Morales-Vezquez, et al v. Abbott Laboratories, Inc.

Filing 61

OPINION AND ORDER re 44 Motion for Summary Judgment; and re 56 Report and Recommendation. The Court ADOPTS IN FULL the magistrate judge's findings and GRANTS defendant Abbott's motion for summary judgment. This case is therefore DISMISSED with prejudice. Judgment shall be entered accordingly. Signed by Judge Francisco A. Besosa on 10/30/2012. (brc)

UNITED STATES DISTRICT COURT FOR THE
DISTRICT OF PUERTO RICO
KIZZY MORALES VELAZQUEZ, et al.,
Plaintiffs,
v.

Civil No. 11-1131 (FAB)

ABBOTT LABORATORIES,
Defendant.

OPINION AND ORDER
BESOSA, District Judge.
Plaintiffs Kizzy Morales-Vazquez1 (“Morales”) and Fernando
Guzman-Merly (“Guzman”) bring this diversity action on their own
behalf and on behalf of their minor child F.J.G.M. against Abbott
Laboratories, Inc. (“Abbott” or “defendant”) for strict product
liability and negligence.

(Docket No. 1.)

Pending before the Court is the magistrate judge’s Report and
Recommendation

(Docket

No.

56),

recommending

that

defendant

Abbott’s motion for summary judgment (Docket Nos. 44, 45 and 46.),
be GRANTED.
I.

Background
A.

Procedural History
On

February

4,

2011,

plaintiffs

Morales

and

Guzman

(collectively, “plaintiffs”), on their own and as parents of their

1

Plaintiff Morales’ surname is listed as “Velazquez” in the
caption of the case, but both plaintiffs and defendant refer to her
as “Kizzy Morales Vazquez” in their briefs. Therefore, the Court
will use “Vazquez” as her second last name.

Civil No. 11-1131 (FAB)
minor

child,

negligence

2

F.J.G.M.,

and

strict

filed

a

complaint

product

against

liability.

Abbott

(Docket

No.

for
1.)

Plaintiffs allege that they fed their infant Similac Go & Grow
formula, which Abbott manufactured, promoted, and advertised.
at ¶¶ 9 & 12.
milk,

which

Id.

They also contend that after F.J.G.M. ingested the
was

allegedly

recalled

by

Abbott

for

possible

contamination, their child began to have diarrhea, fever, and pain.
Id. at ¶¶ 13 & 17.

The child was allegedly admitted to Ryder

Hospital and was eventually discharged with a diagnosis of acute
gastroenteritis.

Id. at ¶ 14.

On May 3, 2011, Abbott filed a motion to dismiss pursuant
to

Federal

of

Civil

Procedure

failed

plaintiffs

Rule

to

state

a

claim

liability under Puerto Rico law.

12(b)(6),
of

arguing

negligence

(Docket No. 7.)

and

that
strict

On June 17,

2011, plaintiffs filed a response in opposition to the motion to
dismiss, (Docket No. 11), and Abbott filed a reply to plaintiffs’
response on June 21, 2011, (Docket No. 14).
Pursuant to a referral order issued by the Court, on
September 30, 2011, Magistrate Judge Camille Velez-Rive filed a
report and recommendation (“R&R”) regarding Abbott’s motion to
dismiss.

(Docket Nos. 19 & 23.)

The magistrate judge recommended

that Abbott’s motion to dismiss be denied.
p. 10.)

(Docket No. 23 at

Both plaintiffs and defendant Abbott failed to file any

objections.

On March 26, 2012, the Court adopted the findings of

the R&R in a Memorandum and Order.

(Docket No. 28.)

Civil No. 11-1131 (FAB)

3

On June 29, 2012, Abbott filed a motion for summary
judgment, a statement of uncontested facts, and a memorandum in
support of its motion for summary judgment.
& 46.)

(Docket Nos. 44, 45,

Abbott argues (1) that plaintiffs fail to provide any

expert testimony, which they allege is mandatory in this case;
(2) that plaintiffs

have

not

provided

evidence

from

which a

reasonable jury could find defect or causation; and (3) that
plaintiffs

have

not

provided

negligent.

(Docket No. 46.)

opposition

to

Abbott’s

any

evidence

that

Abbott

was

On July 16, 2012, plaintiffs filed an

motion

for

summary

judgment,

(Docket

No. 48), to which Abbott filed a reply on July 23, 2012, (Docket
No. 51).

On August 6, 2012, plaintiffs filed a sur-reply to

Abbott’s reply.

(Docket No. 55.)

On September 26, 2012, the magistrate judge filed a R&R
recommending that Abbott’s motion for summary judgment be granted.
(Docket

No.

56.)

The

magistrate

judge

found

(1)

that

the

plaintiffs failed to introduce any expert testimony for its strict
liability claim; and (2) that Abbott’s recall notice for the powder
milk

formula,

as

Administration’s

well

as

(“FDA”)

the

notices

United

States

about

Food

Abbott’s

and

recall

inadmissible under Federal Rules of Evidence 403 and 407.
pp.

13–23.

Neither

the

plaintiffs

nor

the

defendant

Drug
are

Id. at
filed

objections to the magistrate judge’s R&R. The Court addresses each
of defendant Abbott’s arguments and the magistrate judge’s findings
in turn.

Civil No. 11-1131 (FAB)
B.

4

Factual Background
1.

F.J.G.M’s Hospitalizations and Abbott’s Recall of
its Similac Powder Milk
The relevant facts of the case are summarized here

after applying Local Rule 56, which imposes requirements for the
presentation of proof at summary judgment.2
Plaintiffs’ child, F.J.G.M., was born in July 2009
and has suffered from health problems since birth. (Docket No. 463 at p. 16.)

Initially, his pediatrician, Dr. Juan Vargas-Raposo

(“Dr. Vargas”), recommended that his parents feed him a specific

2

The First Circuit Court of Appeals has “repeatedly . . .
emphasized the importance of local rules similar to Local Rule 56
[of the District of Puerto Rico].” Hernandez v. Philip Morris USA,
Inc., 486 F.3d 1, 7 (1st Cir. 2007). Rules such as Local Rule 56
“are designed to function as a means of ‘focusing a district
court’s
attention
on
what
is—and
what
is
not—genuinely
controverted.’” Id. (quoting Calvi v. Knox County, 470 F.3d 422,
427 (1st Cir. 2006)). Local Rule 56 sets out the requirements for
both the movant and the party opposing summary judgment; it
“relieve[s] the district court of any responsibility to ferret
through the record to discern whether any material fact is
genuinely in dispute.” CMI Capital Market Inv. v. Gonzalez-Toro,
520 F.3d 58, 62 (1st Cir. 2008); Loc. Rule 56.
A party moving for summary judgment must submit factual
assertions in “a separate, short, and concise statement of material
facts, set forth in numbered paragraphs.”
Loc. Rule 56(b).
A
party opposing a motion for summary judgment must “admit, deny, or
qualify the facts supporting the motion for summary judgment by
reference to each numbered paragraph of the moving party’s
statement of facts.” Loc. Rule 56(c). The moving party may reply
and admit, deny, or qualify the opponent’s newly-stated facts,
again in a separate statement and by reference to each numbered
paragraph. Loc. Rule 56(d). Facts which are properly supported
“shall be deemed admitted unless properly controverted.” Loc. Rule
56(e); P.R. Am. Ins. Co. v. Rivera-Vazquez, 603 F.3d 125, 130 (1st
Cir. 2010). Due to the importance of this function to the summary
judgment process, “litigants ignore [these rules] at their peril.”
Hernandez, 486 F.3d at 7.

Civil No. 11-1131 (FAB)

5

milk formula called Enfamil A.R., which is only given to patients
who exhibit vomiting and reflux.

(Docket No. 46-3 at pp. 39-40.)

In July 2010, when F.J.G.M. was about one-year old, his parents
switched

him

to

the

Similac

Go

&

Grow

formula,

which

is

manufactured by Abbott, because Enfamil is only used for the first
year of a child’s life.

(Docket Nos. 46-1 & 48-8 at p. 33; Docket

No. 46-3 at p. 39.)
On March 13, 2010, several months before he switched
to the Similac formula, F.J.G.M. visited Dr. Vargas with a cough.
He was diagnosed with an upper respiratory infection.
No. 46-3 at pp. 20-21.)

(Docket

On July 29, 2010, about one month after

F.J.G.M. began consuming the Similac formula, F.J.G.M. was taken to
Ryder Memorial Hospital because he had nasal discharge and a fever.
(Docket No. 46-3 at p. 45; Docket No. 46-5 at p. 8.)
and

tonsils

were

inflamed,

and

he

was

His throat

prescribed

medications, including an antibiotic called Cephalexin.

several
Id.

On August 10, 2010, F.J.G.M. visited the emergency
room again, where he was diagnosed with an upper respiratory
infection.

(Docket No. 46-3 at pp. 46-47; Docket No. 46-5 at

p. 9.) An x-ray taken the following day showed a viral respiratory
infection

and gastric

distention–bloating of

the

stomach–from

excessive swallowing of air. (Docket No. 46-3 at pp. 47-49; Docket
No. 46-5 at p. 10.)

About two weeks later, on August 31, 2010,

F.J.G.M. visited Ryder Hospital again because of a cough.

(Docket

Civil No. 11-1131 (FAB)

6

No. 46-3 at p. 49; Docket No. 46-5 at p. 11.)
with another upper respiratory infection.

He was diagnosed

Id.

On September 15, 2010, Abbott detected warehouse
beetles in its powdered milk while performing quality testing on an
unreleased batch of Similac powdered milk at its Sturgis, Michigan
facility.

(Docket Nos. 46-8 & 18-10 at ¶¶ 6-8.)

The Sturgis

facility reported this finding to Abbott’s headquarters, and it
stopped all production and shipment of its powder products the
following day.

Id. at ¶ 15.

Despite extensive quality testings,

Abbott had not previously detected warehouse beetles in its Similac
powder milk product.3

Id. at ¶¶ 11-14.

After the detection of warehouse beetles, Abbott
tested 30,486 additional containers from twenty-two batches of its
powdered milk.

Id. at ¶ 16.

To test the milk, Abbott liquified it

and passed it through a sock filter with pores that were 200-micron
(0.2 millimeters or 0.0079 inches) in size.

Id.

In the 30,486

containers tested, Abbott detected a total of forty-nine beetles,
larvae, or parts; a rate of 0.16% of the milk tested was deemed
contaminated.

Id.

Even though the tests showed that a very small

percentage of the milk contained warehouse beetles or parts, on

3

Abbott employed a prominent third-party pest-control company
to service its Sturgis facility on a regular basis and Abbott
followed the company’s advice for pest-control. (Docket Nos. 46-8
& 48-10 at ¶¶ 11-15 & 18-20.)
An internal compliance audit
performed from July 27 to August 3, 2010 and an inspection by the
FDA in March 2010 found no significant problems with the Sturgis
facility. Id. at ¶¶ 21-22.

Civil No. 11-1131 (FAB)

7

September 22, 2010, Abbott issued a voluntary recall of Similac
powder products that were manufactured since September 2007 in the
Sturgis facility because the shelf life of the powdered milk is up
to three years.

Id. at ¶¶ 6, 9-10 & 16.
Two

days

before

the

recall

occurred,

on

September 20, 2010, plaintiffs took F.J.G.M. to the hospital again.
(Docket Nos. 46-1 & 48–8 at pp. 26 & 37; Docket No. 46-3 at p. 50;
Docket No. 46-5 at p. 12.)
infection.

He had another upper respiratory

(Docket No. 46-3 at p. 52; Docket No. 46-5 at p. 12.)

Plaintiff Morales also reported that the minor had diarrhea that
would not stop, but the hospital emergency room record reflected
that the “No” box was checked off next to “nausea, vomiting,
diarrhea.”4

(Docket Nos. 46-1 & 48-8 at pp. 27 & 30; Docket

No. 46-5 at p. 12.)

At that time, F.J.G.M. was taking Amoxil, an

oral antibiotic used to treat the upper respiratory and tonsil

4

Plaintiffs also state a number of other facts in their
memorandum of law in opposition to Abbott’s motion for summary
judgement, (Docket No. 48), and in their opposition to Abbott’s
statement of uncontested facts, (Docket No. 48-1), and cite only to
their complaint, (Docket No. 1), for support. The Court will not
consider these bare assertions of fact in rendering its decision on
defendant’s motion for summary judgment. It is fundamental that
plaintiffs may not rest on this type of allegations, uncorroborated
by evidence, to overcome a properly supported motion for summary
judgment. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 256
(1986) (stating that the non-moving party “may not rest upon the
mere allegations or denials of [the] pleading, but must set forth
specific facts” to show the existence of a genuine issue of
material fact); Serrano-Cruz v. DFI Puerto Rico, 109 F.3d 23, 27
(1st Cir. 1997) (finding that “to oppose [a] summary judgment
motion, plaintiff cannot rely on assertions in [her] pleadings and
must come forward with evidence that a jury could consider”)
(internal citation omitted).

Civil No. 11-1131 (FAB)
infection.

8

(Docket No. 46-3 at p. 52; Docket No. 46-5 at p. 12.)

Dr. Vargas also indicated that the infant was “asymptomatic,”
meaning that he had no fever and that he was sent home with a
regular diet.
p. 12.)

(Docket No. 46-3 at p. 52; Docket No. 46-5 at

There was no order to stop taking the Amoxil and there

were no other medications prescribed on this date.

Id.

One day before the recall, on September 21, 2010,
the infant had another chest x-ray taken.

(Docket Nos. 46-1 & 48-8

at p. 29-30; Docket No. 46-3 at p. 54-55; Docket No. 46-5 at
p. 13.)

The x-ray suggested that F.J.G.M. had a viral type of

pneumonia or an upper respiratory infection.
pp. 55-56; Docket No. 46-5 at p. 13.)

(Docket No. 46-3 at

On September 22, 2010, the

date of the Similac formula recall, plaintiffs took the infant to
see Dr. Vargas.

(Docket Nos. 46-1 & 48-8 at pp. 31-32; Docket

No. 46-3 at p. 56; Docket No. 46-5 at p. 14.)

Dr. Vargas indicated

that he saw the results from the x-ray taken the day before.
(Docket No. 46-3 at p. 56; Docket No. 46-5 at p. 14.)

Dr. Vargas

said that F.J.G.M. was suffering from diarrhea and was vomiting.
(Docket Nos. 46-1 & 48-8 at pp. 31-32; Docket No. 46-3 at pp. 56 &
60; Docket No. 46-5 at p. 14.)

He told the plaintiffs to stop

giving Amoxil to the infant because it might cause diarrhea.5

5

Plaintiff also stated that on this date, Dr. Vargas told her
to “stop the milk” but there is no indication of this in the
hospital records or in Dr. Vargas’ testimony about this visit.
(Docket Nos. 46-1 & 48-8 at p. 38; Docket No. 46-3 at pp. 57–58;
Docket No. 46-5 at p. 14.)

Civil No. 11-1131 (FAB)

9

(Docket No. 46-3 at pp. 57–58; Docket No. 46-5 at p. 14.)

Instead

of Amoxil, he prescribed a stronger antibiotic called Rocephin to
F.J.G.M. Id.
that date.

Dr. Vargas also admitted F.J.G.M. to the hospital on

(Docket No. 46-3 at p. 59; Docket No. 46-5 at p. 15.)

F.J.G.M. was diagnosed with acute gastroenteritis with a secondary
diagnosis of otitis–an ear infection– and moderate dehydration.
(Docket No. 46-3 at pp. 61–62; Docket No. 46-5 at p. 17.)
At

some

point

during

this

hospitalization,

the

plaintiffs learned about Abbott’s recall from a television news
show.

(Docket Nos. 46-1 & 48-8 at pp. 41-42; Docket No. 46-7 at

pp. 17-18.) The recall indicated that “there is a possibility that
the infants who consume formula containing the beetles or their
larvae could experience gastrointestinal discomfort and refusal to
eat as a result of small insect parts irritating the GI tract.”
(Docket Nos. 8-5 & 48-6 at p. 2.)

Plaintiff Morales went to

Abbott’s website to determine whether the can of Similac that she
fed F.J.G.M. was part of the recall; she discovered that the
formula was in fact a part of the recall.

(Docket Nos. 46-1 & 48-8

at pp. 41-42; Docket No. 46-7 at p. 18.)
Plaintiff Morales testified that she had six more
containers of Similac milk at her house.6
at p. 42.)

(Docket Nos. 46-1 & 48-8

While the infant was still hospitalized, plaintiff

Morales sent her father to the supermarket to exchange all of the

6

Plaintiff Morales failed to indicate, however, if F.J.G.M.
consumed any milk from these containers.

Civil No. 11-1131 (FAB)

10

Similac cans for another brand of formula. (Docket Nos. 46-1 & 488 at pp. 46-47.)

Plaintiff Guzman said that he did not examine the

remaining cans of Similac formula in detail before they were
returned to the supermarket.

(Docket No. 46-7 at pp. 21–22.)

Both

plaintiffs also stated that they had not seen insects in the
Similac formula that they fed to their infant.

(Docket Nos. 46-1

& 48-8 at p. 50; Docket No. 46-7 at pp. 20–21.)

Plaintiff Morales

also testified that she called Abbott on the same day the infant
was released from the hospital and was offered a refund check in
the amount of $54.95.

(Docket Nos. 46-1 & 48-8 at p. 45.)

She

does not remember, however, the name of the representative who she
spoke to during the call, and she did not take any notes when she
called.

(Docket Nos. 46-1 & 48-8 at p. 42.)
On September 25, 2010, F.J.G.M. was discharged from

the hospital.

(Docket Nos. 46-1 & 48-8 at p. 40; Docket No. 46-3

at pp. 59-60; Docket No. 46-5 at pp. 15 & 17.)

After the recall,

plaintiffs stopped giving F.J.G.M. the Similac formula and switched
to a different formula.

(Docket Nos. 46-1 & 46-8 at p. 50.)

On October 26, 2010, the FDA issued an official
press release,7 which announced that Abbott had worked with state
and FDA officials to correct the situation at the Sturgis facility

7

The FDA also issued press releases regarding the Abbott
recall of the Similac powdered milk formula on September 23, and
September 27, 2010. (Docket Nos. 8-1, 8-2, 48-3, & 48-4.)

Civil No. 11-1131 (FAB)

11

and to prevent its reoccurrence.

(Docket Nos. 8-3, 8–4, 48-4, &

48-5.)
On

November

27,

2010,

over

two

months

after

plaintiffs stopped giving F.J.G.M. the Similac formula, plaintiffs
took F.J.G.M. to the emergency room with an ear infection in both
ears, a throat infection, a cold, and a fever.

(Docket Nos. 46-1

& 48-8 at p. 53; Docket No. 46-3 at pp. 74–75; Docket No. 46-5 at
p.

19.)

He

November

30,

hospital.
his

not

2010,

Id.

September

dehydration.

was

hospitalized

however,

the

on

that

infant

was

date.

Id.

admitted

to

On
the

He had symptoms similar to those that had led to
2010

hospitalization:

diarrhea,

vomiting,

and

(Docket Nos. 46-1 & 48-8 at pp. 56 & 58; Docket

No. 46-3 at p. 77; Docket No. 46-5 at p. 22.)
moderate

He was diagnosed

with acute

gastroenteritis,

dehydration,

otitis,

and

tonsilitis.

(Docket No. 46-3 at p. 76; Docket No. 46-5 at p. 20.)

Another x-ray of F.J.G.M.’s lungs suggested that he might have a
viral type of pneumonia.
No. 46-5 at p. 21.)
December 4, 2010.

(Docket No. 46-3 at pp. 76-77; Docket
F.J.G.M. stayed in the hospital until

(Docket Nos. 46-1 & 48-8 at pp. 53 & 59; Docket

No. 46-3 at p. 76; Docket No. 46-5 at pp. 20 & 22.)
2.

Findings from Abbott’s Expert Witness
Abbott submitted an expert report by Dr. Paul E.

Hyman, (“Dr. Hyman”), Professor of Pediatrics at Louisiana State
University and Chief of Pediatric Gastroenterology at Children’s
Hospital of New Orleans.

(Docket No. 46-2 at p. 1.)

Dr. Hyman is

Civil No. 11-1131 (FAB)

12

also a fellow in Digestive Diseases at the National Institutes of
Health and a fellow in Pediatric Gastroenterology at the University
of California, Los Angeles.

Id.

He has chaired and co-chaired two

working teams that developed the official criteria for diagnosing
childhood functional bowel disorder, and has received an award for
outstanding achievements from both the American Gastroenterological
Association

and

Gastrointestinal

the

International

Disorders.

Id.

Foundation
at

pp.

for

1-2.

Functional

In

addition,

Dr. Hyman has published over 100 peer-reviewed articles, edited
three books, and given lectures all over the world.

Id. at p. 2.

Dr. Hyman’s medical opinion is that “the ingestion
of Trogoderma variabile beetles, [which are the beetles that were
found at the Abbott Sturgis facility,] larvae, or parts has no
capability of causing any injury or disorder in human infants.”
(Docket

No.

46-2

at

p.

2.)

While

it

is

“undesirable”

and

“disturbing to some” to have insects in infant formula, he stated
that “there is no health risk from ingestion of warehouse beetles.”
Id.

Additionally, he indicated that his research of medical

literature “revealed no reports of warehouse beetle ingestion
associated with illness or disease of any sort.”

Id.

He did find

one case report from the 1960s in an agricultural newsletter–not a
medical journal–that suggested there may be a connection between
two different types of beetle (but there was no discussion about
the warehouse beetle at issue) and two episodes of illness in
infants. Id. In those two episodes, however, no causal connection

Civil No. 11-1131 (FAB)
was shown.

Id. at pp. 2–3.

13
Furthermore, since the 1960s article,

he has found no studies demonstrating a link between warehouse
beetle consumption and illness.

Id. at p. 3.

Dr. Hyman also specified four reasons why he does
not believe that F.J.G.M.’s symptoms were caused by the warehouse
beetles that were found in Abbott’s Sturgis facility:

(1) “there

is no physiological process by which consuming Trogoderma variabile
beetles could cause gastrointestinal illness;” (2) in addition to
gastrointestinal symptoms, F.J.G.M. also had respiratory symptoms,
tonsilitis, and ear infections, and none of these symptoms can be
caused by insect parts in the digestive system even if one assumes
that the insect parts could cause gastrointestinal problems; (3) in
November 2010, the infant experienced similar symptoms, months
after the recall and after the plaintiffs switched F.J.G.M. to a
different

formula,

which

cannot

be

caused

by

the

Trogoderma

variabile; and (4) plaintiffs never saw anything “abnormal in
F.J.G.M’s formula.”

(Docket No. 46-2 at p. 9.)

Dr. Hyman stated

that “the possibility that F.J.G.M.’s [September 2010] illness was
caused by consumption of warehouse beetles is zero.” Id. Instead,
he stated that a viral respiratory illness was most likely the
underlying cause of F.J.G.M’s illness.
3.

Id.

Observations by Dr. Vargas, F.J.G.M.’s Treating
Physician
Aside from the testimony of F.J.G.M.’s parents,

plaintiffs only introduce the deposition testimony of Dr. Vargas,

Civil No. 11-1131 (FAB)

14

F.J.G.M.’s pediatrician.

(See Docket Nos. 46-3 & 48-9.)

Although

Dr. Vargas’ license is up-to-date and he has to “report 200 credit
hours [of

training]”

every

year

to

receive

approval

for

his

license, id. at p. 95, he is not board-certified by any medical
organization

and

has

no

gastroenterology, id. at p. 10.

specialization

in

pediatric

Aside from the 200 credit hours

each year, he has had no additional medical training since he
concluded his residency in the early 1970s.

Id.

Dr. Vargas admitted that he has never read or heard
of

a

child

suffering

gastroenteritis

including warehouse beetles.

due

to

eating

insects,

(Docket Nos. 46-3 & 48–9 at p. 66.)

He also conceded that the acids or enzymes in the stomach would
digest or dissolve any insect parts before they could cause any
damage to the gastrointestinal system. (Docket Nos. 46-3 & 48–9 at
pp. 67–68).

He also indicated that when he treated F.J.G.M., he

did not contemplate that F.J.G.M.’s illness was caused by insect
consumption.

Id. at p. 81.

He stated that the infant’s blood test

and white cell counts suggested that his vomiting and diarrhea
could have been bacteria-related.
pp. 60 & 90-94.)

(Docket Nos. 46-3 & 48–9 at

Dr. Vargas admitted, however, that he could not

completely rule out that F.J.G.M.’s condition was caused by a virus
because

the

infant

was

taking

antibiotics,

which

“changes” to the blood and “the picture gets fuzzy.”

can

cause

Id. at 96-97.

Although Dr. Vargas did not believe that F.J.G.M.’s
condition was caused by a viral infection, he identified several

Civil No. 11-1131 (FAB)
other

possible

causes

15
of

the

infant’s

gastroenteritis,

which

include an intolerance to the lactose in the milk; a secondary
infection, such as the ear infection that F.J.G.M. had at the time;
the infant’s ingestion of Amoxil, an antibiotic that can provoke
diarrhea; rotavirus, which is a regular virus that attacks the
gastrointestinal area; and some other food or beverage that the
infant ingested.

(Docket Nos. 46-3 & 48-9 at pp. 62–64 & 80.)

Furthermore, when questioned about whether it was more likely than
not

that

the

recalled

Abbott

formula

caused

the

infant’s

hospitalization in September 2010, he answered, “I do not believe
so.”

(Docket Nos. 46-3 & 48–9 at pp. 85–87.)

He said that “many

things” are feasible and that “[i]t’s possible” that the F.J.G.M’s
illness was somehow related to the recall, “but [he] do[es] not
have the elements to say so.”
II.

Id. at p. 87.

STANDARDS
A.

STANDARD UNDER 28 U.S.C. § 636(b)(1)
A district court may refer, inter alia, “motions for

summary

judgment”

recommendation.

to

a

magistrate

judge

for

a

report

and

Loc. Rule 72(a)(9); see 28 U.S.C. § 636(b)(1)(B);

Fed.R.Civ.P. 72(b). Any party adversely affected by the report and
recommendation may file written objections within fourteen days of
being served with the magistrate judge’s report.
§ 636(b)(1)(C); Loc. Rule 72(d).

See 28 U.S.C.

A party that files a timely

objection is entitled to a de novo determination of “those portions
of the report or specified proposed findings or recommendations to

Civil No. 11-1131 (FAB)

16

which specific objection is made.” Sylva v. Culebra Dive Shop, 389
F.Supp.2d 189, 191 (D.P.R. 2005) (citing United States v. Raddatz,
447 U.S. 667, 673 (1980)).

Failure to comply with this rule

precludes further review. See Davet v. Maccarone, 973 F.2d 22, 3031 (1st Cir. 1992) (“Failure to raise objections to the Report and
Recommendation waives the party’s right to review in the district
court . . . .”).

In conducting its review, a court is free to

“accept, reject, or modify, in whole or in part, the findings or
recommendations

made

by

the

magistrate

judge.”

28

U.S.C.

§ 636(b)(1)(C); Jasty v. Wright Med. Tech., Inc., 528 F.3d 28, 3334 (1st Cir. 2008).

Furthermore, a court may accept those parts of

the report and recommendation to which the parties do not object.
See Hernandez-Mejias v. Gen. Elec., 428 F.Supp.2d 4, 6 (D.P.R.
2005) (citing

Lacedra

v. Donald

W.

Wyatt

Det.

Facility, 334

F.Supp.2d 114, 126 (D.R.I. 2004)).
B.

Summary Judgment Standard
The Court may grant a motion for 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).

A fact is “material” if it has the potential

to “affect the outcome of the suit under the governing law.”

Id.

A dispute is “genuine” when it “could be resolved in favor of
either party.”

Calero-Cerezo v. U.S. Dep’t. of Justice, 355 F.3d

6, 19 (1st Cir. 2004).

Civil No. 11-1131 (FAB)

17

The party moving for summary judgment has the initial
burden of “demonstrat[ing] the absence of a genuine issue of
material fact.”
(1986).

Celotex Corp. v. Catrett, 477 U.S. 317, 323

The party must identify “portions of ‘the pleadings,

depositions, answers to interrogatories, and admissions on file,
together with the affidavits, if any’” which support its motion.
Id. (citing Fed.R.Civ.P. 56(c)).

Once a properly supported motion

has been presented, the burden shifts to the non-moving party “to
demonstrate that a trier of fact reasonably could find in [its]
favor.” Santiago-Ramos v. Centennial P.R. Wireless Corp., 217 F.3d
46, 52 (1st Cir. 2000) (internal citation omitted); see also
Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574,
586 (1986) (discussing how the burden shifts to the nonmoving
party, who “must do more than simply show that there is some
metaphysical doubt as to the material facts”).
It is well-settled that “[t]he mere existence of a
scintilla

of

evidence”

is

insufficient

supported motion for summary judgment.

to

defeat

a

properly

Anderson, 477 U.S. at 252.

It is therefore necessary that “a party opposing summary judgment
must ‘present definite, competent evidence to rebut the motion.’”
Maldonado-Denis v. Castillo-Rodriguez, 23 F.3d 576, 581 (1st Cir.
1994) (internal citation omitted).

Otherwise, summary judgment is

appropriate if the non-moving party’s case rests merely upon
“conclusory allegations, improbable references, and unsupported

Civil No. 11-1131 (FAB)
speculation.”

18

Forestier Fradera v. Municipality of Mayagüez, 440

F.3d 17, 21 (1st Cir. 2006).
III. Legal Analysis
A federal court sitting in a diversity case must apply the
substantive law of the forum where the action is filed.

See

Rodriguez v. Señor Frog’s de la Isla, Inc., 642 F.3d 28, 36 (1st
Cir. 2011) (internal citations omitted).

In their complaint,

plaintiffs fail to identify the Puerto Rico Civil Code provisions
on which they base their claims.

(Docket No. 1.)

In Puerto Rico,

strict liability and negligence claims are governed by Article 1802
of the Puerto Rico Civil Code (“Article 1802”).

P.R. Laws. Ann.

Tit. 31 § 5141; see also Isla Nena Air Servs., Inc. v. Cessna
Aircraft Co., 449 F.3d 85, 88 (1st. Cir. 2006) (Even though the
Puerto

Rico

Civil

Code

does

not

explicitly

incorporate

“the

doctrine of strict liability, it is well-settled that Puerto Rico
courts have adopted that doctrine under Article 1802.”) (internal
citations omitted). Defendant Abbott claims that it is entitled to
summary

judgment

negligence claims.

on

both

plaintiffs’

(Docket No. 46.)

strict

liability

and

The Court first addresses

defendant Abbott’s arguments regarding strict liability and then
turns to Abbott’s arguments regarding negligence.
A.

Strict Liability
With

regard

to

products

liability,

Puerto

Rico

has

adopted the doctrine of strict liability “under principles flowing
from Article 1802.”

Isla Nena Air Servs., 449 F.3d at 88 (internal

Civil No. 11-1131 (FAB)
citation omitted).

19

Puerto Rico courts rely upon the principles in

section 402A of the Restatement (Second) of Torts in adopting the
strict liability doctrine.

Id.; see also Cruz-Vargas v. R.J.

Reynolds Tobacco Co., 348 F.3d 271, 276 (1st Cir. 2003); PerezTrujillo v. Volvo Car Corp (Sweden), 137 F.3d 50, 55 (1st Cir.
1998); Malave-Felix v. Volvo Car Corp., 946 F.2d 967 (1st Cir.
1991) (citing Montero Saldaña v. Am. Motors Corp., 107 D.P.R. 452
(1978)).

Under Puerto Rico law, a plaintiff must prove four

elements to prevail in a strict liability action:
had a

manufacturing

defect;

(2)

the

defect

(1) the product

made

the

product

unsafe8; (3) plaintiff used the product in a reasonably foreseeable
way; and (4) the defect proximately caused injury to the plaintiff.
Perez-Trujillo, 137 F.3d at 55 (internal citations and quotation
marks omitted).
Defendant Abbott argues that plaintiffs fail to provide
any expert testimony regarding the first element, that the product
was defective, or the fourth element, proximate causation. (Docket
No. 46 at p. 14.)

Plaintiffs respond that the evidence on the

docket–Abbott’s admission regarding the recall and the depositions
of plaintiffs and their infant’s treating physician–are sufficient
to establish that the infant’s acute gastroenteritis was caused by
contamination of the Similac formula.

8

(Docket No. 48 at p. 7.)

This criteria is “the single significant departure” from the
Restatement of Torts, which requires a plaintiff to prove that “the
defective product was unreasonably dangerous.” Perez-Trujillo, 137
F.3d at 55 (internal citations and quotation marks omitted).

Civil No. 11-1131 (FAB)

20

The magistrate judge found that plaintiffs failed to establish
causation, and, therefore, did not meet their burden to survive
summary judgment.

(Docket No. 56 at pp. 15-16.)

The Court agrees

with the magistrate judge because the plaintiffs have failed to
demonstrate a genuine dispute about (1) whether a defect existed in
the product, and (2) whether a defect in the milk formula caused
F.J.G.M.’s injury.
1.

Defect
Defendant Abbott argues that there is no evidence

from which a reasonable jury could find a defect in the milk
formula.
only

(Docket No. 46 at p. 18.)

use

the

recalls

and

the

Abbott argues that plaintiffs

FDA

notices

to

support

contention that the milk formula contained a defect.

their

Id.

This

evidence, Abbott contends, is inadmissible under the Federal Rules
of Evidence.

Id.

Even if this evidence is admissible, however,

Abbott argues that it contains little probative value.
pp. 18-19.

Id. at

Finally, Abbott argues that aside from the recall

notices, there is no other admissible evidence showing a defect in
the milk formula.

Id. at p. 18.

Plaintiffs respond that the

notices serve as Abbott’s admission that the formula was defective.
(Docket No. 48 at p. 11.)
The magistrate judge agreed with Abbott in her R&R
regarding Abbott’s motion for summary judgment.

She found that

Abbott’s recall notice and the FDA notices regarding the recall are
inadmissible under Federal Rules of Evidence 407 and 403.

The

Civil No. 11-1131 (FAB)

21

Court concurs with the magistrate judge; it finds that defendant
Abbott has shown that there is no genuine dispute of material fact
regarding the element of defect and that plaintiffs have failed to
show that a jury could reasonably find for them on this matter.
a.

Federal Rule of Evidence 407
Federal Rule of Evidence 4079 (“Rule 407”)

prohibits plaintiffs from introducing evidence that a defendant,
after an injury, took steps that would have made the injury or harm
less likely to occur.

The rule only applies to evidence of a

defendant’s remedial measures when offered to prove the defendant’s
fault; this includes, but is not limited to, when the evidence is
offered to prove a product defect.

Id.

Rule 407 allows this type

of evidence, however, for other purposes, such as to show that a
defendant

had

ownership

or

control

of

a

product,

or

that

precautionary measures were feasible, if controverted. Id. Recall

9

Rule 407 provides, in relevant part:
“When, after an injury or harm allegedly
caused by an event, measures are taken that,
if taken previously, would have made the
injury or harm less likely to occur, evidence
of the subsequent measures is not admissible
to prove negligence, culpable conduct, a
defect in a product, a defect in a product’s
design,
or
a
need
for
a
warning
or
instruction. This rule does not require the
exclusion of evidence of subsequent measures
when offered for another purpose, such as
proving ownership, control, or feasibility of
precautionary measures, if controverted, or
impeachment.”
Fed.R.Evid. 407 (emphasis
added).

Civil No. 11-1131 (FAB)

22

notices and warning decals that are issued after an accident or
injury are considered to be subsequent remedial measures under
Rule 407.

See Carballo-Rodriguez v. Clark Equipment, Co., Inc.,

147 F.Supp.2d 66, 77 (D.P.R. 2001); see also Cameron v. Otto Brock
Orthopedic Indus., Inc., 43 F.3d 14, 17 (1st Cir. 1994); Raymond v.
Raymond Corp., 938 F.2d 1518, 1523 (1st Cir. 1991); Benitez-Allende
v. Alcan Aluminio do Brasil, S.A., 857 F.26, 33 (1st Cir. 1988).
Abbott’s

recall

notice

occurred

on

September 22, 2010, announcing “a proactive, voluntary recall of
certain Similac-brand, powder infant formulas.” (Docket No. 48-6.)
In addition, Abbott stated that “[t]he FDA has determined that
while the formula containing [the] beetles poses no immediate
health risk, there is a possibility that infants who consume
formula containing the beetles or their larvae, could experience
symptoms of gastrointestinal discomfort and refusal to eat as a
result of small insect parts irritating the GI tract.”

Id.

The

FDA notices, which were issued on September 23, September 27, and
October 26, 2010, respectively, also state that while there are “no
long-term health problems, there is a possibility that infants who
consume formula containing the beetles or their larvae could
experience gastrointestinal discomfort and refusal to eat as a
result of small insect parts irritating the GI tract.”

(Docket

Nos. 48-2, 48-3, & 48-5.)
These statements, the plaintiffs argue, are
sufficient to show that a defect occurred. The recall notices that

Civil No. 11-1131 (FAB)

23

plaintiffs seek to use as evidence of a defect fall within the
purview of Rule 407:

they were issued after the accident or

injury, and they indicated that consumers should return the product
to Abbott.

Therefore, the notices are inadmissible to show that

the Similac formula contained warehouse beetles.

Plaintiffs fail

to

other

argue

that

the

notices are

permitted by Rule 407.

admissible

for

purposes

Nor do plaintiffs argue that defendant

Abbott has controverted any of the Rule 407 admissible purposes.
That result serves the “twofold purpose of Rule 407” as stated in
the Advisory Committee Notes.

Raymond, 938 F.2d at 1523.

First,

it prevents unfair prejudice to a defendant because “jurors would
too readily equate subsequent design modifications with admissions
of a prior defective design.”

Id.

social

manufacturers

policy

of

encouraging

Second, it “further[s] the
to

create

safer

products” by “continuing to update and improve upon the safety
features of their products after initial manufacture.”
b.

Id.

Federal Rule of Evidence 403
Even if the notices are admissible and are

relevant,10 they must comport with the requirement of Federal Rule
of Evidence 403 (“Rule 403”) that their probative value outweigh

10

Evidence is relevant when “(a) it has any tendency to make
a fact more or less probable than it would be without the evidence;
and (b) the fact is of consequence in determining the action.”
Fed.R.Evid. 401. The recall notices from Abbott and the FDA are
relevant because they have a tendency to make more probable the
existence of a defect in the Similac formula that F.J.G.M.
consumed.

Civil No. 11-1131 (FAB)

24

the danger of “unfair prejudice, confusing the issues, misleading
the jury, undue delay, wasting time, or needlessly presenting
cumulative evidence.”

See also United States v. Varoudakis, 233

F.3d 113, 122 (1st Cir. 2000).

The First Circuit Court of Appeals

has held that Rule 403 protects “against unfair prejudice, not
against all prejudice” (emphasis added). United States v. Whitney,
524 F.3d 134, 141 (1st Cir. 2008); see also United States v. AmayaManzanares, 377 F.3d 39, 45 (1st Cir. 2004) (discussing how all
relevant evidence that the government introduces is prejudicial in
some way to a defendant).

“‘Unfair prejudice’” within its context

means an undue tendency to suggest decision on an improper basis,
commonly, though not necessarily, an emotional one.”

Fed.R.Evid.

403, Advisory Committee Notes. Pursuant to Rule 403, a trial court
has “considerable latitude in determining whether to admit or
exclude evidence.”

Santos v. Sunrise Medical, 351 F.3d 587, 592

(1st Cir. 2003) (internal citations omitted).

When a trial court

finds the balancing close, “Rule 403 tilts the balance in favor of
admission.” Whitney, 524 F.3d at 141 (internal citations omitted).
Defendant

Abbott

contends

that

the

notices are “not remotely probative of defectiveness.”
No. 46 at pp. 18-19.)
this contention.

recall
(Docket

Plaintiff makes no arguments in response to

They merely state, in a cursory manner, that

Abbott admits in its notices that the formula was contaminated and
thus, defective.
defendant Abbott.

(Docket No. 48 at p. 11.)

The Court agrees with

Civil No. 11-1131 (FAB)

25

First, the First Circuit Court of Appeals has
stated that “[a]t best, subsequent remedial measures are considered
marginally probative of prior negligence.”

Keller v. United

States, 38 F.3d 16, 32 (1st Cir. 1994) (internal citation omitted).
Second, defendant Abbott has provided other evidence to suggest
that the probative value of the recall notices is low.

Matthew

Painter, the Senior Program Manager for Third Party Manufacturing
in the Abbott Nutrition Supply Chain of Abbott Laboratories,
provided an uncontested declaration that after Abbott discovered
beetles in its machinery, it tested an additional 30,486 containers
from over twenty batches of Similac powder manufactured in the
Sturgis plant. In total, only forty-nine beetles, larvae, or parts
were found in these containers, which means that only 0.16% of the
sample was found to be contaminated.

Plaintiffs also stated that

they never saw any insects in the formula that they fed to F.J.G.M.
Furthermore, defendant’s expert witness, Dr. Hyman, indicated that
he thoroughly reviewed the two sources that the FDA relied upon in
issuing its statement that the warehouse beetles “could” cause
minor illness, and he concluded that the FDA was not realistically
assessing the actual medical risk of ingesting the beetles; rather,
his research indicates that the FDA was acting with the “utmost of
caution.”

(Docket No. 46-2 at p. 4.)
The danger of unfair prejudice is high in this

case because of the possibility that the recall notices would
confuse or mislead the jury.

A recall notice by a manufacturer

Civil No. 11-1131 (FAB)

26

“does not admit a defect in a particular product, but refers to the
possibility of a defect in a class of products.”

See e.g., Bailey

v. Monaco Coach Corp., 350 F.Supp.2d 1036, 1045 (N.D. Ga. 2004)
(internal citation omitted).

As the Court indicated earlier,

however, jurors would too readily equate a recall notice with an
admission that the product was defective, and make the leap that
because warehouse beetles were found in the facility that produced
the milk formula, then the particular can of formula ingested by
F.J.G.M. also contained warehouse beetles.

Raymond, 938 F.2d at

1523; see also Carballo-Rodriguez, 147 F.Supp.2d at 77 (citing
Bogosian v. Mercedes-Benz of N. Am., Inc., 104 F.3d 472, 481 (1st
Cir. 1997)).
Because the high danger of unfair prejudice
outweighs the marginal probative value of the recall notices issued
by defendant Abbott and the FDA, the Court finds that there is no
evidence from which a reasonable jury could find a defect in the
milk formula.

Therefore, the Court ADOPTS IN FULL the magistrate

judge’s findings on the element of a product defect.
2.

Causation
Even if the plaintiffs established that a jury could

reasonably find for them with regard to whether there was a defect
in the milk formula, they have failed to demonstrate that a jury
could reasonably find that the milk formula caused F.J.G.M.’s
injuries. As the magistrate judge found, plaintiffs have failed to
introduce any expert testimony or any circumstantial evidence to

Civil No. 11-1131 (FAB)

27

support their claims that the milk formula caused the infant’s
illness.11 The Court ADOPTS IN FULL the magistrate judge’s findings
on the element of causation.
In Puerto Rico, strict liability claims “need not
adduce expert testimony to overcome a motion for summary judgment.”
Perez-Trujillo, 137 F.3d at 55.

“Strict liability claimants may

resort to an array of circumstantial evidence,” including direct
observations regarding the malfunction of a product, or other
circumstantial evidence, such as similar accidents involving the
same product, elimination of other possible causes of the accident,
and proof tending to establish that the accident does not occur
absent a manufacturing defect.

Id. at n. 10.

The necessity of

expert opinion evidence, however, is whether the question is one of
common knowledge such that lay people could “reach the conclusion
as intelligently as the witness.” Collazo-Santiago v. Toyota Motor
Corp., 937 F.Supp. 134, 140 (D.P.R. 1996) (internal citation and
quotation marks omitted).

If the question cannot be answered by

common experience, then expert testimony is required.

Id.

For

example, in Collazo, the plaintiff established that a car airbag
caused her injury because she “will personally testify that she
felt the airbag hit her face and abrade it.”

11

Id.

In this case,

Plaintiffs also argue that the recall notices issued by
Abbott and the FDA are sufficient to prove causation. Because the
Court found that these notices are inadmissible under Rule 407 and
Rule 403 as to the element of product defect, they are inadmissible
under these rules as to the element of causation as well.

Civil No. 11-1131 (FAB)

28

the facts are scientifically driven and plaintiffs cannot show that
the

milk

formula

experience.

caused

F.J.G.M.’s

injury

simply

via

common

Cf. Martinez-Serrano v. Quality Health Servs. of

Puerto Rico, Inc., 568 F.3d 278, 286 (1st Cir. 2009) (discussing
how plaintiffs generally have to provide expert testimony in
medical malpractice cases because “they tend to be scientifically
driven and more nuanced than most tort cases” but in a “narrow
band” of tort cases, some plaintiffs may not have to produce expert
testimony).
In her R&R regarding defendant Abbott’s motion to
dismiss, the magistrate judge warned that plaintiffs must provide
“expert medical testimony” because the issue of medical causation
is not something “within common knowledge of the layman.”
No. 23 at pp. 9-10.)

(Docket

The fact that the infant was sick after

consuming the Similac formula is insufficient to show that the
formula caused the infant’s illness.

See, e.g., Carmona v. S. Am.

Rests. Corp., No. 07-1314 (SEC), 2009 WL 928722, at *5 (D.P.R.
March 31, 2009) (granting summary judgment in a negligence action
when “nothing in the record points to [d]efendants’ product as the
cause of [plaintiff’s illness]” even though plaintiff was clearly
ill after consuming food at the restaurant).

Yet, plaintiffs have

failed to provide any expert testimony regarding causation. Abbott
argues

that

plaintiffs

have

not

tendered

any

expert

during

discovery in compliance with Federal Rule of Civil Procedure 26.
(Docket No. 46 at p. 17.)

Plaintiffs do not respond to this

Civil No. 11-1131 (FAB)
argument
judgment.

in

their

29

opposition

(Docket No. 48.)

to

Abbott’s

motion

for

summary

Indeed, their only testimony aside

from that of F.J.G.M.’s parents comes from Dr. Vargas, the infant’s
treating physician.

(Docket No. 48–9.)

Even if no expert testimony is required in this
case, plaintiffs fail to provide any circumstantial evidence to
establish that the Similac formula caused F.J.G.M.’s illness.

In

fact, both the testimony of the plaintiffs and Dr. Vargas show
circumstantial evidence establishing that F.J.G.M.’s sickness was
not caused by the Similac formula.
First, the plaintiffs testified that they did not
see any insect parts in the formula and have presented no other
evidence that anyone else who consumed the Similac formula has
experienced similar problems.

Second, on November 30, 2010, about

two months after the plaintiffs stopped giving F.J.G.M. the Similac
formula, F.J.G.M. was admitted to the hospital again with symptoms
similar

to

his

September

2010

illness,

including

acute

gastroenteritis, moderate dehydration, otitis, and tonsilitis.
This suggests

that

F.J.G.M.’s

illness

was not

caused

by

the

formula, as contended by plaintiffs; rather, the infant’s medical
history suggests that these symptoms are recurring problems for
F.J.G.M.
Finally,

Dr.

Vargas’

testimony

eliminates

contamination of the Similac formula as the cause of F.J.G.M.’s
illness and suggests that there are other more likely causes of the

Civil No. 11-1131 (FAB)
sickness.

30

For example, he testified that not only has he never

read or heard of a child suffering gastroenteritis due to eating
insects, including warehouse beetles, but that he also stopped
F.J.G.M’s ingestion of Amoxil because it can cause diarrhea.

He

also listed a number of other reasons that could have caused
F.J.G.M.’s gastroenteritis, including lactose intolerance and the
possibility that the infant’s ear infection caused a secondary
infection in the stomach and intestines.

Furthermore, Abbott’s

expert report confirms Dr. Vargas’ observations that F.J.G.M. may
have had a secondary infection from his illness:

Dr. Hyman stated

that there is “zero” chance that F.J.G.M.’s September 2010 illness
was caused by the ingestion of warehouse beetles and instead
indicated that the illness was probably due to an underlying
infection.
Plaintiffs have failed to establish that a jury
could reasonably find for them as to whether Abbott’s allegedly
defective milk formula caused the F.J.G.M.’s injury.

Instead, the

defendant has provided sufficient evidence to show that there is no
genuine dispute on the issue of causation.

Therefore, the Court

ADOPTS IN FULL the magistrate judge’s findings on the element of
causation.
Defendant Abbott has shown that there is no genuine
issue of

material

fact

regarding

the elements

of

defect

and

causation in a strict liability action, and plaintiffs have failed
to show that a jury could reasonably find in their favor.

For

Civil No. 11-1131 (FAB)

31

these reasons, the Court GRANTS defendant Abbott’s motion for
summary judgment regarding plaintiffs’ products liability claim.
B.

Negligence Under Article 1802
In Puerto Rico, Article 1802 of the Civil Code12 provides

for a cause of action resulting from an individual’s negligent act.
Isla Nena Air Servs., 449 F.3d at 88 (1st. Cir. 2006).

Under

Article 1802, plaintiffs must prove three elements of negligence:
(1) an injury, (2) a breach of duty, and (3) proximate causation.
Vasquez-Filippetti v. Banco Popular de P.R., 504 F.3d 43, 49 (1st
Cir. 2007) (internal citations omitted).

The second element

requires plaintiffs to show the existence of a duty and its breach.
Id. (quoting Rodriguez-Ortega v. Philip Morris, Inc., Civil No. 031529

(CCC),

2005

(“Plaintiffs

bear

WL
the

2977795,

at

*5-6

(D.P.R.

burden

of

establishing

Nov.
the

7,

2005)

applicable

standard of care and proving that [defendant] acted below that
standard.”) (internal citations and quotations omitted).

Abbott

correctly argues that plaintiffs have failed to establish the
applicable standard of care and that Abbott acted below that
standard.

(Docket No. 46 at p. 21.)

Abbott has provided evidence

to show that it performed extensive quality testing on the Similac
powdered milk formula at the Sturgis facility. Furthermore, Abbott
provided specific evidence that it employs a third-party pest-

12

The statute states, in relevant part, that “[a] person who
by an act or omission causes damage to another through fault or
negligence shall be obliged to repair the damage so done.” P.R.
Laws Ann. Tit. 31, § 5141.

Civil No. 11-1131 (FAB)

32

control company to service its Sturgis plant and that a July-August
2010 internal compliance audit and a March 2010 audit by the FDA
found no significant issues with the facility.

There is no

evidence from plaintiffs in the record establishing that these
actions by Abbott breached any applicable standard of care.

Thus,

there is no evidence in the record from which a jury could conclude
that Abbott breached any duty owed to plaintiffs.

Plaintiffs fail

to make any argument regarding this portion of Abbott’s motion even
though they acknowledge that they must show the duty owed by
defendant and that defendant breached that duty. (Docket No. 48 at
p.

11.)

Therefore,

defendant

Abbott

is

entitled

to

summary

judgment on plaintiffs’ Article 1802 negligence claim.
For

these

reasons,

the

Court

ADOPTS

IN

FULL

the

magistrate judge’s findings on plaintiffs’ negligence claim and
GRANTS defendant Abbott’s motion for summary judgment regarding
plaintiffs’ negligence claim.
IV.

CONCLUSION
Accordingly, the Court GRANTS defendant Abbott’s motion for

summary judgment. This case is therefore DISMISSED with prejudice.
Judgment shall be entered accordingly.
IT IS SO ORDERED.
San Juan, Puerto Rico, October 30, 2012.

s/ FRANCISCO A. BESOSA
FRANCISCO A. BESOSA
UNITED STATES DISTRICT JUDGE