Internal company memos were leaked to the FDA
By Sylvia Hsieh
The Daily Record Newswire
BOSTON — Litigation over the dialysis product GranuFlo is underway, months after the Food and Drug Administration recalled the product amid concerns that it can cause cardiac arrhythmia, which in some cases has led to sudden death.
One of the first cases filed alleges that Robert Davis Juba went in for a routine dialysis appointment on Oct. 12, 2010, went into cardiac arrest and died while connected to the dialysis machine.
His widow is suing Fresenius Medical Care, a German company with U.S. headquarters in Waltham, Mass., the largest manufacturer of dialysis equipment and products and the owner and operator of an estimated 1,600 dialysis clinics in the U.S.
Only a handful of cases have been filed so far, but lawyers say they expect to file more in the coming months.
Kristian Rasmussen, an attorney at Cory, Watson, Crowder & DeGaris in Birmingham, Ala., who filed the first case in the country in August, has conducted more than 1,000 intakes of potential clients.
Walter, who practices at Kelley Bernheim Dolinsky in Boston, represents 100 families and estimates that the total number of claimants will be 5,000 to 10,000.
New concentrated formula
GranuFlo is a powder concentrate of a solution used to cleanse and remove waste from the blood during kidney dialysis.
According to plaintiffs’ attorneys, Fresenius created GranuFlo to replace a liquid solution that was more costly to store and ship in large drums.
“They came up with a drug in granular form that clinics can add water to on the premises,” said Kelley.
The lawsuits allege that GranuFlo has twice the acetate the previous liquid solution. As a result, they claim that when it’s used in dialysis, it causes a patient’s blood to become too alkaline, spiking the blood’s pH and throwing off the patient’s heart rhythm.
“Part of the goal of dialysis is to keep the blood’s pH neutral,” said Dr. F. Philip Robin, an attorney at Kolsby Gordon Robin Shore & Bezar in Philadelphia, who is also a doctor. His firm has signed up over a dozen clients.
According to the lawsuits, GranuFlo and NaturaLyte, another concentrated solution in liquid form, contain more acetate than other products and the liver converts that acetate to bicarbonate, upsetting the pH in the blood.
On March 29, the FDA conducted a Class 1 recall of GranuFlo and NaturaLyte, stating that the high bicarbonate level is associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which may culminate in cardiopulmonary arrest.
Plaintiffs’ attorneys allege that Fresenius knew about the risks of the higher bicarbonate levels but did nothing about it, such as warning clinics to change the measurements to make up for the excess bicarbonate.
Lawyers disagree over whether there is a defective product claim.
“This is not one of those cases alleging the product is defective on its face. It’s really a failure to give instructions and warn that this is a new preparation,” said Robin. “It’s not like it’s inherently harmful. You could still use it as long as everyone is educated. The FDA recalled it because nobody knew how to change the settings on the machine [to account for the higher bicarbonate levels].”
But other attorneys say they will allege that the product is defective.
“We believe the product itself is defective because it contains twice the bicarbonate,” said James Klick, an attorney at Herman, Herman & Katz in New Orleans.
Plaintiffs say any defense argument that doctors should have known how to recalibrate according to the new concentrated powder form will be difficult for Fresenius to make given that its own clinics had problems with the formulas.
Leigh Anne Hodge, an attorney for Fresenius, did not return a call seeking comment for this article.
Statute of limitations
Shortened statutes of limitations may necessitate stepped up advertising for clients and filing of cases, as well as jurisdiction selection.
“Unfortunately, most states have a strict statute of limitations for death cases,” said Rasmussen, who noted that Florida, for example, has a four-year statute of limitations for personal injury but a two-year limit for wrongful death claims and no discovery rule.
Kelley, who has filed a case in state court in Massachusetts, said that Massachusetts has a favorable wrongful death statute along with being the corporate headquarters of Fresenius.
“Massachusetts has a three-year statute of limitations with the discovery rule,” he said. “If a patient died in 2010 but the spouse has no idea [about the connection to GranuFlo] until the recall in March 2012, they could be foreclosed in a state with a two-year statute of limitations. But in Massachusetts, it’s three years from when the spouse discovered the connection between Fresenius’ product and the death.”
Leaked memos
Internal company memos anonymously leaked to the FDA suggesting the company knew about problems with the product are already providing ammunition for plaintiffs’ attorneys.
In 2010, after 941 patients experienced cardiac arrest at 667 Fresenius-owned clinics, the company warned its own clinics to halve the acetate value when using GranuFlo concentrate.
The company issued an internal memo on Nov. 4, 2011 to all of its dialysis centers, stating that the elevated bicarbonate levels carry a “6 to 8-fold greater risk of cardiopulmonary arrest and sudden cardiac death.”
The lawsuits charge that the company failed to warn about the risks, and when it did, it warned only its own clinics.
“The company knew that patients who used GranuFlo and NaturaLyte had a 6-8 times [greater] risk of heart attack but what did they do with this? They sat on it for 10 months,” said Rasmussen. “Finally a doctor who has now left the company distributed a six-page memo to all of their [own] clinics, but not to 2,800 other clinics using their products.”
In addition to finding leaked memos, plaintiffs’ lawyers have culled information from the website RenalWeb, a portal for all information on dialysis.
Plaintiffs’ attorneys say the serious injuries and deaths, combined with the internal memos showing the company knew about the product’s risks add up to high damages.
Klick said what the company knew opens the door to punitive damages in these cases.
Rasmussen agreed.
“The liability picture in these cases — just from information that is in the public domain — is stronger than any case I’ve seen,” he said.
