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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 eightytwo 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 antiinflammatory 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 lifethreatening 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 antiinflammatory 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 sideeffects 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 "lifethreatening" 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 lifethreatening 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 GarciaDoval, 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 inturned 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 eightytwo 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 factfinding 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).