The Food and Drug Administration (FDA) has issued a public notice to health care providers and patients that certain hemodialysis machines manufactured by Fresenius Medical Care may be exposing users to toxic chemicals. Exposure to these toxins could cause patients to suffer neurologic conditions and hormone disorders. Our firm is not evaluating potential lawsuits against Fresenius by individuals who were harmed by this issue.
Fresenius Dialysis Machines May Expose Users to Toxic Chemicals
In a public notice letter dated May 6, 2022, the FDA announced that a handful of hemodialysis devices manufactured by Fresenius Medical Care could potentially be exposing users to toxic chemicals, including non-dioxin-like PCBAs (polychlorinated biphenyl acids) and NDL PCBs (polychlorinated biphenyls).
The FDA safety warning applies to the following Fresenius Medical Care hemodialysis machine models: 2008T, 2008K2, and 2008K. The 2008T is the most current model hemodialysis machine from Fresenius. The 2008K and 2008K2 are older model machines that Fresenius no longer manufacturers, but which are still in clinical use.
The toxic chemicals from the Fresenius hemodialysis devices are originating from the silicone tubing used in hydraulic components of the machines and in the dialysate lines. The silicone tubing in the hydraulic and dialysate components of the machines do not come in direct contact with the patient’s blood. However, “back filtering” through the dialyzer may cause the toxic chemicals from these tubes to enter the user’s bloodstream.
The FDA notice letter states that the agency has not received any adverse event report involving PCB or PCBA exposure from a Fresenius hemodialysis machine. This is hardly reassuring, however, since it seems very unlikely that the user (or their doctor) would have any way of knowing that their hemodialysis machine exposed them to these harmful toxins. Even if the patient displayed physical symptoms of exposure, linking these symptoms to a previously unknown defect in a hemodialysis machine would be impossible.
The FDA is continuing to collaborate with Fresenius on how to best address the problem. Based on preliminary reports and testing, it appears that the potential for exposure to harmful chemicals is higher during the first few months that the Fresenius machine is in use. Further testing and analysis is still being performed by the FDA and Fresenius.
Potential Health Consequences of Exposure to NDL PCBs and PCBAs
The harmful chemicals that users of the Fresenius hemodialysis machines may be exposed to are NDL PCBs and NDL PCBAs. These chemicals are a byproduct of certain chemical manufacturing processes and they are known to present a risk of harm to humans and animals. Animal lab testing has found that exposure to these particular chemicals can cause dysfunction of the endocrine system, live and kidney problems, and neurologic disorders.
Fresenius Dialysis Machine Lawsuits
This public warning notice from the FDA indicates that the hemodialysis machines from Fresenius Medical Care are defective and potentially dangerous to the user. Our firm is currently evaluating Fresenius dialysis machine lawsuits. If you used a Fresenius hemodialysis machine and were subsequently diagnosed with a health condition involving your endocrine system (the glands which regulate your hormones), problems with your liver, and/or neurologic conditions, you may potentially have a product liability case against Fresenius.
Prior Lawsuits Involving Fresenius
Fresenius Medical Care, one of the largest providers of dialysis treatments in the United States, owns and operates thousands of clinics as well as manufactures many products used during dialysis treatment. In November 2011, Fresenius conducted an internal review of the use of Granuflo and NaturaLyte, products used during hemodialysis, not only in their clinics but in other dialysis centers across the country. During the internal review, Fresenius identified at least 941 instances in which patients suffered cardiac arrest during treatment in 2010. The company issued a warning memo to the doctors within their clinics but did not inform outside clinics that used their products. In March 2012, the memo was leaked to the FDA and pushed Fresenius to provide a warning to all health care providers. The FDA classified the issue as a NaturaLyte and Granuflo Recall. There are currently at least 188 complaints in the MDL, and that number is expected to increase to the thousands as product liability lawyers review Fresenius’s lawsuits. The cases involve similar allegations: sudden cardiac arrest, heart attack, or death after Granuflo or NaturaLyte dialysis treatments. The plaintiffs’ attorneys have alleged that Fresenius withheld information from consumers about the possible risk of problems during dialysis with their Granuflo and NaturaLyte products. According to the suits, both products contain sodium acetate that converts bicarbonate at levels that were just not safe.
Getting Counsel For Your Case
If you or someone you love experienced cardiac arrest, heart attack, or death after undergoing dialysis using NaturaLyte or Granuflo, protect your rights. Call us at 800-553-8082 or talk to us online. There is no fee or cost for you in pursuing your claim unless you win a recovery. – See more here. For More Information:
- Fresenius Granuflo and NaturaLyte Lawsuit – April 2013
- Granuflo and NaturaLyte Lawsuit Information