"Drug & Device Law Update - Key Developments in Recent Case Law"

This meeting will be held at the MBC Offices, located on the ninth floor of One Cambridge Center, Cambridge, MA 02142.

The Law & Policy Committee is pleased to present a morning discussion about three recent federal court cases with particular significance to those in FDA-regulated life science industries.

§ Riegel v. Medtronic, recently decided by the U.S. Supreme Court, significantly enhanced the "regulatory compliance defense" for certain FDA-approved medical devices. This case is likely to become an important precedent in how courts decide similar disputes about whether federal law "preempts" state law in tort claims against biotechnology companies.

§ Amgen v. Roche, currently being litigated in the Massachusetts Federal District Court, is being closely watched for its influence on patent protection for drug products, and the extent to which courts can authorize compulsory (albeit compensated) licensing in the event of patent infringement.

§ Wyeth v. Levine, scheduled for argument in the U.S. Supreme Court this fall, will address whether FDA's approval of prescription drugs under the New Drug Approval (NDA) process preempts state law claims for failure to warn (and other challenges to safety or efficacy).

Panelists

Christopher Allen, Nixon Peabody LLP
Jim Foster, Wolf, Greenfield & Sacks, P.C.
George Xixis, Nutter McClennen & Fish LLP