Second Baby Dies in Heparin Overdose TragedyJul 11, 2008 | Parker Waichman LLP
Over a dozen premature babies were overdosed with the blood thinner, Heparin, at Christus Spohn Hospital South in Corpus Christi, Texas. We recently reported on the tragic death of twin, Keith; now Kay Lynn Garcia, his sister, has died, according to an attorney for the Garcia family.
Heparin, an anticoagulant used to clean intravenous tubes and prevent blood from clotting in the lines, is the drug involved in Dennis Quaid's twins’ overdose this past autumn at Cedars-Sinai Hospital in Los Angeles, California. In that case, the Heparin was made by Baxter Healthcare. Christus Spohn Hospital South said the Heparin used in its case was not made by Baxter, but would not say who manufactured it because the mistake was a mixing error, not a confusion of bottle labels.
Spokeswoman Sherry Carr-Deer confirmed 14 babies received a more concentrated dose of Heparin than prescribed saying, "We know for sure, we know absolutely for sure, that there were 14 babies who got the concentrated heparin," Carr-Deer said. She said three other babies were in the unit when the higher doses were given, but could not confirm if those babies were overdosed. The other babies who received a higher-than-prescribed dose of Heparin remain in critical but stable condition at the hospital, Carr-Deer said. According to standard procedure, nurses were supposed to clean the infants' IV lines with Hep-Lock, a drug containing a very small dose—10 units—of Heparin. Instead, the twins received 10,000 units, or 1,000 times the prescribed amount.
A judge approved the Garcia family’s attorney’s request for a temporary restraining order directing the hospital to save medication, documents, lab results, and vials involved in the babies' care. "We haven't filed a lawsuit seeking damages, just trying to find out what happened," the attorney said. He said he plans to ask the court to let him take depositions from hospital personnel. "The babies were roughly four weeks' premature and should not have been at high risk. The doctor assured the parents the newborns' lungs were fully developed, he added.
In February 2007, the Food and Drug Administration (FDA) and Baxter International, issued a two-page safety alert warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of Heparin. The memo advised hospitals to double-check inventory to ensure dispensing errors did not occur and was issued after three infants died in Indiana when they were mistakenly given adult doses. According to US Pharmecopia, during the past 18 months, there have been roughly 250 medical errors nationwide involving Heparin and children a year or younger. Also, this year tainted Heparin has been implicated in 149 deaths and hundreds of allergy-type reactions. In March, the FDA confirmed it found oversulfated chondroitin sulfate in samples of the active ingredient used in Heparin supplied by Baxter International. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.