The NY Times Business section (and the WSJ Health Blog) this morning picked up the story — that we noted last week — that Waxman and Pallone plan to reintroduce legislation essentially reversing the Supreme Court’s ruling in Reigel v. Medtronic. Those stories also note a Senate version to be introduced by Sen. Kennedy and Sen. Leahy.
The basis for the Supreme Court’s decision in Reigel v. Medtronic is the interpretation of the Medical Devices Amendments of 1976, so by enacting changes that specifically disclaim preemption of state tort law, Congress could effectively moot the Supreme Court’s ruling.
However, two state-level developments may change the debate:
The Wisconsin Supreme Court’s decision this week in Blunt v. Medtronic, which was dictated by Reigel v. Medtronic, may create additional pressure in favor of federal action and maintaining state tort liability (although note that only two of seven justices signed on to the Wisconsin concurring opinion decrying the result); but on the other hand
The Georgia Senate Economic Development Committee held its first hearing yesterday on legislation protecting Georgia-based businesses or companies with more than 200 employees headquartered out of state from liability for defects in any drug or medical device that has been approved by the FDA. If this initiative is successful, and is replicated in other states, both the Supreme Court’s ruling(s) and the federal legislation would be moot, since there would be no underlying state tort liability.
Graeme’s talk, as usual, was very interesting and not very print-able.
Carol’s talk was also great. Of course, Atlanta, Georgia is hosting BIO 2009, which is moving ahead full-steam. Georgia also has some interesting capabilities and initiatives
One focus in Georgia is on healthcare IT. Atlanta in particular has an extensive fibre optic infrastructure from having hosted the Olympics, and this will be a valuable asset as Electronic Medical Records are more widely adopted.
Most interestingly, the State has a “life sciences facilities fund“ that provides low interest loans secured by fixed assets to assist start-ups with finding appropriate space. Carol mentioned that the program just funded a 15-year loan with deferred interest at 60% of Prime.
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