Beruflich Dokumente
Kultur Dokumente
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Plaintiff,
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vs.
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2:09-cr-00403-3-LDD
Philadelphia, PA
November 21, 2011
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APPEARANCES:
For the Government:
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ESR OPERATOR:
DONNA CROCE
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Proceedings recorded by electronic sound recording.
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I N D E X
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PAGE
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RULING:
Defendant's motion under 18 U.S. Code
3143(b)(1)(B)(iv), denied
PAGE
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LINE
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THE COURT:
All right.
is 09-403.
government.
course, here.
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and legal.
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have resolved.
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MR. POE:
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THE COURT:
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MR. POE:
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Yes, sir.
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treatment of VCFs.
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THE COURT:
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MR. POE:
Right.
I remember that.
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PSR states, "Notes from the meeting show that the participants
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death, as well as the fact that there already had been three
corrected.
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THE COURT:
Okay.
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MR. POE:
Yes, sir.
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THE COURT:
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MS. CRAWLEY:
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THE COURT:
Okay.
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overlooked?
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MR. POE:
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THE COURT:
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MS. CRAWLEY:
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THE COURT:
Government?
No, Your Honor.
All right.
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preserved.
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MR. POE:
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MS. CRAWLEY:
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THE COURT:
MR. POE:
THE COURT:
That's correct.
And he concurs that in light of my
MR. POE:
THE COURT:
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We agree.
All right.
it?
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MS. CRAWLEY:
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THE COURT:
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defense on sentencing.
MR. POE:
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THE COURT:
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this room?
MR. POE:
I do remember.
Your
Honor, no witnesses.
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THE COURT:
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MS. CRAWLEY:
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THE COURT:
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Okay.
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MR. POE:
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now.
good friend.
decent man.
He's a
He's a compassionate,
this case and the offense conduct and the relevant conduct and
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THE COURT:
And
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MR. POE:
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THE COURT:
MR. POE:
THE COURT:
Friends and
So it's
would say.
MR. POE:
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friends and family, Your Honor, but I did want to let the
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THE COURT:
Right.
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MR. POE:
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THE COURT:
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MR. POE:
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THE COURT:
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MR. POE:
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THE COURT:
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MR. POE:
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And the
seriously.
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doing community work in the last two and a half years, since
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he pleaded guilty.
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community work in the last two and a half years and what that
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life.
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Your Honor, on a --
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THE COURT:
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And I listen to
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tell me the affirmative truths that you see from your side,
MR. POE:
THE COURT:
MR. POE:
And I'm
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THE COURT:
Okay.
Yeah.
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MR. POE:
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The
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authority.
THE COURT:
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parties argue for upward and downward variances all the time
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right.
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sentence people.
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And the
The government is
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But the fact of the matter is, the pre-sentence officer is not
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right.
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MR. POE:
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THE COURT:
So I
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MR. POE:
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THE COURT:
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however.
Understood.
Your objection is certainly preserved,
But go ahead.
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MR. POE:
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deterrence.
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deterrence point.
So given what
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HHS to exclude.
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THE COURT:
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continue.
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MR. POE:
But
That sanction,
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public ways.
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aspect that we would suggest to the Court does not require any
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Because the fine in the Food, Drug and Cosmetic Act, the
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dollars.
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the idea that Mr. Huggins has now agreed to pay, in the plea
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sentence of incarceration.
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necessary.
And so
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Now Mr. Huggins also, for the last two and a half
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years, Your Honor, and I don't want to put too much emphasis
make.
the maximum fine that he's paid but I do wish to note it.
I don't put
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treatment.
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times.
The issues of promoting respect for the law, assuring
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Court's views of the case, the need for general deterrence and
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ruling.
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needs to be punished.
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purposes of sentencing.
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It
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incarceration.
THE COURT:
government, please.
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MS. CRAWLEY:
Mary Crawley
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obligation of honesty.
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We
And this
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depend on it.
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with the FDA at all times, and that is what did not happen
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here.
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First, by lying to the FDA about what their true intended use
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had occurred.
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And
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medical devices.
do?
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the test market of XR, which was the second of the two illegal
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clinical trials.
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Mr. Huggins took part in all four aspects of the crime that
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THE COURT:
MS. CRAWLEY:
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please.
THE COURT:
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Okay.
MS. CRAWLEY:
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to press and finding out that there were documents, there were
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they didn't want him to find but documents that showed the
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him when he told Captain Despins that the XR test market had
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in its order.
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And this
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2003 meeting, about the -- the meeting about XR that the first
injected with SRS that had been back-table mixed with barium
sulfate.
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his patient had died, could not rule out the SRS as a cause of
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company.
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that an adverse event report was filed for that first death,
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other duties.
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was involved in all four of the aspects of the crime for which
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may have.
So as a result of the subversion of the FDA process,
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dangerous.
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to get the device to the market faster, to cut out the FDA's
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oversight.
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risk.
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entitled to have.
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memo for Mr. Huggins and in the other memoranda, what they
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case.
that had they known of the things that they were not told, the
things that were concealed from them, they would not have used
this device.
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death of Dr. Sachs' patient before the test market began, the
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THE COURT:
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MS. CRAWLEY:
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THE COURT:
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hypotensive events.
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MS. CRAWLEY:
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THE COURT:
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correct?
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MS. CRAWLEY:
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THE COURT:
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MS. CRAWLEY:
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THE COURT:
They were.
And they were pretty explicit in terms of
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right?
MS. CRAWLEY:
THE COURT:
MS. CRAWLEY:
That is correct.
And then filed by Synthes, right?
They were filed by Synthes.
A -- there
who insisted.
THE COURT:
MS. CRAWLEY:
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Right.
Dr. Sharp insisted that these reports
be filed.
THE COURT:
Okay.
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instances.
Is that a fair --
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MS. CRAWLEY:
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THE COURT:
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MS. CRAWLEY:
Go ahead, ma'am.
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investigational plan.
If that were
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out.
boards, Your Honor, is that they are not just doctors, they
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was done was that the patients, all of the patients who were
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could not give informed consent because they did not know of
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the risks that the people at Synthes knew, that the people at
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this case, as the Court may be aware, both took place at John
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second death, that it would have been very unlikely that the
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they had, they would have been given information, perhaps even
And if
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informed consent.
happen.
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consent.
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sick people who were in pain, and that is at the heart of what
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would point out that Mr. Huggins' conduct only highlights his
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not.
his words but the government would hope that it is the first,
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THE COURT:
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MS. CRAWLEY:
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he is represented.
THE COURT:
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MS. CRAWLEY:
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THE COURT:
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MS. CRAWLEY:
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THE COURT:
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MS. CRAWLEY:
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THE COURT:
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MS. CRAWLEY:
We don't.
So this is blind speculation, right?
Your Honor, I am pointing out -Agreed?
Agreed?
I would -Agreed?
No, Your Honor.
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are the two alternatives and I will leave that for the Court's
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consideration.
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THE COURT:
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MS. CRAWLEY:
THE COURT:
MS. CRAWLEY:
THE COURT:
Yes.
And the way that you see things as an
advocate, the way that Mr. Poe sees things as an advocate and
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me so we'll get there and we'll find out what the truths are.
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MS. CRAWLEY:
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THE COURT:
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ahead.
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MS. CRAWLEY:
Go
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THE COURT:
And it is --
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I forget
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correctly?
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MS. CRAWLEY:
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THE COURT:
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the culture within the larger field and the culture within the
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So that's not
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Because here,
could die but the point was that the market to be captured was
our age are growing older and have spinal problems and have
compression factures.
THE COURT:
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I beg your
pardon.
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MS. CRAWLEY:
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THE COURT:
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MS. CRAWLEY:
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THE COURT:
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my prime yet.
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MS. CRAWLEY:
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THE COURT:
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MS. CRAWLEY:
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THE COURT:
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MS. CRAWLEY:
There
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could be that many new cases a year and a great many of those
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THE COURT:
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MS. CRAWLEY:
Right.
And of course we know now that this
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fractures.
was necessarily the best route for -- the last best hope for
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differently.
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THE COURT:
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and -- but that just spirals back to your point that since
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make sure that what occurs occurs consistent with medical and
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MS. CRAWLEY:
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THE COURT:
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The
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THE COURT:
MS. CRAWLEY:
the individuals was going to come down from New York and I do
THE COURT:
Sure.
(Pause)
THE COURT:
MS. CRAWLEY:
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THE COURT:
No one's responding.
Okay.
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insights.
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MS. CRAWLEY:
As to Lois Eskind,
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who was Dr. Sachs' patient who had -- was -- who had died in
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January of 2003, January 13th; she was the second patient that
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procedure.
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But
the days right after the surgery, that Mrs. Eskind had died of
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concerned.
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is critical.
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THE COURT:
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And
critical?
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MS. CRAWLEY:
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not.
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thing to do, the best thing to do, the safest thing to do.
But it was not done and in fact the company did not even
event.
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know that those were Mrs. Eskind's x-rays that were being put
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in the technique guide but this is what happens when the laws
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are disregarded, when people are not doing what they need to
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people's attention.
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And
The second patient who died was Mr. Kikuchi who had
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He was
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Up until a month
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But he had
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Norian XR was injected into his back, Mr. Kikuchi, his blood
resuscitated.
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was performed.
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manager had told him the day before that Dr. Nottingham had
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during the injection and feels that this was a cause of the
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incident.
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leak during the injection and feels that this was the cause of
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the incident.
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MS. CRAWLEY:
THE COURT:
MS. CRAWLEY:
Yes.
This is the same one?
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THE COURT:
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MS. CRAWLEY:
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that took place in late September and the notes state that
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allegation is valid.
this complaint."
event report for Dr. Sachs' patient death, treated this as the
first death.
FDA could see that this was not just an isolated incident.
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body augmentation.
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THE COURT:
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MS. CRAWLEY:
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Actually, Dr.
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And Dr. Ball had been -- actually had been present at
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And
session.
By January of 2004 Dr. Ball had performed several VCF
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after his partner, Dr. Nottingham, had had his patient die,
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Norian XR.
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25th of 2004.
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surgery on the third person who died and that was a lady who
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Hospital.
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She lived in
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what would happen to him if she were not around because she
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And
She
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Her heart
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CPR began at
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past midnight and that was Thursday, January 22nd, with the
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cancelled.
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THE COURT:
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MS. CRAWLEY:
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THE COURT:
Go ahead.
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MS. CRAWLEY:
was performed and the pathologist report noted that there was
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injected.
So Your Honor, because what happened here -- well, it
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is.
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the Court has found that Mr. Huggins and the remainder of the
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But in
We say you
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law allows.
Thank you.
THE COURT:
arrive?
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MS. CRAWLEY:
(Pause)
THE COURT:
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MS. CRAWLEY:
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THE COURT:
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(Pause)
THE COURT:
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please, sir.
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Please.
THE REPORTER:
State
S-P-I-N-S.
COURT'S WITNESS, CAPTAIN DESPINS, SWORN
THE COURT:
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hear you she's not necessarily able to record you unless you
THE WITNESS:
THE COURT:
Understood?
court before?
THE WITNESS:
THE COURT:
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any notice, isn't it, because you might have gotten nervous if
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This is a conversation.
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know.
THE WITNESS:
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THE COURT:
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THE WITNESS:
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Understood?
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Administration.
THE COURT:
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THE WITNESS:
THE COURT:
THE WITNESS:
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FDA?
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All right.
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regulated industry.
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animals.
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THE COURT:
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THE WITNESS:
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THE COURT:
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They're inspections of
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medical department.
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O-M-O-L-O-G-I-S-T.
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THE COURT:
THE WITNESS:
THE COURT:
THE WITNESS:
vectors of disease.
THE COURT:
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THE WITNESS:
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THE COURT:
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We -- we -- our mission
sir?
THE WITNESS:
All right.
So in terms of your
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that they -- that the agency provides to you all to let you
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THE WITNESS:
Do you share
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THE COURT:
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THE WITNESS:
Right.
And I can't speak for other
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Right.
I look at --
THE WITNESS:
THE COURT:
Yes.
I understand that's what you just said.
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right?
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THE WITNESS:
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THE COURT:
That's correct.
Okay.
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are concerned, and this is really what I'm interested in, how
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market?
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THE WITNESS:
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THE COURT:
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of use?
THE WITNESS:
THE COURT:
THE WITNESS:
Yeah.
All right.
For labeled indications, indications
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That's right.
THE WITNESS:
THE COURT:
THE WITNESS:
So keep going.
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2004.
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THE COURT:
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THE WITNESS:
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THE COURT:
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THE WITNESS:
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looks like you would have -- you would have -- you wouldn't
have very much faith in what you -- the preparatory work that
you conducted.
THE COURT:
But of
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right?
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THE WITNESS:
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THE COURT:
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THE COURT:
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THE WITNESS:
Which are?
Which are to obtain an investigational
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THE COURT:
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THE WITNESS:
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THE COURT:
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THE WITNESS:
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THE COURT:
Okay.
THE WITNESS:
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review board.
THE COURT:
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THE WITNESS:
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THE COURT:
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ahead.
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Clinical
All right.
So go
THE WITNESS:
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that happens.
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THE COURT:
Right.
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judgments, right?
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THE WITNESS:
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THE COURT:
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THE WITNESS:
Understood.
Go ahead.
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informed consent and look to see if all the known risks are
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twelve months.
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It comes back to
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status report, summary of data and any adverse events that may
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have occurred.
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THE COURT:
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THE WITNESS:
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THE COURT:
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potentially impacted.
THE WITNESS:
THE COURT:
Okay.
So go ahead.
Go ahead.
THE WITNESS:
Yes.
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the inspection.
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THE COURT:
Sure.
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THE WITNESS:
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all involving animals that are, you know, at the end of the
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THE WITNESS:
THE COURT:
circumstances?
THE WITNESS:
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groups.
Yes.
You can have -- for a drug study you can have a range
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of dosages.
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some sort of time point observation that you made on all the
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involved?
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THE WITNESS:
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THE COURT:
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THE WITNESS:
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THE COURT:
All right.
percent dosage.
THE WITNESS:
THE COURT:
THE WITNESS:
That's correct.
Go ahead, sir.
So in an LD-50 study you would
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THE COURT:
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THE WITNESS:
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THE COURT:
No, sir.
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effects, right?
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THE WITNESS:
Your Honor.
THE COURT:
You're the
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THE WITNESS:
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THE COURT:
Yes, sir.
Okay.
All right.
So -- all right.
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THE WITNESS:
So you
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THE WITNESS:
THE COURT:
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THE WITNESS:
THE COURT:
So go ahead.
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THE WITNESS:
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THE COURT:
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THE WITNESS:
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The -- when I first arrived and asked about and confronted the
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FDA, the -- I was told that there was no clinical trial and it
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THE COURT:
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THE WITNESS:
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THE COURT:
Right.
You know, if that's -And then you interviewed a number of
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THE WITNESS:
THE COURT:
Yes, sir.
Did anyone from Synthes ever -- I think
THE WITNESS:
THE COURT:
THE WITNESS:
THE COURT:
Yes, sir.
No.
All right.
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them and you wrote up your notes and that's how you, sort of,
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ask you this, did you speak to this defendant, Mr. Huggins?
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THE WITNESS:
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THE COURT:
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Well, he was
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THE WITNESS:
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THE COURT:
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THE WITNESS:
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inspection.
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THE COURT:
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THE COURT:
THE WITNESS:
THE COURT:
THE WITNESS:
2003.
That's the Tucson meeting, right?
THE COURT:
THE WITNESS:
Okay.
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THE COURT:
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THE WITNESS:
I think in Westchester.
All right.
Go ahead.
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Okay.
Go
ahead.
THE WITNESS:
21
22
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meeting.
24
25
the phase two test market for Norian XR, a test market.
And
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1
risk device.
9
10
11
12
THE WITNESS:
13
THE COURT:
14
THE WITNESS:
Yes.
So go ahead.
I posed those questions to Mr. Huggins
15
16
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different.
18
that the IDE was to expand -- IDE study was to expand the
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Norian XR.
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They were
THE COURT:
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4
5
THE COURT:
efficacy, right?
THE WITNESS:
THE COURT:
8
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Go ahead.
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THE COURT:
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THE WITNESS:
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THE COURT:
13
THE WITNESS:
No, sir.
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THE COURT:
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could not rule out the possibility that it could cause large
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clots quickly.
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THE WITNESS:
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THE COURT:
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And
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THE COURT:
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THE WITNESS:
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THE COURT:
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THE WITNESS:
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THE COURT:
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THE WITNESS:
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THE COURT:
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that they had injected into the pig, was it the full amount
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THE WITNESS:
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THE COURT:
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THE WITNESS:
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All right.
saw.
Page 58
THE WITNESS:
in an animal.
THE COURT:
5
6
THE WITNESS:
THE COURT:
expected, right?
Because there's a --
10
THE WITNESS:
11
THE COURT:
12
communications, right?
13
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THE WITNESS:
15
THE COURT:
They didn't
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go ahead.
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THE WITNESS:
And
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time trying to deal with, you know, how you could know that
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THE COURT:
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THE WITNESS:
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THE COURT:
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1
analogous situation?
THE WITNESS:
4
5
No, sir.
All right.
So continue.
You're talking
10
THE WITNESS:
11
THE COURT:
12
proposal?
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THE WITNESS:
14
THE COURT:
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THE WITNESS:
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THE COURT:
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THE WITNESS:
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THE COURT:
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THE WITNESS:
I don't recall.
Okay.
If I could see -That's fair.
-- my -- it's all in the report.
That's all right.
20
21
asked him about, because his name was on the document along
22
23
24
THE COURT:
25
THE WITNESS:
There's a timeline
Page 60
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THE COURT:
THE WITNESS:
THE COURT:
Go ahead.
And -But there was no indication that she'd
that?
THE WITNESS:
Am I fair about
It may
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THE WITNESS:
17
THE COURT:
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meetings?
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THE WITNESS:
recollection.
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THE COURT:
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there, correct?
25
THE WITNESS:
Correct.
Page 61
THE COURT:
1
2
correct?
THE WITNESS:
THE COURT:
Yes, sir.
discussions, correct?
THE WITNESS:
THE COURT:
Yes, sir.
He couldn't remember if there were
THE COURT:
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THE WITNESS:
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THE COURT:
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THE WITNESS:
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THE COURT:
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there.
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correct?
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THE WITNESS:
21
THE COURT:
Yes, sir.
And he has no recollection, no knowledge,
22
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period.
24
25
Yes --
yes, sir.
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THE COURT:
THE WITNESS:
So continue.
I think I had -- if someone denies the
inspection.
THE COURT:
THE WITNESS:
interaction with --
10
THE COURT:
All right.
Okay.
11
12
13
14
But I
15
Okay.
16
document.
17
18
19
FDA?
20
THE WITNESS:
21
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THE COURT:
Okay.
All right.
information.
24
THE WITNESS:
25
THE COURT:
Was it
Page 63
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painful?
THE WITNESS:
THE COURT:
Okay.
5
6
No, sir.
Okay.
10
11
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MS. CRAWLEY:
13
THE COURT:
14
MR. POE:
15
THE COURT:
16
much.
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THE WITNESS:
18
THE COURT:
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THE CLERK:
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All rise.
All right.
24
MR. POE:
25
THE COURT:
Thank you.
All right.
Page 64
1
2
3
Your Honor.
MR. POE:
THE COURT:
sentencing hearing.
10
Because you've
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15
resolution.
16
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18
evidence.
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It
Page 65
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in part.
process.
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11
interests.
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do what is right.
21
How do we find
That's my process.
22
23
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25
And I
I read it when I
Page 66
1
3
4
life, as your friends and your family and your colleagues saw
you.
Certainly,
They respect
You're
10
11
be.
12
13
community.
14
15
16
this situation.
17
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21
22
who to this point has lived a very good, solid life, how did
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But
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1
10
And it's
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I'm not going to know, gain special insight, into what caused a
13
14
So what do I see?
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duty of communication.
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I've learned
And I understand
Page 68
1
to be honest.
representations.
5
6
this is -- the only way that this can occur is through an IDE.
And the
10
We both
11
know it.
But there
12
13
14
could have been any mistake in your mind or the minds of the
15
other three gentlemen that I'll see later today, that it was a
16
17
do.
18
19
We understand that.
20
21
22
23
24
25
was appropriate; and the FDA was clear and consistent at every
Page 69
1
your desk.
and show you how I know that it made its way to your desk.
there was never any mistake about what was approved or not
approved.
So
10
appropriate.
11
the other leaders, including the CEO who sat down and talked
12
13
14
15
as you chose.
16
17
18
were.
19
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you did it; I don't know why you diverged from your lifelong
23
24
25
And you made the decisions that will, for reasons that
So then we proceed.
Page 70
1
along the way -- and there are six or seven critical steps
where you sat down and spoke about it, and you were there for
and safety meetings -- at each step along the way you assess
you, in the way that you had chosen to proceed from the
10
11
beginning.
So we had the adverse events that to one -- to a
12
13
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15
16
17
18
adverse event should have been enough to let you know that
19
20
So one
21
discussed.
22
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Page 71
But then you later on than that -- the animal studies
1
2
says.
what it said.
And all they did was make you pause, make you
10
11
thoughts" memo.
12
13
14
15
16
17
And if it ever comes to light, the only defense that you will
18
19
wrote -- and you got a copy of the initial e-mail, and then he
20
wrote to you and the CEO and said I'm not sure what makes it
21
22
23
I think this
24
you very clearly that this conduct will have consequences far
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Page 72
1
3
4
proceed.
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course.
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I wanted to
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Page 73
1
today.
acts.
parallel.
8
9
And your lawyer and all the other lawyers have argued
that this is a strict liability misdemeanor.
And I read
10
11
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15
16
17
Hermelin case.
18
And we
19
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24
his watch, that he could have had the power to stop, that he
25
didn't stop.
Page 74
1
those are the events for which most people previously have
been sentenced.
This is more.
3
4
8
9
Because this
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18
19
responsibility.
20
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22
that.
23
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I understand
And this
Page 75
1
isn't clear.
promoting.
10
11
And
institution's part.
So those are my very broad thoughts.
But where we
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a warning letter.
24
use of -- the FDA said any use of this compound in the body
25
was off-label.
Specific discussion.
There's
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1
whether the advice and the structure and the oversight of the
6
7
10
11
12
13
14
infirm.
15
choices.
16
That's a fact.
Right?
That's why
17
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21
needs to be changed.
There needs
22
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Page 77
1
the felonies.
misdemeanors.
But
5
6
information.
10
So I
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17
be.
18
19
It wouldn't
So
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Page 78
1
confinement.
assessment.
And if I did it
10
11
significant act.
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on a scale of ten.
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18
25 dollars.
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4
5
6
7
Your Honor.
THE COURT:
MR. POE:
THE COURT:
11
MR. POE:
12
THE COURT:
10
13
And you'll
Go ahead.
MR. POE:
14
15
16
institution.
THE COURT:
17
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19
that.
20
MR. POE:
21
THE COURT:
It's a
22
23
24
what I've been thinking about since about 4:30 this morning,
25
Page 80
And I think not, because of the magnitude of the
1
2
wrongful conduct.
ability to transition.
He knew it.
10
knew it.
11
12
And he
Because he
13
14
15
16
17
starts today.
So the sentence
MR. POE:
18
And so I
19
20
21
decision.
22
THE COURT:
Right.
And I
23
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25
And
Page 81
1
honor it.
agreement.
10
11
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THE DEFENDANT:
16
THE COURT:
Yes, I do.
All right.
17
18
19
if you ask.
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25
understand that?
Do you
Page 82
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THE DEFENDANT:
THE COURT:
Yes.
Okay.
and fair.
right?
MR. POE:
THE COURT:
10
MR. POE:
Sure.
The first is, we'd request the Court -- if
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THE COURT:
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MR. POE:
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THE COURT:
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MR. POE:
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THE COURT:
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MR. POE:
I don't make
Okay.
Because I can't run the prisons.
Understood Your Honor.
Right.
And the last is, as the Court has
22
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24
THE COURT:
25
MR. POE:
Right.
-- it's six months.
Page 83
1
THE COURT:
MR. POE:
Absolutely.
And so, Your Honor under -- I do have a
point -- and the appeal is not for the purpose of delay, and
10
11
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13
14
sentence."
And so under the
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20
determination.
21
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apply.
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We believe
25
that the factual basis for those Court's rulings, under any
Page 84
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therefore we would ask the Court to grant that motion and put
THE COURT:
And so
Let's start by
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16
So those are my
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where we'd find error in the factual basis upon which I based
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different ways.
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heard today.
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couldn't do it.
addressed.
10
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greater than the fear of jail for a young drug dealer from the
18
'hood, right?
19
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think the basis was strong, was clear, if I hadn't made all of
22
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24
25
And I,
Because if I didn't
But I don't
Page 86
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will occur.
MR. POE:
THE COURT:
MR. POE:
THE CLERK:
8
9
Good day.
Good day.
All rise.
(Court is adjourned)
* * * * *
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Administration
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anesthesiologist
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Antlers 31:22
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appear 26:7
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appropriately
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approximately
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autopsy 32:5 34:9
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California 24:21
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call 22:14
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