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Case Brief: Wyeth v. Levine - Essay Example

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Case Brief: Wyeth v. Levine Table of Contents I. Facts 3 II. Issue 4 III. Decision 4 IV. Reasons 5 References 8 I. Facts Wyeth markets the drug Phenergan, the generic name of which is promethazine hydrochloride, which is indicated for nausea, as an antihistamine medication…
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Case Brief: Wyeth v. Levine
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Download file to see previous pages Such is the case with the plaintiff Levine in this case, whose right hand and later the whole forearm was amputated following the entry of Phenergan into her artery by way of an inadvertent needle injection via the IV-push method. Either that, or else the drug was able to reach the blood in the artery via Phenergan leaking out of the vein where it was injected, into the tissue surrounding the vein and the artery. Levine, after going after the doctor and the health center, went after Wyeth. Standing on theories relating to strict liabilities as well as negligence as it is framed in common law, Levine made the allegation that Phenergan's labeling was defective because of the labeling's failure to tell doctors to make use of the IV-drip method for administering Phenergan, versus the IV-push method used on her. This is in spite of the fact that the Phenergan label did warn of the possible gangrene complication and the amputation risks from that if the drug entered the artery by mistake. The further allegation by Levine was that more generally, the drug fails at demonstrating reasonable safety for administration via intravenous modes as has been used on Levine, given that weighed against its potential benefits in therapy, there are great risks relating to the possibility of the loss of one's limbs from gangrene. The jury found for Levine, and ordered Wyeth to pay Levine $7.4 million in damages. The jury found Wyeth guilty of negligence, and that Phenergan was, by virtue of not being accompanied by adequate instructions and warnings, defective. Moreover, the jury ruled that there is a direct, unbroken causal link between Phenergan's defects and the injuries Levine sustained from them. Wyeth filed a petition for certiorari arguing that the FDA's judgments on drug labeling essentially supersedes product liability claims from state law, as was made by Levine, and that therefore the drug liability claim based on state law is invalid (Wyeth v. Levine 74-75). II. Issue Do FDA judgments on drug labeling preempt product liability claims made based on state law? (Wyeth v. Levine 75) III. Decision The trial court ruled to reject the preemption argument on a number of legal foundations. One is that in essence, state law has had functions of compensation separate from the regulations crafted at the federal level. Two is that in essence there are no conflicts between the state law claims on the one hand and the regulatory work of the FDA, because in effect the same FDA regulations allow room for intensified warnings sans the approval of the FDA, and the state law claims do just that, by surfacing problems. The ruling cited data showing that from the 1960's to the time of the case, there had been 20 amputations reported, similar to the one on Levine. Three, the trial court ruled that no conflict exists between state tort law claims and the work of the FDA due to the fact that the FDA had not keenly looked at the issue of whether or not to issue a warning against using the IV-push method to administer Phenergan. The Supreme Court of Vermont ruled to affirm the decision of the trial court (Wyeth v. Levine 74). IV. Reasons The Supreme Court based its decision on two tenets related to pre-emption. One is the purpose of Congress for enacting the laws. Two is that corollary to this, federal regulations are not to supersede state laws, unless Congress has made it so, unambiguously and clearly. On the argument of impossibility of compliance with both state law and FDA regulations on ...Download file to see next pagesRead More
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