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

It wasn’t until then that Martin learned the syringe he had used on his young son was part of a recalled batch that was found to have been contaminated at the manufacturing plant AM2PAT. The tainted syringes killed five people and sickened at least 100 more before the Angier plant was closed. The company’s “clean room” was found to be a frightful mess.

Last month, two AM2PAT managers pleaded guilty to federal fraud and a warrant is out for AM2PAT president Dushyant Patel, who is still at large.

Knowledge of the recall did little to put Martin’s mind at ease. He wants answers from the company, the distributor of the syringes, and the Food and Drug Administration (FDA).

“I just felt, why? Why didn’t somebody stop this?” he told media. “Not only did they hand me a loaded gun, they enabled me to pull the trigger on my own son.”

An FDA warning letter to the plant in 2005 reported no major safety violations. However, an FDA spokesperson says in August 2007 the company began producing the syringes at a “dramatic rate” and that was when quality began to slip.

The FDA was notified by the Centers for Disease Control and Prevention about the adverse events reported, and within five days the FDA had closed down the plant for manufacturing violations. The FDA also contends that “evidence of a casual link between the AM2PAT product” and the infections was “never conclusively established.”

The FDA’s claims don’t sit well with Martin, who says he will pursue legal action.

Source: WRAL

SOURCE: Heparin Recall › Father blames FDA for not taking precautions to protect son

AM2PAT is now the subject of a criminal investigation. Federal investigators say the company was so focused on making profits that it did not conduct necessary safety tests and instead covered up the matter by falsifying reports to make it appear those tests had been conducted.

Earlier this week, workers at the plant pleaded guilty for their roles in the scandal and were sentenced to four years in prison. The company’s president, Dushyant Patel, faces numerous charges but has apparently fled to his native country India. If convicted, he faces up to 95 years in prison.

According to reports, the FDA received complaints that there were “orange specks,” or “yellow sediment” floating in the unopened syringes, or that the medicine inside appeared “muddy brown.” Despite the reports, which are recorded as early as November 2005, the FDA didn’t follow up on the complaints until 22 months later.

Food and drug manufacturing plants should be inspected by the FDA every two years, but many plants, such as AM2PAT have received site visits about every five years, according to a report from the Government Accountability Office. The report also shows that between 2002 and 2007, FDA inspectors visited only about 25 percent of the 5,616 registered plants each year.

SOURCE: Heparin Recall › FDA knew of tainted syringes two years before inspecting plant

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