IN THE COURT OF APPEALS OF TENNESSEE
AT KNOXVILLE FILED
August 31, 1998
DON HARDEN, Cecil Crowson, Jr.
) C/A NO. 03A01-9801-CV-00020
Appellate C ourt Clerk
)
Plaintiff-A ppellant, ) KNOX CIRCU IT
)
v. ) HON. WHEELER ROSENBALM,
) JUDGE
DAN EK M EDIC AL, IN C., )
) AFFIRMED AND
Defendant-Appellee. ) REMANDED
CLINT J. WOOD FIN, RALPH BRO WN & A SSOCIATES, Knoxville, for Plaintiff-
Appellan t.
ROBERT R. CAMPBE LL, HODGES, DOUGHTY & CARSON, and STEPHEN S.
PHILLIPS AND JAMES M. BECK, PEPPER HAMILTON, LLP, Philadelphia, PA,
for Defendant-Appellee.
O P I N IO N
Franks, J.
In this action for allegedly manufacturing a defective product which
harmed plaintiff, the Trial Judge granted defendant summary judgment, and plaintiff
has appealed.
The principal issue on appeal stated in plaintiff’s brief is:
Did the Trial Court commit reversible error by holding that no genuine
issues of material fact existed in the record on August 19, 1997, and
granting summary judgment to the defendant on that basis.
Appellant in his brief argu es that the Trial Judge com mitted several errors which were
not specified as issues in the statement of issues. The issue as stated is simply not
reviewable. We said in Leeson v. Chernau, 737 S.W.2d 634 (Tenn. App. 1987) p.637:
T.R.A.P. does not contemplate that an appellant may submit one blanket
issue as to the correctness of the judg ment and thereby open the door to
argument upon various issues which might affect the correctness of the
judgmen t.
Since the appellee eff ectively cured this defect by filing a “counter-
statement of the issues presented”, we will consider the issues presented.
This case arises from an operation that was performed by Dr. Glenn
Jeffries in 1992 on the plaintiff who had been suffering back pain. Dr. Jeffries
determined that plaintiff would benefit from back surgery stabilized by spinal
instrumentation. In March of 1992, Dr. Jeffries performed the surgery and implanted
a construct built from components made by Defendant Danek Medical , Inc.
(“Danek”). In the operative procedure, Dr. Jeffries used bone screws to attach the
construct through the pedicles of plaintiff’s vertebrae.1 Plaintiff’s condition improved
after surgery, but in July of 1993 his pain returned. On August 8, 1995, plaintiff
underwent surgery to have the hardware removed from his back.
This action then followed in October 1995, wherein plaintiff alleged
injuries from the implantation of a Danek device that was defective and/or
unreasonably dangerous. In June 1996, Danek filed a Motion for Judgment on the
Pleadings, arguing that the complaint failed to state a cause of action. Plaintiff moved
to amend his complaint on July 17, 1996. On July 30, 1996, the Trial Court granted
Danek’s motion and dismissed the amended complaint. However, on August 8, 1996,
plaintiff mo ved to file a s econd am ended co mplaint an d for recon sideration of the July
30 order. The Trial Court allowed the second amended complaint, but denied
reconsideration of its dismissal of the claims in the first amended complaint. On June
4, 1997, Danek moved for summary judgment on the allegations in the second
amended compliant, and as a part of that motion, Danek included Dr. Jeffries’
1
Each vertebra has left and right pedicles which face out and are more readily accessible to a
surgeon than other parts of the vertebra.
2
deposition. On June 30, 1997 plaintiff gave notice to depose Dr. Jeffries. On August
15, 1997, plaintiff filed a N otice of Deposition. O n August 19, 19 97, the Trial Court
quashed the N otice and denied plaintiff’s M otion to Amend and granted D anek’s
Motio n for S umm ary Judg ment.
Plaintiff contends that the T rial Court erred in granting sum mary
judgment on his fa ilure to warn claim. He a rgues that defendan t owed a duty to warn
him that the safety of its system had been determined only for certain types of
conditions and that implanting a pedicle screw system was a potentially dangerous
proced ure that o nly expe rienced surgeo ns perf ormed .
As the moving party for summary judgment, the defendant had the
burden of dem onstratin g that no genuin e issue o f mater ial fact e xisted. Shadrick v.
Coker, 963 S.W.2d 726 (Tenn. 1998). On appeal “we are required to view the
evidence in the light mo st favorab le to the non -moving party, draw all re asonable
inferen ces in h is favo r, and di scard a ll counte rvailing eviden ce.” Id. Summary
judgmen t is only proper “[ i]f both the f acts and co nclusions to be draw n from the facts
permit a reasonable person to reach only one conclusion . . .” Id.
Summary judgment was proper on this issue because the treating
physician was aware of the risks and limitations of the surgery he performed with the
hardw are he in stalled. T he def endan t relied o n the de fense o f learne d interm ediary.
Under th is doctrine, m anufactu rers of certain medical p roducts “m ay reasonably rely
on intermediaries to transmit their warnings and instructions.” Pittma n v. Up john C o.,
890 S.W.2d 425, 429 (Tenn. 1994). This defense is based upon the pivotal role that
physician s play in the distribu tion of p rescriptio n prod ucts. Id. Physicians can be
learned interme diaries o nly whe n they rec eive ad equate warnin gs. Id. Thus,
manufa cturers are no t shielded fro m liability if they prov ide inadeq uate warn ings to
physician s. Id.
3
In order to recover for fa ilure to warn under the lea rned intermediary
doctrine, a plaintiff must show : (1) that the defendant failed to warn the physician of
a risk associated with the use of the product not otherwise known to the physician; and
(2) that the failure to warn the physician was both a cause in fact and proximate cause
of the plaintiff’s injury. 63A Am.Jur.2d Products Liability §1200 (1984 ).
Generally, “a m anufactu rer will be ab solved of liability for failure to
warn for lack of causation where the consumer w as already aware of the da nger,
because the failure to warn cannot be the proximate cause of the user’s injury if the
user had actual knowledge of the hazards in question.” Id. at §1162. U nder this
doctrine, ph ysicians are the “ consum ers” who must be w arned. Th us, it is generally
held that the le arned interm ediary doctrine may shield a m anufactu rer from liab ility
when the physician was independently aware of the risks involved. Id. at §116 2. See
Odom v. G.D . Searle & Co., 979 F.2d 1001 (4th Cir. 1992) (applying South Carolina
law); Stanback v. Parke, Davis & Co., 657 F.2d 642 (4th C ir. 1981)(ap plying Virginia
law); Spych ala v. G .D. Sea rle & Co ., 705 F.Supp. 1024 (D.N.J. 1988) (applying New
Jersey law); Ashman v. SK & F Lab Co., 702 F.Supp 1401 (N.D. Ill. 1988)(applying
Illinois law); Zanzuri v. G.D. Searle & Co., 748 F.Supp. 1511 (S.D. Fla.
1990)(ap plying Florida la w); Andre v. Mecta Corp., 587 N.Y.S.2d 334, (NY. App.
Div. 1992) appeal denied, 648 N .E.2d 7 91.
In Dr. Jeffries’ affidavit submitted by defendant, he stated that he was
fully aw are of th e risks in volved in using the hard ware in this type of surgery.
Moreover, he stated that he was familiar with the FDA regulatory status of the
product. Finally, he stated that he did not rely upon certain literature distributed or
sponsored by the defen dant in making his de terminations. Thus, the defe ndant’s
alleged failure to warn plaintiff is not considered to be the proximate cause of
plaintiff’s inju ry under this do ctrine. Wh ile the “indep endent kn owledg e” defen se is
4
not uni versally ac cepted , see Seley v. G.D. Searle & Co., 423 N.E.2d 83 1 Ohio 1981 ),
we follow the majority view among th e courts that h ave decid ed this issue, w hich is
consiste nt with Tenn essee c ase law . See Ball v. Mallinkrodt Chem. Works, 381
S.W.2d 5 63, 568 (T enn. Ap p. 1964). (T rial Court did not err in refu sing to subm it
improper warning claims to jury when “there was no evidence that [the treating
physician] relied upon the b rochure an d all of the ev idence sho ws that he was fully
aware of the toxicity. . . “).
Plaintiff also argues that the Trial Court erred in granting judgment on
the issue of his negligence per se claim. The complaint alleges that defendant violated
21 U.S .C. § 36 0 of the Food , Drug and C osmetic Act (“F DCA ”).
Plaintiff contends that common law negligence suits are not preempted
by the FD CA. See Medtronic, Inc. v. Lohr, 116 S.Ct. 2240 (1996). Although
Medtronic establishes that state common law negligence claims are generally not
preempted, it does not resolve the precise issue in this case. The defendant does not
argue that the negligence per se claim is preempted. Rather, it argues that since the
FDCA does not provide for a private right of action, allowing negligence per se claims
based on violations of the statute w ould be co ntrary to Cong ressional inten t.
21 U.S.C. §337 provides:
Except a s provided in subsectio n (b) of this se ction, all
such proc eedings fo r the enforc ement, or to restrain
violations, of this chapter shall be by and in the name of
the United States.
Thus, it is necessary to determine if it would be proper to use the FDCA
provision as a basis for a negligence per se claim.
In order to recover under the theory of negligence per se, a party must
establish three elements. First, the defendant must have violated a statute or ordinance
that imp oses a d uty or pro hibition for the b enefit o f a pers on or th e public . Mem phis
Street Railway v. Haynes, 81 S.W.374 (Tenn. 1904). Second, the injured party must
5
be within the class of persons intended to benefit from or be protected by the statute.
Traylor v. Coburn, 597 S.W.2d 319 (Tenn.App. 1980). Finally, the injured party must
show that t he neglig ence was the p roximate caus e of t he in jury. Long v. Brookside
Manor, 885 S .W.2d 70 (Te nn. Ap p. 1994 ).
The F DCA was d esigne d to pro tect the p ublic as a who le. “Toole v.
Richards on-Me rrell, 60 Cal.Rptr. 398, 409 (Cal.Ct.App. 1967) (citing United States v.
Sullivan, 332 U.S . 689 (194 8)). Since the statute was designed at least in part to
protect the public from unsafe medical products, the plaintiff has met the first two
required ele ments. Th e issue thus b ecomes w hether the F DCA ’s lack of a p rivate
cause of action precludes using it as a basis for negligence per se claims.
We have been cited no Tennessee authority which has determined
whether a violation of the FDCA can support a negligence per se claim. Defendant
cites Rogers v . Memp his City Sch ools, 1997 W L 6751 94 (Tenn . App.) for its
contention that FDCA violations cannot support negligence claims. In Roge rs, the
plaintiff sough t to bring a neglig ence a ction un der the T enness ee Tor t Liability A ct.
This claim was based in part on the defendant’s alleged violation of the federal
Individuals With Disabilities Act (IDEA). The plaintiff sought to recover damages for
pain and suffering, which were not available under the remedial provisions of the
IDEA. The court determined that the plaintiff could not circumvent or supplement the
IDEA’s provisions merely by bringing a state law claim. Since the IDEA constituted
“the exclusive remedy for a child with disabilities asserting the right to a free
approp riate pub lic educ ation,” th e plaintif f “faile d to state a claim under t he TG TLA .”
Id. at *4.
While Rogers is an instructive and well-reasoned opinion, it is not
precise ly on poin t. First, Rogers obviously dealt with a different statute, with different
provisions from the one at issue in this case. Moreover, the IDEA provided an
6
independent remedial scheme whereby injured parties could seek relief. There is no
similar provision in the FDCA. Thus, while Rogers provides guidance, it is not
dispositive.
Other jurisdictions have reached differing results on this issue. Some
jurisdictions have allowed plaintiffs to bring negligence claims per se on FDCA
violations. In Orthopedic Equip. Co. v. Eutsler, 276 F.2d 455 (4th Cir. 1960), the
Fourth C ircuit determin ed that althou gh the FD CA do es not exp ressly provide a civil
remedy for in jured cons umers, ma nufacture rs who v iolated their statu tory duties could
be sub ject to ne gligenc e per se claims. Accord: Stanton v. Astra Pharmaceutical
Prods ., Inc., 718 F.2d 553 (3rd C ir. 1983); Toole v. Richardson-Merrell, Inc., 60 Cal.
Rptr. 398 (Cal.Ct.Ap p. 1967).
Assuming arguendo that FDCA violations could be the bas is for a
negligenc e per se actio n, we belie ve summ ary judgmen t was still appr opriate in this
case. The plaintiff alleg es that the de fendant “ marketed , promoted and distribu ted” its
product for the purposes which the FDA had not approved, in violation of § 360 of the
FDCA . Section 36 0 primarily dea ls with the du ty of produce rs of drugs or devices to
register with the Secretary of State for the state in which certain establishm ents are
located.
It is not clear from plaintiff’s complaint which portion of §360 the
defendant is alleged to have violated. Plaintiff may have intended to allege violations
of the Medical Device Amendments to the FDCA and not the general reporting
require ments o f § 360 . If so, this allegatio n is not s tated in th e com plaint. See
T.R.C.P. 8.05 (addressing the pleading of statutory violations). It is not clear how the
defendant failed to comply with its statutory duties. The complaint recites several
examples of alleged misconduct by defen dant. Assuming th at these instances were
breaches of § 36 0, summary judgme nt, nevertheless, was prope r.
7
Assuming defendant did breach § 360, such breach was not the
proximate cause of plaintiff’s injuries. Assuming that the Appellant marketed,
promoted and distributed its product for non-FDA approved purposes, Dr. Jeffries’
affida vit states t hat he w as fully aw are of th e FDA regulato ry status of this prod uct.
The doctor chose to make an “off-label” use of the product. He relied entirely upon
his own expertise an d experience in decid ing whether and how to use the d efendant’s
product. Accordin g to his affidavit “[m]y profession al decision concerning w hether,
how, or where to use instrumentation is not determined by whether a particular use of
a particular drug or device has or has not been evaluated by the FDA.”
To the extent that the plaintiff’s complaint alleges improper marketing
through th e use of ce rtain literature an d promo tional camp aigns, Dr. Je ffries’ affid avit
establishes that he was not familiar with, and did not rely upon, any of these marketing
techniques. Thus, assuming arguendo, that defendant violated § 360 of the FDCA,
such v iolation was n ot, as a m atter of la w, the p roxima te cause of plain tiff’s inju ry.
Plaintiff filed a notice of deposition before summary judgment was
granted. The Trial Court quashed the notice and granted summary judgment. Plaintiff
then filed a motion to alter or amend the final judgment and as a part of that motion,
the plaintiff again attached an affidavit stating his need to depose Dr. Jeffries. The
Trial Judge also denied this motion.
Rule 56.0 7 of the T ennessee Rules of Civil Proce dure prov ides:
Should it appear from the affidavits of a party opposing
the motion that such party cannot for reasons stated
present by affidavit facts essential to justify the
opposition, the court may refuse the application for
judgmen t or may order a continuan ce to perm it affidavits
to be obtained or depositions to be taken or discovery to be
had or m ay make suc h other ord er as is just.
In this case, the Trial Court did not abuse its discretion in refusing to allow further
discovery. Defendant raised the learned intermediary defense in its answer. Over
8
seventeen months p assed bef ore the def endant, relying o n Dr. Jeff ries’ affidav it,
moved for summary judgment. The plaintiff waited until the day argument was to be
heard on the motion before giving formal notice that he wished to take Dr. Jeffries’
deposition. This was some seventy days after the summary judgment motion had been
filed. Und er these circu mstances , we conc lude the T rial Judge d id not abus e his
discretio n in den ying this m otion.
Finally, plaintiff contends that the Trial Cou rt erred in denying his third
proposed amendment to his complaint. Plaintiff moved to amend for a third time on
June 30, 1997.
Rule 15.01 of the Tennessee Rules of Civil Procedure provides:
“A party may amend his pleadings once as a matter of course at any time before a
responsive pleading is served . . . [o]therwise a party may amend his pleadings only by
written con sent of the a dverse pa rty or by leave of c ourt . . .” Althou gh perm ission to
amend should be liberally granted, the decision is “ within the sound discretion of the
trial court, and will not be reversed unless abuse of discretion has been shown.”
Welch v. Thuan, 882 S.W.2d 7 92, 793 (Tenn.A pp. 1994). Factors the trial court
should co nsider wh en decidin g wheth er to allow a mendm ents include “undue d elay in
filing; lack of notice to the opposing party; bad faith by the moving party, repeated
failure to cure deficiencies by previous amendments, undue prejudice to the opposing
party, and futility of amendment.” Merrim an v. Sm ith, 599 S.W.2d 548, 559
(Tenn.App. 19 79).
In this case, plaintiff sought to amend his complaint to include
allegations th at one of th e nuts hold ing the screw s in his back was loose and that all
four of the screws b ecame loo se within h is spine. The report upo n which this
amendm ent was b ased is dated Augus t 8, 1995, yet the a ppellant did not attemp t to
utilize it before, even when the defendant moved for judgment on the pleadings. The
9
plaintiff attempted to use the operative report as evidence that “[t]he TSRH spinal
system and the pedical screws in particular were unreasonably dangerous and
defective . . . “ The alleged looseness in the screws, however, was observed only after
the product was b eing dismantled, not w hile it was implanted. The screws were
observed to be loose o nly after the rod s and con nectors w ere remov ed. There is
nothing in th e operative report to estab lish that any of th e screws b ecame loo se while
in the pla intiff’s b ack, on ly that one of the n uts wa s loose.
For the fo regoing rea sons, we c onclude th e Trial Co urt did not ab use its
discretion in d enying this am endmen t.
We affirm the judgment of the Trial Court and remand with cost of the
appeal asse ssed to the a ppellant.
__________________________
Herschel P. Franks, J.
CONCUR:
___________________________
Houston M. Godd ard, P.J.
___________________________
Don T. McM urray, J.
1 0