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From Products Liability Law Daily, May 28, 2014

Failure to warn of jaw disease claims blocked by manufacturer’s rebuttable presumption

By Melissa Skinner, J.D.

The application of a rebuttable presumption, which shielded a drug manufacturer from liability stemming from claims that the manufacturer failed to warn that the drug could cause jaw disease, was affirmed by the U.S. Court of Appeals for the Fifth Circuit. The court specifically affirmed the application of the presumption by the lower court which handled this matter as a part of ongoing multidistrict litigation and additionally affirmed the subsequent grant of summary judgment by another lower court as to breach of warranty against the drug manufacturer (McKay v Novartis Pharmaceutical Corp., May 27, 2014, Higginson, S.).

Background. Thomas and Leticia McKay (the McKays) brought suit against the Novartis Pharmaceutical Corporation (Novartis), the manufacturer of Aredia® and Zometa®, two drugs that were prescribed to Mr. McKay to treat his prostate cancer. The McKays alleged that Aredia and Zometa caused Mr. McKay to develop osteonecrosis of the jaw bone (ONJ). Specifically, the McKays alleged that Novartis failed to warn both the public and the dental professional community of the possibility of developing ONJ as an effect of these drugs. The McKays asserted causes of action for strict liability, failure to warn, negligence, breach of express warranty, breach of implied warranty, and loss of consortium against Novartis in a Texas district court in 2006.

MDL. The matter was transferred by Judicial Panel on Multidistrict Litigation (MDL) to a Tennessee district court later in 2006. The MDL court granted Novartis partial summary judgment. The order granting summary judgment included the following “two significant rulings: (1) Texas law applied to the McKays’ case, and (2) Tex. Civ. Prac. & Rem. Code [section] 82.007(a)—which provides manufacturers a rebuttable presumption against liability for failing to warn—foreclosed the McKays’ failure to warn claims.” The MDL court found that the FDA approved the warnings that were included with Aredia and Zometa. Under section 82.007(b)(1) of the Texas statute, the presumption guarding against liability could be rebutted with evidence showing that in dealings with the FDA, the manufacturer withheld or misrepresented information that was material to the performance of the product and related to the injuries at issue. However, the MDL court also found that that particular section was preempted by federal law and, therefore, it granted Novartis summary judgment to the extent that the McKays’ claims were premised on the failure to warn.

Remand. On remand, the Texas district court refused to disturb the findings of the MDL court and “recognized that if any of the McKays’ remaining claims were premised on inadequate warnings, then they did not survive the MDL court’s ruling.” In so deciding, the remand court rejected the McKays’ arguments that certain facts, including that Novartis’ off-label promotion of the drugs, could rebut the presumption and that the preemption of one of the Texas provisions required that the rebuttable presumption statute be struck down as a whole. The remand court additionally determined that all of the McKays’ claims were based on the failure to warn except the breach of warranty claims. However, the remand court dismissed that claim, too, based on the failure to provide the requisite statutory notice.

Appeal. On appeal, the McKays challenged the MDL court’s denial of their motion for reconsideration based on new evidence that supported the application of California law, as well as the remand court’s failure to consider evidence of off-label promotion and rejection of the argument that the Texas rebuttable provision statute should be struck down. The McKays also appealed the remand court’s grant of summary judgment as to the breach of warranty claims.

The Fifth Circuit found that the MDL’s application of Texas law was appropriate given the fact that McKay was a Texas citizen and resident, that he was treated for his prostate cancer in Texas, that the medication at issue was shipped to his address in Texas, and that the ONJ manifested itself in Texas. Therefore, the court concluded that the MDL’s application of Texas law was appropriate. The court also held that the remand court correctly affirmed the decision of the MDL court because no new evidence was presented to the remand court to warrant disturbing the MDL decision. Finally, the court affirmed the remand court’s determination of summary judgment as to the breach of warranty claims because the McKays did not satisfy the notice requirements for breach of warranty actions.

The case number is 13-50404.

Attorneys: John Julian Vecchione (John J. Vecchione Law, PLLC) for Thomas W. McKay. Katharine Ruth Latimer (Hollingsworth, LLP) for Novartis Pharmaceutical Corp.

Companies: Novartis Pharmaceutical Corp.

MainStory: TopStory PreemptionNews WarningsNews DrugsNews LouisianaNews MississippiNews TexasNews

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