Having worked in the federal government, we are familiar with how important Department of Justice Guidance Policy memoranda can be.  They set priorities, outline criteria for acceptable guilty pleas and sentencing factors, and can make a huge difference in terms of who gets indicted or sued for what, when, and under which circumstances.  These DOJ guidances are seldom secret.  They can make quite a splash and set in motion a series of CLE conferences, complete with client glad-handing, Statements of the Obvious, and rubber chicken lunches. 

 

Now that we work on drug and device law, we are familiar with how important Food and Drug Administration Guidances can be.  They can address all sorts of things, such as off-label communications, social media, 510(k) submissions, cybersecurity, and 3D printing, just to name a few.  They, too, inevitably prompt a series of CLE circuses.  We have also become familiar with the propensity for plaintiff lawyers to hire FDA ‘experts’ who skillfully turn to the jury at just the right moment, break out in a wise and world-weary grin, and spin a tale of how the corporate malefactor broke the law.  It is, frankly, a mystery to us why some judges permit these travelling pseudoexperts to instruct the jury on the law,  and it is even worse when the experts’ legal opinions are not close to being legally sound.  For example, think of cases where an expert pretend-ruefully lays out a company’s purported violation of some FDA guidance (a violation, by the way, that the FDA itself has not decried), that is not even an actual violation of law.  What we have in such cases is a faux negligence per se theory – call it negligence per say so.

 

We’re now more than a month past Christmas, but the federal government seems to be handing out swell presents to the drug and device defense bar.  We wrote earlier this week about the Pharmaceutical Information Exchange Act, which is pending in the House of Representatives and which would introduce a rare note of sanity into the controversy over off-label communications.  A couple of weeks ago we praised the FDA’s decision to postpone implementation of its execrable “intended use” rule.  Today, we have the good fortune to report on the DOJ’s January 25, 2018 announcement that “Guidance documents cannot create binding requirements that do not already exist by statute or regulation.”  This remarkably refreshing policy flows from the Attorney General’s November 16, 2017 Guidance Policy, which stated that government guidances, which are not subject to the notice-and-comment rulemaking process, cannot bind the public.  The Attorney General in November 2017 was talking about DOJ guidances, but last week’s announcement makes clear that the same principles “should guide Department litigators in determining the legal relevance of other agencies’ guidance documents in affirmative civil enforcement.”  Thus, going forward, DOJ “litigators may not use noncompliance with guidance documents as a basis for proving violations of applicable law” in civil enforcement cases.  To the extent that guidances offer a useful paraphrase from existing statutes or regulations, they might be relevant.  To the extent that a defendant read a specific guidance, that fact could conceivably establish knowledge of a legal mandate that can be traced to a statute or regulation.  But the government cannot “treat a party’s noncompliance with an agency guidance document as presumptively or conclusively establishing that the party violated the applicable statute or regulation.”

 

At first blush, this new guidance will have immediate and profound effects on actions brought by the government against health care companies under the False Claims Act.  Too many of those actions are premised on no actual false statement and no actual violation of a statute or regulation.  Instead, these FCA cases have been permitted to go forward and exercise their in terrorem effect based on some vague violation of vague FDA guidances.  Even if not vague, an FDA guidance has no real legal effect.  The DOJ’s recognition of what guidances are and, more importantly, what they are not, should have the effect of cabining FCA actions in some reasonable and predictable fashion.  (If you think we are leaping to an unwarranted conclusion about what looks to us like the government’s concern about overreaching FCA cases, consider the fact that on January 10, 2018 – shortly before the policy guidance that inspired this post – the government published another policy memorandum, and that memorandum set out the factors that government attorneys should take into account in deciding whether the government should dismiss unmeritorious qui tam lawsuits.  QED.)  Since January 25, some defendants in qui tam cases have already filed motions based on the new DOJ policy.  If you represent a qui tam defendant, and if the complaint cites an alleged violation of an FDA policy, you might want to file a motion.  

 

What about civil cases brought by private plaintiffs?  The DOJ closed its January 25 announcement of the new policy by stating that “it is not intended to, does not, and may not be relied upon to, create any rights, substantive or procedural, enforceable at law by any party in any matter civil or criminal.”  That is all fine and good and is a typical  of careful draftsmanship.  But why wouldn’t the DOJ announcement strengthen an argument that we have already made (here, for example) that FDA guidances are only what they say they are – guidances – and are not laws or regulations?  Such guidances  have no legal effect on defendants, certainly do not establish negligence per se, and should not be in the bag of tricks of some plaintiff FDA expert who seeks to invade the province of both jury and judge.  Maybe a court will not consider the DOJ’s guidance to be binding, but wouldn’t it be fine if the court at least took the guidance as a worthy source of … guidance?