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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.

§ 82.007(b)(3).

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.Continue Reading Investigational and Off-Label – Not the Same Thing

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Every now and then we come across something new and interesting that, frankly, we hadn’t thought of ourselves.  That’s how we felt when we read the recent opinion in Boudreaux v. Corium International, Inc., C.A. No. :12-cv-2644-M, slip op. (N.D. Tex. May 7, 2013).   We mentioned the same sort of thing a few years…

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One of the avowed purposes of the blog is to make available to all defense lawyers the kind of extremely detailed legal research that that we large firm lawyers frequently end up doing.  After all, a win anywhere helps defendants everywhere.  Sometimes we’ve done this research ourselves; sometimes we’ve come across research done by others. …

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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 cardio- 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.Continue Reading Excellent Texas Learned Intermediary Decision

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           We read
the decision in Tigert v. Ranbaxy Pharms.,
No. 12-00154 (RBK/JS), 2012 U.S. Dist. LEXIS 178475 (D.N.J. Dec. 18, 2012),
with interest.  It involved a recurring
question that the Supreme Court failed to address in Warner-Lambert Co. v. Kent, 552 U.S. 440 (2007)—whether state
statutory provisions that require a plaintiff to…

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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.Continue Reading Murthy Update – The Case That Wouldn’t Go Away

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Everything seemed to go right for the defense in Anderson v. Abbott Labs., 2012 U.S. Dist. LEXIS 141585 (N.D. Tex. Sept. 30, 2012).  The court applied Buckman preemption, it applied TwIqbal, it dismissed the case early, and it didn’t allow an amended complaint.  Everything was good in Texas.  It’s an easy decision to

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Today’s post is of the “this and that” variety − dealing with things we’ve come across that we haven’t yet blogged about this week.
 

Medical Device Preemption − The Greatest

As defense counsel appreciate, PMA preemption post-Riegel floats like a butterfly and stings like a bee.  Anybody representing PMA medical device clients will…

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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