Products Liability Law Reporter

A federal district court held that the manufacturer of a left ventricular assist device may be liable to a deceased patient’s family and estate for its alleged failure to manufacture the device in accordance with FDA-approved dimensional and process specifications.

Ramon Flores Sr. experienced shortness of breath and went to a hospital ER. He later underwent surgery to implant the HeartMate 3 left ventricular assist device. During the procedure, a large amount of air was observed entering Flores’s left ventricle and aortic root. The treating surgeon eventually removed the HeartMate 3 and replaced it with a new HeartMate 3 device. Flores never regained consciousness and later died. The surgeon returned the first HeartMate 3 to Thoratec LLC, whose engineers allegedly confirmed that the device’s locking arms were damaged and bent out of FDA-specifications.

Flores’s family and estate sued Thoratec LLC, alleging neglience, gross negligence, and strict liability based on breach of the duty to manufacture the HeartMate 3 in accordance with dimensional and process specifications approved by the FDA. The defendant moved to dismiss on the basis that the plaintiffs’ causes of action were expressly and impliedly preempted under the Federal Food Drug and Cosmetic Act (FDCA). The HeartMate 3’s premarket approval triggered express preemption under 21 U.S.C. §360K(a), the defendant also asserted.

Denying the motion, the district court noted that plaintiffs may allege a parallel claim not preempted by the FDCA by alleging that a defendant failed to comply with FDA-approved manufacturing specifications and that those failures resulted in injury. Citing case law, the court found that a plaintiff must plead with specificity how a device deviated from its premarket approval specifications and how the manufacturing process failed. Here, the court found, the defendant’s own engineers confirmed that at least one of the HeartMate 3’s locking arms was bent out of specification. The plaintiff also alleged the product deviated from the FDA-approved manufacturing process, which resulted in air embolization to Flores’s brain. Consequently, the court concluded that the plaintiffs had alleged a quintessential parallel claim and also sufficiently alleged that the defendant’s manufacturing violated federally mandated standards.

The plaintiffs will nevertheless have to offer sufficient evidence to support their allegations at a later stage of litigation, the court found, holding that the plaintiffs had met their pleading burden.

Citation: Flores v. Thoratec LLC, 2024 WL 2331828 (W.D. Tex. May 22, 2024).