Drugmaker to halt production of sedative

by Walter Olson on June 17, 2010

Following a Nevada jury’s highly controversial $500 million verdict over allegedly inadequate warnings against multiple patient use, as well as bad publicity over possible abuse by music legend Michael Jackson, “Israel-based Teva Pharmaceutical Industries recently announced it will stop production of its sedative propofol, which many worry will intensify an already existing shortage of one of the most widely used anesthetics in the United States.” [Abnormal Use, earlier]

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1 Todd Rogers 06.17.10 at 10:04 am

Could someone briefly explain the causal link between the product, its manufacturer, and the plaintiff’s injury? I can see how the person who delivered the drug could be negligent – that much is easy. I just can’t get passed the chasm between the nurse and Teva. Cognitively, I don’t think my brain operates in such a way that I could come to such a conclusion. Please help me.

2 Mark Biggar 06.17.10 at 12:36 pm

The problem with “Failure to Warn” as a theory of liability as I see it, is that it is an impossible standard to meet as there is no way to determine how much warning is sufficient. A plaintiff can always argue that the defendant failed to cover the exact sequence of events in the case and how can we expect juries to make such fine distinctions as to whether the warnings given actually covers the case in question. Besides what ever happened to professional responsibility to know the proper use of thier tools.

3 nevins 06.17.10 at 4:25 pm

Out of professional interest I’ve followed the many cases of propofol contamination that have been reported over the decades. Every bottle, regardless of size or manufacturer that I’ve seen over the years has had the same strict asepsis warning and single patient use warning; it is reasonable to presume that these FDA required bits were on the Teva manufactured bottles.
Big bottles are designed for use on long cases or continuous sedation in an intensive care unit for hours to days. The drug acquired in this manner is a bit less expensive than in the smaller bottles. Therefore it is tempting as a cost saving measure to part out the big bottle into aliquots for multiple patients.
All well and good at this point if it is done in a sterile manner. But some people get sloppy or lazy and will re-enter the bottle with a dirty syringe, or use the IV tubing from the bottle to patient on subsequent patients.
This is of course a big no-no from infection control perspective regardless of the drug used. For this reason I would say the manufacturer has no conceivable liability because their product is no different than any other drug on the market with regard to this type of provider malpractice.
From the victims perspective recovery is a big problem from the clinic docs because most malpractice insurance max out at a finite, usually 3, events per year, and this group was so systematically egregarious in their practice that they managed to infect possibly hundreds of patients. Their conduct was not merely a one off bone headed blunder, but was systematically calculated to trade risk to the patient for profit on a scale that would make Bernie Madoff green with envy.
I’d have no problem with life imprisonment for such wanton disregard. Undoubtedly some of the patients with Hepatitis C will die; capital case maybe?

4 William Nuesslein 06.18.10 at 10:07 am

I do not understand how Hepatitis C transfers from one person to another through the drug. Wouldn’t the drug flow from the bottle into the patient? Why would the pathogen swim upstream into the bottle?
Could this be a case of a hired gun putting a crackpot theory to dumb Americans.

5 Robert 06.18.10 at 12:38 pm

I forgot that Teva was Israeli. Given Jackson’s ties to the Nation of Islam, I’m sure they’ll end up blaming The Jews for his death….

6 Dirk D 06.18.10 at 7:03 pm

William,

The outside of the needle would also be contaminated. When you put the used needle in the fluid it contaminates it. Needles are like shared nachos: double dipping is verboten.

7 William Nuesslein 06.21.10 at 7:08 am

Dirk D.

Your comment is interesting. But then the drug itself has nothing to do with the Hepatitis C problem.

When I did soil pathology work in High School, we use alcohol to prevent contamination. The reuse of needles is scientifically OK, but not culturally OK, if proper disinfectant procedures are used.

Shakedown comes to mind.

8 Bill Alexander 06.21.10 at 9:10 am

I am old enough that as a child I got the polio vaccine when it first came out. They didn’t have disposable needles then and always just sterilized and re-used them. As I recall, they were a lot bigger needle then, maybe with a hook in the end, and we had to walk through 6 feet of snow uphill both ways to get the shot (in Pasadena).

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