodiamide before the development of nephrogenic systemic fibrosis. The ratio for acquiring the disease when exposed to gadodiamide was seven (54%) patients became severely disabled, and one died 21 months after exposure. No other exposure or event related to gadodiamide was common in the patients that could be identified. These findings indicate that gadodiamide played a role in Nephrogenic Systemic Fibrosis.

Posted by Kerry N. Jardine at 06:13 AM | Permalink | Comments (0) | TrackBacks (0)

The FDA has announced that labeling for MRI and MRA imaging contrast agents that contain gadolinium will have stronger new warnings. The contrast agents are often used to improve the visibility of internal structures when patients undergo MRI/MRA procedures. Five of the contrasting agents have been approved in the US: Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. The new boxed warning describes risks and necessary screening procedures for a serious condition related to gadolinium exposure called nephrogenic systemic fibrosis (NSF). NSF is characterized by fibrosis of the skin, muscle and internal organs. It is debilitating and potentially fatal. The warning will state that certain patients have a higher risk of developing NSF if they are given any of these gadolinium-based agents. Specifically those affected with severe acute or chronic renal failure and those with acute renal failure of any severity who have hepato-renal syndrome or are currently preparing for or are healing from a liver transplant. Hepato-renal syndrome is a term used for a group of diseases involving both the liver and kidney. Clinicians should avoid using these products with high-risk patients unless the diagnostic information is essential and cannot be obtained any other way.

Continue reading "New Warnings for MRI Contrast Agents Containing Gadolinium " »

Posted by Kerry N. Jardine at 02:29 PM | Permalink | Comments (0) | TrackBacks (0)

At present, there is no known effective treatment for NSF. Physical therapy or treatment with topical and systemic steroids has had a variable benefit. Immunosuppressive therapy is ineffective. Plasmapheresis, a process in which blood taken from a patients is treated to extract the cells and corpuscles which are then added to another fluid and returned to the body, has led to an improvement in some. The drug Thalidomide led to an improvement in a few patients as well. Others have improved after restoration of normal renal function either spontaneously or as a result of a renal transplant. There is a proposal that a dose reduction in erythropoietin, a hormone produced in the kidneys that increases development of red blood cells in bone marrow, might improve NSF. Two patients were given Pentoxifylline, a substance with activity against tumor necrosis factor. Skin changes in the first patient who had late-stage disease seemed to slow or arrest it and the second patient stabilized and had a slight reversal of disease.

Posted by Kerry N. Jardine at 10:16 AM | Permalink | Comments (0) | TrackBacks (0)

Gadolinium contrast agents have long been used in Magnetic Resonance Imagining (MRI) to enhance the quality of images, but in some patients, it can have a toxic affect, causing a condition known of Nephrogenic Systemic Fibrosis (NSF). It is injected into the bloodstream right before an individual undergoes an MRI. The agent helps the MRI computer differentiate between normal and abnormal tissue. In 2006, researchers discovered that the use of Gadolinium based contrast agents had a direct correlation to the development of NSF in patients with pre-existing kidney problems. The FDA then warned that the agents were tied to a number of NSF cases. At that time the FDA warned physicians to screen patients for kidney problems prior to using a Gadolinium based contrast agent during MRIs. In May 2007, the FDA requested that the manufactures of the five Gadolinium contrast agents (including Ominiscan, Magnevist and OptiMark) used in MRIs include a boxed warning on their labels highlighting the risk they pose to patients with kidney problems.

Continue reading "Gadolinium Contrast Used in MRI Can Cause NSF" »

Posted by Kerry N. Jardine at 06:24 AM | Permalink | Comments (0) | TrackBacks (0)

A lawsuit has been filed in the United States District Court, Middle District of Tennessee, Nashville Division (Case No. 3:07-0774), on behalf of clients Jerry and Lynne Hensley against Tyco International, Ltd., because of serious injuries caused by an injectable dye used in magnetic resonance imaging (MRI) scans. In 2004, Jerry Hensley, a kidney failure patient, underwent an enhanced MRI, which included injecting the drug OptiMARK, a gadolinium-based dye. One week after the MRI, Hensley started showing signs of Nephrogenic Systemic Fibrosis (NSF). Hensley's symptoms included thickened skin around both elbows and knees, additionally, pain in legs, knees and elbows as well as difficulty in walking.

Continue reading "Suit against MRI Dye Manufacturers Filed in Tennessee" »

Posted by Kerry N. Jardine at 10:22 AM | Permalink | Comments (0) | TrackBacks (0)

As of February 2007, evidence to support an association between gadodiamide known as Omniscan and development of NSF has increased. Of the marketed gadolinium-based contrast agents, most cases of NSF have been associated with Omniscan, followed by OptiMARK (gadoversetamide, which is not licensed in Europe but is available in the USA) and a small number of cases have been reported with Magnevist (gadopentetate dimeglumine). The latest figures suggest that 90 cases of NSF associated with Omniscan, OptiMARK, or Magnevist have been reported to the US FDA. Elsewhere, more than 150 patients have developed NSF after exposure to a gadolinium-based contrast medium, more than 90% of which were exposed to Omniscan. The reports, collated by the European Society of Urogenital Radiology (ESUR), showed that patients who developed NSF had received Omniscan a few weeks before. Four patients may have received OptiMARK and Magnevist. The remaining cases the agent is not known because several agents were given or because there is inadequate information available.

Continue reading "Breakdown of causative agents for NSF" »

Posted by Kerry N. Jardine at 02:27 PM | Permalink | Comments (0) | TrackBacks (0)

At present, there is no known effective treatment for NSF. Physical therapy or treatment with topical and systemic steroids has had a variable benefit. Immunosuppressive therapy is ineffective. Plasmapheresis, a process in which blood taken from a patients is treated to extract the cells and corpuscles which are then added to another fluid and returned to the body, has led to an improvement in some. The drug Thalidomide led to an improvement in some patients as well. Others have improved after restoration of normal renal function either spontaneously or as a result of a renal transplant. There is a proposal that a dose reduction in erythropoietin, a hormone produced in the kidneys that increases development of red blood cells in bone marrow, might improve NSF. Two patients were given Pentoxifylline, a substance with activity against tumor necrosis factor. Skin changes in the first patient who had late-stage disease seemed to slow or arrest it and the second patient stabilized and had a slight reversal of disease.

Posted by Kerry N. Jardine at 10:26 AM | Permalink | Comments (0) | TrackBacks (0)

NSF develops over a period of days to several weeks. Rapid, new-onset hypertension has been reported before development of skin lesions. The skin changes start as reddened or darkened patches, papules, or plaques. Over time, the skin feels “woody”, and the surface may have an appearance and texture of orange peel. Diagnosis is confirmed by the presence of specific features found on a skin biopsy, i.e. thickened collagen bundles. Skin lesions are usually symmetrical, with zones between the ankles and thighs. Later, lesions develop between the wrist and upper arms. Patients may have burning, itching, or severe sharp pains in areas of involvement, and may have swelling of the hand and foot with blister-like lesions. Some patients have reported yellow papules or plaques on or near the eyes.

Continue reading "Tracking NSF signs and symptoms" »

Posted by Kerry N. Jardine at 06:23 AM | Permalink | Comments (0) | TrackBacks (0)

According to the FDA, patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing the debilitating, and a potentially fatal disease, Nephrogenic Systemic Fibrosis (NSF). Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents. In addition, patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity. FDA first notified health care professionals and the public about the gadolinium-related risks for NSF in June 2006.

Continue reading "Recipients of a Liver Transplant or Victims of Liver Disease at Risk for NSF" »

Posted by Kerry N. Jardine at 06:36 PM | Permalink | Comments (0) | TrackBacks (0)

A rare and painful disease, known as Nephrogenic Systemic Fibrosis (NSF), has caused Jeanie Deason’s legs and right arm to become frozen in a bent position. She fears that the condition will take hold of her left arm, leaving her an invalid. "It's completely stopped my life. My mother comes over here to take care of me. She's 77 years old. I should be taking care of her." Deason's disease is newly recognized and not well understood by doctors. Deason was born with kidney disease and underwent a magnetic resonance imaging scan in October. Her symptoms began a few weeks later. "Up until this disease you wouldn't have even known I was sick," she said. Now, Deason uses a wheelchair, which she has trouble maneuvering because she has use of only her left hand.

Continue reading "NSF Sufferer Seeking FDA Approved Treatment" »

Posted by Kerry N. Jardine at 06:29 PM | Permalink | Comments (0) | TrackBacks (0)

The Loma Linda University Medical Center wrote an abstract on a study of 12 patients who had contracted NSF after an MRI/MRA event. It was published in American Journal of Roentgenology in November 2006. The department of Radiology, Surgery and Medicine at Loma Linda all contributed to the report.

Continue reading "A Loma Linda University Med Center Abstract on NSF" »

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As of May 31, 2007, Bayer HealthCare Pharmaceuticals and its parent company have received 78 reports where patients purportedly developed NSF following Magnevist administration, and all these reports have been filed with the Health Authorities. Onset of NSF signs and symptoms in the reports dates back up to several years, and the time span between the administration of MR contrast medium and the occurrence of signs and symptoms ranges between several days and several years. In terms of standardized causality assessments, 27 of the 78 reports have been assessed as "possibly" related to the administration of Magnevist; 46 have been assessed as "unclassifiable" since currently available information is not sufficient to verify the diagnosis of NSF by deep skin biopsy and histopathology and/or to link the cases exclusively to the administration of Magnevist; and 5 have been assessed as "unlikely" to be related to the administration of Magnevist.

Posted by Kerry N. Jardine at 06:57 PM | Permalink | Comments (0) | TrackBacks (0)

The Centers for Disease Control and Prevention (CDC) co-investigated cases of NFD/NSF with doctors from the University of California in San Francisco when the disorder was first identified. Since then, the investigative effort has moved to Yale University. Dr. Shawn Cowper is currently in charge of confirming and investigating cases of NSF. The NSF Registry is a project that collects and organizes information about patients with NSF from all over the world. The goal of the project is to identify factors that may be related to or causative of NSF. In addition, information about treatment successes and failures will be collected in order to try to find effective therapies and design future medication/therapy trials. In order to ensure that the data collected in the registry are accurate, it is important to first confirm the diagnosis. Several conditions resemble NSF, and these must be excluded from the data collection effort.

Posted by Kerry N. Jardine at 06:53 PM | Permalink | Comments (0) | TrackBacks (0)

The ICNFDR is a new designation for a collaborating group of researchers based at Yale University who are involved with NSF research. The team consists of physicians and basic science researchers from several disciplines who have committed to working together in the search for the cause, treatment, and eventual eradication of NSF. The heart of the project is the NSF Registry, a direct offshoot of the original CDC investigation that began in California several years ago. Until recently, the Centers for Disease Control have not been involved in NSF investigation. Cases reported to the Food and Drug Administration are not necessarily fully reported to the ICNFDR, and vice versa. Ideally, all cases should be reported to both organizations.

Continue reading "The International Center for NFD/NSF Research (ICNFDR)" »

Posted by Kerry N. Jardine at 06:50 PM | Permalink | Comments (0) | TrackBacks (0)

Nephrogenic Systemic Fibrosis is a rare and relatively recent diagnosis for people suffering from renal failure and who have been exposed to gadolinium-containing MRI contrast agents, the natural history of the disease is not well understood. Some patients report a gradual improvement in mobility and slight softening of the skin over time. Complete spontaneous healing in a patient with ongoing kidney disease has not yet been reported. Several patients with NSF have died as a result of complications of their kidney disease or transplant surgery. One patient, who elected to discontinue dialysis, had widespread fibrosis involving the diaphragm, psoas muscles, proximal esophagus and intimal areas of vessels of the kidney and lungs. Some patients with NSF (estimated at 5% or less) have an exceedingly rapid and fulminant disease course that may result in death. NSF, by itself, is not a cause of death, but may contribute to death by restricting effective ventilation, or by restricting mobility to the point of causing an accidental fall that may be further exacerbated by fractures and clotting complications.

Posted by Kerry N. Jardine at 06:46 PM | Permalink | Comments (0) | TrackBacks (0)

NSF appears to affect males and females in approximately equal numbers. NSF has been confirmed in children and the elderly, but tends to affect the middle-aged most commonly. It has been identified in patients from a variety of ethnic backgrounds and from North America, Europe, and Asia. Besides kidney disease, conditions that may be associated with NSF include coagulation abnormalities and deep venous thrombosis, recent surgery (particularly vascular surgery), recent failure of a transplanted kidney and sudden onset kidney disease with severe swelling of the extremities. It is very common for the NSF patient to have undergone a vascular surgical procedure (such as angioplasty of a blood vessel) or to have experienced a thrombotic episode (thrombotic loss of a transplant or deep venous thrombosis) approximately two weeks before the onset of the skin changes. The associated conditions frequently confirm the use of gadolinium-enhanced MRI or MRA studies.

Posted by Kerry N. Jardine at 07:40 AM | Permalink | Comments (0) | TrackBacks (0)

While there is no consistently successful treatment for NSF, improving renal function seems to slow or arrest NSF (and in many cases allows for gradual reversal of the process over time).

Treatments that have been tried and continue to be investigated include:

Continue reading "Treatment options for NSF sufferers" »

Posted by Kerry N. Jardine at 07:35 AM | Permalink | Comments (0) | TrackBacks (0)

Dr. Ambreen Gul, nephrologist and Director of the Monroe Clinic Dialysis Center in Wisconsin, was recently published in leading health care publications. Gul wrote a chapter for third edition of Comprehensive Clinical Nephrology titled, "Assessment of Renal Function." Comprehensive Clinical Nephrology is a highly-respected source of the best and newest information on every clinical condition encountered in nephrology, the branch of medicine focused on kidney health. The chapter written was published in January 2007, and discussed the condition called nephrogenic systemic fibrosis, which is a relatively recent identified disorder seen only in patients with kidney failure. While these publications are designed to reach medical experts and helping them build on another's findings, Gul explained that patients will ultimately benefit from the literature. "We must take the initiative to introduce new findings into literature instead of keeping it to ourselves. Doing so not only allows us to make progress, but it also keeps us on our toes," Gul said. "It's a little bit of an intellectual stimulation. If you want to contribute, you have to stay up-to-date."

Posted by Kerry N. Jardine at 06:40 AM | Permalink | Comments (0) | TrackBacks (0)

Greta Carolus, a former nurse, resident and citizen of Loveland, Colorado, is suing General Electric Company, GE Healthcare, Inc. and GE Healthcare Bio-Sciences Corporation for a rare disease caused by the drug OmniscanTM, through the Law Firm of Burg Simpson Eldredge Hersh & Jardine, P.C. claiming that their drug caused her the debilitating skin and joint disease known as Nephrogenic Systemic Fibrosis (NSF). Burg Simpson is currently involved in the representation of more than 20 individuals with Nephrogenic Systemic Fibrosis (NSF). The suit seeks damages for fifteen separate causes of action. "Within days after being administered OmniscanTM, Ms. Carolus developed symptoms associated with NSF/NFD, which was formally diagnosed in November 2005, and which has progressed to widespread fibrosis and edema in areas including, but not limited to, her arms, legs, and associated joints," says Peter W. Burg, a partner in the Denver litigation law firm of Burg Simpson Eldredge Hersh & Jardine. "This disease has caused Ms. Carolus to suffer this condition and has caused permanent effects affecting her throughout her lifetime and could lead to death," said Burg. Ms. Carolus is now wheelchair bound with limited extension of her legs, several fingers and elbows. Ms. Carolus was forced to leave her employment as a nurse as a result of her debilitating injuries.

Continue reading "Former Nurse Sues GE for NSF Caused By Omniscan" »

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The FDA issued a press release on May 23, 2007 to ask manufacturers to include a new black box warning on the labeling of all gadolinium based contrast agents because of the risk of Nephrogenic Systemic Fibrosis. This NSF warning will likely bring into the spotlight the MRI for profit scheme revealed on January 17, 2007. Illinois Attorney General Lisa Madigan announced that her office had intervened in a whistleblower lawsuit filed by John Donaldson in 2006 against more than 10 Chicago-area MRI centers over their payment of kickbacks to doctors in exchange for referring patients to the centers. According to the complaint, "Each participating MRI Service Center involved performs the subject MRI services and then engages in the making of illegal and unlawful kickbacks to the physicians from payments made by both Illinois citizen patients and their insurers." The kickbacks, the complaint alleges, provide a financial incentive for a physician to order unnecessary scan services, or excessive scan services, and thus bill insurers for unnecessary scans. The schemes, the lawsuit alleges, make it impossible for legitimate providers to engage in legitimate practice of providing MRI services and remain in business if the scheme and unlawful practice of paying kickbacks for patients is not stopped.

Continue reading "MRI for Profit Scheme back in the spotlight" »

Posted by Kerry N. Jardine at 06:34 PM | Permalink | Comments (0) | TrackBacks (0)

Debbie Bochanski has struggled with chronic kidney disease for 15 years. Even receiving and then rejecting a transplant during that time. The 46-year-old mother of two is dependent on dialysis. She is now confined to a wheelchair, immobilized by a rare disease that has been linked to the dye that was injected into her veins as part of an MRI test in 2002. The disease, which seems to only afflict people with kidney disease, has just recently been identified and linked to the contrast agent. When she suffered a seizure in August 2002, she had two MRIs done. Within a month, the first signs appeared of what would eventually be diagnosed as NFD. The skin on her legs became tight and red and patchy. "When it was first diagnosed they thought it was scleroderma," Joe Bochanski recalled. "At first she could walk across the room," said Lisa Bellopede, 39, Debbie's sister. "Then she needed a walker. Then she needed a wheelchair." In 2003, doctors at the University of Pennsylvania diagnosed the problem as NFD, a rare and little known illness first identified in 1997, for which there was no known cause. "Until then, we didn't know what we were dealing with," Joe Bochanski said. It wouldn't be until late 2006 that the medical community finally settled on the dye used in MRI testing as the likely cause.

Continue reading "MRI test immobilizes woman" »

Posted by Kerry N. Jardine at 09:27 PM | Permalink | Comments (0) | TrackBacks (0)

The Food and Drug Administration has requested that makers of all gadolinium-based contrast agents (GBCAs) add new warnings, including a "black box" warning about the risk of nephrogenic systemic fibrosis (NSF). Brand names affected by the new warnings include: Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. A black box warning is the strongest warning the FDA can mandate.

Continue reading "Stronger Warnings for Gadolinium-Based Contrast Agents" »

Posted by Kerry N. Jardine at 09:47 PM | Permalink | Comments (0) | TrackBacks (0)

The U.S. Food and Drug Administration (FDA) has asked manufacturers of Magnevist (gadopentetate dimeglumine), Omniscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance; (gadobenate dimeglumine); and Prohance (gadoteridol) to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI). The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.

Continue reading "FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images" »

Posted by Kerry N. Jardine at 09:11 PM | Permalink | Comments (0) | TrackBacks (0)

Through the law firm of Burg Simpson, Eldredge, Hersh & Jardine, P.C. in Denver, Greta Carolus a former nurse and resident of Loveland, Colorado, recently filed a lawsuit in U.S. District Court for the District of Colorado against General Electric Company, GE Healthcare, Inc. and GE Healthcare Bio-Sciences Corporation claiming that their drug caused her a debilitating skin and joint disease known as Nephrogenic Systemic Fibrosis (NSF). The suit seeks damages for fifteen separate causes of action stemming from the effects of Omniscan(TM) also known as gadodiamide. “Within days after being administered Omniscan(TM), Ms. Carolus developed symptoms associated with NSF/NFD, which was formally diagnosed in November 2005, and which has progressed to widespread fibrosis and edema in areas including, but not limited to, her arms, legs, and associated joints," says Peter W. Burg, a partner in the Denver litigation law firm of Burg Simpson Eldredge Hersh & Jardine, who filed the suit. “This disease has caused Ms. Carolus to suffer this condition and has caused permanent effects affecting her throughout her lifetime and could lead to death," said Burg. Ms. Carolus is now wheelchair bound with limited use of her legs, several fingers and elbows. She was forced to leave her employment as a nurse as a result of these injuries. Burg Simpson is currently involved in the representation of more than 20 individuals with Nephrogenic Systemic Fibrosis (NSF).

Continue reading "Former Fort Collins Nurse Sues GE Healthcare for complications with Omniscan" »

Posted by Kerry N. Jardine at 10:08 PM | Permalink | Comments (0) | TrackBacks (0)

In the last eight months O'hara Wells has bound to a wheelchair while his body is slowly shutting down. He was diagnosed with NSF, or Nephrogenic Systemic Fibrosis. "It (NSF) was actually caused by the medical care he received.," says Bob Spohrer, Wells' attorney. Spohrer says the harm came from a product that can be used in an MRI. It is a contrasting agent called Omniscan, which is made of metal and manufactured by GE Healthcare. The agent helps doctors see the result of an MRI better. Wells says he was given the dangerous product in August 2006, when he had two MRIs done at the Mayo Clinic in Jacksonville. The diabetic says he was being treated at Mayo for kidney problems and was on dialysis. Wells says days after the MRIs were done, the changes started. "My hands starting drawing up, my legs starting drawing up and everything was getting real hard," says Wells.

Continue reading "Product Used In MRIs Under Investigation" »

Posted by Kerry N. Jardine at 07:43 PM | Permalink | Comments (0) | TrackBacks (0)

http://www.burgsimpson.com/nsf.htmlIn the last eight months O'hara Wells has bound to a wheelchair while his body is slowly shutting down. He was diagnosed with NSF, or Nephrogenic Systemic Fibrosis. "It (NSF) was actually caused by the medical care he received.," says Bob Spohrer, Wells' attorney. Spohrer says the harm came from a product that can be used in an MRI. It is a contrasting agent called Omniscan, which is made of metal and manufactured by GE Healthcare. The agent helps doctors see the result of an MRI better. Wells says he was given the dangerous product in August 2006, when he had two MRIs done at the Mayo Clinic in Jacksonville. The diabetic says he was being treated at Mayo for kidney problems and was on dialysis. Wells says days after the MRIs were done, the changes started. "My hands starting drawing up, my legs starting drawing up and everything was getting real hard," says Wells.

Continue reading "Product Used In MRIs Under Investigation" »

Posted by Kerry N. Jardine at 05:59 PM | Permalink | Comments (0) | TrackBacks (0)

In May 2006, nephrologists at a hospital in St. Louis, Missouri, reported to CDC and the Missouri Department of Health and Senior Services (MoDHSS) a cluster of NFD among patients treated in their dialysis units. CDC and MoDHSS conducted an investigation to determine the number of affected patients and identify risk factors for NFD. Thirty-three patients with NFD were identified in St. Louis, 28 of whom had been treated at the hospital. A matched case-control study was conducted at the hospital. This is a summary report of the preliminary results of that study, which indicated that exposure to gadolinium-containing contrast agents during magnetic resonance imaging (MRI) studies was independently associated with NFD. Clinicians have been encouraged to be aware of the potential for NFD, and when possible, should avoid use of gadolinium-containing contrast agents in patients with advanced renal disease.

Continue reading "Nephrogenic Fibrosing Dermopathy Associated With Exposure to Gadolinium" »

Posted by Kerry N. Jardine at 08:28 AM | Permalink | Comments (0) | TrackBacks (0)

Toshiba America Medical Systems, Inc. has developed three imaging techniques for its MR product line that allow for contrast-free imaging during MRA procedures. Contrast-free imaging is particularly important because gadolinium, the common contrast agent used for magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) exams, recently has been directly linked to nephrogenic systemic fibrosis/dermopathy (NSF/NFD). "Toshiba has been at the forefront of contrast-free imaging since 1998 - long before reports of the negative effects of gadolinium," said Bob Giegerich, director, MR Business Unit at Toshiba. "With Toshiba's contrast-free imaging techniques, physicians can perform MRA procedures and capture images superior to those acquired through techniques that require contrast agents."

Continue reading "Toshiba MR Systems Allow for Safe MRA Exams" »

Posted by Kerry N. Jardine at 08:22 AM | Permalink | Comments (0) | TrackBacks (0)

In a letter dated December 22, 2006 Larry Bell, MD, Vice President, Global Head of Regulatory and Pharmacovigilance at GE Healthcare wrote a letter to healthcare professionals stating the latest information regarding OmniscanT contrasting agent used in MRIs and MRAs. In it, Bell informs the healthcare professional establishment of new case reports strengthening the association between OmniscanT (gadodiamide) injections and the development of the serious medical condition known as Nephrogenic Systemic Fibrosis (NSF) a.k.a. Nephrogenic Fibrosing Dermopathy (NFD). Since June 2006, when GE Healthcare issued the safety advisory regarding OmniscanT and NSF, they have received additional reports of over 50 cases.

Continue reading "Summary of a letter written to Healthcare Professionals regarding Omniscan" »

Posted by Kerry N. Jardine at 02:12 PM | Permalink | Comments (0) | TrackBacks (0)

Research has shown a possible association between a popular magnetic resonance imaging (MRI) contrast agent and the incidence of a rare disease called nephrogenic systemic fibrosis (NSF) in patients with kidney disease, according to an editorial appearing in the March issue of Radiology. "We recommend avoiding the use of gadodiamide in patients with any degree of renal disease," said Phillip H. Kuo, M.D., Ph.D., assistant clinical professor of diagnostic radiology at Yale University School of Medicine in New Haven, Conn. "At this point, the data clearly show the vast majority of NSF cases are associated with the use of gadodiamide." Approximately 400 cases of NSF have been reported worldwide. While gadolinium-based agents have not been definitively shown to cause NSF, as many as 90 percent of known NSF patients had previously received gadodiamide, and a recent survey of approximately 100 NSF patients revealed that more than 95 percent were exposed to a gadolinium agent within two to three months prior to disease onset. Other evidence linking gadolinium with NSF includes residual gadolinium in a skin biopsy of an NSF patient 11 months after the contrast agent was administered. Studies investigating the relationship between NSF and gadolinium are currently underway at Yale, as well as the Centers for Disease Control, U.S. Food and Drug Administration (FDA) and the medical regulatory agencies of the European Union. In the meantime, the FDA advises cautionary use of all gadolinium-based contrast agents in patients with moderate to advanced renal disease.

Continue reading "Link between MRI contrast agent and Nephrogenic Systemic Fibrosis" »

Posted by Kerry N. Jardine at 09:53 PM | Permalink | Comments (0) | TrackBacks (0)

Nephrogenic systemic fibrosis, previously known as nephrogenic fibrosing dermopathy, is a newly recognized systemic fibrosing disorder primarily affecting patients with chronic renal failure. Patients with skin involvement often develop papules and plaques with peau d'orange surface changes. The lower extremities and trunk are most commonly affected. The most important histologic differential diagnosis is with scleromyxedema. This is possibly the first report of a case of nephrogenic systemic fibrosis involving the breasts of a 61-year-old woman with end-stage renal disease. Clinically, it mimics inflammatory breast carcinoma. Nephrogenic systemic fibrosis (NSF) is a recently described systemic fibrosing disorder primarily affecting patients with chronic renal insufficiency. Although the exact cause is unknown, bone marrow–derived circulating fibrocytes are suspected to be involved in the pathogenesis of this rare condition. Skin involvement in NSF frequently presents on the extremities as erythematous papules or plaques, often with peau d'orange surface changes and woody induration. Upper body involvement is less common, and breast involvement has not previously been reported.

Continue reading "Nephrogenic Systemic Fibrosis Mimicking Inflammatory Breast Carcinoma" »

Posted by Kerry N. Jardine at 09:49 PM | Permalink | Comments (0) | TrackBacks (0)

Health Canada has notified Canadian hospitals about safety concerns over contrast agents containing gadolinium which are used primarily in MRIs and have been linked to a condition called nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy, or NSF/NFD. To date, 109 cases of NSF/NFD associated with gadolinium-containing contrast agents have been reported worldwide, although none has been reported in Canada. So far, NSF/NFD has been observed only in patients with serious kidney disease, Health Canada said yesterday in an advisory.

Continue reading "Health Canada issues contrasting agent advisory" »

Posted by Kerry N. Jardine at 07:27 PM | Permalink | Comments (0) | TrackBacks (0)

Health Canada is advising consumers of a notice sent to Canadian hospitals advising relevant health care professionals of safety concerns related to contrast agents containing gadolinium. A contrast agent is a liquid that is injected into the body to make certain tissues more visible during imaging procedures. To date, 109 cases of NSF/NFD associated with gadolinium-containing contrast agents have been reported worldwide. There are no reported cases of NSF/NFD in Canada. So far, NSF/NFD has only been observed in patients with serious kidney disease. The seven gadolinium-containing contrast agents authorized for sale in Canada are Omniscan, Magnevist, Optimark, Gadovist, ProHance, MultiHance, and Vasovist. Health Canada will be working with the marketing authorization holders of the gadolinium-containing contrast agents authorized for sale in Canada to update the product information for these agents.

Continue reading "Health Canada Advises Issues Related to Gadolinium" »

Posted by Kerry N. Jardine at 12:53 PM | Permalink | Comments (0) | TrackBacks (0)

http://www.ajronline.org/aheadofprint/AJR_06_1616.dtlThe American College of Radiology (ACR) has updated its MR safe practice guidelines in a whitepaper titled ACR Guidance Document for Safe MR Practices: 2007. The whitepaper is available on the American Journal of Roentgenology Web site.

Continue reading "ACR Releases Updated MR Safety Guidelines" »

Posted by Kerry N. Jardine at 12:50 PM | Permalink | Comments (0) | TrackBacks (0)

A professor at the Yale New Haven hospital in Connecticut is a world-renowned expert on a rare disease that may be more common than anyone thought. His most recent research also points to a very "popular medical test" as the "cause" of the disease.

Continue reading "Potential MRI Risk for Some Patients - NSF" »

Posted by Kerry N. Jardine at 12:47 PM | Permalink | Comments (0) | TrackBacks (0)

Federal health officials are warning doctors that certain types of metallic dye injected for MRI scans have been linked to a rare and dangerous skin disease in kidney patients. More than two dozen dialysis patients in St. Louis over a four-year period contracted the unusual skin ailment, which causes burning and itching that can lead to discoloration and stiffening of the skin. The U.S. Centers for Disease Control and Prevention investigated a number of the cases last year and found the illnesses were tied to a contrasting agent used for magnetic resonance imaging tests. The disease occurred in patients with advanced kidney disease who had undergone an MRI or a similar test.

Continue reading "CDC warns of rare skin disease risk to kidney patients" »

Posted by Kerry N. Jardine at 12:43 PM | Permalink | Comments (0) | TrackBacks (0)

Nephrogenic Systemic Fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD), is a condition that, so far has occurred only in people with kidney disease. There is no convincing evidence that NSF is caused by a medication, a microorganism, or by dialysis. There have been no cases identified prior to early 1997. At this point it appears NSF is a systemic disorder with its most prominent and visible effects in the skin. For this reason, Nephrogenic Systemic Fibrosis has been suggested as an equivalent terminology in those previously diagnosed with NFD, and is preferred in that it more accurately reflects the current understanding of the disorder. Neither the duration of kidney disease nor its underlying cause are related to the development of NSF. Some patients with NSF develop skin tightening in the earliest stages of kidney disease, and others may have had kidney disease for years. Specific triggers for the development of NSF are still being investigated. Recent reports have strongly correlated the development of NSF with exposure to gadolinium-containing MRI contrast agents. GE healthcare is one manufacturer of gadolinium-containing MRI contrast.

Continue reading "NSF…what is it?" »

Posted by Kerry N. Jardine at 12:39 PM | Permalink | Comments (0) | TrackBacks (0)

The FDA urges patients to call their doctor right away if any time after the gadolinium injection the following conditions occur:

Skin and eyes: Swelling, hardening and tightening of the skin, reddened or darkened patches on the skin, burning or itching of the skin and yellow raised spots on the whites of the eyes.

Bones and muscles: Stiffness in joints; problems moving or straightening arms, hands, legs, or feet, pain deep in hip bones or ribs and muscle weakness.

What should healthcare providers do in response to this new information?

According to the FDA, physicians should consider the risks and benefits of using gadolinium-based contrast agents for MRI or MRA in patients with moderate to end-stage kidney disease. If such a patient receives gadolinium-based contrast agent, the physician should consider prompt dialysis.

What additional actions are likely to follow?

The FDA will complete its ongoing analysis of these preliminary findings and then consider multiple options such as: modifying the product label or requiring additional studies. FDA may also consider other risk management options.

Posted by Kerry N. Jardine at 12:31 PM | Permalink | Comments (0) | TrackBacks (0)

The FDA is urging patients to call their doctor right away if any time after the gadolinium injection the following conditions happen.

Skin and eyes: Swelling, hardening and tightening of skin, reddened or darkened patches on the skin, burning or itching of skin and yellow raised spots on the whites of the eyes.

Bones and muscles: Stiffness in joints; problems moving or straightening arms, hands, legs, or feet, pain deep in hip bones or ribs and muscle weakness.

What should healthcare providers do in response to this new information?

According to the FDA, physicians should consider the risks and benefits of using gadolinium-based contrast agents for MRI or MRA in patients with moderate to end-stage kidney disease. If such a patient receives gadolinium-based contrast agent, the physician should consider prompt dialysis.

What additional actions are likely to follow?

The FDA will complete its ongoing analysis of these preliminary findings and then consider multiple options such as: modifying the product label or requiring additional studies. FDA may also consider other risk management options.

Where can I find more information about gadolinium-based agents and about NSF/NFD?

The package inserts provide additional information about each of the approved gadolinium-based agents.

Posted by Kerry N. Jardine at 12:26 PM | Permalink | Comments (0) | TrackBacks (0)

Federal health officials are warning doctors that certain types of metallic dye injected for MRI scans have been linked to a rare and dangerous skin disease in kidney patients. More than two dozen dialysis patients in St. Louis over a four-year period contracted the unusual skin ailment, which causes burning and itching that can lead to discoloration and stiffening of the skin. Steroid treatments or kidney transplants have helped some patients recover. The researchers noted that patients on peritoneal dialysis were more likely to develop the condition than those than on hemodialysis. CDC officials believe stricken patients weren't able to clear the contrasting agent from their body.

Continue reading "Kidney Patients At Risk From MRI Dye" »

Posted by Kerry N. Jardine at 12:22 PM | Permalink | Comments (0) | TrackBacks (0)

The FDA is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure. New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). During an MRA test, a drug known as a gadolinium-contrast agent is injected into a patient’s vein so blood vessels can be distinguished from other nearby tissues. There are five gadolinium-containing contrast agents FDA-approved for use during magnetic resonance imaging (MRI). They are: OptiMARK, Magnevist, ProHance, and MultiHance. However, the FDA has not approved them for the use in MRA. The dose of gadolinium-containing contrast agent given to patients undergoing an MRA test is often higher (up to three times) than the approved dose for MRI.

Continue reading "Gadolinium Contrast Agents for MRI vs. MRA" »

Posted by Kerry N. Jardine at 12:15 PM | Permalink | Comments (0) | TrackBacks (0)