Niedner v. Ortho-McNeil Pharmaceutical, Inc.

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15-P-1272 Appeals Court

LESLIE NIEDNER, administratrix,1 vs. ORTHO-McNEIL
PHARMACEUTICAL, INC., & others.2

No. 15-P-1272.

Suffolk. May 5, 2016. - September 21, 2016.

Present: Cypher, Blake, & Henry, JJ.

Negligence, Duty to warn, Pharmaceutical manufacturer, Design,
Defective product, Manufacturer. Contract, Warranty.
Warranty. Negligence, Misrepresentation. Consumer
Protection Act, Unfair or deceptive act. Conscious Pain
and Suffering. Practice, Civil, Summary judgment.

Civil action commenced in the Superior Court Department on
September 21, 2010.

The case was heard by Heidi E. Brieger, J., on a motion for
summary judgment.

Roopal P. Luhana, of New York, for the plaintiff.
Susan M. Sharko, of New Jersey, for Ortho-McNeil
Pharmaceutical, Inc., and others.

1
Of the estate of Adrianna Duffy.
2
Johnson & Johnson; Johnson & Johnson Pharmaceutical
Research and Development, LLC (formerly known as R.W. Johnson
Pharmaceutical Research Institute); and Sara M. Nelson.
2

BLAKE, J. Adrianna Duffy was a seventeen year old college

student when she collapsed in her dormitory room and died of a

pulmonary embolism. Duffy's mother, Leslie Niedner, as

administratrix of Duffy's estate, filed a complaint against the

defendants, Ortho-McNeil Pharmaceutical, Inc.; Johnson &

Johnson; and Johnson & Johnson Pharmaceutical Research and

Development, LLC (collectively, J & J), alleging multiple causes

of action relating to J & J's birth control product, Ortho Evra.3

Following a hearing on J & J's motion for summary judgment, a

judge of the Superior Court allowed the motion and ordered the

dismissal of the complaint in its entirety. We affirm.

Background. The following undisputed facts are taken from

the summary judgment record. Sara M. Nelson of the

Massachusetts General Hospital Chelsea Healthcare Clinic was

Duffy's pediatrician from about October of 2004, until her death

in 2009. In July, 2008, Duffy, accompanied by Niedner, met with

Nelson to discuss birth control options. Nelson recommended and

prescribed an oral birth control pill. The prescription was

filled in July, August, and September of 2008. Duffy also used

3
Defendant Sara M. Nelson, Duffy's pediatrician, entered
into a stipulation with the other parties that Nelson would be
dismissed from the case. Whether the dismissal is with or
without prejudice depends on the outcome of this appeal.
3

condoms when she was sexually active. At some point thereafter,

Duffy discontinued her use of oral birth control pills.

In June, 2009, Duffy decided that she needed a backup birth

control method, again, in addition to condoms. She and Niedner

met with Nelson on June 23, 2009, to discuss Duffy's options.

Duffy asked Nelson about the Ortho Evra patch (patch), as she

wanted an easy and simple method of birth control. The patch

prevents pregnancy by transferring synthetic forms of the

hormones estrogen and progestin through the skin. Unlike oral

birth control pills, which must be taken at the same time each

day, the patch is applied to the skin once per week for three

weeks, followed by a fourth patch-free week.

Nelson prescribed the patch for Duffy at that meeting. As

she had when she prescribed oral birth control pills, Nelson

informed Duffy and Niedner of the risks associated with using

the patch, including that all hormonal contraceptives come with

a risk of suffering blood clots.4 When the prescription was

filled by Walgreens pharmacy (pharmacy), the package included an

insert prepared by J & J (the manufacturer), as well as a

leaflet from the pharmacy, both of which set forth the risks

associated with use of the patch, including the risks of stroke,

4
Nelson testified at her deposition that she was aware of
one study that suggested that the risk of clotting was
potentially double in users of the patch as compared to users of
oral contraceptives.
4

heart attack, and blood clots. Approximately three months after

Duffy began using the patch, she died from a massive bilateral

pulmonary embolus.

On October 29, 2010, Niedner filed her first amended

complaint alleging that Duffy's use of the patch had caused her

death, and that J & J was liable for breach of warranty (under

theories of design defect, failure to warn, and manufacturing

defect), breach of express warranty, negligence, fraudulent

concealment, conscious pain and suffering, and violating the

consumer protection act, G. L. c. 93A.5 The complaint centers on

Niedner's failure to warn claim, which is based on her

allegation that she and Duffy were not told that the risk of

suffering a blood clot is significantly increased with use of

the patch as compared to an oral contraceptive. Put another

way, Niedner's complaint is focused on the comparative risk of

developing blood clots, not the risk of developing blood clots

in and of itself. J & J moved for summary judgment, arguing

that the risks of using the patch, including the increased risk

of blood clots, were adequately disclosed, and that Niedner's

remaining causes of action fail as a matter of law for lack of

evidence. The judge agreed and allowed the motion. After

5
An additional count alleged professional negligence as to
Nelson only.
5

judgment entered, this appeal followed. Additional facts will

be set forth as necessary.

Discussion. 1. Standard of review. "We review a grant of

summary judgment de novo to determine 'whether, viewing the

evidence in the light most favorable to the nonmoving party, all

material facts have been established and the moving party is

entitled to a judgment as a matter of law.'" Juliano v.

Simpson, 461 Mass. 527, 529-530 (2012), quoting from Augat, Inc.

v. Liberty Mut. Ins. Co., 410 Mass. 117, 120 (1991). See

Mass.R.Civ.P. 56(c), as amended, 436 Mass. 1404 (2002). "The

moving party bears the burden of affirmatively demonstrating the

absence of a triable issue." Lev v. Beverly Enterprises-Mass.,

Inc., 457 Mass. 234, 237 (2010). "Conclusory statements,

general denials, and factual allegations not based on personal

knowledge [are] insufficient to avoid summary judgment." Madsen

v. Erwin, 395 Mass. 715, 721 (1985), quoting from Olympic Jr.,

Inc. v. David Crystal, Inc., 463 F.2d 1141, 1146 (3d Cir. 1972).

2. Duty to warn. Ordinarily, a manufacturer of a product

with known dangers has a duty to warn consumers who will

foreseeably come in contact with, and be endangered by, the

product of those dangers. H. P. Hood & Sons v. Ford Motor Co.,

370 Mass. 69, 75 (1976). When communication with a consumer is

unreasonable, however, the "manufacturer may be absolved from

blame because of a justified reliance upon . . . a middleman."
6

MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 135

(1985), quoting from Carter v. Yardley & Co., 319 Mass. 92, 99

(1946). Under this "learned intermediary rule," a drug

manufacturer's duty to warn is generally discharged by providing

physicians with an adequate warning about any risks associated

with its prescription drug products. Id. at 136, quoting from

McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 386-387

(1974) ("the duty of the ethical drug manufacturer is to warn

the doctor, rather than the patient, [although] the manufacturer

is directly liable to the patient for a breach of such duty").

"The rationale underlying the prescription drug rule is that the

prescribing physician, as the 'learned intermediary' standing

between the manufacturer and consumer/patient, is generally in

the best position to evaluate the potential risks and benefits

of ingesting a certain drug and to advise the patient

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

Cir. 1992) (applying Massachusetts law).

In MacDonald, the Supreme Judicial Court created a narrow

exception to the learned intermediary rule, holding that a

manufacturer of oral contraceptives was "not justified in

relying on warnings to the medical profession to satisfy its

common law duty to warn," but also had a duty to directly warn

the consumer about the risks of taking birth control. Id. at

138. The court noted several factors that set birth control
7

pills apart from other prescription drugs, such as "the

heightened participation of patients in decisions relating to

use of 'the pill'; . . . the limited participation of the

physician," and that less medical supervision is provided as

compared with other prescription drugs. Ibid. The court also

found significant that Federal regulations require that

manufacturers of oral contraceptives warn consumers directly of

their risks. Ibid. Because the patch is a hormonal birth

control product, like the birth control pills at issue in

MacDonald, the court's holding in that case controls here.

Accordingly, J & J had a duty to directly warn Duffy of the

risks associated with use of the patch.

3. Adequacy of the warning. The box containing the

patches purchased by Duffy contained an insert entitled

"DETAILED PATIENT LABELING." The insert explains how to use the

patch and the risks associated with its use, and informs

consumers that they should consult their physician to discuss

the information contained in the insert. Both Duffy and Niedner

read the insert for the patches Duffy purchased. Neither Duffy,

nor Niedner, consulted Nelson concerning the patch after she

prescribed it. The relevant portions of the insert, as reviewed

by Duffy and Niedner, are as follows:

"DESCRIPTION
8

"The contraceptive patch ORTHO EVRA® is a thin, beige,
plastic patch that sticks to the skin. The sticky part of
the patch contains the following hormones: norelgestromin
(progestin) and ethinyl estradiol (estrogen). These
hormones are absorbed continuously through the skin and
into the bloodstream. On average, the amount of estrogen
delivered through the skin produces estrogen exposure that
is higher than the exposure when taking a birth control
pill containing 35 micrograms of estrogen" (emphasis
supplied). . . .

"INTRODUCTION
"Any woman who considers using the contraceptive patch
ORTHO EVRA® should understand the benefits and risks of
using this form of birth control. This leaflet will give
you much of the information you will need to make this
decision and will also help you determine if you are at
risk of developing any serious side effects. It will tell
you how to use the contraceptive patch properly so that it
will be as effective as possible. However, this leaflet is
not a replacement for a careful discussion between you and
your health care professional. You should discuss the
information provided in this leaflet with him or her, both
when you first start using the contraceptive patch ORTHO
EVRA® and during your revisits. . . .

"OTHER CONSIDERATIONS BEFORE USING ORTHO EVRA®
"Hormones from ORTHO EVRA® get into the blood stream and
are processed by the body differently than hormones from
birth control pills. You will be exposed to about 60% more
estrogen if you use ORTHO EVRA® than if you use a typical
birth control pill containing 35 micrograms of estrogen.
In general, increased estrogen may increase the risk of
side effects." (Emphasis in original.)

"The risk of venous thromboembolic events (blood clots in
the legs and/or the lungs) may be increased with ORTHO
EVRA® use compared with use of birth control pills.
Studies examined the risk of these serious blood clots in
women who used either ORTHO EVRA® or birth control pills
containing one of two progestins (levonorgestrel or
norgestimate) and 30-35 micrograms of estrogen. Results of
these studies ranged from an approximate doubling of risk
of serious blood clots to no increase in risk in women
using ORTHO EVRA® compared to women using birth control
pills" (emphasis supplied).
9

"You should discuss this possible increased risk with your
healthcare professional before using ORTHO EVRA®. Call
your healthcare professional immediately if any of the
adverse side effects listed under 'WARNING SIGNALS' occur
while you are using ORTHO EVRA®. . . .

"RISKS OF USING HORMONAL CONTRACEPTIVES, INCLUDING ORTHO
EVRA® . . . .

"1. Risk of Developing Blood Clots
"Blood clots and blockage of blood vessels that can cause
death or serious disability are some of the most serious
side effects of using hormonal contraceptives, including
the ORTHO EVRA® contraceptive patch. In particular, a clot
in the legs can cause thrombophlebitis, and a clot that
travels to the lungs can cause sudden blocking of the
vessel carrying blood to the lungs. . . .

"The risk of venous thromboembolic disease (blood clots in
the legs and/or the lungs) may be increased with ORTHO
EVRA® compared with that of oral contraceptives containing
norgestimate and 35 mcg of estrogen (see the earlier
Section OTHER CONSIDERATIONS BEFORE USING ORTHO EVRA®).
You should discuss this possible increased risk with your
healthcare professional before using ORTHO EVRA®. Call
your healthcare professional immediately should any of the
adverse effects listed under 'WARNING SIGNALS' occur while
you are using ORTHO EVRA®." (Emphasis supplied.)

Here, it is undisputed that Duffy developed blood clots in

her lungs. This is a risk expressly set forth in the insert,

where it is described in no less than four places. The greater

dose of estrogen, and the corresponding increased risk of

adverse events, such as blood clots, also is clearly stated in

plain language. The insert also cautions that it is not a

replacement for careful discussion between the patient and her

healthcare professional and that these discussions should take

place when the patient first uses the patch and during the
10

patient's revisits. As a matter of law, the insert adequately

warned both Niedner and Duffy of the increased risk of

developing blood clots that could result in death, as compared

to the risks associated with the birth control pill, in terms

understandable to a lay person. See MacDonald, 394 Mass. at

140, quoting from Restatement (Second) of Torts § 328B(d) and

comment g (1965) ("A court may, as a matter of law, determine

'whether the defendant has confirmed to [the common law duty to

warn] standard'").

Niedner nevertheless claims the holding in MacDonald

compels a reversal of the summary judgment in favor of J & J

because the insert failed to warn that the patch "delivers a

variable and unreasonably dangerous amount of estrogen, up to 56

micrograms, directly to the bloodstream, unlike any

contraceptive on the market and, as a result, it is twice as

likely to cause a fatal blood clot." In MacDonald, supra at

134, the plaintiff suffered a stroke. The manufacturer in that

case, however, did not expressly warn of "stroke," but only of

fatal blood clots that could lodge in the lungs or the brain.

Id. at 132-133. The court upheld a jury's determination that

the warning was insufficient because it failed to include the

word "stroke." Id. at 141. Here, the insert was abundant in

its warning of the possibility of blood clots in the lungs that

could lead to death, including the outcome of one study that
11

showed a doubling of the risk of serious blood clots as compared

to oral contraceptives. Unlike in MacDonald, the insert here

did not omit language that would have been more understandable

to an average user. Rather, as we have noted, the warnings were

plain, numerous, and comprehensive.

4. Design defect. For a product to be defective, it must

be "'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), quoting from Prosser, Torts § 99, at 659 (4th ed. 1971).

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 290-291. See Evans v.

Lorillard Tobacco Co., 465 Mass. 411, 428 (2013). Here, Niedner

contends that oral contraceptives, which are taken daily, are a

feasible and safer alternative design to the patch, which is

applied once per week for three weeks, with the fourth week

being patch-free. While both products are hormonal

contraceptives that prevent pregnancy, the difference in the

drug delivery method, each of which has its own advantages and

disadvantages, makes the pill fundamentally different from the

patch. See id. at 431 ("[I]n a case where the allegedly

defective product is a cigarette, the reasonable alternative

design must also be a cigarette"). See also Restatement (Third)
12

of Torts: Products Liability § 2 illustration 9, at 26-27

(1998). As such, one cannot serve as a safer alternative for

the other.

5. Manufacturing defect. A manufacturer of a product that

is dangerous due to a lack of reasonable care in its manufacture

or inspection owes a legal duty to those who will foreseeably

come into contact with it to use reasonable care to prevent

injury to those persons. Carter v. Yardley & Co., 319 Mass. at

96. The proper inquiry is "whether the deviation from the

design rendered the product unreasonably dangerous and therefore

unfit for its ordinary purposes." Back v. Wickes Corp., 375

Mass. 633, 641 (1978). The summary judgment record is devoid of

any evidence that the specific patch used by Duffy was

manufactured differently, or deviated in any respect from its

intended design.6

6. Remaining claims. Niedner's remaining claims are

likewise unsupported by the record and require little analysis.

No breach of express warranty occurred because the risks

associated with use of the patch were clearly explained in the

insert, and J & J made no representations or specific promises

to Niedner or Duffy other than those contained therein. See

G. L. c. 106, § 2-313(1)(a). Because Niedner has failed to

6
Niedner does not contend that the patch was ineffective
for the purpose of birth control. Indeed, there is no evidence
that Duffy became pregnant.
13

demonstrate that the insert was inaccurate, false, or deceptive,

her c. 93A and negligent misrepresentation claims also fail.

See G. L. c. 93A, § 2; Fox v. F & J Gattozzi Corp., 41 Mass.

App. Ct. 581, 587-588 (1996).7

Finally, recovery for a decedent's conscious pain and

suffering requires "cognizable proof beyond mere surmise." Heng

Or v. Edwards, 62 Mass. App. Ct. 475, 492 (2004). Because the

summary judgment record contains no evidence to support this

claim beyond Niedner's unsupported contention that sudden death

from blood clots would cause such suffering, it also fails.

Judgment affirmed.

7
Massachusetts does not recognize an independent claim for
fraudulent concealment. Rather, G. L. c. 260, § 12, tolls the
statute of limitations for a cause of action if an alleged
wrongdoer concealed its existence through some affirmative act
done with the intent to deceive. The statute has no application
here. See Hays v. Ellrich, 471 Mass. 592, 601-602 (2015).