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From Products Liability Law Daily, April 17, 2015

$50 M award following allergic reaction to Children’s Motrin stands up against preemption argument

By Pamela C. Maloney, J.D.

Finding that the manufacturer of a children’s over-the-counter ibuprofen medication could have added a warning regarding the seriousness of allergic reactions, the Massachusetts Supreme Judicial Court refused to set aside a $50 million dollar compensatory award to a young girl whose allergic reaction to the drug led to life-threatening and permanent injuries. The court ruled that the amount of the award, as well as the $6.5 million awards to each of the girl’s parents for their loss of consortium, were not excessive. Finally, the court found that the plaintiff’s causation expert was qualified to testify and that his “third dose” opinion was reliable (Reckis v. Johnson & Johnson, April 17, 2015, Botsford, M.).

Background. After seven-year-old Samantha Reckis was given two doses of Children’s Motrin—an over the counter (OTC) medication with ibuprofen as its active ingredient—to treat a fever and sinus congestion, she developed redness and a rash on her chest and neck and a sore throat. Pursuant to a doctor’s instructions, she was given another does of the medication, but the symptoms worsened, prompting her parents to take her to the hospital for treatment. Samantha was diagnosed with toxic necrolysis (TEN), a rare but life-threatening skin disorder that is a more serious version of Stevens-Johnson Syndrome (SJS). Samantha’s parents brought a products liability action against MacNeil-PPC and its parent company Johnson & Johnson, alleging that Samantha developed TEN as a of result of being exposed to ibuprofen in Children’s Motrin and that the medication was defective because the label on the bottle failed to warn consumers adequately about the serious risk of developing a life-threatening disease from it. Following a lengthy trial, the jury found in favor of the family, awarding Samantha $50 million in compensatory damages and each of her parents $6.5 million for loss of consortium.

MacNeil-PPC and Johnson & Johnson appealed the verdict on three grounds: (1) the failure-to-warn claim was 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) there was no competent evidence on causation because the parents’ causation expert was not qualified to render opinions on causation and his opinions were not scientifically reliable; and (3) the damages awarded to each of the plaintiffs were “grossly excessive” and unsupported by the record. The Supreme Judicial Court, however, upheld the jury’s verdict.

Preemption. The appellate court rejected the manufacturers’ argument that the parents’ failure to warn claim, which alleged that the medication’s label should have warned of SJS or TEN by name, or of the possibility of the onset of a life threatening illness, presented a classic case of conflict preemption because “exceptionally clear evidence” established that the FDA would not have approved such a warning, thus making it impossible for them to comply with conflicting federal regulatory requirements and state tort law. The court explained that a central premise of federal drug regulation is that a drug manufacturer bears responsibility for the content of its label at all times and that it had an obligation to warn of risks that became evident before receiving FDA approval of label changes. In accordance with the U.S. Supreme Court’s decision in Wyeth v. Levine, 555 U.S. 555 (2009), unless the manufacturers could provide “clear evidence” that the FDA would not have approved the label changes proposed by the parents, compliance with both federal and state requirements would be possible and conflict preemption would not apply.

The court went on to find that the manufacturers could not rely on the FDA’s explicit rejection of a citizens petition proposing the inclusion of a specific mention of SJS or TEN by name on OTC ibuprofen drug labels because most consumers were not familiar with those terms as providing the necessary “clear evidence” that the FDA would have rejected the addition of the warning proposed by the parents. Although the FDA rejected the proposal to place the actual names of the diseases on any OTC ibuprofen label because the terms were unfamiliar to most consumers, the FDA did adopt the citizen petition proposal to list specific early symptoms of the disease. The question of whether the FDA would consider including a mention of “life-threatening diseases,” as proposed by the parents, was unclear because consumer unfamiliarity would not apply to use of that phrase. Finally, the FDA’s response to the citizen petition did not answer the question of how the agency would have responded had the proposed warning changes been sought by the manufacturers themselves.

Because the appellate court could not glean from the FDA’s response to the citizens petition or from any other evidence in the record, 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,” the parents’ failure-to-warn claim based on the absence of this wording from the label was not preempted. However, conflict preemption would bar any claim of failure to warn based on the premise that the Children's Motrin label should have warned of SJS or TEN by name, because the FDA clearly decided not to require such a warning. Based on these two distinct findings, the court examined the basis for the jury’s verdict on the parents’ failure-to-warn claim and determined that the jury did not base its liability finding on the manufacturers’ failure to warn of SJS or TEN by name but instead relied on the parents’ testimony that they would not have continued to administer the medication had the warning label mentioned the possibility that redness, rash, or blisters could have led to a life-threatening disease. Thus, the court refused to set aside the jury’s findings.

FDCA’s savings clause. In rejecting the conflict preemption defense, the court also rejected the parents’ argument that the FDCA’s saving clause expressly exempts or saves products liability suits involving OTC drugs from preemption. Because the savings clause frames its exemption with a reference to the preemption provision, the ordinary workings of conflict preemption principles still applied to products liability claims, the court opined.

Expert testimony. The court also affirmed the trial court’s ruling that the parents’ causation expert, a pathologist, was qualified to testify and that his testimony establishing a causal link between OTC ibuprofen and the child’s injuries was scientifically reliable. The expert, who had a master’s degree and doctorate in pharmacology, had been a professor of pharmacology and toxicology at the University of Georgia’s College of Pharmacy for more than 30 years and had served as the chair of the pharmacology and toxicology department. He had written numerous peer-reviewed publications on the topic, was experienced in reviewing medical records to determine the effects of a drug on a patient, and had served as a peer-reviewer of papers written by physicians. Although he had not treated a patient with SJS or TEN, or published an article on those diseases, he had received instructions on TEN during his training and had read a majority of the scientific literature concerning the causes of SJS and TEN. Based on these credentials, the appellate court refused to set aside the trial court’s decision on this issue. In addition, his conclusions were supported by the diagnoses of the child’s treating physicians.

As to the argument that the expert had no foundation for what was referred to as his “third dose” opinion, i.e., that the child would not have contracted SJS or TEN if, once her rash appeared, she had not received the third dose of Children's Motrin, which was the essential causation component of the parents’ failure-to-warn claim, the court again refused to overturn the lower court’s ruling. The pharmacologist’s testimony was based on his review of the child’s medical records and on his awareness and working knowledge of scientific literature, which supported the conclusion that prompt withdrawal of the drug causing TEN symptoms would lessen the toxic effects. The court suggested that the criticism leveled at the expert’s dose opinion went to the weight of the opinion rather than its admissibility. In light of the fact that the manufacturers had had the opportunity to extensively cross-examine the expert as to the basis of his opinion and as to whether the literature on which he relied supported his testimony, there was no basis for overturning the trial court’s ruling.

The case is No. SJC-11677.

Attorneys: Michael B. Bogdanow (Meehan, Boyle, Black & Bogdanow, PC) for Lisa Reckis. Joan A. Lukey (Ropes & Gray LLP) and Charles C. Lifland (O'Melveny & Myers LLP) for Johnson & Johnson.

Companies: Johnson & Johnson; MacNeil-PPC

MainStory: TopStory PreemptionNews ExpertEvidenceNews DamagesNews DrugsNews MassachusettsNews

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