United States: Comparative Fault of Government Regulators Might be a Defense

'Pointing to the empty chair' is a well-known defense trial tactic.  It allows the defendant to go on offense.  Maybe the plaintiff deserves some compensation, so the narrative goes, but the plaintiffs sued the wrong party.  If the jury believes that narrative, it might exonerate the defendant completely.  Or it might at least assign some percentage of fault elsewhere and reduce the damage award.

Playing the blame game can be a way of redirecting jury anger.  It can also be tricky.  Is pointing to the empty chair inconsistent with major defense themes?  If you're saying that an injury is not real, or not so bad, or was caused by something completely different, can you also say that non-party X should be on the hook?  The great Texas trial lawyer Racehorse Haynes died last week.  He won some trials that nobody thought were winnable.  He famously told a story about how he would defend a dog-bite case:

Say you sue me because you say my dog bit you. Well, now this is my defense:

My dog doesn't bite.

And second, in the alternative, my dog was tied up that night.

And third, I don't believe you really got bit.

And fourth, I don't have a dog.

Of course, a little too much of that alternative pleading and the jury might start to doubt the lawyer's credibility.  Here, we are talking about a slightly different defense:  some other dog bit you.  That other dog might be a health care practitioner.  But, as is often the case, doctors sometimes get special, favorable treatment from the judicial system.  In some jurisdictions, a defendant cannot point to a non-party doctor at all, or can do so only by making out a prima facie case of medical malpractice, complete with an expert opinion.  (At this point we are not even getting into the fact that many of our clients do not ever want to point the finger at a doctor, whether that doctor is a co-defendant or is a non-occupant of the empty chair.  Granted, the latter is much easier conceptually if not practically.) 

The toughest version of the empty chair defense is trying to pin blame on an actor that enjoys some degree of immunity.  That is what happened in the eccentric case of In re New England Compounding Pharmacy, Inc., Prods. Liab. Litigation, 2017 WL 1458192 (D. Mass. April 24, 2017).  The plaintiffs alleged that contaminated compounded drugs hurt a lot of people.  The main defendant  went bankrupt, so the plaintiffs went about suing all manner of unusual defendants on unusual theories.  A couple of relatively minor defendants asserted the comparative fault of the FDA, the Massachusetts Board of Pharmacy ("MBOP"), and some Tennessee governmental entities.  The Plaintiffs' Steering Committee ("PSC") moved for judgment on the pleadings against those defendants.  They won a little and lost a little.  The bit they lost is fascinating and prompts us to speculate on all sorts of outlandish possibilities. 

But first to the part the PSC won.  The Tennessee public duty doctrine shields public employees from suits for injuries caused by the breach of a duty owed to the public at large.  A duty owed to everyone turns out to be a duty owed to no one.  The public duty doctrine renders the public actors immune from duty and immune from fault.  Therefore, there can be no comparative fault laid at the door of such public actors.  Of course there is an exception to the rule of non-liability.  It seems there are always exceptions to non-liability rules.  That exception is triggered when the public employee owes a "special duty" to the plaintiff.  Such a special duty arises when, (1) the public employee undertakes to protect the plaintiff, and the plaintiff relies upon such undertaking, (2) a statute specifically creates a cause of action against an official or municipality for injuries resulting to a particular class of individuals, of which the plaintiff is a member, from failure to enforce certain laws, or (3) the public employee acted intentionally, maliciously, or recklessly.  The defendants in this case did not even allege that the Tennessee entities fit into these categories, so those Tennessee entities cannot be the focus of a comparative fault defense.

Goodbye Tennessee entities.  Any hopes of dragging them into the case via comparative fault "rode away on a Tennessee stud."

By contrast, the defendants did allege that the FDA and the MBOP acted recklessly.  The defendants alleged that the FDA and MBOP were aware long ago that the compounder had sterility and potency issues, but failed to take any "meaningful, substantive action."  The FDA had issued a warning letter to the compounder but, according to the defendants, never followed up appropriately.  Viewing the defendants' allegations in the light most favorable to them, the court concluded that the comparative fault defense lived to fight on in the case.  Perhaps it will be tested again. 

Meanwhile, one cannot help but wonder how an FDA comparative fault defense might play out in future cases.  Many drug or device defendants face the issue of how much to highlight the fact of federal regulation in defending against liability.  It seems a worthwhile point to make, if only to let the jury know that companies cannot unleash products on the populace without some sort of review, clearance, and/or approval from the FDA.  We know of one court that has held that a 510(k) clearance is so meaningless as to merit preclusion from trial, but that opinion seems to be an outlier.  More often, the decision for the defendant is whether the fact of FDA regulation is worth the inevitable onslaught from plaintiffs and their experts about how the FDA is allegedly a paper tiger.   But now that we have read the New England Compounding case, we wonder whether that plaintiff onslaught potentially sets up a comparative fault defense — that the FDA acted recklessly in not initiating stricter enforcement action.  That would be a weird and risky position for a defendant to take.  But if the plaintiffs are doing everything they can to make the case, why not take advantage of it?  Still, there are wrinkles everywhere in such a scenario.  The Food, Drug and Cosmetics Act affords the FDA with discretion.  See 21 U.S.C. §336 ("Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution . . . whenever he believes that the public interest will be adequately served by a suitable written notice or warning"). Such discretion might protect the FDA from suit under the Federal Tort Claims Act.  It might even preempt this kind of argument. We don't know, because we haven't seen it before.  Even aside from that legal impediment, given FDA discretion, the concept of a common-law duty owed to any person to enforce the law in a particular way would seem to be a challenging argument.  As to the Massachusetts regulators, the comparative fault theory is intriguing as an empty chair defense, but what if someone tries to fill that empty chair with an actual state entity defendant?  Could parties in one state sue the regulatory bodies of another state for negligence concerning damages caused by a regulated product sold in interstate commerce?  The 11th amendment would seem to be an insuperable barrier, at least in federal court such as this MDL.    

Sometimes, weird little one-off rulings in unusual cases do not end up being so one-off.   

This article is presented for informational purposes only and is not intended to constitute legal advice.

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