Heparin, manufactured by Baxter Healthcare Corporation, is an intravenous blood thinner with a very narrow therapeutic window, which means that the dosage at which it is effective is very close to the dosage at which it is toxic. As a result, the administration of Heparin must be carefully controlled. Many people have been injured as a result of accidental overdosing of the version of Heparin named Hep-Lock, and others by exposure to contaminated batches of Heparin.
There are three categories of litigation concerning heparin injuries:
1.The ten-unit bottle and ten thousand-unit bottle of Hep-Lock used to be similar in size and both were colored in shades of blue. In the right lighting, it was difficult to tell them apart. Baxter eventually changed the labels and bottle coloring in order to prevent these problems. However, Baxter did not recall the old bottles of Hep-Lock. As a result, hospitals still used the poorly-labeled bottles of Hep-Lock, leading to some horrifying experiences, including hypotension (low blood pressure), organ damage, organ failure, and death.
The children of actor Dennis Quaid received Hep-Lock when they were eleven days old. In November of 2007, the twins were hospitalized for staph infections at Cedars-Sinai Medical Center. They were given Hep-Lock, but thanks to the confusion in packaging, instead of receiving ten units they received ten thousand units. This caused their blood to flow freely internally and from all external wounds. At one point, blood from a wound in son Thomas’ spine “spurted six feet across the room and splattered on the wall.”
In September of 2006, a hospital in Indianapolis had experienced a similar mix-up and three infants died. Three other infants were seriously injured.
Other users of Heparin have been injured as a result of receiving contaminated batches of the drug. Some batchs of Heparin contain a manmade ingredient, oversulfated chondroitin sulfate, that is manufactured in China. Due to problems with the manufacturing process, batches of Heparin were contaminated by impurities, leading patients (who are already in medical distress when they receive the Heparin) to experience allergic reactions, organ damage, organ failure, and death.
2. Heparin is made from pig intestines and has been marketed in the United States since the 1930s. Since Jan. 1, 2007, the deaths of at least eighty-one people have been linked to contaminated heparin. There are hundreds of other suspected cases of death and serious bodily injury resulting from heparin use.
In January of 2008, the FDA announced it had learned about an increase in the number of serious allergic-type hypersensitivity reactions, including oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension in association with the use of intravenous bolus doses of heparin sodium for injection manufactured by Baxter Healthcare. FDA scientists subsequently identified a contaminant in heparin, called oversulfated chondroitin sulfate. This is a substance derived from animal cartilage that was chemically modified to mimic the biological activity of heparin. This substance replaces the active pharmaceutical ingredient in heparin, is a less-expensive alternative, and is not approved for use in medicine.
The oversulfated chondroitin sulfate used to make Baxter’s heparin was supplied by Scientific Protein Laboratories (“SPL”). SPL has facilities in Changzhou, China and in Wisconsin where it produces the active pharmaceutical ingredient for Baxter’s heparin.
In April of 2008, FDA Commissioner Andrew von Eschenbach testified before a Senate Appropriations Committee’s agriculture subcommittee hearing on the agency’s fiscal 2009 budget that the FDA suspected the ingredient switch had been made “by virtue of economic fraud.” von Eschenbach said that the presence of oversulfated chondroitin sulphate could not have arisen as a result of normal processing and formulation operations, and that the replacement of heparin with oversulfated chondroitin sulphate could only have been carried out deliberately.
3. Beginning in October of 2007, many people received syringes pre-filled with Heparin and saline that were contaminated with a bacterium named serratia marcescens. This led to outbreaks of a bloodstream infection, primarily in Texas and Illinois.