2009 CSUCI Biol 503 FINAL Presentations Part 2 of 2

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    2009 CSUCI Biol 503 FINAL Presentations Part 2 of 2 - Presentation Transcript

    1. Levine v. Wyeth Naveen Nunna, Drew Shami, and Sora Yoon
    2. Phenergan Injection Sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Clear, colorless solution Light sensitive Possesses antihistamine, sedative, antimotion-sickness, antiemetic, and anticholenergic. Duration of action is 4 to 6 hours, may last up to 12 hours Metabolized in the liver
    3. Usuage Amelioration of allergic reactions Anaphylaxis as an adjustment to epinephrine and other standard measures Other uncomplicated allergic conditions For sedation and relief of apprehension and to produce light sleep Active treatment of motion sickness Prevention and control of nausea and vomiting associated with anesthesia and surgery. Postoperative pain
    4. Contraindications Pediatric patients under 2 years old In comatose states and in patients who have demonstrated idiosyncratic reaction or hypersensitivity to promethazine. Injection given by intra-arterial due to severe arteriospasm and possible resultant gangrene. Not given by subcutaneous route
    5. cont. 1950 FDA approved 1988 Wyeth submit revised Phenerganinjectable changes 1981 new FDA 1996 FDA request Wyeth to requirements on labeling retain verbiage in current label 1950 1960 1970 1980 1990 2000 2005 2010 1973 & 1976 FDA 1998 FDA approve 1981 application, approved labeling changes final printed label must be identical to package insert 1987 FDA suggest different warnings of arterial exposure
    6. Background Diana Levine, musician, visited a local clinic on April 7, 2000 for treatment for migraine headache. Injected via Intramuscluar with Demerol for headache and Phenergan for nausea. A week later she returned for unsuccessful treatment. Received a second injection of both drugs administered by Physician’s Assistant via IV-push. IV-push is IV directly into vein IV-drip is introduced into saline solution then through a catheter Phenergan entered artery by direct injection or perivascularextravasation, which is escape from vein into surrounding tissue and come in contact with arterial tissue. She developed gangrene and first had her right hand amputated then her forearm.
    7. Her claim Medical malpractice Physician assistant ignored label Brought actionfordamages against Wyeth Common-law negligence Phenergan’s labeling did not prohibit IV-push and strict-liability theories Labeling did have a warning but failed in proper instructions
    8. The warning for “Inadvertent Intra-arterial Injection” stated: “Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascularextravasation or inadvertent intra-arterial injection. Reports compatible with inadvertent intra-arterial injection of Phener- gan Injection, usually in conjunction with other drugs intended forintravenous use, suggest that pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Intravenous injection was in- tended in all the cases reported but perivascularextravasation or arterial placement of the needle is now suspect. There is no proven successful management of this condition after it occurs. . . . Aspiration of dark blood does not preclude intra-arterial needle placement, be- cause blood is discolored upon contact with Phenergan Injection. Use of syringes with rigid plungers or of small bore needles might obscure typical arterial backflow if this is relied upon alone. When used intra- venously, Phenergan Injection should be given in a concentration no greater than 25 mg per mL and at a rate not to exceed 25 mg per minute. When administering any irritant drug intravenously, it is usually preferable to inject it through the tubing of an intravenous infusion set that is known to be functioning satisfactorily. In the event that a patient complains of pain during intended intravenous injection of Phenergan Injection, the injection should be stopped immediately to provide for evaluation of possible arterial placement or perivascularextravasation.” App. 390.
    9. Torts State tort suit uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. Distinct compensatory function that may motivate injured persons to come forward with information. Can interfere with FDA’s desire to create a drug label containing a specific set or cautions and instructions. Can sometimes raise prices to where those who are sick are unable to obtain the drugs they need Product liability” Marketing defects: Inadequate warning labels or instructions
    10. Cont. Implies preexemption Preemption is more appropriate because the FDCA contains no evidence that Congress intended the FDA to set only “minimum standards,” and the FDCA does not contain a saving clause. Impossible for Wyeth to satisfy both state and federal labeling requirements FDA told Wyeth that Phenergan’s label renders its use “safe.” Through state tort law: NO Federal law does not preempt state law.
    11. Wyeth v. Levine: Washington County Superior Court Levine (the bailiff) filed a common-law negligence claim against Wyeth, a state tort lawsuit. She claimed that the warning label was negligent in its failure to adequately address the danger of IV push administration of the Phenergen antihistamine. Wyeth countered that the warning label was sanctioned by the FDA under the Food, Drug, and Cosmetic Act. Therefore the lawsuit was “impliedly preempted” by federal law.
    12. Wyeth v. Levine: Washington County Superior Court The pharmaceutical corporation claimed that it was impossible to satisfy both state as well as federal labeling requirements. Wyeth also argued that state liabilities for FDA-approved labels would be counter-productive for the intended objectives of the FDCA and FDA. The jury sided with Levine, who was awarded with more than $6 million in damages.
    13. Wyeth v. Levine: Vermont Supreme Court Wyeth appealed to the Vermont Supreme Court. The Supreme Court upheld the ruling by a 4-1 majority. A specific provision of the FDCA said that FDA approval of a label was not required to strengthen that label’s warnings. Thus Wyeth could have supplemented the FDA-required information with additional warning measures and could have conceivably complied with both federal and state laws. Since FDA labeling requirements were intended to be a minimum framework of safety precautions, state liabilities for inadequate labels would not interfere with the overall intention of the FDCA.
    14. Wyeth v. Levine: Vermont Supreme Court The lone dissenter on the Court argued that the demand for “IV push” to be removed entirely from the label’s listing of appropriate uses of the drug was unreasonable. IV push was still an acceptable, albeit risky, procedure that yielded satisfactory results. He also argued that the majority’s position seemed to condemn the drug as completely unsafe, which was in direct contradiction to the FDA’s previous approval of the drug. Being the persistent corporation that it was, Wyeth appealed to the United States Supreme Court (certiorari).
    15. Wyeth v. Levine: U. S. Supreme Court
    16. Wyeth v. Levine: U. S. Supreme Court The question presented by the petition is whether the FDA’s drug labeling judgments “preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.”
    17. Wyeth v. Levine: U. S. Supreme Court Wyeth’s Pre-emption arguments it would have been impossible for them to comply with the state-law duty to modify Phenergan’s labeling without violating federal law recognition of Levine’s state tort action creates an unacceptable “obstacle to the accomplishment and execution of the full purposes and objectives of Congress,” because it substitutes a lay jury’s decision about drug labeling for the expert judgment of the FDA
    18. Wyeth v. Levine: U. S. Supreme Court Generally speaking, a manufacturer may only change a drug label after the FDA approves a supplemental application. There is, however, an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency’s approval. Among other things, this “changes being effected” (CBE) regulation provides that if a manufacturer is changing a label to “add or strengthen a contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product,” it may make the labeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval.
    19. Wyeth v. Levine: U. S. Supreme Court Decided March 4, 2009 Vermont verdict upheld with a 6-3 majority JUSTICE THOMAS, I agree with the Court that the fact that the Food and Drug Administration (FDA) approved the label for petitioner Wyeth’s drug Phenergan does not pre-empt the state-law judgment before the Court. Justices Breyer, Ginsburg, Kennedy, Souter, and Stevens concurred with Justice Thomas
    20. Wyeth v. Levine: U. S. Supreme Court JUSTICE ALITO, with whom THE CHIEF JUSTICE (Roberts) and JUSTICE SCALIA join, dissenting. This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration (FDA), is ultimately responsible for regulating warning labels for prescription drugs. I respectfully dissent. The FDA told Wyeth that Phenergan’s label renders its use “safe.” But the State of Vermont, through its tort law, said: “Not so.” The state-law rule at issue here is squarely pre-empted. Therefore, I would reverse the judgment of the Supreme Court of Vermont.
    21. Wyeth v. Levine: U. S. Supreme Court Wyeth V Lavine
    22. References http://images.google.com/imgres?imgurl=http://www.ecomm.baxter.com/ecatalog/loadResource.do%3Flid%3D10001% 26hid%3D10001%26cid%3D10016%26bid%3D38182&imgrefurl=http://www.ecomm.baxter.com/ecatalog/browseCatalo g.do%3Flid%3D10001%26hid%3D10001%26cid%3D10016%26key%3D947c2a4f75d6713c9d37674ff1349878%26pageNr% 3D1&usg=__gtr5J7gb8Fm2- 5GEsPJWaHTAN0M=&h=80&w=49&sz=2&hl=en&start=14&um=1&tbnid=nknYLBuv25qHUM:&tbnh=74&tbnw=45 &prev=/images%3Fq%3Dphenergan%2Binjection%26hl%3Den%26client%3Dsafari%26rls%3Den- us%26sa%3DN%26um%3D1 http://www.baxter.com/products/anesthesia/anesthetic_pharmaceuticals/downloads/phenergan.pdf http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf http://images.google.com/imgres?imgurl=http://www.injuryboard.com/uploadedImages/InjuryBoardcom_Content/Blog s/News_Blog/News/Diana%2520Levine%2520REAX%2520npr%2520picture%2520%2520500.jpg&imgrefurl=http://ww w.injuryboard.com/national-news/diana-levine-reflects-on-high-court- decision.aspx%3Fgoogleid%3D258544&usg=__0hTmEzVo8Y__L0J06xw9OSnCuGo=&h=275&w=407&sz=52&hl=en&st art=20&tbnid=51X2FyPwliyljM:&tbnh=84&tbnw=125&prev=/images%3Fq%3Ddiana%2Blevine%26gbv%3D2%26hl%3 Den%26sa%3DG http://images.google.com/imgres?imgurl=http://graphics8.nytimes.com/images/2008/02/21/business/21fda.190.jpg&im grefurl=http://www.nytimes.com/2008/02/21/washington/21fda.html%3Fref%3Dbusiness&usg=__3CDr7bRIzhIWKv9 ykIz4gRcNUjQ=&h=290&w=190&sz=19&hl=en&start=5&tbnid=BGtN- GE4AxEquM:&tbnh=115&tbnw=75&prev=/images%3Fq%3Ddiana%2Blevine%26gbv%3D2%26hl%3Den%26sa%3DG www.supremecourtus.gov/opinions/08pdf/06-1249.pdf www.supremecourtus.gov/docket/06-1249.htm
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