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Bish v. Smith & Nephew Richards8/23/2000
These are consolidated interlocutory appeals of products liability suits against the manufacturers of spinal fixation devices. The trial court dismissed plaintiffs' negligence per se claims based on the alleged violation of the Food, Drug and Cosmetics Act (FDCA) and the Medical Device Amendments (MDA). In one of the cases, the trial court also granted defendants' motion in limine to exclude all Federal Drug Administration (FDA) regulatory evidence information and documents concerning the fixation devices. Plaintiffs appeal the rulings of the trial court.
Tenn.R.App.P. 9; Interlocutory Appeal; Judgment of the Circuit Court Affirmed and Remanded.
W. Frank Crawford, P.J., W.S., delivered the opinion of the court, in which Alan E. Highers, J. and David G. Hayes, J., joined.
OPINION
The three cases before the court on interlocutory appeal were consolidated because they involve common questions of law and fact. In September and October, 1995, complaints were filed in Shelby County, Tennessee on behalf of numerous plaintiffs who allegedly suffered injuries and damages as a result of the implantation of internal spinal fixation devices utilizing pedicle screws against numerous manufacturers of these devices, including Sofamor Danek Group, Inc., Warsaw Orthopaedic, Inc., Danek Medical, Inc.(hereinafter collectively referred to as Danek), and Smith & NEPHEW Richards, Inc. The complaints assert multiple causes of action against the defendants, including strict liability, negligence, negligence per se, breach of express warranty, breach of implied warrant, failure to warn, unlawful promotion, negligent misrepresentation, civil conspiracy, concert of action, and negligent infliction of emotional distress. The complaints also allege that the devices involved had not received the required FDA clearance and/or approval and allege fraud, fraudulent marketing and unlawful promotion against the named defendants.
Due to the number of plaintiffs, a Case Management Order was entered by the trial court. This Order designated fourteen plaintiffs for trial, and the plaintiffs in this appeal are some of those designated.
Of the three appeals now before this Court, one appeal is in the Haffey suit, originally filed in the Circuit Court of Shelby County on October 3, 1995 against Danek. The second appeal is a separate, similar complaint, represented by plaintiff, Gretchen Bish, filed against manufacturer, Smith & Nephew Richards, Inc. The third appeal is in a case represented by plaintiff Donald Burton, and presents the issue of the admissibility of Federal Drug Administration ("FDA") related evidence during the trial of the case involving only Smith & Nephew Richards, Inc.
On November 12, 1997, the trial court granted appellees' motion to dismiss the plaintiffs' negligence per se claims, holding:
1. No private right of action exists under the federal Food, Drug & Cosmetic Act (FDCA), and to allow a negligence per se claim based upon alleged violations of it would be inconsistent with the FDCA;
2. The federal and Tennessee Statutes, federal FDA Regulations, and FDCA sections referred to by Plaintiffs in their Complaints and Memoranda are not suitable as negligence per se standards in these pending cases;
3. Even if the federal and Tennessee Statutes, and federal FDA Regulations and FDCA sections referred to by Plaintiffs in the Complaints and Memoranda were suitable as negligence per se standards, the causal connection between the alleged violations of the federal and Tennessee Statues, federal FDA Regulations and FDCA and Plaintiffs' alleged injuries is too tenuous to constitute proximat
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