Supreme Judicial Court of Massachusetts, Plymouth
Argued December 1, 2014.
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.
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.
Present: Gants, C.J., Spina, Cordy, Botsford, Duffly, & Lenk, JJ.
[28 N.E.3d 448] 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, claim that Samantha developed TEN as a result of being exposed to ibuprofen in the Children's Motrin that was 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. [28 N.E.3d 449] 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.
We summarize the facts from the evidence presented
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.
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-Johnson Syndrome (SJS) or TEN. 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. 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.
[28 N.E.3d 450] 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) 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 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 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 [28 N.E.3d 451] 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. 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 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 as glaucoma. 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. In 1989, [28 N.E.3d 452] the FDA, which approves and regulates 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. 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 predis-
posed 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. The jury 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 ...