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King v. Danek Medical3/28/2000
DCA violation. The trial court granted summary judgment to the defendants on the plaintiffs' negligence per se claim because the plaintiffs could not demonstrate proximate cause between the claimed FDCA violation and the injury. In a footnote, the Ponthieux court cited In Re: Orthopedic Bone Screw Products Liability Litigation, 159 F.3d 817 (3rd Cir. 1998), for the proposition that "the FDCA's lack of a private right of action does not bar Ponthieux from asserting this claim." We do not interpret this language in the footnote to be a finding, as the plaintiffs claim, that Tennessee allows a negligence per se claim based solely upon the FDCA. Rather, it simply recognizes that such a claim would not be preempted.
Additionally, the plaintiffs cite several cases from other states as authority for their arguments as to an FDCA based negligence per se claim. However, those cases differ so substantially from the instant cases that we do not find them to be persuasive. The decedent in Milkiewicz v. Baxter Healthcare Corp., 963 F. Supp. 1150 (M.D. Fla. 1996), had undergone a mitral valve replacement, with a valve which had been designed, constructed, and sold by the defendant. Claims of negligence were made against the defendant after the deceased allegedly died because of a leak in the valve. Milkiewicz simply construes Lohr to hold that state law negligence claims were not preempted by the FDCA. McNeil Pharmaceutical v. Hawkins, 686 A.2d 567 (D.C. 1996), also cited in the plaintiffs' brief, involved an action that had been brought on behalf of a decedent who had died from severe liver failure three months after ingesting a drug manufactured by the defendant and prescribed for muscle stiffness. Contrary to the plaintiffs' assertion that the court in McNeil held that "the FDCA and the FDA regulations . . . were proper for use in a negligence per se cause of action," the Court of Appeals reversed the trial court for allowing evidence of statutes and regulations without first making the proper determination as to their applicability. The court explained:
Our review of the statutes and regulations admitted here raises questions on whether they can be used to establish a standard of care for negligence per se purposes in the absence of adequate examination by the trial court to determine whether they were applicable and whether they could be understood by the jury without guidance from the court or expert testimony concerning their meaning. The court admitted dozens of statutes and regulations, some possibly applicable in the determination of a standard of care and at least one clearly not. McNeil, 686 A.2d at 580.
McNeil also explained the relationship between a statute or regulation and a claim of negligence per se:
To prevail on a negligence per se theory, the plaintiff may, in certain circumstances and under specified conditions as discussed in Part B, rely on a statute or regulation as proof of the applicable standard of care. Proof of " unexplained violation of that standard renders the defendant negligent as a matter of law," so long as the violation was the proximate cause of the injuries, and the alleged injuries were of the type which the statute was designed to prevent. Id. at 578 (citations omitted).
The court in McNeil examined many of the same cases relied upon by King and the Littles to determine the extent to which statutes and regulations were admissible to show negligence per se and determined that they did not support such a claim:
In support of that argument, Hawkins cites several cases in which FDA regulations were admitted to establish the standard of care. We think that Hawkins's reliance on those cases is misplaced because in each
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