FDA regulations and the regulation of constitutionally protected speech *

USA - May 7 2012
“Speech in aid of pharmaceutical marketing…is a form of expression protected by the Free Speech Clause of the First Amendment.”

Co-authors: Ralph S. Tyler.

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IOM recommends elimination of 510(k) process *

USA - November 16 2011
At the direction of the Food and Drug Administration (FDA), the Institute of Medicine (IOM) recently reviewed the 510(k) clearance process for medical devices.

Co-authors: Andrea S. Andrews.

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Supreme court decision limits class action suits *

USA - April 29 2011
In a decision handed down on Wednesday, April 27th, the United States Supreme Court put the brakes on a growing judicial trend to deny enforcement of consumer contract arbitration provisions in class action cases.

Co-authors: Thomas E. Gilbertsen, Elizabeth E. Forbes .

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New Consumer Product Safety Commission database sharply raises regulatory risks and product liability exposure for a surprisingly broad range of products and substances *

USA - December 10 2010
Many manufacturers and private label distributors who do not regularly monitor developments at the Consumer Product Safety Commission ("CPSC") may find themselves doing an abrupt about-face on March 11, 2011, when SaferProducts.gov, a publicly available, searchable database created by new regulations promulgated by the CPSC, begins operations.

Co-authors: Jill B. Deal, Michelle C. Jackson.

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The myths and realities of self-insured entities' responsibilities in light of recent changes to the Medicare Secondary Payer Act and recent CMS guidance *

USA - July 10 2009
These are uncertain times for self-insured entities trying to comply with the Medicare Secondary Payer Act ("MSP") and accompanying federal regulations.

Co-authors: David S. Gray.

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