Trower v. Department of Correctional Mental Health Doctors et al
Filing
205
MEMORANDUM OPINION. Signed by Judge Richard G. Andrews on 4/11/2019. (nms)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
LAMAR A. TROWER,
Plaintiff,
Civil Action No. 1:16-cv-00135-RGA
V.
JANSSEN PHARMACEUTICALS, INC. ,
Defendant.
MEMORANDUM OPINION
Kelly E. Farnan, Christine D. Haynes (argued), Sara M. Metzler (argued), and Tyler E.
Cragg (argued), RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE.
Attorneys for Plaintiff.
Michael P. Kelly (argued), Daniel J. Brown, and Hayley J. Reese, McCARTER & ENGLISH,
LLP, Wilmington, DE; Heather C. Giordanella and Andrew P. Reeve, DRINKER BIDDLE &
REATH LLP, Philadelphia, PA.
Attorneys for Defendant.
AprilJL, 2019
Presently before me are Defendant' s Motion for Summary Judgment (D.I. 155),
Defendant's Motion to Preclude Expert Testimony of Brendan Carroll, M.D. (D.I. 158), and
Defendant's Motion to Exclude Certain Opinion Testimony of Dr. Mahyar Etminan (D.I. 161).
The Parties have fully briefed the issues. (D.I. 156, 159, 162, 177, 178, 179, 187, 189, 191). I
heard oral argument on March 7, 2019. For the reasons set out below, I will grant Defendant's
Motion for Summary Judgment and I will dismiss Defendant's Daubert motions as moot.
I.
BACKGROUND
Plaintiff suffers from a variety of serious mental illnesses. (D.I. 178 at 2). He has been
diagnosed with ADHD, conduct disorder, oppositional defiant disorder, generalized anxiety
disorder, major depressive disorder, PTSD, impulse control disorder, antisocial personality
disorder, mild mental retardation, bipolar disorder, and schizophrenia. (Id.). Doctors have
prescribed him Risperdal, 1 Haldol, Doxepin, Prozac, Depakote, Seroquel, Thorazine, Cylert,
Clonidine, Elavil, Lexapro, Mellaril, Trazadone and Vistaril to treat these conditions. (Id.) .
Plaintiff was prescribed Risperdal from February 2011 through June 2011; October 2011 through
February 2012; and August 2012 through August 2013. (Id.). Plaintiff allegedly discontinued
use of Risperdal in early 2014. (Id. at 3).
Risperdal is FDA-approved for treatment of schizophrenia and bipolar disorder. (D.I.
156 at 5 n.2). Defendant is the manufacturer of brand name Risperdal. (D.I. 178 at 4).
Risperidone is the generic name for Risperdal. (D.I. 156 at 5). Other drug manufacturers, such
as Zydus Pharmaceuticals (USA), Inc., manufacture risperidone. (Id.).
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I use the brand name "Risperdal" to refer to the drug Plaintiff took. This is not meant to
indicate whether Plaintiff took the brand name or a generic drug at any given time.
Gynecomastia is a potential side effect of risperidone. (D.I. 178 at 5-7). Increased levels
of prolactin may also be a side effect and is allegedly connected to an increased risk of
gynecomastia. (D.I. 162 at 8). Gynecomastia is the enlargement of the male breast gland due to
a hormonal imbalance. Prolactin is a hormone which enhances breast development and initiates
lactation in the human (typically female) body.
Plaintiff filed this lawsuit on March 4, 2016. (D.I. 1). He pied seven claims against
Defendant based on its marketing and sale of Risperdal: negligence (Count I), negligent
misrepresentation (Count II), breach of warranty (Count III), breach of the implied warranty of
merchantability (Count IV), breach of the implied warranty of fitness for a particular purpose
(Count V), breach of express warranty (Count VI), and fraud by concealment (Count VII). (D.I.
29 at 4-7). He alleges that because of Defendant's conduct, he developed gynecomastia, breast
pain, and discomfort, including hard nipples. (D.I. 156 at 6).
Defendant filed the present motions on October 12, 2018 . It sought summary judgment
on each count of the second amended complaint. (D.I. 29). In response to Defendant's summary
judgment motion, Plaintiff voluntarily withdrew Counts III-VIL (D.I. 178 at 1 n.1 ). Thus, the
only Counts remaining are negligence and negligent misrepresentation.
II.
LEGAL ST A OARD
"The court shall grant summary judgment if the movant shows that there is no genuine
dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.
R. Civ. P. 56(a). The moving party has the initial burden of proving the absence of a genuinely
disputed material fact relative to the claims in question. Celotex Corp. v. Catrett, 4 77 U.S. 317,
330 (1986). Material facts are those "that could affect the outcome" of the proceeding, and "a
dispute about a material fact is ' genuine ' if the evidence is sufficient to permit a reasonable jury
to return a verdict for the nonmoving party." Lamont v. New Jersey, 637 F.3d 177, 181 (3d Cir.
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2011) (quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242,248 (1986)). The burden on the
moving party may be discharged by pointing out to the district court that there is an absence of
evidence supporting the non-moving party' s case. Celotex, 477 U.S . at 323.
The burden then shifts to the non-movant to demonstrate the existence of a genuine issue
for trial. Matsushita Elec. Indus. Co. v. Zenith Radio Corp. , 475 U.S. 574, 586-87 (1986);
Williams v. Borough of West Chester, Pa., 891 F.2d 458 , 460-61 (3d Cir. 1989). A non-moving
party asserting that a fact is genuinely disputed must support such an assertion by: "(A) citing to
particular parts of materials in the record, including depositions, documents, electronically stored
information, affidavits or declarations, stipulations .. . , admissions, interrogatory answers, or
other materials; or (B) showing that the materials cited [by the opposing party] do not establish
the absence ... of a genuine dispute .... " Fed. R. Civ. P. 56(c)(l).
When determining whether a genuine issue of material fact exists, the court must view
the evidence in the light most favorable to the non-moving party and draw all reasonable
inferences in that party' s favor. Scott v. Harris , 550 U.S. 372, 380 (2007); Wishkin v. Potter,
476 F.3d 180, 184 (3d Cir. 2007). A dispute is "genuine" only if the evidence is such that a
reasonable jury could return a verdict for the non-moving party. Anderson, 477 U.S. at 247-49.
If the non-moving party fails to make a sufficient showing on an essential element of its case
with respect to which it has the burden of proof, the moving party is entitled to judgment as a
matter oflaw. See Celotex Corp., 477 U.S. at 322.
Ill.
D ISCUSSION
A. Brand Name Liability for Plaintiff's Use of Generic Risperidone
The Parties do not dispute that Plaintiffs claim is based on his ingestion of generic
risperidone. (D.I. 156 at 4-6; D.I. 178 at 12-17). Rather, they dispute whether, under Delaware
law, a brand name manufacturer can be held liable, on a negligent failure to warn theory, for a
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plaintiffs injuries that result from consumption of a generic drug. (D.I. 156 at 10-11; D.I. 178 at
12-17). That question is an issue of first impression in Delaware.
Under federal law, brand name and generic drug manufacturers are not equally
responsible for drug labeling. "A brand-name manufacturer seeking new drug approval is
responsible for the accuracy and adequacy of its label. A manufacturer seeking generic drug
approval, on the other hand, is responsible for ensuring that its warning label is the same as the
brand name's." PLIVA, Inc. v. Mensing, 564 U.S. 604, 613 (2011) (citations omitted). This
regulatory reality led the Supreme Court in PLIVA to find that federal law preempts state tort
liability for a generic drug manufacturer' s inadequate label. Id. at 623-24.
In her dissent, Justice Sotomayor noted that the PLIVA majority opinion "strips genericdrug consumers of compensation when they are injured by inadequate warnings." Id. at 643
(Sotomayor, J. , dissenting). Plaintiff argues, "The problem is exacerbated because federal law
encourages generic drug use and a majority of states have passed law[ s] permitting pharmacists
to substitute generic drugs without a patient' s consent to save costs." (D.I. 178 at 15). Delaware
is among the states with such a law. Del. Code Ann. tit. 24, § 2549A.
Plaintiff proposes that the appropriate solution is to allow plaintiffs to maintain claims
against brand name manufacturers for failure to warn, even when the plaintiffs ingested only the
generic manufacturers' products. (D.1. 178 at 13). He argues this solution is desirable for two
policy reasons: (1) "it ensures drug labels are consistent and consumers adequately warned,
regardless of whether a generic or brand name drug is dispensed by a pharmacist," and (2)
"imposing liability on brand name manufacturers better reflects what is actually at issue in
failure to warn claims." (Id. at 15).
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Beyond his policy-based argument, Plaintiff notes that some courts have allowed claims
against brand name drug manufacturers in these circumstances. In 2014, the Alabama Supreme
Court held that brand name manufacturers may be liable for harm caused by a generic
manufacturer' s product due to the brand name manufacturer's unique regulatory position.
Wyeth, Inc. v. Weeks , 159 So. 3d 649, 676-77 (Ala. 2014), superseded by statute, Ala. Code§ 6-
5-530(a) ("In any civil action for personal injury, death, or property damage caused by a product,
regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must
prove, among other elements, that the defendant designed, manufactured, sold, or leased the
particular product the use of which is alleged to have caused the injury on which the claim is
based, and not a similar or equivalent product."). Additionally, in 2010, a district court sitting in
diversity held, "There is no reason, under Vermont law, to limit [a defendant's] duty of care to
physicians by the pharmacist' s choice of a generic bioequivalent drug to fill the physician' s
prescription." Kellogg v. Wy eth, 762 F. Supp. 2d 694, 708-09 (D. Vt. 2010).
Defendant responds that Delaware law does not support imposing liability on defendants
that did not make the allegedly harmful product. To state a claim in a products liability case, a
plaintiff must plead facts that identify the allegedly defective product and the manufacturer of
that product. In re Benzene Litig. , 2007 WL 625054, at *6 (Del. Super. Ct. Feb. 26, 2007).
" [G]eneric identification of a product is not enough to establish liability absent some other
evidence that that generic product was the specific product of a defendant." Lee v. A. C. & S.,
Inc. , 1986 WL 15421 , at *2 (Del. Super. Ct. Dec. 15, 1986). Moreover, at least one Delaware
court has expressed hesitation when pressed to make changes to traditional tort law in the
product liability space. Nutt v. A . C. & S. Co. , 517 A.2d 690, 694 (Del. Super. Ct. 1986)
(choosing to defer to the legislature rather than judicially expand the scope of liability).
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In response, Plaintiff cites to just one Delaware case, Wilkerson v. Am. Honda Motor Co.,
2008 WL 162522, at *2 (Del. Super. Ct. Jan. 17, 2008). In Wilkerson, the Superior Court held
that a defendant may be liable for a plaintiff's asbestos exposure from a third-party product if it
was reasonably foreseeable that use of defendant's product would result in use of the third-party
product that would result in exposure to asbestos. Id. at *2. The court also held, "Any necessary
warning must be tailored to the risks associated with the reasonably-anticipated use of the
manufacturer' s own product." Id. I understand Wilkerson to allow liability for a reasonably
foreseeable harm that stems from use of a manufacturer' s product, even when the actual vessel
for the harm-causing agent was manufactured by a third party. I do not, however, agree with
Plaintiff's conclusion that Wilkerson stands for the proposition that the question of liability starts
and ends with whether a defendant owed a duty to a plaintiff. (D.I. 178 at 12 ("[T]he appropriate
initial question is not whether Plaintiff ingested a drug manufactured by Defendant, but whether
Defendant owed a duty to Plaintiff.")). Consistent with other Delaware cases, Wilkerson requires
that defendant produced the product at the center of the dispute.
Defendant further argues that the Third Circuit disfavors district courts creating new state
law while sitting in diversity. When faced with "two competing yet sensible interpretations" of
state law, the Third Circuit instructs that district courts should "opt for the interpretation that
restricts liability, rather than expands it, until the [state' s supreme court] decides differently. "
Werwinski v. Ford Motor Co. , 286 F .3d 661 , 680 (3d Cir. 2002); see also Bruffett v. Warner
Commc 'ns, Inc. , 692 F .2d 910, 920 (3d Cir. 1982) ("One of the authentic obligations of
federalism at the judicial level requires that we permit the state courts to decide whether and to
what extent they will follow the emerging law.").
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I agree with Defendant. Delaware law does not support imposing liability on a brand
name defendant for a generic manufacturer' s product. I further agree with Defendant that, even
if Delaware law provided some basis for imposing liability for failure to warn on brand name
manufacturers, it would be imprudent for me to extend Delaware's law to that point while sitting
in diversity. Accordingly, as it is undisputed that Defendant did not manufacture the pills that
Plaintiff ingested, I will grant Defendant's motion for summary judgment.
B. Learned Intermediary Doctrine
Defendant also argues that it is entitled to summary judgment because Plaintiff cannot
establish that an additional warning would have changed Plaintiffs physician' s decision to
prescribe Risperdal. (D.1. 156 at 12-13). Plaintiffs evidence of the inadequacy of the Risperdal
label is identical to the evidence presented in a related case, Green v. Janssen Pharms., Inc.,
Case No . 15-401-RGA (D. Del.), and is similarly insufficient to establish the Risperdal label was
inadequate as a matter of law. Moreover, it is undisputed that none of Plaintiffs physicians were
deposed for this litigation. (D.I. 156 at 12-13). Thus, as I explain more fully in my
simultaneously-entered summary judgment opinion in the Green case, Plaintiff cannot overcome
Delaware's learned intermediary doctrine. I will grant Defendant's summary judgment motion
for this additional reason.
IV.
CONCLUSION
Delaware law does not support Plaintiffs claim against Defendant, a brand name
manufacturer that did not produce the product that Plaintiff ingested. Plaintiff is also unable to
establish that an additional warning would have impacted his prescribing physician' s decision to
prescribe Risperdal. Thus, I will grant Defendant' s Motion for Summary Judgment and enter
judgment in Defendant's favor. As no claims remain pending in the case, I will also dismiss
Defendant' s Daubert motions as moot.
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