Today’s guest post is by frequent contributor Dick Dean of the Tucker Ellis firm. This time, Dick is sharing some insights on Wyeth v. Levine, 555 U.S. 555 (2009), which we consider the single worst prescription medical product decision since we started blogging. Not surprisingly, Dick shares our views of Levine. We agree with him. Further, if Levine had been decided the way Dick advocates, all of the subsequent preemption focus on “independent”action, “major” changes and “newly acquired” information could have been avoided, and a more rational system turning on the substance of the conflict would have ensued.
As always, our guest bloggers are 100% responsible for the contents of their posts, deserving of all the credit (and any blame) for what they have written.
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Cases involving the “purposes and objectives” obstacle part of the implied preemption doctrine are rare. The recent decision in Fontana v. Apple, Inc., ___ F. Supp. 3d ___, No. 2:18-cv-00019, 2018 WL 3689044 (M.D. Tenn. August 3, 2018), is a reminder of the efficacy of this powerful, but little used, defense. Plaintiff brought a personal injury action claiming he developed cancer from the use of a cell phone. In the 1990s these claims were addressed by extensive Daubert practice. But this claim was dismissed at the pleadings stage because it interfered with the FCC’s ability to carry out its mission of setting radio frequency emission levels established by the Telecommunications Act of 1996. It was specifically based on “purposes and objectives” obstacle preemption. That is good for the cell phone industry but does it “speak” to us in the pharmaceutical defense world? Indeed it does. Fontana relied heavily on Farina v. Nokia Inc. 625 F.3d 97 (3rd Cir. 2010) [ed. note: blogged about here], finding a similar claim obstacle preempted, and Robbins v. New Cingular Wireless PCS, LLC, 854 F.3d 315 (6th Cir.2017) (barring an attempt to prohibit the building of a cell tower based on health reasons finding obstacle preemption). The rationale of Fontana, Farina and Robbins is straightforward:
The reason why state law conflicts with federal law in these balancing situations is plain. When Congress charges an agency with balancing competing objectives, it intends the agency to use its reasoned judgment to weigh the relevant considerations and determine how best to prioritize between these objectives. Allowing state law to impose a different standard permits a re-balancing of those considerations. A state-law standard that is more protective of one objective may result in a standard that is less protective of others.
Farina, 625 F.3d at 123 quoted by Fontana, 2018 WL3689044 at *2.
Allowing juries to impose liability on cell phone companies for claims like [plaintiff’s] would conflict with the FCC’s regulations. A jury determination that cell phones in compliance with the FCC’s SAR guidelines were still unreasonably dangerous would, in essence, permit a jury to second guess the FCC’s conclusion on how to balance its objectives.
Farina, at 125-6 quoted by Fontana at *3.
Of course, the parallel to FDA determinations about efficacy and safety of drugs and the sufficiency of labels is striking. The FDA engages in a classic weighing process as to whether a drug can come on the market and what its label should say. Its processes are far more detailed than those of the FCC which played out in these three cases. But jury second guessing of pharmaceutical labels is permitted by the Supreme Court in Wyeth v Levine, 555 U.S. 555 (2009), where the Court rejected preemption because of the manufacturer’s ability to submit a change in the label. But that leaves the second issue in Wyeth—who should decide adequacy. The three-Justice dissent (Alito, Roberts and Scalia) fully adopted the “purposes and objectives”...
