5th Circuit Finds for Novartis, Affirming Dismissal of Aredia/Zometa Suit

May 27, 2014

The U.S. Court of Appeals for the Fifth Circuit affirmed a summary judgment ruling in favor of Novartis Pharmaceuticals Corporation dismissing all of the plaintiff’s claims in a pharmaceutical products liability action arising out of the Aredia/Zometa multidistrict litigation, McKay v. Novartis Pharm. Corp., 751 F.3d 694 (5th Cir. 2014). The MDL court had dismissed all of plaintiff’s warnings-based claims (along with those raised by numerous other Texas plaintiffs) under Texas Civ. Prac. & Rem. Code Sec. 82.007(a), which establishes a rebuttable presumption in favor of FDA-approved prescription drug labeling.  The MDL court held that the one statutory exemption to this presumption raised by the plaintiffs – fraud on the FDA – was preempted under the U.S. Supreme Court’s opinion in Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).  Following remand, a federal district court in Texas held that the MDL ruling was law of the case and required dismissal of all of Mr. McKay’s strict liability and negligence claims because they each relied on allegations related to the drug warnings. The remand court dismissed plaintiff’s breach of warranty claim because he had failed to provide Novartis with pre-suit notice.

In affirming the MDL and federal Texas court opinions, the 5th Circuit rejected each of the following arguments raised by plaintiffs:  First, the court held that the MDL court had not erred in applying Texas law, notwithstanding the fact that plaintiff’s prescribing physician was in California, because that factor was outweighed by the fact that the plaintiff resided in Texas, had most of his medical treatments in Texas, and had his first manifested injury in Texas. The court also rejected Mr. McKay’s argument that the MDL court had erred in rejecting his Rule 56(f) motion for additional discovery on choice of law (and his subsequent motion for reconsideration of that ruling), agreeing with the MDL court that plaintiff had not been sufficiently diligent in obtaining his own allegedly unavailable medical records through informal means.  Second, the court rejected Mr. McKay’s arguments that his claim was not barred by the Texas statutory presumption because (1) he allegedly satisfied another exemption in the statute for off-label promotion and (2) the fraud-on-the-FDA exception could not be severed from the rest of the statute, requiring the statutory presumption to be struck in its entirety.  The court held that plaintiff had waived each of these arguments by failing to raise them in the MDL court.  Third, the 5th Circuit agreed with the Texas district court’s holding that Texas law requires pre-suit notice of a breach of warranty claim both to an intermediate seller and the manufacturer.  The court further held that Mr. McKay could not satisfy this requirement through the filing of a lawsuit or through a general notice from his prescribing physician to Novartis.