Tainted Heparin Still a Lightning Rod of Opinion, Litigation

Raleigh, NCImagine the panic of a father, rushing his son to hospital. The child was shaking uncontrollably and had developed a fever of 106. Dusty Martin didn't know it at the time, but the basis for his son's intense suffering was a contaminated heparin syringe from AM2PAT.

Michael Martin, all of 8 years old, is a hemophiliac and in constant danger of bleeding to death resulting from the simplest of things. Beyond the possibility of infection, a slight cut on the finger for you and I is little more than an inconvenience.

However to a hemophiliac such a boo-boo on the finger could mean much more. Thus, as a preventative measure Martin regularly uses pre-filled syringes of saline and heparin to flush out a port imbedded in little Michael's chest prior to the administration of medication.

It was last year when the suddenly-ill child was rushed to hospital for emergency surgery to help prevent the spread of a bacterial infection caused by a contaminated pre-filled heparin syringe from AM2PAT. It turns out that the syringe was part of a lot of heparin syringes recalled due to contamination.

The plant was closed, but not before five people died and more than 100—including wee Michael Martin—were sickened. It has been reported that conditions in the facility's so-called 'clean room' were frightfully inadequate.

Tainted heparin has become just the latest in a series of lightning-rod issues that has focused attention on a woefully inadequate and under-funded government watchdog. In recent years the US Food and Drug Administration (FDA) has been dogged by criticism after food recalls, prescription drug deaths and problems with medical devices have caused the American people to lose confidence in an agency charged with the massive responsibility of keeping the nation's food and drug supply safe.

Heparin is one such issue. From tainted heparin from China, to poorly labeled heparin vials that are thought to have led to the deaths of several infants, the blood thinner and problems arising from its manufacture and packaging have galvanized public opinion.

Baxter is one such company that has been at the epicenter for two separate issues involving heparin: the emergence of tainted heparin sourced from China (since recalled), and the mix-up of similarly labeled heparin vials in the hospital setting. In the latter case infants were given heparin from the wrong vial, resulting in the administering of an adult dose of heparin 100 times stronger than appropriate for an infant. Many infants in several separate cases were taken severely ill and some died.

The vials have since been redesigned. Originally the vials were the same size and shape, with blue labels—although different shades of blue to identify adult strength, vs. doses suitable for infants. Baxter, in one of the cases blamed the attending nurses for the mix-up. However critics maintain that given the highly-charged atmosphere often present in a hospital setting, vials should carry much more obvious differences in order to help mitigate errors.

In the case of AM2PAT, neither issue was at play. There were no similarly shaped and labeled vials, nor was there any tainted heparin from China. No, the problem was allegedly at the AM2PAT facility itself. Two AM2PAT managers have already pled guilty to federal fraud. As for AM2PAT president Dushyant Patel, he fled the country and is still at large.

The plant, it has been said, was a mess. However it has been reported that the FDA was concerned much earlier. Even though there were no safety violations identified, the FDA is said to have sent a warning letter to AM2PAT in 2005. Two years later, after AM2PAT had ramped up production the Centers for Disease Control and Prevention (CDC) in Atlanta began receiving adverse reaction reports. Within five days of reporting those findings to the FDA, the AM2PAT plant was shut down.

That's not good enough for Dusty Martin. He wants answers. "I just felt, why? Why didn't somebody stop this?" he said in a media interview. "Not only did they hand me a loaded gun, they enabled me to pull the trigger on my own son."

According to a media report Martin plans to pursue legal action—as are a score of patients who have suffered adverse reactions to heparin.