A seven-year-old girl had a fever and sinus congestion. After reading the warning labels on the box and the bottle, her father administered two doses of an over-the-counter (OTC) medication containing ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), as its active ingredient.
The “warnings” section of the FDA-approved label contained an “[a]llergy alert” that read, “Ibuprofen may cause a severe allergic reaction which may include:
- facial swelling
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 Stevens–Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN), the possibility of skin reddening, rash, blisters, or the onset of a life-threatening disease.
By the following morning the girl had developed redness and a rash on her chest and neck and a sore throat. She continued to have fever and congestion so her father gave her a third dose of the OTC medication. The father would not have given the girl the third dose and would have prevented others from administering additional doses 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 SJS or TEN.
Around noon the girl had a fever, nasal congestion, crusty eyes, cracked lips, and a rash. Her parents took her to her pediatrician who opined that the girl had the measles. The pediatrician told the girl’s parents to treat her with the OTC medication three times per day. After reading the warning label on the bottle, her mother gave the girl another dose of the OTC medication that evening. The mother would not have given this dose had the drug label mentioned rash as a warning signal.
When the girl awoke the next morning, most of her body was covered in blisters. She could not open her eyes or mouth, and her lips were bleeding. Her parents took her to the emergency room where she received another dose of ibuprofen. When her condition worsened that day, she was transferred first to one hospital, then to another. Doctors at the third hospital diagnosed the girl with TEN and informed her parents that the girl had a minuscule chance of surviving through the night. Tests at all three hospitals ruled out a virus as the cause of the girl’s disease.
The girl was put into a medically induced coma to ease her pain for approximately one month. She was hospitalized for the next six months. During her hospitalization the girl’s TEN resulted in bloody secretions and 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 suffered a stroke followed shortly thereafter by an aneurysm. She suffered a cranial hemorrhage that caused seizures and underwent brain surgery. While in the hospital, she had only 20% of her lung capacity. Falling below 15% of lung capacity puts one at high risk of death. Her eyes were inflamed. She became addicted to pain medications that were given to her to ease her discomfort. She suffered visible withdrawal symptoms, shaking and shivering as she was weaned off the medications. Around the time of her release from the hospital she weighed approximately 35 pounds.
For two years after being released from the hospital, the girl needed to eat through a feeding tube and required oxygen assistant at night. On occasion, the feeding tube would become dislodged, resulting in pain. The girl returned to school the fall after her discharge from the hospital. She repeated first grade. Her teacher had to carry her up and down stairs due to her small size. The girl needed to visit the school nurse every day to eat lunch through her feeding tube.
After her initial hospitalization, the girl was hospitalized several times with pneumonia and for trouble with her breathing. She had multiple bouts of bronchitis. She had scarring in her lungs. Seven years after her initial hospitalization her lungs had improved but they still functioned at less than half their capacity. She could not engage in any athletic activities. Her pediatrician determined that as a result of her low lung capacity she will never be able to maintain a pregnancy.
Since her initial hospitalization, she underwent more than 12 eye surgeries. She was legally blind until she underwent surgery during which doctors implanted a prosthesis to replace the lens of the cornea in her left eye. Following this surgery, the girl was required to apply topical antibiotics to her eye for the remainder of her life and have her contact lens changed by a specialist monthly. Her right eye had in-turned eyelashes that rubbed against her scarred cornea, resulting in mucus stimulation collecting on the cornea. To read, she used a projector to enlarge the type, and she sat very near to the screen onto which the words were projected. She needed to press her nose to her telephone or the television to see what was on the screen of each.
The girl suffered cognitive limitations. Her memory was not as sharp as it was before her illness. Due to her memory loss, she struggled to retain information, which made completing her schoolwork a constant challenge. She will never be able to drive an automobile, and she remained 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. Nine years after her initial hospitalization she weighed only 82 pounds at the age of 16.
During the acute stage of the girl’s TEN and in the years that followed, her parents devoted themselves to caring for her many needs. They stayed with her throughout her hospitalization. Her father spent nights in a reclining chair. Her mother slept in a room the size of a closet. They suffered significant distress in monitoring the progression of her disease and were often told during her hospitalization that she would not survive. Since then, the girl’s father, who previously worked as a chef, took a job at a local gasoline station because the shorter hours permitted him to better tend to his daughter. They have not been able to watch their daughter enjoy a normal childhood as a result of the numerous, significant, and constant challenges to her health.
About two and a half years after the girl’s initial hospitalization, the FDA acknowledged that “NSAIDs , including ibuprofen, 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.” The FDA advised that the labeling of OTC ibuprofen products such as the one administered to the girl “should be improved to warn consumers about the risks of severe skin reactions associated with” such products. The FDA 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.”
The girl and her parents sued the manufacturer of the medication and its parent company for negligence, breach of warranty, failure to warn of potentially lethal side effects of the OTC medication, loss of consortium, and negligent infliction of emotional distress. The complaint alleged that the girl developed TEN as a result of being exposed to ibuprofen in the OTC medication that was administered to her and the warning label on the bottle rendered the OTC medication defective because it failed to warn consumers adequately about the serious risk of developing a life-threatening disease from it.
Prior to trial, the manufacturer and its parent company filed a motion for summary judgment claiming they were entitled to judgment because the family’s failure to warn claim was preempted by the Food, Drug, and Cosmetic Act (FDCA). The manufacturer and its parent company also filed a motion in limine to exclude evidence or argument at trial that the OTC medication’s 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 failure to include these warnings was preempted. The manufacturer and its parent company also filed a motion in limine to exclude the family’s expert pharmacologist’s opinion testimony that ibuprofen caused the girl’s TEN because he lacked the qualifications necessary to offer such an opinion. The Plymouth County Superior Court denied all of these motions.
At trial the family’s expert pharmacologist testified that the OTC medication caused the girl’s TEN. The director of dermatology at the hospital, who treated the girl during her initial six-month hospitalization, also testified that the OTC medication caused the girl’s TEN. The girl’s treating ophthalmologist at the time of trial, who had treated the girl since her initial hospitalization, also testified that the OTC medication caused the girl’s TEN. Other experts, including two doctors called by the manufacturer and its parent company, testified that ibuprofen had not caused the girl’s TEN.
The jury answered special questions to the effect that the girl’s ingestion of the OTC medication caused the girl’s TEN, and that both the manufacturer and its parent company negligently failed to provide adequate warning in connection with the OTC medication, causing harm to the girl. The jury further found that the mother and father suffered a loss of consortium as a result of the girl’s injuries. The jury awarded the girl $50 million in compensatory damages, and awarded $6.5 million to each parent for their loss of consortium. The trial court entered judgment in favor of the girl and her parents for $63 million.
The Supreme Judicial Court of Massachusetts affirmed. The court held that the failure to warn claim was not expressly preempted by federal law, the failure to warn claim was barred in part by conflict preemption, there was no reason to disturb the verdict on preemption grounds, the trial court did not abuse its discretion in determining that the pharmacologist was qualified to testify regarding causation, the pharmacologist’s opinion was reliable and admissible, damages of $50 million for the child were not greatly disproportionate to the child's grave injuries, and damages of $6.5 million awarded to each parent for loss of consortium were not excessive.
The failure to warn claim was not expressly preempted by federal law. The federal law prohibiting states or their political subdivisions from establishing or continuing any requirement relating to the regulation of OTC drugs, 21 U.S.C. § 379r(e) (2012), expressly exempted or saved product liability suits concerning OTC drugs from preemption. The savings clause stated that nothing in the section could be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State. The court interpreted the savings clause to spare the family’s State law claim from express preemption by the FDCA that otherwise would result by virtue of § 379r(a), but the claim remained susceptible to implicit conflict preemption.
The failure to warn claim was barred in part by conflict preemption. The FDA's explicit rejection of the inclusion of a specific mention of SJS or TEN by name on OTC ibuprofen drug labels because “most consumers are unfamiliar with these terms” provided 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. However, the family’s claim that the OTC ibuprofen’s label should have warned of redness, rash, or blisters that might lead or be a “pathway” to a life-threatening disease was not preempted. The court found no clear evidence that the FDA would not have approved 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.
There was no reason to disturb the verdict on preemption grounds. When multiple theories are before a jury, at least one of which is improper, a new trial would be necessary if there is no way of knowing on which basis the jury reached its verdict. The court was reasonably confident that the jury did not base liability on the failure to warn of SJS or TEN by name. The court noted that the father testified that he had never heard of SJS or TEN when he gave the girl the OTC ibuprofen, making it unlikely the jury would have credited his subsequent testimony that he would have stopped administering the drug to the girl if the label had warned that a rash could be a sign of TEN. The mother testified that if the warning label had mentioned rash as a warning signal, she would not have given the girl the additional dose of the OTC ibuprofen. The mother did not mention SJS or TEN in connection with a warning. The family’s trial counsel stated explicitly to the jury in his closing argument that the family did not contend that the warning should have mentioned SJS or TEN by name; he argued solely that the warning should have mentioned the possibility that redness, rash, or blisters could lead to a life-threatening disease.
The trial court did not abuse its discretion in determining that the pharmacologist was qualified to testify regarding causation. 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 subject matter of the testimony. The manufacturer and its parent company argued that as a pharmacologist rather than a medical doctor, the expert never diagnosed or treated a patient with TEN. The pharmacologist had a doctorate in pharmacology and toxicology, was a professor of pharmacology and toxicology who had taught those subjects for three decades, wrote numerous peer-reviewed or refereed publications primarily on pharmacology and toxicology, taught courses that focused on the interactions of drugs with the human body and on NSAIDs, and was experienced in reviewing medical records to determine the effects of a drug. Pharmacology, 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 is primarily concerned with the adverse, or toxic, effects of a drug. He had 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 court found no error in the trial judge’s ruling that the pharmacologist was qualified to render an opinion on whether ibuprofen specifically caused the girl’s TEN despite the fact he was not a physician treating TEN patients. The court also noted that the pharmacologist’s specific causation opinion was in accord with that of the girl’s treating physicians who testified at trial.
The pharmacologist’s opinion was reliable and admissible. The pharmacologist's opinion that the girl would not have contracted SJS or TEN, if, once her rash appeared, she had not received the additional doses of ibuprofen, was reliable and admissible. The pharmacologist based his testimony, generally, on his review of the girl’s medical records and his awareness and working knowledge of the relevant scientific literature. The literature supported the pharmacologist’s opinion in that it recognized that prompt withdrawal of the drug causing TEN symptoms led to a better prognosis for the patient.
Damages of $50 million for the child were not greatly disproportionate to the child's grave injuries. A damages award is an error of law if they were greatly disproportionate to the injury proven or represented a miscarriage of justice. Damages are 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 was influenced by passion, partiality, prejudice, or corruption. The court reasoned that $50 million in pain and suffering damages was proportionate to the injury proven. The court specifically noted that as a result of having TEN, the seven year old girl suffered lesions (blisters) all over her body and lost the top layer of her skin (over ninety-five percent of it), substantially the same as for a severe burn victim; she was hospitalized for six months, where she needed to be placed in a medically induced coma for a full month to deal with the pain; while in the hospital, she suffered liver and heart failure, a stroke, seizures, and a cranial hemorrhage, and had only twenty per cent of her lung capacity; upon discharge she was required to eat through a feeding tube for two years and required oxygen every night for the same period of time; at the time of trial, she weighed just eighty-two pounds as a sixteen year old; she is legally blind; 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.
Damages of $6.5 million awarded to each parent for loss of consortium were not excessive. 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. The court noted that the parents’ lives were significantly restructured as a result of the girl’s illness. Both parents slept at the hospital every night for six months. Both parents testified to the distress caused by the pain their daughter endured and by her devastating prognosis. They suffered many close calls when it appeared that their child would not survive. Both parents devoted years to caring for their child's myriad needs, including feeding her through a tube for two years. The girl’s father, who previously worked as a chef, took a job at a local gasoline station because the shorter hours permitted him to better tend to his daughter. Based on the evidence before them, the jury could reasonably infer that the girl would remain dependent upon her parents, physically, emotionally, and financially, for the indefinite future.
The Supreme Judicial Court of Massachusetts affirmed the trial court’s entry of judgment on a jury verdict in favor of the child and her parents for $63 million.
See: Reckis v. Johnson & Johnson, 2014 WL 8623324 (Mass., April 17, 2015) (not designated for publication).
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication