Dopson-Troutt et al v. Novartis Pharmaceuticals Corporation

Filing 112

ORDER granting in part and denying in part 67 Daubert Motion to Exclude Certain Testimony. Signed by Judge Susan C Bucklew on 4/3/2013. (GMS)

UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION

RUTH DOPSON-TROUTT and
FRANK TROUTT
Plaintiffs,
v.

Case No: 8:06-cv-1708-T-24EAJ

NOVARTIS PHARMACEUTICALS
CORPORATION,
Defendant.

ORDER
This matter comes before the Court on the Daubert Motion to Exclude Certain Testimony
of Plaintiffs’ Expert Dr. Robert Marx (Doc. 67) filed by the Defendant, Novartis Pharmaceuticals
Corporation (“Novartis”) and the response (Doc. 76) filed by the Plaintiffs. The Court conducted a
hearing on March 8, 2013.
I. Background
The instant products liability case involves Aredia and Zometa, drugs manufactured by
Novartis. Ms. Dopson-Troutt was diagnosed with breast cancer in 1997, and while undergoing
treatment, received infusions of both Aredia and Zometa. She reported having a tooth extracted in
2004 while receiving Zometa infusions. Ms. Dopson-Troutt then developed osteonecrosis of the
jaw (“ONJ”), a condition in which part of the jawbone essentially dies.
Marx is a board-certified oral and maxillofacial surgeon at the University of Miami. He
was one of the first physicians to allege a connection between bisphosphonates, such as Aredia
and Zometa, and osteonecrosis of the jaw, and is widely cited on these topics in medical literature.
By way of the instant motion, Novartis challenges the following “discrete aspects” of Marx’s
proposed expert testimony:

(a) opinions regarding Novartis’s “intent, motives or state of mind” when the company
was responding to the evidence regarding its product and osteonecrosis of the jaw;
(b) his belief that certain dental procedures – screening before treatment with Aredia and
Zometa, and avoidance of invasive procedures during such treatment – can help prevent what
Marx refers to as bisphosphonate-induced osteonecrosis of the jaw (henceforth, “BIONJ”);
(c) criticism of the clinical trials of Aredia and Zometa;
(d) his contention that some of the patients in those trials had BIONJ;
(e) general causation opinions based on adverse event reports he has not reviewed; and
(f) opinions as to the biological mechanism that allegedly causes ONJ.1
II.

Standards

In Daubert v. Merrill Dow, 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), the
Supreme Court admonished trial courts to fulfill a gatekeeping role in the presentation of expert
testimony. Federal Rule of Evidence 702 (“Rule 702”) provides that:
If scientific ... 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.
To guide district courts' assessments of the reliability of an expert’s testimony, the
Supreme Court has identified four factors that district courts should consider when assessing the
reliability of an expert's testimony: (1) whether the expert’s methodology has been tested or is

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In its motion, Novartis sets forth one additional category of testimony that it wishes to
preclude: “general causation opinions not disclosed by plaintiffs previously in this case.” (Doc.
67 at 2). However, Novartis never identifies any such testimony or makes any argument in regard
to it. Accordingly, this order will not address that issue.

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capable of being tested; (2) whether the theory or technique used by the expert has been subjected
to peer review and publication; (3) whether there is a known or potential error rate of the
methodology; and (4) whether the technique has been generally accepted in the relevant scientific
community. See id. at 593–94, 113 S.Ct. 2786. At the same time, the Court has emphasized that
these factors are not exhaustive and are intended to be applied in a “flexible” manner. Kumho
Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 141, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999).
From the reference to “scientific knowledge” and the condition that it “will assist the trier
of fact,” the Supreme Court, in Daubert, interpreted Rule 702 to require that expert testimony on
scientific matters have the following inter-connected attributes:
• that it be “scientific,” having a “grounding in the methods and procedures of science”;
• that it bear the hallmarks of “knowledge,” which “connotes more than subjective belief
or unsupported speculation”; and
• that it “assist the trier of fact” or “fit” a matter at issue, meaning that it expresses
scientific knowledge as to the proposition for which it is offered.
Daubert, 509 U.S. 579, 592, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Expert testimony need not
purport to reveal a known certainty, but it must be derived by the “scientific method,” which
requires that it be supported by appropriate validation based on what is known. Id.
III. Analysis
This Court adopts the analysis of Judge Presnell in his March 28, 2013 order granting in
part and denying in part the Daubert motion to exclude certain testimony of Plaintiffs’ expert Dr.
Robert Marx entered in Guenther v. Novartis, Case No: 6:08-cv-Orl-31DAB, Doc. No. 101. The
motions and responses in both cases are essentially identical.
Initially, it should be noted that the MDL court has already addressed several of these

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issues.

(Doc. 67-1).

Specifically, the MDL court allowed Marx’s testimony regarding the

usefulness of pre-treatment dental screenings and avoidance of invasive dental procedures
(category “b” above) and the alleged causal connection between Aredia/Zometa and ONJ
(categories “e” and “f”). Novartis has not offered any basis for this Court to revisit those rulings.
Novartis does raise one argument specifically to Ms. Dopson-Troutt in regard to category
“b”.

Novartis contends that Marx’s opinions about dental pre-screenings and avoidance of

invasive dental procedures are not relevant in the instant case because there are no dental records
or testimony, other than that of Ms. Dopson-Troutt , as to the state of Ms. Dopson-Troutt’s oral
condition when she began taking Aredia and Zometa and it would be speculation to conclude that
pre-screening would have shown need for any dental procedures. Assuming that Plaintiffs’
counsel is able to demonstrate relevance at trial, Marx will be permitted to offer his opinions
regarding the pre-screenings and invasive dental procedures.
As for the clinical trials (categories “c” and “d”), Plaintiffs’ counsel asserted at the hearing
that, contrary to the representations of defense counsel, Marx does not intend to opine about the
way in which Novartis designed or conducted those trials. Instead he intends to discuss what
occurred during those trials, and specifically to offer his opinion, based on medical records, as to
whether some of the participants in those trials developed BIONJ. This appears to fall within his
area of expertise, and his testimony on this point will be permitted.
Finally, in regard to Marx’s opinions regarding Novartis’s intent, motive, and state of mind
(category “a”, Plaintiffs’ counsel appears to agree that such a topic would not be a proper topic for
expert testimony. Accordingly, no such testimony will be permitted.
In consideration of the foregoing, it is hereby
ORDERED that the Daubert Motion to Exclude Certain Testimony of Plaintiffs’ Expert

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Dr. Robert Marx (Doc. 67) is GRANTED IN PART and DENIED IN PART as set forth above.
DONE and ORDERED in Tampa, Florida on April 3rd, 2013.

Copies furnished to: Counsel of Record

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