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.
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

 Sofamor 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 from the H affey suit. 

-2-

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 expresswarranty, 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;
-3-

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:
-4-

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 pilotresponsible 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.
-5-

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 PreMarket 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
-6-

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
-7-

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
-8-

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.FRANKCRAWFORD,PRESIDINGJUDGE,W.S.