By now most trial attorneys have heard about the case Levine v. Wyeth which will be argued before the U.S. Supreme Court on November 3, 2008. Ms. Levine is a 60'ish year old Vermont women who inadvertently had the drug Phenergan injected by "IV Push" into a hand artery by a physician's assistant. This led to gangrene and amputation of her hand and then later her arm up to her elbow. The medical negligence case was settled last year for $700,000.00. Levine has now sued Wyeth in a product liability action alleging that the product labeling is inadequate. She contends that the Phenegan label should state that it should never be given by direct "IV push".If the court agrees with the plaintiff this will have serious and far reaching consequences for the medical and pharmaceutical industries. The drug's labeling clearly spells out the dangers of intra-arterial injection but it does not say that it should never be given IV push. All physicians know that Phenergan is given safely by IV push when it is given intravenously as it should be given. Out of the millions of IV push doses given each year in this country only a handful somehow affect the artery, either by extravasation or by inadvertent direct arterial injection. Gangrene as a complication of the administration of Phenergan has been reported only 4 times in the medical literature. It is a very rare complication indeed. The FDA reviewed this drug and approved the labeling. What this means from the medical and regulatory perspective is that this drug is safely administered by IV push as long as it is done properly. Like any other area of medicine where things go awry it is usually due to operator error, and when damages result, there is legal recourse for the victim.
But to set a legal precedent where a state can overrule medicine's regulatory body, the FDA, is sheer madness. Never mind that this case even got this far because a lay jury passed judgment against Wyeth. Never mind that arterial damage can even occur if you give it intramuscularly which is the recommended and accepted way to deliver the medication. The fact that the U.S. Supreme court is even considering this matter should make any thinking person shudder.
The basic premise being considered has to do with regulating labelling. In this case, the question is whether a label that states never to give the medication by IV push would have prevented the adverse outcome, that is, if you don't try to give it IV push, then you won't accidentally give it intra-arterially. What the court is considering is that this product (and medications in general therefore) can or should be further restricted by individual states above and beyond what Federal oversight (FDA) has already deemed appropriate. A victory against Wyeth would debilitate the FDA and would allow any state to add their own regulations regarding medications whenever they wanted to. Phenergan could be given IV push in Maine, but not in Vermont. Some other drugs could become illegal in New Jersey but could be used in other states.
The bottom line is that the dangers of this drug, Phenergan, were properly described on it's label, and the adverse event was just a matter of operator error. It is a breach in the standard of medical practice to inject this drug intra-arterially or to give it when an IV has extravasated. The physician's assistant simply breached the standard of care, and the case was properly adjudicated. However, for the state to supercede the FDA, and thus, medicine as a profession, and put their own restrictions on the use of legal and safe drugs that are medically indicated and necessary, and perhaps lifesaving in order to avoid a one in a million chance for a human error goes against the way medicine is practiced and is wrong. I'll keep you appraised of developments....