The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Georgia

More Waxman-Pallone Reporting on State Tort Liability, Preemption, Medical Devices and FDA Approval

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:

  1. 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
  2. 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.

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TBI Breakfast: BIO and Biotech in the State of Georgia

I just came back from a very enjoyable TBI Breakfast with talks by Carol Henderson, the Director of the Georgia Department of Economic Development and Graeme McRae, the Chairman & CEO of Bioniche Life Sciences, Inc. which has an Animal Health division facility in Athens, Georgia.

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

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.

Here in Ontario, we have also identified access to facilities as a key area for government support, and the Georgia program is a model that I haven’t heard discussed here.

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Wednesday Brain Dump: February 11, 2009

Deep Appreciation:for Phillip Terrence Ragon, founder and sole proprietor of database-software provider InterSystems who donated $100 million to establish a research institute that focuses on expediting the development of an AIDS vaccine, and to Pfizer Canada which contributed a further $2 million to British Columbia’s Center for Drug Research and Development (CDRD); and The State of Georgia is contemplating a $180 million bioscience research park.

Social Agitation: French scientists decided their street protests were their best approach to halting the government’s science and higher education reforms and rejected mediation.

Better Cogitation:Brain-Derived Neurotrophic Factor (BDNF) shows neuroprotective effects in animal models of Alzheimers’, but it won’t stop cries of ‘brain drain’ following Canada’s 2009 Budget.

Free Publication: ScienceInsider reports that Rep. Conyers’ (D-MI) bill that would eliminate free full-text publication of NIH-funded research is back on the table this session.

Self Regulation:More Pharma companies are implementing voluntary disclosure of physician payments (under threat of legislation); and some researchers are taking steps to prevent disclosures of potentially harmful research (under threat of annihilation).

Reconsideration: Researchers at Emory decided that flu pandemic deaths in 1918 may have been primarily from bacterial superinfections rather than the virus itself; Icahn decided to nominate another slate of Biogen-Idec directors; Everybody decided to take another look at their luciferase screening assay controls; and the Ontario Health Insurance Plan (OHIP) decided to take another look at payment for PSA testing for prostate cancer detection.

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