The opinion
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
In re Seroquel XR (Extended Release
Quetiapine Fumarate) Antitrust
Litigation
Master Docket No. 20-1076-CFC
This Document Relates to:
All Actions
MEMORANDUM ORDER
Defendants have moved pursuant to Federal Rule of Evidence 702 and
Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993) to preclude Plaintiffs’
expert Dr. Joseph Fix from offering at trial the opinions he set forth in two
sentences in paragraph 164 of his Reply Report. D.I. 643; see also D.I. 772 at 1
(confirming that the motion is “limited to the two sentences”). Dr. Fix discusses in
the two sentences the following two graphs, each of which depict the dissolution
profiles of two tablets:
50mg Dissolutions: Oven-cured vs Pan-cured
| "| issolution Comparedto Curing Process i
i 1 8 8 8
oe] to sas
ie oe ; [08 Oniekten Coopuredt Cucag | i
3 | . 1 as meen |
12 i dou .
jo | i - [pe i
is i $ jead oo. & | i
3 ba i | i a ¢ | i
} “ + - Gt 1
| 074 □ sf
RE LN j
3 a4 i ;
.
3 i i © Tene thy 3 0 22 _ a!
300mg Dissolutions: Oven-cured vs Pan-cured
Dissolution Compared to Curing Process
. § □
2 08 . 2 □
3 7 !
3 08 §
8 6 OPanGured
“i - !
°
“92 i 98
: g i
0 2 4 Stim che}? 10 12 14)
D.I. 719-7 at 7-8.
The two sentences in paragraph 164 of Dr. Fix’s report read as follows:
Although numerical data are not provided [in the charts],
the graphic representation of dissolution profiles for oven-
cured and pan-cured tablets exhibit average drug release
percentages extremely close to each other and the clear
overlap of standard deviation of the averages of individual
time points strongly suggest that there was no statistical
difference between the dissolution profiles. These results
indicated the success of the alternative curing process and
indicated that it should be applicable to other tablet
strengths.
D.I. 719-2 | 164. Defendants argue that the opinions set forth in these two
sentences are inadmissible under Rule 702(b) and (c) because they are neither the
product of reliable principles and methods nor based on sufficient facts or data.
D.I. 644 at 3.
Defendants say that the opinions in paragraph 164 are not the product of
reliable principles and methods because Dr. Fix did not have access to the “raw
data” on which the graphs were based and therefore Dr. Fix has no reliable basis to
offer an opinion about whether the graphs depict any “statistical” differences or
similarities between the two drugs profiled in the graphs. D.I. 644 at 3. Plaintiffs
counter that “as a matter of law, the unavailability of raw data underlying these
graphs does not make Dr. Fix’s analysis unreliable.” D.I. 717 at 14. But Plaintiffs
do not cite any binding case law in support of that proposition; and the cases they
do cite were decided before Rule 702 was amended effectively to preclude the
admission of proffered expert testimony unless the proponent of the testimony
demonstrates by a preponderance of the evidence that the proffered expert opinions
are based on sufficient facts and data and are the product of reliable principles and
methods. Fed. R. Evid. 702 advisory committee’s note to 2023 amendment.
Plaintiffs also insist that “experts in the field routinely rely on these kinds of
dissolution profiles to assess dissolution results and develop generic drug
products.” D.I. 717 at 14. But the only support they offer for this assertion is
Dr. Fix’s expert reports.
Defendants say that the challenged opinions in paragraph 164 are not based
on sufficient facts or data because there are no “clear overlaps” of standard
deviations in the 300 mg tablet chart and, to the extent there are clear overlaps in
the 50 mg tablet chart, that single chart provides an insufficient basis for Dr. Fix to
conclude anything about other tablet strengths. D.I. 644 at 3-5. Plaintiffs counter,
again relying on Dr. Fix’s expert reports, that “[i]t is routine within the industry,
and reliable, to conduct a ‘bracketing study’ .. . on higher and lower dosage
strengths, and then infer results in strengths in between.” D.I. 717 at 17.
Suffice it to say, I have no expertise in the pharmaceutical industry, drug
dissolution rates, or statistics. For that reason, I am not in a position to assess the
merits of the factual assertions made by the attorneys in the parties’ briefing and at
the February 6 oral argument that underly, and must be resolved to decide, the
pending motion.
Accordingly, I will have Dr. Fix testify about his relevant experience and
expertise at trial before making a determination about whether he will be permitted
to offer testimony about the opinions in paragraph 164 of his Reply Report. See
29 Fed. Prac. & Proc. Evid. § 6264.3 (2d ed.) (explaining that a court may “hear
qualification evidence before permitting the witness to give opinion testimony”
and that such a hearing “may take place either in the presence or absence of the
jury, at the discretion of the court”). The parties shall be prepared to address at the
Pretrial Conference whether that testimony should be in the presence or absence of
the jury.
NOW THEREFORE, at Wilmington on this Thirty-first day of March in
2025, itis HEREBY ORDERED that Defendants’ Motion to Exclude Dr. Fix’s
Analysis of Certain Dissolution Data (Daubert Motion No. 3) (D.I. 643) is
DEFERRED until trial.
CHIEF JUDGE