Court of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 1 of 20

A TTORNEY FOR P LAINTIFFS J OE AND L INDA A LCOZAR ; A RDEMUS A LLEN ; G EORGE AND A RLENE B OSTIC ; T RACEY AND R ON B RIGGS ; R OBERT AND E LIZABETH C OBB ; L EISA AND D AVID C OPP ; C INDY M. W ILSON , P ERSONAL R EPRESENTATIVE OF E STATE OF V IOLA C OPSEY ; E LLEN C RAIGO , P ERSONAL R EPRESENTATIVE OF E STATE OF A LAN C RAIGO ; C HRISTOPHER D URBEN , P ERSONAL R EPRESENTATIVE OF E STATE OF J ACK N. D URBEN ; D AWN E LLIOTT ; P ATRICIA F ORTIER ; B RENDA AND D AVID G ARL ; D ONNA AND R I CKIE H AAS ; S USAN R. AND M ICHAEL E. H ANCOCK ; N ANCY AND D ON H INKLE ; D ONNA M. AND L ONNIE L. H OSEA ; K ENNETH H URS T ; K ENNYATTA J ACKSON ; E LIZABETH J ONES ; T ERRY AND C YNTHIA K ASER ; C INDYLU K ONANZ ; Y VONNE K UBISZEWSKI ; M ARY L AMBER T ; C HARLOTTE AND T OM L AY ; K ATHY AND D ANIEL L ENHART ; J OHN AND T AMARA P AVLEKOVICH ; S ANDRA P OLK ; R ESHONDA P RINGLE ; J OAN R EINHARDT , P ERSONAL R EPRESENTATIVE OF THE E STATE OF D ONALD R EINHARDT ; V ERONICA M ERWIN

- R OSS , P ERSONAL R EPRESENTATIVE OF THE E STATE OF G AIL R OSS ; J O A NN AND R ICHARD A TTORNEYS FOR A PPELLEE A NONYMOUS C LINIC David J. Beach Louis W. Voelker Eichhor n & Eichhorn, LLP Hammond, Indiana A TTORNE Y FOR A PPELLEE C OMMISSIONER O F THE I NDIANA D EPARTMENT O F I NSURANCE An ne L

. Cowgur Taft Stettinius & Hollister LLP Indianapolis, Indiana A TTORNEYS FOR A PPELLEES ASC S URGICAL V ENTURES , LLC ; O RTHOPEDIC AND S PORTS M EDICINE C ENTER O F N ORTHERN I NDIANA ; AND OSMC L yle R. Hardman Hunt Suedhoff Kearney, LLP Sout h Bend, Indiana Margaret M. Christensen Dentons Bingham Green e baum L LP Indianapolis, IndianaCourt of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 2 of 20

S CHROCK ; R

ACHELLE AND G REG S HUFF ; D AVID , J R

. AND W INNIE S IMS ; P AULETTE AND D OUGLAS S INN ; J ERRY G. S MITH , III ; R ICHARD T ALLMAN ; C YNTHIA J. T UFF , P ERSONAL R EPRESENTATIVE OF THE E STATE OF J ACK B. T UFF ; K AREN W YRES ; J OHN D ILLION , P ERSONAL R EPRESENTATIVE OF THE E STATE O F K ATHY D ILLON ; S USAN AND J ACK F RICK ; K

AREN R OMANO ; J OY AND J ACK S MITH ; J OHN AND J UDY S OLI ; B ARBARA AND A LBERT T IROTTA ; T ERRY T ROST ; R ONDA AND D AVY T ROXEL ; M ICHAEL AND B ARBARA V ITOU ; M ICHAEL AND D EBBIE W ALTER ; A UGUSTA AND D UANE W EGNER ; G REG AND G AIL W ILFIN G ; W ILBUR , J R

. AND R ACHEL W OLFE ; J ENNIFER Y OE ; L ARRY B ROWNING ; J AMES G REENWOOD ; K ARISSA K LEMM ; S TEVE K OZIATEK ; S AMUEL L OCK ; J IM M C Q UEEN ; C ARRIE M OHR ; D ONALD O WEN ; S TACEY H OFFLANDER ; T HOMAS R EED ; K IMBERLY R ICE ; B RENDA R OARK ; M ICHELE R OBINSON ; D EBORAH B ARNES ; W AYNE O BLINGER , D ENNIS C RESSY , AND T HOMAS H URTEKANT , AS P ERS

. R EP S

. O F THE E STATE OF K RISTI O BLINGER ; S TACI V AN S CHOIACK ; Y OLANDA I VORY ; C HARLES F ORD , AS A DMINISTRATOR IN THE E STATE OF S HARON S HAFER ; P EARL S TOKES ; D ONNA AN D L ONNIE H OSEA ; L AURA AND J AMES W YZA Douglas D. Small Foley & Small , LLP South Bend , IndianaCourt of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 3 of 20

A TTORNEY FOR P LAINTIFFS C OURTNEY M. G ERRING AND A MY G ERRING B IVIANO , C O

- P ERS ONAL R E PRESENTATIVES OF THE E STATE OF S HIRLEY B ARNES ; L INDA B LACK ; D ONALD F LOREA , P ERSONAL R EPRESENTATIVE OF THE E STATE OF P AULINE B UREMA ; B RUCE C OX AND E UGENE T OPOLSKI , C O

- P ERSONAL R EPRESENTATIVES OF THE E STATES OF M ARJORY C OX AND E. W AYNE C OX ; R UDOLPH AND M ONICA C HERNIAK ; C HRISTY R

AMSEY , P ERSONAL R EPRESENTATIVE OF THE E STATE OF I SABEL LE F LOOR ; S COTT AND J AN H UXFORD ; N ANCY I SLAS (M ORRIS ) AND J ORGE I SLAS ; D ORIS AND R OBERT J EWEL ; R OY AND D ORIS K EIM ; J ACQUIE F ARR AND L YNNE W ILLIAMS , C O

- P ERS ONAL R EP RESENTATIVES OF THE E STATES OF S ETH K NIFFIN AND B ILLIE K NIFFIN , D ECEASED ; T HOMAS L EGG , J R

. AN D L ORI L EGG

- W ILLIAMS ; F LORENCE AND P ATRICK M AKOUSKY ; D OUGLAS A. M ULVANEY , P ERSONAL R EPRESENTATIVE OF THE E STATE OF C AROLYN M ALONEY ; J OSHUA R EAMS ; S ANDRA R HODES ; D IANA R OHRER AND D AWN C UBBERNESS , C O

A DMINISTRATORS OF THE E STATE OF D ANIEL R OHRER ; D ANNY S WART ZELL ; N ATHAN T ACY ; AND S TEVE M INSEL , P ERS ONAL R EP RESENTATIVE OF THE E STATE OF J OAN W ILSON Will iam N. Riley Riley Cate , LLC Fishers , Indiana A TTORNEY FOR P LAINTIFFS J ANET AND F RED S CHROCK , M ARY J O T OLBERT , AND T ERRI R ETHLAKECourt of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 4 of 20

Jeffrey J. Stesiak Pfeifer Morgan & Stesiak South Bend , Indiana A TTORNEY FOR P LAINTIFFS J UDITH AND G EORGE B ROWN Robert T. Dassow Hovde Dassow & Deets , LLC Indianapolis , Indiana A TTORNEY FOR A PPELLANT J OAN R OTHBALLER Vincent Campiti Nemeth Feeney Masters & Campiti South Bend , Indiana



### I N T H E 

# COURT OF APPEALS OF INDIANA

Joe Alcozar , et al

. , Appellant s - Plaintiffs ,

v. 

### Orthopedic & Sports Medicine Center of Northern Indiana, et al ., Appellees-Defendants. September 28, 2023 Court of Appeals Ca se No. 22A

- CT

- 909 Interlocutory Appe al from the St. Joseph and Elkhart Superior Court s The Hon orable Jamie C. Woods , Judge The Hon orable Kristine Osterday , Judge Trial Co urt Cause No s

. 71D06

- 1406

- CT

- 181 71D06

- 1407

- CT

- 257 71D06

- 1409

- CT

- 320 71D06

- 1405

- CT

- 136 20D01

- 1404

- CT

- 72Court of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 5 of 20 Opinion by Judge Bradford Judges May and Mathias concur.
Bradford, Judge. 

# Case Summary 1
[1] Beginning in 2012, several patients in St. Joseph and Elkhart Counties (“Plaintiffs”) were injured , and , in some cases, died, after being given injections of preservative

- free methylprednisolone acetate (“MPA”), a steroid purchased from New England Compounding Pharmacy, Inc., a/k/a , the New England Compounding Center (“NECC”)

. Plaintiffs brought suit in St. Joseph and
Elkhart C ounties against ASC Surgical Ventures, LLC ; Orthopedic and Sports Medicine Center of Northern Indiana; and OSMC (collectively, “ASC”) and Anonymous Clinic . In 2016, we ruled that Plaintiffs ’ claims against Anonymous Clinic and ASC (co llectively, “Defendants”) were subject to the provisions of the Indiana Medical Malpractice Act (“the MMA”).

[2] In 2018, Plaintiffs moved for preliminary determination/partial summary judgment on their prescription

- law claims before the St. Joseph and Elkha rt trial courts. Both trial courts denied Plaintiffs ’ partial

- summary - judgment motions, concluding the cases first had to be presented to medical

- review panels (“MRPs”). Further discovery, selection of MRP chairpersons and their
members and submissions t o MRPs were undertaken. The handling of those

1 We held oral argument in this case on September 7, 2023, in the Court of Appeals of Indiana courtroom in Indianapolis. We commend counsel for the high quality of their written submissions and oral advocacy.Court of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 6 of 20

MRPs led to the filing of a motion for preliminary determination by ASC with the Elkhart trial court and a joint motion for preliminary determination with the St. Joseph trial court.

[3] The St. Joseph trial cou rt concluded that Plaintiffs ’ claims of prescription

- drug

law violations by Anonymous Clinic should be presented to the MRPs in each case and rejected its preemption argument. The St. Joseph trial court concluded that the decision in Sherrow v. GYN, Ltd. , 745 N.E.2d 880 (Ind. Ct. App. 2001) , did not preclude the parties from discussing the prescription

- drug laws in their MRP submissions.

[4] The Elkhart trial court denied Plaintiffs ’ m otion for p artial s ummary j udgment , concluding that Plaintiffs were asserting fraud on the federal Food and Drug Administration (“the FDA”) , a claim that was preempted by the federal Food, Drug, and Cosmetic Act (“the FDCA ”) . The Elkhart trial court further held
that Plaintiffs ’ negligence per se claims ba sed upon ASC ’ s violations of Indiana ’ s Food, Drug, and Cosmetic Act (“the IFDCA”) were preempted. The Elkhart trial court entered summary judgment in favor of Defendants on Plaintiffs’ claimed prescription

- drug law violations. T he Elkhart trial court con cluded
that Sherrow precluded the parties from discussing the prescription

- drug laws in
their MRP submissions and that the MRP chairpersons should not instruct the MRPs regarding Plaintiffs ’ prescription

- drug

- law claims.

[5] Plaintiffs argue that (1) Defenda nts violated various Indiana and federal laws pertaining to prescription drugs, (2) those violations establish negligence per se , (3) medical testimony is not necessary to establish the violation of a statute, (4)Court of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 7 of 20

their claims of medical negligence are not preempted by the FDCA, (5) discussion of statutes in a submission to a MRP is not prohibited when a plaintiff asserts a statutory violation, and (6) the trial courts erred in denying Plaintiffs’ motions for partial summary judgment. Because we reject Pla intiffs’
firs t, fifth, and sixth arguments, we need not address the others and affirm in part, reverse in part, and remand with instructions. 

# Facts and Procedural History

[6] We summarized t he facts underlying this case in a previous appeal:

Beginning in 2012 , patients around the country began suffering meningitis after being injected with [ MPA ] , a steroid purchased from [ NECC ]

. It was soon discovered that some lots of MPA had become contaminated with fungus. This consolidated appeal
concern s claims brought by injured patients (or those suing on their behalf) (collectively , “the Plaintiffs”) against Anonymous Clinic in St. Joseph County and [ASC]

. Plaintiffs contend that the Defendants were negligent in choosing to administer preservative

fr ee MPA and in failing to properly evaluate NECC before using it as a supplier. Some of the Plaintiffs brought suit without using the procedures laid out in the [ the MMA ] , and Defendants moved either for dismissal or summary judgment on the basis that Plai ntiffs ’ claims were claims of medical malpractice. Stephen W. Robertson , acting in his capacity as Commissioner of Indiana Department of Insurance , which administers the Indiana Patient ’ s Compensation Fund (“the PCF”) intervened , arguing that Plaintiffs ’ c laims were of general negligence and therefore not subject to the provisions of the MMA. The trial courts ultimately agreed with Defendants and Plaintiffs (who had reversed their initial position) that Plaintiffs ’ claims were governed by the MMA. In this consolidated appeal , the PCF contends that the trial courts erred in concluding that Plaintiffs ’ claims are claims of medical malpractice. Plaintiffs , Defendants , and Amici Curiae (health

- careCourt of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 8 of 20

providers facing similar claims in other cases) , contend that Plaintiffs ’ claims are subject to the MMA as they involve actions informed by the exercise of professional medical judgment. Because we conclude that Plaintiffs ’ claims are subject to the MMA , we affirm the judgments of the trial courts and remand for further proceedings consistent with this opinion. Robertson v. Anonymous Clinic , 63 N.E.3d 349 , 352 (Ind. Ct. App. 2016) , trans. denied

.
[7] Following our decision in Robertson , Plaintiffs moved for preliminary determination/partial summary judgme nt on their prescription

- law claims before the St. Joseph trial court on November 21 , 2018 , and the Elkhart trial

court on June 28 , 2018. On July 23 , 2019 , both trial court s denied Plaintiffs ’ partial

- summary -

judgment motions , concluding the cases first had to be presented to MRPs

.
[8] F urther discovery , selection of MRP chairpersons and their members , and submissions to MRPs were undertaken. The handling of those MRPs led to the filing of a motion for preliminary determination by ASC with the Elkhart trial

court on February 1 , 2021 , and a joint motion for preliminary determination with the St. Joseph trial court on March 26 , 2021.

[9] The St. Joseph trial court held a hearing on January 13 , 2022 , and thereafter entered an order on February 17 , 2022. A summary of that order is as follows:

1. The St. Joseph trial court concluded that Plaintiffs ’ claims of prescription

- drug

- law violations by Defendants should be presented to the MRPs in each case and rejected Defendants’ preemption argument.Court of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 9 of 20

2. The St. Joseph trial court concluded that the decision in Sherrow , 745 N.E.2d at 880 , did not preclude the parties from discussing the prescription

- drug laws in their MRP submissions. 3. The St. Joseph trial court concluded that it was for the MRP to determine whether a violation of the prescription

- drug laws by a healthcare provider constituted a violation of the standard of care , i.e. , negligence. Appellant s’ App. Vol. XIV pp. 58

– 68.

[10] The Elkhart trial court held a hearing on June 2 , 2021 , on the m otion for
p reliminary d etermination filed by ASC and on Plaintiffs ’ m otion to r econsider the denial of Plaintiffs ’ motion for partial summary judgment

. On June 18 , 2021 , t he Elkhart trial court granted Plaintiffs ’ motion to reconsider

. The
Elkhart trial court entered its order on February 22 , 2022. A summary of that order is as follows:

1. The Elkhart trial court denied Plaintiffs ’ m otion for p artial
s ummary j udgment concluding Plaintiffs were asserting fraud on the FDA claims and such claims were preempted by the FDCA. The Elkhart trial court further held that Plaintiffs ’ negligence per se claims based upon ASC ’ s violations of Indiana prescription sta tutes were preempted. 2. On ASC ’ s m otion for p reliminary d etermination , the Elkhart trial court concluded that the decision in Sherrow precluded the parties from discussing the prescription

- drug laws in their MRP submissions. The Elkhart trial court f urther concluded that the MRP chairpersons should not instruct the MRP s regarding Plaintiffs ’ prescription

- drug

law claims as the Elkhart trial court was entering summary judgment against Plaintiffs on those claim s. Appellants’ App. Vol. XIII pp. 31

– 46.Court of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 10 of 20

[11] Motions to certify the St. Joseph and Elkhart trial court s ’ orders for interlocutory appeal were granted on March 28 , 202 2

. On May 13 , 2022 , we accepted jurisdiction. 

# Discussion and Decision

[12] Plaintiffs argue that (1) Defendants violated various Indiana and f ederal laws pertaining to prescription drugs , (2) those violations establish negligence per se , (3) medical testimony is not necessary to establish the violation of a statute , (4) their claims of medical negligence are not preempted by the FDCA , (5) discussion of statutes in a submission to a MRP are not prohibited when a plaintiff asserts a statut ory violation , and (6) the trial court s erred in denying Plaintiffs ’ motions for partial summary judgment.

[13] Defendant Anonymous Clinic argues that (1) the FDCA and Indiana ’ s prescription

- drug laws do not apply to Plaintiffs ’ claims, (2) Plaintiffs ’ claims are preempted by the FDCA , (3) Plaintiffs are improperly attempting to circumvent the MMA, and (4) Plaintiffs ’ motions for partial summary judgment

are not properly before us in this appeal.

[14] Defendant ASC argues that (1) Plaintiffs’ allegations amount to a claim of fraud on the FDA, (2) Plainti ffs cannot prevail on their claims of negligence per se because they cannot establish that any alleged violations of federal or state prescription

- drug laws caused their injuries or, indeed, that Defendants even violated any federal or state prescription

- d rug laws, and (3) the Elkhart trialCourt of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 11 of 20

court correctly determined that Plaintiffs are prohibited from making legal arguments before the MRPs.

[15] The Commissioner of the Indiana Department of Insurance argues that (1) we reserved determination of whether Defend ants ’ conduct fell below the standard of care for MRPs, (2) the trial courts lacked jurisdiction to rule on issues of negligence per se , (3) the Elkhart trial court correctly ruled that Plaintiff s ’ claims are preempted , and (4) the medical

- review process i s not intended to be a mini

trial that involves legal arguments.

[16] Plaintiffs contend that Defendants violated various federal and Indiana laws related to prescription drugs , which, they allege, establishes negligence per se
. T he establishment of negligence per se , the argument continues, eliminates the
need for MRP review, resulting in going straight to trial on the question of damages only.


### A. Causation
[17] As an initial matter, ASC argues that Plaintiffs have failed to establi sh that any of the Plaintiffs’ alleged violations of federal or state law, even if they occurred , caused Plaintiffs’ injuries. ASC correctly points out that the statutory violations must still be shown to have been the proximate cause of the injury. Lind sey v. DeGroot , 898 N.E.2d 1251, 1260 (Ind. Ct. App. 2009)

. The violation of statutory duty is not actionable negligence unless it is also the proximate cause of the injury. The violation of a statute raises no liability for injury to another unless the i njury was in some manner the result of such violation. In order to find that an injury was the proximate result of a statutory violation, the injury must have been a foreseeable consequence of the violationCourt of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 12 of 20

and would not have occurred if the requirements of the statute had been observed. Id . at 1261 (cleaned up).

[18] Put another way, the “violation of a statute raises no liability for injury to another unless the injury was in some manner the result of such violation.” Conway v. Evans , 549 N.E.2d 1092, 1095 (Ind. Ct. App. 1990) . “In order to find that an injury was t he proximate result of a statutory violation, the injury must have been a foreseeable consequence of the violation and would not have occurred if the requirements of the statute had been observed.” Inland Steel v. Pequignot , 608 N.E.2d at 1378, 1383 (Ind. Ct. App. 1993) , trans. denied ; see also McBride v. Cole Assocs., Inc. , 753 N.E.2d 730, 738 (Ind. Ct. App. 2001) (concluding that there was no liability under a theory of negligence per se for failing to have a posted speed limit of forty

- five miles per ho ur when there was no evidence the vehicles involved in the accident were traveling in excess of that speed).

[19] Plaintiffs allege the following violations of law:

• ASC ordered five vials of MPA at a time from NECC;

• ASC did not provide individual prescri ptions;

• the prescriptions did not include the patients’ addresses or dates of birth;

• prescriptions were not signed by the physician;

• vials of MPA did not contain NECC’s address or phone number;

• the vials did not have a serial number but, instea d, a lot number;Court of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 13 of 20

• the prescribing doctor’s name was not on the vial;

• there were no instructions for use of the medication;

• there was no refill information; and

• there was no information concerning possible substitute medications.
[20] ASC argues th at fulfilling each of these alleged requirements would not have changed anything, as none of them would have had any effect on NECC’s failure to use sterile ingredients in compounding the MPA or maintain sterility in its compounding facility. We agree. N one of these provisions, whatever their purpose or utility, have any connection whatsoever with the undisputed cause of the injuries in this case

— contaminated MPA. Had Defendants done
any

— or all

— of the things that Plaintiffs argue they were required to do , it would have changed nothing, as none of the alleged requirements have anything to do with the compounding of the MPA or its handling. Put another way, the allegedly illegal lack of information on labeled vials of MPA did not injure Plaintiffs, the con taminated drug within did. While we conclude that Plaintiffs cannot establish any causal connection between Defendants’ alleged statutory violations and Plaintiffs’ injuries, we nonetheless elect to address their specific allegations.


### B
. Federal Law
[21] The FDCA p rohibits “[t]he introduction or delivery for introduction into interstate commerce of any [...] drug [...] that is adulterated or misbranded.” 21 U.S.C. § 331(a)

. A drug is misbranded if its “labeling is false or misleading in any particular.” 21 U.S.C. § 352(a)

. Plaintiffs argue that Defendants orderedCourt of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 14 of 20

and administered misbranded MPA to their patients in two respects : (1) t he
MPA administered by Defendants to Plaintiffs bore false labeling in that each vial indicated it was to be used by an iden tified person when , in fact , it was known by Defendants that it would be injected into a different patient and (2) Plaintiffs argue that t he MPA administered by Defendants was misbranded because 21 U.S.C. § 352(f) specifies that a drug is misbranded “ [u] nless its labeling bears (1) adequate directions for use” and t he labeling on the vials containing MPA administer ed by Defendants to Plaintiffs contained no such directions

. Plaintiffs also argue that Defendants improperly provided MPA that had not gone through the FDA ’ s new - drug

- approval process and , finally, that the prescription exemptions for misbranding and new

- drug approval were not met in this case.

[22] We conclude , as a matter of law, that Plaintiffs have failed to establish any violat ions of FDCA labeling provisions

. Put simply , 21 U.S.C. § 352(f) ’ s labeling requirements do not apply to the actions of Defendants in this case , i.e. , order ing MPA from NECC and then administering it to patients in a clinical setting

. As for the alleged requirement that Defendants were required to order MPA from NECC by issu ing a prescription that identified, inter alia , the name of the patient to whom it was to be administered, Plaintiffs are asking us to apply a requirement from a completely different scenario to one in which it makes no sense. It is, of course, true that had NECC been administering the MPA to Plaintiffs instead of Defendants, Defendants would have had to issue prescription s to NECC with a specific patient’s name, but that never occurred.Court of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 15 of 20

Plaintiffs point to no FDCA requirement that such information be included in

a n order for medicine to be delivered to the doctor who ordered it.

[23] Moreover, as ASC points out , because 21 U.S.C. § 353(b)(2) allows a drug to be
admi nistered by an oral prescription , it follows that doctors are, in fact, not required to provide patients with any of the labeling information specified in 21
U.S.C. § 352(f)

. This is not surprising, because, for one example, it would be nonsensical to require directions for patient use for a drug that is injected into the patient by a doctor in a clinical setting , such as MPA

. Our conclusion is consistent with t he court ’s decision in United States v. Evers , 643 F.2d 1043 ( 5t h Cir. 1981) , which correctly recognized that a prescription drug delivered by a physician is required to adhere to the provisions of 21 U.S.C. § 353(f) only if delivered to another physician. Id

. at 1053 . Put another way, i f a doctor
administers a prescription drug directly to a patient, the 21 U.S.C. § 352(f) use and warning labels are not required. Id

.
[24] Plaintiffs’ contention that Defendants illegally dispensed a new drug is also without merit. Pursuant to 21 U.S.C. § 355(a) , “[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective wit h respect to such drug.” A drug prepared by a compounding pharmacy is considered a “new drug” unless the exemptions under the FDCA for a compounded prescription drug are met. See 21 U.S.C. § 353(b)

. Plaintiffs
contend that neither the prescription nor c ompounded

- drug exemptions operate
to remove the requirement that MPA be treated as a new drug

.Court of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 16 of 20

[25] Plaintiffs first argue that the prescription exemption does not help Defendants

. Pursuant to 21 U.S.C. § 353(b) , (1) A drug intended for use by man which

-- (A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such d rug [...] shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale. (2) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer s uch drug shall be exempt from the requirements of section 352 of this title, except paragraphs (a), (i)(2) and (3), (k), and (l), and the packaging requirements of paragraphs (g), (h), and (p), if the drug bears a label containing the name and address of t he dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescri ption. The provisions above, as with the labeling requirements addressed in the previous section, have no relevance to what occurred in this case : no MPA was

“ dispensed ” by anyon e

— it was administered by Defendants

. Consequently,Court of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 17 of 20

the requirements for di spensing drugs to a patient did not have to be met in this

case.

[26] As for the compounded

- drug exemption, Plaintiffs cite 21 U.S.C. § 353(a) for the proposition that label ing (and other) requirements apply under the circumstances of this case

. This provision , however, only applies if “the drug product is compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient[.]” Id

. Here, the MPA was not compounded for identified patients based on the receipt of a prescription, it was ordered in bulk. Any suggestion that the FDCA required Defendants to provide additional info rmation to NECC in connection with its MPA orders or to the patients to whom it was administered is entirely unsupported by any FDCA provision

. 

### C
. State Law
[27] Plaintiffs argue that Defendants also violated the IFDCA by obtaining MPA from NECC without issui ng prescriptions for each individual patient to NECC. Plaintiffs cite authority for the proposition that a compounding pharmacist “may provide compounded drugs to patients only upon receipt of a valid prescription from a doctor or other medical practitioner licensed to prescribe medication.” Thompson v. W. States Med. Ctr. , 535 U.S. 357, 360

– 61 (2002) (emphasis added)

. It is undisputed , however, that NECC never distribute d any
MPA to any patients, only to medical providers like Defendants

.Court of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 18 of 20

[28] Anonymous Clinic argues that the only obligation it had under state law was to issue a prescription before administering MPA to a patient, not before ordering it from NECC. We agree. F or the purpose of a physician treating a patient , Indiana defines “prescription” as follows: “‘Prescribe or prescription’ means to direct, order, or designate the use of or manner of using a drug, medicine, or treatment, by spoken or written words or ot her means and in accordance with
IC 25

- 1

- 9.3 [which relates only to controlled substances

. ]” Ind. Code § 25

- 22.5

- 1

- 1.1(f)

. In other words, Indiana physicians are permitted to orally prescribe medication before administering it to a patient. This statute is consistent with the statutory authority for the Indiana Pharmacy Board, which acknowledges that a “prescription” may be transmitted in writing or by another form. See Ind. Code § 25

- 26

- 13

- 2

. Anonymous Physician ’ s injection of MPA during patient procedures meets th is statutory definition of prescription for a physician, fulfilling Anonymous Clinic ’ s statutory obligation s

. W hile it is true that Defendants would have had to issue a prescription to NECC in order for NECC to deliver or admini ster MPA to a patient, that has nothing to do with this case because all agree that NECC never delivered or administered MPA to any Plaintiff, Defendants did.

[29] ASC also argues that, a lthough the Indiana Legend Drug Act, Ind. Code ch.
16

- 42

- 19, provides la beling requirements for prescription drugs, these requirements do not apply to drugs sold to practitioners. See Ind. Code § § 16

- 42

- 19

- 11 (setting forth labeling requirements including patient name and instructions for use) and 16

- 42

- 19

- 21 (exempting drugs sold to practitionersCourt of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 19 of 20

from the Ind. Code § 16

- 42

- 19

- 11 labeling requirements). Moreover , “practitioner” is defined to include physicians and other medical professionals with prescription licensure , so the Drug Legend Act’s labeling req uirements do not apply to Defendants

. Ind. Code § 16

- 42

- 19

- 5

. 2 Plaintiffs have failed to allege, much less establish, that Defendants violated any federal or state prescription laws. 

# Conclusion

[30] Because Plaintiffs cannot establish that Defendants ’ alle ged statutory violations caused their injuries or, indeed, that Defendants have violated any federal or state prescription

- drugs law whatsoever, any questions regarding negligence per

se and preemption are moot. Even if we were to assume that an MMA plaintiff
could discuss allegations of statutory violations in the MRP under certain
circumstances (a question we leave for another day), Plaintiffs certainly cannot continue to press those claims in this case. We affirm the judgment of the
Elkhart trial court in its entir ety. We reverse the judgment of the St. Jos ep h trial court and remand with instruction s to enter summary judgment in favor of Defendants on Plaintiffs’ federal and state prescription

- law claims. This opinion has no effect on Plaintiffs’ ability to proceed with their MMA claims as

2 It is apparent that the provisions Plaintiffs would like us to apply to Defendants

— who administered a drug to patients in a clinical se tting

— are meant to regulate another transaction entirely , in which a doctor evaluates a patient, de cides the patient needs a certain drug , and issues a prescription to a pharmacy , which then dispenses the drug to the patient.Court of Appeals of Indiana | Opinion 22A

- CT

- 909 | September 28, 2023 Page 20 of 20

they see fit ; they may not , however, continue to pursue their allegations of statutory violations or mention them in the MRPs

.
[31] We affirm t he judgm ent of the Elkhart trial court . We reverse the judgment of the St. Joseph trial court and remand with instructions.

May, J., and Mathias, J., concur.