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By: Irvin Jackson | Published: August 10th, 2012
A product liability lawsuit has been filed against Fresenius Medical Care, the largest provider of dialysis services in the United States, alleging that the company knew that use of its Granuflo and NaturaLyte hemodialysis products were causing individuals to suffer heart attacks, cardiac arrests and sudden death, but failed to warn the medical community.
The wrongful death complaint (PDF) was filed by Arthurine Williams, whose husband, Johnny Williams, died in 2010 after receiving dialysis treatment.
The lawsuit was filed in the U.S. District Court for the Northern District of Alabama on July 27, naming Fresenius, Inc. and its subsidiaries as defendants, as well as DaVita, Inc., which ran the dialysis clinic where Williams received treatment with Granuflo and NaturaLyte.
Johnny Williams began receiving hemodialysis treatment at DaVita Ensley dialysis clinic in Birmingham, Alabama, on July 28, 2010, according to the complaint. The treatment included the use of GranuFlo and NaturaLyte; acid concentrates that are manufactured by Fresenius for use during the hemodialysis process. Williams died of a sudden heart attack on July 29, 2010.
Arthurine Williams alleges that the death of her husband was caused by side effects of NaturaLyte and GranuFlo, and that Fresenius Medical Care knew or should have known about the risk of heart problems from the hemodialysis treatments and failed to disclose that information to doctors and dialysis clinics using their products.
According to the complaint, the company has known about GranuFlo and NaturaLyte heart problems for years, but kept those problems under wraps.
Fresenius Dialysis Treatments Used At Clinics Throughout U.S.
Fresenius Medical Care is the largest chain of dialysis treatment centers in the United States, operating 1,600 dialysis clinics. However, the company is also a major supplier of dialysis drugs and equipment used at competing centers.
In November 2011, Fresenius issued an internal memo to its own facilities warning that inappropriate prescription of the dialysis drugs could result in a high sodium bicarbonate level, which can cause metabolic alkalosis. This can lead to a heart attack or death for dialysis patients. However, the memo did not go out to the other dialysis centers that use Fresenius products until March, leaving them uniformed about the possible risks to their patients for months.
The FDA decided that the warnings constituted a Class I medical device recall for Granuflo and Naturalyte, which means the agency believes the products are likely to cause severe injury and death.
In response to the problems, the FDA issued a safety communication in May 2012, warning about the risk of dosing problems during hemodialysis treatments with Granuflo and NaturaLyte, and urging doctors to consider the impact of the acetate levels in these dialysate concentrates when ordering or administering hemodialysis treatments.
An internal analysis by Fresenius has found at least 941 instances where individuals suffered a cardiopulmonary arrest within their dialysis centers between January 1, 2010 and December 31, 2010.
According to the complaint, it became irrefutably evident to Fresenius by 2010, but top executives chose not to properly report these complications or Granuflo risks and withheld important information in an attempt to maintain their market share and diffuse the legal risks.
Arthurine Williams accuses the defendants of strict liability, failure to warn, breach of warranty, fraud, negligence, wrongful death, unjust enrichment, and accuses Fresenius of wantonly and recklessly making and selling NaturaLyte and GranuFlo in spite of knowing the dangers of the two drugs. The lawsuit seeks both compensatory and punitive damages.
The complaint is believed to be the first dialysis treatment lawsuit filed against Fresenius Medical Care since information about the risk of heart problems from Granuflo and NaturaLyte has become widely reported.