By Paul Sizemore, Esq. and Jaime E. Moss, Esq., The Sizemore Law Firm, PLC
Rising star among U.S. plaintiff attorneys, Paul Sizemore practices exclusively in the areas of mass torts, products liability and mesothelioma. He was recently selected as a Top 20 California attorney and has twice been awarded law firm litigator of the year. He has and continues to play a leadership role in many of the nation’s largest consolidated actions. [Along with Vance Andrus of Andrus, Hood & Wagstaff, Paul co-chaired HB’s recent Plaintiff Pharma Forum in Los Angeles. If you are interested in participating in these events, write to us at Editor@LitigationConferences.com.] Jaime Moss graduated summa cum laude from University of California at Los Angeles in 2008 with a B.A. in Sociology. In 2012, she graduated summa cum laude from Thomas Jefferson School of Law ranked as the number one female and third overall in her graduating class. Jaime was staff associate and editor of the Thomas Jefferson Law Review, for which the faculty nominated her for the Burton Award for Legal Writing.
GranuFlo®, manufactured by Fresenius Medical Care North America and regulated as a medical device by the FDA, is a dry acid concentrate used to treat acute and chronic renal failure during hemodialysis. GranuFlo is used with a hemodialysis machine that is calibrated for specific acid and bicarbonate concentrations. Bicarbonate is in the blood naturally, but during dialysis bicarbonate levels are set slightly higher than normal to encourage diffusion of bicarbonate into the blood and to act as a pH buffer to neutralize the metabolic acidosis that is often present in dialysis patients because they lack kidney function.
During hemodialysis the patient gets bicarbonate from two sources; the bicarbonate level that is prescribed and set on the machine and acetate contained in the GranuFlo product, which is rapidly converted into bicarbonate in the liver and should be counted as part of the bicarbonate that the patient receives. The bicarbonate prescription underestimates the “total buffer,” or total bicarbonate level, that the patient receives because it is not displayed on the hemodialysis machine. To calculate “total buffer,” the amount of bicarbonate that is entered into the machine is added to an extra 8.0 mEq/L of acetate contained in the GranuFlo product (shown as “Ac.” on the dialysate label) that is converted into bicarbonate.
Thus, patients who received GranuFlo were exposed to 8.0 mEq/L of additional bicarbonate that was unaccounted for. For instance, using a bicarbonate setting of 33 mEq/L on the hemodialysis machine and adding an additional 8.0 mEq/L of acetate contained in the GranuFlo product gives the patient a “total buffer” of 41 mEq/L. Pre-dialysis concentrations of bicarbonate in the body range from 20 to 29 mEq/L. The additional bicarbonate received from GranuFlo in patients with both high (>28 mEq/L) and low (<20 mEq/L) pre-dialysis bicarbonate levels placed them at a two-fold to six-fold increased risk for cardiac arrest and sudden death because of the rapid change in electrolytes and the high serum acid levels.
In response to a high rate of cardiac arrests during dialysis in Fresenius Medical Care Clinics in 2010 (941 reported deaths in 667 Fresenius Medical Care facilities), the company circulated an internal memo to its own dialysis clinics on November 4, 2011 warning of the risk of excessive bicarbonate levels. Fresenius was aware of the significant risk of cardiac arrest and death during hemodialysis treatments associated with GranuFlo, even acknowledging that the “issue needs to be addressed urgently,” and that the “total buffer [is] equal to ‘prescribing bicarbonate plus 8,’” but only provided the memo to Fresenius’ physicians and dialysis facilities, and not to non-Fresenius physicians and clinics. The FDA received an anonymous tip of the internal memo.
On March 29, 2012 the FDA issued a Class I recall for GranuFlo concentrate manufactured and distributed between January 2008 and June 2012. This recall, however, only cautioned clinicians to be aware of the concentration of acetate contained in GranuFlo and did not remove the product from the market. On May 25, 2012 the FDA disseminated a safety memo, warning of dosage errors that can cause elevated bicarbonate levels during the hemodialysis procedure that can contribute to metabolic alkalosis, which presents a significant risk of cardiopulmonary arrest, cardiac arrhythmia, and sudden cardiac death.
Plaintiff’s counsel, headed by Paul Sizemore, Lowell Finson, and Jaime E. Moss, filed a petition for coordination of GranuFlo cases pending in California state courts. On March 20, 2013, Honorable Judge Emilie H. Elias of the Superior Court of California, County of Los Angeles, granted the coordination of GranuFlo cases (GranuFlo/Naturalyte Cases, JCCP 4749). Paul Sizemore will likely be lead counsel for the ensuing litigation, flanked by Lowell Finson and other prominently recognized attorneys in the field.
Subsequently on March 29, 2013, the United States Judicial Panel on Multidistrict Litigation issued an order coordinating federal actions and transferring them to the Honorable Douglas P. Woodlock in the District of Massachusetts (In Re: Fresenius GranuFlo/Naturalyte Dialysate Products Liability Litigation, MDL No. 2428). Fresenius Medical Care North America has its principal place of business in Waltham, Massachusetts. Fresenius USA, Inc. has its principal place of business in Walnut Creek, California. Fresenius USA, Inc. manufactures dialysis machines, equipment and supplies necessary to use GranuFlo during hemodialysis, and operates dialysis clinics across the United States.