United States: Texas Federal Court Rejects Attempt To Misapply Buckman To Invalidate Statutory Rebuttable Presumption Of Warning Adequacy

Last Updated: January 11 2017
Article by John Sullivan

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.

All of this, and more, was clear to the T.R.M. court.  In fact, the court not only applied these basic rules of statutory construction but also a Texas code that favors severing only an invalid portion of a statute to invalidating the entire scheme:

Courts typically refrain from invalidating more of a statute than is necessary, and instead maintain statutes as far as they are valid by severing unconstitutional provisions from unobjectionable provisions. Alaska Airlines, Inc. v. Brock, 480 U.S. 678, 684, 107 S. Ct. 1476, 94 L. Ed. 2d 661 (1987). Federal courts apply state law on the issue of severability. See Leavitt v. Jane L., 518 U.S. 137, 138-39, 116 S. Ct. 2068, 135 L. Ed. 2d 443 (1996); Virginia v. Hicks, 539 U.S. 113, 121, 123 S. Ct. 2191, 156 L. Ed. 2d 148 (2003). When deciding severability in Texas, the Court looks to § 311.032 of the Texas Government Code. Nat'l Fed'n of the Blind of Texas, Inc. v. Abbott, 647 F.3d 202, 210-11 (5th Cir. 2011). § 311.032(c) provides that:

   In a statute that does not contain a provision for severability or nonseverability, if any provision of the statute or its application to any person or circumstance is held invalid, the invalidity does not affect other provisions or applications of the statute that can be given effect without the invalid provision or application, and to this end the provisions of the statute are severable.

Id.; Tex. Gov't Code Ann. § 311.032.

"Thus, '[u]nder the Texas Code Construction Act, a Texas statute should be deemed severable if the invalidity of one provision does not affect the other provisions, unless it has an express provision for severability or nonseverability.'" Corporate Health Ins., Inc. v. Texas Dep't of Ins., 12 F. Supp. 2d 597, 626 (S.D. Tex. 1998) (quoting Texas Pharmacy Ass'n v. Prudential Ins. Co. of America, 105 F.3d 1035, 1038 (5th Cir. 1997)); see In re Johnson, 554 S.W.2d 775, 787 (Tex. Civ. App.–Corpus Christi 1977, writ ref'd n.r.e.). In severability cases, a preempted statute can be considered an invalid statute. See Rose v. Doctors Hosp., 801 S.W.2d 841, 844 (Tex. 1990). "If, when the unconstitutional portion is stricken out, that which remains is complete in itself, and capable of being executed in accordance with the apparent legislative intent, wholly independent of that which was rejected, it must stand." Rose v. Doctors Hosp., 801 S.W.2d 841, 844 (quoting Sharber v. Florence, 131 Tex. 341, 115 S.W.2d 604, 607 (1938)); see Ass'n of Texas Prof'l Educators v. Kirby, 788 S.W.2d 827, 831 (Tex. 1990).

T.R.M., 2015 U.S. Dist. LEXIS 183272 at *9-10.

The court also addressed the legislative history of §82.007. And, giving all due respect to the late Justice Scalia, who would have disapproved of any resort to legislative history at this point, the legislative history helps here. It suggests that the legislature was fully aware that the fraud-on-the-FDA rebuttal provision might be preempted under Buckman, yet it did not choose to include a non-severability clause as part of §82.007:

The Texas Senate State Affairs Committee considered this exact issue when debating § 82.007 in 2003. (Instrument No. 54-2 at 1-2). At that time, the Senate Affairs Committee recognized that "the FDA's regulatory authority within its ambit was so broad . . . [that] a cause of action based upon fraud upon the FDA would not be permissible . . . [and] the FDA completely occupies that area of regulation." (Instrument No. 54-2 at 1). The Senate Committee recognized that the § 82.007 exemption would likely meet a court challenge under Buckman. (Instrument No. 54-2 at 2). At least one Texas court has noted that, "in passing the Texas Act, the legislature expressly considered the possibility that the law would not survive a Buckman analysis. Yet, notwithstanding this forewarning, the legislature did not insert a nonseverability provision into § 82.007." Ledbetter v. Merck & Co., No. 2005-59499, 2007 WL 1181991, at 10 (157th Dist. Ct., Harris Cnty., Tex. Apr. 19, 2007), see also (Instrument No. 71-5 at 12). The Court finds that the legislature's decision not to include a nonseverability provision, despite considering a Buckman challenge, indicates the legislature's intent to allow severability of § 82.007(b)(1) from the rest of § 82.007. See Rose, 801 S.W.2d at 844 (quoting Sharber v. Florence, 131 Tex. 341, 115 S.W.2d 604, 606 (1938)).

T.R.M., 2015 U.S. Dist. LEXIS 183272 at *11-12.

Accordingly, the court upheld the viability of the remainder of §82.007 and the use of its rebuttable presumption of adequacy as a valid defense for manufacturers.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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