Amputee Files Lawsuit against Heparin Maker

Charleston, NCLast month, LawyersandSettlements interviewed an amputee whose problems allegedly stemmed from his use of heparin. Now a different man reports that an adverse reaction to heparin resulted in the amputation of his toes. He and his wife filed a lawsuit, naming as defendants Baxter Healthcare Corp.; Baxter International, Inc.; Scientific Protein Laboratories, Inc.; Changzhou SPL Company, LTD.; and American Capital LTD.

James Bradley was prescribed heparin in 2007. Immediately after being injected with the blood thinner, he began to suffer disabling and debilitating injuries, eventually leading to the loss of his toes.

His lawsuit, filed November 10 in Kanawha Circuit Court, claims that Bradley has suffered severe physical and mental pain and suffering.

The suit alleges that heparin was defective and not reasonably fit, suitable or safe for its intended purpose and/or its foreseeable risks exceed the benefits associated with its design and formulation.

James and Shirley Bradley are suing the makers of heparin for compensatory and punitive damages for product liability, defective design, failure to warn, consumer fraud, breach of express warranty, tort of malpractice and loss of consortium.

Google "Heparin and Amputations" and the results are alarming. According to the website for the Institute for Scientific and Technical Information (CAT.INIST.fr), "Heparin-induced thrombocytopenia (HIT) is a potentially serious adverse reaction caused by platelet-activating antibodies." At Princess Alexandra Hospital in Australia, 14 out of 22 patients were identified with HIT. Seven patients died and HIT was considered contributory in four. One patient required mid-forearm amputation.

In 2006, the US National Institutes of Health reported that a patient was diagnosed with HIT, which resulted in bilateral above-knee amputations.

HIT has been reported to occur in patients receiving heparin with a reported incidence of 0 to 30 percent. While often mild and of no obvious clinical significance, such thrombocytopenia can be accompanied by severe thromboembolic complications such as gangrene of the extremities that may lead to amputation.

Baxter's website reports the following Heparin side effects: "Stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening."

Perhaps Baxter should include HIT and amputation in its list of Heparin side effects.