Court of Appeals of Indiana | Opinion 22A-CT-909 | September 28, 2023 Page 1 of 20

ATTORNEY FOR PLAINTIFFS JOE 

AND LINDA ALCOZAR; ARDEMUS 

ALLEN; GEORGE AND ARLENE 

BOSTIC; TRACEY AND RON BRIGGS;

ROBERT AND ELIZABETH COBB;

LEISA AND DAVID COPP; CINDY M.

WILSON, PERSONAL 

REPRESENTATIVE OF ESTATE OF 

VIOLA COPSEY; ELLEN CRAIGO,

PERSONAL REPRESENTATIVE OF 

ESTATE OF ALAN CRAIGO;

CHRISTOPHER DURBEN, PERSONAL 

REPRESENTATIVE OF ESTATE OF 

JACK N. DURBEN; DAWN ELLIOTT;

PATRICIA FORTIER; BRENDA AND 

DAVID GARL; DONNA AND RICKIE 

HAAS; SUSAN R. AND MICHAEL E.

HANCOCK; NANCY AND DON 

HINKLE; DONNA M. AND LONNIE L.

HOSEA; KENNETH HURST;

KENNYATTA JACKSON; ELIZABETH 

JONES; TERRY AND CYNTHIA 

KASER; CINDYLU KONANZ;

YVONNE KUBISZEWSKI; MARY 

LAMBERT; CHARLOTTE AND TOM 

LAY; KATHY AND DANIEL 

LENHART; JOHN AND TAMARA 

PAVLEKOVICH; SANDRA POLK;

RESHONDA PRINGLE; JOAN 

REINHARDT, PERSONAL 

REPRESENTATIVE OF THE ESTATE OF 

DONALD REINHARDT; VERONICA 

MERWIN-ROSS, PERSONAL 

REPRESENTATIVE OF THE ESTATE OF 

GAIL ROSS; JOANN AND RICHARD 

ATTORNEYS FOR APPELLEE 

ANONYMOUS CLINIC 

David J. Beach 

Louis W. Voelker 

Eichhorn & Eichhorn, LLP

Hammond, Indiana 

ATTORNEY FOR APPELLEE 

COMMISSIONER OF THE INDIANA 

DEPARTMENT OF INSURANCE

Anne L. Cowgur 

Taft Stettinius & Hollister LLP 

Indianapolis, Indiana 

ATTORNEYS FOR APPELLEES ASC

SURGICAL VENTURES, LLC;

ORTHOPEDIC AND SPORTS 

MEDICINE CENTER OF NORTHERN 

INDIANA; AND OSMC 

Lyle R. Hardman 

Hunt Suedhoff Kearney, LLP 

South Bend, Indiana 

Margaret M. Christensen 

Dentons Bingham Greenebaum 

LLP

Indianapolis, Indiana 
Court of Appeals of Indiana | Opinion 22A-CT-909 | September 28, 2023 Page 2 of 20

SCHROCK; RACHELLE AND GREG 

SHUFF; DAVID, JR. AND WINNIE 

SIMS; PAULETTE AND DOUGLAS 

SINN; JERRY G. SMITH, III; RICHARD 

TALLMAN; CYNTHIA J. TUFF,

PERSONAL REPRESENTATIVE OF THE 

ESTATE OF JACK B. TUFF; KAREN 

WYRES; JOHN DILLION, PERSONAL 

REPRESENTATIVE OF THE ESTATE OF 

KATHY DILLON; SUSAN AND JACK 

FRICK; KAREN ROMANO; JOY AND 

JACK SMITH; JOHN AND JUDY SOLI;

BARBARA AND ALBERT TIROTTA;

TERRY TROST; RONDA AND DAVY 

TROXEL; MICHAEL AND BARBARA 

VITOU; MICHAEL AND DEBBIE 

WALTER; AUGUSTA AND DUANE 

WEGNER; GREG AND GAIL 

WILFING; WILBUR, JR. AND RACHEL 

WOLFE; JENNIFER YOE; LARRY 

BROWNING; JAMES GREENWOOD;

KARISSA KLEMM; STEVE KOZIATEK;

SAMUEL LOCK; JIM MCQUEEN;

CARRIE MOHR; DONALD OWEN;

STACEY HOFFLANDER; THOMAS 

REED; KIMBERLY RICE; BRENDA 

ROARK; MICHELE ROBINSON;

DEBORAH BARNES; WAYNE 

OBLINGER, DENNIS CRESSY, AND 

THOMAS HURTEKANT, AS PERS.

REPS. OF THE ESTATE OF KRISTI 

OBLINGER; STACI VANSCHOIACK;

YOLANDA IVORY; CHARLES FORD,

AS ADMINISTRATOR IN THE ESTATE 

OF SHARON SHAFER; PEARL STOKES;

DONNA AND LONNIE HOSEA;

LAURA AND JAMES WYZA

Douglas D. Small

Foley & Small, LLP

South Bend, Indiana
Court of Appeals of Indiana | Opinion 22A-CT-909 | September 28, 2023 Page 3 of 20

ATTORNEY FOR PLAINTIFFS COURTNEY M.

GERRING AND AMY GERRING BIVIANO,

CO-PERSONAL REPRESENTATIVES OF THE 

ESTATE OF SHIRLEY BARNES; LINDA 

BLACK; DONALD FLOREA, PERSONAL 

REPRESENTATIVE OF THE ESTATE OF 

PAULINE BUREMA; BRUCE COX AND 

EUGENE TOPOLSKI, CO-PERSONAL 

REPRESENTATIVES OF THE ESTATES OF 

MARJORY COX AND E. WAYNE COX;

RUDOLPH AND MONICA CHERNIAK;

CHRISTY RAMSEY, PERSONAL 

REPRESENTATIVE OF THE ESTATE OF 

ISABELLE FLOOR; SCOTT AND JAN 

HUXFORD; NANCY ISLAS (MORRIS) AND 

JORGE ISLAS; DORIS AND ROBERT JEWEL;

ROY AND DORIS KEIM; JACQUIE FARR AND 

LYNNE WILLIAMS, CO-PERSONAL

REPRESENTATIVES OF THE ESTATES OF 

SETH KNIFFIN AND BILLIE KNIFFIN,

DECEASED; THOMAS LEGG, JR. AND LORI 

LEGG-WILLIAMS; FLORENCE AND 

PATRICK MAKOUSKY; DOUGLAS A.

MULVANEY, PERSONAL REPRESENTATIVE 

OF THE ESTATE OF CAROLYN MALONEY;

JOSHUA REAMS; SANDRA RHODES; DIANA 

ROHRER AND DAWN CUBBERNESS, COADMINISTRATORS OF THE ESTATE OF 

DANIEL ROHRER; DANNY SWARTZELL;

NATHAN TACY; AND STEVE MINSEL,

PERSONAL REPRESENTATIVE OF THE 

ESTATE OF JOAN WILSON

William N. Riley

Riley Cate, LLC

Fishers, Indiana

ATTORNEY FOR PLAINTIFFS JANET AND 

FRED SCHROCK, MARY JO TOLBERT, AND 

TERRI RETHLAKE
Court of Appeals of Indiana | Opinion 22A-CT-909 | September 28, 2023 Page 4 of 20

Jeffrey J. Stesiak

Pfeifer Morgan & Stesiak

South Bend, Indiana

ATTORNEY FOR PLAINTIFFS JUDITH AND 

GEORGE BROWN

Robert T. Dassow

Hovde Dassow & Deets, LLC

Indianapolis, Indiana 

ATTORNEY FOR APPELLANT JOAN 

ROTHBALLER

Vincent Campiti

Nemeth Feeney Masters & Campiti

South Bend, Indiana

I N T H E

COURT OF APPEALS OF INDIANA

Joe Alcozar, et al.,

Appellants-Plaintiffs,

v.

Orthopedic & Sports Medicine

Center of Northern Indiana, et 

al., 

Appellees-Defendants.

September 28, 2023

Court of Appeals Case No.

22A-CT-909

Interlocutory Appeal from the St. 

Joseph and Elkhart Superior

Courts

The Honorable Jamie C. Woods,

Judge

The Honorable Kristine Osterday,

Judge

Trial Court Cause Nos.

71D06-1406-CT-181

71D06-1407-CT-257

71D06-1409-CT-320

71D06-1405-CT-136

20D01-1404-CT-72
Court 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 Summary1

[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 Counties 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 (collectively, “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 Elkhart 

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 to 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 court concluded that Plaintiffs’ claims of prescription-druglaw 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’ motion for partial summary judgment,

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 based 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. The Elkhart trial court concluded 

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) Defendants 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 Plaintiffs’ 

first, 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 the 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 

concerns 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 preservativefree 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 

Plaintiffs’ 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’ claims 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-care 
Court 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 judgment 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 courts denied Plaintiffs’

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

presented to MRPs. 

[8] Further 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.

Appellants’ App. Vol. XIV pp. 58–68. 

[10] The Elkhart trial court held a hearing on June 2, 2021, on the motion for 

preliminary determination filed by ASC and on Plaintiffs’ motion to reconsider 

the denial of Plaintiffs’ motion for partial summary judgment. On June 18,

2021, the 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’ motion for partial 

summary judgment 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 statutes were preempted. 

2. On ASC’s motion for preliminary determination, 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

further concluded that the MRP chairpersons should not 

instruct the MRPs regarding Plaintiffs’ prescription-druglaw claims as the Elkhart trial court was entering summary 

judgment against Plaintiffs on those claims. 

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 courts’ orders for 

interlocutory appeal were granted on March 28, 2022. On May 13, 2022, we 

accepted jurisdiction. 

Discussion and Decision

[12] Plaintiffs argue that (1) Defendants 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) 

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 statutory violation, and (6) the trial courts 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) Plaintiffs 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-drug laws, and (3) the Elkhart trial 
Court 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 Defendants’ 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 Plaintiffs’ claims 

are preempted, and (4) the medical-review process is not intended to be a minitrial 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. 

The 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 establish 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. Lindsey 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 injury 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 violation 
Court 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 the 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 hour 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 prescriptions; 

• 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, instead, 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 that 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. None 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 contaminated 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 prohibits “[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 ordered 
Court 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) the 

MPA administered by Defendants to Plaintiffs bore false labeling in that each 

vial indicated it was to be used by an identified person when, in fact, it was 

known by Defendants that it would be injected into a different patient and (2)

Plaintiffs argue that the 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 the labeling on the vials 

containing MPA administered 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 

violations 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., 

ordering 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 issuing 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 

prescriptions 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 

an 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 

administered 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 the court’s decision in United States v. Evers, 643 F.2d 1043 (5th 

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, if 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 with 

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 compounded-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 

drug[...] 

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 such 

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 the 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 prescription. 

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 anyone—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 dispensing 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 labeling (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 

information 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 issuing 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 distributed 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. For 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 other 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 this statutory definition of prescription for a physician, 

fulfilling Anonymous Clinic’s statutory obligations. While it is true that 

Defendants would have had to issue a prescription to NECC in order for NECC

to deliver or administer 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, although the Indiana Legend Drug Act, Ind. Code ch.

16-42-19, provides labeling 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 practitioners 
Court 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 requirements 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’ alleged 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 entirety. We reverse the judgment of the St. Joseph 

trial court and remand with instructions 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 setting—are meant to regulate another transaction entirely, in which a doctor

evaluates a patient, decides 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 the judgment 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.