Heparin Recall

On January 25th, 2008, Baxter International Inc. issued an urgent recall of certain batches of heparin following reports of serious allergic reactions. Those who have been victimized by these adverse heparin side effects have experienced stomach pains, nausea, diarrhea, decreased blood pressure, vomiting, dizziness, facial swelling and arrhythmia. Although the recall was an urgent action, it has also been labeled a precautionary measure designed to quell further allergic reactions. Thus far, the U.S. Centers for Disease Control and Prevention (CDC) reports no fatalities associated with the reaction.

The heparin recall follows a CDC investigation that found 53 dialysis patients who developed adverse reactions to heparin injections. (Another 36 cases are under investigation by the CDC.) Although Baxter International Inc. issued a voluntary recall of nine different batches of heparin, details of the recall were not released until February 1st.

While the problem has not yet been isolated, CDC investigators have stated that heparin is being viewed as the leading candidate. Heparin is a common blood thinner used to treat patients suffering from kidney problems. CDC officials noted that the allergic reaction experienced in the 53 cases occurred within mere minutes after heparin dialysis began. Most patients recovered after heparin treatment was halted.

Heparin-related allergies have been reported in 19 different dialysis facilities throughout the country, including California, Florida, New York and New Jersey. Several cases are being investigated in which cardiac patients were given heparin; specifically, nice cases of allergic reactions in North Carolina, and four in Florida. (One of the Florida cardiac patients died as a result of the reaction). These cases are currently being investigated and have not yet been linked with heparin.

2.21.08 – FDA Error Linked with Heparin Contamination

An ongoing investigation into the heparin contamination scare affecting hundreds of patients treated with the blood thinner has taken another turn. The main ingredient used in the production of Baxter’s heparin-filled syringes was supplied by a Chinese factory co-owned by Wisconsin-based Scientific Protein Laboratories. According to FDA spokespersons, the Chinese plant was never inspected by FDA officials, even though it was supposed to be.  

The FDA has admitted an internal error resulted in the failure to inspect the Chinese factory producing raw heparin for Baxter. Although the contaminated vials of heparin have not yet been definitively linked with the Chinese facility, the FDA failure underscores questions regarding the effectiveness of the government-run agency to adequately inspect foreign products and manufacturing facilities.

The FDA has dispatched a number of investigators to the Chinese facility with the hope that the source of contamination can be uncovered. Thus far, contaminated heparin has resulted in approximately 350 cases of adverse reaction, including four deaths.

Legal Recourse

If you or a loved one has been injured as a result of using one of the contaminated heparin-filled syringes or as a result of a heparin-related allergy, you may be entitled to receive compensation for your pain and suffering. Medical product manufacturers are required to ensure the safety and efficacy of their products before they are marketed for public use. Failure to adequately measure the potential for side effects or injury is considered negligent and can be grounds for personal injury litigation.

The law offices of Aylstock, Witkin, Kreis and Overholtz boast some of the most experienced personal injury lawyers Pensacola, Florida has to offer. The lawyers and staff of AWKO law specialize in victims’ rights and the litigation of personal injury claims. Contact the law offices of Aylstock, Witkin, Kreis and Overholtz today at (888) 255 2956 to get more information about your rights as a contaminated syringe injury victim or heparin allergy victim.