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Sierra Pre-Filled Syringe Lawsuit Filed in Illinois, and More are Expected to Follow

Dec 26, 2007 | Parker Waichman Alonso LLP

A contaminated Sierra Pre-Filled Syringe made a leukemia patient seriously ill, and now she is suing the maker of the defective devices.  The 30-year-old Illinois woman reportedly spent 9 days in the hospital as a result of the bacterial infection she contracted from the Sierra Pre-Filled Heparin Syringe she used as part of her home treatment.  Late last week, the tainted Sierra Pre-Filled Syringes where pulled from the market after dozens of blood infections where traced to them.  

Around 40 people have been sickened in Texas and Illinois by the tainted Sierra Pre-Filled Syringes, including 20 outpatients at Rush University Medical Center in Chicago; no deaths have been reported.  Of the 20 Rush outpatients who fell ill, 14 required hospitalization.  Doctors at Rush were able to trace the infections to heparin-filled Sierra Pre-Filled Syringes the patients used during home treatment for cancer and other ailments.  Heparin is a blood thinner and the syringes are used to clear out catheters and intravenous lines.  The infections were caused by bacterium called Serratia marcescens found in a single batch of the heparin-filled syringes made in North Carolina, by a company called Sierra Pre-Filled.  Serratia marcascens generally causes fever, chills and vomiting, but responds well to antibiotics.  However, in cancer patients, the blood infection can be much more serious because the immune systems of such patients are already compromised.  In such cases, infections caused by the bacteria could be life-threatening,

The Food & Drug Administration (FDA) ordered the contaminated Sierra Pre-Filled Syringes recall late last week.  The FDA is asking doctors  to trace the recalled Sierra Pre-Filled Syringes and make sure their patients stop using them at once. The contaminated Sierra Pre-Filled Syringes should be put into “quarantine” and returned to the distributor. In announcing the Sierra Pre-Filled Syringe recall, the FDA said that an ongoing inspection of Sierra Pre-Filled showed that the firm is “not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes”.

In what will likely be the first of many Sierra Pre-Filled Syringe lawsuits, the Buffalo Grove, Illinois leukemia patient alleges that she “became ill with uncontrollable shaking, vomiting and a fever that reached as high as 105.5 degrees Fahrenheit."  The complaint, which was filed in Illinois state court last Friday, is asking for unspecified damages.

The Sierra Pre-Filled Syringe recall includes the company’s Heparin Lock Flush Solution USP, 100 units/ml, 5ml in pre-filled syringes; lot number: 070926H; NDC number: 64054-1003-02; Catalog number: 1003-02. Tainted Sierra Pre-Filled syringes from that batch were also sent to Colorado, Florida, and Pennsylvania but infections—so far—have turned up only in Illinois and Texas.