Sierra Pre-Filled Syringe Debacle Yields Five More LawsuitsJan 25, 2008 | Parker Waichman LLP Sierra Pre-Filled bacteria tainted syringes continue to be the target of lawsuits. Five people filed a lawsuit Thursday against Sierra Pre-Filled of Angier, North Carolina, manufacturer of the contaminated pre-filled syringes. All five claimants are Illinois residents and patients at Rush University Medical Center in Chicago. The five Sierra Pre-Filled syringe lawsuit plaintiffs allege they became seriously ill and were hospitalized because of the defective medical devices.
In December, doctors traced numerous infections to heparin-filled syringes used during home treatment for cancer and other ailments. Around 40 people were sickened, including 20 outpatients at Rush. Of the 20 who fell ill, 14 required hospitalization. Doctors at Rush were able to trace the infections to heparin-filled syringes patients used during home treatment for cancer and other ailments. The Sierra Pre-Filled syringes were found to be contaminated with Serratia marcescens bacteria.
Dushyant Patel, president of Angier, N.C.-based Sierra Pre-Filled, told The Associated Press on Thursday that he did not know about the new lawsuits and couldn't comment.
Another woman, Katie Abrams, a 30-year-old leukemia patient, filed in December what is believed to be the first lawsuit involving the tainted syringes. More lawsuits are expected. Abrams claimed a batch of Sierra Pre-Filled heparin syringes contaminated with bacteria made her fall violently ill. Abrams was hospitalized for nine days after using the Sierra Pre-Filled Syringes at home, when she "became ill with uncontrollable shaking, vomiting and a fever that reached as high as 105.5 degrees Fahrenheit."
In December 2007, Sierra Pre-Filled recalled syringes from the lot that was implicated in the infections. Then, on January 18th, the Food and Drug Administration (FDA) and Sierra Pre-Filled announced an expansion of the recall to include all lots and sizes of the heparin and saline pre-filled syringes because they were tainted with the bacteria Serratia marcescens.
The Sierra Pre-Filled syringe products are distributed under two brand names: Sierra Pre-Filled Inc. and B. Braun and products are sold in pre-filled syringes in 3 ml and 5 ml sizes for Heparin and in 3 ml, 5 ml, and 10 ml sizes for Normal Saline. Consumers and user facilities with the Sierra Pre-Filled recalled pre-filled syringes or Heparin or Saline Lock Flush Solution USP, should stop using the products immediately. Recalled products should be immediately quarantined in inventory and immediately returned to the distributor. The product was distributed to Florida, Texas, Illinois, Colorado, and Pennsylvania.
Infections resulting from the Serratia marcescens can cause fever and chills and can be serious, but generally respond well to antibiotics. In people with weakened immune systems, however, this type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. Many of those using the tainted Sierra Pre-Filled syringes were undergoing chemotherapy treatments which would have compromised their immune systems.
An ongoing FDA inspection of Sierra Pre-Filled’s facility revealed the company is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.