The Cross-Border Biotech Blog

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

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

  1. Pingback: More Waxman-Pallone Reporting on State Tort Liability, Preemption b…/b | travelinmiami.com

  2. Pingback: Preemption Update: Waxman and Pallone Hit the Ground Running « The Cross-Border Biotech Blog

  3. Pingback: No Preemption No Problem: State Supreme Courts Wade Into Drug and Device Preemption « The Cross-Border Biotech Blog

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