Eberhart v. Novartis Pharmaceuticals Corp.

867 F. Supp. 2d 1241, 2011 U.S. Dist. LEXIS 130146, 2011 WL 5289372
CourtDistrict Court, N.D. Georgia
DecidedOctober 31, 2011
DocketNo. 1:08-cv-2542-WSD
StatusPublished
Cited by10 cases

This text of 867 F. Supp. 2d 1241 (Eberhart v. Novartis Pharmaceuticals Corp.) is published on Counsel Stack Legal Research, covering District Court, N.D. Georgia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Eberhart v. Novartis Pharmaceuticals Corp., 867 F. Supp. 2d 1241, 2011 U.S. Dist. LEXIS 130146, 2011 WL 5289372 (N.D. Ga. 2011).

Opinion

OPINION AND ORDER

WILLIAM S. DUFFEY, JR., District Judge.

This matter is before the Court on Defendant Novartis Pharmaceuticals Corporation’s (“NPC”) Renewed Motion for Summary Judgment [39] and Plaintiff Susan Eberhart’s (“Plaintiff’) Motion to Strike Declaration of Dr. Randall A. Cog-gins, DMD, MS [52].

I. BACKGROUND

In this pharmaceutical products liability action, Plaintiff claims she was injured by NPC’s failure to warn her or her oncologist about a purported increased risk of osteonecrosis of the jaw (“ONJ,” essentially dying bone in the jaw) associated with two drugs that NPC manufactures. Plaintiff was prescribed the medication to treat recurrent breast cancer that had metastasized to her sternum. She contends that had NPC properly warned about the risk of ONJ created by its drugs, she would not have allowed for three of her teeth to be extracted during the course of her cancer treatment and would have elected endodontic treatment instead. She alleges the extractions caused her to develop ONJ. NPC argues that any alleged failure to warn was not the proximate cause of Plaintiffs injuries because endodontic treatment was not a treatment option for the dental conditions that required Plaintiffs extractions and because the extractions were the only treatment option for Plaintiff. Thus, NPC claims, even if it had given an ONJ warning, the extractions still were required to be performed.

Plaintiffs Aredia And Zometa Treatments

Plaintiff suffers from breast cancer that was originally diagnosed in February 1987 and that, after remission, recurred in February 2001. (NPC’s Statement of Material Facts (“DSMF”) [39-8] ¶¶ 1-2; Pl.’s Response to NPC’s Statement of Material Facts (“RDSMF”) [61] ¶¶ 1-2). In February 2001; Plaintiffs oncologist, Dr. Galleshaw, diagnosed bone metastases on Plaintiffs sternum. (DSMF ¶ 3; RDSMF ¶ 3). Beginning in March 2001, Dr. Galleshaw prescribed to Plaintiff monthly doses of Aredia, which NPC manufactures.1 (DSMF ¶ 6; RDSMF ¶ 6). Aredia is a type of drug known as a bisphosphonate and is FDA-approved for the treatment of breast cancer that has metastasized to the bones. (DSMF ¶¶ 10, 12; RDSMF ¶¶ 10, 12). Aredia is also FDA-approved to treat hypercalcemia of malignancy. (DSMF ¶ 11; RDSMF ¶ 11). Hypercalcemia of malignancy is a potentially fatal elevation [1244]*1244of calcium levels in the blood, which results either when the cancer causes direct loss of bone that elevates the amount of calcium in the blood, or when the cancer triggers other processes that cause elevations of calcium levels without accompanying bone loss. (Galleshaw Dep. 13:17-23, 14:21-25).

By December 2001, despite the Aredia treatment, Plaintiff developed hypercalcemia and her health significantly deteriorated. (DSMF ¶¶ 6, 20-21; RDSMF ¶¶6, 20-21). Dr. Galleshaw changed Plaintiffs treatment regimen from Aredia to Zometa, which NPC also manufactures. (DSMF ¶ 6; RDSMF ¶ 6). Like Aredia, Zometa is a bisphosphonate that is FDA-approved for the treatment of bone metastases of breast cancer and hypercalcemia of malignancy. (DSMF ¶¶ 13-14; RDSMF ¶¶ 13-14). After starting the Zometa treatment, Plaintiffs hypercalcemia immediately improved and she remains alive. (DSMF ¶ 22; RDSMF ¶ 22). Plaintiff continued receiving monthly infusions of Zometa until December 2004. (DSMF ¶ 7; RDSMF ¶ 7). There is no evidence that Plaintiff or Dr. Galleshaw knew or were warned of any connection between bisphosphonates and ONJ during the course of Plaintiffs treatment, until Dr. Galleshaw received a letter from NPC in September 2004 noting reports of a possible connection. (PL’s Statement of Additional Material Facts (“PSMF”) [61] ¶ 1; Def.’s Resp. to PSMF (“RPSMF”) ¶ 1).

Plaintiffs Tooth Extractions And Subsequent Complications

In July 2002, Plaintiff reported a “stabbing pain” in some of her teeth and was referred by her dentist to Dr. Randall Coggins, an endodontist. (DSMF ¶ 26; RDSMF ¶ 26). Dr. Coggins examined Plaintiff on July 8, 2002. (Dr. Coggins’s Records for Susan Eberhart, Coggins Decl. ¶ 4, Ex. 1). Dr. Coggins observed that tooth “# 18 [is] mobile — seems to be perio in nature.” (Id. at 8). Dr. Coggins drafted a report for Plaintiffs referring dentist. The report is on a form that lists potential diagnoses and treatment outcomes, and provides space for Dr. Coggins to mark the options that apply in a specific case. In the report, Dr. Coggins indicated that he had examined teeth numbers 18, 19, and 20. (Id. at 9).2 The report notes that Plaintiffs teeth “Tested within normal limits to clinical tests,” but that there was “periodontal pocketing” with respect to “[tooth] # 18.” (Id.). Discussing the treatment recommendations for Plaintiff, Dr. Coggins stated that “Endodontic treatment is not indicated at this time,” and recommended “Periodontal evaluation/treatment” for “gingivitis/periodontitis.” (Id.). Although “Extraction” was a treatment recommendation listed on the form, Dr. Coggins did not indicate that option. (Id.). Dr. Coggins referred Plaintiff to the office of Dr. Allen French and Dr. Virginia Kirkland, who are both periodontists. (Id. at 10). The referral form asked Drs. French and Kirkland to evaluate Plaintiffs periodontal condition. (Kirkland Dep. Exs. at 0061-0015). Under the section entitled “Special Problem Areas Limited To,” which contained a diagram of teeth numbers, Dr. Coggins circled tooth 18. (Kirkland Dep. Exs. at 0061-0015).

On July 11, 2002, Plaintiff visited Dr. Kirkland for a periodontal examination.3 [1245]*1245(Kirkland Dep. 46:6-7). Dr. Kirkland diagnosed Plaintiff with “isolated severe periodontal disease” around teeth 18, 19, and 20. This disease is unrelated to Plaintiffs cancer and is not caused by the medications manufactured by NPC and prescribed for Plaintiff by Dr. Galleshaw. (Id. at 33:25). According to Dr. Kirkland, her examination revealed two factors indicative of periodontal disease: pocketing and mobility. (Id. at 29:8-15, 30:24-31:6). Pocketing refers to the loss of attachment between the gum and tooth; ratings of 1 to 3 are considered normal while 6 denotes a severe loss of attachment. (Id. at 29:8-30:7). A mobility classification of 1 is considered moderate, while class 2 or 3 is consistent with severe periodontal disease. (Id. at 30:24-31:6, 43:7-9, 80:20). Plaintiffs tooth 18 had pocket measurements in the 5s and 6s and class 2 to 3 mobility. (Id. at 30:21-23; 43:7-9). Tooth 19 did not display significant pocketing, but Dr. Kirkland testified that “even though 19 is not pocketing, it’s got a Class 2 mobility. So something’s going on there, too.” (Id. at 31:4-6). Dr. Kirkland also testified that tooth 20 appeared to be healthy, although it had class 1 mobility. (Id. at 59:2-4, 80:20).

Tooth 18 was also abscessed, and Dr. Kirkland’s July 11, 2002, treatment focused on tooth 18.4 (Id. at 46:4). Dr. Kirkland testified that she “did an I & D, which is an incise and drain; it’s treatment for an abscessed tooth. Also, at the same time we did scaling and root planing for the other areas of pocketing. Scaling and root planing, all of this is a non-surgical type of a treatment done specifically to reduce the number of bacteria in these deep pockets. If enough of the bacteria is removed — also, placed her on an antibiotic, too — these together will encourage healing of the area so that I could better evaluate what to do.” (Id.

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Cite This Page — Counsel Stack

Bluebook (online)
867 F. Supp. 2d 1241, 2011 U.S. Dist. LEXIS 130146, 2011 WL 5289372, Counsel Stack Legal Research, https://law.counselstack.com/opinion/eberhart-v-novartis-pharmaceuticals-corp-gand-2011.