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Over 2,000 Fresenius Dialysis Lawsuits Pending Before MDL

Fresenius Medical CareIn a series of ongoing products liability lawsuits filed against Fresenius Medical Care, the list of plaintiffs and lawsuits continues to grow, topping 2,089 total cases according to a recent MultiDistrict Litigation statistics report. The multidistrict litigation mounting against Fresenius with regard to its Granuflo and Naturalyte products represents one of the largest MDL cases on the federal dockets today.

Comparable litigation, in terms of number of active cases, include those against DePuy and its hip implant products, cases against the makers of Avandia, and lawsuits stemming from the tragic oil spill in the Gulf of Mexico.

The lawsuits against Fresenius are awaiting adjudication in the United States District Court for the District of Massachusetts. The judge assigned to the case is Hon. Douglas P. Woodlock, who has been sitting on the bench since 1986.

Details of allegations in Fresenius dialysis lawsuits

The Fresenius dialysis lawsuits allege alarming side effects occurring in patients undergoing kidney dialysis treatment for renal dysfunction and failure. Fresenius, a company treating over one-third of all dialysis patients in the United States, operates several dialysis centers across the nation. Its products are also delivered to patients opting to undergo dialysis treatments at home – including the components, fluids and medical parts necessary to complete the process.

During the dialysis procedure, the blood is cleansed and purified through the use of artificial filtration systems and the introduction of various chemicals to neutralize and balance the blood – all tasks formerly performed by the kidneys prior to the onset of renal failure. One of the goals of the dialysis process is to ensure the patient’s bloodstream remains at a neutral ph level – not too acidic and not too alkaline. In order to achieve this result, Fresenius dialysis treatments involve the introduction of bicarbonate – labeled as Granuflo and NaturaLyte – to patients during their dialysis appointments. However, patients in Fresenius clinics began to experience cardiac arrest at alarming rates, after being given improper doses of Granuflo and/or Naturalyte.

In 2012, an internal memorandum circulated within the German-based Fresenius headquarters acknowledging the increased risks of heart attack in Granuflo patients infused with the bicarbonate mixtures – signaling to many that the company knew or should have known about the risk.

Fresenius faces untold damages and restitution to plaintiffs

With the number of Naturalyte and Granuflo lawsuits growing steadily, it is difficult to speculate as to the true extent of Fresenius’s liability with regard to its bicarbonate products. In any products liability lawsuit, the burden is placed on the plaintiff to prove that the defendant failed to warn consumers as to a known or foreseeable risk associated with its product. In other words, a product with a known risk should contain a clear warning label – or be pulled from the market altogether.

A foreseeable risk is one that a reasonable company would be able to estimate was likely to occur given the set of facts and circumstances at hand (e.g., history of problems with bicarbonate, results of studies with other bicarbonate products, etc.). If a jury concludes that a medical device manufacturer should have known of the risks through the use of reasonable foreseeability, that defendant will be held liable. In other words, a defendant cannot escape consumer product liability for willfully failing to uncover the pertinent facts.

The first Granuflo trial is scheduled to begin on January 11, 2016.

  1. Judicial Panel on Multidistrict Litigation, Pending MDL DOckets by District,

  2. NY Times, FDA investigates Fresenius for failure to warn of risk,