The anticoagulant drug Heparin, made by Baxter Healthcare, has been plagued by problems during the past few years. In 2008, the U.S. Food and Drug Administration ordered a recall of Heparin after finding that contaminants in the drug caused severe injury and death in a number of patients. It was reported that Baxter’s confusing packaging led to Heparin overdoses in infants and small children, causing injuries and deaths.
Heparin (also known as heparin sodium) is an anticoagulant, or blood thinner. Because blood thinners make it harder for blood to clot, doctors use them to treat and prevent blood clots in veins, arteries and lungs. Heparin comes in liquid form and is usually injected into a vein, under the skin, or by way of an intravenous catheter. In some instances, doctors use large multiple-dose vials of intravenous heparin (called bolus doses) in order to thin a patient’s blood over a short period of time.
Heparin is also used to coat some medical devices, such as lock flushes (used to clear IV lines and catheters), catheters and oxygenators. Prior to 2008, Baxter Healthcare manufactured about half of the heparin available in the United States. The other big heparin manufacturer is APP Pharmaceuticals. Beginning around 2006, patients and physicians reported an increase in severe allergic-type reactions to bolus doses of Baxter’s heparin. Those reactions – which caused a number of patient deaths included extreme nausea, vomiting, breathing difficulty, excessive sweating and decreased blood pressure.
In January and February 2008, almost all Baxter heparin products were recalled from the market. Subsequent investigation revealed that Baxter’s Heparin contained a contaminant that caused the adverse reactions in patients. The contaminant, known as oversulfated chondroitin sulfate, was supplied by a Chinese firm, Changzhou SPL. Oversulfated chondroitin sulfate mimics the biological activity of Heparin, but is less expensive. According to reports, the contaminated Heparin killed 81 people and sickened hundreds more.
Even before the FDA ordered the heparin recall, lawsuits were being filed against Baxter Healthcare because of patients’ adverse reactions to bolus doses. The FDA recall definitely was good for the plaintiffs in the Heparin litigation. The lawsuits, which alleged that Heparin bolus doses caused some patients to get sick or die, include several theories of liability. Those theories include:
• Negligence – Baxter had a duty to ensure that heparin was safe and failed to fulfill that duty by not adequately monitoring or testing the drug for contaminants or adverse side effects.
• Product liability – Baxter knew, or should have known, that the heparin was defective, but manufactured, marketed and supplied it anyway.
• Strict product liability – In strict liability, a manufacturer is held liable for injuries caused by a defective drug regardless of how careful the manufacturer was in producing or marketing the drug. It’s contended in the heparin lawsuits that Baxter’s heparin was defective because of the contaminant and because it caused such severe side effects.
• Fraud – Baxter or Changzhou SPL knew the contaminant might be dangerous, but used the cheaper ingredient to dilute heparin sodium in order to increase profits. Baxter misrepresented the safety of heparin in its marketing of the drug.
• Breach of warranty – It’s alleged under the theory that Baxter’s heparin was not fit for its intended purpose.
In the last four years, a number of children have died or been injured because hospitals unintentionally gave them massive overdoses of heparin. Some parents sued Baxter, alleging that it was at fault for the dosing errors because it packaged adult and pediatric versions of heparin in vials of the same size and with nearly identical blue backgrounds, so that hospitals had difficulty distinguishing between the two. Parents also claimed that although Baxter agreed to change the labeling, it did not recall the existing stock of pediatric heparin.
In the summer of 2008, all of the federal Heparin lawsuits (more than 50 in number) were transferred to the U.S. District Court in Toledo, Ohio, becoming part of multidistrict litigation (MDL) coordinated by Judge James G. Carr.
For more information concerning this litigation, contact Melissa Prickett, a lawyer in our firm’s Mass Torts Section, at 1-800-898-2034 or by email at Melissa.Prickett@beasleyallen.com.
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