Drug error that harmed Quaid twins shows need for better safety measures

Michael L. Langberg, chief medical officer for Cedars-Sinai, said the Nov. 18 overdose was the "result of a preventable error." Quaid's twins and one other patient had their IV catheters flushed with heparin from vials containing a concentration of 10,000 units per milliliter instead of similar vials that had a concentration of 10 units per milliliter.

All three patients given the wrong dose were children and were receiving intravenous medications. The error was identified by hospital staff, who quickly tested the blood-clotting function of the three affected, along with four other patients as a precaution, Langberg explained. Two patients were given protamine sulfate, a drug that reverses the effects of heparin and helps restore normal blood clotting function.

The Indiana infants died in September 2006 after they were given an accidental overdose of heparin through their IVs at Methodist Hospital in Indianapolis. A hospital investigation concluded the overdose was caused by a pharmacy technician mistakenly storing adult doses of the blood thinner in Methodist's neonatal unit drug cabinet.

Those deaths prompted the drug's manufacturer, Baxter Healthcare Corp. of Deerfield, Ill., and the Food & Drug Administration to issue a statement warning of the "potential for life-threatening medication errors involving heparin products." Baxter also revamped its packaging and labeling of heparin; the drug's new label features bigger font size, a unique color combination and a large red cautionary tear-off label.

Baxter's warning and new labeling, however, was not enough to fend off a lawsuit filed by Quaid. The lawsuit accuses Baxter of failing to put clear distinguishing labels on its 10-unit and 10,000-unit vials of heparin, and failing to recall the product after the Indiana infants died. The Quaids are asking at least $50,000 in damages.

Baxter spokeswoman Erin Gardiner declined to comment on the lawsuit, saying the company had not yet received a copy of it. But she noted that the medical mix-up is "not a product issue" but rather the "improper use of a product."

Susan E. Loggans, a Chicago attorney who filed the lawsuit on the Quaids' behalf, said the twins have recovered from the overdose. "The Quaids are very religious and they believe their children's recovery is a real miracle.

THE AUTHOR is a writer based in New Jersey.