Unit 12 Assignment(1) FAD
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Unit 12 Assignment: Lohr, Riegel, Levine, and Pliva
Analyze four Supreme Court pre-emption cases. Two are device cases, and two are drug cases. Two of these cases were decided within months of each other. The cases are listed below.
Medtronic v. Lohr, 116 S. Ct. 2240 (1996)
Riegel v. Medtronic, 128 S. Ct. 999 (2008)
Wyeth v. Levine, 129 S.Ct. 1187 (2009)
Pliva v. Mensing, 131 S.Ct 2567 (2011)
Answer the following questions (one point each):
1.
Compare the holding in Lohr with the holding in Riegel. What differences in the facts of each case led to the different holdings?
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In Lohr vs Medtronic, the court ruled that the Medical Devices Amendment (MDA) of 1976 was not intended to preempt traditional common-law remedies against manufacturers and distributors of defective devices as long as those requirements paralleled federal requirements. Thus, the lawsuit was allowed to proceed. In Riegel vs Medtronic, the court decided that Section 360k(a) pre-empted common state law claims for defective devices. Thus, the lawsuit was not allowed to proceed. The major
difference between the 2 cases was that the catheter in Riegel’s case went through a rigorous premarket approval process (PMA) while the pacemaker in Lohr’s case did not. The pacemaker fell under one of the two exceptions to section 360k and only had
to provide a premarket notification. In contrast to the 1200 hours of review to complete a PMA, the 510k premarket notification only takes around 20 hours. 2.
Compare the holding in Levine with the holding in Pliva. Why are they different?
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In Levine vs Wyeth, the Supreme Court held that federal law did not preempt the state
claim that labeling of Phenergan failed to warn of its potential adverse side effects. In Pliva vs Mensing, the Supreme Court ruled that the Pliva could not be sued due to labeling since their label matched that of the brand name. The difference between the two cases lies in the existence of a brand name for metoclopramide. Pilva argued that government regulation required them to have the same label as its brand name Reglan. Reglan did not have a warning about tardive dyskinesia while Mensing was taking metoclopramide. 3.
Briefly describe “changes being effected” regulation at 21 CFR 314.70(c)(3) and (6)
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A supplement (must be submitted for any change in the drug substance, drug product, production process, quality controls, equipment, or facilities) submitted under 21 CFR 314.70(c) must be labeled “Supplement-Changes Being Effected in 30 Days” or “Supplement-Changes Being Effected”. 4.
Compare express pre-emption (Riegel) with implied pre-emption (Pliva).
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Express pre-emption contains explicit preemptive language as was present in Riegel vs Medtronic. Implied pre-emption is when the preemptive intent is implicit in the federal law’s structure and purpose as was present in Pilva vs Mensing. 5.
Compare the holding in Riegel with the holding in Levine. What differences in the facts of each case led to the different holdings?
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The catheter in Riegel’s case had gone through an extensive PMA process and thus via the requirements in section 360k of the MDA received express pre-emption. In Levine’s case, there was no express pre-emption. Furthermore, the court argued against implied pre-emption stating that Congress did not intend to pre-empt state law
when it created the FDA.
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