Fresenius Late Recall of GranuFlo Product Draws Inquiry Over Cardiac Arrests


The U.S. Food & Drug Administration (FDA) has been investigating whether German based, Fresnius Medical Care, violated federal regulations and put profits ahead of patient safety by not timely disclosing of risks associated with their dialysis product GranuFlo and Naturlayte. The product may have contributed to hundreds of deaths, cardiac arrests and related complications during dialysis throughout the United States.

In the United States, Fresenius Medical Care is the largest provider of dialysis products and services, or claims to be on their website, with over 1,800 kidney dialysis clinics. The company displays the following motto on their website: “The world lead in quality dialysis products and services“. Fresenius Medical Care also claims it is the World’s leading company devoted to patient oriented renal therapy with over 2,700 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa. It also holds itself out as the pre-eminent provider of dialysis products with revenues in 2010 exceeding $12 Billion. The companies position as a leader, who controls manufacturing of the product at issue, the machines used during dialysis, and some clinics at the center of the controversy, make it vulnerable for a Lions share of any legal culpability.

granuflorecall2012-resized-600In mid-June 2012, The New York Times reported, on a little publicized story, that the company may have failed to timely or openly warned physicians and labs of a safety signal with their product. The background provided by A. Pollack, in “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry“, if accurate, is troubling. Reportedly, in November 2011, Fresnius’ medical office issued an internal memo warning physicians of the potential for patients dying of sudden cardiac arrest if their product wsa not properly used during dialysis.

Dialysis already comes with known risks and complications as patients in need of the procedure are often at varying stages of renal failure. Dialysis acts as a substitute for normal kidneys and removes was and water from blood. It is a tedious and time consuming process where blood circulates outside of a persons body while it is filtered and the person remains connected through a catheter.

Fresenius Medical Care warned certain centers but did not issue a broader warning, nor alert public health officials or the FDA. The FDA obtained an anonymous copy of the internal warning, reports The New York Times, and only then did the company advise of an issue. The November 4 2011, memo reported that nearly 1,000 patients had suffered cardiac arrest inside Fresenius clinics in 2010. Reportedly, GranuFlo contains more bicarbonate than other products, which is used to neutralize blood during dialysis. By analyzing information, Fresenius’ medical staff allegedly confirmed that patients with higher levels of bicarbonate had 6x the risk of cardiac arrest in comparison to those with lower levels. Industry insiders have openly questioned the companies failure to timely warn the medical community as well as patients.

The Chief Medical Officer for Fresenius in North America, Dr. Franklin W. Maddux, claims the company had no way of communicating with non-company clinics other than through medical journals or papers and that information was limited at the time his office issued the memo. Really? This seems to be a weak argument or position given what is now known. Arguably, the company made a decision to keep information “in house” while it sorted out a broader strategy. Given the availability of web based PR services, Social Media, Websites and countless other ways of spreading information this position is not likely to hold much water in coming lawsuits. As discussed here  GRANUFLO LAWSUITS claim that FMC put profits over safety and failed to timely communicate known risks to medical providers, patients, the FDA and other public health authorities.

The products became the subject of a Class 1 Recall or Market Withdrawal and litigation has now been initiated on behalf of patients that suffered cardiac arrest, cardiopulmonary arrest, heart attacks or related complications following dialysis treatment. Ironincally, Fresenius Medical Care maintains a website with a “Newsroom“, however it does not have any clear directive or information relating to the recall possibly as a result of pending litigation or simply because they never thought of using the site to spread the word about the dangers of their product either prior to or after the recall and FDA involvement.

Our GRANUFLO LAWYERS are  actively investigating cases involving the GRANUFLO RECALL, Fresnius Medical Care, GranuFlo and Naturalte Dialysis Concentrates nationwide. Unfortunately, individuals that suffered GRANUFLO INJURIES, or adverse events linked to these products include injuries like cardiovascular death, sudden cardiac death, heart attacks, cardiopulmonary arrest or other catastrophic injuries.

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