Fresenius, Maker of Recalled Dialysis Drugs GranuFlo And NaturaLyte, Now Has Problems At Its Dialysis Center In Bessemer, Alabama

Fresenius, the maker of the recalled dialysis drugs GranuFlo and NaturaLyte, is back in the news because its Bessemer, Alabama dialysis center has been closed due to two deaths and five hospitalizations of dialysis patients last month.

Consumer injury attorney Michael J. Evans announced today that he and two other law firms have launched a new website dedicated to providing information and offering legal assistance to people with potential claims caused by dialysis drugs, such as GranuFlo and NaturaLyte, or other dialysis malfeasance. The website is http://www.DialysisLawsuitAttorneys.com.

“My litigation partners and I decided it was time to begin offering legal services to people who may have been injured by the recalled dialysis drugs GranuFlo and NaturaLyte, or who may have suffered injuries due to some other form of negligent conduct by the company performing dialysis,” said Evans.GranuFlo & NaturaLyte Dialysis Drug Recall by FDA

“Fresenius, the maker of GranuFlo and NaturaLyte, not only makes dialysis drugs, but it also provides dialysis services through dialysis centers located throughout the United States.” said Evans.

“The GranuFlo and NaturalLyte recall in 2012 was followed up by the filing of so many GranuFlo lawsuits that they were given multidistrict litigation status and transferred to the federal court in the District of Massachusetts on March 29, 2013,” Evans said.

Evans noted that “a June 17, 2013 AL.com report says that Bessemer Kidney Center, operated by Fresenius in Bessemer, Alabama, was closed in May 2013 after 2 deaths and 5 hospitalizations occurred within a few days. Although an investigation by the Alabama Department of Public Health did not find “a common thread” tying the deaths and hospitalizations together, the investigation did find “deficiencies” that must be addressed with a plan of action before the center can re-open, according to the report on AL.com. The report says that “deficiencies” were found at the dialysis center last year, as well.”

The new website, http://www.DialysisLawsuitAttorneys.com, will focus on more than just GranuFlo and NaturaLyte lawsuits,” said Evans. “We plan to look at other potential cases for people who have been harmed by dialysis mistakes, defective dialysis equipment, or dialysis drugs such as GranuFlo or NaturaLyte.”

[Continue reading…]

Diabetes drug safety: Avandia maker’s guilty plea and Actos whistleblower lawsuit raise concerns (Part 3 in a series)

[Part 3 of a series]

So here is what we now know about Avandia:

  • The maker of Avandia lied to medical doctors to and told them Avandia had a beneficial cardiovascular profile even though the drug actually incr

    eased patients’ risks of getting congestive heart failure.

  • To help perpetrate the lie, GSK hid or failed to report congestive heart failure cases to the FDA.
  • GSK spent millions actually bribing some doctors to prescribe its drugs.

Most folks would expect that type of behavior to have serious consequences. Fraud and bribery are pretty serious charges, too. And GSK actually agreed to plead guilty to a felony. So what happens to GSK and its guilty employees?

So how many GSK executives are going to jail?

None. Here is what GSK agreed to do: it’s taking $3 billion of its shareholders’ money and paying a fine. What about the GSK employees who were guilty of the illegal conduct? The Justice Department settlement says GSK will withdraw bonuses from top executives if they engaged in or supervised illegal behavior.

That will teach them a lesson, won’t it?

Actually, it will probably teach them the wrong lesson. Most top executives at large corporations get a lot of their compensation in stock or stock options. So if the corporation makes a lot of money and the shares go up, the executives make a lot of money, too.

Did GSK make a lot of money because of its fraudulent, felonious conduct? Yes, it did.

In spite of the $3 billion fine, GSK made a huge amount of money because of its illegal promotion and sales of these drugs. GSK was able to falsely promote Avandia until its sales reached $10.4 billion. Paxil brought in $11.6 billion sales, and Wellbutrin sales were $5.9 billion during the years covered by the settlement, according to IMS Health, a group that consults for drug manufacturers.

Almost $27 billion in drug sales, much of it due to illegal conduct, but the drug maker paid a fine of only $3 billion. It makes it look as if drug companies might just consider fines and settlements a part of the cost of doing business. Perhaps that’s why the CEO of GSK minimized the illegality when he issued a statement commenting on the settlement.

Andrew Witty, the CEO, sought to portray the illegal actions as part of the company’s past.

“Whilst these originate in a different era for the company, they cannot and will not be ignored,” he said in the statement. “On behalf of GSK, I want to express our regret and reiterate that we have learned from the mistakes that were made.”

If GSK were just one bad apple there would be less cause for concern. But some of the largest drug companies in the world have paid billions of dollars in settlements so far in 2012:

  • May 2012 – Abbott Laboratories agreed to pay $1.6 billion to settle charges of illegal marketing of Depakote. (Link to article.)
  • June 2012 – AstraZeneca entered a plea of guilty to one felony count of health care fraud and agreed to pay $355 million because of a scheme to illegally market a prostate cancer drug. (Link to article.)
  • June 2012 – Johnson & Johnson agreed to plead guilty to a misdemeanor and pay up to $2 billion to settle charges of off-label promotion of its drug Risperdal. (Link to article.)

None of these guilty pleas, fines or settlements would not have occurred without whistleblower lawsuits started by employees or former employees of the drug companies.

So one can’t lightly dismiss charges made by Dr. Helen Ge, the former medical researcher who helped test Actos for Takeda, in her whistleblower lawsuit (see Actos whistleblower lawsuit excerpts here). Although Dr. Ge may be making up all the (very specific) charges in her lawsuit, she and her lawyers are certainly acting as if Takeda hid bladder cancer and heart risks from the FDA.

In this country, one is presumed innocent until proven guilty, and Dr. Ge will have to prove her claims in a court of law. But that doesn’t mean that people who are taking Actos can’t consider the culture of fraud at so many drug companies, and the claims Dr. Ge has made, when they choose whether to talk with their physicians about switching from Actos to another drug.

[End of series on diabetes drugs.]

AVANDIA is a registered trademarks of GlaxoSmithKline. ACTOS is a registered trademark of Takeda Pharmaceutical Company Limited.Rich Text AreaToolbarBold (Ctrl + B)Italic (Ctrl + I)Strikethrough (Alt + Shift + D)Unordered list (Alt + Shift + U)Ordered list (Alt + Shift + O)Blockquote (Alt + Shift + Q)Align Left (Alt + Shift + L)Align Center (Alt + Shift + C)Align Right (Alt + Shift + R)Insert/edit link (Alt + Shift + A)Unlink (Alt + Shift + S)Insert More Tag (Alt + Shift + T)Proofread WritingToggle fullscreen mode (Alt + Shift + G)Show/Hide Kitchen Sink (Alt + Shift + Z)
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[Part 3 of a series]
So here is what we now know about Avandia:
The maker of Avandia lied to medical doctors to and told them Avandia had a beneficial cardiovascular profile even though the drug actually increased patients’ risks of getting congestive heart failure.
To help perpetrate the lie, GSK hid or failed to report congestive heart failure cases to the FDA.
GSK spent millions actually bribing some doctors to prescribe its drugs.
Most folks would expect that type of behavior to have serious consequences. Fraud and bribery are pretty serious charges, too. And GSK actually agreed to plead guilty to a felony. So what happens to GSK and its guilty employees?
So how many GSK executives are going to jail?
None. Here is what GSK agreed to do: it’s taking $3 billion of its shareholders’ money and paying a fine. What about the GSK employees who were guilty of the illegal conduct? The Justice Department settlement says GSK will withdraw bonuses from top executives if they engaged in or supervised illegal behavior.
That will teach them a lesson, won’t it?
Actually, it will probably teach them the wrong lesson. Most top executives at large corporations get a lot of their compensation in stock or stock options. So if the corporation makes a lot of money and the shares go up, the executives make a lot of money, too.
Did GSK make a lot of money because of its fraudulent, felonious conduct? Yes, it did.
In spite of the $3 billion fine, GSK made a huge amount of money because of its illegal promotion and sales of these drugs. GSK was able to falsely promote Avandia until its sales reached $10.4 billion. Paxil brought in $11.6 billion sales, and Wellbutrin sales were $5.9 billion during the years covered by the settlement, according to IMS Health, a group that consults for drug manufacturers.
Almost $27 billion in drug sales, much of it due to illegal conduct, but the drug maker paid a fine of only $3 billion. It makes it look as if drug companies might just consider fines and settlements a part of the cost of doing business. Perhaps that’s why the CEO of GSK minimized the illegality when he issued a statement commenting on the settlement.
Andrew Witty, the CEO, sought to portray the illegal actions as part of the company’s past.
“Whilst these originate in a different era for the company, they cannot and will not be ignored,” he said in the statement. “On behalf of GSK, I want to express our regret and reiterate that we have learned from the mistakes that were made.”
If GSK were just one bad apple there would be less cause for concern. But some of the largest drug companies in the world have paid billions of dollars in settlements so far in 2012:
May 2012 – Abbott Laboratories agreed to pay $1.6 billion to settle charges of illegal marketing of Depakote. (Link to article.)
June 2012 – AstraZeneca entered a plea of guilty to one felony count of health care fraud and agreed to pay $355 million because of a scheme to illegally market a prostate cancer drug. (Link to article.)
June 2012 – Johnson & Johnson agreed to plead guilty to a misdemeanor and pay up to $2 billion to settle charges of off-label promotion of its drug Risperdal. (Link to article.)
None buy viagra online of these guilty pleas, fines or settlements would not have occurred without whistleblower lawsuits started by employees or former employees of the drug companies.
So one can’t lightly dismiss charges made by Dr. Helen Ge, the former medical researcher who helped test Actos for Takeda, in her whistleblower lawsuit (see Actos whistleblower lawsuit excerpts here). Although Dr. Ge may be making up all the (very specific) charges in her lawsuit, she and her lawyers are certainly acting as if Takeda hid bladder cancer and heart risks from the FDA.
In this country, one is presumed innocent until proven guilty, and Dr. Ge will have to prove her claims in a court of law. But that doesn’t mean that people who are taking Actos can’t consider the culture of fraud at so many drug companies, and the claims Dr. Ge has made, when they choose whether to talk with their physicians about switching from Actos to another drug.
[End of series on diabetes drugs.]
AVANDIA is a registered trademarks of GlaxoSmithKline. ACTOS is a registered trademark of Takeda Pharmaceutical Company Limited.


This post was written or edited by personal injury lawyer Michael J. Evans, so an attorney advertising disclaimer will be found below. Evans's law practice is limited to representing injured people and small businesses filing lawsuits to collect money damages. These are primarily consumer lawsuits involving dangerous drugs, defective medical devices, serious medical malpractice lawsuits. dangerous products recalls and lawsuits, and environmental lawsuits. Evans works with prominent environmental and personal injury lawyers nationwide to handle lawsuits involving deaths or serious injuries. Evans is also an online publisher and Apple app developer, and Internet entrepreneur. You can connect with Evans using social media or by using the contact form at Michael J. Evans: Law + Marketing + Technology. You can also find Mike Evans on the following social media sites: Linkedin:  Michael J. Evans Google+:  Michael J. Evans Twitter:  Michael J. Evans SlideShare:  Michael J. Evans Facebook: Michael J. Evans

Because personal injury lawyer Michael J. Evans is a practicing lawyer who represents injured parties or the estates of people killed by dangerous drugs, defective medical devices, and other defective products, it seems prudent to include the Attorney Advertising Disclaimer here: "No representation is made that the quality of legal services to be performed is greater than the quality of legal services performed by other lawyers. The hiring of a law firm is a serious decision that should not be based on advertising alone."