Reckis v. Johnson & Johnson

Majority - Botsford, J.

No, the Food, Drug, and Cosmetic Act (FDCA) did not preempt the plaintiffs' failure-to-warn claim because there was no 'clear evidence' that the FDA would have rejected the specific warning of 'life-threatening disease' as proposed by the plaintiffs, distinct from the specific disease names the FDA had rejected. Additionally, the trial court did not abuse its discretion in qualifying a pharmacologist to testify on specific medical causation, nor were the damages excessive. The court first clarified that 21 U.S.C. § 379r(e), a savings clause for product liability law, only prevents express preemption of state claims under § 379r(a) for OTC drugs but does not preclude ordinary conflict preemption principles. Applying the Supreme Court's standard from Wyeth v. Levine, conflict preemption occurs only where there is 'clear evidence' that the FDA would not have approved a label change. The FDA's formal response to a 2005 citizen petition explicitly rejected adding the specific disease names 'SJS' or 'TEN' to OTC ibuprofen labels due to consumer unfamiliarity, which constitutes 'clear evidence' that a claim based on failing to warn of these diseases by name would be preempted. However, the FDA did not explicitly reject or provide reasoning for declining to require a warning about the general 'risk of life-threatening diseases,' a proposal distinct from the specific disease names. The court emphasized the 'changes being effected' (CBE) regulation (21 C.F.R. § 314.70(c)(6)(iii)(A)), which allows manufacturers to strengthen warnings upon filing a supplemental application without prior FDA approval. Absent 'clear evidence' of FDA rejection for a warning about 'life-threatening diseases,' the court found no impossibility for defendants to comply with both state and federal requirements. The court also concluded it was 'very slim' that the jury based its verdict on the preempted theory given Richard's unfamiliarity with SJS/TEN and counsel's explicit statement during closing arguments. Regarding expert testimony, the court reiterated that medical causation requires expert opinion and that a witness is qualified if they have 'sufficient education, training, experience and familiarity' with the subject. Dr. Randall Tackett, a professor of pharmacology and toxicology with relevant degrees, publications, and teaching experience, was found qualified despite lacking a medical degree. His expertise in how drugs are metabolized, absorbed, distributed, and cause adverse effects, coupled with experience reviewing medical records, supported his qualification to opine on specific medical causation. His 'dose opinion' (that Samantha would not have developed TEN if she had not received the doses after her rash appeared) was supported by general pharmacological tenets and scientific literature indicating that prompt withdrawal of causative drugs improves prognosis for SJS/TEN. Criticisms of the opinion's basis were deemed to affect its weight, not admissibility, as the defendants had ample opportunity for cross-examination. Finally, concerning damages, the court affirmed that an award stands unless it was an abuse of discretion, 'greatly disproportionate to the injury proven,' or indicative of a miscarriage of justice. The defendants' arguments regarding specific categories of Samantha's damages (future medical expenses, earning capacity) were deemed waived due to failure to request itemization or challenge evidence sufficiency via a directed verdict motion. Even if not waived, the court found ample evidence for substantial pain and suffering due to Samantha's severe, extensive, and permanent injuries, including 95% skin loss, coma, organ failure, stroke, seizures, legal blindness, severe lung impairment, and lifelong dependence. The substantial awards for Lisa and Richard Reckis for loss of consortium were also upheld, as evidence showed Samantha's severe and permanent injuries rendered her dependent on them, significantly restructuring their lives in a manner justifying the awards. The court rejected the argument that the awards were punitive, noting the clear jury instructions against such.