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Fosamax July 31
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The Future of Preemption
Jul 29, 2015 | Inside Counsel
By Maja C. Eaton and Rebecca K. Wood
...In re Fosamax, 951 F. Supp. 2d 695 (D.N.J. 2013), found that “preemption is warranted because there is clear evidence” that FDA rejected requests to add warnings to the “Precautions” section of the labeling, permitting them only as “Adverse Reactions.” Id. at 701-05...
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Jul 29, 2015 | Inside Counsel
By Maja C. Eaton and Rebecca K. Wood
For FDA (Food and Drug Administration)-regulated companies, federal preemption can provide a potentially powerful defense to state tort claims. In recent years, the U.S. Supreme Court has decided numerous preemption cases, each emphasizing the highly context-sensitive nature of the inquiry. Determining when preemption applies and how to deploy it to limit claims and to manage discovery requires a keen awareness of evolving doctrine and the regulatory record for the product at issue.
Preemption stems from the Supremacy Clause of the U.S. Constitution, which precludes state law from conflicting with federal law on the same subject. Preemption may be express—where a provision of federal law explicitly displaces state law, as in the case of certain medical devices — or implied — where state and federal law are incompatible. In general, the greater the regulatory oversight of a matter, the stronger the foundation for a potential preemption defense.
...Classwide warnings may provide another basis for preemption. In Dobbs v. Wyeth Pharms., 797 F. Supp. 2d 1264, 1277-80 (W.D. Okla. 2011), the FDA rejected warnings specific to the drug at issue “in favor of uniform language applicable to all” drugs in the class, thereby supplying “clear evidence” that FDA would not have approved drug-specific warnings. Id. Preemption may also supply a strong defense where plaintiffs challenge the location of warnings in labeling. In re Fosamax, 951 F. Supp. 2d 695 (D.N.J. 2013), found that “preemption is warranted because there is clear evidence” that FDA rejected requests to add warnings to the “Precautions” section of the labeling, permitting them only as “Adverse Reactions.” Id. at 701-05.
These cases underscore the importance of a painstaking review of the regulatory record, and companies should be mindful of memorializing the agency’s safety determinations to better facilitate potential future preemption defenses...
For full story:
http://www.insidecounsel.com/2015/07/29/the-future-of-preemption?page=2
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