Title: Reckis v. Johnson & Johnson

State: massachusetts

Issuer: Massachusetts Supreme Court

Document:

NOTICE:  All slip opinions and orders are subject to formal 
revision and are superseded by the advance sheets and bound 
volumes of the Official Reports.  If you find a typographical 
error or other formal error, please notify the Reporter of 
Decisions, Supreme Judicial Court, John Adams Courthouse, 1 
Pemberton Square, Suite 2500, Boston, MA, 02108-1750; (617) 557-
1030; SJCReporter@sjc.state.ma.us 
 
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).