On April 17, 2015, the Supreme Judicial Court of Massachusetts (“Court”), which is Massachusetts’ highest appellate court, affirmed a $63 million verdict against Johnson & Johnson in a pharmaceutical case that claimed that a seven-year-old child developed toxic epidermal necrolysis (“TEN”), which is a rare but life-threatening skin disorder, after receiving multiple doses of Children’s Motrin in November 2003.
The active ingredient of Children’s Motrin, which is an over-the-counter (“OTC”) medication, is ibuprofen (a nonsteroidal anti-inflammatory drug (“NSAID”) used to treat minor aches and pains as well as fever). Children’s Motrin is manufactured and sold by Neil-PPC, Inc. (doing business as McNeil Consumer & Specialty Pharmaceuticals (“McNeil”)), and Johnson & Johnson is McNeil’s parent company.
The Child’s Suffering And Injuries Due To TEN
TEN and SJS (Stevens-Johnson Syndrome) are severe disorders 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 10% of the body’s surface is affected by the disorder, while TEN occurs where more than 30% of the body’s surface is affected.
Both TEN and SJS 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. SJS has a mortality rate of 5%, while TEN is fatal in some 30% of cases.
Ibuprofen, the active ingredient in Children’s Motrin, is associated with SJS and TEN.
According to the Court’s lengthy written opinion, the child was hospitalized and diagnosed with TEN. She needed to be placed in a medically induced coma for a full month to deal with the pain. Her symptoms and conditions included bloody secretions that affected approximately 95% of her body’s surface area; the top layer of her skin died and sloughed off; she suffered heart and liver failure; she had a stroke followed shortly afterwards by an aneurysm; she suffered a cranial hemorrhage that caused seizures, requiring brain surgery; she was left with only 20% of her lung capacity; her eyes were inflamed; she became addicted to pain medications used to ease her discomfort; she suffered visible withdrawal symptoms while she was weaned off the medications; by the time of her release from the hospital in May 2004, she weighed only 35 pounds; at home, she was required to eat through a feeding tube for two years; she required oxygen assistance at night for two years; her teacher had to carry her up and down stairs due to her small size; and, she needed to visit the school nurse every day to eat lunch through her feeding tube.
She was hospitalized several times with pneumonia and for trouble with her breathing, along with suffering multiple bouts of bronchitis. Her lungs were scarred (by 2011, her lungs had improved but they still functioned at less than half of their capacity and she could not engage in any athletic activities). As a result of her low lung capacity, she will not be able to maintain a pregnancy.
She has had more than twelve eye surgeries, including eye surgery shortly before trial during which a prosthesis was implanted to replace the lens of the cornea in her left eye.
She suffers cognitive limitations and her memory is not as sharp as it was before she developed TEN. She will never be able to drive a car 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 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 (she weighed only 82 pounds as a sixteen year old).
The Lawsuit And The Appeal
The child and her parents filed their lawsuit against Johnson & Johnson and McNeil, alleging that the child 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. The jury trial was held in January and February 2013, after which the jury awarded the child $50 million in compensatory damages and awarded the parents $6.5 million each, for their loss of consortium claims.
The defendants raised the following claims on appeal: (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 were entitled to judgment as a matter of law because the plaintiffs failed to prove causation as a matter of law, claiming that the plaintiffs’ causation witness 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.
The Court rejected each of the defendants’ claims on appeal and therefore affirmed the jury’s verdict.
Source Reckis & another vs. Johnson & Johnson & another, SJC-11677.
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