Comments on: Supreme Court Hears Important Product Liability Case

By: deeply worried

deeply worried — Thu, 06 Dec 2007 13:34:13 +0000

One last point. Ted Olson’s remarks concerning post-PMA coordination between the FDA and the manufacturers was predicated on the FDA being at the funding and staffing and leadership it enjoyed in previous political eras.

Consistent with the political philosophy in the Administration, the FDA doesn’t enjoy the resources it formerly had nor is its mission what it was.

I hope the Justices bear that in mind, although the ruling by no means will hinge on what was essentially a placative device by Olson.

By: deeply worried

deeply worried — Thu, 06 Dec 2007 04:50:56 +0000

Odd but were no questions were directed as to the legislative history? I thought the SG would have to deal with at least one such.

It would seem that there was no Congressional intent to pre-empt the common-law tort process. Indeed there seemed to be the over-arching goal of consumer, not industry, protection. This would cast 360k(a) in a different, narrower light

If the Court rules as I suspect it will, that goal is going to be turned on its head.

The common-law tradition of civil remedies is beginning to resemble Napoleon’s army in its winter retreat from Moscow. Once mighty, now in full retreat.

By: Patty C

Patty C — Thu, 06 Dec 2007 00:22:07 +0000

The question of whether it is, arguably, prudent to limit excessive jury awards in medical product liability cases and medical malpractice cases is different than what’s being decided here.

There is an obvious distinction raised between drugs and devices.

I question how much improvement constitutes a different device, entirely, and if instituted, whether by whom, when, and under what circumstances constitutes a different cause of action.

By: James Beck, Philadelphia, Pennsylvania

James Beck, Philadelphia, Pennsylvania — Wed, 05 Dec 2007 19:06:26 +0000

Actually, the composition of the Court hasn’t changed materially on the preemption issue. Roberts and Alito replaced justices who had supported preemption in the prior Lohr decision. I think your view of the import of the Riegel case is a bit overstated, since the issue is express preemption, which is limited to the one statute, and PMA approval (which is how this product was approved) applies to less than 1% of medical devices (although they are the most sophisticated).

We have a justice-by-justice analysis of the Riegel argument at our (admittedly pro-industry) site:

http://druganddevicelaw.blogspot.com/2007/12/riegel-our-intrepid-correspondent.html

By: Commoner

Commoner — Wed, 05 Dec 2007 17:24:13 +0000

If the government is so confident in the FDA, and completely backs any product it approves, can the government be held liable for those decisions? If not, there will be a sort of corporate holiday for pharmaceutical companies the day this law gets passed. Conversely, consumers will be completely screwed with noone to hold liable for faulty medications.

By: deeply worried

deeply worried — Wed, 05 Dec 2007 16:06:31 +0000

I’ve been wrong before!

I have a Supreme Court Magic Eight ball on my desk with a custom answer polygon. My custom Eight Ball this morning came up with:

Narrowly Crafted Ruling

I didn’t like that answer so I shook it and the window showed:

Kennedy assigned Opinion

Speaking of oral arguments, today Boumediene/Al Odah.

By: jonathanturley

jonathanturley — Wed, 05 Dec 2007 15:35:09 +0000

I am not so sure. With Alito, Scalia, Roberts, Thomas, and likely Kennedy, we could see a sweeping opinion. Hard to say from oral argument.

By: deeply worried

deeply worried — Wed, 05 Dec 2007 15:11:26 +0000

Agree this is an important case. While most of America will be following the infotainment news-de-jour, the supervising adults will be attending to this “little,” boring, item.

Anticipate a very narrowly written ruling.