Comments on: Why They Hate Preemption In Michigan

By: HG

HG — Sat, 24 Nov 2007 04:10:15 +0000

Gary - Unfortunately, attempts by Michigan citizens to file out of state have generally been turned back because it has been ruled that the Michigan law “occupies the field.” If you are an exception to that, keep us informed.

By: Gary Konyha

Gary Konyha — Tue, 20 Nov 2007 00:07:49 +0000

I am a victom of VIOXX and I am deaply concerned of Michigan Law. What I have gone through and my damaging results is only me. Thousands were hurt or killed by this drug being told that there were no side effects. I took VIOXX for lower back problems for 2.5 yrs and at the age of 43 I suffered a heart attack with 98% blockage in my LAD which should have killed me. My health was in great in shap @ 5′ 7″ 148lbs. with a colestrol level of 82 (I work out religiously). My cardioligest could not understand why I had this blockage at the time. It is sad to see that because I live in Michigan that I could be laughed at in the end. I can only pray that this will be overturned, my case has been filed in New Jersey by a firm from Raleigh North Carilina.

Please write back with your thought and/or comments.

Thanks - Gary

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By: HG

HG — Sat, 29 Sep 2007 17:59:28 +0000

I’m indebted to Ed for the chance to get the word out about our situation in Michigan and beyond. A couple of addenda that may be of interest:

- Actually, we have had some success in repealing our drug industry immunity law. The issue was key in some of the 2006 state elections, and - as their first order of business in Jaunary 2007 - the Michigan House voted to repeal our immunity law by a vote of 60-41, with solid bipartisan representation. But the State Senate has proved to be the stumbling block to full repeal - a matter of 3 votes or so that would need to change,. Statewide polls show that Michigan citizens favor repealing our shield law by about 70%.

- As Ed notes, the “rationale” of the argument in favor of preemption is that courts ought not to “second-guess” the FDA. The reality, however, is that no court has ever “second-guessed” FDA, nor made any judgement whatever about what FDA should or shouldn’t have done. Rather, civil liability _complements_ FDA regulation, which was the FDA’s own position until the current Administration. Viewing FDA compliance as a basic requirement, courts have asked: (1) Even if technically in compliance, has this company done more to play _with_ regulation than _by_ it (what Jerry Avorn of Harvard calls “passive-aggressive” compliance) such as though delaying or disguising important risk information. (2) Is there a pattern of deliberately misleading physicians and the public in areas that are not covered by FDA regulation at all - such as through inappropriately spinning journal articles, intimidating researchers, and so on.

It’s important to know that whether or not a company is in FDA compliance is already a part of civil trials. As covered in the interview, the question is: is that always and everywhere enough?