Comments on: NJ Judge Tosses Hormone Replacement Suit

By: Justice in MI

Justice in MI — Sun, 13 Jul 2008 04:00:17 +0000

Just a follow-on: As Ed notes, DDL suggests that plaintiff must have “substantial evidence” that a company did the relevant misdeeds. But where could the average get such evidence, other than through the discovery process? Not many places. Under preemption, that source will be gone.

As some may know, the pro-preemptions lawyers will be gathering for a big conference in Philly on July 14th and 15th. This will (I hope) generate ink about the issue.

From my perspective, the more the better. This is a policy that doesn’t stand up well to sunlight.

By: Justice in MI

Justice in MI — Sat, 12 Jul 2008 13:31:03 +0000

Yes/no, to Nathan. The proposal you suggest was _exactly_ what we’ve been fighting for in Michigan. FDA approval/compliance provides what is called a “rebuttable presumption” (of innoence). There are a number of states that have such a law - it is a very long way from preemption as is going forward. It’s been around a long time.

So if we arrived at that place nationally, it would be, in my view, a very good thing.

This language raises interpretive questions: ““deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects or manipulation of the post-market regulatory process”

While it sounds good, and reasonable, does it mean in practice that FDA/DOJ must find felony fraud and prosecute it? If so, it is meaningless since, as we’ve discussed, that essentially never happens. Rather, settlements are made, remedial plans are put in place, etc..

Otherwise, this is precisely the balance between supporting FDA’s authority and the authority of legitimate claims to a hearing.

By: Vince

Vince — Sat, 12 Jul 2008 11:47:29 +0000

Preemtion the ultimate shield for dangerous drugs. The judge I believe imposed this definition

By: Nathan

Nathan — Sat, 12 Jul 2008 10:32:42 +0000

This is interesting: “Superior Court Judge Jamie Happas ruled that Dora Bailey failed to provide the specific type of evidence necessary to overcome state law that presumes FDA-approved labeling on the three drugs was adequate.”

This almost sounds as if New Jersey has some sort of “preemption doctrine” already in place. In my mind, this sounds like a nice compromise to preemption. FDA decisions on safety should be presumed to be adequate unless there is material evidence of “deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects or manipulation of the post-market regulatory process”

Any thoughts Justice? I wonder why the original judge (or jury) didn’t use that standard?