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Tag Archives: Reigel

Corporate Liability Journal Article on Wyeth v. Levine, Reigel v. Medtronic and Medtronic v. Lohr

Check out Jeremy’s latest article, published in the current issue of Corporate Liability Journal.

In The Changing Landscape of U.S. State Tort Liability for FDA-Approved Drugs and Medical Devices (pdf), Jeremy and his co-author, Alison Varga, take a more detailed look at this year’s U.S. Supreme Court decisions in Wyeth v. Levine and Reigel v. Medtronic, which Jeremy has been following on the blog.

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Hearings on the Medical Device Safety Act of 2009

Reps. Waxman and Pallone introduced legislation in March, with a parallel effort by 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.

This week, they held a hearing on the bill – H.R. 1346, the Medical Device Safety Act of 2009. 

The witnesses were (click for their statements):

There is also video of the hearings available.

Opening Statements:

Panel Testimony:

Panel Questions:

More to come when I get a chance to dig in…

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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Supreme Court Rules 6-3 Against Preemption in Wyeth v Levine

The Wyeth v. Levine opinion (pdf) was handed down this morning, holding that state tort law claims (in this case, inadequate warning) are not preempted by the FDCA.  Justice Thomas’ concurring opinion starts at page 30 of the pdf.  Alito and Scalia’s dissent starts at page 54 of the pdf.

Now we have different preemption rules for PMA-approved devices (Reigel v. Medtronic), where state tort law is preempted, than for 510(k) devices (Medtronic v. Lohr) and for drugs (Wyeth v. Levine) where state law claims are still available.

Let’s see where Waxman and Pallone head with this.

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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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Device Liability Preemption: Blunt v. Medtronic

In a 7-0 ruling that it said was dictated by last year’s U.S. Supreme Court ruling in Reigel v. Medtronic, the Wisconsin Supreme Court dismissed a products liability claim against Medtronic relating to one of its defibrillator models. 

Two justices wrote a concurrence (agreeing with the result, but) criticizing the reliance it places on the FDA’s PMA process, citing criticism of that process from within the Agency itself:

It is not at all apparent that the FDA approval process actually guarantees a minimum level of safety for medical devices.

However, the concurring  justices are mistaken to rely on the cited concerns.  The GAO and “dissident” scientist concerns, as I understand them, were about devices approved through the 510(k) process, not the PMA process, but only PMA-approved devices are exempt from State tort liability under Reigel v. Medtronic.   Medtronic v. Lohr specifically denied preemption for 510(k)-approved devices.

That is not to say that as a matter of institutional competence, I believe the FDA is better suited than the courts to assess post-approval device safety.  I don’t think we have the data to make that assessment.  Certainly if the FDA is expected to competently act as the final arbiter of product safety, it would need more funds, and perhaps revisions to post-approval regulations.  Or maybe Waxman will succeed and legislate tort un-reform.

Read our other posts on this topic.

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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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