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.
This post is part 2012 and part 2024 as we look back on this litigation, how it played out, and how much the Fresenius dialysis settlements were.
Fresenius Dialysis Machines Exposes 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.
Litigation Timeline
Thsi is a brief timeline of key events related to the Fresenius Granuflo lawsuits:
1. Product Introduction and Issues (2003 – 2011):
- 2003: Granuflo and NaturaLyte are introduced to the market by Fresenius Medical Care.
- 2010: Fresenius conducts an internal study and finds that patients treated with Granuflo have a higher risk of sudden cardiac arrest. This study is based on data collected from their own dialysis centers.
2. Internal Memo and FDA Involvement (2011 – 2012):
- November 2011: Fresenius sends an internal memo to its own dialysis centers, warning about the increased risk of cardiac arrest linked to improper use of Granuflo and NaturaLyte.
- March 2012: The memo is leaked to the FDA, which raises concerns about why Fresenius did not inform other dialysis centers and healthcare providers.
- May 2012: The FDA issues a Class I recall of Granuflo and NaturaLyte, citing the risk of high bicarbonate levels leading to cardiac arrest and other serious health issues.
3. Legal Actions and Settlements (2013 – Present):
- 2013: The first lawsuits are filed against Fresenius Medical Care. The core of everyone of these lawsuits was that the company failed to warn doctors and patients about the risks associated with Granuflo and NaturaLyte they knew or should have known about.
- 2014: Fresenius agrees to a $250 million settlement to resolve a significant portion of the lawsuits filed in the U.S. This settlement addresses claims that the company did not provide adequate warnings and instructions regarding the use of their products.
- 2016: Additional lawsuits continue to be filed, and settlements are reached in various cases. The legal battles also lead to increased scrutiny of the dialysis industry and the safety protocols for dialysis products.
What Happened in These Lawsuits?
In the 2014 global settlement, Fresenius Medical Care agreed to pay approximately $250 million to resolve thousands of claims. Based on this settlement, you can roughly guess that the average payout per plaintiff ranged from around $150,000 to $300,000, depending on the specifics of each case, including the severity of harm suffered and the strength of the evidence presented. Our firm never got deeply involved in this litigation.