Monroe v. Novartis Pharmaceuticals Corp.

29 F. Supp. 3d 1115, 2014 WL 3378345, 2014 U.S. Dist. LEXIS 93777
CourtDistrict Court, S.D. Ohio
DecidedJuly 10, 2014
DocketCivil Action No. 1:12-cv-00746 (WOB-KLL)
StatusPublished
Cited by16 cases

This text of 29 F. Supp. 3d 1115 (Monroe v. Novartis Pharmaceuticals Corp.) is published on Counsel Stack Legal Research, covering District Court, S.D. Ohio primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Monroe v. Novartis Pharmaceuticals Corp., 29 F. Supp. 3d 1115, 2014 WL 3378345, 2014 U.S. Dist. LEXIS 93777 (S.D. Ohio 2014).

Opinion

Memorandum Opinion and Order

WILLIAM O. BERTELSMAN, District Judge.

This is a product liability case under Ohio law, and this Court has original subject matter jurisdiction based on diversity. Shirley Monroe, substituted plaintiff Joseph Kaufman, and William Monroe, Jr. (“Plaintiffs”) allege inadequate warning, nonconformance with manufacturer’s representation, design defect, and loss of consortium claims against Novartis Pharmaceutical Corporation (“Defendant”). Shirley Monroe developed osteonecrosis of the jaw (“ONJ”) while taking Zometa, a drug manufactured by Defendant, giving rise to these product liability claims.

This matter is before the Court on the Defendant’s motion for summary judgment as to all claims against it. (Doc. 48, Defendant’s Motion for Summary Judgment). Defendant also filed motions to exclude expert witnesses. (Doc. 46, 54, 55, 56, 57). However, they are not all essential to the resolution of Defendant’s Motion for Summary Judgment.1

FACTS

A. Facts relating to the merits

Mrs. Monroe was referred to Dr. Arthur Richards in 2005 after a sneeze fractured a lumbar vertebra. (Doc. 58-3 p. 19, Depo-[1119]*1119sitian of Dr. Richards). A biopsy was conducted which showed plasmacytoma, a type of cancer. (Id.) Dr. Richards first saw Mrs. Monroe on May 18, 2005. (Id.) He first prescribed Zometa on May 25, 2005. (Id. at p. 23). She was prescribed four milligrams of Zometa every four weeks to be administered by IV. (Id. at p. 28). Mrs. Monroe’s last dose of Zometa was administered on June 16, 2008. (Id. at p. 41). On August 11, 2008, Dr. Richards diagnosed osteonecrosis of the jaw and told her “that the osteonecrosis is partly due to Zometa and that all of the bisphosphonates have been associated with this problem.” (Id. at p. 38). He also stopped her Zometa at this time. (Id.).

Dr. Richards testified that he did not remember discussing the risks of Zometa with Mrs. Monroe. (Id. at pp. 23-24). When asked what risks he generally discussed when prescribing Zometa, he answered “renal toxicity and headache with the infusion, and ... I would like to think that we discussed ONJ. I would hope so. I think we probably did.” (Id. at p. 24). Mrs. Monroe signed a consent form that she accepted the risk of certain side effects as it related to Zometa. (Doc. 48-22, Oncology/Hematology Care, Inc. Informed Consent for Treatment). This form was for treatment and did not mention ONJ, but Defendant points out it did warn about “Life Threatening complications/death.” (Id.).

Dr. Richards’s notes of September 5, 2007 state that he wanted to reduce Mrs. Monroe’s dosing of Zometa to every eight weeks “because of concerns of osteonecro-sis.” (Id. at p. 32). Dr. Richards could not state with certainty if the concern was with her upcoming dental surgery or his general practice of reducing Zometa treatments because of a Mayo Clinic recommendation to reduce the frequency of administration of Zometa. (Id. at pp. 34-35).

Mrs. Monroe was diagnosed with ONJ and referred to Dr. Patil. (Doc. 51-9 p. 28, Deposition of Dr. Patil). He initially was concerned she had cancer in her jaw, but he ruled this out. (Id. at p. 29). Eventually, he performed several surgeries removing teeth, bone fragments, and later performed mandible and maxilla reconstruction surgery. (Id. at pp. 38-39, 55, 68-69).

Defendant emphasizes.that Mrs. Monroe failed to obtain proper dental treatment prior to the discovery of her ONJ. However, there is no evidence that this impacted her development of ONJ. Instead, Plaintiffs’ retained expert, Dr. Kraut, opined that unless there was some prior dental extraction shortly before she was diagnosed with ONJ, it would likely be spontaneous ONJ. (Doc. 48-23 p. 210, Deposition of Dr. Kraut).

Dr. James Vogel’s expert report indicates that “the risk for developing ONJ increases with the amount of bisphospho-nate a patient takes.” (Doc. 54-8 ¶ 22).2 However, Dr. Richards’s affidavit states that he would still prescribe Zometa, even knowing what he knows now, if Mrs. Monroe presented today exactly as she did in 2005. (Doc. 48-3 ¶ 12). Plaintiffs object to this affidavit because the Defendant obtained it by ex parte communications with Dr. Richards; the Defendant drafted the entire affidavit; Dr. Richards made no changes to the affidavit; and Defendant told him the affidavit would prevent him from having to be deposed. (Doc. 58-3 pp. 47-50, Deposition of Dr. Richards).

Since learning of the connection between bisphosphonates, ONJ, and dental extractions, Dr. Richards now works closely with his patients’ oral surgeons. (Id. at p. 62). [1120]*1120He also notifies his patients that they need to let their oral health care professionals know they are on bisphosphonates. (Id. at p. 64). It is unclear exactly when Dr. Richards made this change to his general practice. (Id. at p. 62).

B. Facts relating to Daubert motions.

Plaintiffs have presented three treating physicians as expert witnesses and one retained expert. The three treating physician's are: Dr. Richards, Mrs. Monroe’s oncologist; Dr. Patil, Mrs. Monroe’s oral surgeon; and Dr. Huntress, Mrs. Monroe’s dentist. The retained expert is Dr. Kraut, an oral and maxillofacial surgeon.

All of Mrs. Monroe’s treating physicians disclaimed any specific causation expertise. Dr. Patil testified he would need to further review Mrs. Monroe’s records to determine the cause of her ONJ, which he did not do. (Doc. 46-28 pp. 68-69, Deposition of Dr. Patil). Dr. Richards testified he had no opinion to a reasonable degree of scientific certainty as to what caused Mrs. Monroe’s ONJ. (Doc. 46-17 p. 45, Deposition of Dr. ■ Richards). Dr. Huntress testified he did not feel qualified to offer an expert opinion as to what caused Mrs. Monroe’s ONJ. (Doc. 47-1 p. 47, Deposition of Dr. Huntress). Further, he testified that he did not perform a differential diagnosis to determine the cause of Mrs. Monroe’s ONJ. (Id. at 27-28).

Plaintiffs also introduced Dr. Richard Kraut as a specific causation expert. Dr. Kraut is board certified in oral medicine, oral and maxillofacial surgery, and dental anesthesia. (Doc. 50-2 Ex. 6 p. 1, Expert Report of Dr. Kraut). In addition, he has published two articles on bisphosphonates. (Id.) In 1988, following his discharge from the U.S. Army, Dr. Kraut became the Director of oral and maxillofacial surgery for Montefiore Medical Center/Albert Einstein College of Medicine, a position he still holds. (Id.) In addition, in 2003, he became the chairman of the Department of Dentistry of Montefiore Medical Center/Albert Einstein College of Medicine. (Id.) He is a Senior Section Editor of the Journal of Implant Dentistry and a reviewer for oral surgery, oral pathology, and the Journal of Oral and Maxillofacial Surgery. (Id.).

Dr. Kraut’s expert report details a differential diagnosis where he concludes that bisphosphonate-related jaw necrosis is the correct diagnosis. (Id. at 4).

Dr. James Vogel also submitted an expert report as a general causation expert and an expert on the inadequacy of the warnings for the risks of Zometa.

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29 F. Supp. 3d 1115, 2014 WL 3378345, 2014 U.S. Dist. LEXIS 93777, Counsel Stack Legal Research, https://law.counselstack.com/opinion/monroe-v-novartis-pharmaceuticals-corp-ohsd-2014.