Kidney dialysis lawsuits have moved on several distinct tracks: product liability claims over acid concentrates and equipment, federal fraud and kickback cases, a foreign bribery prosecution, antitrust actions, insurance-steering and reimbursement disputes, individual malpractice claims, and challenges to Medicare payment rules. The biggest cases have targeted Fresenius Medical Care and DaVita — the two companies that together operate roughly 75 to 80 percent of U.S. outpatient dialysis clinics — and have produced settlements and verdicts reaching into the hundreds of millions of dollars.
GranuFlo and NaturaLyte Product Liability
The largest single wave of dialysis litigation involved GranuFlo and NaturaLyte, acid concentrate products Fresenius manufactured for use in hemodialysis machines. Plaintiffs alleged that excess acetate in GranuFlo caused metabolic alkalosis, which in turn could trigger low blood pressure, cardiac arrhythmia, and sudden cardiac arrest. A 2011 internal Fresenius memo had identified a link between elevated pre-dialysis bicarbonate levels and cardiopulmonary arrest, and the FDA issued a Class I recall of GranuFlo acid concentrate on March 29, 2012.
The cases were consolidated as MDL No. 2428 in the U.S. District Court for the District of Massachusetts. At its peak the MDL held more than 4,500 lawsuits alleging fraud, negligence, breach of warranty, failure to warn, and wrongful death.
In February 2016, Fresenius proposed a $250 million global settlement, contingent on 97 percent of plaintiffs agreeing by that July. Insurers funded $220 million of the total; Fresenius took a $60 million pre-tax charge for its share and associated costs. The company maintained throughout that GranuFlo and NaturaLyte were safe and effective and made no changes to the products’ composition.
Not every case settled. In a March 2017 bellwether trial, a Massachusetts federal jury found for Fresenius, concluding plaintiffs had not proven the product was the proximate cause of a patient’s death. In July 2018, however, a federal jury in Colorado returned a $383.5 million verdict against DaVita in three wrongful death cases involving patients who died of cardiac arrest after dialysis treatments using GranuFlo. Each family received $125 million in punitive damages plus compensatory damages ranging from $1.5 million to $5 million. The MDL itself closed in October 2023.
Healthcare Fraud and Kickback Settlements
Both of the dominant dialysis companies have paid large sums to resolve allegations of defrauding federal healthcare programs.
In January 2000, Fresenius Medical Care, acting through its predecessor National Medical Care, agreed to pay $486 million to settle federal civil and criminal fraud charges — at the time the largest healthcare fraud settlement in U.S. history. Three company divisions pleaded guilty to criminal conspiracy involving false laboratory claims, illegal kickbacks tied to blood testing orders, and obstruction of government agencies. Two executives pleaded guilty to felony charges. The deal included $385 million in civil recoveries under the False Claims Act and $101 million in criminal fines.
DaVita reached a similar resolution in 2014, agreeing to pay $350 million to settle allegations that it violated the False Claims Act by paying kickbacks to physicians for patient referrals. The underlying whistleblower suit, United States ex rel. David Barbetta v. DaVita, Inc., was filed in 2009 by a former senior financial analyst in DaVita’s mergers and acquisitions group. He alleged DaVita sold joint-venture shares to doctors at below-market prices, bought physician-owned shares back at inflated rates, and disguised kickbacks as profit distributions. The settlement included a $39 million civil forfeiture and a Corporate Integrity Agreement requiring DaVita to unwind certain physician arrangements and accept an independent compliance monitor.
Fresenius Foreign Bribery Case
In March 2019, Fresenius agreed to pay more than $231 million to resolve parallel SEC and DOJ investigations into Foreign Corrupt Practices Act violations. The SEC found that between 2007 and 2016, Fresenius used sham consulting contracts, falsified records, and third-party intermediaries to funnel roughly $30 million in bribes to government officials in Saudi Arabia, Morocco, Angola, Turkey, Spain, China, and eight West African countries. The company earned more than $140 million in profit from the schemes.
The resolution included $147 million in disgorgement and interest to the SEC and an $84.7 million criminal fine under a DOJ non-prosecution agreement. Fresenius was required to retain an independent compliance monitor for two years. The SEC said senior management had directed employees to destroy records and that the company had ignored corruption red flags going back to the early 2000s.
Antitrust Cases
The concentration of the dialysis market has drawn both criminal and civil antitrust actions.
In 2021, the DOJ charged DaVita and former CEO Kent Thiry with criminal antitrust violations, alleging they conspired with other healthcare companies on no-poach agreements covering senior employees between 2012 and 2017. The case was tried in April 2022 in the U.S. District Court for the District of Colorado. A jury acquitted both DaVita and Thiry on all counts, finding the government had not proven the agreements were anticompetitive. The prosecution had been a high-profile test of the DOJ’s 2018 policy of pursuing no-poach agreements criminally.
A civil class action filed in September 2025, United Food and Commercial Workers Local 1776 v. DaVita Inc. et al., alleges a far broader conspiracy. The complaint claims DaVita and Fresenius ran a decade-long scheme to fix private-pay prices, reduce treatment quality, and divide geographic territories, operating as a “de facto duopoly” that controls about 80 percent of outpatient clinics and more than 90 percent of market revenue. Both defendants have moved to dismiss, arguing the pricing patterns reflect ordinary competition in a concentrated market. No ruling has been reported.
Separately, the Federal Trade Commission opened an investigation in early 2024 into whether DaVita and Fresenius use noncompete clauses in medical director contracts to keep physicians from working for competitors or opening new practices.
Equipment Recalls
Fresenius’s 2008 Series hemodialysis machines became the subject of a Class I FDA recall after the agency determined that silicone tubing in the machines could leach non-dioxin-like polychlorinated biphenyl acids into dialysate fluid during treatment. Potential health effects identified by the FDA included endocrine dysfunction, liver problems, neurobehavioral changes, skin conditions, and male infertility.
The FDA first communicated the risk in May 2022. Fresenius began a correction in November 2022, offering free replacement tubing manufactured through a platinum-cured process. The FDA formally classified the recall in October 2023 and sent an urgent correction letter to customers that September. The recall covered 207 machines in the United States manufactured between August 2008 and June 2022. No deaths were reported.
In a separate action beginning in January 2024, Fresenius recalled nearly 2.2 million Stay-Safe catheter extension sets and adapters over similar leaching concerns, particularly for patients weighing under 40 kilograms. No injuries or deaths were reported in connection with that recall.
Insurance Steering and Reimbursement Disputes
A recurring legal fight involves allegations that DaVita and Fresenius steer dialysis patients away from Medicare and toward private insurance plans that reimburse at rates three to six times higher. Insurers, unions, and consumer advocates have alleged that the companies donate to the American Kidney Fund, which then provides premium assistance helping patients enroll in private marketplace plans. The American Kidney Fund had a 2023 operating budget of $349 million, with 86 percent of that total coming from just two anonymous donations totaling $301 million, according to a University of Southern California analysis. The dialysis companies and the American Kidney Fund have denied the steering allegations.
California tried to curb the practice through Assembly Bill 290, signed by Governor Gavin Newsom in 2019, which capped reimbursement rates for patients receiving charitable premium assistance at Medicare levels and required charities to disclose patient identities to insurers. In 2026, the Ninth U.S. Circuit Court of Appeals struck down the law’s core provisions, ruling that the reimbursement cap and disclosure requirements violated the First Amendment by burdening the American Kidney Fund’s right to associate with the dialysis providers. A district court had earlier invalidated the provision banning clinics from steering patients to specific insurance options, finding the state had not shown such steering was occurring.
The U.S. Supreme Court addressed a related question in June 2022. In Marietta Memorial Hospital Employee Health Benefit Plan v. DaVita Inc., the Court ruled 7-2 that private employer health plans may designate all dialysis facilities as out-of-network without violating the Medicare Secondary Payer Act, so long as the network restrictions apply to every plan member equally. The decision cleared the way for employers to reduce dialysis reimbursement rates. Researchers have warned the ruling could threaten smaller and rural dialysis facilities and push patients onto Medicare faster.
Patient Care and Malpractice Claims
Individual dialysis malpractice suits arise from a range of clinical errors. Vascular access complications, especially those tied to central venous catheter insertion, are the most frequent basis for litigation. A study of hemodialysis malpractice cases found vascular access issues accounted for more than half of all claims, with catheter insertion problems involved in roughly 43 percent of cases where courts recognized malpractice. Other grounds include infections from improperly sterilized equipment, use of incorrect dialysate solutions, inadequate patient monitoring, and machine malfunctions.
In November 2025, a proposed class action was filed in California against DaVita alleging the company systematically pressured patients into at-home peritoneal dialysis to boost profits and capture government incentives. The complaint in Sanchez v. DaVita, Inc. alleges DaVita staff used a sales program called “MATCH-D” with quotas, leading to patients being coerced through exaggerated claims and without adequate disclosure of risks including peritonitis, hernias, and potential negative effects on kidney transplant eligibility. The proposed class covers all current and former California DaVita patients who received peritoneal dialysis in the preceding ten years. No ruling or settlement has been reported.
Medicare Payment Rule Challenge
In July 2024, the pharmaceutical company Ardelyx, the American Association of Kidney Patients, and the National Minority Quality Forum sued to block a CMS decision folding oral-only phosphate-lowering drugs into the End-Stage Renal Disease bundled payment system beginning in January 2025. Plaintiffs argued the move violated the Medicare Improvements for Patients and Providers Act and would restrict patient access to newer medications by removing them from Medicare Part D coverage. In November 2024, Judge Beryl Howell of the U.S. District Court for the District of Columbia dismissed the lawsuit, allowing the rule to take effect on schedule.
California Ballot Measures
The dialysis industry has repeatedly been targeted by California ballot initiatives, backed largely by the Service Employees International Union. Proposition 8 in 2018, the “Fair Pricing for Dialysis Act,” would have capped clinic revenue at 115 percent of allowable costs; it failed with 60 percent of voters opposed. Proposition 23 in 2020 would have required a licensed physician on-site during all clinic operating hours and mandated quarterly infection reporting; it also failed. DaVita and Fresenius spent heavily against both measures. Proponents alleged the two companies took in combined annual profits of $350 million in California and spent at least $100 million on lobbying in 2018 and 2019 alone.