Barbara Jordan v. Sofamor S.N.C. ( 1999 )

IN THE COURT OF APPEALS OF TENNESSEE
WESTERN SECTION AT JACKSON
______________________________________________
BARBARA JORDAN,
Plaintiff-Appellant,
FILED
Shelby Circuit No. 73049
Vs. C.A. No. 02A01-9803-CV-00067
February 16, 1999
SOFAMOR DANEK GROUP, INC.,
ET AL, Cecil Crowson, Jr.
Appellate C ourt Clerk
Defendants-Appellees.
____________________________________________________________________________
FROM THE SHELBY COUNTY CIRCUIT COURT
THE HONORABLE JOHN R. MCCARROLL, JR., JUDGE
Sam B. Blair, Jr.; Baker, Donelson, Bearman & Caldwell of Memphis
Steve Phillips and Murray Levin; Pepper Hamilton of Philadelphia, PA
George Lehner; Pepper Hamilton of Washington, D.C.
For Appellees
Roy F. Amedee,Jr. of LaPlace, LA
Lisa June Cox of Jackson
For Appellant
AFFIRMED AND REMANDED
Opinion filed:
W. FRANK CRAWFORD,
PRESIDING JUDGE, W.S.
CONCUR:
DAVID R. FARMER, JUDGE
HEWITT P. TOMLIN, JR., SPECIAL JUDGE
This is a products liability case. Plaintiff-Appellant, Barbara Jordan, appeals the order
of the trial court granting summary judgment to Defendants-Appellees, Sofamor Danek Group,
Inc., Danek Medical, Inc., and Warsaw Orthopaedic, Inc. (collectively referred to as Sofamor
Danek).
After suffering from back problems since an automobile accident in 1975, Ms. Jordan
underwent spinal surgery on November 5, 1992, during which a laminectomy and
foraminoctomy was performed, disc material and scar tissue was removed, and a spinal fixation
system utilizing pedicle screws was implanted in her spine to aid in bone fusion.1 Sofamor
Danek was the manufacturer of the device implanted during the 1992 surgery.2 Several weeks
after the surgery, Ms. Jordan’s back problems reoccurred. After two years of conservative
treatment, Ms. Jordan underwent back surgery again on May 30, 1995, during which, among
other things, the spinal fixation system was removed. It was noted during this surgery that bone
fusion was solid on the right side of her vertebrae, not solid at all levels on the left side, and that
further fusion was not necessary. There is no evidence that the implanted device broke, bent,
loosened or malfunctioned in any way.
After removal of the device, Ms. Jordan continued to experience back problems. After
an examination by another physician, it was revealed through x-rays that Ms. Jordan’s spine had
collapsed. On July 15, 1996, Ms. Jordan underwent further spinal surgery in which, among other
things, another spinal fixation system utilizing pedicle screws was implanted. The manufacturer
of this device is unknown, but it is conceded that Sofamor Danek was not the manufacturer.
On October 3, 1995, a complaint was 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. On October 12, 1995, a First Amended
Complaint was filed naming additional plaintiffs including Ms. Jordan. The case was
subsequently removed to federal court but was later remanded. After remand, a Second
Amended Complaint was filed naming Danek Medical, Inc. and Warsaw Orthopaedic, Inc. as
manufacturers of the devices. The complaints asserted numerous causes of action against the
1
Ms. Jordan underwent surgery on the discs in her back in 1985. This surgery did not
involve any internal fixation device.
2
In its brief, Sofamor Danek states that the device implanted in Ms. Jordan was not
manufactured by any of them. Rather, they assert that the device has always been manufactured
by Sofamor, S.N.C., a French company that in November 1992 was not related to any of them.
However, Sofamor Danek states in its brief that the technical arguments concerning Sofamor
Danek Group, Inc.’s current position as a holding company were not presented to the trial court
and are not an issue on appeal.
2
defendants including strict liability, negligence, negligence per se, breach of express warranty,
breach of implied warranty, failure to warn, unlawful promotion, negligent misrepresentation,
civil conspiracy, concert of action, and negligent infliction of emotional distress.3
Due to the number of plaintiffs, a Case Management Order was entered by the trial court.
This order designated fourteen plaintiffs for trial, and Ms. Jordan is one of those designated.
On August 6, 1997, Sofamor Danek filed a motion for summary judgment which the trial
court granted by order entered November 4, 1997.
Ms. Jordan has appealed, and the only issue on appeal is whether the trial court erred in
granting summary judgment to Sofamor Danek.
A motion for summary judgment should be granted when the movant demonstrates that
there are no genuine issues of material fact and that the moving party is entitled to a judgment
as a matter of law. Tenn. R. Civ. P. 56.04. The party moving for summary judgment bears the
burden of demonstrating that no genuine issue of material fact exists. Bain v. Wells, 936 S.W.2d
618, 622 (Tenn. 1997). On a motion for summary judgment, the court must take the strongest
legitimate view of the evidence in favor of the nonmoving party, allow all reasonable inferences
in favor of that party, and discard all countervailing evidence. Id. In Byrd v. Hall, 847 S.W.2d
208 (Tenn. 1993), our Supreme Court stated:
Once it is shown by the moving party that there is no genuine
issue of material fact, the nonmoving party must then
demonstrate, by affidavits or discovery materials, that there is a
genuine, material fact dispute to warrant a trial. In this regard,
Rule 56.05 provides that the nonmoving party cannot simply rely
upon his pleadings but must set forth specific facts showing that
there is a genuine issue of material fact for trial.
Id. at 211 (citations omitted) (emphasis in original).
Summary judgment is only appropriate when the facts and the legal conclusions drawn
from the facts reasonably permit only one conclusion. Carvell v. Bottoms, 900 S.W.2d 23, 26
(Tenn. 1995). Since only questions of law are involved, there is no presumption of correctness
regarding a trial court's grant of summary judgment. Bain, 936 S.W.2d at 622. Therefore, our
review of the trial court’s grant of summary judgment is de novo on the record before this Court.
Warren v. Estate of Kirk, 954 S.W.2d 722, 723 (Tenn. 1997).
3
The non-product liability claims were dismissed by the trial court for all designated
plaintiffs and are not part of this appeal.
3
Ms. Jordan asserts that the trial court erred in granting summary judgment in that there
is a genuine dispute of material facts as to whether the implantation of the pedicle screws
manufactured by Sofamor Danek was the proximate cause of her injuries. She relies primarily
on the affidavit of her orthopedic expert, Dr. Christopher E. Cenac, which states:
1.) [Dr. Cenac] has been requested . . . to give an
opinion as to what damages, if any, were suffered by Barbara
Jordan as a result of her first operation in 1992 wherein she was
implanted with a spinal fixation device utilizing pedicle screws
manufactured by Sofamor Danek.
2.) He is of the opinion that she did in fact incur
injuries as a result of the implantation of the Sofamor Danek
device;
3.) Specifically, as a result of the extensive dissection
and decompression of the bony structures that occurred during the
implantation of the Sofamor Danek spinal fixation device, her
back was more susceptible to spinal collapse, which in fact
occurred after the hardware was removed in 1995;
4.) His review of the medical records indicates that as
a result of the collapsing of the spine which was first noted in
April of 1995 at L-3 and L-4, which resulted from the
decompression, she was required to undergo additional surgery in
1996;
5.) Therefore, it is more likely than not, that the
Sofamor Danek pedicle screw device utilized in the 1992 implant
was a substantial contributing cause to the necessity of Barbara
Jordan’s second surgery.
Dr. Cenac’s previous testimony in a pretrial deposition established that he is not an expert
with respect to implants, including spinal implants, nor is he an expert in the area of design and
manufacture of implants of any kind. He also testified regarding Ms. Jordan’s condition in
relation to the spinal fixation device as follows:
Q. You indicated that she had a rather complicated medical
history, is that correct?
A. She certainly did.
Q. What do you mean by that?
A. Well, she started having a laminectomy diskectomy and
instrumentation, and that failed, and as a result of that she
developed a rather severe collapse of the spine, scoliosis,
deformity.
Q. That was an uninstrumented procedure; is that correct?
A. That was an instrumented procedure.
Q. Excuse me. That’s what I meant. The ‘92 procedure was
an instrumented procedure, is that correct?
A. She had an instrumented procedure in ‘92.
Q. Right.
A. And it failed. As a result of that she developed a rather
severe scoliosis deformity and forward tilting of the spine. . . .
The problems that I associated with the instrumentation
device was the muscle fibrosis from the inflammatory response,
the radiculitis from the inflammatory response, and the severe
spinal disability because of the initial failed instrumentation
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fusion because of resorption of the graft and the rigidity of the
device.
Q. Given her rather complicated history, is it possible to
attribute any of the residuals that you’ve identified to any
particular device?
A. I don’t think so. It would be very hard to objectively
quantify that for you.
Q. Or to any particular component of any one of the devices
that was used?
A. No, that’s correct. Or the answer remains the same for
that question.
Q. I will mark as I guess this would be 16-D a report
prepared by Dr. Levy on Barbara Jordan, dated June 7th. And
certainly feel free to review the whole report, but I’m going to
direct your attention to Page 10, particularly the last paragraph
beginning on Page 10.
A. The same conclusion.
Q. The same conclusion?
A. Yes.
Q. You don’t disagree with his conclusion there that -- and
I’m looking on page 10, “It is virtually impossible to determine
what specific neurological deficit Miss Jordan had prior to the
operation on November 5, 1992, as compared with the
neurological abnormalities in the lower extremities following that
operation because of the varied postoperative findings.”
A. Yes. We came to the same conclusion in that she had
severe atrophy of the right lower extremity, reflex and sensory
deficits. There has been a significant change in the examination
neurologically following the July ‘96 two-stage operation.
Q. But Dr. Levy does not attribute that to the instrumentation
because that was a very complicated -- multiple stage operation,
is that correct?
A. Two stages.
Q. Right.
A. Well, he says that it’s an inescapable conclusion that Mr.
Jordan has had -- that Mrs. Jordan has had both objective and
subjective evidence of deterioration in her postoperative
neurological state which must be considered a complication of the
July ‘96 surgery, and I said the same thing.
Q. But it would be impossible to really attribute it to the
instrumentation at that point given the nature of the multiple
entries made at that surgery; is that correct?
A. Well, we got different devices. We got one in the front
and we got one in the back, et cetera, so I can’t tell you thirty
percent is from this and forty percent is from that. I got to tell
you --
Q. It’s the whole package?
A. The whole package, that’s a good word.
Dr. Cenac’s deposition was filed by Sofamor Danek in support of its motion for summary
judgment. Sofamor Danek also filed a deposition of Ms. Jordan’s other expert, Dr. Richard W.
Levy, a neurosurgeon. Dr. Levy evaluated Ms. Jordan concerning her injuries and damages and
testified that he was not presenting himself as an expert of epidemiology, manufacturing
standards, design standards, or any FDA regulatory standards. He further testified in pertinent
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part as follows:
Q. Do you have an opinion, to a reasonable degree of medical
certainty, that the first procedure dated 11/5/92 -- strike that -- do
you have an opinion to a reasonable degree of medical certainty
that the surgical stainless steel internal fixation device used in the
November 5th, 1992 surgery caused any neurological deficit that
you have found in your exam?
A. No. . . .
* * *
Q. Did Ms. Jordan suffer from retroscoliosis?
A. Yes.
Q. How long did she suffer from that?
A. I don’t know.
Q. But is that a situation that develops, or is that a congenital
type development?
A. Well, I think it probably is not congenital or
developmental in this lady; but I can’t answer how long she’s had
it.
Q. She also had degenerative disc disease?
A. Yes, sir.
Q. And she had kyphosis?
A. Yes.
Q. And she had spondylosis?
A. Yes.
Q. Osteoporosis?
A. Yes.
Q. Stenosis?
A. Yes.
Q. Those, would you call those diseases or conditions?
A. No. Those are manifestations of age, I would think.
Q. But those are certainly not caused by surgical stainless
steel?
A. No.
Q. And certainly those conditions, in some part, play into her
current condition?
A. Yes.
* * *
Q. And I know you may say [the device] may impinge on the
nerve, but I’m trying to determine whether you have opinions
beyond the neurological deficit.
A. Yes. If the pedicle in which the screw is placed was, for
whatever reason, malformed developmentally or fractured as a
result of the screw being placed in it, I will have a comment about
that.
I will not have a comment about the screw, per se, other
than for its length and the appropriateness of using a particular
length screw in a given case.
Sofamor Danek asserts that the trial court properly granted summary judgment because
Ms. Jordan has no proof to establish the necessary elements of her claim.
As part of the Tennessee Products Liability Act, T.C.A. § 29-28-105(a) (1980) provides:
A manufacturer or seller of a product shall not be liable for any
injury to person or property caused by the product unless the
product is determined to be in a defective condition or
unreasonably dangerous at the time it left the control of the
6
manufacturer or seller.
(emphasis added). Thus, a plaintiff must prove that the product was either defective or
unreasonably dangerous at the time it left the control of the manufacturer or seller, regardless of
the legal theory relied upon. Fulton v. Pfizer Hosp. Products Group, Inc., 872 S.W.2d 908, 911
(Tenn. App. 1993).
T.C.A. § 29-28-102(2) (1980) defines defective condition as “a condition of a product
that renders it unsafe for normal or anticipatable handling and consumption.” A product is
unreasonably dangerous if it, as defined in T.C.A. § 29-28-102(8) (1980), is “dangerous to an
extent beyond that which would be contemplated by the ordinary consumer who purchases it,
with the ordinary knowledge common to the community as to its characteristics, or that the
product because of its dangerous condition would not be put on the market by a reasonably
prudent manufacturer . . . assuming that he knew of its dangerous condition.”
Moreover, T.C.A. § 29-28-105(b) (1980) provides that in determining whether a product
is defective “the state of scientific and technological knowledge available to the manufacturer
. . . at the time the product was placed on the market . . . is applicable.” Consideration should
also be given “to the customary design, methods, standards and techniques of manufacturing,
inspecting and testing by other manufacturers or sellers of similar products.” T.C.A. § 29-28-
105(b) (1980).
As a general rule, an injury in and of itself is not proof of a defect and thereby does not
raise any presumption of defectiveness. Fulton, 872 S.W.2d at 911 (citing Gates v. Ford Motor
Co., 494 F.2d 458, 459 (10th Cir. 1974); Mullins v. Seaboard Coastline Ry. Co., 517 S.W.2d
198, 201 (Tenn. App. 1974)). Thus, it is not enough to show that the product caused the
plaintiff’s injury or was involved in it. Whaley v. Rheem Mfg. Co., 900 S.W.2d 296, 300 (Tenn.
App. 1995). Rather, “[t]he burden is upon the plaintiff to ‘show that there is something wrong
with the product.’” Fulton, 872 S.W.2d at 911 (quoting Tatum v. Cordis Corp., 758 F. Supp.
457, 461 (M.D. Tenn. 1991)).
From a review of the record, we find no proof that the product was defective or
unreasonably dangerous. Ms. Jordan offered no proof that Sofamor Danek failed to employ or
follow proper manufacturing procedures or that the design of the product was deficient. No
proof was offered that the medical device was designed or manufactured improperly or that
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Sofamor Danek violated some standard of care in the design or manufacture of the medical
device. She offered no proof that the product should have been made a different way or by using
a different material. Furthermore, there is no evidence in the record that Sofamor Danek
deviated from acceptable standards of quality or conduct.
Although the trial court's order does not specify the basis for granting summary
judgment, it appears that summary judgment was granted because there are no genuine issues
of material fact in that Ms. Jordan failed to provide any proof that a defect in the implanted
device caused her injuries and damages. “Summary judgment is required if . . . the non-moving
party fails to make a showing sufficient to establish the existence of an element essential to that
party’s case, and on which that party will bear the burden of proof at trial.” Tatum, 758 F. Supp.
at 461 (citing Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S. Ct. 2548, 2552, 91 L. Ed. 2d
265 (1986)). See also Blair v. Allied Maintenance Corp., 756 S.W.2d 267, 270 (Tenn. App.
1988).
In opposition to the summary judgment motion, Ms. Jordan relies solely on the affidavit
and deposition of Dr. Cenac. Sofamor Danek first argues that the affidavit testimony contradicts
the deposition testimony and thus results in cancelling out both testimonies. Tibbals Flooring
Co. v. Stanfill, 219 Tenn. 498, 410 S.W.2d 892 (1967); Ayers v. Rutherford Hosp., Inc., 689
S.W.2d 155 (Tenn. App. 1984). Dr. Cenac testified in his deposition that it is impossible to
attribute any of Ms. Jordan’s residuals to a particular device, and yet in the affidavit he opines
that the Sofamor Danek device was a contributing cause of Ms. Jordan’s second surgery. This
appears to be a direct contradiction and thus, under the authority cited, the testimony is rendered
a nullity.
However, even if we assume that the affidavit testimony is admissible, Ms. Jordan has
still failed to prove an essential element of her case. Dr. Cenac’s affidavit states that the premise
for his above-stated opinion is that “as a result of the extensive dissection and decompression
of the bony structures that occurred during the implantation of the Sofamor Danek spinal fixation
device, her back was more susceptible to spinal collapse, which in fact occurred after the
hardware was removed in 1995.” Dr. Cenac’s premise does not lead to the conclusion he states
in his opinion. In effect, what he is stating is that the actions of the surgeon caused the
subsequent spinal collapse. There is nothing in Dr. Cenac’s affidavit or his deposition that can
8
serve as proof that a defective or unreasonably dangerous device manufactured by Sofamor
Danek caused Ms. Jordan’s problems. In the absence of such proof, which is essential for
plaintiff to proceed, summary judgment was properly granted.
Accordingly, the order of the trial court is affirmed, and the case is remanded to the trial
court for such other proceedings as may be necessary. Costs of the appeal are assessed against
the appellant.
_________________________________
W. FRANK CRAWFORD,
PRESIDING JUDGE, W.S.
CONCUR:
____________________________________
DAVID R. FARMER, JUDGE
____________________________________
HEWITT P. TOMLIN, JR.
SPECIAL JUDGE
9