Monday, November 10, 2008

Obama to Hit "Undo"

The Washington Post has an AP story that the incoming administration intends to reverse by executive order dozens of Bush administration actions, ranging from stem cell research to climate change-related actions.  Not mentioned are the many regulatory agency efforts to increase the preemptive effect of regulatory actions by the FDA and other federal agencies; the administration might, I suppose, be waiting the outcome of Levine.  The NYT has a similar story, again not mentioning products stuff specifically.  Update: I wrote this too quickly, and only referenced executive order actions.  The coverage more generally (including the NYT piece) is not limited to executive order actions, and I didn't intend to focus exclusively on executive orders.  The issue is more about early action by the administrative, whether through executive order, regulatory action, or legislation.  Thanks to Mark Herrmann for pointing out my vagueness.

As an aside, given the likely legislative response if the Supreme Court does find for Wyeth: I did a piece in the now-gone Minnesota Intellectual Property Review when I first came on the market that suggested that FDA determinations be given roughly the same deference as the PTO -- i.e., that a jury be directed to presume that the decision is correct and that to find counter to the decision would require clear and convincing evidence.  (This is, if memory serves, similar to a state-created structure in...Texas?  I don't remember where offhand, and my reprints are in my office while I'm at home.) 

Perhaps something along those lines could be a semi-middle-ground, giving some protection but not outright preemption?

--BC

http://lawprofessors.typepad.com/tortsprof/2008/11/obama-to-hit-un.html

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» A compromise on federal pre-emption? from PointOfLaw Forum
Bill Childs suggests a way to split the difference.... [Read More]

Tracked on Nov 10, 2008 12:34:44 PM

» Obama to Hit "Undo" from Administrative Law Prof Blog
From Bill Childs (Western New England) at the TortsProf Blog: Obama to Hit Undo The Washington Post has an AP story that the incoming administration intends to reverse by executive order dozens of Bush administration actions, ranging from stem cell [Read More]

Tracked on Nov 10, 2008 5:31:37 PM

Comments

FYI, Bill. I'm cutting and pasting the Texas Civil Practices and Remedies Code's rebuttable presumption. While Texas is on the cutting edge of limiting plaintiff's rights, I assume some other states have something similar.

Sec. 82.008. COMPLIANCE WITH GOVERNMENT STANDARDS. (a) In a products liability action brought against a product manufacturer or seller, there is a rebuttable presumption that the product manufacturer or seller is not liable for any injury to a claimant caused by some aspect of the formulation, labeling, or design of a product if the product manufacturer or seller establishes that the product's formula, labeling, or design complied with mandatory safety standards or regulations adopted and promulgated by the federal government, or an agency of the federal government, that were applicable to the product at the time of manufacture and that governed the product risk that allegedly caused harm.
(b) The claimant may rebut the presumption in Subsection (a) by establishing that:
(1) the mandatory federal safety standards or regulations applicable to the product were inadequate to protect the public from unreasonable risks of injury or damage; or
(2) the manufacturer, before or after marketing the product, withheld or misrepresented information or material relevant to the federal government's or agency's determination of adequacy of the safety standards or regulations at issue in the action.
(c) In a products liability action brought against a product manufacturer or seller, there is a rebuttable presumption that the product manufacturer or seller is not liable for any injury to a claimant allegedly caused by some aspect of the formulation, labeling, or design of a product if the product manufacturer or seller establishes that the product was subject to pre-market licensing or approval by the federal government, or an agency of the federal government, that the manufacturer complied with all of the government's or agency's procedures and requirements with respect to pre-market licensing or approval, and that after full consideration of the product's risks and benefits the product was approved or licensed for sale by the government or agency. The claimant may rebut this presumption by establishing that:
(1) the standards or procedures used in the particular pre-market approval or licensing process were inadequate to protect the public from unreasonable risks of injury or damage; or
(2) the manufacturer, before or after pre-market approval or licensing of the product, withheld from or misrepresented to the government or agency information that was material and relevant to the performance of the product and was causally related to the claimant's injury.
(d) This section does not extend to manufacturing flaws or defects even though the product manufacturer has complied with all quality control and manufacturing practices mandated by the federal government or an agency of the federal government.
(e) This section does not extend to products covered by Section 82.007.

Posted by: brooks schuelke | Nov 10, 2008 7:07:09 AM

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