HUTT et al v. BRISTOL-MYERS SQUIBB COMPANY et al
ORDER - Defendants' 28 Motion for Summary Judgment is GRANTED IN PART and DENIED IN PART, for the reasons stated in this Order. With the entry of this Order, all pretrial proceedings in this direct-filed case are complete and the case is ready for trial. By separate order, the case will be transferred to the District of Massachusetts for trial. Signed by JUDGE M CASEY RODGERS on 1/06/2021. (tvj)
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UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF FLORIDA
IN RE: ABILIFY (ARIPIPRAZOLE)
PRODUCTS LIABILITY LITIGATION
This Document Relates to:
Case No. 3:16md2734
Judge M. Casey Rodgers
Magistrate Judge Gary Jones
Plaintiff Samantha Hutt, and her parents Ellen and Jeffrey Hutt, brought this
action against Defendants, the makers and marketers of Abilify. Plaintiffs allege
that Samantha Hutt developed compulsive behaviors after taking Abilify as
prescribed, including compulsive gambling, binge eating and hypersexuality.
Plaintiffs assert nine claims under Massachusetts law and Defendants have moved
for summary judgment on all of them.1 In their briefing, Plaintiffs failed to address
Defendants’ arguments regarding their claims for strict liability, breach of express
warranty, negligence per se, and fraudulent concealment. Consequently, those
claims are considered abandoned and summary judgment will be entered in
Defendants’ favor. See Jones v. Bank of Am., N.A., 564 F. App’x 432, 434 (11th
The Hutts direct-filed their complaint in the MDL and assert claims for strict liability,
breach of express and implied warranty, negligence, negligence per se, negligent
misrepresentation, violation of consumer protection laws, fraudulent concealment and loss of
consortium. See ECF No. 1 at 5. The Court agrees with the parties that Massachusetts substantive
law governs their claims.
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Cir. 2014) (“[W]hen a party fails to respond to an argument or otherwise address a
claim [in response to a motion for summary judgment], the Court deems such
argument or claim abandoned.”). As to the remaining claims, which are all premised
on a failure-to-warn theory, the Court finds there exists a genuine dispute of material
fact on the sole issued raised by Defendants—whether Plaintiffs’ claims are barred
by the learned intermediary doctrine.2 Therefore, Defendants’ motion for summary
judgment will be denied as to those claims.
Ordinarily, a manufacturer of a product which it “knows or should know is
dangerous” has a duty to warn foreseeable users of the dangers associated with using
the product. MacDonald v. Ortho Pharm. Corp., 394 Mass. 131, 135 (1985); see
also Laaperi v. Sears, Roebuck & Co., Inc., 787 F.2d 726, 729 (1st Cir. 1986).
Massachusetts law carves out a “middleman” exception to this rule that allows
pharmaceutical manufacturers to discharge their duty to warn consumers by
adequately informing prescribing physicians—as opposed to patients directly—of
any risks associated with their prescription drug products.3 Garside v. Osco Drug,
Inc., 976 F.2d 77, 80 (1st Cir. 1992). Where a manufacturer breaches the duty to
In Plaintiffs’ brief, they request that Rule 11 sanctions be imposed against Defendants for
filing the instant summary judgment motion. See ECF No. 33 at 21-25. Because Plaintiffs did not
comply with the procedural prerequisites for seeking sanctions, their request is denied.
“The rationale underlying [this] rule is that the prescribing physician, as the ‘learned
intermediary’ standing between the manufacturer and consumer/patient, is generally in the best
position to evaluate the potential risks and benefits of ingesting a certain drug and to advise the
patient accordingly.” Garside v. Osco Drug, Inc., 976 F.2d 77, 80 (1st Cir. 1992).
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warn a physician, however, it is directly liable to the patient. MacDonald, 394 Mass.
Massachusetts courts employ a burden-shifting framework in determining
whether a plaintiff can establish a prima facie case of failure-to-warn when a
defendant invokes the learned intermediary doctrine. Under this framework,
(1) the plaintiff carries the initial burden of producing sufficient
evidence that the defendant manufacturer failed to warn of a nonobvious risk about which the manufacturer knew or should have
known; (2) assuming the plaintiff raises a triable issue on this question,
a rebuttable presumption arises that the physician would have heeded
an adequate warning; (3) defendant must then come forward with
sufficient evidence to rebut that presumption; and (4) once the
presumption is rebutted, plaintiff must produce sufficient evidence to
create a triable issue on the question of causation.
Garside, 976 F.2d at 81 (internal marks omitted).
Here, for purposes of summary judgment, Defendants “assume[d] that
Plaintiffs can meet their initial burden of showing that the Abilify warning was
inadequate because it did not warn about compulsive behaviors while Samantha was
on the drug, and that a rebuttable presumption therefore arises that Dr. Wozniak[,
her physician,] would have heeded such a warning.” See ECF No. 28-20 at 20-21.
The Court will do the same. Additionally, the Court will assume without deciding
that Defendants can come forward with sufficient evidence to rebut that
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presumption. 4 Thus, the only question to be resolved is whether Plaintiffs produced
sufficient evidence to create a triable issue on causation. The Court finds that they
Briefly, Plaintiffs produced an email showing that Dr. Wozniak learned about
the association between Abilify and compulsive gambling, eating, shopping and
sexual activity from an FDA News Alert on May 3, 2016. See ECF No. 33-5. Dr.
Wozniak emailed the alert to Ellen Hutt within 15 minutes of receiving it, expressed
her belief that Samantha’s compulsivity problems were “Abilify-induced” and
apologized “for likely prolonging [Samantha’s] disability” by prescribing her the
drug and never suspecting that Abilify could be responsible for her “risky
behaviors.” See id. at 2. A jury could reasonably infer from Dr. Wozniak’s actual
response to the FDA’s warning—that is, recognizing that Samantha “likely” suffered
The Court has serious reservations about whether the evidence cited by Defendants is
sufficient to rebut the presumption, given Dr. Wozniak’s equivocation—offered in hindsight, years
after her Abilify prescribing decisions for Samantha—about what she would have done if she had
received an adequate warning. However, the Court need not definitively resolve that question
because Plaintiff has plainly come forward with sufficient evidence to create a triable fact on the
issue of causation. See Garside, 976 F.2d at 83, n.9 (finding based on Massachusetts failure-towarn jurisprudence that “the Massachusetts Supreme Judicial Court would likely be reluctant to
allow a physician’s pre-trial testimony about what s/he would have done had s/he been warned to
insulate a manufacturer from liability”); see also Doe v. Miles Lab., Inc., 927 F.2d 187, 195 n.32
(4th Cir. 1991) (applying Maryland law) (“Although [the physician] testified that she would have
administered the drug regardless of the AIDS risk, her hindsight opinion is not conclusive of what
she would have done had she been invested with all the pertinent facts regarding [the drug]. Thus,
the causation issue . . . presents a genuine issue of material fact.”); Williams v. Lederle Lab., 591
F. Supp. 381, 386 (S.D. Ohio 1984) (applying Ohio law) (“What [the physician might or might not
have done involves to some degree his credibility. Thus, we conclude that it is for the jury to
determine whether the presence of an adequate warning would have made no difference in [the
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dangerous side effects from Abilify and immediately communicating the warning to
Samantha’s mother—that she would have heeded an adequate warning about the
potential dangers of Abilify, if given at the time of her prescribing decisions for
Samantha. This reasonable inference is bolstered by evidence that Dr. Wozniak
changed Samantha’s treatment regimen numerous times before in response to risk
warnings on other prescription drug labels and/or when Samantha experienced
adverse labeled side effects from a drug, such that a jury could reasonably infer that
the doctor would have followed that same practice in response to warnings about
potential adverse side effects from Abilify. Contrary to Defendants’ assertion, Dr.
Wozniak’s deposition testimony that she cannot now say what she might or might
not have done years ago in the presence of an adequate Abilify warning does not
overcome the uncontroverted evidence supporting a conclusion that she would have
heeded any such warning. In short, the evidence is more than sufficient to create a
triable issue as to whether Defendants’ alleged failure to provide an adequate
warning was the proximate cause of Plaintiffs’ injuries. Therefore, Defendants are
not entitled to summary judgment on the claims premised on a failure-to-warn.
Defendants’ Motion for Summary Judgment, ECF No. 28, is
GRANTED IN PART and DENIED IN PART, as follows:
The motion is GRANTED with respect to Count I (strict
liability), Count II (breach of express warranty), Count V
(negligence per se), and Count VIII (fraudulent concealment).
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The motion is DENIED with respect to Count III (breach of
implied warranty), Count IV (negligence), Count VI (negligent
misrepresentation, Count VII (violation of Massachusetts
consumer protection laws, and Count IX (loss of consortium).
With the entry of this Order, all pretrial proceedings in this direct-filed
case are complete and the case is ready for trial. By separate order, the
case will be transferred to its proper venue, the District of
Massachusetts, for trial.
SO ORDERED, on this 6th day of January, 2020.
M. Casey Rodgers
M. CASEY RODGERS
UNITED STATES DISTRICT JUDGE
Case No. 3:17cv634/MCR/GRJ
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