For the second time in three years the Pennsylvania legislature has proven itself entirely unable to carry out its most basic function, which is to pass a budget – any budget – which is balanced and otherwise meets constitutional requirements. Instead, it seems bent on distracting the public from its abject failures with empty gestures.
We’ve generally been skeptical of state “Right To Try” statutes, for several reasons. First, to the extent that they try to circumvent the FDCA, they’re likely to be preempted. Second, drugmakers aren’t likely to distribute experimental drugs due to liability concerns, and these statutes don’t go far enough in removing that threat. Third, such statutes…
One of the issues that the federal Civil Rules Committee’s discovery subcommittee considered, but that eventually fell by the wayside, on the way to the 2015 discovery rules amendments, were proposals to convert to a “requestor pays” discovery system. That would be a very significant change, and one of the criticisms that the other…
Regular blog readers may recall that, every year, we eagerly await a Monday and Tuesday right around February 14th. This has nothing to do with Valentine’s Day (though we like a dozen roses and a box of chocolates as much as the next person.) No, at this time every year (for the past…
We’ve addressed many times Texas Civil Practice & Remedies Code §82.007, a tort reform statute that, essentially, creates a presumption in drugs cases that a drug’s warning is adequate if the FDA approved it. See §82.007(a)(1). The statute gives plaintiffs with five ways to rebut that presumption, one of which is to show that the defendant withheld information from, or misrepresented information to, the FDA. §82.007(b)(1). That means of rebuttal, however, was held to be preempted by the Fifth Circuit under Buckman because it requires a plaintiff to prove fraud on the FDA. Lofton v. McNeil Consumer & Specialty Pharma., 672 F.3d 372 (5th Cir. 2012).
We recently uncovered a case in which a plaintiff actually tried to expand the Fifth Circuit’s ruling as a way around §82.007’s presumption of warning adequacy. See T.R.M. v. GlaxoSmithKline LLC, 2015 U.S. Dist. LEXIS 183272, (S.D. Tex. Aug. 21, 2015). In particular, the plaintiff argued that, if Buckman preemption applies at all, it must invalidate all of §82.007, not just its fraud-on-the-FDA based rebuttal. In short, even though the statute created a presumption of adequacy and five ways to rebut it, the plaintiff asked the court to scrap the entire presumption regime because one means of rebuttal was preempted.
Rules of statutory construction require courts to give effect to as much of a statute as possible while maintaining its original purpose, severing only as little as necessary. Preempting only the fraud-on-the-FDA rebuttal provision of §82.007 accomplishes that. Plaintiffs still have the potential options of four other means of rebuttal and, in fact, might even be able to use the fraud-on-the-FDA rebuttal if the FDA itself made such a finding.
It’s hard to believe that, with over half of all cases pending in the federal courts now docketed in multi-district litigations (“MDLs”), the statutory basis for all this litigation is but one section of the United States Code:
(a) When civil actions involving one or more common questions of fact are pending in different districts, such actions may be transferred to any district for coordinated or consolidated pretrial proceedings. Such transfers shall be made by the judicial panel on multidistrict litigation authorized by this section upon its determination that transfers for such proceedings will be for the convenience of parties and witnesses and will promote the just and efficient conduct of such actions. Each action so transferred shall be remanded by the panel at or before the conclusion of such pretrial proceedings to the district from which it was transferred unless it shall have been previously terminated: Provided, however, That the panel may separate any claim, cross-claim, counter-claim, or third-party claim and remand any of such claims before the remainder of the action is remanded.
(b) Such coordinated or consolidated pretrial proceedings shall be conducted by a judge or judges to whom such actions are assigned by the judicial panel on multidistrict litigation. For this purpose, upon request of the panel, a circuit judge or a district judge may be designated and assigned temporarily for service in the transferee district . . . The judge or judges to whom such actions are assigned, the members of the judicial panel on multidistrict litigation, and other circuit and district judges designated when needed by the panel may exercise the powers of a district judge in any district for the purpose of conducting pretrial depositions in such coordinated or consolidated pretrial proceedings.
(c) Proceedings for the transfer of an action under this section may be initiated by −
(i) the judicial panel on multidistrict litigation upon its own initiative, or
(ii) motion filed with the panel by a party in any action in which transfer for coordinated or consolidated pretrial proceedings under this section may be appropriate. A copy of such motion shall be filed in the district court in which the moving party’s action is pending.
[Procedures for the JPML deliberations on creating MDLs, notice, and filing of transfer orders]
(d) [Composition of JPML]
(e) [Restrictions on appealability of JPML orders]
(f) The panel may prescribe rules for the conduct of its business not inconsistent with Acts of Congress and the Federal Rules of Civil Procedure.
(g) [Peculiar to antitrust]
(h) [Peculiar to antitrust]
28 U.S.C.A. §1407.
That’s it. There are as many subsections of the MDL statute (2) peculiar to antitrust as there are governing the substance of what MDLs are intended to accomplish.
We blogged about possibly interesting nuggets in the 21st Century Cures Act (“21CCA”) back in February, 2015 – when it was only 400 pages long. In true congressional fashion, it’s now twice as long and loaded up with enough goodies (mostly of the $$$ variety) that it just passed the House of Representatives by a 392 to 26 margin. It thus seems poised to become law. Given the prospects for imminent passage, we decided to revisit this monster and see if there’s anything more of interest to product liability defendants. We aren’t interested in the spending-related aspects of this bill, which are what’s really greasing its skids.
So here goes.
The first thing we wanted to see is if there is any preemption of civil lawsuits, so we searched the text of the bill for the word “state.” More than 100 matches.
Even after having read it through twice, we find the result in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), hard to fathom, and even harder to stomach. For several years after starting the blog, one of our aphorisms was “nothing good ever comes out of Missouri.” Then legal developments caused us to retire that slogan. Now we may have to bring it back – maybe.
Barron affirmed a $48 million verdict – concerning birth defects – against the maker of a drug that had a black box warning – about birth defects
|[THE DRUG] CAN PRODUCE TERATOGENIC EFFECTS SUCH AS NEURAL TUBE DEFECTS (E.G., SPINA BIFIDA). ACCORDINGLY, THE USE OF [THE DRUG] IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS.|
Barron, 2016 WL 6596091, at *1.
Astonishingly, this boxed warning, which only the FDA can mandate, was a sufficiently inadequate advisory that the drug could cause birth defects that a St. Louis (City) jury awarded $23 million in punitive damages to the plaintiff, who was from Minnesota.
And those two places – St. Louis City and Minnesota – are as much the problem as the “Show-Me-The-Money State” verdict itself. Barron is a poster child for venue and joinder run amok. First, the underlying action was filed by 24 plaintiffs from all over the country (13 different states), with nothing in common save claiming somewhat similar injuries to different persons from the same drug. Id. at *4. Of course, a couple of plaintiffs were from Missouri (and another presumably from the home state of a defendant), in order to defeat diversity. Id. at *2.
No, we’re not here to muse about how our lack of contact with advanced extra-terrestrial civilizations might be due to an unfortunate proclivity for “intelligent” life to invent technology that destroys their home planets before developing technology that permits the colonization of other planets. We limit ourselves to the drug and medical device product liability space.
First, we reiterate our belief that under a Trump administration, the FDA’s proposed – and oft-postponed − final rule, the one that seeks to abolish generic preemption by enacting regulations that likely violate the FDCA’s “sameness” requirement for generic drugs, is kaput. When we learned earlier this year that the FDA had postponed the finalization date until after the election, we immediately pronounced it dead. We still believe that. We find it difficult to believe that a Trump FDA would continue a controversial Obama FDA proposal that has always been pursued as a sop to the plaintiffs’ bar, a major supporter of the outgoing president. If there’s one thing we know Donald Trump believes in, it is getting revenge.
Second, the odds of another pro-tort-preemption Supreme Court justice to fill the vacant seat created by Justice Scalia’s death have increased significantly. The stark fact is that tort preemption has become a distinctly partisan issue on the Supreme Court. The two most recent drug/device Supreme Court decisions, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 246 (2013), were both decided by five Republican appointees favoring preemption and four Democratic appointees opposing it. Had the outcome been different, we would have considered the ultimate survival of Mensing/Bartlett unlikely.
Bexis recently attended the “Emerging Issues in Mass-Tort MDLs Conference” sponsored by Duke Law School (those of us from Philly remember Duke as part of “Black Saturday” back in 1979). Several panels discussed various issues relating to MDLs including using early, issue-specific fact sheets, which Bexis advocated be considered amended pleadings subject to…