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Investigation of Patient Participants in 1999-2001 Clinical Trial Study of Surgery Drugs Hetastarch and Hextend at New York’s Columbia Medical Center Hospital

If you or a loved one underwent open heart surgery at the New Presbyterian Hospital/Columbia Medical Center between December 999 and February 2001 and may have been a part of a clinical trial of the surgical fluid replacement drugs Hetastarch and/or Hextend, Weitz & Luxenberg’s attorneys would like to speak with you. An investigation into the clinical trial has revealed that study participants may not have received complete information about the trial and the health risks before agreeing to participate.

Even if you did not suffer any injuries or health complications as a result of being involved in the study, you may still be able to file a lawsuit against those responsible for administering Hetastarch or Hextend during surgery. Please complete the form on this page for information about your legal rights to pursue a lawsuit.

For over 75 years, the Columbia University Medical Center has served the healthcare needs of hundreds of thousands of New Yorkers and others needing medical care. The hospital, located in the Washington Heights section of New York City, is also involved in medical research, which includes clinical trials of any number of new drugs, medical devices and other new medical treatments.

Clinical Trial Studies and the Hetastarch/Hextend Clinical Trial
Before any hospital, university, or other medical research facility can conduct a clinical trial of a new drug, to use an already approved drug to treat another condition, or the continued testing of an experimental drug to treat life-threatening diseases, they must first obtain approval from the U.S. Food and Drug Administration (FDA). The FDA requires that patient participants in clinical trial studies clearly understands the purpose of the research, why it is being conducted, what drugs they will be given, and the potential health risks that can result from being given the drug.

In December 1999, the Columbia Medical Center began a study of two fluid replacement drugs routinely administered during surgery to prevent blood and fluid loss.

Hetastarch, the generic name for one of the drugs, is a liquid solution that contains salt, starch and other components. The drug is manufactured by Abbott Laboratories. Because of the risks of excess bleeding that can occur if a patient is administered too much Hetastarch, Abbott developed a new form of the drug, called Hextend. This new trial drug had been formulated so that patients could be given the drug in higher doses than Hetastarch.

Were Risks Explained to Clinical Trial Patients?
Over 200 patients undergoing open heart surgery were enrolled in the clinical trial, where they would be given either the normal dose of Hetastarch or the larger dosage of Hextend during surgery.

Both during the time of the clinical trial and after it was concluded, Columbia physicians and others are alleged to have reported serious problems with the study, and that that a number of patients had had complications such as hemorrhages, cardiac arrest, liver, brain and other organ damage.  Two clinical trial patients were reported to have died after surgery.

However, one of the key issues in the subsequent investigation was whether the patients in the trial had been given complete information about the study, the potential risks if they were given Hextend and other important information that was needed in order to understand the nature of the study.

How Weitz & Luxenberg Can Help
If you or a loved one underwent heart surgery at the Columbia University Medical Center between 1999 and 2001 and was part of the Hetastarch/Hextend clinical trial, our attorneys would like to hear your story.

Complete the form on this page for a free Hetastarch lawsuit review. A Weitz & Luxenberg representative will contact you as soon as possible.


see also:

New Form of Drug Lawsuit info: NYC hospital study of albumin-containing drug Hetastarch
Prolems with Albumin-containing surgery drug Hetastarch hospital study

Drug Study Free lawsuit review: NYC hospital clinical trial study of Hetastarch
Free lawsuit info for those in Hetastarch/Hextend clinical trial study

Heart Surgery Risks Heart surgery lawsuit information: Hetastarch study at NYC hospital
Info for NYC Columbia Hospital heart surgery patients given Hetastarch

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