Wyeth v. Levine
Pre-emption is a judicial principle of supremacy of Federal legislation over state regulations on the same subject created by Congressional legislation. State law cannot create laws on the same subject that is already occupied in federal law. Pre-emption occurs when Congress passes a law. If the regulation does not define pre-emption, state and federal courts may examine pre-emption. Wyeth argued pre-emption when Diana Levine successfully sued the health care center in Vermont. The Vermont jury ordered Wyeth to change the labeling to prohibit improper administration of Phenergan.
Case
The Supreme Court case number 06-1249, Review Vermont Supreme Court case, regarding a lack of labeling instructions for administering Phenergan resulting in the amputation of a musicians arm. The injury the Vermont jury found correlated with Wyeth’s inadequate procedures for administration. The trial court denied overturning the appeal on Wyeth’s position,
“… Pre-empted by federal law because Phenergan labeling had been approved by the federal Food and Drug Administration (FDA). The FDA deemed the Phenergan label, sufficient. The Vermont Supreme Court affirmed” (Rein, 2008).
Phenergan
Phenergan combats nausea. The route of administration injection is intramuscularly or intravenously through an IV-push into the vein. The IV-drip method introduces medication into a saline liter bag and infuses slowly. An IV-push injection resulted in the injury.
Injury
April 7th 2000, Levine saw the doctor for a migraine headache. She received Demerol, and Phenergan then sent home. She returned when the initial medication was ineffective. Levine received a second dose of the same medications. Perivascular Extravasation occurred because of the medication entering an artery directly or through the surrounding tissue coming into contact with the artery. This resulted in the limb becoming gangrene, and subsequently necessitating amputation of her right hand and forearm.
The Arguments
Wyeth labeling acknowledges gangrene following intra-arterial injection. The manufacturer identifies amputation as a result. The argument presented the failure of instructions including methods of administration regarding IV-drip, rather than intravenous injection. Intravenous administration held a higher risk than the IV-push method.
Levine argued a conflict between Wyeth and the FDA regarding ‘failure to warn’ action. Levine argued the lack of contraindication of the IV- push method, and not administer intravenously.
Wyeth argued state-law duty contraindicates the IV-push method. In response to the Supreme Court, the Vermont Supreme Court responded stating the jury position. The position of the jury was that Wyeths had insufficient labeling, without mandating changes to the label.
The Supreme Court stated, “We therefore need not decide whether a statue rule proscribing intravenous administration would be pre-empted” (Wyeth v. Levine, 2009).
Food and Drug Administration
Upon review of correspondence between the FDA and Wyeth requested strengthen the warning regarding intra-injection method and evidence of objection to strengthen language. The court also reviewed FDA failure to responds to the change to the label upon request. The court cited lack of evidence that the FDA objected to strengthening the language. The warning, “when administering any irritant drug intravenously it is usually preferable to inject it through the tubing of an intravenous infusion set that is know to be functioning satisfactorily” (Wyeth v. Levine).
In 1987, The Food and Drug Administration requested Wyeth to change the labeling to include the risk of arterial exposure. Wyeth submitted the application without receiving a response from the Food and Drug Administration. The FDA in 1996 requested labeling information in use excluding response to the 1987 request. The FDA advised Wyeth to retain the instructions, regarding the arterial injection. The changes to labeling did not relate to the injection. The application sent from Wyeth to the FDA received approval for the (1981) application in 1998. The instruction from the FDA regarding the label must be match the application.
Legislation
In 1962, Congress switched the burden of proof responsibility to the pharmaceutical manufacturers, from the FDA. Congress in 1906 implemented the Federal Food and Drugs Act. The act pertaining to the case prohibits misbranding drugs. In 1930, Congress passed the Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration requires pre-approval of all medications, submitting applications with reports of studies and drafts of labels for review. Distribution does not begin until the application approval. Congress preserved state law by a stating the law would invalidate, with direct evidence to the contrary.
The Supreme Court Ruling
The Supreme Court concluded that Wyeth failed to follow state and federal regulations. Levine’s case common-law claim lacks pre-emption to the Federal Food, Drug, and Cosmetic Act.
Conclusion
After the injury in 2007, Congress amended the Federal Food, Drug, and Cosmetic Act for the first time. This amendment gave statutory authority to require need for safety labeled until approval. Congress though did not enact pre-approval changes for FDA in the Senate bill. The Senate adopted the rule to clarify the manufacturer’s responsibility to update labels. Wyeth stated that if they had changed the label Wyeth would be in violation of the Act for misbranding drugs.
References
Rein, Brent (2008) On writ of certiorari to the vermont supreme court brief for petitioner. Retrieved on February 7, 2010 from Pharmalot.com at http://www.pharmalot.com/wp-content/uploads/2008/05/wyeth-levine-brief.pdf
Wyeth v. Levine (March 2009). Supreme court of the united states, case number 06-1249 certiorari. Retrieved on February 2, 2010 from Supreme Court of the United States, 2008 term opinions of the court http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf
Pre-emption is a judicial principle of supremacy of Federal legislation over state regulations on the same subject created by Congressional legislation. State law cannot create laws on the same subject that is already occupied in federal law. Pre-emption occurs when Congress passes a law. If the regulation does not define pre-emption, state and federal courts may examine pre-emption. Wyeth argued pre-emption when Diana Levine successfully sued the health care center in Vermont. The Vermont jury ordered Wyeth to change the labeling to prohibit improper administration of Phenergan.
Case
The Supreme Court case number 06-1249, Review Vermont Supreme Court case, regarding a lack of labeling instructions for administering Phenergan resulting in the amputation of a musicians arm. The injury the Vermont jury found correlated with Wyeth’s inadequate procedures for administration. The trial court denied overturning the appeal on Wyeth’s position,
“… Pre-empted by federal law because Phenergan labeling had been approved by the federal Food and Drug Administration (FDA). The FDA deemed the Phenergan label, sufficient. The Vermont Supreme Court affirmed” (Rein, 2008).
Phenergan
Phenergan combats nausea. The route of administration injection is intramuscularly or intravenously through an IV-push into the vein. The IV-drip method introduces medication into a saline liter bag and infuses slowly. An IV-push injection resulted in the injury.
Injury
April 7th 2000, Levine saw the doctor for a migraine headache. She received Demerol, and Phenergan then sent home. She returned when the initial medication was ineffective. Levine received a second dose of the same medications. Perivascular Extravasation occurred because of the medication entering an artery directly or through the surrounding tissue coming into contact with the artery. This resulted in the limb becoming gangrene, and subsequently necessitating amputation of her right hand and forearm.
The Arguments
Wyeth labeling acknowledges gangrene following intra-arterial injection. The manufacturer identifies amputation as a result. The argument presented the failure of instructions including methods of administration regarding IV-drip, rather than intravenous injection. Intravenous administration held a higher risk than the IV-push method.
Levine argued a conflict between Wyeth and the FDA regarding ‘failure to warn’ action. Levine argued the lack of contraindication of the IV- push method, and not administer intravenously.
Wyeth argued state-law duty contraindicates the IV-push method. In response to the Supreme Court, the Vermont Supreme Court responded stating the jury position. The position of the jury was that Wyeths had insufficient labeling, without mandating changes to the label.
The Supreme Court stated, “We therefore need not decide whether a statue rule proscribing intravenous administration would be pre-empted” (Wyeth v. Levine, 2009).
Food and Drug Administration
Upon review of correspondence between the FDA and Wyeth requested strengthen the warning regarding intra-injection method and evidence of objection to strengthen language. The court also reviewed FDA failure to responds to the change to the label upon request. The court cited lack of evidence that the FDA objected to strengthening the language. The warning, “when administering any irritant drug intravenously it is usually preferable to inject it through the tubing of an intravenous infusion set that is know to be functioning satisfactorily” (Wyeth v. Levine).
In 1987, The Food and Drug Administration requested Wyeth to change the labeling to include the risk of arterial exposure. Wyeth submitted the application without receiving a response from the Food and Drug Administration. The FDA in 1996 requested labeling information in use excluding response to the 1987 request. The FDA advised Wyeth to retain the instructions, regarding the arterial injection. The changes to labeling did not relate to the injection. The application sent from Wyeth to the FDA received approval for the (1981) application in 1998. The instruction from the FDA regarding the label must be match the application.
Legislation
In 1962, Congress switched the burden of proof responsibility to the pharmaceutical manufacturers, from the FDA. Congress in 1906 implemented the Federal Food and Drugs Act. The act pertaining to the case prohibits misbranding drugs. In 1930, Congress passed the Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration requires pre-approval of all medications, submitting applications with reports of studies and drafts of labels for review. Distribution does not begin until the application approval. Congress preserved state law by a stating the law would invalidate, with direct evidence to the contrary.
The Supreme Court Ruling
The Supreme Court concluded that Wyeth failed to follow state and federal regulations. Levine’s case common-law claim lacks pre-emption to the Federal Food, Drug, and Cosmetic Act.
Conclusion
After the injury in 2007, Congress amended the Federal Food, Drug, and Cosmetic Act for the first time. This amendment gave statutory authority to require need for safety labeled until approval. Congress though did not enact pre-approval changes for FDA in the Senate bill. The Senate adopted the rule to clarify the manufacturer’s responsibility to update labels. Wyeth stated that if they had changed the label Wyeth would be in violation of the Act for misbranding drugs.
References
Rein, Brent (2008) On writ of certiorari to the vermont supreme court brief for petitioner. Retrieved on February 7, 2010 from Pharmalot.com at http://www.pharmalot.com/wp-content/uploads/2008/05/wyeth-levine-brief.pdf
Wyeth v. Levine (March 2009). Supreme court of the united states, case number 06-1249 certiorari. Retrieved on February 2, 2010 from Supreme Court of the United States, 2008 term opinions of the court http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf
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