Tuesday, November 11, 2008

Label Liability Gone Loony

Catching up on my WSJ reading this past weekend , I came across this piece on Wyeth v. Levine. It's almost Wednesday and I still dont understand the underlying premise and logic used in Levine's lawyer's arguments. The deeper I read into the factual logisitics of the case, the less sense it reads in terms of liability, the angles of the arguments and the party being sued.
I haven't come across any logical reason on as to why
Wyeth is responsible for an IV push that was administered incorrectly. Wouldnt this be the responsibility of the individual administering the IV push. And not the drug being administered. For Cornell's case recap, see here .
For WSJ's argument recap see here
For The FDA Law blog recap see here

What does the FDA approved label featuring warnings against IV push administration that include this - "INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY"
have to do with an IV push gone arterial in error?
Are the risks associated with IV push, medication specific.
Is Phenergan the only medication that runs the risk of accidently being injected into an artery instead of a vein when administered via an IV push ?

Why would or should the FDA bar everyone from using the IV push ? Different methods have different risk levels, the existence of risk does not render it bar worthy. Life in and of itself is a risk.
My heart goes out to Levine for all the trauma shes been through, it must be devasting and heartbreaking to have gone through what she did, but I believe that unfortunately her lawy
ers are suing the wrong party.

Shouldnt they be suing the migraine clinic that gave her phenergan in the artery.
I like phamaceutical companies and think they get way more than their fair share of suings by disgruntled end users or lawyers that are clearly not thinking straight, many of whom are just as liable for misuse, misconstrues etc....
When suing for liability its always important to sue the proper party, cuz otherwise its not fair.

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