Thorn v. Novartis Pharmaceuticals Corporation

Filing 139

ORDER granting in part and denying in part 26 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, as it relates to the testimony of Robert Marx, D.D.S., and Suzanne Parisian, M.D. to the extent set forth herein. The challenges to the other experts referenced in the motion will be addressed in orders of the Court to follow this Memorandum and Order. Signed by Magistrate Judge C Clifford Shirley on December 13, 2012. (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. These Daubert motions have been filed in both of the cases captioned above.
On October 4, 2012, the parties appeared before the Court to address these motions.
Attorney Robert Germany was present representing Plaintiff Jenkins. Attorney Sidney Gilreath
was present representing Plaintiff Thorn. Attorneys William Cople and Dwight Tarwater were
present representing the Defendant.
The hearing on October 4, 2012, was set to address the Defendant’s Daubert challenges
to the testimony of Robert Marx, D.D.S., and Suzanne Parisian, M.D. Both Dr. Marx and Dr.

Parisian testified at the hearing. The instant Memorandum and Order will rule only on the
challenges relating to Dr. Marx and Dr. Parisian. The remaining Daubert challenges will be
addressed in later orders of the Court. For the reasons stated below, the Daubert motions 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 if manufacturing, marketing, distributed,
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].

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Plaintiff Jenkins currently has a motion to amend her Complaint pending. The motion requests leave to add an
allegation that she was also prescribed and took Zometa. The Court finds that the disposition of the motion to
amend will not affect the Court’s rulings on the Daubert challenges to Dr. Marx and Dr. Parisian.

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II.

STANDARD
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.
In Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme
Court of the United States stated that a district court, when evaluating evidence proffered under
Rule 702, must act as a gatekeeper, ensuring “that any and all scientific testimony or evidence
admitted is not only relevant, but reliable.” Id. at 589.
The Daubert standard “attempts to strike a balance between a liberal admissibility
standard for relevant evidence on the one hand and the need to exclude misleading ‘junk science’
on the other.” Best v. Lowe’s Home Ctrs., Inc., 563 F.3d 171, 176–77 (6th Cir. 2009). There is
no definitive checklist for applying the Daubert challenge. However, there are four relevant
inquiries: (1) whether the theory or technique can be or has been tested; (2) whether it “has been
subjected to peer review and publication”; (3) whether there is a “known or potential rate of
error”; and (4) whether the theory or technique enjoys general acceptance in the relevant
scientific community. 509 U.S. at 593–94. These factors are neither “definitive, nor exhaustive,
and may or may not be pertinent to the assessment in any particular case.” Nelson v. Tenn. Gas
Pipeline Co., 243 F.3d 244, 251 (6th Cir. 2001). “The inquiry envisioned by Rule 702 is . . . a
flexible one.” Daubert, 509 U.S. at 594.
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In the end, the party proffering expert testimony must show by a preponderance of the
proof that the expert whose testimony is being offered is qualified and will offer testimony,
based on scientific knowledge, which will assist the trier of fact in understanding and disposing
of the case. Pride v. BIC Corp., 218 F.3d 566, 578 (6th Cir. 2000).

III.

ANALYSIS

A.

Daubert Rulings in the Multi-District Litigation
These cases were originally part of a multi-district case presided over by the Honorable

Todd Campbell, United States District Judge for the Middle District of Tennessee.

The

Defendant pursued Daubert challenges to both Robert Marx, D.D.S., and Suzanne Parisian,
M.D., in the multi-district litigation. Judge Campbell found that “testimony of Plaintiffs’ expert
Dr. Robert Marx was admissible, for purposes of summary judgment, on the issues of causal
connection and treatment and preventative measures for ONJ.” [MDL No. 3:06-MD-1760, Doc.
4695 (citing Doc. 2814)]. Judge Campbell declined to address a Daubert challenge to Dr.
Parisian. [MDL No. 3:06-MD-1760, Doc. 2816].
In its own analysis, the Court has considered Judge Campbell’s ruling that, for purposes
of summary judgment, Dr. Marx’s testimony is admissible as to causal causal connection and
treatment and preventative measures for ONJ. However, in reaching its decision in these cases,
the Court has also considered Dr. Marx’s testimony presented before the undersigned and
considered the ability of this testimony to withstand a Daubert challenge as this matter proceeds
toward trial by jury.

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B.

Robert Marx, D.D.S.
Robert Marx, D.D.S., is a dentist and maxillofacial surgeon, who has been licensed to

practice dental surgery in Illinois, since 1971, and Florida, since 1984. Currently, Dr. Marx is a
Professor of Surgery and Chief of the Division of Oral and Maxillofacial Surgery at the
University of Miami, Miller School of Medicine. Dr. Marx estimates that in this position he
devotes one day per week to treatment and consultation with established and new patients and
devotes the other four days to surgeries. Dr. Marx has published monographs, textbooks, and
peer-reviewed articles addressing diagnosis and surgical treatment of maxillofacial diseases and
disorders. His publications include Oral and Maxillofacial Pathology: A Rationale for Diagnosis
and Treatment, (Quintessence Pub. Co. 2002), authored with Diane Stern, D.D.S., which
received the American Medical Writers Best Book of the Year Award in 2002, and over fiftyfive articles in refereed scientific journals.
At the hearing, Dr. Marx explained the bone resorption, i.e. bone turn-over, process that
is allegedly inhibited to bisphosphonates such as Aredia.

Specifically, he explained the

destruction of osteoclasts, the effect of this destruction on the jawbone, and how ONJ can result.
He testified that he has prescribed Aredia and Zometa on a handful of occasions and testified that
his practice has developed what is now the standard of care for dental pretreatment to prevent
bisphosphonate-related ONJ. Dr. Marx testified that he has experience in oncological surgery –
specifically, he performs head and neck surgery – but he acknowledged that he is not a medical
oncologist.

Dr. Marx testified that as of the week of the hearing, he had seen over three

hundred patients with ONJ.
As an initial matter, the Court finds that Dr. Marx is qualified, generally, to testify to the
matters before the Court. The Court finds that Dr. Marx is well-versed in the resorption by the
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jawbone that is at the heart of this matter. He is experienced in oncologic surgery and is wellqualified to testify to dental and medical issues relating to the jaw. Moreover, the Court finds
that Dr. Marx possesses an ability to explain complicated biological matters in practical and
easily-digestible terms.
The Court turns now to the specific challenges posed to Dr. Marx’s testimony under
Daubert. The issues presented to the Court at the hearing conducted on October 4, 2012, were
greatly narrowed from the Defendant’s initial filing. Thus, to the extent any previous Daubert
challenge or aspect of a challenge to Dr. Marx’s testimony was not addressed at the hearing, the
Defendant has both implicitly and explicitly represented that such challenges are moot, and they
are DENIED AS MOOT.
Further, at the hearing, counsel for the Plaintiffs represented that Dr. Marx would not
offer certain testimony identified in the Defendant’s motion, including: (1) Dr. Marx’s ‘new’
opinion that he can look at pathology and distinguish between osteomyelitis and osteonecrosis of
the jaw (“ONJ”); (2) Dr. Marx’s testimony regarding bad faith on the part of Novartis; (3) Dr.
Marx’s testimony criticizing clinical trials relating to Aredia; and (4) his opinion that specific
patients in clinical trials of Aredia and/or Zometa had ONJ, which Novartis erroneously failed to
detect.
The parties agreed that argument and/or testimony on these points was unnecessary
because this testimony would not be presented. The Court finds that the Plaintiffs have agreed
that Dr. Marx will not offer testimony on the four points identified above. This agreement
essentially grants the Defendants’ request and, therefore, moots the need for the Court to rule on
the issue. The Court, thus, finds that the Defendant’s request that Dr. Marx be prohibited from

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testifying on this issue is DENIED AS MOOT but based on Plaintiffs’ representation and
agreements as to Dr. Marx’s testimony.
The three Daubert challenges that remain in contention are: (1) Dr. Marx’s opinion that
pretreatment dental screenings and “drug holidays” are useful in preventing ONJ; (2) Dr. Marx’s
opinion that adverse event reports support his general causation opinion; and (3) Dr. Marx’s
opinion regarding the mechanism by which bisphosphonates allegedly cause ONJ. With regard
to these opinions the Court finds as follows.

1.

Pretreatment Dental Screenings and Drug Holidays
The Court finds that Dr. Marx is qualified to testify regarding pretreatment dental

screenings based upon his experience as a dentist and oral and maxillofacial surgeon. Moreover,
Dr. Marx testified that his work with patients at the University of Miami helped develop the
current industry standard for pretreatment, by which patients are now referred to a dental
provider prior to beginning their bisphosphonate therapy. [See Marx Report at ¶ 52]. The Court
finds that Dr. Marx is qualified to testify with regard to pretreatment dental screenings as a
preventative measure to prevent ONJ induced by biphosphates.
The perplexing part of the Daubert challenge regarding the pretreatment testimony is that
Dr. Marx and the Defendant appear to hold the same opinion regarding pretreatment, yet the
Defendant argues that Dr. Marx’s opinion is not reliable. Dr. Marx’s opinion, as stated at the
hearing, is that: undertaking dental care prior to beginning a bisphosphonate regimen will
prevent ONJ from developing in a significant number of cases, because the provocative factor
for ONJ is trauma to the jaw. Stated differently, pretreatment can prevent intrusive procedures –
such as tooth extractions – that provoke ONJ.
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A flyer for Zometa was admitted into evidence as Exhibit 4 to the hearing. It was
described by Plaintiff’s counsel as coming from Novartis’s website; the Defendant did not
dispute its origin. The flyer, which contains Novartis’s company emblem, endorses the same
opinion regarding pretreatment’s role in preventing ONJ. It states that ONJ may be prevented
by: (a) obtaining a dental exam prior to starting the bisphosphonate regimen and (b) avoiding
invasive dental procedures and soft-tissue injuries to the maxillofacial area. See Ex. 4 to Hrg.
The Court cannot reconcile this statement, contained in materials endorsed by Novartis, with
Novartis’s position that Dr. Marx’s opinion is unreliable.
Regardless, the Court finds that Dr. Marx’s opinion regarding pretreatment has shown a
sufficient degree of reliability to withstand the Daubert challenge. In reaching this conclusion,
the Court has considered Dr. Marx’s general qualifications in this area, the fact that he developed
his opinion through his treatment of patients at the University of Miami, and his numerous
scholastic writings on the issue. The Court would specifically note that the white paper/letter to
the editor, admitted as Exhibit 3 to the hearing, demonstrates the opinion’s reliability. The letter,
composed by Dr. Marx, relies upon thirty-six cases at the University of Miami in concluding that
“[p]revention, surgically by avoiding tooth removals if possible, control of periodontal disease
by nonsurgical means, avoiding dental implants, and using soft liners on dentures also seems
prudent.” Ex. 3 to Hrg. At 1117.
The Court finds that Dr. Marx’s opinion as to pretreatment as a preventative measure
against ONJ is relevant, reliable, and offered by a qualified source. Accordingly, the Court finds
that the Daubert challenge to this testimony is not well-taken. It is DENIED.
As to drug holidays, the Court finds that drug holidays are not at issue in these cases.
Drug holidays have been considered as a possible preventative or remedial measure for ONJ
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caused by oral bisphosphonates. Neither party has argued that the Plaintiffs in this matter used
oral bisphosphonates, and Dr. Marx did not offer any relevant testimony regarding drug holidays
at the hearing. The Court finds that such testimony is not relevant to these cases, and any
challenge to this testimony under Daubert is GRANTED based upon this lack of relevance.
2. Adverse Event Reports
Dr. Marx did not testify at any length that adverse event reports support his general
causation opinion. Plaintiffs directed the Court to paragraph sixty-one of Dr. Marx’s report for
discussion of “adverse event reports.” The Court has reviewed paragraph sixty-one and finds it
discusses only generally the causal connection between various medical conditions and the
conditions or exposures that are widely believed to cause such conditions. The Defendant
maintained that there was no “adverse event reports” opinion in Dr. Marx’s report, and the
Plaintiff conversely argued that a challenge to any “adverse event reports” opinion was not
properly before the Court. The parties essentially conceded this issue was not ripe. Having
considered the posture of this issue and the contents of Dr. Marx’s report, the Court finds that it
does not have sufficient evidence to rule on a challenge to this testimony, and the Court declines
to so rule at this time.
Accordingly, the undersigned declines to rule on any challenge to potential testimony that
adverse event reports support Dr. Marx’s general causation opinion. This challenge, to the
extent it has even been presented, is DENIED WITHOUT PREJUDICE. If this testimony is,
in fact, offered at the trial of this matter, the District Judge will have heard the relevant trial
testimony and be better equipped to rule on this issue at that time.

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3. The Mechanism by Which Bisphosphonates Allegedly Cause ONJ
The Court finds that Dr. Marx is well-qualified to testify as to the mechanism by which
bisphosphonates allegedly cause ONJ. As more fully described above, the Court finds that Dr.
Marx is well-versed in the resorption by the jawbone that is at the heart of this matter. The Court
further finds that his testimony regarding the resorption mechanism is relevant to this case and
goes to the heart of this matter. His discussion and demonstration of the role of osteoclast
destruction will aid the jury in understanding the condition for which Plaintiffs seek to hold
Defendant liable. The Court further finds that Dr. Marx’s testimony is reliable, because it is
based on a combination of relevant academic findings and his experience with patients with
ONJ. See Marx Rpt. at ¶¶ 17, 53-54.
Moreover, as stated initially, the Court finds that the MDL rulings as to his causation
testimony are the law of this case.
Thus, the Court finds that Dr. Marx’s testimony regarding the mechanism by which
bisphosphonates allegedly cause ONJ is relevant, reliable, and offered by a qualified source.
Accordingly, the Court finds that the Daubert challenge to this testimony is not well-taken. It is
DENIED.

B.

Suzanne Parisian, M.D.
Suzanne Parisian, M.D., received her medical doctorate degree from the University of

South Florida in 1978 and her board certification in anatomic and clinical pathology in 1989.
She testified that she was a general practitioner in Lenoir, North Carolina early in her career.
From 1991 to 1995, she served as an officer in the United States Public Health Service and was
assigned to the Office of the Medical Examiner for the Armed Forces, Washington, D.C. From
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1991 to 1993, Dr. Parisian was a FDA Medical Officer, providing regulatory support to the
FDA’s Office of Compliance and Office of Device Evaluation. Dr. Parisian submits that she has
presided over 162 health risk assessments for the FDA. Dr. Parisian testified that she is familiar
with the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301, et seq., and its application.
As with Dr. Marx, the Daubert challenges posed to Dr. Parisian have been reduced
through the agreement of the parties. The parties have agreed that Dr. Parisian cannot testify to:
(1) general or specific causation between Aredia or Zometa and ONJ; (2) the intent and/or
motives of Novartis; and (3) the means by which Novartis should have conducted clinical trials
or critique the clinical trials conducted. In addition, the challenges not argued before the Court
were represented to the Court as no longer being pursued in this matter. Therefore, the Daubert
challenges to the testimony listed above and the testimony not addressed before the Court are
DENIED AS MOOT.
The Court finds that Dr. Parisian is qualified to offer testimony as to the FDA
requirements applicable to Aredia and Zometa and the FDA labeling requirements and the
labeling process. She is also qualified to testify as to what materials Novartis submitted to the
FDA and when. She may not, however, decide what Novartis knew and did not know at various
times during the relevant period. Novartis’s knowledge is an issue for the jury. Dr. Parisian has
no specialized knowledge or scientific/medical expertise that provides her with a superior ability
to judge Novartis’s knowledge, and there is no basis for finding that the jury needs her assistance
in evaluating Novartis’s knowledge. Dr. Parisian’s testimony will be guided by and related to
the FDCA.
Moreover, the Court finds that Dr. Parisian’s FDA/FDCA-related testimony is relevant
and reliable so as to satisfy the Daubert standard. To the extent the Defendant challenges this
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FDA/FDCA-related testimony, pursuant to Daubert, the Court finds that the challenge is not
well-taken. It is DENIED.
The Court finds that Dr. Parisian is not qualified to testify as to the mechanism by which
Zometa and Aredia, or bisphosphonates generally, cause ONJ. While Dr. Parisian holds a doctor
of medicine, she testified that the vast majority of her career has been spent in the field of
medical regulation rather than the practice of even general medicine. Moreover, the Plaintiff has
not presented any evidence indicating that Dr. Parisian has any special experience treating
bisphosphonate-related disorders, jaw conditions, or bone conditions.

Further, there is no

evidence in the record to indicate that Dr. Parisian has either treated ONJ or studied ONJ in an
academic setting. Finally, Dr. Parisian did not offer causation testimony at the hearing before the
undersigned, and she, at least implicitly, acknowledged that ONJ causation was not her area of
expertise. Thus, the Court finds that the Defendant’s Daubert challenge with respect to such
testimony is well-taken, and it is GRANTED.

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IV.

CONCLUSION
In sum, 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 [Doc. 42 in No. 3:11-CV-342; Doc. 26 in No.
3:11-CV-373], as it relates to the testimony of Robert Marx, D.D.S., and Suzanne Parisian,
M.D., is DENIED IN PART and GRANTED IN PART to the extent stated above. The
challenges to the other experts referenced in the motion will be addressed in orders of the Court
to follow this Memorandum and Order.
IT IS SO ORDERED.

ENTER:
s/ C. Clifford Shirley, Jr.
United States Magistrate Judge

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