Court Opinion

ID: 807968
Source: CourtListenerOpinion
Date Created: 2012-09-06 14:50:53+00
Date Added: 2024-06-11T18:00:28.491891
License: Public Domain

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                              Pursuant to Sixth Circuit Rule 206
                                      File Name: 12a0306p.06

                 UNITED STATES COURT OF APPEALS
                                  FOR THE SIXTH CIRCUIT
                                    _________________

                                                   X
                                                    -
 VICKI MARSH, THE ESTATE OF SHAY BLAIR,
                                                    -
 by personal representative Trisharla Brown,
 DAVID TIEFENTHAL, and THE ESTATE OF                -
                                                    -
                                                        Nos. 11-2373/ 2385/ 2417/
 EDDIE A. MUNIZ, by personal representative
                                                    ,
                                                             2419
                                                     >
                          Plaintiffs-Appellants, -
 Sheila Muniz,

                                                    -
                                                    -
                                                    -
           v.
                                                    -
                                                    -
                         Defendants-Appellees. -
 GENENTECH, INC. and XOMA (U.S.) LLC,
                                                   N
                    Appeal from the United States District Court
               for the Western District of Michigan at Grand Rapids.
             Nos. 1:11-cv-482; 1:11-cv-683; 1:11-cv-688; 1:11-cv-689;
                           Robert J. Jonker, District Judge.
                                     Argued: July 20, 2012
                           Decided and Filed: September 6, 2012
 Before: SILER and MOORE, Circuit Judges; VAN TATENHOVE, District Judge.*

                                      _________________

                                           COUNSEL
ARGUED: Alyson Oliver, KRESCH OLIVER PLLC, Southfield, Michigan, for
Appellants. Richmond T. Moore, WILLIAMS & CONNOLLY LLP, Washington, D.C.,
for Appellees. ON BRIEF: Alyson Oliver, KRESCH OLIVER PLLC, Southfield,
Michigan, for Appellants. Richmond T. Moore, Jennifer N. Wimsatt Pusateri,
WILLIAMS & CONNOLLY LLP, Washington, D.C., for Appellees.

        *
         The Honorable Gregory F. Van Tatenhove, United States District Judge for the Eastern District
of Kentucky, sitting by designation.

                                                  1
Nos. 11-2373/ 2385/ 11-2417/ 2419          Marsh et al. v. Genentech et al.               Page 2

                                    _________________

                                          OPINION
                                    _________________

        KAREN NELSON MOORE, Circuit Judge. Vicki Marsh, Shay Blair, David
Tiefenthal, and the Estate of Eddie Muniz (collectively, “Marsh”), the plaintiffs in these
consolidated products-liability actions, brought suit against drug manufacturers
Genentech, Inc. and Xoma (U.S.) LLC (collectively, “Genentech”) to recover for injuries
allegedly sustained from use of the psoriasis medication Raptiva. The district court
granted Genentech’s motion to dismiss, holding that Genentech was entitled to immunity
under the Michigan Products Liability Act (the Act) and that Marsh’s claim that
immunity did not apply was preempted by federal law. Because the allegations
underlying Marsh’s argument that immunity does not apply are essentially the type of
claim that Supreme Court and Sixth Circuit precedent holds is preempted, we AFFIRM.

                                    I. BACKGROUND

        Genentech designed, manufactured, and sold the psoriasis medication Raptiva,
which was approved by the federal Food and Drug Administration (“FDA”) in 2003 and
sold in the United States from 2003 until 2009. Raptiva works by suppressing T-cells
to prevent them from migrating to the skin and causing psoriasis. Because T-cells help
fight infections, however, their suppression has the potential to cause potentially life-
threatening side effects. Following reports of adverse health effects, including a rare
brain infection, in patients treated with Raptiva, Genentech voluntarily removed Raptiva
from the market in 2009.

        Marsh began using Raptiva in 2004 and subsequently suffered viral meningitis
and a collapsed lung; she attributes these conditions to her use of Raptiva.1 She brought
suit against Genentech in 2011, alleging strict products liability under design-defect and
failure-to-warn theories, negligence, breach of warranty, and fraud. She contends that,

        1
        Blair and Tiefenthal used Raptiva in 2006-2008 and 2007-2008, respectively. Both developed
lymphoma in 2008. Muniz used Raptiva in 2007 and died of kidney and liver failure later that year.
Nos. 11-2373/ 2385/ 11-2417/ 2419               Marsh et al. v. Genentech et al.                   Page 3

both prior to and after FDA approval of Raptiva, Genentech knew of dangerous side
effects that it concealed from the public and did not include in the drug’s label. Marsh
also alleged that Genentech “intentionally and negligently failed to update statement of
contraindications, warnings, precautions, and adverse reactions that Defendant
affirmatively knew about” and “intentionally and negligently failed to comply with
various but not limited to, 21 CFR 201, 21 CFR 202, 21 CFR 314.80, and 21 CFR
314.81.” R.1 (Marsh Complaint) at ¶¶ 110–111 (PageID #27).2

         Following a transfer of venue, Genentech moved to dismiss on the grounds that
it was immune from suit under the state Act, which provides that drug manufacturers are
not liable in products-liability actions if the allegedly dangerous drug and its label were
approved by the FDA and were in compliance with the FDA’s approval at the time that
the drug left the manufacturer’s control. See Mich. Comp. Laws § 600.2946(5). Marsh
countered that Genentech was not entitled to immunity because it failed to submit
updated safety information to the FDA after Raptiva had gone to market or otherwise
comply with various FDA regulations regarding post-marketing reporting, which was
a condition of FDA approval.

         The district court granted Genentech’s motion to dismiss, holding that Genentech
was immune from suit because neither statutory exception to immunity for drug
manufacturers—that the manufacturer had defrauded or bribed the FDA—applied.
Citing our decision in Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir.
2004), the district court explained that federal law preempts tort claims premised on the
Act’s exceptions absent a finding by the FDA itself that the manufacturer had committed
fraud or bribery. The district court concluded that, because Marsh had not alleged that
the FDA had found that Genentech committed fraud, her claim was preempted. The
district court subsequently denied Marsh’s motion for reconsideration. Marsh timely
appealed.

         2
           With the exception of factual allegations related to each plaintiff’s use of Raptiva and adverse
health effects, the four complaints are identical. We follow both the parties’ briefs and the district court
in citing Marsh’s complaint.
Nos. 11-2373/ 2385/ 11-2417/ 2419       Marsh et al. v. Genentech et al.            Page 4

       On appeal, Marsh again contends that immunity does not apply because
Genentech’s failure to submit updated safety information rendered Raptiva non-
compliant with the FDA’s approval at the time it left Genentech’s control. Because her
claim is premised on non-compliance rather than the fraud exception, she argues that it
is not preempted under Garcia. In addition, she characterizes this suit as the type of
state-law tort claim that the Supreme Court held was not preempted in Wyeth v. Levine,
555 U.S. 555 (2009). Finally, Marsh argues that immunity is an affirmative defense and
thus that the district court erred by not requiring Genentech to prove Raptiva’s
compliance with the FDA’s approval after Marsh alleged non-compliance in the
complaint.

       In response, Genentech characterizes failure to submit safety update reports as
a species of fraud that falls within the Act’s first exception and is thus preempted absent
a finding of fraud by the FDA. Alternatively, Genentech argues that Marsh’s claim is
preempted under Garcia regardless of how it is characterized.

               II. JURISDICTION AND STANDARD OF REVIEW

       We have jurisdiction over this diversity action pursuant to 28 U.S.C. § 1332.
Both parties agree that Michigan law applies. We review the district court’s grant of
Genentech’s motion to dismiss de novo. Brown v. Cassens Transp. Co., 675 F.3d 946,
953 (6th Cir. 2012).

                                    III. ANALYSIS

A. Implied Preemption and Michigan Products-Liability Law

       Michigan’s products-liability regime is statutory. A drug manufacturer or seller
is not liable for injuries caused by the use of its products “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.” Mich.
Comp. Laws § 600.2946(5). As a matter of law, “a drug is not defective or unreasonably
Nos. 11-2373/ 2385/ 11-2417/ 2419               Marsh et al. v. Genentech et al.                    Page 5

dangerous” if such criteria are met. Id. Statutory immunity does not apply, however,
if the manufacturer or seller:

         (a) Intentionally withholds from or misrepresents to the United States
         food and drug administration information concerning the drug that is
         required to be submitted under the federal food, drug, and cosmetic act,
         chapter 675, 52 Stat. 1040, 21 U.S.C. 301 to 321, 331 to 343-2, 344 to
         346a, 347, 348 to 353, 355 to 360, 360b to 376, and 378 to 395, and the
         drug would not have been approved, or the United States food and drug
         administration would have withdrawn approval for the drug if the
         information were accurately submitted.

or

         (b) Makes an illegal payment to an official or employee of the United
         States food and drug administration for the purpose of securing or
         maintaining approval of the drug.

Id. The Michigan Supreme Court has described the Act’s immunity provision as “an
absolute defense to a products liability claim” premised on the determination that
“compliance with federal governmental standards (established by the FDA) is conclusive
on the issue of due care for drugs.” Taylor v. SmithKline Beecham Corp., 658 N.W.2d
127, 130–31 (Mich. 2003).

         In Garcia, 385 F.3d at 965–66, we held that federal law impliedly preempts the
Act’s two exceptions.3 In so holding, we relied on Buckman Co. v. Plaintiffs’ Legal
Committee, 531 U.S. 341 (2001), in which the Supreme Court held that the federal Food,
Drug, and Cosmetic Act (“FDCA”) impliedly preempts state-law fraud-on-the-FDA
claims.4

         3
          We also held that the Act’s exceptions are not preempted when the FDA itself has determined
that the manufacturer committed fraud or bribery. Because Marsh does not contend that the FDA made
such a determination, this aspect of Garcia has no bearing on this case.
         4
           As relevant for this case, federal law impliedly preempts a state law if the state law “creates an
unacceptable ‘obstacle to the accomplishment and execution of the full purposes and objectives of
Congress.’” Wyeth, 555 U.S. at 563–64 (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)). The
Supreme Court has identified two “cornerstones of . . . pre-emption jurisprudence”: “First, the purpose
of Congress is the ultimate touchstone in every pre-emption case. Second, in all pre-emption cases, and
particularly in those in which Congress has legislated in a field which the States have traditionally
occupied, we start with the assumption that the historic police powers of the States were not to be
superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Id. at 565
(internal quotation marks, citations, and alterations omitted).
Nos. 11-2373/ 2385/ 11-2417/ 2419       Marsh et al. v. Genentech et al.            Page 6

        The plaintiffs in Buckman brought suit against a medical-device manufacturer
under state law, alleging that the manufacturer had made fraudulent representations to
the FDA in the course of the approval process and that, as a result, the device was
improperly placed on the market. 531 U.S. at 346–47. The Court held that such claims
are preempted because they interfere with the federal regulatory scheme for the approval
of drugs and medical devices, id. at 348–50, and because they implicate the “inherently
federal” issue of “the relationship between a federal agency and the entity it regulates,”
id. at 347. Indeed, because “[p]olicing fraud against federal agencies is hardly ‘a field
which the States have traditionally occupied,’” the traditional presumption against
preemption did not apply. Id. (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218,
230 (1947)).

        The FDCA sets forth a “comprehensive scheme” of disclosure requirements as
part of the approval process. Id. at 348. Along with these requirements, the FDCA
empowers the FDA to investigate and penalize fraud in a manufacturer’s disclosures or
elsewhere in the approval process. Id. at 348–49. The Court viewed these provisions
of the FDCA as evidence that Congress intended exclusively federal enforcement. Id.
at 352. State-law fraud-on-the-FDA claims would thus “inevitably conflict with the
FDA’s responsibility to police fraud consistently with the Administration’s judgment
and objectives” by allowing state courts to rule on the adequacy of a manufacturer’s
disclosures. Id. at 350. These claims could also interfere with the FDA’s approval
process, because the possibility that “disclosures to the FDA, although deemed
appropriate by the Administration, will later be judged insufficient in state court” could
lead manufacturers to oversubmit information and thus burden the evaluation process.
Id. at 351.

        At its core, a fraud-on-the-FDA claim implicates “the relationship between a
federal agency and the entity it regulates,” a relationship that is “inherently federal in
character.” Id. at 347. Moreover, the basis for the claim is violation of a federal statute
or regulation. Unlike a common-law tort claim, these “fraud claims exist solely by
virtue of the FDCA disclosure requirements.” Id. at 352–53. The alleged wrong is
Nos. 11-2373/ 2385/ 11-2417/ 2419               Marsh et al. v. Genentech et al.                   Page 7

inadequate disclosure to a federal agency rather than breach of the common-law duty to
use reasonable care. Id.

         Following Buckman, we held in Garcia that suits against drug manufacturers
under Michigan law in which the plaintiff seeks to defeat immunity by invoking the
Act’s fraud exceptions are equivalent to fraud-on-the-FDA claims and are thus
preempted. Garcia, 385 F.3d at 965–66.5 Even though, under Michigan law, fraud on
the FDA is an exception to a grant of immunity to the manufacturer rather than a stand-
alone cause of action, it nonetheless ultimately “requir[es] proof of fraud committed
against the FDA” to succeed. Id. (internal quotation marks omitted). Garcia thus
essentially requires treating a plaintiff’s fraud arguments against manufacturer immunity
as a threshold “claim” that can be preempted.6 We subsequently held that Garcia
applied to claims that the manufacturer misrepresented or withheld information about
a drug from the FDA after the FDA had approved it. In re Aredia & Zometa Prods.
Liab. Litig., 352 F. App’x 994, 995 (6th Cir. 2009) (unpublished opinion) (holding that
such claims are preempted under the FDCA “unless some federal agency has already
found the requisite fraud on the FDA”).

         Subsequent to Buckman and Garcia, the Supreme Court again dealt with the
implied preemptive effect of the FDCA on state-law tort claims against drug
manufacturers. In Wyeth, 555 U.S. at 558–59, the Court held that a state-law failure-to-
warn claim premised on the inadequacy of a brand-name drug’s label was not preempted
simply because the FDA had approved the label. The manufacturer could still be liable
under state law for failing to update the drug’s label based on newly acquired
information. See id. at 571. Because Congress has not provided a federal cause of

         5
           We also held that the fraud exceptions are not preempted “when the federal agency itself
determines that fraud marred the regulatory-approval process.” Garcia, 385 F.3d at 966. Accordingly,
“claims based on federal findings of bribery or fraud on the FDA” can defeat manufacturer immunity under
the state Act. Id.
         6
           At oral argument, Marsh cited the Second Circuit’s opinion in Desiano v. Warner-Lambert &
Co., 467 F.3d 85 (2d Cir. 2007), aff’d by an equally divided court sub nom. Warner-Lambert Co. v. Kent,
552 U.S. 440, 441 (2008), which held that the Michigan Act’s exceptions were not preempted because,
unlike in a stand-alone fraud-on-the-FDA claim, plaintiffs’ claims under the Act are traditional tort claims
that do not contain fraud as an element. We are, of course, bound by our own published precedent in
Garcia to the contrary.
Nos. 11-2373/ 2385/ 11-2417/ 2419        Marsh et al. v. Genentech et al.           Page 8

action for consumers harmed by unsafe drugs, state-law failure-to-warn claims provide
“an additional, and important, layer of consumer protection that complements FDA
regulation.” Id. at 579.

B. Compliance With FDA Approval

       Marsh would protest that the above analysis is an irrelevant detour, because she
does not invoke the Act’s fraud exception. Instead, her argument that immunity does not
apply is premised on Genentech’s alleged non-compliance with the terms of the FDA’s
approval of Raptiva.       Whatever vitality this distinction might have in other
circumstances, the nature of Marsh’s allegations of non-compliance does not take this
case outside of Garcia’s precedential reach.

       As described above, the state Act provides immunity from liability if “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.” Mich. Comp. Laws § 600.2946(5). The Act does not define “compliance with
[FDA] approval,” and the parties have not cited, and we have not found, any Michigan
caselaw interpreting this requirement.

       The nature of Marsh’s allegations of non-compliance is somewhat obscure, but
she seems to allege that Genentech failed to comply with the FDA’s post-marketing
reporting requirements. The complaint alleges that Genentech “intentionally and
negligently failed to update statement of contraindications, warnings, precautions, and
adverse reactions that Defendant affirmatively knew about” and “intentionally and
negligently failed to comply with various but not limited to, 21 CFR 201, 21 CFR 202,
21 CFR 314.80, and 21 CFR 314.81.” R.1 at ¶¶ 110–111 (Page ID #27). Marsh
contends that these failures constitute non-compliance with the FDA’s approval because,
as part of its application for approval of Raptiva, Genentech signed FDA Form 356h,
which requires the applicant to certify as follows:

       “I agree to update this application with new safety information about the
       product that may reasonably affect the statement of contraindicaitons
       [sic], warnings, precautions or adverse reactions in the draft labeling. I
Nos. 11-2373/ 2385/ 11-2417/ 2419              Marsh et al. v. Genentech et al.                   Page 9

         agree to submit safety update reports as provided for by regulation or as
         requested by the FDA. If this application is approved, I agree to comply
         with all applicable laws and regulations that apply to approved
         applications. . . .”

Id. ¶ 108 (Page ID #27).

         Such allegations do not fit comfortably within the statutory language requiring
compliance for immunity to apply. Marsh’s complaint alleges that Genentech did not
comply with the terms of the FDA approval by failing to update its application or submit
safety reports, not that “the drug and its labeling” did not comply. Mich. Comp. Laws
§ 600.2946(5); see also Taylor, 658 N.W.2d at 129–30 (explaining that the Act limits
a manufacturer’s liability when “the drug at issue was . . . labeled in compliance with
FDA standards”). Put another way, the statutory language suggests that immunity
requires substantive compliance with FDA approval, but Marsh essentially alleges
procedural non-compliance. Marsh does not allege that the dose of Raptiva she received
was adulterated or that its label varied from the label that the FDA approved.7

         Moreover, failure to submit reports to the FDA that the FDA requires is arguably
a species of fraud on the agency under the state Act. Indeed, the Michigan Act’s fraud
exception specifically encompasses at least some of the misconduct Marsh alleges—a
manufacturer “[i]ntentionally withhold[ing] from . . . the [FDA] information concerning
the drug that is required to be submitted under the [FDCA]” when the FDA “would have

         7
           The complaint’s C.F.R. citations support this view of Marsh’s allegations. Sections 314.80 and
314.81 set forth post-marketing reporting requirements. Section 201 governs labeling, which would seem
more relevant, but that section has seven subparts and seventy-one subsections, and Marsh does not specify
with which regulation therein Genentech failed to comply. In her response to Genentech’s motion to
dismiss, Marsh attempted to clarify, stating that “Plaintiffs allege post-marketing failure to warn” and
“21 C.F.R. 201 covers warnings and therefore, a failure to warn is a failure to comply with 21 C.F.R. 201.”
R.15 at 16 (Pl.’s Resp. to Defs.’ Mot. to Dismiss) (Page ID #100). If Marsh means failure to warn
consumers or physicians with an adequate label, this action does not constitute non-compliance if the FDA
has approved the label. If she means failure to “warn” the FDA by reporting new safety information, she
is essentially reiterating her allegation of non-compliance with the FDA’s reporting requirements. Section
202 poses a similar problem; that section governs advertising, which, like the regulations governing post-
marketing reporting, does not go to the issue of whether a drug itself complies with the terms of FDA
approval.
Nos. 11-2373/ 2385/ 11-2417/ 2419              Marsh et al. v. Genentech et al.                  Page 10

withdrawn approval for the drug if the information were accurately submitted.” Mich.
Comp. Laws § 600.2946(5)(a).8

         If Marsh’s allegations do constitute non-compliance within the meaning of the
Act, her “claim” that immunity does not apply triggers the same concerns that animated
Buckman and Garcia. Marsh alleges that Genentech failed to submit updated safety
information to the FDA as required of all applicants by FDA Form 356h and generally
applicable FDA regulations, and thus relies on “federal enactments [a]s a critical element
in [her] case.” Buckman, 531 U.S. at 353. Moreover, this alleged wrong was perpetrated
upon the agency, and thus implicates the “inherently federal” relationship described in
Buckman. Id. at 347. Finally, Marsh’s suit would require a court to rule on the
adequacy of Genentech’s post-marketing disclosures to the FDA, which is the kind of
“inter-branch[]meddling” that concerned the Court in Buckman. See Garcia, 385 F.3d
at 966. The FDA regulates post-marketing reporting, requiring manufacturers to report,
inter alia, “adverse drug experience information,” 21 C.F.R. § 314.80(c), and “significant
new information . . . that might affect the safety, effectiveness, or labeling of the drug
product,” id. § 314.81(b)(2)(i). The FDA also has the discretionary authority to
withdraw approval of a drug based on failure to submit these reports. Id. §§ 314.80(j),
314.81(d). Having a court determine whether any non-disclosed information “‘may
reasonably affect the statement of contraindications, warnings, precautions or adverse
reactions in the draft labeling,’” R.1 at ¶ 108 (Page ID #27) (quoting FDA Form 356h),
would both usurp the agency’s role and go beyond the court’s institutional expertise.9

         8
           The district court interpreted Marsh’s argument as an allegation of fraud. Marsh’s contention
on appeal that the district court ignored the Act’s requirement of compliance with the FDA’s approval or
held that immunity does not apply only if non-compliance was intentional rather than negligent stems from
a misreading of the district court’s opinion. The district court never held that a drug’s compliance with
FDA approval is not a condition precedent to immunity for the manufacturer under the Act, but instead
concluded that Marsh was not alleging non-compliance. Nor did the district court hold that only
intentional fraud, rather than negligence, could result in a finding of non-compliance. Such a holding
would be incorrect. Because the district court did not believe that the non-compliance element was
implicated, however, its ruling did not address what is required for a showing of non-compliance.
         9
          Because the only alleged act of non-compliance in this case is the manufacturer’s failure to
comply with generally applicable requirements of disclosure to the agency, we take no position as to
whether an allegation of substantive non-compliance that is unique to the terms of approval of a particular
drug or that more directly involves a consumer, such as a chemical variance or an inaccurate label, would
be preempted under Garcia.
         We also note that, as in Garcia, a claim of non-compliance based on failure to submit safety
Nos. 11-2373/ 2385/ 11-2417/ 2419           Marsh et al. v. Genentech et al.                Page 11

        The fact that Marsh’s substantive claims sound in negligence and strict products
liability would not enable her to avoid preemption, because so did the claims in Garcia.
Marsh alleges that Raptiva was “defective and unreasonably dangerous,” R.1 ¶ 128
(Page ID #30), but Michigan has concluded that a drug that is approved by the FDA and
is in compliance with that approval is, as a matter of law, “not defective or unreasonably
dangerous,” Mich. Comp. Laws § 600.2946(5). In order to reach her substantive claim
under Michigan law, Marsh must first defeat immunity, and, as noted above, Garcia
essentially treats this task as a threshold claim that can be preempted. Although Marsh’s
allegations of failure to report are a “claim” against immunity rather than the substantive
basis of her tort claim, Garcia conflates the two for preemption purposes; under Garcia,
the nature of Marsh’s underlying substantive claim is immaterial to the preemption
analysis.

        Finally, Marsh attests that her claim, like the failure-to-warn claim in Wyeth,
complements rather than conflicts with the FDA’s regulatory regime and thus survives
preemption. This argument confuses the validity of her substantive claim with the
validity of her argument that immunity does not apply. Marsh is correct that Wyeth
preserves a role for state law in post-marketing enforcement of drug safety; as a general
matter, FDA approval of a drug label does not preempt a state common-law failure-to-
warn suit premised on the claim that the FDA-approved label is nonetheless inadequate.
See Wyeth, 555 U.S. at 558–59. Absent the Michigan Act’s immunity provision, Marsh
could bring such a claim. Wyeth does not help plaintiffs in Michigan, however.
Although preemption principles do not foreclose state-law failure-to-warn claims once
the FDA has approved a drug, Michigan law does so. Absent a successful “claim” that
immunity does not apply, the Act prevents Michigan plaintiffs from recovering on the
type of claim brought by the plaintiff under Vermont law in Wyeth.

update reports would not be preempted if the FDA itself had found that the manufacturer had failed to
report.
Nos. 11-2373/ 2385/ 11-2417/ 2419      Marsh et al. v. Genentech et al.          Page 12

C. Affirmative Defense

        Marsh argues that immunity is an affirmative defense and thus that the district
court should have required Genentech to prove that the dose of Raptiva that Marsh
received was in compliance with the FDA’s approval when it left Genentech’s control
before granting immunity to Genentech. Marsh does not cite any authority for the
proposition that immunity under the Act is an affirmative defense, but we will assume
for present purposes that it is.

        If immunity is an affirmative defense, a defendant manufacturer would normally
bear the burden of proving that the FDA approved the allegedly defective drug and that
the drug was in compliance with that approval when it left the manufacturer’s control.
A motion to dismiss can be premised on an affirmative defense, however, if “the
plaintiff’s own allegations show that a defense exists that legally defeats the claim for
relief.” 5B Charles Alan Wright, Arthur Miller, Mary Kay Kane & Richard Marcus,
Federal Practice & Procedure § 1357 at 713 (3d ed. 2004). Here, Marsh’s complaint
quoted the Act’s immunity provision and preemptively alleged non-compliance in order
to defeat immunity. After setting forth the allegations that Genentech failed to submit
updated safety information, the complaint concludes that “[a]s Raptiva was not in
compliance with the United States food and drug administration’s approval at the time
it left the control of the Defendant, Mich. Comp. Laws § 600.2946(5) will not shield the
Defendants from liability in this action.” R.1 at ¶112 (Page ID #28) (capitalization
omitted). In her response to Genentech’s motion to dismiss, Marsh references these
allegations and states that she “has pled that Raptiva was not in compliance with its
approval at the time it left Defendants control.” R.15 at 13 (Page ID #97).

        Although the fact that “the plaintiff merely has anticipated the defendant’s
answer and tried to negate a defense he believes his opponent will attempt to use against
him” is generally not enough to merit dismissal based on an affirmative defense, 5B
Wright & Miller, Federal Practice & Procedure § 1357 at 713, Marsh anticipated the
defense of immunity in a way that shows that her response to the defense lacks merit.
Nos. 11-2373/ 2385/ 11-2417/ 2419      Marsh et al. v. Genentech et al.          Page 13

The complaint makes clear that Marsh could not defeat Genentech’s arguments for
immunity.

                                 IV. CONCLUSION

        The State of Michigan has decided to limit the availability of tort remedies
against drug manufacturers. As a federal court sitting in diversity, we are of course
required to apply Michigan law. We are also bound by our precedent interpreting that
law. Even characterized as non-compliance, Marsh’s “claim” that Genentech is not
entitled to immunity under the Act triggers the same concerns that animated Buckman
and Garcia—it is premised on violation of federal law, implicates the relationship
between a federal agency and the entity it regulates, and asks the court to assume a role
usually held by the FDA—and is thus preempted. We AFFIRM the judgment of the
district court.