Terri Schiavo Trial Transcript October 11, 2002

pages 172-250

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1 A. Well, yes. You know, when we first started

2 dealing with this therapy, it was really an

3 anti-migraine medication. But we started having

4 patients, psychologists call us up and say within a

5 month of treatments, "what are you doing? These people

6 are getting better on the psychological tests."

7 We had a large amount of people return to work

8 in 90 days. We actually wrote a paper about that.

9 These were folks on Social Security disability between

10 one and ten years or so who returned to work within 90

11 days of starting vasodilators.

12 But not all -- they weren't necessarily

13 normal. They were returning to work off of Social

14 Security, but not normal for the most part. What that

15 means is that there is still injury, although, there is

16 also return of function, too.

17 Q. And they were not normal in the sense that

18 they had to continue with these medications?

19 A. No, they weren't normal in that they weren't

20 always normal. They were not back to their preinjury

21 baseline. They were -- you know, you don't always have

22 a psychological test or a physical exam on a patient

23 before an injury. But you can figure out pretty much

24 what they were on the basis of standardized school test

25 scores and as well as other standardized things we all






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1 go through everyday. So you get an idea of what these

2 folks did to return to that level. But they did return

3 well enough where they were able to go back and hold

4 jobs.

5 So what that means is that there is a number

6 in those patients, a number where there is still injury

7 but also a reversible area where improvement can be

8 obtained.

9 Q. Did your findings lead you to believe that the

10 reversible area was larger than was previously

11 suspected?

12 A. Well, it was suspected there was no reversible

13 area. What was remarkable about this was several

14 things. I was at the Medical College of Virginia when a

15 lot of the early work on vasodilators was done and

16 successful. It was thought prior to this that there was

17 medication that would expand and increase blood flow to

18 the brain, that the blood brain barrier was insolvable

19 problem. First, we found it was solvable.

20 Q. Has any one you before used vasodilators

21 specifically for the treatment of brain injury?

22 A. Yes. Vasodilators have been tried

23 repetitively or the last 50 years for the treatment of

24 brain injury as well as the treatment of stroke.

25 Q. Had they been given by mouth?






174

1 A. They had been given by mouth as well as by

2 cream and as well as intravenous techniques.

3 Q. And traditionally, the blood brain barrier had

4 caused them to fail?

5 A. I think that the failures were for a variety

6 of reasons. I think one reason is the blood brain

7 barrier resistent to some medications. Others, I think

8 they gave the wrong dose. The monitoring tools out

9 there were not sufficient to follow the therapy.

10 The third reason that they failed is that some

11 of the medications that we use did not exist.

12 Q. So it's a combination of improvements in

13 medication and the technology?

14 A. Right. And the fourth is the double blind

15 study problem.

16 Q. What do you mean by that?

17 A. Well, in medicine in the United States,

18 historically, medical communication and medical

19 treatment came about from observing patients, seeing if

20 it worked, and then trying to reproduce it or to do more

21 of the same and observe the results and customize the

22 therapy.

23 Back about 20 years ago, the FDA, in order to

24 identify whether a new drug should be released, had to

25 develop a standardized testing mechanism. And that






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1 standardized testing mechanism to determine whether a

2 new drug should be released was the double blind study

3 where you give one population of people one set of

4 medications. Everybody in that population gets the

5 identical dose. You give a second group of people a

6 different placebo, usually a placebo.

7 Q. And what was significant for your work about

8 the requirement of identical doses?

9 A. Well, it's extremely dangerous. When they try

10 to do the double blind studies with vasodilators, they

11 found that vasodilators caused strokes in many
patients.

12 You know, we never treat patients in clinical

13 practice as a double blind patient. We don't give them

14 all of the same dose that was first done in the original

15 papers. The dose we give for anything, whether it is an

16 infection or heart attack, depends on what that patient

17 needs and what side effects they get. If you don't

18 customize a dose to the patient, you could cause strokes

19 with medication. The reason you cause strokes is you

20 drop the blood pressure. It could decrease the blood

21 pressure.

22 Q. Now, what is the relationship between blood

23 pressure and blood flow inside the brain?

24 A. There is a -- essentially, blood flow is

25 determined by several different things in the brain. It






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1 used to be thought that blood flow to the brain was

2 entirely dependent upon blood pressure. So, therefore,

3 it used to be thought that patients who had a blockage

4 in artery, you would allow their blood pressure to rise

5 to whatever level it wanted to. The idea being that you

6 had partial blockage in the blood vessels like a pipe.

7 You increase the blood pressure in one end, you force

8 more blood through that blocked area to the tissues

9 downstream in the brain. That's what the old theory

10 was.

11 In our work, that wasn't true. Our work's has

12 been reproduced by now quite a few major studies around

13 the world. What these studies show is blood flow to the

14 brain is more complicated. It's dependent upon blood

15 flow to the area of blockage, yes. But it's also

16 dependent upon the area of blockage. You can make that

17 area go away or get less as you get more blood to the

18 brain.

19 Q. And thus vasodilation?

20 A. And thus vasodilation.

21 And, third, it's depend -- the third is

22 dependent upon blood vessel downstream from the

23 blockage. If that blood vessel -- what happens in a

24 normal person is that that blood vessel in response to

25 blockage should dilate, make a partial vacuum, and suck






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1 blood into the brain tissue. That does happen a little

2 bit, but these are not normal people. Those arteries

3 become injured and they lose the ability to autoregulate

4 or to function normally. They don't expand the way they

5 should and thus they don't pull enough blood to

6 compensate for the blockage.

7 Q. So your vasodilation therapy, in a sense, is a

8 substitute for autoregulation?

9 A. Right. Just like it is in the heart. You

10 know, the heart attack patient comes through the office

11 or the emergency room. They have a partial blockage.

12 And the medications given do not raise blood pressure,

13 the medication given vasodilate. They dilate small

14 blood vessels in the area damaged as well as the blocked

15 area themselves directly.

16 Q. Now, Dr. Hammesfahr, have you reviewed the

17 medical literature on these topics that you have touched

18 upon here this morning?

19 A. I have reviewed quite a bit of literature

20 about this, yes.

21 MS. ANDERSON: Your Honor, I have some

22 exhibits on medical literature that I would like to

23 approach the witness with and have him discuss. I

24 want him to read them into the record.

25 THE COURT: That's fine.






178

1 MR. FELOS: Your Honor, I'm going to interpose

2 my objection at this time. It is improper on

3 direct examination of an expert witness to rely on

4 authoritative text. And to that, I'm citing

5 Liberatore versus Hoffman, which is a 2002 Fourth

6 District case.

7 In that case, the court reversed the trial

8 court saying it abused its discretion in allowing

9 defendants to use bulletins published by the

10 American College of Obstetricians and Gynecologists

11 to bolster the testimony of their expert witness.

12 You will note on page -- I guess page eight of

13 this printout, "Experts cannot, on direct

14 examination, bolster their testimony by testifying

15 that a treatise agrees with their opinion.

16 Authoritative publications can only be used during

17 the cross-examination of an expert and not to

18 bolster the credibility of an expert."

19 And that's exactly what respondents' counsel

20 is trying to do here, bolster the credibility and

21 opinion of her expert on outside sources and it's

22 not proper on direct examination.

23 MS. ANDERSON: I offer that the abstract is

24 not bolstering evidence. But you will recall the

25 Second District wanted to know the state of






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1 scientific literature. And these various abstracts

2 and articles go to that very point. He has simply

3 said that he has viewed the literature and it's out

4 there.

5 As I say, I am not offering him enough time to

6 go into it through substantive evidence. But

7 certainly the Second DCA wants to know what the

8 state of the scientific literature is, and it will

9 be very helpful to this court to know what the

10 state of scientific literature is in these areas of

11 stroke and the use of vasodilators for brain

12 injuries.

13 MR. FELOS: Your Honor, the Second District

14 also wants the court to follow rules of evidence

15 and follow the law. And in the -- we can parse

16 words about bolster and evidence and substantive,

17 but the word in this case is "use." They reversed

18 the trial court for allowing the defendants to use

19 the bulletins.

20 Authoritative publication can only be used

21 during cross-examination. And what opposing

22 counsel is doing is attempting to use these

23 bulletins to bolster the -- bulletins, articles,

24 treatises, whatever they are, to bolster the

25 opinion and credibility of an expert. It's not






180

1 proper on direct examination.

2 THE COURT: My guess is the trial judge in

3 this case, again, Mr. Felos, would not have a

4 lengthy opinion of the appellate court upon him or

5 her on how they are to proceed. I am required to

6 assess the new medical treatment and their

7 acceptance in the relevant scientific community.

8 So I'm not sure how I assess Dr. Hammesfahr's

9 treatment in the relevant scientific community

10 unless I hear from the relevant scientific

11 community. And quite candidly, documents take a

12 whole lot less time than a live witnesses.

13 We've restricted ourselves to the six

14 physicians. I think it would do me a disservice

15 not to have all of what the relevant scientific

16 community uses.

17 MR. FELOS: Well, Your Honor, so I gather the

18 Court is denying my objection?

19 THE COURT: That's where I'm headed,

20 Mr. Felos. I just -- in the abstract, you're

21 absolutely correct in that the doctor is not going

22 to be able to get on the stand and say this patient

23 of mine has whiplash and, therefore, he is --

24 that's just start from scratch lawsuit as opposed

25 to this particular litigation, which giving this






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1 court, anyway, a guidebook of what I'm supposed to

2 do. Other than getting copies of these documents,

3 I don't know how I can assess the acceptance in the

4 relevant scientific community.

5 MR. FELOS: Well, that would be done, Your

6 Honor, through the witness's testimony. Not

7 through use of a -- not through use of external

8 publications, documents, and treatises.

9 MS. ANDERSON: You know --

10 MR. FELOS: And if I may, Your Honor, on this

11 topic. The proper procedure would be here, when

12 our witness testifies, opposing counsel, if she can

13 show that the witness admits that these treatises

14 are authoritative or she can independently

15 establish that to the Court, then you can cite from

16 those treatises on the cross-examination of those

17 witnesses.

18 That's what authoritative treatises are used

19 for in purposes of cross-examination. And if

20 they're found to be authoritative, she can use them

21 in cross-examination and bring them before the

22 court in that way, but they are not to be used on

23 direct examination of her own witness.

24 MS. ANDERSON: You know, Mr. Felos did not

25 object when I asked Dr. Hammesfahr if the medical






182

1 literature had progressed since 1994. In fact, he

2 did testify there has been quite a bit of research

3 on the use of drugs, specifically vasodilators as

4 it relates to vasospasm, cerebral and otherwise.

5 But in any event, Judge, the Second DCA has

6 sort of created a -- coupled together two aspects

7 of the Frye hearing which normally precedes an

8 evidentiary hearing. So that's why we're stuck.

9 We've got to provide them and provide you with the

10 literature base, and at the same time, provide

11 substantive opinion evidence about the ultimate

12 fact question.

13 So while I certainly agree, as you say, in the

14 abstract, it wouldn't ordinarily -- treatises are

15 used strictly for cross-examination. Here,

16 Dr. Hammesfahr has to be able to say what his

17 understanding of the current literature is.

18 THE COURT: Frye test, I'm not addressing that

19 on this subject in this case at this time.

20 Let me do this: Let me try and fashion

21 something and see if we can satisfy the Second

22 District as well as the Fourth District.

23 I'm going to allow this in. But unless some

24 other physician testifies these are good

25 authorities, I will allow Mr. Felos' motion to






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1 strike. Now he is the only one that says these are

2 good, then I'll hear, again, his motion to

3 supplement here.

4 MS. ANDERSON: The motion about Mr. Schiavo?

5 THE COURT: This motion. So let's do that.

6 And we might want to reserve ruling on this. I'm

7 going to let it in but I will consider a motion to

8 strike, unless you can tie it up. Fair enough?

9 MS. ANDERSON: Perfect.

10 MR. FELOS: Your Honor, just to clarify this.

11 When you say "let it in," you don't mean to say

12 that these documents are accepted into evidence,

13 but that counsel can approach the witness and

14 discuss them.

15 THE COURT: If he identifies them, I'll let

16 them in subject to your motion at the end of your

17 case. They haven't been tied up to another witness

18 to start.

19 MS. ANDERSON: Well, why don't I ask

20 Dr. Hammesfahr if the Lancet, for example, is

21 considered an authoritative source? Because that's

22 the preliminary question.

23 THE COURT: Sure.

24 MR. FELOS: Your Honor, I guess -- and forgive

25 me because I don't quite understand. If these are






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1 deemed to be authoritative, at least preliminarily,

2 and the witness is questioned about them, do I

3 understand the Court's ruling that these documents

4 can be used during the testimony of the witness as

5 they would on cross-examination under the normal

6 rule. But under the normal rule, even if they're

7 used for purposes of cross-examination, they're not

8 accepted as exhibits in evidence.

9 So that was my question: Is the Court

10 allowing their use in terms of questioning the

11 witness about them or is the Court accepting these

12 documents into evidence? If the Court is going

13 that further step, I formally object to the

14 introduction of these exhibits as evidence.

15 MS. ANDERSON: You know, the judges and the

16 law clerks who will be mightily relieved not to

17 have to do this research. I can stand here at this

18 podium and ask Dr. Hammesfahr to read the citations

19 into the record, if that would satisfy Mr. Felos.

20 But it seems awfully sudden, particularly when the

21 appellate court has specifically asked about the

22 acceptance in the relevant scientific community.

23 MR. FELOS: I'm not talking about the citation

24 but having the substantive articles introduced into

25 evidence.






185

1 THE COURT: Well, Mr. Felos, if they're not in

2 evidence, why would you need a reservation on a

3 motion to strike?

4 MR. FELOS: Well, because there's two parts

5 here. One is accepting them into evidence. The

6 other is their use in any fashion even though

7 they're not accepted into evidence.

8 MS. ANDERSON: Again, he has -- you know, we

9 are all sort of operating under this quasi

10 half-Camel-half-elephant-type of hearing where we

11 have to address Frye issues, but also we have to

12 illicit opinions and fact testimony.

13 THE COURT: Well --

14 MS. ANDERSON: So I think your ruling is

15 appropriate, Judge, under the circumstances.

16 THE COURT: Well, I'm not sure how Frye

17 applies because Frye is a rule of evidence. So I

18 think the Second District has said that

19 Professor Erhardt's book controls unless the

20 opinion of the Second District says it doesn't in a

21 specific hearing. And in this hearing, for the

22 purpose only of the court assessing several things,

23 one of which is acceptance of this new treatment in

24 the relevant scientific community.

25 Quite candidly, Mr. Felos, you're talking






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1 about not wanting to get this witness to make a

2 proffer. If we do it your way, it may be eight

3 o'clock in the morning. So I'm not certain what

4 you really want the Court to do.

5 MR. FELOS: Well, Your Honor, what I would

6 want the Court to do is, number one, not use them

7 at all on direct examination and wait until

8 cross-examination of my witness. But since the

9 Court is allowing they can be used, show the

10 witness a little of the articles, mark that for

11 identification, and ask him are these articles --

12 do you consider authoritative. And if he says yes,

13 then counsel can question the witness about the

14 articles without the documents being introduced

15 into evidence.

16 THE COURT: Well, Mr. Felos, unless a

17 document, a pertinent portion of it's read into the

18 record, how in the world am I or the three other

19 judges in Tampa going to know what it says? Gee,

20 this is authoritative. I agree. All of us four

21 doctors agree this is authoritative. So I

22 enumerate this and scratch my head and say, what do

23 they say, who sent them, who wrote this book.

24 MS. ANDERSON: You know, Judge --

25 THE COURT: It's an impossible burden on the






187

1 court.

2 MR. FELOS: That would be developed through

3 the examination of the witnesses.

4 THE COURT: Would you rather the witness

5 testify ad nauseam as to what's contained in all

6 these articles or do you simply prefer to let these

7 articles in, if they're not tied up and he is the

8 only witness who can authenticate them? We will

9 hear you again only at this time on the motion to

10 strike.

11 I think I agree, if he is the only physician I

12 hear from that says that this particular article is

13 newsworthy from a medical prospective, then it is,

14 obviously. But I think we're better served from

15 judicial economy, if nothing else, just having the

16 burden of this in evidence. If they are tied up,

17 they stay in evidence. And if they are not tied

18 up, I will hear you.

19 MS. ANDERSON: May I approach the witness,

20 Your Honor?

21 BY MS. ANDERSON:

22 Q. Dr. Hammesfahr, I have handed you a number of

23 premarked exhibits for identification: Exhibit 24,

24 Exhibit 29, Exhibit 28, Exhibit 30, Exhibit 32, Exhibit

25 33, Exhibit 34, 35, 40, 41, 42, 44, 45, 46, 47, 50, 54,






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1 58, 64, 72, 74, 75, and 76.

2 Do you have those before you?

3 A. Yes, I do.

4 Q. Is this a combination of abstracts, articles,

5 and articles themselves on medical topics?

6 A. Yes, it is.

7 Q. And do these articles appear in publications

8 that are considered authoritative in the medical

9 research world?

10 A. Yes, they are.

11 Q. Can you briefly name those publications?

12 A. Lancet, Stroke. Current Controls and Trials

13 in Cardiovascular Medicine. Medical Review, Liege,

14 L-I-E-G-E. Anesthetist. Cardiovascular Drug Therapy.

15 CNS Drugs.

16 Q. What does CNS stand for?

17 A. Central Nervous System.

18 Current Opinions of Cardiology. Medical

19 Science Monitor. Circulation. The British Medical

20 Journal. Journal of Hypertension. The Journal of

21 Cardiovascular Oncology. The Journal of Human

22 Hypertension.

23 Q. Dr. Hammesfahr, have there been any changes in

24 the last year or so as a result of research findings in

25 the treatment of stroke?






189

1 A. Yes. There have been dramatic changes in

2 prospectives on stroke in the last two and a half, three

3 years, yes.

4 Q. Can you explain to the court what those

5 changes are?

6 A. The changes essentially are that stroke is not

7 just an embolic phenomenon where a clot goes to the

8 brain and blocks off oxygen. But rather a stroke itself

9 and -- and all medical treatment, most medical treatment

10 prior to two-and-a-half years ago was based on this

11 concept that we were trying to stop embolisms to the

12 brain, and a few cases of hypertension.

13 But rather it's been determined and found that

14 we can treat the blood vessels in the brain, themselves

15 directly, both to prevent stroke as well as treating

16 stroke itself. So what has happened in the last two and

17 a half years or so is that the medications we identified

18 seven years ago, eight years ago, have now been

19 identified with widespread use in randomized studies of

20 sometimes thousands of patients that it should be used

21 in the treatment of stroke or prevention of stroke.

22 Q. So this group in '94, this group of patients

23 that you described earlier is now the subject of

24 research?

25 A. Right. What has been found is that these






190

1 types of medications do in fact work on the blood

2 vessels of the brain. They also find that certain

3 medications work better than other medications in the

4 brain, but they work regardless of the blood brain

5 barrier and that you could have dramatic improvements in

6 a patient's problem from these medications. For

7 instance, the reduction in stroke risk by 30 to

8 40 percent by those who are expected to have strokes.

9 Q. Is it that finding, that research finding that

10 dramatically changed stroke treatment in the last few

11 years?

12 A. Yes, it has. It used to be thought that --

13 now the recommendations are specific medications be used

14 in those patients for strokes and high risk of strokes.

15 Those medications are medicines that we advocate and

16 use, ACE inhibitors, nitrates, and so on. Second, that

17 these medicines' effect is not due to the blood pressure

18 effect but rather the effect on the brain's blood

19 vessels themselves.

20 So just as in cardiology, we use these

21 medicines to treat heart attacks for the vasodilators

22 quality. And the issue of the blood pressure is not an

23 issue other than how you customize the dose. This is

24 the same. We found that these medicines have a benefit,

25 and it's not due to blood pressure but due to the direct






191

1 effect on the blood vessels of the brain just like we

2 use on the blood vessels of the heart.

3 Also, interesting, to make a similar comment.

4 It also works in the blood vessels of the kidneys.

5 Q. What does research in cardiology have to do

6 with your field?

7 A. Well, most of these -- many of these articles

8 were actually done primarily by cardiologists and

9 circulatory experts with neurologists as a relatively

10 minor part of the team but a present part of the team.

11 Others of these articles are done specifically by stroke

12 specialist teams, headed by stroke specialist teams. So

13 being it's identified across the board now by people who

14 do vascular diseases, whether it's brain or other types.

15 Q. What is a stroke team in a hospital?

16 A. Well, a stroke team hospital specialists are

17 involved in the treatment of stroke.

18 Q. So it would consist of neurologists,

19 radiologists, interns?

20 A. Yes.

21 Q. Who else?

22 A. Emergency room physicians, and frequently

23 intensive care unit nurses and doctors, also.

24 Q. So it's a cross-disciplinary approach to a

25 particular stroke?






192

1 A. Very much, yes.

2 Q. Now, what does the term "perfusion" mean?

3 A. Perfusion means blood clot.

4 Q. So if the perfusion in the brain has been

5 damaged or reduced, it simply means that the blood flow

6 itself -- can blood flow be lowered if the pressure

7 remains strong?

8 A. I'm sorry?

9 Q. Can perfusion be lowered -- will we rarely see

10 lowered perfusion if the blood pressure is normal?

11 A. Yes. You can lower perfusion of brain tissue

12 if you lower blood pressure. Now, blood pressure is in

13 a range so that if you have a normal-low blood pressure

14 and you have a low blood pressure, you lower it using

15 the wrong medicine, you can lower the perfusion.

16 That was the problem with the early studies is

17 that they used the wrong medicine that resulted in a

18 lower blood pressure with a lower perfusion. Whereas,

19 these studies talked about lowering blood pressure into

20 a normal range or sometimes even in a low-normal range

21 and yet maintaining perfusion.

22 So if you use the right medicines, you have an

23 effect in the brain itself. If you use the right

24 medicine, but the wrong dose, you can lower perfusion.

25 You have to customize it.






193

1 Q. And how are you able to customize it?

2 A. Well, we customize it through repetitive

3 physical examinations as well as the monitoring that's

4 done, an ultrasound and electronic monitoring. So we

5 are using a method of customizing these outpatient's

6 medicine similar to what somebody in an emergency room

7 or intensive care unit setting would do. They use the

8 same technique of repetitive monitoring of the testing

9 and repetitive physical exam and blood pressure

10 monitoring.

11 Other ways that they have monitored here is

12 things like blood flow studies. There are different

13 ways of monitoring.

14 Q. Is Transcranial Doppler ultrasound an accepted

15 monitoring device?

16 A. Yes. Transcranial Doppler monitoring, you'd

17 go to Medline, there would be thousands of records.

18 Medline is the National Library of Medicine essentially

19 archived in many print journals, many medical journals

20 there. If you go in there and type in the words

21 "Transcranial Doppler monitoring," you will get a large

22 number of published papers that deal with the monitoring

23 of blood gas which are in blood vessels and guide to

24 therapy by the use of Transcranial Doppler.

25 Q. Now, what is titration?






194

1 A. Titration is the customizing of the dose --

2 titration of medicine is the customizing of the dose of

3 medicine to -- against some variable. That variable can

4 be blood pressure or could be chest pain, heart attack,

5 or could be neurological function. It's the customizing

6 of the dose of medication, both at one time as well as

7 over time, over months or years.

8 So your physician can treat blood pressure in

9 the office and he treats it -- changes the dose of blood

10 pressure every six months or a year is titrating the

11 medicine against blood pressure and against the

12 patient's physical response.

13 In the emergency room you titrate medication

14 against a patient's chest pain and having a heart attack

15 and their cardio function.

16 Q. Now, Dr. Hammesfahr, have you ever published

17 your observations and findings about vasospasm and

18 Transcranial Doppler, the use of Transcranial Doppler

19 and vasodilators?

20 A. Yes, I have.

21 MS. ANDERSON: May I approach the witness,

22 Your Honor?

23 THE COURT: Yes, ma'am.

24 BY MS. ANDERSON:

25 Q. Dr. Hammesfahr, I have given you Respondent's






195

1 Exhibit 17, premarked for identification, and ask you if

2 you recognize that document?

3 A. Yes, I do.

4 Q. What is it?

5 A. That's an article that was published in 1995

6 that deals with cerebral vasospasm. Is that the

7 question?

8 Q. Yes.

9 In brief, what is the subject matter -- what

10 is encompassed within the subject matter of this

11 article?

12 A. Briefly, what we identified in the paper and

13 discussed was that cerebral vasospasm is common to many

14 different disorders that it wasn't suspected in

15 previously or had very limited suspicions of it, and

16 that there is a medical approach to having reproduced a

17 consistent improvement in patients that suffer from

18 vasospasm. In that improvement, you use vasodilators to

19 monitor, Transcranial ultrasound, and physical

20 examinations.

21 Q. Now, did you find that your treatment protocol

22 was affected in a variety of neurological deficits?

23 A. Yes. This was a great surprise at that point

24 because vasospasm was only theoretically suspected in

25 some of these disorders and not suspected in other






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1 disorders.

2 Q. What were some of the disorders?

3 A. Well, it was known to exist in stroke and

4 cerebral palsy, hypoxic encephalopathy, and anoxic

5 encephalopathy. But in those areas, it was primarily

6 known to exist through pathology and autopsy studies

7 done on patients and also on injured graphic studies

8 done on patients. It wasn't known that you could treat

9 a patient.

10 Where I came from the medical college of

11 Virginia, a great deal of the effort of the department

12 was spent on publishing and working on research treating

13 patients that had a subarachnoid type of stroke.

14 Q. What is a subarachnoid hemorrhage?

15 A. A subarachnoid hemorrhage is a condition where

16 a blood vessel breaks and causes the blood pressure to

17 affect the blood pressure to the brain, throughout the

18 brain, causes the pressure to affect the brain itself

19 and causes blood to spill which is causes a toxic injury

20 to the blood vessel.

21 Similar to what you get in anoxic

22 encephalopathy in some cases, because you have the

23 injury to the blood vessel which causes constriction of

24 the blood vessel. So there are several different

25 methods that would develop constriction or vasospasm of






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1 the blood vessels and subarachnoid hemorrhage common to

2 stroke and common to anoxic and hypoxic encephalopathies

3 and common to cerebral palsy.

4 Q. So subarachnoid refers to what?

5 A. It refers to the location of blood vessel that

6 has ruptured in the brain. It's underneath the

7 arachnoid, which is a thin covering of the brain.

8 MS. ANDERSON: May I approach the witness,

9 Your Honor?

10 THE COURT: Yes, ma'am.

11 BY MS. ANDERSON:

12 Q. Dr. Hammesfahr, I have handed you what I have

13 premarked as Respondent's Exhibit 15 and ask you if you

14 recognize that?

15 A. Yes, I do.

16 Q. And how do you recognize that?

17 A. Well, this is a copy of my patent, which I

18 applied for, I think, in 1996 or 1997. Somewhere in

19 that time frame. It deals with the treatment through

20 titration of vascular injuries to the brain. Vascular

21 injuries to the brain include injuries which injure the

22 control mechanism that controls blood flow to the brain

23 thus causing vascular injury.

24 Q. This patent is on the technique that we talked

25 about this morning; is that correct?






198

1 A. Yes, it is.

2 Q. When was it issued?

3 A. It was issued --

4 Q. Hint: Top right-hand corner.

5 A. July 10, 2001.

6 Q. Now, why did you patent this?

7 A. I patented it for several reasons. For the

8 standpoint of medicine, it clearly identifies the state

9 of a prior art to have a patent issued. A patent is

10 issued for something new and novel and by definition,

11 not intuitively obvious to other practitioners in the

12 field. By having a patent, you are clearly identifying

13 the state of the prior art prior to these observations,

14 these discoveries.

15 Q. Now, can anybody just apply to the U.S.

16 government and get a patent for a medical procedure?

17 A. Well, anybody can apply. But what happens

18 after the application is that the patent goes to review

19 by patent officers.

20 MR. FELOS: Your Honor, I object. Lack of

21 foundation. I believe this witness has been

22 established as a medical person. He hasn't been

23 established as an expert in patent and the patent

24 process.

25 MS. ANDERSON: Well, I can ask him that






199

1 foundation question.

2 THE COURT: Just for my edification. Isn't a

3 patent just simply something that hasn't been

4 patented before?

5 BY MS. ANDERSON:

6 Q. Dr. Hammesfahr, can you answer that? It has

7 to be new, correct?

8 A. It has to be new.

9 Q. Does it also have to be anything else?

10 A. Well, it has to work. It has to be new. It

11 has to be --

12 MR. FELOS: Excuse me, Your Honor. I renew my

13 prior objection. I don't believe the witness is

14 qualified to testify as to what he recalls.

15 THE COURT: I don't know if he is either.

16 BY MS. ANDERSON:

17 Q. Well, do you know what review your patent

18 application underwent?

19 A. I know a great deal about what this patent

20 went through.

21 Q. How do you know that?

22 A. Because we go through communications with my

23 attorneys and the patent office directly and as well as

24 their reviews of what was published.

25 Q. By "them," you mean who, the patent office?






200

1 A. The patent office. The patent office in the

2 process of the patent will send back initial reviews and

3 hearings and ask for additional information.

4 Q. So this is ongoing dialog with the patent

5 office and you don't know until the end whenever you

6 satisfied that?

7 A. Correct.

8 Q. Is that right?

9 A. Right.

10 MS. ANDERSON: Does that answer your question?

11 THE COURT: My basic question is: To what

12 extent does a patent have to accomplish something?

13 MS. ANDERSON: He said it has to work.

14 THE COURT: Well, I don't know what the word

15 work means. There are lots of things that are

16 patented and ongoing.

17 MS. ANDERSON: And in terms of --

18 THE COURT: I'm not sure why you brought that

19 up.

20 BY MS. ANDERSON:

21 Q. In terms of treatment protocol, medical

22 treatment protocol, when you say it has to work, what do

23 you mean by that?

24 MR. FELOS: Your Honor, again, I renew my

25 objection. This witness is not qualified to






201

1 testify as to what standard of review for granting

2 patents is.

3 MS. ANDERSON: He knows as a patent applicant

4 what the government asked him to provide.

5 THE COURT: What the government told him to

6 provide?

7 MS. ANDERSON: What the government told him to

8 provide, yes.

9 THE COURT: Or what his lawyer told him?

10 BY MS. ANDERSON:

11 Q. Well, you were a part of this process, were

12 you not, Dr. Hammesfahr?

13 A. Yes, I was.

14 Q. And it lasted how many years?

15 A. It lasted about four to five years.

16 Q. Periodically, the patent office make inquiries

17 for additional information?

18 A. Yes, they did.

19 Q. Did they raise questions periodically?

20 A. Yes, they did.

21 Q. Were the people raising questions

22 medically-framed?

23 A. The people raising the questions relied on

24 information from background, medically trained --

25 MR. FELOS: Your Honor, I object. He is






202

1 testifying as to the state of mind of another

2 person.

3 MS. ANDERSON: No. No, he is not. There is

4 nowhere in that testimony about the state of mind.

5 He simply said that --

6 BY MS. ANDERSON:

7 Q. Are doctors involved in the patent review

8 process?

9 A. Doctors are involved in the part of the patent

10 review process that is one level behind the hearing

11 officers. So, yes.

12 MR. FELOS: Your Honor, I move to strike all

13 of that testimony on the basis that it's hearsay.

14 It's apparently what a patent examiner told him

15 that somebody in the review process was doing.

16 THE COURT: Well, this doctor will be

17 testifying as to medical matters, and a patent is

18 not a medical matter.

19 MS. ANDERSON: Well, Mr. Felos is the one who

20 had identified this angle, that the patent was an

21 issue.

22 THE COURT: He has done that.

23 MS. ANDERSON: Correct.

24 THE COURT: To have him testify as to all of

25 the steps that were done by others in order to






203

1 arrive at that is -- I'm not sure he is qualified

2 to do that.

3 MS. ANDERSON: Judge, that's fine. I did not

4 ask him those questions. It was Mr. Felos who is

5 making the objection.

6 MR. FELOS: Well, to the question. The man

7 identified the document as a patent, so he

8 identified a document that hasn't been sought to be

9 introduced into evidence. And the whole question

10 of what the procedure of applying for the patent is

11 and what he was told by the patent office and his

12 impressions of the patent law is hearsay and it's

13 also irrelevant.

14 THE COURT: He can't testify to what others

15 have done or what the standard involvement in

16 obtaining a patent would be unless you can qualify

17 him as an expert.

18 BY MS. ANDERSON:

19 Q. Dr. Hammesfahr, what is your patent number?

20 A. 6258032.

21 Q. The question that provoked that colloque was

22 why you got it patented. You said it has to be new and

23 it has to work, right?

24 A. Correct.

25 Q. Was it your intention to have stake and






204

1 ownership claim and demand royalties if another

2 physician used your treatment protocol?

3 A. That was not my intention; although, that is

4 legally what I can do.

5 Q. You have not exercised those rights?

6 A. I have not.

7 Q. Thank you.

8 What is the "Therapeutic Window Concept" that

9 is referred to in the patent?

10 MR. FELOS: Your Honor, I object. The patent

11 is not in evidence. He cannot refer to it from the

12 witness stand.

13 MS. ANDERSON: It has been identified, Judge.

14 I'll move it into evidence.

15 MR. FELOS: The fact that he has identified a

16 document does not mean that he can read from it

17 because it's not in evidence.

18 MS. ANDERSON: I'm not asking him to read from

19 it. I'm asking him to explain a term that is used

20 in the patent "therapeutic window." I am entitled

21 to ask a question about that term and that

22 document.

23 And by the way, Judge, I move into evidence at

24 this time all previously identified exhibits that

25 this witness has handled, including Exhibit Number






205

1 15 which is the patent. I'm asking him what the

2 term "therapeutic window" means.

3 MR. FELOS: Your Honor, I object to

4 introduction of the patent on, number one, lack of

5 communication, and number two, it's hearsay.

6 THE COURT: Well, every document is hearsay,

7 Mr. Felos.

8 MR. FELOS: What other document is hearsay?

9 THE COURT: Every single document is hearsay

10 unless it's introduced into court.

11 MR. FELOS: Your Honor, frankly, I'm not --

12 MS. ANDERSON: Let me get my Exhibit 15.

13 THE COURT: Now, the first bulk of documents,

14 you've already objected to those and I've overruled

15 the objection. So I will receive those and the

16 court reporter will have those numbers in the

17 record.

18 MS. ANDERSON: And also Exhibit 17, Your

19 Honor, I move to introduce into evidence at this

20 time, his document.

21 THE COURT: His paper?

22 MS. ANDERSON: His paper.

23 MR. FELOS: I object on the same basis as my

24 previous objection as to medical articles and also

25 as to hearsay.






206

1 THE COURT: Well, his article is hearsay? He

2 authored it. It's hearsay?

3 MR. FELOS: It's an -- it is a statement of

4 the declarant, but it was a statement not made

5 under oath, which was the definition of hearsay,

6 Your Honor.

7 MS. ANDERSON: What? That is not the

8 definition of hearsay.

9 THE COURT: What does hearsay have to do with

10 under oath, Mr. Felos? That's a new one on me.

11 MR. FELOS: Your Honor, hearsay --

12 MS. ANDERSON: Is an out-of-court statement

13 offered to prove the truth of the matter asserted

14 therein.

15 THE COURT: There's an exception for prior

16 testimony which is under oath.

17 MR. FELOS: "Hearsay is a statement made other

18 than one made by the declarant while testifying in

19 trial or hearing offered into evidence to prove the

20 truth of the matter asserted."



To be continued in next email

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