Rowley et al v. AbbVie Inc et al
MDL CASE MANAGEMENT ORDER No. 123 (rulings on certain motions in limine in Rowley v. AbbVie Inc. et al., Case No. 15 C 2760), signed by the Honorable Matthew F. Kennelly on 5/28/2018. (mk)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
In re Testosterone Replacement
Therapy Products Liability Litigation
Coordinated Pretrial Proceedings
----------------------------------------------------This document applies to all cases
and to Rowley v. AbbVie, Inc. et al.,
Case No. 15 C 2760
Case No. 14 C 1748
MDL No. 2545
CASE MANAGEMENT ORDER No. 123
(rulings on certain motions in limine in
Rowley v. AbbVie Inc. et al., Case No. 15 C 2760)
MATTHEW F. KENNELLY, District Judge:
Robert Rowley was prescribed AndroGel, a testosterone replacement therapy
(TRT) drug, by physician assistant Teryl Hunsaker in April 2012. In April 2013, Rowley
was diagnosed with a deep vein thrombosis (DVT) in his left leg. He alleges that
AndroGel caused the DVT and has sued AbbVie, Inc. and Abbott Laboratories
(collectively AbbVie), which make and sell the drug.
Rowley's case is the fifth AbbVie "bellwether" case in this multidistrict litigation
proceeding to go to trial. In this order, the Court rules on certain of the parties' motions
in limine. At the final pretrial conference set for May 31, 2018, the Court will hear
argument on the remaining motions.
Evidence about off-label marketing
AbbVie contends that Rowley was prescribed AndroGel on-label and that, as a
result, evidence about off-label marketing is irrelevant and should be excluded. Rowley
contends that these marketing efforts affected PA Hunsaker's decision to prescribe the
drug and are therefore relevant. The Court will hear argument on this point at the final
Evidence of AbbVie's sales and profits from AndroGel
Rowley contends that evidence regarding the amount and growth of AbbVie's
sales and profits from AndroGel is admissible to show its motive to expand the market
for the drug beyond the allegedly narrow group of persons to whom the drug was
approved for sale by the Food and Drug Administration (FDA). AbbVie argues this
evidence is irrelevant because Rowley was prescribed the drug on-label. This motion is
interrelated with the previous one; the Court will hear argument on the point at the final
Causation opinions by Rowley's treating medical personnel
PA Teryl Hunsaker
AbbVie seeks to exclude opinion testimony regarding causation by PA Hunsaker,
another PA named Brent Pitcher, and Dr. Douglas Hyldahl, Rowley's primary care
physician. (Rowley has agreed not to offer opinion testimony by Dr. Daniel Sharp,
which AbbVie had also moved to exclude.)
It appears that after being diagnosed with a DVT in April 2013, Rowley continued
to take AndroGel. PA Hunsaker discontinued the prescription in June 2013, noting in
his records that he was doing so because "I do believe that [Rowley's] androgel is a
significant contributing factor to his development of dvt." AbbVie's attorneys questioned
Hunsaker about this in detail during his deposition, and he fully explained the basis for
the notation and his decision to discontinue the prescription. Because Hunsaker formed
this opinion during the course of his treatment of Rowley, no report under Federal Rule
of Civil Procedure 26(a)(2)(B) was required as a prerequisite for admission of his
testimony. See Meyers v. Nat'l R.R. Passenger Corp., 619 F.3d 729, 734-35 (7th Cir.
2010). And though Rowley appears not to have disclosed Hunsaker under Rule
26(a)(2)(A) as a witness who would present opinion testimony, the non-disclosure was
harmless because the opinion was disclosed in Hunsaker's treatment notes, and
AbbVie had a full and fair opportunity to question him about it during his deposition.
See Fed. R. Civ. P. 37(c)(1).
AbbVie also argues that Hunsaker's opinion is insufficiently supported and that,
as a PA, he is not qualified to render an opinion on causation. The Court will hear
argument on these points at the final pretrial conference.
PA Brent Pitcher
PA Brent Pitcher worked with Hunsaker. It appears from Pitcher's notes that he
related to Rowley a message from Hunsaker related to Hunsaker's view that AndroGel
was a significant contributing factor to Rowley's DVT. Assuming that Hunsaker's
opinion is admissible, testimony by Pitcher on this point would be unnecessarily
duplicative. The Court excludes it under Federal Rule of Evidence 403.
Dr. Douglas Hyldahl
Dr. Hyldahl, as indicated earlier, was Rowley's primary care physician. His notes
from June 2013 reflect that he agreed with the recommendation to stop Rowley's use of
AndroGel due to his DVT two months earlier. AbbVie's counsel questioned Dr. Hyldahl
about this during his deposition, and he stated that "[a]s a general rule, in both men and
women, we avoid hormone replacement in individuals who have deep vein thrombosis"
and that this is because "we would look at it as a possible contributing factor." He did
not conclude that AndroGel caused the DVT, "[o]nly that it might have been a
contributing factor." Pl.'s Resp. to Defs.' Mots. In Limine, Ex. V at 105-06. Contrary to
AbbVie's contention, Dr. Hyldahl does appear to have formed this conclusion during and
as a part of his care and treatment of Rowley, so as with PA Hunsaker, no report under
Rule 26(a)(2)(B) was required. And as with Hunsaker, any non-disclosure of the fact
that Dr. Hyldahl might render this opinion testimony was harmless, see Fed. R. Civ. P.
37(c)(1), because it was disclosed in his records and AbbVie had a full and fair
opportunity to question him about his during his deposition. At the final pretrial
conference, the Court will address AbbVie's contention that Dr. Hyldahl's testimony on
this point is not sufficiently supported to be admissible.
Marketing materials not seen by Rowley's prescribing physicians
AbbVie has moved to bar evidence of its marketing of AndroGel to PA Hunsaker
and Rowley. It relies on Rowley's testimony that he did not think he had ever seen an
ad for AndroGel before he started taking it and that he did not rely on such advertising.
AbbVie also relies on Hunsaker's testimony that he had prescribed AndroGel (to other
patients) before being visited by an AbbVie sales representative who pitched him on the
drug and that he could not recall whether the representative provided any information
about the drug's risks and benefits. But as Rowley contends, and as the Court has
ruled when this issue has been presented in previous bellwether trials, there is
circumstantial evidence that would permit a reasonable jury to find that in prescribing
AndroGel to Rowley, Hunsaker was influenced by the sales representative's efforts,
even if he does not now recall them.
The Court wishes to inquire further, however, regarding the purpose for which
Rowley proposes to introduce this evidence. If this is related to the question of off-label
marketing, it is likely that the admissibility of this evidence will rise or fall with the Court's
ruling on the admission of off-label marketing evidence. If, however, Rowley intends to
offer this on his claims of fraudulent or negligent misrepresentation, he will need to
articulate to the Court what (if anything) in the sales representative's marketing pitches
he contends was false or misleading. The Court will address this point with counsel at
the May 31 final pretrial conference.
Adverse event reports evidence
The Court denies AbbVie's motion to bar evidence of adverse event reports
(AERs). The Court has previously ruled that such evidence may be relied upon by an
expert to support a causation opinion, even if it is not the strongest form of causation
evidence that is available. And assuming for purposes of discussion that AERs are
hearsay, an expert may rely on otherwise inadmissible evidence if it is reasonably relied
upon by experts in the field, as the Court has previously ruled. Fed. R. Evid. 704. And
the Court again concludes, as it has in connection with past trials, that the probative
value of this evidence to the jury in weighing an expert's opinion substantially outweighs
any prejudicial effect it may have, enabling Rowley to disclose the contents of the
reports to the jury. Id.
The Court also notes that AERs regarding venous thromboembolic (VTE) events
are admissible as evidence of notice to AbbVie, a non-hearsay purpose. The Court is
unpersuaded by AbbVie's argument that to be admissible for this purpose, a particular
AER must involve a VTE event substantially similar to Rowley's—given, among other
things, the similarity of the mechanisms involved in various types of VTE events. See
Pl.'s Resp. to Defs.' Mots. In Limine at 20.
In limine rulings from prior trials
Rowley asks the Court to adopt in limine rulings made in connection with prior
trials. It's unclear the request is even needed; the Court's pretrial rulings apply
throughout the MDL unless otherwise noted at the time. In the Court's view, the onus is
on a party contending that a ruling should be changed or does not apply given particular
circumstances to seek reconsideration or a modification.
Several of the prior rulings identified by Rowley are fully applicable here,
specifically points 1a (communications with the FDA regarding unbranded advertising);
1b (the FDA's 1996 webpage regarding Androderm); 1d (expert testimony from AbbVie
corporate fact witnesses); 1e ("good company" conduct); 1f (circumstances surrounding
plaintiff's retention of counsel); 1h (commentary about litigation abuse, tort reform, or the
societal costs of litigation); 1i (emphasis on the plaintiff's state of residence); and 1j
(AbbVie's responsibility for the acts of its predecessor entities).
With regard to point 1c (the Court's instruction regarding responsibility for a
drug's label), AbbVie argues that the instruction given by the Court in prior trials runs
afoul of Utah law, which applies in Rowley's case. In addition, with regard to point 1g
(the plaintiff's use of other prescription drugs), AbbVie argues that Rowley's use of
certain medications is relevant for reasons applicable to this case. The Court will hear
argument on these points at the final pretrial conference.
Evidence / argument excluded by agreement
AbbVie has agreed not to present evidence or argument regarding Rowley's
religious affiliation or beliefs; the timing of disclosure during discovery of a second DVT
that Rowley had in 2016 or a sanction order relating to this; or the fact that AbbVie's trial
counsel examined Rowley's expert Dr. Rinder in an unrelated case. Both parties have
agreed not to reference the number of lawyers representing the other side. The Court
adopts the parties' agreements on these points.
Evidence off-label marketing
As indicated earlier, the Court will hear argument at the final pretrial conference
regarding the admissibility of evidence of off-label marketing by AbbVie.
IMS data that postdates Rowley's use of Androgel;
Dr. Khera's opinions regarding post-2015 TRT prescribing trends
The Court adopts its prior rulings precluding evidence of TRT prescriptions
postdating plaintiff's injury and testimony regarding prescribing trends after a post-injury
label change, for the reasons discussed when the Court made those rulings.
Cumulative expert testimony
AbbVie reports that it intends to call one of its two general causation witnesses,
Dr. Bierer or Dr. Marais, but not both. See Defs.' Resp. to Pl.'s Mots. In Limine at 15.
AbbVie should be prepared to advise the Court and defense counsel at the final pretrial
conference which of the two it intends to call. This will resolve the primary
cumulativeness issue that has been the subject of prior rulings by the Court. Any
additional issues regarding cumulativeness of defense expert testimony are to be
asserted by Rowley if and when it becomes appropriate to do so during trial.
MATTHEW F. KENNELLY
United States District Judge
Date: May 28, 2018
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