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Our Lawyers Provide Information and Help for Heart Surgery Patients Who Took Part in 1999-2001 Clinical Trial Study of Hetastarch and Hextend

Our lawyers are currently looking to speak with patients and the families of the patients that took part in a clinical trial study involving two surgical medications: Hetastarch and Hextend. The study was conducted at New York City’s Columbia University Medical Center between 1999 and 2001. An investigation has revealed that participants may not have been properly informed about the purpose and risks involved in the study.

Even if your loved one did not suffer any adverse health affects after being given either of these drugs during surgery, Weitz & Luxenberg would still like to speak with you.  Complete the form on this page for more information about your rights to pursue a Hetastarch/Hextend lawsuit.

Between December 1999 and February 2001, approximately 200 heart patients admitted to the to the New York Presbyterian Hospital/Columbia Medical Center were enrolled in a clinical trial study of Hetastarch, a drug administered during surgery to compensate for blood and fluid loss during surgery.

Hetastarch and Hextend
Hetastarch is manufactured by Abbott Laboratories, a pharmaceutical company with U.S. headquarters in Chicago. At the time, Abbott also manufactured a new formulation of the drug, known as Hextend.

Because of dosing restrictions for patients who received Hetastarch during surgery, Abbott developed Hextend, which could be administered in higher doses.

Before Hextend could receive approval from the U.S. Food and Drug Administration (FDA), Abbott was required to have the drug undergo a number of scientific and clinical tests, which eventually led to the clinical trial study at Columbia.

Problems with the Study
Since the study concluded in 2001 and June 2009, a number of internal Columbia investigations, as well as investigations conducted by the Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) were conducted regarding allegations that the study participants were not appropriately informed about the purpose and risks involved in participating in the study.

Concerns were raised on a number of issues, including whether patients and families had been informed of the purpose of the study, whether they would be administered doses of Hetastarch or Hextend during surgery, and whether they were properly advised of the potential for serious, life threatening side effects if they received Hextend.

Another area of concern was raised by two whistleblowers, later identified as anesthesiologists at Columbia. These doctors expressed concern that some of the patients enrolled in the study were from a low income, primarily Spanish-speaking neighborhood in the Washington Heights area.  These patients were not referred to the study by a private physician or healthcare professional; rather, they were admitted to the Columbia cardiac surgery unit directly from the hospital Emergency Room.

Finally, the doctors reported that a number of surgical complications arose in the patients in the study, including post-operative hemorrhaging, cardiac arrest, and brain or other organ damage. Two patient deaths were reported to be associated with their participation in the study.

OHRP Takes Action
In June 2009, the OHRP took a step that has only been ordered a handful of times in the past 20 years: to order Columbia to contact the patients and families of all the study participants to advise them that their loved ones many not have been properly informed about the study. The OHRP has also ordered Columbia to prepare an internal analysis about the outcomes for all of the patients in the study.

How Weitz & Luxenberg Can Help
If you or a loved one underwent heart surgery at the Columbia Health Center between 1999 and 2001 and was part of the Hetastarch/Hextend clinical trial, the lawyers in our Dangerous Drugs and Medical Devices unit 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:

hetastarch lawyer Lawyer guidance for heart patients tested with hetastarch at Columbia
Free lawyer review for patients in NY medical study of hetastarch med

hextend law firm Law firm for heart patient tested at Columbia with hetastarch, hextend
Free law firm review for patients in hetastarch and hextend NYC study

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