Navigation Links
GranuFlo Lawsuit News: Bernstein Liebhard LLP Comments on Fresenius FDA Warning Letter, as GranuFlo Recall Claims Mount
Date:8/31/2013

New York, New York (PRWEB) August 31, 2013

As GranuFlo lawsuits (http://www.granuflodialysislawsuits.com/) filed in the aftermath of Fresenius Medical Care’s recall of GranuFlo and NaturaLyte dialysis concentrates continue to mount, Bernstein Liebhard LLP notes that another Fresenius entity recently received a Warning Letter from the U.S. Food & Drug Administration (FDA) for problems at a manufacturing plant in Puerto Rico. According to a report from Reuters, the letter cited issues with complaint-handling procedures and labeling at a Fresenius Kabi facility that manufactures blood bags.*

“The FDA was already investigating Fresenius for its handling of the GranuFlo recall. Taken as a whole, these issues are certainly concerning,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently offering free GranuFlo lawsuit evaluations to dialysis patients who suffered cardiac arrest, heart attacks, stroke, sudden cardiac death or other side effects allegedly related to the administration of GranuFlo and NaturaLyte during dialysis treatments.

GranuFlo Recall

This marks the second FDA Warning Letter received by a Fresenius entity since March 2013. That month, Fresenius Medical Care North America was cited by the agency for issues at a plant in Ogden, Utah. That same entity was also behind the GranuFlo recall, which was issued in March 2013 after GranuFlo and NaturaLyte were linked to a rapid and unsafe elevation of bicarbonate, which creates a substantially increased risk of cardiopulmonary arrest and death. The GranuFlo recall was eventually given the FDA’s most serious recall designation, Class I.**

The New York Times reported last summer that the FDA had launched an investigation of Fresenius Medical Care’s handling of the GranuFlo recall, after learning that the company had issued a memo in November 2011 to its own clinics that warned of the heart risks associated with GranuFlo and NaturaLyte. However, nothing was done at that time to notify thousands of dialysis centers outside the Fresenius network about the potential dangers associated with the products.***

According to court records, more than 300 GranuFlo lawsuits alleging personal injury and death due to the use of GranuFlo and NaturaLyte have been filed in a federal multidistrict underway in U.S. District Court, District of Massachusetts. All of the pending claims allege that Fresenius Medical Care failed to provide adequate warnings regarding the use of the products, and assert that the company continued to aggressively market the drugs even after the company became aware of their dangers. The Court is scheduled to hold a conference in the proceeding on September 27, 2013. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428)

Dialysis patients who suffered serious heart problems, including cardiac arrest, heart attacks, stroke, and sudden cardiac death, within 48 hours of a dialysis treatment with GranuFlo or NaturaLyte may be entitled to compensation for their injury-related damages. Learn More about the GranuFlo recall by visiting Bernstein Liebhard LLP’s website. For additional information, please call 800-511-5092.

*reuters.com/article/2013/08/23/fresenius-fda-idUSWEB00AFY20130823, Reuters, August 23, 2013
**fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm, FDA March 29, 2012
***nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html; New York Times, June 14, 2012

About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.

Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
800-511-5092

ATTORNEY ADVERTISING. © 2013 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Contact Information:

Felecia L. Stern, Esq.
Bernstein Liebhard LLP
info(at)consumerinjurylawyers(dot)com
http://www.granuflodialysislawsuits.com/

Read the full story at http://www.prweb.com/releases/granuflo-lawsuit/granuflo-recall/prweb11079971.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. GranuFlo Lawsuits News: Calif. Lawsuit Alleges Drug Maker Hid Serious Health Risks, Rottenstein Law Group LLP Reports
2. 201 Actions Pending in the Granuflo Multidistrict Litigation: Now, AttorneyOne Can Provide Advice
3. GranuFlo Lawsuits Move Forward, as Bernstein Liebhard LLP Notes Upcoming Conference in Federal GranuFlo Recall Litigation
4. NaturaLyte and GranuFlo Lawsuits Are Heating Up
5. New Fresenius NaturaLyte, GranuFlo Dialysis Heart Attack Lawsuit Allegations Update: Resource4thePeople Reports Important Hearing Is Scheduled in Fresenius Multidistrict Litigation
6. Rottenstein Law Group LLP Announces Launch of GranuFlo Lawsuit Center
7. GranuFlo Recall Lawyers at Wright & Schulte LLC Investigating GranuFlo Lawsuits on Behalf of Dialysis Patients Allegedly Injured by GanuFlo or NaturaLyte
8. Granuflo Multidistrict Litigation Moves Forward: Now, AttorneyOne Can Provide Advice
9. GranuFlo Lawsuit News: W.Va. Man’s Lawsuit Goes to Federal Court, Rottenstein Law Group LLP Reports
10. GranuFlo Lawsuits Move Forward, as Bernstein Liebhard Notes Issuance of New Order in Federal GranuFlo Recall Litigation
11. GranuFlo Lawsuits Moving Forward in Federal Multidistrict Litigation, Bernstein Liebhard LLP Reports
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can ... CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn ... X . Simply select a ProHand generator and drag it above media or text ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... On Friday, ... presented a Bronze Wellness at Work award to iHire in recognition of their exemplary ... part of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... June 19, ... the dangers associated with chronic pain and the benefits of holistic treatments, Serenity ... who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016 Dehaier Medical Systems Ltd. (NASDAQ: ... develops, markets and sells medical devices and wearable sleep ... a strategic cooperation agreement with Hongyuan Supply Chain Management ... on June 20, 2016, to develop Dehaier,s new Internet ... agreement, Dehaier will leverage Hongyuan Supply Chain,s sales platform ...
(Date:6/24/2016)... Belgium , June 24, 2016 /PRNewswire/ ... announced the appointment of Dr. Edward Futcher ... a Non-Executive Director, effective June 23, 2016.Dr. Futcher ... and Nominations and Governance Committees.  As a non-executive ... provide independent expertise and strategic counsel to VolitionRx ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... the "Pharmaceutical Excipients Market by Type (Organic Chemical ... Preservative), Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast ... The global pharmaceutical excipients ... 2021 at a CAGR of 6.1% in the forecast ...
Breaking Medicine Technology: