• Screen patients prior to administration of a GBCA to identify those with AKI or chronic, severe, kidney disease.  These patients appear to be at highest risk for NSF.

• Use the clinical history to screen patients for features of AKI or risk factors for chronically reduced kidney function.

• Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the need for the diagnostic information is essential and not available with non-contrasted MRI or other alternative imaging modalities.

• Monitor for signs and symptoms of NSF after a GBCA is administered to a patient suspected or known to have impaired elimination of the drug.

• Not repeat administration of any GBCA during a single imaging session.

Another favorable ruling was issued in the federal multi-district litigation (MDL), where the claims of some people suffering from nephrogenic systemic fibrosis (NSF) are being adjudicated.  On Friday, June 18, 2010, Judge Aaron Polster declined to change his earlier ruling on the admission of expert testimony, with one small exception.  We reported the earlier ruling in a previous blog entry.

Defendant GE Healthcare filed a motion asking the Court to reconsider its ruling on expert testimony issued on May 4, 2010.  GE Healthcare is the manufacturer of Omniscan, one of the most popular and dangerous brands of gadolinium-based contrast agents.  As Judge Polster explained in his order, GE Healthcare's motion for reconsideration challenged "every ruling by this Court that resulted in the partial or wholesale exclusion of the testimony or opinions of [GE Healthcare]'s expert witnesses."

Judge Polster declined to change his earlier ruling, with one narrow exception.  The previous order excluded in its entirety the testimony of Dr. Waymack, GE Healthcare's lone regulatory expert.  However, the plaintiffs had only sought to exclude a portion of his testimony.  The Court therefore modified its order to permit Dr. Waymack to testify on matters other than those that the plaintiffs asked to exclude.

Significantly, the Court observed that "the association between gadolinium-based contrast agents, severe renal impairment and NSF is virtually inescapable."  NSF, also known as Nephrogenic Fibrosing Dermopathy (NFD), is an incurable disease characterized by hardening of the skin and other body tissues.  Gadolinium-based contrast agents are used in various medical procedures, including MRI, MRA, and CT scans (CAT scans).  As the Court's order observed, diabetics and others with severe kidney impairment are most at risk of developing NSF.

Important news for Californians suffering from nephrogenic systemic fibrosis (NSF):  California NSF lawsuits have been consolidated in Department 304 of the San Francisco Superior Court, with the Honorable Richard A. Kramer presiding.  This means if a case is filed anywhere in a California state court, and is not removed to federal court by the defendants, the case will be overseen by Judge Kramer.  You can learn more about California NSF Lawsuits HERE .

NSF is a progressive, debilitating disease caused by gadolinium-based contrast agents used in MRIs, MRAs, and other medical scans.  The people most likely to develop NSF are those on dialysis or with renal impairment, past kidney transplant recipients, or past liver transplant recipients.  Symptoms of NSF include:

• Swelling, thickening and tightening of the skin, especially on the legs or arms;
• Skin is hard, and feels "woody" or "leathery";
• The skin has an "orange peel" appearance;
• Hair loss on the affected area of the skin;
• Joints contract and become inflexible, especially the hands, wrists, elbows or feet, ankles, knees;
• Yellow papules in the whites of the eyes;
• Severely affected people may be unable to walk or close their hands.

• A warning that the elderly may be at particular risk of NSF due to impaired ability of their kidneys to clear gadolinium from the body.


• A statement that there is no evidence to support the initiation of hemodialysis to prevent or treat NSF in patients not already undergoing hemodialysis. 

• A statement that the type and dose of contrast agent used should be recorded.

A recent clinical trial shows that the cancer drug Gleevec (generic name Imatinib Mesylate) helps lessen the skin symptoms of Nephrogenic Systemic Fibrosis (NSF).

The study was conducted by Dr. Jonathan Kay of the University of Massachusetts Medical School, Worcester, MA.  Dr. Kay presented the results of his study on October 18, 2009, at the 2009 Annual Scientific Meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals.

Participants in the clinical trial were given 400 mg of Imatinib Mesylate daily for four months.  The six subjects who completed the trial showed an improved modified Rodnan skin score (mRSS), which is a measurement of skin thickness at 17 different parts of the body.  But the improvements did not last after treatment stopped.  The mRSS scores of four of the six participants worsened after they stopped taking the drug.  The participants also experienced known side effects of Imatinib Mesylate, including nausea, vomiting and diarrhea.

A summary of the results of Dr. Kay’s study may be found HERE.

In May 2007, the FDA ordered all manufacturers of gadolinium-based contrast agents to warn of the risk of Nephrogenic Systemic Fibrosis (NSF) for people with kidney disease.  However, the FDA considered specifically targeting General Electric product Omniscan and recommending that it never be used on people with kidney failure.

The current warning required for gadolinium-based contrast agents applies to all brands of gadolinium-based contrast agents.  The warning does not state that gadolinium-based contrast agents should never be used for patients with renal failure, just that they only should be used if the diagnostic benefits outweigh the risk of developing NSF.

However, one FDA staff member recommended more.  In a recently released FDA document, FDA staff member Dr. Louis Marzella stated that “a contraindication for Omniscan is warranted in patients with severe renal insufficiency.”  The term “contraindication” means a recommendation against using a specific medical treatment under certain circumstances.

In the United States, GE’s product Omniscan has an approximately 30% market share of gadolinium-based contrast agents.  Bayer HealthCare’s product, Magnevist, is the market leader, with a 50% market share.  But despite Omniscan’s smaller market share, in the data reviewed by the FDA in 2007, there were nearly twice as many incidents of NSF among people treated with Omniscan as there were for people treated with Magnevist.

An internet search for the phrase “MRI lawsuit” will pull up various law-firm and attorney-sponsored websites.  The term “MRI lawsuit,” however, is misleading.  Magnetic resonance imaging (MRI) itself does not cause nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD).

The real culprits are gadolinium-based contrast agents.  An injection of a gadolinium-based contrast agent  --  even just one  --  can cause NSF/NFD.  These contrast agents are used in some, but not all, MRIs.  If nothing was injected into you for your MRI, you did not receive a gadolinium-based contrast agent and therefore are not at risk of developing NSF.  Further, gadolinium-based contrast agents are also used in medical scans other than MRIs, despite the fact that the FDA has not approved their use in these treatments.  These unapproved uses include the following:  MRA, angiogram/angioplasty, CT scan (CAT scan), fistulogram, and venogram.