J-A01023-18

                                  2018 PA Super 158



    JOSEPH A. CALTAGIRONE, AS                          IN THE SUPERIOR COURT
    ADMINISTRATOR AD PROSEQUENDUM                                OF
    FOR THE ESTATE OF JOSEPH F.                             PENNSYLVANIA
    CALTAGIRONE, DECEASED AND JOSEPH
    A. CALTAGIRONE, INDIVIDUALLY,

                             Appellant

                        v.

    CEPHALON, INC. AND TEVA
    PHARMACEUTICALS USA, INC.,

                             Appellees                   No. 1303 EDA 2017


                  Appeal from the Order Entered March 23, 2017
              in the Court of Common Pleas of Philadelphia County
             Civil Division at No.: September Term, 2016 No. 02877


BEFORE: LAZARUS, J., OTT, J., and PLATT, J.*

OPINION BY PLATT, J.:                                         FILED JUNE 08, 2018

        Appellant,   Joseph     A.   Caltagirone,   appeals    individually   and   as

administrator of the estate of his deceased son, Joseph F. Caltagirone, from

the order sustaining preliminary objections of Appellees, Cephalon, Inc. and

Teva Pharmaceuticals, USA, Inc., to his second amended complaint, and

dismissing it with prejudice.1         We conclude that the trial court properly

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*   Retired Senior Judge assigned to the Superior Court.

1On October 14, 2011, Cephalon was acquired by Teva Pharmaceuticals, USA,
Inc. Once Teva completed its acquisition of Cephalon, Cephalon became a
wholly owned subsidiary of Teva and ceased to be publicly traded.
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determined that Appellant’s wrongful death and survival claims, premised on

asserted violations of the Federal Food, Drug, and Cosmetic Act (FDCA),2 (and

implementing regulations), are pre-empted by the federal system of

regulation    and    enforcement      by       the   United   States   Food   and   Drug

Administration (FDA). Accordingly, we affirm.

        We derive the facts of this case from the trial court’s opinion, (see

Memorandum in Support of Order Dismissing Plaintiffs’ Second Amended

Complaint, 3/23/17, at 1-4), and our independent review of the record.

        The decedent, Joseph F. Caltagirone, suffered from migraine headaches.

In 2005, he began treating with Thomas C. Barone, D.O., who prescribed

ACTIQ, a form of fentanyl marketed and sold by co-Appellee Cephalon, Inc.

        ACTIQ is a very powerful opioid approved by the FDA in 1998 only for

“breakthrough” cancer pain of opioid-tolerant patients.3 It is packaged and

sold as a berry-flavored “lollipop” on a stick.4 ACTIQ carries a “Black Box”

warning label, (the most serious type of FDA warning, named for the required

distinctive black perimeter), advising of the risk of serious adverse health


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2   21 U.S.C.[A.] §§ 301-399.

3Breakthrough pain “breaks through” despite the pain relief medication the
patient is already taking.

4ACTIQ is a “transmucosal immediate–release fentanyl” (TIRF) product, which
means the drug is delivered across mucous membranes, such as inside the
cheek or under the tongue. This is particularly useful for cancer patients who
have difficulty swallowing or taking medication in other ways.

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consequences from the use of ACTIQ, including respiratory depression,

addiction, and death. The Black Box label warns against the use of ACTIQ for

any condition other than cancer pain, including, specifically, migraine

headaches.

      Appellant acknowledges that physicians may prescribe medications for

purposes other than those approved by the FDA, (known as “off-label” uses).

However, he maintains that Appellees unlawfully and recklessly promoted,

marketed and sold ACTIQ for off-label uses not approved by the FDA, in

violation of the FDCA, and the FDA’s implementing regulations, to increase

sales. (See Second Amended Complaint, 1/05/17, at 8 ¶ 30).

      Dr. Barone prescribed ACTIQ to Decedent for about six years, from 2005

to 2011, for the relief of pain from his migraine headaches.         This period

included at least two episodes of inpatient hospitalization for Mr. Caltagirone’s

detoxification and related treatment. In 2011, Dr. Barone stopped prescribing

ACTIQ for Mr. Caltagirone and moved him to other opioids. About two and a

half years later, on May 15, 2014, Mr. Caltagirone died. The autopsy stated

the cause of Mr. Caltagirone’s death was “drug intoxication” from “methadone

toxicity.”

      Appellant brought a wrongful death and survival action suit against

Cephalon and Teva. In pertinent part, the complaint alleged:

            16. Despite Actiq’s very limited purpose, approval and
      instructions for use, during the period from 2000 through at least
      2011, Defendants engaged in an unlawful, deceptive and reckless
      pattern and practice of marketing, promoting and selling Actiq, for

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     inter alia, the treatment of pain of patients with a wide range of
     conditions for which Actiq was inappropriate, highly dangerous,
     contradicted and specifically forbidden by the FDA as further
     set forth herein.

(Second Amended Complaint, at 4-5, ¶ 16) (emphasis added).

     Appellant    maintains     that    Appellees      engaged   in   a   deliberate

comprehensive marketing campaign to boost sales of ACTIQ beyond pain relief

for cancer patients by promoting off-label use, including for migraine

headaches.       He   asserts   this   program   set    higher   quotas   for   sales

representatives than could be met solely by sales for cancer patients. It also

allegedly encompassed promotional distribution of “free” coupons for ACTIQ,

the preparation of pertinent marketing materials for promotion of other uses

including for migraine headaches, and commissioning key opinion leaders to

write articles, do studies, and make presentations at medical conferences on

the use of ACTIQ for pain management by non-cancer patients.

     The overarching theme of the complaint is that even though Mr.

Caltagirone died from methadone toxicity, an adverse reaction to the

methadone he was taking as prescribed by Dr. Barone, his underlying

addiction was proximately caused by Appellees’ program of promoting ACTIQ

for non-FDA approved pain management. (See id. at 12 ¶ 54).

     The trial court sustained Appellees’ preliminary objections and dismissed

the second amended complaint with prejudice, on March 23, 2017, with a

supporting memorandum. Appellant timely appealed on April 13, 2017. The

trial court did not order a Rule 1925(b) statement of errors. On May 2, 2017,

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the trial court filed a Rule 1925(a) opinion referring to its memorandum of

March 23, 2017 for the reasons of its decision. See Pa.R.A.P. 1925.

       Appellant raises nine questions on appeal:

            1. Did the trial court err in holding that federal law preempts
       the state law tort claims presented in the second amended
       complaint?

             2. Did the trial court err in holding that the “learned
       intermediary” doctrine bars the claims here?

             3. Did the complaint have attached to it all requisite
       writings?

            4. Are causation elements of negligence and negligent
       misrepresentation claims for a jury to determine?

              5. Was fraud pled with sufficient particularity?

              6. Did the complaint allege sufficient elements?

            7 Was the complaint free of scandalous or impertinent
       matter?

             8. In the alternative, did the court erred [sic] under Pa. R.
       Civ. Proc. [sic] 1028(e)?

(Appellant’s Brief, at 2-3).5

             Our standard of review of an order granting preliminary
       objections is well-settled:

                 Preliminary objections in the nature of a demurrer
          should be granted where the contested pleading is legally
          insufficient. Cardenas v. Schober, 783 A.2d 317, 321 (Pa.
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5 We also have the benefit of a brief filed on behalf of         amici curiae, the
Chamber of Commerce of the United States of America,             the Pennsylvania
Chamber of Business and Industry and the Pennsylvania            Coalition for Civil
Justice Reform, as well as an amicus curiae brief filed          on behalf of the
Pennsylvania Association for Justice.

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J-A01023-18


         Super. 2001) (citing Pa.R.C.P. 1028(a)(4)). “Preliminary
         objections in the nature of a demurrer require the court to
         resolve the issues solely on the basis of the pleadings; no
         testimony or other evidence outside of the complaint may
         be considered to dispose of the legal issues presented by
         the demurrer.” Hess v. Fox Rothschild, LLP, 925 A.2d
         798, 805 (Pa. Super. 2007) (quoting Cardenas, 783 A.2d
         317 at 321). All material facts set forth in the pleading and
         all inferences reasonably deducible therefrom must be
         admitted as true. Id.

      Cooper v. Church of St. Benedict, 954 A.2d 1216, 1218 (Pa.
      Super. 2008). In reviewing a trial court’s grant of preliminary
      objections, the standard of review is de novo and the scope of
      review is plenary. Martin v. Rite Aid of Pennsylvania, Inc., 80
      A.3d 813, 814 (Pa. Super. 2013). Moreover, we review the trial
      court’s decision for an abuse of discretion or an error of law.
      Lovelace ex rel. Lovelace v. Pennsylvania Prop. & Cas. Ins.
      Guar. Ass'n, 874 A.2d 661, 664 (Pa. Super. 2005).

Kilmer v. Sposito, 146 A.3d 1275, 1278 (Pa. Super. 2016).

      Here, the trial court reasoned that Appellant’s claims for negligence,

misrepresentation, fraud, and violation of the Unfair Trade Practices and

Consumer Protection Law (UTPCPL), explicitly premised on violation or

disregard of FDCA and FDA regulation, “could not exist in the absence of

federal laws and regulations.” (Trial Court Memorandum, 3/23/17, at 6). We

agree.

      Appellant’s pleadings are legally insufficient. Even admitting as true all

well-pled material facts set forth in the pleading and all inferences reasonably

deducible therefrom, as we must under our rules, our independent review

confirms that the pervasive claim of Appellant’s complaint is that Appellees’

various derelictions, (principally, promoting sales for off-label purposes), were


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J-A01023-18


not approved or were in direct violation of the FDCA or its implementing

regulations.

      However, with narrow exceptions not asserted and not applicable here,

the general rule is that there is no private right to enforce the law and

regulations of the FDCA. See 21 U.S.C.A. § 337(a) (“Except as provided in

subsection (b) of this section, all such proceedings for the enforcement,

or to restrain violations, of this chapter shall be by and in the name of

the United States.”) (emphasis added); see also Buckman Co. v.

Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (where federal enactments

form critical element of plaintiff’s case, litigation over “fraud-on-the-agency”

claims do not rely on traditional state tort law, and are pre-empted).

      Because Appellant’s claims rely on asserted violations of the FDA’s “off-

label” restrictions, which are pre-empted, the trial court properly sustained

Appellees’ preliminary objections to his complaint.         Accordingly, it is

unnecessary for us to review the remainder of Appellant’s issues, and we

decline to do so.

      Order affirmed.

Judgment Entered.




Joseph D. Seletyn, Esq.
Prothonotary

Date: 6/8/18



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