For some reason, people just love to misrepresent the issues underlying the Wyeth vs. Levine case. I have written extensively about this case here and here because I found it so amazing that the media has bungled the story so badly – and that no one is really calling them on it.
In case you don’t recall – Ms. Levine was the victim of medical malpractice. An anti-nausea drug (phenergan) was injected into (or very near) her artery by accident (the potential consequences of such an error are clearly indicated on the drug label). Tragically, the resulting chemical reaction with the oxygen in her artery caused such severe tissue irritation that her arm eventually had to be amputated. Ms. Levine settled out of court for $700,000 with the clinic where the injection occurred. Unfortunately the story doesn’t stop there.
Ms. Levine’s attorney counseled her to sue the drug manufacturer for inadequate label warnings (the potential hazard is in fact mentioned on the label six times – though it does not forbid IV administration of the drug, though it recommends a low dose and slow push). In a precedent-setting judgment, a jury in Vermont decided that the FDA-approved label was inadequate, and that it should have fully contraindicated administration via IV push. The jury awarded Ms. Levine $6.8 million and Wyeth contested the judgment, bringing the case to the US Supreme court in November, 2008. The case has not yet been decided, though it has been compared to deceptive labeling of “light cigarettes.”
How on earth is a drug that has been successfully administered (without harmful side effects and with good efficacy) over 200 million times in the U.S. equivalent to cigarettes (a known carcinogen with no therapeutic value)? It’s an exceedingly poor analogy.
To put it another way, if a nurse took an insulin syringe and injected it into a diabetic’s eyeball, causing blindness, should I say that the insulin manufacturer (because it did not forbid the injection into the eye) was engaging in deceptive labeling and should be at fault for the patient’s loss of vision? The PA who injected the phenergan into Ms. Levine’s artery, and our hypothetical nurse who injected insulin into an eyeball are the ones to blame.
But wait, it gets worse.
The attorney (David C. Frederick) who is arguing Ms. Levine’s case in front of the Supreme Court is being considered by our President elect for the position of Solicitor General of the United States. Yes, this very man who is engaged in a law suit that could potentially set a precedent that would allow all 50 states to set up their own mini-FDAs with the lay public (i.e. juries) deciding what drug label language should say.
The pro-Levine camp argues that a court ruling in favor of Wyeth would preempt consumers from being able to sue drug companies for damages related to incomplete disclosure of risks (such as the Vioxx case) but in reality, the Wyeth vs. Levine case has no bearing on pharmaceutical non-disclosure, since Wyeth did not hide the irritant risks of phenergan from the FDA. They have been known for decades.
So Wyeth vs. Levine is NOT about deceptive labeling or non-disclosure of risks – it’s about whether medically uneducated juries should have the power to set arbitrary drug labeling language standards in order to facilitate litigation against deep-pocketed pharmaceutical manufacturers whenever a patient is harmed in a case of medical malpractice.
I understand that many folks are frustrated with pharmaceutical wrong doing (and there are many cases of it), but this is just not one of them. In America, we are not supposed to bring pre-conceived notions to bear on law suits, but objectively review the facts in each case, separate from our general feelings about those involved. I do think that Wyeth isn’t getting a fair shake in the media because of the general mistrust/dislike of Big Pharma. But everyone has a right to a fair trial. I sure hope they get it.