               NOT FINAL UNTIL TIME EXPIRES TO FILE REHEARING
                      MOTION AND, IF FILED, DETERMINED


                                              IN THE DISTRICT COURT OF APPEAL
                                              OF FLORIDA
                                              SECOND DISTRICT

JEANNE M. SORENSON, as executor of )
the Estate of DARRYL RAY SORENSON, )
                                     )
         Appellant,                  )
                                     )
v.                                   )               Case No. 2D15-441
                                     )
PROFESSIONAL COMPOUNDING             )
PHARMACISTS OF WESTERN               )
PENNSYLVANIA, INC., a Foreign        )
Corporation; CHARLOTTE PAIN          )
MANAGEMENT CENTER, INC.;             )
ANZAOHEALTH CORPORATION, a           )
Florida Corporation; LEONARD A.      )
BENTON, M.D.; HAROLD E. SLEIGHT, II, )
M.D.; JOHN HUBICKI, PA-C; NANCY      )
HARRIS, R.N.; GINA PROVENCAL; and )
JOHN DISTASIO,                       )
                                     )
         Appellees.                  )
___________________________________)

Opinion filed May 11, 2016.

Appeal from the Circuit Court for Charlotte
County; Donald H. Mason, Judge.

Christian D. Searcy of Searcy Denny
Scarola Barnhart & Shipley, P.A., West
Palm Beach; William E. Partridge and
Patrick S. McArdle of Grossman Roth P.A.,
Sarasota; and David J. Sales of David J.
Sales, P.A., Jupiter, for Appellant.

Shelley H. Leinicke of Wicker, Smith,
O'Hara, McCoy & Ford, P.A., Ft.
Lauderdale; and Michael R. D'Lugo of
Wicker, Smith, O'Hara, McCoy & Ford,
P.A., Orlando (substituted as counsel of
record), for Appellee Professional
Compounding Pharmacists of Western
Pennsylvania, Inc.

No appearance for remaining Appellees.


SILBERMAN, Judge.

              Jeanne M. Sorenson, as Executor of the Estate of Darryl Ray Sorenson,

seeks review of the order dismissing with prejudice the claims in her wrongful death

negligence suit against Professional Compounding Pharmacists of Western

Pennsylvania, Inc. (the Pharmacist). The trial court dismissed these claims, which were

set forth in counts VI and VII of the second amended complaint, for failing to allege a

cognizable duty that the Pharmacist owed Mr. Sorenson. We conclude that count VI

alleged a breach of a cognizable duty to use due and proper care in filling a prescription

and reverse on this basis. We affirm the dismissal as it pertains to count VII.

              The second amended complaint alleges that Mr. Sorenson was an Ohio

resident who suffered from chronic low back pain caused by a car accident. Mr.

Sorenson's physician was managing his pain by administering hydromorphone through

a pain pump that had been inserted into his spinal canal. While vacationing in Florida in

2012, Mr. Sorenson visited Charlotte Pain Management Center, Inc. (Charlotte Pain),

based on a referral from his physician. One of Charlotte Pain's physicians wrote a

prescription for hydromorphone that increased the concentration from 10 mg/mL to 30

mg/mL. Charlotte Pain transmitted this prescription directly to the Pharmacist, and the

Pharmacist compounded the medication and released it to Charlotte Pain. Charlotte




                                           -2-
Pain then administered the medication to Mr. Sorenson through his pain pump. He died

that same day.

              Ms. Sorenson's wrongful death suit included medical negligence claims

against Charlotte Pain, several of its health care providers, and the Pharmacist. Count

VI of the second amended complaint alleged negligence of the Pharmacist by, among

other things, "negligently preparing and dispensing" a prescription for hydromorphone

that was "unreasonable on its face, due to the dosage strength." Count VII alleged

negligence per se of the Pharmacist by filling the unreasonable prescription without

being registered or licensed in Florida as required by law.

              The question before this court is whether the trial court properly dismissed

these counts for failing to allege a cognizable duty that the Pharmacist owed Mr.

Sorenson.1 This court conducts a de novo review of an order dismissing claims for

failing to state a cause of action. Ferguson Enters., Inc. v. Astro Air Conditioning &

Heating, Inc., 137 So. 3d 613, 615 (Fla. 2d DCA 2014). However, our review is limited

to the four corners of the complaint, and we are required to accept the allegations

therein as true and to resolve any inferences in favor of the plaintiff. Id.

I. Count VI - Wrongful Death Negligence

              In McLeod v. W.S. Merrell Co., 174 So. 2d 736 (Fla. 1965), the supreme

court addressed the issue of a pharmacist's obligations to its customers in a breach of

warranty case. The court concluded that

              a druggist who sells a prescription warrants that (1) he will
              compound the drug prescribed; (2) he has used due and
              proper care in filling the prescription (failure of which might


              1
              The counts against Charlotte Pain and the health care providers remain
pending in the trial court, but they have been stayed until this appeal is decided.


                                            -3-
              also give rise to an action in negligence); (3) the proper
              methods were used in the compounding process; (4) the
              drug has not been infected with some adulterating foreign
              substance.

Id. at 739 (emphasis added). Our sister courts have relied upon this language to

conclude that a pharmacist has a common law duty to use due and proper care in filling

a prescription and that the failure to do so may give rise to an action for negligence.

See Oleckna v. Daytona Disc. Pharmacy, 162 So. 3d 178, 181-82 (Fla. 5th DCA 2015);

Powers v. Thobhani, 903 So. 2d 275, 278 (Fla. 4th DCA 2005); Dee v. Wal-Mart Stores,

Inc., 878 So. 2d 426, 427 (Fla. 1st DCA 2004).

              These courts have also determined that this duty to use due and proper

care may involve more than simply filling the prescription as written. Oleckna, 162 So.

3d at 182; Powers, 903 So. 2d at 278; Dee, 878 So. 2d at 427. A pharmacist may

breach the duty of care even when he or she fills a prescription in accordance with the

physician's instructions if the prescription is unreasonable on its face.

              In Dee, the complaint alleged that a prescription for a Duragesic patch

was unreasonable on its face because it was more than four months old and did not

contain a time limit for filling or using it. 878 So. 2d at 427. Thus, a pharmacist who

viewed the prescription would reasonably conclude that the patient is opioid-naive and

not on the necessary drug regimen and that the patch would likely be fatal to the

patient. Id. at 427-28. The First District concluded that the complaint stated a cause of

action in negligence. Id. at 428.

              In Powers, the complaint alleged that a pharmacist breached its duty by

filling a patient's multiple prescriptions in too short a time frame, noting that some of the

prescribed narcotics were contraindicated and that the drugs were being repeatedly



                                            -4-
prescribed before preceding prescriptions would have been depleted. 903 So. 2d at

276-77. The Fourth District concluded that the complaint set forth a cognizable breach

of the "duty to warn customers of the risks inherent in filling repeated and unreasonable

prescriptions with potentially fatal consequences." Id. at 279 (emphasis added).

              The complaint in Oleckna contained allegations of filling prescriptions that

were unreasonable on their faces because the physician was overprescribing narcotics.

162 So. 3d at 179-80. The Fifth District determined that the complaint alleged a

cognizable duty to use due and proper care. Id. at 182-83. The court explained that a

pharmacist's duty of care "extends beyond simply following the prescribing physician's

directions" and held that the duty could not be "satisfied by 'robotic compliance' with the

instructions of the prescribing physician." Id. at 182.

              We agree with our sister courts that a pharmacist's duty to use due and

proper care involves more than simply filling the prescription as written. We share in the

Fifth District's conviction that "robotic compliance" with a prescribing physician's

instructions will not shield a pharmacist from liability when the prescription is

unreasonable on its face.

              The second amended complaint contains the following allegations

regarding the Pharmacist's breach of the duty of care as set forth in count VI:

              21. The Defendant PROFESSIONAL COMPOUNDING
              PHARMACISTS sent 40 ml of Hydromorphone in a
              preservative free solution at a concentration of 30 mg/ml to
              Defendant CHARLOTTE PAIN without confirming the
              previous concentration and dose; without reviewing the
              Decedent DARRYL RAY SORENSON's patient history to
              determine past dosing; and by failing to determine the pump
              type, the various settings, or the programming used to
              deliver the Hydromorphone, thereby negligently and
              inappropriately filling a prescription which was unreasonable



                                            -5-
             on its face due to the potency and strength of this highly
             controlled pain medication[.]

             ....

             46. At all times material hereto, Defendant
             PROFESSIONAL COMPOUNDING PHARMACISTS owed a
             duty by and through its agents, apparent agents, employees,
             and/or contractors to provide pharmacy and narcotic
             dispensing services in accordance with the prevailing
             professional pharmacy standards of care, which in light of all
             relevant surrounding circumstances, is recognized as
             acceptable and appropriate by reasonably prudent and
             similar pharmacists in the same or similar community.

             47. Notwithstanding the duty undertaken, Defendant
             PROFESSIONAL COMPOUNDING PHARMACISTS is
             independently and/or vicariously liable for doing, or by failing
             to do one or more of the following acts, any or all of which
             are departures from the acceptable professional pharmacy
             standards of care in Charlotte County, Florida, or any other
             similar pharmacy community:

                    i. negligently preparing and dispensing an order for
             30 mg/ml of Hydromorphone without a license in Florida,
             which Defendant PROFESSIONAL COMPOUNDING
             PHARMACISTS knew, or should have known was
             unreasonable on its face, due to the dosage strength of the
             medication, and was likely to result in serious injury or death
             to the decedent, DARRYL RAY SORENSON;

                    ii. Negligently failing to inform DARRYL RAY
             SORENSON and/or his other healthcare providers that the
             pharmacy had no active license to compound drugs in
             Florida, which led to the filling of the prescription of 30 mg/ml
             of Hydromorphone, a prescription unreasonable on its face
             due to dosage strength, and likely to result in serious injury
             or death to the decedent DARRYL RAY SORENSON.

(Emphasis added.) Accepting these allegations as true and resolving inferences in

favor of Ms. Sorenson, the Pharmacist knew or should have known that the prescribed

concentration of hydromorphone was potentially fatal and nonetheless filled the




                                           -6-
prescription without further inquiry. We conclude that these allegations of count VI set

forth a cognizable duty that the Pharmacist owed Mr. Sorenson.

              We recognize that the complaint is unartfully drafted. For example, the

use of the word "thereby" in paragraph 21 could be read to limit the Pharmacist's

negligent actions to those preceding that word: filling the prescription without confirming

the previous concentration and dose, reviewing Mr. Sorenson's patient history, and

inquiring into the details of the pump specifications. These allegations, standing alone,

may not support a claim against a compounding pharmacist. However, when read in

conjunction with the subsequent assertions in count VI, we conclude that the

Pharmacist's allegedly negligent actions included filling a prescription that is claimed to

be facially unreasonable and failing to consult the prescribing physician regarding that

dosage strength.

              This is where the dissent's argument misses the mark. The dissent

frames the issue, as does the Pharmacist, solely as a question of negligence arising out

of the Pharmacist's failure to inquire as to the patient's history and related information in

order to determine whether the prescription was appropriate for the patient. But that

reading of the complaint ignores the allegation of negligence in filling a prescription for

hydromorphone at a concentration of 30 mg/mL, which the Pharmacist "knew, or should

have known was unreasonable on its face, due to the dosage strength of the

medication." By rejecting this allegation as "conclusory," the dissent appears to have

decided that a prescription for hydromorphone in that concentration may be reasonable

for other patients. However, the issue of whether the prescription concentration was, in

fact, facially unreasonable is not an issue that can be resolved on a motion to dismiss.




                                            -7-
See Ferguson, 137 So. 3d at 616 ("It is not for the court to speculate whether the

allegations of the complaint are true or whether they can be proven.").

              The Pharmacist argues that Oleckna, Powers, and Dee do not support a

finding of a duty for the Pharmacist because the pharmacists in those cases were retail,

as opposed to compounding, pharmacists. The Pharmacist asserts that, as a

compounding pharmacist, it was two steps removed from Mr. Sorenson because it

dispensed the medication to the prescribing physician who then administered it to Mr.

Sorenson. We recognize that compounding pharmacists may have no direct contact

with patients. However, we are not persuaded that the lack of direct patient contact

shields a compounding pharmacist from its duty to use due and proper care in filling a

prescription that is intended for administration to that patient. We also note that this

duty arises not from a duty to warn the patient; rather it arises from the duty to not fill a

facially unreasonable prescription without appropriate inquiry.

              The Pharmacist also argues that count VI does not set forth a cognizable

duty to inquire about the hyrdomorphone's concentration because the administering

physician could reduce the concentration or reduce the dosage to compensate for the

higher concentration. However, these asserted facts are beyond the four corners of the

complaint and are therefore beyond this court's consideration. The complaint

unequivocally asserts that the prescription as written was "likely to result in serious

injury or death," and we are required to accept this allegation as true. Evidence to the

contrary would at best present a question of fact to be resolved in later proceedings.

II. Count VII - Wrongful Death Negligence Per Se




                                             -8-
              Count VII of the second amended complaint asserts a cause of action for

negligence per se by filling the prescription without being registered or licensed as

required by law. See §§ 465.0156(1), 456.065, Fla. Stat. (2011). The complaint alleges

that "[Mr. Sorenson] falls within the statute's protected class, namely a Florida resident

who received treatment from an unlicensed health care provider that resulted in his

death due to a lack of services at a high level of protection and competence." This

language is taken from a line of cases recognizing a cause of action for negligence per

se based on a violation of a "statute which establishes a duty to take precautions to

protect a particular class of persons from a particular injury or type of injury." deJesus

v. Seaboard Coast Line R.R. Co., 281 So. 2d 198, 201 (Fla. 1973); see also Lingle v.

Dion, 776 So. 2d 1073, 1077 (Fla. 4th DCA 2001) ("A cause of action in negligence per

se is created when a penal statute is designed to protect a class of persons, of which

the plaintiff is a member, against a particular type of harm." (quoting Newsome v.

Haffner, 710 So. 2d 184, 186 (Fla. 1st DCA 1998))).

              The trial court rejected Ms. Sorenson's allegation that the statutes meet

this standard and instead concluded that the failure to be licensed merely constitutes

evidence of negligence. The court explained, "Although failure to be licensed or

permitted may be evidence of negligence, this is relevant only after the law has imposed

a duty of care which has been breached." The trial court concluded that Ms. Sorenson

did not state a cause of action in count VII because she failed to allege the breach of a

cognizable duty. We agree.

              Ms. Sorenson's argument, relying on deJesus and its progeny, is

misplaced. The question of whether a statute establishes a duty to take precautions to




                                            -9-
protect or benefit a particular class of persons is no longer determinative on the

question of whether a cause of action should be recognized. Murthy v. N. Sinha Corp.,

644 So. 2d 983, 985 (Fla. 1994). "[L]egislative intent, rather than the duty to benefit a

class of individuals, should be the primary factor considered by a court in determining

whether a cause of action exists when a statute does not expressly provide for one." Id.

              Chapter 456 was enacted to regulate lawful professions "for the

preservation of the health, safety, and welfare of the public under the police powers of

the state." § 456.003(1), (2). A pharmacist is a "health care practitioner" under section

456.001(4), which extends to chapter 465, the Pharmacy Act. And "[i]t is the legislative

intent [of chapter 465] that pharmacists who fall below minimum competency or who

otherwise present a danger to the public shall be prohibited from practicing in this state."

§ 465.002.

              "In general, a statute that does not purport to establish civil liability but

merely makes provision to secure the safety or welfare of the public as an entity, will not

be construed as establishing a civil liability." Murthy, 644 So. 2d at 986 (quoting Moyant

v. Beattie, 561 So. 2d 1319, 1320 (Fla. 4th DCA 1990)). We can discern no language in

either chapter suggesting an intent to create a private cause of action for the violation of

its requirements. See Estate of Johnson ex rel. Johnson v. Badger Acquisition of

Tampa, 983 So. 2d 1175, 1182 (Fla. 2d DCA 2008) (affirming summary judgment in

favor of a pharmacist because the plaintiff had not established a duty of care arising

from the Pharmacy Act and the Act did not set forth a legislative intent to create a

private cause of action); Oleckna, 162 So. 3d at 183 n.4 ("The Florida pharmaceutical

regulatory statutes and administrative codes do not create a private cause of action




                                            - 10 -
against pharmacists."); Johnson v. Walgreen Co., 675 So. 2d 1036, 1038 (Fla. 1st DCA

1996) (holding that the language and legislative history of the Florida Pharmacy Act "is

devoid of any indication that the Legislature intended to create a private cause of action"

for negligence). Accordingly, count VII does not set forth a private cause of action for

negligence per se.

              In conclusion, we reverse the dismissal of count VI of the second

amended complaint because it alleged a breach of a cognizable duty to use due and

proper care in filling a prescription. We affirm the dismissal of count VII because it sets

forth no basis for a private cause of action for failing to be registered or licensed as

required by law.

              Affirmed in part, reversed in part, and remanded.



MORRIS, J., Concurs.
LaROSE, J., Concurs in part and dissents in part with opinion.




LaROSE, Judge, concurring in part and dissenting in part.

              I concur, without reservation, in the court's affirmance of the trial court's

decision to dismiss count VII of the second amended complaint. A cause of action for

negligence per se cannot stand.

              I respectfully dissent from the court's holding that the second amended

complaint alleged facts sufficient to impose on the Pharmacist a duty to use due and

proper care in filling a prescription for Mr. Sorenson's ultimate use. Certainly, there may




                                            - 11 -
be cases where a compounding pharmacy owes a duty of care in filling a prescription

for a patient. See McLeod v. W. S. Merrell Co., Div. of Richardson-Merrell, Inc., 174 So.

2d 736, 739 (Fla. 1965). This is not that case. In my view, the second amended

complaint fails to allege ultimate facts showing any duty owed by the Pharmacist. See

Fla. R. Civ. P. 1.110(b)(2); Mather v. Northcutt, 598 So. 2d 101, 101 (Fla. 2d DCA 1992)

("To state a cause of action in negligence, a complaint must allege ultimate facts which

establish a relationship between the parties giving rise to a legal duty in the defendant

to protect the plaintiff from the injury of which he now complains." (citing Ankers v.

District School Bd. of Pasco Cty., 406 So. 2d 72, 73 (Fla. 2d DCA 1981))); Estate of

Sharp v. Omnicare, Inc., 879 So. 2d 34, 36 (Fla. 5th DCA 2004) (concluding that the

complaint's allegations failed to discern a duty that the pharmacy owed to the plaintiff).

Accordingly, I would affirm the dismissal of count VI.

              The second amended complaint alleges that the Pharmacist failed to

"reasonably determine [Mr. Sorenson's] medical history and condition prior to

dispensing a highly potent prescription of a controlled substance . . . ." As I understand

the allegations, I see no such duty. Unlike the situations in Oleckna v. Daytona Disc.

Pharmacy, 162 So. 3d 178 (Fla. 5th DCA 2015), and Powers v. Thobhani, 903 So. 2d

275 (Fla. 4th DCA 2005), there is no allegation that the Pharmacist had any prior

dealings with Mr. Sorenson. Nothing indicates that the Pharmacist ever filled a

prescription for Mr. Sorenson or on the order of Mr. Sorenson's pain management

physician in Ohio. Allegedly, Mr. Sorenson's Ohio physician had previously prescribed

hydromorphone for Mr. Sorenson in a concentration of 10 mg/mL. The second

amended complaint does not allege that the Pharmacist filled that prescription.




                                           - 12 -
              We do know that Mr. Sorenson presented to the Charlotte Pain

Management Center as recommended by his Ohio physician. A physician at Charlotte

Pain prescribed hydromorphone. A copy of the prescription is not in our record. The

court reasonably assumes, however, that the Charlotte Pain physician ordered a

concentration of 30 mg/mL, three times higher than previously ordered by Mr.

Sorenson's Ohio physician. Allegedly, the Charlotte Pain physician forwarded the

prescription to the Pharmacist, who, in turn, filled it. The Pharmacist sent the allegedly

fatal concentration of hydromorphone to the Center. A physician at Charlotte Pain

administered the hydromorphone to Mr. Sorenson a couple of days after his initial visit.

              The source of any alleged duty owed by the Pharmacist to Mr. Sorenson

hinges on the conclusory allegation that the prescription was "unreasonable on its face

due to the potency and strength" of the medication. Consequently, the Pharmacist, as

the second amended complaint alleges, had a duty to determine Mr. Sorenson's health

history, investigate his prior doses, ascertain the type of pain pump he used, and inquire

about pain pump settings. Strikingly, the second amended complaint alleges no facts

from which one could say that the prescription, as written, was inappropriate so as to

trigger some duty on the part of the pharmacy. See Dee v. Wal-Mart Stores, Inc., 878

So. 2d 426, 427 (Fla. 1st DCA 2004) (alleging that the prescription rendered was

unreasonable on its face because it lacked a time limit); Oleckna, 162 So. 3d at 182

(holding that allegations that the pharmacist filled too many prescriptions too close in

time should have put pharmacist on notice). The second amended complaint fails to tell

us why the Pharmacist should have hesitated. Despite what I see as a pleading

deficiency, the court imposes an undue burden of investigation on a compounding




                                           - 13 -
pharmacy. Even the cases relied upon by the court demonstrate the need for some

factual setting from which to impose duties such as those claimed by the second

amended complaint.

              Taken to its logical conclusion, the court's decision will require a

compounding pharmacy, upon receipt of a prescription for a new patient, to contact the

prescriber to inquire about the patient's history and course of treatment, even if the

prescription appears regular on its face. I know of no law or regulation that requires

such a burdensome inquiry.




                                           - 14 -
