We remember how, shortly after the atrocious decision in Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), rejecting altogether the learned intermediary rule, litigation tourists visiting West Virginia argued that Karl represented that state’s “public policy” and therefore the learned intermediary rule could not apply even to their out-of-state cases under

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

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.

Uh, no.

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.


Continue Reading Texas Federal Court Rejects Attempt to Misapply Buckman to Invalidate Statutory Rebuttable Presumption of Warning Adequacy

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.


Continue Reading The Multi-District Litigation Statute Needs Rewriting