The Cross-Border Biotech Blog

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.

Of course, last year’s bill didn’t pass, which speaks to the difficulty of “circumventing” a Supreme Court decision with legislative action and points to the uphill battle such efforts will continue to face. This year’s bill has a good chance of passing the House, where the Democratic majority is more significant, but the challenge lies in the Senate that is generally a more moderate body with a narrower Democratic majority. While certain Senators would side against the medical device industry (i.e., in favor of the bill), namely Senator Ted Kennedy, who serves as Chairman of the Senate committee that would have jurisdiction over this legislation, it will be difficult to get Republicans and more conservative Democrats on board on this one.

At some point, with the Reigel v Medtronic decision sufficiently secure, we can look for changes in medical device makers’ decisions.  This could provide an empirical assessment of the accuracy of the tort-reform claims as follows:

• Immunity from State tort claims is provided by Reigel v. Medtronic for PMA approved devices but not, under Medtronic v. Lohr, for 510(k) approved devices.
• Medical device makers could, if they wanted to, choose the PMA process for 510(k)-eligible devices.
• Therefore, they should do so if the benefits of immunity from State tort claims outweigh the costs of the PMA process.
• Estimates in the 1990′s put the direct costs at $13 million for 510(k) vs $36 million for PMA (plus the opportunity cost of a longer process).

Anyone seeing ‘voluntary’ PMA submissions for 510(k)-eligible devices?  Is the cost differential too high? (I suspect one can buy a good chunk of liability insurance for $23 million.)

It will be interesting to watch, but harder to quantify, the competing incentives with respect to NDA applications (compared to off-label promotion) created by the new FDA guidance and the pending Wyeth v. Levine ruling.