Fresenius Dialysis Death Lawsuit Filed in Massachusetts

A wrongful death action was recently brought by the estate of Jerry L. Lingerfelt in the U.S. District Court for the District of Massachusetts (Boston). In her GranuFlo and Naturalyte lawsuit, plaintiff Brenda Lingerfelt alleges that due to his exposure to the defectively designed Granuflo, Jerry went into cardiac arrest, resulting in his death on February 14, 2007.

This action seeks monetary damages under the Massachusetts Wrongful Death Statute, under allegations that Fresenius failed to adequately warn of the dangers associated with the use of its products Granuflo and Naturalyte, and attempted to conceal those dangers from the public and the FDA through March 29, 2012, when both dialysates were subject to a Class I recall – the FDA’s most stringent. Brenda Lingerfelt was appointed personal representative of the decedent’s estate on April 26, 2013 in Suffolk Probate and Family Court.

Allegations raised in Granuflo and Naturalyte lawsuit

Designed, manufactured and distributed by Fresenius Medical Care, GranuFlo – a dry concentrated dialysate – has a unique formulation that, when not administered in the correct doses, can result in increased levels of bicarbonate in the bloodstream. Court documents report that the hazards of elevated bicarbonate levels and resulting risk of cardiopulmonary arrest were known in the medical community as early as 2004. Fresenius was generally aware of high rates of alkalosis and increased incidents of heart attack and sudden death in Granuflo patients, according to an internal memo the company issued in 2011. The company had knowledge of potential for Fresenius dialysis death as early as 2002, says the complaint, and the need for individualized dialysate prescriptions, but failed to alert health care providers about this crucial information.

The lawsuit contends that from 2008 through 2010, the defendant failed to provide notification to all users of GranuFlo of the need to “halve” acetate levels when administering the product via dialysis machines and setting the proper parameters. The way in which Fresenius provided information, it did so selectively and haphazardly in a calculated manner as to avoid general distribution of necessary warnings and instructions and adverse side effects associated with Granuflo and Naturalyte, argues the plaintiff.

It wasn’t until March 29, 2012 that the FDA reported Fresenius’s voluntary Naturalyte and Granuflo recall, which cautioned consumers and medical professionals about the heightened risk for low blood pressure, hypokalemia, hypoxemia, hypercapnia (high carbon dioxide levels), and cardiac arrhythmia, possibly leading to death, associated with its products.

Decedent suffers cardiac arrest shortly after given Granuflo

Like the dozens of other plaintiffs who’ve filed claims against Fresenius Medical Care, Brenda Lingerfelt contends that GranuFlo was in a dangerous and defective condition at the time of its sale to Jerry L. Lingerfelt. She further argues that Fresenius should be held liable marketing and selling its products when the company knew or should have known about inherent design defects. Fresenius is also accused of failing to notify the families of patients that suffered cardiac death during dialysis of the association between GranuFlo complications and sudden cardiac death.

Causes of action listed in the Granuflo and Naturalyte lawsuit:

• Breach of warranty
• Negligence
• Strict Liability
• Fraudulent concealment / misrepresentation

In addition to the above claims, Brenda Lingerfelt is also demanding punitive damages for Fresenius’ alleged gross negligence. Her complaint joins current Granuflo multidistrict litigation, MDL No. 2428, which was established on March 29, 2013 to streamline pre-trial proceedings for the growing number of cases alleging life-threatening injuries and Fresenius dialysis death.