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SJC-11677
LISA RECKIS & another1 vs. JOHNSON & JOHNSON & another.2
Plymouth. December 1, 2014. - April 17, 2015.
Present: Gants, C.J., Spina, Cordy, Botsford, Duffly, & Lenk,
JJ.
Negligence, Pharmaceutical manufacturer, Defective product,
Adequacy of warning, Causation, Causing loss of consortium.
Consortium. Parent and Child, Consortium. Federal
Preemption. Witness, Expert. Evidence, Expert opinion,
Qualification of expert witness. Damages, Tort, Future
damages, Future earning capacity, Conscious pain and
suffering, Loss of consortium.
Civil action commenced in the Superior Court Department on
January 12, 2007.
The case was tried before Christopher J. Muse, J., a motion
for remittitur was heard by him, and motions for a new trial and
for judgment notwithstanding the verdict were considered by him.
The Supreme Judicial Court granted applications for direct
appellate review.
1
Richard Reckis. Both Lisa and Richard sued individually
and as parents and natural guardians of their minor child,
Samantha T. Reckis.
2
McNeil-PPC, Inc., doing business as McNeil Consumer &
Specialty Pharmaceuticals.
2
Joan A. Lukey (Charles C. Lifland, of California, & Justin
J. Wolosz with her) for the defendants.
Michael B. Bogdanow (Bradley M. Henry, Leo V. Boyle, &
Victoria Santoro with him) for the plaintiffs.
The following submitted briefs for amici curiae:
David C. Spangler, Richard F. Kingham, & Robert A. Long,
Jr., of the District of Columbia, & Paul W. Schmidt & Colleen
Kelly for Consumer Healthcare Products Association.
Lisa Blue Baron, Andre M. Mura, & Jeffrey R. White, of the
District of Columbia, & Anthony Tarricone for American
Association for Justice.
Hugh F. Young, Jr., of Virginia, & David R. Geiger &
Catherine C. Deneke for Product Liability Advisory Council, Inc.
Martin Healy, Charles Alagero, Jeffrey N. Catalano, & Maria
Davis for Massachusetts Bar Association & another.
Charlotte E. Glinka, Elizabeth N. Mulvey, Thomas R. Murphy,
& Jeffrey S. Beeler for Massachusetts Academy of Trial
Attorneys.
Martha Coakley, Attorney General, & Eric Gold, Assistant
Attorney General, for the Attorney General.
BOTSFORD, J. Samantha T. Reckis was seven years old in
late 2003, when she developed toxic epidermal necrolysis (TEN),
a rare but life-threatening skin disorder, after receiving
multiple doses of Children's Motrin. Children's Motrin is an
over-the-counter (OTC) medication with ibuprofen as its active
ingredient, and is manufactured and sold by the defendants
McNeil-PPC, Inc. (doing business as McNeil Consumer & Specialty
Pharmaceuticals [McNeil]), and its parent company, Johnson &
Johnson. The plaintiffs, Lisa and Richard Reckis, and their
child, Samantha,3 claim that Samantha developed TEN as a result
of being exposed to ibuprofen in the Children's Motrin that was
3
Because all the plaintiffs share a last name, we refer to
them by their first names in this opinion.
3
administered to her, and that the warning label on the
Children's Motrin bottle rendered the product defective because
it failed to warn consumers adequately about the serious risk of
developing a life-threatening disease from it. After a lengthy
jury trial in the Superior Court, the jury found in favor of the
plaintiffs, awarding general damages to Samantha and loss of
consortium damages to each of her parents.
Before us is the defendants' appeal from the Superior Court
judgment. They raise three claims: (1) the defendants were
entitled to judgment as a matter of law because the plaintiffs'
central claim of failure to warn is preempted by the Food, Drug,
and Cosmetic Act (FDCA), 21 U.S.C. §§ 301 et seq., as
administered by the Federal Food and Drug Administration (FDA);
(2) the defendants also are entitled to judgment as a matter of
law because the plaintiffs failed to prove causation as a matter
of law -- in the defendants' view, the plaintiffs' causation
witness, Randall Tackett, Ph.D., was unqualified to render the
opinions on causation that he did, his opinions were not
scientifically reliable in any event, and there was no other
competent evidence on which the necessary element of causation
could be based; and (3) the damages awarded to each of the
plaintiffs were "grossly excessive" and unsupported by the
record. For the reasons we shall discuss, we affirm the
Superior Court judgment.
4
Background. We summarize the facts from the evidence
presented at trial.
1. On the afternoon of November 28, 2003, seven year old
Samantha had a fever and sinus congestion and, consequently, her
father purchased a bottle of OTC Children's Motrin. The bottle
was packaged inside a box, with identical warnings on the
outside of the box and on the bottle. Richard read the warnings
on each, and administered a dose of Children's Motrin to
Samantha around 2 P.M. that day. Samantha then took a nap until
approximately 10 P.M., at which point she woke still with a
fever and congestion, and Richard gave her a second dose of
Children's Motrin.4
The next morning, on November 29, Samantha woke with
redness and a rash on her chest and neck, and a sore throat; she
also had the same fever and congestion as she had had the night
before. Richard gave her a third dose of Children's Motrin.
Richard testified at trial that he would not have given Samantha
the third dose had the drug's label warned that redness, rash,
or blisters might lead to a life-threatening disease, or if the
label had warned that these symptoms could be signs of Stevens-
4
Samantha had taken Children's Motrin once before, in
October, 2002.
5
Johnson Syndrome (SJS) or TEN.5 He further stated that he would
have prevented others from administering additional doses of
Children's Motrin to Samantha had these warnings been on the
drug.
Around 9 A.M. on November 29, Richard telephoned Samantha's
mother to tell her about Samantha's rash, and Lisa made an
appointment for Samantha to see her pediatrician.6 When Richard
brought Samantha to Lisa's home around noon that day to pick up
Lisa on the way to the appointment, Samantha had a fever, nasal
congestion, crusty eyes, cracked lips, and a rash. The
pediatrician opined that Samantha had the measles, and told
Richard and Lisa to treat Samantha with Motrin three times per
day. Lisa gave Samantha another dose of Children's Motrin that
evening after reading the warning label on the bottle. Lisa
testified at trial that she would not have given this dose had
the drug's label mentioned rash as a warning signal.
When Samantha woke up the next morning, on November 30,
most of her body was covered in blisters. She could not open
her eyes or mouth, and her lips were bleeding. Richard and Lisa
took Samantha to the emergency room of Jordan Hospital (Jordan)
5
Richard also testified, however, that he was not familiar
with Stevens-Johnson Syndrome (SJS) or toxic epidermal
necrolysis (TEN) at the time.
6
Richard and Lisa were separated at the time, and were
divorced by the time of trial.
6
where she received another dose of ibuprofen. When Samantha's
condition worsened that day, she was transferred to
Massachusetts General Hospital (MGH) and, shortly thereafter, to
Shriners Hospitals for Children (Shriners) in Boston, where
doctors diagnosed Samantha with TEN and informed Lisa and
Richard that Samantha had a minuscule chance of surviving
through the night. Tests administered at Jordan, MGH, and
Shriners essentially ruled out a virus as the cause of
Samantha's disease.
Samantha was put into a medically induced coma to ease her
pain for approximately one month beginning on December 1, and
was hospitalized for the next six months. During her
hospitalization, Samantha's TEN resulted in bloody secretions
and affected approximately ninety-five per cent of her body's
surface area; the top layer of her skin died and sloughed off.
She suffered heart and liver failure. At one point, while Lisa
cradled Samantha in her arms at the hospital, Samantha suffered
a stroke followed shortly thereafter by an aneurysm. She also
suffered a cranial hemorrhage that caused seizures, and
underwent brain surgery. While in the hospital, she had only
twenty per cent of her lung capacity; falling below fifteen per
cent of lung capacity puts one at high risk of death. Her eyes
were inflamed. Samantha became addicted to pain medications
that were given to her to ease her discomfort, and she suffered
7
visible withdrawal symptoms, shaking and shivering as she was
weaned off the medications. Around the time of her release from
the hospital in May of 2004, Samantha weighed approximately
thirty-five pounds.
The jury heard conflicting expert testimony concerning
whether Children's Motrin had caused Samantha's TEN. The
plaintiffs' expert witness Randall Tackett testified that the
medication did so, as did both Dr. Bonnie Mackool, the director
of inpatient dermatology services at MGH and the director of
dermatology at Shriners, who treated Samantha during her initial
six-month hospitalization, and Dr. Stephen Foster, Samantha's
treating ophthalmologist at the time of trial who had treated
Samantha since that initial hospitalization. Other experts,
including the defense witnesses Dr. Stanford T. Shulman and Dr.
Maja Mockenhaupt, testified that ibuprofen had not caused
Samantha's TEN.
After being released from the hospital in the spring of
2004, Samantha needed to eat through a feeding tube for two
years, and required oxygen assistance at night for two years as
well. On occasion, the feeding tube would become dislodged,
resulting in pain. She returned to school in the fall of 2004
and repeated first grade; during that school year, Samantha's
teacher had to carry her up and down stairs due to her small
size, and Samantha needed to visit the school nurse every day to
8
eat lunch through her feeding tube. At the time of trial in
early 2013, Samantha was sixteen years old and weighed eighty-
two pounds.
Between her initial release from MGH and Shriners in 2004
and trial, Samantha had been hospitalized several times with
pneumonia and for trouble with her breathing, and she had had
multiple bouts of bronchitis. She had scarring in her lungs.
By 2011, Samantha's lungs had improved but they still functioned
at less than half of their capacity, and she could not engage in
any athletic activities. Samantha's pediatrician testified
that, as a result of Samantha's low lung capacity, she will not
be able to maintain a pregnancy.
Since 2004, Samantha has had more than twelve eye
surgeries. Before a surgery conducted shortly before trial
during which doctors implanted a prosthesis to replace the lens
of the cornea in Samantha's left eye, Samantha was legally
blind.7 Following this surgery, Samantha will be required to
apply topical antibiotics to her eye often for the remainder of
her life, and have her contact lens changed by a specialist each
7
Although there was a complication deriving from this
surgery, the eye surgeon who performed it testified at trial
that he was confident this problem could be addressed. However,
while not part of the trial record, posttrial filings include an
affidavit of the eye surgeon indicating that since trial,
Samantha had undergone multiple surgeries to correct the
problem, to no avail by that point, and would lose her left eye
if surgical correction were ultimately to prove unsuccessful.
9
month. Samantha's right eye suffers from in-turned eye lashes
that rub against her scarred cornea, resulting in mucus
stimulation collecting on the cornea. To read, she has used a
projector to enlarge the type, and she sits very near to the
screen onto which the words are projected. She needs to press
her nose to her telephone or the television to see what is on
the screen of each.
At the time of trial Samantha was in the ninth grade. She
was an honors student, but it took her much longer than other
students to complete her homework. She enjoyed her coursework
at school, liked to shop at the mall with friends, and often
played video games. Samantha was close to her parents before
developing TEN and remained so after it. She testified that she
wants to attend college and study nursing, and that she hopes to
work as a nurse at MGH.
Despite her optimism, Samantha suffers cognitive
limitations, and her memory is not as sharp as it was before her
illness. Due to her memory loss, she struggles to retain
information, which makes completing her schoolwork a constant
challenge. She will never be able to drive an automobile, and
she remains dependent on others for assistance in her daily
life. For the remainder of her life, she will be at increased
risk for frequent hospitalizations, lung problems such as asthma
and wheezing at a minimum, and further eye complications, such
10
as glaucoma.8 She also will always be at a great risk of illness
and at a severe disadvantage in terms of fighting disease due to
her pulmonary deficiencies and low body weight.
During the acute stage of Samantha's TEN and in the years
that followed, her parents devoted themselves to caring for
Samantha’s many needs. They stayed with her throughout her
hospitalization. Richard spent nights in a reclining chair, and
Lisa slept in a room the size of a closet. They suffered
significant distress in monitoring the progression of Samantha's
disease and were often told during Samantha's hospitalization
that she would not survive. Since then, Richard, who previously
worked as a chef, took a job at a local gasoline station because
the shorter hours permitted him to better tend to Samantha. In
all, they have not been able to watch Samantha enjoy a normal
childhood as a result of the numerous, significant, and constant
challenges to her health.
2. The defendants manufacture and market the Children's
Motrin brand of ibuprofen, which is a nonsteroidal anti-
inflammatory drug (NSAID) used to treat minor aches and pains as
well as fever.9 In 1989, the FDA, which approves and regulates
8
See note 7, supra.
9
At trial, the defendants disputed that Johnson & Johnson
played a role in the manufacture of over-the-counter (OTC)
Children's Motrin, and Johnson & Johnson moved for a directed
verdict on this ground. The judge denied the motion. The jury
11
prescription and nonprescription medications, approved McNeil to
sell pediatric prescription ibuprofen called Pedia Profen, and
in 1995, McNeil obtained FDA approval to sell Children's Motrin
as an OTC pediatric fever reducer and pain reliever.
TEN and SJS are severe disorders or diseases that attack
the skin, resulting in a rash and a diffused eruption of
blisters and significant damage to the mucosal membranes
throughout the body, particularly the mouth, eyes, and genital
and anal areas. SJS occurs where less than ten per cent of the
body's surface is affected by the disorder, while TEN occurs
where more than thirty per cent of the body's surface is so
affected.10 Both diseases can lead to scarring and infection;
with TEN, the top layer of skin dies and the skin sloughs off,
leaving raw areas that are predisposed to infection, a condition
that can lead to death. SJS and TEN can cause blindness and
significant damage to the respiratory and reproductive systems.
According to the FDA, SJS has a mortality rate of five per cent,
and TEN is fatal in some thirty per cent of cases.11 The jury
answered separate special questions finding each defendant
equally liable. The defendants do not raise any issue
concerning Johnson & Johnson individually on appeal.
10
If between ten per cent and thirty per cent of the body's
surface is affected by the skin reaction, the disease is
classified as SJS/TEN.
11
SJS and TEN are rare disorders or diseases. The Food and
Drug Administration (FDA) estimated in 2006 that "the overall
12
heard testimony from both parties' experts indicating that
ibuprofen, the active ingredient in Children’s Motrin, is
associated with SJS and TEN.
3. When Samantha was given OTC Children's Motrin in 2003,
the "warnings" section of the FDA-approved Children's Motrin
label contained an "[a]llergy alert" that read as follows:
"Ibuprofen may cause a severe allergic reaction which
may include:
▪ hives ▪ facial swelling
▪ asthma (wheezing) ▪ shock"
The warnings section of the label also alerted consumers to
"[s]top use and ask a doctor if . . . an allergic reaction
occurs" or if "any new symptoms appear." The label did not
mention SJS or TEN, the possibility of skin reddening, rash,
blisters, or the onset of a life-threatening disease.12
On February 15, 2005, a group that included physicians and
Tackett13 submitted to the FDA a petition concerning the
relationship between ibuprofen and SJS and TEN (citizen
incidences of SJS and TEN range from 1.2 to 6 [cases] per
million [persons] per year and 0.4 to 1.2 [cases] per million
[persons] per year, respectively."
12
However, the label of prescription Children's Motrin did
warn at this time that Motrin may cause SJS and TEN.
13
Randall Tackett, Ph.D., is a pharmacologist who was an
expert witness for the plaintiffs at trial.
13
petition).14 The citizen petition requested the FDA to "conduct
a risk assessment of [SJS] and [TEN] associated with the use of
ibuprofen products" and to "require manufacturers of ibuprofen
to amplify their prescription and [OTC] labeling to adequately
warn" of the risks of SJS and TEN.15 Specifically, the citizen
petition requested two alterations to the OTC ibuprofen warning
label. The first request was the inclusion of the following
language in the "[w]arnings" section of the label:
"Serious Skin Reactions: Ibuprofen may cause serious
skin reactions that begin as rashes and blisters on
the skin, and in the areas of the eyes, mouth and
genitalia. These early symptoms may progress to more
serious and potentially life-threatening diseases,
including . . . [SJS] and [TEN]. Seek immediate
attention if any of these symptoms develop while
taking ibuprofen" (emphasis added).
The second request was for the addition of the following new
warning:
"Stop use and ask a doctor if: a skin rash or
blisters on the eyes, mouth or genitalia occur because
these symptoms may be an early sign of rare and life-
threatening reactions including" SJS and TEN.
14
An individual may file a petition with the FDA to request
that it "issue, amend, or revoke a regulation or order, or . . .
take or refrain from taking any other form of administrative
action." 21 C.F.R. § 10.25(a)(2) (1989). See In re Prograf
Antitrust Litig., U.S. Dist. Ct., No. 1:11-md-2242-RWZ (D. Mass.
Feb. 1, 2012).
15
The citizen petition included references to studies and
literature that, according to the petition, indicated an
association between ibuprofen and SJS and TEN. It also
incorporated an analysis of reports of adverse reactions to
ibuprofen, and a safety assessment of nonsteroidal anti-
inflammatory drugs (NSAIDs) performed by the petitioners.
14
In the alternative, the citizen petition requested that the
FDA reconsider its approval of OTC pediatric ibuprofen
products.
The FDA responded formally to the citizen petition in 2006.
Before doing so, the agency engaged in what it termed "a
comprehensive review of the risks and benefits" of ibuprofen,
"including the risks of SJS and TEN," and in April of 2005, the
FDA announced its request that manufacturers of OTC NSAIDs
include warnings regarding symptoms that were associated with
SJS and TEN, and specifically, "skin reddening," "rash," and
"blisters."16 In a June, 2005, letter to McNeil, the FDA
requested that McNeil revise the "[a]llergy alert" warning on
OTC Children's Motrin to add warnings about these three
symptoms.
The FDA's formal response to the citizen petition, dated
June 22, 2006, acknowledged that "NSAIDs, including ibuprofen,
16
The updated warnings were to appear in the "[a]llergy
alert" section of the OTC pediatric ibuprofen label, and were to
read as follows:
"Ibuprofen may cause a severe allergic reaction,
especially in people allergic to aspirin. Symptoms
may include:
"▪ hives ▪ facial swelling ▪asthma (wheezing)
"▪ shock ▪ skin reddening ▪rash ▪ blisters"
"If an allergic reaction occurs, stop use and seek
medical help right away."
15
are known to cause SJS and TEN," and that "[p]rompt recognition
of the onset of symptoms, such as the appearance of rash or
blisters on the skin, and withdrawal of the suspected drug can
minimize the effects of SJS/TEN and improve prognosis."
Accordingly, the FDA agreed with the petitioners that the
labeling of OTC ibuprofen products such as Children's Motrin
"should be improved to warn consumers about the risks of severe
skin reactions associated with" such products. The FDA,
however, also took the position that it was not useful for OTC
ibuprofen labels "to include the specific terms SJS, TEN, . . .
Stevens-Johnson syndrome, and toxic epidermal necrolysis"
because "most consumers are unfamiliar with these terms."
Finally, the FDA declined to reconsider its stance on allowing
the sale of OTC pediatric ibuprofen based on the grounds that
"the incidence of SJS or TEN is not as great as cited" in the
citizen petition, that "the overall benefit versus risk profile
for ibuprofen products remains very favorable when they are used
according to the labeled instructions," and that it is in the
public health's interest "to maintain in the pediatric OTC
market a range of therapeutic options for the short-term relief
of pain."
4. The plaintiffs filed their complaint in the Superior
Court in January, 2007. The amended complaint, filed
December 14, 2012, alleges negligence, breach of warranty,
16
failure to warn of potentially lethal side effects of Children's
Motrin, violation of G. L. c. 93A, loss of consortium, and
negligent infliction of emotional distress.17 Prior to trial,
the defendants filed a motion for summary judgment claiming they
were entitled to judgment because the plaintiffs' central cause
of action based on failure to warn was preempted by the FDCA.
Hedging their bets, they also filed a motion in limine to
exclude evidence or argument at trial that the OTC Children's
Motrin label should have warned of SJS or TEN by name, or of the
possibility of the onset of a life-threatening disease, on the
ground that any claim based on the defendants' failure to
include these warnings was preempted. The trial judge denied
both of these motions. The trial judge also denied the
defendants' motion in limine seeking to exclude Tackett's
opinion testimony that ibuprofen caused Samantha's TEN,
rejecting the defendants' argument that he lacked the
qualifications necessary to offer such an opinion.18
17
In their amended complaint the plaintiffs effectively
withdrew previous claims alleging defective design and
manufacturing.
18
The defendants subsequently challenged Tackett's
testimony on the basis that he was not qualified to offer an
opinion supporting a finding on specific causation in their
motion for a directed verdict at trial. The judge denied the
motion.
18
The defendants subsequently challenged Tackett's
testimony on the basis that he was not qualified to offer an
opinion supporting a finding on specific causation in their
17
The case was tried in January and February, 2013. The jury
answered special questions to the effect that Samantha's
ingestion of Children's Motrin caused her TEN, and that both
defendants negligently failed to provide adequate warnings in
connection with Children's Motrin, causing harm to Samantha.
The jury further found that both Lisa and Richard suffered a
loss of consortium as a result of Samantha's injuries.19 The
jury awarded Samantha $50 million in compensatory damages, and
awarded $6.5 million to each of Lisa and Richard for their loss
of consortium.20
Following trial, the defendants filed motions for judgment
notwithstanding the verdict and for a new trial in which they
renewed their preemption argument, as well as their contention
motion for a directed verdict at trial. The judge denied the
motion.
19
With regard to breach of warranty, the jury found each
defendant liable for rendering Children's Motrin defective due
to inadequate warnings, and that this defect caused harm to
Samantha. The plaintiffs' negligent infliction of emotional
distress claim was withdrawn at trial and not submitted to the
jury.
20
After a jury-waived trial on the G. L. c. 93A claim, the
judge found that the defendants knowingly or wilfully engaged in
unfair and deceptive acts or practices under c. 93A.
Nevertheless, the judge found in favor of the defendants on the
ground that the plaintiffs' c. 93A claim was barred by the
permitted practices exemption. See G. L. c. 93A, § 3 ("Nothing
in this chapter shall apply to transactions or actions otherwise
permitted under laws as administered by any regulatory board or
officer acting under statutory authority of the commonwealth or
of the United States"). See also Fleming v. Nat'l Union Fire
Ins. Co., 445 Mass. 381, 389 (2005).
18
that Tackett lacked the proper qualifications to opine as to the
cause of Samantha's TEN. The judge denied these motions in
their entirety. The judge also denied the defendants' motion
for remittitur, in which they argued that the jury's damage
awards were excessive and unsupported by the evidence. The
defendants filed a timely appeal in the Appeals Court, and we
granted direct appellate review.21
Discussion. 1. Preemption. The defendants renew their
argument that the plaintiffs' claim of failure to warn is
preempted by the FDCA, and that the trial judge erred in denying
them judgment as a matter of law on this ground.22 Preemption
"may be either expressed or implied, and 'is compelled whether
Congress' command is explicitly stated in the statute's language
or implicitly contained in its structure and purpose.'" Gade v.
National Solid Wastes Mgt. Ass'n, 505 U.S. 88, 98 (1992),
quoting Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977).
Conflict preemption is a type of implied preemption; it occurs
21
We acknowledge the amicus briefs submitted by The
Consumer Healthcare Products Association; American Association
for Justice; Product Liability Advisory Council, Inc.;
Massachusetts Bar Association and Massachusetts Medical Society;
Massachusetts Trial Attorneys; and the Attorney General.
22
In addition to raising their Federal preemption claim in
their summary judgment motion and motion in limine, the
defendants advanced the claim again in their motion for a
directed verdict at the close of the plaintiffs' case, motion
for judgment notwithstanding the verdict, and motion for a new
trial, all of which the judge denied.
19
"where compliance with both federal and state regulations is a
physical impossibility, . . . or where state law stands as an
obstacle to the accomplishment and execution of the full
purposes and objectives of Congress" (quotations and citations
omitted). Gade, supra. See Wyeth v. Levine, 555 U.S. 555, 588-
589 (2009) (Thomas, J., concurring in the judgment). See also
In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., 951 F.
Supp. 2d 695, 702-703 (D.N.J. 2013) (Fosamax).
The defendants contend that this is a classic case of
conflict preemption, in that the warning the plaintiffs say
would have made a difference -- difference in the sense of
changing the outcome by persuading Richard to cease giving any
further doses of Children's Motrin to Samantha once the rash
appeared after the second dose23 -- is one that the FDA has
23
The defendants point to the following testimony of
Richard:
Q.: "If this label that you had purchased the day before
had said to beware of redness and rash because they
might -- redness, rash, blisters because they might be
the pathway to a life-threatening disease -- . . .
[w]ould you have ever given Sammy that third dose of
Motrin?"
A.: "Absolutely not."
Q.: "Now if it had said beware and keep an eye out for
redness among the other things we've already read but
redness, rash, blisters because this could be the
warning sign of toxic epidermal necrolysis or Stevens
Johnson Syndrome, would you ever have given Sammy that
for a third dose?"
20
expressly rejected, thereby putting the defendants in the
impossible position of having to comply with conflicting Federal
and State requirements.24 We disagree that conflict preemption
defeats the plaintiffs' claim of failure to warn, but before
discussing the reasons why, we consider the plaintiffs'
contention that principles of conflict preemption are irrelevant
here because a section of the FDCA, 21 U.S.C. § 379r(e) (2012),
expressly exempts or saves product liability suits concerning
OTC drugs from preemption.
The plaintiffs' argument fails. Section 379r is entitled,
"[n]ational uniformity for nonprescription drugs," and it
expressly preempts certain State requirements relating to the
regulation of OTC drugs. See 21 U.S.C. § 379r(a) (2012) ("no
State . . . may establish or continue in effect any requirement
. . . that is different from or in addition to, or that is
otherwise not identical with, a requirement under [the FDCA]").
The "savings clause" on which the plaintiffs rely, § 379r(e),
begins with a heading stating, "[n]o effect on product liability
law," and then provides: "Nothing in this section shall be
construed to modify or otherwise affect any action or the
A.: "Absolutely not."
24
The conflict between Federal and State law would exist
because the FDA regulates OTC drug labels as a matter of Federal
law, and a State jury verdict and judgment in this case
constitutes State law.
21
liability of any person under the product liability law of any
State" (emphasis added). Thus, by its terms, the § 379r(e)
savings clause frames its exemption from preemption with a
reference to § 379r itself and, as a result, must be read in the
context of § 379r as a whole and specifically the express
preemption provision set out in § 379r(a).25 The savings or
exemption from preemption provided by § 379r(e), however, does
not extend beyond the provisions of § 379r, and in particular
does not preclude "the ordinary working of conflict pre-emption
principles." See Geier v. American Honda Motor Co., 529 U.S.
861, 869 (2000). That is, even if the savings clause in
§ 379r(e) "removes tort actions from the scope of [an] express
pre-emption clause" such as § 379r(a), the savings clause "does
not foreclose . . . the possibility that a federal [law] will
pre-empt a state common-law tort action with which it
conflicts," see Geier, supra at 869-870, and principles of
implicit conflict preemption would still bar the plaintiffs'
claim if the result the plaintiffs sought would require the
defendants to use a warning label that conflicted with FDA
requirements. See id. at 871 (without operation of ordinary
preemption principles, "state law could impose legal duties that
would conflict directly with federal regulatory mandates").
25
The additional subsections of 21 U.S.C. § 379r (2012) are
not relevant to this discussion.
22
Accordingly, we interpret the savings clause to spare the
plaintiffs' State law claim from express preemption by the FDCA
that otherwise would result by virtue of § 379r(a), but the
plaintiffs' claim remains susceptible to implicit conflict
preemption.26
We turn to the defendants' conflict preemption claim. They
argue that under the Supreme Court's decision in Wyeth, the
plaintiffs' claim of failure to warn is preempted because
exceptionally "clear evidence," Wyeth, 555 U.S. at 571, exists
that the FDA would not have approved the warning that the
plaintiffs argue was called for, thus creating an impossible
conflict between State tort law and the Federal regulatory
requirements of the FDCA.
In Wyeth, the plaintiff prevailed in a products liability
suit that included a claim of failure to warn relating to the
warning label on a prescription drug manufactured by the
defendant Wyeth. Id. at 559-560, 562. The FDA had approved the
26
To the extent the plaintiffs construe a footnote in Evans
v. Lorillard Tobacco Co., 465 Mass. 411 (2013), to mean this
court has determined as a general matter that conflict
preemption principles do not come into play in the face of an
express preemption savings clause in a Federal statute, the
plaintiffs are mistaken. The footnote in question, see id. at
431 n.11, discussed and concerned only the Federal Family
Smoking Prevention and Tobacco Control Act. The footnote was
not intended to, and did not, establish a general rule to govern
the relationship between express statutory savings clauses and
Federal principles of conflict preemption.
23
label when it approved the defendant's supplemental new drug
application. Id. at 561-562.27 The question before the Supreme
Court was whether Federal law -- specifically the FDCA --
preempted the plaintiff's State tort law claim of failure to
warn concerning the prescription drug's warning label. Id. at
565. Wyeth argued in favor of preemption on the ground that it
was "impossible" for it to comply with both the State law
warning duties that formed the basis of the plaintiffs' tort
claims and the FDA's Federal labeling regulations. Id. at 568.
The Court acknowledged that typically a drug manufacturer may
change a drug label only upon FDA approval of its supplemental
application to do so, but noted that the FDA's "changes being
effected" (CBE) regulation "provides that if a manufacturer is
changing a label to 'add or strengthen a contraindication,
warning, precaution, or adverse reaction," then the manufacturer
"may make the labeling change upon filing its supplemental
application with the FDA; it need not wait for FDA approval."
Id., quoting 21 C.F.R. § 314.70(c)(6)(iii)(A). Noting that "it
has remained a central premise of federal drug regulation that
the manufacturer bears responsibility for the content of its
27
The plaintiff's claim was that Wyeth's drug warning label
"was defective because it failed to instruct clinicians to use
the IV-drip method of intravenous administration" of the drug
Phenergan "instead of the higher-risk IV-push method" used in
the plaintiff's case. Wyeth v. Levine, 555 U.S. 555, 559-560
(2009).
24
label at all times," Wyeth, supra at 570-571, the Court
concluded that once the risk of the "IV-push" injection method
(see note 27, supra) was evident, Wyeth was obligated to warn of
that risk, and "the CBE regulation permitted it to provide such
a warning before receiving the FDA's approval." Id. at 571.
The Court recognized that "the FDA retains authority to reject
labeling changes made pursuant to the CBE regulation," but
"absent clear evidence that the FDA would not have approved a
change to Phenergan's label," it was not "impossible for Wyeth
to comply with both federal and state requirements" (emphasis
added). Id. at 571. Accordingly, the plaintiff's claim was not
preempted. Id. at 572-573.28
Wyeth did not "define 'clear evidence,' so 'application of
the clear evidence standard is necessarily fact specific.'"
Fosamax, 951 F. Supp. 2d at 703, quoting Dobbs v. Wyeth Pharms.,
797 F. Supp. 2d 1264, 1270 (W.D. Okla. 2011). In looking at the
specific facts of this case, the first step is to identify what
28
At oral argument in this case, the defendants' counsel
noted a disagreement in the drug industry over whether the
"changes being effected" (CBE) regulation applies to OTC drugs.
Such a controversy was not discussed in the defendants' briefs,
and they have not cited any cases or other authorities in
support of the point. Because the defendants' preemption
argument relies on Wyeth, and Wyeth incorporated the CBE
regulation into its reasoning, we consider the CBE regulation as
applicable to OTC drugs. Other courts have applied the CBE
regulation in cases asserting failure to warn in relation to an
OTC drug. See, e.g., Newman vs. McNeil Consumer Healthcare,
U.S. Dist. Ct., No. 10-CV-01541 (N.D. Ill. Jan. 9, 2012).
25
warnings the plaintiffs claim the defendants should have
provided to give fair warning of the potentially deadly side-
effects from Children's Motrin. The defendants argue that at
trial the plaintiffs claimed that the Children's Motrin label
should have mentioned SJS and TEN by name; the plaintiffs
disagree that they did so, and we address this dispute, infra.
However, the defendants are correct that the FDA's explicit
rejection of the 2005 citizen petition's proposed inclusion of a
specific mention of SJS or TEN by name on OTC ibuprofen drug
labels because "most consumers are unfamiliar with these terms"
provides the necessary "clear evidence" that the FDA would have
rejected the addition of a warning on OTC ibuprofen's labeling
that mentioned SJS or TEN by name. See Robinson v. McNeil
Consumer Healthcare, 615 F.3d 861, 873 (7th Cir. 2010) ("The
'clear evidence' in this case is the agency's refusal to require
a reference to SJS/TEN on the label of over-the-counter drugs
containing ibuprofen, when it had been asked to do so in the
submission [i.e., citizen petition] to which the agency was
responding"). See also Fosamax, 951 F. Supp. 2d at 703 (FDA's
denial of drug manufacturer's requested change to
"[p]recautions" section of label soon after plaintiff's injury
provided clear evidence FDA would have rejected change before
injury occurred); Dobbs v. Wyeth Pharms., 797 F. Supp. 2d at
26
1276-1277 (FDA rejected defendant drug manufacturer's proposed
expanded cautions on drug label -- "clear evidence" found).
The question whether Federal law preempts the plaintiffs'
claim that the Children's Motrin's label should have warned of
redness, rash, or blisters that might lead or be a "pathway" to
a life-threatening disease is another matter. The defendants
assert the FDA's response to the citizen petition demonstrates
that, like the disease names "SJS" and "TEN," the FDA
specifically rejected the request to require that OTC ibuprofen
labels warn that rashes and blisters may lead to a "life-
threatening" disease. We do not read the FDA to have done so.
The FDA stated in its response the following:
"You[, the signers of the citizen petition,] recommend that
FDA reconsider the OTC status of the pediatric formulation
of ibuprofen or, at a minimum, add the following changes to
ibuprofen OTC labeling:
"In the 'Warnings' of the labeling: 'Serious
Skin Reactions: Ibuprofen may cause serious skin
reactions that begin as rashes and blisters on
the skin, and in the areas of the eyes, mouth and
genitalia. These early symptoms may progress to
more serious and potentially life-threatening
diseases, including Erythema Multiforme, Stevens
Johnson Syndrome and Toxic Epidermal Necrolysis.
Seek immediate attention if any of these symptoms
develop while taking ibuprofen.'
"In the 'Stop use and ask a doctor if': 'a skin
rash or blisters on the eyes, mouth or genitalia
occur because these symptoms may be an early sign
of rare and life-threatening reactions including
Erythema Multiforme, Stevens Johnson Syndrome and
Toxic Epidermonecrolysis.'
27
". . .
"We agree that the labeling for OTC NSAIDs, including all
ibuprofen products, should be improved to warn consumers
about the risks of severe skin reactions associated with
OTC ibuprofen products . . . . As a result, we have
requested that manufacturers include under the Allergy
alert subheading the symptoms associated specifically with
SJS and TEN. We do not believe that it is useful to
include the specific terms SJS, TEN, or erythema
multiforme, Stevens-Johnson syndrome, and toxic epidermal
necrolysis in the OTC label because most consumers are
unfamiliar with these terms. In addition, effective OTC
labeling communicates warning information in a manner that
consumers can quickly and easily identify and understand.
Consequently, we believe a description of symptoms is more
appropriate. Therefore, prominently displayed under the
Allergy alert subheading in the Drug Facts Label, the
labeling will include:
skin reddening
rash
blisters
"In addition, under the Allergy alert subheading, the
labeling will state: 'If an allergic reaction occurs, stop
use and seek medical help right away.' We believe that
adding these symptoms to the Allergy alert, with advice to
stop use and seek medical attention immediately, will alert
and educate consumers to the nature of the allergic
reactions associated with SJS and TEN. Further, we intend
to continue our consumer education efforts regarding the
safe and effective use of OTC pain relievers."
As just discussed, this response clearly stated that (1) the FDA
rejected the proposal to place the actual names of the diseases
mentioned -- Erythema Multiforme, SJS, and TEN -- on any OTC
ibuprofen label; and (2) the FDA adopted the citizen petition
proposal to list specific early symptoms of the diseases. But
that is all that we find clear. The proposed language,
"potentially life-threatening diseases," was part of the same
28
sentence as, and immediately followed by, the names of the three
diseases or conditions that the FDA specified it did not think
proper for an OTC ibuprofen label. Accordingly, the FDA's
decision not to request that manufacturers add a warning about
life-threatening diseases could well have been merely a
byproduct of its rejection of these requested warnings on the
basis that they mentioned Erythema Multiforme, SJS, and TEN by
name. Whether the FDA also would consider including a mention
of life-threatening diseases, by itself, to be inappropriate and
off limits on the OTC label is anybody's guess; certainly the
reason specified by the FDA for rejecting use of the disease
names -- consumer unfamiliarity -- does not apply to use of such
a phrase. See Newman vs. McNeil Consumer Healthcare, U.S. Dist.
Ct., No. 10-CV-01541 (N.D. Ill. Jan. 9, 2012) (discussing same
portion of FDA response to same citizen petition: "The Citizen
Petition did include phrases like 'serious skin reactions' and
'life-threatening diseases' and the FDA did not ultimately
require such language, but the agency provided no reasoning for
those particular decisions; therefore, conclusions regarding how
those phrases and their alleged analogues were considered and
evaluated by the FDA are speculative"). See also Lofton v.
McNeil Consumer & Specialty Pharms., 682 F. Supp. 2d 662, 677-
678 (N.D. Tex. 2010).
29
Moreover, because the defendants were not involved in the
submission of the citizen petition, the absence of the FDA's
explicit rejection of the phrase "life-threatening diseases" or
any rationale for the decision not to request that manufacturers
add such a warning takes on increased significance. That is,
even assuming for sake of argument that we could predict the
FDA would have rejected a citizen petition proposal to add only
this warning, that would not answer whether the FDA would have
rejected the warning had it been sought by the defendants
themselves. See Schedin v. Ortho-McNeil-Janssen Pharms., Inc.,
808 F. Supp. 2d 1125, 1133 (D. Minn. 2011) (FDA's decision not
to seek label change "in the face of a Citizen's Petition, not
supported by the [drug] manufacturer does not constitute clear
evidence that the FDA would have rejected a label change
proposed" by manufacturer [emphasis in original]). Cf. Dorsett
v. Sandoz, Inc., 699 F. Supp. 2d 1142, 1157 (C.D. Cal. 2010)
(FDA's rejection of warning requests in citizen petitions
"constituted determinations that the warnings should not be
mandated; they were not determinations that manufacturers could
not choose to add warnings that they believed were
scientifically substantiated" [emphasis in original]). This is
so in part because "the very idea that the FDA would bring an
enforcement action against a manufacturer for strengthening a
30
warning pursuant to the CBE regulation is difficult to accept."
Wyeth, 555 U.S. at 570.29,30
In sum, "[i]mpossibility pre-emption is a demanding
defense," id. at 573, and we cannot glean from the FDA's
response to the citizen petition, or from any other source in
this record, clear evidence that the FDA would not have approved
29
The Court in Wyeth specifically suggested that "clear
evidence" could be established by the FDA's rejection of a drug
maker's attempt to give the warning underlying a claim of
failure to warn, see Wyeth, 555 U.S. at 572, but there was no
evidence of such a rejection here. Contrast, e.g., In re
Fosamax (Alendronate Sodium) Prods. Liab. Litig., 951 F. Supp.
2d 695, 703 (D.N.J. 2013). This is not to say that the Wyeth
standard of clear evidence can be satisfied only by the FDA's
rejection of a manufacturer's request for an additional warning.
Clear evidence that the FDA would have rejected a new warning
can be shown in other ways, as indicated in this case: as
discussed, the FDA's response to the 2005 citizen petition
plainly rejected warnings that mentioned SJS and TEN by name.
30
The Court in Wyeth also pointed out that the "FDA has
limited resources to monitor the 11,000 drugs on the market, and
manufacturers have superior access to information about their
drugs, especially in the postmarketing phase as new risks
emerge." Wyeth, 555 U.S. at 578-579 & n.11. In light of the
burden on the FDA, we are reluctant to infer that its response
to the citizen petition conclusively rejected a warning
regarding a life-threatening disease in the absence of a direct
statement on the subject. This view is supported by the
observation in Wyeth that claims of failure to warn under State
law "uncover unknown drug hazards and provide incentives for
drug manufacturers to disclose safety risks promptly," and that
they "also serve a distinct compensatory function that may
motivate injured persons to come forward with information." Id.
at 579. Moreover, the savings clause in 21 U.S.C. § 379r(e)
(2012) that exempts from express preemption products liability
actions brought under State law, although not dispositive on the
issue of conflict preemption, supports the general notion that
products liability suits remain an important avenue for relief
and indicates congressional intent that such actions are not to
be prevented lightly.
31
a warning on OTC ibuprofen labels stating that redness, rash,
and blisters may lead to a life-threatening disease, so if an
allergic reaction occurs, stop use and seek medical help right
away. But because we have concluded that principles of conflict
preemption would bar any claim of failure to warn advanced by
the plaintiffs on the premise that the OTC Children's Motrin
label should have warned of SJS or TEN by name, we must
consider, and therefore turn to, the defendants' argument that
the jury may have based its finding of liability on this
preempted theory.
The defendants contend that the jury were free to decide
liability on the basis of the preempted theory of failure to
warn because (1) Richard testified he would have stopped
administering Children's Motrin to Samantha once her rash
appeared if the label had warned that a rash could be a sign of
TEN, and (2) the trial judge declined to instruct the jury that
they could not find the warning label inadequate for failing to
mention SJS or TEN by name.31 This argument is unavailing.
Certainly, where multiple theories were before a jury, at
least one of which was improper, a new trial would be necessary
if there is "no way of knowing on which basis the jury reached
31
The defendants proposed that the judge instruct the jury
that they could not find the defendants liable for failing to
warn of SJS or TEN by name or for failing to warn of life-
threatening diseases; the judge declined to give the instruction
as proposed.
32
its verdict." Rosado v. Boston Gas Co., 27 Mass. App. Ct. 675,
678 (1989). See Slate v. Bethlehem Steel Corp., 400 Mass. 378,
384 (1987). Cf. Evans v. Lorillard Tobacco Co., 465 Mass. 411,
445 (2013) ("Where we cannot ascertain on which theory the jury
relied in finding causation, the jury's finding of liability as
to negligence cannot stand"). This is not a case in which there
is "no way of knowing" the basis for the jury's verdict; we are
reasonably confident that the jury did not base liability on the
defendants' failure to warn of SJS or TEN by name. For one,
Richard testified that he had never heard of SJS or TEN when he
gave Children's Motrin to Samantha, making it unlikely the jury
would have credited his subsequent testimony that he would have
stopped administering the drug to Samantha if the label had
warned that a rash could be a sign of TEN. In addition, Lisa
testified that if the warning label had mentioned rash as a
warning signal, she would not have given Samantha the additional
dose of Children's Motion when Richard brought Samantha to
Lisa's house on November 29; Lisa did not mention SJS or TEN in
connection with a warning. Moreover, the plaintiffs' trial
counsel stated explicitly to the jury in his closing argument
that the plaintiffs did not contend that the warning should have
mentioned SJS or TEN by name;32 he argued solely that the warning
32
Counsel told the jury: "Now, just to be clear, I mean,
just to be clear what we say the label should have said, we
33
should have mentioned the possibility that redness, rash, or
blisters could lead to a life-threatening disease. In these
circumstances, although it is theoretically possible that the
jury reached their verdict on the basis of the defendants'
failure to warn about the possible occurrence of SJS and TEN,
the likelihood appears very slim, and we find no reason to
disturb the jury's verdict on preemption grounds.
2. Expert testimony. The defendants argue that they were
entitled to judgment as a matter of law on the ground that the
causation evidence essential to the plaintiffs' case came from
Dr. Randall Tackett, a pharmacologist, who offered the testimony
without the necessary qualifications or a proper foundation.
We start on common ground with the defendants: expert
testimony is required to establish medical causation.33 See
Canavan's Case, 432 Mass. 304, 316 (2000). "'The crucial
issue,' in determining whether a witness is qualified to give an
expert opinion, 'is whether the witness has sufficient
"education, training, experience and familiarity" with the
don't take the position that it had to have the technical names
of the diseases. That stuff. That doesn't happen because most
people don't know what they are."
33
Medical causation has two components, both of which
require expert opinion evidence. See Kerlinsky v. Sandoz Inc.,
783 F. Supp. 2d 236, 240 (D. Mass. 2011) ("an expert opinion on
medical causation must contain two elements -- general
causation, i.e., that the drug can cause the injury, and
specific causation, i.e., that the drug did cause the injury in
this case" [emphasis in original]). Specific causation is the
focus of the defendants' challenge here.
34
subject matter of the testimony.'" Commonwealth v. Frangipane,
433 Mass. 527, 533 (2001), quoting Commonwealth v. Richardson,
423 Mass. 180, 183 (1996). With regard to the adequacy of the
methodology supporting expert testimony, a "party seeking to
introduce scientific evidence may lay an adequate foundation
either by establishing general acceptance in the scientific
community or by showing that the evidence is reliable or valid
through an alternate means." Canavan's Case, supra at 310. See
Commonwealth v. Lanigan, 419 Mass. 15, 26 (1994). In the end, a
"trial judge has wide discretion to qualify an expert witness
and to decide whether [a] witness's testimony should be
admitted," and we will reverse a judge's decision to admit
expert testimony "only where it constitutes an abuse of
discretion or other error of law." Frangipane, supra. See
Canavan's Case, supra at 312. The defendants contend that
Tackett was unqualified to render an opinion as to specific
medical causation in Samantha's case because as a pharmacologist
rather than a medical doctor, he has never diagnosed or treated
a patient with TEN. The trial judge concluded otherwise, and we
find no abuse of discretion in his doing so.
Tackett testified that he is a professor of pharmacology
and toxicology at the University of Georgia's College of
Pharmacy, and a former chair of its department of pharmacology
and toxicology; he has taught these subjects there for three
35
decades. Pharmacology, Tackett explained, involves the study,
at the molecular level, of how a drug is metabolized and
absorbed by the body, including how the drug is distributed once
ingested and how particular dosages of drugs may lead to certain
side effects. Toxicology, in turn, is primarily concerned with
the adverse, or toxic, effects of a drug.
Tackett has a bachelor's degree in biology, and a master's
degree and doctorate in pharmacology and toxicology. He has
written numerous peer-reviewed or refereed publications,
primarily on pharmacology and toxicology. He has taught courses
(forensic pharmacy and advanced therapeutics) that focus on the
interactions of drugs with the human body. He has taught
courses on NSAIDs as well. He also is experienced in reviewing
medical records to determine the effects of a drug because doing
so is a component of pharmacology and toxicology, and he has
served as a peer-reviewer of papers written by physicians. He
has not treated a patient with SJS or TEN or published an
article on these diseases, but he was instructed on TEN during
his training, and at the time of trial he had read a majority of
the scientific literature concerning the causes of SJS and TEN.
The judge was entitled to credit Tackett's testimony about
the depth and scope of his education, training, and experience
in determining the manner in which drugs adversely affect the
human body, and could also credit Tackett's testimony that he
36
has considerable experience in reviewing patient medical records
in order to determine the effects of a drug on the body. In
light of the evidence of Tackett's qualifications, we find no
error in the judge's ruling that Tackett was qualified to render
an opinion on whether ibuprofen specifically caused Samantha's
TEN despite the fact that he was not a physician treating TEN
patients. See Allen v. Martin Surfacing, 263 F.R.D. 47, 57-58
(D. Mass. 2009) (neurotoxicologist qualified to offer expert
testimony as to specific medical causation despite lacking
medical degree). See also Frangipane, 433 Mass. at 533-535.34,35
34
The defendants rely on Commonwealth v. Frangipane, 433
Mass. 527 (2001), for the proposition that Tackett was
unqualified to testify as to specific causation, but the
reliance is misplaced. In that case, a prosecution for rape of
a child, we concluded that the trial judge had acted within his
discretion in permitting a social worker called as an expert
witness by the Commonwealth to offer opinion evidence on
dissociative memory loss, recovered memory, and delayed
disclosure among sexually abused children, based on the
witness's extensive training, education and experience in the
field; that she was not a medical doctor or psychologist did not
"alter this conclusion." See id. at 527, 530-531, 533-535. We
also concluded, however, that the witness was not competent, and
should not have been permitted, "to testify about how a trauma
victim stores and retrieves, or dissociates, a traumatic memory
because the witness's testimony on these issues involved
pronouncements concerning the physical functioning of the brain,
a scientific and medical matter on which the Commonwealth failed
to establish that the witness was qualified to testify"
(emphasis in original). Id. at 535. Unlike the social worker
witness in Frangipane, however, Tackett's education, training,
and experience as a pharmacologist and toxicologist did
encompass the science of how a drug, such as ibuprofen, produces
adverse effects on the body.
35
Our conclusion that Tackett was qualified to testify as
to specific medical causation is in accord with other courts
37
We note also that Tackett's specific causation opinion was in
accord with that of Samantha's treating physicians who testified
at trial. Dr. Bonnie Mackool, a dermatologist, and Dr. Stephen
Foster, an ophthalmologist, each of whom treated Samantha and
examined her extensively, testified that ibuprofen had caused
her to develop TEN. In addition, the jury heard evidence that
the medical resident who examined Samantha upon her initial
admission to MGH in 2003 indicated that Samantha's disease was
caused by ibuprofen.
We turn to the defendants' argument that Tackett had no
foundation for what the defendants refer to as his "third dose"
opinion -- that is, according to the defendants, the opinion
that Samantha would not have contracted SJS or TEN if, once her
rash appeared, she had not received the third dose of Children's
Motrin.36 The defendants contend that the "third dose" theory
that have considered his qualifications to testify to an opinion
that Motrin caused SJS or TEN. See Wolfe v. McNeil-PPC, Inc.,
881 F. Supp. 2d 650, 659 (E.D. Pa. 2012) (finding Tackett
qualified to testify as to causation on basis of his experience
as pharmacologist, "notwithstanding his lack of a medical
degree"); Lofton vs. McNeil Consumer & Specialty Pharms., U.S.
Dist. Ct., No. 3:05-CV-1531-L (N.D. Tex. July 25, 2008).
36
The plaintiffs assert that the defendants did not object
at trial to the foundation for Tackett's opinion that Samantha
would not have contracted TEN had she not received any ibuprofen
after suffering a rash. Accordingly, they argue, the defendants
have waived this issue on appeal. The trial judge, however,
recognized the defendants' continuing objection to, among other
things, a lack of foundation for Tackett's testimony regarding
specific medical causation. In the circumstances, we decline to
find a waiver.
38
was an essential component of causation in the plaintiffs' claim
of failure to warn, but was not medically or scientifically
valid and not supported by medical literature.37
It is true that the plaintiffs' claim of failure to warn
was premised in substantial part on Richard's testimony that he
would not have given Samantha more Children's Motrin once her
rash appeared had the drug's label warned that redness, rash, or
blisters might lead to a life-threatening disease.38 That is,
the omitted warning underlying the plaintiffs' claim became
relevant to those caring for Samantha only once she woke up with
a rash on the morning of November 29, the same morning that
Richard gave her the third dose of Children's Motrin. To
prevail on their claim of failure to warn, the plaintiffs had to
establish that the lack of this warning caused Samantha's harm
because its omission resulted in Samantha receiving more
ibuprofen than she otherwise would have, resulting, ultimately,
in TEN. See Laaperi v. Sears, Roebuck & Co., 787 F.2d 726, 729
37
As we discuss infra, this "third dose" theory is more
accurately described as a "second dose" opinion because
Tackett's testimony primarily conveyed an opinion that Samantha
would not have contracted TEN had she received only the first
two doses of Children's Motrin, and not the three subsequent
doses. To avoid quibbles about numbers, we will refer to this
as Tackett's "dose opinion."
38
Richard also testified that he would have prevented
others from giving Children's Motrin to Samantha once her rash
appeared had the drug's label warned of the significance of a
rash.
39
(1st Cir. 1986) ("the failure to warn of hazards associated with
foreseeable uses of a product is itself negligence, and if that
negligence proximately results in a plaintiff's injuries, the
plaintiff may recover"; applying Massachusetts law); Jones v.
Walter Kidde Portable Equip., 16 F. Supp. 2d 123, 125 (D. Mass.
1998) (claim of failure to warn requires establishing causation
through evidence indicating that if additional "warnings had
been given and heeded, the outcome would have been different";
applying Massachusetts law). Accordingly, we agree with the
defendants that Tackett's dose opinion, coupled with Richard's
testimony, was an important step in establishing that an
adequate warning on the Children's Motrin label about the
significance of a rash would have prevented Samantha from
receiving more ibuprofen and developing a full-blown case of
TEN.
We are not convinced, however, that to establish liability
it was essential for the plaintiffs to show that the third dose
of Children's Motrin administered to Samantha, as opposed to the
fourth or fifth dose, caused her to develop TEN. In 2003, when
the warning on the Children's Motrin label that the plaintiffs
argue should have been present was not, there appears to have
been a general unfamiliarity about the significance of
Samantha's rash. Thus, in addition to the third dose of
Children's Motrin administered by Richard, Samantha's
40
pediatrician ordered continued treatment with the Children's
Motrin despite the presence of her rash, resulting in Lisa
administering a fourth dose to Samantha,39 and Samantha was
administered a fifth dose of ibuprofen the next day in the
Jordan Hospital emergency department. Therefore, the plaintiffs
could prevail on the issue of causation through evidence that
any or all of the three doses administered to Samantha after she
contracted a rash caused her to develop TEN and, thus, that an
adequate warning to stop administering the drug upon the
presence of a rash more likely than not would have resulted in a
different outcome. See Jones, 16 F. Supp. 2d at 125. In this
regard, Dr. Foster, Samantha's treating ophthalmologist,
testified that Samantha did not have TEN after receiving the
first two doses of Children's Motrin, but that her TEN symptoms
materialized after the administration of the third dose. And
Dr. Stanford T. Shulman, an expert witness of the defense,
testified that "one or two doses of a drug like Motrin" cannot
"trigger such a severe disease" as Samantha's TEN.
In any event, we cannot agree with the defendants that
Tackett's dose opinion was incompetent and therefore
inadmissible. Tackett based his testimony, generally, on his
39
As previously mentioned, Lisa testified that she would
not have given Samantha the fourth dose of Children's Motrin had
the label warned to discontinue use upon the appearance of a
rash.
41
review of Samantha's medical records, including those from MGH
and Shriners, as well as his awareness and working knowledge of
relevant scientific literature. See Canavan's Case, 432 Mass.
at 314-315 (expert scientific opinion must be based on relevant
literature or other indicia of reliability). After opining that
ibuprofen caused Samantha's TEN, Tackett testified that had
Samantha received only two doses of Children's Motrin, her
illness would not have progressed to TEN. It is true, as the
defendants note, that Tackett agreed that the scientific
literature does not specifically support an opinion that had
Samantha ingested only two doses of Children's Motrin, she
probably would not have contracted TEN. However, Tackett's
opinion testimony appeared to vary somewhat during his lengthy
appearance as a witness and, although he did testify at one
point that the third dose of Children's Motrin caused the
disease, the thrust of his opinion testimony, as we read it, was
that Samantha would not have contracted TEN had she received
only the first two doses of Children's Motrin, and not the
third, fourth, and fifth doses after her rash appeared. This
opinion appears to find some support, as Tackett stated, in the
literature, which recognizes that prompt withdrawal of the drug
causing TEN symptoms leads to a better prognosis for the
patient.40 Tackett's testimony indicated as much, in that he
40
The FDA recognized in its response to the citizen
42
stated that a "basic pharmacology tenet" holds that "if you keep
giving a drug that's producing a toxic effect, it's going to
amplify or make that toxic effect worse," and that stopping the
petition that "[p]rompt recognition of the onset of symptoms [of
SJS and TEN], such as the appearance of rash or blisters on the
skin, and withdrawal of the suspected drug can minimize the
effects of SJS/TEN and improve prognosis" (emphasis added).
Furthermore, one of the defendants' expert witnesses in this
case, Dr. Maja Mockenhaupt, has written that with regard to
treating SJS and TEN the causative drug "should be rapidly
identified and withdrawn." Mockenhaupt, Severe Drug-Induced
Skin Reactions: Clinical Pattern, Diagnostics and Therapy, 7
JDDG 142, 142 (2009).
Additionally, Tackett referenced in his testimony a study
that examined the effect of the withdrawal of a causative drug
on patients who were diagnosed with SJS or TEN. See Garcia-
Doval, Le Cleach, Bocquet, Otero, & Roujeau, Toxic Epidermal
Necrolysis and Stevens-Johnson Syndrome: Does Early Withdrawal
of Causative Drugs Decrease the Risk of Death?, 136 Arch.
Dermatol. 323 (2000). This study selected patients diagnosed
with SJS or TEN who had taken a drug believed to have caused
their disease. Id. at 324. For purposes of the study, patients
"were determined to have stopped [causative] drug administration
early if the last dose of the causative drug was administered no
later than the same day that a definite sign of TEN or SJS
appeared," such as a blister or skin erosion. Id. The study
revealed a better mortality rate among patients who stopped
ingesting the causative drug early as opposed to those who
stopped after the day on which a sign of SJS or TEN appeared.
Id. at 324-325. The defendants contend that because each
patient in this study was diagnosed with SJS or TEN at the
outset, the study cannot support Tackett's opinion that ceasing
administration of ibuprofen to Samantha after the second dose
would have prevented her disease from worsening into TEN. We
agree that the study cannot explicitly support Tackett's
opinion, but the study's conclusion that "early withdrawal of
the causative drug(s) is associated with a better prognosis for
patients with TEN or SJS," id. at 327, provides general support
for the notion that ceasing administration of Children's Motrin
to Samantha sooner rather than later would have improved her
prognosis.
43
causative drug allows the body to metabolize it and rid itself
of the drug.41
Based on the state of the knowledge in the field concerning
early withdrawal of causative drugs, see note 40, supra, the
judge did not abuse his discretion in determining that Tackett's
testimony was reliable and admissible. See Palandjian v.
Foster, 446 Mass. 100, 111 (2006) (trial judge "has broad
discretion to determine how to assess the reliability of expert
testimony"). Cf. Vassallo v. Baxter Healthcare Corp., 428 Mass.
1, 12-13 (1998) (judge did not err in admitting expert testimony
that implants cause disease, despite lack of epidemiological
study specifically supporting testimony, where causation opinion
was based on, among other things, other relevant studies).
In any event, we have found Tackett qualified to testify as
to specific medical causation. The defendants' criticisms of
his dose opinion essentially go to the basis of his opinion, and
affect the weight of the opinion rather than its admissibility.42
41
Tackett's dose opinion also must be considered in light
of his unchallenged testimony that a diagnosis of TEN simply
represents a determination that over thirty per cent of a
person's body has been affected by the adverse skin disorder; an
opinion that Samantha's condition would not have developed into
TEN if only two doses of Children's Motrin had been administered
in effect states a view that over thirty per cent of her body
would not have become affected -- not an opinion that Samantha
would not have been ill.
42
Accordingly, the judge appropriately instructed the jury
that they had the prerogative to determine whether to accept the
44
See generally Commonwealth v. Crouse, 447 Mass. 558, 569 (2006).
The defendants extensively cross-examined Tackett as to the
basis of his dose opinion, and specifically as to whether the
literature on which Tackett relied for his opinion was, in fact,
supportive. See Higgins v. Delta Elevator Serv. Corp., 45 Mass.
App. Ct. 643, 648 (1998), quoting Lanigan, 419 Mass. at 26 ("The
judge's ruling 'is not final on the reliability of the [expert]
opinion evidence, and the opponent of that evidence may
challenge its validity before the trier of fact'").
3. Damages. Last, the defendants challenge the jury's
awards of damages. The jury awarded a total of $50 million in
compensatory damages to Samantha as a general award of damages;
although instructed on pain and suffering, future medical
expenses, and loss of future earning capacity as categories of
damages Samantha was entitled to have them consider, the jury
were not asked to itemize or specify what portion, if any, of
the total award represented damages for each or any of these
categories. The jury also awarded $6.5 million to each of
Samantha's parents for loss of consortium. As noted at the
outset, the defendants moved for remittitur on the ground that
the awards of damages were not supported by evidence in the
record. The judge denied the motion, concluding that the
opinions of expert witnesses. See Higgins v. Delta Elevator
Serv. Corp., 45 Mass. App. Ct. 643, 648-649 (1998).
45
evidence at trial supported the jury's total award, which, in
the judge's view, was "not greatly disproportionate to the
injuries proven."
"[A]n award of damages must stand unless . . . to permit it
to stand was an abuse of discretion on the part of the court
below, amounting to an error of law." Labonte v. Hutchins &
Wheeler, 424 Mass. 813, 824 (1997), quoting Mirageas v.
Massachusetts Bay Transp. Auth., 391 Mass. 815, 822 (1984). "It
is an error of law if 'the damages awarded were greatly
disproportionate to the injury proven or represented a
miscarriage of justice.'" Labonte, supra, quoting doCanto v.
Ametek, Inc., 367 Mass. 776, 787 (1975). Damages are also
excessive when they are "so great . . . that it may be
reasonably presumed that the jury, in assessing them, did not
exercise a sound discretion, but were influenced by passion,
partiality, prejudice or corruption." Bartley v. Phillips, 317
Mass. 35, 41 (1944), quoting Coffin v. Coffin, 4 Mass. 1, 43
(1808). However, "[a]buse of discretion in granting or refusing
a new trial" on the ground of excessive damages "can so seldom
be found that actual instances in which this court has set aside
the action of the trial judge . . . are almost nonexistent, and
it has repeatedly been stated that occasions when this court can
do so are exceedingly rare." Loschi v. Massachusetts Port
Auth., 361 Mass. 714, 715 (1972), quoting Hartmann v. Boston
46
Herald-Traveler Corp., 323 Mass. 56, 61 (1948). See Blake v.
Commissioner of Correction, 403 Mass. 764, 771 (1989) ("We do
not substitute our judgment for that of the trial judge who saw
the witnesses").
a. Award of damages to Samantha. As a general matter,
Samantha was "entitled to compensation for all damages that
reasonably are to be expected to follow, but not to those that
possibly may follow" the injuries she suffered. Donovan v.
Philip Morris USA, Inc., 455 Mass. 215, 223 (2009), quoting
Pullen v. Boston Elevated Ry., 208 Mass. 356, 357 (1911).
Although they did not request the jury to be asked to specify
separate amounts for future medical expenses, impairment of
future earning capacity, and pain and suffering, the defendants'
challenge on appeal focuses on each of these categories
separately, and we consider them separately.
i. Future medical expenses.43 The defendants assert that
the trial evidence here (1) presented for the most part
possibilities, not probabilities, of types of future medical
expenses Samantha might incur, and possibilities are an
insufficient basis for an award, see Donovan, 455 Mass. at 223;
and (2) in any event, even with probable future medical expense
categories, failed to present any evidence -- "dollars and cents
43
The parties stipulated to approximately $810,000 in past
medical expenses.
47
evidence" -- of what the future medical expenses were reasonably
likely to be.
The defendants' argument suffers from two fatal flaws. The
first is the defendants' failure to request that the jury be
instructed to consider the discrete categories of damages
separately. Since there is no way of knowing whether the jury
did, in fact, include any amount for future medical expenses in
their award, a claim premised on the assumption that they did
can go nowhere; certainly the defendants' way around the problem
of the missing information, which is to assume that the entire
award of $50 million was for future medical expenses and then to
assert that there was insufficient evidence to support such an
award, does not provide a permissible solution. See Dalessio v.
Dalessio, 409 Mass. 821, 830 (1991), S.C., 413 Mass. 1007 (1992)
(where jury returned general verdict it was unknown "exactly how
the jury calculated their award or exactly how much of the total
award was meant to compensate" for pain and suffering as opposed
to other compensatory damages). Second, central to the
defendants' argument is the assertion that there was
insufficient evidence introduced at trial on which the jury
could permissibly fashion an award to cover future medical
expenses. But the defendants never challenged the absence or
insufficiency of such evidence through a motion for a directed
verdict on this ground and did not include this ground in their
48
motion for judgment notwithstanding the verdict. The plaintiffs
argue correctly that the defendants have waived this claim. See
Shafir v. Steele, 431 Mass. 365, 371 & n.13 (2000) (defendant
waived objection to damages awarded for claim of interference
with contract where he had not raised objection in motion for
directed verdict; defendant also waived claim that judge erred
in allowing jury to consider particular theory of measuring
damages where he had not objected to instruction on this
ground).44
44
We note that the record does contain evidence, such as
the testimony of treating doctors, as to Samantha's reasonably
expected future medical expenses -- e.g., medical expenses for
monitoring her pulmonary system, monthly ophthalmologist
appointments, periodic eye surgeries necessitated by her in-
turned eyelashes, and likely hospitalizations due to her reduced
lung function and low body weight. There was testimony that
Samantha's medical concerns will follow her for her life, which,
at the time of trial, was expected to last some sixty-six more
years. That future medical expenses "cannot always be foretold
with exactness is a fact which the jury have to deal with in
determining what . . . expense reasonably will follow as
distinguished from what possibly may follow." Donovan v. Philip
Morris USA, Inc., 455 Mass. 215, 223 (2009), quoting Pullen v.
Boston Elevated Ry., 208 Mass. 356, 357-358 (1911).
On the issue of what anticipated future medical expenses
might cost, although a plaintiff may offer evidence of future
medical expenses through expert testimony, see Harlow v. Chin,
405 Mass. 697, 714-715 (1989), we have held that "[h]ospital
records and the testimony of physicians" as to "anticipated
future services permit[] the jury to use their judgment to award
more than nominal amounts" as future medical expenses. Bencosme
v. Kokoras, 400 Mass. 40, 44-45 (1987). See VanAlstyne v.
Whalen, 15 Mass. App. Ct. 340, 347 n.1 (1983), S.C., 398 Mass.
1004 (1986).
49
ii. Impairment of future earning capacity. For the same
reasons, the defendants' arguments concerning damages for
impairment of future earning capacity also must be rejected:
the jury's award of general damages offers no insight into
whether they awarded any amount for loss of future earning
capacity and, if they did, what that amount was; and the absence
of any challenge (e.g., a motion for a directed verdict) to the
purported insufficiency of the evidence on this issue serves to
waive the defendants' claims in any event.45
iii. Pain and suffering. As they did with the future
medical expenses, the defendants again assume that the jury's
entire award of $50 million in general damages represented pain
and suffering damages, and they again assert that such a sum is
excessive and "greatly disproportionate to the injury proven."
See Labonte, 424 Mass. at 824. For reasons previously stated,
45
Insofar as the jury may have included some damages for
loss of future earning capacity in their award, we add the
following. Although, as the defendants point out, Samantha and
her parents testified that she plans to attend college and
become a hospital nurse, the jury could reasonably infer that
despite Samantha's commendable optimism, her health will not
allow her to pursue her chosen career in nursing or in any
number of other occupations. See Halnan v. New England Tel. &
Tel. Co., 296 Mass. 219, 222 (1936). Instead, the evidence at
trial regarding Samantha's lasting injuries and her appearance
on the witness stand allowed the jury, "with their knowledge of
practical affairs," to "measure the probable extent of the
impairment of [Samantha's] earning capacity." See Cross v.
Sharaffa, 281 Mass. 329, 331 (1933). The "assessment of damages
for impairment of earning capacity rests largely on the common
knowledge of the jury, sometimes with little aid from evidence."
Griffin v. General Motors Corp., 380 Mass. 362, 366 (1980).
50
we do not accept the defendants' governing assumption, but even
were we to do so, we would disagree with their claim of
excessiveness. It is unnecessary to recount again a full litany
of Samantha's injuries, but the most severe of her injuries bear
repeating in evaluating the amount of the award. As a result of
having TEN, the seven year old Samantha suffered lesions
(blisters) all over her body and lost the top layer of her skin
(over ninety-five percent of it), substantially the same as for
a severe burn victim; she was hospitalized for six months, where
she needed to be placed in a medically induced coma for a full
month to deal with the pain; while in the hospital, she suffered
liver and heart failure, a stroke, seizures, and a cranial
hemorrhage, and had only twenty per cent of her lung capacity;
upon discharge she was required to eat through a feeding tube
for two years and required oxygen every night for the same
period of time; at the time of trial, she weighed just eighty-
two pounds as a sixteen year old; she is legally blind;46 her
short-term memory is damaged; her lung capacity remains
significantly impaired, and she will never be able to carry a
child as a result; and she faces hospitalizations and
limitations for the remainder of her life.
46
As mentioned, see note 7, supra, the corneal implant
Samantha received has required many surgeries to try to correct
problems interfering with the implant's success, so far
unsuccessfully.
51
To be sure, Samantha's parents testified about her
remarkable ability to endure these injuries while maintaining a
positive outlook and prospects for the future. Samantha herself
testified to her belief that she will lead a "great life." The
jury could applaud this optimism but nevertheless reasonably
infer from the significant extent of Samantha's past pain and
suffering, and the state of her health, that she will likely
experience pain and suffering throughout her life. See
Pemberton v. Boas, 13 Mass. App. Ct. 1015, 1018 (1982)
(upholding damages award where "[f]actors which would have
warranted a lesser amount of damages were fully explored before
the jury and apparently rejected by them"). Accordingly, we
cannot say that the jury's award is "greatly disproportionate"
to Samantha's grave injuries. See Labonte, 424 Mass. at 824.
See also Bartley, 317 Mass. at 40 (damages may be "incapable of
computation" and, thus, dependent on "judgment of the fact-
finding tribunal in appraising suffering and deprivation and
translating them into a compensatory sum").47
b. Loss of consortium damages. Finally, we decline to
disturb the jury's awards to Lisa and Richard for loss of
47
We decline the invitation of the parties to engage in the
"dangerous game" of comparing the verdict in this case to that
in other personal injury cases. See Griffin v. General Motors
Corp., 380 Mass. 362, 371 (1980).
52
consortium.48 In explaining the parameters of loss of consortium
of a child, we have stated that parents may recover for "loss of
filial society if they can show that [their child's] injuries
are of such severity and permanence as to render [her]
physically, emotionally, and financially dependent on them and
that, as a result, their lives have been significantly
restructured and their expectations of enjoying those
experiences normally shared by parents and children have been
seriously impaired." Monahan v. Methuen, 408 Mass. 381, 388-389
(1990), quoting Norman v. Massachusetts Bay Transp. Auth., 403
Mass. 303, 316 (1988) (Liacos, J., dissenting). It is difficult
to imagine how Lisa and Richard's lives could have been more
"significantly restructured" as a result of Samantha's illness
than they have been. Despite being employed at the time, Lisa
stayed at the hospital with Samantha throughout her six-month
hospitalization; Rick did so as well. Both slept at the
hospital every night, and each testified to the distress caused
by the pain Samantha endured and by her devastating prognosis.
During this time, they suffered many "close calls" when it
appeared that Samantha would not survive. In the years that
followed, both parents devoted their time to caring for
48
"The parents of a minor child or an adult child who is
dependent on his parents for support shall have a cause of
action for loss of consortium of the child who has been
seriously injured against any person who is legally responsible
for causing such injury." G. L. c. 231, § 85X.
53
Samantha's myriad needs, including feeding her through a tube
for two years. A chef by trade, Richard has since taken
employment at a local gasoline station because the shorter hours
allow him to attend to Samantha's medical problems. He lamented
at trial that due to Samantha's injuries and ongoing medical
treatment, he is unable to see her enjoy a normal life. Cf.
Norman, 403 Mass. at 315 (Liacos, J., dissenting) (one's child
is valued because he or she "is a source of emotional sustenance
and joy").
Based on the evidence before them, the jury could
reasonably infer that Samantha would remain dependent upon her
parents, "physically, emotionally, and financially," for the
indefinite future. Monahan, 408 Mass. at 389. We recognize
that the awards to Lisa and Richard are generous, but the
evidence warrants the jury's finding that their lives have been
"significantly restructured" in a manner justifying these
awards.49 See id. See also Smith v. Kmart Corp., 177 F.3d 19,
49
Finally, we find unavailing the defendants' argument that
the size of the jury's award indicates that their purpose was to
punish the defendants rather than to fairly compensate the
plaintiffs. See Bartley v. Phillips, 317 Mass. 35, 41 (1944).
The defendants imply that remarks in the plaintiffs' counsel's
closing argument concerning the defendants' wealth and resources
may have led to a verdict based on passion or prejudice. The
defendants do not contend that these remarks, alone, require
reversal, and we agree with the plaintiffs that the remarks were
not without an evidentiary basis. Moreover, the judge
explicitly instructed the jury that the purpose of damages in
this case was "not to reward the plaintiffs" and "not to punish
54
30 (1st Cir. 1999), quoting Wagenmann v. Adams, 829 F.2d 196,
215 (1st Cir. 1987) ("Translating legal damage into money
damages is a matter 'peculiarly within a jury's ken' . . .").
Judgment affirmed.
the defendants." He added that the jury were to "put aside
[their] personal feelings" during deliberations, and that they
were "not to be swayed by sympathy" in awarding damages. We
presume that the jury followed these instructions in rendering
their verdict. See O'Connor v. Raymark Indus., Inc., 401 Mass.
586, 590 (1988).
Reckis v. Johnson & Johnson
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