                    RECOMMENDED FOR FULL-TEXT PUBLICATION
                        Pursuant to Sixth Circuit I.O.P. 32.1(b)
                               File Name: 14a0018p.06

              UNITED STATES COURT OF APPEALS
                            FOR THE SIXTH CIRCUIT
                              _________________


                                                   X
                                                    -
 BETH ANN MILLER, Personal Representative

                             Plaintiff-Appellant, --
 of the Estate of Beth Ann Kelly,

                                                    -
                                                        No. 12-2502

                                                    ,
                                                     >
                                                    -
             v.

                                                    -
                                                    -
 MYLAN INC., MYLAN PHARMACEUTICALS
                                                    -
 INC., and MYLAN TECHNOLOGIES INC.,
                          Defendants-Appellees. N
                     Appeal from the United States District Court
                    for the Eastern District of Michigan at Detroit.
                 No. 2:12-cv-11684—Paul D. Borman, District Judge.
                             Argued: October 8, 2013
                       Decided and Filed: January 21, 2014
        Before: MERRITT, GIBBONS, and McKEAGUE, Circuit Judges.

                               _________________

                                    COUNSEL
ARGUED: S. Jay Ahmad, ISHBIA & GAGLEARD, P.C., Birmingham, Michigan, for
Appellant. Clem C. Trischler, PIETRAGALLO GORDON ALFANO, Pittsburgh,
Pennsylvania, for Appellees. ON BRIEF: S. Jay Ahmad, ISHBIA & GAGLEARD,
P.C., Birmingham, Michigan, for Appellant. Clem C. Trischler, PIETRAGALLO
GORDON ALFANO, Pittsburgh, Pennsylvania, for Appellees.
       MERRITT, J., delivered the opinion of the court in which GIBBONS, J., joined.
GIBBONS, J. (pp. 8–10), delivered a separate concurring opinion. McKEAGUE, J. (pp.
11–19), delivered a dissenting opinion.




                                         1
No. 12-2502         Miller v. Mylan, Inc., et al.                                    Page 2


                                   _________________

                                         OPINION
                                   _________________

        MERRITT, Circuit Judge. Beth Ann Kelly died after receiving a fatal dose of
fentanyl. Her estate subsequently brought this lawsuit alleging that the defendant’s
fentanyl patch caused Kelly’s death. The defendant pleaded immunity under a Michigan
statute that immunizes manufacturers of “drugs” from suit. The district court determined
that the fentanyl patch was a “drug” and consequently granted the defendant’s motion
to dismiss the complaint. We conclude that the district court’s analysis was incomplete
and that a factual question remains as to whether the fentanyl patch was a “combination
product,” the manufacturers of which do not enjoy immunity under Michigan law. We
therefore reverse the judgment of the district court and remand for further proceedings.

                                      I. Background

        Defendant Mylan is the manufacturer of a fentanyl patch that is the generic
version of Duragesic. The product is intended to treat pain. It essentially has two parts:
fentanyl (its active ingredient) and a “transdermal system” (i.e., the patch that delivers
the drug). The patch is affixed to the patient’s skin and is designed to deliver a regulated
dose of fentanyl to the patient for a prolonged period. According to the complaint, the
defendant’s patch caused Kelly’s death by delivering an excessive amount of fentanyl.

        Kelly’s estate brought suit in Michigan state court, alleging counts based on
common law and statutory torts, i.e., strict products liability, negligence, negligent
misrepresentation, fraud, warranty, and the Michigan Consumer Protection Act. The
defendant removed the case to federal court and subsequently moved to dismiss the
complaint for failure to state a claim upon which relief can be granted. As is relevant
here, the defendant based its motion on Mich. Comp. Laws § 600.2946(5), which
provides that manufacturers of “drugs” are immune from suit. The district court
No. 12-2502           Miller v. Mylan, Inc., et al.                                              Page 3


concluded that the fentanyl patch is a “drug” and dismissed the complaint in its entirety.
The correctness of this conclusion is the sole issue on appeal.1

                                            II. Analysis

         Mich. Comp. Laws § 600.2946(5) grants immunity from suit to drug
manufacturers. In pertinent part, the statute reads:

         In a product liability action against a manufacturer or seller, a product
         that is a drug is not defective or unreasonably dangerous, and the
         manufacturer or seller is not liable, if the drug was approved for safety
         and efficacy by the United States food and drug administration, and the
         drug and its labeling were in compliance with the United States food and
         drug administration’s approval at the time the drug left the control of the
         manufacturer or seller.

As the statute plainly states, a manufacturer is immune only if the product at issue is a
“drug.” Michigan defines “drug” as the term is defined in federal law: “‘Drug’ means
that term as defined in section 201 of the federal food, drug, and cosmetic act, chapter
675, 52 Stat. 1040, 21 U.S.C. 321.” Mich. Comp. Laws § 600.2945(b). In turn, the
federal Act defines “drug” to mean:

         (A) articles recognized in the official United States Pharmacopoeia,
         official Homoeopathic Pharmacopoeia of the United States, or official
         National Formulary, or any supplement to any of them; and (B) articles
         intended for use in the diagnosis, cure, mitigation, treatment, or
         prevention of disease in man or other animals; and (C) articles (other
         than food) intended to affect the structure or any function of the body of
         man or other animals; and (D) articles intended for use as a component
         of any article specified in clause (A), (B), or (C).

21 U.S.C. § 321(g)(1). Michigan’s definition of “drug” also provides that a “drug” is
not a “medical appliance or device,” though the statute neither defines “medical




         1
          Before the district court, the plaintiff consented to dismissal of her claim under the Michigan
Consumer Protection Act and her products-liability claim insofar as it was premised on a failure to warn.
These particular claims are not before us.
No. 12-2502             Miller v. Mylan, Inc., et al.                                         Page 4


appliance or device” nor refers to the federal definition of “device.”2 Mich. Comp. Laws
§ 600.2945(b).

        Before the district court, the plaintiff argued that the patch is not a drug even if
fentanyl, the product’s active ingredient, is. The district court disagreed, holding that
“there is no factual or legal basis to disassociate the pharmacologically active and
inactive components of the [fentanyl patch],” and that the fentanyl patch, “including all
its system components, is an FDA-approved drug.” The court determined that the patch
was akin to a time-release capsule in a pill and that it qualified as an “article intended
for use as a component of any article specified in clause (A), (B), or (C).”

        The district court’s conclusion is problematic for two reasons. First, it is unclear
that the patch is an “article intended for use as a component” of fentanyl, as that phrase
is most naturally understood. The phrase applies to certain inactive ingredients such as
“coatings, binders, and capsules.” See United States v. Generix Drug Corp., 460 U.S.
453, 454 (1983). We are not entirely convinced that it applies to a product, like the
patch, that appears to have a mechanical (rather than chemical) effect on the human
body.




        2
            Federal law defines “device” as follows:
                   The term “device” (except when used in paragraph (n) of this section
                   and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means
                   an instrument, apparatus, implement, machine, contrivance, implant,
                   in vitro reagent, or other similar or related article, including any
                   component, part, or accessory, which is—
                   (1) recognized in the official National Formulary, or the United States
                   Pharmacopeia, or any supplement to them,
                   (2) intended for use in the diagnosis of disease or other conditions, or
                   in the cure, mitigation, treatment, or prevention of disease, in man or
                   other animals, or
                   (3) intended to affect the structure or any function of the body of man
                   or other animals, and
                   which does not achieve its primary intended purposes through
                   chemical action within or on the body of man or other animals and
                   which is not dependent upon being metabolized for the achievement
                   of its primary intended purposes.
        21 U.S.C. § 321(h).
No. 12-2502         Miller v. Mylan, Inc., et al.                                    Page 5


        Second, and more importantly, the district court failed to take full account of the
statutory scheme governing federal drug regulation. See K Mart Corp. v. Cartier, Inc.,
486 U.S. 281, 291 (1988) (“In ascertaining the plain meaning of the statute, the court
must look to the particular statutory language at issue, as well as the language and design
of the statute as a whole.”). The court assumed a binary scheme whereby a particular
item is defined as either a “drug” or “device” and is regulated accordingly. That is how
things used to work, but no longer. In 1990, Congress amended the federal Act to add
a third category of products known as “combination products.” Pub. L. No. 101-629,
§ 16, 104 Stat. 4511, 4526 (1990) (codified as amended at 21 U.S.C. § 353(g)). The
apparent purpose of this law was to determine whether ambiguous products would be
regulated as drugs or as devices. (The approval process is different for each.) The law
gives the Secretary authority to determine a combination product’s “primary mode of
action” and to regulate the product accordingly. Simultaneously, Congress deleted
language in the definition of “drug” stating that drugs do not “include devices or their
components, parts, or accessories.” The deletion reflected the replacement of the binary
scheme with a tripartite scheme.

        The effect of the 1990 amendment was to create a distinction between how a
product is defined and how that product will be regulated. In many cases, it will be
obvious that a product should be defined as a statutory “drug” or a statutory “device”
and will be regulated as such. In other cases, a product is neither a statutory “drug” nor
“device” but rather is a “combination product.” Whether a combination product is
regulated as a drug or a device is left to the Secretary’s discretion.

        The defendant argues that it is irrelevant whether the fentanyl patch is labeled a
“combination product” or a “drug” because the FDA actually regulated the patch as a
drug. This argument ignores the plain language of the Michigan immunity statute. A
manufacturer is only immune if the suit regards a “product that is a drug” (i.e., if it is
defined as a drug) and “if the drug was approved for safety and efficacy by the United
States food and drug administration” (i.e., if it is regulated as a drug). Mich. Comp.
Laws § 600.2946(5). In turn, a product is a “product that is a drug” only if it falls within
No. 12-2502         Miller v. Mylan, Inc., et al.                                     Page 6


the federal definition of “drug.” Mich. Comp. Laws § 600.2945(b). It follows that if a
product is better defined as a “combination product” than a “drug” under federal law,
then its manufacturer is not immune from suit in Michigan.

        At best, Michigan law is ambiguous as to whether the manufacturer of a
combination product should be immune from suit. Accepted canons of statutory
construction require this ambiguity to work against immunity for manufacturers of
combination products. “It is axiomatic that statutes in derogation of the common law
should be narrowly construed.” Badaracco v. Comm’r, 464 U.S. 386, 403 n.3 (1984)
(Stevens, J., dissenting). Put in a slightly different form, “statutes will not be interpreted
as changing the common law unless they effect the change with clarity.” Antonin Scalia
& Bryan A. Garner, Reading Law: The Interpretation of Legal Texts 318 (2012). There
was no immunity such as this at common law (and indeed, Michigan appears to be the
only state that provides immunity in this fashion). In light of the Michigan legislature’s
failure to clearly immunize manufacturers of “combination products,” the statute should
not be construed to exempt those manufacturers from suit.

        The remaining question is whether the fentanyl patch is indeed a “combination
product” rather than a “drug.” The federal Act does not explicitly define “combination
product” except to say that such products “constitute a combination of a drug, device,
or biological product.” 21 U.S.C. § 353(g)(1). FDA regulations more thoroughly define
“combination products” to include “product[s] comprised of two or more regulated
components, i.e., drug/device, . . . that are physically, chemically, or otherwise combined
or mixed and produced as a single entity.” 21 C.F.R. § 3.2(e)(1).

        Whether the fentanyl patch meets this definition is a question of fact that we are
unprepared to answer in the first instance. Therefore, we find that a remand is
appropriate. In light of the now tripartite division of products into drugs, devices, and
combination products, the district court shall determine whether the fentanyl patch
should be designated as only a “drug” for purposes of the Michigan statute.
No. 12-2502        Miller v. Mylan, Inc., et al.                                 Page 7


       Accordingly, the judgment of the district court is reversed and the case remanded
for further proceedings consistent with this opinion.
No. 12-2502        Miller v. Mylan, Inc., et al.                                    Page 8


                              _______________________

                                  CONCURRENCE
                              _______________________

       GIBBONS, Circuit Judge, concurring. I agree that we must reverse the district
court’s dismissal of the complaint and remand for further proceedings. And I agree that
there may well be an issue on remand about whether the patch was a “combination
product.” My additional reasons for reversal, however, are broader than a focus on that
single issue and are more procedurally based.

       Miller carefully crafted her complaint to make clear that it is the manner in which
the patch delivers fentanyl that she alleges was defective and unreasonably dangerous
in its design, manufacture, and marketing. Similar, it is the manner in which the patch
delivers fentanyl that is the basis for the negligence and other claims. The district court
did not focus on the complaint as pled, however, but instead focused on documents
submitted by Mylan in support of its motion to dismiss. The district court justified its
consideration of the documents by saying that Tellabs, Inc. v. Makor Issues & Rights,
Ltd., 551 U.S. 308, 322 (2007), authorizes the court, in ruling on a motion to dismiss, to
consider letters from a federal agency and matters of public record whose authenticity
cannot be questioned, when those documents are incorporated by reference into or are
central to the claims set forth in plaintiff’s complaint. The court secondarily relied on
our opinion in Greenberg v. Life Insurance Co. of Virginia, 177 F.3d 507, 514 (6th Cir.
1999), which found that documents attached to a motion to dismiss that are referred to
in the complaint and central to the claim are deemed to form part of the pleadings. The
district court apparently determined that the documents were referenced in the complaint
and central to the claim because the complaint “specifically refers to the warnings and
labels that accompanied MFTS” and because neither party questioned their authenticity.

       No documents were attached to plaintiff’s complaint, and it did not mention any
specific document or its contents. The documents submitted by Mylan included a letter
from the Director of the Office of Generic Drugs in the Food and Drug Administration
No. 12-2502         Miller v. Mylan, Inc., et al.                                      Page 9


with the date of January 28, 2005, stamped on it, that approves the patch as “safe and
effective for use as recommended in the submitted labeling;” a number of medication
guides dealing with, among other things, appropriate use of MFTS and Duragesic; and
some labeling materials. Mylan made no effort to authenticate the documents.

        The documents considered by the district court appear quite different from the
sorts of documents approved in Tellabs and Greenberg for use in connection with a
motion to dismiss. The plaintiff does generally refer to labeling in her complaint. But
no specific reference is made to the labeling of the patch used by plaintiff’s decedent
Kelly, and there is no indication that the labeling submitted by Mylan was labeling
provided to Kelly or submitted to the FDA. Nor is there any indication that the
medication guides were submitted to the FDA or that they would have been provided to
the ultimate user of the product. The relevance, if any, of these documents to the
complaint is unknown at this time. The letter from the Office of Generic Drugs does
provide some support for Mylan’s arguments that the FDA considered the entire patch
to be a drug, as it refers to Mylan’s “abbreviated new drug application” and refers to the
patch as a “drug.” But it is not clear that the FDA was doing anything other than using
a natural way of referring to the product since it was in fact approving a drug
application. Clearly, this document is in no way referenced in the complaint, and it is
not central to plaintiff’s claim. If anything, it seems central to the defense. It is precisely
the sort of document on which defendant could properly rely in a motion for summary
judgment, along with appropriate authentication supporting its admission. That motion
would of course be made after plaintiff had an opportunity for discovery about all the
exchanges between Mylan and the FDA with regard to the patch. Moreover, there is
some question whether the letter should be considered at all in connection with a motion
to dismiss, regardless of whether it is central to the plaintiff’s claim. See Pension Benefit
Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1197 (3d Cir. 1993)
(discussing whether written correspondence subject to FOIA requests are public records
for purposes of a motion to dismiss and holding that they are not).
No. 12-2502         Miller v. Mylan, Inc., et al.                                    Page 10


        Rather than taking the complaint as it was, the district court and, in this court, the
dissent immersed themselves in drawing conclusions from the documents and the
relevant statutes. At a later point in this litigation, that might be appropriate. But from
my perspective it is inappropriate to use the documents submitted by Mylan as if they
were a part of plaintiff’s pleadings. Submission of the additional materials should have
likely triggered conversion of the motion to a motion for summary judgment, which
would have required Mylan to provide some evidentiary basis for their admission and
would have required the district court to permit presentation of all evidence pertinent to
the motion.

        One may fairly question why this court should embark on a discussion of the
procedural error when plaintiff did not brief it before the district court or this court. And
certainly, we should generally avoid issues not raised by the parties. See generally
Barney v. Holzer Clinic, Ltd., 110 F.3d 1207, 1213 (6th Cir. 1997) (citing Hines v.
United States, 971 F.2d 506, 508–09 (10th Cir. 1992)). But this case presents one of
those exceptions—it implicates an important nonjurisdictional concern that transcends
the interests of the parties. See Hines, 971 F.2d at 508. Maintaining the integrity of the
procedures contemplated by the Federal Rules of Civil Procedure is an important goal,
one which is best advanced here by pointing out the irregularity.
No. 12-2502              Miller v. Mylan, Inc., et al.                                              Page 11


                                       ____________________

                                             DISSENT
                                       ____________________

         McKEAGUE, Circuit Judge, dissenting. The Majority finds that there remains
a factual determination as to whether the fentanyl patch is a “combination product”
under the Food, Drug, and Cosmetic Act. I disagree with the Majority’s interpretation
of the Michigan immunity statute and would instead hold that Mylan’s Fentanyl
Transdermal System is a “drug” under 21 U.S.C. § 321(g)(1) and therefore Mylan is
immune from suit under Michigan law. I respectfully dissent.

         Determining whether the Mylan Fentanyl Transdermal System should be
considered a “drug,” a “device,” or “combination product” requires first looking at the
definition of “combination products.”1 As the Majority correctly notes, one must look
to the FDA regulations, 21 C.F.R. § 3.2(e)(1),2 to find a definition. Under the
regulations, a combination product is simply “two or more regulated components,”
comprising either a “drug” and “device” or a “drug” and “biologic,” etc. Id. There is



         1
            As a preliminary matter, the parties never mention the term “combination product” in their initial
briefs before this Court. Furthermore, the parties did not argue that Mylan’s Fentanyl Transdermal System
was a “combination product” before the district court. Plaintiff does not allege that the product was a
“combination product” in the Complaint. R. 1-7, Complaint, et seq. The term “combination product” was
sua sponte raised by this Court, when it asked the parties to address whether Mylan’s Fentanyl
Transdermal System is a “combination product” and whether the manufacturer of a “combination product”
is immune from suit under Michigan law. The Plaintiff had an opportunity to amend her complaint when
Defendants filed their motion to dismiss based on Michigan’s immunity statute, to allege that Mylan’s
Fentanyl Transdermal System was a “combination product” and therefore was not immune from suit;
Plaintiff took no such course of action. Accordingly, I would not even address the question of whether
this product is a “combination product” because Plaintiff has waived raising this argument in the district
court. See Scottsdale Ins. Co. v. Flowers, 513 F.3d 546, 551 (6th Cir. 2008). And, while this Court can
consider novel questions for the first instance on appeal in exceptional circumstances where a miscarriage
of justice would otherwise occur, the “novel issue,” of whether the fentanyl patch is a “combination
product,” was not even raised by the parties. Friendly Farms v. Reliance Ins. Co., 79 F.3d 541, 545 (6th
Cr. 1996) (providing the standard for when the court of appeals may entertain issues not raised in the
district court). Accordingly, I do not think this Court should even be addressing the legal issue of whether
this product is a “combination product,” as the issue was waived by the Plaintiff in the district court and
this case does not present exceptional circumstances where a miscarriage of justice would otherwise occur.
         2
             21 C.F.R. § 3.2(e)(1) provides the definition of “combination product:”
         (1) A product comprised of two or more regulated components, i.e., drug/device,
         biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically,
         or otherwise combined and produced as a single entity; . . . .
No. 12-2502            Miller v. Mylan, Inc., et al.                                           Page 12


no claim that the transdermal patch includes a “biologic.” Following our invitation,
Plaintiff now argues that the transdermal patch comprises a drug (fentanyl) and a device
(the patch), and that the device malfunctioned. Pl.’s Br. at 12–13. The Michigan
immunity statute does not define “device” but simply provides that “drug does not
include a medical appliance or device.” Mich. Comp. Laws § 600.2945(b). As the
Michigan immunity statute relies on the federal Act for its definition of “drug” and the
regulation defining “combination product” relies on the federal Act for defining “drug”3
and “device”4 I turn to those definitions to see if Mylan’s Fentanyl Transdermal System
is a “combination product.”

       Mylan’s Fentanyl Transdermal System’s “components” are described in the
official labeling of the product, which is approved by the FDA. See R. 12, Dist. Court
Op. at 4, PageID # 283; R. 5-3, Mylan’s Labeling at 2, Page ID # 125. The components
are described as follows:

       System Components and Structure. The amount of fentanyl released
       from each system per hour is proportional to the surface area (25mcg/hr
       per 6.25 cm). The composition per unit area of all system sizes is
       identical.


       3
           21 U.S.C. § 321(g)(1) provides the definition of “drug,” as:
       (A) articles recognized in the official United States Pharmacopoeia, official
       Homeopathic Pharmacopoeia of the United States, or official National Formulary, or
       any supplement to any of them; and (B) articles intended for use in the diagnosis, cure,
       mitigation, treatment, or prevention of disease in man or other animals; and (C) articles
       (other than food) intended to affect the structure or any function of the body of man or
       other animals; and (D) articles intended for use as a component of any article specified
       in clause (A), (B), or (C).
       4
           21 U.S.C. § 321(h) provides the definition of “device,” as:
       an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent,
       or other similar or related article, including any component, part, or accessory, which
       is—
       (1) recognized in the official National Formulary, or the United States Pharmacopeia,
       or any supplement to them,
       (2) intended for use in the diagnosis of disease or other conditions, or in the cure,
       mitigation, treatment, or prevention of disease, in man or other animals, or
       (3) intended to affect the structure or any function of the body of man or other animals,
       and which does not achieve its primary intended purposes through chemical action
       within or on the body of man or other animals and which is not dependent upon being
       metabolized for the achievement of its primary intended purposes.
No. 12-2502           Miller v. Mylan, Inc., et al.                                            Page 13


         Fentanyl transdermal system is a translucent rectangular patch with
         rounded corners comprising a protective liner and two functional layers.
         Proceeding form the outer surface toward the surface adhering to the
         skin, these layers are: 1) a backing layer of polyester film; and
         2) fentanyl containing silicone adhesive layer. Before use, a protective
         liner that is attached to and covering the adhesive layer is removed and
         discarded.
         Fentanyl transdermal systems are packaged with additional pieces of
         protective film above the system within each pouch. These are also
         discarded at the time of use.
         The active component of the system is fentanyl.                     The remaining
         components are pharmacologically inactive.

Id.

         After considering the definition of “device” and “drug,” I conclude that the patch
does not include a “device.” While the fentanyl patch could possibly be considered an
“instrument” or “apparatus,” because the patch achieves its “primary intended purposes”
of relieving pain through some “chemical action within or on the body” and fentanyl
must be metabolized in order for it to be effective, the patch does not fit the definition
of “device.” 21 U.S.C. § 321(h)(3). A “device” may not achieve its “primary intended
purpose” through “chemical action” or metabolization. Id. As indicated in the labeling
of the Mylan Fentanyl Transdermal System, the fentanyl patch achieves its “primary
intended purpose” through both means, and therefore does not meet the definition of
“device.” R. 5-3, Mylan’s Labeling at 2, Page ID # 125. Furthermore it is noteworthy
that the labeling for the Mylan Fentanyl Transdermal System, approved by the FDA,
includes absolutely no suggestion that the system includes a device or is a combination
product.5 There is nothing to suggest that the FDA, when approving the label thought


         5
           The FDA’s premarket approval of a new drug application includes the approval of the exact text
in the proposed label. 21 U.S.C. § 355. In general, a manufacturer may only change a drug label already
approved by the FDA by filing a “supplemental application” with the FDA. Wyeth v. Levine, 555 U.S. 555,
568 (2009); Strayhorn v. Wyeth Pharms., Inc., 887 F. Supp. 2d 799, 809 (W.D. Tenn. 2012) (noting that
in order for a drug manufacturer to change the label, the manufacturer must go through a formal process
through the FDA). Regulations provide that the FDA must approve the labeling in order for a new drug
to be “approved.” 21 C.F.R. § 314.105 (2008). Therefore, the language included in the label is approved
by the FDA. This Court should not begin second-guessing labels approved by the FDA, which has primary
jurisdiction over labeling such products.
No. 12-2502            Miller v. Mylan, Inc., et al.                                              Page 14


any part of Mylan’s Fentanyl Transdermal System was a device. Furthermore, Mylan’s
Fentanyl Transdermal System does accurately fit the FDA’s definition of “drug.” As
defendants articulate in their brief, the FDA’s definition of “drug” includes “articles
intended for use as a component of any article,” where an “article” may be any of the
three earlier described categories for “drugs.” The Mylan Fentanyl Transdermal System
could be considered either an article “intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man” or an article “intended to affect the structure
or any function of the body of man,” as the fentanyl patch is designed to alleviate long-
term pain.         Furthermore, the FDA describes the adhesive matrix and the
pharmacologically inactive ingredients as “components” of the product in the labeling.
R. 5-3, Mylan’s Labeling at 2, Page ID # 125. Accordingly, because the Mylan Fentanyl
Transdermal System is a “drug,” and the system does not include a “device,” it is not a
“combination product” under the FDA’s definition.

         My interpretation of the term “combination product” and conclusion that the
Mylan Fentanyl Transdermal System is a “drug” and not a combination product is
further supported by the FDA’s statutory scheme and limited caselaw.

         The statutory scheme of “combination products” and evidence before the district
court, in particular, support my conclusion that the Mylan Fentanyl Transdermal System
consists of only a “drug.” The FDA promulgated the final rule defining “combination
products” on November 21, 1991. “Assignment of Agency Component for Review of
Premarket Applications,” 56 FR 58754-01, Nov. 21, 1991; see 21 C.F.R. § 3.2(e). The
rule sets forth the process by which the FDA designates the agency that has primary
jurisdiction over a combination product. 21 C.F.R. § 3.7.6 In order for “combination

         6
           The regulation provides, in part, that an applicant requesting that his product be designated, as
either a “drug,” “device,” or “combination product”:
         (a) Who should file: the sponsor of:
         (1) Any combination product the sponsor believes is not covered by an intercenter
         agreement; or
         (2) Any product where the agency component with primary jurisdiction is unclear or in
         dispute.
         (b) When to file: a sponsor should file a request for designation before filing any
         application for premarket review, whether an application for marketing approval or a
No. 12-2502            Miller v. Mylan, Inc., et al.                                              Page 15


products” to obtain FDA approval two steps must be met. First, the applicant files a
“request for designation” with the FDA.                Id. Second, the FDA issues a “letter of
designation,” informing the applicant which FDA division has primary jurisdiction over
the product. See 21 C.F.R. § 3.2(I) (“Letter of designation means the written notice
issued by the product jurisdiction officer specifying the agency component with primary
jurisdiction for a combination product.”). The “letter of designation” constitutes an
“agency determination,” and the division which has primary jurisdiction is only subject
to change by the product jurisdiction officer, as specified by the procedures in the
regulations. See 21 C.F.R. § 3.9.

         In designating the division that will have primary jurisdiction over the product,
the FDA determines the “primary mode of action” of the product. 21 C.F.R. § 3.4. The
“primary mode of action” determination involves the technical application of the
definition provided in 21 C.F.R. § 3.2(k) to ascertain the means by which a product
achieves an intended therapeutic effect. For example, where the primary mode of action
is determined to be through a “drug,” then the division of the FDA that is in charge of
regulating drugs has primary jurisdiction over the product.

         In this case, after reviewing the record before the district court, it appears that the
defendants did not file a “request for designation,” nor did they receive a “letter of
designation” from the FDA. This is important, as the FDA is the agency primarily
responsible for categorizing “combination products.” 21 U.S.C. § 353(g); see also
Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 627 (1973) (holding
that the FDA has primary jurisdiction to determine that a product is a ‘new drug,’ subject
to review in the court of appeals).

         Moreover, the one letter from the FDA in the record, a letter from the FDA
approving the fentanyl patch, only uses the word “drug.” See R. 5-2, Approval Letter


         required investigational notice. Sponsors are encouraged to file a request for designation
         as soon as there is sufficient information for the agency to make a determination.
21 C.F.R. § 3.7.
No. 12-2502            Miller v. Mylan, Inc., et al.                                              Page 16


to Mylan at 2-4, Page ID # 121–23. There is no mention of the terms “combination
product” or “device.” Id. The division responsible for sending the letter of approval was
the “Office of Generic Drugs, Center for Drug Evaluation and Research.” Id. at 4,
PageID # 123.         Accordingly, even if the defendants had requested a “letter of
designation” to determine which unit of the FDA had primary jurisdiction, the fact that
the Office of Generic Drugs approved Mylan’s Fentanyl Transdermal System suggests
that the FDA determined that the primary mode of action of fentanyl was that of a
“drug.” The FDA was acutely aware of the various designations under which the
fentanyl patch could be classified.7 There was no indication before the district court, or
before this Court, that fentanyl was designated as any product other than a “drug.”8

         The Majority’s approach leads to courts second-guessing the FDA’s designation
of a given product. As in this case, the only evidence in the record shows that the FDA
designated the fentanyl patch as a “drug.” In my view, the inquiry stops there. While
the letter may is not a “formal” agency action, intended to have the force of law, the
FDA’s designation of a product as a “drug,” “device,” or “combination product,” is
entitled to deference as it comes from the agency charged with making such nuanced


         7
           If the Office of Combination Products determined that the product was a “combination product,”
the “letter of designation” could specify any of the following divisions having primary jurisdiction over
the product : “Center for Drug Evaluation and Research”; “Center for Devices and Radiological
Health”; or the “Center for Biologics Evaluation and Research.” The “Office of Generic Drugs” is a
subpart of the “Center for Drug Evaluation and Research.”                        Combination Products,
“Capsular            Descriptions              of    Jurisdictional           Determinations,”
http://www.fda.gov/CombinationProducts/JurisdictionalInformation/RFDJurisdictionalDecisions/Caps
ularDescriptions“One-Liners”/default htm (last visited Jan. 14, 2014). It is not clear whether any of the
divisions exercising jurisdiction over the “combination product” would refer to the product as a
“combination product” or would rather simply refer to the product by its primary mode of action.
Accordingly, the only clear indication of whether the FDA considers a product to be a “combination
product” is its designation in the “letter of designation.”
         8
         It is also worth noting that the district court recognized the significance of the FDA’s Office of
Generic Drugs approving Mylan’s Fentanyl Transdermal System:
  [I]t appears beyond dispute that the FDA deemed and approved the MFTS (the system–not some
  discrete part of the system) as a drug. As noted above, on January 29, 2005, the FDA issued its
  approval of Mylan’s Abbreviated New Drug Application for “Fentanyl Transdermal Systems,”
  concluding that “the drug is safe and effective for use as recommended in the submitted labeling.” . . .
  There is no question that in considering Mylan’s ANDA [Abbreviated New Drug Application], the
  FDA deemed the MFTS, the patch, to be a drug; not a device and not something less than its whole.
See R. 12, District Court Op. at 11, PageID # 290.
No. 12-2502         Miller v. Mylan, Inc., et al.                                  Page 17


designations. See Air Brake Sys., Inc. v. Mineta, 357 F.3d 632, 643 (6th Cir. 2004). The
Majority’s approach appears to give little or no deference to the FDA’s designation,
instead opting for courts to make an independent evaluation of whether a product is a
“drug,” “device,” or “combination product.” As the FDA is the agency with the
authority to make such designations and has far greater expertise in this area than courts,
I would continue to give deference to the FDA’s determinations and not grant courts the
purview to begin making their own designations, particularly where the complaint does
not even allege that the product is anything other than a drug.

        The Majority’s biggest criticism of the district court’s determination that the
fentanyl patch is a “drug,” for purposes of the Michigan immunity statute, is that it failed
to take “full account of the statutory scheme governing federal drug regulation.” Maj.
Op. at 5. The Majority argues that the district court did not consider the 1990
amendment to the federal act adding combination products as a third category of
products to the FDA’s regulatory scheme. Because Michigan’s immunity statute was
passed in 1995 and the changes to the FDA’s statutory scheme occurred prior to the
Michigan legislature’s enactment of the Michigan immunity statute, the Majority finds
the omission of the term “combination product” in Michigan’s immunity statute to be
significant. As courts often employ the canon that inclusion of one definition implies
the exclusion of the other, Nationwide Mut. Ins. Co. v. Cisneros, 52 F.3d 1351, 1357
(6th Cir. 1995), the Majority seems to say that this Court should presume that the
Michigan legislature knew that there was a distinction between “drugs” and
“combination products” and therefore, chose to not provide immunity for “combination
products.” Because I conclude that Mylan’s Fentanyl Transdermal System is not a
“combination product,” I would not reach the question of whether the district court erred
in not taking full account of the “statutory scheme” governing federal drug regulation.

        The Majority also takes issue with the district court’s refusal to distinguish the
pharmacologically active and inactive components of the fentanyl patch in considering
whether the fentanyl patch is a “drug” or includes a “device.” Maj. Op. at 3–4. The
Majority states that it is not convinced that the phrase “article intended for use as a
No. 12-2502               Miller v. Mylan, Inc., et al.                                           Page 18


component” applies to a product that “appears to have a mechanical (rather than
chemical) effect on the human body,” like the patch. Maj. Op. at 4. First, there is no
support for that conclusion whatsoever in the record. Morever, the limited caselaw
addressing products with features similar to the fentanyl patch have not drawn such
distinctions. In Lake-Allen v. Johnson & Johnson, L.P., No. 08-cv-930, 2009 WL
2252198 (D. Utah Jul. 27, 2009), a Utah district court specifically addressed the fentanyl
patch. The case involved a products liability action against the manufacturer of
Duragesic,9 “an FDA-approved prescription transdermal pain medication containing
fentanyl.” Id. at *1. Plaintiff claimed that the decedent’s death was “due to a deadly
dose of fentanyl introduced into his body via the reservoir system of a Duragesic patch.”
Id. Defendant moved to dismiss all causes of action that were based on design defect
liability, based on Utah’s strict liability design defect jurisprudence. Plaintiff argued that
the Duragesic patch is more akin to a “drug container and is therefore not exempt from
any design defect claims.” Id. at *2. The district court rejected plaintiff’s argument,
stating:

           Plaintiffs’ argument that the patch is more akin to a container is
           unpersuasive. The Duragesic patch was approved by the FDA as a drug
           and to categorize it as a container is akin to categorizing any substance
           available in a time release capsule as a container. In the case of
           prescription pharmaceutical patches, it is nonsensical to separate the
           liability of the overall product and the substance that it releases.

Id. at *3; see also R.12, District Court Op. at 14, PageID # 293 (quoting same language);
Bowers v. Johnson & Johnson, 795 F. Supp.2d 672 (N.D. Ohio 2011).10




           9
               Mylan’s Fentanyl Transdermal System is the generic version of Duragesic.
           10
            In Bowers v. Johnson & Johnson, 795 F. Supp.2d 672 (N.D. Ohio 2011), the district court
reviewed a motion for summary judgment in litigation involving the Ortho Evra birth control patch. The
suit involved a products liability claim. It is unclear from the opinion what specific type of defects the
plaintiff was alleging with the patch. The district court held, after considering plaintiff’s claims in the
context of the Michigan immunity statute “and there being no dispute that Ortho Evra was subject to and
successfully completed the FDA approval process,” that plaintiff’s products liability claims were precluded
as a matter of Michigan law. Id. at 677. Accordingly, the court in Bowers held that the fact that the “drug”
was approved by the FDA, immunity attached.
No. 12-2502         Miller v. Mylan, Inc., et al.                            Page 19


       Accordingly, based on the statutory scheme for “combination products” and
caselaw addressing fentanyl transdermal systems and similar products, I do not agree
with the Majority’s conclusion that Mylan’s Fentanyl Transdermal System is a
“combination product.” Instead, I would hold that Mylan’s Fentanyl Transdermal
System is a “drug” and that immunity attaches in this case, and I would not reach the
question of whether immunity attaches to “combination products” under Michigan’s
immunity statute.

       I respectfully dissent.
