"wyeth v. levine: limits on the scope of fda preemption and implications for drug and medical device manufacturers," bna's pharmaceutical law & industry report (april 2009)
PHARMACEUTICAL LAW & INDUSTRY!
Reproduced with permission from PharmaceuticalLaw & Industry Report, 7 PLIR 388, 04/03/2009. Copy-right 2009 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com
Wyeth v. Levine: Limits on the Scope of FDA PreemptionAnd Implications for Drug and Medical Device Manufacturers
BY KAREN A. GIBBS, HEATHER L. HODGES, AND
nies instead now face both a new regime within theFDA and the continued threat of unpredictable litiga-
tion exposure to a myriad of state product liability lawschemes.
I. Preemption Defense Provides Little Shelter
II. Wyeth v. Levine: Turning Back the Clock
On March 4, 2009, the United States Supreme
Court, in the case of Wyeth v. Levine, rejected
At its core, Wyeth v. Levine was a medical malprac-
what many industry observers had predicted
tice case. Vermont resident Diana Levine was a patient
would curb product liability litigation involving pre-
at a local clinic where she was treated for migraine
scription pharmaceuticals: judicial endorsement of the
headaches with two drugs: Demerol for her headache
argument that the U.S. Food and Drug Administration’s
and Phenergan for her nausea. Phenergan is Wyeth’s
(the ‘‘FDA’’) approval of a drug’s label provided a com-
brand name for the antihistamine promethazine hydro-
plete defense to state-law tort claims premised on the
chloride. Phenergan is marketed in an injectable form
inadequacy of the label.1 Deprived of this shield against
that is delivered directly into a patient’s vein, the ‘‘IV-
mounting litigation expenses, pharmaceutical compa-
push method,’’ or via an ‘‘I-V drip’’ protocol in whichthe drug is mixed with a saline solution in a hanging in-
travenous bag. The label for Phenergan contained a
Wyeth v. Levine, No. 06-1249, —- S. Ct. —-, 2009 WL
warning against intra-arterial use due to the likelihood
529172 (Mar. 4, 2009) (7 PLIR 249, 3/6/09).
of severe arteriospasm and the possibility of resultant gangrene. Karen A. Gibbs is a partner in the Healthcare
In April 2000, Levine visited the clinic and received
Group of Crowell & Moring LLP’s Orange
an intramuscular injection of Demerol and Phenergan. County, Calif., office; she also is on the advi-
She returned to the clinic later that day for a second in-
sory board for BNA’s Medical Devices Law
jection after the initial injection failed to relieve her
& Industry Report. She can be reached
symptoms. The physician assistant used the IV-push
directly at [email protected] and (949) 798-
method for the second injection, and the needle pen-
1329. Heather L. Hodges, counsel, is a mem-
etrated an artery. Levine subsequently developed gan-
ber of the firm’s Torts and Product Risk Man-
grene resulting in the amputation of her right hand and
agement groups; Kristina M. Pisanelli,
forearm. Since Levine was a musician, she sustained
associate, is a member of the firm’s Public
significant damages in the form of lost income. Her
Policy Group. Hodges and Pisanelli both prac-tice in the firm’s Washington office.
settled her claims against the clinic and medical person-nel and successfully pursued an action for damages
COPYRIGHT 2009 BY THE BUREAU OF NATIONAL AFFAIRS, INC.
against the manufacturer, Wyeth.2 The gravamen of Le-
not itself provide any remedies for consumers harmed
vine’s claims was that the Phenergan label in use at the
by unsafe pharmaceutical products. The Court notes in
time of her injury, failed to adequately warn of the
its opinion that it granted Wyeth’s petition for certiorari
higher risk of adverse effect associated with the IV-
not just because of the preemption issues but also be-
push method. She also claimed that Phenergan was not
cause the FDA had recently—and apparently in a
‘‘reasonably safe’’ to use as prescribed because the risk
of gangrene and amputation exceeded the claimed
announced that agency approval should preempt state
tort law.5 The Court then set forth an analytical frame-
At the trial court level, Wyeth lost a summary judg-
work which left no mystery as to how the majority
ment motion premised on the argument that federal law
would find on the issue of whether Levine’s state tort
preempted Levine’s failure-to-warn claims. Wyeth ini-
claims were preempted: in the absence of evidence
tially argued that there was both field preemption and
demonstrating congressional intent to preempt tradi-
conflict preemption which together provided a com-
tional areas of state authority, there must be a presump-
plete defense since (a) the warnings on the Phenergan
label had been provided by the FDA when it approved
A review of the legislative history of the 1906 Pure
Wyeth’s New Drug Application (‘‘NDA’’) for Phenergan
Food and Drug Act, which was replaced by the 1938
in 1955 and (b) subsequent changes have been made to
Food, Drug and Cosmetic Act (‘‘FDCA’’) and its subse-
the original label. The trial court rejected both preemp-
quent amendments, led the Court to two critical conclu-
tion contentions. The trial court also did not find that
sions. First, there was evidence that Congress intended
there was any evidence of a substantial regulatory
to preserve state law claims going so far as to add a sav-
record documenting an attempt by either Wyeth or the
ings clause in a round of 1962 Amendments that ex-
FDA to engage each other on the issue of whether a
pressly provided that a provision of state law could only
stronger warning against intra-arterial injection was
be invalidated if there was a direct and positive conflict
necessary. A more complete examination of the regula-
with the FDA. The 1962 Amendments also switched the
tory record during the trial uncovered no stronger evi-
burden of establishing that a drug was safe and effec-
dence that the issue of the adequacy of the warning re-
tive to the manufacturers and away from the FDA
garding intra-arterial injection had been rigorously ex-
which historically needed to establish that a drug was
harmful before it could be removed from the market.
In what is likely to be a harbinger of how future
A second and arguably more persuasive fact was that
courts address this evidence, the Vermont trial court in-
in 1976 Congress amended the FDCA to add an express
structed the jury that it could consider Wyeth’s evi-
preemption provision for medical devices but made no
dence of compliance with FDA regulation but that mere
parallel provision for prescription drugs. Equally sig-
compliance did not establish that the warnings were ad-
nificant to the Court as this legislative activity preced-
equate. Equally problematic for Wyeth’s position was
ing Levine’s lawsuit, was the fact that in 2007 Congress
an FDA regulation which permits a drug manufacturer
again revisited the FDCA and granted the FDA statu-
to change a product label to add or strengthen a label
tory authority to require a manufacturer to revise its la-
without prior approval, commonly referred to as the
bel based on safety information available after the
‘‘Changes Being Effected’’ or ‘‘CBE’’ regulations. 3
drug’s approval. Congress did not however enact a pro-
After the jury reached a verdict in Levine’s favor and
posed provision in the Senate’s version of the bill which
found that Wyeth was negligent for failing to provide an
would have required prior FDA approval for all changes
adequate warning, Wyeth moved for judgment as a
to drug labels.6 From the Court’s perspective, the con-
matter of law again on preemption. In denying the mo-
clusion was inevitable: not only could prescription drug
tion, the trial court again concluded that there was no
manufacturers make a change to their label without
conflict between the FDA regulations and Levine’s
prior FDA approval, they also had an obligation to keep
state-law claims because Wyeth could have strength-
ened the warnings consistent with FDA regulations and
The Court then dispatched Wyeth’s attempt to use
preemption as a complete defense. Wyeth’s strongest
Unsurprisingly, what appears to be a basis for the Su-
and primary argument was premised on its contention
preme Court’s holding is the belief that preservation of
that it was ‘‘impossible’’ for it to comply with federal la-
consumers’ state rights of actions is a necessary
beling regulations and state law duties derived from
complement to a federal regulatory scheme which does
state law claims. Wyeth took the position that the CBEregulation was not availing with respect to the Phener-gan label because it permits a manufacturer to revise
2 See, e.g., Adam Liptak, Drug Label, Maimed Patient And
the label based on ‘‘newly acquired information’’ and
Crucial Test for Justices, N.Y. Times at A1 (Sept. 19, 2008);David G. Savage, Drug makers seek shield from suits, L.A. Times at 16 (Sept. 7, 2008); Miriam Hill, When can a drug con-
5 In 2006, the FDA published a notice of final rulemaking
sumer sue? The principle of ‘preemption’ could strengthen
which sets forth new regulations governing the content and
FDA, Philadelphia Inquirer at C1 (Nov. 2, 2008).
format of prescription information. 71 Fed. Reg. 3922 (Jan. 24,
3 FDA regulations provide that a manufacturer can change
2006) (4 PLIR 69, 1/20/06). Included in the notice was the
a label to add or strengthen a contraindication, warning, pre-
broad statement that the agency believed that its approval of a
caution, or adverse reaction to add or strengthen an instruc-
drug label preempted conflicting or contrary state law. ‘‘FDA
tion about dosage and administration that is intended to in-
believes that under existing preemption principles, FDA ap-
crease the safe use of the product without FDA approval and
proval of labeling under the act, whether it be in the old or new
upon the filing of a supplemental application. See 21 C.F.R.
format, preempts conflicting or contrary State law.’’ Id. at
Levine v. American Home Products, Inc., 2004 WL
6 See Food and Drug Administration Revitalization Act, S.
5456809 (Vt. Super. July 30, 2004)(trial court order denying
1082, 110th Congress, § 208 at 107-04 (2007) as passed (pro-
Wyeth’s motion for judgment as a matter of law).
COPYRIGHT 2009 BY THE BUREAU OF NATIONAL AFFAIRS, INC.
the plaintiff failed to point to any newly-discovered evi-
any discussion of how state law had interfered with
dence of the risks of IV-push administration. The Court,
FDA regulation in the nearly 100 years since the FDCA
however, pointed to the FDA’s own explanation of the
was enacted. To the contrary, the Court cited to numer-
proposed scope of this provision which noted that
ous reports which concluded that the FDA had limited
‘‘newly acquired information’’ referred to both new
resources to monitor the thousands of drugs on the
data as well as new analyses of previously submitted
market and this supported the conclusion that (1) state
data. Thus, since evidence in the case established that
tort suits were a necessary safety net for consumers and
Wyeth first received notice of a case in which a Phener-
(2) state law could and had existed peaceably with fed-
gan injection led to gangrene and an amputation in
eral regulation and that the regulators themselves had
1967, as additional adverse events were reported over
time, the company could have added a stronger warn-ing against IV-push administration.
III. Reconciling Levine and Riegel: Moving
Wyeth also was not successful in persuading the
Court that if it had unilaterally added a warning, it
would have violated federal law governing unautho-
As the Court noted in Wyeth v. Levine, the FDCA
rized distribution and misbranding. As a practical mat-
does provide for express preemption of state law claims
ter, the Court did not believe that the FDA would bring
involving medical devices that have been subjected to
an enforcement action against Wyeth for strengthening
premarket approval (PMA) by the FDA. In Riegel v.
a warning. As a legal matter, it did not believe that a
Medtronic Inc., in an 8-1 decision, the Court barred a
stronger warning would have rendered Phenergan a
suit claiming a New York man suffered permanent in-
‘‘new drug’’ as that term is defined in the regulations or
jury when a Medtronic heart catheter burst during an
a ‘‘misbranded drug’’ since the misbranding regulations
angioplasty procedure.7 The Court ruled that federal
are focused on labels that fail to provide adequate warn-
medical device law preempts state tort claims against
ings. In short, in light of Wyeth’s ability to adopt (at
manufacturers whose products are approved through
least on a temporary basis) a label with a stronger
warning and in the absence of ‘‘clear evidence’’ that theFDA would not have approved a supplemental applica-
Under the FDCA, federal law bars the imposition of
tion to revise the label, there was no basis for conclud-
any state ‘‘requirements’’ that are ‘‘different from’’ or
ing that it was ‘‘impossible’’ for Wyeth to comply with
‘‘in addition to’’ requirements established by the FDA.
both federal and state labeling requirements.
The Court previously held that this express preemptionprovision does not bar state law claims against makers
Wyeth also failed to persuade the Court that, as a
of devices that have gone through FDA’s 510(k) pro-
matter of policy, requiring it to comply with state law
cess, also known as ‘‘pre-market notification,’’ because
duties would obstruct and undermine the purposes and
that process does not create device-specific federal re-
objective of the federal drug labeling regulation
quirements that trigger preemption. In an earlier case,
scheme. The Court found no merit to this argument
Medtronic Inc. v. Lohr, the Court left unanswered the
which it concluded rested on a misapprehension of both
question of whether the PMA process—which is more
Congress’s intent and the FDA’s power to announce the
rigorous than the 510(k) process—creates the kind of
preemption of state law. First, the Court found that the
device-specific federal requirements that are needed to
evidence in the record established that while the FDCA
was enacted to protect consumers from unsafe or inef-fective drugs, it did not provide any remedies to those
In the Riegel case, petitioner Donna Riegel argued
harmed by the products. Instead, the lack of an express
that claims arising out of injuries caused by the burst-
preemption provision and the availability of relief for
ing of a balloon catheter during angioplasty should be
consumers via state rights of actions strongly suggested
allowed to go forward, even though the catheter used in
the lack of any intent to preempt state tort remedies. As
surgery received PMA approval. The Court, however,
additional support, the Court cited to its own preemp-
rejected that argument and held that the express pre-
tion jurisprudence which held that the case for finding
emption language governing medical devices barred
federal preemption is weakened when there is evidence
such litigation. The decision aligns with the majority of
that Congress is aware of state law in a field of interest
cases in which courts have considered the issue of
yet decides to tolerate the tension between federal regu-
‘‘whether approval via the PMA process’’ bars state
claims. Thus, going forward, at least in the short term,manufacturers are confronted with two problematic le-
In light of this evidence of a strong presumption
gal frameworks for analyzing product liability litigation
against FDCA preemption of state tort law, it is not sur-
prising that the Court declined to give any deference to
With respect to prescription drug manufacturers,
the FDA’s assertion in the preamble to the Final Rule
Wyeth v. Levine does not completely foreclose the avail-
that regulatory approval of a label preempted state tort
ability of a complete preemption defense. The Court,
liability. To merit deference, the FDA was required to
however, has offered little guidance about what consti-
show that prior to announcing its explanation of the im-
tutes a regulatory record which would support a finding
pact of state law on its federal scheme, it must be the
of preemption beyond the obvious case of a manufac-
result of thorough analysis, be consistent and be per-
turer who has been ordered not to strengthen or add a
suasive. The FDA failed on all three accounts: the Final
particular warning. Guidance may come from the lower
Rule and preamble were finalized without offering the
courts in a handful of cases that were stayed pending a
states or other interested parties an attempt to comment
decision in the Wyeth v. Levine case. These cases in-
on the proposal; it was at odds with the record evidenceof Congress’s purposes; and it reversed without expla-nation its historically anti-preemption stance. The
Court was struck by the fact that the preamble omitted
PHARMACEUTICAL LAW & INDUSTR Y REPOR T
clude two Third Circuit Court of Appeals cases in which
rights to pursue state law claims against the manufac-
prescription drug manufacturers successfully prevailed
turers of medical devices. On March 5, 2009, House En-
on a preemption defense and which the Court has now
ergy and Commerce Health Subcommittee Chairman
remanded back to the Court of Appeals for further re-
Frank Pallone, Jr. (D-N.J.) and House Energy and Com-
merce Chairman Henry Waxman (D-Calif.) introduced
The picture is even cloudier for medical device manu-
the Medical Device Safety Act of 2009 (H.R. 1346)
facturers. As anticipated, post-Riegel, medical device
(‘‘MDSA’’). If passed, the MDSA would authorize state
manufacturers scored numerous legal victories. For ex-
product liability lawsuits for medical devices, effectively
ample, in In re Medtronic, Inc. Sprint Fidelis Leads
overturning the U.S. Supreme Court’s 2008 decision in
Products Liability Litigation, a district court dismissed
Riegel v. Medtronic. Introduction of this legislation
all twenty-one counts in an MDL master complaint in-
came just one day after the Supreme Court’s ruling in
cluding claims alleging consumer fraud and a number
of derivative claims (e.g., loss of consortium).10 How-
The MDSA was referred to the House Energy and
ever, plaintiffs have already won a motion to file a pro-
Commerce Committee and has seventy-three co-
posed revised and amended complaint to plead a claim
sponsors. Also on March 5, 2009, Senate Health, Edu-
for damages based on what they claim are newly re-
cation, Labor and Pensions Chairman Edward Kennedy
ceived FDA documents and a revised allegation—
(D-Mass.) introduced companion legislation in the Sen-
consistent with Wyeth v. Levine —that Medtronic failed
ate (S. 540). The Senate bill has eighteen co-sponsors
to amend a warning on the product without FDA ap-
and has been referred to the Senate Health, Education,
Labor and Pensions Committee. Supporters of the new
In the wake of Levine and Riegel, the United States
legislation include editorial writers in the New England
Congress has taken initial steps to restore consumers’
Journal of Medicine and the leadership of the AmericanBar Association, which have both adopted the positionthat state product liability suits are necessary to hold
9 See Colacicco v. Apotex, Inc., No. 08-437, —- S. Ct. —-,
manufacturers accountable and to ensure safe medical
2009 WL 578682 (Mar. 9, 2009) (vacating judgment and re-
manding to the United States Court of Appeals for the ThirdCircuit for further consideration in light of Wyeth v. Levine);Pa. Employees Benefit Trust Fund v. Zeneca, Inc., No. 07-822,
12 Gregory Curfman , M.D., Stephen Morrisey, M.D., and
—- S. Ct. —-, 2009 WL 578681 (Mar. 9, 2009) (same) (7 PLIR
Jeffrey M. Drazen M.D., The Medical Device Safety Act of
10 592 F. Supp. 2d 1147 (D. Minn. 2009), mot. for reconsid-eration denied, No. 08-1905 (RHK/JSM), 2009 WL 294353 (Feb
from H. Thomas Wells, Jr., President of the American Bar As-
11 In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liability,
Committee on Health, Committee on Energy and Commerce
COPYRIGHT 2009 BY THE BUREAU OF NATIONAL AFFAIRS, INC.
Gdansk, 13.03.2012 PP 19: Institute of Fluid-Flow Machinery, Polish Academy of Science Gdansk, 13.03.2012 Characteristics of the deliverable according to detailed work plan Description according to project application: Renewable Energy Guide is supposed to foster processes to identify all necessary steps that need to be taken when developing new models for sustainable ene
Condiciones cognitivas para un desarrollo sostenible Literatura de referencia. ( En castellano:) El Capitalismo en la era de la Globalización . Paidos 1999. La condición humana. Editorial Paidos 1992. Las etapas del pensamiento sociológico. Siglo XX. 1970. Teoria Social de Giddens. Prometeo, 1999. La formación del espíritu científico. Siglo XX. 1974. El desorden, La t