The Cross-Border Biotech Blog

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

Tag Archives: Kennedy

Preemption Update: Waxman and Pallone Hit the Ground Running

When we reported on the Supreme Court’s decision in Wyeth v. Levine, we wondered what the effect would be on legislation proposed by Reps. Waxman and PalloneWe did not have to wonder long — they introduced legislation yesterday, with a parallel effort from Sens. Kennedy and Leahy, to moot the Supreme Court’s decision in Reigel v. Medtronic and reinstate (har) state tort liability for PMA-approved medical devices.

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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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Rep. Waxman, Reigel v Medtronic and Wyeth v Levine

Last Summer, the U.S. Supreme Court held in Reigel v. Medtronic that the premarket approval (PMA) process for medical devices pre-empts liability under State common law for claims challenging the safety or effectiveness of medical devices.  Wyeth v. Levine, which the U.S. Supreme Court heard last Fall, but has not decided, makes a parallel argument with respect to labelling of FDA-approved drugs. Together, these two cases could reshape liability for products under the FDA’s purview in a way that looks very much like tort reform, and therefore, have seemed ripe for a legislative response.  A story in yesterday’s Minneapolis-St.Paul Star Tribune includes a statement from Rep. Henry Waxman, D- Calif. that

Waxman and Rep. Frank Pallone Jr., D-N.J., plan to introduce legislation that would circumvent the Supreme Court ruling and “protect Americans from dangerous medical devices.”

and notes that Barack Obama was one of the cosponsors of the Senate bill introduced last year to address the issue. more analysis after the jump…

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