No, we have not been drinking. Yes, we know the title of the post is jumbled. That is because the concepts of the learned intermediary doctrine, consumer protection, and class certification do not normally fit together so well. (See how we were being creative? If the format allowed it, we would channel e.e. cummings in
In a week with the Supreme Court’s Bartlett preemption ruling, every other drug and device case looks like small potatoes. But we actually like small potatoes. And we love tater tots. And we love the idea from Evan Goldberg (like Seth Rogen, a very funny Canadian, and like Seth Rogen, a screenwriter of Superbad and
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
Once again, this discussion of a decision in the Pelvic Mesh litigation comes only from the Dechert side of the blog.
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As part of our continuing discussion of the pelvic mesh MDL court’s recent pre-trial decisions, today we discuss the court’s Daubert opinion, which addresses many experts and many of the key expert issues that we ordinarily see in drug and device mass-tort litigation. To review all of the court’s rulings, feel free to read the opinion, which is quite long. It can be found at: In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012; 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 78061 (S.D.W.V. June 4, 2013) (“Daubert Opinion”). There’s also a short reconsideration opinion: In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012; 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 84133 (S.D.W.V. June 44, 2013) (“Reconsideration Opinion”). For now, we’re going to discuss some of the rulings that we find particularly interesting. The defense did well:
Relationship Testimony
The plaintiffs offered what were called “relationship experts.” They were really damages experts. They offered opinions on “the impact of the bellwether plaintiffs’ loss in terms of body image, self-esteem, confidence, sexual drive and the ability to maintain an affectionate sexual relationship.” Id. at *23. There were a number of problems with these experts. See id. at *23-29. The most obvious was that a jury doesn’t seem to really need an expert’s help with this. Once the plaintiffs testified on these subjects, jurors should be fully equipped to reach conclusions. The court thought so too:
Expert testimony which “merely regurgitates factual information that is better presented directly to the jury rather than through the testimony of an expert witness” is properly excluded. Parts of the Relationship Experts’ expert reports merely state what the plaintiffs told them. Such testimony is better presented directly to the jury via the bellwether plaintiffs themselves. . . . [E]xpert testimony on this issue is unnecessary because it is understandable to the average juror. To the extent that the bellwether plaintiffs may be uncomfortable speaking to the jury about the personal issues and the impact that these issues have had on their relationships and lives, the average juror will also understand.
Id. at *29-30. We’ll also note that the use of such experts could be, more than anything, an effort to put this type of information before the jury for a second time. That seems not just inefficient, but unduly prejudicial. The opinions were excluded in their entirety.Continue Reading Pelvic Mesh Litigation: Rule 702 Rulings, Lots of Them
It’s not the Supreme Court (there are no preemption cases left to be decided this term), but still this is welcome. Thanks to Jay Lefkowitz at Kirkland for letting us know of his win in Guarino v. Wyeth, ___ F.3d ___, No. 12-13263, slip op. (11th Cir. June 25, 2013). Guarino is a one-two
While the Supreme Court’s docket is famously compacted (it will only issue an estimated 77 opinions from this term), the October 2012 Term featured 6
reported decisions in class or collective action cases. Given the depth and breadth of the issues addressed as well as the continuing development of
aggregate litigation issues in the lower
Well, the First Circuit just had its bluff called. In Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012), it essentially dared the Supreme Court to take the case and close off what Bartlett viewed as the plaintiff’s last option – a “pure” design defect claim, with no alternative design offered, explicitly
amounting to a claim that – under state law − an FDA-approved product should have been pulled from the market.
The Supreme Court has obliged. Most fundamentally, from our perspective, it has definitively killed off (for all federally-regulated products everywhere, we believe) the facile “stop-selling” argument that conflict-based preemption can be avoided because a defendant can simply remove its product from the market. That’s a red herring we remember from all the way back to airbag preemption days:
The Court of Appeals’ solution − that [defendant] should simply have pulled [the drug] from the market in order to comply with both state and federal law − is no solution. Rather, adopting the Court of Appeals’ stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court’s pre-emption case law.
Mutual Pharmaceutical Co. v. Bartlett, No. 12–142, slip op. at 2 (U.S. June 24, 2013).
Good riddance. We’re happy to announce that one of our earlier #1 worst annual decisions list toppers, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), is no longer good law for the proposition that earned it that ranking. The Supreme Court wasn’t buying “stop-selling.”Continue Reading Bartlett – A Big Win For Preemption
The Supreme Court just decided Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, slip op. (U.S. June 24, 2013). That, of course, is the generic drug case out of the First Circuit where that court had permitted the plaintiffs to recover on a “design defect” claim alleging that the drug should never have been sold
We generally leave discussion of current events to others on the blog, but two in the last few days struck us as worthy of comment. The first was the death of James Gandolfini, best known for his portrayal of Tony Soprano on The Sopranos. Much could be said about the show, its writing, and its influence. The meaning of the playing of “Don’t Stop Believin’” during the final scene of the series was the subject of much debate, while spurring the song’s sales on iTunes. The most noteworthy aspect of Gandolfini’s performance as Tony Soprano, from our perspective, was that viewers actually cared for the character while he regularly carried out murders, violence against women, and a variety of criminal schemes. To the end, viewers wanted to believe that things would work out for Tony, that he and his family would survive and prosper. Gandolfini was, of course, an accomplished actor outside of The Sopranos, but he will always be Tony to us.
The second was the drama of the NBA Finals. Watching old guys like Tim Duncan and Ray Allen make key plays was inspiring. We remember watching Duncan play as underage freshman back at Wake, so it also made us feel old. We felt for Duncan when he missed shots late in game 7, even though we have no allegiance to the Spurs or the Heat. In fact, we do not have much interest in the NBA most of the time. Sure, there are great athletes making amazing plays, but most of the long season lacks the intensity and angst that makes regular season college games between conference foes more entertaining to us. The drama of the last few games of the NBA Finals, however, was enough to draw our attention, which is about when it usually perks up. We know others find the NBA’s entire regular season and the first three rounds of the playoffs worth watching. That is fine. People find different things interesting.
The decision in U.S. ex rel Paulos v. Stryker, No. 11-0041-CV-W-ODS, 2013 U.S. Dist. LEXIS 82294 (W.D. Mo. June 12, 2013), is somewhat like that. We have posted on False Claims Act cases from time to time, but we have generally focused on the aspects relevant to drug and device product liability cases. We know that FCA cases matter to our clients. We know they probably care about the FCA’s Public Disclosure Bar, discussion of which took up the majority
of the Paulos decision. We, on the other hand, did not see how the issue relates to our cases, so we will focus on the analysis of failure to state a claim. The court applied familiar Twiqbal standards to two different versions of the FCA, the original one that required proof of specific intent to defraud the US government into paying false claims and the one from a 2009 statutory amendment that imposed liability based on knowingly causing “a false record or statement material to a false or fraudulent claim.”Continue Reading We Feel Your Pain (Pump)
We’ve just been informed by a source at Drinker Biddle (Dan Carroll of that firm that won the case) of a brand new decision in the New Jersey Levaquin litigation granting summary judgment and finding that an FDA-mandated black box warning was adequate as a matter of law. Hain v. Johnson & Johnson,