How Might a Trump Administration Affect Our Sandbox?

by Reed Smith

No, we’re not here to muse about how our lack of contact with advanced extra-terrestrial civilizations might be due to an unfortunate proclivity for “intelligent” life to invent technology that destroys their home planets before developing technology that permits the colonization of other planets. We limit ourselves to the drug and medical device product liability space.

First, we reiterate our belief that under a Trump administration, the FDA’s proposed – and oft-postponed − final rule, the one that seeks to abolish generic preemption by enacting regulations that likely violate the FDCA’s “sameness” requirement for generic drugs, is kaput.  When we learned earlier this year that the FDA had postponed the finalization date until after the election, we immediately pronounced it dead.   We still believe that.  We find it difficult to believe that a Trump FDA would continue a controversial Obama FDA proposal that has always been pursued as a sop to the plaintiffs’ bar, a major supporter of the outgoing president.  If there’s one thing we know Donald Trump believes in, it is getting revenge.

Second, the odds of another pro-tort-preemption Supreme Court justice to fill the vacant seat created by Justice Scalia’s death have increased significantly. The stark fact is that tort preemption has become a distinctly partisan issue on the Supreme Court.  The two most recent drug/device Supreme Court decisions, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 246 (2013), were both decided by five Republican appointees favoring preemption and four Democratic appointees opposing it.  Had the outcome been different, we would have considered the ultimate survival of Mensing/Bartlett unlikely.

During the campaign, candidate Trump offered lists of over twenty possible United States Supreme Court appointees he might consider. That’s too unwieldy for us to evaluate, but this recent 360 article identified four judges supposedly on a Trump shortlist:  Hon. Don Willett (Texas Supreme Court); Hon. Diane Sykes (Seventh Circuit); Hon. Frederico (S.D. Fla.), and Hon. Joan Larsen (Michigan Supreme Court).


Justice Willett wrote one tort preemption opinion for the Texas Supreme Court, and it did not involve any of the usual suspects.  In In re GlobalSanteFe Corp., 275 S.W.3d 477 (Tex. 2008), Judge Willett held that the Jones Act (involving ocean-going ships), did not preempt Texas statutes requiring, essentially, a Lone Pine-type order in silica injury cases, but did preempt state law concerning what was sufficient “injury.”  Preemption applied seemingly backwards in this case, with a non-preemption ruling actually benefitting the defense.  None of Justice Willis’ other preemption decisions involved federal preemption of state-law tort actions.


Judge Sykes has recognized federal preemption in a personal injury case. Fifth Third Bank v. CSX Corp., 415 F.3d 741 (7th Cir. 2005) (tort claims regarding railroad crossing injury preempted by federal railroad legislation).  Otherwise, Judge Sykes’ preemption cases have mostly involved ERISA, which is like shooting fish in a barrel because of ERISA’s strong preemption clause.


As a district court judge, we thought it more likely that Judge Moreno would actually have encountered the kind of preemption decisions that DDLaw discusses.  We were right.  Not long ago, in Ward v. St. Jude Medical, Inc., 2016 WL 1208789 (S.D. Fla. March 28, 2016), appeal dismissed (June 23, 2016), threw out a PMA medical device case as entirely preempted.  On the other hand, in a gun injury case, he found no complete preemption by the Commerce Clause and other federal enactments.  Penelas v. Arms Technology, Inc., 71 F. Supp.2d 1251 (S.D. Fla. 1999).  Judge Moreno also had a raft of ERISA preemption cases.


Justice Larsen of the Michigan Supreme Court does not appear to have written any preemption decisions.

With a Trump win, we’re thus more optimistic now about the long-term survival of the “independence principle” and, indeed, it’s logical extension to medical devices and beyond.  Had the result been otherwise, we thought that the other side would abandon FDA proceedings and seek to overrule that principle outright after a new justice had been confirmed.  For those of you not inclined to sort through the linked post, the independence principle was the Supreme Court’s impossibility preemption definition in Mensing:

[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.

563 U.S. at 623-24. The president-elect has, of course, not made any policy statements concerning tort preemption, but given his business background, we suspect he would be more likely to respond favorably to a position backed by business than by business opponents, such as the Mensing/Bartlett dissenters.

Third, it is not likely that a President Trump likes California all that much. The state single-handedly is very likely to make him a popular-vote minority president, and even before that he wasn’t cut much slack by most of the Hollywood crowd.  Revenge, again – if nothing else.  Thus, we doubt he would be in favor of California’s effort to set itself up as the nationwide jurisdiction of last (or even first) resort for product liability litigation involving businesses anywhere in the country.  Thus, we think it is a good bet that the new administration might support the recently filed Supreme Court petition for review in Bristol-Myers Squibb Co. v. Superior Court, 377 P.3d 874 (Cal. 2016).

Fourth, a number of the president-elect’s supporters have either been proponents, or beneficiaries, of applications of First Amendment rights to corporate entities.  A couple of examples of such decisions – rather far afield from drug/device − are Citizens United v. FEC, 558 U.S. 310 (2010), and Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751 (2014).  Whatever their substantive merits, or lack of same, their logical extension to the truthful promotion of off-label uses, would also seem to be a development that the new administration could be convinced to stand behind.  Thus, either internally (via the administrative procedure that the FDA just undertook) or externally (via litigation under United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), and progeny), we see a more favorable prospect for the quicker demise of the FDA’s longstanding prohibition against truthful off-label promotion.

On the other hand, president-elect Trump has not evinced particular support for First Amendment protections for the press (statements about libel laws) or for individuals (encouraging the ejection of protestors from meetings), so maybe a new administration would support restrictions on attorney advertising. The First Amendment could cut either way (or even both ways), and our side of the “v.” should be ready to take full advantage.

Fifth, and more globally, this would seem like an auspicious time for the Chamber of Commerce to dust off some of their product liability-related legislative proposals – not necessarily limited to the drug/device – concerning product liability litigation. A uniform set of federalized defect standards worthy of a national economy, bringing an end to the eternal weight of asbestos litigation on American industry, express preemption for prescription drugs – any one of these may be possible.  While product liability was certainly not one of the Trump campaign’s top priorities, if given the opportunity, we doubt a Trump Administration would veto such measures, if passed by a more receptive Congress.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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