There is a split  of authority within the Sixth Circuit concerning the scope of federal question jurisdiction and the reach of federal courts.  Viewed narrowly, the  split is important for those who litigate claims of “off-label” use and marketing under the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act.  But the heart of the debate is trans-substantive and involves the reach of federal courts.  As such, this split of authority should be of interest to all judges and practitioners within the Sixth Circuit, and beyond.  On one side of the split is the Western District of Tennessee (Jenkins v. Medtronic, Inc.) and the Southern District of Ohio (H.R. v. Medtronic, Inc. ).  On the other side is the Eastern district of Kentucky (Dillion v. Medtronic, Inc.).

The cases concern medical bone graft devices, allegedly promoted and used “off-label,” resulting in injury to the plaintiff.  Each case was brought in state court and removed to federal court.  The devices at issue fall within the scope of the MDA and are designated Class III devices, which means that they are the most heavily regulated by the federal government.  And, importantly, the MDA includes a preemption provision that could potentially foreclose the claims of each plaintiff.  In short, the resolution of each case involves an important interpretation of federal law concerning a medical device that the federal government regulates with the utmost oversight.  But the federal issue in question – preemption – is a defense; it is not necessary for the plaintiff to make out their claim.  As a result, the plaintiff’s claims do not satisfy the well-pleaded complaint rule.   The legal question then becomes whether or not that failure bars federal question jurisdiction.  The Eastern District of Kentucky said yes; the Western District of Tennessee and Southern District of Ohio said no.

The crux of the debate stems from differing interpretations of case precedent, specifically, the Supreme Court’s 2005 decision in Grable & Sons Metal Products, Inc. v. Darue Eng’g & Mfg.  and the Sixth Circuit’s 2007 decision in Mikulski v. Centerior Energy Corp.  Preceding Grable, and for nearly one hundred years, the well-pleaded complaint rule served as the analytical focus of  federal question jurisprudence.  The lodestar of that analysis was a famous test formulated by Justice Holmes that a “suit arises under the law that creates the cause of action.”  But the boundaries of federal question jurisdiction extended beyond Justice Holmes’s famous test which, over time, created a doctrinal maze where the only certainty became confusion.  In Grable, the Supreme Court cleared up some of that confusion but also created new areas of uncertainty.  This intra-circuit split highlights one of those areas.  Under what has been termed the substantial-federal-question doctrine, the Grable Court said that “the question is, does a state-law claim [1] necessarily raise a stated federal issue, [2] actually disputed and [3] substantial, [4] which a federal forum may entertain without disturbing any congressionally approved balance of federal and state judicial responsibilities.”  (emphasis added).

The position of the Western District of Tennessee and the Southern District of Ohio is that this formulation is the third true exception to the well-pleaded complaint rule (joining complete preemption and artful pleading), which means that it can apply in situations where the federal issue is not necessary for the plaintiff’s affirmative claim (i.e. the defense of preemption).  In contrast, the position of the Eastern District of Kentucky is that the Grable test defines the extent to which the well-pleaded complaint rule expands beyond Justice Holmes’s famous formulation.  Or to frame the debate another way, does the Grable test’s first requirement retain the traditional limitation that prevents the existence of a preemption defense from giving rise to federal jurisdiction?  That depends on how one interprets the words “necessarily raise a stated federal issue,” which is why we emphasized them above.

This intra-circuit debate presents a genuinely difficult question of law.  On the one hand, the analysis to determine federal question jurisdiction has long resisted a true bright line rule, and it makes a lot of sense to think that federal courts should be able to interpret federal law concerning important objects of federal regulation.  In addition, a plain reading of some language in Mikulski suggests that the Grable test is a true exception to the well-pleaded complaint rule.  On the other hand, it also makes sense to interpret Supreme Court precedent as not setting aside century-old boundaries absent clear direction.  And the Eastern District of Kentucky reads Mikulski, as a whole, to be consistent with its opinion, which is consistent with the Grable Court’s admonishment that “an opinion is to be read as a whole.”  Finally, as we noted here, where legal uncertainty exists in other areas of law, the Sixth Circuit has shown restraint in not displacing state authority without clear direction.  In sum, this is an important and interesting (but also difficult) debate that the Sixth Circuit may have to clarify at some point, and we will keep our eye on any developments.