“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall.” These words from Acting United States Attorney Jonathan Lenzer merely scratch the surface of the horrors inflicted on unwitting patients by a company that
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St. Jude to Settle Defibrillator Allegations for $27 Million
Posted July 27, 2021 in Drug and Medical Device Lawsuits | Product News and Recalls
At-home dialysis helps quality of life
Posted December 11, 2013 in Granuflo Recall Lawsuit | Health | Legal Issues | Product Liability | Product News and Recalls
The East Montgomery County Observer tells the story of a 27-year-old man with kidney failure, whose quality of life was greatly improved when he began using a portable, in-home dialysis system.
He previously had to make a long drive and arrive at a dialysis center at 5 a.m. in order to finish the 4-hour treatment, then make it to work on time. Doctors told him that routine would be necessary three ...
continue reading...Pattern still sought for deadly dialysis center infections
Posted July 18, 2013 in Granuflo Recall Lawsuit | Health | Product Liability | Product News and Recalls
AL.com reports that a dialysis center in Bessemer, Alabama, remains shut down, but investigators have yet to identify a specific cause or pattern for the infections that killed two patients and hospitalized several others in May.
Although a laboratory analysis by the U.S. Centers for Disease Control and Prevention recovered six different bacteria from blood cultures of patients who were sickened, no pattern indicating a specific cause has been established.
The center’s ...
continue reading...Experts: Dialysis not always best option for older patients
Posted June 26, 2013 in Granuflo Recall Lawsuit | Health | Product Liability | Product News and Recalls
A federal law dating to the 1970s provides virtually free dialysis to anyone suffering from kidney failure, according to a story in the New York Times. But renal experts are trying to encourage doctors to give older kidney failure patients, many of whom suffer from other ailments, a more realistic assessment of how much the procedure is likely to help them.
According to the story, recent studies have concluded that not ...
continue reading...Closed Fresenius dialysis center had history of problems
Posted June 19, 2013 in Granuflo Recall Lawsuit | Health | Product Liability | Product News and Recalls | Recall
A dialysis center that was shut down in Bessemer, Alabama, following the infection-related deaths of two patients has a prior history of health violations, according to a report on Al.com.
In a report about a year ago, the Alabama health department cited the clinic over multiple infection-control deficiencies. In one of those cases, a patient was hospitalized.
The clinic’s owner, German company Fresenius, has previously been accused of subjecting patients to continue reading...
For-profit dialysis centers used more dangerous drugs
Posted June 15, 2013 in Drug and Medical Device Lawsuits | Granuflo Recall Lawsuit | Health | Legal Issues | Product Liability | Product News and Recalls
An analysis of for-profit kidney dialysis centers published in the medical journal JAMA Internal Medicine found that they used more of an expensive and dangerous class of drugs known as erythropoiesis-stimulation agents (ESAs) than non-profit facilities.
This isn’t the first time that commercial dialysis centers have been accused of engaging in unsafe practices.
The U.S. Food and Drug Administration is investigating allegations that Fresenius, a German company that is the largest operator ...
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