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Vital Signs and Remedies for a Full Spectrum World
by Roxanne Nelson

20 September 2008

Deeper Pockets

So what happens when a medical error causes a musician to lose part of her arm? She sues, right? Is she justified? Was it a real unavoidable accident or real negligence, or done maliciously?

Well, she is justified, as far as I can tell, and I would call it negligent. The musician, a woman named Diana Levine, received a relatively benign drug that was delivered in a manner that has the potential of causing great harm. The story is in the New York Times, if you want to have a look.

It seems pretty straightforward–at first.  The patient sued Wyeth, the drug manufacturer, because she said it failed to provide adequate warning about a drug. She was awarded $6 million. Okay, nobody sheds too many tears when a drug company has to shell out, because we always assume they are wrong and we are right. But now the woman is back in court, battling over whether she can keep the money.

When I read the first few paragraphs, I thought the usual–that the drug company had blundered and was now trying to cover its tracks and using all sorts of legal jargon and new fangled and obscure laws to get out of paying her. But then, I read on…

In the spring of 2000, suffering from a migraine, Ms. Levine visited a clinic near here for a treatment she had received many times: Demerol for the pain and Wyeth’s drug Phenergan for nausea.

“Nothing wrong with either drug,” Ms. Levine said. “They’re both safe when given the right way.”

But if Phenergan is exposed to arterial blood, it causes swift and irreversible gangrene. For that reason, it is typically administered by intramuscular injection. According to Ms. Levine’s lawyers, using an intravenous drip is almost entirely safe as well.

This time, though, a physician’s assistant used a third method. She injected the drug into what she thought was a vein, a method known as “IV push.” But the assistant apparently missed.

In the following weeks, Ms. Levine’s hand and forearm turned purple and then black, and they were amputated in two stages.

Uh, excuse me, but this case has nothing whatsoever to do with Wyeth. The drug is clearly labeled, and the fault lies solely with the physician’s assistant who administered it, as well as the clinic in general, for having a policy that permits the non-emergent use of IV push phenergren.  Nausea sucks big time, I grant you that, but there is no excuse for giving this drug as an IV push, rather than IM or a slower IV drip, to an ambulatory outpatient who has a migraine! Please.

Nurses, physicians, physician’s assistants–would you ever give this as IV push to a patient with a migraine? And let’s take that a step further–whoever injects a drug straight into a vessel like that without first flushing it through to make sure that you are indeed, in a vein? Since this wasn’t any sort of emergency, the PA could have quickly started an IV infusion, and then slowly gave the drug IV push into the line. And checked before hand if it was a vein or artery?  The only time you would stick a needle directly into a vessel, and not bothering to assess if you were in a vein or artery, if it is a life threatening situation where every second counts.

The Human Stain

This whole situation reeks of total negligence, on the part of Ms. Levine’s clinic. But yet, the article barely touches on it. It says that Ms. Levine settled with the clinic and then moved on to attack Wyeth because she thinks it needs a stronger warning.

“All they had to do,” Ms. Levine said, “was change the label and say, ‘Don’t give it this way.’ ”

But Ms. Levine, the warning clearly states that this drug should never be given into an artery. How much clearer does it need to be?  This is a case of pure negligence on the part of the clinic and the PA who administered it.

Ms. Levine and her lawyers apparently turned to Wyeth because the pockets are deeper than the clinics. That’s my guess.  Their assertion that they are entitled to a payout because the label needs a broad warning to cover all human errors, and for failing to say “do not administer using the IV push method just in case you hit an artery”, is beyond pathetic.

Perhaps the drug should also have a warning that it should not be administered directly into the eyes, or inhaled, or used intra-rectally or intra-vaginally.  Perhaps it should also read not to apply directly to an open wound, or do not swallow.

It is the responsibility of the healthcare provider to administer the drug in the prescribed fashion, and not use an alternative method not specifically mentioned on the label. If the label says administer intra-muscularly or intravenously, why administer it using the IV push method? And putting it into an artery is a blatant error.

So while I do feel sorry for Ms. Levine, that she lost part of her arm due to a medical error, that sympathy is tempered by her greed in trying to make the manufacturer responsible. Sorry, but I’ve had my fill of hearing about these bogus lawsuits. This is about as bad as the smoker who sues the cigarette companies–you know, the one who started smoking after warning labels appeared on cigarette packs that they could be harmful to your health.  And this same person, who never even tried to quit until after he was diagnosed with lung cancer. And now, its time to sue the manufacturer because he failed to adhere to warnings.

The Saga of Polyvisol

A little anecdote to make my point….when I was working in Florida many moons ago, a nurse working in the NICU failed to make use of her brain. This unit was small and sort of weird, and she was trained on the job–sort of. She used to walk around saying, “I just do what they tell me to.” I told her that no, you need to understand why you are doing something.

Well, she definitely wasn’t the sharpest knife in the drawer, because one day, she went to give a baby Poly-vi-sol. For those of you unfamiliar with this delectable item, it is an oral vitamin supplement. She drew some up in a syringe, and then proceeded to stick the needle into the infant’s IV line. A nurse standing nearby fortunately saw it as well, and grabbed her arm before she could push the syringe. The oral formulation, nice and greasy, could have killed that baby.

So should Poly-vi-sol be labeled–”DO not give IV?” “Do not give IV push?” Is the word “oral” on the label sufficient? Shouldn’t a healthcare practitioner be able to read and understand that 4-letter word? And if that nurse had gone ahead and given that dose, and the baby died or suffered from other damage, would the parents have been justified in suing the manufacturer of Poly-vi-sol?

Absurd, you may think, but it is an identical story to the one of the Vermont woman. Different drug, different circumstances, but it all boils down to one thing—gross human error.