Heparin Contamination Just the Tip of the Iceberg

Indianapolis, INThe heparin contamination debacle that has been blamed for 81 deaths and scores of injuries, turned out to be the first landmark example of problems with drugs coming from foreign countries—in this case, China. But heparin injection has been in the news within another context of late; adult dosages of the drug flowing through heparin syringes into the veins of infants. It's a problem, it seems, that's happening with increasing frequency.

In this case, several infants died over the span of 18 months after receiving an overdose of heparin, and the families of the doomed children have variously sued Baxter Healthcare, alleging confusing packaging, as well as negligent conduct on the part of hospital workers.

Baxter, you will recall, was at the center of the tainted heparin scare last year. While it was not the only pharmaceutical company to be touched by tainted raw heparin from China, it certainly was the largest victim of what the US Food and Drug Administration (FDA) now calls deliberate contamination by unsavory foreign parties simply motivated by greed. Baxter was forced to trigger a massive recall.

However, it seems that tainted heparin is not the only problem to touch Baxter.

It was on September 16th of 2006 that infants Emmery Miller and D'myia Alexander Nelson, 2 and 5-days-old respectively, died at Methodist Hospital in Indianapolis. Four other infants fell ill after having been administered heparin, a common blood thinner.

Two days later the hospital announced new safety precautions and training for staff. But that didn't prevent a third infant from dying the next day. It was since discovered that vials of Baxter adult, and infant heparin (representing vastly different strengths) are of the same size, and both have blue labels, even though the color is a slightly different shade. It was determined that due to the similarity of labels; the infants were accidentally given adult doses.

On September 21st of that year the families of the deceased infants called on Baxter Healthcare to update the packaging on injectable heparin, in an effort to avoid future tragedy.

Baxter Healthcare did, indeed, issue a warning letter to health care workers, and announced a re-design of the heparin labeling to better distinguish adult doses from infant doses. But the letter was not issued until February 2007—five months after the infants died—and Baxter is said to have not recalled existing vials, with older packaging.

Nine months later, in a highly publicized case, the infant twins of actor Dennis Quaid were accidentally given overdoses of heparin. Mercifully, the twins survived. The Quaids have since sued Baxter Healthcare, but the suit has yet to be resolved.

As for contaminated drugs coming into this country, as was the case with tainted heparin, things aren't getting any better. It was recently announced that more than 30 generic versions of popular drugs manufactured at two facilities in India by Ranbaxy Laboratories were barred from entering the country due to manufacturing problems at the offshore plants.

The move is perhaps the first sign that the FDA has a few more teeth these days, after a boost in funding allowed the agency to beef up its staff. By months' end, the agency expects to have 1300 additional staff in place, the largest contingent—633—assigned to the Center for Drug Evaluation and Research. The latter is responsible for assessing new agents and monitors the safety of pharmaceutical products already on the market. Food safety gets 104 new staff, while 245 will be assigned to the enforcement division.

That's the good news. The bad news is that, according to reports, the FDA has known about the Ranbaxy problems for three years, but has done nothing until now. Critics have decried the FDA for being 'asleep at the switch.'

It is generally felt that such funding increases for the FDA is but a drop in the bucket, given the burgeoning shipments of drugs into this country manufactured offshore. Thus, the health and well being of Americans will hang in the balance until there is adequate supervision of drug imports.

And lawyers will be busy.