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Here’s another guest post by Reed Smith’s own Kevin Hara, this time about a recent Texas case holding that health care providers involved in clinical trials are still protected by a state medical malpractice statute, and thus were fraudulently joined.  While we are of two minds about such statutes (making it harder to sue HCPs increases litigation against our clients), since HCPs are our clients’ clients, and thus the heart of their businesses – and we’re defense lawyers by temperament – in the end we come out in favor of less liability generally.  This is an interesting use of fraudulent joinder that could well apply to the definition of “health care provider” under similar statutes in other states.

As always, our guest posters deserve all the credit and any blame for the contents of their posts.

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When it comes to Texas, one might never know based on its jurisprudence that the state motto, and indeed the state’s moniker, is derived from “Tejas,” a Native American term for Friendship.  At least from a defense perspective, the Lone Star State at times seemed mighty inhospitable; after all, Texas invented that awful “heeding presumption” back in 1972, touching off a Reign of Fire, as states followed suit, adopting a variety of feeding presumptions.  It also allowed personal injury recovery under its consumer protection statute, made a big deal of Restatement Second §402B, and was the last of the large states to adopt the learned intermediary rule.  While we’re at it, let’s not forget the decision that would never die, the Murthy case, making the worst decisions list in consecutive years in 2011 and 2012, giving us not just one opinion to lament, but Two for the Money.

But we’re forgiving, and won’t “mess with Texas” too much.  Although it took until 2012, with some help from Bexis, for the Texas Supreme Court to finally adopt the learned intermediary doctrine, deciding that it was A Time to Kill an awful decision from 2010 whose name should have been Mud.  Texas adopted the Third Restatement, which should kill the heeding presumption, and even if it doesn’t, that presumption now excludes prescription drugs and medical devices, at least forcing it into Submission.  The Legislature amended the DTPA to eliminate personal injury damages, and we haven’t heard a peep from §402B in a while, and this section’s Failure To Launch into widespread acceptance is a good thing.  Texas Daubert decisions have been outstanding.  Not only that, a lot of excellent Reed Smith practitioners are based in our Houston office.

Texas has other positive attributes as well, including being the birthplace and home of Matthew McConaughey, and of baseball standout Nolan Ryan, who we believe, despite numerous accolades, remains underrated because of his somewhat pedestrian won loss record (which for pitchers reveals more about the team and much less about the individual).  Seriously, seven no-hitters?  Ryan pitched in an era where starters routinely went the distance, and they were their own closers; we urge you to check out his career innings pitched, hits allowed, complete games, and well, the strikeouts speak for themselves. No disrespect to Madison Bumgarner, who was otherworldly in the 2014 World Series, but who has 6 complete games in his career.  Ryan had an incredible 222, including several years where he had more than 20.  We realize that people smarter and more knowledgeable than we are will correctly we might add, mention that Ryan also walked many hitters and never won the Cy Young. That’s the beauty of sports.

And then there’s ZZ Top and Janis Joplin and Beyonce.

But we digress.  Back to the legal issues.  It would be remiss not to note that Texas also has some very favorable statutes, including Civil Practice and Remedies Code 82.007, which provides a rebuttable presumption of nonliability for manufacturers and prescribers in pharmaceutical product liability actions involving failure to warn for FDA approved warnings, and 82.008, which provides a presumption of nonliability for compliance with government standards.  See Tex. Civ. Prac. & Rem. Code §§ 82.007(a)(1) and 82.008.  We were concerned that a recent Southern District of Texas decision would a la Murthy, run roughshod over state law like the TCU Horned Frogs in an 82-27 rout of Texas Tech this year or UCLA in a 66-3 drubbing of Texas in 1997 (the Longhorns’ worst loss ever).  Fortunately, we were pleasantly surprised.Continue Reading Guest Post – When It Comes To Fraudulent Joinder In Texas, Let’s Hail The Glory Daze And Just Keep Winning

We have seen the news that FDA is preparing a proposed rule to change the regulations to permit generic drug manufacturers (ANDA holders) to update their labels based on post-approval information without waiting for the branded/NDA drug’s label to change.  This seems like a fairly obvious response to Mensing’s preemption of most generic drug labeling claims and the call to a legislative solution by various judges and commentators.

It is for another day whether FDA can actually offer a regulation that both undoes Mensing and makes enough sense within the statutory scheme that can it survive inevitable challenges.  In the meantime, we return to the gap in Mensing that some plaintiffs exploit.

As in many of the decisions on generic preemption and innovator liability over the last several years, Garza v. Wyeth LLC, No. 2:12-CV-00198, 2013 WL 329356 & 3293704 (S.D. Tex. June 28, 2013), involves allegations of “abnormal muscle movements” with long-term use of the generic prescription drug metoclopramide.  Like many of the decisions we have griped about, the plaintiff in Garza was permitted multiple amendments of her complaint, including one after the first set of motions to dismiss had been argued.  Those motions resulted in Garza v. Wyeth LLC, 2013 WL 878586 (S.D. Tex. March 7, 2013), where warning claims—the only type of claim permitted with a prescription drug under Texas law—against two generic manufacturers were preempted “as there are no allegations that their labels were inconsistent with the FDA-approved, name-brand drug labels.” Id. at *4.  The claims against two other generic manufacturers were not preempted because the current complaint alleged that they had failed to update their labels to match the branded labels.  Id.  The court also held that, to get past a motion to dismiss, the complaint need not allege the fraud-on-the-FDA exception to the statutory rebuttable presumption of adequacy for FDA-approved labels was met.  Id. at **4-5.  This followed from the fact that the complaint did not allege that the labels at issue had been approved; rather, it alleged that the same two generic manufacturers that ended up on the wrong side of the preemption decision had “failed to adhere to FDA label requirements.”  Setting aside whether plaintiffs would ever agree that approval of a drug’s label meant that the manufacturer had adhered to “FDA label requirements,” the March decision set the stage for the two in June.Continue Reading The Generic Preemption Door Stays Open, At Least Until The Facts Matter

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

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. …

           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…

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

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

…

Does Buckman v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), apply any time that a plaintiff raises a fraud on the FDA allegation in litigation, or is it limited to causes of action denominated “fraud on the FDA?  Most courts have agreed with the Sixth Circuit that Buckman applies across the board.  See , 385 F.3d 961 (6th Cir. 2004).  A persistent minority, however, has limited Buckman to complete “fraud on the FDA” causes of action.  See Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006).  The Supreme Court attempted, but failed, to close the split in Desiano, but failed – splitting 4-4.  See Warner Lambert LLC v. Kent, 552 U.S. 440 (2008). Garcia v. Wyeth-Ayerst Laboratories
Both Garcia and Desiano involved the “fraud on the FDA” exception to a Michigan tort reform statute that imposes a presumption of adequacy on warnings that are FDA approved – that is, just about every warning.  The Michigan statute was essentially dispositive.
Then Texas passed a similar presumption statute that is almost as dispositive in the ordinary case as Michigan’s.  It was only a matter of time before the Fifth Circuit would be called upon to decide the same question as in Garcia/Desiano.
Also in the mix is the Supreme Court’s later, extremely anti-preemption, decision in Wyeth v. Levine, 555 U.S 555 (2008).Continue Reading Fifth Circuit Breaks Buckman Tie

A couple of weeks ago we posted about the recently enacted Wisconsin tort reform statute, which, among a bunch of other things, included a “rebuttable” presumption that a product compliant with federal or state standards isn’t defective. Specifically, the statute provides:

Evidence that the product, at the time of sale, complied in material respects with relevant

…

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