*1 RICHARDSON, Cynthia et al. MILLER, M.D., et al.
James Tennessee, Appeals Court at Nashville. Aug. 2000. Appeal Permission to Denied Supreme Court March *4 Wiseman, III, Nashville, TN, A.
Thomas Miller, M.D. James appellee, Nashville, TN, ap- Pinckney, Thomas Corporation. Tokos Medical pellee,
OPINION Jr., J., KOCH, delivered
WILLIAM C. court, in which HENRY opinion M.S., TODD, P.J., joined. H. F. BEN CANTRELL, J., opinion. dissenting filed a malprac- medical appeal involves a This the use of stemming tice from action to administer terbutaline preg- to arrest a sulphate subcutaneously suffering nant labor. After woman’s *5 shortly giving before birth to heart attack child, the and her hus- healthy woman in the for filed suit Circuit Court band her County against attending Davidson physician, supplier of the negli- alleging and others their pump, gence her attack. had caused heart The inter- woman’s medical insurance carrier its contractual vened to assert reimburse- payments on it had rights ment based ex- advanced for woman’s medical The the in- penses. trial court dismissed re- complaint, jury and a surance carrier’s for and the physician turned a verdict supplier. Among their issues pump woman and her husband appeal, the take with the exclusion evidence issue of ter- regarding FDA-approved uses refusal butaline and with trial court’s give requested missing evidence physician pump and the instruction. supplier they assert that were entitled to a verdict at the close of all the directed insurance car- proof. Finally, medical rier issue with the dismissal takes Lawson, Mary A. Parker Michael and C. have de- reimbursement claim. While we Nashville, TN, Cynthia for appellants, correctly the trial court termined that Richardson and William Richardson. verdict, directed overruled the motions for Nashville, by court erred TN, appel- we trial Douglas Berry, conclude off- lant, excluding Life Insurance evidence Principal Mutual by declining to label use of terbutaline and Company. give requested instruction. The trial cerned that the labor was premature and court also erred dismissing the medical that there possibly could be complications insurance carrier’s claim. Accordingly, baby we for the if at thirty-five born weeks. judgment vacate the physician hydration He ordered bed rest and manufacturer and remand the tested Ms. Richardson to rule out mere case for a new trial. irritability. uterine When the contractions signs showed no of abating, Dr. Miller Cynthia Richardson married William opted to affirmatively retard Ms. Richard- Richardson 1991. Ms. Richardson was i.e., son’s premature by tocolysis, labor a 26-year-old physical therapist, Mr. giving her stop medication to her contrac- years junior. Richardson was four her tions relaxing her uterine muscles. children, Ms. Richardson loved and the couple decided not delay starting a fam- Dr. Miller first prescribed and adminis- ily Richardson, because Ms. put as she it magnesium tered sulfate limited suc- later, felt “biological her ticking 24,1993, clock .” cess. On June frequen- when the Ms. Richardson learned preg- cy that she was of Ms. Richardson’s contractions did not nant with couple’s decrease, first child on Dr. Miller ordered a different Thanksgiving Day (“terbu- 1992. Her tocolytic estimated sulfate —terbutaline 28,1993. taline”). July due date was ap- While terbutaline had been proved by FDA only for treating bron- Ms. sought prenatal her care Richardson asthma, chial it was being widely also used from Dr. early James Miller. January tocolytic agent as because it relaxes 1993, Ms. Richardson complained that she muscles, smooth including the muscles of *6 was experiencing periods palpitations, the uterus. heartbeats, rapid and shortness of breath. Dr. Miller referred her to Dr. James W. Ms. Richardson received her first oral Ward, Jr., a cardiologist previous- who had dose of terbutaline at approximately 8:30 ly evaluated Ms. Richardson in p.m. dose, 1987 for a June and her second similar complaint. mouth, Dr. placed again by Ward Ms. four hours later. Some- Richardson on a 24-hour heart monitor during early time morning hours of only that showed benign changes in her June she with pain” awoke a “horrible rhythm. heart Accordingly, Dr. Ward re- in her chest. Ms. Richardson had not ported to Dr. Miller that he gone recommended back to sleep when a nurse came no additions to Ms. Richardson’s medical at approximately 4:00 a.m. with a third care. Ms. Richardson made no other car- oral dose of terbutaline. Ms. Richardson complaints during diac subsequent nurse, office drug, telling refused the as the visits with reflect, Dr. Miller. *7 subcutaneously
infuse terbutaline set p.m. on approximately 3:00 June She deciding doses. Other than start Ms. upset when sister told her that became her time, Richardson the Dr. Miller pump, on was dog died. At that mother’s had directly installing chest, arm, involved with jaw, Ms. and Richardson’s pump determining dosage terbu- began hurting. a nurse ar- head When taline Ms. Richardson would receive while rived, Ms. Richardson exclaimed that she on pump. having heart attack and insisted that a she be removed from terbutaline On the afternoon of June Christine some confusion and hesi- pump. After Evans, Tokos, a employed nurse ar- tation, the nurses Ms. Rich- disconnected the infu- Hospital rived Memorial with pump, ardson from the and she was subse- by Dr. sion ordered Miller. She did care unit quently transferred to a critical Miller, instead, not confer with Dr. but she electrocardiogram confirmed where Richardson’s medical rec- reviewed Ms. fact, had, in a experienced that she heart ords, Richardson, Ms. talked with then attack. gave hospital Ms. Richardson and the Richardson birth to nursing concerning night gave staff instructions That Ms. days A la- conferring healthy, six-pound boy. with few pump. use of the After ter, open-heart underwent pharmacists, one staff Ms. Ev- Ms. Richardson of Tokos’s in her repair a tear dosage by-pass surgery ans of terbuta- also established coronary (“PDR”) artery associated with her heart Reference indicating that attack. After recuperating for several drug had not been approved by the federal days, Ms. Richardson baby and her were Food and Drug Administration for use in discharged from Hospital. Memorial stopping premature labor.2 trial The court granted Dr. Miller’s motion. 23, 1994,
On June the Richardsons filed a medical malpractice products liabili- When the trial commenced in June ty action in the Circuit Court for Davidson the Richardsons asked the trial court to County $3,500,000 seeking in compensato- Dr. reconsider Miller’s motion in limine. ry Miller, and punitive damages from Dr. request prompted Their Dr. Miller to ask Tokos, and two other They defendants.1 rulings for additional specifically preclud- alleged that the administration of terbuta- ing any reference at trial to off-label use of line during Ms. Richardson’s labor caused terbutaline taken drug’s from the package her to suffer a heart attack resulting insert, Physicians’ Reference, Desk permanent Later, heart damage. pretrial deposition testimony of Dr. Principal Mutual Life Company Insurance Gaudino, Ciba-Geigy Mario employee. Mutual”), (“Principal the issuer of Ms. court, Miller, trial siding Dr. with Richardson’s employer-provided group prohibited all references at trial to the off- policy, sought health to intervene as By label use of terbutaline. the time of plaintiff $52,000 to recover approximately trial in June the Richardsons had paid medical bills in connection Ms. negligence narrowed their against claims Richardson’s heart attack. On Dr. Miller’s motion, Dr. Miller and Tokos. They long- were no the trial court Principal dismissed asserting er complaint Mutual’s Dr. Miller was ground negligent (1980) § Tenn.Code Ann. initially 29-26-119 pre- attempting orally to use admin- injured vented an plaintiff from seeking istered terbutaline to slow Ms. Richard- medical care expenses as damages when Rather, son’s labor. they asserting were plaintiffs paid insurance had those ex- that Dr. Miller breached the standard of penses. care continuing tocolysis using terbuta- line began after Ms. Richardson experienc-
The remaining parties, Richardsons, pain taking chest while Miller, Tokos, terbutaline Dr. requested all a trial orally by electing by jury. trial, to administer the anticipation all subcutaneously using terbutaline an infu- sides moved in limine to exclude certain Tokos, sion pump. regard evidence. Dr. Miller With prevent moved to *8 introducing asserting Richardsons from or Richardsons were using any the com- information pany from both acted drug negligently by failing terbutaline’s to inform package insert and Physicians’ Desk Dr. Miller that Ms. Richardson was not a 1. The two other bronchospasm defendants were A+ Stat patients reversal of in Care, Inc., Home employer of the home bronchial asthma and reversible bronchos- accompanied health nurse who Christine Ev- pasm emphy- associated with bronchitis and 25, 1993, hospital ans to the on June and the that, expressly sema.” Both sources warn Ciba-Geigy Corporation, the manufacturer of "Terbutaline sulfate should not be used for terbutaline. These defendants were later dis- tocolysis. may Serious adverse reactions oc- play missed from the lawsuit and no role in cur after of administration terbutaline sulfate appeal. this mother, to women in labor. In the these rate, hyper- include increased heart transient Ciba-Geigy’s package 2. parallel insert and the glycemia, hypokalemia, arrhythmias, "Usage” PDR reference cardiac state under that ter- edema, butaline prevention pulmonary "is indicated for the myocardial and and ischemia.” defini begin with a under must prescription for the infusion candidate The guidelines because of advanced of term “off-label use.” term tion her pregnancy of her and because of stage essentially concept de regulatory an is complaints problems and of cardiac history Drug Food and rived the federal from failing insist before and on EKG (“FDA”) of regulation Administration’s beginning pump. on the Ms. Richardson labeling. drugs and their See prescription Azari, D. Elizabeth M. Beck <& James in jury returned a
The later verdict FDA, Uses, Con Tokos, trial of Dr. Miller and and the favor Off-Label Informed Misconcep subsequently judgment Debunking Myths court entered sent: (1998) tions, court jury’s verdict. After the trial Drug& L.J. 53 Food trial, Rich- their motion for new (“Beck Azari”); Salbu, denied R. & Steven Off- perfected appeal. ardsons this Use, Marketing Prescription Label of Dmgs: An FDA-Approved Assessment of I. Policy, 51 Fla. Legislative Regulator (1999) (“Salbu”). The L.Rev. Regarding The Exclusion of Evidence term, care customarily as used health Use Terbutaline Off-Label medically neutral and refers providers, is Tocolysis for in which a uses a patient to a circumstance trial The Richardsons assert in drug or a manner that prescribed device entitling court committed five errors them drug’s way from the or varies some a new trial. We have concluded labeling. FDA-approved device’s dispositive issue trial involves the 85; Azari, Drug Beck & 53 Food & L.J. prevent court’s decision to the Richardsons Finley, Guarding Lucinda M. the Gate to introducing regarding from evidence Judges How Tñal Are the Courthouse: cross-examining Dr. or Tokos’s Miller’s Screening Using Evidentiary Role Their concerning witnesses FDA-approved Rules, terbutaline, 49 De- Ciba-Geigy’s uses of directions to Remake Tort Causation terbutaline, Salbu, (1999); using for the off-label use Paul L.Rev. tocolytic agent. terbutaline as We at 188.3 the term is Fla.L.Rev. Because determined that evidence relevant closely oversight linked so with the FDA’s and that the trial court revers- committed fully it cannot be prescription drugs, by excluding ible error it. without some basic under understood standing procedures ap the FDA’s
A. pre and sale of proving promotion scription drugs. Regulatory The FDA Process Food, Drug, and Cosmetic federal admissibility Any discussion (“FDCA”) later amendments of a Act and its evidence off-label use usage Drug of three circumstances: of the FDA’s Center for occurs one The director (l)Off-label physician prescriptions where a off-label Evaluation and Research describes form, indication, any dosage orders or device be used "[u]se use as the label’s instruc- *9 regimen, population param- manner that varies from tions; dose of other use (2) marketing labeling.” promotion approved off-label or in the eter mentioned Woodcock, promotes drug a or Regulatory A the where a manufacturer Janet See Shift (Presentation patient purposes, populations, or Montreal June device for Approach to DIA 1997) 23, approved by (<http://www.fda.gov.cder/pres- in combinations other than those FDA; (3) (visit- by patient use eal/regappr/sld003.htm>) and off-label ent/diamontr 5, knowledge 2000); place Legal may without the July Washington take ed see also Found, Friedman, physician. F.Supp.2d prescribing 55 the manufacturer or v. 13 Salbu, (D.D.C.1998). matter, general Fla.L.Rev. at 188-92. a off-label See 51 As 10 807.100(b)(1)
were prevent (1999); enacted to wide-spread trag see Washington also Found, edies such involving Friedman, as Legal those sulfanilam-i v. 13 F.Supp.2d de4 55; improving Salbu, thalidomide at 51 Fla.L.Rev. at 187. manufacture, testing, labeling of pre After receiving drug application new . scription Note, drugs Drug See The data, and the supporting the FDA con Amendments How Regula 1962: Much a analysis ducts risk-benefit to ascertain tion?, (1963). Rutgers 18 L.Rev. 115 drug’s safety new and therapeutic ef The premise legislation of the is that a fectiveness for intended use or uses federal agency necessary to protect con specified by its Marga manufacturer. See sumers from products profit-seek of a Drugs ret Gilhooley, When Are For Safe ing drug industry on increasing bent Some But Not The Experi Others: FDA profits. Bird, sales and See James R. ence and Alternatives Products Liabil for Package Prescription Inserts Drugs as for (“Gil (1999) ity, 36 Hous.L.Rev. 928 Cases, Evidence in Malpractice Medical FDA, hooley”), citing Dep’t U.S. of Health (1977) (“Bird”). 44 U.Chi.L.Rev. 406 Servs., & Managing Human the Risks FDCA, Under the a manufacturer cannot Use, From Medical Creating Product a market or prescription sell a new drug Framework, Management Report to the without first FDA obtaining approval. See FDA Comm’r from Task Force on (West 1999). 355(a) 21 § U.S.C.A. (1999); Risk 21 Management Sidney A. The process FDA’s approval begins Shapiro, Physician Limiting Freedom to when a submits a drug manufacturer new Prescribe Drug Any Purpose: The for application. This must application include Regulation, Need FDA Nw. 73 detailed information the drug, (1978) U.L.Rev. (“Shapiro”). 805 (1) (2) including its components, its manu- Once the FDA determines the new (3) facturing process, samples of drug, drug effective, is safe and the FDA and (4) studies conducted to determine the drug’s negotiate manufacturer the lan drug’s efficacy safety and for a particular guage drug’s to be included labeling. (5) uses, use or proposed labeling Bird, See U.Chi.L.Rev. 410. drug. 355(b)(1); § See 21 U.S.C.A. 807.87(e)(1999). 314.50, The labeling5 §§ C.F.R. submitted man- The ufacturer must limited to the FDA’s of a new intended drug appli- consideration drug. cation use or is limited the use or uses Manufacturers uses for which the are nor required expected manufacturer has neither conducted sub- safety and mit all efficacy labeling drug’s studies. See 21 of a reflecting possi- (West 360e(d)(l)(A) 807.87(e). 1999); § U.S.C.A. 21 ble uses. See C.F.R. The 314.50-54, 807.92(a)(5), §§ C.F.R. purpose drug’s to ensure that a 4. any drug's wrappers The infamous "Elixir Sulfanilamide” disas- ac- containers ter involved the of over deaths one hundred drug. companying See 21 U.S.C.A. poisoned Tennesseans who were after a reck- 321(k) (m) (West 1999); § Washington & Le- Found, supposedly less manufacturer marketed Friedman, gal F.Supp.2d at 55. therapeutic potion containing the solvent die- It any also includes other form of a Cavers, thylene glycol. David F. activities, company’s promotional including Food, Drug, and Act Cosmetics 1938: Its booklets, bulletins, pamphlets, mailing pieces, Legislative History Its Substantive Provi- supplements, and all other literature ex- sions, (1939). Contemp. 6 Law & Probs. plains, drug. related or is otherwise to the 202.1(Z)(1), (2) (1999). § See 21 C.F.R. "Labeling” encompass- is a of art that term written, graphic printed, es all material on
H Salbu, taking it. See who will be patients accurate literature contains promotional with comply 187. To the Fla.L.Rev. at regarding 51 complete and information in a of the information regulations, and known risks FDA approved use or uses Noah, drug. Imperative Lars The the same as the See PDR reference must be drug’s Disentangling “Right la FDA-approved Warn: in the the information About the “Need to Know” Know” 21 See C.F.R. beling package and inserts. from Hazards, 11 on (1999). Yale J. 201.100(d)(2) Consumer Product § (1994). Thus, 293, the label- 326 333 Reg. warnings and contained The instructions necessary for ing must include information labeling and its drug’s prescription drug, and effective use of the such safe primary are the parallel PDR reference administration, of dosage as and methods Phy drug’s use. insuring safe way indica- warnings, precautions, as well as informa expected are to take the sicians contraindications, drug abuse and tions when prescribing tion into account dependence, and reactions. and adverse Gilhooley, at 36 Hous.L.Rev. drug. See (1999). 201.56, §§ 21 201.57 See C.F.R. inserts, in the reprinted as Package drug will a new approve The FDA not PDR, frequently the most consult are now proposed labeling accept- it until finds the on the use ed source of information ap- the FDA will not particular, able. Congres At one drugs. least prescription if prove drug application a new the label- evidence committee has received sional uses regarding contains instructions physicians only not consult suggesting drug those for has other than which parallel PDR package inserts or the been shown to be safe and effective. See they rely on them references but that also 355(d)(1); 21 Opder- § David U.S.C.A. W. dosage on and making when decisions beck, Pre- Regulate FDA How Should Morlino v. of administration. See method Inter- scription Drug Promotion on the 721, Ctr., 563, A.2d 152 N.J. 706 Medical (1998); 47, Drug net? 53 Food & L.J. (1998); Bird, 44 at U.Chi.L.Rev. 187; Saibu, Raspar I. Fla.L.Rev. at Pharmaceutical citing Examination of Comment, Liability Stoffelmayr, Products 1973-71, S. Hearings on Industry, SfH Prescription Label” Uses of “Off on Health the Subcomm. and S. 966 Before (1996) 275, 276 Drugs, 63 U.Chi.L.Rev. and Pub. Comm. on Labor Sen. (“Stoffelmayr”). Sess., pt. 2d Welfare, Cong., 93rd 1st & FDA-required labeling The includes the (1973-74). at 1548 drug. package accompany inserts that drug new does approval The FDA’s of a information is also included The same drug’s of the use. oversight end its PDR, encyclopedia of medications the manufacturer must the FDA and Both annually provid published written and positive negative continue to collect physicians. Spen all practicing ed to safety the actual regarding information Lasky, sieri v. 94 N.Y.2d 701 N.Y.S.2d efficacy drug patients. on (1999); Edmund 723 N.E.2d collection regulations emphasize the FDA III, Note, Polubinski, Closing the Chan the clini- negative information A Amend First nels Communication: “to experience prescription cal Analysis Policy FDA’s ment a determination of facilitate make Promotion of “Off-Label” Manufacturer may grounds ... (1997). are or Use, whether there Both 83 Va.L.Rev. withdrawing approval of suspending PDR parallel and the drug’s 310.303(a) § 21 C.F.R. application.” physicians are directed reference (1999). prescrip- If of a the off-label use rather than at the prescribe who *11 12 drug Smith,
tion becomes widespread or endan- Avoiding Alchemy-In Awkward health, gers public obligat- the FDA is Drug Beyond: Context Off-Label investigate ed to it thoroughly and to take Fully Independent Protected Research whatever action is protect warranted to Transmognfy Should Not Into Mere Com public. Legal See of Approved Status Speech mercial Just Because Product Labeling for Prescription Drugs: Pre- It, Distribute 34 Wake Manufacturers scribing Unapproved By for Uses (1999) 963, (“Smith”). Forest L.Rev. 969 FDA, (to 16,503, 16,504 Fed.Reg. 37 be Because of the time and expense of obtain 130) pt. codified at 21 (proposed C.F.R. FDA approval of new for uses an 14, 1972);6 Aug. Nightengale, Stuart L. already approved drug, drug manufactur Approved Drugs, Unlabeled Uses 26 of frequently voluntarily request ers not do (1992).7 Drug J. Info. 143 FDA FDA approval for a new use unless the may approval drug withdraw of a if new change in the will pay for itself in information indicates that drug profits. Beales, increased See J. Howard and effective for safe use under the condi- III, Regula Analysis Economic and the tions drug’s labeling, discussed in the see 24 Advertising, tion Pharmaceutical Se of 314.150(a)(2)© § (1999), 21 C.F.R. or it 1370, 1387, (1994); ton Hall L.Rev. 1392-93 may require the manufacturer to include Bird, 412; Merrill, 44 at U.Chi.L.Rev. 82 statements the drug’s labeling that cer- 1855; Salbu, at Va.L.Rev. 51 Fla.L.Rev. at tain uses are contraindicated. 21 See 188; Shapiro, 811; 73 Nw. U.L.Rev. at 201.57(d), (1999). §§ C.F.R. 801.109 Stoffelmayr, 63 U.Chi.L.Rev. at 277. the FDA approved Once has a prescrip uses, drug
tion
for a
or
particular use
B.
drug’s manufacturer
pro
cannot market or
Drugs
Off-Label
Use
PRESCRIPTION
drug
mote the
an
for
off-label use until it
The FDA’s broad
over
authority
drug
resubmits the
another
for
series of
prescription drugs and devices does not
clinical trials
required
similar to those
physician’s
extend to a
decisions
approval
initial
of a new drug application.
products.
Washing
the use of
314.54,
these
(1999);
§§
See 21 C.F.R.
314.70-.71
Friedman,
Legal
ton
v.
Friedman,
Found.
13
Washington Legal Found. v.
13
Azari,
55;
at
Salbu,
F.Supp.2d
Beck &
53 Food
55;
&
F.Supp.2d at
51 Fla.L.Rev. at
76; Smith,
Drug
L.J.
34 Wake Forest
already
187-88. As
ap
new uses for an
limiting
L.Rev. at
proved drug
known,
969. To avoid
the abili
become
drug’s
ty
physicians
treat
may
patients,8
manufacturer
the FDA’s
request
ap
proval
drug
add
lack
FDA
or
approved
approval
new
uses to
device
Merrill,
particular
for a
use
drug’s labeling.
imply
See Richard A.
does not
Regula
using
The Architecture
or device for that use is
Government
Products,
tion
disapproved
improper.
Medical
82 Va.L.Rev.
either
or
See Beck
(1996)
(“Merrill”);
Azari,
1775
Drug
Glenn C. &
53 Food &
L.J. at 83-84.9
proposed
grounds,
This
rule was never made fined.
rev'd on other
470 U.S.
(1985).
S.Ct.
13 drug a or device is once acknowledged that drugs Thus, may use physicians approved market, as of may, part a “physician on the in any way they, their or devices medicine, prescribe lawfully of practice judgment, believe will best professional dosage patient her] for his [or a different regardless of whether patients, serve vary the of may conditions otherwise drug approved has or device the FDA package in the approved from use those Washington particular for that use. See insert, obtaining the informing or without 331, Henney, 202 333 Legal Found. v. F.3d Drug and Adminis of the Food approval Evers, (D.C.Cir.2000); United States v. Label Approved Legal tration.” Status (5th Cir.1981); 1043, Proc 1048 643 F.2d Prescribing Drugs: Prescription For Davis, 265, Ill. Ill.App.3d 291 225 tor v. FDA, 37 Unapproved by For Uses 1203, 1 126, n. 682 N.E.2d 1206 Dec. (to 16,504 16,503, at be codified Fed.Reg. (1997); v. Abbott Northwestern Femrite 130) 14, (proposed Aug. pt. 21 C.F.R. 535, Hosp., (Minn.Ct.App. 541 568 N.W.2d 1972).10 has An FDA technical bulletin 1997); Biscup, App.3d 109 Ohio Klein v. of an ap use recognized that the off-label (1996). 855, 225, This N.E.2d 231 673 and proved drug represents acceptable, (1) drug prescribing a prerogative includes essential, See practice. clinical sometimes it than for which for conditions other those Dmgs Unlabeled Unapproved Use of for (2) drug approved, prescribing has been Bull., Indications, Drug Apr. 12 FDA groups other than those for patient for 59,820, 1982, 4-5, Fed.Reg. in 59 at cited (3) originally approved, which it was 59,821 for (noting that new uses “[v]alid varying dosage or of adminis method are often first drugs already on the market from in its tering drag that contained serendipitous observa through discovered labeling. Stoffelmayr, See 63 U.Chi. innovation”).11 It is therapeutic tion and 277. L.Rev. at of a the off-label uses possible also environment, regulatory In the current which the may the uses for drug exceed prescription when FDA authorizes a See John drug originally approved. marketed, it is well Calfee, Regulation, or device be Speech, Free FDA likely will In aware that the device the Pharmaceutical Market on Effects Azari, Prescription Bad put dustry, reprinted to an off-label use. See Beck & Censorship FDA Drug 53 Food at 82. The FDA the First Amendment: & L.J. has Adams, 423, (David G. et customarily by physicians. 426 use is followed Professionals 194, al., eds., 1997). Reagen, See Weaver v. 886 F.2d 198-99 2d ed. (8th .1989); Stattford, Salgo Cir v. Leland Jr. Trustees, Cal.App.2d 154 317 Univ. Bd. discovery pace 11. Because the of medical (1957); Farr, 770 P.2d 180 Ramon v. regulatory machin of the FDA’s runs ahead Azari, (Utah 1989); 53 P.2d 135 Beck & drugs ery, is fre the off-label use some Drug& L.J. Food quently to be "state-of-the-art” considered Azari, & Beck and 53 Food treatment. See position though 10. Even found circumstances, Drug L.J. at 79. some final, re never made the FDA rule that was particular drug or device use of a off-label Re cently it. See Citizen Petition restated may the standard of care. even define garding Policy Promotion of the FDA’s Inc., Med., F.Supp.2d v. Danek Hartwell Drugs De Unapproved Approved Uses of Legal (W.D.Va.1999); Washington Comments, 705 n. 3 Fed.Reg. Request vices: 56; Friedman, F.Supp.2d at 820, 59, 821(Nov. 18, 1994). v. und. position This Fo Proctor Davis, "important agency 225 Ill.Dec. N.E.2d remains an statement Adams, Drug policy." David G. The Food at 1210. Regulation Care Health Administration’s Drug Advertising and Promotion 64 at precluded lower costs and have medical (Richard ed.1993). Kaplar, T. insurers declining pay from ap *13 for proved drugs prescribed solely off-label prescriptions Off-label are now an inte because the FDA has not approved the gral part of the modern practice medi drug for that use. See Tenn.Code Ann. cine. Washington See Legal Found. v. § 56-7-2352(a)(6)(7), -2352(c)(1); Beck & Henney, 202 at F.3d 333. While estimates Azari, Drug 53 Food & at 76 n. 56. L.J. concerning prevalence of off-label use The repeatedly courts have also recognized varies, there is a prac consensus that the legitimacy ap the off-label use of widespread. Azari, tice is See Beck & 53 proved drugs and devices. See Rhone- 80; Drug Noah, Food & at L.J. Lars Pharm., Poulenc Rover Inc. v. Marion Constraints on Prescription the Off-Label Dow, Inc., 511, Merrell 93 F.3d n. 514 33 Drugs, J. 139, 16 Prods. & Toxics Liab. (8th Cir.1996); Bristol-Myers Squibb Co. (1994); 139 United States General Ac Shalala, (D.C.Cir. 1493, v. 91 F.3d 1496 Office, counting Drugs, Reim Off-Label 1996); Corp. Ortho Pharm. v. Cosprophar, bursement Physicians Policies Constrain (2d Inc., Cir.1994); 32 F.3d 692 Weav in Their Choice Cancer Therapies, 198; er Reagen, v. 886 F.2d at Alvarez v. (“GAO 91-14, at (Sept.1991) 5 GAO/PEMD Smith, (Fla.Dist.Ct. 714 So.2d 653-54 Report”). Off-label of approved uses App.1998); Biscup, Klein v. 673 N.E.2d at drugs have extremely become important in 231; Temple Southard Univ. 731 Hosp., cancer,12 specialities such pediatric as medi A.2d 611 (Pa.Super.Ct.1999). cine,13 disease,14 circulatory heart and AIDS,15and kidney disease.16 The approved off-label use of re- drugs sults significant complication one
Recognition
for
of the propriety of the off-
physicians.
Because
drugs
label use of
FDA’s restric-
spread
devices has
beyond
tions
the dissemination
profession.
the medical
A
of information
number
of state legislatures, including
drugs,
off-label uses of approved
the Tennes-
Assembly,
physicians
see General
recognized
readily
do not have
available
that off-label
of approved drugs
use,
uses
concerning
are
same information
appropriate ways
provide
medical
dosage,
care
and method of administration of
12. The
Accounting
971;
Government
has
Office
es-
34 Wake
Cong.Rec.
Forest L.Rev. at
143
28, 1997) (statement
timated
drugs
of all
(daily
July
25%
anti-cancer
are
S8165
ed.
Frist).
prescribed off-label and that
Bill
of all cancer
Sen.
56%
patients
drug
receive at least one
off-label.
5, 11, 13-14, 40;
Report,
See GAO
at
see
al.,
also
Gregory
14.
Mundy,
See
et
Current Medical
56-7-2352(a)(6)
§
Tenn.Code
(Supp.
Ann.
Drug
Practice and
Food and
Administra-
1999) (reflecting
tion,
(1974).
Tennessee General As-
229 JAMA
1746
sembly's finding
approximately fifty per-
cent of all cancer
treatment
for
is
off-
Forty percent
15.
drugs prescribed
of all
for
indications); Smith,
label
34 Wake Forest
per-
eighty
AIDS treatment are
off-label
L.Rev. at 971.
patients
cent of AIDS
receive at least one off-
prescription.
Brosgart,
label
See Carole
Off-
Levine,
Immunodeficiency
Regulation
13. See
Label Use in Human
Disease,
Virus
Robert
Ethics
Research,
ed.1986);
Acquired
(2d
Deficiency
12 J.
Immune
Clinical
Beck
of
&
Azari,
Syndromes
Retrovirology
79-80;
and Human
57-
Drug
53 Food &
L.J.
J.S.
(1996).
Holland,
Jameson & M.E.
Use
Off-Label
Agents
Infants,
Antimicrobial
Children and
Action,
Azari,
A
Adolescents:
Time
17 Pediatric
16.
Beck
Drug
See
&
53 Food &
L.J. at
Smith,
(1998);
Infectious Disease J.
n.
c.
approved
provided
labeling
FDA-approved
Neither the
uses.
Admissibility
That a
of Evidence
PDR
contain
parallel
reference
nor the
A DRUG IS
ÜSE OF
PARTICULAR
uses.
about off-label
information
Off-Label
Friedman, 13
Legal Found. v.
Washington
is wheth-
be addressed
next issue to
at 56.17
F.Supp.2d
parallel
drug’s
a prescription
er
regard
is admissible
PDR reference
drug be
use of a
the off-label
When
*14
and ad-
using
of care for
standard
to the
an increased
there is
widespread,
comes
Virtually every
drug.
ministering the
inadequate
a
with
possibility
physician
that
has conclud-
addressing
question
this
court
prescribe
Shapiro,
it.
knowledge will
See
PDR refer-
drug’s labeling and
that the
ed
Accordingly,
at 826.
73 Nw. U.L.Rev.
care
are relevant to
standard
ence
a
or device
physicians prescribing
dispute among the
primary
issue. The
well-
responsibility
a
to be
off-label have
given to
weight to be
courts involves the
drug or device. See
informed about the
author-
great weight of
this
The
evidence.
Mem’l Lutheran
v. Froedtert
Staudt
parallel
drug’s labeling
a
or
ity is that
773,
361,
217
580 N.W.2d
Hosp.,
Wis.2d
admissible,
as it
long
is
as
PDR reference
(1998);
Northwest
Femrite v. Abbott
363
evidence
expert
other
accompanied
542; Cynthia
N.W.2d at
Hosp.,
ern
568
of care.
regarding the standard
Starr,
Approach
A Careful
Off-Label
in a
proof
burden of
plaintiff’s
A
1999) (visit
30,
(Sept.
Dmgs, Patient Care
governed by
case is
malpractice
medical
2000)
July
<http://pe.pdr.net/pc/stat
ed
matter,
will
the law
general
As a
statute.
ournals/p/data/
ic.htm?path=content/j
provider
a health care
presume
not
In the absence of
1999/0930/offlabel.html>.
a treat
because
negligently simply
acted
FDA-ap
found in the
the information
unsuccessful.
Tenn.Code
ment was
re
labeling, physicians
obtain
proved
must
29-26-115(c) (1980); Roddy v. Vol
§Ann.
liable,
from other
up-to-date information
Clinic, Inc.,
926
unteer Med.
S.W.2d
(1)
may
These sources
include:
sources.
Thus, in order
(Tenn.Ct.App.1996).18
578
(2)
colleagues,
professional
discussion with
prima facie case of medical
to make out a
(3)
continuing
programs,
medical education
must come forward
negligence,
plaintiff
journals,
professional
case studies
complies
Tenn.
with
with evidence
(4) reports
clinical results of the use
of the
29-26-115(a). This
§
statute
Ann.
Code
Baker
in other countries. See
provid
conduct of health care
requires the
Med.,
F.Supp.2d
873
v. Danek
35
objective communi
by an
judged
ers to be
(N.D.Fla.1998); Washington Legal Found.
Ann.
TenmCode
Accordingly,
ty standard.
56;
29-26-115(a)(l)
Friedman,
Shapiro,
plaintiff
13
at
F.Supp.2d
requires
§
v.
stan-
recognized
present
“[t]he
evidence
at
Nw. U.L.Rev.
809-10.
73
recently
Supreme Court
publishes
18. The Tennessee
publisher of the PDR now
17. Guide,”
1,800
exception
princi
page
Companion
recognized
narrow
to this
the "PDR
guide
augmenting
negli
This
jury
PDR.
ple
reference
that a
could infer
when it held
Guide” list-
"Off-Label Treatment
expert
includes an
if an
gence
an unsuccessful result
from
used,
approved,
ing drugs routinely
never
but
ordinarily
the result would not
testifies that
nearly
dis-
one thousand
for the treatment
negligence.
in the absence
have occurred
Co., Physi-
Medical Economics
orders. See
Ctr., 9 S.W.3d
v. Methodist Med.
See Seavers
(54th
Reference,
Desk
Foreword
cians’
ed.2000).
(Tenn. 1999).
case,
dard of acceptable professional
practice
any particular
adhering to the manu-
profession
and the specialty thereof
facturer’s
warnings
recommendations and
...
practices
defendant
in the
labeling
may
in the
or
PDR
ormay
community which he
practices
[or she]
have been within the standard of care
...
the time the
alleged injury
alleged
when the
negligent act occurred.20
wrongful
Establishing
action occurred.”
majori-
Four
support
considerations
professional
requires
standard of care
ty view
governing
admissibility
expert testimony. See
v.
Moon
St. Thom-
prescription drug’s
parallel
(Tenn.1998);
Hosp.,
as
S.W.2d
PDR
in a
malpractice
reference
medical
Bechtol,
Cardwell
724 S.W.2d
First, permitting
case.
the labeling or the
(Tenn.1987);
Case,
Jennings v.
10 S.W.3d
PDR reference
physi-
alone
establish a
625, 627 (Tenn.Ct.App.1999).
cian’s standard of care would be inconsis-
Plaintiffs in
malpractice
other medical
§
*15
tent
Tenn.Code Ann.
29-26-
argued
cases have
that the
instructions
115(a)(1)
permit
drug
because it would
a prescription drug’s FDA-approved label-
manufacturer,
pro-
rather than the medical
parallel
or the
PDR reference should
fession, to establish the standard of care.
sufficient,
themselves,
by
to establish a
Ctr.,
v.
See Morlino Medical
706
at
A.2d
physician’s standard of care regarding the
730;
689,
Spensieri
Lasky,
v.
701 N.Y.S.2d
drug.
jurisdictions,
use of the
Several
be-
Second,
723
at
N.E.2d
548.
the FDA-
lieving drug
uniquely
manufacturers to be
required labeling
parallel
and
PDR refer-
knowledgeable about
the proper use of
may
ence
easily
not be
understood
products,
have held that a drug’s
jury
expert
without
assistance because
labeling
parallel
or its
PDR reference
these materials are written for the medical
amounts to prima facie
evidence
profession,
general
not the
public. See
standard of care as far as the use of that
Peebles,
17;
v.
N.E.2d at 548. 1970’s, approved the FDA early In the beta-adrenergic the use of called adopt majority approach We (“ritodrine”) hydrochloride ritodrine evidentiary introduction and regarding the tocolysis. drug, This which could be use weight FDA-approved drug given to be intravenously, orally, in- administered PDR parallel reference. muscle relax- tramuscularly, was smooth materials, themselves, Neither of these er uterine helped relax contractions prescribing are prima facie evidence of the buying thus time for babies more devel- Thus, physician’s proof standard care. op in being their mother’s womb before departure of a from recommendations delivered. At approximately same in a or PDR drug’s labeling reference time, a manufacturer named As- Swedish prove sufficient to alone breach (“Astra”) developed tra Pharmaceuticals *16 However, the standard of care. label the terbutaline, drug, beta-adrenergic another provide and the PDR reference can to principally as a bronchodilator relax and significant the identifying assistance open airways persons the of constricted Accordingly, standard of care. we find suffering After obtaining from asthma. that a drug’s labeling prescription FDA’s the to market terbutaline approval reference, PDR along when introduced medication, an Astra manufac- as asthma with expert other evidence on standard the drug and the tured sold the under trade care, of is admissible to assist the trier-of- Thereafter, “Bricanyl.” name li- Astra drug fact the pre determine whether Ciba-Geigy censed to manufacture and sented unacceptable patient. an risk to the Ciba-Geigy began market terbutaline. selling trade terbutaline under the name D. “Brethine” same using Bricanyl. FDA for approved Adrenergic Drugs had of Use Tocolysis for mid-1970’s, In the physicians began to trial, terbutaline, At in the Richardsons claimed that discover that administered by travenously, Dr. tocolytic Miller violated standard care had effects similar to of Lam, al., Fung continuing Ms. Richardson on those of ritodrine. See et terbutaline Surrounding the complained after she of severe Clinical pains, chest Issues Use of Preterm, Labor, by deciding and to administer terbutaline Terbutaline Sulfate for S85, using Gyn. Survey to Ms. an subcutaneously (Supp. Richardson Obstet. & S86 1998) (“Lam”). However, survey infusion A of 1980 or pump. the evidence FDA-approved labeling information about off-label Astra other amended Bricanyl against drugs tocolysis use like terbutaline for to warn intramus tocolysis provides helpful framework cular use of terbutaline for after for deter- mining it properly reports whether the trial received adverse reactions to court drug pur used excluded the evidence the off- when it was tocolysis pose. approved FDA Astra’s label of terbutaline for After the use changes Bricanyl’s labeling, Ciba-Geigy practice stetric because of its lack of effica- warning added same incy presence toxicity.23 the Brethine’s its known labeling.21 In Accordingly, both Astra and Ciba- the FDA advised ritodrine’s Geigy warnings pre- added same perform manufacturer to more studies to cautions to their terbutaline tablets. drug’s efficacy. validate the Rather than burden, taking on this financial the manu- Despite warnings in the label- drug’s facturer oral simply withdrew ritodrine for ing regarding the use of terbutaline for tocolysis maintenance from the United tocolysis, drug increasing found favor Lam, States market. See 53 Obstet. & physicians with country around the as an Gyn. Survey at S91. As a result of this appropriate way prolong premature la- decision, became com- terbutaline the most treatment, typical bor. The course al- monly beta-adrenergic used for toco- off-label, beit involved ter- administering lysis, despite the warnings. manufacturer’s intramuscularly butaline patient while the hospitalized switching and then to oral May In Fertility the FDA’s if medication had the effect of Drugs Advisory Maternal Health Commit- slowing patient’s down the labor.22 In tee concluded that “terbutaline adminis- 1986, a physician San Francisco ex- began intravenously tered appeared to have an perimenting an with to ad- acceptable profile risk-benefit for the acute out-patient minister terbutaline ba- treatment of preterm labor under limited sis without requiring hospitalization. See (i.e., in pregnancies circumstances Lam, Gyn. Survey 53 Obstet. & at S86- less, weeks or when cervical dilation is 4 physician reported S87. no prema- centimeters less and there is Pump his “Subcutaneous Terbutaline membranes, rupture ture Therapy” (“SQTP”) produced dramatic to- careful maternal monitoring).” and fetal colytic greatly dosage effects at reduced (cit- Letter, supra Woodcock note 2at *17 reports prompted These in- level. various Fertility of ing Transcript and Maternal pump fusion manufacturers to and others Drugs Advisory Health meet- Committee SQTP begin heavily promoting therapy. 181-83); 21, 1993, ing, at May see also Lam, Gyn. Survey
In October 53 Obstet. Fertility FDA’s & at S92. Drugs Advisory concluding may and Maternal Health After that terbutaline preventing preterm Committee concluded that oral ritodrine effective in labor for a maintenance no therapy place period forty-eight had in ob- brief of to seventy-two 21.Following changes, labeling pro- hyperglycemia, hypokalemia, these ar- cardiac following warning edema, vided the for the intave- rhythmias, pulmonary myocar- nous of use Brethine: dial ischemia. Controlled clinical studies and other clini- Brethine, experience College Gy- of cal have shown that American Obstetricians and p-adrenergic agonists, pro- like other necologists, can Technical Bulletin No. Pre- significant (June duce a in 1995) ("ACOG cardiovascular effect term Bulletin Labor rate, pulse patients, some as measured 206”). No. pressure, symptoms, blood ECG and/or changes. Woodcock, Director, 23. Letter from Janet following appeared "precau- also in the Research, Drug Center for Evaluation to labeling: tions" section of the Lam, M.D., Fung Strategy Group, Terbutaline Terbutaline sulfate should not be for used (Oct. 1999) p. (<hltp:// tocolysis. may Serious adverse reactions www.fda.gov/ohrms/ dockets/dai- occur after of administration terbutaline (visited July lys/102999/pdn0001.pdf>) mother, sulfate to in In the women labor. 2000) ("Woodcock Letter"). rate, these include increased heart transient delivery” those of versus pregnancy long-term but that evidence of hours begin clinicians treatment FDA invited lacking, and that “most effectiveness ap- but gestation new re- of applications to 34 weeks supplemental prior use terbutaline for approval to labor questing management preterm of proach encouraged the The FDA also tocolysis. ba- on an individualized at 34-37 weeks to their to manufacturers review concluded Accordingly, ACOG sis.” the need for clarification address ... therapy forms of different “[ajlthough Wood- risks of terbutaline. See uses and prevent prematurity, being are used 2-3, Letter, 23, at 9. De- supra cock note for proper place benefit and their true invitation, spite the FDA’s terbutaline’s remain to be estab- application request approval manufacturers did not lished.” tocolysis use the and did National Women’s Health In drug’s labeling. request changes the FDA to review petitioned Network surrounding safety The debate of terbu- administration subcutaneous efficacy tocolytic agent as a of terbutaline pump.29 infusion On No- using taline an inju- has since Ms. Richardson’s continued 13, 1997, the FDA’s Associate vember College ry. June American issued a for Health Affairs Commissioner (“ACOG”) and Gynecologists Obstetricians medical letter to the Colleague” “Dear regarding pre- a technical bulletin issued physicians about community warning While tocolytic noting term labor.24 administration continuous subcutaneous used, agents are the bulletin commonly FDA’s concern Noting the terbutaline.30 “no pointed out that studies have convinc- increasingly “promotion and over ingly improvement an demonstrated widespread of subcutaneous terbuta- use any long-term survival or index of neonatal line delivered tocolytic therapy. outcome with the use of labor,” preterm treatment/prevention hand, potential damage the other On that “it clear that the the letter stated is tocolytic therapy to the mother and the tocolytics gener- demonstrated value spe- is well With neonate documented.”25 initial, period brief al limited to is SQTP therapy, cific the bulletin regard treatment, than 48-72 probably no more support noted that “there no evidence *18 pro- benefit from “[n]o hours” and that efficacy costly complicated the of this and has been documented.” longed treatment The bulletin observed approach.”26 also Thus, “practition- alerted the FDA letter judged case must be individu- “[e]ach ers, agencies, insurance continuing home health care ally weighing the risks of 206, 22, bulletin, supra at No. note purposes 24. ACOG 28. ACOG Bulletin For occurring "preterm defined labor” as "labor 8. prior gesta- completion of 37 weeks of (less days men- than 259 from the last tion 23, Letter, at supra note 6. 29. Woodcock See 206, period).” ACOG Bulletin No. su- strual 22, pra note at 1. Nightengale, As- See Letter from Stuart L. 30. Affairs, (vis- for Health sociate Commissioner 206, 22, supra at 25. ACOG Bulletin No. note 13, 1997) 6, (Nov. July 2000), ited 6. < http gov/medwatch/safe- ://www.fda. 206, supra at No. note 26. ACOG Bulletin (“Dear Colleague Let- ty/1997/terbut. htm> ter”). 6. supra note 27. ACOG Bulletin No.
carriers, prudent, and others that continuous unprofessional. sub- or The Richard- cutaneous administration of terbutaline sons’ causes of Dr. against action Miller sulfate not has been demonstrated to be and simply Tokos are not based on the fact effective and potentially dangerous.” is tocolysis is an off-label use of terbuta- In April Strategy the Terbutaline Rather, line.32 their negligence claim rests Group, a coalition prac- of researchers and theories:(l) following two Dr. Miller ticing physicians, requested the FDA to administering should have discontinued position regarding reevaluate its use tocolysis terbutaline began when she of terbutaline subcutaneous infusion. experiencing pain following chest the sec- However, 19, 1999, on October FDA (2) ond oral dose and Dr. Miller should not reaffirmed its concerns regarding the ordered, and Tokos should not have “prolonged, at-home use subcutaneous provided, the subcutaneous administration terbutaline” and declined to withdraw the using terbutaline infusion pump be- November Colleague” 1997 “Dear let- cause the using effect of towas ter require or to manufacturers increase, maintain or de- even rather than warnings terbutaline to remove crease, sys- level terbutaline her drug’s labeling against for the use tem. management of preterm labor or to sub- The Richardsons did intend limit not mit a new application approval of regarding applicable their evidence terbutaline as a tocolytic agent. See solely standard care terbutaline’s Letter, Woodcock supra note at 9-12. FDA-approved labeling parallel They PDR reference. also intended to call E. Gaudino, Farr, Drs. Glen Mario Ronald
Admissibility of The Richardsons’ Evi- Krone, Dingfelder provide James dence That the Use of Terbutaline expert opinions on this Dr. issue. Gaudi- Tocolysis For is Off-Label no, representing‘terbutaline’s manufactur- er, (1) practice While the of using drugs off- drug’s would have authenticated the widespread (2) label in- inherently FDA-approved labeling, testified re- appropriate, there are well-documented in- origin garding manufacturer’s accepted stances where an and popular off- warnings precautions against using (3) ultimately label use of proved has tocolysis, terbutaline for confirmed Azari, to be harmful. Beck & 53 Food that the no contained instructions 71-72; Smith, Drug & L.J. at Wake dosage method of admin- Physicians L.Rev. at tocoly- Forest 971.31 bemay istering terbutaline when used for Farr, negligent found if their decision to pharmacologist, pre- use sis. Dr. *19 careless, sufficiently testify dosage off-label is im- pared to that the absence recent, ket; however, well-publicized example 31. The most phentermine remains available using prescription obesity. the harmful effects of for the short-term treatment (The drugs fen-phen off-label is combination phentermine). of fenfluramine and reported Combin- note We the existence two drugs using these an them for extend- alleged patients cases in which the that their period ed are off-label uses. After the use of physician failing negligent was to use ter- fen-phen widespread, became it was Maricopa discover- tocolysis. butaline for See Bell v. suffering Ctr., 192, 1180, ed that users were from cardiac Med. 157 Ariz. P.2d 755 1182 Clinic, damage. Accordingly, (1988); valvular the use of fen- Bridges Shelby v. Women's P.A., 15, 372, phen was N.C.App. discontinued. Fenfluramine has 72 323 S.E.2d 374-76 (1984). been the withdrawn from United States mar-
21 policy the 402 reflects Tenn.R.Evid. in terbuta- administration directions or meeting Tenn.R.Evid. that all evidence required physi- would have line’s unless relevancy is admissible 401’s test of policies rely individual cians to or on constitutional otherwise excluded or administering prescribing standards virtue of other statutory grounds This retard labor. preterm terbutaline to See rules themselves. provisions Dr. Ding- testimony, coupled when Co., 867 Phillips v. F.W. Woolworth Dr. Miller should testimony felder’s (Tenn.Ct.App.1992). 318 S.W.2d Richardson on ter- not have continued Ms. excep- such provides 403 one Tenn.R.Evid. began experiencing after butaline she general principles of admissibil- tion to the pain would have been sufficient to chest trial court to exclude ity. It authorizes the explain why Dr. to he con- require Miller probative if its otherwise relevant evidence administering tinued terbutaline after Ms. of un- outweighed danger value began experiencing severe Richardson confusion, misleading prejudice, fair pains, as well as the basis for his chest delay. language jury, unnecessary an infusion and how decision use strongly suggests 403 of Tenn.R.Evid. dosage determined.33 proper if be admitted relevant evidence should probative value of the balance between Decisions admissi prejudicial effect is close. evidence and its bility evidence address themselves Cohen, al., et Law Neil P. Tennessee discretion, the trial court’s See Seffernick (3d 1995) 403.3, § at 152 ed. Evidence of (“Tennessee v. Hosp., Saint Thomas 969 S.W.2d Evidence”). Thus, ex- Law of (Tenn.1998); v. Dockery 393 Board of under cluding otherwise relevant evidence Responsibility, 937 S.W.2d 866 Prof'l extraordinary step 403 is an Tenn.R.Evid. (Tenn.1996). While the trial courts have sparingly. that should be used See White decisions, in making wide latitude these Univ., 215, 227 v. Vanderbilt 21 S.W.3d Inc., 4 Shoney’s, see Overstreet v. S.W.3d (Tenn.Ct.App.1999). they (Tenn.Ct.App.1999), 702 must take into consideration factual circum out, recently pointed we have As legal principles. stances and the relevant trial of Tenn.R.Evid. application court’s Shuck, See State v. 669 S.W.2d steps. The first proceed two should (Tenn.1997). Accordingly, appellate courts step requires to balance the the trial court evidentiary will not' overturn trial court’s sought of the evidence pi’obative value ruling applied unless the trial court weight combined against excluded standard, legal incorrect based decision countervailing in Tenn. factors clearly on a erroneous view of evi If the court determines that R.Evid. 403. dence, against countervailing outweigh or has reached decision factors do not injustice evidence, logic and reason that caused probative value Shuck, v. complaining party. proceed See State court should no further and trial Herzke, 669; deny v. to exclude the Ballard the motion 953 S.W.2d should (Tenn.1996); If, evidence under Tenn.R.Evid. 403. how S.W.2d Overstreet Inc., ever, that the coun- Shoney’s, the court determines S.W.3d at 708. *20 If, pump example, using using the fact that the infusion results he asserted that higher to administer terbutaline in levels of terbutaline in the same or Letter, posed danger less of a to Ms. Richardson patient’s system. Woodcock administered, being because lower doses were supra at 6. note required explain away have been he would tervailing outweigh probative Buddy Attractions, factors Lee Inc. v. William evidence, value it proceed Inc., should to Morris Agency, 13 S.W.3d step in second which the Collins, court exercis (Tenn.Ct.App.1999); State es its discretion whether decide 20 (Tenn.Crim.App.1998). S.W.2d evidence should be excluded notwithstand Likewise, we find little concern basis for relevancy. See White v. Vanderbilt permitting that the Richardsons to use the . Univ., 21 S.W.3d 227 tocolysis evidence that is off-label use of terbutaline will confuse the issues or
We have that determined the trial jury. mislead the arguments Such assume misapplied court Tenn.R.Evid. this lay persons that will be unable to under- case. The regarding evidence terbuta- stand prescribing that a prescription line’s off-label is usage particularly rele for an necessarily off-label use is not negli- vant regard with to Dr. Miller’s decision to gent. State and federal courts around the continue Ms. Richardson on terbutaline af country have dealt with very sort of ter experienced she chest pain, as well as evidence without becoming bogged down his decisions regarding the method ad with the sorts of problems Dr. Miller and ministration and the proper dosage. In imagine. Tokos may Richardsons light of the absence the manufacturer’s very well jury want the to believe Dr. regarding instructions recommended dos Miller should not have continued Ms. age levels and administration, methods of However, Richardson if terbutaline. pinpointing the basis Dr. Miller’s deci Dr. Miller’s actions were consistent with regarding sions the use of the is applicable care, standard we have integrally related the Richardsons’ no doubt that present he will be able to claim that Dr. Miller not should have con expert competent to support evidence tinued Ms. on tocolysis Richardson using propriety Vigorous of his actions. cross- terbutaline after experienced she chest examination, the presentation of contrary pain. evidence, and proper instructions will head In comparison, very there is little basis any off possibility that will jury support the record to the conclusion confused or regarding signifi- misled that permitting the Richardsons to intro- regulatory cance of the status of terbuta- duce this evidence toor cross-examine the line. experts defendants and their based on this produced Furthermore, evidence would any find we do not countervailing factors included in Tenn. the status FDA-approved of terbutaline’s arguable alone, R.Evid. 403. There is no labeling misleading. claim Standing it permitting the Richardsons to use this does establish the standard of care. evidence would have resulted undue de- The trial court will no doubt make this time, lay, waste of presen- needless clear to jury in its instructions. case, tation cumulative evidence. The only this the fact that was put terbutaline grounds colorable for excluding the evi- to an simply off-label use is one piece of dence are unfair prejudice, confusion of along information everything else for issues, or misleading jury. We the fact-finders to sort out and consider. perceive no real danger prejudice considerations, of unfair Based on these we find because this evidence will not prompt the that the possible prejudice to defen jury to decide the improper stemming case based on dants from the admission of the bias, sympathy, considerations such as ha- evidence the off-label of ter- use tred, retribution, contempt, tocolysis or horror. See butaline for not outweigh does *21 on either of long dwell need not Ac- see. We of the evidence. probative value the however, addressing issues; we are these no basis for cordingly, the trial court had likely the will reoccur them because issues its discretion to exclude exercising again. this case be tried should prevent or to the Richardsons evidence the and cross-examining defendants from A. based on this evidence. We experts their decision to that the trial court’s also find Regarding Policy An EKG The Tokos materially hampered exclude this evidence that trial Richardsons assert the The ability prove their Richardsons’ to the to plaintiffs allowed court “should have and, more malpractice claims medical policy regarding [the] introduce the Tokos not, than the outcome probably affected and should requirement of an EKG trial. plaintiffs to cross-examine permitted to failure follow about defendants therefore, find, court that the trial We argument This protocols.” their own Dr. motions to by granting erred Miller’s Although the record puzzling. somewhat terbuta- regarding the evidence exclude desired, to it point leaves much on this use, including line’s off-label its permitted court appears that trial Dr. PDR parallel and the reference point that Dr. to make their Richardsons testimony, as that of the as well Gaudino’s order, repre- the Tokos Miller did not experts. The Richardsons’ other medical request; an suggest not sentatives did jury to this evidence was entitled consider infu- beginning before immediately EKG opinions Ms. Richard- along with the the Tokos therapy though even sion Dr. experts son’s Miller breached one. protocols recommended by continuing prescribe standard of care to both parties had several skirmishes The tocolytic after Ms. agent terbutaline as the To- regarding trial during before complained of cardiac-related Richardson start- an EKG before policy requiring kos Accordingly, appropriate symptoms. pump. an infusion ing tocolysis using remedy re- is to vacate the verdict and asserted that Tokos violated Richardsons mand the case for new trial. EKG, insisting on policy own to introduce the they prepared were II. employ- Tokos prove and to that no policy Evidentiary The Tokos-Related Issues an EKG before requested suggested ee Dr. part, The Richardsons raise two other eviden- starting pump. For their First, argued policy they and Tokos tiary regarding Tokos. Miller issues irrelevant, failure to was first because by pre- the trial court erred assert infu- using to prior an EKG administer venting introducing them from Tokos’s Richardson’s not cause Ms. pump did sion policy strongly an EKG before suggesting the Tokos injuries, and second because therapy. beginning terbutaline while Richardson apply did not Ms. policy Second, they the trial take issue with hospitalized.34 was prove them to permit court’s refusal license, permit, jury, the trial empaneling not have a that Tokos did Before pol- Tennes- court held that evidence operate or certificate of need Elmore, hospital her home from president of and then send Judy Tokos’s vice place. There is no argument pump in with the infusion pharmacy, the latter undermined intended dispute that defendants employees were factual when testified that Tokos she her con- discharge Ms. Richardson once company’s proto- expected to to the adhere they patient stopped and that intended tractions were plan cols when the stabilize *22 icy was admissible a work, as factual matter but cent appropriate EKG and lab et not on cetera, the issue of cetera, causation.35 Based on et et cetera. So to me that ruling, the Richardsons introduced the policy is that an strongly EKG—it is portions Palmer, the deposition of Bev of patients recommended that a have re- Tokos’s pharmacy manager. zone Ms. cent EKG. policies
Palmer discussed two Tokos dur- portions her deposition of that First, were read to the jury. she acknowl- QUESTION: asking you, I’m from edged required that PBH 00322 the Tokos your understanding of responsibilities of clinical staff “to confirm physician’s orders an area clinical pharmacist June of for an as part EKG guidelines '93, would pharmacist the area clinical tocolytic initiation of therapy infusion for a policies procedures under Tokos patient.”36 Second, she por- referred to a June of '93 a responsibility have con- tion PBH-00304 stating that is “[i]t firm an that EKG had been conducted strongly recommended that patients have prior to the initiation of a toco- patient’s a recent EKG and lab appropriate ” lytic therapy? infusion work.... The trial court directed that PBH-00304 be admitted and as marked I ANSWER: believe so. addition, Exhibit 3.37In following three questions and Ms. Palmer’s answers were jury.
read to the QUESTION: You do believe it was a QUESTION: Well, you know do policy for the Tokos nurse converse policy whether it was a of Tokos Medical with physician June '93 prior to Corporation for the clinical Tokos staff of tocolytic initiation infusion therapy? to confirm that physician a had ordered an EKG? I poli- ANSWER: believe that was a
cy. Three employees other Tokos discussed ANSWER: is strongly The note. It policies during two other Tokos their testi- patients mony, recommended that have re- policy a but neither directly dealt pregnancy using fer her to maintain her language strongly "It is recommended and a uterine monitor. patients recent EKG ...” be admitted copy containing as Exhibit Exhibit Specifically, the trial court stated: "First language actually only.” is marked "ID EKG, question of all on the I think that’s addition, appellate Ex- record contains whether Dr. Miller his own decision mak- copy hibit 3A which is also PBH-00304 ing powers given should have an EKG. I think strong but from which the recommendation question its also a to discuss whether Tokos obviously EKG has been out. whited should have talked with the other nurse itself, stamp Other than the exhibit the tran- not, again, talked with Dr. Miller. It is be script contains no indication that 3A Exhibit any anything, inferred as causation for it but Having was ever admitted into evidence. no happened.” a fact explanation concerning how came Exhibit 3A part 36. PBH-00322 was never made admitted, we will base our decision record in this case. transcript clearly Exhibit 3 because the indi- permitted cates that trial court Ms. Palm- 37. The status of Exhibit 3 is somewhat un- testify very language er to though clear. Even the trial court directed out whited on Exhibit 3A. unequivocally containing that PBH-00304 *23 whole, we as a the record Considering necessity beginning an EKG before the asser- for Richardsons’ find no basis the an infusion ad- tocolysis using pump.38 inappropriately trial court tion that the testimony, introducing dition to use to ability introduce limited their to lawyers permitted were Richardsons’ policies per- involving Tokos’s the evidence Miller Tokos cross-examine Dr. and the prior begin- to taining obtaining to EKG’s their failure to order employees regarding therapy. The record ning pump infusion they the infu- began using an before EKG a fair the Richardsons had that shows Likewise, one of Richard- pump. sion fact point to make their about chance jury that the lawyers argued to the sons’ any Dr. nor neither Miller that to employees had failed follow Tokos Ms. Rich- employees working with Tokos EKG requiring a recent protocol Tokos commenc- an EKG before ardson obtained patient a on an infusion starting before therapy. ing pump infusion pump. B. court’s with the trial We concur policies regard that Tokos’s determination Status Tokos Licensure and contraindications for ing indications The Richardsons also assert deter using pump, guidelines for by excluding trial court erred evidence mining candidates for patients which were a had not obtained license that Tokos using pump, procedures and its for of Ten of need from the State certificate therapy were implementing pump infusion was They insist this evidence nessee. They were cer relevant admissible. be under Tenn.R.Evid. 608 admissible tainly negli to the relevant Richardsons’ licensing appropriate “failure to have cause They gence against claims Tokos. were certainly affecting factor the credibili a regard to the Rich- likewise relevant Tokos in this case.” We ty Defendant against claims Dr. Miller. While ardsons’ of the admissi question reach need not policies these like terbuta- protocols, in this case bility of this sort of evidence reference, parallel line’s PDR to have failed the Richardsons because not, physi just required a state law by themselves establish how do demonstrate or a certifi Tokos to have either license determining cian’s standard care for provide pre used, need order to cate of pump when the infusion should be hospitalized device to scribed medical materially of fact assist the trier they can her physician. on orders of patient Dr. Miller acted determining whether Richard negligently by ordering that Ms. home dealing are not here with We continue to receive terbutaline subcu plan, prior son though the health care even 27, 1993, after she com taneously pump infusion had been the events of June permit her to taking she was Richardson to discharge that the terbutaline Ms. plained home for ten pregnancy her pain. continue orally causing chest was Evans, regard- with Ms. McBride cist who consulted registered nurse em- 38. Christine proper dosage for Ms. Richard- level Richard- ployed by who assessed Ms. Tokos son, responsible that Dr. Miller was testified suitability pump, for an testi- son's therapy determining tocolytic whether patient regarding selection criteria fied Later, Judy testi- appropriate. Elmore "Hospital She also testi- Protocol." Tokos's PBH-00301, policy Tokos’s fied an EKG was not she decided that fied that accepting pa- containing guidelines she ob- the information warranted based on tocolytic infusion for subcutaneous her chart. tients Richardson and tained from Ms. Gamer, pharma- therapy. area clinical Gail Tokos 1997) days. (“T.P.I.3 Civil”). fourteen more Tokos entered the ed. We de- picture when Miller Dr. ordered infu- termined Richardsons enti- were sion while Ms. Richardson was hos- tled the instruction but that the trial *24 nurse, pitalized. registered Tokos sent a court’s to give refusal the instruction is Tennessee, not, properly itself, licensed in by to hos- reversible error because the pital to pump deliver the and to educate trial court permitted the Richardsons’ law- hospital Ms. Richardson and the in staff yer argue its to the presumption to jury. use.39 The Tokos nurse was not However, allowed to retried, should this case be we deliver the until pump hospital ap- have concluded that will Richardsons then, proved her credentials. Even she be entitled to the if instruction Tokos’ ex- was not allowed to touch Ms. Richardson. planation missing for the nursing assess- The insertion the needle for the pump ment form surrounding and the re- facts performed was aby registered nurse em- main the same. ployed by the hospital, and the terbutaline After Dr. Miller ordered an infusion hospital
was obtained from the pharmacy Richardson, for pump hospital Ms. on Dr. Miller’s orders. staff telephoned request Tokos to the de- evidence,
From this we conclude that livery pump. a Tokos telephoned Chris- Tokos supplying was a piece of medical Evans, registered tine nurse in the equipment and providing consulting advice area, Nashville her instructed to deliv- to Dr. Miller hospital regard- and the staff er a pump to the Ms. hospital for Richard- use of pump its infusion and the Evans, son. Ms. accompanied by Jackie proper to dosage terbutaline be adminis- Harris, employed by a nurse A+ Stat tered. pointed Ms. Richardson has to no Care, Home pump hospital. took the regulation, state law or and our research room, Upon arriving at Ms. Richardson’s one, has failed to requiring discover that Ms. Evans reviewed Ms. Richardson’s Tokos obtain a license or certificate of history medical chart and took her medical in need its activities this case. to determine whether Ms. Richardson met preconditions using Tokos’s
III. and to obtain the information needed to Missing Requested determine much how terbutaline Ms. Rich- The Evidence ardson should receive. Ms. Evans record- Instruction forms, findings ed her on two Tokos challenge Richardsons the trial nursing tocolytic assessment form and a court’s give requested jury refusal to infusion intake form. placed She these regarding instruction a missing nursing patient’s forms file she maintained form by assessment filled out Tokos’s copies regional and sent to Tokos’s office nurse on trial June While the According Atlanta. to Tokos’s policy, permitted lawyer court the Richardsons’ these forms would have been sent to To- argue jury to the that it could conclude kos’s office in California after Ms. Richard- that the contents the missing form were using pump. son discontinued Tokos, give adverse to it declined to During produced instruction based Tennessee Pattern discovery, Tokos (3d Jury nursing tocolytic T.P.I. 3-Civil 2.04 Instructions assessment form and registered accompanied provided through 39. Tokos's nurse was would have A+ Stat been employed by a home health nurse A+ Stat Home has raised Care. No issue been Presumably, credentialing Home Care. Ms. Richardson’s record home, discharged, care at she A+ had been home health nurse or Stat Home Care. language ciously because the out that form. It turned infusion intake strong.” “too instruction was proposed form that Tokos nursing assessment However, permitted Ms. Christine the trial court was not form that produced jury 1993. It lawyer on June ask the completed Evans had Richardson’s Rather, it missing nursing form. was even a Tokos as- not whether consider nursing only page two-page one of a indicated that might was form sessment A+ Home form used Stat Rich- assessment had that Ms. Evans concluded Ms. Ev- in Christine form for the Care. The candidate proper was not a ardson by Lisa handwriting signed and was ans’s pump.40 *25 A+ Evans, Stat Home employee A trial court’s instructions at present hospital not the Care who was accurate complete should be Evans 1993 when Christine on June the theories of fairly parties’ reflect should the medical information obtained needed Co., v. Motor Ladd Honda the case. See from Richardson. Ms. (Tenn.Ct.App.1996). 939 S.W.2d trial, by only explanation At offered the carefully special the must consider Courts employees Tokos for the absence of the parties requested by the be instructions by completed nursing assessment form in are entitled to these parties cause the 25,1993, Evans on June was that Christine (1) by they supported if the are structions lost in the mail or it must have been either (2) evidence, theory if a re they embody No explanation was offered misfiled. (3) they if are parties, on the lied presence nursing in the file of the the (4) law, if of the correct statements Evans, signed by Lisa assessment form in already contained their substance is not not hospital who was even the June Ingram portions charge. other 25, 1993, presence the in the file of (Tenn. Earthman, 611, 636 v. 998 S.W.2d tocolytic the form that intake criteria, the Ct.App.1998). Based on these missing the nurs- accompanied would have to an instruction were entitled Richardsons ing Accordingly, form. assessment based on T.P.I. 3 Civil 2.04. to requested Richardsons the trial court charge in “missing evidence” give T.P.I. 3-Civil 2.04 instruction re- is a nod the direction T.P.I. 3-Civil 2.04 from garding the conclusions to be drawn that dog Holmes’ famous did of’Sherlock to that party’s a failure introduce evidence It is a that some recognition not bark. Noting it have that it had produced. could something expected the absence missing a times never before encountered evi- Tennessee, as in issue, be significant. can give trial declined to dence court pro a failure to jurisdictions, party’s instruction because there other requested shedding capable light a acted mali- document proof was no that Tokos had duce case, out Number was not filled lawyer argued the fol- Exhibit 40. Ms. Richardson’s that objection: undated. She testified lowing jury to the Chris Evans. It’s without nursing out she that she filled assessment type person conspiracy that be- I’m not something missing. it in and it’s It’s mailed Kennedy conspiracy and the President lieves all, look to at. really person. not And I am that kind of just goes along with the attitude I it submit may probably conspir- there not be-there’s no throughout company this that’s been something acy, strange about these but there’s nursing I what the as- whole trial. wonder missing. just too That is medical records said. I’d like to really that she filled out sessment is. coincidental. It ap- it said. Not accusing do- I wonder what anyone potentially see that. I'm not this, It’s proved Who knows. ing for treatment? but the fact of matter is nursing an exhibit in this here. assessment that’s give on a material can contested issue possession give rise document must to a permissive inference that the missing explanation reasonable for failing pro- document would have been unfavorable to Wilson, duce it. See State generally the party possessing it. See Tennessee S.W.2d 724 (Tenn.Crim.App.1984). 401.9, § Law of Evidence at 99. Parties
seeking to
Evidence
advantage
party failing
take
of this inference
acting
introduce a document
must
was
mali
demonstrate:
ciously
not required.
par
is
Seldom will
(1)
against
party
whom
in-
prove
adversary
ties
able
sought
ference is
could have intro-
maliciously
destroyed
secreted miss
duced the evidence but failed to do
ing document. Courts should
giv
consider
so;
missing
evidence instruction where
(2) that
the document
uniquely
missing
evidence
shown
be un
possession
party against
due to questionable negligence,
available
whom
sought
the inference is
see DeLaughter v.
County
Lawrence
that party could
produced
*26
(Miss.1992),
818,
Hosp., 601 So.2d
822
document
exercising reasonable
dubious
See
mishandling.
Sacramona v.
diligence;
Inc.,
Bridgestone/Firestone,
444,
F.3d
106
(3) that
the document
not equally
was
(1st Cir.1997).
447
available to the other parties;
(4) that
the document
not
would
have
A jury
is
issue
created when
evidence;
been cumulative to other
the party seeking
missing
the
evidence
(5) that a
person
reasonable
under the
(1)
puts
showing
instruction
on evidence
same or similar circumstances would
exists, (2)
that the document
that the docu
produced
have
the document had it
(3)
relevant,
ment
opposing
is
and
that the
favorable;
been
and
party had exclusive control of the docu
(6)
party against
that the
whom the in-
party
ment
the docu
possessing
sought
ference is
has not offered a ment
proffers
explanation
pro
for not
failing
pro-
reasonable excuse for
v.
ducing
Bayliner
it. See Beers
Marine
duce the document.
769,
829,
Corp.,
Conn.
236
675 A.2d
831-33
2.04;
Jones,
See T.P.I. 3-Civil
State v.
598 (1996); DeLaughter
County
v. Lawrence
209,
(Tenn.1980), superseded
S.W.2d
224
Hosp.,
Where missing is a evidence should decide the when matter itself document, the party seeking the missing evidence, whole, a colorably viewed as evidence instruction must demonstrate creates credibility a issue about whether that the was in document existed and document was not. See Bihun lost adversary’s exclusive See control. Fares Inc., v. Sys., Cal.App.4th AT&T 13 Info. Fox, 396, 892, v. 198 A.D.2d 603 N.Y.S.2d 976, 787, Cal.Rptr.2d (Ct.App. 16 794-97 (App.Div.1993). party 893 The must also 1993); State, Rogers 2 generally see v. party possessing demonstrate that the 491, 502-03, 2 Tenn.Crim.App. Tenn.Crim. document it. produced could (1970). 491, 182, 187 455 S.W.2d Co., Cleveringa v. J.I. Case Ill.App.3d 230 831, 523, 1193, 172 Ill.Dec. 595 judge credibility N.E.2d Juries should (1992). M.V.R.R., missing a To avoid evidence issues. See v. Yazoo Kinney & instruction, party failing produce a 116 Tenn. 92 S.W. signed by Deardan, (1906); apparently completed form 834 S.W.2d Lorentz employee not a Tokos person a who was (Tenn.Ct.App.1992). jury If a hos- at the present was not even and who missing document was concludes that Based on on June pital ab- genuinely lost and that the document’s evidence, jury could conclude by manipu- brought sence about con- form missing nursing assessment lation, no infer- jury then should draw Ms. indicating that tained information against non-producing party ence pa- not meet Tokos’s own Richardson did unfavora- document would have been also juryA could tient criteria. selection Quaker Oil See Brewer v. State ble. Ref. produce could not conclude that Tokos (3rd Cir.1995). 72 F.3d Corp., because, form missing nursing assessment surrounding circumstances completed never one. reality, Ms. Evans form cre missing nursing assessment bearing on Either conclusion has direct missing nursing a jury ated issue. The that it conducted a careful Tokos’s defense form Tokos’s solely assessment under determining medical assessment before equally control and was not available was a candidate that Ms. Richardson light Richardsons. of the evidence tocolysis using the and set- keeping prac Tokos’s record dosage amounts of terbutaline the ting the tices, to pro Tokos should have been able pump would administer. difficulty. duce the without much document The Richardsons were entitled negligence In the face of the Richardsons’ every legal jury factual instructions claims, reasonably expected Tokos can pleadings put issue raised *27 to introduce the form nursing assessment However, their what issue evidence. supported it would have its claim because hand, it with one away the trial court took amade careful and that Christine Evans it with the other when gave permit back complete medical assessment of Ms. Rich lawyer argue to the ted Richardsons’ infu beginning ardson before her on the jury. to the presumption evidence missing The not have pump. sion document would Rich- permitted trial court Because the cumulative to other evidence because been lawyer to make rhetorical use ardsons’ it only would have been the written evi find closing, in we do not presumption dence, prepared contemporaneously with in declining give requested to that events, the other relevant of the informa struction, itself, affected the out Christine Evans used to assess Ms. tion however, Assuming, the trial. come of suitability Richardson’s for infusion missing surrounding the the facts therapy dosage determine the same, remain the assessment form nursing she receive. terbutaline would give the trial court on retrial should innocently lost Whether form was if 2.04 on T.P.I. 3-Civil instruction based in the in Tokos’s misplaced mail jury it. request Richardsons jury of two question light files permitted to decide for itself should be First, produce able to facts. Tokos was missing nursing assessment whether the intake form that tocolytic form, produced, if would be adverse completed at the same Christine Evans Tokos. completed missing nursing time she form, no and Tokos offered assessment IV. it could lost one explanation how FORDirected Verdict The Motions Second, Tokos form but not the other. Tokos Dr. Miller and assert explanation presence no offered mo- granted should have nursing assessment trial court its file of the undated 30
tions directed verdict the close of all favorably we review the evidence most proof. Obviously, party against were we affirm whom the motion is defendants, made, give jury’s party for the of all verdict benefit evidence, trial reasonable inferences from the court’s failure to direct a verdict for disregard contrary all evidence to that the defendants would be a non-issue. McLain, However, party’s position. See Eaton v. because we have vacated the 587, (Tenn.1994); 891 S.W.2d 590 verdict based Gann v. on the trial court’s erroneous Co., International evidence, Harvester 712 exclusion of we S.W.2d relevant must (Tenn.1986). 100, 105 address Dr. argu- Miller’s and Tokos’s they ments that were entitled to a directed appropri Directed verdicts are verdict. only ate when reasonable minds can reach but one conclusion. See Williams v. A. Brown, 854, (Tenn.1993); 860 S.W.2d 857 To avoid a directed verdict un 379, Alsup, Crosslin v. 594 S.W.2d 380 non-moving der par Tenn.R.Civ.P. (Tenn.1980). go jury, A case should to the ty present must some on every evidence even if the are undisputed, facts when enough element of its evidence to case— persons reasonable draw conflicting could establish at least a prima facie case. See conclusions from the M. Gulf, facts. See & Harrogate Corp. v. Systems Corp., Sales Underwood, 467, 474, O.R.R. Tenn. 182 915 S.W.2d (Tenn.Ct.App.1995). 818 (1945); 187 S.W.2d Pettus v. Normally, a directed verdict is proper only Hurst, 882 S.W.2d (Tenn.Ct.App. where no material evidence exists on one 1993). however, conclusions, These must non-moving par more elements that the conjec than speculation, based more ty prove. must See generally Conatser v. ture, guesswork. See Daniels v. Co., Bottling Clarksville Coca-Cola Indus., Inc., White Consol. 692 S.W.2d (Tenn.1995). S.W.2d Whether the (Tenn.Ct.App.1985). trial court should have directed a verdict *28 presents legal us with question of B. whether material evidence was introduced Both Dr. Miller and assert Tokos every on element to a jury sufficient create trial that the court should have a directed Lazy issue. See Seven v. Stone Coal Sales in their at all verdict favor the close of Hinds, (Tenn.1991); & 813 S.W.2d 403 proof because the Richardsons’ evidence Underwood v. HCA Health Servs. of failed to Richard establish causation. Ms. Tenn., Inc., (Tenn.Ct. 892 S.W.2d son had the at trial that prove burden App.1994). Stephens, Dickson v. 20 Tenn. injuries she suffered she would other 195, 211,
App. 211-12 96 S.W.2d proximate wise have as a suffered result (1935). negligence. Dr. Miller’s and Tokos’s 29-26-115(a)(3); § Kilpa Tenn.Code Ann. reviewing When a trial court’s (Tenn. Bryant, trick v. S.W.2d verdict, disposition of a motion for directed 1993). Dr. and Miller Tokos maintain appellate disputes courts do in not resolve Ms. evidence did not show Richardson’s evidence, weigh evidence, see Co prox that the administration terbutaline natser v. Clarksville Bottling Coca-Cola coronary imately artery caused her dissec Co., or evaluate S.W.2d tion and heart attack. credibility of the See Benson v. witnesses. Valley Coop., Tennessee Elec. sought prove 868 S.W.2d The Richardsons Instead, 638-39 causal link terbutaline she (Tenn.Ct.App.1993). between the Dr. Ding- Dr. attack artery her Miller and Tokos taking coronary dissec- was testimony contradicting pri- his felder’s as testimony with of Dr. Ronald tion being deposition testimony and as medi- or Krone, cardiologist, and Dr. a Missouri was not cally Dingfelder because Dr. weak a Dingfelder, North obste- James Carolina testimony Dingfelder’s Dr. cardiologist. a trician and Dr. Krone saw gynecologist. subject to attack on may very well approximately year a after Ms. Richardson However, this court these grounds. examining In her heart attack. addition challenged testi- charged viewing himself, Ms. Richardson he reviewed her mony strongest possible light in the favor- records. medical hospital Based on his the evi- ing Weighing the Richardsons. plain- his experience knowledge task. When we view jury’s dence is tiff, sure-footedly testified Dr. Krone testimony favorably, and physicians’ both damage heart Ms. Richardson’s that would lessen its everything we discard by artery splitting caused an serv- say we that Dr. Krone’s weight, cannot her profes- heart. When asked for his testimony provided Dingfelder’s and Dr. opinion of what caused the arterial sional on causation. Weak no material evidence attack, he splitting led to the heart testimony strong, at least created terbutaline, in opinion, answered that his causation, jury and therefore question in preg- increased risk heart attacks refusing the trial court did not err nant of ter- women the administration ground. a verdict on that direct butaline is what caused Ms. Richardson’s heart attack.41 V. op PRincipal addition, Dingfelder gave Dr. the fol- Mutual Dismissal Company
lowing regard opinion with to causation: Life Insurance The final involves the trial issue I looking believe after at all of the in Principal court’s Mutual’s dismissal explanations this pa- alternative had tervening complaint. Ms. Richardson injury put tient’s which have been for- non-contributory employer-provided, considered, I ward and which health insurance underwritten group news, including hearing shock at bad Principal policy Mutual. Her contained with, something that she was born stating allowed provision that “where anomaly, these, congenital my who benefits for law” insured receives opinion, significance to the ob- pale has “a injury and who lawful sickness vious known effects terbutaline. damages against parties claim” third *29 mean, patient already I has mani- injury sickness must related to that pain fested from terbutaline to chest company pay insurance reimburse the begin perfect logic, with. So it’s medical out made the insured’s behalf ments on from a opinion, recovery in terbutaline is the receives my any insured wrongdoer.42 third-party cause. cross-examination, on During cross-examination Tokos’s law- Dr. Krone's concession 41. his weight testimony, of his which went to got yer Dr. admit that he could not Krone to jury to was for the determine. medically possibility that rule out the Ms. have had the heart attack Richardson could Although Principal Mutual characterizes merely pre-delivery labor. due to stress subrogation, as it is more in its claim one However, that in his Dr. Krone never said the nature a claim for reimbursement. professional opinion was due the heart attack Principal policy provision on which Mutual event, any only to Ms. Richardson’s labor. j-ecoup payments to made to relies it allows Following case, Ms. heart Richardson's at- In this Ms. Richardson’s le tack, $52,434.54 gal obligation Principal paid repay Mutual to the approximately in $52,000 of covered expenses medical medical bills. After the Richardsons filed part contractual. As of her health cover Miller, Tokos, against others, suit Dr. age, has contractually agreed she reim to Principal Mutual sought to intervene based Principal burse Mutual for medical bene on its contractual right reimbursement paid fits on her subsequently behalf if she sought of any reimbursement out re- receives those parties amounts from third covery may Ms. Richardson obtain her responsible for her injury. Contractual malpractice action. The court trial dis- provisions like Principal Mutual’s are en Principal complaint missed Mutual’s evi- forceable the extent that has insured dently on theory that Tenn.Code Ann. compensation full received been has § prohibited 29-26-119 Ms. Richardson made whole for his or her losses. See recovering any from medical expenses that Auth., County York v. Sevier Ambulance paid by Principal had been Mutual. 621; S.W.3d at Board Trustees v. § Tenn.Code Ann. Graves, 29-26-119 M1997-00069-COA-R3-CV, No. states that a medical malpractice plaintiff *2 1999 WL n. (Tenn.Ct.App. (No Dec.3, 1999) not may Tenn.R.App.P. applica recover for the cost of medical filed).43 law, tion aAs matter of contract if care that cost was indemnified whole Principal may legitimately Mutual seek re part or in by employer-provided insurance. imbursement from Ms. Richardson. Con injured The statute seeks to prohibit par sequently, her losses not been “re from making recovery ties a double placed or indemnified” her own health reducing plaintiffs recovery by the insurance, § and Tenn.Code Ann. 29-26- paid by amount of benefits employer-pro 119 does not from prevent pursuing her vided insurance. See Nance v. Westside recovery of expenses against those medical (Tenn.1988). Hosp., 750 S.W.2d reason, Dr. Miller and Tokos. For that Excluded, however, gen from the statute’s the trial court should not have dismissed operation eral are collateral payments Principal intervening Mutual’s complaint. made where the payor collateral has sub- rogation rights. See Nance v. Westside VI. Hosp., 750 at 743. S.W.2d Where the foregoing, Based we reverse injured repay insured must the insurer out judgment dismissing Richardsons’ any recovered, damages the insured against Dr. claims Miller and Tokos and gets recovery. no double Stated another remand the for a trial case new consistent way, right where a of subrogation exists or opinion. with this tax the We costs of this where the tort victim a legal, obligation has appeal equal proportions Mil- James repay the collateral source payor, then ler, Corpora- M.D. to Tokos Medical “replaced the victim’s losses have been execution, necessary, may tion for which if or indemnified” for purposes Tenn.Code issue.
§Ann. 29-26-119. See Nance v. Westside *30 CANTRELL, P.J., M.S., dissenting. 743; Hosp., Hughlett 750 S.W.2d at v. Shelby County Corp., IV, Health Care HA, IIB, III, I in concur Parts (Tenn.Ct.App.1996). S.W.2d V of I majority opinion. disagree, course, generally question own any its insured. See v. 43. York Sevier Of about whether Ms. Auth., County Ambulance 8 S.W.3d Richardson has been made whole in this case (Tenn.1999). litigated remains to be on remand. however, reached in with the conclusion Therefore, I dissent.
Part IE. opinion contains con- Part IE grant- trial court erred clusion to exclude motion in limine ing Dr. Miller’s off-label regarding terbutaline’s evidence use, parallel and the including is I think this evidence
PDR reference. this case to the issues on which irrelevant tried, set be tried or that were motion. judge granted the when the trial (1) them, I read these issues were As Dr. deviated from standard Miller so late Ms. using drug care in experienced pains. Richardsons chest PDR refer- only relevance label the drug have is ence would whether All at all. should been used commonly agreed that the experts premature labor. prevent stop used to plaintiffs joined Dr. Miller issue theory also two theories and contested fact that the caused Ms. Richard- my opinion attack. these son’s heart fairly jury jury issues went returned a verdict the defendants. Therefore, verdict. I would affirm the INC., MARINA, D al.
R & et Tennessee, COUNTY, et al. ROANE Tennessee, Appeals Court Section, Eastern at Knoxville. Sept. 2000. 20, 2000. Oct. Rehearing Denied Denied Appeal Permission April Supreme Court notes nurse’s that her chest hurt. Richardson, Said Ms. “I’m taking Ms. Richardson made her prenatal last [M]y that.... is killing chest me. I don’t 23, 1993, office visit to Dr. Miller on June want any more of that stuff.” when approximately she was thirty-five pregnant. weeks The checkup was routine morning, nursing next staff in- and ended with the doctor’s office schedul- formed Dr. Miller Ms. Richardson had ing her for a return visit following complained pain of chest and had refused Events, however, week. brought par- to take the third dose of terbutaline. together ties sooner. theOn afternoon of When Dr. Miller examined Ms. Richard- son, very day, next Ms. Richardson was he pains discovered that her chest had admitted Hospital to Nashville Memorial subsided but that she was still in labor. in labor. Dr. immediately Miller was con- At that Dr. point, suggested using Miller line would receive. subcutaneously infuse that Ms. Richardson pump an infusion to then the terbu- smaller, hospital staff obtained terbutaline into The timed doses of filled hospital pharmacy, from the taline system. Ms. Richardson Ms.Richardson’s the needle that pump, the infusion inserted may pump not have understood that the medication, activated would deliver very give would be used to her same Ms. Richardson remembers pump. As drug that she had earlier refused to take it, “[t]hey initially up, [hospi- set it and the orally, but the whole she understood that in. And I put the needle re- tal] nurse purpose pump give was to her medi- every machine four hours the member to retard her labor and that it was cation And give [me a] [of medicine]. would dose Dr. Miller’s intention stabilize her con- to my pulse I to before time was check [each] to her home with tractions then send range to see if it was in don’t rate until her place preg- —I range they gave me.” remember the full nancy was term. regular Richardson received subcu- Ms. prior experience Dr. Miller had little approxi- of terbutaline for taneous doses pumps with terbutaline infusion than other forty-eight hours. Her mately next seminar, attending conversing a 1989 stop labor contractions did not immediate- representative, manufacturer’s read- however, ly; they eventually began de- ing professional completing articles. After By around noon on June three crease. Richardson, his examination Ms. Dr. onset, days after their the contractions attending Miller directed the nurses to Although expe- Ms. stopped. Richardson Hospital contact University Vanderbilt rienced shakiness and what she character- about for a arranging pump. terbutaline rate,” heart the nurses’ “rapid ized as eventually Nurse Gail Harris was directed vital notes stated that Ms. Richardson’s (“Tokos”), Corporation Tokos Medical the time her signs were “stable” around California-based medical services and stopped. contractions provider, arranged who a toco- supply lytic pump designed and programmed Ms. Richardson visited with her sister