Photo of Stephen McConnell

Sunday was a pretty good day. It was both Father’s Day and Bloomsday.  June 16 is called Bloomsday because that is the day that Leopold Bloom and Stephen Daedalus wandered around Dublin in James Joyce’s Ulysses.  There is an all-day reading of Ulysses every June 16 at the Rosenbach Library in Philadelphia, the home of the original manuscript of the novel that many critics call the greatest of the 20th Century.  It’s been a long time since we read Ulysses, and we didn’t sneak a peak at even one page on Sunday.  Instead, the Drug and Device Law Daughter took her dad to see Before Midnight, the latest film about an American man, Jesse, and French woman, Celine, who show up on movie screens every nine years to talk about love and time.  The Before trilogy (Before Sunrise (1995), Before Sunset (2004), and Before Midnight (2013)) might be the lowest grossing trilogy of all time, but it is the best one we can name.  Like Apted’s Up movies (Seven Up, 14 Up, 21 Up, etc., with 56 Up being the latest), the Before movies show what happens to people over time.  Love and time (and that pesky razor boy that ends our time) are the biggest themes, aren’t they?

The proportion of dreams, experience, and memories running around our heads changes over time.  Love erodes under a steady drop of complications.  We saw the first segment, Before Sunrise, during a trial last century.  We had slunk back to the hotel room after a tough day in court, flipped on the tv, and happened to catch the beginning of the film.  It was all walking and talking, but it was riveting.  Perhaps it was impossible to resist immediate infatuation with Julie Delpy.  Most American males who backpack through Europe are sure to carry, right next to their Eurail pass, a determination to canoodle with someone just like Julie Delpy.  But back to the movie.  It has been said before that the most exciting spectacle is a good conversation.  In Before Sunrise, Jesse and Celine meet semi-cute on a train, get off in Vienna, and walk and talk.  Near the end of the movie, we learn that the date was June 16.  They must head off in separate directions.  They have promises to keep.  But they make a promise to each other to meet again.  Will they keep that promise?

The latest film is about a couple in their 40s.  Meeting cute happened long ago.  There are kids.  And complications.  And recriminations.  Most of the movie is a fight.  It sounds sort of awful.  But it ends up being exhilarating.  Argument is a form of commitment.  It is also great theater when done right.  If a better movie comes out in 2013, we’ll be astonished.  Thanks, Richard Linklater.  Thanks, DDLD.  So, now that we think of it, Sunday was a really good day.  And then to cap it off, just before watching Mad Men, we read through some of our mail.

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You might not know it from the Comments section of our blog, but we get lots of interesting reader mail. While the Comments often seem confined to robo-spam or gripes from plaintiff lawyers – and it is hard to say which is worse – practitioners and students often share their insights, questions, or corrections. Recently, a law student wrote us that she has been following our posts on primary jurisdiction (here, here, and here, for example) and that she has trouble wrapping her mind around why that doctrine is often applied in food and cosmetics matters but seldom in drug cases.

We share that concern, and it is timely. Primary jurisdiction is a doctrine that has been around a while – at least since we took federal jurisdiction with Professor David Currie in the Pleistocene era.  Primary jurisdiction applies when a plaintiff seeks to enforce a legal claim that requires resolution of issues within the special competence of a regulatory agency. The issues are likely complicated and of first impression.  The judicial process is suspended pending referral of such issues to the agency. The practice seems consistent with the “judicial modesty” that nominees always speak of, right up to the moment when they are confirmed.
Why aren’t more of the claims against FDA-approved products and labels subject to primary jurisdiction? Might not the FDA have a few things to do and say that would shed light on issues in a litigation?  Naturally, what we mean by that, since we are defense lawyers, is might not the FDA make it pretty clear that the plaintiff’s allegations are hogwash?  A couple of primary jurisdiction cases slid into our inbox last week, and we find ourselves as intrigued and perplexed as ever.

Cox v. Gruma Corp., 2013 U.S. Dist. LEXIS 80613 (N.D. Cal. June 7, 2013), involves a putative class action where the plaintiffs complained that tortilla chips are falsely labeled because the manufacturer did not disclose that the chips contain genetically modified organisms (GMOs) and that the claim that the chips are “all natural” is misleading. In a tentative ruling (and we understand that supplemental briefing is under way), the court was inclined to stay the matter under the doctrine of primary jurisdiction. That inclination seems exactly right to us.  The FDA clearly has regulatory authority over food labeling. It has expertise. The issue is complicated. Uniformity is needed. All of the primary jurisdiction bells are ringing.  Thus far, the FDA has issued only a non-binding guidance indicating it is unaware of any need to disclose bioengineering. The FDA has also issued a guidance with respect to the use of the term “natural” on food labels. But the FDA has never directly addressed whether GMOs or bioengineered ingredients may be labeled “all natural.”
It is interesting how the Cox court emphasizes that the plaintiff “concedes” that there is a “gaping hole” in the regulatory landscape for natural claims and GMOs. For all we know, the plaintiff might have thought that regulatory silence was a strong point, not a concession. The plaintiff might have thought that agency silence was leaving an opening for the tort system.  But what that agency silence really means is that there is something more for the agency to say.  And therein lies the puzzle at the heart of primary jurisdiction — or at least the puzzle in our head about primary jurisdiction.  Courts have tinkered with the doctrine over the years, perhaps even overthinking it, and seem to place the primary jurisdiction doctrine in a milieu where an agency has power and expertise and has something else to say — but if the agency has apparently said all it is going to say, then primary jurisdiction is called off and the case is frog-marched to the jury.  It seems strange that agency inaction can strengthen invocation of primary jurisdiction, whereas agency inaction almost never strengthens invocation of preemption.

Do you follow? We’re not sure we do, either.

There is another recent primary jurisdiction case, Velasco v. SEI Pharmaceuticals, Inc., 2013 WL 2444646 (S.D. Cal. June 5, 2013), that may or may not illustrate this point.  And by “point,” what we really mean is “mess.”  The plaintiff in Velasco alleged that a dietary supplement product label was misleading because it listed a “natural” ingredient that was really synthetic. The FDA sent a warning letter to the defendant stating that the synthetic was not a dietary ingredient. The letter required the defendant to cease distribution of the supplement and the defendant complied. The Velasco court declined to apply the primary jurisdiction doctrine because it simply did not look like there was anything for the FDA to do.

Maybe the result in Velasco is right.  Maybe not.  We know that the court in Cox is right to want to stay that case on grounds of primary jurisdiction.  But forgive us if we conclude that primary jurisdiction, like the parallel claim exception or the law of obscenity, has been hopelessly muddled by the courts.  The law student is right to wonder why primary jurisdiction does not come up more often in drug and device cases. If uniformity and expertise matter, then perhaps primary jurisdiction should not be so unduly cabined in drug and device cases. To be sure, some scholars have constructed reasons for restricting the sway of the doctrine. See, e.g., Struve, “Greater and Lesser Powers of Tort Reform: The Primary Jurisdiction Doctrine and State-Law Claims Concerning FDA-Approved Products,” 93 Cornell L. Rev., 1039 (2008). Professor Struve discusses potential constitutional limitations on the doctrine, such as Article III, the Seventh Amendment, and federalism. Struve is brilliant and her article is well worth reading. But being brilliant is not necessarily the same as being right. There is a book out now by Mario Livio called From Darwin to Einstein — Colossal Mistakes by Great Scientists that Changed Our Understanding of Life and the Universe. If Einstein, Darwin, Kelvin et al. can misfire, who is to say that a law professor is perfect? We have also seen some commentators say that primary jurisdiction should apply only if the relief sought is relief that the agency can provide.  Under this reasoning, primary jurisdiction might apply if the relief sought is a product recall, but not if the relief sought is monetary damages.

It is hard to take that distinction seriously. It does not reside in the seminal case law, and it ignores reality. After a couple of runaway jury verdicts you will essentially get a product recall. Further, we have heard more than one self-righteous plaintiff lawyer proclaim that his or her aim was to take a product off the market. The wisdom of primary jurisdiction is that complicated scientific judgments belong in the hands of an agency that offers expertise and consistency. Leaving such judgments in the hands of disparate jurors throughout the land, many in places with a disproportionate percentage of UFO sightings, seems silly and self-destructive.  Maybe it would at least make sense to hear what the FDA has to say.

But what if we don’t like what the FDA would say? You’d better think of that before raising the primary jurisdiction doctrine.   We can talk about primary jurisdiction incessantly – and there is much more to be said – but there isn’t much point if it does not lead somewhere good.