Investigators now know that the pre-filled heparin and saline syringe Fullerton used was part of a contaminated lot that has since been linked to at least four deaths and 162 illnesses. And that lot could have and should have been prevented from being shipped to hospitals by the Food and Drug Administration (FDA).

Months before the syringes were shipped out, the FDA received reports about debris in syringes filled with heparin and saline distributed by drug manufacturer AM2PAT, yet the agency didn’t follow up on the complaints until 2007 after the reports of deaths and illnesses following use of the syringes. Reports from 2007 inspections show that investigators found a “gummy brown” substance on the syringe-filling machine. The plant was closed in January 2008.

Consumer advocates say the FDA should have acted faster and more aggressively to prevent the contamination of the pre-filled syringes at AM2PAT. Congress, too, has been critical of the agency for not properly or adequately inspecting food and drugs that are distributed to American hospitals and health care centers, and are pushing for better inspection standards within the agency.

Source: Pro Publica

SOURCE: Heparin Recall › FDA should have acted faster to prevent contamination

Earlier this week two former workers at the plant, plant manager Aniruddha Patel and quality control director Ravindra Kumar Sharma, were sentenced in federal court to more than four years in prison for allowing the tainted drugs into hospitals and clinics in Colorado, Florida, Illinois and Texas. Last week, the company’s chief executive, Dushyant Patel, was indicted on 10 charges for fraud and selling adulterated medical devices. A warrant is out for his arrest.

The drugs were not produced at the plant, but were put into the syringes and shipped to the hospitals and clinics from there. According to Patel, the company recalled the syringes a year ago after federal officials began investigating the outbreak.

“Citizens in this country trust that producers of medical devices aren’t lying when they say that have adequately tested a given product,” said U.S. Attorney George Holding to the Associated Press. “As we’ve seen in this case, such lies can literally mean the difference between life and death.”

SOURCE: Heparin Recall › Two sentenced for role in tainted heparin, saline syringes

Ralph Sell of Lincoln, Nebraska, says that his wife Alice was undergoing cancer treatments in December 2007 when a syringe contaminated with Serratia marcescens, a bacteria that can cause serious injury or death, was used on her. She suffered high blood pressure, disorientation and sepsis. She died a year later at the age of 82 of “acute respiratory failure.” It has not yet been determined if the contaminated syringe may have led to her death.

Sell filed suit against Baxter International as well as its subsidiary Baxter Healthcare Corp., B. Braun Medical Inc., and AM2 PAT Inc, also known as Sierra Prefilled. A spokesperson for Baxter says the company has no role in the lawsuit, as it does not sell prefilled saline syringes. AM2 PAT did recall saline prefilled syringes in December 2007 and January 2008 because some of the syringes were tainted with the bacteria.

Baxter currently faces numerous lawsuits stemming from a 2008 recall of the blood thinner heparin. Batches of the company’s heparin manufactured in China were found to have been contaminated with over-sulfated chondroitin sulfate (OSCS). The tainted heparin is believed to have contributed to the deaths of more than 80 Americans and caused serious illnesses in hundreds more.

Sell’s lawsuit against the companies seeks unspecified damages and payment for medical costs.

SOURCE: Heparin Recall › Baxter named in contaminated saline syringe lawsuit