Heparin

BAXTER HEPARIN RECALL: CONTAMINATION AND OVERDOSE CAUSE REACTION RESULTING IN SERIOUS INJURY AND DEATH

Heparin, one of the oldest drugs currently on the market, is used to thin blood clots in patients undergoing dialysis, surgery or those who have heart problems or are bedridden. Since the beginning of this year, Heparin, manufactured by pharmaceutical giant Baxter International, has been linked to serious injuries, allergy-type reactions and deaths due to both product contamination and mistaken overdoses. If you or a loved one has suffered a severe adverse reaction or death due to Heparin, please contact a lawyer to help learn your rights. In California, call the Law Offices of Greenberg & Rudman LLP at 1-800-ALAWPRO now for your free consultation.

Heparin History and Use
Heparin is an anticoagulant, or blood thinner, used to prevent blood clots in patients undergoing certain procedures or with certain conditions. Heparin is a naturally occurring substance, normally processed from animal products for medical usage. Heparin was first discovered in 1916 and put through clinical medical trials in 1935. Its generic name is Heparin sodium, and it was approved for usage in 1972. It has been available in multi-dose, single-dose vials and flush forms. About half of multi-dose Heparin in the U.S. is made by Baxter International.

Heparin is favored and used widely as a blood thinner because of its speedy effectiveness and ease in reversing its effects. Millions of people have used Heparin since its availability.

Following is a list of conditions and procedures in which Heparin is used:

  • Kidney Dialysis
  • Surgery, especially Cardiac-Invasive
  • Heart Attack
  • Cardiac Arrhythmia
  • Acute Coronary Syndrome
  • Pulmonary Embolism, or Stroke
  • Deep-vein Thrombosis
  • Blood Clot Prevention in Bedridden

Baxter Heparin Contamination and Recall
As of today, all of Baxter's Heparin products have been recalled as a result of contamination of their China-produced product. The FDA now reports that 62 deaths and hundreds of serious injuries have resulted from Baxter Heparin usage since January, 2007. Here is a history of the Baxter Heparin recall.

  • January 17, 2008: Baxter began recall a of Heparin, starting with its 1000mL multi-dose injections, as a result of an alarming increase in reports of serious allergic reactions to the product. At the time, Baxter also stated that it was suspending Heparin manufacture until reasons for the adverse effects were discovered.

  • Mid-February, 2008: A month later, the FDA (Food and Drug Administration) released a Public Health Advisory regarding the perils of Baxter Heparin. The warning cited 350 reports of side effects and multiple deaths from Baxter's Heparin products. The advisory recommended that continued Heparin usage should be monitored using the slowest and lowest dosage possible.

  • February 28, 2008: Amid an increase in the number of near-fatal and fatal reactions reported, Baxter recalled all Heparin products in conjunction with FDA recommendations.

  • March 5, 2008: The FDA and Baxter publicly announce the Heparin recall, citing a contamination of the raw materials used to manufacture the drug in Baxter's Chinese manufacturing plant. Additionally, the FDA concedes that it was remiss in its inspection of the China factory, having never conducted a required inspection. At the time, the FDA linked 19 deaths and 785 serious injuries to contaminated Heparin.

  • April 8, 2008: The FDA releases a report stating that the number of deaths resulting from Baxter Heparin is up to 62, three times the previous estimate.

Heparin Baxter Overdose
Serious reports of accidental overdoses have also been cited with Baxter Heparin. The overdose errors are the result of two Heparin products that look similar but vary greatly in dosage.

Since 2001, at least 8 patients are known to have received mistaken Heparin overdoses. Three babies died in Indiana from mistaken overdose of Heparin. As a result, along with the FDA, Baxter International released a warning in February, 2007 regarding the potentially fatal mistake of confusing two of their Heparin products: 10,000mL dosage units and 10mL dosage units.

December, 2007 saw actor Dennis Quaid and his wife name Baxter in a lawsuit regarding a mistaken Heparin overdose received by their infant twins at Cedars-Sinai Medical Center in Los Angeles, CA.

Baxter Heparin Risks and Side Effects
Varied and multiple side effects are associated with an allergic-type reaction to Baxter Heparin. Following is a list of some of the reported symptoms of adverse effects of the drug:

  • abdominal pain
  • difficulty breathing
  • burning sensation
  • chest pain
  • loss of consciousness
  • nausea, vomiting, diarrhea
  • excessive sweating
  • rapidly falling blood pressure, potentially leading to shock
  • death

If you or someone closed to you has suffered serious injury or death as a result of taking Baxter Heparin in California, please seek the help of an experience law team. At Greenberg & Rudman LLP, our attorneys have over 50 years combined experience in taking on large companies and winning. Let us help you in this difficult time of need by calling 1-800-ALAWPRO (1-800-252-9776) for your free and confidential consultation. We are here to help you. Please call us now.