Tuesday, January 08, 2013

Excellent Texas Learned Intermediary Decision

            We call them like we see them – which of course is with a defendant’s eye.  But nonetheless, excellent is how we view Solomon v. Bristol-Myers Squibb Co., 2013 U.S. Dist. LEXIS 534 (D.N.J. Jan. 3, 2013).  And while the ruling was made by a New Jersey federal court judge, it is all about Texas learned intermediary law.  It may have taken until late 2012 for Texas to join the ranks of states adopting the learned intermediary doctrine, but now that it has we get to enjoy decisions like this.  It is so chock full of golden nuggets, we think it best to just walk you through the highlights.  If you have a drug or device case pending in Texas, you’ll want to read the whole opinion more closely – and here’s why.
            The case involves Plavix – an antiplatelet drug, more commonly thought of as a blood thinner typically prescribed to people who have had heart attacks, strokes, or other cadio- or vascular-related illnesses.  Because its job is to inhibit the formation of clots, it carries a risk of increased bleeding.  Its label sets forth that risk in great detail.  Id. at *4-6.  Plaintiff Solomon suffers from coronary artery disease and following stent placement post-heart attack, he was prescribed combination Plavix and aspirin therapy.  After approximately 2 ½ years, plaintiff suffered chronic gastrointestinal bleeding requiring repeated blood transfusions and surgery.  Id. at *6-7.   Then he brought his lawsuit asserting several products liability claims under Texas law – all of which boil down to whether there was a failure to warn of the risk of bleeding.  Id. at *8.  And because there was no failure to warn – plaintiff has no claim.
            Toward the end of a nice recitation of Texas’s learned intermediary law, id. at *11-16, we get our first highlight – no heeding presumption.  The Texas Supreme Court hasn’t created such a presumption, the Fifth Circuit has predicted that they won’t, and there is no other authority to the contrary.  Id. at *16-17.  Short, sweet and to the point.
            The court next moves on to the accuracy of the label on warning of the risk of serious bleeding complications.  Here, because the label is so strong, plaintiff throws a plate full of Plavix studies against the wall.  But none of them stick.  First to fall are studies that don’t pertain to the underlying health condition suffered by plaintiff:  “As an initial matter, this Court finds that although Plaintiff presents various studies and articles . . . none of those studies are relevant to plaintiff’s medical situation.”  Id. at *18.  For example, plaintiff attempted to rely on studies dealing with transient ischemic stroke, post-coronary bypass treatment, patients over 75, and the use of Plavix without aspirin – none of which pertain to plaintiff Solomon.  Id. at *18-20.
            Applying state-of-the-art to the science, the court also rejected studies that post-date plaintiff’s use of Plavix:
Perhaps even more crucial is the fact that the findings of the [ ] study were published in 2006 - a year after Plaintiff stopped taking Plavix.  Therefore, those findings cannot bolster Plaintiff's failure-to-warn claim since this study was not available at the time Plaintiff was taking Plavix.

Id. at *24-25 (emphasis in original).  The study at issue in fact was in line with the risk level reported in the Plavix label – so even if accepted by the court, it wouldn’t have helped plaintiff.  But we like the state-of-the-art point even more.
            Perhaps most significantly, the court noted that all of the studies relied upon by plaintiff challenged the efficacy of the drug, not its risks.  But efficacy wasn’t the issue:
Plaintiff's claim is essentially premised on the fact that he suffered substantial bleeding as a result of taking both Plavix and aspirin at the same time - not that Plavix did not work.

Id. at *20.  If plaintiff had suffered a blood clot while on Plavix and brought a claim on that basis arguing that the product didn’t do what it was supposed to do (and there are lots of reasons why such a claim shouldn’t hold up, but that’s a tangent for a different post) – maybe, just maybe some of the studies about the effectiveness of Plavix would matter.  But “[p]laintiff’s efficacy arguments are not relevant in the context of a failure-to-warn analysis.”  Id.   Rather, on a failure to warn claim, the issue is whether the drug’s labeling included a warning adequate to alert the learned intermediary of the risk which plaintiff suffered.  The court in Solomon cites to other cases rejecting failure to warn of efficacy claims, id. at *21, and finds that allowing it in this case would “impermissibly expand liability under Texas law on the adequacy of pharmaceutical warning labels.”  Id. 
            Discounting all of the science relied on by plaintiff, the courts sums it up nicely:
[O]n the issue of the accuracy of Plavix's warning label, Plaintiff presents a number of studies and articles which are neither relevant nor probative in demonstrating that the warnings regarding the risks of increased bleeding in ACS patients taking Plavix and aspirin were inaccurate in any way.

Id. at *28-29.  Having found the Plavix warning adequate as a matter of law, the court could have stopped there.  But, it went on to examine causation as well.  There, defendant hit the trifecta.  Plaintiff’s prescriber and treater both testified (1) they were aware of the risk of increased bleeding, (2) they didn’t rely on the label or company information, and (3) they wouldn’t treat plaintiff any differently today.  Id. at *30-34.  Because plaintiff “produced no evidence – testimonial or otherwise – to suggest that a different warning would have led these doctors to alter their treatment for Plaintiff” – plaintiff’s claims fail for lack of causation as well.  Id. at *36. 
            All of this before the court even got to Texas’s statutory presumption of adequacy for FDA-approved labels.  When it does get there – it is simply icing on the cake.  Id. at *37-41.  Finally, the court dismissed plaintiff’s defective design claim as essentially identical to failure to warn; his manufacturing defect claim because there were no allegations that the drug deviated from the specifications for Plavix; and his negligence claim as simply a restatement of the other already dismissed claims. 
            Try as we might, we couldn’t resist ending with a pun – we think the court displayed the judgment of Solomon in reaching this wise decision.

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