The Role of Consumer Protection Law in Prescription Drug Advertising
Lauren Guth Barnes
Hagens Berman Sobol Shapiro LLP
1 Main Street, 4th Floor
Cambridge, MA 02142
(617) 482-3700
lauren@hbsslaw.com
1
I.
INTRODUCTION
State consumer protection law has long played a central role in ensuring that individuals
harmed by prescription pharmaceuticals and their manufacturers have recourse to recover for
those injuries through the judicial branch of government. For years, the Food and Drug
Administration (“FDA”), the federal agency charged with approving and regulating prescription
drug products, recognized the important function of state law claims in inducing manufacturers
to avoid fraudulent behavior and enhance the safety of their products. But the FDA recently
changed its tune and now argues that state claims against pharmaceutical manufacturers based on
inadequate warnings of adverse side effects are preempted by federal law and thus cannot be
prosecuted. Such an interpretation effectively closes the courtroom doors to individuals harmed
by prescription drugs and provides near immunity to manufacturers. Fortunately, courts
encountering the defense of preemption in prescription pharmaceutical litigation have generally
responded to the FDA’s argument by reaffirming the significance of state consumer protection
law and Congress’s intent that claims brought thereunder remain viable.
In Section II of this paper, I briefly outline the types and sources of claims typically
raised in pharmaceutical litigation. Section III introduces the doctrine of preemption and
examines the FDA’s historical and newly revised positions on the preemption of state law claims
involving prescription drugs. Section IV provides examples of a number of recent decisions by
federal and state courts rejecting the preemption defense and reiterating the importance of private
rights of action, guaranteed by state law, in protecting consumers.
II.
CLAIMS MADE UNDER STATE CONSUMER PROTECTION LAW
“Consumer protection law” encompasses common and statutory law. Both kinds of law,
and the claims available under them, are critically important in protecting consumers and have
been used to prosecute a variety of pharmaceutical-related litigation.
Traditionally, litigation involving personal injuries as a result of use of a prescription
drug has been grounded in common law causes of action. These include negligence, strict or
product liability, breach of warranty of merchantability, and fraud or deceit claims. This is
particularly true where plaintiffs alleged the manufacturer of the pharmaceutical provided
insufficient warnings or failed to disclose side effects. As one court recently noted, “failure to
warn claims ‘have long been a part of traditional state tort law’.”1
In recent years, attorneys have filed a number of cases against the manufacturers of
pharmaceuticals alleging violations of state consumer protection statutes. All fifty states, as well
as the District of Columbia, have at least one such statute (which are also referred to as “unfair
and deceptive trade practices acts” or “consumer fraud acts”).2 These statutes typically prohibit
1
Cona v. Merck & Co., Inc., ATL-L-3553-05 MT, at *33 (N.J. Super. Law. Div., June 8, 2007) and McDarby v.
Merck & Co., Inc., ATL-L-1296-05 MT, at *33 (N.J. Super. Law. Div., June 8, 2007) (quoting Silkwood v. KerrMcGee Corp., 464 U.S. 238, 255 (1984)).
2
Ala. Code §§ 8-19-1 to -15; Alaska Stat. §§ 45.50.471 to .561; Ariz. Rev. Stat. Ann. §§ 44-1521 to 1534; Ark. Stat.
Ann. §§ 4-88-101 to 105; Cal. Civ. Code §§ 1750 to 1785; Cal. Bus. & Prof. Code §§ 17200 to 17209; Colo. Rev.
Stat. §§ 6-1-101 to 709; Conn. Gen. Stat. §§ 42-110a to 110q; Del. Code Ann. tit. 6, §§ 2501 to 2598; D.C. Code
Ann. §§ 28-3901 to 3909; Fla. Sta. Ann. §§ 501.201 to .976; Ga. Code Ann. §§ 10-1-370 to 407; Hawaii Rev. Stat.
2
unfair or deceptive trade practices in an attempt to protect consumers from abusive sales
behavior and are, by and large, modeled on the Federal Trade Commission Act.3 With the
exception of Iowa, a consumer protection statute in each state expressly or implicitly allows
private actors to bring claims under the act. (Iowa’s statutes include provisions for the state’s
Attorney General to bring suit.)
Most private actions brought under state consumer protection statutes do not seek
damages for personal injuries caused by a defective pharmaceutical or other product. Rather,
these claims frequently assert that the product is neither as safe or effective as advertised or, in
the case of drugs and medical devices, that the drug or product was fraudulently promoted for
“off label” or non-approved uses for which there is no proven benefit.4 Consumers allege they
were harmed by fraudulent sales practices, did not receive the benefit of the bargain they sought,
and thus should receive actual, as well as punitive and multiple, damages.
The growth of claims brought under state consumer protection statutes has seemingly
come about as a result of three things: an increase in class actions (and the attendant reluctance
of courts to certify classes based on personal injury); difficulties of proof in individual personal
injury actions; and possibilities of recovering on behalf of those exposed to a dangerous device
but not yet manifesting personal injury. More importantly, however, is the recognition by the
plaintiffs’ bar that use of the consumer fraud acts is an effective method of providing additional
incentives to pharmaceutical manufacturers to refrain from fraudulent practices in marketing and
selling their products. State consumer protection laws – whether through common law claims or
statutory enactments – provide consumers with private causes of action and real access to the
civil justice system. Most federal laws regulating pharmaceuticals lack any such private cause of
action thus without state consumer protection law, consumers would have no recourse when
harmed by a prescription drug.
§§ 480-1 to 24; Hawaii Rev. Stat. §§ 481A-1 to 3; Idaho Code §§ 48-601 to 619; Ill. Rev. Stat. ch. 815, §§ 505/1 to
/12; Ill. Rev. Stat. ch. 815, §§ 510/1 to /7; Ind. Code Ann. §§ 24-5-0.5 to 18; Iowa Code Ann. §§ 714.16 to .25; Kan.
Stat. Ann. §§ 50-601 to 640; Ky. Rev. Stat. §§ 367.110 to .993; La. Rev. Stat. Ann. §§ 51:1401 to 1420; Me. Rev.
Stat. Ann. tit. 5, §§ 205A to 214; Me. Rev. Stat. Ann. tit. 10, §§ 1211 to 1216; Md. Com. Law Code Ann. §§ 13-101
to 501; Mass. Gen. Laws Ann. ch. 93A, §§ 1 to 11; Mich. Comp. Laws §§ 445.901 to .922; Minn. Stat. Ann. §§
325D.09 to .16; Minn. Stat. Ann. §§ 325D.43 to .48; Minn. Stat. Ann. §§ 325F.67 to .99; Miss. Code Ann. §§ 75-241 to 131; Mo. Rev. Stat. §§ 407.010 to .915; Mont. Code ann. §§ 30-14-101 to 142; Neb. Rev. Stat. §§ 59-1601 to
1623; Neb. Rev. Stat. §§ 87-301 to 306; Nev. Rev. Stat. §§ 598.0903 to .990; N.H. Rev. Stat. Ann. §§358-A:1 to 13;
N.J. Stat. Ann. §§ 56:8-1 to 106; N.M. Stat. Ann. §§ 57-12-1 to 22; N.Y. Gen. Bus. Law §§ 349 to 350e; N.C. Gen
Stat. §§ 75-1 to 89; N.D. Cent. Code §§ 51-15-01 to 11; Ohio Rev. Code Ann. §§ 1345.01 to .99; Ohio Rev. Code
Ann. §§ 4165.01 to .04; Okla. Stat. Ann. tit. 15, §§ 751 to 789; Okla. Stat. Ann. tit. 78, §§ 51 to 55; Or. Rev. Stat. §§
646.605 to .656; Pa. Stat. Ann. tit. 73, §§ 201-1 to 209-6; R.I. Gen. Laws §§ 6-13.1-1 to 18; S.C. Code §§ 39-5-10 to
170; S.D. Codified Laws Ann. §§ 37-24-1 to 35; Tenn. Code Ann. §§ 47-18-101 to 5104; Tex. Bus. Com. Code
Ann. §§ 17.01 to .854; Utah Code Ann. §§ 13-11-1 to 23; Vt. Stat. Ann. tit. 9, §§ 2451 to 2480g; Va. Code §§ 59.1196 to 207; Wash. Rev. Code §§ 19.86.010 to .920; W. Va. Code §§ 46A-6-101 to 108; W. Va. Code §§ 46A-7-101
to 116; Wis. Stat. §§ 100.01 to .52; Wyo. Stat. §§ 40-12-101 to 209.
15 U.S.C.A. §§ 41-77. The Federal Trade Commission Act states, in part, that “Unfair methods of competition in
or affecting commerce, and unfair or deceptive acts or practices in or affecting commerce, are hereby declared
unlawful.” 15 U.S.C.A. § 45(a)(1).
3
4
See, e.g., In re Zyprexa Prods. Liab. Litig., 2007 U.S. Dist. LEXIS 46710 (E.D.N.Y. June 28, 2007).
3
III.
PREEMPTION AND ITS RISE AS A DEFENSE IN PRESCRIPTION DRUG
LITIGATION
Regardless of the type and source of the consumer’s state law cause of action, the defense
of preemption has become the hallmark reaction to such claims. In a number of cases,
pharmaceutical manufacturers have argued that consumer claims relating to inadequate warnings
of the risks of drugs are preempted by federal regulation and thus cannot be pursued. The
following section briefly discusses the doctrine of federal preemption and its use in
pharmaceutical litigation.
A.
Federal Preemption of State Law Causes of Action
The Supremacy Clause of Article VI of the United States Constitution provides that “This
Constitution, and the Laws of the United States which shall be made in Pursuance thereof… shall
be the supreme Law of the Land… any Thing in the Constitution or Laws of any State to the
Contrary notwithstanding.” Accordingly, in the event of a conflict or inconsistency between
state and federal law, federal law wins and state law is preempted. The preemptive effect
extends to both state statutory and common law and may be triggered by both federal statutes
and federal regulations.5
Preemption is grounded in federalism. America’s founding fathers were concerned about
preserving the rights of states to enact and retain their own laws except in the limited instances in
which federal law was needed. In Federalist Papers No. 45, James Madison wrote “The powers
reserved to the several States will extend to all the objects which, in the ordinary course of
affairs, concern the lives, liberties, and properties of the people, and the internal order,
improvement, and prosperity of the State.” Article X of the Constitution reflects this
understanding as well.6
In recognition of this desire not to intrude upon state sovereignty, particularly in areas
traditionally regulated by the states (such as health and safety), unless the federal government
has clearly manifested its intentions to do so, the Supreme Court has repeatedly asserted that
there exists a presumption against preemption.7 And as Justice Stevens pointed out in his dissent
in Geier v. American Honda Motor Company, Inc., 529 U.S. 861, 907 (2000), “The signal
virtues of this presumption are its placement of the power of pre-emption squarely in the hands
of Congress, which is far more suited than the Judiciary to strike the appropriate state/federal
balance (particularly in the areas of traditional state regulation), and its requirement that
Congress speak clearly when exercising that power.”
To overcome the presumption against preemption, a party must show that (1) Congress,
or an agency acting on the delegated authority of Congress, has expressly stated that it intends to
5
See, e.g., Feldman v. Lederle Laboratories, 125 N.J. 117, 133 (1991).
“The powers not delegated to the United States by the Constitution, nor prohibited to it by the States, are reserved
to the States, respectively, or to the people.”
6
7
Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449 (2005) (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485
(1996) and writing “[B]ecause the States are independent sovereigns in our federal system, we have long presumed
that Congress does not cavalierly pre-empt state-law causes of action.”).
4
preempt state law in a particular area; (2) Congress explicitly or implicitly intended to occupy an
entire field of legislation and leave no room for state regulation; or (3) state law conflicts with
federal law to such a degree that it would be “‘impossible for a private party to comply with both
state and federal requirements,’… or where state law ‘stands as an obstacle to the
accomplishment and execution of the full purposes and objectives of Congress.’”8 These types
of preemption are referred to as express preemption, field preemption, and conflict or implied
preemption, respectively.
Preemption, where found, is a complete defense to liability under state law, which has the
effect of wiping out a victim’s ability to recover any compensation. Further, preemption of state
law causes of action removes a powerful incentive to manufacturers of pharmaceuticals, devices,
and other consumer goods to make their products safer.9 As such, courts entertaining a
preemption defense must carefully scrutinize the language and intent of the federal government
in regulations affecting a particular area.
B.
Preemption in the Context of Prescription Drugs
1.
The FDA’s Pre-2002 Position
Prior to 2002, the Food and Drug Administration’s long-standing and oft-stated position
was that the federal Food, Drug and Cosmetic Act (“FDCA”) and its provisions would not be
“construed as invalidating any provision of State law which would be valid in the absence of
such amendments unless there is a direct and positive conflict between such amendments and
such provision of state law.”10 In fact, in 1994, the FDA’s Deputy Commissioner for Policy
explained in comments regarding a proposed rule to protect the identity of individuals reporting
adverse events or adverse reactions to drugs or medical devices (and thus preempting any state or
local regulations requiring or permitting the disclosure of that identity) that the “FDA recognizes
the sophistication and complexity of private tort litigation in the United States and the proposed
preemption action is not intended to frustrate or impede tort litigation in this area. Indeed, FDA
recognizes that product liability plays an important role in consumer protection.”11
In 1998, the FDA further affirmed its views that federal law surrounding prescription
drugs did not preempt state regulations. A number of drug manufacturers encouraged the FDA
to “provide for Federal preemption of State regulation with respect to civil tort liability claims
and other labeling requirements” and that “without preemption, FDA regulation would
encourage ‘failure to warn’ claims and challenges to the adequacy of the… labeling.”12 In
8
Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995) (quoting English v. General Elec. Co., 496 U.S. 72, 78-79
(1990) and Hines v. Davidowitz, 312 U.S. 52, 67 (1941), respectively).
The removal of incentives under state law causes of action is particularly dangerous given that the FDA’s
enforcement actions, designed to manage postmarket safety issues, have dropped precipitously in the last several
years. See, e.g., Prescription for Harm: The Decline in FDA Enforcement Activity, U.S. House of Representatives
Committee on Govt. Reform, Minority Staff, Special Investigations Division, June 2006, available at
http://oversight.house.gov/story.asp?ID=1074.
9
10
Drug Amendments of 1962, S. 1552, 87th Cong. (1962) (Public Law 87-781, Oct. 10, 1962).
11
59 Fed. Reg. 3944, 3948 (Jan. 21, 1994).
12
63 Fed. Reg. 66378, 66383 (Apr. 21, 1998).
5
response, the FDA, through its Lead Deputy Commissioner and the Secretary of Health and
Human Services, wrote
Tort liability can not be a major consideration for FDA which must
be guided by the basic principles and requirements of the act in its
regulatory activities. Nevertheless, FDA does not believe that this
rule would adversely affect civil tort liability…
…
FDA does not believe that the evolution of state tort law will cause
the development of standards that would be at odds with the
agency’s regulations. FDA’s regulations establish the minimal
standards necessary, but were not intended to preclude the states
from imposing additional labeling requirements. States may
authorize additional labeling but they cannot reduce, alter, or
eliminate FDA-required labeling.13
Finally, in December 2000, in a proposal of amendments to the requirements for the
labeling of prescription drugs, published in the Federal Register, the FDA explicitly stated that it
had “determined that this proposed rule does not contain policies that have federalism
implications or that preempt State law.”14 That language did not make it into the final rule.
2.
Recent Changes in the FDA’s Position on Preemption
The FDA’s public position on FDA changed substantially in 2002 when it submitted an
amicus brief in litigation in California over the prescription drug Zoloft. In 1998, Victor Motus
committed suicide after taking Zoloft, a drug made by Pfizer, for approximately one week. His
widow brought suit against Pfizer and alleged, in part, that Pfizer failed to adequately warn
consumers and the medical community of the suicide risk associated with the drug. Pfizer
moved for partial summary judgment on those claims, arguing they were preempted and thus
barred by the FDA’s approval of the labeling for the drug. In late 2000, the District Court for the
Central District of California denied Pfizer’s motion for partial summary judgment on grounds of
federal preemption.15
During the appeal process, the FDA submitted an amicus brief on behalf of Pfizer, urging
the Court of Appeals to find that the plaintiff’s claims were preempted. While the case was
decided on other grounds on appeal, the FDA’s brief marked a clear turning point.
Since 2002, the FDA has submitted amicus briefs in a number of cases asserting that the
manufacturers of prescription drugs failed to adequately warn patients and the health care
community of the risks associated with the pharmaceuticals.16 Frequently, the FDA contends, in
13
Id. at 66383-84.
14
65 Fed. Reg. 81082, 81103 (Dec. 22, 2000).
15
Motus v. Pfizer, Inc., 127 F. Supp. 2d 1085, 1087 (C.D.Ca. 2000)
16
See, e.g., Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D.Pa. 2006); McNellis v. Pfizer, Inc., 2005 U.S. Dist.
LEXIS 37505 (D.N.J. Dec. 29, 2005); Witczak v. Pfizer, Inc., 377 F. Supp. 2d 726 (D. Minn. July 20, 2005); Zikis v.
6
parallel to the manufacturer’s argument, that drug makers are prohibited from modifying an
FDA-approved label for a pharmaceutical thus the federal agency’s regulations necessarily
preempt any efforts under state law to enhance the warnings on the product’s labeling.
In January 2006, the FDA increased the stakes. In the Preamble to its final rule
governing the “Requirements on Content and Format of Labeling for Human Prescription Drug
and Biological Products”, the agency declared that state law causes of action alleging inadequate
warning were preempted by federal law where the warning had been expressly approved by the
FDA.17 Instead of viewing FDA regulations as delineating the minimum or floor requirements
for safety (as it had since the creation of the FDCA), the agency asserted that the regulations
acted as both a floor and a ceiling for the content and format of prescription drug labels,
obviating any state law failure to warn claims. The FDA explained its reasoning as follows:
State law actions… threaten FDA’s statutorily prescribed role as
the expert Federal agency responsible for evaluating and regulating
drugs. State actions are not characterized by centralized expert
evaluation of drug regulatory issues. Instead, they encourage, and
in fact require, lay judges and juries to second-guess the
assessment of benefits versus risks of a specific drug to the general
public – the central role of FDA – sometimes on behalf of a single
individual or group of individuals. That individualized
reevaluation of the benefits and risks of a product can result in
relief – including the threat of significant damages awards or
penalties – that creates pressure on manufacturers to attempt to add
warnings that FDA has neither approved nor found to be
scientifically required. This could encourage manufacturers to
propose “defensive labeling” to avoid State liability, which, if
implemented, could result in scientifically unsubstantiated
warnings and underutilization of beneficial treatments.18
The Preamble to the final rule was not subject to the notice and comment period required
for the enactment of federal rules. (Indeed, the FDA provided no notice of its intent to include
this language in its final rule, in violation of Executive Order 13132.) Such language can be
changed at any time. Accordingly, as many courts have recognized, the Preamble is not a
binding portion of the regulations (which became effective June 30, 2006) but is instead an
advisory opinion by the enacting agency.19 Yet since the publishing of the Preamble,
Pfizer, Inc., 2005 U.S. Dist. LEXIS 9591 (N.D. Ill., E.D. May 9, 2005); Szybinski v. Pfizer, Inc., No. YC047439,
Superior Court of California, County of Los Angeles, July 12, 2005.
17
71 Fed. Reg. 3922 (Jan. 24, 2006).
18
Id. at 3935. Going further, the agency declared that not only were claims against manufacturers preempted but so
too were claims against physicians and other health care providers regarding the “dissemination of risk information
to patients beyond what is included in the labeling.” Id. at 3935-36.
See 21 C.F.R. § 10.85(d)(1) (classifying as an advisory opinion “[a]ny portion of a Federal Register notice other
than the text of a proposed or final regulation, e.g., a notice to manufacturers or a preamble to a proposed or final
regulation.”).
19
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manufacturers have speciously argued, and FDA amicus briefs have concurred, that courts
should defer to the FDA’s interpretations of the regulations as expressed in the Preamble.
This complete reversal by the FDA on the issue of federal preemption, beginning with
amicus briefs and culminating in the Preamble to the final rule, aims to strike a mighty blow at
the heart of state consumer protection law, particularly where advertising and warnings related to
prescription pharmaceuticals are concerned. While the FDA’s new opinion has gained some
traction, most courts have recognized that Congress did not intend to exclude the states from
protecting their citizens in this area and thus have rejected the FDA’s position on preemption.
IV.
HOW THE COURTS ARE RESPONDING
Although courts in a small number of high profile cases have recently deferred to the
FDA’s current view and found an implied Congressional intent to preempt certain state law
claims (including failure to warn),20 more courts are recognizing the FDA’s position for what it
is – an attempt by a federal agency, without the explicit authorization of Congress, to eliminate
state law protections for consumers. Judges presiding over prescription drug cases, whether
brought under the common law or under state statutory law, have begun to clarify a number of
very important issues regarding the role of state law in protecting consumers in pharmaceutical
litigation.
First, the vast majority of courts recognize that while the FDA must approve a drug’s
label, including all warning information contained therein, before it can be marketed and sold to
the public, current federal regulations allow manufacturers to add or increase a warning on a
drug without FDA approval.21 Federal regulations further provide that the manufacturer has a
duty to warn of a safety risk where there is “reasonable evidence of an association between a
particular hazard and the drug.”22 Because the regulations provide a specific procedure for
manufacturers to strengthen the warnings on the drug’s label, the “FDA’s approved label… can
therefore be said to set the minimum labeling requirement, and not necessarily the ultimate label
where a manufacturer improves the label to promote greater safety.”23 Accordingly, as the
Supreme Court of Vermont recently noted,
There is thus no conflict between federal labeling requirements and
state failure-to-warn claims. Section 314.70(c) allows, and
arguably encourages, manufacturers to add and strengthen
warnings that, despite FDA approval, are insufficient to protect
customers. State tort claims simply give these manufacturers a
concrete incentive to take this action as quickly as possible.24
20
See, e.g., In re Bextra and Celebrex Marketing Sales Prac. and Prod. Liab. Litig., 2006 U.S. Dist. LEXIS 95500,
at *57-69 (N.D.Ca. August 18, 2006); Colacicco, 432 F. Supp. 2d at 528-532.
21
21 C.F.R. § 314.70(6)(iii)(A).
22
21 C.F.R. § 201.57(e).
23
McNellis, 2005 U.S. Dist. LEXIS 37505, at *13.
24
Levine v. Wyeth, 2006 Vt. 107, *13 (Vt. 2006).
8
Perhaps most significant, however, is the courts’ reaffirmation of the importance of state
law causes of action and Congress’s intent that these state law remedies remain viable options
for consumers. Below is a short survey of language and reasoning arising in prescription
pharmaceutical failure-to-warn and consumer fraud litigation refusing to give deference to the
FDA’s Preamble and finding the FDA’s regulations do not preempt state law claims.
A.
In re Zyprexa Prods. Liab. Litig., ___ F. Supp. 2d ___, 2007 U.S. Dist. LEXIS 42641
(E.D.N.Y. June 11, 2007)
In 2004, in the wake of numerous cases filed by individuals alleging personal injuries
arising out of use of the prescription drug Zyprexa, the Judicial Panel on Multidistrict Litigation
consolidated the cases for pre-trial purposes in front of Judge Jack Weinstein in the Eastern
District of New York. Zyprexa is an atypical antipsychotic approved for use in treating
schizophrenia and bipolar mania. Patients taking the drug claimed they suffered undisclosed
health risks including significant weight gain, development of hyperglycemia and diabetes, and
associated cardiovascular problems – risks allegedly known to Eli Lilly, the drug’s manufacturer,
since the drug became available for sale in 1996. (Other parties, bringing claims under state
consumer protection statutes as well as federal law, alleged Eli Lilly fraudulently misrepresented
both the safety and efficacy of Zyprexa and illegally promoted the drug for off-label purposes,
such as the treatment of dementia in the elderly and ADHD in children.)
Eli Lilly filed a motion for summary judgment on grounds of federal preemption of the
plaintiffs’ claims that the company failed to adequately warn of the risks of Zyprexa. In denying
Eli Lilly’s motion, Judge Weinstein recognized the importance of claims brought under
consumer protection laws, writing “Jury verdicts and adequacy of warning claims serve an
important regulatory role in the tort system. State law adequacy of warning claims may alert the
FDA to potential inadequacies in product labeling. The current litigation against Lilly may be a
testament to that.”25 Going further, the Court reaffirmed the critical role of the judiciary in
ensuring that consumers are protected and pharmaceuticals are as safe and effective as possible:
The lesson of prescription drug tort litigation cautions against
permitting the FDA to sweepingly remove adequacy of warning
claims from the prescription drug regulatory landscape:
“Notwithstanding the structural inability of the FDA to carefully
investigate and monitor drug safety, drug makers assert a
preemption defense premised on the notion that FDA approval of a
drug indicates a validation of the drug’s safety. This position
shirks the responsibility of drug manufacturers to carefully monitor
the adverse effects of their products. One could reasonably assume
that Vioxx might still be on the market if Merck had not been
25
In re Zyprexa Prods. Liab. Litig., 2007 U.S. Dist. LEXIS 42641, at * 117 (citing Letter from FDA to Eli Lilly &
Co. (Mar. 28, 2007)).
9
concerned about its financial exposure in products liability
lawsuits.
“The availability of courts to redress injuries provides the public
powerful leverage against negligent drug manufacturers. The
threat of litigation reduces the risk of misconduct by drug makers,
providing the public with necessary protections against the effects
of dangerous pharmaceuticals. If courts extended federal
preemption to drug claims… manufacturers would have little
incentive to conduct post-approval clinical studies to examine a
drug’s safety. The FDA would also lose one of its few bargaining
chips in pressuring companies to amend labels to warn of newly
discovered risks.”26
B.
In re Vioxx Prods. Liab. Litig., 2007 U.S. Dist. LEXIS 48367 (E.D.La. July 3, 2007)
On September 30, 2004, five years after gaining approval for the drug, Merck & Co.
withdrew its pain reliever Vioxx from the market. Vioxx had been promoted as a more effective
pain reliever than traditional non-steroidal anti-inflammatory drugs (or “NSAIDs”), including
ibuprofen, for treatment of arthritic and other chronic or acute pain. This was in part because
traditional NSAIDs can lead to gastrointestinal perforations, ulcers, and bleeding and initial
studies seemingly showed that patients taking Vioxx suffered from fewer gastrointestinal side
effects. Yet studies also showed a significantly increased risk of adverse cardiovascular effects
in patients on Vioxx. Merck continues to face innumerable personal injury and consumer fraud
claims as a result of its failure to disclose and warn of the increased risk of cardiovascular side
effects. The majority of these cases were consolidated for pre-trial proceedings before Judge
Eldon Fallon in the Eastern District of Louisiana.
Merck filed a motion for summary judgment on federal preemption grounds in two
individual Vioxx cases before Judge Fallon. In denying Merck’s motion, the Court
acknowledged the Supreme Court’s admonition to be cautious in applying the doctrine of
implied preemption because of the strong presumption against it:
In many preemption cases, finding state law preempted leaves
plaintiffs with no make-whole remedy, creates inequitable results,
or produces a dangerous regulatory gap…. Why choose the
presumption against preemption as the pragmatic default rule
instead of the opposite presumption? Because the presumption
against preemption allows each state to satisfy the preferences of
its own citizens, while a presumption in favor of preemption would
In re Zyprexa Prods. Liab. Litig., 2007 U.S. Dist. LEXIS 42641, at * 118-19 (quoting Jonathan V. O’Steen & Van
O’Steen, The FDA Defense: Vioxx and the Argument Against Federal Preemption of State Claims for Injuries
Resulting from Defective Drugs, 48 Ariz. L. Rev. 67, 94 (2006)).
26
10
impose a uniform national policy even when national preferences
are unclear.27
After reviewing the Preamble to the FDA’s final rule on labeling, Judge Fallon reiterated that
historically, “the several States have… exercised their police powers to protect the health and
safety of their citizens.”28 Accordingly,
Because there are no federal remedies for individuals harmed by
prescription drugs, a finding of implied preemption in these cases
would abolish state-law remedies and would, in effect, render
legally impotent those who sustain injuries from defective
prescription drugs.... Far from standing ‘as an obstacle to the
accomplishment and execution of the full purposes and objectives
of Congress,’ state-law claims against prescription drug
manufacturers ‘necessarily perform an important remedial role in
compensating’ injured individuals. Sprietsma v. Mercury Marine,
537 U.S. 51, 64 (2002).29
C.
Cona v. Merck & Co., Inc., ATL-L-3553-05 MT (N.J. Super. Law. Div., June 8, 2007)
and McDarby v. Merck & Co., Inc., ATL-L-1296-05 MT (N.J. Super. Law. Div., June
8, 2007)
Although the majority of cases involving personal injury or consumer fraud claims
regarding Vioxx were consolidated before Judge Fallon, several remain in state court. On June
8, 2007, Judge Carol Higbee of the Superior Court of New Jersey denied Merck’s motion for a
new trial or judgment NOV. Merck claimed, in part, that the plaintiffs’ claims for failure to warn
should have been preempted. The Court noted that the removal of Vioxx from the market
prompted congressional hearings on prescription drug safety but Congress decided not to
dismantle state remedies
The fact is that following the withdrawal of Vioxx from the
market, congressional hearings were held specifically to address
the concerns of some members of Congress about the failure of the
FDA to provide adequate drug safety protection to the public.
These hearings resulted in proposed changes in statutes governing
the FDA itself, but no decision by Congress to preempt
prescription drug tort law.30
27
In re Vioxx Prods. Liab. Litig., 2007 U.S. Dist. LEXIS 48367, at * 23, n7 (quoting Note, New Evidence on the
Presumption Against Preemption: An Empirical Study of Congressional Responses to Supreme Court Preemption
Decisions, 120 Harv. L. Rev. 1604, 1623-24 (2007)).
28
In re Vioxx Prods. Liab. Litig., 2007 U.S. Dist. LEXIS 48367, at *33.
29
Id. at *33-34 (internal citations omitted).
30
Cona v. Merck & Co., Inc., ATL-L-3553-05 MT, at *35; McDarby v. Merck & Co., Inc., ATL-L-1296-05 MT, at
* 35.
11
… Despite the large number of lawsuits filed, Congress has not
moved to expressly preempt State law governing “failure to warn,”
but has instead placed its focus on changing laws governing the
FDA.
D.
Deutsch v. Wyeth, Inc., HRT Mass Tort Case Code 266, MID-L-998-06 MT (N.J.
Super. Ct. June 22, 2007)
Prempro is a hormone replacement therapy drug manufactured and sold by Wyeth and
has been the subject of a number of cases filed by patients alleging they developed breast cancer
as a result of use of the product. In a recent decision of the Superior Court of New Jersey, Judge
Bryan Garruto denied Wyeth’s motion for summary judgment on federal preemption grounds,
noting
…numerous decisions in both state and federal law cases hold that
FDA approval of a drug’s warning label alone is insufficient to
preempt a state’s authority to provide laws that protect the health,
safety, and welfare of its citizens and to deprive litigants injured by
a product’s inadequate warning from a remedy at law.
This Court adopts U.S. District Judge Jack B. Weinstein’s
reasoning and findings in In re: Zyprexa Products Liability
Litigation, No. 04-MD-1596, 06-CV-1729 (E.D.N.Y. June 11,
2007) and Superior Court Judge Carol E. Higbee’s reasoning
findings in Cona/McDarby v. Merck, Nos. ATL-L-3553-05 MT,
ATL-L-1296-05 MT (N.J. Super. Law. Div., June 8, 2007), which
both hold that the FDCA does not preempt state tort law claims
based on a pharmaceutical company’s inadequate warnings of the
risks involved in ingesting its FDA-approved product.31
V.
CONCLUSION
State laws and the causes of action they provide to individuals are of critical importance
in protecting the rights and recovery of consumers harmed by prescription drugs and the
manufacturers of such products. The FDA’s new view of preemption stands as a threat to those
rights. Fortunately, however, courts are continuing to recognize the significant role of state law
in inducing manufacturers to refrain from fraudulent behavior in the marketing and sale of their
products and refusing to find state law claims preempted.
31
Deutsch v. Wyeth, Inc., HRT Mass Tort Case Code 266, MID-L-998-06 MT, at * 4.
12