Welcome, Diana!

Hello, everyone. I’m excited to be here and thanks for joining me.

Thanks so much for joining us today! Your story has definitely struck a chord with millions of Americans!

Diana, welcome to Firedoglake! Looking forward to a great discussion.

Good afternoon everyone. I first want to say thanks to the folks at firedoglake for providing this forum to talk about Diana’s case.

Welcome, Diana and everyone. 10 years if an awfully long time to continue fighting — kudos to you for keeping it up. And thanks to all the lawyers who have helped you through the various stages of this. Quite an undertaking to deal with a SCOTUS appeal after already losing your hand in such an egregious medical error.

Huge thanks to AFJ for putting together the team which produced the film we are premiering here today. It’s very informative, and brings home just how far-reaching Diana’s case could be for all of us. I hope folks will take the time to watch it.

Me, too!

Great to see you again, Nan!

Hi Diana! Thank you so much for both being here today and fighting for all of our rights in the Supreme Court!

Hi Diana,

I spoke with you about two weeks ago about my wife’s injury with IV Phenergan.

I look forward to a good discussion.

Jim in Dallas

It’s great to be here.

Welcome Diana and thank you for giving your time to talk with us!

Kia

Diana, what has been the most challenging part of this journey for you?

Diana, how did the argument in the Supreme Court go? Did you get a sense that the justices were empathetic to your plight?

Nan — on the after litigation front: no matter which side SCOTUS rules on, there will be a push on both sides of the case for future legislation to further define or rollback parts of the decision. Is the stage being set on your philosophical end of the argument on things that can be done? And are there things we ought to be doing now to get things rolling in a better direction overall?

I ask because, as you know, we’re still trying to rectify things from the Ledbetter case, and I know how much work that has taken just to get it this far. Any groundwork we can lay to undercut preemption where real injury has been suffered due to corporate malfeasance is good work, in my book.

But Wyeth now argues that if it receives permission from a federal agency, such as the FDA, to market a product, that permission preempts unsafe product lawsuits at the state level, even if the product turns out to be harmful.

1) that would assume the FDA is not subject to corruption and having their approval bought

2) it would assume the FDA was given all pertinent information available to weigh against public interest

3) that we want the government held responsible for corporate malfeasance

4) that corporations are not responsible for the expenses they cause simply because they enjoy government agency approval

there are others, this is just off the top of my head

ianal

Thanks, Christy. Yep, it has been just under 10 years–since 2000. I’ve done all I can up to this point, but now it is out of my hands–or should I say hand, but I’m glad for this opportunity to get the word out to whomever it might in the goal of preventing this from happening again.

Believe it or not, I got a letter from a woman in the mail yesterday that had the same thing happen to her.

Welcome, Diana;

This case has the attention of everyone with whom I have spoken about it.

Welcome, Nan.

Welcome to FDL Diana!

So am I correct in reasoning that if Wyeth were to bring a drug like Thalidomide to the market today and get it approved by the FDA, their argument would be that they get a pass because of that approval? Am I reading this correctly?

If so, then discussions of what happened with Thalidomide should be enough to abrogate their argument immediately.

Diana — Thank you for being here, and for sharing your story with all of us! What happens if the Supreme Court rules against you? Could Congress change the law to make sure people are protected?

The most challenging thing has been reconstructing a life as a single-handed person, particularly after years of being a professional musician. Plus, all I’ve learned with regard to the situation, some of which is discouraging, though it is not cause for giving up.

Nan Aron is also here to help out with some of these technical questions, too.

If the case is decided in Wyeth’s favor, we would be left with little choice but to push for remedial legislation. There was legislation introduced last year to remedy a similar case that the Supreme Court handed down relating to medical devices – Reigel v. Medtronics. That legislation has stalled, but with the new Congress coming in, we are positive that changes can occur.

We are also circulating a petition to encourage people to take action on the issue. Our petition is located at: http://ga1.org/campaign/accessdenied. I hope everyone will sign on.

[link repaired by moderator]

Yes, they could. Just as we tried to push for in the Ledbetter case, and will continue to push for as we go forward. (If I’m wrong on that, Nan, let me know…)

Well, the first step is getting a decision from the Supreme Court, and I hope for a fair and reasonable decision. If it comes to Congress–and yes, they can pass laws that clearly say that companies can be held liable in state court–I will be willing to do whatever it takes to get the message out and pass laws that help Americans like me.

But Wyeth now argues that if it receives permission from a federal agency, such as the FDA, to market a product, that permission preempts unsafe product lawsuits at the state level, even if the product turns out to be harmful.

I have it;

I get a drivers license

I lose consciousness and my car crashes through a person’s house causing injury, death and property damage

wyeth argues that since I have a government approval for this license, I am therefore not responsible

patently absurd

Welcome,Diana. Thank you for coming to Firedoglake.
And thank you, AFJ.
God help us all if this lawsuit fails.

Diana, proponents of preemption say that efforts like yours are just about helping the trial bar stay in business. Obviously with your personal experience you know that there’s much more at stake than plaintiffs’ lawyers’ paychecks. But if you could say one thing to these skeptics in response, what would it be? I ask this as a blogger who debates and writes about these tort issues every day, where I constantly encounter the trial lawyer scapegoat.

In response to questions about what might happen to other cases involving other drugs – if Wyeth were to win, it is likely that drug companies would try to extend the “preemption” argument to cover any number of state tort claims. This means that persons injured by a drugs might well lose the ability to sue the manufacturers.

Lawsuits have often been the only way to expose coverups, dangerous products, and to ultimately make people whole. It’s important that these things remain intact.

Absolutely. Congress can explicitly state that it never intended federal law to preempt state law here. Luckily, Congressman Waxman, in his capacity as chairman of the House Oversight Committee has been very good at looking into the problems with this doctrine. In fact, just before Diana’s case was heard by the Supreme Court, the congressman and the committee’s majority staff released a very interesting report entitled “FDA Career Staff Objected to Agency Preemption Policies.”

You can see it here: http://oversight.house.gov/doc…..102934.pdf

In the documentary, they talk with your physician about the drug and it having had no labels warning against IV push. That must have been such a horrifying moment for him as your doctor, above and beyond how hard it had to have been for you — especially having been a proficient musician. The loss of being able to play would be so devastating — am so sorry, Diana.

During the course of your case, I understand that you learned there was information that Wyeth had showing that the damage you suffered was possible (if not probable), and yet they sold it without a warning label. Was there ever any explanation given by them as to why no labeling for public safety? Whatever it was, your trial jury ust have found it grossly insufficient, but I wondered what, if any, explanation they tried to give for that level of indifference?

That is not a question Nan or anyone can really answer, given that the case is currently pending. See my note above.

I never envisioned myself as someone who would sue. It’s certainly not about me getting a new Mercedes or house in Provence. It’s about holding a company who is at fault responsible, and inspiring them to change the label and prevent this from occurring again. I’m up here in Vermont with a country lawyer who is supremely ethical. There has to be a mechanism in place.

We don’t like to predict what might happen with SCOTUS, however, we are hopeful that the Court will view Diana’s case differently from the Reigel case involving preemption for medical devices. The statute governing medical devices had an express preemption clause, unlike the statue governing drugs which has no express preemption clause. The Court would have to find an implied preemption claim to decide against Diana and for Wyeth.

So am I correct in reasoning that if Wyeth were to bring a drug like Thalidomide to the market today and get it approved by the FDA, their argument would be that they get a pass because of that approval? Am I reading this correctly?

What Wyeth is arguing THIS TIME (emphasis added, because you know, win or lose, the pharma industry will be back in court for more), is that the preemption they feel entitled to only applies as long as the company disclosed all risk data to the FDA at the time of approval. They want us to be reassured that, if a company withholds pertinent data FROM the FDA, they might still be held liable.

Of course, if they DID provide full risk data to the FDA once upon a time, with respect to Phenergan, then what happened to Diana and many others just serves to prove that FDA approval is entirely inadequate as the public’s only safeguard.

btw, ACS and some other groups have done quite a bit of work on preemption and have put together some great background information well worth reading.

– On preemption, health and safety and SCOTUS.

– Regulatory preemption.

– Preemption discussion at the tortdeform blog.

Wyeth has tried to use the argument, in addition to the arguement that the FDA approved it, concerning the risk/benefit ratio, using numbers to benefit their case, as if 20 people losing their limbs is not enough to change the label to prevent this. Any ethical risk/benefit evaluation that looks at the benefits–in this case, anti-nausea versus the severity of the risk–gangrene and loss of limb. If you measure that, then one would think this method of administration would not be given to doctors as an option. They could have changed the label to eliminate that risk and failed to do so.

Wyeth’s warning against Phenergan IV was in the PDR since 1989 when my wife’s hand injury occured. Wyeth(American Home Products) just ignored the problem knowing that Phenergan was administered IV thousands of times a day. It became a “Standard of Practice” while Wyeth collected revenues for sale of Phenergan IV.

There are multiple groups beyond the “trial bar” that are interested in the outcome of Diana’s case. In fact, career professionals inside the FDA, including former FDA commissioner David Kessler, have spoken out against preemption. But, also, consumer and health and safety groups, the Journal of American Medicine, various states attorneys general and a host of other organizations are against this radical shift.

Thanks, that was my reasoning as to why — good to see it confirmed. You’d think that the state’s rights issue might give more conservative-leaning legal minds some pause, but it doesn’t seem to trouble a lot of them who are pushing preemption as a doctrine for corporate cover. That’s certainly an issue that ought to be raised at every opportunity with folks who have been pushing this under the guise of tort reform, but not addressing the constitutional issues which arise from the imposition of federal over state law, especially as it impacts public health and safety concerns in so many cases.

That David Kessler was willing to go on the record against preemption says a lot.

Thanks so much for being here today Diana, and for not giving up. Your tenacity is admirable and very much appreciated.

I do want to make the point that anyone who knows the details of the case is going to be tempted to blame the person who inserted the needle. But what they don’t understand is that this is an accident waiting to happen. Wyeth knew that IV push dramatically increases the risk of gangrene and limb loss. So in fact, doctors and other medical care givers who would like to trust the instructions they are given, can’t. It is my hope that anybody that knows ahead at a hospital while we’re waiting for SCOTUS to come back with a good ruling that the policy of a hospital is not to use the IV Push method. That’s only necessary because Wyeth hasn’t done their job of warning medical care givers.

The FDA’s ability to regulate drugs that go on the market pales in comparison to the resources the drug companies have to do the same. The FDA has approved thousands of drugs, and once they go on the market the FDA recieves only the information the drug companies provide. This undermines the argument that the agency has the resources to truly monitor drug safety.

Sorry. I scanned over that part too quickly. I understand.

I agree. I happen to be the off-spring of an 88 year old father who has been a staunch Republican as long as I can remember. He was heartbroken, of course, with what happened to his daughter, and disillusioned that this administration would do the exact opposite of states’ rights and monkey with the regulations and try to make the FDA have ultimate responsibility for the safety of the public.

Diana, what was it like to make a film about this issue with Jon and Matt?

What happened in Diana’s case isn’t an isolated event. The Bush Administration has added “preemption” language into the preambles of over seven federal agencies affecting over seventy rules. These changes are usually in favor of big business at the expense of regular people like Diana. It is important that the incoming administration work diligently to reverse these rules changes.

Thanks very much Diana.

Has this experience affected the way you view our justice system or our government at all?

And have you been able to reach out to others who’ve been wronged by corporate abuse over the years, or have they reached out to you, as a result of what you are doing to prevent this from happening to others in the future?

Thanks again.

KIA

Thanks!

With regard to this particular case, I think one thing that gets underemphasized in the media has been the fact that there are perfectly safe ways of administering Phenergan to get the anti-nausea benefit, so there is no earthly reason that Wyeth should have such an unsafe option along with the safer ones. They talk about the possibility of inadvertant arterial injections, as if that’s enough. Nobody intends to inject Phenergan into an artery. The only solution is to eliminate the opportunity to inject into an artery altogether by taking away the opportunity to use it as an IV Push.

Nan — isn’t one of the other enormous elephants in the room on this the fact that a lot of the research on these drugs is funded by the very drug companies who are seeking FDA approval? So to get independently verified research that fully discloses all the inherent risks, drawbacks, etc., can also be incredibly difficult in that environment, since so much of the university research we see these days is corporate-funded for corporate purpose-driven rationales. That isn’t to say all such research is defective or that every company tries to hide bad information — some do not, and they should be commended for it.

But far too many put profit margin over safety considerations. And we have seen that time and time again in litigation after the fact where companies knew of substantial inherent risks and hid that data from the public until it was too late for far too many people who had been injured or killed by the products. To put those folks in an even longer leash and allow them to simply police themselves, or to think that an already overwhelmed FDA could possibly keep up with that qualitative demand is insane in terms of public health and safety.

And we wouldn’t just be talking about drugs with this. This argument could be extended to food (USDA approved, so no salmonella or defective ingredient taint can be a cause of action, so there!); products (UL approved!); or anything that passes through any governmental approval process, state or federal. What they are asking for is, essentially, blanket immunity from their own wrongdoing.

In addition to madymae’s question about filming, I would like to know how it felt for you, Diana to see the Justice’s contemplate your case in the Supreme Court?

I’m late as usual. Thank you, Diana. This preemption policy was new to me.

You are most welcome — it’s great stuff!

In a country where if spinach gets recalled because it causes diarrhea and health actually retruns after that, how could a company not withdraw a method of administration that has an adverse outcome that you don’t get better from?

Tom, anything you would like to add? (My friend Tom Daley has joined us today.)

Thanks Nan,

Absolutely. The proponents of preemption want to paint a picture of “the enemy,” and they think trial lawyers are the easiest scapegoat because of all the false negative stereotypes about them. But I agree with you that there’s a much larger community that understands the vast importance of this issue.

Question: do you see the broader public getting on board this issue as well? There are lots of other things going on these days, especially when it comes to our economy and the war. But do you see this issue reaching “kitchen table” status with the broader public?

When will the court make a ruling? Is there an anticipated time window? We would love to hear how it turns out.

Christy – you are right. Too often profit over safety prevails. And, because the FDA does so much they rely on companies to provide information. Also, once a drug gets approved Many companies are hesitant to present new information given fears that fewer consumers will buy their products.

Speaking of profits, a quick google search just turned up Wyeth’s profits — and, wow, it was in the top five pharma companies last year! http://money.cnn.com/magazines…..ts/86.html

Since the argument was just held on Nov. 3rd, it will likely be a little while until there is any announced ruling on the case. The justices will have time to consider the arguments and the briefs filed for or against, and will have discussion in chambers as well as have time to draft potential court decisions (also, likely, for and against). And then will begin the dance of negotiations on where each justice may or may not fall, whose brief will or will not ultimately gain majority support, etc. It takes a while. But we’ll certainly cover whatever decision is rendered when it is finally announced.

FWIW, Jan Crawford Greenberg’s book on the Court — which we had for Book Salon a while back — does a great job of talking about how these decisions are rendered from start to finish. She does talk quite a bit about the Ledbetter case as well, near the end. Definitely worth a read.

This issue absolutely impacts millions of Americans. And, because of that it is inherently a “kitchen table” issue. Every person taking a prescription drug – from antibiotics to cholesterol medicine – has a stake in the outcome of this case.

If the case is decided against Diana, the solution will be to push for remedial legislation in Congress. Already both the House and the Senate have introduced legislation to this effect. And, we will continue to urge people to join this campaign and sign our petition at http://ga1.org/campaign/accessdenied.

In comparison to how I am now, I was a political novice when it comes to the government, justice system and pharmaceutical industry, for that matter. So yes, it was a big eye opener for me. It was shocking to learn that an administration can get away with fiddling with the preeambles in regulatory agency guidelines essentially behind our backs. So, it is important to me to let people know that there has been a political effort to make preemption like this a policy. I just hope that the courts don’t allow the drug companies and administration get away with this. I feel much more hopeful with the new administration that this kind of behind-the-scenes wrongdoing won’t occurr and that our system of checks and balances will be restored.

As for people being in touch, that has been one of the most satisfying aspects of being out in the public and having to expose myself is that people have heard about it and have e-mailed, written and called with their own stories of injuries they’ve suffered. Often, they are people who didn’t go the distance of knowing that this is something that could have been changed by the drug company, so they didn’t sue. And so, imagine how many people there are out there that haven’t reported what has happened to them because they didn’t know there was recourse. And right now, there is recourse and I hope that doesn’t go away. A letter I got yesterday ended with an apology. “I’m sorry if this is hard to read, I used to be right-handed. Good luck with your lawsuit.” It made me cry. Fortunately, that woman’s hospital, as a result of what happened, modified their policy so that Phenergan cannot be administered by IV push. Wouldn’t it be nice if Wyeth would warn all hospitals so it wouldn’t have to be word of mouth, one at a time and firsthand experience of someone getting hurt.

This SCOTUS ruling is going to impact another GA case too, regarding child vaccine injury. HHS recently declared an “anthrax state of emergency” that indemnifies all those connected with the manufacture and use of the anthrax vaccine. FDA allowed fudged clinical trials of Merck’s Gardasil vax to get it over the approval threshold in record time.

Are there any aspects of this case that address how FDA or consumers would know if a pharma company were witholding pertinent data on the safety of their products? Or whether there were collusion between FDA and Pharma at the expense of consumers?

I was really grateful that there were people who wanted to this message out enough to spend 3 days with me in Vermont filming, even though it was stressful. It’s kind of like trying to show my triumphant spirit and yet communicate how devastating this has been to my life and that I stand here as living proof that we need to be able to ask for help when we are hurt by products put out by drug.

My feet weren’t touching the ground. I was glad I had a sister on one side and a daughter on the other. It was illuminating and overwhelming and I’m still digesting it.

Hi Diana (and friends far and wide)-

Another canard to be aware of in these cases is the assertion that lay juries just don’t have the expertise to evaluate medical data, chemical evidence, and the other arcana that goes into an FDA submission. But they are certainly as expert as anyone else can be in the question of whether someone like Diana, and her health provider, had adequate warning about the true risks of what she was being subjected to. Because they know what their own answer would be if offered the option of, say, marginally faster relief from their nausea at the risk, however small, of needing to have a limb amputated following treatment. The only people receiving Phenergan by IV push are, by any definition, inadequately warned, because no sane human would accept the real risk.

That’s probably harder for a medical expert to see than it is for a lay jury. In a word, the field of expertise most important here is justice. Presumably that’s why we have a 7th amendment.

Definitely by June, and hopefully sooner. I’ve been told around March.

The points Garbo raises are intersting, but Diana’s case doesn’t directly deal with them. If companies knowingly withold data from the FDA, suits against them can still proceed.

I think people who resort to the “lay juries won’t be able to understand this” fail to comprehend the basic thing that juries do understand quite well: when someone is lying to them, it is palpable in a courtroom. The data can be gone over any number of ways, but that squirming, sweaty browed, blinking fitfully, stammering witness who testifies in a half-hearted way and avoids answering direct questions from a knowledgeable lawyer? That sticks out directly for jurors and they get that above and beyond the science.

Plus, a good trial attorney can walk a jury through all of this step by step. If I’ve been able to walk a jury through forensic evidence on fly maggots to determine an approximate range of murder time, then no scientific bit can be that impossible to explain. (Talk about your squeamish jury. *g*)

There is something I don’t understand. If I listened to the video accurately, your IV was inserted correctly into a vein (otherwise, presumably, you’d have a lawsuit against your doc). So how did the drug get into your artery? And is there a difference in the possibility of that happening between a push IV and a drip IV?

I would like to give a special thank you to Diana, who has been a true hero. She has shown courage in the face of diversity. We are indebbted to you. Thank you.

And, also I would like to thank Christy again for hosting this forum. It is wonderful to see so many people interested in this topic.

Everyone, take care. And, let’s hope for a positive result!

Thanks so much, Nan — and a huge thank you to Diana for being here to discuss her case with us today. Here’s hoping for a good result for you, Diana. We’ll keep an eye on it, gang, and let you know when a decision is made.

To me, it’s the drug companies. They are the ones with the information. The knew this for years and it was their responsibility to go to the FDA and propose that this method of administrations not be offered because the risk was too high. If they didn’t communicate that message to the FDA you can’t blame the FDA.

I’m really glad the FDA exists, as it has for years, as a floor to keeping us safe. But it is only a floor. As those internal memos indicated, actual FDA staffers have said the same thing–the only way to have rapid response to problems with drugs is to have ordinary people letting you know, and the only way you know is to have legal redress through the courts.

Also, another Q. Depending on the answer to my 71, it seems that changing the labeling (required or not) to eliminate the risk, or at least to push the liability back on the doc, would not cost the drug company very much. Why did Wyeth not so it? Fear that earlier cases would have a more robust cause of action?

Thank you to Diana, Nan, and Christy for this enlightening discussion. What a wonderful opportunity! Take good care! We’re rooting for you (and, by extension, for ourselves as consumers and patients)!

looseheadprop upstairs on possibility of Eric Holder as AG.

This is a really important question. The clinic where this happened DID take responsibility for the fact that it happened under their roof. If you look at just the surface, it stops there. But, when you look beyond that, you see that this was a predictable outcome of using Phenergan by IV push–when you look at the chain, the link where change can be made in order to prevent an occurrance lies squarely with Wyeth Pharmaceutical. By not warning caregivers, they essentially set them up. This could happen to the most skilled, competent, experienced person. I’m sure there are many doctors out there who are thinking “There but for the grace of God go I” when it comes to the consequences of administering Phergan by IV Push. There is a different between push and drip. The reason that drio you can tell that you are in the vein, whereas with the push, you don’t know for sure until the drug has leaked into the arteries and then it is too late. The only safe ways that give relief quickly are intramuscalar injection and IV drip.

I think one of the things we all need to do a better job with is public education about these issues. Because, in my experience anyway, most folks have no idea what is going on with any of this — or how far-reaching its impact could be. And no amount of scapegoating trial lawyers on the part of preemption proponents takes away the fact that it is individuals who are already injured who have to pay the price for corporate malfeasance in these cases, while they hide behind a technicality to escape any accountability.

Exactly. It would not cost them very much. They would sell the same amount of Phenergan, it would just be administered in a safe way. The only possible way of interpreting what is happening now is that they want this case to be the one that establishes preemption as a way to insulate themselves from liability when their products injure consumers. They are stubbornly refusing to do the right thing, so that is the only explanation that comes to my mind. They are the only ones that can prevent this from happening again. They are behaving in a very “big business” way, and removing the right of an average citizen to have a redress of grievance.

Thanks. I’m amazed to learn what you say about push. That’s strikes me likely dangerous in a whole variety of cases besides Phenergen.

When I was on Wall St. (economist, not securities analyst), I presented at a dinner meeting in LaJolla, which included 2 out of 3 docs who invented IV push. By then they had sold out to Medtronics (iirc) and had quite a bit of net worth.

I know I’ll never get my arm back, but I hope the loss of limb doesn’t become loss of limb and liberty.

Thank you to everyone for being here and to Alliance for Justice for getting the word out. I hope everyone enjoys the movie; I’d love feedback once you have had a chance to take look. I’ve enjoyed being here today and thank you all again.

Thanks again. Yours is a reasonable hypothesis.

And, Diana. The very best of luck.

Amen!

Thank you, Diana and Nan, as well as everyone else, this has been most informative. Regardless of how SCOTUS may decide, for thoughtful persons, the verdict is already in.

Diana, I wish you the best in all things and applaud your courage and humanity in seeking a broader justice. Truly, you are a remarkable human being.

David