Stop us if you’ve heard this one before. Actually, you mostly have, at least if you’ve been paying attention to our posts (here, here, and here) on the Bartlett v. Mutual Pharmaceuticals litigation. Judge LaPlante has issued a number of rulings, some of which we like, and some of which we’re not sure about, but all of which are well-written and thoughtful. Peter King in Sports Illustrated has a column called “Things I Think I Think.” We think we think Judge LaPlante’s latest Bartlett decision is pretty good.

By now we’re used to how middle-brow tv shows start with a “Previously on [Hill Street Blues or Weeds or Mad Men, etc].” So, here goes our “previously in Bartlett:” Plaintiff claimed she came down with Stevens Johnson Syndrome after taking a drug called Sulindac, an anti-inflammatory NSAID. Plaintiff’s complaint was chock-full of theories. Before trial, the court made some preemption rulings, which we viewed as a mixed bag. The court also granted summary judgment on some (but not all) of the claims. Of particular note, the court granted summary judgment on the failure to warn claims because the prescriber never read the label. Some failure to warn claims discussed items other than the label, such as the failure to issue a medication guide, Dear Doctor letter, black box warning, or educational materials. The court held that these non-label theories ran afoul of the learned intermediary rule or, more simply, were devoid of legal authority.

The case went to the jury, which found for plaintiff on strict liability design defect. After summary judgment and before trial, Plaintiff filed a brief in support of three negligence theories:

  1. failure to seek FDA approval of a patient medication guide;
  2. failure to survey the medical literature regarding the risks of Sulindac and report such information to the FDA; and
  3. failure to file a citizen’s petition with the FDA regarding Sulindac’s safety risk.

Like we said, you’ve heard this before. The court correctly concluded that Plaintiff was trying to “resurrect” her failure to warn theories, “in contravention of this court’s summary judgment ruling.” Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789 at *1 (D. N.H. Sept. 14, 2010). Plaintiff was persistent, but not subtle. Sometimes losing parties (even if they win on something else) keep rearguing losing positions, hoping to wear the judge down. That apparently doesn’t work with Judge LaPlante.

As we’ve come to expect from Judge LaPlante, the court’s decision is sharply reasoned and sharply written. “Resurrect” is a colorful synonym for a much more mundane motion, one for reconsideration. Such a motion for reconsideration must meet certain well-established criteria, none of which is satisfied here. In any event, Plaintiff’s negligence theories are all failure to warn claims that violate the learned intermediary doctrine and, moreover, flunk warning causation. Plaintiff argued for a “special exception to the learned intermediary rule for medication guides, since they are a ‘new development’ in the law.” Bartlett, 2010 WL 3659789 at *6. Sadly for Plaintiff, this “special exception” is not only bereft of authority, it is explicitly contradicted by the FDA’s pronouncement that the medication guide regulation was not intended to affect the learned intermediary rule. Id. Oops. Plaintiff in the alternative argued that the doctor could have read the medication guide, which would have been added to the end of the label … except that the prescriber didn’t read the label, remember? Double oops.

Plaintiff also argued that Defendant should have filed a petition with the FDA to remove Sulindac’s indication for shoulder pain, thereby “advising doctors of this through effective means.” Id. *7. Sounds like failure to warn, right? Sounds like another theory foreclosed by the doctor’s failure to read the label, right? Judge LaPlante writes that Plaintiff, in submitting this argument, is “[s]eemingly unfazed by the rule of summary judgment.” Id. Persistence is an overrated virtue.

Plaintiff also argues that if Mutual had filed a citizen’s petition with the FDA regarding Sulindac’s risks, the FDA would have removed Sulindac from the market entirely. How’s that’s for warning causation? But the court pointed out that the main flaw with Plaintiff’s argument is that it is “contrary to what actually happened.” Id. at *8. Ah, pesky reality. Facts are indeed stubborn things. The FDA had reviewed the evidence, including adverse event data, and had not removed Sulindac from the market. Plaintiff, in short, was being “counterfactual.” Id. If one wanted to be more charitable (not likely in our case), one could say that Plaintiff was engaged in “pure speculation” as to what might have changed the FDA’s mind. Id. at *9. This is one of the faults of a fraud on the FDA claim, as well (more on that below), because it puts parties in the position of arguing what a regulatory agency might have done had the regulatory process been different than what it actually was. Courts rightly leave those kind of things to the regulators themselves.

Be that as it may, Mutual could have cut out the middleman (the FDA) altogether and unilaterally withdrawn Sulindac from the market. But Plaintiff had to reinsert the middleman, because the court had already ruled that “there is no common law duty to recall products from the market, even if they are unreasonably dangerous. Id. at *10. That is, “Bartlett has lengthened the chain of causation to include the FDA in an attempt to overcome the lack of any duty on Mutual’s part to stop selling Sulindac.” Id.

Even aside from causation deficiencies, this negligence theory raises serious Buckman preemption concerns. Granted, here the claim is not one of affirmative fraud-on-the-FDA but, rather, negligent “failure to communicate with the FDA.” Id. at *11. As a practical matter, they’re the same thing. If such a theory were viable, “then there is a very real possibility that the FDA would be ‘deluged’ with citizens’ petitions and other correspondence from manufacturers seeking to protect themselves against such state tort liability.” Id. At this point, Judge LaPlante alludes to the Desiano/Garcia debate we’ve discussed before (here, for example). We suspect that Judge LaPlante’s heart is in the right place on this issue, but it doesn’t matter, because Plaintiff’s theories are doomed by want of causation” “[W]hile the court need not decide this issue in light of lack of causation, the claim raises substantial federal preemption concerns under the Supreme Court’s holding in Buckman, since it is premised on Mutual’s alleged ‘failure to communicate with the FDA.'” Id. at *12.

That same lack of causation means that Plaintiff is not eligible for “enhanced” compensatory damages — an odd creature of New Hampshire law that is most certainly NOT punitive damages (Why? Because they say so.). Since the conduct complained of cannot be tied to an injury, it cannot play any role in calculating compensation. Id. at *13. That is sound reasoning and is good for Mutual. But if you read the opinion you’ll see that the jury was already more than liberal in compensating Plaintiff.