Thorn v. Novartis Pharmaceuticals Corporation
Filing
146
ORDER granting in part and denying in part 26 the MOTION to Exclude Testimony of Plaintiff's Experts Dr. Robert Fletcher, Dr. Keith Skubitz, Dr. James Vogel, Professor Wayne Ray, Dr. Suzanne Parisian, and Dr. Robert Marx as set forth more fully herein, with regard to the testimony of James M. Vogel, M.D. Signed by Magistrate Judge C Clifford Shirley, Jr on March 5, 2013. (AYB)
UNITED STATE DISTRICT COURT
EASTERN DISTRICT OF TENNESSEE
AT KNOXVILLE
IRENE JENKINS,
Plaintiff,
V.
NOVARTIS PHARMECEUTICALS CORP.,
Defendant.
SANDRA THORN,
Plaintiff,
V.
NOVARTIS PHARMECEUTICALS CORP.,
Defendant.
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No. 3:11-CV-342
(CAMPBELL/SHIRLEY)
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No. 3:11-CV-373
(CAMPBELL/SHIRLEY)
MEMORANDUM AND ORDER
These cases are before the undersigned pursuant to 28 U.S.C. § 636, the Rules of this
Court, and the orders of the District Judge. Now before the Court is Novartis Pharmaceuticals
Corporation’s Daubert Motion to Exclude Testimony of Plaintiffs’ Experts Dr. Robert Fletcher,
Dr. Keith Skubitz, Dr. James Vogel, Professor Wayne Ray, Dr. Suzanne Parisian, and Dr. Robert
Marx.
This Daubert motion has been filed in both of the cases captioned above.
This
Memorandum and Order, however, addresses the testimony of Dr. James Vogel. Dr. Vogel is
only expected to offer testimony on behalf of Plaintiff Thorn.
On June 14, 2012, the parties appeared before the Court to address this motion. The
parties and the Court agreed that the Court would decide the Daubert challenge to the testimony
of James M. Vogel, on the papers. The parties have submitted their materials on this issue to the
Court, and the Court has completed its review.
For the reasons stated below, Novartis’s
objection and challenge to James M. Vogel, M.D., will be GRANTED IN PART and DENIED
IN PART.
I.
BACKGROUND
Both Plaintiff Jenkins and Plaintiff Thorn (“the Plaintiffs”) underwent treatment for
cancer in the late 1990s and early 2000s. Plaintiffs were prescribed Aredia by their physicians. 1
It is undisputed that Novartis was in the business of manufacturing, marketing, distributing,
promoting, testing, labeling, and selling Aredia. The Plaintiffs allege that they suffered from
osteonecrosis of the jaw caused by Aredia, and they argue that Novartis should be held liable for
their personal injuries under theories of strict liability and negligence. Novartis disputes both
general causation and specific causation.
The parties agree that Aredia is a bisphosphonate and the principal pharmacological
action of Aredia is inhibition of bone resorption. Bisphosphonates are approved by the Food and
Drug Administration (“FDA”) for prevention and treatment of osteoporosis. Aredia and Zometa
are “FDA-approved intravenous bisphosphonate drugs typically prescribed by oncologists to
prevent bone pain, fracture and other skeletal complications in patients with cancer that has
metastasized to bone.” [MDL No. 3:06-MD-1760, Doc. 4695 at 2].
At the time of his initial report in these cases, James M. Vogel, M.D., (“Dr. Vogel”), had
been a practicing physician in the field of hematology and medical oncology for thirty-five years.
In his report, Dr. Vogel estimates that he is visited by eighty to one hundred patients per week.
Dr. Vogel primarily sees patients with “solid tumors,” predominately of breast and lung
1
Plaintiff Jenkins currently has a pending motion to amend her Complaint. The motion requests leave to add an
allegation that she was also prescribed and took Zometa. Plaintiff Thorn’s Complaint [Doc. 1] does not allege use of
Zometa, nor has she moved to amend her Complaint in this case.
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etiologies, as well as patients with hematologic malignancies involving multiple myeloma,
lymphoma, and leukemia. In this case, Dr. Vogel was retained by Plaintiff Thorn’s counsel and
asked to, inter alia: explain his experience prescribing bisphosphonate drugs; provide an opinion
as to whether or not bisphosphonate drugs cause ONJ; review internal Novartis documents and
provide an opinion as to whether hematologists and medical oncologists were fully informed of
the risk of ONJ in patients prescribed bisphosphonates; and discuss measures for reducing and
preventing ONJ in bisphosphonate patients.
Novartis challenged Dr. Vogel’s testimony in its Motion to Exclude Testimony of
Plaintiffs’ Experts Dr. Robert Fletcher, Dr. Keith Skubitz, Dr. James Vogel, Professor Wayne
Ray, Dr. Suzanne Parisian, and Dr. Robert Marx. [Doc. 42 in Case No. 3:11-CV-342, Doc. 26 in
Case No. 3:11-CV-373]. After briefing on this challenge was complete, the parties reached an
agreement partially resolving the challenges to Dr. Vogel’s testimony. The parties stated their
agreement as:
a. Based upon plaintiffs’ agreement, Dr. Vogel would not present opinion testimony
that:
i. Pretreatment dental screenings could prevent ONJ;
ii. Aredia labels violate FDA regulations;
iii. Novartis had an improper intent, motive, or “state of mind” during
relevant events.
b. The Court will take under advisement Dr. Vogel’s opinion that the August 2004
Zometa label was inadequate because it did not say that ONJ may occur
“spontaneously,” as opposed to following an invasive dental procedure.
[Novartis] asserts that Dr. Vogel has not disclosed this opinion in his expert
report. Plaintiff Thorn asserts that Dr. Vogel has disclosed this opinion. Plaintiff
will submit the transcript of Dr. Vogel’s expert testimony from the Brodie trial,
Dr. Vogel’s expert report, and an explanation of the opinion Dr. Vogel intends to
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assert at the trial in Thorn. If the Court finds that this opinion was not disclosed
in Dr. Vogel’s expert report, plaintiffs must supplement his expert report and offer
Dr. Vogel for a limited deposition.
[Doc. 99 in 3:11-CV-342 at 3; Doc. 103 in 3:11-CV-373 at 3 (emphasis added)]. 2 Thus, the
Court now turns to the remaining, pending issues, as agreed upon by the parties above.
II.
ANALYSIS
The issues before the Court involve application of both the Federal Rules of Evidence
and the Federal Rules of Civil Procedure. The Court will apply each in turn.
A.
Federal Rule of Evidence 702
Federal Rule of Evidence 702 governs the admission of expert testimony. It provides:
If scientific, technical, or other specialized knowledge will assist
the trier of fact to understand the evidence or to determine a fact in
issue, a witness qualified as an expert by knowledge, skill,
experience, training, or education, may testify thereto in the form
of an opinion or otherwise, if (1) the testimony is based upon
sufficient facts or data, (2) the testimony is the product of reliable
principles and methods, and (3) the witness has applied the
principles and methods reliably to the facts of the case.
Fed. R. Evid. 702.
The Court finds that Dr. Vogel is qualified to offer testimony regarding his experience
prescribing bisphosphonates and treating ONJ. His expertise as a medical doctor specializing in
hematology and his experience in these areas is more than sufficient, and there appears to be no
dispute on this point. As the parties’ agreement reflects, Dr. Vogel’s expertise is limited with
regard to certain topics. The Court finds that the parties’ agreement that Dr. Vogel will not
testify as to pretreatment dental screenings as a ONJ prevention measure, Aredia labels violating
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Novartis further agreed to defer its challenge to Dr. Vogel’s opinions regarding irrelevant scientific and/or medical
articles published after Plaintiff Thorn ceased pamidronate therapy until trial.
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FDA regulations, or Novartis’s intent, motive, or “state of mind” during relevant events, is wellsupported.
Accordingly, to the extent the Motion to Exclude objects to Dr. Vogel’s testimony
pursuant to Rule 702 of the Federal Rules of Evidence, it will be GRANTED as to the three
lines of testimony discussed above – pretreatment dental screenings as a ONJ prevention
measure, Aredia labels violating FDA regulations, or Novartis’s intent – and it will be DENIED
as to the other proposed testimony.
B.
Disclosure of the Opinion Relating to Labeling and the Term “Spontaneous”
Novartis argues that Dr. Vogel failed to disclose an opinion which can be summarized as:
Failure to use the term “spontaneous” on the bisphosphonate label rendered the 2004 Zometa
label inadequate. Plaintiff Thorn maintains that this opinion was timely disclosed.
Rule 26 of the Federal Rules of Civil Procedure governs expert disclosures. Rule 26
requires that expert like Dr. Vogel provide a written report that includes: “(i) a complete
statement of all opinions the witness will express and the basis and reasons for them; (ii) the
facts or data considered by the witness in forming them; (iii) any exhibits that will be used to
summarize or support them; (iv) the witness’s qualifications, including a list of all publications
authored in the previous 10 years; (v) a list of all other cases in which, during the previous 4
years, the witness testified as an expert at trial or by deposition; and (vi) a statement of the
compensation to be paid for the study and testimony in the case.”
In this case the parties do not dispute the timeliness of Dr. Vogel’s first report, “Expert
Report of James M. Vogel, M.D.,” nor do they dispute the timeliness of Dr. Vogel’s second
report, “Rebuttal Report of James M. Vogel, M.D.” Instead, Defendant argues that the opinion
regarding the use of the term “spontaneous” in Zometa labeling was not included in either of the
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reports. The Plaintiffs dispute the Defendant’s position, and counsel for the Plaintiffs directed
the Court to page forty of Dr. Vogel’s first report, specifically to ¶¶ (b)(c).
The Court has reviewed the portions of paragraph forty cited to the Court, and the Court
has further reviewed the entirety of paragraph forty and paragraph forty-one. The Court finds
that these paragraphs do not disclose an opinion that failing to use the term “spontaneous” on the
bisphosphonate label rendered the label inadequate.
In addition, the Court has reviewed the transcript of Dr. Vogel’s testimony in Brodie v.
Novartis, No. 4:10-CV-138 (E.D. Mo.), offered at trial on January 26, 2012. The Court initially
finds that none of the attorneys who made an appearance in the trial transcript for Brodie are
counsel of record in either of the cases pending before the undersigned. In addition, the Court
finds that Dr. Vogel’s brief reference that the 2004 Zometa label “didn’t inform in terms of
spontaneous development of ONJ” was the subject of an objection sustained by the Court but
later allowed by the Brodie court. [Vogel Tr. at 25-26; 31]. The Court has considered the
testimony provided in Brodie, but the Court finds that this opinion does not constitute sufficient
disclosure in this case.
Accordingly, the Court finds the Zometa labeling opinion relating to using or failing to
use the term “spontaneous” in 2004 Zometa labeling was/is not sufficiently disclosed in Dr.
Vogel’s expert reports. The Court, therefore, finds that Novartis’s request that the Court order
supplementation is well-taken, and it is GRANTED. The Court finds that if Plaintiff Thorn
plans to use this opinion, Dr. Vogel must supplement his expert report with regard to this opinion
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on or before April 1, 2013, and Plaintiff Vogel must offer Dr. Vogel for a limited supplemental
deposition on or before June 28, 2013. 3
III.
CONCLUSION
In sum, the Court finds that James M. Vogel, M.D., is well-qualified to testify in this case
to matters within his knowledge and experience. He will be precluded from offering testimony
on pretreatment dental screenings as an ONJ prevention measure, Aredia labels violating FDA
regulations, or Novartis’s intent. Moreover, if Plaintiffs plan to offer the use of the term
“spontaneous” in 2004 Zometa labeling, then they must supplement Dr. Vogel’s disclosures and
allow a deposition consistent with the Court’s instructions above.
Accordingly, and for the reasons more fully stated above, the Motion to Exclude
Testimony of Plaintiffs’ Experts Dr. Robert Fletcher, Dr. Keith Skubitz, Dr. James Vogel,
Professor Wayne Ray, Dr. Suzanne Parisian, and Dr. Robert Marx [Doc. 42 in Case No. 3:11CV-342, Doc. 26 in Case No. 3:11-CV-373] is GRANTED IN PART and DENIED IN PART,
as stated above, with regard to the testimony of James M. Vogel, M.D.
IT IS SO ORDERED.
ENTER:
s/ C. Clifford Shirley, Jr.
United States Magistrate Judge
3
However, as previously noted Plaintiff Thorn has, and her experts and her counsel have, repeatedly stated that she
took only Aredia and not Zometa. [See, e.g., Ex. 3 from Oct. 4, 2012 hrg. (showing Ms. Thorn took only Aredia);
Ltr. dated Jan. 18, 2012 from Sid Gilreath, counsel for Plaintiff Thorn (stating “Ms. Thorn . . . received monthly
Aredia infusions . . . .”)]. They have also failed to dispute Novartis’s assertion of the same. [See, e.g. Novartis’s
Supp. Memo., Doc. 72 in No. 3:11-CV-373 (“Plaintiff Thorn asserts that she was only treated with Aredia . . . .”)].
Accordingly, while the Court herein is ruling on the legal and Daubert issues presented, the Court is at a loss as to
understand ultimate relevance of Dr. Vogel’s testimony regarding labeling on Zometa – a drug that Plaintiff Thorn
did not use – in the Thorn case.
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