• 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.

The Cleveland Plain Dealer has reported that C.B. Fleet Co. is "close to reaching a final settlement" with people across the country who say their kidneys were harmed by Fleet's over-the-counter laxatives.  See Diana Suchetka, "Settlement Coming in Suit Concerning Oral Laxatives," The Plain Dealer, May 19, 2010.  C.B. Fleet Co. was the manufacturer of Fleet Phospho-Soda and Fleet Phospho soda EZ Prep Bowel Cleansing system.

The article attributed the following statements to C.B. Fleet:  "While we are encouraged by the progress made to date on the global settlement, there are several matters remaining to be resolved."  "Fleet hopes that a conclusion can be reached soon that serves as a positive outcome for all concerned."

Fleet Phospho-Soda and Fleet Phospho soda EZ Prep Bowel Cleansing System were over-the-counter products used for bowel cleansing to prepare for a colonoscopy.  These products were recalled from the market after the FDA issued a safety alert on December 11, 2008, warning that they can cause kidney failure (renal failure).  Side effects include dialysis and the need for a kidney transplant.

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.