Samuel L. Coleson v. Janssen Pharamceuticals, Inc. et al

Filing 41

OPINION. For the foregoing reasons, Defendants' motion for summary judgment is granted. It is so ordered. re: 24 MOTION for Summary Judgment filed by Janssen Pharamceuticals, Inc., Johnson & Johnson Subsidies. (Signed by Judge Robert W. Sweet on 5/3/2017) (rjm)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK

Plaintiff,
15 Civ. 4792
- against OPINION
JANSSEN PHARMACEUTICAL, INC.,
JOHNSON & JOHNSON SUBSIDES,
Defendants.

-------------------------------------------x
A P P E A R A N C E S:

Attorney for Plaintiff
Plaintiff, pro se
Samuel Coleson, Jr.
2247 Hughes Ave, Apt. 8
Bronx, NY 10457

Attorney for Defendants
PATTERSON BELKNAP WEBB & TYLER LLP
1133 Avenue of the Americas
New York, NY 10036
By:
John D. Winter, Esq.
Thomas P. Kurland, Esq.
Cassye M. Cole, Esq.

(RWS)

Sweet, D.J.

Defendants Janssen Pharmaceuticals, Inc. and Johnson &
Johnson (collectively, "Janssen" or the "Defendants") have moved
pursuant to Fed. R. Civ. P. 56 for summary judgment dismissing
the complaint of Plaintiff Samuel Coleson, Jr.

("Coleson" or the

"Plaintiff") . As set forth below, the motion is granted.

Prior Proceedings

On April 23, 2015, Coleson filed a pro se complaint against
Defendants in the Supreme Court, Bronx County, which alleged
that he developed gynecomastia as a result of taking Risperdal
and generic risperidone. On June 18, 2015, Janssen properly
removed the suit to federal district court.

On October 14, 2016, after discovery, Defendants filed the
instant motion for summary judgment. The motion was taken on
submission and marked fully submitted on November 28, 2016.

1

Facts

The facts have been set forth in Defendants' Rule 56.1
Statement of Undisputed Material Facts ("Defs.' 56.1"),
Plaintiff's Response to Defendants' Statement of Undisputed
Material Facts ("Pl.'s 56.1"), and the Declaration of Samuel
Coleson, Jr. dated November 18, 2016 ("Coleson Deel."), which
are not in dispute except as noted below.

Coleson has a history of substance abuse and psychiatric
care for which he has had different mental health providers. One
provider was Woodhull Hospital, where Coleson states he was
first diagnosed with bipolar schizophrenia around 2009 or 2010.
According to Coleson, physicians at Woodhull prescribed him
Risperdal and risperidone, which he began taking. Coleson states
that the side-effect warning information on the risperidone he
received at that time was different than the FDA-approved
Risperdal label. Specifically, the label he read did not include
language stating that the drug's hormonal side-effects could
affect both male and female consumers.

Janssen, a subsidiary of Johnson & Johnson, manufactures
Risperdal, a prescription medication intended to treat
schizophrenia in adult patients. Risperdal has been approved for
2

sale by the Food and Drug Administration ("FDA") since 1993.
Since at least 1996, Risperdal's FDA-approved disclosures have
indicated that Risperdal is associated with endocrine-related
side-effects, including gynecomastia, the non-cancerous
enlargement of male breasts, and galactorrhea, the production of
breast milk independent of childbirth. Janssen l ost patent
protection over Risperdal in June 2008, after which other
manufacturers began producing, marketing, and selling generic
versions of Risperdal, known as risperidone.

According to the Defendants, Coleson was first prescribed
risperidone by New York City Correctional Health Services
following an arrest in July 2010 and that the FDA-approved
Risperdal label was used both by brand-name Risperdal and
generic risperidone for the entire period that Coleson claims to
have taken Risperdal and risperidone.

Medicaid paid for all of Plaintiff's prescriptions. One
feature of New York 's Medicaid program is that it excludes
coverage of brand-name drugs when there is an FDA-approved
generic equivalent on the market unless one's healthcare
provider specifically requests an exempt ion for the patient.

3

Coleson was prescribed risperidone from July 2010 to April
2014. Around late 2013 or early 2014, Coleson switched his
antipsychotic medication from risperidone to Seroquel, a drug
also linked to gynecomastia. Around this time, Coleson spoke
with doctors about his chest pain, his development of a lopsided
chest, and discharge from his chest.

On May 30, 2014, Coleson was examined by Dr. Ajay Shah, who
did not find gynecomastia. On September 26, 2014, after
reviewing an ultrasound taken on September 8, 2014, Dr. Shah
confirmed that Coleson did not have gynecomastia.

Around March 2015, Dr. Shah diagnosed Coleson with
gynecomastia.

Applicable Standard

Summary judgment is appropriate only where "there is no
genuine issue as to any material fact and

the moving party

is entitled to a judgment as a matter of law." Fed. R. Civ. P.
56(c). A dispute is "genuine" 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). The

relevant inquiry on application for summary judgment is "whether
4

the evidence presents a sufficient disagreement to require
submission to a jury or whether it is so one-sided that one
party must prevail as a matter of law." Id. at 251-52. A court
is not charged with weighing the evidence and determining its
truth, but with determining whether there is a genuine issue for
trial. Westinghouse Elec. Corp. v. N.Y. City Transit Auth., 735
F. Supp. 1205, 1212 (S.D.N.Y. 1990)

(quoting Anderson, 477 U.S.

at 249). "[T]he mere existence of some alleged factual dispute
between the parties will not def eat an otherwise properly
supported motion for summary judgment; the requirement is that
there be no genuine issue of material fact." Anderson,
at 247-48

477 U.S.

(emphasis in original). Furthermore, "[t]he mere

existence of a scintilla of evidence in support of the [nonmovant' s] position will be insufficient; there must be evidence
on which the jury could reasonably find for the [non-movant] ."
Id. at 252.

When sitting in diversity cases, federal courts are bound
to follow the substantive law of the forum state. Travelers Ins.
Co. v. 633 Third Assocs., 14 F.3d 114, 119 (2d Cir. 1994)
(citing Erie R.R. Co. v. Tompkins, 304 U.S. 64, 58 S.Ct. 817, 82
L.Ed. 1188 (1938)). "To determine the substantive law of the
forum,

federal courts will look to the decision law of the forum

state, as well as to the state's constitution and statutes." Id.
5

In the Second Circuit, if the substantive law of the forum state
is unsettled, the federal court "must carefully review available
resources to predict how the New York Court of Appeals would
resolve the questions at bar." In re Eastern and Southern
Districts Asbestos Litig., 772 F.Supp. 1380, 1389 (E.
1991), rev'd on other grounds,
Litig.,

& S.D.N.Y.

In re Brooklyn Navy Yard Asbestos

971 F.2d 831 (2d Cir. 1992). "In making such a

determination, a federal court is free to consider all of the
resources to which the highest court of the state could look,
including decisions in other jurisdictions on the same or
analogous issues." Leon's Bakery, Inc. v. Grinnell Corp.,
F.2d 44,

48

990

(2d Cir. 1993).

Defendants' Motion For Summary Judgment Is Granted

Reading Plaintiff's complaint in the light most favorable
to him as a non-moving pro se party, he has brought state law
claims of strict products liability and negligence. Defendants
have drawn the same conclusion, upon which they have briefed the
instant motion (Memo in Supp. at 6 n.2)

and the arguments made

by Plaintiff in his reply papers accord with this construction,
(see Memo in Opp. at 3-6). Based on the following,
motion for summary judgment is granted.

6

Defendants'

Plaintiff's complaint can be construed to put forward two
different strict products liability claims. Plaintiff asserts
that Defendants failed to warn him of the hormonal risks of
taking generic risperidone, which requires that he establish:
"(1) the manufacturer has a duty to warn;

(2) against dangers

resulting from foreseeable uses about which it knew or should
have known; and (3) that failure to do so was the proximate
cause of the harm." Barrett v. Black & Decker (U.S.)
06 Civ. 1970 (SCR) (MDF), 2008 WL 5170200, at *10
9, 2008)

Inc., No.

(S.D.N.Y. Dec.

(citing Barban v. Rheem Textile Sys., Inc., No. 01 Civ.

8 4 7 5 (I LG) , 2 0 0 5 WL 3 8 7 6 6 0, at * 9 ( E. D. N. Y. Feb. 11, 2 0 0 5) ,
aff'd,

147 F. App'x 222

(2d Cir. 2005)). Plaintiff has also

claimed that Risperdal suffered from a design defect and caused
him gynecomastia. This requires that Plaintiff establish: "(1)
the product as designed posed a substantial likelihood of harm;
(2) it was feasible to design the product in a safer manner; and
(3) the defective design was a substantial factor in causing the
plaintiff's injury." Id.

(citing Colon v. Bic USA,

Inc., 199

F.Supp.2d 53, 86 (S.D.N.Y. 2001)).

Design defect strict products liability claims differ from
negligently designed product claims "in that the plaintiff is
not required to prove that the manufacturer acted unreasonably
in designing the product." Voss v. Black & Decker Mfg. Co., 59
7

N.Y.2d 102, 107, 450 N.E.2d 204, 207

(1983). Given this

difference, "New York courts generally consider strict products
liability and negligence claims to be functionally synonymous"
and "analyze both claims under a single test." Barrett, 2008 WL
5170200, at *12
Nephew,

Inc.,

(collecting cases); see also Simon v. Smith &

990 F. Supp. 2d 395, 406 (S.D.N.Y. 2013).

Plaintiff alleges he was prescribed and took both namebrand Risperdal and generic risperidone, which caused him to
develop gynecomastia. Defendants respond that each of
Plaintiff's claims must fail because Plaintiff has put forward
no evidence showing that he ingested name-brand Risperdal, only
generic risperdone. Consequently, Defendants argue they cannot
be held liable for injury resulting from using a product that
they did not manufacture, distribute, or sell. Defendants also
argue that Plaintiff cannot show medical causation between
Risperdal and his gynecomastia.

The New York Court of Appeals has not yet addressed whether
a manufacturer of a name-brand prescription drug can be held
liable for injuries resulting from another company's generic
equivalent. However,

Defendants point this Court to two other

New York court decisions, both of which have rejected such
liability: Goldych v. Eli Lilly & Co., No. 04 Civ. 1477
8

(GLS) (GJD),
v.

Pfizer,

32563

2006 WL 2038436

(N.D.N.Y. July 19, 2006) and Weese

Inc., 2013 N.Y. Misc. LEXIS 4761, 2013 N.Y. Slip Op.

(Sup. Ct., N.Y. Cty. Oct. 8, 2013).

In Goldych, the

Northern District of New York rejected a widow's claims against
the manufacturer of Prozac, who she blamed for her husband's
suicide after he ingested Prozac's generic equivalent.
Construing her claims as ones for products liability, the court
concluded that the brand-name manufacturer had "no duty to the
users of other manufacturers' products" and dismissed her
action. Goldych, 2006 WL 2038436, at *6.

In Weese, a mother gave

birth to a daughter with a serious heart defect after ingesting
the generic version of Zoloft and sued the name-brand
manufacturer,

Pfizer. The court there similarly concluded that

Pfizer's "duty should not extend to products and labeling over
which it has no control, even if those products and labels
mirrors its own, because it has done nothing toward putting them
in the hands of consumers." Weese,

2013 N.Y. Misc. LEXIS 4761,

at *4-5. These views accord with the majority of courts to
consider the topic: fifty-five other state courts across twentyone states, in addition to all six circuit courts of appeal to
have ruled on the question. See In re Darvocet,

Darvon,

Propoxyphene Prods. Liab. Litig., 756 F.3d 917,

938-39

2014)

&
(6th Cir.

(surveying the legal landscape and collecting cases).

9

A minority of courts have found liability against brandname drug manufacturers, including one identified by Plaintiff.
See Conte v. Wyeth, 168 Cal. App. 4th 89, 85 Cal. Rptr. 3d 299,
309 (2008); see also In re Darvocet, 756 F.3d at 938-39
(collecting cases to have taken the minority view). These courts
have generally found that a duty exists for brand-name
manufacturers over the warnings of their generic equivalents
because name-brand manufacturers should "reasonably foresee"
that patients will be prescribed generic medication in reliance
on the brand-name manufacturer's representations. Conte, 168
Cal. App. 4th at 111; see also Wyeth, Inc. v. Weeks, 159 So. 3d
649,

676 (Ala. 2014). At least one court has found a duty for

brand-name manufacturers over their generic equivalents with
regard to negligent design defects. See Dolin v. SmithKline
Beecham Corp., 62 F. Supp. 3d 705, 723 (N.D. Ill. 2014).

Recent New York Court of Appeals case law suggests that New
York will side with the majority of courts. Last year, in In re
N.Y. City Asbestos Litig., 27 N.Y.3d 765, 59 N.E.3d 458

(2016),

the Court of Appeals expanded product manufacturer liability by
finding that manufacturers had a duty to warn of potential
dangers resulting from their products' use in conjunction with
third party products. Id. at 792. To support this expansion, the
court noted that the manufacturers had "knowledge and ability to
10

warn of the dangers" when consumers used the product with a
third party's product. The new liability was unlikely to make
"the cost of liability and litigation .

. unreasonable," id.,

and the manufacturers "derive[d] a benefit from the sale of the
[other party's] product." Id. at 794. This rationale weighs in
the opposite direction here. Defendants had no oversight in the
manufacturing of the generic drugs. They earned no profit from
the sale of the generic drugs. Given the length of time generic
drugs can sell following a patent's expiration, to find a new
duty would unforeseeably expand the cost of liability on brandname drug manufacturers.

With this judicial landscape, it is concluded that the New
York authorities are consistent with the majority of other
courts around the country in rejecting liability for a company
that itself did not manufacture, sell, or distribute generic
versions of its name-brand drug. Accord In re Darvocet, 756 F.3d
at 949 (predicting that New York would either require product
identification for a product liability claim or that name-brand
manufacturers did not owe a duty over generically manufactured
drugs). Applying this rule to the instant matter, Plaintiff's
failure to warn claim must fail because he only alleges a
warning defect as to risperdone, over which Defendants had no
duty of care.
11

Plaintiff's design defect and negligence claims also fail
because he cannot show by a preponderance of the evidence that
he ever ingested name-brand Risperdal. See Anderson, 477 U.S. at
252

("The judge's inquiry [in civil cases]

. unavoidably

asks whether reasonable jurors could find by a preponderance of
the evidence that the plaintiff is entitled to a verdict .").
Plaintiff's declaration and deposition states that he was
prescribed, amongst other drugs, "Risperdal (risperidone)" and
received while at Woodhull Hospital around 2009 or 2010
"Risperdal and/or risperidone." (Coleson Deel.

~~

2 , 5; see also

Declaration of Thomas P. Kurland dated October 14, 2016
("Kurland Deel.") Ex. Hat 40-41.) Nothing else supports
Plaintiff's statements. Plaintiff claims hospital records that
prove he actually received Risperdal while at Woodhull were
likely destroyed by a fire in January 2015.
3; Kurland Deel. Ex. Hat 40-41.)

(Coleson Deel.

~~

2-

It is unfortunate that

evidence that might have been valuable to Plaintiff's case was
potentially lost due to external forces.

In the absence of that

evidence, however, the Court is left only with Plaintiff's "mere
speculation or conjecture " as to those files' existence and his
naked assertion. Fletcher v . Atex,
Cir. 1995)

(citation omitted) .

12

Inc.,

68 F.3d 1451, 1456 (2d

A "fair-minded jury" could conclude that Plaintiff received
drugs while at Woodhull, and even that Plaintiff was prescribed
Risperdal. Anderson, 477 U.S. at 252 .

However , the foll owi ng

facts remain undisputed. By 2009 , risperidone was a widely
available generic t o Risperdal.
~~

6,

(Defs.' 56.1

~~

6,

9; Pl.'s 56.1

9.) All of Plaintiff's prescriptions were paid by

Medicaid.

(Defs.' 56.1

~

29; Pl.'s 56.1

~

29; Coleson Deel. Ex.

Hat 161.) Aside from exceptional circumstances Plaintiff has
not shown, Plaintiff's prescriptions under Medicaid needed to be
filled with generic drug equivalents.
56.1

~

8 .)

(Defs.' 56.1

~

8; Pl.'s

From the evidence presented, no jury could draw the

"justifiable inference" that Plaintiff received name-brand
Risperdal for his prescriptions. 1 Id. at 254. Plaintiff has shown
the possibility of injury from his ingestion of risperdone, and
were he to pursue claims against the generic drug manufacturers,
it might lead to a different outcome . See Guvenoz v. Target
Corp., 30 N.E.3d 404,

420

(co lle cting cases), appeal denied,

1

39

The fact that Plaintiff ' s medical records at times recorded his
prescription as only for Risperda l do not permit an inference that when
filling those prescriptions he received and ingested Risperdal. (See Kurland
Deel. Exs . K, M, P (no tin g that Plaintiff was prescribed "Risperdal,u
"Respiridol [sic],u and "Resperdol [sic]u) .) Gener ic risperidone is regularly
wr itten as "Risperdal (risperidone) ,u a nomenclature even Plaintiff adopts in
his papers . (See Coleson Deel . ~ 27 , Kurland Deel . Exs. G, L.) That a drug is
prescribed under its brand-name does not mean that a patient receives that
name - brand drug, and is not "justifiableu to infer that it does . Anderson ,
477 U.S. at 256; see Goldych , 2006 WL 2038436, at *l (observing that while a
name-brand was prescribed , the pharmacy substituted a generic according to
"accepted standardsu) . (See also Co leson Deel . Exs . A, C (prescription
receipts sh owing Coleson receiving risperdone during the time-frame of being
prescribed Risperdal) . )

13

N.E.3d 1002 (Ill . 2015), cert. denied, 136 S. Ct. 2409 (2016).
Here, though, it cannot "serve as a basis for liability" against
Risperdal's manufacturer. In re Darvocet, 756 F.3d at 938 .

Even assuming that Plaintiff had ingested Risperdal, his
design defect and negligence claims against Defendants would
still fail because he cannot establish that Risperdal caused his
gynecomastia. "[I]n any products liability or personal injury
action , Plaintiffs must prove causation-that the Defendants'
conduct

. was the proximate cause of Plaintiff's injuries."

In re Mirena IUD Prods. Liab. Liti g ., 202 F . Supp. 3d 304 , 310
(S .D.N. Y. 2016)

(citations omitted)

(finding summary judgment

for defendants for strict product liability and negligence
claims). "Generally, in products liability cases, to establish
causation,

[plaintiffs] must offer admissible expert testimony

regarding both general .

and specific causation,"

particularly "where a causal link is beyond the knowledge or
expertise of a lay jury." Id.

(quoting Amorgianos v . Nat ' 1 R. R.

Passenger Corp., 303 F. 3d 2 56, 268

(2d Cir. 2002))

(quotation

marks omitted) .

Plaintiff argues that he has sufficient evidence for a jury
to find causation. He points to Risperdal's warning label , which
discusses gynecomastia , to prove general causation and a July
14

2015 medical report , which concludes that Plaintiff ' s
gynecomastia "is re l ated to phychiatric [sic] medical
ingestion ," to prove specific causation .

(Coleson Deel. Ex . F ;

Memo in Opp. at 5 . )

Risperdal ' s warning label cannot establish general
causation. Product warn i ng l abels can have over-inclusive
information on them, often out of "an abundance o f causation or
the avo i dance of lawsuits . " In re Mirena , 202 F . Supp . 3d at
323 . Unless a warning label specifically i ndicates that an
alleged injury can be caused by a drug, courts have found that a
drug's product warning label alone cannot "raise a genuine issue
of materia l fact with respect to general causation . " Id .
Risperdal ' s label states i t " elevates pro l actin levels" and that
"gynecomastia .

ha[s] been reported in patients receiving

prolactin elevating compounds . "

(Kur l and Deel . Ex . C . ) This is

not the same as an admission of "a genuine phenomenon" creating
a "material fact with respect to general causation . " In re
Mirena, 202 F . Supp. 3d at 323 .

Plaintiff's July 2015 medical report does not establish
proximate c a use. Plaintiff claims to have taken Risperdal only
around either 2009 or 20 1 0 . Throughout 20 1 0 to 2014 , Pla i ntiff
took risperido ne . In early 2014 , Plaintiff switched to a
15

different antipsychotic, Seroquel, which is undisputedly
associated with cases of gynecomastia. Plaintiff was diagnosed
with gynecomastia only in early 2015, and the medical report to
which Plaintiff points indicates Plaintiff had taken both
Seroquel and risperidone.

(See Coleson Deel. Ex.

F.) This report

does not state which, if any, of these complicated drugs is
responsible for Plaintiff's injury. Without "competent medical
expert testimony on the issue of causation," a jury would be
left only to "theorize" as to how Plaintiff came to suffer from
gynecomastia. Fane v. Zimmer, Inc.,
1991)

927 F.2d 124, 131

(2d Cir.

(rejecting a showing of causation without expert testimon y

as to the relationship between the alleged defective product and
a broken bone).

16

Conclusion

For the foregoing reasons, Defendants' motion for summary
judgment is granted .

It is s o ordered.

New York, NY
May
2017

'3 '

OBERT W. SWEET
U.S.D.J.

17