Sean Gugerty and Rick Barnes obtained a dismissal in the United States District Court for Western Michigan on behalf of a defendant pharmaceutical company for claims involving an over-the-counter (“OTC”) topical acne product. The case is one of a series of economic loss class action lawsuits, in which plaintiffs allege that acne treatment products with benzoyl peroxide (“BPO”) as an active ingredient may form benzene, and that they would not have purchased or paid less for the products had they been advised of that issue. Plaintiff did not allege that taking the OTC products caused him any personal injury or rendered the products ineffective.
The court held that plaintiff’s claims are expressly preempted under 21 U.S.C. § 379r because they would impose state-law requirements “different from” or “in addition to” to federal law. The court pointed specifically to the FDA’s approval of an OTC drug “monograph” for topical acne products, in which the agency determined that acne products containing BPO are safe to sell with appropriate labeling. The court rejected plaintiff’s purported exceptions to express preemption based on allegations of misbranding, adulteration, and failure to adhere to current Good Manufacturing Practices (“cGMPs”).
