Legal Specialties > Dangerous Drugs > Heparin

Drug INFORMation

DRUG NAME:
Heparin

DRUG USE:
Heparin is a blood thinning agent used to prevent and treat blood clots in the veins, arteries and lungs.

Heparin is also used in:

• Coronary heart surgery
• Kidney dialysis

RECALL INFO:
Baxter Corporation product recalls:

• Multi-dose vials of heparin sodium for injection
• Single-dose vials of heparin sodium for injection
• HEP-LOCK heparin flush products

Other manufacturers of heparin containing products and medical devices have issued recalls as well. For more information on contaminated heparin recalls, visit the FDA Web site:

• FDA Heparin Information
  
  
• Questions and Answers on Heparin Sodium Injection (Baxter)
  
  
• Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays

Heparin Headlines

Heparin Taint Tied to Deaths
The Chicago Tribune — July 30, 2008

FDA boosts number of heparin-related deaths
Reuters — June 16, 2008

FDA Probes Devices Containing Heparin
Wall Street Journal — June 6, 2008

Medtronic Recalls Select Heparin-Coated Devices and Products Used During Heart Surgeries
FDA Web site — May 7, 2008

Heparin Contamination May Have Been Deliberate, FDA Says
81 deaths linked to contaminated blood thinner
New York Times — April 30, 2008

FDA Warns Public of Contaminated Heparin IV Syringes
FDA Web site — January 25, 2008

 

 

 

Contaminated Heparin API from China

Topics on this page:

• Contaminated Heparin Recall
• What is Heparin?
• What are the adverse reactions of contaminated Heparin?
• FDA Recalls Related to Contaminated Heparin
• Contact an attorney experienced with dangerous drug recall cases

 

Contaminated Heparin Recall

On January 25, 2008, the FDA announced a recall by Baxter Healthcare Corporation of heparin sodium injection multi-dose vials due to increased reports of adverse patient reactions, including death. On February 28, 2008, the recall was expanded to all remaining lots and doses of Baxter’s heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.

An FDA investigation identified a previously unknown contaminant, oversulfated chondroitin sulfate, in the heparin, which was manufactured by Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories (SPL). SPL provided the heparin used in Baxter’s products.

Prior to the recall, Baxter provided 50 percent of the heparin used in the U.S. market. From 2004 through 2008, Baxter reportedly bought heparin ingredients from the SPL's Chinese subsidiary but did not inspect the facility until September 2007.

At least 81 deaths and hundreds of serious adverse reactions have been linked with the use of the blood-thinning drug with many more deaths suspected from the contaminated drug.

Contaminated heparin has also been found in association with some medical devices, such as certain catheters. Some of these medical devices have also been recalled. See recall information below.

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What is Heparin?

Heparin is a blood thinning drug used to prevent and treat blood clots in the veins, arteries and lungs. Heparin is injected intravenously (into a vein) or deeply under the skin or as a diluted solution that is injected into intravenous catheters. Heparin may be administered by a doctor, nurse or other health care provider or it may be prescribed for patient self-injection at home.

Heparin is also commonly used in:

• Coronary artery bypass graft surgery
• Kidney patients before they undergo dialysis

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What are the adverse reactions?

Patients who have been exposed to contaminated heparin, have reported severe allergic or hypersensitivity-type reactions, with symptoms such as:

• Low blood pressure
• Angioedema (swelling of the skin of the face, typically around the mouth, the mucosa of the mouth, the throat and tongue)
• Shortness of breath
• Nausea
• Vomiting
• Diarrhea
• Abdominal pain

Several patients known to have taken contaminated heparin have died from complications of the adverse reactions.

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FDA Recalls Related to Contaminated Heparin

Several recalls are associated with the contaminated heparin API from China. The following is a list of FDA recalls related to the contaminated product:

• 5/14/2008 — Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass
• 3/28/2008 — Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin
• 3/21/2008 — B. Braun's Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions
• 3/20/2008 — American Health Packaging Announces a Recall of Approximately 1,400 Units of Heparin Sodium Vial Products as Part of Broader Baxter Recall
• 2/28/2008 — Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products
• 1/25/2008 — Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials

 

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Contact an experienced drug recall attorney

If you or a loved one has been injured because of exposure to contaminated Heparin, you may be entitled to compensation for:

• Medical treatment
• Hospitalization
• Lost wages
• Pain and suffering
• Other damages arising from your exposure 

If a loved one has died from adverse reactions of contaminated heparin, you may be entitled to wrongful death compensation or compensation to the estate.

KCR personal injury attorneys have handled thousands of cases involving defective and dangerous drugs such as Heparin. In recent years, KCR has litigated and settled numerous nationwide cases involving dangerous drugs and medical devices and products such as:

• Vioxx
• Phen-Fen diet drugs
• Intergel anti-adhesion surgical product
• Guidant defibrillators and pacemakers

We have the specific knowledge and expertise to help our injured clients obtain fair compensation in these complex cases. Some of the recent cases we've resolved include:

• $240 Million Guidant Defibrillator Settlement — KCR clients who were injured by malfunctioning Guidant cardiac defibrillators will claim shares of the $240 million fund as part of a 2008 nationwide settlement.
  
  
• In a confidential settlement, our attorneys successfully resolved a case against Johnson & Johnson on behalf of over 200 individuals who alleged that they contracted post operative infections from sutures that had not been properly sterilized.
  
  
• In another case, we successfully resolved a case against a Johnson & Johnson subsidiary, Ethicon, Inc. on behalf of approximately 56 women who allege that they were injured by a defective medical device known as Intergel.

If you or a loved one has been exposed to contaminated heparin, please fill out and submit the contact form on this page for a free case evaluation or call us toll-free at (888) 285-3333.

 

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