Status Conference Scheduled for Granuflo MDL 2428

Federal Judge Douglas P. Woodlock, who is presiding over multidistrict litigation (MDL) that centralizes similar Fresenius dialysis injury lawsuits involving injuries from Granuflo and Naturalyte, has scheduled an initial status conference for August 30, 2013. According to the July 29th judicial order, the first scheduling conference will take place in the Joseph Moakley Courthouse in Boston, Massachusetts. The conference will allow Judge Woodlock to meet with legal counsel to discuss pending motions and review the structure and organization for the consolidated proceedings.

MDL 2428: In Re: Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation is proceeding in the U.S. District Court, District of Massachusetts, and was established this past April to better manage the growing number of complaints regarding Fresenius’ controversial dialysis products.

Granuflo and Naturalyte lawsuits filed in state and district courts throughout the country allege that the dialysates caused serious complications and damages including heart attacks, cardiac arrest and sudden death. Qualifying federal cases were transferred to the MDL court for pretrial proceedings; any claims that aren’t resolved will be remanded back to their original court of filing for trial.

Granuflo and Naturalyte litigation

At the core of Fresenius dialysis injury lawsuits is that the manufacturer withheld vital information about adverse Granuflo side effects – information that Fresenius knew of as early as 2010. Granuflo and Naturalyte have the same basic ingredients but are sold in powdered and liquid forms. Plaintiffs contend that Fresenius failed to adequately warn consumers and health care professionals about the importance of monitoring patient’s bicarbonate levels, since both products were shown to substantially increase these levels, leading to problems with low blood pressure, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia and cardiopulmonary arrest.

In an internal Fresenius memo which bolsters Granuflo lawsuit allegations, the company found evidence of more than 900 incidents of heart attacks among dialysis patients who were given the products during 2010. Once this information was leaked to the FDA, an urgent recall was issued for Granuflu and Naturalyte. Since the 2012 Class I recall, a growing number of dialysis patients and their families have made the connection between their injuries and Fresenius’ products. As of July 10, the U.S. Judicial Panel on Multidistrict Litigation case list shows at least 188 Granuflo and Naturalyte lawsuits have been transferred to MDL before Judge Woodlock. Court recordings indicate that 700 additional cases are pending filing in 46 states, and many products liability lawyers anticipate the MDL to include thousands of claims as more tag-along actions are moved to the Massachusetts court.

Unlike a class action lawsuit, in multidistrict litigation each plaintiff retains the individual status of his or her complaint, and maintains the right to an individual jury verdict or out-of-court settlement with the defendant. MDL is formed to facilitate more efficient pretrial proceedings under a single judge, in an effort to reduce inconsistent rulings and avoid redundant discovery.

Fresenius dialysis injury lawsuits level similar allegations

The following are among the more common allegations raised in lawsuits against Fresenius Medical Care.

Fresenius is being held liable for:

• Failing to uphold their duty to warn the medical community about the risk of heart attack from bicarbonate overdose associated with their products
• Intentionally withholding crucial information regarding adverse cardiac events and the potential for dialysis death
• Withholding information about dangerous Granuflo side effects from physicians and clinics operating outside the Fresenius network
• Failing to remedy known product defects in its dialysate products before marketing and making them available for public consumption
• Failing to warn acute dialysis patients of increased risks associated with GranuFlo and NaturaLyte products