So far this week, we’ve brought you very positive news. Unfortunately, that’s about to change. As much as we don’t like reporting it, we think it is important to get the word out about decisions that trouble us almost as much as it’s important to celebrate the victories. So, when we came across Lucas v. Abbott Laboratories, 2103 WL 2905488 (N.D. Tex. Jun. 13, 2013) and saw that the court was allowing plaintiff to amend his complaint and that the decision cited Murthy v. Abbott Laboratories, 2012 U.S. Dist. LEXIS 171246 (S.D. Tex. Dec. 3, 2012) – we knew we weren’t going to like the result.
There have been multiple Murthy decisions that haven’t made us happy and our discussion of last year’s decision can be found here. Unfortunately, on off-label promotion, the Lucas decision appears to go even a step further than Murthy.
In Lucas, plaintiff alleged injury from the drug Humira that was prescribed off-label – which we all know doctors are allowed to do. In response to defendant’s motion to dismiss, plaintiff Lucas sought leave to file an amended complaint which he claimed sufficiently pled an exception to Texas’s pharmaceutical products liability immunity statute. Lucas, at *1-2 (plaintiff’s original complaint was filed by now disbarred counsel and new counsel admitted it did not contain sufficient allegations regarding the immunity exceptions). The statute provides that in a pharmaceutical products liability action “there is a rebuttable presumption that the defendant . . . [is] not liable with respect to the allegations involving failure to provide adequate warnings . . . if the warnings or information that accompanied the product . . . were those approved by the [FDA].” § 82.007 of the Texas Civil Practices and Remedies Code. One of the exceptions to this bar on liability is where:
the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the United States Food and Drug Administration; the product was used as recommended, promoted, or advertised; and the claimant's injury was causally related to the recommended, promoted, or advertised use of the product.
As to the second element, defendant conceded that plaintiff was prescribed the drug for an off-label use. Id. at *4. It was the first and third elements that Defendants challenged. So, what was the alleged off-label promotion? Defendant conducted clinical trials. If you are waiting for more, keep waiting. That’s it. That’s all. Plaintiff alleged that by conducting FDA-approved clinical trials to study off-label indications, defendant was promoting the drug for those off-label indications.
Let’s start with the defendant’s attempt to clarify the different types of FDA approval:
Defendant counters that there are two types of FDA approval, marketing approval and investigative approval. Defendant argues that its alleged activities sponsoring clinical trials with Humira were to study indications that were given investigational approval by the FDA, such as for treatment of [plaintiff’s condition]. Thus, Defendant argues that sponsoring such studies was not “promotion” of Humira for an indication not approved by the FDA.
Id. This, however, didn’t seem to hold any sway with the court which found that at the pleadings stage it had to accept as true plaintiff’s allegation that “Humira was never approved, in any capacity, by the FDA to treat [plaintiff’s condition].” Id. But it is also the case that amendments that are futile shouldn’t be allowed. Here, where defendant could demonstrate that the drug had investigational approval – and the court could have taken judicial notice of the FDA approval -- it would seem that plaintiff’s unsupported assertion shouldn’t be enough to carry the day. Now, maybe defendant can attach the approval to its answer and seek judgment on the pleadings -- game over. But we think it shouldn't even need to come to that.
As to the third element – did the alleged off-label promotion cause plaintiff’s doctor to prescribe the drug off-label? Here, plaintiff hung his hat on the fact that the prescriber was a clinical investigator for Abbott and therefore “would have had an express financial incentive” to prescribe the drug and downplay the side effects. Id. Again, the court found this to be enough to satisfy plaintiff’s pleading obligations. It is really this complete lack of factual support that makes this case even more bothersome than Murthy. While we still disagree with the result in Murthy, at least there plaintiff was a clinical trial participant and to support her allegations, plaintiff pointed to call notes and a doctor’s report that plaintiff may not have met the criteria for inclusion in the clinical trial. Murthy, 2012 U.S. Dist. LEXIS 171246 at *7. Plaintiff Lucas doesn’t even come close to having any factual support for his bald assertions on causation. We think this should have flunked TwIqbal too.
Now, let’s look at the practical implications of the plaintiff’s argument and this ruling. Drugs are approved by the FDA for marketing for certain indications. In use, doctors often discover additional benefits – the classic example being the heart benefit from aspirin. When science supports the possibility of additional indications for usage, manufacturers can obtain investigational approval to study the drug for those new indications. If the results of those studies then warrant it, the additional indications can be approved by the FDA for marketing. If investigational approval and clinical trials can be considered off-label promotion, it begs the question how new indications could ever gain market approval. It is a clear case of circular logic. You need clinical trials to support new indications being put on-label, but you can’t conduct clinical trials because they are considered off-label promotion. Around and around we go. Talk about a deterrent to investigating new health benefits.
Under no circumstances of which we can conceive could clinical trials be deemed off-label promotion. Yet, this court said such an allegation was enough to allow the amended complaint. And, in a jurisdiction with an immunity statute. It gives us pause for this type of claim in other jurisdictions.
As distasteful as that ruling is, Lucas wasn’t all bad news. Plaintiff originally filed his complaint in state court and it included claims against his non-diverse doctors. When those claims were dismissed for failure to file the requisite expert report, the case was removed to federal court. Lucas, at *1. In addition to amending his claim against Abbott, plaintiff sought to add as a defendant Texas Dermatology Associates – plaintiff’s prescriber’s practice. Because the original complaint identified the prescriber’s place of business, the court found that plaintiff was aware of the practice as a potential defendant from the outset. Therefore, the court concluded that plaintiff was dilatory in seeking to add the practice as a defendant and that the primary reason for the motion to join was to defeat diversity jurisdiction. The motion was denied and the case remains in federal court. Id. at *5-7. It’s not much, be we’ll take it. Hopefully, once the court goes beyond the pleadings, it will see plaintiff’s allegations for what they are, unsupported both factually and legally.?