Jody Ryerson
5 years ago
Fresenius, a prominent player in the field of dialysis, is currently facing scrutiny from the U.S. Food and Drug Administration (FDA) due to its prolonged efforts in addressing concerns related to its hemodialysis machines. In a recent warning letter issued in December, the FDA highlighted several violations related to Fresenius’ slow response to identifying […]
PCBs in Dialysis Machines
Fresenius, a prominent player in the field of dialysis, is currently facing scrutiny from the U.S. Food and Drug Administration (FDA) due to its prolonged efforts in addressing concerns related to its hemodialysis machines. In a recent warning letter issued in December, the FDA highlighted several violations related to Fresenius’ slow response to identifying potentially harmful chemicals in the silicone tubing of these machines.
The FDA’s stern warning stated that Fresenius failed to take corrective and preventive action until nearly two years after being alerted to a potential problem with its Hemodialysis Machines, which contained peroxide crosslinked silicone tubing. Furthermore, the company neglected to thoroughly investigate the potential health impacts of polychlorinated biphenyl (PCB) related compounds leaching from the machine components and failed to document their first awareness of these PCB related compounds.
The timeline of events is particularly concerning. Fresenius first became aware of the issue with its silicone tubing in December 2020, but corrective action was not initiated until November 2022. An official recall was only posted on the FDA’s website nearly a year later, in October 2023. In the interim, the FDA issued a warning to healthcare providers in March 2023, cautioning them about the potential impact on other dialysis machines. During this period, the FDA worked with device manufacturers to collect data, although definitive information on the risks was lacking at that time.
The FDA’s initial involvement in May 2022 occurred when it notified healthcare providers about the potential exposure of patients to non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) and NDL polychlorinated biphenyls (NDL-PCBs) from Fresenius’ 2008-series hemodialysis machines. The FDA pointed out that these harmful substances were leaching from the silicone tubing used in the machine’s hydraulics and dialysate lines. It is important to note that no adverse events were reported at that time.
In response to these findings, Fresenius issued a “field notification” around the same time. However, according to the FDA’s most recent warning letter, the company had been aware of the issue for a year and a half by that point, dating back to December 2020.
Fresenius’ stance, as communicated through testing to meet International Organization for Standardization (ISO) standards, was that unused 2008-series machines posed the greatest risk. Toxicologists determined that there were no detectable levels of NDL-PCBAs in dialysate specimens from machines in use for over 30 days, suggesting that the risk decreased rapidly after initial exposure. Fresenius concluded that these chemicals did not pose an immediate risk to patients’ health, considering the substantial chronic hemodialysis patient population requiring frequent treatment.
Despite this assertion, Fresenius took precautionary measures, including replacing peroxide catalyst silicone tubing with platinum catalyst tubing and recommending the replacement of Fresenius machines in use for less than a month. The company also committed to additional testing and the development of a protocol for extra “pre-use rinsing” of new machines and replacement parts.
The FDA “cleared” the updated platinum catalyst silicone tubing for use in October 2022 after no chemicals were detected in the modified tubing. Platinum curing is a more recent and costly process compared to peroxide curing, with the advantage of not producing leachable by-products.
PCBs are persistent and bioaccumulate, categorized as “forever chemicals,” with known carcinogenic properties. While less is known about NDL-PCBs compared to DL-PCBs, the European Union (EU) places limits on NDL-PCB content in livestock, acknowledging their potential to cause adverse health effects.
In March 2023, the FDA informed healthcare providers of other dialysis systems with parts made of chlorinated peroxide cured silicone, though the agency could not confirm any risk of exposure to NDL-PCBAs or NDL-PCBs at that time. Collaborating with manufacturers, the FDA aimed to gather more data to assess the risks to patients.
The FDA’s Class I recall notice in October 2023, nearly three years after Fresenius first learned of the issue, applied to 2008 series Fresenius dialysis machines, emphasizing that it was a correction, not a product removal. According to the FDA, 207 devices were affected, primarily those in use for less than 36 days or 486 total hours.
The FDA’s warning about the use of affected machines highlighted potential serious health consequences, including endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), and male infertility. Notably, there were no reported deaths. The notice also mentioned that Fresenius had previously sent an “Urgent Medical Device Correction letter” to affected customers in September 2023.
An important development highlighted in the FDA’s warning letter was Fresenius’ adoption of platinum cured silicon tubing in its new machines without formal notification to the FDA. In response to the FDA’s concerns, Fresenius stated its commitment to address the issues raised in the warning letter and to provide comprehensive information to demonstrate regulatory compliance and commitment to quality.
Individuals who have suffered harm due to Fresenius’ dialysis machines and the PCB-related issues may have grounds to file a product liability lawsuit to seek compensation for their damages. Understanding the legal process and the importance of an attorney at each stage is vital for those seeking justice.
When pursuing a product liability lawsuit due to injuries caused by a defective product, victims must navigate a multifaceted legal process. Here is a step-by-step overview of how victims can seek compensation through legal action:
Consultation with an Attorney: The initial and crucial step for victims is to consult with an experienced product liability attorney. These cases often involve intricate legal and medical aspects that demand specialized knowledge. During the initial consultation, an attorney will listen to the victim’s account of the incident, assess the circumstances surrounding the injury, and evaluate the viability of a lawsuit. The attorney will also explain the potential legal options available to the victim based on the facts presented.
Investigation and Gathering Evidence: Attorneys play a pivotal role in thoroughly investigating the case. They will diligently collect evidence aimed at establishing the product’s defect, negligence, or failure to provide adequate warnings. This investigative phase may involve a detailed examination of the product’s history, testing results, manufacturing processes, and any communications between the manufacturer and regulatory agencies. The goal is to build a robust case supported by compelling evidence.
Determining Liability: Product liability lawsuits frequently involve multiple parties who may share liability, including manufacturers, distributors, retailers, and sometimes even regulatory agencies. An experienced attorney will help victims identify who bears responsibility for their injuries and work to construct a strong case against these parties. Determining liability is a critical aspect of the legal process and requires careful examination of the roles played by each entity within the supply chain.
Negotiation and Settlement: Attorneys will engage in negotiations with the at-fault parties or their insurance companies on behalf of the victim. During this phase, attorneys will work diligently to reach a fair and just settlement that adequately compensates the victim for their losses. This compensation may encompass various types of damages, such as medical expenses, lost wages, pain and suffering, and even future healthcare costs. Negotiating a satisfactory settlement is often the preferred outcome to avoid protracted litigation.
Litigation if Necessary: In cases where a satisfactory settlement cannot be achieved through negotiations, the lawsuit may proceed to litigation. In these instances, an attorney will represent the victim in court, presenting a compelling case supported by evidence, witnesses, and expert testimony to substantiate the claim. The litigation phase is where legal arguments are presented, and the case is ultimately decided by a judge or jury.
Recovering Damages: In the event of a successful product liability lawsuit, victims can recover various types of damages. These include economic damages, such as medical bills and lost income, non-economic damages like compensation for pain and suffering, and, in some cases, punitive damages intended to penalize the responsible party for their wrongful actions.
By following these steps and seeking the guidance of our experienced product liability attorneys, victims of defective products can pursue legal action to seek the compensation they rightfully deserve for their losses and suffering. Each case is unique, and a thorough legal approach is essential to achieve a favorable outcome.
If you or a loved one has suffered harm due to Fresenius’ dialysis machines or any other defective product, it is crucial to seek legal guidance from experienced attorneys who can navigate the complexities of product liability cases. Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products. For your free consultation, contact our national product liability law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
Regardless of your location or where your injury occurred, our nationwide personal injury law firm is ready to assist you.