Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
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Tuesday, December 05, 2006

CLOSING ARGUMENTS - Tobin v SmithKline Beecham


IN THE UNITED STATES DISTRICT COURT
DISTRICT OF WYOMING
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TOBIN
vs.
SMITHKLINE BEECHAM PHARMACEUTICALS
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EXCERPTED TRANSCRIPT OF TRIAL PROCEEDINGS
CLOSING ARGUMENTS

MR. FITZGERALD: Members of the jury, I'm going to talk about a couple of things. We join in the defense and we trust you not to let sympathy govern you here. And I'll tell you why. It is because sympathy is what we feel when we see a situation that we can't help. When we see an orphan child, of course we're going to feel sympathy.

It is not sympathy when you have the power to do something about it. You have the power. You have the power to right a wrong here. You have the power to make a difference. And you will never have this kind of power again in your lives. This courtroom right here is a United States courtroom. It is the same as a United States courtroom in Washington, D.C. You have the power that a jury would have anywhere in the United States to right this wrong. You have the power.

And will you exercise that power? Yes, you will, in one way or another. And I'm here to tell you why they're wrong and we're right, but I do want you to know, that your verdict is so important that it will live forever. That's how important this case is.

The defense says they're not here to blame Don Schell, but we've heard a lot of blaming of Don Schell. You know, one of the most important things that happened in this courtroom happened yesterday. And that's when the defense doctor testified about the practice of medicine and here's what he said.
"Question: In order to do a detailed mental status examination you have to get the information from the patient or his family, true?"
And the doctor said, "That's true. And not only that, you're not going to get a detailed mental examination from an internist. This is where psychiatry training will come into the picture."
What does this mean? SmithKline Beecham's own witness comes in here and says an internist is not going to have enough information. So where would the internist get the information that the internist needs? There's only one place. And that's from SmithKline Beecham.
This proves that SmithKline Beecham should have put more information in the product instructions, in the Physician's Desk Reference, the blue book that all practicing physicians have in their office about drugs and their side effects, because an internist is not going to get the detailed information.
You have to tell the prescribing physician, the internist, and others throughout this nation, "Dr., this drug has no sedative effect. You may wish to consider giving a sedative."
The prescribing doctor who gave Grandpa the Paxil testified: "If I had known that, I would have handled the case differently."
The defendant should have said: "Dr., you are like many general practitioners or internists and you're not going to have the information you need unless we tell you in the package insert if you're going to prescribe the drug, and we hope you do" -- and I hope they do because it does a lot of people a lot of good -- "but if you're going to prescribe it, please sit down with your patient and get a detailed history."
Think about it, members of the jury. We've all been the doctor. You go in and you sit down and you answer the doctor's questions. If only SmithKline Beecham had said, "Get a detailed history, you internists and general practitioners. It is very important and watch out for these things. Find out if there's been a bad reaction in the past on an SSRI."
The prescribing doctor said, "If I had been given that kind of information, it would have made a difference in how I handled this case."
And what kind of information was he talking about? He wasn't talking about Don Schell hiding something or filling out a questionnaire to minimize his condition or misleading the doctor or withholding information. He was talking about "If SmithKline Beecham had told me this information, I would have handled this case differently." And that, members of the jury, is the crux of our case.
It is very important for me to try to clarify exactly where we stand. SmithKline Beecham says that their product is not defective. Let's get real clear about one thing. There is nothing wrong with the Paxil pill. We're not claiming there's anything wrong with the Paxil pill. Nothing.
So why are we here? We are here because the product consists of the pill and the instructions and warnings that go along with it and those instructions and warnings are inadequate and defective. That's why we're here.
When they say that the product is not defective and they argue the facts, they're leaving out a very important part of the picture, and that is that a product maker must foresee the uses of its product.
You don't have to take my word for this. His Honor will be giving you comprehensive instructions on product liability law.
When SmithKline Beecham says their product is not defective, they overlook the fact and the law that an inadequate or improper warning can make a product defective. Let me tell you what the jury instructions will say: A defective product can include a product which has inadequate or improper warnings.
When the defendant says their product is not defective, they overlook the fact that a manufacturer like SmithKline Beecham has an obligation to give appropriate warnings of any, any dangerous condition which is likely to be encountered and sometimes there will be a dangerous condition.
Sometimes because Paxil, a good pill, is given, but there are inadequate instructions, inadequate warnings, inadequate information is given out, so it becomes a defective product, not the pill itself, but because it doesn't have the proper warnings.
So, members of the jury, I just wanted to clarify where we stood. We're not attacking Paxil as a drug, itself.
Now, the defense says that SmithKline Beecham did not cause these deaths. It is very important that we talk for a minute about what that means. You will hear later from the Court about what goes into cause. A cause is something that plays a substantial part in bringing about an event like happened here.
I want to make this very clear because you're going to hear the word "strict liability." When we're talking about strict causation and SmithKline Beecham defends on the issue of causation, we're not talking about absolute liability. That's not what it means. And we're not here to tell you that strict product liability means absolute liability.
If Paxil is lacking the defective instructions for prescribing doctors and that played a substantial part, then it is a cause. SmithKline Beecham defends on the grounds that they didn't cause this. But SmithKline Beecham's lack of instructions and warnings are a cause. As Mr. Vickery told you, you might find that Mr. Schell was somewhat at fault here and he would be, if you did so find, a cause. SmithKline Beecham would be a cause.
We are not saying that you must absolutely find it is 100 percent SmithKline Beecham's fault here. Our view as we put this case to you is that it is SmithKline Beecham's fault, but you have the power. I don't have the power. I don't go back to the jury room. But you have the power. You can walk back in here with your verdict form and put any percentages that you want to on that verdict form.
So was it defective? Yes, it was defective. Not as a pill but because of what wasn't said. And that is the defect. As to causation, it only has to be a cause, not the only cause. And when you find those two things, then you can turn to the question of whether Don Schell should be blamed to some degree. It is your power.
Now, let's look at a couple of common-sense things -- If Deb Tobin had had any idea that her baby was in danger in that household, she wouldn't have stayed. She would have left that evening. She would have gone somewhere else.
Now, SmithKline Beecham tells you that the pills are prescribed, and it is true, to be taken at bedtime. So here's the mother, newborn child, it is like -- it is just a powerful instinct. She's going to take care of that newborn child.
If that baby were in danger, she wouldn't have stayed. They went to bed. They were in their bedclothes. Don Schell took his second dose of Paxil. It was in his system, caused him agitation. There's evidence in this courtroom in Exhibits 12 and 14 that it can cause hallucinations. Something went terribly wrong and he killed 1, 2, 3, 4 people. The unsuspecting mother of the infant. Something went terribly wrong.
The defense experts say that suicide is multi-factorial, it has a biological component. Let's think about it. What is different in the biology of Don Schell that wasn't present for these whatever number of years, depressions that he suffered. Depression is such a terrible thing. I'm sorry for people who suffer it. But what changed in his biology? It is multi-factorial. It has a biological component.
Well, throughout all of those depressions he never harmed a flea, but he takes Paxil pills, and these are established facts. The toxicology report for Donald Schell indicated that he had Paxil in his blood at the time of his death.
Well, they say the plaintiffs have no evidence. You know, we look at these Exhibits, and you will see them, and it is all these defense studies. You don't have to take my word for it. You can look at it.
I have two pages here and they say agitation, definitely related; restless, definitely related; anxiety, disoriented, confusion, definitely related; depersonalization, definitely related; attempted suicide, definitely related; attempted suicide, definitely related; suicidal ideas, definitely related; suicide attempt, definitely related; hallucinations, definitely related; hallucinations, definitely related.
They say, "Well, you can't just rely on a single report." Well, let's talk about this. Remember the defense witness who came in here and he gave us the four different styles or types of murder/suicide. But when they're defending this case, what do they do, they go to single case reports.
Let me look at this. I have it exactly right because I thought it was striking. He cited a single case report from Japan in 1956 for one of his categories. He cited a single case report from Australia of 1975 for one of his categories.
They can't pick and choose, ladies and gentlemen. And they want to. And they want you to. They want you to say well, there was that committee of scientists and that committee of scientists met and they voted 6 to 3 to allow Paxil to be sold in this county.
Well, the 3 are sitting with us, not physically, but they're here in spirit, and you have the power to join them and to say, "Please just tell the prescribing doctor and doctors like him the whole truth. That sometimes there is a connection. Sometimes people will have suicidal ideation. Sometimes they will have hallucinations. Sometimes they will need a sedative. So please, you internists out there who prescribe our pills, please take heed, please take heed and remember to get a detailed history and to monitor carefully and to empower the family."
Well, that's a perfectly good idea. We heard about that. Let's empower the family with the information so that the prescribing doctor can give the whole picture.
Let's go to the prescribing doctor’s office. Here he is and he says "I have examined you now, Mr. Schell. And, Mrs. Schell, thank you so much for coming in. And I'm going to prescribe the medication. It is called Paxil. I think it will help you. It helps a lot of people. I do want to caution you about some things. For some people it causes hallucinations. For some people it causes agitation or anxiety.
"Tell me, let's go through your history. Have you seen a psychiatrist? How many times? What for? What was the outcome? Have you had medications before? How did they work? Tell me about your experience on them."
Don’s doctor could have been empowered by SmithKline Beecham and then he could empower the family and say, "Okay, Mrs. Schell, Mr. Schell, now that I have your history I want to tell you, I'm going to prescribe a sedative."
Don Schell’s doctor said: "If I had known this information, I would have handled the case differently."
"I'm going to prescribe a sedative and I'm going to make certain that you monitor Mr. Schell very carefully. And I'm going to check on you and I'm going to and I'm going to and I'm going to and I'm going to," because he would have had power.
Mr. Vickery asked for a lot of money. It is because there's a lot of justice to be done here. And I want to tell you that the eight of you have precisely the right instrument at precisely the right time in history with precisely the right kind of information and with precisely the right kind of courage to say to them, "Stand up and take responsibility for getting better information out to the prescribing doctors of this world and the Don and Rita Schells of this world."
Now, I want to close with this: It is time to say good-bye to Don Schell, good-bye to Rita Schell, good-bye to Deb Tobin and good-bye to Alyssa Schell. But I ask you this, please make their lives and their deaths stand for something. You have the power.
THE COURT: Thank you very much, Counsel.

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