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PREEMPTING A PROBLEM: MENSING, TEVA, AND THE PROPER SCOPE OF CONFLICT
State-law product liability claims provide a powerful incentive for companies to create
safe products. Federal law, however, provides a defense for manufacturers: preemption of state-
law claims when federal and state law conflict such that dual compliance is impossible. The
Supreme Court recently addressed the scope of conflict preemption regarding state-law failure-
to-warn claims against generic drug manufacturers in PLIVA, Inc. v. Mensing
however, lingered regarding the scope of Mensing
and the California judiciary adopted a narrow
reading of Mensing
in Teva Pharmaceuticals USA, Inc. v. Superior Court
,2 allowing a plaintiff to
advance state-law failure-to-warn claims against a generic drug manufacturer. The defendants
appealed to the Supreme Court, arguing that the claims were preempted based on a broad reading
. On January 20, 2015, the Supreme Court denied the petition for writ of certiorari.
This Paper argues that the Supreme Court should have heard the case and affirmed the California
appellate court's decision because precedent and public policy suggest that conflict preemption
should be a demanding and limited defense to state-law tort claims.
I. Failure-to-Warn Claims, Conflict Preemption, and Mensing
Under state law, a manufacturer that sells a product with inadequate warnings may be
liable to an injured consumer for any harm caused by that failure to warn.3 But state law is not
1 PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2012).
2 Teva Pharmaceuticals USA, Inc. v. Superior Court of Orange County, 217 Cal. App. 4th 96
RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY §§ 1, 2(c) (1998).
alone in affecting product safety: the Federal Food, Drug and Cosmetic Act (FDCA) empowers
the Food and Drug Administration (FDA) to ensure the safety and efficacy of drugs, which
includes oversight over labeling in order to warn consumers of harmful side effects.4 When state
and federal law conflict, however, state law must be disregarded because the Supremacy Clause
states that federal law "shall be the supreme law of the land."5 State and federal law conflict
when it is "impossible for a private party to comply with both state and federal requirements."6
This doctrine is known as conflict preemption and it is a powerful defense that can insulate drug
manufacturers from state-law tort claims insofar as they comply with the FDCA.
In order for a new drug to be sold, the FDCA requires that the manufacturer prove that
the drug is safe and effective for its intended use and that the proposed label for the drug is
accurate and adequate. There are regulatory differences, however, between name-brand and
generic drugs. Name-brand drugs refer to pioneer products with original uses or chemical
compositions and they must supply their own scientific data proving safety and efficacy. Generic
drugs, however, have the same intended use and composition as drugs already on the market, and
may reference the scientific data of an approved name-brand drug. As a condition on using the
name-brand's data, the labeling for the generic must be identical to the reference drug's labeling.
4 See generally
21 U.S.C. §§ 301–399f (2012). The FDA regulates "labeling," which means "all
labels and other written, printed, or graphic matter (1) upon any article or any of its containers or
wrappers, or (2) accompanying such article." Id.
§321(m). A physical connection to the article is
not necessary for material to count as "labeling." Kordel v. United States, 335 U.S. 345, 350
5 U.S. CONST. art. VI, cl. 2.
6 Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995).
Name-brand manufacturers may strengthen their warning labels after FDA approval, but generic
manufacturers may not unilaterally strengthen their warning labels. Generic labeling must always
be the same as the labeling of the reference product, thus, "generic drug manufacturers have a
federal duty of ‘sameness.'"7
, the Supreme Court held by a 5-4 vote that federal law preempted a state-law
tort claim against a generic drug manufacturer for failing to update a warning label. The
plaintiffs in Mensing
took a generic drug, metoclopramide, and suffered tardive dyskinesia, a
severe neurological disorder, as a side effect. The plaintiffs sued the manufacturer under state
law, alleging a failure to provide adequate warning labels because even though there was
evidence that long-term use of metoclopramide carried a greater risk than was indicated on the
label, the defendants did not strengthen their warnings. The Court found that it was impossible
for the generic manufacturers to unilaterally change their labels to provide an adequate warning.
The only action that the manufacturers could have taken was to petition the FDA to require
stronger warnings, which was sufficiently impossible to warrant preemption.8 Hence, the Court
found that the plaintiffs' state-law failure-to-warn claims against the generic manufacturer were
preempted by the FDCA's duty of sameness.9 Although, the scope of the majority's holding—
that generic manufacturers cannot be sued for failing to warn given the name-brand
manufacturer's failure to update the product's labeling—was not clearly defined.
II. Teva and the Disputed Scope of Conflict Preemption
, 131 S. Ct. at 2575.
8 The Court stated that the test for "impossibility" is "whether the private party could
independently do under federal law what state law requires of it." Id.
The riddles of Mensing
surfaced in Teva Pharmaceuticals USA, Inc. v. Superior Court
, the plaintiff suffered injuries from taking a brand-name drug, Fosamax, and its generic,
alendronate sodium. Fosamax is meant to treat osteoporosis, but long-term use can cause femur
fractures. In April 2011 the Teva
plaintiff suffered a femur facture, allegedly due to her
prolonged use of either Fosamax or alendronate sodium. The suit was pleaded under state law
and filed against several manufacturers in the Orange County Superior Court in California. The
trial court concluded that the plaintiff's failure-to-warn allegations were not preempted, but
certified the question of preemption to the California Court of Appeal for the Fourth District,
citing "substantial grounds for difference of opinion" due to the Supreme Court's decision in
.10 The appellate court applied Mensing
to the state-law claims and found that it was
possible for the defendants to comply with both federal and state duties. Specifically, the
defendant could have communicated updated safety information to physicians, but did not. The
allegedly tortuous conduct, thus, was a failure to disseminate FDA-approved warnings.
Standing in opposition to Teva
, the Fifth Circuit in Morris v. PLIVA, Inc.
broadly. The plaintiff in that case took a generic drug, suffered tardive dyskinesia, and
sued its manufacturers, alleging state-law tort claims. The plaintiff contended that the claims
were not preempted because Mensing
did not preempt claims alleging that a defendant failed to
communicate approved warnings. But the Fifth Circuit rejected this, finding that Mensing
preempted such claims because the duty of sameness extends "beyond just a label change."12
10 Teva Pharmaceuticals USA, Inc. v. Superior Court of Orange County, 217 Cal. App. 4th 96,
11 Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013).
Accordingly, the court found that the defendants could not unilaterally send out "Dear Doctor"
letters13 to health care professionals because that would violate the duty of sameness: "Under
federal law, the inquiry is whether the brand-name manufacturers sent out a warning, not
whether the proposed warning to be disseminated contains substantially similar information as
the label."14 Hence, the Fifth Circuit found the plaintiff's claims to be preempted since it was
impossible for the generic manufacturers to comply with the state-law duty in light of the brand-
name manufacturer's refusal to send out "Dear Doctor" letters, which was not impossible under
III. Preempting Further Error
Courts facing conflict preemption disputes should adopt the narrow understanding of
found in Teva
. The Fifth Circuit's holding in Morris
should be ignored due to its feeble
reading of precedent and the policy goal of incentivizing safe products.
A. Precedent Supports a Narrow, Substantive Approach to Conflict Preemption
The Fifth Circuit's reading of Mensing
is illogically broad. As applied to "Dear Doctor"
interpreted the Mensing
test to be "whether the brand-name manufacturers sent
out a warning, not whether the proposed warning to be disseminated contained information that
is substantially similar to the label."15 This interpretation likely comes from dicta in Mensing
regarding Dear Doctor letters: "A Dear Doctor letter that contained substantial new warning
would not be consistent with the drug's approved labeling . . if generic drug
13 A "Dear Doctor" letter is a letter sent from a medical company to a physician, informing the
medical professional of the uses and risks of the company's product.
, 713 F.3d at 777.
manufacturers, but not the brand-name manufacturer, sent such letters, that would inaccurately
imply a therapeutic difference . . and thus, could be impermissibly ‘misleading.'"16 The Fifth
Circuit could have read this language two ways: dispersing Dear Doctor letters without
substantial new warning information violate the duty of sameness or that dispersing such letters
would not. The Fifth Circuit held that even without substantial new warning information, a claim
against a generic manufacturer alleging a failure to warn by not sending "Dear Doctor" letters
would still be preempted if the brand-name manufacturers had not sent such letters. Why would
the Supreme Court mention "substantial new warning information" as part of the preemption-
triggering example, if not to imply that letters without
substantial new warning information
would not violate the duty of sameness? The Fifth Circuit focused on the act of sending Dear
Doctor letters instead of the information contained within those letters. While this is a possible
reading of Mensing
, it seems inimical to the plain meaning of the words.
The issue in Mensing
was whether conflict preemption should take into account the
possible actions by third parties. The Supreme Court held that possible actions by third parties
were insufficient to show the possibility of compliance with both state and federal law. The
relevant third-party inaction in Mensing
, however, had to do with FDA approval of stronger
warnings. But Morris
found impossibility based on the inaction of brand-name companies to
send out Dear Doctor letter containing information that already had FDA approval and that
matched the generic labeling. While the Fifth Circuit may have thought the facts of Morris
nearly identical to Mensing
, the two cases are meaningfully distinct. There is a difference
between the content of a warning label and the act of disseminating the content of those labels;
the former is a substantive requirement of the FDCA, while the latter is a procedural mechanism
16 PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2576 (2012) (emphasis added).
for dispensing information. Mensing
found preemption in the first scenario based on the inability
of generic manufacturers to act independently, but Morris
erred in applying Mensing
to the latter
scenario. In effect, Morris
finds impossibility, and hence preemption, based on advertising
efforts, which seems to be an improper extension of Mensing
, which was focused on the
product's warning, not that warning's audience.
B. Public Policy Demands a Limited Conflict Preemption Jurisprudence
The Supreme Court has stated that "the purpose of Congress is the ultimate touchstone in
every pre-emption case."17 It is noteworthy that the type of preemption at issue here is implied
preemption, not express preemption. Express preemption is when Congress explicitly includes a
statutory provision to preempt state law whereas implied preemption is determined by a conflict
of law that render state and federal compliance impossible. Congress has never stated that the
FDCA preempts all state law claims against generic-drug manufacturers. Indeed, state-law
litigation against drug companies has become a fixture of the legal landscape. Hence, Congress
has acquiesced to the vitality of state-law tort claims against drug manufacturers and courts
should not needlessly expand conflict preemption doctrine against the implicit will of the
Product liability is an important means to ensure that consumers are well-informed about
drug risks. Federal regulation is crucial for ensuring drug safety, but by eliminating state-law
duties through an expansive conflict preemption jurisprudence, courts eviscerate a strong
deterrence to corporate misconduct. Broadly construing conflict preemption is a misallocation of
risk from sophisticated entities with marketplace agency to individual consumers that may be
victimized by negligence. Given the importance of public health and the general population's
17 Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996).
lack of medical knowledge, drug companies should be exposed to the highest potential of
liability in order to ensure that consumers are informed about the health products in which they
place their trust.
State-law product liability claims play an important role in consumer protection. Mensing
is best read as a route application of precedent, which is compatible with the vitality of state-law
tort claims against generic drug manufacturers. The California appellate courts in the Teva
were correct, but the Supreme Court should have affirmed that state court holding to fully
repudiate the mistakes that some courts have made interpreting Mensing
. Courts should continue
to construe conflict preemption as a narrow defense, instead of extending Mensing
inappropriate situations. Conflict preemption doctrine in the FDCA context should be recognized
as limited by its focus on the substance of warning information approved by federal law, and the
policy goal of ensuring consumer safety should counsel against an interpretation of precedent
that suggests otherwise.
Responsabilité du médecin Le consentement thérapeutique et le consentement économique éclairés du patient Quelles sont l'origine et l'évolution du consentement libre et éclairé du patient ? Quelle est la portée de cette notion ? Qui est le garant du consentement ? Qu'en est-il de la prise en charge du traitement ? Y a–t-il
Martin Howe QC: Curriculum Vitae and Practice Summary MARTIN HOWE Q.C. 8 New Square, Lincoln's Inn London WC2A 3QP Tel: 020 7405 4321 Fax: 020 7405 9955 Chambers website: SUMMARY OF PROFESSIONAL PRACTICE Chambers of Mark Platts-Mills QC Called to the Bar: 1978. Appointed Queen's Counsel: 1996.