GranuFlo Recall Linked to Heart Attack Lawsuits

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Resource4thePeople follows up on FDA Class 1 Recall of GranuFlo, NaturaLyte

Resource4thePeople is now offering referrals to attorneys who are filing lawsuits on behalf of victims of cardiac problems stemming from side effects from the use of GranuFlo and NaturaLyte dialysis products.

The action comes in the wake of a Class 1 Recall of the products issued by the Food and Drug Administration. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.*

The New York Times followed up on the recall by confirming with an FDA official that the agency is investigating whether German-based Fresenius Medical Care, described as the nation’s largest operator of dialysis centers, was aware of these dangerous side effects and failed to warn consumers.** If this is proven it would be a violation of FDA regulations, the official said.

The newspaper described the company's dominance of the dialysis industry by noting that it treats over one-third of about 400,000 men and women in the country by administering NaturaLyte and GranuFlo for the treatment of acute and chronic rental failure.

Resource4thePeople notes that NaturaLyte and GranuFlo heart attack lawyers have filed lawsuits claiming that GranuFlo and NaturaLyte products have caused kidney dialysis patients to suffer heart attacks, sudden cardiac death, or other catastrophic heart problems because of their treatment with the products.

Typical of the allegations are those contained in a suit (12cv1046 Southern District of Ohio) recently filed by the family of an Ohio man who died of cardiac arrest while receiving dialysis treatment at a Fresenius center.***

These attorneys are offering free consultations in which the cases are being evaluated for these victims. There may be legal time limits involved in filing GranuFlo and NaturaLyte lawsuits so the lawyers are recommending that contacts be made as soon as possible in order to preserve all legal options to obtain compensation for lost wages, medical expenses and other costs that may have been suffered in such cases.

The Times reported that Fresenius’s medical office sent an internal memo to doctors practicing in the company’s dialysis centers, warning them that failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.

According to the Times story, Fresenius issued an internal memo about the heart attack dangers associated with the products to its own dialysis centers but did not simultaneously inform other, non-Fresenius clinics about these problems.

It was only after an anonymous sender provided the FDA with a copy of the memo that Fresenius notified the other clinics, according to the report.

“Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern,” Steven Silverman, director of compliance for the FDA’s medical devices division, told the Times in an interview. The paper also reported these details of its investigation:

" Silverman said the agency could issue a warning letter to Fresenius if it determined the company should have reported the safety concerns. But even if the company had no legal obligation, he said, 'Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.'

Dr. Thomas F. Parker III, chief medical officer at Renal Ventures, a dialysis chain that uses Fresenius products, agreed. 'If the data was sufficient to warn their doctors, then all users of the product should have been made aware of it,' he said."

The Times also included this information in its report:

"The Fresenius memo, dated Nov. 4, found that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010. By comparing these patients with others, the company’s medical staff concluded that patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels."

The language from the FDA's Class 1 Recall raises these significant concerns about the safety of NaturaLyte and GranuFlo:

"The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius' Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death."

The FDA also noted that Fresenius sent an Urgent Product Notification to their clinics and customers. This notification provided clinicians with prescribing information regarding the NaturaLyte Liquid and GranuFlo Acid Concentrate.

The FDA also asked health care professionals and consumers to report adverse reactions or quality problems they experienced using these products.

Resource4thePeople is also advising dialysis patients to be aware of the following FDA recommendations to health care providers in connection with the Class 1 Recall:

  •     Be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels > or = to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients.
  •     Before writing the bicarbonate component of the dialysate prescription or using dialysate concentrates:

o    Review the dialysate acid concentrate labeling for the specific concentrate that you prescribe or use to determine the components that can contribute to the patient’s bicarbonate level. The levels of acetate, citrate and/or acetic acid vary by product and manufacturer.

o    Be sure to understand how your specific hemodialysis device proportions (mixes) the acid and base concentrates.

o    Be aware that some dialysate acid concentrates contain acetate, citrate and acetic acid level combinations up to 8 mEq/L, and some products may contain both acetate and acetic acid.

  •     Discuss laboratory results with your patients as appropriate.





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W.J. Callahan
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