Novartis summary judgment win confirms Texas statutory presumption of adequacy.



W.D. Tex. -- United States District Court for the Western District of Texas

Complex Litigation


On September 19, 2014, the U.S. District Court for the Western District of Texas granted Novartis Pharmaceuticals Corporation’s motion for summary judgment on all of plaintiffs’ remaining claims in Massey v. Novartis Pharm. Corp., No. A-12-1054-LY (W.D. Tex. Sept. 19, 2014).  Massey is the fourth case arising out of the Aredia®/Zometa® multi-district litigation where summary judgment has been granted for Novartis, primarily as a result of the warning-adequacy presumption found in Section 82.007 of the Texas Civil Practice and Remedies Code.  Section 82.007, save for enumerated exceptions, deems FDA-approved labels adequate as a matter of law.  The Massey decision relied upon an earlier Novartis victory in McKay v. Novartis Pharm. Corp., 934 F. Supp. 2d 898, 915 (W.D. Tex. 2013), aff’d McKay v. Novartis Pharm. Corp., 751 F.3d 694 (5th Cir. 2014).

Texas plaintiffs Jean and Michael Massey alleged that Zometa® – an intravenous bisphosphonate medication that is the standard of care for patients with cancer that has metastasized to bone and is proven to significantly reduce and prevent serious skeletal related events like pathologic bone fractures and spinal cord collapse – caused Jean Massey to develop osteonecrosis of the jaw (ONJ).  Plaintiffs brought claims for strict liability, negligence, breach of express and implied warranty, failure to warn, and loss of consortium. When Jean Massey died from metastatic breast cancer approximately two months after filing suit, her husband Michael Massey continued to pursue the claims of her estate, as well as his own loss of consortium claim. 

The case was subsequently transferred to MDL 1760, where on July 25, 2008, applying Texas law, Judge Todd Campbell of the Middle District of Tennessee granted Novartis’s motion for partial summary judgment by ruling generally that the failure-to-warn claims of several Texas plaintiffs could not survive Section 82.007.  Novartis subsequently secured an order extending the initial order to several additional MDL cases with Texas plaintiffs, including Massey. See Order, In re Aredia & Zometa Prods. Liab. Litig., No. 3:06-MD-1760 (M.D. Tenn. Nov. 24, 2008) (ECF No. 1860).

Following Massey’s remand to the Western District of Texas, Novartis filed a motion for summary judgment, arguing the 2008 MDL Orders applied to all of plaintiff’s remaining claims because each of those claims, regardless of whether the causes of action were titled a failure to warn or were pleaded under some other theory, all involved the adequacy of Novartis’s warnings and information.  As did other courts before him, Judge Lee Yeakel determined that the law of the case doctrine foreclosed plaintiff Massey’s attempt to re-litigate the applicability of Section 82.007 generally and that, when the gravamen of the claims were examined, all claims turned on the alleged adequacy of the warnings and information provided by Novartis.  Judge Yeakel, therefore, dismissed the claims as being within the 2008 MDL Orders, including plaintiff’s claims of strict liability and negligent manufacture.  Order at 4-5.  For instance, with regard to plaintiff’s effort to state a claim for an alleged failure to test, Judge Yeakel reasoned that under Skotak v. Tenneco Resins, Inc., 953 F. 2d 909 (5th Cir. 1992), plaintiff Massey had the burden of showing warning inadequacy, which he could not do in light of the 2008 MDL court’s rulings applying Section 82.007.  Order at 6. 

The court also dismissed plaintiff’s warranty claims, rejecting plaintiff’s argument that Novartis’s receipt of adverse event reports pertaining to other Zometa® users satisfied the pre-suit notice requirements of Texas Business and Commercial Code Section 2.607(c)(1).  The court determined that “under Texas law, such generalized notice is not sufficient to satisfy the notice requirement,” Order at 6, and that “[t]he manufacturer must be made aware of a problem with a particular product purchased by a particular buyer.”  Id. at 6-7 (quoting U.S. Tire-Tech, Inc. v. Boeran, B.V., 110 S.W.3d 194, 201-02 (Tex. App. – Houston [1st Dist.] 2003, pet. denied)).

The Massey decision is just the latest of hundreds of resolutions favorable to the Company related to plaintiffs’ claims regarding ONJ after treatment with Zometa® (zoledronic acid) injection and/or Aredia® (pamidronate disodium), which include more than 300 dismissals, summary judgments, and trial wins in the Company’s favor.

Novartis is represented in Massey by Firm partner Donald R. McMinn.