Yes, Paulette, we have been on the wrong end of the drill bit. But perhaps….a turn around is coming.

Why was the House speaker so committed to this law? And is there any one state senator who is likely to take on the same role? Let’s converse.

ed at Pharmalot

While it is true that Michigan Dems have been out front in the effort to rescind drug industry immunity, one-third of the those who voted in favor of the bill for rescinding that passed in the House were Republican state reps.

The key issue in the shift of majority was not so much vote count but rather who was the House Speaker. The former Republican Speaker was personally committed to sustaining our shield law, even when many in his party were not. As Speaker, however, he was able to keep a vote from coming to the House floor.

One of the reasons the Republicans lost the majority in the House was precisely this issue.

That same situation now prevails in the Senate. If history is any guide, the Republicans may well lose the state Senate too, in part as a result of their leadership’s unwillingness to allow any hearings (let alone a vote) on this issue.

Partisanship narratives may make good AP stories, but the reality is more complicated.

Let me note again that the argument about “second-guessing the FDA” is, from my perspective, pure rhetoric, without substance. FDA’s determinations figure in every product liability case involving a drug. In our state, most of us would be very happy to have FDA approval as a “rebuttable presumption” of a company’s innocence, as is the law in a few other states. That is, you have to show that - in spite of being “in compliance” with FDA regulations - a company nevertheless acted in ways for which they can appropriately be held liable.

There are many such ways that could happen: What Jerry Avorn calls “passive-aggressive compliance” (playing as much with, as by, FDA regulations though a variety of delaying and fudging tactics that don’t rise to the level of felony fraud); intimidating researchers (totally outside purview of FDA); spinning medical journal articles in misinforming ways (as in the now infamous JAMA article on CLASS) and, again, journal editorial policy is an area over which FDA has no authority whatsoever; and so on.

Bottom line: Until the last few years, FDA itself has described its own regulations and civil liability as two, usually complementary, layers of consumer protection. Only in our state did one of those layers get thrown away.