                IN THE COURT OF APPEALS OF TENNESSEE
                             AT JACKSON
                                     April 2000 Session

GRETCHEN BISH, ET AL. v. SMITH & NEPHEW RICHARDS, INC., ET AL.
 EUGENE HAFFEY, ET AL. v. SOFAMOR DANEK GROUP, INC., ET AL.
GRETCHEN BISH, ET AL, Relating to Donald Burton v. SMITH & NEPHEW,
                              ET AL.

     An Interlocutory Appeal from the Circuit Court for Shelby County
    Nos. 72995-1, 73049-1 The Honorable John R. McCarroll, Jr., Judge



              No. W1998-00373-COA-R9-CV - Filed August 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.

Roy F. Amedee, Jr., LaPlace, LA; Lisa June Cox, Jackson, TN, for Appellants, Haffey, Bish and
Burton

Glen Reid, Jr., Memphis, TN; James B. Irwin, Nathan T. Gisclair, Jr., Sally I. Gaden, New Orleans,
LA, for Appellees, Smith & Nephew, Inc.

Murray Levin, Philadelphia, PA; George Lehner, Washington, D.C., Sam B. Blair, Jr., Memphis,
TN, for Appellees Danek Medical, Inc., Warsaw Orthopaedic, Inc. and Sofamor Danek Group, Inc.
                                                          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.1

       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.2 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;



         1
             The no n-prod uct liability claim s were dism issed by th e trial court an d are no t part of this ap peal.

         2
               Sofam or Dan ek Gro up, Inc. (n ow M edtronic S ofamo r Danek , Inc.), Danek Medical, Inc., and Warsaw
Orthopaedic, Inc. were party defendants in the Bish lawsuit but have been voluntarily dismissed with prejudice and now
are parties o nly to the a ppeal fro m the H affey suit.

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               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 proximate
               cause.

               4. Plaintiffs have failed to state a negligence per se claim upon which
               relief can be granted.

               IT IS ORDERED, ADJUDGED AND DECREED that Defendants’
               Motions to Dismiss Plaintiffs’ Negligence per se claims are granted,
               and Plaintiffs’ negligence per se claims are dismissed with prejudice.

        On January 21, 1998, the trial judge ruled in open court that the FDA regulatory information
would not be proper evidence and would only serve to confuse the jury. On April 3, 1998, the trial
court entered its order granting defendants’ motion in limine regarding the admissibility of all
regulatory (FDA) evidence as it previously ruled. The Haffey and Bish appellants were granted
interlocutory appeals. Subsequently, after a mistrial, the Burton appellant was granted an
interlocutory appeal. The three appeals were consolidated.

       The appellants present four issues for review as stated in their brief:

               1. Whether the use of FDA regulatory information or regulations as
               evidence is proper?

               2. Whether use of FDA regulatory information or regulations is
               relevant to issues to be determined at trial?

               3. Whether admission of evidence of FDA regulatory information or
               regulations would be precluded under Section 403 of the Tennessee
               Rules of Evidence in that such evidence would be prejudicial,
               confusing to a jury or a waste of time?

               4. Whether the trial court erred in granting Appellees’ Motion to
               Dismiss Appellants’ Negligence per se Claims?

       We will consider the fourth issue first.

         This issue is controlled by our Opinion in King v. Danek Medical, Inc., No. W1999-02651-
COA-R3-CV, 2000 WL 311143 (March 28, 2000, Tenn.Ct.App.). In King, the trial court dismissed
precisely the same negligence per se claims made by the plaintiffs in the instant case. In affirming
the trial court, the King Court stated:

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        When alleging a statute or regulation based on a negligence
per se claim, it is not sufficient for a plaintiff to assume, as these
plaintiffs have, that the alleged violation of a statute automatically
supports a claim of negligence per se. Even if the plaintiffs are
within the class to be protected by the statute, see Harden, 985
S.W.2d at 452, a statutory negligence per se claim cannot stand
unless the statute establishes a standard of care. Talley explains the
reason for this rule:

                Where a statutory provision does not define a
       standard of care but merely imposes an administrative
       requirement, such as the requirement to obtain a
       license or to file a report to support a regulatory
       scheme, violation of such requirement will not
       support a negligence per se claim. Even if the
       regulatory scheme as a whole is designed to protect
       the public or to promote safety, the licensing duty
       itself is not a standard of care, but an administrative
       requirement. See Ridge v. Cessna Aircraft Co., 117
       F.3d 126, 131 (4th Cir.1997) (holding that federal
       regulations making a pilot responsible for operation of
       his aircraft and requiring him, upon request, to submit
       a written report to the government whenever he
       deviates from an aviation rule in an emergency
       provide for "general standards of conduct," but do
       "not impose a particular duty," and thus their violation
       was not negligence per se in Virginia)[.]

       ....

       In concluding that the FDCA requirement for prior
       approval of a medical device does not itself support a
       claim for negligence per se, we do not intend to
       trivialize the alleged violation of administrative
       statutory provisions. They are essential to the
       underlying federal regulatory scheme that serves
       important societal interests. But because such specific
       approval rules are administrative, they do not amount
       to a legislative judgment as to the standard of care,
       and accordingly, breach of these provisions in
       themselves cannot underlie a negligence per se claim.

       179 F.3d at 159.


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                        We have examined the statutes cited by the plaintiffs as the
                basis for their negligence per se claim and agree that they lack
                sufficient substantive content to support such a claim. Accordingly,
                based upon all of these considerations, we conclude that the plaintiffs
                cannot bring an FDCA based negligence per se claim.

                        Thus, as to the plaintiffs’ claims of negligence per se, we
                conclude that they can prove no set of facts which would entitle them
                to relief. Accordingly, the trial court was correct in granting the
                defendants’ motion to dismiss as to this claim.

King, at *34.

       In light of the ruling in King, we find this issue without merit.

        Appellants’ Issues 1 through 3 address the question of admissibility into evidence of FDA
regulatory information and regulations. The initial briefs filed in the case for the most part referred
to the ruling of the court that generally denied the introduction of FDA regulatory evidence in
response to a motion in limine in the Burton case. At oral argument, reference was made to plaintiff
Burton’s offer of proof, and the court requested supplemental briefs from the parties concerning a
more precise description of the evidence that was not allowed. Burton’s supplemental brief
highlights the offers of proof of Leslie Sprinkle, Jeff Cobb, and Dr. Carl Larson. The offers of proof
were quite extensive and detailed, and we will attempt to briefly summarize the key elements of each
witness’s testimony.

        Leslie Marvin Sprinkle testified that he is vice-president of regulatory and clinical affairs
and quality of Smith & Nephew. His testimony primarily focused on clinical studies of orthopaedic
implants in humans. In connection with FDA regulations, Sprinkle defined a 510 (k) submission
as documents that are provided to the FDA to determine whether a product is essentially equivalent
to a product that was in interstate commerce prior to May 28, 1976. He also explained that Pre-
Market Approval (PMA) was an application to the FDA which involves clinical trials as an
Investigation of Device Exemption (IDE). He testified that between 1991 and 1993, Smith &
Nephew had no 510 (k) clearing the Simmons spinal rating system for the posterior or pedicular
application. His testimony detailed his understanding of FDA regulations which was related to his
company and the Simmons rating system. He also discussed the company’s actions in response to
FDA communication and explained Smith & Nephew’s decision-making process related to the
Simmons pedicle screw device.

       Jeff Cobb testified that he is the director of regulatory affairs for Smith & Nephew. He was
questioned concerning the 510 (k) submission of a clearance letter for the pedicle screw device for
only the intended use of anterior lateral fixation. He testified that this was the only clearance they
had until 1995, but that Smith & Nephew made their own independent determination that the 510
(k) submission was unnecessary for other uses. He was also questioned concerning communications
from the FDA concerning IDE and proposed deficiencies in the IDE application. He testified

                                                 -5-
concerning the company’s decision to terminate the IDE. He was also questioned concerning
various communications from the FDA and identified exhibits dealing with FDA communications
concerning the fixation device. He was further questioned concerning his trip report for a seminar
discussing advertising, labeling, and consumer education, and testified concerning a recall of a
reported defective locking nut.

         Dr. Carl Larson testified that he was a former director of the General Restorative Devices
Division of the FDA. Dr. Larson testified in depth about FDA regulations as they relate to medical
devices and his perception of a manufacturer’s duties pursuant to the law. He testified that the FDA
identified certain risks with regard to posterior pedicle screw fixation. He testified that anterior
lateral fixation was not subject to the same risks as the pedicle screw fixations and that neither Smith
& Nephew nor other manufacturers successfully completed IDE and generated scientifically reliable
data to establish the safety of any pedicle screw device. Dr. Larson’s testimony extensively
discussed the regulations and the duties of the manufacturer with regard to the law.

       The evidentiary rules pertinent to our inquiry are Tenn.R.Evid. 401, 402, and 403. They
provide:

               Rule 401. Definition of “relevant evidence.” - “Relevant
               evidence” means evidence having any tendency to make the existence
               of any fact that is of consequence to the determination of the action
               more probable or less probable than it would be without the evidence.

               Rule 402. Relevant evidence generally admissible; irrelevant
               evidence inadmissible. - All relevant evidence is admissible except
               as provided by the Constitution of the United States, the Constitution
               of Tennessee, these rules, or other rules or laws of general applicable
               in the courts of Tennessee. Evidence which is not relevant is not
               admissible.

                Rule 403. Exclusion of relevant evidence on grounds of
                prejudice, confusion, or waste of time. - Although relevant,
                evidence may be excluded if its probative value is substantially
                outweighed by the danger of unfair prejudice, confusion of the issues,
                or misleading the jury, or by considerations of undue delay, waste of
                time, or needless presentation of cumulative evidence.

        All of plaintiffs’ asserted causes of action comprise a product liability action as defined in
T.C.A. § 29-28-102 (5)(1980). In order to recover in such an action against a manufacturer or seller
of a product, the plaintiff must prove that the product was “in a defective condition or unreasonably
dangerous at the time it left the control of the manufacturer of seller.” T.C.A. § 29-28-105 (1980).

        Relevant evidence means evidence having any tendency to make existence of any fact that
is of consequence to determination of the action more probable or less probable than it would be

                                                  -6-
without the evidence. Given v. Low, 661 S.W.2d 687 (Tenn. Ct. App. 1983). In Otis v. Cambridge
Mut. Fire Ins. Co., 850 S.W.2d 439 (Tenn. 1992), the Court said:

                       In Tennessee admissibility of evidence is within the sound
               discretion of the trial judge. When arriving at a determination to
               admit or exclude even that evidence which is considered relevant trial
               courts are generally accorded a wide degree of latitude and will only
               be overturned on appeal where there is a showing of abuse of
               discretion. Strickland v. City of Lawrenceburg, 611 S.W.2d 832
               (Tenn. Ct. App. 1980); Tennessee Rules of Evidence 401; Austin v.
               City Memphis, 684 S.W.2d 624 (Tenn. Ct. App. 1984); Inman v.
               Aluminum Co. of America, 697 S.W.2d 350 (Tenn. Ct. App. 1985).

                      We consider the rule in McCormack v. Riley, 576 S.W.2d
               358, 360 (Tenn. Ct. App. 1978) to be applicable here:

                       Not all logically relevant evidence is admissible.
                       Thus evidence which would advance the inquiry but
                       would also inflame or unduly distract the jury or
                       require an undeserved expenditure of judicial time or
                       unfairly surprise the opponent may not be admissible.
                       See McCormick on Evidence § 185 (2d ed. 1972).
                       The probative weight of evidence must be balanced
                       against those attendant costs in determining that
                       evidence should be admitted.

               Id. at 360.

850 S.W.2d at 442-443.

       Evidence upon a fact not in issue is irrelevant and not admissible unless collaterally
admissible. Bridges v. CSX Transp., Inc., 845 S.W.2d 760 (Tenn. Ct. App. 1992). In Bridges, the
Court noted: “[T]here must be some relevance between evidence offered and the issues for trial.
Simply because evidence may bolster a plaintiff’s case does not make it irrelevant.” Id. at 764.

        In the instant cases, the plaintiffs are required to prove that the fixation devices were
defective or unreasonably dangerous at the time they left the manufacturer’s control. It appears from
our review of the record that the evidence excluded by the trial court and offered in proof does not
tend to prove the determinative issues in the case nor lead to evidence that would prove such issues.
The FDA’s approval or nonapproval of the devices without more does not tend to prove that the
devices were defective or unreasonably dangerous. Moreover, a review of the testimony of the three
witnesses offered by plaintiff Burton aptly illustrates the reason for Tenn.R.Evid. 403. The
introduction of the proof concerning the FDA activity in regulation would result in a confusion of
the issues, could mislead the jury, and without question would result in undue delay and a waste of

                                                -7-
time. Under the state of this record, if there is any probative value to the testimony, it is substantially
outweighed by the dangers outlined in Rule 403. The trial court did not abuse its discretion in
excluding the proffered evidence.

        Accordingly, the orders of the trial court are affirmed. These cases are remanded to the trial
court for such further proceedings as are necessary. Costs of the appeal are assessed against the
appellants, Eugene Haffey, Gretchen Bish, and Donald Burton.


                                                 __________________________________________
                                                 W. FRANK CRAWFORD, PRESIDING JUDGE, W.S.




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