GranuFlo, NaturaLyte Raises Cardiac Arrest, Mortality Risks

GranuFlo and NaturaLyte, two dialysis medications manufactured by leading dialysis treatment provider Fresenius Medical Care (FMC), have been reportedly linked to a six-fold increase in the risk of cardiac arrest, and a greater mortality risk among patients, according to online news reports. These potential health repercussions have reportedly prompted the United States Food and Drug Administration to issue a Class I recall notice on products manufactured and sold from January 2008 through June 2012, which may have also consequently harbored a growing number of dialysis injury lawsuits brought against FMC.

Generally, dialysis medications are concurrently used with a dialysis machine, and another substance known as bicarbonate in a hemodialysis treatment, medical experts say. However, these products, when inappropriately prescribed, have been reported to cause considerably elevated levels of bicarbonate in the blood. This in turn may lead to metabolic alkalosis, a major risk factor of high or low blood pressure, and cardiac arrhythmia, which when not addressed promptly may precipitate cardiac arrest, or worse, death. The federal agency advises nephrology experts to take utmost precaution in their doses to possibly avoid these potentially irrevocable adverse effects.

Sources:

nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0
drugs.com/fda/dialysate-concentrates-hemodialysis-safety-communication-alkali-dosing-errors-13138.html

Stryker Wins $70 Million In Infringement Case Against Zimmer

Stryker Corporation won $70 million over patent infringement lawsuit against fellow medical equipment company, Zimmer Holdings Inc. in U.S. District Court in Grand Rapids, court officials say. But while Stryker managed to win this case, however, it is facing a mounting lawsuits against one of its hip implant device, Stryker Rejuvenate recall.

The lawsuits consist of Zimmer’s Pulsavac products and Stryker’s Surgilav and InterPulse machines. These products are known as pulsed lavage irrigation system.

Surgeons use these devices to clear away blood and clean the bones as well during hip or knee replacement operation. In addition, they are also used to clean the wounds from bedsores and burns. These are hand-held, light-weight, and battery-operated.

Stryker Corporation said that they generated these products in the 1990s. On the other hand, Zimmer started creating their products just about 10 years ago. Although both products did not have the same names, as for the design and manufacturer, the resemblance is there, indicative that Zimmer had infringed on the patents by Stryker.

Zimmer is saddened with the decision and plans to appeal in due time, said a spokesperson from Zimmer.

Meanwhile, Stryker is thinking to pursue greater damages for the reason that Zimmer acted irresponsibly. This is another $210 million for Stryker if they will win. Moreover, Stryker may file an injunction so as to stop Zimmer to sell those products involved.

Sources:
mlive.com/business/west-michigan/index.ssf/2013/02/stryker_corp_wins_70_million_a.html
businessweek.com/news/2013-02-05/zimmer-told-to-pay-stryker-70-million-for-surgical-tool-patents