Since 1958, The Beasley Firm has fought for injured patients and consumers, recovering over $2 billion for our clients through hundreds of multi-million dollar settlements and jury verdicts. If you or a loved one suffered a heart attack or other cardiac problem within 48 hours of receiving dialysis, at any point between 2008 and July 2012, contact us for a free and confidential consultation by filling out our online form.
Yesterday, I received a call from a man in his fifties who, two years ago, had suffered a heart attack a day after receiving his routine dialysis from Fresenius Medical Care. He had recently seen a television commercial – coincidentally while receiving his dialysis treatment – with an actor in a dark suit standing in front of law books and pointing his finger at the camera urging anyone who had suffered a heart problem while on dialysis to call the number now to make sure they had a claim. He called, and a day later two lawyers showed up at his house with a lot of paperwork, telling him he had to sign the attorney’s fee agreement now or lose out on a lot of money. In other words, he just wanted answers and instead he got the same “hard sell” that has become all too common in personal injury law. It’s disturbing and embarrassing.
Thankfully, the man had two friends who were lawyers, so he asked them what to do, and they both told him to call us. Like most mass torts lawyers, I’ve been following the GranuFlo and NaturaLyte litigation with interest, but I haven’t written about it yet. With that call, I suppose it’s time to explain what’s happening – unfortunately, most of the law firm websites out there are filled with so many advertising hooks it’s hard for affected dialysis patients (or their survivors) to figure out what’s going on. First, a little bit of history.
Hemodialysis involves using machines to remove waste products like creatinine, urea, and water from the blood in kidney failure patients. Those waste products, in turn, break down proteins, which in turn produce acid when they break down. One of the complications of kidney failure is metabolic acidosis, because the kidney can’t remove acid and can’t produce bicarbonate, which is a base. So, hemodialysis involves both removing waste and adding bicarbonate, and a patient’s nephrologist will include with the dialysis prescription some particular level of bicarbonate to be maintained in the patient’s blood.
That’s where GranuFlo and NaturaLyte come in. The “dialysate” in dialysis is a mixture of purified water, a bicarbonate concentrate (usually sodium bicarbonate), and an acid concentrate (either acetic acid, citric acid, or sodium diacetate). GranuFlo and NaturaLyte are used as the acid concentrate: GranuFlo is a solid sodium diacetate concentrate, while NaturaLyte is a liquid acetic acid concentrate. Both are made by Fresenius (and used by Fresenius and sold to other dialysis centers), and together they’ve been the most widely used dialysate acid concentrates for years.
But there’s a problem: from 2008 through early 2012, GranuFlo and NaturaLyte included more bicarbonate than it should, and so the patients received too much bicarbonate. The excess bicarbonate then produces metabolic alkalosis (the opposite of metabolic acidosis), which dramatically increases the risk of heart attacks, cardiac arrest, arrhythmia, and stroke, and thus increases the risk of death, too.
The shocking part is that this is all basic chemistry that should have been revealed by basic pre-market testing – and Fresenius apparently knew for some time that there was a serious problem. According to complaints filed in court, some Fresenius employees were told as early as 2008 to cut the acetate dose below the prescription, which, if true, would be an admission that the GranuFlo and NaturaLyte were producing too high levels of bicarbonates. By 2009 or 2010, Fresenius had change the operator’s manual for some of its machines to instruct operators to cut the acetate dose in half, again showing awareness of the problem. But Fresenius didn’t change the GranuFlo and NaturaLyte mixtures themselves.
Instead, apparently, they just studied it more, and the results were shocking. An internal memorandum at Fresenius (PDF copy here), sent only to the directors and attending physicians of their dialysis clinic in November 2011, revealed that its patients’ serum pre-dialysis bicarbonate levels gradually increased from 2004 to 2011, and found that that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010. The internal researchers at Fresenius concluded that their patients had a six-fold increase in the risk of cardiopulmonary arrest and sudden cardiac death.
Fresenius knew its patients were suffering heart attacks – and many of them were dying – but they still didn’t do anything about it. A whistleblower leaked the memo to the Food & Drug Administration, which took swift action, and in March 2012 the FDA issued a class 1 recall for the GranuFlo and NaturaLyte produced from January 2008 through 2012.
Now comes the legal fall-out, and the inevitable “class actions.” I write “class action” in quotes because there won’t be any class actions, but there will be what’s known as “consolidated litigation.” (So far, only a handful of lawsuits have been filed, but, given the scope of the damage, we are confident there will be so many lawsuits the courts will order consolidation.) Here’s the core difference between the two: how individuals are treated.
In a class action, all of the plaintiffs are treated the same, i.e., they are win or lose together, and they all recover roughly the same in a settlement or jury verdict. In consolidated litigation, most of the pre-trial work in the case is done in a coordinated manner (e.g., depositions of corporate executives, gathering of scientific evidence, etc.), but each plaintiff will win, lose, or settle on their own. Each injured Fresenius will need to prove their individual injury was caused by the GranuFlo / NaturaLyte, and each will prove their own level of damages and thus be awarded their own amount of compensation.
We, as lawyers for the injured Fresenius patients, are confident that we will be able to prove Fresenius was negligent (1) in designing the product improperly; (2) in failing to test it; (3) in failing to act on the reports of problems; and (4) in failing to warn patients, doctors, and clinic staff of the problem. It will take a year or more of consolidated discovery proceedings to do it, but we are confident we will.
The real issue in each case will likely be “causation.” That is, proving the patient suffered a heart attack, or cardiac arrest, or died as a result of the excessive bicarbonates in the mixture, as compared to something else, like their pre-existing risk factors for heart problems, including the fact that they are already kidney patients.
How do we evaluate “causation?” By the time in between the last dialysis treatment and the cardiac event. Of course, every patient follows a different dialysis schedule (in general, more dialysis is better than less, but everyone has their own life to attend to, and no one wants to sit in a dialysis clinic for even longer than they need). We’re not in the business of filing frivolous lawsuits or wasting our client’s time, we in the business of helping seriously injured people obtain adequate compensation, and so we limit our cases to those supported by the science and the medicine.
Based on we know and have studied, we have set an internal timeline of 48 hours, and a time frame of 2008 through July 2012: if you or a loved one began to suffer a heart attack within 48 hours of receiving dialysis at any point between 2008 and July 2012, and you received GranuFlo or NaturaLyte (which is possible even if you were not at a Fresenius clinic) we think you might have a viable claim, and we’re happy to review it and, if it lines up then we’ll represent you in a lawsuit on a contingent fee.
Since 1958, The Beasley Firm has fought for injured patients and consumers, recovering over $2 billion for our clients through hundreds of multi-million dollar settlements and jury verdicts. If you or a loved one suffered a heart attack or other cardiac problem within 48 hours of receiving dialysis, contact our dangerous drug lawyers for a free and confidential consultation by filling out our online form.
Disclaimer: The information on this website is for general information purposes only. Nothing on this site should be taken as legal advice for any individual case or situation. This information is not intended to create, and receipt or viewing does not constitute, an attorney-client relationship.