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King v. Danek Medical3/28/2000
The plaintiffs, Tamara Little, her husband, Brian Little, and Ann King brought this action against the defendants, Danek Medical, Inc. and Warsaw Orthopedic, Inc., alleging liability for the spinal system devices utilizing pedicle screws manufactured by the defendants. The Shelby County Circuit Court granted summary judgment as to the product liability claims and motions to dismiss as to the negligence per se claims. The plaintiffs timely appealed, raising three issues on appeal:
I. The trial court erred in finding that the Learned Intermediary Doctrine applied to the plaintiffs' claims pursuant to the Tennessee Products Liability Act.
II. The trial court erred in dismissing the plaintiffs' negligence per se claims.
III. The Federal Drug Administration- related testimony and documents concerning the TSRH device are admissible evidence in view of the plaintiffs' claims pursuant to the
Tennessee Products Liability Act.
The defendants presented four additional issues:
I. Does Plaintiffs' failure to prove a defect or unreasonably dangerous condition in the TSRH medical device preclude their claims?
II. Does Plaintiffs' failure to prove cause in fact and proximate cause to a reasonable degree of medical certainty preclude their claims?
III. Does Plaintiffs' failure to prove that their alleged injuries were caused by a defect in the TSRH system preclude Plaintiffs' claims?
IV. Is cross-jurisdictional class action tolling permitted in mass tort settings, thereby precluding the running of the Tennessee personal injury statute of limitations during the pendency of any meritless class action in any court in the United States?
Based upon our review, we affirm the orders of the trial court granting the defendants' motions to dismiss the claims of negligence per se and motions for summary judgment as to the product liability claims.
I. FACTUAL BACKGROUND
The claims of these plaintiffs are among the several thousand that were filed nationwide against the manufacturers of internal fixation devices. The Danek system, which is the subject of the lawsuit, is described as follows:
Danek's Texas Scottish Rite Hospital (TSRH) Spinal System device consists of screws, hooks, rods, transverse traction devices, connectors and other components which may be customized, for spinal fusion surgery purposes, on a patient-by-patient basis. The TSRH construct, once surgically inserted, is intended to immobilize the diseased portion of the patient's spine by connecting adjacent spinal vertebrae with steel rods or plates. The rods or plates are anchored to the patient's spine by metal screws which are themselves inserted into the spinal pedicles. Minisan v. Danek Medical, Inc., 79 F. Supp. 2d 970, 972 (N.D. Ind. 1999) (footnote omitted).
In utilizing the TSRH device with pedicle screws, the physicians who implanted them into the plaintiffs were making an "off-label" use of the product, as explained in Bell v. Danek Medical, Inc., No. CIV.A.96-1393, 1999 WL 335612, at *4 n.9 (E.D. La. May 24, 1999):
"Off-label" is a term used to indicate that a particular medical device being used was not cleared by the FDA for marketing for that use. In the instance of pedicle screws, they have subsequently been approved for marketing for use in certain circumstances. As noted by Judge Lemelle, " he FDA is the agency that clears labels not uses. It is unrefuted [with regard to pedicle screws] that "off- label" use of this product is not illegal and is in fact common place." McCarthy v. Danek Medical, Inc., 1999 WL 262097, *4 (E.D. La. Jan. 5, 1999).
Page 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 Tennessee Personal Injury Attorneys
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