Winter v. Novartis Pharmaceuticals Corp.

882 F. Supp. 2d 1113, 2012 WL 3156768, 2012 U.S. Dist. LEXIS 109005
CourtDistrict Court, W.D. Missouri
DecidedAugust 3, 2012
DocketNo. 06-4049-CV-C-MJW
StatusPublished

This text of 882 F. Supp. 2d 1113 (Winter v. Novartis Pharmaceuticals Corp.) is published on Counsel Stack Legal Research, covering District Court, W.D. Missouri primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Winter v. Novartis Pharmaceuticals Corp., 882 F. Supp. 2d 1113, 2012 WL 3156768, 2012 U.S. Dist. LEXIS 109005 (W.D. Mo. 2012).

Opinion

ORDER

MATT J. WHITWORTH, United States Magistrate Judge.

Following a three-week jury trial, defendant Novartis Pharmaceuticals Corporation (NPC) filed a post-trial motion for judgment of acquittal as a matter of law, pursuant to Rule 50(b) of the Federal Rules of Civil Procedure, together with suggestions in support (docs. 241-42). Plaintiff Christine Winter, Personal Representative of the Estate of Ruth Baldwin, Deceased, has filed her suggestions in opposition (doc. 246). Defendant NPC has filed reply suggestions in support (doc. 251) and a notice of supplemental authority (doc. 253). The Court has carefully reviewed the filings of counsel and rules as follows:

I. Background

Aredia and Zometa are intravenous bisphosphonate medications prescribed to individuals with, among other things, cancers that have metastasized to bone. The drugs are prescribed to prevent devastating skeletal complications that frequently occur in patients with such cancers. These complications include pathologic [1115]*1115fractures, spinal cord compression (which can result in paralysis), and hypercalcemia of malignancy (an elevation of calcium in the blood which can prove fatal). Dr. Robert Marx, plaintiffs expert, testified the drugs have played “a key role in the management of cancer-related bone disease,” and are “extremely effective in halting the progression of both small and large bone metastases.” In fact, he has written that these drugs “have dramatically extended life[J reduced skeletal complications, reduced pain and thus improved the quality of life for individuals with metastatic bone cancer.” Since 1991, the United States Food and Drug Administration has approved these medications as safe and effective on six separate occasions and, each time, approved the labeling.

Although Aredia was first approved in 1991, plaintiff’s evidence revealed that the connection between bisphosphonate medication and osteonecrosis of the jaw (ONJ) was first described in 2002. Late that year, Dr. Robert Marx published a textbook in which he included a chapter describing what he called “Avascular Necrosis” connected with Aredia. Marx Pathology Textbook, “Avascular Necrosis,” PX 1092A. The following September 2003, Dr. Marx wrote a letter to the editor, which was published in the Journal of Oral and Maxillofacial Surgery, describing case reports of ONJ in Aredia and Zometa patients. PX 1089.

Three months later, in December 2003, NPC updated the medications’ package insert (i.e., the label) to state that “[cjases of osteonecrosis (primarily of the jaws) have been reported since market introduction” of these drugs. PX-1086D. In February 2004, NPC revised the Zometa label’s discussion of ONJ to state that “[t]he majority of the reported cases are in cancer patients attendant to a dental procedure” and that “although causality cannot be determined, it is prudent to avoid dental surgery as recovery may be prolonged.” Notably, however, evidence presented at trial revealed that NPC failed to include the information concerning the possibility of ONJ in the “Warnings” section of the label. Rather, the information was included in the “Post Marketing Experience” section of the label. PX-1086E. NPC again updated the Zometa label in August 2004 to include additional information about ONJ and sent out a letter to oncologists and oral surgeons that included the new language. See Sept. 24, 2004 Dear Doctor Letter, PX-0247.

In July 2003, Ruth Baldwin was diagnosed with recurrent breast cancer with metastases to her spine and liver. DX-RB-48. Mrs. Baldwin’s oncologist, Dr. James Hueser, prescribed Aredia to Mrs. Baldwin beginning on July 24, 2003. DX-RB-24. Two months later, at her request, Dr. Hueser switched Mrs. Baldwin’s prescription to Zometa. DX-RB-29. She received her last dose in October 2004. DX-RB-29.

On September 9, 2004, Mrs. Baldwin’s dentist, Dr. Douglas Miller, extracted tooth # 30.1 A week later, Mrs. Baldwin reported that she could feel bone in the area where tooth # 30 was removed. As a result, Dr. Miller referred her to Dr. Timothy Coyle, an oral surgeon. On October 26, 2004, Dr. Coyle diagnosed Mrs. Baldwin as having ONJ secondary to her bisphosphonate use. Dr. Coyle contacted Mrs. Baldwin’s oncologist, Dr. Hueser, and informed him of his diagnosis of ONJ. As a result, Dr. Hueser immediately discontinued Mrs. Baldwin’s prescription for Zometa.

[1116]*1116Mrs. Baldwin filed her lawsuit in 2006. She alleged that NPC was liable due to a failure to provide adequate warnings of the risk of developing ONJ. Testimony from relatives and friends at trial revealed that Mrs. Baldwin suffered a rather slow and painful decline. In addition to the devastating effects of her cancer, Mrs. Baldwin also suffered a great deal of pain in her jaw as a result of the ONJ during the last year of her life. She could not eat solid foods because of the pain and risk of infection. She also lost a great deal of weight. At one point, Mrs. Baldwin removed a section of her dying jaw bone, described as the size of a quarter to a silver dollar, from her mouth while she was brushing her teeth. Her grandson, Brett Winter, witnessed the event and described for the jury the sharp pain he observed Mrs. Baldwin experience when she removed the bone from her jaw, and the “awful” smell, like a “dead animal smell,” of the section of jaw bone that his grandmother held in her hand. (Tr. 1036.) Christine Winter, Mrs. Baldwin’s daughter, testified she observed the gaping hole in her mother’s mouth and described for the jury how the exposed jagged jaw bone would cut into her mother’s mouth and tongue. Mrs. Baldwin died on November 4, 2006, from metastatic breast cancer. Mrs. Baldwin’s daughter, Christine Winter, was later substituted as plaintiff following Mrs. Baldwin’s death.

A jury trial began on March 20, 2012. Following the close of plaintiffs case on March 30, 2012, NPC filed a Rule 50(a) Motion for Judgment as a Matter of Law (doc. 206). On April 4, 2012, NPC rested and filed a renewed Motion for Judgment as a Matter of Law (doc. 213). Both motions were provisionally denied by the Court. On April 6, 2012, the jury returned a split verdict in favor of plaintiff on her negligent failure-to-warn claim and in favor of NPC on her strict liability claim. On April 9, 2012, judgment was entered for plaintiff for compensatory damages in the amount of $225,000 (doc. 222). The jury declined to award punitive damages.

II. Issues before the Court

In its Motion for Judgment as a Matter of Law (doc. 241), defendant NPC asserts that:

A. Plaintiff did not establish proximate cause because the prescribing oncologist, Dr. James Hueser, testified he did not read the package insert with the alleged inadequate warning; and

B. Plaintiff did not establish proximate causation because the alleged inadequate warning did not affect Mrs. Baldwin’s treatment plan or outcome. NPC further alleges:

1. Plaintiff cannot recover as a matter of law based on an alleged failure to warn regarding pretreatment dental screenings; and
2. Plaintiff cannot recover as a matter of law based on an alleged failure to warn to avoid dental surgery.

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Bluebook (online)
882 F. Supp. 2d 1113, 2012 WL 3156768, 2012 U.S. Dist. LEXIS 109005, Counsel Stack Legal Research, https://law.counselstack.com/opinion/winter-v-novartis-pharmaceuticals-corp-mowd-2012.