McKay v. Novartis Pharm. Corp.

• Decision Date: 27 May 2014
• Docket Number: No. 13–50404.,13–50404.
• Citation: 751 F.3d 694
• Parties: Thomas W. McKAY; Leticia McKay, Plaintiffs–Appellants v. NOVARTIS PHARMACEUTICAL CORPORATION, Defendant–Appellee.
• Court: U.S. Court of Appeals — Fifth Circuit

751 F.3d 694

Thomas W. McKAY; Leticia McKay, Plaintiffs–Appellants

v.NOVARTIS PHARMACEUTICAL CORPORATION, Defendant–Appellee.

No. 13–50404.

United States Court of Appeals, Fifth Circuit.

May 27, 2014.

John Julian Vecchione, Esq., John J. Vecchione Law, P.L.L.C., Fairfax, VA, Lynn Anne Coyle, Attorney, Francisco X. Dominguez, Esq., Dominguez & Coyle, P.L.L.C., El Paso, TX, for Plaintiffs–Appellants.

Katharine Ruth Latimer, Joe Gregory Hollingsworth, Eric Gordon Lasker, Esq., Rebecca Anne Womeldorf, Hollingsworth, L.L.P., Washington, DC, for Defendant–Appellee.

Appeal from the United States District Court for the Western District of Texas.

Before WIENER, ELROD, and HIGGINSON, Circuit Judges.

HIGGINSON, Circuit Judge:

Thomas and Leticia McKay's lawsuit against Novartis Pharmaceutical Corporation (“Novartis”) has spanned eight years and two forums. Originally filed by Thomas McKay in the Western District of Texas, this case was transferred by the Judicial Panel on Multidistrict Litigation (“MDL”) to the Middle District of Tennessee in May 2006 as part of the ongoing multidistrict litigation involving, inter alia, two drugs manufactured and distributed by Novartis. The MDL court granted partial summary judgment for Novartis and made two significant rulings: (1) Texas law applied to the McKays' case, and (2) Tex. Civ. Prac. & Rem.Code § 82.007(a)—which provides manufacturers a rebuttable presumption against liability for failing to warn—foreclosed the McKays' failure to warn claims. On remand, the district court in Texas (the “remand court”) granted summary judgment on the McKays' remaining claims. Concluding that neither court erred, we AFFIRM.

I.

As part of Thomas McKay's treatment for prostate cancer, he took two drugs—Aredia and Zometa. Novartis manufactures both drugs and markets them accompanied by warnings approved by the FDA. In 2006, McKay sued Novartis in the Western District of Texas. He alleged that Aredia and Zometa caused him to develop “osteonecrosis of the mandible or jaw bone [sic].” As a result of this condition, McKay has lost a number of teeth, has a large, exposed bone protruding through his gums, and has undergone many corrective surgeries on his jawbone. His complaint faults Novartis for, among other things, failing to notify the public and physicians of “the possibility of suffering osteonecrosis of the jaw” until 2004, and failing to notify dental professionals until 2005. McKay's claims sound in strict liability, negligence, breach of express warranty, and breach of implied warranty. McKay subsequently amended his complaint to add his wife, Leticia McKay as a plaintiff and to add claims for failure to warn and loss of consortium.

In June 2008—almost a year and a half after the McKays amended their complaint—Novartis moved for partial summary judgment on the McKays' failure to warn claims in the MDL court.¹ Novartis relied on Tex. Civ. Prac. & Rem.Code § 82.007(a), which provides defendant manufacturers a rebuttable presumption against liability when plaintiffs assert failure to warn claims involving drugs accompanied by FDA-approved warnings.

The MDL court granted Novartis's motion for partial summary judgment. First, the MDL court applied the transferor forum's choice of law rules (Texas) to determine that Texas substantive law governed the McKays' case. Second, the MDL court denied the McKays' Federal Rule of Civil Procedure 56(d)² motion for additional discovery on the choice of law issue because “McKay has not shown that, for specified reasons, he cannot present facts essential to justify his position concerning the choice of substantive law applicable to his claims.” Finally, the MDL court applied § 82.007(a)'s rebuttable presumption and granted partial summary judgment on the McKays' failure to warn claims. The MDL court recognized that the FDA approved the warnings accompanying Aredia and Zometa and that “[n]either side claims that any of the specifically enumerated ways to rebut the presumption applies in this instance except subsection (b)(1).” Section 82.007(b)(1) provides that a plaintiff may rebut § 82.007(a)'s presumption against liability if the plaintiff establishes, among other things, that a defendant “withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant's injury.” § 82.007(b)(1). Correctly anticipating our decision in Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir.2012), the MDL court held that federal law preempted one application of § 82.007(b)(1). See Lofton, 672 F.3d at 380 (holding that § 82.007(b)(1) is preempted “unless the FDA itself has found fraud”). The MDL court granted summary judgment on the McKays' claims premised on Novartis's “failure to provide adequate warnings or information,” holding them precluded by § 82.007(a)'s unrebutted presumption.

On May 22, 2011—almost three years after the MDL court's summary judgment ruling—the McKays moved the MDL court to reconsider under Rule 60(b)(6). The MDL court denied the McKays' motion because their purportedly “new” evidence was available prior to discovery and had been available long before the McKays filed their Rule 60(b) motion. On August 23, 2011, the MDL Panel remanded the case to the Western District of Texas.

On remand, Novartis recognized that “[t]he MDL court's order did not specify the particular counts from each case's complaint that were resolved by its order,” and moved for summary judgment on the McKays' remaining claims “because they all involve the adequacy of [Novartis's] warnings or information.” ³ The “remand” court interpreted the MDL court's order as deciding that § 82.007(a)'s presumption applied to the McKays' complaint, leaving open only “which of Plaintiff's claims rest on allegations that Novartis failed to warn of Aredia and Zometa's dangerous side effects.” Noting that it would “not disturb or revisit the findings made by the MDL court,” the remand court recognized that if any of the McKays' remaining claims were premised on inadequate warnings, then they did not survive the MDL court's ruling.

The remand court rejected the McKays' attempt to rebut § 82.007's presumption under § 82.007(b)(3)-(5) by providing evidence of off-label promotion because the McKays did not make this argument in the MDL court and the MDL court's prior ruling was the law of the case. Alternatively, the remand court held that the McKays' evidence did not create a genuine issue of fact on off-label promotion. The remand court next rejected the McKays' argument that, Lofton requires that § 82.007 be struck. Again, the remand court held that the MDL court had already decided the applicability of § 82.007(a)'s rebuttable presumption but alternatively found that the remaining provisions of § 82.007 were severable from § 82.007(b)(1)'s invalid application.

The remand court then held that most of the McKays' remaining claims were premised on Novartis's failure to warn and therefore were precluded by § 82.007(a)'s presumption against liability, as decided by the MDL court. Although it determined that the McKays' breach of warranty claims were not premised on inadequate warnings, the remand court nevertheless granted summary judgment on these claims because the McKays failed to provide Novartis with statutorily required notice. Finally, having dismissed all of the underlying claims, the remand court granted Novartis summary judgment on the McKays' loss of consortium claim. This appeal followed.

II.

The McKays assert on appeal that the MDL court abused its discretion by denying their Rule 56(d) motion to continue summary judgment and by “subsequently ... refusing to apply the overwhelming facts to that decision.” The McKays also fault the remand court for refusing to consider evidence of off-label promotion under § 82.007(b)(3) and rejecting their argument that § 82.007 should be struck down in its entirety. Finally, they contend that the remand court erred when it granted summary judgment on their breach of warranty claims.

A.

We begin with the McKays' appeal of the MDL court's denials of their Rule 56(d) and Rule 60(b) motions.

1.

In opposition to Novartis's motion for summary judgment in the MDL court, the McKays disputed the application of Texas substantive law to their claims. They filed a Rule 56(d) motion for additional time to discover McKay's own medical records in order to adequately brief which state has the “most significant relationship” to the litigation. The MDL court denied the McKays' Rule 56(d) motion because the information that the McKays requested—information concerning Thomas McKay's own treatment—was already available to them:

The information concerning McKay's infusions, prescriptions and other treatments, however, is available to McKay without any need for formal discovery. Indeed, that information became available to McKay when the infusions, prescriptions and treatments occurred. The issues concerning where and how Plaintiff McKay's injuries occurred involve information in the possession of McKay and his treating health care providers, and there has been no showing that anything prevented Plaintiff from obtaining that information before he filed this action or, more specifically, in response to Defendant's Motion.

On appeal, the McKays contend that this ruling was an abuse of discretion because Thomas McKay did not have his medical records at the time of discovery, and because discovery was stayed.

We review a denial of a Rule 56(d) motion for abuse of discretion. Am. Family Life Assurance Co. of Columbus v. Biles, 714 F.3d 887, 894 (5th Cir.2013). Rule 56(d) provides:

If a nonmovant shows by affidavit or declaration that, for specified reasons, it cannot present facts essential to justify its opposition, the court may: (1) defer considering the motion or deny it; (2) allow time to obtain...