Loreto et al v. AbbVie, Inc. et al
Filing
49
MDL CASE MANAGEMENT ORDER NO. 193 (Order on AbbVie's motion for summary judgment and motion to exclude testimony of Dr. Joshua Sharlin and Dr. Hossein Ardehali in Loreto v. AbbVie Inc., No. 16 C 2561), signed by the Honorable Matthew F. Kennelly on 2/7/2023. (mk)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
In re Testosterone Replacement
Therapy Products Liability Litigation
(This document applies to
Loreto v. AbbVie Inc.,
Case No. 16 C 2561)
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Case No. 14 C 1748
MDL No. 2545
CASE MANAGEMENT ORDER NO. 193
(Order on AbbVie's motion for summary
judgment and motion to exclude testimony
of Dr. Joshua Sharlin and Dr. Hossein Ardehali
in Loreto v. AbbVie Inc., No. 16 C 2561)
MATTHEW F. KENNELLY, District Judge:
Plaintiffs in this multidistrict litigation (MDL) proceeding allege that they suffered
either arterial cardiovascular injuries or injuries related to blood clots in the veins
(venous thromboembolisms) as a result of taking prescription testosterone replacement
therapy (TRT) drugs. Defendants AbbVie Inc., AbbVie Products LLC, Abbott
Laboratories, Inc., and Unimed Pharmaceuticals, Inc (collectively, AbbVie) manufacture
AndroGel, one of the TRT products at issue in this litigation. Michael Loreto alleges that
his use of AndroGel caused him to suffer a heart attack in February 2014. He asserts
claims against AbbVie for strict liability, negligence, breach of warranty, fraud, consumer
protection, and punitive damages, as well as other claims. His wife, plaintiff Patricia
Loreto, has also asserted a claim for loss of consortium.
AbbVie has moved for summary judgment on all of Loreto's claims. For the
following reasons, the Court grants AbbVie's motion for summary judgment on the
negligence, implied warranty, fraud, negligent misrepresentation, unjust enrichment,
consumer protection, and punitive damages claims but otherwise denies the motion.
Background
A.
Factual background
The Court assumes familiarity with the background as set out in its prior case
management orders and therefore discusses only those details uniquely relevant to the
plaintiffs' claims. The Court recounts the following facts from the parties' Local Rule
56.1 statements, exhibits, and summary judgment briefing. The facts are undisputed
except where otherwise stated.
Loreto is a citizen of New Jersey. He began using AndroGel in March 2012 after
his family physician, Dr. James Agresti, II, prescribed it to treat low libido. Loreto saw
Dr. Agresti, II regularly from 1984 until 2013, when he began seeing Dr. James Agresti,
III. During his April 2021 deposition, Loreto testified that he has seen Dr. Agresti, III for
annual physical checkups since 2013. He also stated that he used AndroGel daily from
March 2012 until February 2014.
On January 31, 2014, the Food and Drug Administration (FDA) issued a "Safety
Announcement" stating that it was investigating the risk of cardiovascular injury in men
using TRT products like AndroGel. Less than a month later, on February 26, 2014,
Loreto suffered a heart attack. Loreto stopped using AndroGel after his heart attack
and brought this suit in February 2016 in the District of New Jersey.
B.
Experts
In support of his case, Loreto offers the reports and testimony of two experts: Dr.
Joshua Sharlin and Dr. Hossein Ardehali.
Dr. Sharlin, Loreto's regulatory expert, states in his report that he believes
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AbbVie should have warned Loreto or his doctors of the cardiovascular risks of
AndroGel before Loreto's 2014 injury. Dr. Sharlin testified that he relied on Dr.
Ardehali's medical conclusions on causation in making his regulatory conclusions. Dr.
Sharlin also testified that he believes AbbVie failed to properly analyze the adverse
events in the FDA's Adverse Event Reporting System (FAERS).
FAERS contains all the reports on adverse events—such as heart attacks—that
the FDA receives concerning various medications, including TRT drugs like AndroGel.
Dr. Sharlin stated that he believed AbbVie's safety analysis undercounted the number of
heart attack-related adverse event reports because it only investigated AndroGelrelated adverse events reports in FAERS, whereas Dr. Sharlin's analysis also
accounted for adverse event reports associated with other TRT drugs. During his
deposition, Dr. Sharlin admitted that FAERS contains duplicate reports and
underreports the total number of adverse events, and he stated that he did not check
whether the data he used contained any duplicates. He also testified that confirming his
data would require AbbVie or a third party to examine the "Primary ID" numbers of the
adverse event reports he analyzed, but he did not list those ID numbers in his report.
Dr. Ardehali, Loreto's causation expert, states in his reports that he believes
Loreto would not have suffered a heart attack if he had not taken AndroGel. Dr.
Ardehali submitted a general report in the MDL in October 2016 and prepared a casespecific report regarding Loreto in February 2021. In November 2021 the Court ordered
Loreto to submit any supplemental expert reports by March 25, 2022. In January 2022
the Court ordered the parties in this case and a few others that remained pending to
participate in mediation. After the mediation process concluded in June 2022, the Court
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extended the deadline for completing non-duplicative fact and expert discovery to
August 17, 2022. Loreto did not submit any supplemental reports before March 25,
2022, but he served three supplemental reports prepared by Dr. Ardehali on AbbVie on
August 17—one day before Dr. Ardehali's deposition on August 18. Two of the
supplemental reports are nearly identical to reports that were previously served on
AbbVie in other litigation, and the third supplemental report is specific to Loreto's
medical condition.
Discussion
In multidistrict litigation, procedural matters are governed by the law of the
transferee jurisdiction, in this case the Seventh Circuit. See, e.g., In re Pradaxa
(Dabigatran Etexilate Prods. Liab. Litig.), No. 3:12-md-02385-DRH-SCW, 2013 WL
656822, at *2 (S.D. Ill. Feb 22, 2013); In re Darvocet, Darvon & Propoxyphene Prods.
Liab. Litig., 889 F. Supp. 2d 931, 936 n.7 (E.D. Ky. 2012); Various Plaintiffs v. Various
Defendants (Oil Field Cases), 673 F. Supp. 2d 358, 362 (E.D. Pa. 2009). A party is
entitled to summary judgment if it shows that there is no genuine issue of material fact
and that it is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a). There is a
genuine issue of material fact, and summary judgment is precluded, "if the evidence is
such that a reasonable jury could return a verdict for the nonmoving party." Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). In ruling on a motion for summary
judgment, a court examines the record in the light most favorable to the non-moving
party and draws all reasonable inferences in that party's favor. Id. at 255; see also
Parker v. Four Seasons Hotels, Ltd., 845 F.3d 807, 812 (7th Cir. 2017).
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A.
Failure to warn
The parties agree that substantively, New Jersey law governs most of Loreto's
claims. New Jersey's Product Liability Act (PLA) "imposes strict liability if a product
manufacturer or seller has failed to provide adequate warnings concerning the dangers
posed by a product's use." Hrymoc v. Ethicon, Inc., 467 N.J. Super. 42, 84, 249 A.3d
191, 217 (App. Div. 2021) (citing New Jersey Stat. Ann. § 2A:58C-2(b)). Because New
Jersey has adopted the learned intermediary doctrine, "a pharmaceutical manufacturer
generally discharges its duty to warn the ultimate user of prescription drugs by
supplying physicians with information about the drug's dangerous propensities." Perez
v. Wyeth Labs. Inc., 161 N.J. 1, 10, 734 A.2d 1245, 1250 (1999) (quoting Niemiera by
Niemiera v. Schneider, 114 N.J. 550, 559, 555 A.2d 1112, 1117 (1989)).
"A plaintiff must prove that the lack of a warning was a proximate cause of the
harm," and "[i]t suffices if the proximate cause is a 'substantial contributing factor to the
harm suffered.'" Hrymoc, 467 N.J. Super. at 85, 249 A.3d at 217 (citing Perez, 161 N.J.
at 27, 734 A.2d at 1261). The New Jersey Supreme Court has recognized, however,
that "in a failure to warn case, establishing that the absence of a warning was a
substantial factor in the alleged harm to have resulted from exposure to the product
itself is particularly difficult." Coffman v. Keene Corp., 133 N.J. 581, 600, 628 A.2d 710,
719 (1993) (internal citation and quotation marks omitted). The court in Coffman
therefore adopted the heeding presumption, agreeing with the Appellate Division's
holding that "if a seller or manufacturer is entitled to a presumption that an adequate
warning will be read and heeded, plaintiff should be entitled to the same presumption
when no warning is given." Id. at 596, 628 A.2d at 717 (internal citation and quotation
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marks omitted) (emphasis added). Once the heeding presumption applies, "the burden
of production on the issue of proximate cause shifts to the defendant to come forward
with rebuttal evidence." Sharpe v. Bestop, Inc., 314 N.J. Super. 54, 68, 713 A.2d 1079,
1086 (App. Div. 1998). "[I]f [the] defendant presents sufficient evidence to rebut the
presumption, . . . the presumption disappears and the plaintiff, consistent with his
original burden of persuasion, must prove by a preponderance of the evidence that the
failure to warn was a proximate cause of his injury." Id. at 67, 713 A.2d at 1086.
In this case, it is undisputed that AbbVie itself did not warn Loreto or either of the
Dr. Agrestis of the cardiovascular risks of AndroGel before Loreto's heart attack. Loreto
can therefore rely on the heeding presumption to establish causation even though he
was not able to depose his prescribing physicians, as "plaintiffs should be entitled to the
[] presumption when no warning is given" and the presumption is "primarily applicable in
circumstances in which plaintiff lacks the ability to prove by direct evidence that a proper
warning, if given, would have been heeded." Coffman, 133 N.J. at 596, 628 A.2d at 717
(emphasis added); McDarby v. Merck & Co., 401 N.J. Super. 10, 82, 949 A.2d 223, 268
(App. Div. 2008). 1 AbbVie relies largely on a nonprecedential decision to argue
otherwise, but that case is inapplicable because it concerned "a pharmaceutical learned
Although AbbVie argues that Loreto could have deposed either of the Dr. Agrestis and
chose not to, it does not dispute plaintiffs' counsel's account of both parties' efforts to
depose the doctors. Rather, it contends that because Loreto testified that he has seen
Dr. Agresti, III regularly for medical purposes since 2013, he did not lack the ability to
secure Dr. Agresti, III's testimony or affidavit. But Loreto's deposition occurred in April
2021—before the parties attempted to contact and subpoena either Dr. Agresti—and
nothing in the record indicates that either party has been able to contact the doctors
since then. Because the Court must draw all reasonable inferences in favor of Loreto
as the non-moving party, it declines to infer that Loreto had the ability to provide direct
evidence from his prescribing physicians and decided not to do so.
1
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intermediary case where a manufacturer provided a warning and its adequacy remains
in issue[.]" In re Accutane(r) Litig., No. 271, 2016 WL 5958374, at *11 (Law. Div. Oct.
12, 2016) (emphasis added). Because AbbVie provided no such warning in this case,
the heeding presumption applies and "serves to lighten [his] burden of proof concerning
proximate causation." Coffman, 133 N.J. at 600, 628 A.2d at 719.
AbbVie contends that even if the heeding presumption applies, a court cannot
presume that a prescribing physician would not have prescribed the drug. That is not
the law. When the heeding presumption applies because a drug manufacturer failed to
provide a warning, New Jersey courts have presumed that a physician would not have
prescribed the drug had there been an adequate warning. See, e.g., McDarby, 401 N.J.
Super. at 81–82, 949 A.2d at 268 (rejecting defendant's argument that "one cannot
'presume' that additional risk information would lead a prescribing physician to avoid the
drug" because "[r]ecognition of that circumstance is incorporated into the generally
rebuttable nature of the heeding presumption"); Baker v. APP Pharms. LLP, No. 09 C
5725, 2012 WL 3598841, at *8 (D.N.J. Aug. 21, 2012) ("A heeding presumption allows
one to presume that the plaintiff's physician would not have prescribed the drug to the
plaintiff if there had been an adequate warning; in other words, the plaintiff's physician
would have heeded the adequate warning.") (citing McDarby, 401 N.J. Super. at 81, 949
A.2d at 267). The Court therefore presumes for purposes of the present case that
Loreto's prescribing physician "would have followed an adequate warning had one been
provided" and would not have prescribed AndroGel. The burden therefore shifts to
AbbVie to rebut the heeding presumption by "produc[ing] evidence that such a warning
would not have been heeded." Coffman, 133 N.J. at 603, 628 A.2d at 720.
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AbbVie has not met this burden via its motion for summary judgment. It cites to
no evidence suggesting that either of the Dr. Agrestis would have prescribed AndroGel
to Loreto even if AbbVie had warned them of the cardiovascular risks. Instead, AbbVie
argues that Loreto must show that he or his physicians had not received the FDA's 2014
safety announcement before his heart attack. Yet the basis of Loreto's claim is that
AbbVie—not the FDA—failed to warn of the cardiovascular risks of AndroGel, and
AbbVie provides no legal support for its assumption that an FDA statement is equivalent
to a warning from a drug manufacturer for purposes of a failure to warn claim.
Had AbbVie shown that either of the Dr. Agrestis had "independent knowledge of
the risks" of AndroGel because of the FDA's announcement, then there would be an
intervening cause that would preclude Loreto from establishing causation. Hrymoc, 467
N.J. Super. at 89, 249 A.3d at 219–20. But nothing in the record suggests that Loreto's
prescribing physicians received the announcement or were aware of its contents before
Loreto's heart attack, and AbbVie fails to cite any legal authority indicating that a court
may assume that physicians are aware of all FDA announcements. 2 Rather, it is "the
manufacturer's burden to prove an intervening superseding cause or another sole
proximate cause of the accident," and any evidence of an intervening cause "must be
clear and unequivocal." Navarro v. George Koch & Sons, Inc., 211 N.J. Super. 558,
AbbVie cites to a district court decision that stated "[e]ven an express warning from a
drug company, which, of course, was present here, that company will not be liable if the
physician had sufficient knowledge from other sources." Spychala v. G.D. Searle & Co.,
705 F. Supp. 1024, 1032 (D.N.J. 1988) (emphasis added). AbbVie has not shown
however, that Loreto's physicians had any knowledge of the cardiovascular risks of
AndroGel from other sources. To the extent that AbbVie is asking the Court to infer that
Loreto's doctors knew of the FDA announcement, the Court cannot do so because at
this stage it must draw all reasonable inferences in favor of Loreto, the non-moving
party.
2
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573, 512 A.2d 507, 515 (App. Div. 1986) (emphasis added); Hrymoc, 467 N.J. Super. at
89, 249 A.3d at 219–20. AbbVie has provided no such evidence at all. Because
AbbVie is unable to satisfy its burden of proof and rebut the heeding presumption, the
Court concludes that a reasonable jury could find that Loreto has established the
causation element of his failure to warn claim.
AbbVie also argues that Loreto's failure to warn claim is preempted because it
could not have provided a stronger warning, but this argument is unpersuasive. AbbVie
contends that the preemption analysis is different in this case because Loreto's injury
occurred after the FDA's January 2014 safety announcement, citing to the Court's prior
opinion that rejected AbbVie's argument that "communications from the FDA in 2014
further informed doctors about a possible increase in cardiovascular risk" because
"each of the bellwether plaintiffs bringing claims based on cardiovascular risk suffered
an injury prior to 2014." In re Testosterone Replacement Therapy Products Liability
Litig., No. 14 C 1748, MDL No. 2545, 2017 WL 1836435, at *16 (N.D Ill. May 8, 2017)
(CMO 47). Yet because AbbVie provides no evidence that Loreto's physicians were
aware of the FDA's announcement, the warning that could have been strengthened is
not the announcement but AndroGel's label at the time of Loreto's injury. The
preemption analysis is therefore no different for Loreto than it was for the earlier
bellwether plaintiffs, as AbbVie does not assert that it made changes to AndroGel's label
between the bellwether plaintiffs' injuries and Loreto's February 2014 heart attack. The
Court has considered and rejected AbbVie's arguments that the bellwether plaintiffs'
failure to warn claims were preempted and that AndroGel's label at the time of the
bellwether plaintiffs' injuries was adequate as a matter of law. Id. at *7–11, *15–16.
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Because AbbVie's preemption arguments are all based on the incorrect assumption that
it only needed to provide a greater warning than the FDA's announcement, the Court
has no reason to revisit its prior ruling on this issue.
Consequently, the Court denies AbbVie's motion for summary judgment on
Loreto's failure to warn claim. 3
B.
Design defect
AbbVie also contends that Loreto's design defect claims are preempted, relying
on Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015)
and a prior decision by this Court in this MDL. See CMO 47, 2017 WL 1836435, at *19–
21. Although the Court analyzed Yates in granting summary judgment on the
bellwether plaintiffs' negligent design defect claims, in that same decision the Court also
held that strict liability design defect claims are not preempted in states that have
adopted comment (k) to section 402(A) of the Restatement (Second) of Torts. Id. New
Jersey has adopted comment (k). See Feldman v. Lederle Labs., Inc., 97 N.J. 429,
447, 479 A.2d 374, 383 (1984) (“Moreover, even if a prescription drug were unavoidably
unsafe, the comment k immunity would not eliminate strict liability for failure to provide a
proper warning.”). The Court has previously found that "a genuine dispute exists
regarding whether [AbbVie] provided adequate warnings," CMO 47, 2017 WL 1836435,
at *19, and AbbVie has presented no basis to conclude otherwise in this case. For this
reason, the Court denies AbbVie's motion for summary judgment on Loreto's strict
The parties also dispute whether AbbVie's alleged off-label promotion of AndroGel
negates the impact of the FDA's safety announcement. Because AbbVie has failed to
produce any evidence showing that Loreto's prescribing physicians were aware of the
FDA announcement, the Court need not reach this question for purposes of the motion
for summary judgment on the failure to warn claim.
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liability design defect claim.
The Court next addresses the negligent design claim. Loreto argues that the
Court's rationale for granting judgment on the bellwether plaintiffs' negligent design
defect claim does not apply to his case. The Court previously granted summary
judgment because it concluded that Yates foreclosed any design defect claims based
on alternative product designs and the bellwether plaintiffs "cite[d] no case law which
supports their contention that they can bring a negligent design defect claim without
demonstrating the existence of a feasible alternative design." CMO 47, 2017 WL
1836435, at *20. Loreto contends that New Jersey law does not require proof of a
feasible alternative design because it applies a "risk-utility analysis" that "may justify a
conclusion that even though no alternative design existed which would have made a
product safer, the product is 'so dangerous and of such little use that under the riskutility analysis [the] manufacturer [should] bear the cost of liability to others.'" Truchan
v. Nissan Motor Corp., 316 N.J. Super. 554, 563–64, 720 A.2d 981, 986 (App. Div.
1998) (quoting Smith v. Keller Ladder Co., 275 N.J. Super. 280, 283-84, 645 A.2d 1269
(App. Div. 1994)). AbbVie correctly points out, however, that the Supreme Court
rejected a similar risk-utility approach under New Hampshire law—which also held that
"a product is defective if the magnitude of the danger outweighs the utility of the
product"—because it amounted to a "'stop-selling' rationale" that was "incompatible with
[the Supreme Court]'s pre-emption jurisprudence." Mut. Pharm. Co. v. Bartlett, 570
U.S. 472, 483, 488 (2013) (internal citation and quotation marks omitted). Loreto
therefore cannot rely on Truchan and the risk-utility analysis to support his negligent
design defect claim. The Court grants AbbVie's motion for summary judgment on this
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point. 4
C.
Other claims
1.
Negligence, implied warranty, unjust enrichment, fraud negligent
misrepresentation, consumer protection
The parties agree that Loreto's negligence, implied warranty, and unjust
enrichment claims are barred by the New Jersey Product Liability Act (PLA), but they
dispute whether the statute also subsumes his fraud, negligent misrepresentation, and
consumer protection claims. Loreto argues that although the Court held in a prior case
management order that the PLA barred all of the above claims, In re Testosterone
Replacement Therapy Products Liability Litig., No. 14 C 1748, 2018 WL 4030586, at *5
(N.D Ill. Aug. 23, 2018) (CMO 132), that order did not address AbbVie’s off-label
promotion of AndroGel specifically and the condition “low testosterone” more generally.
Yet even if Loreto’s claims involve advertising by AbbVie that went beyond
AndroGel itself, it is still true that “AbbVie's advertising cannot have caused [the
plaintiff]’s injury unless AndroGel did.” CMO 132, 2018 WL 4030586, at *5. Loreto
alleges that he suffered a heart attack because he took AndroGel while he or his
prescribing physicians were unaware of its cardiovascular risks. Unlike the plaintiff in
Knipe v. SmithKline Beecham, 583 F. Supp. 2d 602 (E.D. Pa. 2008), Loreto is alleging
both that AndroGel was "not reasonably fit for its intended use because it failed to
contain adequate warnings or instructions" and that AndroGel itself caused his injury.
Id. at 618. Consequently, the Court follows CMO 132 and holds that all of Loreto's
As discussed below, the parties agree that Loreto's negligence claim is subsumed by
the New Jersey Product Liability Act. See section C.1, infra. Loreto's design defect
claim can therefore only be based on strict liability.
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claims are barred by the PLA except "failure to warn; design defect; breach of express
warranty; and loss of consortium." CMO 132, 2018 WL 4030586, at *5.
2.
Punitive damages
Next is the question of the availability of punitive damages, which turns on which
state's law governs that point. The parties agree that New Jersey's "governmentalinterest" choice of law analysis applies, but Loreto contends that Illinois law regarding
punitive damages should apply under that analysis. Yet in a case involving a Michigan
plaintiff suing a New Jersey drug manufacturer, the New Jersey Supreme Court
determined that Michigan law applied under the governmental-interest analysis because
"[t]o allow a life-long Michigan resident who received an FDA-approved drug in Michigan
and alleges injuries sustained in Michigan to by-pass his own state's law and obtain
compensation for his injuries in this State's courts completely undercuts Michigan's
interests" and "where the . . . challenged drug was approved by the FDA and suit was
brought by an out-of-state plaintiff who has no cause of action in his home state, this
State's interest in ensuring that our corporations are deterred from producing unsafe
products . . . is not paramount." Rowe v. Hoffman-La Roche, Inc., 189 N.J. 615, 629,
917 A.2d 767, 776 (2007). Loreto is in the same position as the plaintiff in Rowe.
Specifically, he is a lifelong New Jersey resident who took AndroGel in New Jersey and
is suing an Illinois corporation. The Court therefore applies New Jersey law regarding
punitive damages because under Rowe New Jersey has a stronger governmental
interest than Illinois.
AbbVie is correct that punitive damages are unavailable under New Jersey law.
The PLA "bar[s] punitive damages if the drug has received FDA approval, but grant[s]
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an exception 'where the product manufacturer knowingly withheld or misrepresented
information required to be submitted under the agency's regulations, which information
was material and relevant to the harm in question.'" McDarby, 401 N.J. Super. at 91–
92, 949 A.2d at 274 (quoting N.J. Stat. Ann. § 2A:58C–5c). The Appellate Division has
expressly held, however, that “[b]ecause the punitive damages provisions of [the PLA]
impinge upon federal statute and regulation . . . . [w]e thus find [the plaintiff]’s punitive
damage claim to have been preempted and reverse that award.” McDarby, 401 N.J.
Super. at 94, 949 A.2d at 276. Loreto cites to only one case, In re Accutane Litigation,
235 N.J. 229, 194 A.3d 503 (2018), that discusses McDarby in other contexts but does
not contradict its holding that the punitive damages exception provision is preempted.
The Court concludes that McDarby governs here and therefore grants summary
judgment in favor of AbbVie on the question of availability of punitive damages.
D.
Experts
Federal Rule of Evidence 702 governs admissibility of expert testimony, and the
district court acts as a gatekeeper in determining whether proposed expert testimony
meets Rule 702's standards. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597
(1993). The district court's gatekeeping role involves three determinations: (1) whether
the expert witness is qualified, (2) whether the expert's methodology is scientifically
reliable, and (3) whether the testimony will assist the trier of fact to understand the
evidence or determine a fact in issue. See Myers v. Ill. Central R.R. Co., 629 F.3d 639,
644 (7th Cir. 2010).
1.
Dr. Sharlin
AbbVie moves to exclude Dr. Sharlin's report, arguing that he did not review all of
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the published studies on the cardiovascular risks of TRT. AbbVie concedes that the
Court has admitted a similar opinion from another doctor because "[i]t was appropriate
for [that doctor], in offering these opinions, to rely on the testimony of plaintiffs'
causation experts regarding what the studies showed and the risks posed by TRT." In
re Testosterone Replacement Therapy Products Liability Litig., No. 14 C 1748, 2017 WL
1836443, at *14 (N.D Ill. May 8, 2017). AbbVie argues that this case is different,
however, because Dr. Sharlin did not expressly state during his deposition that he relied
on Dr. Ardehali's opinion about when the published studies suggested a link between
TRTs and cardiovascular injuries, but instead testified that he will rely on Dr. Ardehali’s
conclusions as to Loreto’s case specifically. Yet Dr. Sharlin (1) answered "no" when he
was asked if he was going to testify regarding medical causation, (2) stated that he had
"the conclusions about what condition [Loreto and other individual plaintiffs] had from
Dr. Ardehali," and "based on Dr. Ardehali’s medical conclusions, then I can make a
regulatory conclusion." Pls.' Opp. to Mot. for Summ. J., Ex J, Sharlin Dep. Tr. ("Sharlin
Dep.") at 49:21–24, 49:5–6; 47:22–24. AbbVie seems to argue that Dr. Sharlin will only
rely on Dr. Ardehali’s analysis for the plaintiffs’ individual medical condition and nothing
else, but given that Dr. Sharlin repeatedly testified that he would rely on Dr. Ardehali to
prove "causation" the Court sees no basis to interpret Dr. Sharlin's statements in such a
narrow manner and exclude his testimony on this basis.
AbbVie also contends that Dr. Sharlin's analysis of the adverse event reports in
in the FDA's Adverse Event Reporting System (FAERS) is not reliable. Dr. Sharlin
analyzed the adverse event reports to conclude that AbbVie did not investigate all the
relevant data, as it considered adverse events related to AndroGel but not those related
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to other TRT products. AbbVie responds that Dr. Sharlin's analysis is inaccurate and
not verifiable, pointing to Dr. Sharlin's testimony that (1) he did not check the data he
used for duplicates even though he was aware that FAERS can contain duplicate data,
and (2) he could have listed the ID numbers of the adverse event reports he examined
so AbbVie could recreate his analysis but did not do so.
Yet both these alleged errors concern the verifiability of Dr. Sharlin’s data rather
than his methodology, and "[r]eliability . . . is primarily a question of the validity of the
methodology employed by an expert, not the quality of the data used in applying the
methodology or the conclusions produced." Manpower, Inc. v. Ins. Co. of Pa., 732 F.3d
796, 806 (7th Cir. 2013). Courts are not to "unduly scrutinize[] the quality of the expert's
data and conclusions rather than the reliability of the methodology the expert
employed," and when there is "a rational connection between the data and the
opinion—as there was here—an expert's reliance on faulty information is a matter to be
explored on cross-examination; it does not go to admissibility." Id. at 806, 809
(emphasis added). Even if Dr. Sharlin’s data is inaccurate or difficult to confirm, there is
a rational connection between the adverse events data and Dr. Sharlin's conclusion that
AbbVie did not sufficiently investigate the adverse events suggesting there were
cardiovascular risks to AndroGel. AbbVie's concerns with Dr. Sharlin's data thus go to
the weight of his testimony rather than its admissibility. The Court declines to exclude
Dr. Sharlin's testimony regarding his adverse event report analysis.
2.
Dr. Ardehali
AbbVie argues that the Court should exclude Dr. Ardehali's three supplemental
reports because Loreto did not serve them until August 17, 2022, about five months
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after the March 25, 2022 deadline and one day before Dr. Ardehali's deposition. "Rule
37(c)(1) states that expert testimony may not be presented at trial if the expert's report
was not disclosed to the other side within the deadline unless the party was justified in
missing the deadline or the untimeliness of the disclosure was harmless." Dura Auto.
Sys. of Ind. v. CTS Corp., 285 F.3d 609, 614 (7th Cir. 2002)
The Court finds that the delay was not justified. Loreto argues that the March 25
deadline for supplemental expert reports was expressly or impliedly understood to be
stayed, but in a status report after that deadline, the parties expressly requested an
extension of the discovery deadline from April 30 to May 20. There was no indication by
the Court (or, for that matter, by the parties in the report) that the supplemental expert
report deadline had been stayed, and Loreto did not request a further extension after
failing to submit his reports in question by May 20. Loreto also contends that Dr.
Ardehali’s supplemental reports depended on the data AbbVie produced on May 4,
2022, but he cites to nothing in the record that supports this assertion (nor would this
have prevented submission of a report by May 20). As a result, the Court concludes
that Loreto's nearly five-month delay in producing Dr. Ardehali's supplemental reports
was not justified.
The delay was also not harmless. Of Dr. Ardehali's three supplemental reports,
one explained his conclusions after reviewing Loreto's updated medical records. It is
undisputed that AbbVie first received this report the day before Dr. Ardehali's
deposition, and thus the delay cannot be harmless because it prejudiced AbbVie's
ability to prepare for the deposition. Loreto argues that the delay in serving the other
two reports was harmless because they were served on AbbVie in other litigation in
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New Mexico, but as AbbVie points out, it had no reason to believe that the information
in those reports would be introduced in this litigation. Even if the delay in serving those
two reports may have been less harmful than the delay of the Loreto-specific report, the
Court cannot conclude that serving them less than twenty-four hours before Dr.
Ardehali's deposition was harmless.
The Court therefore excludes testimony by Dr. Ardehali related to the contents of
his supplemental reports. Dr. Ardehali may, however, testify about the contents of his
October 2016 general report and his February 2021 case-specific report regarding
Loreto.
Conclusion
For the foregoing reasons, the Court grants AbbVie's motion for summary
judgment [dkt. no. 37] on Loreto's negligence, implied warranty, fraud, negligent
misrepresentation, unjust enrichment, consumer protection, and punitive damages
claims. The Court denies AbbVie's motion on Loreto's other claims, including his strict
liability and breach of express warranty claims and Patricia Loreto's loss of consortium
claim. The Court also grants AbbVie's motion to exclude Dr. Ardehali's testimony as it
relates to his supplemental reports but denies AbbVie's motion to exclude Dr. Sharlin's
testimony.
________________________________
MATTHEW F. KENNELLY
United States District Judge
Date: February 7, 2023
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