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Fresenius Medical Care, the German-based company responsible for treating over one third of American dialysis patients, is under scrutiny after information came to light linking their dialysis products GranuFlo and NaturaLyte to an increased risk of cardiac arrest. More troubling than the up to six-fold increase in risk of cardiac arrest over competing products is that Fresenius appears to have hid the information from the public, as evidenced by an internal memo that was released in November 2011. The memo, titled “Dialysate Bicarbonate, Alkalosis and Patient Safety,” was distributed to doctors operating in Fresenius-owned medical care centers in the United States, and warned that their products could be linked to an increased risk of patients dying through sudden cardiac arrest. It wasn’t until the memo was anonymously leaked in March of 2012 that the problem became public knowledge.
Of particular import in a case such as this are the dates in which the situation unfolded, e.g., there was over a four months between the date of the initial memo and the release of the leaked version. Therefore, to help make the case clearer, we have outlined the most crucial developments in the case in the timeline below.
January 1st – December 31st, 2010 – First Information Concerning Risks Emerges
Research carried out by Fresenius Medical Care (FMC) discovers that 941 patients from 667 facilities suffered from cardiopulmonary arrest. This figure is over six times higher than that of competing products.
September 15th, 2011 – FDA Sends Warning Letter to Fresenius
The FDA sends a warning letter to the Fresenius CEO after their investigation reveals FMC is inadequately addressing complaints filed by patients using the company’s products. The letter addresses five major areas of fault, including “Failure to establish procedures for investigating the cause of nonconformities stemming from incidents pertaining to NaturaLyte Acid Concentrate” and “Failure to establish and maintain an adequate preventative action to ensure identification of actions needed to corrects and prevent problems.”
November 4th, 2011 – Internal Memo Circulated
The internal memo, “Dialysate Bicarbonate, Alkalosis and Patient Safety,” is sent out to Fresenius doctors warning of the risks associated with their GranuFlo and NaturaLyte products. In the document it is written that “[the] issue needs to be addressed urgently.”
March, 2012 – Memo is Leaked to the FDA
Over four months after the original internal memo was circulated, the memo is anonymously leaked to the Food and Drug Administration (FDA).
March 29th, 2012 – Fresenius Issues Warning to Doctors
On March 29th, 2012, Fresenius releases a modified update to the original memo, warning doctors of the dangers associated with its products. The same day, the FDA issues a statement informing the public of the notice. In the statement, the FDA writes, “The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate…This product may cause serious adverse health consequences, including death.” The recall is listed as “voluntary.”
May 25th, 2012 – FDA Issues Update Warning Doctors of Dosing Dangers
The FDA releases an update warning doctors of “alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate.” The press release recommends that doctors exercise more caution when prescribing these products to patients and urges doctors to “be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels greater than or equal to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients.
June 14th, 2012 – New York Times Reports that FDA is Investigating Fresenius Medical Care
An article released on June 14th raises the public profile of the Fresenius case by reporting that the FDA is investigating the company to determine if Fresenius “violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products.” The report gives a brief summary of the case until that date, and includes a statement from Steven Silverman, the director of compliance for the FDA’s medical device division, in which he states, “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.”
June 27thth, 2012 – FDA Issues a Class I Recall of GranuFlo and NaturaLyte Products
FDA releases a statement announcing a Class I recall of GranuFlo and NaturaLyte, citing that “Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis.” Class I recalls are the most serious recalls of their kind and the move is considered one of the most important developments in the ongoing case against Fresenius.
For more information, visit www.seegerweiss.com/granuflo-lawsuit.
For some patients, the recent hip implant recall by Stryker Orthopaedics will lead to revision hip surgery. Hip revision surgery will unfortunately be needed to replace their faulty Rejuvenate or ABG II module implants. This is truly unfortunate because the typical lifespan of a well-functioning artificial hip joint is 10-15 years and revision surgery brings a lengthier and riskier procedure, as well as greater uncertainty of its outcome.
Few Options Available for Patients
The most pressing and problematic issues with the Stryker recall devices center on its fretting and corrosion, which may lead to metallosis, a serious condition from metal debris leaking into a patient’s bloodstream, the loosening of the implant causing grave pain and discomfort, and the inflammation and damage to surrounding bone and tissue. All of these conditions may warrant a hip revision surgery and bring forth new complications that the patient and surgeon need to consider, for example:
- Quality of patient’s bone and the ability to securely fit revision hip replacement into position
- Higher chance of hip dislocation after surgery due to weaker tissue surrounding the bone as well as more fragile bone
- Lengthier surgery by having to remove old implant and securely placing new one
- Longer rehabilitation timeframe
- Possibility of smaller range of motion
- New prosthesis won’t last as long (eight to 10 years vs. 10-15 years)
If your physician is recommending hip revision surgery because of the Stryker recall and its inherent problems, contact us as soon as possible. Legal options may be available.
For more information about the Stryker hip implant recall and your legal options, visit www.seegerweiss.com/stryker-hip-recall.
Stryker Manufacturing Practices Questioned
Concerns about Stryker Orthopaedics hip replacement products began in 2005, two years after the Trident Acetabular Cup System, a hip implant system, was approved and released to the market. Patients started complaining about the squeaking noises of their Stryker hip replacements and the improper seating of their hip replacements causing bone fractures, so the FDA took action. After inspecting the Stryker Ireland manufacturing plant and finding a lack of conformity with Current Good Manufacturing Practice (CGMP), the FDA issued a warning letter to the company on March 15, 2007. The warning said the facility was failing to establish and maintain adequate procedures for fixing products and analyzing risks.
A second warning was issued by the FDA on November 28, 2007, following another inspection—this time of the company’s New Jersey plant. Once more, the FDA brought attention to the fact that the company had failed to establish procedures for identifying and correcting nonconforming products and addressing other quality problems.
For more information about the Stryker hip implant recall and your legal options, visit www.seegerweiss.com/stryker-hip-recall.
Following a string of troubling findings concerning the risks involved with the use of GranuFlo and NaturaLyte dialysis products, Seeger Weiss LLP is advising that the Food & Drug Administration (FDA) has opened up an inquiry into the parent company Fresenius Medical Care (FMC), combined with a Class I recall of both products. The inquiry’s goal is to determine whether Fresenius violated federal regulations by omitting critical information concerning the potentially deadly risk associated with use of the products.
FMC, based in Germany, is the largest operator of hemodialysis centers in the United States, and processes more than a third of the nearly 400,000 Americans who receive dialysis treatment each year. A memo that Fresenius issued in November of 2011 warns that the GranuFlo and NaturaLyte products could lead to a greater risk of cardiac arrest and other heart problems.
The issue was first brought to public attention after an internal memo was anonymously leaked to the FDA earlier this year. In the memo dated November 4th, 2011, FMC warned doctors operating in their dialysis centers that their products may be causing dangerously high biocarbonate levels that would put their patients at a risk of cardiac arrest up to six times higher than that of patients using competing products. The memo also stressed that “This issue needs to be addressed urgently.”
Despite the findings, it was only after the FDA opened an investigation into the matter that FMC issued a wider warning to other care centers, which it did in March of this year. In June, the FDA issued a Class I recall of all GranuFlo and NaturaLyte products from Fresenius.
As more information becomes public, patients who have suffered injuries are seeking redress and exploring their legal options. Chris Seeger, one of the partners of the law firm Seeger Weiss LLP, said that the decision Fresenius made not to inform the public of potential dangers reflects a failing on behalf of the company. “By not advising the FDA, the medical community and dialysis patients as soon as possible about the dangers of GranuFlo and NaturaLyte, Fresenius made the decision to put profits ahead of patient safety. They aren’t the first pharmaceutical company to make that decision and, unfortunately, they won’t be the last.”
Additionally, Mr. Seeger says that the error is made all the more egregious due to the fact that much of the damage to patients was preventable if Fresenius had responded quickly and efficiently to initial reports of the problem. “You would not expect a company that makes millions of dollars a year from dialysis patients to knowingly put those patients at risk for serious injuries, including death, but that’s exactly what Fresenius did. Fresenius was in position to prevent these injuries but chose not to do so. They must be held accountable.”
Seeger Weiss LLP is offering free consultations to those that might have been affected by the products. If you suspect that you or someone you know has been injured after using GranuFlo and NaturaLyte products in dialysis, contact Seeger Weiss by visiting http://www.seegerweiss.com/ or by calling directly at 888.584.0411.
Donald Foster III, a former dialysis equipment manager at Fresenius Medical Care (FMC), has been charged with attempted murder and burglary after allegedly pouring bleach into the dialysis machines at a South Carolina clinic. A judge has set his bond at $525,000.
According to Lexington County Sherrif James Metts, Foster had been suspended from his position on July 2 at FMC for providing prescription painkillers to patients. Five days later, Foster returned to pour bleach into the dialysis holding tanks despite being told to stay of the property. Metts suspects that Foster’s motive was seeking revenge against FMC for his suspension.
Fortunately, this potentially fatal plot was foiled by workers at the clinic who noticed a high level of chlorine before the machines were used on the 20 patients scheduled for dialysis treatment that day.
According to Metts, Donald Foster had full knowledge and intent to harm or kill these clients and that he knew the lethal effect of bleach in dialysis treatment. “Thank goodness, his plan failed due to the fact the technicians, even though they had checked the water on Saturday afternoon after they finished all of their clients for the day and took no clients on Sunday and was going to begin back on Monday, they went through their checks and found the high contamination of the chlorine bleach in the water,” Metts said.
FMC has also been in the news recently for unrelated issues with their dialysis products, GranuFlo® and NaturaLyte®, which have been discovered to potentially cause metabolic alkalosis – a significant risk associated with low blood pressure, cardiac arrhythmia, cardiopulmonary arrest, and even death. The FDA has issued a Class I recall of these products, the most urgent recall option, after an FMC memo describing the risks was leaked anonymously.
Noticing an absence of any support groups or forums online for patients who have suffered from the dialysis drugs NaturaLyte® and GranuFlo® , we have decided to create a forum here for dialysis patients to voice there concerns and complaints in a supportive environment.
On March 29th of 2012, the FDA issued a recall of the NaturaLyte® and GranuFlo® dialysis products made by Fresenius Medical Care (FMC). This occurred after an earlier FMC internal memo warning of the dangers of these drugs was disseminated to FMC’s clinics, but not other clinics that also used these drugs. Research show that these drugs cause an elevated risk of cardiopulmonary arrest, metabolic askalosis, hypotension, heart problems, stroke, and even death. Today FMC continues to aggressively market GranuFlo and NaturaLyte despite the FDA’s class I recall.
We hope that this forum will be helpful to people who have been injured by these drugs, and we will also be enlisting the support of medical and legal experts to answer any questions beyond our scope that might arise here.
For more information, visit our GranuFlo information resource page or call us directly at 888.584.0411.
Weeks after founding partner Christopher Seeger was appointed Co-Lead Counsel in the Multidistrict Litigation surrounding allegations that the National Football League improperly treated player injuries, the case continues to gain momentum in the media both in the US and abroad. A recent article in the Australian publication The Sydney Morning Herald discusses controversy around the removal of an Australian football player from the field after he experienced a concussion. Citing the consolidated American lawsuits, led by Chris Seeger in Philadelphia, the article noted that the Australian Football League’s strict handling of the player’s injury is actually best practice. The article notes, “Last month, a class action lawsuit was filed in Philadelphia, with up to 80 former NFL players and their families claiming the league had purposely hid links between concussion-related head trauma and permanent brain damage suffered to players. If this claim is successful, there will be global ramifications.” Follow the latest developments in the NFL concussion lawsuit through Seeger Weiss’ up-to-date NFL Football Concussions Page.
On Friday, June 29, 2012, counsel for the plaintiff in yet another Hoffman La-Roche Accutane trial, led by Seeger Weiss partner David Buchanan and Troy Rafferty of Levin Papantonio, PA were able to secure an $18 million verdict. The plaintiffs in the drug injury lawsuit were Katie Rossitto and Riley Wilkinson, two former Accutane users who took the prescription acne medication in the 1990s and developed ulcerative colitis as a result. Ulcerative colitis, a debilitating, permanent gastrointestinal disease, is among the reported side effects of Accutane use. The New Jersey jury ultimately sided with Mr. Buchanan and the plaintiffs, finding that Hoffman La-Roche, the defendants and makers of Accutane, withheld its knowledge and conclusions about the risk of ulcerative colitis from doctors and patients. In response to the verdict, Mr. Buchanan, of Seeger Weiss LLP stated: “We’re extremely pleased for Katie and Riley. They’ve suffered greatly at the hands of Roche’s drug, and the jury’s verdict provides a measure of justice for each of them.” Learn more about the verdict here.
AboveTheLaw.com, a leading legal blog that provides original commentary on developments within the industry, published a profile on Seeger Weiss LLP today. David Lat, the managing editor of the website, interviewed founding partner Stephen A. Weiss and new partner Eric H. Jaso on their perspectives on the differences between a boutique plaintiffs’ firm like Seeger Weiss and a large Biglaw firm. On the practice areas of firms like Seeger Weiss, Lat writes, “I’ve always wondered why more law school graduates don’t go into plaintiffs’ work and why we don’t hear about this side of practice as much. It can represent a chance to do well while also doing good, by vindicating victims’ rights or blowing the whistle on misconduct — especially in the qui tam practice area, a focus of Seeger Weiss.”
Following founding partner Christopher A. Seeger’s appointment to the position of Plaintiffs’ Co-Lead Counsel in the NFL Concussion Multidistrict Litigation, Seeger Weiss has set up a special investigation page to keep those following the lawsuit up to date on the latest information. At our NFL Football Concussions Page, the Seeger Weiss personal injury attorneys working on the NFL concussion investigation will post the latest interviews, news items and medical research surrounding the case.
Visit http://www.seegerweiss.com/football-concussions/ for more information.