Court Opinion

ID: 9897274
Source: CourtListenerOpinion
Date Created: 2023-11-14 19:09:32.916797+00
Date Added: 2024-06-11T09:16:35.776348
License: Public Domain

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