In case you haven’t noticed, we like preemption.  We’ve even called ourselves “obsessed” with it.  And with good reason.  Preemption, where it’s available, is the most powerful defense around – capable of wiping out an entire MDL with a single motion to dismiss.  Preemption is not dependent on the strength of a plaintiff’s underlying case.  It doesn’t matter how solid medical causation might be, or how much the prescribing physician has (or has not) been suborned during ex parte chats with the other side.  If preemption applies, than it’s bye-bye claim, and often bye-bye plaintiff.  No discovery necessary.

Thus, it’s not surprising that plaintiffs’ lawyers fight preemption tooth and nail.  That’s their job.  They are just as ethically bound to represent their clients zealously within the boundaries of the law as we are.  Thus they pick every preemption nit they can find.

That’s what we’re on about today.  We’re discussing some recent decisions that address some lesser-known – but equally deadly − preemption arguments.


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An inter-agency taskforce is proposing a comprehensive overhaul of “Federal Policy for the Protection of Human Subjects” in today’s issue of the Federal Register (comments close on 12/7/2015).  See 80 Fed. Reg. 53933 (Sept. 8, 2015). The proposal is 130 pages long, but most of it won’t have much relevance to product liability, except insofar as a plaintiff might have been injured during the course of a clinical trial.  In the past we’ve been interested in clinical trial regulations primarily for three reasons: (1) if they allow plaintiffs to argue that entities other than treating physicians (usually hospitals) have informed consent obligations; (2) if they clearly distinguish between off-label and “investigational” use of prescription medical products, and (3) preemption.

With that in mind we’ve looked through the new proposal.

Informed Consent:

We don’t see much in the new rule expanding who is required actually to obtain informed consent – only that the informed consent requirement would be extended to a lot more types of research, such as that involving “biospecimens” lacking individualized identifying information.  That seems like a lot more work in situations without additional risk of physical injury to research subjects, id. at 54028, but precisely because of the low risk of harm inherent in most biospecimen situations, we doubt it will have much impact on product liability.  It could increase other kinds of litigation, however, such a privacy (won’t keeping all these informed consent forms effectively re-identify the specimens?) and intellectual property (identifiable research subjects are more likely to want a piece of the economic “pie” created through research using their specimens).


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The Federal Trade Commission has a long reach, but its grip is not quite as strong as it was before the D.C. Circuit’s recent opinion in PomWonderful, LLC v. FTC, No. 13-1060, 2015 WL 394093 (D.C. Cir. Jan. 30, 2015). Section 5 of the FTC Act prohibits “unfair or deceptive acts or practices in or affecting commerce” and grants the FTC the power to enforce.  Since this broad mandate was enacted during the administrative explosion that accompanied the New Deal, the FTC has parlayed it into regulatory authority over a broad array of commercial activities, including data privacy, spam emails, product labeling, and marketing and advertising of all kinds. The drug and medical device industries certainly feel the FTC’s presence, including its regulation of advertising in connection with over-the-counter products.

It turns out, however, that product sellers have First Amendment rights that limit the FTC’s prerogative.  PomWonderful does not involve a drug of any kind, but it is fascinating reading because it involves fruit juice products for which the seller made numerous efficacy claims, such as that consuming the products would treat or reduce the risk of certain diseases.  The claims are similar to those we sometimes hear on the radio promoting dietary supplements or herbal remedies:

  • “Proven to promote cardiovascular health”
  • “30% decrease is arterial plaque”
  • “Prolonged post-prostate surgery PSA doubling time”

These are just a few examples, and there were others involving sexual function that we will leave aside for the moment.  But you get the idea.  The seller was engaged in more than mere puffery or vague claims that the juice was “good for you.”  These were specific disease-related efficacy claims.


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We saw the movie “Whiplash” last weekend.  In this Oscar contender, a drum student at a prestigious music conservatory seeks the approval of a harsh and punishing conductor, as well as a berth in the conductor’s competition jazz band.  The film is so tense and so consistently painful to watch that it would not be accurate to say that we “enjoyed” it, but we wouldn’t have missed it for the world.

Early in the movie, the conductor demands that the student play several measures over and over and over again in a relentless and seemingly futile attempt to find the correct tempo. In today’s decision out of the Denture Cream MDL pending in the Southern District of Florida (thanks to David Walz at Carlton Fields for sending it to us)  Plaintiffs are back, beating the same drum, in a repeat attempt to surmount defendant Procter & Gamble’s (“P & G’s”) Daubert challenges to their general causation experts.  In re Denture Cream Prods. Liab. Litig., No. 09-2051-MD-Altonaga, 2015 U.S. Dist. LEXIS 9653 (S.D. Fla. Jan.. 28, 2015).  In these cases, Plaintiffs allege that, with long-term use of Fixodent denture adhesive, the zinc in the product causes copper deficiency and, ultimately, a neurological condition known as copper deficiency myeloneuropathy (“CDM”).  In 2011, the court granted P & G’s Daubert motions to exclude Plaintiffs’ general causation experts. See In re Denture Cream Prods. Liab. Litig. (Chapman, et al. v. Procter & Gamble Distributing, LLC), 795 F. Supp. 2d 1345 (S.D. Fla. 2011), aff’d, 766 F.3d 1296 (11th Cir. 2014) (“Chapman’).  As we discussed at the time, the Court held, “[Plaintiffs’] theory is not ridiculous, but neither is it necessarily true; it is ripe for testing.  . . . [T]aking everything together, there is enough data in the scientific literature to hypothesize causation, but not to infer it.”  795 F. Supp. 2d at 1367 (emphasis in original).  This past September, as we reported here, the Eleventh Circuit affirmed the District Court’ Chapman decision.


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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.


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We’ve blogged a number of times about the illogical, and often downright counterproductive, nature of the FDA’s position that regulated manufacturers are generally banned from providing the medical community (or the public) with truthful information about the off-label uses of their products.  Even information about the risks of off-label uses cannot be included on a

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.


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We sometimes tire of reading cases, ours or others, base on the same old allegations about what the drug or device manufacturer allegedly did wrong.  It often seems that the plaintiff lawyers work from the same playbook, written, we suspect, by Velvet Jones.  So, we perk up somewhat when we see atypical allegations of liability.

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.


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On a number of occasions – more during the first couple of years of the blog than recently – we opposed causes of action that would impose liability on drug/device manufacturers for investigational drugs that worked, and indeed worked well. By that we mean claims by research subjects demanding one form or another of continued