United States District Court, E.D. Tennessee
For Charlotte Payne, Brent Payne, Plaintiffs: Annesley H DeGaris, LEAD ATTORNEY, PRO HAC VICE, Cory, Watson, Crowder and DeGaris, Birmingham, AL; Clinton L Kelly, LEAD ATTORNEY, PRO HAC VICE, Fred Dulin Kelly, PRO HAC VICE, The Kelly Firm, Hendersonville, TN; Megan England, LEAD ATTORNEY, Berke, Berke & Berke, Chattanooga, TN; Robert G Germany, LEAD ATTORNEY, PRO HAC VICE, Pittman, Germany, Roberts & Welsh, LLP, Jackson, MS.
For Novartis Pharmaceuticals Corporation, Defendant: Buffy J. Mims, Frank Leone, Katharine R Latimer, Robert E Johnston, William J Cople, III, LEAD ATTORNEYS, PRO HAC VICE, Gregory S Chernack, PRO HAC VICE, Hollingsworth LLP, Washington, DC; Dwight E Tarwater, Matthew J Evans, LEAD ATTORNEYS, Daniel C Headrick, Katherine Sanford Goodner, Paine, Tarwater, Bickers, LLP, Knoxville, TN; Edward S Sledge, III, LEAD ATTORNEY, PRO HAC VICE, Frederick G Helmsing, Jr, PRO HAC VICE, McDowell, Knight, Roedder & Sledge LLC, Mobile, TN.
CURTIS L. COLLIER, UNITED STATES DISTRICT JUDGE.
Before the Court is Defendant Novartis Pharmaceuticals Corporation's (" Novartis" ) motion for summary judgment (Court
File No. 36). Plaintiffs Charlotte Payne and Brent Payne (collectively, " Plaintiffs" ) claim Mrs. Payne's condition, osteonecrosis of the jaw, was caused by two drugs manufactured by Novartis: Aredia® and Zometa® . Novartis argues Plaintiffs have not produced sufficient evidence to establish all the elements of their claims. In relevant part, Novartis argues Plaintiff has failed to demonstrate proximate cause between the inadequate warning and her injury. Plaintiffs filed an opposition to Novartis' motion (Court File No. 55), and Novartis replied to Plaintiffs' response brief (Court File No. 63). Additionally, both parties submitted a number of supplemental briefs discussing legal developments that occurred after the initial briefs were filed in this case (Court File Nos. 66, 71, 151, 156, 174, 176). The Court has considered the evidence, arguments of the parties, and relevant case law. For the following reasons, the Court will GRANT Novartis' motion (Court File No. 36).
I. FACTUAL & PROCEDURAL BACKGROUND
This case involves two bisphosphonate medications, Aredia® and Zometa®, typically prescribed to patients with cancer that has spread or metastasized to their bones. The drugs apparently have been quite successful at preventing or minimizing bone conditions caused by metastasized cancer and reducing the risk of bone fracture. These drugs, approved by the Food and Drug Administration (" FDA" ) in 1996 and 2002, respectively (Court File Nos. 36-3, 36-4), are still on the market and prescribed for these purposes. However, some years after these drugs were released to market, some patients began developing osteonecrosis of the jaw (" ONJ" ). ONJ is bone death in an area of the jaw or maxilla bone. ONJ can result in total loss of a patient's jaw bone.
Plaintiffs are a married couple, of over forty years, who have three children and four grandchildren. As is tragically common, Mrs. Payne was diagnosed with Stage II breast cancer in 1998. She was treated by Dr. Sylvia Krueger in Cleveland, Tennessee who performed a lumpectomy and treated Mrs. Payne with radiation therapy (Court File No. 55-1, Payne Dep., p. 14) (Court File No. 55-2, Johnson Dep., p. 23). After approximately three months of treatment, Mrs. Payne left Dr. Krueger's care and began treatment with Dr. Darrell Johnson (Court File No. 55-1, Payne Dep., p. 31). After Dr. Johnson began treating Plaintiff, her cancer progressed to Stage IV and metastasized to her bones (Court File No. 55-2, Johnson Dep., p. 23-25).
To reduce Mrs. Payne's risk of fracturing her bones, Dr. Johnson prescribed Aredia® in 1999 ( id. at p. 49-50). Dr. Johnson did not provide Mrs. Payne any warnings regarding Aredia® and he was unaware at the time that ONJ and bisphosphonates were linked ( id. at 114). In 2001, after Mrs. Payne had been taking Aredia® for over two years, Dr. Johnson discussed changing her medication from Aredia® to Zometa® ( id. at 56). Whereas Aredia® treatments would take approximately two hours, Zometa® would cut Mrs. Payne's treatments to thirty minutes (Court File No. 55-1, Payne Dep., p. 50) (Court File No. 55-2, Johnson Dep., p. 57). Dr. Johnson warned Mrs. Payne she may experience headache, but did not discuss any other potential side effects of the new drug (Court File No. 55-1, Payne Dep., pp. 50-51). Dr. Johnson testified he was unaware of the risk ...