Theriot Ex Rel. Theriot v. Danek Medical, Inc.

REVISED 3/19/99
IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
_____________________
No. 98-30044
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WAYNE THERIOT, individually and on behalf
of his two minor children, Micah Theriot and
Raine Theriot; LYNN THERIOT; DONOVAN THERIOT,
Plaintiffs-Appellants,
MICAH THERIOT; RAINE THERIOT,
Movants-Appellants,
versus
DANEK MEDICAL, INC., ET AL.,
Defendants,
DANEK MEDICAL, INC.,
Defendant-Appellee.
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Appeals from the United States District Court for the
Eastern District of Louisiana
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March 10, 1999
Before JOLLY, WIENER, and PARKER, Circuit Judges.
PER CURIAM:
Wayne Theriot appeals a district court summary judgment ruling
in favor Danek Medical, Inc. (“Danek”). He argues that the
district court erred when it concluded that he failed to provide
evidence that the pedicle screw sold by Danek was defective in
design and when it concluded that Danek had adequately warned the
treating physician of potential side effects. As we find no error
on the part of the district court, we affirm.
I
Danek sells multiple component systems that are used as
internal fixation devices for the treatment of degenerative,
traumatic, and other disorders of the spine. Orthopedic and
neurological surgeons who specialize in spinal procedures use
components of Danek’s systems as an adjunct to spinal fusion
surgery to immobilize the vertebrae.
As part of a series of treatments for his back problems,
Theriot underwent surgery in which his orthopedic surgeon, Dr.
Charles R. Billings, used Danek plates and pedicle screws to help
achieve fusion. The parties contest the success of the operation.
Theriot claims he is now in constant pain and needs another
operation to remove the Danek components. Danek claims that the
products accomplished a solid fusion and that none of the plates
and screws has broken, loosened, or failed.
Theriot sued Danek, claiming that the pedicle screws sold by
Danek were defective. On October 3, 1994, the suit was transferred
to the Eastern District of Pennsylvania for multidistrict
litigation, In re: Orthopedic Bone Screw Products Liability
Litigation, MDL 1014. The suit was then remanded back to the
Eastern District of Louisiana with advice from the MDL court that
“discovery has been completed with regard to substantially all
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issues.” In re: Orthopedic Bone Screw Products Liability
Litigation, MDL 1014 at 10 (E.D. Pa. Aug. 29, 1997) (Pretrial Order
No. 1056).
The district court granted summary judgment for Danek on the
only remaining claim--that Danek had violated the Louisiana
Products Liability Act (“LPLA”), LSA R.S. 9:2800.52 et seq.
Theriot then filed a motion to reconsider, which was denied, and
appealed to this court. While the case was on appeal, Theriot
claims to have discovered new evidence withheld by Danek that, if
known, would have led the district court to deny Danek’s motion for
summary judgment. Theriot filed motions in this court requesting
us to grant a stay and to order the district court to reconsider
its summary judgment motion. Both motions were denied. In
addition, Theriot filed a motion in the district court pursuant to
rule 60(b)(2) seeking relief from the district court’s final
judgment. That motion also was denied.
II
Summary judgment is proper if “the pleadings, depositions,
answers to interrogatories and admissions on file, together with
affidavits, if any, show that there is no genuine dispute as to any
material fact and that the moving party is entitled to judgment as
a matter of law.” Fed.R.Civ.P. 56(c). A summary judgment ruling
is reviewed de novo, applying the same criteria employed by the
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district court. Conkling v. Turner, 18 F.3d 1285, 1295 (5th Cir.
1994).
Under the LPLA, there are four theories under which a
plaintiff may demonstrate that a product is defective. On appeal,
Theriot only alleges two of them: (1) that the product was
defective in design and (2) that the product was unreasonably
dangerous due to inadequate warning.
A
Under the LPLA, in order to prove that a product has a
defective design, the plaintiff must show that an alternative
design existed capable of preventing the claimant’s damage. La.
Rev. Stat. § 9:2800.56. Because Theriot did not present evidence
of an alternative design to the pedicle screw sold by Danek, the
district court held that a rational trier of fact could not
conclude that the product was defective.
Theriot advances four arguments to challenge this holding:
(1) that the surgical treatments that do not use pedicle screws
should be considered alternative designs under the LPLA; (2) that
there was evidence of other alternative designs; (3) that, in this
case, evidence of an alternative design is unnecessary; and (4)
that new evidence withheld by Danek would have demonstrated the
existence of an alternative design.
Theriot claims that the product at issue here is a product
whose purpose is to provide biomechanical stability. Theriot
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therefore argues that other products that do not use pedicle screws
should be considered as alternative designs, such as external neck
braces or internal systems that use hooks or wires. Underlying
this argument is the assumption that all pedicle screws are
defective and there can be no system using pedicle screws that
would be an acceptable product. The problem with this argument is
that it really takes issue with the choice of treatment made by
Theriot’s physician, not with a specific fault of the pedicle screw
sold by Danek.
Theriot next argues that there existed alternative designs to
the pedicle screws used by Danek. Theriot does not explain,
however, how he presented evidence of an alternative design to the
district court. It may well be that an alternative pedicle screw
design exists that Theriot could have relied on in making his
claim. In order to reverse the summary judgment ruling, however,
Theriot must show that he presented such a design to the attention
of the district court.
Theriot also claims that he should not have to present
evidence at the summary judgment phase that he has an alternative
design. Instead, if he can show the grievous extent to which the
product causes harm, he should be able to proceed to a jury trial.
This argument asks the court to disregard the requirements of the
LPLA and the district court properly refused to do so.
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Finally, Theriot argues that because Danek withheld
information about alternative designs, Theriot should be able to
rely on his newly discovered evidence in responding to the motion
for summary judgment. It is not necessary for us to determine
whether the district court was correct in its ruling on the
appellant’s 60(b)(2) motion since the appellant has failed to
demonstrate that the withheld information would have provided the
appellant with evidence sufficient to satisfy his burden of
establishing the existence of an alternate design under the LPLA.
After a review of the record, a study of the briefs, and
consideration of the oral argument presented in this case, we
conclude that the district court did not err in holding that
Theriot failed to demonstrate an alternative design under the LPLA.
We find this failure fatal to Theriot’s claim that the Danek’s
product was unreasonably dangerous due to a design defect.
B
Theriot’s second claim is that Danek failed to provide
adequate warnings. Because this case involves a medical product,
the learned intermediary doctrine applies. See, e.g., Willett v.
Baxter Intern., Inc., 929 F.2d 1094, 1098-99 (5th Cir. 1991).
Under the learned intermediary doctrine, Danek had an obligation to
inform Dr. Billings of the risks of pedicle screws. Despite the
fact that Dr. Billings has testified that he was fully apprised of
the potential risks of the product, Theriot argues that Danek did
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not fulfill this obligation. Theriot argues that because Danek did
not adequately test the product, Danek could not properly inform
Dr. Billings of the risks and, since Dr. Billings cannot have been
properly informed, his belief that he was is irrelevant.
In essence, Theriot is arguing that he should be permitted to
proceed to trial if Danek cannot demonstrate that it adequately
tested its product. There is no basis in the LPLA or case law for
such a rule and we therefore conclude that the district court did
not err in granting summary judgment.
III
For the foregoing reasons, the judgment of the district court
is
A F F I R M E D.
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