No. ______ IN THE Supreme Court of the United States ____________________ JOHNSON & JOHNSON AND MCNEIL-PPC, INC., Petitioners, v. LISA RECKIS AND RICHARD RECKIS, Respondents. ____________________ On Petition for a Writ of Certiorari to the Supreme Judicial Court of Massachusetts ____________________ PETITION FOR A WRIT OF CERTIORARI ____________________ WALTER DELLINGER JAY P. LEFKOWITZ, P.C. O’MELVENY & MYERS LLP Counsel of Record 1625 Eye Street NW STEVEN J. MENASHI Washington, DC 20006 KIRKLAND & ELLIS LLP (202) 383-5300 601 Lexington Avenue
[email protected] New York, NY 10022 (212) 446-4800 CHARLES C. LIFLAND
[email protected] CARLOS M. LAZATIN
[email protected] O’MELVENY & MYERS LLP 400 South Hope Street MICHAEL D. SHUMSKY Los Angeles, CA 90071 KIRKLAND & ELLIS LLP (213) 430-6000 655 Fifteenth Street NW
[email protected] Washington, DC 20005
[email protected] (202) 879-5000
[email protected] Attorneys for Johnson & Johnson and McNeil-PPC, Inc. i QUESTION PRESENTED In Wyeth v. Levine, this Court explained that state tort claims against drug manufacturers for fail- ing to provide additional warnings would be preempted if “clear evidence” shows “that the FDA would not have approved a change to [the drug’s] la- bel.” 555 U.S. 555, 571 (2009). The question pre- sented is: Whether the Massachusetts Supreme Judicial Court erred when it held, in direct conflict with the Seventh Circuit, that FDA’s rejection of warning language proposed in a Citizen Petition is not “clear evidence” sufficient to preempt state tort claims that the manufacturer was obligated to add the FDA- rejected language to its drug’s labeling.