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Fresenius Media Coverage
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Kentucky attorney general sues dialysis company over product
Sep 1, 2016 | Associated Press
By Bruce Schreiner
Kentucky's attorney general accused the nation's largest provider of kidney dialysis services of Medicaid fraud Thursday in a lawsuit that says it promoted a harmful product for use in clinics. -
Beshear sues nation’s largest kidney dialysis provider
Sep 1, 2016 | Lexington Herald Leader
By Jack Brammer
Attorney General Andy Beshear filed a lawsuit Thursday against Fresenius Medical Care Holdings Inc., the nation’s largest kidney dialysis provider, which has more than 50 clinics in Kentucky and has served dozens of independent clinics in the state. -
AG Beshear files lawsuit against dialysis clinic
Sep 1, 2016 | The State Journal
By Brad Bowman
The Fresenius Kidney Care dialysis center on Chamberlin Avenue in Frankfort is one of more 50 clinics in Kentucky which is part of the Massachusetts-based Fresenius Medical Care Holdings Inc. company. -
Kentucky's attorney general is accusing a medical company of Medicaid fraud for allegedly promoting a kidney dialysis product it knew was harmful to patients
Sep 1, 2016 | Register-Guard
Kentucky's attorney general is accusing a medical company of Medicaid fraud for allegedly promoting a kidney dialysis product it knew was harmful to patients. -
Attorney general sues largest provider of dialysis services, alleging Medicaid fraud over recalled product
Sep 2, 2016 | CN/2 (Louisville, KY)
By Kevin Wheatley
Attorney General Andy Beshear is suing the largest provider of dialysis and renal care products and services, accusing the company of using a kidney dialysis product it knew brought health risks to patients and defrauding Medicaid. -
Ky. Atty General Accuses Dialysis Product Maker Fresenius of Medicaid Fraud
Sep 2, 2016 | 88.9 WEKU (Richmond, KY)
By John Hingsbergen
Kentucky's attorney general is accusing a medical company of Medicaid fraud for allegedly promoting a kidney dialysis product it knew was harmful to patients. -
Beshear filed lawsuit against nation’s largest kidney dialysis provider
Sep 1, 2016 | WKYT-CBS (Lexington, KY)
Attorney General Andy Beshear has filed a consumer protection lawsuit against Fresenius Medical Care Holdings Inc. for deceptive marketing practices. -
AG Sues Nation's Largest Kidney Dialysis Provider
Sep 1, 2016 | 1080 WKJK (Louisville, KY)
A consumer protection lawsuit is filed by Kentucky's Attorney General against a kidney dialysis provider's product. -
WDRB in the Morning
Sep 2, 2016 | WDRB-FOX (Louisville, KY)
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News 3 News This Morning
Sep 2, 2016 | WSIL-ABC (Paducah, KY)
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ABC 36 News Good Morning Kentucky
Sep 2, 2016 | WTVQ-ABC (Lexington, KY)
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ABC 36 News at 11
Sep 1, 2016 | WTVQ-ABC (Lexington, KY)
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ABC 36 News at 6
Sep 2, 2016 | WTVQ-ABC (Lexington, KY)
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Local 6 Today
Sep 2, 2016 | WPSD-NBC (Paducah, KY)
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Local 6 at 10:00
Sep 1, 2016 | WPSD-NBC (Paducah, KY)
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Fox 56 10 O'Clock News
Sep 1, 2016 | WDKY-FOX (Lexington, KY)
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Kentucky attorney general sues dialysis company over product
Sep 1, 2016 | Associated Press
By Bruce Schreiner
Kentucky's attorney general accused the nation's largest provider of kidney dialysis services of Medicaid fraud Thursday in a lawsuit that says it promoted a harmful product for use in clinics.
The lawsuit against Fresenius Medical Care Holdings Inc. seeks to restore money spent by Kentucky's Medicaid program for dialysis treatments that used the product called GranuFlo. It also aims to recoup costs to treat other health problems allegedly related to the product's use.
Attorney General Andy Beshear said the company concealed serious risks posed by GranuFlo, which is used in screening blood to remove impurities during dialysis.
"Fresenius put Kentucky at risk, and they billed our Medicaid program while they were doing it. They will be held accountable," Beshear said at a state Capitol press conference.
Beshear didn't say how much he'll seek to recoup for the Medicaid program but a press release from his office said it would be millions of dollars.
In response to the lawsuit, Fresenius spokesman Kent Jarrell said: "All the company's actions involving these products were appropriate, responsible and consistent with the company's commitment to patient safety."
The product was subject to a 2012 recall by the U.S. Food and Drug Administration. The recall resulted in relabeling of the product, Jarrell said.
"The FDA has never suggested that the product should be withdrawn from the market, that the product compositions should be changed in any way, or that the products are unsafe when used as directed and prescribed," the company spokesman said.
Beshear's suit, filed in Franklin County Circuit Court, also seeks damages and civil penalties for the state. The suit says the company ignored health risks associated with use of GranuFlo.
Fresenius is the largest provider of kidney dialysis and renal care products, treatment and services in the U.S., Beshear said. It owns and operates more than 50 clinics in Kentucky, he said. The company also provided GranuFlo for use in independent clinics in Kentucky, he said.
Overall, the company owns and operates about 2,150 dialysis facilities in North America, Jarrell said. Its North American operations are based in Waltham, Massachusetts.
Beshear said the company concealed a clinical study that found risks associated with the product. Beshear said he doesn't know if anyone died in Kentucky due to use of GranuFlo.
The company's clinical study of 667 of its dialysis facilities in 2010 revealed that 941 patients had cardiopulmonary arrests, Beshear's office said.
In 2011, Fresenius issued an internal memo disclosing limited results of its clinical trials that failed to clearly relay the severity of the problem, the AG's office said.
The company shared the memo with its dialysis clinical staff but did not disclose it to independent clinics obtaining GranuFlo, Beshear's office said.
"This concealment was a blatant disregard for human life, and we cannot tolerate it in this state," Beshear said. "Fresenius put profits over human life."
The company is fighting similar lawsuits in Louisiana and Mississippi, Beshear said.
Read more here: http://www.charlotteobserver.com/news/article99330317.html#storylink=cpy -
Beshear sues nation’s largest kidney dialysis provider
Sep 1, 2016 | Lexington Herald Leader
By Jack Brammer
Attorney General Andy Beshear filed a lawsuit Thursday against Fresenius Medical Care Holdings Inc., the nation’s largest kidney dialysis provider, which has more than 50 clinics in Kentucky and has served dozens of independent clinics in the state.
Beshear claimed in the suit filed in Franklin Circuit Court that Fresenius, headquartered in Waltham, Mass., promoted its kidney dialysis product, GranuFlo, as safe despite clinical trials finding it harmful.
The lawsuit seeks to recover damages and civil penalties for the state. It claims the company ignored the health risks associated with and the possibility of death from the use of GranuFlo.
Fresenius has “outright lied to promote their product while putting the health of Kentuckians at risk,” Beshear said.
Fresenius spokesman Kent Jarrell said in an email Thursday that GranuFlo continues to be a market leader for the company and that the Federal Drug Administration has never suggested that it “should be withdrawn from the market, that the product compositions should be changed in any way, or that the products are unsafe when used as directed and prescribed.”
The FDA issued a recall notice for Fresenius GranuFlo (powder) Acid Concentrate on June 25, 2012, citing “false and misleading” labeling, although that action did not remove the product from the market.
Fresenius is fighting similar lawsuits in Louisiana and Mississippi.
Beshear is seeking a refund of millions of dollars the Kentucky Medicaid Program paid for dialysis treatments using GranuFlo or for the medical costs to treat the adverse health consequences of GranuFlo — arrhythmia, heart attacks or strokes.
He said Forsenius has billed the state’s Medicaid program $16 million related to the use of GranuFlo and treatment associated with it.
Beshear did not know if any deaths have occurred in Kentucky due to GranuFlo.
His Office of Medicaid Fraud and Prevention charges that Fresenius committed Medicaid fraud for using a known harmful product in its dialysis machines around patients and employees.
Fresenius is the largest provider of kidney dialysis and renal care products, treatment and services in the nation with more than 2,200 dialysis clinics nationwide.
According to the lawsuit, Fresenius became aware but didn’t immediately or clearly divulge that GranuFlo could result in high bicarbonate levels in patients. These high levels were known to cause dialysis-related adverse cardiac events.
The lawsuit said in 2010 that Fresenius conducted a clinical study at 667 of its dialysis facilities and found that 941 patients had cardiopulmonary arrests.
In 2011, the lawsuit said, Fresenius issued an internal memo disclosing results of its clinical trials that did not clearly relay the severity of the problem. The company allegedly shared the memo with its dialysis clinical staff, but not with the independent clinics that purchased GranuFlo.
A copy of the memo was anonymously leaked to the U.S. Food and Drug Administration, which started investigating.
After the FDA inquiry, Beshear said, Fresenius released a two-page, “stripped-down, scientifically vague” memo to its clinic customers in 2012 that omitted critical information and references regarding the harmful side effects discovered in the clinical trials.
Beshear said individuals who were treated with GranuFlo should seek class action lawsuits or a private attorney.
He also said health care professionals and patients are encouraged to report adverse events or side effects related to GranuFlo to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program or call 800-332-1088.
Any civil penalties from Kentucky’s lawsuit would be returned to the state and its Medicaid program, said the state’s top law-enforcement official.
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AG Beshear files lawsuit against dialysis clinic
Sep 1, 2016 | The State Journal
By Brad Bowman
The Fresenius Kidney Care dialysis center on Chamberlin Avenue in Frankfort is one of more 50 clinics in Kentucky which is part of the Massachusetts-based Fresenius Medical Care Holdings Inc. company.
Thursday, Attorney General Andy Beshear announced he has filed a lawsuit against the provider for promoting the dialysis product GranuFlo which in clinical trials, Beshear said, has caused health complications like arrhythmia, heart attacks, strokes and death.
The federal government recalled GranuFlo after it ran on the market from 2003 to 2012.
Beshear filed the lawsuit against the company for promoting the product despite the clinical trial evidence and seeks to recover millions of Kentucky Medicaid Program payments for the GranuFlo treatments, as well as, the medical costs for treating adverse caused from its use.
The Attorney General’s Office of Medicaid Fraud and Prevention has charged that Fresenius committed Medicaid fraud by knowingly using the harmful product in its dialysis machines around both patients and employees.
“It is incomprehensible that a company would knowingly jeopardize a patient’s health or life just to make a profit,” Beshear said. “These actions are unacceptable, and my office is determined to hold them accountable for their actions that took place in the more than 50 clinics across the state where Kentuckians were treated with GranuFlo.”
According to Beshear’s lawsuit, Fresenius knew but didn’t divulge that the use of GranuFlo in the dialysis process resulted in dangerously increased bicarbonate levels, which led to the serious health complications and possible death.
Fresenius shared the memo of the clinical trials with its dialysis clinical staff, but not the independent clinics that purchased GranuFlo.
According to the lawsuit, a copy of the memo was anonymously leaked to the U.S. Food and Drug Administration, causing the FDA to inquire about the GranuFlo memo.
Beshear said Kentuckians treated with GranuFlo should seek class action lawsuits or a private attorney.
Health care professionals and patients can report adverse events or side effects related to GranuFlo to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at http://bit.ly/2c4mT3D or call 800-332-1088.
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Sep 1, 2016 | Register-Guard
Kentucky's attorney general is accusing a medical company of Medicaid fraud for allegedly promoting a kidney dialysis product it knew was harmful to patients.
Attorney General Andy Beshear is suing Fresenius Medical Care Holdings Inc. His lawsuit, filed in Franklin County Circuit Court, says Fresenius is the nation's largest provider of kidney dialysis and renal care products, treatment and services.
Beshear says the company put patients at risk with its GranuFlo product, which was used in screening blood to remove impurities during dialysis. He says the company concealed the product's risks of causing heart attacks, strokes or arrhythmia.
He says the federal government issued a 2012 recall for the product.
Fresenius spokesman Kent Jarrell said the company's actions "were appropriate, responsible and consistent with the company's commitment to patient safety."
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Sep 2, 2016 | CN/2 (Louisville, KY)
By Kevin Wheatley
Attorney General Andy Beshear is suing the largest provider of dialysis and renal care products and services, accusing the company of using a kidney dialysis product it knew brought health risks to patients and defrauding Medicaid.
The German company continued using a product called GranuFlo despite conducting a clinical study at its dialysis clinics in 2010 and finding that 941 patients suffered heart attacks on the drug.
Beshear, in a Capitol news conference Thursday, said Kentucky patients at 50 of Fresenius’ clinics and dozens of independent clinics depended on Fresenius with their lives.
“Fresenius broke that trust by knowingly and deceptively marketing a product called GranuFlo Dry Acid Concentrate,” Beshear said. “GranuFlo, as it’s known, is a product used in screening the blood to remove impurities during the dialysis process — what your kidneys are supposed to do.
“GranuFlo was recalled in 2012 by the FDA because it can have serious effects on patients, such as heart attacks, strokes, arrhythmia and even death.”
Fresenius spokesman Kent Jarrell said acid concentrates offered by the medical company “continue today to be market leaders, as they have been for many years.”
“The FDA has never suggested that either product (GranuFlo and Naturalyte) should be withdrawn from the market, that the product compositions should be changed in any way, or that the products are unsafe when used as directed and prescribed,” Jarrell said in a statement.
The Food and Drug Administration recalled GranuFlo in 2012 after it received a leaked copy of an internal memo on Fresenius’ clinical trials.
The medical company has been sued by two other states, Mississippi and Louisiana, and in February, it settled thousands of lawsuits over GranuFlo for $250 million.
“Fresenius knew the harm its product was causing, but it was covering its own behind,” Beshear said.
It’s unclear how many Kentuckians were affected by GranuFlo, and Beshear urged those who used the product to contact an attorney.
“Understand that dialysis is common in Kentucky,” he said. “We have over 50 Fresenius clinics and dozens of independent clinics.”
Unclear, too, is how much Medicaid money is involved.
Beshear said that will be revealed as the case moves forward in Franklin Circuit Court.
“Fresenius at large billed over $16 million to Medicaid,” he said. “Now, once we are in discovery and in the litigation, the actual recovery figure that we’ll seek may become more definite, but we are talking significant funds.”
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Ky. Atty General Accuses Dialysis Product Maker Fresenius of Medicaid Fraud
Sep 2, 2016 | 88.9 WEKU (Richmond, KY)
By John Hingsbergen
Kentucky's attorney general is accusing a medical company of Medicaid fraud for allegedly promoting a kidney dialysis product it knew was harmful to patients.
Attorney General Andy Beshear says his lawsuit seeks damages and civil penalties from Fresenius Medical Care Holdings Inc. The suit also seeks to restore Medicaid funds that paid for dialysis treatments using the product.
He says Fresenius is the nation's largest provider of kidney dialysis and renal care products, treatment and services.
Fresenius spokesman Kent Jarrell says the company's actions were consistent with its commitment to patient safety.
Beshear says the company put patients at risk with use of its GranuFlo product, used in screening blood to remove impurities during dialysis.
He says the company concealed the product's risks of causing heart attacks, strokes or arrhythmia.
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Beshear filed lawsuit against nation’s largest kidney dialysis provider
Sep 1, 2016 | WKYT-CBS (Lexington, KY)
Attorney General Andy Beshear has filed a consumer protection lawsuit against Fresenius Medical Care Holdings Inc. for deceptive marketing practices.
Fresenius is accused in the lawsuit of promoting its kidney dialysis product, GranuFlo, as safe - despite clinical trials finding it harmful.
The lawsuit seeks to recover damages and civil penalties for the state. It claims the company ignored the health risks associated with the use of GranuFlo, a product used in the dialysis process.
Beshear is seeking restoration for millions of dollars the Kentucky Medicaid Program paid for dialysis treatments using GranuFlo, or to recover medical costs to treat the adverse health consequences of GranuFlo, including arrhythmia, heart attacks, and strokes, and even death.
Beshear’s Office of Medicaid Fraud and Prevention is charging that Fresenius committed Medicaid fraud for using a known harmful product in its dialysis machines around patients and employees.
“It is incomprehensible that a company would knowingly jeopardize a patient’s health or life just to make a profit,” Beshear said. “These actions are unacceptable, and my office is determined to hold them accountable for their actions that took place in the more than 50 clinics across the state where Kentuckians were treated with GranuFlo.”
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AG Sues Nation's Largest Kidney Dialysis Provider
Sep 1, 2016 | 1080 WKJK (Louisville, KY)
A consumer protection lawsuit is filed by Kentucky's Attorney General against a kidney dialysis provider's product.
Attorney General Andy Beshear says the suit is against Fresenius Medical Care Holdings, for promoting its kidney dialysis product GranuFlo as safe, despite clinical trials finding it harmful. The FDA had it taken off the market four years ago.
Beshear says the suit seeks damages and civil penalties and millions in restitution to Kentucky's Medicaid Program.
He adds, Kentucky is the third state to take such action.
Read more: http://talkradio1080.iheart.com/articles/newsradio-840-whas-local-news-283307/ag-sues-nations-largest-kidney-dialysis-15069526/#ixzz4J6UJO537 -
Sep 2, 2016 | WDRB-FOX (Louisville, KY)
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Sep 2, 2016 | WSIL-ABC (Paducah, KY)
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ABC 36 News Good Morning Kentucky
Sep 2, 2016 | WTVQ-ABC (Lexington, KY)
View Clip Here: http://app.criticalmention.com/app/#clip/view/23984606?token=26bccea8-db81-4bb6-b837-ecc13462aed9
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Sep 1, 2016 | WTVQ-ABC (Lexington, KY)
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Sep 2, 2016 | WTVQ-ABC (Lexington, KY)
View Clip Here: http://app.criticalmention.com/app/#clip/view/23985118?token=26bccea8-db81-4bb6-b837-ecc13462aed9
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Sep 2, 2016 | WPSD-NBC (Paducah, KY)
View Clip Here: http://app.criticalmention.com/app/#clip/view/23984619?token=26bccea8-db81-4bb6-b837-ecc13462aed9
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Sep 1, 2016 | WPSD-NBC (Paducah, KY)
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Sep 1, 2016 | WDKY-FOX (Lexington, KY)
View Clip Here: http://app.criticalmention.com/app/#clip/view/23984704?token=26bccea8-db81-4bb6-b837-ecc13462aed9
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