Around 40 people were injected with a fluid that was not tested against harmful pathogens at New York-Presbyterian/Weill Cornell Medical Center in New York City. The fluid, called BioBurst, is derived from umbilical cord blood, and was being used in spinal surgeries. Doctors learned it was unsafe from an FDA letter that warned Smart Surgical, Inc., the company that produces BioBurst, that it was not adhering to FDA guidelines.

Firstly, BioBurst is not approved for these spinal procedures. In order for the product to be legally sold it needed a biologics license, which is given after the product is proven to be safe and effective. Bioburst does not have this license.

Secondly, Smart Surgical, Inc.’s screening process is faulty. It failed to remove donors who had an increased risk of having Zika virus, which can cause birth defects when contracted during pregnancy. The fluid injected into those spinal surgery patients could have contained Zika virus.

And lastly, the FDA determined that the manufacturing facility that is producing BioBurst is not safe. Its facility doesn’t effectively prevent contamination and doesn’t adequately test for contaminants. 

Furthermore, patients who received this treatment were not told of the potential harm it could cause. This is a failure of informed consent. It is your doctor’s responsibility to tell you the risks and benefits of any treatment they offer you. Without accurate information, a patient can end up agreeing to harmful treatment that they wouldn’t have agreed to if they had known the risks.

We still don’t know if anyone has been hurt by the fluid, because the patients who received it have still not been told they were injected with a potentially contaminated product. If a patient  was seriously injured by an infection caused by the BioBurst fluid, they would be a good candidate for a  medical malpractice case.