Posts Tagged ‘recall’

Lawyer Warns of Recall – Fresenius Granuflo Causing Heart Attack and Stroke

0 Lawyer Warns of Recall   Fresenius Granuflo Causing Heart Attack and Strokehttp://www.fresenius-dialysis-lawyer.com/

Fresenius, the German based medical and pharmaceutical manufacturing giant, have a 15 year history of warnings from the FDA,

The largest provider of dialysis equipment and chemicals and the largest US operator of dialysis clinics has received 7 warning letters stating that their products were adulterated or that their processes were in violation of FDA rules.

Most recently Fresenius has been in the news for failing to provide safe peritoneal dialysis and hemodialysis for both home and clinic patients.

While the failures were well documented in the FDA warnings, the actual recalls by Fresenius came too late for many. Injuries and deaths have occurred associated with the defective dialysis products. Medical product defect attorney Jeffrey Bowersox:

“Don’t underestimate corporate America’s willingness to sacrifice your safety to improve their bottom line profit. The sad reality is that there are products sold on a daily basis that cause serious, catastrophic even, injuries that continue to be sold.”

Fresenius also may have known since 2011 that the higher amount of acetate it was using in its dialytes Granuflo and Naturalyte were overloading patient’s bodies with bicarbonate, which led to a high incidence of heart attacks during and after dialysis. Fresenius even documented the danger in an internal memo dated November 4, 2011 but the company did not warn doctors or patients until March of 2012 that its Granuflo and Naturalyte dialysates were causing a potentially deadly residual bicarbonate level in dialysis patients across the US in both Fresenius owned clinics and non Fresenius clinics that bought the products. According to the 2011 Fresenius memo, 941 Fresenius patients suffered a cardio-pulmonary arrest after dialysis at their facilities during 2010, which represents a very large increase in heart attacks yet Fresenius did not warn customers until March 29th, 2012

“There’s money to be made in the medical device market. The longer they keep a product on the market with less oversight and less expense through regulation to assure safety the more money they make. “

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Fresenius Dailysis Products Recall – GranuFlo, NaturaLyte and Liberty Cycler Cassettes

0 Fresenius Dailysis Products Recall   GranuFlo, NaturaLyte and Liberty Cycler CassettesFresenius, the German based medical and pharmaceutical manufacturing giant, have a 15 year history of warnings from the FDA,

The largest provider of dialysis equipment and chemicals and the largest US operator of dialysis clinics has received 7 warning letters stating that their products were adulterated or that their processes were in violation of FDA rules.

Most recently Fresenius has been in the news for failing to provide safe peritoneal dialysis and hemodialysis for both home and clinic patients.

While the failures were well documented in the FDA warnings, the actual recalls by Fresenius came too late for many. Injuries and deaths have occurred associated with the defective dialysis products. Medical product defect attorney Jeffrey Bowersox:

“Don’t underestimate corporate America’s willingness to sacrifice your safety to improve their bottom line profit. The sad reality is that there are products sold on a daily basis that cause serious, catastrophic even, injuries that continue to be sold.”

The FDA has come down hard on Fresenius’ failures to warn for both the “Liberty” peritoneal dialysis machines which caused peritoneal infections due to leaks, and their hemodialysis solutions Granuflo and Naturalyte, reportedly responsible for an increase in patient heart attacks.

Fresenius did not sell an alternative non-defective product in either case. A warning or recall would have by necessity led to a significant drop in customer share and revenue.

Liberty peritoneal dialysis machines employed potentially leaky cassettes made 100% by a single supplier, Magnum. Hemodialysis treatments provided in Fresenius owned clinics across the US were dependent on the use of their dry and liquid form acid concentrates, Granuflo and Naturalyte.

Fresenius may have believed that in warning customers about the defects in these products, they would lose customers to competitors, since Fresenius customers would have no choice but to seek out rivals like Baxter for their life sustaining dialysis.

“One would expect that the market force would require a manufacturer to make a device that worked well and in fact worked better than its competitors in order to have a better share of the market. Unfortunately that’s just not the case. Our society is too large. There are no nearly eight billion people in the world, you don’t matter so much to any individual manufacturer. Really, you really don’t matter to them, you matter to your family, you matter to the people who love you. You’re just a source of revenue to most manufacturers.”

Fresenius may have known about each of the products dangers long before the FDA convinced Fresenius to mount a recall. In the case of the Liberty Cycler, Fresenius waited far too long to warn patients. An excerpt from an FDA warning letter states, ” …you failed to identify any actions to reduce the risk of Liberty Cassettes in commercial distribution,” “Your firm investigated 118 complaints from January 2001 through October 2009 of cassette leaks during patient hemodialysis treatments”

“Your firm identified a root cause, initiated shipping holds on existing inventory and ordered a product rework in November 2009, but failed to identify an action to address units in commercial distribution.”

During the inspection the firm indicated that a calculated turnover rate for the Liberty cassettes would address any concerns of the dangerous product in the market; however, FDA wrote, “the agency disagrees that a turnover rate is an action to reduce known risk to patients.”

Fresenius distributed a large amount of the defective cassettes to their Fresenius clinics all over the USA and these cassettes were still being distributed by Fresenius to clinic customers long after they knew the cassettes to be defective, causing life threatening peritoneal infections, and causing patients to lose the ability to employ peritoneal dialysis in their battle against kidney failure.

Fresenius also may have known since 2011 that the higher amount of acetate it was using in its dialytes Granuflo and Naturalyte were overloading patient’s bodies with bicarbonate, which led to a high incidence of heart attacks during and after dialysis. Fresenius even documented the danger in an internal memo dated November 4, 2011 but the company did not warn doctors or patients until March of 2012 that its Granuflo and Naturalyte dialysates were causing a potentially deadly residual bicarbonate level in dialysis patients across the US in both Fresenius owned clinics and non Fresenius clinics that bought the products. According to the 2011 Fresenius memo, 941 Fresenius patients suffered a cardio-pulmonary arrest after dialysis at their facilities during 2010, which represents a very large increase in heart attacks yet Fresenius did not warn customers until March 29th, 2012

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OMT Depakote

0 OMT DepakoteThe Food and Drug Administration issues another warning about a seizure and epilepsy drug called Depakote. Consumer Lawyer Eric Seidel explains the risks. For more of Eric’s One Minute Tips, be sure to check out his website: www.EricCanHelp.com

Duration : 0:1:20

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Seroquel Drug Injury

0 Seroquel Drug InjuryDescribes the background of Seroquel, the status of Seroquel litigation, and AstraZeneca’s efforts to hide their own studies that revealed significant problems with the drug. For more information, see http://www.millerandzois.com/Seroquel-pancreatitis-lawyer.html and www.drugrecalllawyerblog.com.

Duration : 0:9:47

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What Is Darvocet?

0 What Is Darvocet?http://RightsForConsumers.com Consumer Lawyer Kendall Almerico brings you the latest information about Darvocet, Darvon and drugs containing propoxyphene. These prescription pain medications have recently been taken off the market by the FDA due to studies showing these drugs can cause serious heart problems.

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Dr. Andy on DIABETES DRUG RECALL

0 Dr. Andy on DIABETES DRUG RECALLOffering house-calls exclusively, Dr. Andy Oakes-Lottridge is able to give his patients a level of convenience not seen for many decades. Dr. Andy sees patients of all ages, and has hospital credentials for both pediatrics (newborns, children, adolescents) and adult medicine in Lee County, Florida. Dr. Andy is currently accepting new patients of all ages. For more information, please visit Dr. Andy’s Web site at www.drandy.us

Duration : 0:2:53

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Pfizer Recalls Birth Control Pills, Women At Risk Of Pregnancy

0 Pfizer Recalls Birth Control Pills, Women At Risk Of PregnancyThe world’s largest drug maker, Pfizer, is pulling birth control packets off pharmacy shelves and nearly 1 million women could be at risk of unintended pregnancies.

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Endorphin Ecstasy 4

0 Endorphin Ecstasy 4Violent, obscene and more than a bit sick.

If you like this, see the other Endorphin Ecstasy videos in the playlist below.

http://www.youtube.com/playlist?list=PL3DDC543F850E463D

It took a few years and countless man-hours, but the Endorphin Ecstasy trilogy has at last become a quadrilogy. This fourth and possibly final instalment is at least as random, violent and daft as any of its predecessors, and only came about after many sleepless afternoons. Watch it. Love it. Crave it. It’s what makes all the pain worth it.

Endorphin: Learning Edition, a program from NaturalMotion, is insanely amusing to use, if you have the patience. Google it if this looks like something you might care to try, not least because it’s FREE.

Music credits are at the end, so don’t go asking about them, eh?

All music tracks featured are the property of their creators.

Duration : 0:4:12

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Digitek and Trasylol Drug Recall

0 Digitek and Trasylol Drug Recallhttp://www.elkandelk.com – Digitek and Trasylol Drug Recall

To learn more about nursing home abuse and neglect please visit http://www.elkandelk.com/personal-injury-lawyers/drug-recalls.shtml

Meet our Attorneys:
Dave J. Elk.
Arthur Elk.
J. M. Kelley III
Stephen S. Crandall
Martin S. Delahunty III
R. Craig McLaughlin
Matthew J. Carty
Robert Gross
Gary Cowan
Tom R. Kelly
Todd O. Rosenberg
Amy L. Papesh
William J. Price
Michael Eisner
Phil Kuri

Elk & Elk
“Serious Lawyers for Serious Injuries”
Ph. 1 800 ELK OHIO

Website:

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Areas of Practice:
Automobile Accidents, Motorcycle Accidents, Semi/Truck Accidents, Aviation Accidents, Railroad Accidents, Product Defects, Medical Device Recalls, Drug Recalls, Workers’ Compensation, Mesothelioma, Cerebral Palsy, Surgical Errors, Birth Injuries, Medication Errors, Emergency Room Errors, Anesthesia Malpractice, Late Cancer Diagnosis, Erb’s Palsy, Wrongful Death, Nursing Home Neglect and abuse.

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OMT Depakote

0 OMT DepakoteThe Food and Drug Administration issues another warning about a seizure and epilepsy drug called Depakote. Consumer Lawyer Eric Seidel explains the risks. For more of Eric’s One Minute Tips, be sure to check out his website: www.EricCanHelp.com

Duration : 0:1:20

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