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Archives : 2012 : October

Timeline Breakdown of Fresenius Recall of Dialysis Drugs

October 22nd, 2012

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.

 

Stryker Recall may cause Revision Surgery for Many

October 15th, 2012

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 Hip Replacement Recall

October 15th, 2012

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.