2. Manufacturing Claims Claims alleging that devices were not manufactured as approved by the FDA persist.
3. Post PMA Defects – Newly Discovered Evidence In her dissent, Justice Ginsburg urged that the “Court's holding does not reach an important issue outside the bounds of this case: the preemptive effect of § 360k(a) where evidence of a medical device's defect comes to light only after the device receives premarket approval.” Whether that will be found to be the case is another question. Most defects, as a practical matter, will be known prior to PMA approval. As in Levine, the cumulative information that comes to the attention of the manufacturer following PMA-approval – even about a risk known at the time of PMA approval - should be considered relevant to the question of whether a state law action is subject to preemption.
Post-Levine
compare Bausch v. Stryker Corp., 2008 WL 5157940 (
N.D.Ill.Dec.9, 2008)(following restrictive approach and holding that a claim is “parallel” to a federal requirement only when it provides a cause of action for violation of the federal requirement) to Prudhel v. Endoligix, Inc., 2009 WL 2045559 (2009)(declining to follow restrictive approach); Hofts v. Howmedica Osteonics Corp., 597
F.Supp.2d 830, 835 (
S.D.Ind.2009), In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592
F.Supp.2d 1147, 1157-58 (D.Minn.2009)(same).
Generic Medications: Probably Not Preempted
Te vast majority of decisions following Levine have
found no preemption of state claims related to Class III prescription drugs subject to FDA premarket approval.
In
so holding, those courts relied on the absence of a federal preemption clause; on the further absence of proof by the drug manufacturer that the state claim at issue would obstruct the purposes of federal drug regulation; and the absence of proof that the FDA would have disapproved the strengthening of labels or other measures at issue.78
A number of courts have
addressed the question whether generic medications are within the holding of Levine. Tose decisions following the Supreme Court’s decision in Levine have held that state claims against drug manufacturers are not preempted; some courts, pre-
Levine, held that such claims were preempted.79 78 See, e.g., In re Prempro Products Liability Litigation, ---F.3d --- 2009, WL 3518245 (8th Cir. 2009) (failure to warn of risk of breast cancer for combination hormone therapy not preempted; no evidence that FDA would not have permitted strengthening of labels in a manner consistent with Arkansas law).
79 Not preempted: Bartlett v. Mutual Pharmaceutical Co., ---
F.Supp. 2d ---, 2009 WL 3126305 (D.N.H. 2009)( Patient's state-law failure-to-warn claim against drug manufacturers alleging manufacturers failed to change generic non-steroidal anti-inflammatory drug's label to warn of risks of Stevens-Johnson Syndrome and toxic epidermal necrosis was not preempted, by FDCA requirement that abbreviated new drug applications (ANDA) contain information to show that labeling proposed for new drug was same as labeling approved for listed drug; nothing in FDCA requirement barred manufacturers from changing drug's label after their ANDA was approved); Brockert v. Wyeth Pharmaceuticals, Inc., 287 S.W.2d 760 (Tex. App. 2009)(federal law did not preempt consumer's failure-to-warn claims against manufacturer of prescription hormone therapy); Stacel v.Teva Pharmaceuticals, USA, 620
F.Supp.2d 899 (
N.D.Ill.,2009).
(“Although it is clear that the
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Trial Reporter / Winter 2010 41
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