King v Danek Medical

ANN KING, TAMARA LITTLE and BRIAN LITTLE, Plaintiffs/Appellants vs DANEK MEDICAL, INC. and WARSAW ORTHOPEDIC, INC., Defendants/Appellees

No. W1999-02651-COA-R3-CV

IN THE COURT OF APPEALS OF TENNESSEE WESTERN SECTION AT JACKSON

March 28, 2000

APPEAL FROM THE CIRCUIT COURT OF SHELBY COUNTY AT MEMPHIS, TENNESSEE

Shelby Circuit No. 73049 T.D.

THE HONORABLE JOHN R. McCARROLL, JR., JUDGE

ROY F. AMEDEE, JR., LaPlace, Louisiana, LISA JUNE COX, Jackson, Tennessee, Attorneys for Plaintiffs/Appellants

SAM B. BLAIR, JR., Memphis, Tennessee, MURRAY LEVIN, Philadelphia, Pennsylvania,

GEORGE LEHNER, Washington, D.C., Attorneys for Defendants/Appellees

AFFIRMED

ALAN E. GLENN, SPECIAL JUDGE

W. FRANK CRAWFORD, P.J., W.S., DAVID R. FARMER, J. (Concurs)

OPINION

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, "[T]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).

These consolidated cases present claims regarding the design and manufacture by the defendants of spinal system devices utilizing pedicle screws, which were implanted in the plaintiffs, Ann King and Tamara Little. We will consider each claim separately for the purpose of setting out the relevant facts.

A. Ann King

In September, 1992, plaintiff Ann King was diagnosed as having degenerative disc disease and instability of the spine by Dr. Orderia F. Mitchell. He is a graduate of the United States Air Force Academy and of Tulane University Medical School in 1977. Dr. Mitchell's internship was at Wright-Patterson Medical Center, and his orthopedic residency was at Tulane University Medical Center where he was chief resident during his final year. He has been board certified in orthopedic surgery since 1983 and, at the time of his deposition, was chief of orthopedic surgery and chief of orthotics at the United States Air Force Academy Hospital.

When Dr. Mitchell first saw King in 1992, she was having difficulty walking and was complaining of severe pain in her back, buttocks, thighs, and legs. As the result of his examination, Dr. Mitchell determined that she also was suffering from "nerve root compression, [a] slight bulging disk, and osteophyte formations," as well as instability of the spine. Accordingly, in September, 1993, Dr. Mitchell performed surgery on King during which he installed a TSRH spinal system that utilized pedicle screws. As the result of this surgery, King achieved a "solid fusion." Following the surgery, she did well and apparently did not report neck pain again until December, 1994. She went through several physical therapy sessions as a result and, as of January, 1995, was on a walking program. Dr. Mitchell testified that part of King's problems following the surgery resulted from the fact that she was "deconditioned," meaning that her activity level was limited to the "basic things" which she had to do for her daily lifestyle. Dr. Mitchell believed that her surgery was successful and that he had achieved a good result for her.

King testified in her deposition that she was sixty-three years old and had degenerative disc disease, which she did not relate to the allegation of the lawsuit. She said that she had back surgery in 1979 on discs C-4 and C-5 and on disc C-7 in 1987. She had that surgery because she had "spurs which caused tingling in [her] arms," as well as numbness, and had pain in her back or neck. The 1979 surgery resulted in fusion of discs C-5 and C-6, according to King. In 1989, she fell while at Jitney Jungle grocery store, resulting in a "mild concussion," as well as back and neck pain.

She further testified that one of her legs was shorter since the Danek spinal implementation was installed, and she attributes the difference in leg length to that device. She was overweight at the time of the surgery and had gained some weight following the surgery. She had been told by a doctor that her extra weight would put a strain on her back.

The device was removed from King by Dr. Darrel S. Brodke in June, 1997. She had first consulted with him in May, 1996, complaining of low back pain radiating into her left buttock and leg. Dr. Brodke thought that "much of her pain was not pedicle screw - was not originating from the screw." Following the removal of the device, King reported to Dr. Brodke that she was "significantly better." He testified that "[t]here was no evidence in the operating room that the hardware was causing any problems with [King's] nerves." As to whether the internal fixation device had caused certain of King's complaints, Dr. Brodke stated:

I can't see how the internal fixation, specifically the screws and rods, are directly related to the leg pain or the improvement after their removal. I certainly believe Ms. King that she does have less pain both in her leg and her back. I don't think she's making it up, but I don't have an explanation for it.

In response to whether the device had failed, Dr. Brodke testified:

There was very slight loosening of one screw in a sacral pedicle, but that wasn't significant enough to report it as a hardware failure because she had a solid fusion across that, and certainly none of the screws were loose or broken and the rod was not broken. None of the screws were loose - let me rephrase that. None of the screws were loose at their connection to the rod and the rod was not broken, and there wasn't a screw that was broken.

If a pedicle screw was loose enough to cause a nonunion, I sort of consider that a hardware failure although it's not in the classic sense a hardware failure because it's not the fault of the hardware, more the biology of the patient.

B. Tamara Little

An internal fixation device manufactured by Danek was implanted in plaintiff Tamara Little in August, 1993, utilizing pedicle screws, by Dr. William Capicotto, a board certified orthopedic surgeon since 1988. He was a graduate of the medical school of the State University of New York at Buffalo, where he had also done his residency in orthopedic surgery. From 1986 until 1996, he was an assistant clinical professor in the department of orthopedic surgery at State University of New York Medical School. He was a past president of the Western New York Orthopaedic Society.

He testified that he had first seen Little on April 21, 1993, when she was complaining of severe pain in "her back and her right leg," as well as "mild weakness of the toe and ankle extensors on the right side." She had injured her back lifting a "cart of dishes from a bus tray." He stated that her leg was reddish blue and cold,...