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. This post concerns the latter. It is shamelessly plagiarized from a recent brief filed by friend-of-the-blog Jay Lefkowitz and others at Kirkland in a Fifth Circuit appeal in a case called Anderson v. Abbott Laboratories.
One thing that’s often very hard to carry out is state-law legislative history (in Pennsylvania it can be virtually impossible). In the wake of the Fifth Circuit’s holding in Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012), holding that preemption barred the fraud on the FDA exception to the Texas statute (Tex. Civ. Prac. & Rem. Code §82.007(b)(1)) presuming FDA-approved warnings to be adequate, plaintiffs have counterattacked by arguing that the entire presumption (all of §82.007) should be invalidated on grounds of non-severability. For you non-lawyers, when part of a statute is declared unconstitutional, if the statute is “severable,” then the rest of the statute stands and remains in force; if the statute is “non-severable,” then the whole thing is invalidated.
This counterattack is not unexpected. We remember the same thing happening with Michigan law, where the drug immunity statute had a similar exception. Buckman preempted the exception (see Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004)), and the plaintiffs played the same non-severability card. Bexis participated as amicus curiae in the Michigan case (Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003)) that ultimately face-planted that non-severability claim.
Here they go again – even though the statute contains an express severability clause:
If any provision of this Act or its application to any person or circumstance is held invalid, the invalidity does not affect other provisions or applications of this Act that can be given effect without the invalid provision or application, and to this end the provisions of this Act are declared to be severable.
78th Leg., R.S., ch. 204, art. 23 §23.03, 2003 Tex. Sess. Law Serv. 847, 899 (West 2003) (since it appears to be uncodified, and thus harder to find, we included it).
Severability/non-severability is a matter of presumed legislative intent, one way or another. It’s certainly not unheard of for a legislative body to consider explicitly the prospect that part, but not all, of legislation it is considering might be declared unconstitutional (as the severability clause here indicates), but digging out the actual history can be difficult and tedious. However, the reaction of the legislature to such a threat (unhappily frequent in the case of tort reform legislation) is one of the strongest pieces of evidence possible as to whether it intended for the endangered portion to be severable.
The Anderson brief demonstrates exactly what happened when the “Lege” (as it’s known colloquially) considered what became §82.007. Because this question could well recur − Anderson might not produce a precedential opinion; the defense brief states that oral argument is unnecessary − we thought we’d pass along the state legislative history discussion establishing the severability of this statute … just in case someone out there might need it in the future.
Dean Bradley Toben of Baylor Law School testified in Senate committee hearings that §82.007(b)(1) “could very easily meet a court challenge on an analysis that would be very akin to Buckman” because “[i]t places within the ambit of the state court an obligation to inquire in regard to whether a fraud or misrepresentation, or a deceit has been brought upon the [FDA].” Hearings on Tex. H.B. 4 Before S. State Affairs Comm., 78th Leg., R.S. at 1847 (tape 2) (May 5, 2003). Attorney Tommy Fibich (a plaintiff lawyer seeking to defeat the bill) testified that Buckman would likely preclude a claimant from overcoming the presumption of non-liability by showing fraud-on-the-FDA:
[T]he argument is that, that we could not overcome this grant of immunity, or a rebuttable presumption by showing fraud on the FDA, that our ability is restricted by that case [Buckman]. That we, in an effort to rebut the presumption in 82007, that we can’t show that fraud was committed on the FDA in getting these warnings. . . . I think that if we had a drug manufacturer that went to the FDA, and misrepresented something to them, and lied to ‘em and did all kinds of bad conduct, and got warnings out there, and we attempted to overcome this presumption with evidence, I think we would be precluded from doing that by that case.
Hearings on Tex. H.B. 4 Before S. State Affairs Comm., 78th Leg., R.S. at 1977 (tape 2) (May 7, 2003). Fellow plaintiff attorney Michael Slack testified, with respect to the exceptions to the presumption of non-liability:
I think Buckman lurks as a problem. . . . [T]hese are gonna be federal courts interpreting Chapter 82. Buckman and the Supreme Court decision, and other cases like that, then are going to be applied to 82, and anytime we see words like cheated FDA, withheld from FDA, the, the agency process was deficient, yada, yada . . . you’re playing into the heart and soul of Buckman. So, I think that, I think Buckman is a real problem.
Hearings on Tex. H. B. 4 Before S. State Affairs Comm., 78th Leg., R.S. at 5 (tape 4) (May 7, 2003).
It’s nice when we can quote the other side’s words back at them.
Thus, Buckman was precisely why the severability clause was included. The chairman of the Senate Committee on State Affairs, understood that under Buckman, “the state cannot enforce something . . . that requires or that we can’t enforce a misrepresentation or fraud on . . . the Food and Drug Administration” but decided that “since we have severability clause . . ., it wouldn’t damage the bill itself” should what eventually happened in Lofton finally occur. Hearings on Tex. H.B. 4 Before S. State Affairs Comm., 78th Leg., R.S. at 77-78 (tape 1) (May 13, 2003) (statement of Sen. Bill Ratliff, Chairman, S. Comm. on State Affairs). Removal of the presumption altogether (what a non-severability ruling would bring about) was considered and rejected. See Hearings on Tex. H.B. 4 Before S. State Affairs Comm., 78th Leg., R.S. at 14 (tape 2) (May 13, 2003) (statement of Sen. Bill Ratliff, Chairman, S. Comm. on State Affairs) (“Well, the other answer would be to remove the rebuttable presumption, I assume.”).
Thus, the legislative history of the Texas compliance presumption, like the express language of the statute itself, belies any argument that the statute is or was intended to be non-severable.
And now, if it ever comes up in some other Texas law case, you’re armed with the legislative history necessary to make the best argument.
Oh, and thanks, Jay, for putting this together.