NEJM - The FDA, Preemption, and the Supreme Court

[Guest guest]

Article from tomorrow's NEJM..Choice bits:"The Supremacy Clause also empowers the federal government to explicitly "preempt an area" over which it has authority, "completely occupying" it and depriving the states of all authority to enact and enforce laws in that area"  This might apply to Codex Alimentarius (although the Codex AFAIK only deals with 'food', and dietary supplements aren't classed as food - but that could change).  If the FDA decided to preempt state regulations on sales of them somehow..  I don't know the FDA regulates them already in detail, just that they do by the labeling requirement.  Of course, the States could sue the FDA, AFAIK (I think States can sue the Federal gov't in the U.S.)"The 2008 Supreme Court case Riegel v. Medtronic addressed the question of whether the Medical Device Amendments of 1976 preempted the area of device regulation — specifically, whether  preemption precluded lawsuits against manufacturers by persons alleging that they had been injured by a defectively designed medical device that the FDA had deemed safe and effective after a full review.4  The fact that this question was answered in the affirmative by a vote of eight to one indicates that the issue was not a difficult one for the justices.  The Medical Device Amendments to the Food, Drug, and Cosmetics Act contain explicit preemption language that prohibits states from establishing "any requirement" that is "different from, or in addition to" requirements in the federal statute that relate "to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device" under the statute.. "  This is rather scary if the FDA (or some other gov't agency?) decides to preempt States rights to sue companies over vaccine-injuries, as that county in NY might try to do.  Of course, the same idea applies of the States suing the FDA..  With the latest bombshell for the FDA being the Chinese ingridient in the tainted Heparin - which is now thought to have been intentional on the part of the Chinese (to save money, not to kill Americans I assume)..  Anybody wanna take bets on how much longer the "most respected health agency in the world" will continue to last?Jim-- (full article) "The FDA, Preemption, and the Supreme Court" Glantz LH et al.  NEJM 358(18): 1883-1885, May 1, 2008 Everyone would like to be immune from lawsuits. Legislatures sometimes provide immunity in order to advance important social policy goals. For example, by providing health care professionals with immunity under Good Samaritan statutes, legislatures hope to encourage voluntary medical assistance in emergencies. Similarly, Congress provided immunity to vaccine manufacturers who claimed they could not economically manufacture vaccines with the threat of liability hanging over them.Because providing immunity deprives injured people of their day in court, legislation that creates immunity sometimes also creates an alternative compensatory mechanism. For example, the federal law that immunized vaccine manufacturers from lawsuits created a system for the compensation of persons injured by vaccines. Nevertheless, immunity undermines the tort system's goal of deterring unreasonably dangerous actions or omissions.When Congress creates a regulatory scheme through legislation, immunity is seldom a centerpiece. Instead, the question of immunity is usually determined by another doctrine — that of preemption. Under the U.S. Constitution's Supremacy Clause, federal laws are "supreme" over state laws: when the two conflict, the federal law rules, and the state law is unenforceable. If the two do not conflict, they can coexist — and, for example, subject those charged with drug crimes to both federal and state penalties. The Supremacy Clause also empowers the federal government to explicitly "preempt an area" over which it has authority, "completely occupying" it and depriving the states of all authority to enact and enforce laws in that area.The theory behind preemption is that some activities, such as air-traffic control, require nationally uniform federal regulation. The doctrine of preemption itself is not controversial, but its application to lawsuits that are brought by private litigants has been contentious and is governed by a complex body of law.In the 1992 Supreme Court case Cipollone v. Liggett Group, for example, the plaintiffs argued that a cigarette company failed to adequately warn consumers about the risks associated with smoking.1 The failure to warn of risks is a well-established basis for bringing a product-liability suit, but the manufacturer argued that the lawsuit was barred by the federal cigarette-labeling law, which included explicit preemption language: "No requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this Act." This language explicitly limits state legislatures' authority to "require" additional health warnings, but it was less clear that this preemption clause applied to private lawsuits by injured smokers alleging inadequate warning. The Court ruled that the preemption doctrine did apply to state courts, noting that if state juries found that additional warnings were needed to adequately protect potential cigarette purchasers, cigarette companies would be required to add more information to the federally mandated package label to avoid liability. This result would frustrate Congress's goal of protecting "the national economy from the burden imposed by diverse, nonuniform, and confusing cigarette labeling and advertising regulations."1Yet the existence of federal preemption does not always prohibit private litigants from bringing lawsuits. In 1984, the Supreme Court ruled that the estate of Silkwood could sue the owner of a federally licensed nuclear facility over Silkwood's exposure to plutonium.2 In a five-to-four decision, the Court ruled that the state court could award punitive damages even though the federal government has exclusive authority to "regulate the radiological safety aspects involved in the construction and operation of a nuclear plant."3 The Court noted that Congress had enacted the Price– Act to establish an indemnification scheme for personal injuries that were caused by nuclear facilities. Because the scheme anticipated state lawsuits, the Court concluded that Congress's preemption of the area of nuclear safety could not include the prohibition of private lawsuits. Even the four dissenters agreed with this general analysis; they argued only that Congress did not mean to permit the awarding of punitive damages, which are designed to change the safety-related behavior of the operators, a power the dissenters said Congress reserved for itself through the regulation of nuclear-power plants.The differing outcomes in Cipollone and Silkwood resulted from differences in the specific preemptive language in the statutes. A recent medical-device case involving the Food and Drug Administration (FDA) also turned on specific clauses in the relevant statute.The 2008 Supreme Court case Riegel v. Medtronic addressed the question of whether the Medical Device Amendments of 1976 preempted the area of device regulation — specifically, whether preemption precluded lawsuits against manufacturers by persons alleging that they had been injured by a defectively designed medical device that the FDA had deemed safe and effective after a full review.4 The fact that this question was answered in the affirmative by a vote of eight to one indicates that the issue was not a difficult one for the justices.The Medical Device Amendments to the Food, Drug, and Cosmetics Act contain explicit preemption language that prohibits states from establishing "any requirement" that is "different from, or in addition to" requirements in the federal statute that relate "to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device" under the statute. The majority opinion concluded simply that "absent other indication [in the Medical Device Amendments], reference to a State's `requirements' includes its common-law duties" as articulated by courts or legislatures and "applied by juries under a negligence or strict-liability standard."4Justice Ruth Bader Ginsburg dissented, arguing that since the purpose of the Medical Device Amendments was to protect the public from dangerous devices, it is inconceivable that Congress would have taken away the right of injured patients to sue device manufacturers without saying this more directly. Justice Ginsburg raises an important social policy issue. Patients injured by poorly designed but FDA-approved medical devices now have no recourse. The theory behind this decision is that the FDA has such extensive expertise in safety that it can be entrusted with making decisions that are unchallengeable in court. A related argument is that there is no such thing as a "safe" device. Rather, the FDA makes value judgments that a device is "safe enough" to be marketed. Such approvals involve economic and social policy determinations that, it is argued, cannot be made on a case-by-case basis by courts and narrowly focused, nonexpert juries who see the negative effects of a device on one person but not the benefits of a device to society as a whole.Next fall, the Court will hear a case about FDA-approved drugs (see Key Preemption Decisions of the Supreme Court).5 Because drug approval is governed by a different law that contains no explicit preemption language, Riegel provides no indication of how the Court will rule. Nonetheless, the pharmaceutical industry, with the support of the Bush administration, is arguing that once the FDA approves a drug, the preemption doctrine implicitly deprives injured persons of the opportunity to prove it was inadequately labeled. As in Riegel, acceptance of this argument would leave the injured person with no recourse.The support for the preemption doctrine by a starkly conservative administration is probably founded in part on its outspoken disaffection for plaintiffs' lawyers and its belief in "tort reform," which always favors industry over injured individuals. But extensive federal preemption also runs counter to "states' rights," federalism, and "small government," which are supposed to be the cornerstones of modern conservatism. In the model that the administration supports, total control is located in one federal agency.If the Court expands the preemption doctrine and Congress does not rein it in, much closer scrutiny of the FDA's approval process will be required. Since the processes and judgments of drug and device manufacturers and the FDA will no longer be made public through litigation, all the documentation the FDA receives from manufacturers should be made available for scrutiny by the public and Congress. Safety data for drugs and devices should not be protected as trade secrets.The preemption doctrine plays a constructive role in the allocation of regulatory authority over national industries. But its purpose has never been to grant broad legal immunity to private industry. The solution lies not in the courts but in Congress, which is the ultimate creator of preemption.Key Preemption Decisions of the Supreme CourtSilkwood v. Kerr-McGee Corporation, 1984. State courts may award compensatory and punitive damages to a person harmed by exposure to plutonium at a federally licensed nuclear facility, even though the federal government has preempted the area of safety regulation of nuclear facilities.Cipollone v. Liggett Group, 1992. Compliance with the federal law, which preempted the area of cigarette labeling, immunizes cigarette manufacturers from lawsuits brought on the basis of insufficient labeling.Riegel v. Medtronic, 2008. An express preemption provision in federal law precludes lawsuits against manufacturers by persons alleging that they were injured by a defectively designed medical device that the FDA has deemed safe and effective after a full review.Wyeth v. Levine, cert. granted, 2008. The Supreme Court will determine whether FDA approval of a drug's label preempts state-law claims of inadequate warning.No potential conflict of interest relevant to this article was reported.Source Information:Mr. Glantz and Mr. s are professors in the Department of Health Law, Bioethics, and Human Rights at Boston University School of Public Health, Boston.References: Cipollone v. Liggett Group, 505 U.S. 504 (1992). Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984). Pacific Gas and Electric Company v. State Energy Resources Conservation & Development Commission, 461 U.S. 190 (1983). Riegel v. Medtronic, 128 S.Ct. 999 (2008). Wyeth v. Levine, cert. granted 128 S.Ct. 1118 (2008).

[Guest guest]

I've been thinking for a while that Preemption may have been, in

part, designed to cast out the vaccine injury cases which leak

through " Vaccine Court " into civil court. Does anyone REALLY think

the government doesn't recognize that there's an epidemic? It may be

the second wave of legal protection for pharma. I'm not a lawyer but

I think it's quite clear that Preemption can be applied to vaccine

injury cases. If anyone knows otherwise, please chime in.

>

> Article from tomorrow's NEJM..

>

> Choice bits:

>

> " The Supremacy Clause also empowers the federal government to

> explicitly " preempt an area " over which it has

authority, " completely

> occupying " it and depriving the states of all authority to enact

and

> enforce laws in that area "

>

> This might apply to Codex Alimentarius (although the Codex

AFAIK

> only deals with 'food', and dietary supplements aren't classed as

> food - but that could change). If the FDA decided to preempt

state

> regulations on sales of them somehow.. I don't know the FDA

> regulates them already in detail, just that they do by the

labeling

> requirement. Of course, the States could sue the FDA, AFAIK (I

think

> States can sue the Federal gov't in the U.S.)

>

> " The 2008 Supreme Court case Riegel v. Medtronic addressed the

> question of whether the Medical Device Amendments of 1976

preempted

> the area of device regulation — specifically, whether preemption

> precluded lawsuits against manufacturers by persons alleging that

> they had been injured by a defectively designed medical device

that

> the FDA had deemed safe and effective after a full review.4 The

fact

> that this question was answered in the affirmative by a vote of

eight

> to one indicates that the issue was not a difficult one for the

> justices. The Medical Device Amendments to the Food, Drug, and

> Cosmetics Act contain explicit preemption language that prohibits

> states from establishing " any requirement " that is " different

from,

> or in addition to " requirements in the federal statute that relate

> " to the safety or effectiveness of the device or to any other

matter

> included in a requirement applicable to the device " under the

> statute.. "

>

> This is rather scary if the FDA (or some other gov't agency?)

> decides to preempt States rights to sue companies over vaccine-

> injuries, as that county in NY might try to do. Of course, the

same

> idea applies of the States suing the FDA..

>

> With the latest bombshell for the FDA being the Chinese

ingridient

> in the tainted Heparin - which is now thought to have been

> intentional on the part of the Chinese (to save money, not to kill

> Americans I assume)..

>

> Anybody wanna take bets on how much longer the " most respected

> health agency in the world " will continue to last?

>

> Jim

>

> -- (full article)

>

>

> " The FDA, Preemption, and the Supreme Court " Glantz LH et al.

NEJM

> 358(18): 1883-1885, May 1, 2008

>

> Everyone would like to be immune from lawsuits. Legislatures

> sometimes provide immunity in order to advance important social

> policy goals. For example, by providing health care professionals

> with immunity under Good Samaritan statutes, legislatures hope to

> encourage voluntary medical assistance in emergencies. Similarly,

> Congress provided immunity to vaccine manufacturers who claimed

they

> could not economically manufacture vaccines with the threat of

> liability hanging over them.

> Because providing immunity deprives injured people of their day in

> court, legislation that creates immunity sometimes also creates an

> alternative compensatory mechanism. For example, the federal law

that

> immunized vaccine manufacturers from lawsuits created a system for

> the compensation of persons injured by vaccines. Nevertheless,

> immunity undermines the tort system's goal of deterring

unreasonably

> dangerous actions or omissions.

>

> When Congress creates a regulatory scheme through legislation,

> immunity is seldom a centerpiece. Instead, the question of

immunity

> is usually determined by another doctrine — that of preemption.

Under

> the U.S. Constitution's Supremacy Clause, federal laws

are " supreme "

> over state laws: when the two conflict, the federal law rules, and

> the state law is unenforceable. If the two do not conflict, they

can

> coexist — and, for example, subject those charged with drug crimes

to

> both federal and state penalties. The Supremacy Clause also

empowers

> the federal government to explicitly " preempt an area " over which

it

> has authority, " completely occupying " it and depriving the states

of

> all authority to enact and enforce laws in that area.

>

> The theory behind preemption is that some activities, such as air-

> traffic control, require nationally uniform federal regulation.

The

> doctrine of preemption itself is not controversial, but its

> application to lawsuits that are brought by private litigants has

> been contentious and is governed by a complex body of law.

>

> In the 1992 Supreme Court case Cipollone v. Liggett Group, for

> example, the plaintiffs argued that a cigarette company failed to

> adequately warn consumers about the risks associated with

smoking.1

> The failure to warn of risks is a well-established basis for

bringing

> a product-liability suit, but the manufacturer argued that the

> lawsuit was barred by the federal cigarette-labeling law, which

> included explicit preemption language: " No requirement or

prohibition

> based on smoking and health shall be imposed under State law with

> respect to the advertising or promotion of any cigarettes the

> packages of which are labeled in conformity with the provisions of

> this Act. " This language explicitly limits state legislatures'

> authority to " require " additional health warnings, but it was less

> clear that this preemption clause applied to private lawsuits by

> injured smokers alleging inadequate warning. The Court ruled that

the

> preemption doctrine did apply to state courts, noting that if

state

> juries found that additional warnings were needed to adequately

> protect potential cigarette purchasers, cigarette companies would

be

> required to add more information to the federally mandated package

> label to avoid liability. This result would frustrate Congress's

goal

> of protecting " the national economy from the burden imposed by

> diverse, nonuniform, and confusing cigarette labeling and

advertising

> regulations. " 1

>

> Yet the existence of federal preemption does not always prohibit

> private litigants from bringing lawsuits. In 1984, the Supreme

Court

> ruled that the estate of Silkwood could sue the owner of a

> federally licensed nuclear facility over Silkwood's exposure to

> plutonium.2 In a five-to-four decision, the Court ruled that the

> state court could award punitive damages even though the federal

> government has exclusive authority to " regulate the radiological

> safety aspects involved in the construction and operation of a

> nuclear plant. " 3 The Court noted that Congress had enacted the

Price–

> Act to establish an indemnification scheme for personal

> injuries that were caused by nuclear facilities. Because the

scheme

> anticipated state lawsuits, the Court concluded that Congress's

> preemption of the area of nuclear safety could not include the

> prohibition of private lawsuits. Even the four dissenters agreed

with

> this general analysis; they argued only that Congress did not mean

to

> permit the awarding of punitive damages, which are designed to

change

> the safety-related behavior of the operators, a power the

dissenters

> said Congress reserved for itself through the regulation of nuclear-

> power plants.

>

> The differing outcomes in Cipollone and Silkwood resulted from

> differences in the specific preemptive language in the statutes. A

> recent medical-device case involving the Food and Drug

Administration

> (FDA) also turned on specific clauses in the relevant statute.

>

> The 2008 Supreme Court case Riegel v. Medtronic addressed the

> question of whether the Medical Device Amendments of 1976

preempted

> the area of device regulation — specifically, whether preemption

> precluded lawsuits against manufacturers by persons alleging that

> they had been injured by a defectively designed medical device

that

> the FDA had deemed safe and effective after a full review.4 The

fact

> that this question was answered in the affirmative by a vote of

eight

> to one indicates that the issue was not a difficult one for the

> justices.

>

> The Medical Device Amendments to the Food, Drug, and Cosmetics Act

> contain explicit preemption language that prohibits states from

> establishing " any requirement " that is " different from, or in

> addition to " requirements in the federal statute that relate " to

the

> safety or effectiveness of the device or to any other matter

included

> in a requirement applicable to the device " under the statute. The

> majority opinion concluded simply that " absent other indication

[in

> the Medical Device Amendments], reference to a State's

`requirements'

> includes its common-law duties " as articulated by courts or

> legislatures and " applied by juries under a negligence or strict-

> liability standard. " 4

>

> Justice Ruth Bader Ginsburg dissented, arguing that since the

purpose

> of the Medical Device Amendments was to protect the public from

> dangerous devices, it is inconceivable that Congress would have

taken

> away the right of injured patients to sue device manufacturers

> without saying this more directly. Justice Ginsburg raises an

> important social policy issue. Patients injured by poorly designed

> but FDA-approved medical devices now have no recourse. The theory

> behind this decision is that the FDA has such extensive expertise

in

> safety that it can be entrusted with making decisions that are

> unchallengeable in court. A related argument is that there is no

such

> thing as a " safe " device. Rather, the FDA makes value judgments

that

> a device is " safe enough " to be marketed. Such approvals involve

> economic and social policy determinations that, it is argued,

cannot

> be made on a case-by-case basis by courts and narrowly focused,

> nonexpert juries who see the negative effects of a device on one

> person but not the benefits of a device to society as a whole.

>

> Next fall, the Court will hear a case about FDA-approved drugs

(see

> Key Preemption Decisions of the Supreme Court).5 Because drug

> approval is governed by a different law that contains no explicit

> preemption language, Riegel provides no indication of how the

Court

> will rule. Nonetheless, the pharmaceutical industry, with the

support

> of the Bush administration, is arguing that once the FDA approves

a

> drug, the preemption doctrine implicitly deprives injured persons

of

> the opportunity to prove it was inadequately labeled. As in

Riegel,

> acceptance of this argument would leave the injured person with no

> recourse.

>

> The support for the preemption doctrine by a starkly conservative

> administration is probably founded in part on its outspoken

> disaffection for plaintiffs' lawyers and its belief in " tort

reform, "

> which always favors industry over injured individuals. But

extensive

> federal preemption also runs counter to " states' rights, "

federalism,

> and " small government, " which are supposed to be the cornerstones

of

> modern conservatism. In the model that the administration

supports,

> total control is located in one federal agency.

>

> If the Court expands the preemption doctrine and Congress does not

> rein it in, much closer scrutiny of the FDA's approval process

will

> be required. Since the processes and judgments of drug and device

> manufacturers and the FDA will no longer be made public through

> litigation, all the documentation the FDA receives from

manufacturers

> should be made available for scrutiny by the public and Congress.

> Safety data for drugs and devices should not be protected as trade

> secrets.

>

> The preemption doctrine plays a constructive role in the

allocation

> of regulatory authority over national industries. But its purpose

has

> never been to grant broad legal immunity to private industry. The

> solution lies not in the courts but in Congress, which is the

> ultimate creator of preemption.

>

> Key Preemption Decisions of the Supreme Court

>

> Silkwood v. Kerr-McGee Corporation, 1984. State courts may award

> compensatory and punitive damages to a person harmed by exposure

to

> plutonium at a federally licensed nuclear facility, even though

the

> federal government has preempted the area of safety regulation of

> nuclear facilities.

>

> Cipollone v. Liggett Group, 1992. Compliance with the federal law,

> which preempted the area of cigarette labeling, immunizes

cigarette

> manufacturers from lawsuits brought on the basis of insufficient

> labeling.

>

> Riegel v. Medtronic, 2008. An express preemption provision in

federal

> law precludes lawsuits against manufacturers by persons alleging

that

> they were injured by a defectively designed medical device that

the

> FDA has deemed safe and effective after a full review.

>

> Wyeth v. Levine, cert. granted, 2008. The Supreme Court will

> determine whether FDA approval of a drug's label preempts state-

law

> claims of inadequate warning.

> No potential conflict of interest relevant to this article was

reported.

>

> Source Information:

>

> Mr. Glantz and Mr. s are professors in the Department of

Health

> Law, Bioethics, and Human Rights at Boston University School of

> Public Health, Boston.

>

> References:

>

> Cipollone v. Liggett Group, 505 U.S. 504 (1992).

> Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984).

> Pacific Gas and Electric Company v. State Energy Resources

> Conservation & Development Commission, 461 U.S. 190 (1983).

> Riegel v. Medtronic, 128 S.Ct. 999 (2008).

> Wyeth v. Levine, cert. granted 128 S.Ct. 1118 (2008).

>