         IN THE DISTRICT COURT OF APPEAL OF THE STATE OF FLORIDA
                              FIFTH DISTRICT

                                             NOT FINAL UNTIL TIME EXPIRES TO
                                             FILE MOTION FOR REHEARING AND
                                             DISPOSITION THEREOF IF FILED


DOCTORS COMPANY, INSURER,
FOR ITSELF AND FOR ANNABELL
TORRES, M.D.,

             Appellants,

 v.                                               Case No. 5D15-1963

NANCY PLUMMER, INDIVIDUALLY
AND AS PERSONAL REPRESENTATIVE
OF THE ESTATE OF WILLIAM PLUMMER,
AND ON BEHALF OF B.A.P. AND L.J.P.,
MINORS,

             Appellee.

________________________________/

Opinion filed January 20, 2017

Appeal from the Circuit Court
for Volusia County,
Sandra C. Upchurch, Judge.

Thomas E. Dukes, III and Philip F. Moring,
of McEwan, Martinez, & Dukes, P.A.,
Orlando, and Mark Hicks and Dinah Stein,
of Hicks, Porter, Ebenfield & Stein, P.A.,
Miami, for Appellants.

Bryan S. Gowdy and Jessie L. Harrell, of
Creed & Gowdy, P.A., Jacksonville, and
Carlos Diez-Arguelles, Maria D. Tejedor,
and Jack T. Cook, of Diez-Arguelles &
Tejedor, P.A., Orlando, for Appellee.
EVANDER, J.

       Appellants Annabell Torres M.D. (“Dr. Torres”) and her malpractice insurer,

Doctors Company, appeal a final judgment entered pursuant to a jury verdict in this

wrongful death medical malpractice case. Judgment was entered in favor of Appellee,

Nancy Plummer, individually, and as personal representative of the estate of William

Plummer (“Decedent”).       Because Appellee was permitted to present prejudicial,

undisclosed expert testimony and because of certain erroneous evidentiary rulings, we

are compelled to reverse and remand for a new trial.

       On December 4, 2009, Decedent visited the Valentine Family Clinic in DeLand,

Florida, complaining of ear pain that had persisted for two weeks. Decedent was seen

by Dr. Lee Brown, who diagnosed a bilateral otitis media (a middle ear infection) and

“sinusitis chronic with obstruction.”    Dr. Brown wrote two prescriptions for Z-Pak

antibiotics, and told Decedent to follow-up in two weeks.        On December 18, 2009,

Decedent returned to the Valentine Family Clinic and was seen by Dr. Torres, a board

certified family physician. According to Dr. Torres’ notes, Decedent complained of chronic

ear problems that persisted for one month. During this visit, Decedent’s chart failed to

reflect that any ear exam took place. Although not reflected in Decedent’s chart, Dr.

Torres later testified that it “usually would be within my standard to check into the ears.”

Dr. Torres recommended that Decedent take a Medrol Dosepak, a steroid, to aid

Decedent’s mild sinusitis. Additionally, Dr. Torres provided Decedent with samples of

Levaquin, an antibiotic, given that the Christmas holiday was approaching and as a

precaution in case Decedent’s sinusitis worsened over that period of time. At the bottom

of the chart, Dr. Torres’ notes reflected instructions that Decedent follow-up in one month.




                                             2
       Decedent returned to the Valentine Family Clinic on February 25, 2010, when he

complained of “intense right ear pain.” Dr. Torres examined Decedent’s ear and found a

bulging tympanic membrane (ear drum). Dr. Torres diagnosed Decedent with right-ear

otitis media once again. Upon her exam, Dr. Torres noted no redness of the ear, no pus

in Decedent’s ear canal, nor discharge from the ear. Dr. Torres prescribed Decedent

another Z-pak and pain medication. Dr. Torres did not refer Decedent to an ear, nose,

and throat doctor for further consultation.

       The next morning, on February 26, 2010, Decedent visited Atlantic Ear Nose &

Throat, where he was seen by a physician assistant. Decedent complained of a four-

month history of a clogged right ear with muffled hearing. The physician assistant noted

Decedent had pus in the right ear, fluid behind his eardrum, as well as redness of the

eardrum, and diagnosed Decedent with a middle and outer ear infection. The physician

assistant advised Decedent to finish the current Z-pak and Medrol Dospak, and

prescribed Ciprodex with an instruction to follow-up in ten days. The physician assistant

did not note any signs of sinusitis.

       Early the next morning, on February 27, 2010, Decedent collapsed at his home

and was taken to Florida Hospital in DeLand. A CT scan of Decedent’s brain was ordered,

and revealed “effacement of the cerebral hemispheric sulci as well as the basilar cisterns,

concerning for cerebral edema.” The CT final report also noted: “Bone detail shows

opacification of the right mastoid sinus and right middle ear” and bilateral ethmoid sinus

disease (sinusitis). Following Decedent’s admission to the hospital, Dr. Daniel Rothbaum,

a physician with Atlantic Ear Nose & Throat, surgically placed a tube in Decedent’s ear to




                                              3
relieve fluid buildup in the ear. Dr. Rothbaum later recalled his belief that Decedent’s ear

infection had progressed to an infection of the brain, stating:

              This was a patient who, from what I could gather, had had
              problems with an ear infection and had progressed to what
              appeared to be an infection of the brain. And so as part of that
              treatment for that, I thought it was important to try to maximally
              treat the ear infection, even if I couldn’t treat what was going
              on in the brain. And so to do that, I decided to try to drain any
              infection from behind the eardrum. The type of infection we’re
              talking here is one that’s in what's called the middle ear, the
              area between the eardrum and the inner ear.

While completing the surgery, Dr. Rothbaum observed that Decedent’s eardrum was “a

little bit red and that there was fluid behind the eardrum.” Dr. Rothbaum did not recall

seeing pus behind the eardrum or an abscess. During the surgery, a culture of the fluid

found in Decedent’s ear was taken and revealed strep pneumonia, a bacteria likely

resistant to Z-Pak antibiotics.     Following the procedure, Dr. Rothbaum diagnosed

Decedent with Eustachian tube dysfunction, acute otitis media (middle ear infection) with

meningitis/sepsis, and cerebral edema.

       Subsequent to his hospital admission, Decedent stopped breathing and was

placed on a ventilator. He ultimately passed away on March 2, 2010. The cause of death

was meningitis.

       In her initial complaint filed November 8, 2012, Appellee alleged that Dr. Torres

breached her duty of care to Decedent by:

              a. Negligently obtaining history from [Decedent];

              b. Negligently failing to recognize the signs and symptoms of
              serious head and neck disease including acute and chronic,
              potentially fulminant otitis media and sinusitis with extension
              to the meninges and brain, bacterial meningitis and/or other
              brain infection;




                                              4
               c. Negligently failing to include the diagnosis of bacterial
               meningitis in the differential diagnosis;

               d. Negligently failing to STAT refer [Decedent] to the hospital
               Emergency Department for complete laboratory evaluation
               including pan-cultures, CBC, sedimentation rate, imaging
               studies of the head and neck;

               e. Negligently failing to obtain a STAT ENT consult and
               complete neurological evaluation to rule out serious life
               threatening disease;

               f. Negligently ordering a Z-pak after [Decedent] presented
               with months of an ear infection and history of using a Z-pak in
               the past which did not resolve his symptomology.

Notably, the initial complaint did not allege that Dr. Torres was negligent in giving

Levaquin samples to Decedent.

       Appellee’s primary standard of care experts were Dr. Finley Brown, a family

medicine expert, and Dr. Jerrold Dreyer, an infectious disease expert. Their deposition

testimony supported the proposition that Dr. Torres breached her duty of care at the

December 18, 2009 visit by: (a) misdiagnosing Decedent’s condition; (b) failing to take a

complete history from Decedent; (c) failing to perform a proper physical exam of

Decedent; (d) failing to culture Decedent’s ears to determine the type of germ he had; (e)

failing to treat his ear infection; (f) failing to perform bloodwork; (g) failing to order imaging

studies; and (h) failing to send Decedent to an ENT or the emergency room. Significantly,

neither retained expert testified that Dr. Torres had breached her duty of care by providing

Levaquin samples to Decedent. Indeed, when asked about Dr. Torres’ decision to

provide Decedent with Levaquin samples during the December 18, 2009, visit, Dr. Dreyer

testified in his deposition that he did not believe her action was inappropriate.




                                                5
              often, for how long and how many milligrams. And give the
              patient the instructions and you document that in the record.

                      Because you do that so you know whether you gave
              the right amount, the right dose and the right amount that’s
              clinically indicated that the manufacturer tells you, this is what
              you need to give so that you can kill the bug.

                    If you give too little, you’re not going to kill it. If you give
              too much, you may make the patient resistant. She doesn’t
              document the dose, the administration, or how much.

Dr. Torres timely objected and argued that there had been no pretrial expert testimony

regarding Levaquin and testimony regarding same would constitute an “unfair surprise”

and “a new opinion.” Dr. Torres’ counsel further moved for a mistrial. After the trial court

overruled Dr. Torres’ objection and denied her motion for mistrial, Appellee’s counsel

went on to advise the jury that Dr. Torres failed to follow the manufacturer’s instructions

when she gave Decedent the Levaquin.

                       So the package insert for Levaquin calls that you got
              the culture before you give the drug. And the reason for that
              is because it’s a strong drug. It’s got a lot of risk associated
              with it.

                     And it also says that you need to culture because you
              need to see if it’s the right drug for streptococcus. Because
              there are many different types of streptococcus and they don’t
              know if it’s fine on Levaquin.

                     The manufacturer says you first culture, and then it will
              take a day or two to get the results. And when you get the
              results back, you adjust accordingly.

                     So the manufacturer – culture first, don’t give the
              antibiotic unless you culture first. Because if you give the
              antibiotic and you culture it next, that can give you a false
              negative.

                     So you culture first, give – you can give the patient
              antibiotics for a day or two and you get the cultures back in a
              day or two and susceptibility testing, you look at it, you say, is



                                                8
              it the right antibiotic? Great. Keep them on it. If it’s not, the
              manufacturer says you’ve got to adjust.

                     The defendant in this case didn’t follow the
              manufacturer’s instruction when she gave the Levaquin, and
              because she gave the Levaquin without doing that, it was the
              wrong drug. And because it was the wrong drug, it didn’t do
              anything for the ear infection.

Consistent with counsel’s opening statement, and over Dr. Torres’ continued objection,

Appellee’s two standard of care experts testified that Dr. Torres breached her duty by

providing Decedent with Levaquin.

       Dr. Finley Brown explained that Levaquin became a generic drug in 2005, and that

the FDA/manufacturer’s instructions on Levaquin do not indicate that it was intended for

the treatment of otitis media or a middle ear infection. He further opined that a family

practice physician would have the obligation to refer to, and know about, a prescription

drug’s package insert prior to administering that medication. Dr. Brown stated that

Levaquin’s package insert mentions obtaining a culture prior to prescribing the drug in

order to determine whether an infection is bacterial.

       According to the insert, culture and sensitivity testing were needed prior to

prescribing Levaquin as a way to “reduce the development of drug-resistant bacteria and

maintain the effectiveness of Levaquin and other antibacterial drugs.” Dr. Brown opined

that the package insert’s language set the standard for the use of Levaquin and that no

cultures or sensitivities were completed on the December 18, 2009, visit. When asked if

there was a deviation from the standard of care and a deviation from accepted practice

when Dr. Torres provided Decedent with Levaquin samples without taking a culture and

susceptibility test, Dr. Brown answered in the affirmative.




                                             9
              often, for how long and how many milligrams. And give the
              patient the instructions and you document that in the record.

                      Because you do that so you know whether you gave
              the right amount, the right dose and the right amount that’s
              clinically indicated that the manufacturer tells you, this is what
              you need to give so that you can kill the bug.

                    If you give too little, you’re not going to kill it. If you give
              too much, you may make the patient resistant. She doesn’t
              document the dose, the administration, or how much.

Dr. Torres timely objected and argued that there had been no pretrial expert testimony

regarding Levaquin and testimony regarding same would constitute an “unfair surprise”

and “a new opinion.” Dr. Torres’ counsel further moved for a mistrial. After the trial court

overruled Dr. Torres’ objection and denied her motion for mistrial, Appellee’s counsel

went on to advise the jury that Dr. Torres failed to follow the manufacturer’s instructions

when she gave Decedent the Levaquin.

                       So the package insert for Levaquin calls that you got
              the culture before you give the drug. And the reason for that
              is because it’s a strong drug. It’s got a lot of risk associated
              with it.

                     And it also says that you need to culture because you
              need to see if it’s the right drug for streptococcus. Because
              there are many different types of streptococcus and they don’t
              know if it’s fine on Levaquin.

                     The manufacturer says you first culture, and then it will
              take a day or two to get the results. And when you get the
              results back, you adjust accordingly.

                     So the manufacturer – culture first, don’t give the
              antibiotic unless you culture first. Because if you give the
              antibiotic and you culture it next, that can give you a false
              negative.

                     So you culture first, give – you can give the patient
              antibiotics for a day or two and you get the cultures back in a
              day or two and susceptibility testing, you look at it, you say, is



                                                8
              it the right antibiotic? Great. Keep them on it. If it’s not, the
              manufacturer says you’ve got to adjust.

                     The defendant in this case didn’t follow the
              manufacturer’s instruction when she gave the Levaquin, and
              because she gave the Levaquin without doing that, it was the
              wrong drug. And because it was the wrong drug, it didn’t do
              anything for the ear infection.

Consistent with counsel’s opening statement, and over Dr. Torres’ continued objection,

Appellee’s two standard of care experts testified that Dr. Torres breached her duty by

providing Decedent with Levaquin.

       Dr. Finley Brown explained that Levaquin became a generic drug in 2005, and that

the FDA/manufacturer’s instructions on Levaquin do not indicate that it was intended for

the treatment of otitis media or a middle ear infection. He further opined that a family

practice physician would have the obligation to refer to, and know about, a prescription

drug’s package insert prior to administering that medication. Dr. Brown stated that

Levaquin’s package insert mentions obtaining a culture prior to prescribing the drug in

order to determine whether an infection is bacterial.

       According to the insert, culture and sensitivity testing were needed prior to

prescribing Levaquin as a way to “reduce the development of drug-resistant bacteria and

maintain the effectiveness of Levaquin and other antibacterial drugs.” Dr. Brown opined

that the package insert’s language set the standard for the use of Levaquin and that no

cultures or sensitivities were completed on the December 18, 2009, visit. When asked if

there was a deviation from the standard of care and a deviation from accepted practice

when Dr. Torres provided Decedent with Levaquin samples without taking a culture and

susceptibility test, Dr. Brown answered in the affirmative.




                                             9
      Dr. Dreyer similarly testified that the standard of care requires a physician to be

familiar with the package insert for any medication he or she prescribes. Pursuant to the

insert’s language, Levaquin is not an FDA-approved drug for the treatment of otitis media

or ear infections. According to Dr. Dreyer, the insert prescribed the proper dosage of

Levaquin needed to treat sinusitis; however, Dr. Torres did not document the dosage she

provided to Decedent or how long he was supposed to take the prescription. Such

failures, according to Dr. Dreyer, constituted a breach of the standard of care. Dr. Dryer

likewise confirmed that the Levaquin package insert recommended that a culture of the

infection be performed prior to a physician prescribing the drug.

      In closing argument, Appellee’s counsel again emphasized Dr. Torres’ use of

Levaquin and the Levaquin package insert:

                    Why do we know it’s important to take a culture?
             Because we saw from the manufacturer’s package insert on
             Levaquin it’s not FDA approved for ear infections, but the
             manufacturer says this is a strong antibiotic. And if you’re
             going to use this antibiotic, physicians need to culture.

                     Why do they need to culture? Because culturing will
             tell you what the bug is. And when you know what the bug is,
             you can give the right antibiotic because you can’t be giving
             antibiotics willy-nilly because patients develop a resistance to
             it.

      On appeal, Dr. Torres argues that she was unduly prejudiced by Appellee’s

argument and evidence regarding Levaquin. We agree and conclude that the trial court

erred in permitting Appellee to argue and present evidence that Dr. Torres breached her

duty of care by providing Levaquin samples to Decedent and further erred by allowing the

Levaquin package insert to be admitted into evidence.




                                           10
       In Binger v. King Pest Control, 401 So. 2d 1310 (Fla. 1981), the Florida Supreme

Court established a test that trial courts should employ when determining whether certain

undisclosed testimony should be excluded as prejudicial to the opposing party:

              [A] trial court can properly exclude the testimony of a witness
              whose name has not been disclosed in accordance with a
              pretrial order. The discretion to do so must not be exercised
              blindly, however, and should be guided largely by a
              determination as to whether the use of the undisclosed
              witness will prejudice the objecting party. Prejudice in this
              sense refers to the surprise in fact of the objecting party, and
              it is not dependent on the adverse nature of the testimony.
              Other factors which may enter into the trial court’s exercise of
              discretion are: (i) the objecting party’s ability to cure the
              prejudice, or similarly, his independent knowledge of the
              existence of the witness; (ii) the calling party’s possible
              intentional, or bad faith, noncompliance with the pretrial order;
              and (iii) the possible disruption of the orderly and efficient trial
              of the case . . . . If after considering these factors, and any
              others that are relevant, the trial court concludes that use of
              the undisclosed witness will not substantially endanger the
              fairness of the proceeding, the pretrial order mandating
              disclosure should be modified and the witness should be
              allowed to testify.

Id. (footnotes omitted). The Binger analysis has subsequently been applied to cases

where an expert changes his or her opinion or gives a new opinion, which results in

surprise and prejudice to the opposing party. See, e.g., Perryman, M.D. v. Crawford, 968

So. 2d 83, 85-86 (Fla. 4th DCA 2007) (“We find it no stretch to conclude that the failure

to disclose an expert witness’s opinion in compliance with a pretrial order and a proper

discovery request should be analyzed under the principles announced in Binger and is

‘tantamount to permitting an undisclosed adverse witness to testify.’”).

       Here, the record reflects that Dr. Torres was prejudiced by the surprise testimony

and evidence presented at trial regarding Levaquin. Appellee first disclosed its intent to

present evidence that Dr. Torres’ provision of Levaquin samples to Decedent constituted



                                              11
a breach of a duty of care during counsel’s opening statement at trial. As a result, Dr.

Torres was denied the opportunity to conduct discovery on whether Decedent actually

used the Levaquin and, if so, the amount used, and whether such use would have

adversely affected Decedent. Additionally, Dr. Torres was denied the opportunity to

discover whether the package insert introduced at trial was authentic. Indeed, Dr. Brown

stated that the Levaquin given by Dr. Torres was manufactured by Johnson and Johnson,

yet the package insert shown to the jury was from manufacturer Janssen Ortho, LLC.

Furthermore, although Dr. Torres testified that she gave the Levaquin to treat sinusitis

rather than an ear infection, her experts were deprived of the opportunity to fully respond

to the claim that Levaquin samples should not have been provided to Decedent. 1

       The trial court’s error was compounded by permitting the insert to be admitted into

evidence (even assuming its authenticity). Although section 90.706, Florida Statutes

(2014), permits statements of facts or opinion on a subject of specialized knowledge

contained in a learned treatise, pamphlet, or other writing to be used in cross-examination

of an expert witness, it does not permit those statements to be used as substantive

evidence. Nationwide Mut. Fire Ins. Co. v. Darragh, 95 So. 3d 897, 901 (Fla. 5th DCA

2012). The rationale for this rule is, otherwise, an opposing party would be deprived of

the opportunity to cross-examine or impeach the source of the statement of fact or

opinion. Id.2



       1It should be noted that a juror specifically posed a question for Dr. Dreyer on the
use of Levaquin: “If Levaquin is not for use in the treatment of ear infections, why does
the doctor think that Dr. Torres, the ENT and the hospital gave or attempted to give
[Decedent] Levaquin?”
       2Of course, the fact that the insert itself might not be admissible into evidence
would not preclude an expert from discussing same if facts or data in the insert were “of


                                            12
       Other courts have concluded that although a prescription drug package insert may

have some significance in identifying a doctor’s standard of care in the administration and

use of a prescription drug, it cannot be used as “stand-alone proof” of the standard of

care. See In re Richardson-Merrell, Inc. Bendectin Prods. Liab. Litig., 624 F. Supp. 1212,

1232 (S.D. Ohio 1985) (holding that drug manufacturer’s warnings are out-of-court

statements offered to prove the truth of the matter asserted, therefore inadmissible

hearsay); Spensieri v. Lasky, 723 N.E.2d 544, 548 (N.Y. 1999) (“The [Physicians’ Desk

Reference] may have some significance in identifying a doctor’s standard of care in the

administration and use of prescription drugs, but is not the sole determinant. . . . The

testimony of an expert is necessary to interpret whether the drug in question presented

an unacceptable risk of the patient in either its administration or the monitoring of its

use.”); Saccone v. Gross, 84 A.D.3d 1208, 1209 (N.Y. App. Div. 2011) (holding that

plaintiff was properly precluded from offering information from package insert as

republished in Physicians’ Desk Reference into evidence because the proffered evidence

constituted inadmissible hearsay).

       We also hold that the trial court reversibly erred in excluding the deposition

testimony of Dr. Kelley, the emergency room physician who treated Decedent when he

arrived at the hospital on February 27, 2010. Dr. Kelley made certain observations of the

patient that arguably supported Dr. Torres’ theory of defense. In excluding Dr. Kelley’s

deposition, the trial court initially observed that the witness had not been subpoenaed.

When Dr. Torres’ counsel appropriately argued that Florida Rule of Civil Procedure




a type reasonably relied upon by experts in the subject to support the opinion expressed.”
See § 90.704, Fla. Stat. (2014).


                                            13
1.330(a)(3)(F) expressly authorizes the use of a deposition by any party for any purpose

if the court finds that the witness is an expert or a skilled witness, the trial court

inexplicably declined to find Dr. Kelley was a skilled witness.

       The trial court erred in declining to find Dr. Kelley was a skilled witness, particularly

where it was uncontroverted that Dr. Kelley was a licensed and experienced emergency

room physician, who was board certified in emergency medicine. As a result, it was error

for the trial court to preclude Dr. Torres’ use of Dr. Kelley’s deposition.         See, e.g.,

Castaneda v. Redlands Christian Migrant Ass’n, 884 So. 2d 1087, 1093 (Fla. 4th DCA

2004) (holding that it was error of law for trial court to refuse to permit party to use

depositions of opposing party’s employees where use was expressly authorized by

Florida Rule of Civil Procedure 1.330). We reject Appellee’s suggestion that the exclusion

of Dr. Kelley’s deposition was harmless. Although Dr. Kelley’s records were admitted into

evidence, the jury was denied the opportunity to hear her qualifications and any

statements made in her deposition that amplified and/or clarified the contents of her

records.

       We reject, without discussion, Appellants’ other issues raised on appeal.

       REVERSED and REMANDED for new trial.



PALMER and BERGER, JJ., concur.




                                              14
