Michael Stratton of Stratton Faxon, Connecticut’s firm for trial law, is concerned about the controversial blood thinner heparin.
Heparin is a blood-thinning drug that had become practically ubiquitous in hospitals by 2008, especially as part of a regimen for a host of cardiovascular-related conditions. But in the intervening months since, this particular pharmaceutical has been blamed for as many as 100 patient deaths and perhaps thousands of injuries caused by contaminated ingredients and confusing labeling that led to overdoses.
“It used to be considered safe without reservations,” says attorney Michael Stratton of Stratton Faxon based in New Haven, Connecticut, “not anymore.”
In Delaware, the maker of the drug, Baxter International Inc., has confirmed the deaths of a 71-year-old man and a 64-year-old woman who received the drug at Beebe Medical Center in Lewes, Delaware. A third patient who suffered medical complications at the same hospital after receiving the drug survived. “These are tragic cases, but probably only the tips of the proverbial iceberg,” Stratton says, “Cases involving heparin are seldom easy to prove.”
In 2008, Baxter heparin contaminated with a counterfeit active ingredient supplied by a Chinese company was blamed for about 100 deaths and hundreds of injuries to patients receiving the drug. Based on those injuries, the FDA ordered a recall of heparin made by Baxter before the year ended. It later was determined that the FDA had failed to inspect the Chinese plant where the contaminated heparin was made, prompting calls to improve the agency’s monitoring of foreign drug manufacturers.
Baxter was also criticized for labeling that failed to adequately distinguish between full-strength heparin and a lower-dose form of the drug, called HepLock, which is used in newborns.
Confusion between the size of the vials and similar labeling for heparin and HepLock was blamed for mix-ups in which newborns were given multiple doses of full-strength heparin instead of HepLock, causing deadly internal bleeding. In one high-profile case, the newborn twins of actor Dennis Quaid and his wife were critically injured when a nurse at Cedars-Sinai Medical Center in Los Angeles mistakenly administered several doses of heparin to the twins instead of HepLock. “Such mistakes are inexcusable,” Stratton concludes.
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