{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2022,4,4]],"date-time":"2022-04-04T09:36:42Z","timestamp":1649065002965},"reference-count":30,"publisher":"Cambridge University Press (CUP)","issue":"4","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"unspecified","delay-in-days":731,"URL":"https:\/\/www.cambridge.org\/core\/terms"},{"start":{"date-parts":[[2019,1,1]],"date-time":"2019-01-01T00:00:00Z","timestamp":1546300800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J. Law. Med. Ethics"],"published-print":{"date-parts":[[2019]]},"DOI":"10.1177\/1073110519897793","type":"journal-article","created":{"date-parts":[[2020,1,20]],"date-time":"2020-01-20T07:11:06Z","timestamp":1579504266000},"page":"783-787","update-policy":"http:\/\/dx.doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["The Supreme Court's Latest Ruling on Drug Liability and its Implications for Future Failure-to-Warn Litigation"],"prefix":"10.1017","volume":"47","author":[{"given":"Christopher J.","family":"Morten","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aaron S.","family":"Kesselheim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph S.","family":"Ross","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"56","published-online":{"date-parts":[[2021,1,1]]},"reference":[{"key":"S1073110500026036_bib19","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.2011.0370"},{"key":"S1073110500026036_bib24","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.5150"},{"key":"S1073110500026036_bib5","unstructured":"5. Merck, 139 S. Ct. at 1675."},{"key":"S1073110500026036_bib13","unstructured":"13. Id. at 1679."},{"key":"S1073110500026036_bib3","unstructured":"3. See, e.g., Kennerly, M. , \u201cMerck v. Albrecht: The Supreme Court Eviscerates Preemption In Branded Drug Lawsuits,\u201d LexBlog, May 31, 2019, available at <https:\/\/www.lexblog.com\/2019\/05\/31\/merck-v-albrecht-impossibility-preemption\/> (last visited November 19, 2019); Wolfman, B. , \u201cSupreme Court strongly reaffirms 2009 no-preemption decision in Wyeth v. Levine,\u201d Public Citizen Consumer Law & Policy Blog, May 20, 2019, available at <https:\/\/pubcit.typepad.com\/clpblog\/2019\/05\/supreme-court-strongly-reaffirms-earlier-no-preemption-decision-in-wyeth-v-levine.html> (last visited November 19, 2019)."},{"key":"S1073110500026036_bib23","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.282034"},{"key":"S1073110500026036_bib14","unstructured":"14. Wyeth, 555 U.S. at 570-71."},{"key":"S1073110500026036_bib27","unstructured":"27. See PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011)."},{"key":"S1073110500026036_bib17","unstructured":"17. Merck, 139 S. Ct. at 1673. 21 C.F.R. \u00a7 314.70(c) sets the 30 day deadline for FDA review of CBE labeling changes."},{"key":"S1073110500026036_bib11","unstructured":"11. Merck, 139 S. Ct. at 1678 (emphasis added)."},{"key":"S1073110500026036_bib10","unstructured":"10. Wyeth, 555 U.S. at 571."},{"key":"S1073110500026036_bib9","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMhle0902889"},{"key":"S1073110500026036_bib4","unstructured":"4. Neilan, T. , \u201cMerck Pulls Vioxx Painkiller From Market, and Stock Plunges,\u201d The New York Times, September 30, 2004, available at <https:\/\/www.nytimes.com\/2004\/09\/30\/business\/merck-pulls-vioxx-painkiller-from-market-and-stock-plunges.html> (last visited November 19, 2019)."},{"key":"S1073110500026036_bib12","unstructured":"12. Id. at 1680."},{"key":"S1073110500026036_bib18","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e318245a160"},{"key":"S1073110500026036_bib30","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp068119"},{"key":"S1073110500026036_bib6","unstructured":"6. Id. at 1674."},{"key":"S1073110500026036_bib25","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.944"},{"key":"S1073110500026036_bib8","unstructured":"8. Wyeth v. Levine, 555 U.S. 555, 575 (2009)."},{"key":"S1073110500026036_bib16","unstructured":"16. 21 C.F.R. \u00a7 314.70(c)."},{"key":"S1073110500026036_bib1","unstructured":"1. Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019)."},{"key":"S1073110500026036_bib22","doi-asserted-by":"publisher","DOI":"10.3233\/JRS-2008-0426"},{"key":"S1073110500026036_bib26","unstructured":"26. FDA, Step 5: FDA Post-Marketing Drug Safety Monitoring, Jan. 4, 2018, available at <https:\/\/www.fda.gov\/ForPatients\/Approvals\/Drugs\/ucm405579.htm> (last visited November 19, 2019)."},{"key":"S1073110500026036_bib29","unstructured":"29. For a recent court decision, see In re Zimmer (Nexgen Knee Implant Products Liability Litigation), 884 F.3d 746 (7th Cir. 2018)."},{"key":"S1073110500026036_bib7","unstructured":"7. Id. at 1678."},{"key":"S1073110500026036_bib15","unstructured":"15. In our view, this central holding of the Merck decision represents a major victory for patients and a major defeat for drug manufacturers. As noted above, a separate portion of Merck decided a procedural issue: should the question of whether preemption applies in a given case be decided by a judge or a jury? Merck held that the question should be decided by a judge, not a jury. Merck, 139 S. Ct. at 1680. This outcome permits judges to dismiss some failure-to-warn lawsuits prior to trial, and it may favor industry to the extent that juries are more likely than judges to side with a sympathetic plaintiff. However, we believe the import of Merck's central holding on the legal standard for preemption outweighs the import of the procedural judge-versus-jury question, and we therefore disagree that Merck represents a victory for industry, on the whole."},{"key":"S1073110500026036_bib20","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2019.5161"},{"key":"S1073110500026036_bib2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.8515"},{"key":"S1073110500026036_bib21","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39024.487720.68"},{"key":"S1073110500026036_bib28","unstructured":"28. Association for Accessible Medicines, 2018 Generic Drug Access & Savings Report, available at <https:\/\/accessiblemeds.org\/resources\/blog\/2018-generic-drug-access-and-savings-report> (last visited November 19, 2019)."}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1073110519897793","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1073110519897793","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1073110500026036","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,1,14]],"date-time":"2021-01-14T13:06:38Z","timestamp":1610629598000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1073110500026036\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019]]},"references-count":30,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2019]]}},"alternative-id":["S1073110500026036"],"URL":"https:\/\/doi.org\/10.1177\/1073110519897793","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"value":"1073-1105","type":"print"},{"value":"1748-720X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019]]}}}