Joe Alcozar v. Orthopedic and Sports Medicine Center of Northern Indiana ( 2023 )

FILED
Sep 28 2023, 8:45 am
CLERK
Indiana Supreme Court
Court of Appeals
and Tax Court
ATTORNEY FOR PLAINTIFFS JOE ATTORNEYS FOR APPELLEE
AND LINDA ALCOZAR; ARDEMUS ANONYMOUS CLINIC
ALLEN; GEORGE AND ARLENE David J. Beach
BOSTIC; TRACEY AND RON BRIGGS; Louis W. Voelker
ROBERT AND ELIZABETH COBB; Eichhorn & Eichhorn, LLP
LEISA AND DAVID COPP; CINDY M. Hammond, Indiana
WILSON, PERSONAL
ATTORNEY FOR APPELLEE
REPRESENTATIVE OF ESTATE OF
COMMISSIONER OF THE INDIANA
VIOLA COPSEY; ELLEN CRAIGO,
DEPARTMENT OF INSURANCE
PERSONAL REPRESENTATIVE OF
ESTATE OF ALAN CRAIGO; Anne L. Cowgur
CHRISTOPHER DURBEN, PERSONAL Taft Stettinius & Hollister LLP
REPRESENTATIVE OF ESTATE OF Indianapolis, Indiana
JACK N. DURBEN; DAWN ELLIOTT; ATTORNEYS FOR APPELLEES ASC
PATRICIA FORTIER; BRENDA AND SURGICAL VENTURES, LLC;
DAVID GARL; DONNA AND RICKIE ORTHOPEDIC AND SPORTS
HAAS; SUSAN R. AND MICHAEL E. MEDICINE CENTER OF NORTHERN
HANCOCK; NANCY AND DON INDIANA; AND OSMC
HINKLE; DONNA M. AND LONNIE L. Lyle R. Hardman
HOSEA; KENNETH HURST; Hunt Suedhoff Kearney, LLP
KENNYATTA JACKSON; ELIZABETH South Bend, Indiana
JONES; TERRY AND CYNTHIA
Margaret M. Christensen
KASER; CINDYLU KONANZ;
Dentons Bingham Greenebaum
YVONNE KUBISZEWSKI; MARY LLP
LAMBERT; CHARLOTTE AND TOM Indianapolis, Indiana
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
Court of Appeals of Indiana | Opinion 22A-CT-909 | September 28, 2023 Page 1 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 2 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, CO-
ADMINISTRATORS 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 3 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
IN THE
COURT OF APPEALS OF INDIANA
Joe Alcozar, et al., September 28, 2023
Appellants-Plaintiffs, Court of Appeals Case No.
22A-CT-909
v. Interlocutory Appeal from the St.
Joseph and Elkhart Superior
Courts
Orthopedic & Sports Medicine
Center of Northern Indiana, et The Honorable Jamie C. Woods,
Judge
al.,
The Honorable Kristine Osterday,
Appellees-Defendants. 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 4 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 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 5 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-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’ 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 6 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 preservative-
free 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 7 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 8 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-drug-
law 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 9 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 10 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 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.
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 11 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 12 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 13 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 14 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 15 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 16 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 17 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 18 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 19 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.
Court of Appeals of Indiana | Opinion 22A-CT-909 | September 28, 2023 Page 20 of 20