### 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 Donal d Burton v . SMITH & NEPH EW, ET AL



### . An Interlocutory Appeal from the Circuit Cour t for Shelby County Nos. 72995-1, 73049- 1 The Honorable J ohn R. McCarr

oll, Jr., Judge

No. W1998-00373-CO

A-R9-CV - F

iled August 23, 2

000

These are consolidated int erlocutory appeals of products liability suits against the manufacturers of spinal fixa tion 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 th e cases , the trial court also granted defendants’ motion in limine to exclude all Federal Drug Administration (FDA) re gula tory evidence information and documents conce

rning the fixation

devices. Plaintif

fs appeal the rul

ings of the trial co

urt. Tenn.R.App.P. 9; Int

erlocutory Appea

l; Judgment of the C

ircuit Court Affirm

ed and Remanded.
W. F RANK C RAWFORD , P.J., W.S., delivered the opinion of the court, in whichA LAN E. H IGHERS , J. and D AVID G. H AYES , J., joined. Roy F. Amede

e, Jr., L aPlace, L A; Lisa Ju

ne Cox, Jackso n, TN, for Appellants, Haffey, Bish and Burton Glen Reid, Jr., Memphis, TN; James B. Irwin, Nathan T. Giscla ir, Jr., Sally

I. Gaden, Ne

w Orleans, LA, for Appellees, Smith & Nephew, Inc. Murray Levin, Philadelphia, PA ; George Lehner, Washington, D.C ., Sam B. Bl air, Jr., Memphis, TN, for Appellees Danek Medical, Inc., Warsaw Orthopaedic, I nc. 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 Sofam or Dan ek Gro up, Inc. (n ow M edtronic S ofamo r Danek , I nc.) , Danek Medical, Inc., and Warsaw Orthopaedic, Inc. were par ty defendant

s in the Bish lawsui

t but have been volunt

arily di smissed wit

h prejudice

and now are parties o nly to the a ppeal fro m the H affey suit. -2- OPINION
The three cases before the court on interlocutory ap peal 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 th e defendants, including strict liability, negligence, negligence per se , bre ach of express warranty , breach of implied warrant, failure to warn, unlawful promotion, negligent misrepresentation, civil conspiracy, concert of action, and negligent infliction of emotional distre ss. The complaints a

lso allege that the devices involved had not received the required FDA clearance and/or approval and allege fraud, fraudulent marketing and unla

wful promotion aga

inst the named def

endants. 1
Due to the number of plaintiffs, a Case Management Order was en tered by the tria

l court. This Order

designated fourteen plaintiffs for trial, and the pla

intiffs in this appe

al are some of those designated. Of the three appea

ls now before this

Court, one appeal is in the Haffey suit, originally filed in the Circuit Court of She lby County on October 3 , 1995 against Dan ek. The second a

ppeal is a separate, similar complaint, r epresented by pl

aintiff, Gretch

en Bish , fi led against manufacturer, Smith& Nephew Richards, Inc. 2 The third appeal is in a c ase r epresented by pl aintiff Donald Burton, and presents the i ssue of the admissib

ility 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 plaintiff

s’ negligence per se claims, holding:

1. No p rivate 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 FDCAsections re ferred to by Plaintiffs in their Complaints and Memoranda

are not suitable as negligence per se stan dards i n these pending cases;-3- 3. Even if the federal and Tennessee Statutes, and federal FDA Regulations and FDCA section s refer red to by Plaintiffs in the Compl a ints and Memoranda were suitable as negligence per se standards,the causal connection between the alleged violations of the federalandTennessee Statue s, federal FDA Regu

lations and FDCA andPlaintiffs’ alleg

ed injuries is

too tenuous to constitut

e proximate cause. 4. Plaintiffs have fa

iled 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, andPlaintiffs’ 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 or d er granting defendants’ motion in limine regarding the ad missibility of all regulatory (FDA) evi dence as it previously ruled. The Haffey and Bish appellants were granted interlocutory appeals. Subsequently, after a mistrial, the B urton 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 FD

A regulatory info

rmation or regula

tions is relevant to issue

s 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 tha t s uch evi dence would be pr ejudicial, confusing to a jury or a waste of time?
4. Whether the tria

l court erred in g

ranting Appellee

s’ Motion to Dismiss Appellants’ Negligence per seClaims? We will consider t

he fourth issue fi

rst. This issue is controlled by our Opinion in King v. Danek Medica l, 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 neglige n ce per se claim, it is not suffi

cient for a plain

tiff to assume, as t

hese plaintiffs have, that the all eged vio lation of a statute automatically su p ports a claim of negligence per se. Even if the plaintiffs are within the class to be pr otected by the statute, see Harden , 985 S.W.2d at 452, a statut or y 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 standardof carebut merely imposes an administrative requirement,

such as the r e quirement to obtain a license or to file a repor

t t o support a regulatory scheme, violation of such requiremen t wi ll not support a negligence per s e cla im. Even if the regulatory scheme as a who le is designed to protect the public or to promote safety, the l icensi ng duty itse lf i s not a standard of care, but an administrative requirement. See Ridge v. Cessna Aircraft Co. , 117 F.3d 126, 131 (4th

C ir.1997) (holding that federal regulations making a pilo

t respons ible for operation of his aircraft and r

equiring him,upon request, to submit a written report to the governm ent wh enever he deviates from an aviation rule in an emergency pro vi de for "general standards of conduct," but do "notimpose a particular duty," and thus their violation was not negligence per se in Virginia)[.]

.... In conc luding 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 trivia lize the alleged violation of administrative statutory provisions. They are e ssential to the un der lying federal regulatory scheme that serves importantsocietal inte

rests. But b ecause such spe cific approval rules are administrative, they do not amount to a legislative judgme nt as to the standard of care, a nd accordingly, breach of these provision s i n themselves cannot

underlie a

negligence per se claim. 179 F.3d at 159.-5- We have examined the statutes cited b y 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, basedupon 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 p er se , we conclude that they can prove no set of facts which would entitle them to relief. Accordingly, the trial court wa s co rrect in granting the defendants’ moti

on to dismiss as to this c

laim. King , at *34. In light of the ruling in King , we find this issue w ithout merit. Appellants’ Issues 1 through 3 address the question of admissibility into evidence of FDA regulatory information andregulations. The initial briefs filed in the case for the most part referred to the ruling of the court that generally denied the i ntr oduction of FDA re gulatory evidenc

e in response to a motion in limine in the Burton case . At oral argumen t, reference wa

s made to plaintiff Burton’s offer of proof, and the court requested supplemental briefs from the parties concerning a mo re precise descri

ption of the eviden

ce that was not all

owed. Burton’s sup

plemental brie f highlightsthe 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 te

stified th at h e is vice-president of regulatory and clinical affairs andquality of

Smith & Nephew. His te

stimony primarily

focused on clinic

al studies of ortho

paedic implants in humans. In connection w ith FDA re gulations, 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 exp l ained that PreMarket Approval (PMA) was an application to the FDA w hic h involves clinical trials as an Investigation of Device Exemption (IDE). He testified that be tween 1991 and 1993, Smith & Nephew had no 510 (k) clearing the Simmons spinal rating syst em for the posterior or pedicular application. His testimony detailed his understanding of FDA regulations which was relate

d to his company and the Simmons ratin g system. He also dis

cussed the compa

ny’s actions in re

sponse to FDA communication and explained Smith & Ne

phew’s decision-

making process re

lated to th e Simmons pedicle screw device. Jeff Cobb testified that he is the director of regulatoryaffairs 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 defici encies in th e IDE application. He testified-6-

concerning the company’s decision t o termi nate 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 adv e rtising, labeling, and consumer education, and testified concerning a recall of a reported defec

tive locking nut.
Dr. Carl Larson t e stified that he was a former director of the General Restorative Devices Division of the FDA. Dr. Larsontestified 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 andgenerated scie

ntifically reliab

le da tato estab lish the safety of a ny pedicle screw

device. Dr. Lar

son’s testimony exte

nsively discussed the regulations and the duties of the manufacturer with regard to the law. The evidentiary rule

s pertinent to our in

quiry are Tenn.R

. Evid. 401, 402, and 403. They provide:
Rule401. Definition of “relevant evi de nce.” - “Relevant

evidence” means evidence ha ving 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.
Rule402. Relevant evi den ce generally admi ssible; irreleva

nt evidence inadmissible. - All relevant evidence is admissible except as provided by the Constitution of the United States, the Constitution of Tennessee, these rules, or ot her rules or laws

of general appli

cable in the courts of Tennessee. Evidence wh ich is not relevant is not admissible.
Rule403

. Exclusion of r elevant evidence on grounds of prejudice, confusion, or waste of ti me. - Although relevan t, evidence ma y be excluded if its probative value i

s substantially outweighedby 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 produc

t 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 pla

intiff must

prove that the product w

as “in a defecti

ve condition or unr

easonably 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 wo uld be-7-

withoutthe 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 admissibi lity of evidence is within the sound discretion of the trial judge. When arr iving at a determin

ation to admit or exclude even that evidence which is considered relevant trial courts are generally

accorded a wide

degree of latitu

de and will only be overturned o n appeal where there is a showing of abuse of discretion. Strickland v. City of L awrenceburg , 611 S.W.2d 8 32 (Tenn. Ct. App. 1980); Tennessee Rules of Evidence 401; Austin v. City Memph is , 684 S.W.2d 624 (Te nn. Ct. App. 1984); Inman v. Aluminum Co. of

America , 697 S.W.2d 350 (Tenn. Ct. App. 1985).
We consi der th e rule in McCormack v. Riley, 576 S.W.2d 358, 360 (Tenn. Ct. App. 1978) to be applicable here:
Not all logically

rele vant evidence is admissible. Thus evidence which

woul d advance the inquiry but would also inflame or un

duly 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 we ight o f evidence must be balanced against those attendant costs in de termi ning that evidence should be admitted. Id. at 360. 850 S.W.2d at 442-443. Evidence upon a fact not in is sue is irrelevan t and not admissible u

nless c ollaterall

y admissible. Bridges v. CSX Transp., Inc., 845 S.W.2d 760 (Tenn. Ct. App. 1992). In Bridges , the Cour t noted: “[T] here must be some r elevance betwe

en evidence off

ered and the issue

s 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 defectiveor

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. Th e FDA’s approval or

nonapproval of th

e devices without

more does not tend t

o prove that th

e devices were defectiv

e or unreasonab

ly dangerous. Moreover, a review of the testimony of the three witnesses offered by plain tiff Burton aptly ill

ustra tes 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 o

f this record, if t

here is any proba

tive value to the te

stimony, it is substant

ially outweighedby the dangers out lined in Rule 403. The

trial court did not a

buse 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 fur

ther procee dings as are necessary. Costs of the appeal are assessed against the appellants, Eugene Haffey, Gretchen Bish, and Donald Burton.

__________________________________________ W. FRANK C RAWFORD, PRES IDIN G JUDGE, W.S

.