|September 28, 2012|
Previously published on September 27, 2012
The U.S. Food and Drug Administration (FDA) recently recalled dialysis products GranuFlo and NaturaLyte. Both products, manufactured by Fresenius Medical Care, were hit with a Class 1 recall, the most serious type of recall, on March 29, 2012. Studies have shown that the use of these two products can lead to cardiopulmonary arrest and possibly death when bicarbonate levels become too high.
On a lesser scale, the repeated use of these dialysis products can cause other health problems, metabolic alkalosis, low blood pressure, or sudden heart attack or stroke. Currently, 59 percent of dialysis patient deaths are caused by cardiac arrest, compelling the medical community to more thoroughly research possible issues created by dialysis treatment.
Fresenius Medical Care (FMC) also opted to investigate the possible correlation between dialysis risk factors and the untimely deaths of many patients. Like many other investigations following the original findings in 2010, FMC determined that the vast majority of the patient deaths were the result of enlarged muscle walls in the left heart ventricle that become rigid and unable to pulse correctly due to excess fluid. This discovery led FMC to conduct further inquiries into their own products and a possible correlation between these enlarged and rigid muscles and the dialysis products sold by FMC.
In a six-page memo circulated internally at FMC on November 4, 2011, medical directors and physicians learned that their company had been conducting case-studies on patients for the entire 2010 calendar year. Not only had FMC been studying the issues with the products since 2010, the memo also referred to the efforts of the company to educate its staff and scientists since January 2011 without publicly informing patients or the FDA.
By releasing the internal memo to the public eleven months after its initial mailing, FMC quickly tried to explain its findings that 941 FMC patients with cardiopulmonary arrests had been linked. Through its investigations and findings, FMC had discovered that those patients had an elevated pre-dialysis bicarbonate level. According to the memo, this link puts the risk of these patients having cardiopulmonary attacks at almost six times higher than other patients.
The internal memo showed that FMC was aware of this particular risk, as well as the link between the risk and the company’s own GranuFlo and NaturaLyte dialysis products. In fact, this memo indicated to FMC’s doctors and facilities that action should be taken to prevent cardiopulmonary arrests in patients who had exhibited the raised pre-dialysis bicarbonate levels.
Unfortunately, FMC decided to retain that important warning and care directive for only its company-controlled facilities and physicians, although more than 10,000 other patients were receiving GranuFlo and NaturaLyte products at other care locations. Finally, on March 29, 2012, FMC decided to acknowledge and share this critical information to the rest of the public, five months after the damaging memo had leaked to the FDA. Even at the time, FMC opted not to share all its medical findings, choosing not to mention many of the crucial points about patient blood levels or at-risk populations covered in the original internal memo.
There is no indication that FMC attempted to contact the FDA about their discovered findings prior to the leak of the internal memo on November 4, 2011. Companies that fail to notify the FDA in the event of a known problem can face severe fines, product recalls, and possible prohibition from marketing further products. This has led to the recent recalls of GranuFlo and NaturaLyte. Patients who have taken and been injured by either of these two products may be eligible to receive legal compensation.