he Massachusetts Supreme Judicial Court affirmed a $63 million verdict against McNeil PPC and Johnson & Johnson for the companies’ failure to provide adequate warnings for life-threatening symptoms caused by ibuprofen, an active ingredient in Children’s Motrin.
Lisa and Richard Reckis, the child’s parents, filed suit against the companies after their daughter Samantha developed toxic epidermal necrolysis (TEN) after taking Children’s Motrin.
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TEN is a severe disorder that attacks the skin, resulting in a rash, blisters and significant damage to the mouth, eyes, and other parts of the body. TEN occurs when the rash and blisters affect more than 30 percent of the body.
In their 2007 complaint, the parents alleged the warning label on the commonly prescribed medication rendered the drug defective because it failed to warn against the serious risk of developing a life-threatening disease.
The 2012 amended complaint alleged negligence, breach of warranty, failure to warn of potentially legal side effects, loss of consortium and negligent infliction of emotional distress.
The defendants appealed the lower courts decision on three grounds:
In November 2003, Samantha’s parents gave her Children’s Motrin for fever and sinus congestion. Samantha was seven years old at this time.
The following morning, prior to a third dose, Samantha woke with the same fever and congestion, along with a red rash on her chest and neck and a sore throat.
The next day, Samantha was taken to her pediatrician -- she had a fever, nasal congestion, crusty eyes, cracked lips, and a rash. The doctor advised the child had measles and to treat with Motrin three times a day.
By day three of taking the Children’s Motrin, Samantha was covered in blisters, could not open her eyes or mouth. After being transferred from the local emergency to a children’s hospital, the parents learned of Samantha’s rare condition and were left with little hope for her survival.
Samantha was in a medical induced coma for one month and hospitalized for six months. During this time, she suffered from a list of injuries including heart and liver failure, diminished lung capacity, and 95 percent loss of the top layer of her skin.
The defendants argued "conflict preemption," and stated the type of warning the plaintiffs believe would have made a difference is a warning that was prohibited by the FDA. Thus, it caused an impossible conflict between what the federal guidelines allowed and state tort law.
The court relied on Wyeth v. Levine, which stated unless there is clear evidence the FDA would not approve a label change, then it is not impossible to comply with both federal and state requirements. 555 U.S. 555, 571 (2009).
Additionally, Wyeth explained that under a CBE regulation (changes being effected), a drug manufacturer changing a label to strengthen its warnings need not wait for FDA approval of the supplemental application before making the changes. Id. at 568-569.
The Massachusetts court agreed there was clear evidence the FDA rejected mentioning the rare disorder by name, based on the FDA response to a citizen petitioner’s request in 2005. However, mentioning the symptoms of the life-threatening disease does not mean the FDA would have rejected the changes had the defendants proposed them.
In her opinion, Associate Justice Margot Botsford stated the trial judge did not err in its decision to qualify the witness or by allowing his testimony. Specifically, the testimony was deemed appropriate because it was in line with Samantha’s treating physicians testimony and based on the witness's review of Samatha’s medical records.
An expert witness is qualified to give an expert opinion if the person has superior education, training, experience, and familiarity with the subject matter of the case. This special testimony is required to establish medical causation. Whether to qualify an expert witness is at the judge’s wide discretion.
The expert witness was a professor of pharmacology and toxicology at a large university’s college of pharmacy. He had received training on TEN and read scientific literature on the causes of SJS and TEN, and the effects of a drug on the body.
The defendants sole argument was the expert was unqualified because he was not a medical doctor and never diagnosed or treated a patient with TEN. Additionally, the defendants made a “third dose” argument, stating the argument was a substantial factor in the plaintiffs causation claim.
The expert testified had Samantha only received the first two doses of Motrin after the rash appeared, she would not have developed TEN. The witness further explained that if a medication causes toxic affects, prompt withdrawal would cause a better prognosis for the patient.
Samantha’s father testified he would not have given Samantha the third dose of Children’s Motrin had the label warned of the risk.
The third dose argument was essential to causation however, it was not essential for the plaintiffs to establish the third dose or any subsequent doses caused their child to develop TEN.
The damage award was determined to be proportionate to the injuries and cost of care Samantha will need for the rest of her life. Samantha is legally blind, suffers from short-term memory damage and still has impaired lung capacity.
Despite her ailments the parents testified about her “remarkable ability to endure these injuries while maintaining a positive outlook and prospects for the future.” Also stating Samantha herself testified to her belief that she will lead a “great life.”
The jury awarded Samantha’s parents $6.5 million each for loss of consortium. The parents testified their lives were significantly restricted as a result of their daughter’s illness.
The court ruled that, based on all the evidence before it, a jury could reasonably conclude Samantha will suffer pain and need extensive care for the remainder of her life. Additionally, the parents award was justified because their lives were changed in a great way after the illness occurred.
This case is Lisa Reckis & another vs. Johns & Johnson & another Case No. SJC-11677 Supreme Court of Massachusetts.
