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” argument—that the FDA should make these decisions and not be second-guessed by juries as to labeling decisions.

It should first be noted that even given Wyeth, there are areas within the pharmaceutical area where “purposes and objectives” preemption has been applied.  That is exactly what happened in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 353 (2001) (finding state law fraud on the FDA claims to be impliedly preempted).  It also happened in Zogenix v. Patrick, No. 14-11689, 2014 WL 1454696 (D. Mass. Apr. 15, 2014) [ed. note: blogged about here], where Massachusetts state rules made it impossible to market an opioid approved by the FDA.  These rules were struck down since they interfered with the FDA’s ability to carry out its mission of regulating drugs.  Specific reliance was placed on the purposes and objectives portion of implied preemption.

The power of the reasoning in Fontana, Farina and Robbins merits a review the of Wyeth analysis of “purposes and objectives” preemption.  The Wyeth majority’s rejection of the “purposes and objectives” claim is thin and wanting.  It is an afterthought to an opinion that deals primarily with impossibility preemption given the provisions of the “changes being effected” provision.  It is at odds with prior Supreme Court precedent on “purposes and objectives” in Geier v. Am. Honda Motor Co., 529 U.S. 861, 881 (2000) (finding obstacle preemption based on a general rule of the Department of Transportation favoring a “mix of seat restraints), and with subsequent precedent in Arizona v. United States, 567 U.S. 387 (2012) (an immigration case).  In Wyeth, the Court first noted that Congress had long recognized a role for state law causes of action under the FDCA.  Id. at 574–75.  But the fact that some state actions may be “complementary” does not mean that others may not be at cross purposes. Second, the court coupled the “complementary” argument with the fact that there was no express preemption provision in the FDCA.  Id.  But the Supreme Court itself has consistently held that the lack of finding of express preemption does not bar implied preemption.  See Geier, 529 U.S. at 869; Buckman, 531 U.S. at 352.  Third, it refused to consider the “new” FDA legal position on preemption.  An agency position is certainly not conclusive to whether there is “purposes and objectives” preemption, since the position of the United States on this issue is a changing one dependent on the politics of the administration in power. Moreover, implied preemption is not dependent on the FDA advancing that position.  PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (where implied preemption was found over agency objection).  But the major failure was that the Wyeth majority did not compare the entire federal regulatory scheme to the state jury system on the issue of who should decide adequacy; it demanded a specific regulation at odds with the jury system.  Wyeth, 555 U.S. at 580.  It distinguished Geier finding there was a “specific rule” in conflict with state tort lawsuits, but that rule was only that the Department of Transportation allowed a “mix” of restraint systems.  The generality of that “rule” does not begin to compare with the detailed federal regulations on drug approval and labeling decisions.  Simply put, the majority in Wyeth used an incorrect legal test to determine whether there was “purposes and objectives” preemption.

Wyeth, however impaired, is still the law.  But precedents do get changed.  And the Supreme Court’s treatment of this issue after Wyeth helps to demonstrate that Wyeth was wrong in its “purposes and objectives” analysis.   In Arizona v. United States the Supreme Court confronted a preemption challenge to a number of Arizona statutes involving immigration.  One such statute, section 6 of Arizona S.B. 1070, provided that a state officer could arrest someone if the officer had probable cause to believe that a person was “removable” from the country.  The United States argued that this statute was an obstacle to the “removal” system created by federal statutes and regulations.  Section 5 of the state legislation made it a misdemeanor for an unauthorized alien to apply for work in Arizona.  The government argued that was at odds with federal legislation making a specific choice not to impose criminal liability for this conduct.  The Supreme Court agreed that these statutes did create an obstacle to the full “purposes and objectives” of Congress.  567 U.S. at 406–07, 410.  It looked at what was provided for by each regulatory scheme and determined whether there was a conflict between them.

Presuming that Judge Gorsuch would follow the Scalia position in Wyeth—that has three Justices supporting that position.  Justice Thomas does not generally agree with “purposes and objectives” preemption.  But U.S. v. Arizona may be viewed by new Justices as a basis to reevaluate the Wyeth position of “purposes and objectives” preemption.  Justice counting aside, the reasoning of this part of Wyeth makes no sense.

That said, a note of caution is in order.  Cases where this defense is advanced in the pharmaceutical area should be carefully chosen with careful consideration given to the facts and the judges involved.  Enough bad law has already been made in this area.  In the short term, fact patterns like Zogenix where the state tries to intrude into the regulatory area cry out for this defense.  Using it now in a typical failure to warn claim is not likely to succeed.  But Wyeth’s reasoning is subject to challenge.  As other industries get the “cell phone” treatment on “purposes and objectives” preemption, this disparity will increase the focus on that reasoning.