Hetastarch, the generic name for a drug manufactured by Abbott Laboratories, is a drug given to patients undergoing surgery and is administered by an anesthesiologist. Hetastarch, which is also manufactured under the trade names of Hextend and Hespan, is used to compensate for blood and other fluid loss that occurs during surgery.

The amount of Hetastarch that could be given to a patient is limited because of the potential risk of hemorrhage and other surgical complications for patients. This problem led to Abbott Laboratories developing Hextend, a new formulation that would allow it to be administered in higher doses than Hetastarch.

The Columbia University Clinical Trial
Between December 1999 and February 2001, approximately 200 heart surgery patients were enrolled in the Hetastarch/Hextend clinical trial.  While undergoing open heart surgery, they were given doses of either Hetastarch or Hextend.

However, Columbia officials were given information from hospital whistleblowers about the trial, including questions about whether the patients in the study had been given complete information about the purpose of the trial, that they might receive doses of Hextend during surgery, or the potential for serious health risks or other complications.

Investigations Lead to Rarely Issued Order
Between 2001 and 2009, both internal Columbia investigations, as well as investigations led by Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) were conducted.

These investigations led the OHRP to conclude that the allegations regarding patient disclosure may have caused patients in the study to not have been given enough information to properly determine whether they would agree to be part of the clinical trial.

As a result, the OHRP ordered Columbia to contact the patients and/or families of these patients to inform them of the possibility that they had not been provided with complete and accurate information about the study.

While patient privacy rules covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) prevent information about patients to be released, based on whistleblower reports, it is alleged that a number of patients suffered complications after surgery and two study patients reportedly died from post-operative problems that could have been linked to the trial drugs.

For this reason, the OHRP has also requested that Columbia turn over their internal analysis on the surgical outcomes for all of the patients in the study.

How Weitz & Luxenberg’s Lawyers Can Help Your Family
Because of the allegations that patients had not been given complete information about this clinical trial, even patients that did not suffer any adverse health effects may still be eligible to seek compensation from the parties involved in this clinical trial.

If you or a loved one was part of the Columbia Medical Center Hetastarch/Hextend clinical trial, our lawyers want to hear your story.

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

see also:

New York lawyer New York lawyer on filing a Hetastarch lawsuit after Columbia surgery
Free lawyer review for heart patients in 1999 New York Hespan study

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

Clinical Trial Study Free lawsuit info: Hetastarch study at Columbia University Hospital
Legal info about NYC Columbia University Hospital Hetastarch study