Payne v. Novartis Pharmaceuticals Corp.

967 F. Supp. 2d 1223, 2013 WL 4779571, 2013 U.S. Dist. LEXIS 127162
CourtDistrict Court, E.D. Tennessee
DecidedSeptember 6, 2013
DocketCase No. 1:12-CV-77
StatusPublished
Cited by4 cases

This text of 967 F. Supp. 2d 1223 (Payne v. Novartis Pharmaceuticals Corp.) is published on Counsel Stack Legal Research, covering District Court, E.D. Tennessee primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Payne v. Novartis Pharmaceuticals Corp., 967 F. Supp. 2d 1223, 2013 WL 4779571, 2013 U.S. Dist. LEXIS 127162 (E.D. Tenn. 2013).

Opinion

MEMORANDUM

CURTIS L. COLLIER, District Judge.

Before the Court is Defendant Novartis Pharmaceuticals Corporation’s (“Novartis”) motion for summary judgment (Court [1226]*1226File 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 of ONJ at the time he prescribed Zometa® (Court File No. 55-2, Johnson Dep., p. 115). However, he now discusses the risk of ONJ with patients and advises them to undergo a dental examination and to discuss any necessary [1227]*1227dental work with a dentist prior to beginning the treatment (id.).

In October 2005, Dr. Johnson noticed an “uptake” in the right mandible consistent with dental pathology (id. at 75). Around this time, Dr. Johnson became aware Aredia® and Zometa® were associated with ONJ (id.). Although Dr. Johnson does not remember receiving a “Dear Doctor” letter from Novartis, he became aware of the connection by reading journals and medical literature (id. at 77). When he noticed the uptake in Mrs. Payne’s mandible, Dr. Johnson suspended her Zometa® treatments and advised her to see a dentist. Mrs. Payne eventually visited an oral surgeon who removed several of her teeth (Court File No. 55-1, Payne Dep., p. 58).

Mrs. Payne was displeased with her oral surgeon’s performance and continued to feel pain in the area from which her teeth were extracted. When Mrs. Payne discussed her continuing pain with Dr. Johnson in 2007, he observed a tooth he believed to be partially necrotic (Court File No. 55-2, Johnson Dep., p. 98). Following this meeting, Mrs. Payne visited another dentist who noticed exposed bone in Mrs. Payne’s mouth. The dentist referred Mrs. Payne back to her original oral surgeon. However, because Mrs. Payne was unsatisfied with her prior oral surgeon, she visited Dr. Eric Carlson instead. Dr. Carlson diagnosed Mrs. Payne with bisphosphonate-induced ONJ in her right mandible and left mandible. Dr. Carlson initially performed resections of Mrs. Payne’s mandible, but after the condition progressed into her maxilla, he performed a partial maxillectomy in 2009. Mrs. Payne still suffers jaw problems. She has not taken Zometa® since 2005.

Plaintiffs bring the following claims against Novartis: (1) Strict Liability; (2) Failure to Warn; (8) Breach of Warranty of Merchantability; (4) Negligence and Negligence Per Se;1 (5) Wantonness; (6) Fraud, Misrepresentation, and Suppression; and (7) Loss of Consortium. Plaintiffs seek compensatory damages for all past and future health care expenses, physical pain and suffering, mental anguish, and physical disability. They also seek any other incidental and consequential damages, fees, and expenses. Finally, Plaintiffs seek punitive damages where appropriate.

Plaintiffs’ original complaint was filed in the United States District Court for the Northern District of Alabama. The case was then transferred to the United States District Court for the Middle District of Tennessee on January 9, 2009, for inclusion in Multidistrict Litigation (“MDL”) 1760 pursuant to 28 U.S.C. § 1407. On January 26, 2012, the case was remanded back to the Northern District of Alabama for further proceedings. The case was subsequently transferred to this court on March 9, 2012, after the district court in the Northern District of Alabama granted the parties’ consent motion to change venue.

II. STANDARD OF REVIEW

Summary judgment is proper when “the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). The moving party bears the burden of demonstrating [1228]*1228no genuine issue of material fact exists. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Leary v. Daeschner, 349 F.3d 888, 897 (6th Cir.2003).

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Rowland v. Novartis Pharmaceuticals Corp.
34 F. Supp. 3d 556 (W.D. Pennsylvania, 2014)
Gilliland v. Novartis Pharmaceuticals Corp.
34 F. Supp. 3d 960 (S.D. Iowa, 2014)
Garrison v. Novartis Pharmaceuticals Corp.
30 F. Supp. 3d 1325 (M.D. Alabama, 2014)
Guenther v. Novartis Pharmaceutical Corp.
990 F. Supp. 2d 1299 (M.D. Florida, 2014)

Cite This Page — Counsel Stack

Bluebook (online)
967 F. Supp. 2d 1223, 2013 WL 4779571, 2013 U.S. Dist. LEXIS 127162, Counsel Stack Legal Research, https://law.counselstack.com/opinion/payne-v-novartis-pharmaceuticals-corp-tned-2013.