Thursday, March 26, 2009


Make Sense to You?

Today, the Michigan House voted to rescind (i.e., repeal) the state's thirteen-year-old drug industry immunity law....again. In 2007, the House voted similarly, but the bill was killed in the state Senate which has a thin majority favoring the 1996 statute. A difference this year is that a number of the Senators who favor Michigan's full preemption will be running for reelection in 2010. The issue made a significant difference in the 2006 and 2008 state elections.

The Michigan statute is unique, providing a full shield to any drug that is FDA approved. This is a far broader immunity than even the dissent imagined in Wyeth v. Levine. Justice Alito wrote in that dissent:

"To be sure, tort suits can peacefully coexist with the FDA's labeling regime, and they have done so for decades. But this case is far from peaceful coexistence."

The operative phrase is "this case"--the particular circumstances of the Levine case in which, the dissent argued, the FDA had fully reviewed the particular risk in question. In order to make that argument, the dissent itself fully reviewed the history of FDA's considerations of the Phenergan label. So the issue in Levine was not what was, or was not, on the label. It was the regulatory history of how it got there. (Indeed, writing for the majority in Levine, Justice Stevens wryly noted that the dissenting Justices had done a far more thorough job reviewing Phenergan's risks and benefits than the FDA ever did.)

In Michigan, the sheer fact that a drug and its label are "FDA-approved" is, in and of itself, the only criterion necessary to provide a full shield. Thus, in Michigan, there are _no_ situations in which tort suits "can peacefully coexist with the FDA's labeling regime." The fact that they "have done so for decades" is either entirely ignored or dismissed as a mistake.


  1. Seems to me that the policy of FDA Preemption should not float on the waves of partisan politics. Can't politicians think for themselves on issues that affect the safety of consumers?

    The fact that the fear of being re-elected has influence over which side of the preemption issue a politician lands on says a number of things.
    1. Politicians can be bought (Goes without saying)
    2. The voter's safety is a lower priority than the politicians viability.
    3. Trusting politicians to do the best thing for the voter is foolish.
    4. The political system is currently broken.

  2. Indeed. When Nan Aron was here yesterday, she made much the same points. Clumsy and problematic as the tort system often is, it is a more reliable route to justice and to truth than most of what happens in legislatures.

    Unlike last time, this year's Michigan vote was almost straight party line. The pols have been surprisingly open about what has made the difference for them, and principle does not rank very highly.

    Question I wonder is--has the pol system ever truly functioned differently, outside of times of genuine national emergency?

  3. For those interested in the finer points, this an excerpt from a newsletter that covers Michigan legislative issues. In the past, it has been consistently biased in its reporting on the immunity law, drawing on dismissal and a kind of smarmy style of writing. You'll see that here, too, but naming names is a useful thing. So is the expression "hog house."


    Drug Immunity Lives . . . But For How Long In Senate?

    The House shot the politically charged "drug immunity" issue back to the Republican-led Senate today for the second straight session. But whether the GOP majority can deep freeze the issue like it did last year is an open debate among opponents and supporters alike.

    Democrats still claim at least two politically vulnerable House Republicans were tossed out of office in 2006 when campaign commercials depicting the horror of drugs-gone-wrong and the inability for the survivors to sue were aired in their districts.

    If the Senate Republicans ignore the subject over the next 18 months, those same ads almost certainly will air in Monroe, Saginaw and other swing areas, putting incumbent Sen. Randy RICHARDVILLE (R-Monroe) and Sen. Roger KAHN (R-Saginaw), in particular, in political jeopardy, some argue. With the Republicans clinging to a 21-16 majority, the issue isn't one the GOP wants hanging around.

    Business groups and the drug industry pointed to today's House vote in arguing the opposite.

    Michigan Chamber of Commerce's Wendy BLOCK said "momentum is on our side," seeing the flagship bill, HB 4316, only received 61 "yes" votes in the House today, nine less than in 2007 when it received 70 votes . . . and Democrats have nine more members now than they did then.

    "This has no star power," Block said. "It has no universal appeal."

    The legislation, which is identical to last session's offerings, ends Michigan's one-of-a-kind ban on limiting lawsuits against pharmaceutical companies to only those where the drugs in question were not approved by the U.S. Food and Drug Administration or were approved based on false information. It's an almost impossible standard to meet in court, and hasn't been done successfully in Michigan yet.

    [Ed. This is false. It is a fully impossible standard to meet, since it requires conditions that have _never_ been met in the history of FDA's regulation of drugs.]

    The public face for the issue this year is Rep. Lisa BROWN (D-West Bloomfield), but Rep. Mike SIMPSON (D-Jackson) and Rep. Vicki BARNETT (D-Farmington Hills) shared their strong personal support for the bills on the floor today, too.

    "The people of Michigan deserve the same consumer protections as everyone else in the nation," Brown said. "We must put an end to special protections for the big drug companies and make sure that people are put before profits."

    Rep. Tory ROCCA (R-Sterling Heights) was the long Republican to cross over in support of the bill. Reps. Richard BALL (R-Laingsburg), Goeff HANSEN (R-Hart), Ken HORN (R-Frankenmuth), Rick JONES (R-Grand Ledge), Jim MARLEAU (R-Lake Orion), Kim MELTZER (R-Clinton Twp.), Tim MOORE (R-Farwell) and Paul OPSOMMER (R-DeWitt) -- basically any Republican who could be remotely called politically vulnerable -- changed their '07 "yes" vote to "no."

    "After a lot of reading and thought, I decided that this is the wrong message we're sending companies," Jones said. "We're open to more law suits. We can't continue to hemorrhage jobs and have the same Michigan."

    [Ed. All the "hemmoraging" has happened _during_ the time we've had such a law.]

    The six Democrats who crossed over to join Republicans in opposition were Reps. Doug BENNETT (D-Muskegon), Marty GRIFFIN (D-Jackson), Lesia LISS (D-Warren), Roy SCHMIDT (D-Grand Rapids), Jim SLEZAK (D-Davison) and Jimmy WOMACK (D-Detroit).

    Bennett and Griffin didn't support drug immunity last year and the other four “no” votes came from first-term members.

    Still, the pharmaceutical industry declared a type of victory with the 61-48 vote. Maybe the less-than-enthusiastic support will push the issue off Senate Majority Leader Mike BISHOP's (R-Rochester) "Worry List" and the bills will vanish forever in committee, they hope.

    But will they?

    Rest assured Sen. Gretchen WHITMER (D-East Lansing), a likely Democratic attorney general candidate in 2010, will pound this issue, and there's precedence that it could work politically. After all, the basic arguments work better on the public than the "save the big drug company" responses.

    [Ed. Some of that smarminess mentioned]

    Observers say if the Senate GOP wants to take the issue off the table, they could do it two ways. First, they could vote on the bill. Let their vulnerable members get on record supporting it, but let all of the term-limited Republican kill it with their opposition. Of course, they risk the issue passing if some term-limited members actually like the bill, which is a real possibility.

    Or the Republicans could "hog-house" the drug immunity bill by stuffing it with provisions the House Democrats could never support -- like limits on attorney fees or "loser pays" language -- and send it back to the House.

  4. Hi Doug,

    With the decline of newspapers, etc., what we really need is a continuing focus on the issue in other blogs. I don't mean every day, but in regular updates and/or when there is news.

    That would be substantive and useful support.

    Folks should know, too, that no state is immune from immunity, even with the Levine decision. Georgia, your own state, was not that far away. The preemptors are pursuing a state by state strategy. Oklahoma could fall next.

    So this remains a national issue. It's _our_ fight--every one of us--and is anything but Michigan's problem alone.

  5. Correction - It has been called to my attention that, in 2007, the Michigan Senate probably would have voted to rescind the immunity law.

    The problem was that the Senate leadership was in bed with, well, some folks from the hog house. Apparently, they still are.

  6. It is great the House passed the bills, but disappointing that out of 107 votes 49 voted “no.” In other words, 46% of the elected officials voted to deny the people of Michigan their civil right to a day in court. I wonder how many of these folks were touched by the 400 drug lobbyist who descended on Lansing last June 5 (approx. 3 per lawmaker). That event did not make the 6:00 o’clock news. Who owns the media now? How many pockets were filled with cash or whatever? How do we preserve a democracy when thugs are allowed to run things?

    I should be happy. Instead, I’m afraid for America’s future.

  7. Dianne, (my thinking) it’s the disconnect between the consumer and the industry that is the root of the problem. And maintaining this disconnect is the desire of the industry.

    When consumer interests are insulated from the media, when consumer complaints are considered frivolous and self serving, when fabricated fears bolster industry objectives, when political power, judicial power, regulatory power and the power of mass marketing have all been purchased by the industry, is there nothing to stand in their way?

    Only one thing - The un-obscured, unified and focused attention of the consumer. There is no power in this nation (at this time) that can stand against the scrutiny of the consumer as far as commercial endeavors are concerned.

    The pharmaceutical industry is huge, powerful and extremely rich but every thread of its existence depends on the consumer’s favor.

    I fear that some in the industry have come to believe that they are more important than those that they serve. You can certainly see it in the stories of those companies and individuals that have been caught in ever worsening fraudulent activities.

    At this point the red lights of warning are not flashing in the eyes of the pharmaceutical consumer. We've gotten close to this tipping point but the massive medical catastrophe that alerts the majority of the public has not happened.

    I think that if FDA preemption had survived The Supreme Court the lights would have begun to flash.

    Wise industry leaders should be in fear of the proliferation of Preemption. Wise industry leaders know that this kind of attention is sure to do more damage than help in the long term.

    Look at what the industry says are the likely results of the institution of FDA preemption.
    1. Reduction in the cost of products.
    2. Increase in the number of new products to the market
    3. More lives saved because of the reduction of over warning.

    Would these things have actually happened if FDA Drug Preemption had survived? Is this what Michigan has experienced? Is this what’s happening with Medical Devices? Absolutely not!

    Would we have actually seen an increase in unsafe drugs, more fraudulent activities, even higher profits and the same or higher product costs? It's very likely.
    I can see the headlines now – Drug Industry Cuts Prices 20% due to New Preemption Policy Not gonna happen.

    So where would the industry run for protection then? Would the consumer have come down extremely hard on the industry? Very likely so.

  8. Jaynesday, Thanks for your response. There is a huge disconnect between industry and the American public. The average American has no idea what preemption is, and less know about Michigan. It would be great if newspapers, TV, and radio started explaining it to the American public. I’m sure if they did warning lights would be flashing. But they don’t, and industry seems to be holding all the cards.

    At the moment some are breathing a sigh of relief. But I look at the vote in Michigan, and am not at all comfortable that America is rid of a policy like preemption. Almost 50% of the legislators sided with pharma.

    Like last time, Michigan could lose this fight. If so, we will remain the only people in the nation who are denied their day in court. But other states should pay attention because our legislators are probably not that different from those in other states.

    Michigan’s law was passed at the 11th hour and tacked on to another bill. We need laws to protect American citizens from policies that take away civil rights.

  9. A few points--

    --For the most part, consumers ("end-users" as they say in industry) are invisible to pharma. What is visible are the number of scripts written, market share, etc.. It would take a populist result of massive proportions for that to change. I do not see how it will.

    --Michigan's pols are pretty much the same as others. Even some of them admitted (off the record) that their vote had nothing to do with principle. And they were right.

    --Every poll from within the industry shows that the ethical race to the bottom is only getting faster. It may take a full crash to change anything.

  10. I am less pessismistic. The reality is that the preemption argument has lost even its thin veneer of potential credibility when it is imposed on single states. There is no rational or empirical base upon which anyone could claim that taking legal rights away from a small number of citizens could impact new drug development or any of the other, equally groundless, claims that are put forward.

    While politics is often not about what makes sense, or is right, or isn't horribly wrong, it sometimes is. We can only bet on that, since the alternative is worse.

    Meanwhile, it is clear from their rhetoric and their tactics that preemptors themselves are only getting more shrill and more malicious. They will overreach themselves, as they always do.

  11. To Sadly,
    Off hand I don't know of any consumer products industry that does not emphasize focus intently on follow-up with the customer's satisfaction or the product’s performance. I suppose it is due to the fact that for most consumer products there are competing products that force this attention. For example with cars you have a choice of any number of similar products that can do basically the same thing.

    With prescription pharmaceuticals there tend to be fewer or no optional products. Therefore the producer doesn't really have to care if the product is as good as it can or should be, just good enough. The consumer will always be there.

    A single producer has a monopoly so to speak. Therefore the protection should be directed to the consumer. Most governments do not allow monopolies to exist due to the fear of producers taking advantage in a number of ways.

    Without competition there is no monetary reason to follow up on the results of the product on the consumer.

  12. Hi Jaynesday--I'm jumping in. I'm wondering whom you view as the connsumer here, docs or pts.

    In pharma, unlike most businesses, the real consumers (those most instrumental in decision to buy), are docs.

    So a "consumer's movement" that did not engage docs might not get very far. Of course, pts can decide not to shell out. But, also of course, that's different from a decision to buy a different car.

    Thus, the consumer model is, at best, complicated. No question that groups like Public Citizen, AARP, and similar have played a role, but a relatively small one on impact of pharma behavior, which--if anything--has only gotten worse since these groups were formed.

    I suspect that unless docs are genuinely ready to confront the industry--and there is no sign they are; most signs go the other way--there can be no meaningful consumer responses in the pharma arena. Sure, we've seen a bit in the editorial pages of NEJM and JAMA. But the grassroots seems unchanged. In Michigan, convinced that preemption would somehow protect _them_, many docs (or at least their professional organizations) have joined up with the preemptors. That includes the state med society.

  13. JiM, I see your point but maybe a wise patient would be able to raise the awareness of their doctor. I know for a fact that if I told my doctor I needed a particular medicine he would prescribe it without much question. I'm saying this because it has happened.

    Knowing what I do now I will make every effort to avoid prescription medications of any kind.

    The only difference between me and the average person on the street is that I know the kind of devious behavior that exists even in the pharmaceutical world. Most people falsely believe that the Pharma Company and doctors are completely above board and/or working with good information. Little do they know - and I think this would be the point of a consumer's movement.

    But just as important as consumer awareness would be communications directed at pharmaceutical companies. They need to know that patients know that they are being watched or monitored or the like. They need to fear the ramifications of business as usual.

  14. Hear ya, bro. I am lucky in that most of the docs I see pretty much share my perspective on the industry and none are "on the take." So, if it's a prescribing decision, we talk it through together, I go to PubMed and beyond to gather relevant facts, and they do some of their own homework.

    There are still limits, of course. But a consumer's movement that began with docs with divest itself from the industry, as the Institute of Medicine suggested not long ago--no more reps, samples, industry-sponsored CME, full transparency for _everyone_ with published journal articles, counter-detailing, etc. I'll get the official list.

  15. Here are some of the IOM recommendations:

    Banning Gifts. Drug and device makers should be prohibited from giving physicians all gifts, including free meals, payment for travel, and payment for participating in CME. The gift ban also eliminates a major entry point into doctors' offices by industry salespeople.

    Barring direct drug samples. The direct provision of pharmaceutical samples to physicians should be replaced by a system of vouchers for low-income patients or other indirect distribution systems to distance company marketing from physicians.

    Centralizing funds for physician travel and consulting. AMCs should establish a central office or facility, free of influence or conflict, to accept funds for travel and consulting time and to dispense the funds at its discretion.

    Insulating CME. There should be a firewall set up between CME activities and direct industry support. Manufacturers who want to fund educational activities should contribute to the AMC's central office, which would then disperse funds. This approach would enable the recipient to remain free from influence by any one donor company.

    Restricting Formulary Ties. Physicians with financial relationships to drug and medical device manufacturers should be excluded from hospital and medical group formulary committees and committees overseeing purchases of medical devices. This would include physicians who receive any gift, inducement, grant or contract from the company.

    Speaking and Writing Bans. AMC faculty should not participate in speaker's bureaus for pharmaceutical or device makers and should be banned from publishing articles or editorials that are ghostwritten by industry employees.

    Research Contract Transparency. To ensure scientific integrity, more transparency and open communication in consulting and research grants is needed. Open-ended grants or gifts to individual researchers should be prohibited. Consulting and research contracts should be posted on a publicly available website.

  16. Justice,
    I think these ideas will do for starters :)

  17. Great. Because the next step is the Bastille.

  18. Hey, that reminds me of something Dr. B. told me:

    Question: Why did the guillotine cross the road?

    Answer: Because it wanted to get a head of itself.


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