The case of Murthy v. Abbott Laboratories, first came to our attention last year when it took the #8 spot on our list of the top ten worst drug and devices decisions for 2011. That decision, 2011 U.S. Dist. LEXIS 129102 (S.D. Tex. Nov. 7, 2011), without citing any law – and contrary to a lot of law it didn’t cite – announced what amounted to a blanket exception to the learned intermediary rule for all investigational drug cases and carved out a second exception for DTC advertised drugs. You can see our full discussion of this “ugly” decision here. Fortunately, this year’s Texas Supreme Court decision in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012) fully embracing the learned intermediary doctrine and rejecting a DTC exception (see our post on Centocor here) undercuts much of the 2011 Murthy decision making it more like a nightmare – we’ve woken up and it found out it wasn’t real (or at least easily discounted).
A few months before the Centocor decision, the Murthy court was at it again in Murthy v. Abbott Labs., 847 F. Supp. 2d 958 (S.D. Tex. 2012). Here they incorrectly predicted that the Texas Supreme Court would recognize a DTC learned intermediary exception and based on that again refused to dismiss plaintiff’s claims based on the learned intermediary doctrine. Id. at 967-973. Since Texas has gone the way of every other state except New Jersey and rejected the DTC exception, that portion of the March 2012 Murthy decision is likewise just part of history.
The remainder of that decision, however, gave us some better news. The court dismissed all of plaintiff’s claims except breach of contract based on Texas’s immunity statute. 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. Since the presumption is rebuttable, the statute also provides certain exceptions to the rule and for a failure to warn claim to survive, plaintiff must adequately plead at least one of those exceptions. In March, the Murthy court found that plaintiff had not sufficiently pleaded any of the exceptions and dismissed her failure to warn, breach of warranty, strict liability and negligence claims accordingly. Id. at 973-77.
Unfortunately, our hope for Murthy was short-lived. Just last week, the court resurrected this bad penny of a case. See 2012 U.S. Dist. LEXIS 171246 (S.D. Tex. Dec. 3, 2012). Plaintiff filed a motion to vacate the court’s March 2012 ruling and to file an amended complaint alleging that the case fit within two of the exceptions to § 82.007 – both based on off-label promotion. The first exception provides a rebuttal 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.
§ 82.007(b)(3). The difference between March – when plaintiff didn’t meet the exception – and now was “recently discovered” call notes and a doctor’s report that plaintiff may not have met the criteria for inclusion in the clinical trial. Id. at *7. Given that the case is still at the pleadings stage and plaintiff now points to “evidence” of supposed off-label promotion – the court found it was enough to give plaintiff one more shot at her products liability claims. Since the call notes are so case-specific, this portion of the opinion, while not particularly appealing, doesn’t get us too riled up. We presume more discovery will follow which will likely shed light on the “call notes” – including the depositions of both the prescriber and the sale representative. Afterall, call notes are just that – notes -- and certainly don’t tell the whole story.
But, once again we have to take issue with the Murthy court’s over-reaching. The second exception cited by plaintiff states that the presumption can be rebutted if:
the defendant prescribed the pharmaceutical product for an indication not approved by the United States Food and Drug Administration; (B) the product was used as prescribed; and (C) the claimant's injury was causally related to the prescribed use of the product.
§ 82.007(b)(4) (emphasis added). This exception applies to prescribers. The manufacturer isn’t a prescriber. Exception doesn’t apply. Right? Not according to Murthy. Because plaintiff’s prescriber was a clinical investigator for the drug, the court found it was plausible that he could be considered an agent or an independent contractor of the defendant manufacturer and therefore the defendant manufacturer could be held vicariously liable for the investigator prescribing the drug off-label. Murthy, 2012 U.S. Dist. LEXIS 171246 at *13-15.
We find this to be quite a stretch for a number of reasons. First, we could find no Texas court decision (or federal court decision) interpreting § 82.007(b)(4) this way. Second, § 82.007(a) contemplates that a defendant could be a doctor:
In a products liability action alleging that an injury was caused by a failure to provide adequate warnings or information with regard to a pharmaceutical product, there is a rebuttable presumption that the defendant or defendants, including a health care provider, manufacturer, distributor, and prescriber, are not liable with respect to the allegations involving failure to provide adequate warnings or information if . . .
(emphasis added). So, if you read § 82.007(a) together with the exceptions in §§ (b)(3) and (b)(4) – (b)(3) is about off-label promotion and applicable to the manufacturer and distributor defendants whereas (b)(4) is about off-label promotion and applicable to the health care provider and prescriber defendants. Now granted, we are a bit confused about how the prescriber who traditionally is not a seller would be a defendant in a products liability case where that is defined as an “action against a manufacturer or seller.” Tex. Civ. Prac. & Rem. Code § 82.001(2). But, it certainly seems to us like this is one for the Texas courts or legislature to grapple with first. Not a federal court sitting in diversity and constrained by the Erie doctrine. Finally, the Murthy court didn’t need to reach this issue at all. Having already decided that plaintiff had sufficiently pleaded a § 82.007(b)(3) exception, it could have stopped there rather than making an unprecedented interpretation of an at least arguably unclear state court statute.
Bottom line, while the Texas Supreme Court took away most of our angst over Murthy, it continues to trail us like gum on the bottom of our shoe. We can’t quite scrape free of its annoying presence.