Acevedo v. Johnson & Johnson et al

Filing 65

Magistrate Judge Donald L. Cabell: ORDER entered. Memorandum and Order denying without prejudice 51 Motion to Amend; granting 13 Motion to Dismiss; granting 29 Motion to Dismiss for Failure to State a Claim. (Russo, Noreen)

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS

JESSIE ACEVEDO,
Plaintiff,
No. 16-CV-11977-DLC
v.
JOHNSON & JOHNSON, and JANSSEN
RESEARCH AND DEVELOPMENT, LLC,
Defendants.

MEMORANDUM AND ORDER

CABELL, U.S.M.J.
Plaintiff Jessie Acevedo has sued the manufacturers of the
drug Risperdal after he took the drug and reportedly suffered
serious side effects.

The defendants, Johnson & Johnson (“J&J”)

and JANSSEN Research and Development (“Janssen”), moved to dismiss
the complaint and the plaintiff subsequently moved to amend. (Dkt.
Nos. 13, 29, 51).

Those motions are now pending before the court.

For the reasons explained below, the defendants’ motions to dismiss
will be granted and the plaintiff’s motion to amend will be denied.
However, the plaintiff will be permitted to attempt to re-plead
two of his claims provided he can assert specific facts to show
the claims are viable.

I.

BACKGROUND
A. Facts as Stated in the Original Complaint
As alleged in the original complaint, the plaintiff is an

inmate at the Old Colony Correctional Center in Bridgewater,
Massachusetts. He at some point was prescribed Risperdal, an antipsychotic drug.

He subsequently developed breasts as a result of

taking the drug and contends that the defendants failed to warn
him of the drug’s side effects.
B. Additional
Complaint

Facts

as

Complaint at pgs. 1-2.
Stated

in

the

Proposed

Amended

The proposed amended complaint asserts additional facts and
allegations.

As alleged therein, J&J and Janssen developed and

sold Risperdal.
was

Amend. Compl. at ¶ 2.

prescribed

personality

Risperdal

disorder.

in

Id.

In or around 2007, Acevedo

connection

at

¶

4.

with

a

diagnosed

Subsequently,

Acevedo

experienced weight gain, a decreased sex drive, tremors, and
increased breast tissue, that is, gynecomastia.

Id. at ¶ 6.

In or around May 2016, Acevedo saw a doctor regarding his
mental health disorder and that doctor told him about Risperdal’s
side effects.

The doctor told Acevedo that it was the defendants

who informed the doctor of the drug’s potential side effects.
These disclosed side effects did not include gynecomastia.

Id. at

¶ 9-10.
In 2016, Acevedo stopped taking Risperdal but the tremors and
gynecomastia did not decrease.

Id. at ¶ 13.
2

As a result of his

gynecomastia, Acevedo was subject to taunting inside and outside
of prison and suffered from severe depression, suicidal ideation
and thoughts of self-mutilation.
II.

Id. at ¶ 17.

PROCEDURAL HISTORY

The plaintiff filed an original complaint on September 29,
2016, and J&J and Janssen moved to dismiss on January 31 and March
24, 2017, respectively.
The court subsequently issued an order to show cause when the
plaintiff failed to respond and the plaintiff by letter dated May
31, 2017 informed the court that he wanted to prosecute his claims
but was unsure how to proceed.
In June 2017 the court stayed the case in order to see if
counsel could be obtained to assist the plaintiff. In the interim,
on November 20, 2017, the plaintiff moved for leave to amend the
complaint. On December 31, 2017, the defendants opposed the motion
to amend.
On April 4, 2018, the court lifted the stay after efforts to
obtain counsel for the plaintiff proved unsuccessful.
III. THE COMPLAINTS
A. The Original Complaint
The original complaint appears to assert two claims.

It

appears to allege that (1) the defendants negligently failed to
warn the plaintiff of the side effects of Risperdal, and (2) the

3

plaintiff suffered emotional distress by virtue of the side effects
he experienced.
B. The Proposed Amended Complaint
The proposed amended complaint is more fulsome and asserts
five claims.

First, it alleges that the defendants willfully and

intentionally failed to inform medical providers and the plaintiff
about the side effects of Risperdal, in violation of M.G.L. 106 §
2-318

and

M.G.L.

c.

93A

§

2.

Second,

it

alleges

that

the

defendants’ failure to notify medical providers of the possibility
that Risperdal could cause gynecomastia constitutes negligence,
fraudulent concealment and fraud.

Third, it alleges that the

defendants manufactured a defective product where they made a drug
that caused gynecomastia and tremors.

Fourth, it alleges that the

defendants fraudulently concealed Risperdal’s side effects when
they sold it.

Finally, it alleges that the plaintiff suffered

emotional distress as a result of suffering side effects from
taking Risperdal.
C. The Synthesized Claims
Comparing the two complaints, both allege that the defendants
failed to warn others of Risperdal’s side effects, and both assert
claims for emotional distress.

Further, Counts II and IV of the

proposed amended complaint allege fraudulent concealment and are
essentially

duplicative.

Synthesizing

4

the

two

pleadings

and

accounting for duplication, they appear to assert the following
five claims, referred to here as counts for ease and clarity:
Count I alleges that the defendants violated M.G.L. c. 106,
§ 2-318 and M.G.L. c. 93A, § 2 by willfully and intentionally
failing

to

inform

medical

providers

and

the

plaintiff

of

Risperdal’s side effects;
Count II alleges that the defendants negligently failed to
warn the plaintiff of Risperdal’s potential side effects;
Count III alleges that the defendants fraudulently concealed
Risperdal’s

potential

side

effects

from

providers

and

the

plaintiff;
Count IV alleges based on Risperdal’s side effects that the
defendants defectively manufactured it; and
Count

V

alleges

that

the

defendants

inflicted

emotional

distress upon the plaintiff.
IV.

STANDARDS OF REVIEW
A. Motion to Amend

Under Fed. R. Civ. P. 15, a party may amend its pleading once
as a matter of course within 21 days after serving it, or within
21 days after service of a responsive pleading or a motion filed
under Fed. R. Civ. P. 12(b), (e), or (f). Fed. R. Civ. P. 15(a)(1).
In all other cases, a party may amend a pleading only with written
consent of the opposing party or leave of the court.
P. 15(a)(2).

Fed. R. Civ.

“The court should freely find leave when justice so
5

requires.”

Id.

“The leave sought should be granted unless the

amendment would be futile or reward undue delay.” Abraham v. Woods
Hole Oceanographic Inst., 553 F.3d 114, 117 (1st Cir. 2009).

An

amendment is considered futile if the proposed complaint would not
survive a motion to dismiss.

See, e.g., Kemper Ins. Co. v. Federal

Express Corp., 115 F. Supp. 2d 116, 125 (D. Mass. 2000).
B. Motion to Dismiss
On a motion to dismiss, the court “must assume the truth of
all well-plead facts and give the plaintiff the benefit of all
reasonable inferences therefrom.”

Ruiz v. Bally Total Fitness

Holding Corp., 496 F.3d 1, 5 (1st Cir. 2007).

In order to survive

a motion to dismiss, the complaint must state a claim that is
plausible on its face.
570 (2007).

Bell Atl. Corp. v. Twombly, 550 U.S. 544,

That is, “[f]actual allegations must be enough to

raise a right to relief above the speculative level...on the
assumption that all the allegations in the complaint are true (even
if doubtful in fact).”

Id. at 555.

In light of the applicable standards, the court focuses its
inquiry on whether any of the five claims, which in the aggregate
reflect the substance of the original complaint as well as the
amended claims the plaintiff seeks leave to include, states a
viable claim for relief.

6

V.

ANALYSIS
The plaintiff contends that leave to amend should be granted

because the proposed amended complaint helps to flesh out and
clarify the plaintiff’s specific claims.

However, even accepting

that the proposed amended complaint improves upon the original
complaint, and even assuming arguendo that the plaintiff has not
unduly delayed in seeking to amend, or that the amendment would
not unduly prejudice the defendants, the court finds that none of
the claims asserts a valid claim for relief.

The court therefore

will dismiss the original complaint and deny the motion for leave
to amend.

With respect to two claims, however, the court will

give the plaintiff one additional opportunity to seek to cure
deficiencies noted here.
A. Count I
Count

I

intentionally

alleges
failed

that

to

the

inform

the

defendants
plaintiff

willfully
or

his

and

medical

providers of the potential risks associated with taking Risperdal,
in violation of M.G.L. c. 106, § 2-318 and M.G.L. c. 93A, § 2.
Count I fails to state a claim because neither of these statutes
provides the plaintiff with a cause of action here.
First,

M.G.L.

c.

106,

independent cause of action.

§

2-318

does

not

provide

for

an

The statute provides in pertinent

part that a “[l]ack of privity between plaintiff and defendant
shall be no defense in any action brought against the manufacturer,
7

seller, lessor or supplier of goods to recover damages for breach
of warranty, express or implied, or for negligence…”
106, § 2-318.

M.G.L. c.

As the comments to the statute note, the purpose of

this statute is to give entities other than a buyer the same
benefits of any warranty the buyer received.

See Id., Uniform

Commercial Code Comment, No. 2 (“The purpose of this section is to
give certain beneficiaries the benefit of the same warranty which
the buyer received in the contract of sale, thereby freeing any
such beneficiaries from any technical rules as to “privity.”).
The statute moreover is not germane to the present case because
this is not a case where the defendants seek to escape liability
for a breach of warranty or negligence claim on the ground that
there was a lack of privity between the parties.
The second statute cited, M.G.L. c. 93A, § 2, does permit a
plaintiff to bring an action for injury due to unfair or deceptive
business practices, Edlow v. RBW, LLC, 688 F.3d 26, 39 (1st Cir.
2012), but the plaintiff cannot proceed under it here, for two
reasons.
First, a plaintiff seeking to bring a Chapter 93A suit must
first “submit a demand letter to defendants 30 days prior to filing
a private action.”

McKenna v. Wells Fargo, NA, 693 F.3d 207, 217

(1st Cir. 2012).

The demand letter, which is a prerequisite

necessary to filing suit, must include a description of the unfair
or

deceptive

act

and

identify

the
8

injured

as

the

claimant.

Balsassari v. Public Finance Trust, 369 Mass. 33, 41 (2006).

The

plaintiff does not aver that he has supplied the defendants with
a demand later and the defendants state explicitly that he has
not.

Second, even assuming the plaintiff were to do so, or has in

fact done so, his 93A claim would still fail because a plaintiff
seeking

relief

practice

must

under

Chapter

show

that

93A

he

for

an

suffered

unfair
an

or

economic

deceptive
injury.

Tyler v. Michaels Stores, Inc., 464 Mass. 492, 501-02 (2013).

By

contrast, relief is not available where, as here, the plaintiff
seeks redress for a physical injury.

See Rule v. Fort Dodge Animal

Health, Inc, 607 F.3d 250 (1st Cir. 2010)(affirming dismissal of
93A claim where manufacturer concealed risks of medicine at time
of purchase but plaintiff did not suffer economic harm); Donovan
v. Philip Morris USA, Inc., 455 Mass. 215 (2009)(upholding 93A
claim

where

ongoing

risk

of

developing

lung

cancer

required

plaintiff to incur economic costs to cope with consequences of the
risk).

Count I therefore fails to state a valid claim for relief.

B. Count II
Count II asserts that the defendants were negligent for
failing to notify medical providers that use of Risperdal could
cause gynecomastia.

In order to succeed on a claim of negligence,

a plaintiff “must show (1) a legal duty owed by defendant to
plaintiff; (2) a breach of that duty; (3) proximate or legal cause;
and (4) actual damage or injury.”
9

Jorgensen v. Mass. Port Auth.,

905 F.2d 515, 522 (1st Cir. 1990).

A plaintiff must moreover show

that the manufacturer’s failure to warn was the proximate cause of
the plaintiff’s injuries.

Calisi v. Abbott Labs, No. 11-10671-

DJC, 2013 WL 5441355, *15 (September 27, 2013).

To establish that

the manufacturer’s failure to warn was the proximate cause of an
injury, the plaintiff must show that “if additional warning had
been given, it would have been heeded and a different result would
have obtained.”

Chamian v. Sharplan Lasers, Inc., No. 200000171,

2004 WL 2341569, *6-7 (Mass. Super. Ct. Sept. 24, 2004).
Notable

here,

Massachusetts

intermediary doctrine.

has

adopted

the

learned

Under this doctrine, prescription drug

manufacturers only have the duty to warn prescribing physicians,
rather than warning patients directly. Liu v. Boehringer Ingelheim
Pharmaceuticals, Inc., 230 F. Supp. 3d 3, 8 (D. Mass. 2017) (citing
Garside v. Osco Drug, Inc., 976 F.2d 77, 81 (1st Cir. 1992).

The

learned intermediary doctrine came about because “a patient’s
involvement in decision making concerning use of a prescription
drug

necessary

nonexistent.”

to
Id.

treat

a

(citing

malady
MacDonald

Corp., 394 Mass 131, 137 (1985)).

is
v.

typically
Ortho

minimal

or

Pharmaceutical

Under this doctrine, the

manufacturer’s duty is fulfilled once it adequately warns the
physician.
1992).

Garside v. Osco Drug, Inc., 976 F.2d, 77, 80 (1st Cir.

Where the manufacturer fails to provide the physician with

an adequate warning, the manufacturer may still be shielded from
10

liability if it can show that the prescribing physician would not
have heeded an adequate warning.”

Id.

Applied here, Count II fails to assert a valid claim for
relief because it fails to assert facts to show that the defendants
failed to inform the plaintiff’s physician regarding Risperdal’s
side

effects.

The

amended

complaint

fails

to

identify

the

plaintiff’s physician or to assert when s/he treated the plaintiff
or what information, if any, the physician possessed regarding
Risperdal.

Without more, the claim is too vague and imprecise to

provide meaningful guidance to the defendants.
therefore

dismiss

the

complaint

to

the

extent

The court will
it

alleges

a

negligent failure to warn, and will deny the motion for leave to
amend to assert the claim as presently framed.
However, where the defendants’ alleged failure to warn is in
essence the plaintiff’s core claim, the court will grant the
plaintiff leave to try and re-plead Count II, subject to the
plaintiff’s

ability

to

assert

specific,

non-conclusory

facts

demonstrating that the defendants failed to provide an adequate
warning to the plaintiff’s physician.
C. Count III
Count III alleges that the defendants knew that Risperdal
could cause gynecomastia but fraudulently concealed its risks from
medical providers and patients.

Successful claims of fraudulent

concealment “generally require [the] plaintiff to establish that
11

[the] defendant made a false representation which was knowingly
‘false or was recklessly indifferent to its truth or falsity,’
with

the

intention

to

defraud,

upon

which

justifiably relied and incurred damages.”

[the]

plaintiff

In re Neurontin Mktg.,

618 F. Supp. 2d 96, 112 (D. Mass. 2009)(citing Pinney v. Nokia,
Inc., 402 F.3d 430, 444 (4th Cir. 2005)).

Additionally, the

plaintiff must also plead and prove that the defendants took
affirmative steps to conceal defects or to prevent the plaintiff
from acquiring the knowledge of these defects.

Roadmaster Indus.,

Inc. v. Columbia Mfg. Co., 893 F.Supp. 1162, 1179 (D. Mass. 1995).
A plaintiff, in addition to demonstrating there was an intentional
concealment of information material to the transition, must also
establish that the defendant owed the plaintiff a fiduciary duty
or other similar relation of trust and confidence that required
such disclosure.

See Bruno v. Bruno, 10 Mass.App.Ct. 918, 919,

(1980); Walsh v. Chestnut Hill Bank & Trust Co., 414 Mass. 283,
288, n. 6, (1993).
The complaint here simply alleges in conclusory fashion that
the defendants’ failure to notify medical providers and patients
of the risks of Risperdal while continuing to sell the drug
constitutes fraudulent concealment.

By contrast, the complaint

does not assert any facts to show that the defendants knowingly
took steps to conceal the drug’s risks or to prevent the plaintiff
or

others

from

learning

of

them,
12

or

knowingly

made

a

false

representation to the plaintiff’s prescribing physician, or that
the plaintiff relied on the false representation to his detriment.
In short, the plaintiff has not come close to meeting his
burden

to

plead

and

prove

that

the

defendants

knowingly

or

recklessly made false statements regarding the risks of Risperdal
for a fraudulent purpose.
valid claim for relief.

Count III therefore fails to state a
And, as it is improbable the plaintiff

could marshal the facts necessary to prove such a claim, leave to
attempt to re-plead the claim will be denied.
D. Count IV
Count IV alleges a manufacturing defect because Risperdal has
been associated with risks of tremors and gynecomastia.

“A defect

from manufacturing, as opposed to design, occurs when a product
differs

from

manufacturer.”
Mass. 1996).

identical

products

issued

from

the

same

Waslow v. Glock, Inc., 975 F. Supp. 370, 377 (D.
By contrast, a claim that “calls into question the

entire product line...is properly construed as a design defect
claim, not a manufacturing defect claim.”
F. Supp. 3d 868, 876 (N.D. Ohio 2014).

Booker v. Johnson, 54

Here, the plaintiff has

not alleged that the specific Risperdal he used was different from
any other Risperdal the defendants made, but rather appears to
allege

that

Risperdal

is

and

was

defective

as

designed.

Accordingly, the court will presume that the complaint is heard to
assert a claim of design defect.
13

When a product contains a design defect, “the product as
designed is unreasonably dangerous for its ordinary purposes.”
Laspesa v. Arrow International, Inc., No. 07-123370-NMG, 2009 WL
5217030, at 3 (D. Mass. Dec. 23, 2009).
defect,

the

plaintiff

must

show

In order to prove a design

that

the

product

was

“made

according to an unreasonably dangerous design and does not meet a
consumer's reasonable expectation as to its safety.” Everett v.
Bucky Warren, Inc., 376 Mass. 280, 290 (1978) (internal quotations
omitted).

The focus of the claim must be on the design itself,

not on the manufacturer's conduct, and it requires proof of the
existence of a safer alternative design.

Id. at 290-91; see Evans

v. Lorillard Tobacco Co., 465 Mass. 411, 428 (2013).
Here, the complaint alleges only that “the actions of the
defendants in producing a drug that made the plaintiff have tremors
and excessive breast tissue constitutes a manufacturing defect.”
There is by contrast no allegation that Risperdal was unreasonably
dangerous as a product designed to treat a personality disorder
and did not meet a consumer’s reasonable expectation as to its
safety.

In the absence of facts sufficient to make such a showing,

Count IV fails to state a valid claim for relief.

It is improbable

the plaintiff could marshal the facts necessary to prove such a
claim and leave to try to re-plead the claim therefore will be
denied.

14

E. Count V
Count V asserts a claim for emotional distress on the ground
that

Risperdal

caused

the

plaintiff

to

grow

female

breasts,

consider self-mutilation and suicide, and become depressed.

It is

not clear whether the plaintiff alleges negligent or intentional
infliction of emotional distress.
To

raise

a

claim

of

negligent

infliction

of

emotional

distress, a plaintiff must allege that (1) the defendant was
negligent; (2) the plaintiff suffered emotional distress; (3) the
emotional distress was caused by the defendant's negligence; (4)
the

plaintiff

suffered

physical

harm

manifested

by

objective

symptomatology; and (5) a reasonable person would have suffered
emotional distress under the same circumstances.
Abbott Labs, 386 Mass. 540, 557 (1982).

See Payton v.

Here, the court finds

that the complaint as presently framed fails to state a claim for
negligent infliction of emotional distress because it does not
adequately allege specific acts of negligence on the defendants’
part.

True, the plaintiff contends generally that he suffered

side effects from the defendants’ product but the fact that he
suffered side effects does not conflate to a finding that the
defendants were a priori negligent.
To the extent Count V alleges intentional infliction of
emotional distress, the plaintiff in order to prevail must prove:
“‘(1) that the defendant intended to inflict emotional distress,
15

or knew or should have known that emotional distress was the likely
result of his conduct,... (2) that the defendant’s conduct was
extreme and outrageous, beyond all possible bounds of decency and
utterly intolerable in a civilized community, (3) the actions of
the defendant were the cause of the plaintiff’s distress, and (4)
the emotional distress suffered by the plaintiff was severe and of
such a nature that no reasonable person could be expected to endure
it.’”

Heinrich ex rel. Heinrich v. Sweet, 49 F. Supp. 2d 27, 39

(D. Mass. 1999)(quoting Tetault v. Mahoney, Hawkes & Goldings, 425
Mass. 456, 466 (1997)).
Here, the complaint fails to allege that the defendants either
intended to inflict distress upon the plaintiff or knew or should
have known that distress would result from their conduct.

It also

fails to allege sufficient facts to show that the defendants’
conduct was extreme and outrageous, or that their conduct was the
cause of the plaintiff’s distress.
allege

that

the

defendants

had

Indeed, the complaint fails to
any

direct

contact

with

the

plaintiff or that any of their actions were specifically targeted
at the plaintiff.

Again, the fact that the plaintiff may have

suffered serious side effects from Risperdal, while not to be
trivialized,

does

not

necessarily

mean

that

the

defendants

intended the result or were responsible for his distress.
In short, Count V fails to state a valid claim for negligent
or intentional infliction of emotional distress.
16

However, to the

extent Count V is read to assert a claim for negligent infliction
of emotional distress based on the defendants’ failure to warn the
plaintiff (via his physician) of Risperdal’s side effects, that is
the essence of Count II, which the court has given the plaintiff
the opportunity to attempt to resurrect.

Accordingly, the court

will also permit the plaintiff to seek to re-plead Count V to that
extent, understanding that the claim’s viability will turn on the
plaintiff’s ability to assert specific facts showing that the
defendants breached a duty which in turn caused the plaintiff to
suffer harm.
VI.

CONCLUSION

For the foregoing reasons:
1. Defendant

Johnson

&

Johnson’s

motion

to

dismiss

the

original complaint (Dkt. No. 13) is ALLOWED;
2. Defendant JANSSEN Research and Development, LLC’s motion
to dismiss the original complaint (Dkt. No. 29) is ALLOWED;
3. Plaintiff Jessie Acevedo’s motion for leave to amend the
complaint (Dkt. No. 51) is DENIED.

However, the denial is

without prejudice as it relates to Counts II and V.
those

counts,

the

plaintiff

shall

be

permitted

As to
one

additional opportunity to seek leave within 30 days of the
date of this Order to submit an amended complaint that

17

addresses the issues noted here, provided that he has a
good faith basis for doing so.
SO ORDERED.
/s/ Donald L. Cabell
DONALD L. CABELL, U.S.M.J.
DATED:

September 30, 2018

18