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"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.

Source: http://www.crowell.com/documents/Wyeth-v-Levine_Limits-on-the-Scope-of-FDA-Preemption%20And%20Implications-for-Drug-and-Medical-Device-Manufacturers.pdf

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