A few months ago, the New York Times revealed that the Food and Drug Administration (FDA) was investigating Fresenius Medical Care, which bills itself online as “the world’s leading company devoted to patient-oriented renal therapy,” and the ” largest provider of dialysis products and services” in the United States.
Fresenius is a big deal in the kidney dialysis and kidney failure arenas. It’s the self-proclaimed market leader in its industry, after all.
So, it’s a very big deal when Fresenius Medical Care goes under an investigation by the federal government. Today, the story hints of becoming a true national scandal as the FDA is investigating whether or not Fresenius Medical Care intentionally ignored federal law when it failed to inform its customers that there was a real, known risk of fatality (death) connected to its kidney products.
FDA Issues Warning and Then a Class 1 Recall to Fresenius Medical Care of Naturalyte and Granuflo Products
There was a warning letter from the FDA to Fresenius back in September 2010 (read it here). That letter included a concern over the company’s Naturalyte Acid Concentrate products and its failure to respond appropriately to complaints regarding the dialysis product – one of which involved the death of a patient after using Naturalyte.
Then there was the big recall. In March 2012, the FDA issued its biggest and baddest recall — a Class I Recall — to Fresenius for its products Naturalyte and Granuflo Acid Concentrate. (You can read the FDA Class 1 Recall here.)
According to the FDA Recall:
Reason for Recall:
The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.
FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.
Fresenius Internal Memo Reveals Company Knew of Dangers: Whistleblower Sends Memo to FDA
According to the New York Times expose, it was Fresenius’s own internal memo, addressed to its staff physicians working in Fresenius’ own dialysis centers, that set the ball rolling. The company memo told the company doctors that it looked like failure to use one of the company products just right (GranuFlo) might end up with the patients having a fatal cardiac arrest. (You can read that memo online here.)
So, when did Fresenius decide to warn the doctors that were using its products but weren’t connect with Fresenius centers about this real danger? After someone anonymously sent a copy of the internal memo to the FDA and the FDA called up Fresenius and started asking questions about things.
Today, we don’t know the extent of the harm that has been done to people suffering from kidney disease by Fresenius’ products. Lawsuits are popping up all over the country; injured victims are filing products liability lawsuits against Fresenius. Some may file medical malpractice suits too: if doctors knew or should have known about the dangers of these products and still used them, then they may face claims of medical negligence. Sadly, families of those who died after using GranuFlo or Naturalyte will also file suits — as Wrongful Death lawsuits under state law.
Because these products are known to kill people, and it’s clear that the manufacturer knew that its product could result in a fatal heart attack and decided to keep the product on the market anyway, the company may face significant punitive or exemplary (punishment, example) damages. Remember: it was only when the FDA issued a Class 1 Recall that these kidney dialysis products were targeted for removal from the marketplace.
This is just one more tragic example of how we cannot trust a product to be safe for use just because it’s been sold in the United States. If you or a loved one has been injured by GranuFlo or Naturalyte, then you may have a claim for damages against the company under your state’s products liability laws or wrongful death statutes.