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Heparin Contamination leads to Two Heparin Recalls FAQWhat is Heparin?
Heparin is a blood thinner, or anticoagulant, used in the treatment and prevention of blood clots. Heparin injection is given to patients before major surgery and a Heparin drip is often administered after surgery. Heparin is also given during dialysis, and for the bedridden.Â
How did Heparin contamination happen?
Investigations by the FDA and a report published in the New England Journal of Medicine (December 2008) found that the heparin reactions were caused by oversulfated chondroitin sulfate.
Heparin is made with raw pig intestines in China. For a number of reasons, there was a shortage of this raw product and it was replaced with oversulfated chondroitin sulfate (OSCS). Chondroitin sulfate is made from animal cartilage and when it is "oversulfated," OSCS mimics the blood-thinning action of Heparin. The contaminated OSCS was made by a Chinese plant and supplied to Baxter International and B Braun Medical. It is widely believed that chondroitin sulfate was used as a cost-cutting measure.
When did heparin reactions begin?
Baxter claims it started shipping contaminated heparin on September 13, 2007 but OSCS contaminant could have started earlier.
What products were involved in the Heparin Recall?
In January 2008, Baxter International recalled nearly all heparin injections in the US and suspended production of multi-dose vials of heparin after a spike in adverse event reports involving reactions to heparin. Baxter extended its recall to include single-dose vials of heparin sodium for injection and its heparin lock flush products
In October 2010, B Braun Medical recalled seven lots of heparin manufactured in 2008. Both Baxter and Braun used the same supplier-- Scientific Protein Laboratories LLC (SPL). Braun recalled Heparin Sodium USP Active Pharmaceutical Ingredient (API) because this API lot indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. B. Braun recalled seven lots of heparin injection products that were manufactured in 2008 and expired on October 31, 2010 and November 30, 2010.
Some medical devices either contain or are coated with heparin, and others are manufactured using heparin. Products or devices that are currently identified by the CDRH and manufacturers affected by the heparin contamination include:
- Heparin lock flush solutions in vials and solutions in pre-filled syringes
- Devices used during cardiopulmonary bypass procedures (may include oxygenators, filters, reservoirs and cannulae)
- Catheters including vascular access catheters, drainage, re-transfusion and thermodilution catheters and oximetry probes
- Vascular stents and grafts
- Assisted reproduction media devices
- In-Vitro Diagnostic (IVD) media and related devices
How many serious Heparin adverse events have occurred and who was affected?
According to the FDA, from mid-December 2007 through January 2008 Baxter received 350 reports of adverse events reported with their product, many of them serious.Â By March 2008, Baxter's heparin had been linked to over 700 adverse reactions, including 19 deaths.
Patients affected are those with kidney failure on hemodialysis; patients undergoing certain types of cardiovascular surgery; patients undergoing other specialized treatments called photopheresis and plasmapheresis and some patients who have blood clots in arteries or veins.
What are heparin side effects?
Symptoms of Heparin allergic reaction include a swollen throat, increased sweating, unconsciousness and even death. Heparin side effects also include abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli.
When did FDA learn about the adverse events?
FDA learned of the occurrence of adverse events on January 9, 2008 from CDC investigators who were evaluating reports of these events in dialysis centers.Â On January 16, 2008, FDA initiated an inspection of Baxterâs manufacturing plant in Cherry Hill, New Jersey.Â At the time of the inspection, Baxter notified the FDA that nine lots of its heparin sodium were being recalled due to an increase in the rate of adverse events with these lots. The recall was initiated on January 17, 2008.
Can I file a heparin lawsuit or heparin injury claim myself?
Yes, but even some lawyers don't understand the complexities of pharmaceutical injury litigation. It is advisable that you contact a lawyer experienced in heparin injury and illness litigation. [link this to the Heparin claim form on the site]
Do I need to find a heparin lawyer in my state?
No. Your lawsuit may not even be filed in the state where you live. Another state may be more appropriate and more favorable for your claim.
What kinds of lawsuits have been filed?
The first product liability trials over defective heparin were scheduled to begin in November 2010.
You have a choice regarding whether to file a non-class action case in Federal or State Court. The class action cases (non-severe consequences) are being handled in Federal Court. . Baxter has allowed claimants to bring state cases in Cook County, Illinois (Baxter has its home office in Illinois.) A trial date has been scheduled for January, 2011.
Cases involving the heparin contamination have also been filed in the Federal District Court in Ohio (MDL Litigation). A class action suit would be more appropriate for individuals who were administered contaminated Heparin where neither death or serious injury occurred. Where people had death or severe reactions, the case should be handled on an individual basis. An experienced attorney will investigate and handle the details of what happened. If serious injury or damage can be proved, the claimant should receive specific economic damages for all losses that occurred, including wrongful death, survivorship claims, loss of society and companionship, medical expenses, funeral expenses, lost wages and pain and suffering.
Is there a time limit to file a heparin claim?
Statutes of limitation vary among states, and different statutes may apply to your claim, so it is best that you file a claim with a qualified lawyer sooner than later for two main reasons: First, if these legal deadlines expire, your claim may be permanently barred. Second, investigation of your claim will require some time, so it would be beneficial to begin at the earliest time possible. And the sooner a claim is initiated, the sooner you can receive compensation.
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Last updated on Jan-27-11