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Case: 10-10956 Document: 00511764779 Page: 1 Date Filed: 02/22/2012
IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
United States Court of Appeals
CHRISTOPHER TYLER LOFTON, Individually and on behalf of the Estateof Christopher M. Lofton, deceased; TEGAN NICOLE LOFTON, individuallyand on behalf of the Estate of Christopher M. Lofton, deceased; LAURENLOFTON,
MCNEIL CONSUMER & SPECIALTY PHARMACEUTICALS, a Division ofMcNeil-P.P.C. Incorporated; JOHNSON & JOHNSON,
Appeal from the United States District Court
Before JONES, Chief Judge, and STEWART and SOUTHWICK, Circuit Judges.
Christopher M. Lofton tragically died from a rare disease called Toxic
Epidermal Necrolysis (“TEN”) after taking Motrin. Lofton’s wife and children
brought suit against the Appellees asserting that Motrin caused the disease and
the Appellees had failed to warn consumers about the risk of these severe
autoimmune allergic reactions. The district court entered summary judgment
for the Appellees. The only issue on appeal is whether the district court
correctly found that federal law preempts a Texas tort reform law that requires
Case: 10-10956 Document: 00511764779 Page: 2 Date Filed: 02/22/2012
plaintiffs to assert, in failure to warn cases, that a drug manufacturer withheld
or misrepresented material information to the FDA. See
TEX. CIV. PRAC. & REM.
CODE § 82.007(b)(1). We agree with the district court and AFFIRM.
Christopher M. Lofton took over-the-counter Motrin between May 20 and
May 22, 2000 to combat a fever. On May 24, after noticing a rash on his skin,
Lofton went to the Plano Medical Center emergency room, where he reported
both the fever and the rash. After his release, he resumed taking Motrin for
pain. When his skin condition worsened, Loften saw a dermatologist on May 26.
The dermatologist diagnosed him with Stevens-Johnson Syndrome (“SJS”), a less
advanced form of TEN. The following day, Lofton returned to the emergency
room and was soon admitted to the burn unit of Parkland Hospital for treatment
SJS and TEN are extremely rare maladies, occurring in only several
people per million each year. One known cause of the diseases is an
autoimmune reaction to medication. Whether ibuprofen is among the
medications that can cause TEN is a contested issue. In a similar case, the
Seventh Circuit noted that “[t]here is unquestionably an association
SJS/TEN and ibuprofen,” but such association might arise only from patients’
use of ibuprofen to combat the headaches and fevers associated with SJS/TEN.
Robinson v. McNeil Consumer Healthcare
, 615 F.3d 861, 868 (7th Cir. 2010).
The FDA is aware of the connection between ibuprofen and SJS/TEN and,
starting in February of 2005, required that ibuprofen labels carry a warning
about the symptoms of SJS/TEN. The warning listed skin reddening, rash, and
blisters among the signs of an allergic reaction. Also during February 2005, a
Case: 10-10956 Document: 00511764779 Page: 3 Date Filed: 02/22/2012
group that Appellees describe as “experts retained by plaintiffs in Motrin
litigation,” filed a Citizen’s Petition with the FDA. The petition sought
additional labeling requirements, including an express reference to SJS/TEN,
and alleged that McNeil and other manufacturers had withheld information
from the FDA regarding the risk of severe skin disorders. The FDA rejected the
petition, explaining that warnings beyond those already added would not be
useful. Regarding the allegations that McNeil and other manufacturers
withheld information, the agency stated: “[petitioners] provide no evidence to
support this allegation. In addition, we have no evidence that there is additional
undisclosed safety information that was withheld by the ibuprofen
Against this background, Lofton’s family filed suit asserting common law
negligence and strict products liability claims. Appellees moved for summary
judgment on all claims, asserting in particular that the failure to warn claims,
which are subject to a “fraud-on-the-FDA” proof requirement under Texas law,
are preempted by Buckman Co. v. Plaintiffs’ Legal Comm.
, 531 U.S. 341,
121 S. Ct. 1012 (2001). The district court delayed ruling on the motion until the
Supreme Court decided Wyeth v. Levine
, 555 U.S. 555, 129 S. Ct. 1187 (2009),
which asked the Court whether FDA approval of drug labels preempted state
failure to warn claims. Although Levine
rejected a sweeping view of preemption,
the district court in this case nevertheless granted the motion for summary
judgment insofar as it related to the preemption of the Texas provision. Lofton
v. McNeil Consumer & Specialty Pharms.
, 682 F. Supp. 2d 662, 676-78 (N.D.
Tex. 2010). The Loftons’ other claims have been dismissed.
Case: 10-10956 Document: 00511764779 Page: 4 Date Filed: 02/22/2012
Only one issue survives on appeal. Under Texas law, a drug manufacturer
enjoys a rebuttable presumption that it is not liable for failure to warn if the
FDA has approved “the warnings or information” accompanying the product
alleged to have harmed the plaintiff. TEX. CIV. PRAC. & REM. CODE
§ 82.007(a)(1). A plaintiff may rebut the presumption,
by establishing that . . . the defendant . . . withheld from ormisrepresented to the United States Food and Drug Administrationrequired information that was material and relevant to theperformance of the product and was causally related to theclaimant’s injury.
§ 82.007(b)(1). As an affirmative defense, McNeil raised the § 82.007(a)(1)
presumption, and the district court concluded that the conditions for invoking
the provision were satisfied because McNeil complied with all FDA requirements
governing the labels of over-the-counter ibuprofen. Lofton
, 682 F. Supp. 2d at
673. The court went on to consider the plaintiffs’ attempt to rebut that
presumption based on § 82.007(b)(1). The court first concluded that “extending
(a) In a products liability action alleging that an injury was caused by a failureto provide adequate warnings or information with regard to a pharmaceuticalproduct, there is a rebuttable presumption that the defendant or defendants,including a health care provider, manufacturer, distributor, and prescriber, arenot liable with respect to the allegations involving failure to provide adequatewarnings or information if:(1) the warnings or information that accompanied the product in its distributionwere those approved by the United States Food and Drug Administration for aproduct approved under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Section 301 et seq.), as amended, or Section 351, Public Health Service Act(42 U.S.C. Section 262), as amended; or (2) the warnings provided were those stated in monographs developed by theUnited States Food and Drug Administration for pharmaceutical products thatmay be distributed without an approved new drug application.
Case: 10-10956 Document: 00511764779 Page: 5 Date Filed: 02/22/2012
the holding of Buckman
to fraud-on-the-FDA exceptions is warranted.” Id.
675. In addition, after noting that the FDA rejected the 2005 Citizen’s Petition,
the court held that “section 82.007(b)(1) is preempted in some circumstances,
including as here, where Plaintiffs ask the court to reach the conclusion opposite
of that reached by the FDA, that Defendants did not withhold information or
mislead it.” Id.
As a result, the district court granted the Appellees’ motion for
summary judgement. Id.
at 681. This appeal followed.
STANDARD OF REVIEW
This court reviews a district court’s grant of summary judgment de novo
applying the same standard as the district court. Onoh v. Northwest Airlines,
, 613 F.3d 596, 599 (5th Cir. 2010). The court views all evidence in the light
most favorable to the nonmoving party and grants summary judgment if there
is no genuine issue of material fact and the movant is entitled to judgment as a
matter of law. Id.
Questions of law regarding preemption are reviewed de novo.
Tex. Midstream Gas Servs., LLC v. City of Grand Prairie
, 608 F.3d 200, 206 (5th
Provisions similar to § 82.007(a)(1) and (b)(1) have been subject to
conflicting treatment in the courts of appeals. The Sixth Circuit held that a
Michigan statute similar to the contested Texas provision is preempted in some
applications. Garcia v. Wyeth-Ayerst Labs.
, 385 F.3d 961 (6th Cir. 2004). The
Second Circuit, however, held the same Michigan statute not preempted.
Desiano v. Warner-Lambert & Co.
, 467 F.3d 85 (2d Cir. 2006), aff’d by an equally
divided court sub nom. Warner-Lambert Co., LLC v. Kent
, 552 U.S. 440,
128 S. Ct. 1168 (2008). Both cases interpreted Buckman,
which held that state
Case: 10-10956 Document: 00511764779 Page: 6 Date Filed: 02/22/2012
law fraud-on-the-FDA claims are preempted because they “conflict with the
FDA’s responsibility to police fraud consistently with the Administration’s
judgment and objectives.” Buckman
, 531 U.S. at 350, 121 S. Ct. at 1018.
, the Supreme Court held that state common law
failure to warn claims are not preempted by FDA approval of drug labels. Wyeth
555 U.S. 555, 129 S. Ct. 1187. Consequently, the Loftons’ appeal hinges on the
characterization of their case as presenting a failure to warn claim analogous to
, which is not preempted, or a fraud-on-the-FDA claim analogous to
is more analogous, we must determine whether
to follow the Second or Sixth Circuit concerning Buckman’
s applicability to
Buckman or Levine
held that federal law preempts state-law causes of action
claiming that a medical device manufacturer made fraudulent representations
to the FDA. 531 U.S. at 353, 121 S. Ct. at 1020. The case involved orthopedic
bone screws that the FDA approved in an expedited process as “substantially
equivalent” to devices already on the market. 531 U.S. at 346, 121 S. Ct. at
1016. Plaintiffs who suffered injuries after implantation of the screws brought
suit alleging that the manufacturer misled the FDA. They further alleged that
the misrepresentations were a “but for” cause of their injuries because, absent
the misrepresentations, the product would never have reached the market.
The Court rejected the novel cause of action because the state law claim
would conflict with the FDA’s authority to punish fraud on the agency. The
Court stated “that the federal statutory scheme amply empowers the FDA to
Case: 10-10956 Document: 00511764779 Page: 7 Date Filed: 02/22/2012
punish and deter fraud against the Administration.”
at 1017. Not only does federal law provide administrative tools to punish and
deter fraud, but the agency’s decision to employ those tools implicates its
discretion and special competence. Among the factors that make FDA
enforcement “a somewhat delicate balance of statutory objectives,” id.
, are the
need for administrative efficiency and the possibility that tort liability based on
inadequate disclosures would create “an incentive to submit a deluge of
information,” 531 U.S. at 351, 121 S. Ct. at 1019. The Court concluded that
authorizing tort liability for failure to comply with FDA disclosure requirements
“would exert an extraneous pull on the scheme established by Congress, and it
is therefore pre-empted by that scheme.” 531 U.S. at 353, 121 S. Ct. at 1020.
, the plaintiff brought a traditional failure to warn claim under
state common law for injuries accruing from the administration of Phenergan.
The defendant responded that because the FDA approved the drug labels, state
law claims were preempted. 555 U.S. at 559-60, 129 S. Ct. at 1191-92. The
Court rejected the preemption argument as an “overbroad view of an agency’s
power to pre-empt state law.” 555 U.S. at 574, 129 S. Ct. at 1199. Among other
reasons, the Court noted that the Food, Drug and Cosmetic Act (“FDCA”)
contains no express preemption provision regarding prescription drugs, and
federal law provides no remedy for consumers harmed by unsafe drugs. 555 U.S.
at 573-74, 129 S. Ct. at 1199. The Court was unpersuaded by the argument for
conflict preemption, which asserted that Wyeth could not simultaneously comply
with FDA labeling regulations and additional requirements imposed by state
2 The FDA has authority to investigate fraud, 21 U.S.C. § 372, consider citizen
petitions, 21 C.F.R. § 10.30, and seek criminal and civil penalties particular to fraud-on-the-FDA, 21 U.S.C. § 332-33. Buckman
, 531 U.S. at 349, 121 S. Ct. at 1017-18.
Case: 10-10956 Document: 00511764779 Page: 8 Date Filed: 02/22/2012
common law. Id. Levine
is not the Court’s first holding that state tort actions
can complement rather than conflict with FDA safety regulations. In Medtronic,
Inc. v. Lohr
, 518 U.S. 470, 495, 116 S. Ct. 2240, 2255 (1996), the Court held that
a finding of equivalency by the FDA, which led to approval of a medical device,
did not “den[y] Florida the right to provide a traditional damages remedy for
violations of common-law duties when those duties parallel federal
requirements.” Accord Buckman
, 531 U.S. at 353, 121 S. Ct. at 1020 (“Medtronic
can be read to allow certain state-law causes of actions that parallel federal
At first glance, the case at bar bears some resemblance to both Levine
. Texas adopted § 82.007 as a tort reform measure, intentionally
restricting certain common law claims concerning FDA-approved drugs except
where such claims closely parallel the procedures and results required by the
agency itself. Thus, Section 82.007(a)(1) creates a statutory presumption that
drug manufacturers and related parties are not liable for failure to warn claims
if the FDA approved the label. Under § 82.007(b)(1), the relevant exception here,
the presumption against liability can be rebutted if the plaintiff can “establish”
that the drug manufacturer “withheld” from the agency or “misrepresented”
“material” information “required” by the FDA. As in Buckman
, the plaintiffs
must show fraud-on-the-FDA for their claims to survive, but as in Levine
tort covered by the statute is a failure to warn products liability claim. This
hybrid appearance dissolves, however, when one focuses on § 82.007(b)(1), the
’s fraud-on-the-FDA analysis is more factually and legally
apposite to the interpretation of § 82.007(b)(1). Moreover, Levine
Case: 10-10956 Document: 00511764779 Page: 9 Date Filed: 02/22/2012
common law state tort claims that parallel or reinforce the agency’s efforts but
do not involve the relationship between the federal regulator and the regulated
entity, the dispositive factor for federal preemption in Buckman
. In fact, neither
the majority nor dissent in Levine
cut back on Buckman
or, indeed, found a state
law fraud-on-the-agency theory viable in this broader context. Only by denying
that the Texas statute is what it is—a requirement to prove fraud on the
prevail or Buckman
be distinguished. The question then
becomes whether to subscribe to the Sixth Circuit’s or Second Circuit’s
Competing Interpretations of Buckman
As noted above, the courts of appeals split on whether Buckman
preemption of a Michigan provision similar to § 82.007.
3 Although neither party mentions it, the presumption accorded defendants under the
Michigan law is broader than that in Texas law. The Michigan presumption covers severalproducts liability claims if a defendant’s product complies with FDA regulations, while theTexas presumption only applies to failure to warn claims. The statute reads, in relevant part:
(5) In a product liability action against a manufacturer or a seller, a productthat is a drug is not defective or unreasonably dangerous, and the manufactureror seller is not liable, if the drug was approved for safety and efficacy by theUnited States food and drug administration, and the drug and its labeling werein compliance with the United States food and drug administration's approvalat the time the drug left the control of the manufacturer or seller. . . . Thissubsection does not apply if the defendant at any time before the event thatallegedly caused the injury does any of the following:
(a) Intentionally withholds from or misrepresents to the United States food anddrug administration information concerning the drug that is required to besubmitted under the federal food, drug, and cosmetic act . . . and the drug would
Case: 10-10956 Document: 00511764779 Page: 10 Date Filed: 02/22/2012
Circuit concluded that the Michigan provision is preempted unless the FDA
itself finds that fraud has been committed during the approval process. 385 F.3d
at 966. The court observed that under Buckman
, state fraud-on-the-FDA claims
are impliedly preempted by the FDCA because the state provisions “inevitably
conflict with the FDA’s responsibility to police fraud consistently with the
Agency’s judgment and objectives.” Id.
965 (quoting Buckman
, 531 U.S. at
350, 121 S. Ct. at 1018). While the court recognized that the Michigan provision,
which requires evidence of fraud-on-the-FDA to rebut a presumption of non-
liability, is not a direct fraud-on-the-FDA cause of action, the court did not find
the difference from Buckman
Because the provision
ultimately requires the plaintiff to provide proof that the drug manufacturer
defrauded the FDA, it conflicts with the FDA’s duties and is preempted. Id
966. Where the FDA itself finds fraud, however, the Sixth Circuit would allow
the state claim to proceed because the state tort remedy does not intrude upon
the FDA’s responsibility or authority. Id.
Analyzing the same Michigan statute, the Second Circuit disagreed with
and distinguished the Michigan statute from Buckman
in three ways.
467 F.3d at 93. First, the traditional “presumption against preemption”
applied to the Michigan statute because it embodies a state’s regulation of health
and safety where the presumption “stands at its strongest.” Id.
at 94. The court
did not view the statute as an attempt to police fraud-on-the-FDA but instead
have not been approved, or the United States food and drug administrationwould have withdrawn approval for the drug if the information were accuratelysubmitted.
Case: 10-10956 Document: 00511764779 Page: 11 Date Filed: 02/22/2012
a prerequisite to allowing victims to recover under existing state product liability
Second, the underlying claims were traditional product liability claims
not involving a “newly-concocted duty” between the manufacturer and the
federal agency. Id.
at 94-95. Pairing the Michigan provision with the common
law claims distinguished the case from Buckman
, in which the only claim alleged
was fraud-on-the-FDA. Id.
at 95. Moreover, the Second Circuit posited that the
Michigan statute in its entirety creates an affirmative defense available to drug
manufacturers but does not render fraud-on-the-FDA, asserted on rebuttal by
a plaintiff, an “element” of the plaintiff’s claims. Finally, the court discounted
the likelihood that this provision—unlike a stand-alone fraud-on-the-FDA
claim—would engender practical conflict with FDA’s approval process and would
inflict a deluge of unnecessary information on the agency, as the Supreme Court
Buckman applied to TEXAS CIV. PRAC. & REM. CODE § 82.007(b)(1)
The Supreme Court has occasionally stated that a preemption inquiry
“start[s] 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.” Hillsborough Cnty., Fla. v. Automated Med. Labs., Inc.
471 U.S. 707, 715, 105 S. Ct. 2371, 2376 (1985) (internal citations omitted).
Among the traditional police powers, the Court has also occasionally recognized
“the historic primacy of state regulation on matters of health and safety.”
518 U.S. at 485, 116 S. Ct. at 2250. See also Wyeth
, 555 U.S. at 565,
129 S. Ct. 1194-95 (repeating these “presumptions”). But see Wyeth
555 U.S. 624 & n.14, 129 S. Ct. 1228-29 & n.14 (Alito, J., dissenting) (“But the
Case: 10-10956 Document: 00511764779 Page: 12 Date Filed: 02/22/2012
Court specifically rejected the argument . . . that the ‘presumption against
preemption’ is relevant to the conflict-preemption analysis.”). Most recently the
Court cast doubt on a presumption against preemption in PLIVA, Inc. v.
, ___ U.S. ___, 131 S. Ct. 2567 (2011). The five-member majority opinion
made no reference to the “presumption” in the course of upholding
implied conflict preemption over state law claims for failure to maintain
adequate warning labels for FDA-approved generic drugs. Id.
value or relevance a presumption against preemption of state tort law should
What we can conclude with confidence, though, is that the primacy of the
state’s police powers is not universal: “the relationship between a federal agency
and the entity it regulates is inherently federal in character because the
relationship originates from, is governed by, and terminates according to federal
, 531 U.S. at 347, 121 S. Ct. at 1017. Buckman
to apply a presumption against preemption of a state law claim for fraud-on-the-
FDA, as the Court reasoned that federal law dictates which information the
manufacturer is obliged to disclose and imposes penalties for omissions and
misrepresentations. 531 U.S. at 347-48, 121 S. Ct. at 1017. As a result,
disclosures to the FDA are “uniquely federal” and thus beyond the states’
traditional police power. Id.
State laws that depend on such disclosures are not
entitled to a presumption against preemption. Id.
Writing prior to Levine
’s or PLIVA
’s discussion, or omission, of the
“presumption against preemption,” both Garcia
presumption, but then diverged in their analyses. Garcia
Michigan Statute as preserving claims against drug manufacturers for
Case: 10-10956 Document: 00511764779 Page: 13 Date Filed: 02/22/2012
“circumstances involving, inter alia
, fraud on the FDA.” 385 F.3d at 965. The
court felt bound by Buckman
’s analysis. Id.
at 966. Desiano
, however, viewed
the Michigan law at a higher level of generality as just another state-law
harmful drug remedy, albeit a remedy limited by proof of fraud on the FDA
“submitted to neutralize a drugmaker’s use of an affirmative defense available
under state law.” 467 F.3d at 96. The presumption, in other words, might be
said to be tied to the courts’ ultimate preemption decision.
Even with the benefit of Levine
, this court is unable to assess
the current scope or existence of the presumption against preemption. We take
refuge in the conclusion that because § 82.007(b)(1) requires a Texas plaintiff
to prove fraud-on-the-FDA to recover for failure to warn, this requirement
invokes federal law supremacy according to Buckman
b. Section 82.007(b)(1) is a Fraud-on-the-FDA Provision
Section 82.007 is not, like the tort in Levine
, an expression of traditional
state common law. The Texas statute presumptively insulates from liability, for
failure to warn, defendants who made, prescribe, or sell drugs in accord with
FDA standards. TEXAS CIV. PRAC. & REM. CODE § 82.007(a)(1).
Section 82.007(b)(1) eliminates their protection only in cases where a defendant
committed the same fraud that federal law “amply empowers the FDA to punish
and deter.” Buckman
, 531 U.S. at 348, 121 S. Ct. at 1017. Although the
Supreme Court has interpreted the Supremacy Clause to permit some parallel
state law tort suits, the current case does not raise that issue. State tort claims
are impermissible if they “exist solely by virtue of the FDCA disclosure
, 531 U.S. at 353, 121 S. Ct. at 1020. To repeat, the
Texas statute requires a plaintiff to establish that a drug maker “withheld from
Case: 10-10956 Document: 00511764779 Page: 14 Date Filed: 02/22/2012
or misrepresented to the United States Food and Drug Administration required
information that was material and relevant to the performance of the product
and was causally related to the claimant’s injury.” § 82.007(b)(1). The term
“required information” refers to federal requirements under the FDCA; what is
“material” and “relevant” must be determined by FDA itself, not by state court
juries. This language inevitably relies on FDCA disclosure requirements. Thus,
this exception is “premised principally . . . on a drug maker’s failure to comply
with federal disclosure requirements.” Desiano
, 467 F.3d at 95.
The Second Circuit attached significance to its characterization of the
underlying claims in Desiano
as traditional tort claims not based on a duty
between a federal agency and drug manufacturer. Likewise, the Loftons’
attempt to distinguish their claim from Buckman
as a traditional failure to warn
tort claim. Parenthetically, the principal question briefed here is not whether
a traditional failure to warn claim is preempted, but whether § 82.007(b)(1), the
Texas fraud-on-the-FDA exception to a presumption, is preempted. But in any
’s and Appellants’ focus on “traditional” tort duties is
unpersuasive when the statute at issue conditions recovery on “establishing”
Also unpersuasive is the idea that it makes a difference for preemption
purposes whether fraud-on-the-FDA has become an “element” of traditional tort
claims because of the state statutes, or an item of rebuttal to a defendant’s
affirmative defense. We reject the Loftons’ specific argument that § 82.007(b)(1)
“is merely a legislative means to produce some evidence” of fraud on the FDA to
counter the insulation from liability otherwise afforded by § 82.007(a)(1). Either
way, under the Texas provision, a plaintiff must “establish” a violation of FDA’s
required disclosures. In so doing, the plaintiff necessarily re-treads the FDA’s
Case: 10-10956 Document: 00511764779 Page: 15 Date Filed: 02/22/2012
administrative ground both to conduct discovery and to persuade a jury. The
Appellants’ artful reasoning overlooks the reality of trial practice and the precise
We also disagree with the Second Circuit that statutes like § 82.007(b)(1)
and the Michigan statute do not pose the same over-disclosure problems that
contemplated. The Supreme Court was concerned that “disclosures
to the FDA, although deemed appropriate by the Administration, will later be
judged insufficient in state court.” Buckman
, 531 U.S. at 351, 121 S. Ct. at 1019.
When the FDA has not found fraud, two sorts of interference arise from these
claims. First, § 82.007(b)(1) allows the state court to interject varying views on
what disclosures are sufficient. The resulting uncertainty compels
manufacturers to flood the FDA with information to ensure that they retain the
§ 82.007(a)(1) presumption of non-liability. FDA in turn loses control over its
ability, based on scientific expertise, to prescribe––and intelligently limit––the
scope of disclosures necessary for its work. Second, the statutory requirement
of proving fraud-on-the-FDA may directly invade the agency’s processes when
close questions of “withholding” or “misrepresentation” arise. These dangers are
inherent in Buckman
’s concern to preserve the agency’s discretion to police the
strains to evoke distinctions between the claim in Buckman
and the Michigan statute, the Sixth Circuit’s approach is more faithful to
. In cases like this, where the FDA has not found fraud, the threat of
imposing state liability on a drug manufacturer for defrauding the FDA intrudes
on the competency of the FDA and its relationship with regulated entities.
Case: 10-10956 Document: 00511764779 Page: 16 Date Filed: 02/22/2012
Under such circumstances Buckman
found a violation of the Supremacy Clause.
Thus, § 82.007(b)(1), is preempted unless the FDA itself has found fraud.4
Appellants argue for the first time on appeal that § 82.007(b)(1) is not
severable from § 82.007(a). The district court, while concluding that federal law
preempts § 82.007(b)(1), did not discuss the presumption of adequate warning
in § 82.007(a). Appellants concede the severability argument is newly raised.
“[A]rguments not raised before the district court are waived and will not be
considered on appeal unless the party can demonstrate extraordinary
circumstances.” French v. Allstate Indem. Co.
, 637 F.3d 571, 582-83 (5th Cir.
2011). The Fifth Circuit has a “virtually universal practice of refusing to
address matters raised for the first time on appeal.” Karl Rove & Co. v.
, 39 F.3d 1273, 1280 (5th Cir. 1994). There is no reason to deviate
Because we conclude that § 82.007(b)(1) is a fraud-on-the-FDA provision
analogous to the claim considered in Buckman
, we hold that it is preempted by
the FDCA unless the FDA itself finds fraud. The judgment of the district court
4 Having decided that § 82.007(b)(1) is preempted, we need not review the district
court’s factual determination that because FDA rejected the 2005 Citizen’s Petition, the agencynecessarily found that the Appellees neither withheld information nor misled it.
Claudication Treatment Comparative Effectiveness: Authors: Timothy P Murphy, Donald E. Cutlip, Judith G. Regensteiner, Emile R. Mohler III, David J. Cohen, Matthew R. Reynolds, Beth A. Lewis, Joselyn Cerezo, Niki C. Oldenburg, Claudia C. Thum, Alan T. Hirsch. Presenter: Alan T. Hirsch, Chair, on behalf of the CLEVER Study Investigators Acknowledgements and Disclosures Ackn
Experiment 2 2/1 Inorganic Chemistry II THE OXIDATION STATES OF VANADIUM References 1. Folder entitled "The Chemistry of Vanadium" on your bench. 2. Cotton and Wilkinson "Basic Inorganic Chemistry" sections 24-9 to 24-12. 3. Huheey, "Inorganic Chemistry" (3rd edition) Appendix F. 4. Shriver, Atkins, and Langford, "Inorganic Chemistry" chapter 8 Background