defense.”56
Specifically, the Supreme Court noted that the
FDA had itself explained that “newly acquired information is not limited to new data,” but also encompassed new analyses of previously submitted data.57
Te CBE rule “accounts for
the fact that risk information accumulates over time and that the same data may take on a different meaning in light of subsequent developments.”58
In the case before it, Wyeth
became aware of information about amputations resulting from Phenergan injections, and it “could have analyzed the accumulating data and added a stronger warning about IV- push administration of the drug,” even in accordance with the amended CBE regulation.59 Te Court disagreed that unilaterally changing the
warning could have subjected it to liability for misbranding and unauthorized distribution under the FDA regulations, rejecting the “very idea that the FDA would bring an enforcement action” for “strengthening a warning pursuant to the CBE regulation.”60
It was a “central premise of federal drug
regulation,” the Supreme Court urged, that “the manufacturer bears responsibility for the content of its label at all times” and is charged with “ensuring that its warnings remain adequate as long as the drug is on the market.”61
Absent clear evidence
that the FDA would not have approved a change to the drug’s label, the Court refused to conclude that it was impossible for Wyeth to comply with both federal and state requirements.62 Tere was no evidence that the FDA had made an affirmative decision to preserve the IV-push method; no evidence that Wyeth had supplied the FDA with an analysis of the specific dangers posed by the IV-push method; and no evidence that Wyeth would have prohibited a stronger warning. Cautioning that “[i]mpossibility pre-emption is a demanding defense,” the Court held that “the mere fact that the FDA approved Phenergan’s label does not establish that it would have prohibited such a change.”63 Te Supreme Court rejected Wyeth’s second argument that obliging it to comply with state duties to provide a stronger warning about the IV-push method would obstruct the purpose and objectives of federal drug labeling regulation because that would interfere with Congressional entrustment of drug labeling decisions to an “expert agency” capable of “strik[ing] a balance between competing objectives.”64
Wyeth
56 555 U.S. ---, 129 S.Ct. at 1196. 57 555 U.S. ---, 129 S.Ct. at 1197 (citing 73 Fed. Reg. 49609, 49604). 58 555 U.S. ---, 129 S.Ct. at 1196-1197. 59 555 U.S. ---, 129 S.Ct. at 1197. 60 Id. 61 555 U.S. ---, 129 S.Ct. at 1197-1198 (citing 73 Fed. Reg. 49609, 49604). 62 555 U.S. ---, 129 S.Ct. at 1198-99. 63 555 U.S. ---, 129 S.Ct. at 1199. 64 555 U.S. ---, 129 S.Ct. at 1198-1201.
broadly urged that once the FDA had approved a drug’s label, a state-law verdict could not deem the label inadequate, regardless of whether the FDA had considered the stronger warning at issue. Te most “glaring problem”65
with this
argument, in the Court’s view, was the absence of a federal remedy for consumers in the FDCA, “evidently” evidencing Congress’ determination that state rights of action provided necessary consumer protection against harmful products and the further fact that the Congress did not enact an express exemption clause as it had done with the MDA.66
Te Court
further dismissed Wyeth’s argument that because the FDCA required the FDA to determine that a drug is safe and effective under the conditions specified in manufacturer labeling, the FDA must be presumed to have done a balancing of risks and benefits which could not be overridden by state court judgments.67
Wyeth relied on a 2006 preamble to an FDA
regulation in which it declared that the FDCA established both a “floor” and “ceiling” so that “‘FDA approval of labeling…preempts conflicting or contrary State law.’”68 Te Supreme Court gave no weight to the FDA’s “conclusion” regarding preemption, particularly since an earlier
65 555 U.S. ---, 129 S.Ct. at 1198. 66 555 U.S. ---, 129 S.Ct. at 1199. 67 555 U.S. ---, 129 S.Ct. at 1197. 68 555 U.S. ---, 129 S.Ct. at 1199.
MAKE FILING YOUR BRIEFS EASY!
Send files through our website
www.freestatepress.com
Our Legal Services Include:
• Courts of Appeal Filings • Print & File Legal Briefs & Record Extracts • Mail/UPS Certificate of Service Copies • Page/Bates Numbering • Document Scanning & Image Editing • Digital Color, B/W & Wide Copying • Court Records - Scan/Copy/Email • Fast Turnaround, Strictly Confidential
79 West Street / Annapolis, MD 21401 / 410-269-1484 / 800-754-7029 Trial Reporter / Winter 2010 39
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68