US Grand Jury Indictment Synthes, Inc

Case 2:09-cr-00403-LDD Document 207 Filed 01/03/12 Page 1 of 104
UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF PENNSYLVANIA
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UNITED STATES OF AMERICA,
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Plaintiff,
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vs.
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NORIAN CORPORATION, and

MICHAEL D. HUGGINS
Defendants.
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2:09-cr-00403-3-LDD
Philadelphia, PA
November 21, 2011
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TRANSCRIPT OF SENTENCING MICHAEL D. HUGGINS

BEFORE THE HONORABLE LEGROME D. DAVIS
UNITED STATES DISTRICT JUDGE
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APPEARANCES:
For the Government:
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For the Defendant:

Michael D. Huggins
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MARY E. CRAWLEY, AUSA

GERALD B. SULLIVAN, AUSA
OFFICE OF THE UNITED STATES ATTORNEY
615 Chestnut Street-Suite 1250
Philadelphia, PA 19106
LAURA PAWLOSKI, ESQUIRE
ASSOCIATE CHIEF COUNSEL
FOOD AND DRUG ADMINISTRATION
10903 New Hampshire Avenue
Silver Springs, MD 20993-0002
GREGORY L. POE, ESQ.
POE & BURTON PLLC
1030 15TH Street, N.W.
Suite 580 West
Washington, DC 20005
CATHERINE M. RECKER, ESQ.
WELSH & RECKER
2000 Market Street-Suite 2903
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ESR OPERATOR:
DONNA CROCE
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Proceedings recorded by electronic sound recording.
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Veritext National Court Reporting Company

Mid-Atlantic Region
1801 Market Street - Suite 1800
VERITEXT NATIONAL COURT REPORTING COMPANY

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I N D E X
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For the Defendant

For the Government
Sentencing
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RULING:
Defendant's motion under 18 U.S. Code
3143(b)(1)(B)(iv), denied
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LINE
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THE COURT:
All right.
This is the matter of the
United States of America versus Mr. Michael D. Huggins, which
is 09-403.
government.
course, here.
front of Judge Stengel, we are here for sentencing.
Ms. Crawley and Mr. Sullivan are here for the

Mr. Poe is here for the defendant who is, of
And following the plea, which was tendered in
As everyone is familiar, we had a several day hearing
on sentencing guidelines and last week I issued a ruling,
which I believe resolved all of the questions, both factual
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and legal.
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issues -- factual issues; excuse me, that the parties need to
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have resolved.
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I'm not sure if there are any other legal
Anything from you, sir, Mr. Poe?
MR. POE:
Your Honor, I did note one -- the probation
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office, I think, did not accurately reflect, in the final
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report, one of Your Honor's -- one aspect of Your Honor's
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order, in paragraph 42.
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THE COURT:
Tell me about it.
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MR. POE:
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Your Honor directed the PO to correct PSR paragraph
Yes, sir.
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42 to reflect that eight of the thirty-four cases involved the
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treatment of VCFs.
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THE COURT:
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MR. POE:
Right.
I remember that.
Yes, Your Honor.
And the second revised
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PSR states, "Notes from the meeting show that the participants
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also discussed Synthes' failure to file an MDR on the first

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death, as well as the fact that there already had been three
adverse events with a Norian product in eight out of the
thirty-four VCF cases to date".
So as the Court may recall, twenty-six of those cases
were burst fractures and therefore, I think, it just got lost
in translation a bit, Your Honor.
corrected.
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THE COURT:
Okay.
We just ask that that be
And you would propose -- well,
actually, the language is in the order, right?
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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.
So any concern about that?
No, Your Honor.

All right.
Any other factual findings
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that needed to be made, from either party, that I might have
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overlooked?
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MR. POE:
No, Your Honor.
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THE COURT:
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MS. CRAWLEY:
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THE COURT:
Government?
No, Your Honor.
All right.
So obviously the concerns
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that the defendant raised about the guidelines, they're all
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preserved.
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But with that in mind it's a four-one, the guideline range is
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zero to six months.
We don't need to, hopefully, discuss those again.
That's where we stand, correct?
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MR. POE:
Agreed, Your Honor.
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MS. CRAWLEY:
Yes, Your Honor.

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THE COURT:
And obviously, Mr. Poe, you have
discussed this pre-sentence with your client on multiple
occasions, is that correct?
MR. POE:
THE COURT:
That's correct.
And he concurs that in light of my
determinations in my order there are no other factual
corrections or amendments to be made?
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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Yes, Your Honor.

All right.
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So let us here from the
Witnesses first for either side.
Would Your Honor like me to use the podium?

You remember how the acoustics are in
this room?
MR. POE:
I do, Your Honor.
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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Government, you agree with
Okay.
How about for the government?
No witnesses, Your Honor.

All right.
So then we'll just proceed to
argument or discussion, rather.
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MR. POE:
Good morning, Your Honor.
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Your Honor, the entire life of Michael Huggins has
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been defined by the same characteristics, from beginning to

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now.
He's a loving father.
He's a devoted brother.
good friend.
decent man.
befriended a young boy with learning disabilities across the
street to the recent work that he did with a woman to bring
clean water to her village in Kenya, Michael Huggins has been
defined by the same characteristics.
He's a hard worker.
He's a
He's a compassionate,
From the time, as his father describes, when he
Now, I recognize Your Honor's rulings with respect to
this case and the offense conduct and the relevant conduct and
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that, of course, is an extremely important aspect of Your
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Honor's sentencing determination.
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Huggins' characteristics and the life that he has led, we ask
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Your Honor to give great weight to those characteristics and
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to that life, especially now, after Booker, offender
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characteristics are wide open for the Court to consider.
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we ask the Court to --
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THE COURT:
But with respect to Mr.
And
Well, offender characteristics are an
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extremely valid consideration because, if you look at the
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objective facts of a particular criminal violation, say drug -
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- say a robbery affecting interstate commerce, the actual act
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may be identical but it may have been committed by different
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persons who pose entirely separate sentencing considerations.
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So offender characteristics, I absolutely agree with you, are
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relevant, germane and important.
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MR. POE:
And Your Honor, with respect to Mr.

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Huggins' family friends, I just want to inform the Court his
wife, his daughters are present in court today.
family, I won't introduce others, are present.
THE COURT:
MR. POE:
THE COURT:
Friends and
Well, the entire courtroom is full.

Yes.
That's a fair statement.
So it's
probably somewhere between fifty-five and sixty-five people, I
would say.
MR. POE:
And I can't say that those are all his
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friends and family, Your Honor, but I did want to let the
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Court know that he has support here today.
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THE COURT:
Right.
And I would also -- I think the
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record should reflect that I didn't actually count the letters
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that were submitted on his behalf but there was probably
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somewhere between sixty-five and ninety, I would say.
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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:
That's correct, Your Honor.

Right.
Eighty-five, actually.
Eighty-five?
I counted.
Okay.
Your Honor, with respect to those letters,
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one point that I did want to make, is that the government at
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note 3, page 4 of its sentencing memorandum states that many
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of the letters reflect an understanding that the case is about

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off-label marketing and off-label promotion.
And the
government suggests to the Court that that, somehow,
translates into Mr. Huggins taking this offense less
seriously.
the letters submitted on behalf of Mr. Huggins reflect that
position taken by the government.
And I just -- we looked again, Your Honor, none of
So we -- to the extent that the Court would put any
weight on the government's argument, we respectfully suggest
that there is no factual basis for what the government has
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said in that footnote.

The government also, Your Honor, has said at page 16
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of its memorandum, it questions Mr. Huggins' motivation for
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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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community work reflects is what he's been doing his entire
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life.
Mr. Huggins has had time to do that
So we just wanted to point that out as well.
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Your Honor, on a --
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THE COURT:
Well, but, sort of, as we have this
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discussion, I understand that you're representing the
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defendant and by definition you're on the defensive, right?
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And the government is taking the initiative in prosecuting
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this matter and they say certain things.
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lawyers, I listen to how they analyze the case and to the
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extent that I find it to be reasonable and fair and just, I
And I listen to

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will accept it.
But I think it's more important for you to
tell me the affirmative truths that you see from your side,
the things that are important about Mr. Huggins as we -- as we
begin this process of determining a fair sentence.
not so sure that the best strategic approach is to say what's
wrong with the government's presentation, if you will.
MR. POE:
THE COURT:
MR. POE:
And I'm
Your Honor -- I'm sorry, Your Honor.

Oh no, I'm actually trying to be helpful.
I understand.
I wished to point that out.
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I also do have a legal objection that I would like to pose
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with respect to the government.
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THE COURT:
Okay.
Yeah.
As long as it's just
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introduction, as long as it's not the structure that's fine,
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because I think you have more important things to say than
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where you disagree with the government, but go ahead.
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MR. POE:
I agree, Your Honor.
Your Honor, the
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government has made an argument that the Court should vary
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above six months to twelve months under 3553(a).
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government has waived that argument.
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this Court, of the Eastern District of Pennsylvania, states
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that objections to the PSR are waived unless good cause is
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shown that excuses the failure to make the objection.
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The
The standing order of
The government, itself, shows that good cause is
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lacking for its argument because it has said that it has --
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the defendants have been on notice in this case from before

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the plea, that a twelve month sentence is possible in this
case and that therefore we -- no defendant -- Mr. Huggins
should not be in a position of complaining about the
possibility, in this case, of an upward variance.

Now of course the Court has authority to do what the
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Court wishes to do, in light of Irizarri and other
authority.
the government's argument because we believe it's foreclosed
from making it or should be foreclosed from making it.
But I just do wish to pose that legal objection to
THE COURT:
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Well the question of whether a variance
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is appropriate, either upward or downward, is a judicial
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determination that has to be made at the time of sentencing
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based upon the relevant factual considerations.
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parties argue for upward and downward variances all the time
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and those are just arguments, they're not -- the government is
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not in the business of sentencing people.
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in the business of bringing prosecutions where they think that
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the factual circumstances merit them.
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also understand that this very lengthy pre-sentence report
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that we've seen in several forms now is a recommendation,
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right.
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sentence people.
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looking at the legal effect of some of the determinations or
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statements that were made in the pre-sentence report and some
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of them I agreed with and some of them I didn't agree with.
And the
The government is
And I think we should
Like the government, the pre-sentence officer does not

We went through a very lengthy process

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But the fact of the matter is, the pre-sentence officer is not
the ultimate authority on whether an appropriate basis for an
upward or a downward variance exists.

So what we have in front of us is we have two
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recommendations, one by the government and one by the pre-
sentence investigator -- by entities, recommendations by
entities who don't have ultimate sentencing authority.
will consider them and I will make my own determination, all
right.
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MR. POE:
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THE COURT:
So I
Understood, Your Honor.

But ultimately my determination, the
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central component of my determination will be what I think is
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fair, just and right.
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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:
Thank you, Your Honor.
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Now Your Honor, in a case such as this, of course, we
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recognize the importance of the principle of general
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deterrence.
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respectfully submit that a sentence exceeding a probationary
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sentence, and we've requested in this case, is not necessary
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to deter Mr. Huggins from any further conduct, criminal
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conduct, in the future.
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Deterrence, with respect to Mr. Huggins, we
So we have focused our argument on the general

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deterrence point.
And with respect to the general deterrence
point, I can't over-emphasize the likelihood of exclusion from
the industry by the Department of Health and Human Services.
One -- in the month after Mr. Huggins pleaded guilty I spoke
with officials at the Department of Health and Human Services,
Your Honor, who informed me that they would wait until
sentencing to initiate exclusion proceedings.
the Department of Health and Human Services has done, given
what they've said to me, officials of HHS have said to me,
So given what
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given public statements by HHS officials, we think it's fair
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to say that Mr. Huggins is facing near certain proceedings by
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HHS to exclude.
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That sanction, with --
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THE COURT:
And I'll accept that as a fact because I
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think that's, in all likelihood, what is going to occur.
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continue.
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MR. POE:
But
That sanction,
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itself, sends an extraordinarily powerful message to
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executives in the medical device industry, to the public at
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large and that message has been getting out in extremely
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public ways.
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discussions, in other forms where the industry is
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understanding exactly how serious the government is about its
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enforcement authority and its willingness to take steps with
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respect to its enforcement authority, steps that lead to
In leading newspapers, local, national, in blog

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outcomes like this case, Your Honor.

And so, with respect to the idea that a sentence of
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incarceration is necessary to deter, generally, members of the
public or any officials or employees in the medical device
industry, we respectfully submit that that exclusion sanction
itself is sufficient to get the message across.
With respect to the issue of the fine, that's another
aspect that we would suggest to the Court does not require any
sentence exceeding probation to be associated with it.
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Because the fine in the Food, Drug and Cosmetic Act, the
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maximum fine as Congress passed the law in 1937, is 1,000
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dollars.
That remains the case today.
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In 1984 Congress, in the Sentencing Reform Act,
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increased the maximum fine to 100,000 dollars and that's
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exactly the same act that addressed the issues of penalties
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for white collar offenses being perceived as too low.
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the idea that Mr. Huggins has now agreed to pay, in the plea
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agreement, the Court will do what the Court thinks is
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appropriate, but has agreed to pay in the plea agreement a
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100,000 dollar fine is another reason to suggest that
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deterrence of others will be satisfactorily achieved without a
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sentence of incarceration.
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if the Court imposes it then we suggest that no additional
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penalty, especially in light of the exclusion proceedings, is
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necessary.
And so
It is a stiff maximum penalty and

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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
on the point, but I think that it is a point that I need to
make.
on his liberty, and I think that that's a material factor for
the Court to consider in fashioning a sentence.
it anywhere near the status of the exclusion proceedings or
the maximum fine that he's paid but I do wish to note it.
For two and a half years he has had some restrictions
I don't put
Really, Your Honor, the issue of incapacitation, the
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need to protect the public from further crimes by Mr. Huggins,
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we submit the record doesn't suggest that ever will happen.
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Incapacitation is not necessary in this case.
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correctional treatment, there is no -- based on the
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information before the Court we don't believe that
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incarceration is necessary to afford Mr. Huggins correctional
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treatment.
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The need for
The Court's required to consider, under the statute,
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the guideline range, policy statements of the sentencing
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commission and the Court, of course, has and will do that.
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And that results in the calculation that the Court has
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identified and we agreed with this morning.
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The issue of unwarranted disparities, all cases are
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different, Your Honor, but we would note that, of course, a
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sentence exceeding probation in this case would be something
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much different from what has occurred in other cases at other

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times.
The issues of promoting respect for the law, assuring
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just punishment, again, I think those fold back into the
Court's views of the case, the need for general deterrence and
whether, in fact, the other punishments that are -- Mr.
Huggins is going to incur in this case are sufficient to
achieve the purposes of sentencing.

Your Honor, Mr. Huggins, at this point, in light of
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Your Honor's rulings last Tuesday, he stands on the letter
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that he submitted to the Court.
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on the offense conduct or the relevant conduct.
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respect the Court's authority and understand the Court's
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ruling.
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We will not comment further

We certainly
But I ask the Court again to consider, as it decides
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what an appropriate sentence is in this case is, whether a
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sentence of incarceration is necessary to achieve the purposes
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of sentencing, to send the message to the public that the
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conduct that the Court has ruled occurred in this case.
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needs to be punished.
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the fine and the other collateral consequences as Mr. Huggins
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has undergone in this case are sufficient to achieve the
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purposes of sentencing.
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Honor, we respectfully ask the Court to impose the sentence of
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probation we've requested.
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It
We believe the punishment of exclusion,
And for all those reasons, Your
If the Court is inclined to impose a sentence of

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incarceration we would ask the Court to consider substituting
home detention or community confinement as an alternative to
incarceration.
THE COURT:
government, please.
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Thank you, sir.
MS. CRAWLEY:
Let me hear from the
Good morning, Your Honor.
Mary Crawley
for the government.

Your Honor, in this country we believe in process.
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It is how we approach many of our most important problems.
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know that a fair process is not going to, necessarily,
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guarantee a good result but we believe that good results are
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promoted when there are fair procedures in place, when those
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procedures are instituted and insisted on.
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philosophy of procedural fairness imposes on the citizens an
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obligation of honesty.
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interest and they're going to act in that self interest but
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that they must make truthful disclosures to each other and,
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when necessary, also to the governing authority.
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We
And this
It recognizes that people have self
And we believe the requirement of truthful disclosure
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is especially important in the area of medical devices and
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especially here, in connection with a significant risk medical
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device, with the FDA's oversight, because people's lives
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depend on it.
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And I won't repeat here what the Court already knows,

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about how devices are different from drugs.
How drugs are all
tested rigorously to determine that they are safe and
effective for their intended use.
cleared by the FDA upon the information provided by the
manufacturer that the device is substantially equivalent to
another device that's already on the market.
Whereas devices can be
But it is crucial, especially with significant risk
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devices, that FDA get truthful information from device
manufacturers and that the device manufacturers deal honestly
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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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In this case, Your Honor, we believe there were four
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ways in which the defendants subverted the FDA process.
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First, by lying to the FDA about what their true intended use
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for the device was.
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permission to conduct clinical trials on the device by means
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of an investigational device exemption.
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adverse events reports on the first death and then filing
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vague reports later, on the second and third deaths.
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fourth, by lying to the FDA investigator in June -- in May and
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June of 2005, afterwards, about the first three failures that
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had occurred.
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Second, by not obtaining the FDA's
Third, by not filing
And
So each of these acts, in the government's view,
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manifested an intent to undermine the entire system by which
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we safeguard people's health and safety in connection with

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medical devices.
do?
And what did defendant Huggins, Mr. Huggins
The Court found that he knowingly participated in a
business plan to conduct unauthorized clinical trials of SRS,
the predecessor device, mixed with barium sulfate to treat
vertebral compression fractures.
the unauthorized clinical trials on SRS and then the later
device, XR, which was the -- and that he authorized -- the
Court also found that he authorized and/or failed to prevent
And that he participated in
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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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And the Court found, further, that the people who
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were the subjects of the unauthorized clinical testing were
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directly and proximately harmed by the defendant's actions,
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including Mr. Huggins' actions.
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subjected, in these clinical trials, to these risks, the risks
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of these devices without their informed consent and without
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the permission of the FDA.
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Court found, were injured, some of them died.
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conducting these clinical trials, the Court found that the
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defendants, including Mr. Huggins, disregarded the safety of
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all members of society.
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Mr. Huggins took part in all four aspects of the crime that
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I've just outlined.
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And that those people were
So some of those patients, as the

And by
And we would submit to the Court that
At the end he lied to the FDA investigator, Captain

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Joseph Despins, who's here today in Court.
THE COURT:
MS. CRAWLEY:
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Which gentleman is Mr. Despins?

Captain Despins, if you could stand,
please.
THE COURT:
Oh, he's the gentleman with the uniform
and the medals.
him I would have known that.
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Okay.
MS. CRAWLEY:
If I could see -- if I could have seen

But go ahead.
Captain Despins, of course, brought
this all to light because without his five weeks at the
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company, first being told that there were no documents, then
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being told that there was no clinical trial, then continuing
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to press and finding out that there were documents, there were
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documents on the computers of the defendants, documents that
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they didn't want him to find but documents that showed the
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unauthorized clinical trials of the two devices.
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But we submit, Your Honor, that Mr. Huggins lied to
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him when he told Captain Despins that the XR test market had
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involved only cleared -- excuse me -- indications for XR when
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he knew that the test market, which was the second
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unauthorized clinical trial, involved teaching surgeons to use
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the device to treat vertebral compression fractures.
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conclusion flows, inescapably, from the Court's other findings
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in its order.
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25
And this
We also submit that Mr. Huggins had -- he did bear a

responsibility for the failure of Synthes to file an adverse

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event report, an MDR on the first death, the death of Dr.
Sachs' patient because Mr. Huggins learned, at the January
2003 meeting, about the -- the meeting about XR that the first
death had occurred.
patient had died on the operating table after having been
injected with SRS that had been back-table mixed with barium
sulfate.
consistent with pulmonary embolism and she died.
And as the Court is aware, Dr. Sachs'
She suffered a hypotensive episode that was
At that same meeting in January 2003, where Mr.
9
10
Huggins learned of the death, another defendant, Mr. Bohner,
11
mentioned that there was a very short window of time to file
12
an adverse event report.
13
Sachs, in talking with the three employees of Synthes, after
14
his patient had died, could not rule out the SRS as a cause of
15
his patient's death.
And as the Court is aware, Dr.
Now as the Court is aware, Synthes was a hardware
16
17
company.
18
And this first death, in January 2003, was alarming to the
19
company and it was alarming to Mr. Huggins and the other
20
defendants and this focused them on the safety issues.
21
It did not have a history of product-related deaths.
So the government submits that if, after that first
22
death, Mr. Huggins was -- did not follow up by making certain
23
that an adverse event report was filed for that first death,
24
it was not due to inattention, it was not due to his many
25
other duties.
It was due to fear, perhaps, of tainting the

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1
Synthes brand by reporting this death, fear of affecting
profit or perhaps fear of losing his status at Synthes.

Thus we would submit, Your Honor, that Mr. Huggins
3
4
was involved in all four of the aspects of the crime for which
he stands before this Court.

The Court's order outlines, better than I could, the
6
7
outcome of the unauthorized clinical trials.
the kinds of foreseeable consequences that violating the laws
that are designed to protect the public's health and safety,
10
And these are
may have.
So as a result of the subversion of the FDA process,
11
12
Your Honor, all of these defendants made risky procedures more
13
dangerous.
14
and the others to go forward with the clinical trial, the
15
unauthorized clinical trials, despite the mounting safety
16
concerns, despite the lack of FDA permission, it appears to be
17
that it was simply the pursuit of profit.
18
to get the device to the market faster, to cut out the FDA's
19
oversight.
And at the heart of the decision by Mr. Huggins
It was the desire
So this subjected frail, elderly patients, who are
20
21
among the most vulnerable people in our society, to grave
22
risk.
23
entitled to have.
24
memo for Mr. Huggins and in the other memoranda, what they
25
were entitled to have might have made a difference in this
They were not given the protections that they were

And as we pointed out in the sentencing

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1
case.
Because the surgeons in this case told the government
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.
They would not have used it on their patients.
The two earlier adverse events that were not fatal,
5
6
with Dr. Delamarter's patients in 2001, the pilot studies
conducted by the University of Washington researchers and the
death of Dr. Sachs' patient before the test market began, the
XR test market began.

So beyond that, even, the elderly patients who were
10
11
put at risk here --
12
THE COURT:
13
MS. CRAWLEY:
14
THE COURT:
15
hypotensive events.
Let me just stop you for a second.

Yes, Your Honor.
16
MS. CRAWLEY:
17
THE COURT:
The two non-fatal, I think they call them
18
Yes, Your Honor,

MDRs were filed on those, is that
correct?
19
MS. CRAWLEY:
20
THE COURT:
21
That is absolutely correct.

And they were filed in a timely manner,
which I think is thirty days, is that correct?
22
MS. CRAWLEY:
23
THE COURT:
They were.
And they were pretty explicit in terms of
24
what they said, is that right?
They accurately and fairly
25
captured the factual events that had happened during surgery,

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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
was a different person in charge of the reporting at that time
who insisted.
THE COURT:
MS. CRAWLEY:
9
10
Right.
Dr. Sharp insisted that these reports
be filed.
THE COURT:
Okay.
So then we spin forward a period
11
of time and as far as the fatalities are concerned there
12
doesn't seem to be the same clear appreciation and
13
understanding of the obligation to file reports in those
14
instances.
Is that a fair --
15
MS. CRAWLEY:
16
THE COURT:
17
MS. CRAWLEY:
That is very fair.

Okay.
Go ahead, ma'am.
But if -- if someone had spoken up, if
18
Mr. Huggins had taken his corporate responsibilities seriously
19
and decided that Synthes would have to conduct its clinical
20
research legally, then Synthes would have had to obtain the
21
FDA's permission ahead of time and there would have been a
22
number of safeguards in place for patients if the FDA had
23
said, yes you can test the device to treat VCFs.
24
permitted, then there would have been FDA review of an
25
investigational plan.
If that were
There would have been an institutional

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1
review board at the hospitals where the tests were carried
out.
boards, Your Honor, is that they are not just doctors, they
are a mix of people.
are in charge of making sure, among other things, that the
test are adequately supervised, that adverse events are
reported promptly and that patients are told enough so that
they may give true, informed consent because that is what is
at the heart of what happened here.
And the important thing about institutional review
They are -- they include ethicists who
The terrible thing that
10
was done was that the patients, all of the patients who were
11
subjected to these tests, were not told.
12
that they were the subject of experimental treatment.
13
could not give informed consent because they did not know of
14
the risks that the people at Synthes knew, that the people at
15
Synthes, including Defendant Huggins, did not tell them, did
16
not tell the doctors, did not tell the FDA.
17
They did not know

They
And the reason, the specific reason, why permission
18
from the FDA to conduct these tests might have made a
19
difference in this case is that the second and third deaths in
20
this case, as the Court may be aware, both took place at John
21
Muir Hospital in California.
22
an IRB, an institutional review board, been in place after the
23
second death, that it would have been very unlikely that the
24
third person would have been operated on with Norian.
25
they had, they would have been given information, perhaps even
And it is easy to see that had
And if

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including that another person at the hospital had died in that
same sort of treatment.
information that would have permitted them to give true,
informed consent.
happen.
They would have been given
But as the Court is aware, that did not
So because the patients weren't told the truth,
including the risks that the defendants knew about, they
couldn't give informed consent and they could not decide
whether or not to participate in experimental treatment.

To put it most bluntly, Mr. Huggins and the other
10
11
defendants used these people, these elderly patients, as
12
guinea pigs and ignored time honored principles of informed
13
consent.
14
patients' status was not deserving of ethical debate, as if
15
they were subjects not patients, clinical material instead of
16
sick people who were in pain, and that is at the heart of what
17
was so terribly wrong about what Mr. Huggins did.
18
He and the other defendants acted as if these
Now, Mr. Huggins' counsel points to his good works
19
and I would simply point out that when a person has so
20
decisively and so aggressively turned the page on a chapter in
21
his life, when after a plea he so clearly changes his course
22
to set about a concerted program of good works, that may mean
23
that he is turning the page on what he knows is a very immoral
24
chapter in his life.
25
would point out that Mr. Huggins' conduct only highlights his
But far from reflecting well on him, we

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abject failure to acknowledge what he has steadfastly refused
to admit to the government, to the probation office, to the
public and to this Court.

And the other possibility, Your Honor, is even less
4
5
attractive and that is that what he has done is a cynical
attempt to curry favor with the Court in an effort to buy his
way out of jail, to make himself appear repentant when he is
not.
his words but the government would hope that it is the first,
10
In that case, his actions would then be consistent with
that he is simply turned -- he's turned the corner.
11
THE COURT:
12
MS. CRAWLEY:
13
14
15
Have you spoken to him?

Your Honor, we are not in a position,
he is represented.
THE COURT:
So you really don't know what his
motivations are, right?
16
MS. CRAWLEY:
17
THE COURT:
18
MS. CRAWLEY:
19
THE COURT:
20
MS. CRAWLEY:
21
THE COURT:
22
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.
I would say that those
23
are the two alternatives and I will leave that for the Court's
24
consideration.
25
THE COURT:
As you define them, right, that --

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MS. CRAWLEY:
THE COURT:
Yes, Your Honor.

-- I would suggest to you that there are
other alternatives beyond what you see from your perspective,
because really what we're doing here is we're talking about
perspectives, that's all we've been talking about since the
time that we met on this case.
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
10
really the truths that one sees are frequently determined by
11
the position in which one is standing when one looks at them.
12
Mr. Huggins has said in his sentencing documents, a
13
couple of times, that he welcomes the opportunity to talk to
14
me so we'll get there and we'll find out what the truths are.
15
MS. CRAWLEY:
16
THE COURT:
Yes, Your Honor.

But like I said to Mr. Poe, you have
17
better things to talk about so let's speak about those.
18
ahead.
19
MS. CRAWLEY:
Yes, Your Honor.
Go
I am nearly done and
20
all I would suggest at this point is that the need for
21
deterrence here is very great because the profits to be made
22
in these situations are so great.
23
THE COURT:
And it is --
That last point you make is fascinating,
24
because we both saw the release-to-market plan.
I forget
25
which of your -- your -- I don't know what to characterize it.

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I have three bankers' boxes of exhibits and materials in my
office and I read them all.
saw the release-to-market plan.
February or something, I think, '03.
of materials, which were -- I think they're looking at
somewhere between 6 and 700 surgeries projected over a year,
for the cost of materials which is slightly under 100,000
dollars, they look to realize, over six million dollars in
revenue and they look to realize an after-tax profit of over
10
three million dollars.
11
correctly?
12
MS. CRAWLEY:
13
THE COURT:
And somewhere along the way we

I want to say it was dated in
But it said for the cost
Is that -- am I remembering that
Yes, Your Honor.

All right.
So when the government is
14
trying to discern what the motivations for this behavior,
15
which is very difficult to reconcile, with responsible,
16
ethical behavior by very intelligent people, and the
17
government says that you -- you have to look at two things,
18
the culture within the larger field and the culture within the
19
particular corporation, and you have to look at the profits,
20
potential profits to be realized as viewed by the defendants
21
at the time that they were making the decision.
22
an abstract concept in this case, there's abundant evidence in
23
the record to support the government's contention that the
24
financial motive perhaps operated to cloud judgments which had
25
been present in these highly successful lives to this point
So that's not

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but for this period of time seemed to have been lacking.

MS. CRAWLEY:
Yes, Your Honor.
Because here,
fortunately, the test markets were ended before more people
could die but the point was that the market to be captured was
huge because, at the time it was believed that this was a
procedure that many people would want because many people of
our age are growing older and have spinal problems and have
compression factures.
THE COURT:
9
10
I'm still a young man.
I beg your
pardon.
11
MS. CRAWLEY:
12
THE COURT:
13
MS. CRAWLEY:
14
THE COURT:
I beg your pardon?

I said I'm still a young man.
Well, I can see that Your Honor.
As I tell my law clerks, I have not hit
15
my prime yet.
But the projection was, I believe, about
16
700,000 VCF surgeries per year, right?
17
MS. CRAWLEY:
18
THE COURT:
19
MS. CRAWLEY:
20
THE COURT:
21
MS. CRAWLEY:
It was, I believe, that there was -In the entire market.

Yes.
Seven hundred thousand new cases.
There could be that many, yes.
There
22
could be that many new cases a year and a great many of those
23
would be painful and then the surgeries could be performed.
24
THE COURT:
25
MS. CRAWLEY:
Right.
And of course we know now that this

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surgery was not such a good thing because, of course, in
August of 2009 the New England Journal of Medicine published
two studies that suggested that vertebroplasty was not an
effective method of relieving pain from vertebral compression
fractures.
the four individuals' push for profits, to the exclusion of
safety concerns and in derogation of the FDA process, they
should not be heard to say, of course, that the surgical route
was necessarily the best route for -- the last best hope for
And so when we are reflecting on the effects that
10
these people who were in pain, because now we know
11
differently.
12
THE COURT:
Well, one didn't know at the time and, I
13
mean, obviously a number of approaches were being considered
14
and -- but that just spirals back to your point that since
15
this is such a risky market, very difficult issue with very at
16
risk patients, that there's a need for regulatory oversight to
17
make sure that what occurs occurs consistent with medical and
18
ethical standards, right?
19
MS. CRAWLEY:
20
THE COURT:
21
MS. CRAWLEY:
Yes, Your Honor.

So go ahead.
Finally, I want to say a few things
22
about the people who were most affected by the defendant's
23
actions, the people who are not with us any longer.
24
government has obtained the permission of their relatives to
25
speak about them very briefly.
The

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THE COURT:
MS. CRAWLEY:
Are any of the relatives here or not?

There were -- the grandson of one of
the individuals was going to come down from New York and I do
not believe that they are here yet.
moment, Your Honor?
THE COURT:
But if I may have a
Sure.
(Pause)
THE COURT:
MS. CRAWLEY:
10
wait until those --
11
THE COURT:
No one's responding.
Okay.
What I will do, Your Honor, then I will
Oh no, you can say whatever you -- they
12
have given you permission to say and if the grandson arrives
13
before we finish, I'd certainly welcome his thoughts and
14
insights.
15
MS. CRAWLEY:
Yes, Your Honor.
As to Lois Eskind,
16
who was Dr. Sachs' patient who had -- was -- who had died in
17
January of 2003, January 13th; she was the second patient that
18
Dr. Sachs had performed the procedure upon using Norian,
19
having been trained in the SRS test market to use that
20
procedure.
21
And Mrs. Eskind was seventy years old, she was a
22
homemaker and she lived in Antlers, Oklahoma.
And she had,
23
like all of these individuals, a lot of other medical problems
24
and she was in pain from her vertebral compression fractures.
25
I believe she was the subject of a newspaper article

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that was written by someone writing for the "Philadelphia
Inquirer" and her relatives had spoken to the newspaper.
Dr. Sachs began the surgery.
of her back and Mrs. Eskind died on the operating table.
There was no autopsy performed.
But
He was operating on two levels
Dr. Sachs told a group of Synthes Spine employees, in
the days right after the surgery, that Mrs. Eskind had died of
a cardiopulmonary event, myocardial infarction, embolism of
some kind, unknown cause.
And he did not know whether it was
10
an air embolism, the anesthesiologist thought it was a fat
11
embolism -- I'm sorry; the anesthesiologist thought it was an
12
air embolism, Dr. Sachs believed it was more likely a fat
13
embolism and he said that there was no choice but to be
14
concerned.
15
is critical.
16
company had decided not to file an adverse event report.
17
significantly the company did not --
And this is the case, Your Honor, where the
THE COURT:
18
19
And he said that going forward, patient selection
And
He said to whom that patient selection is
critical?
20
MS. CRAWLEY:
He said to Synthes employees that
21
patient selection is critical.
22
affect upon the company's behavior going forward, but it did
23
not.
24
event analyzed by an outside medical expert, although they had
25
no requirement -- there was no requirement to do that in the
So this should have had an
And significantly, the company did not ever have the

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1
law, necessarily, but this would be, obviously, a prudent
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
obtain the x-rays of Mrs. Eskind or medical reports for the
event.
In fact, the first time that the x-rays were --
copies were reviewed by personnel at Synthes was in connection
with Dr. Sachs' presentation that he gave at the first test
market event in San Diego and that was in August of 2003.
10
those x-rays then reappeared, as the Court is aware, at a
11
much -- at later events and in the technique guide for Norian
12
XR which, of course, the Court is aware the defendants did not
13
know that those were Mrs. Eskind's x-rays that were being put
14
in the technique guide but this is what happens when the laws
15
are disregarded, when people are not doing what they need to
16
do to bring safety events to the government's and to other
17
people's attention.
18
And
The second patient who died was Mr. Kikuchi who had
19
been a former professor at UC Berkley and a physicist.
He was
20
eighty-three when he was operated on by Dr. Nottingham and
21
that was, as I mentioned, in John Muir Hospital in California.
22
And this gentleman had VCFs, vertebral compression fractures
23
at three levels and he was -- Mr. Kikuchi was semi-retired and
24
he was an active and mentally alert person.
25
before the surgery he had been walking on a daily basis with
Up until a month

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1
no problems for thirty to forty minutes at a time.
But he had
a history of degenerative spine disease and he had had a
previous kyphoplasty surgery using PMMA.

So, again, with this second surgery there was a --
4
5
like the first surgery, there had been a Synthes Spine
consultant present during the surgery and soon after the
Norian XR was injected into his back, Mr. Kikuchi, his blood
pressure fell quickly, his heart stopped and he could not be
resuscitated.
10
He died on the operating table and no autopsy
was performed.
11
And on September 23rd, 2003, a Synthes complaint
12
handling manager told -- wrote that the Norian XR product
13
manager had told him the day before that Dr. Nottingham had
14
reported the event to Synthes and that he noted a cement leak
15
during the injection and feels that this was a cause of the
16
incident.
17
to begin with, is that the safety concerns had to do with
18
whether or not it could cause blood clots.
19
showed that it could, and those studies were ignored.
20
Which is, of course, the problem with this device
The pilot studies
The summary that the product manager wrote about this
21
event included the notes that Dr. Nottingham noted a cement
22
leak during the injection and feels that this was the cause of
23
the incident.
24
releasing cavity creation and XR.
25
consultant pushed this product on him and was unclear about
He thinks a clinical trial is necessary before

He claims the sales

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1
2
3
4
its status on the market.

So, again, meetings were held and decisions were made
to go forward.
THE COURT:
Is this the report which says that the
Synthes employee notes that the doctor's obviously concerned
about med mal suit?
MS. CRAWLEY:
THE COURT:
MS. CRAWLEY:
Yes.
This is the same one?
10
THE COURT:
11
MS. CRAWLEY:
Exactly, Your Honor.

Okay.
And there were notes from a meeting
12
that took place in late September and the notes state that
13
"Mr. Huggins commented two MDR events, research the number of
14
MDRs for kyphoplasty PMMA.
15
assemble the data, look at trends," et cetera.
16
Synthes did not ask an independent medical expert to look at
17
this death, to review it and this is, at this point-- even --
18
again, there may not be a precise legal requirement for that
19
but at this point it's inconceivable because there are two
20
deaths in a very small sample of individuals.
21
Patients are very frail, need to

And again,
Even someone -- the complaint handling manager at
22
Synthes, at this point, e-mailed a manager about the Dr.
23
Nottingham event stating, "Typically, for MDR events,
24
especially one involving a death, we contact a 'medical
25
consultant' or 'expert' in the field to determine whether the

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allegation is valid.
objective medical professional available for consulting for
this complaint."
It is imperative that we have an
But the company did not do that.
And the company, because it had not filed an adverse
event report for Dr. Sachs' patient death, treated this as the
first death.
baseline report which it basically omitted the trending
information that needed to be provided to the FDA so that the
FDA could see that this was not just an isolated incident.
10
And so that was the first -- they filed a
Finally, as to -- oh, I'm sorry.
There was an MDR
11
filed, the adverse event report.
12
complained that patient expired during a three-level vertebral
13
body augmentation.
14
conclusions could be drawn as no product was returned for
15
evaluation" which, of course, is opaque in the extreme because
16
it doesn't even use the term vertebral compression fracture.
17
It doesn't use the term vertebroplasty.
18
term that someone looking for this sort of information would
19
look for in order to find the report.
20
21
It stated "That surgeon
No evaluation could be performed, no
It does not give any
Finally, as to the last death, that was of Dr. Ball's

patient in January of 2004.
22
THE COURT:
23
MS. CRAWLEY:
And he -- Dr. Ball --
And that one was where?

That was also at John Muir Hospital,
24
Your Honor, the same one as the second death.
25
Ball was Dr. Nottingham's partner.
Actually, Dr.

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And Dr. Ball had been -- actually had been present at
1
2
one of Dr. Delamarter's surgeries back in February 2001.
And
he was courted by Synthes for the Norian XR test market and he
attended the 2003 -- the August 2003 San Diego training
session.
By January of 2004 Dr. Ball had performed several VCF
6
7
surgeries with Norian XR in the test market, one of which had
resulted in a leak, a cement leak.
after his partner, Dr. Nottingham, had had his patient die,
And then in late 2003,
10
Defendant Higgins sent Dr. Ball a proposed consulting
11
agreement, to become a consultant for Synthes in relation to
12
Norian XR.
13
cavity creation surgeon forum in San Diego on January 24th and
14
25th of 2004.
15
agreement with the company.
And Dr. Ball was scheduled to lead a Norian XR
In March of 2004 he did sign the consulting
But it was almost on the eve of the January 24th San
16
17
Diego forum, Your Honor, that he performed a test market
18
surgery on the third person who died and that was a lady who
19
was eighty-three years old, Barbara Marcelino.
20
Pleasant Hill, California.
21
Hospital.
22
She lived in
And this was, again, at John Muir
Mrs. -- excuse me -- Mrs. Marcelino's husband was, at
23
that time, living in assisted living and she worried about
24
what would happen to him if she were not around because she
25
was his caretaker.
She had two daughters, age sixty and

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sixty-three, and she had longstanding lower back pain.
And
she had been using a walker for about eighteen months.
She
was still fairly active and she was still driving.
The surgery did not take place; it was scheduled on
the 19th of January, because there were issues about whether
she could be cleared for the surgery.
on January 21st, in the evening.
Ball began operating.
XR on her second lumbar vertebrae.
But it did go forward
And at 10:30 at night Dr.
He performed a kyphoplasty with Norian

And the same Synthes
10
consultant, the Synthes Spine consultant who had been in the
11
operating room during the death of Dr. Nottingham's patient
12
was in the operating room during this surgery as well.
13
The surgery, according to the records was -- the
14
cement was injected at approximately 11:10 p.m.
Her heart
15
rate fell, her blood pressure fell immediately.
CPR began at
16
11:12 that evening.
17
past midnight and that was Thursday, January 22nd, with the
18
forum scheduled to start on Saturday.
19
cancelled.
She was pronounced dead at twelve minutes
The forum was
20
Again, there was no independent review of this --
21
THE COURT:
So the reaction start at the -- the
22
physiological reaction started two minutes after the
23
injection, is that right?
24
MS. CRAWLEY:
25
THE COURT:
That is correct, Your Honor.

All right.
Go ahead.

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MS. CRAWLEY:
Again, there was no review by an
independent medical expert.
This time, however, an autopsy
was performed and the pathologist report noted that there was
foreign material present in the L2 vertebral body and also in
microscopic blood vessels in the lung.
something that could not necessarily be -- interpretation of
the finding is obscured because Mrs. Marcelino was subject to
CPR for some time.
travelled into the microscopic vessels of her lungs through it
And this finding was
So it's not clear whether the device had
10
leaking or through the CPR.
But the fact remains that she had
11
had the hypotensive event almost immediately upon being
12
injected.
So Your Honor, because what happened here -- well, it
13
14
is difficult to find words to say how egregious the behavior
15
is.
16
this country we don't say -- we don't say that you cannot do
17
clinical testing with a significant risk device.
18
must obtain the FDA's permission.
19
patient's informed consent.
20
the Court has found that Mr. Huggins and the remainder of the
21
defendants didn't, then he has undermined, they all have
22
undermined the fundamental procedural protections that
23
separate a civilized society from an uncivilized society when
24
it comes to human experimentation.
25
And I will -- at this point I will stop trying.
But in
We say you
We say you must get the
And when you don't do this, as
So we would ask the Court, because of these reasons,

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1
to give a sentence of a year in prison, the maximum that the
law allows.
Thank you.
THE COURT:
Before you sit down, though, would you
check and see if your witness -- if -- if he happened to
arrive?
7
8
9
MS. CRAWLEY:
Yes, Your Honor.
(Pause)
THE COURT:
10
MS. CRAWLEY:
11
THE COURT:
The gentleman's going to look outside?
12
13
Yes, Your Honor.

Fine.
We'll wait for him.
(Pause)
THE COURT:
I was wondering if Captain Despins would
14
be willing to be a court witness?
15
but you actually have no choice.
16
please, sir.
17
18
19
20
21
22
23
24
25
It's posed as a question

Just take the stand for me,
Please.
THE REPORTER:
Raise your right hand, please.
State
your name and spell your first and last name.

CAPTAIN DESPINS:
Joseph, J-O-S-E-P-H, Despins, D-E-
S-P-I-N-S.
COURT'S WITNESS, CAPTAIN DESPINS, SWORN
THE COURT:
And pull the microphone in front of you
for me, please.

So where we are is, Ms. Croce, the young lady you
were just talking to, she's making an electronic sound

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recording of everything that we say and because of the
peculiarities of the acoustics in this room, I need you to
speak directly into the microphone.
hear you she's not necessarily able to record you unless you
speak into the microphone.
THE WITNESS:
THE COURT:
Because even though I can
Understood?
Yes, Your Honor.

All right. So have you ever testified in
court before?
THE WITNESS:
THE COURT:
No sir, this is my first experience.
10
Well, it's a good thing I didn't give you
11
any notice, isn't it, because you might have gotten nervous if
12
I gave you notice, right?

All right.
13
So let me just tell you the -- sort of,
14
the way it is.
This is a conversation.
15
questions and you'll give me your answers.
16
know something, just tell me you don't know because what I
17
like to deal with are the truths, things people certainly
18
know.
THE WITNESS:
20
THE COURT:
Yes, Your Honor.

And if you need to explain something just
let me know and you can explain it.
22
So you work for whom, exactly?
23
THE WITNESS:
24
25
And if you don't
Understood?
19
21
I will ask you
I work for Food and Drug
Administration.
THE COURT:
And how long have you worked for the Food

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1
and Drug Administration?
THE WITNESS:
THE COURT:
THE WITNESS:
I work as a consumer safety officer,
otherwise known as an investigator.

THE COURT:
7
8
And in what capacity do you work for the
FDA?
5
6
Since October 14th, 1996.
All right.
And what are your duties as
an investigator or consumer safety officer?

THE WITNESS:
My duties are to conduct inspections of
10
regulated industry.
11
time of -- in 2004 was I conduct -- I conducted biologic --
12
bio mo inspections, they're called.
13
various clinical investigators, sponsors of clinical research,
14
independent institutional review boards, IRBs as was referred
15
to by Ms. Crawley, clinical investigators and non-clinical
16
laboratories where they do evaluations of safety of
17
particular -- either drug compounds or medical devices in
18
animals.
19
THE COURT:
20
THE WITNESS:
21
THE COURT:
I have conducted -- my focus, back at the
22
23
They're inspections of
Very wide ranging, right?

Yes, sir.
And how did the FDA train -- what did you
do before you began to work for the FDA?

THE WITNESS:
24
medical department.
25
O-M-O-L-O-G-I-S-T.
I was in the U.S. Army, U.S. Army

I was trained as an entomologist, E-N-T-

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THE COURT:
THE WITNESS:
THE COURT:
THE WITNESS:
I forget what that is.

That's the study of insects.
Okay.
My degree is in entomology and our
mission is in preventive medicine.
was to keep the troops healthy and so the control of insects,
vectors of disease.
THE COURT:
Sure, depending upon what part of the
world you're in that might be a very significant concern.
10
THE WITNESS:
11
THE COURT:
12
13
14
15
We -- we -- our mission
Yes, that's correct.

And your educational background is what,
sir?
THE WITNESS:
I have a master's degree and a PhD in
the field of entomology from Virginia Tech.

THE COURT:
All right.
So in terms of your
16
familiarity with what other investigators for the FDA were
17
doing, all right, is there some sort of training or exposure
18
that they -- that the agency provides to you all to let you
19
know what's developing in the field, what companies are doing?
20
Or do you just work on your individual cases?
21
information; I guess is what my question is.
22
23
THE WITNESS:
Do you share
When we're assigned an inspection we
get background information that comes in with the assignment.
24
THE COURT:
25
THE WITNESS:
Right.
And I can't speak for other

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1
investigators but what I do is I look at what is in the FDA
databases regarding a particular drug or device.
Google is a wonderful thing.
that may be out in the public domain.

THE COURT:
Right.
I look at --
I search for any information
So you're familiar with the
information in the public domain and you're also familiar with
the information in the FDA's database.
THE WITNESS:
THE COURT:
Yes.
I understand that's what you just said.
10
Because as part of your duties, and we understand every case
11
is different, but as part of your duties you want to
12
familiarize yourself with the knowledge base that exists,
13
right?
14
THE WITNESS:
15
THE COURT:
That's correct.
Okay.
So then, as far as test markets
16
are concerned, and this is really what I'm interested in, how
17
does the FDA define an illegal or inappropriate test market?

Well, let me just back up.
18
Start by telling me what
19
an appropriate test market is, based upon your experience and
20
expertise and knowledge.
21
market?
22
THE WITNESS:
What are you allowed to do in a test
You are allowed to -- you can gather
23
information about usability of, in this case, medical devices,
24
how easy it is to handle by the surgeon.
25
THE COURT:
Usability, that's what it means is ease

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of use?
THE WITNESS:
THE COURT:
THE WITNESS:
Yeah.
All right.
For labeled indications, indications
that have been cleared by the Food and Drug Administration.

THE COURT:
6
7
That's right.
So there's two components to that, ease
of use for FDA approved indications, right?
THE WITNESS:
THE COURT:
That's correct, sir.
THE WITNESS:
So keep going.
10
I first became aware of test markets
11
when I received the assignment to conduct this inspection in
12
2004.
13
marketing study, that an actual clinical trial had been
14
initiated and so I was approaching it -- I got the assignment
15
because my background is conducting the final inspections.
At that time FDA thought it was -- it wasn't really a
16
THE COURT:
17
THE WITNESS:
18
THE COURT:
19
THE WITNESS:
You're a scientist, right?

Yes.
Go ahead.
And so if you look at it from the
20
standpoint of a regulatory body, why would -- why would a
21
company ease a product out into the marketplace as what I saw
22
with the phase two test market.
23
regular processes you have -- you have design and design
24
validation where they test, you know, the manufacturer is
25
supposed to test the product to see if it meets the needs of
The -- according to the

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the end users.
And by doing a test market like this it almost
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:
So what you're saying to me is that each
manufacturer, a substantial amount of work should occur before
a test market is initiated.
right, narrow subject and also narrow, sort of, group of
subjects, if you will, narrow target population.
It should be well designed,
But of
10
course there's also the FDA approval, which is involved,
11
right?
12
THE WITNESS:
13
THE COURT:
14
15
16
Yes, Your Honor.

It's a carefully designed instrument, is
what you're saying to me, in normal test market.

THE WITNESS:
The test market for Norian XR should
have followed the FDA requirements.
17
THE COURT:
18
THE WITNESS:
Which are?
Which are to obtain an investigational
19
device exemptions, present protocol to FDA and a research
20
plan, proposed informed consent document.
21
once an IDE is obtained --
22
THE COURT:
23
THE WITNESS:
24
THE COURT:
25
THE WITNESS:
And then you --
What's that, IEE?

IDE.
IDE?
Yes.

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THE COURT:
Okay.
THE WITNESS:
The sponsor is given clearance to ship
medical devices in interstate commerce, you know, for the
indication that it is going to be tested.
investigators can be engaged and established in clinical sites
before -- before an investigator, a clinical investigator, can
conduct -- begin the investigational research.

The protocol has to be submitted to an institutional
8
9
review board.
THE COURT:
10
11
The clinical investigator in this case
would have been a doctor or a surgeon?
12
THE WITNESS:
13
THE COURT:
It would have been a spine surgeon.

A spine surgeon.
14
ahead.
15
hospital agency, right?
16
Clinical
All right.
So go
And the institutional review board would have been a
THE WITNESS:
It can be in a hospital, oftentimes
17
that happens.
18
centralized IRB where if you have a lot of -- I mean, it's all
19
dependent on how the sponsor sets up the clinical study group.
20
In some larger clinical studies you can have a
THE COURT:
Right.
But they're independent and
21
they'll give you their multi-disciplinary professional
22
judgments, right?
It's a form of protection.
23
THE WITNESS:
24
THE COURT:
25
THE WITNESS:
Yes, Your Honor.

Sure.
Understood.
Go ahead.
The IRB evaluates the protocol for risk

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to patient, what's known about previous research and either a
clinical study that had been done before or an animal study
where you have non-clinical safety data.
informed consent and look to see if all the known risks are
presented in a manner to the potential subject of -- in a
language that the patient can understand.
They look at the
The IRB, if they -- oftentimes it's a back and forth
kind of review between the IRB with changes that are
recommended to the consent form.
It goes back to the clinical
10
investigator and those changes are made.
11
the -- it's resubmitted to the institutional review board and
12
approval is granted by the IRB for typically twelve months,
13
twelve months.
14
It comes back to
If there's considerable risk to the patient, you
15
could have a six month duration before what's called
16
continuing review by the IRB where the investigator presents a
17
status report, summary of data and any adverse events that may
18
have occurred.
19
THE COURT:
20
THE WITNESS:
21
THE COURT:
So it's an ongoing dialogue?

Yes.
Both in the design phase and in the
22
implementation phase where information is shared between the
23
various entities that have an interest.
24
critically and you hopefully reach a balance that adequately
25
advances everyone's interest but also protects all who are
And so it's looked at

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potentially impacted.
THE WITNESS:
THE COURT:
Yes, Your Honor.

Right.
Okay.
So go ahead.
Go ahead.
So you were telling me about the components of a test market,
the things that need to be done normally.
THE WITNESS:
Yes.
Well, when I looked at documents
for this particular activity conducted by Synthes, there were
various elements that were missing.
to FDA, application for an IDE, which was my first observation
10
in the 483 that I issued to Mr. Huggins and -- at the close of
11
the inspection.
12
THE COURT:
Sure.
There was no submission
And you say various elements are
13
missing, that's a bit of an understatement because I read your
14
report five or six times, right, and all of your exhibits.
15
But let me just back up for a second, before you --
16
before I lose the point.
17
just tell me the importance of animal studies, if you will
18
please, for the record.
19
THE WITNESS:
You had mentioned animal studies;
Well Your Honor, with animal studies
20
you can -- you can evaluate the safety of an investigational
21
product in an appropriate animal model in a controlled way,
22
replicated so that you can run statistical analyses on data
23
all involving animals that are, you know, at the end of the
24
inspection -- at the end of the study they're typically
25
sacrificed and various parts of their organs are evaluated by

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pathologists to see what deleterious affects occurred.

THE COURT:
2
3
What we can learn about the device or the
process before it's used on humans, right?
THE WITNESS:
THE COURT:

So when you say animal study, that
implies that there is more than one animal subject in normal
circumstances?
THE WITNESS:
8
9
groups.
Yes.
You have various treatment
You can have -- for a drug study you can have a range
10
of dosages.
Typically you would have anywhere from five to
11
ten animals and observations are performed on a daily basis,
12
depending on the type of research.
13
some sort of time point observation that you made on all the
14
animals across the different treatment groups, and you compare
15
it against the control.
16
treatment that you control -- you're comparing the
17
experimental, the investigational product with.

THE COURT:
18
But typically you have
Perhaps it's the standard of
What about a lethal dose study in a pig,
19
for example, how many pig subjects should normally be
20
involved?
21
22
THE WITNESS:
It would -- it would be the same type
of setup, you know, with LD50 studies you have --
23
THE COURT:
24
THE WITNESS:
25
What's the fifty stand for?

The dosage at which fifty percent of
your test population suffers mortality.

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2
THE COURT:
All right.
So lethal dose at a fifty
percent dosage.
THE WITNESS:
THE COURT:
THE WITNESS:
That's correct.
Go ahead, sir.
So in an LD-50 study you would
replicate the experiment, as I described just now, and you
would run various dosage --
8
9
THE COURT:
You can't do a valid lethal dosage study
with one pig, can you?
10
THE WITNESS:
11
THE COURT:
No, it's not very scientific.
No, sir.
Because either the pig lives or the pig
12
dies but it doesn't allow you to generalize as the biological
13
effects, right?
14
15
16
17
THE WITNESS:
It's not a very good scientific design,
Your Honor.
THE COURT:
It's a bad scientific design.
You're the
scientist; it's a bad design isn't it?
18
THE WITNESS:
19
THE COURT:
Yes, sir.
Okay.
All right.
So -- all right.
20
You've answered my questions about animal studies.
21
were telling me about your arrival at the Synthes facility and
22
examining the records.
23
THE WITNESS:
So you
What did you want to say about that?

Well, the records show that they spoke
24
that -- that there was clinical activity being organized for
25
an indication that was not cleared by FDA, you know, the

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2
3
treatment of vertebral compression fractures.

THE COURT:
Which was a particular area of concern
for the FDA at that timeframe, wasn't it?
THE WITNESS:
THE COURT:
Yes, Your Honor.

And the FDA had, in fact, sent out
bulletins saying that this off-label use is not sanctioned and
this is a very -- an area of high importance to the FDA, is
that a fair statement to summarize what the bulletin said?
9
10
11
THE WITNESS:
THE COURT:
Yes, Your Honor.

All right.
So go ahead.
And you found
those bulletins in the Synthes files, right?
12
THE WITNESS:
13
THE COURT:
14
THE WITNESS:
Yes, Your Honor.

Continue.
I was presented with -- I'm not sure
15
what kinds of information you would like me to talk about.
16
The -- when I first arrived and asked about and confronted the
17
product manager about what had been reported in a complaint to
18
FDA, the -- I was told that there was no clinical trial and it
19
was information that was coming back to Synthes on activities
20
that the surgeons were doing on their own.
21
THE COURT:
22
THE WITNESS:
23
THE COURT:
Right.
You know, if that's -And then you interviewed a number of
24
people on multiple occasions as you, sort of, dug and tried to
25
find out what the truths were, is that a fair statement?

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THE WITNESS:
THE COURT:
Yes, sir.
Did anyone from Synthes ever -- I think
you were there twenty-one days, am I right?
THE WITNESS:
THE COURT:
It was a good bit of time.
Did anyone from Synthes ever tell you
that they were doing clinical trial?
THE WITNESS:
THE COURT:
Yes, sir.
No.
All right.
But you certainly -- you
obtained records each day and in the evening you processed
10
them and you wrote up your notes and that's how you, sort of,
11
structured your activities for the next day.
12
ask you this, did you speak to this defendant, Mr. Huggins?
13
THE WITNESS:
14
THE COURT:
15
But let me just
Yes I did, Your Honor.

And what did he say to you?
Well, he was
the highest ranking official at the facility, right?
16
THE WITNESS:
17
THE COURT:
18
THE WITNESS:
Yes, Your Honor.

And what did he say to you?
I had discussions with Mr. Huggins
19
regarding several documents that I had obtained earlier in the
20
inspection.
21
22
23
THE COURT:
These are the management meetings and the
safety meetings and other things as well, right?

THE WITNESS:
They were documents that both were
24
handed to me after a request and through my discovery of their
25
existence on the computer network.
I had asked -- I was

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asking Mr. Huggins about -- about a particular safety meeting
that occurred in July.
THE COURT:
July 18th, '03, right.
THE WITNESS:
THE COURT:
THE WITNESS:
held in -- I'm not quite sure.
2003.
That's the Tucson meeting, right?
THE COURT:
THE WITNESS:
That particular meeting, I think, was
Okay.
10
THE COURT:
11
THE WITNESS:
I think in Westchester.
All right.
Go ahead.
And I wanted to get information about
12
there was identification of a test market, a phase one test
13
market involving thirty-four patients and one complication.

THE COURT:
14
Did you know anything about a
15
complication at that point?
16
did you know anything about a complication?

THE WITNESS:
17
18
All I knew was that there were, in
general terms, two or three individuals had died.

THE COURT:
19
20
Or before you arrived at Synthes
Okay.
Continue with Mr. Huggins.
Go
ahead.
THE WITNESS:
21
And so I was asking about that
22
particular test market as well as the outcome for the safety
23
meeting.
24
particular outcomes where it was decided to go forward with
25
the phase two test market for Norian XR, a test market.
I looked at the minutes and there were two
And

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an investigation of an IDE study, one that I had described to
you earlier, you know, following the process for a significant
risk device.
I asked why -- why did you go forward with a test
market for Norian XR if it was being advised by the, I thought
it was surgeon consultant, where in the document to me it
looked like that individual was recommending a clinical trial,
an organized clinical trial.
9
10
11
The test market -THE COURT:
That's Synthes' own surgeon consultant
recommending an organized clinical trial to Synthes?
12
THE WITNESS:
13
THE COURT:
14
THE WITNESS:
Yes.
Yes, Your Honor.
So go ahead.
I posed those questions to Mr. Huggins
15
and he stated to me that there were -- the test market was --
16
and the IDE study were for two different things.
17
different.
18
that the IDE was to expand -- IDE study was to expand the
19
indication base that could be used for treating patients with
20
Norian XR.
21
22
23
They were
The test market was for cleared indications and
THE COURT:
Well, did your subsequent investigation
prove or disprove that statement?

THE WITNESS:
Well, I thought it was a curious thing
24
because it's explicitly the indications -- the documents that
25
I saw that were given to the people at this -- it was a safety

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meeting -- were that -- and for handouts at the surgeon
training forums, were to -- the purpose of the test market was
to evaluate the efficacy of Norian XR for treatment --
4
5
THE COURT:
I think the exact quote was safety and
efficacy, right?
THE WITNESS:
THE COURT:
8
9
Safety and efficacy.

Go ahead.
Go ahead.
A test market can
never be used to evaluate safety, can it?

THE WITNESS:
10
THE COURT:
11
THE WITNESS:
12
THE COURT:
13
THE WITNESS:
No, sir.
No, that involves --
That's a fundamental violation, right?

Go ahead.
I involves what, sir?
And so I was aware of what happened to
14
the -- you know, on the limited animal studies, that where a
15
particular -- I think I reviewed a document that came from the
16
University of Washington, which was a -- their efforts to warn
17
Synthes of the potential hazard if Norian XR were to enter the
18
blood stream of a patient, to cause blood clots and with
19
serious consequences involved.
20
THE COURT:
Well, they said, didn't they, that it had
21
the -- because of the chemical composition it appeared -- they
22
could not rule out the possibility that it could cause large
23
clots quickly.
Is that a fair summary?
24
THE WITNESS:
25
THE COURT:
Yes, Your Honor.

And this is the LD50 study of the pig.

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think, in part, right?

THE WITNESS:
It was in that document with -- I think
they were proposing to do an LD50 study.
animal -- preliminary work was to support the need to have
that kind of study.
happen -- they wanted to evaluate what would happen if Norian
XR were to -- or SRS, a radiopaque, is the same kind of
compound -- were to get into the blood stream of the pig.
I reviewed this document.
10
And this particular
Where they simulated the -- what would
And
And the animal -- they said the
animal became immediately hypotensive and died --
11
THE COURT:
12
THE WITNESS:
13
THE COURT:
14
THE WITNESS:
15
THE COURT:
16
THE WITNESS:
17
THE COURT:
What's hypotensive mean?

It's a dramatic drop in blood pressure.
Right.
And -Immediate dramatic drop and died?
And died within thirty seconds.
And the amount of dosage of their product
18
that they had injected into the pig, was it the full amount
19
that they expected or was it a smaller amount?
20
THE WITNESS:
21
THE COURT:
22
THE WITNESS:
23
It was one -It was to mimic how, if the device were
to leak out into the blood stream over a period, so.

THE COURT:
24
25
It was a small amount, I believe.
All right.
So continue with what you
saw.

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THE WITNESS:
I was kind of shocked that such an
activity would be considered in humans in light of the fact
that they knew that it could cause problems in the subject --
in an animal.
THE COURT:
5
6
Immediate, serious, catastrophic
consequences in an animal, right?
THE WITNESS:
THE COURT:
expected, right?

Greater than what the doctors had
Because there's a --
10
THE WITNESS:
11
THE COURT:
I would --- a tone of surprise in those
12
communications, right?
13
expect it to be this quick or this extreme.
14
THE WITNESS:
15
THE COURT:
Surprise by the doctors.
They didn't
Yes, Your Honor.

So continue.
So you saw this animal
16
study, the limited study on one animal and the proposal.
17
go ahead.
18
THE WITNESS:
And
I was -- I was having a very difficult
19
time trying to deal with, you know, how you could know that
20
such a -- that the risk to patients was such as what I had
21
described to you, and the Phase II test market was authorized
22
to evaluate the complication rates.
23
THE COURT:
24
THE WITNESS:
25
THE COURT:
In your years of -In humans.
I'm sorry, Your Honor.
-- in your years of experience as an

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investigator, and in your review of the files and
communication with other investigators, have you ever seen an
analogous situation?
THE WITNESS:
4
5
No, sir.
This is unique in what I
had -- no, I had never seen this before.

THE COURT:
All right.
So continue.
You're talking
to me about your conversation with Mr. Huggins and the things
that he said to you and what you knew.
your conversation with Mr. Huggins.
10
THE WITNESS:
11
THE COURT:
12
And so continue with
Um -Did you ask him about this animal study
proposal?
13
THE WITNESS:
14
THE COURT:
15
THE WITNESS:
16
THE COURT:
17
THE WITNESS:
18
THE COURT:
19
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.
Now, I mean, it's --
I mean, I asked him many questions
20
about various items.
21
asked him about, because his name was on the document along
22
with others that will be in court today.
23
that had identified Norian SRS in test markets --
24
THE COURT:
25
THE WITNESS:
There was another document that I had
There's a timeline
That's Josi Hamilton's timeline, right?

Yes, sir.

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THE COURT:
THE WITNESS:
THE COURT:
Go ahead.
And -But there was no indication that she'd
ever shared her timeline with Mr. Huggins.
that?
THE WITNESS:
Am I fair about
I'm not quite sure of that.
It may
have been shared with him.
But he -- when I showed it to him,
he stated he was not familiar with it.
questions that I'd posed to him, there was a presidents
And through various
10
meeting, there were various things that were identified, that
11
he couldn't quite -- he stated that he didn't recall.

THE COURT:
12
So there were a series of strategic
13
meetings, safety meetings, presidents meetings, where your
14
records indicated that Mr. Huggins was present at some of
15
those meetings or most of those meetings, right?
16
THE WITNESS:
17
THE COURT:
Yes, Your Honor.

Did Mr. Huggins, in your conversations
18
with him, have any recollection as to the discussions at those
19
meetings?
20
21
THE WITNESS:
I didn't get a -- no he had no
recollection.
22
THE COURT:
23
five or six meetings, right?
24
there, correct?
25
THE WITNESS:
And who was there?
We're talking about
He couldn't remember who was
Correct.

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THE COURT:
1
2
He couldn't remember what was discussed,
correct?
THE WITNESS:
THE COURT:
Yes, sir.
discussions, correct?
THE WITNESS:
THE COURT:
He couldn't remember who led the
Yes, sir.
He couldn't remember if there were
minutes taken, correct?

THE WITNESS:
THE COURT:
10
11
minutes in his files.
12
THE WITNESS:
13
THE COURT:
He certainly didn't have any notes or

Is that correct?
Yes, sir.
And he never gave you any documents that
14
he got out of his files that would have assisted your
15
investigation, sir, correct?
16
THE WITNESS:
17
THE COURT:
18
there.
19
correct?

So he is the highest-ranking official
Everyone at the facility works for him and under him,
20
THE WITNESS:
21
THE COURT:
Yes, sir.
And he has no recollection, no knowledge,
22
no records of anything that had transpired over a two-year
23
period.
Is that a fair statement?

THE WITNESS:
24
25
That's what I was being told.
Yes --
yes, sir.

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THE COURT:
THE WITNESS:
So continue.
I think I had -- if someone denies the
existence of particular activities or doesn't know, states
that they don't know anything about an activity, I'd pretty
much come to the end of my interview and moved on with the
inspection.
THE COURT:
THE WITNESS:
interaction with --
10
THE COURT:
All right.
Okay.
And that was my one and only
Was there anything else in your
11
discussion with Mr. Huggins that we neglected to cover that
12
you can recall right now?

THE WITNESS:
13
14
Nothing that comes to mind.
But I
would have to look at my IER to refresh my memory.

THE COURT:
15
Okay.
That's the lengthy single-spaced
16
document.
So to be clear, you've never seen an
17
analogous situation with the test markets and the clinical
18
studies that occurred without the knowledge or consent of the
19
FDA?
20
THE WITNESS:
21
kind of concept and activity.
22
23
THE COURT:
It was my first engagement with this
Okay.
All right.
I thank you for your
information.
24
THE WITNESS:
25
THE COURT:
You're welcome, Your Honor.

So now you testified in court.
Was it

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painful?
THE WITNESS:
THE COURT:
Okay.
I don't know if these lawyers --
well, if it were, would you tell me?

THE WITNESS:
5
6
No, sir.
I have a fourth wall here, so it's like
we're in a room together.

THE COURT:
Okay.
I don't know if there's anything
either of the lawyers wanted to ask you briefly, but I just --
I needed to have a broader context to understand what we're
10
talking about today.
And I appreciate that from you.
11
Anything from the government?
12
MS. CRAWLEY:
13
THE COURT:
14
MR. POE:
15
THE COURT:
16
No, Your Honor.

Sir?
No, Your Honor.

Okay.
You can step down.
Thank you very
much.
17
THE WITNESS:
18
THE COURT:
19
Let's take a five-minute break before we proceed.
20
THE CLERK:
21
22
23

You bet.
All rise.
(Recess from 9:48 a.m. until 10:01 a.m.)

THE COURT:
All right.
Does your client have
anything he wishes to say, sir?
24
MR. POE:
25
THE COURT:
No, Your Honor.

Okay.
Thank you.
All right.
And is there anything

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else either one of the lawyers needs to say?

MS. CRAWLEY:
2
3
Nothing further from the government,
Your Honor.
MR. POE:
THE COURT:
Not on behalf of Mr. Huggins, Your Honor.

All right.
It's sort of hard to know
where to start, because there's so many issues and concerns
and considerations that have surfaced themselves in this
sentencing hearing.
imposed has to be the fair balancing of considerations.
But I think that any sentence that is

It
10
needs to be understood as to why it's imposed.
Because you've
11
been very well-represented by a lawyer who strenuously argues
12
for a particular disposition.

The government has been very well-represented by
13
14
their representatives who argue for a different kind of
15
resolution.
16
been well litigated.
17
good documents, a lot of skillful interpretations of the
18
evidence.
19
gets down to sort of understanding why you are here;
20
understanding what the objectives of sentencing might be.
21
Because if you walk out on probation, there needs to be a
22
legitimately accepted and understood reason.
23
out as a sentenced prisoner, sentenced to incarceration, the
24
thoughts behind it have to be rational and understood.
25
And on both sides of the aisle, this case has

There's been a lot of skill, a lot of
But in the final analysis, it gets down to you.
It
And if you walk
Now, what I'm saying to you is this is about process

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in part.
there's a foundation to those judgments.
process.
Because if we accept the judgments of our courts,

There has to be fair
So that's what we do at sentencing.

The second thing that happens at sentencing, and I've
alluded to this with Ms. Crawley, is that there are a wide
range of sentencing considerations under the statute, 3553.
And if you look at the considerations, they are protection of
the community, rehabilitation of the offender, the nature and
the character of the offense, the nature and the character of
10
the offender, general and specific deterrence, other societal
11
interests.
12
and should be considered as ingredients of a fair sentence.
13
It's a very wide range of things that have to be
And the particular sentence that gets imposed in the
14
specific case is really a question of balance.
15
the appropriate balance amongst all of these factors as to
16
what's a fair and a just sentence?
17
I listen to things, I hear information, I assess the
18
information I hear in the context of the individual defendant,
19
in the context of the larger societal interest, and I try to
20
do what is right.
21
How do we find
And so that's what I do.
That's my process.
I have read, at least once, every single paper that
22
has been submitted in this case.
And sort of yesterday
23
afternoon, I read the incredible testimony that was submitted
24
in your sentencing document from people who knew you.
25
say I read it -- I mean I read it again.
And I
I read it when I

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received it, but I read it so that I could have a fresh
recollection and understanding of it.

Now, what it says to me is that you have lived your
3
4
life, as your friends and your family and your colleagues saw
it, in a good way.
personal and professional respect from -- for your entire
professional career, as it's been presented to me.
you're a pillar to your friends and your family.
you.
You have earned a tremendous amount of
They rely upon you.
You do good things.
Certainly,
They respect
You're
10
everything that a friend and a relative and a neighbor should
11
be.
12
You're viewed very well in your professional
13
community.
And there are some letters in there that say that
14
you're one of the most ethical persons in this whole field.
15
And it's very difficult to understand how you find yourself in
16
this situation.
17
really sure -- since we didn't have the opportunity to
18
converse -- I mean we have the opportunity for you to share
19
your written thoughts and for me to share my oral feelings and
20
observations -- but the question of why, which is the most
21
fundamental question, why did this occur -- why did someone
22
who to this point has lived a very good, solid life, how did
23
he find himself in this situation; the question of why isn't
24
going to be answered to my intellectual satisfaction.
25
that's just the way that it goes.
And really, that's the question that I'm not
But

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But the question of what occurred and the
consequences of what occurred will be answered.
interesting; the why factors into sentencing on some level,
but the criminal law, it punishes acts, it punishes behaviors.
It doesn't -- we've had a lot of discussion in this case about
motivation, mens rea, relevant conduct.
been, probably in the ten years since I've been a federal
judge, the greatest discussion that I've ever participated in
on the whole mental element.
10
And it's
And it's actually
But Im not going to know from your mouth and your
11
mind your motivations, so I'll have to look at the behaviors.
12
I'm not going to know, gain special insight, into what caused a
13
good man to find himself in this position.
14
So what do I see?
The first thing that I see is that
15
there was a corporate commitment to gain this market, because
16
it was a large market, because the potential revenues were
17
very high profit ratio.
18
more about the regulation of medical devices in the year since
19
I've had this case than I ever knew before.
20
the regulatory framework where basically, the FDA works with
21
the manufacturers, and there's a level of trust, and there's a
22
duty of communication.
23
responsibility that the FDA has for oversight.
24
25
And I understand that.
I've learned
And I understand
But at the same time, there is a
So the FDA requires and indeed has the right to rely

upon the people and institutions in this very special field,

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to be honest.
They have a right to rely upon your
representations.
boxes of documents, I see very early on, there was a desire to
capture this market.
And as I read through the three banker's
Initially, the then head of regulation that you had
5
6
said that this -- and communicated directly to you, sir, that
this is -- the only way that this can occur is through an IDE.
And so as -- you wrote a memo, and as a result of that, the
efforts that Synthes made didn't launch immediately.
And the
10
language in the e-mails was clear and unambiguous.
We both
11
know it.
But there
12
was no mistaking how to go about this, because this is not a
13
prior approved use.
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
prior approved use, because you're very skillful at what you
17
do.
18
well in the environment.
19
I could read it out loud if I wanted to.
We understand that.
You understand the regulations.
And there never
And you functioned very
And so for reasons that -- for whatever reason, that
20
particular regulatory authority is no longer a person who's no
21
longer at Synthes, and so you proceeded.
22
various points, communications with the FDA about their
23
concern over whether your medical device could be used with
24
VCF surgeries, whether, if it was augmenting a rigid device it
25
was appropriate; and the FDA was clear and consistent at every
And there were, at

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step along the way.
And the communications made their way to
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.
And if you wanted, I could analyze it all for you
So then a test market is constructed.
So
And given the
number of years that you had as a president of one division or
as the chief officer at the facility, there's no confusion
about whether the test market was appropriate or not
10
appropriate.
Because at various points along the way, you and
11
the other leaders, including the CEO who sat down and talked
12
about -- there are written documents indicating that, as the
13
inspector said, here are our options; pursue and IDE; do a
14
limited test market.
15
as you chose.
And you collectively decided to proceed
And you made that decision, I think, with the
16
17
knowledge of what your professional and legal obligations
18
were.
19
are only known to you at this point -- right, because Ms.
20
Crawley can speculate and I can speculate, but because I
21
didn't have the opportunity to talk to you I don't know why
22
you did it; I don't know why you diverged from your lifelong
23
past of acting in a responsible manner.
24
All I know is that you did it.
25
And you made the decisions that will, for reasons that
So then we proceed.
I just don't know.
And there are adverse events

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which are discussed in the meetings, these meetings, by the
way, for which no one has any minutes for.
along the way -- and there are six or seven critical steps
where you sat down and spoke about it, and you were there for
most of them -- at each step -- I'm talking about presidents
and safety meetings -- at each step along the way you assess
the risk, you evaluated the information that you'd received,
and you continued to proceed, for reasons best understood by
you, in the way that you had chosen to proceed from the
10
11
And at each step
beginning.
So we had the adverse events that to one -- to a
12
rational, and a clear and a responsible mind, if you had an
13
adverse event in one of the first surgeries, you should have
14
wondered whether there was a relationship between your product
15
and the surgery; particularly in light of the fact that the
16
year or two earlier, there had been two nonfatal adverse
17
events, which you did report -- you did file MDRs.
18
adverse event should have been enough to let you know that
19
this course was not right.
20
So one
Then there was a second adverse event which was
21
discussed.
And the decision was made to continue to proceed.
22
And then the third adverse event.
23
understand, I can't fathom how it wasn't a stop sign, it
24
wasn't a red flag, it wasn't absolute notice that we're
25
proceeding along the wrong path.
And I just don't

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But then you later on than that -- the animal studies
1
2
and then the inspector is incredibly understated in what he
says.
what it said.
percent of what they intended to inject the pig with, and it
died almost instantly.
from the University of Washington researchers were -- they
were enough to stop a freight train.
The animal studies, the LD50 study, was alarming in

I believe they injected the pig with twenty
And the communications that came back
And all they did was make you pause, make you
10
hesitate, because you wrote your famous "I have second
11
thoughts" memo.
12
dissipated, and we proceeded.
13
But nevertheless, the second thoughts
Then you had the conversation with the medical
14
consultant which, I believe has been reported in the paper, in
15
the summertime, where the medical consultant says that
16
basically what you're doing is only human experimentation.
17
And if it ever comes to light, the only defense that you will
18
have was that it was limited in scope.
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
to your desk, but you need to know about this.
22
is on the successive day.
23
And I believe you
I think this
And in the e-mail to you, he says that -- he tells
24
you very clearly that this conduct will have consequences far
25
greater than the loss of the FDA approval.
And then so that

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consultant, after a short period of time, is no longer
associated with Synthes, and still, you proceed.

Then you have the Washington proposal, which the
3
4
inspector spoke about, which clearly says this is not ready
for use on humans.
conversations, communications from doctors who have been
involved in these adverse events, and still, collectively, you
proceed.
But still, you proceed.
You have other
You have one doctor who writes an article for
9
10
publication about one of his adverse events, and you discuss
11
it with other high-ranking officials and high-ranking
12
executives at one of your meetings, and it doesn't cause you
13
to pause, cause you to hesitate, or cause you to alter your
14
course.
15
I asked the inspector to testify this morning,
16
because I really only had one question for him.
17
know how unusual this behavior was in the context of what
18
exists in the industry.
19
and they include experience, and knowledge, and examination of
20
the records and communication with other inspectors, he'd
21
never seen anything like this.
22
seemed to me, that it was over the top.
23
I wanted to
And he told me, based upon his years,
Because when I read it, it
It seemed to me that there were so many warning
24
signs, reasons to alter behavior, that were directly
25
communicated to each of the four people that I'm going to see

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today.
why you didn't heed them.
concept of malice in criminal law, which is a knowing
disregard or the consciousness -- for the consequences of your
acts.
the value, sanctity of human life.
parallel.
8
9
And I can't understand why you didn't hear them and

And it's almost analogous to the
It's almost a disregard for the safety of others, for

And I say that by way of
And your lawyer and all the other lawyers have argued
that this is a strict liability misdemeanor.
And I read
10
certainly in many of the documents that were submitted to the
11
pre-sentence investigator, that in the history of the statute,
12
no one had ever gone to jail.
13
our hearing on sentencing guidelines in the early summer,
14
someone in Missouri went to jail for seventeen days.
15
had a great discussion in the documents about how this case is
16
different. It's either greater and it's worse than the
17
Hermelin case.
18
And then I guess after we had
And we
But the particularly statutory vehicle under which
19
we're proceeding, certainly is the strict liability
20
responsible corporate official doctrine.
21
understand that the reason why I do what I'm about to do is
22
not because you're the responsible corporate official who is
23
standing up and taking the burden for things that happened on
24
his watch, that he could have had the power to stop, that he
25
didn't stop.
That's the typical case.
But you need to
That's the instance --

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those are the events for which most people previously have
been sentenced.
This is more.
This is -- you're being punished because of decisions
3
4
that you personally made and participated in.
whole course of events went, from the day that it was
conceived, from the top down.
it's your choices that bring you here.
And so it's your decisions and
And that's why your case is not a parallel to any of
8
9
Because this
the other cases.
That's why we had that great discussion over
10
mens rea, relevant conduct, because we all understood as
11
lawyers, that certainly on the surface of it, this case seemed
12
to be in a category of its own.

So I don't know what it is exactly that causes well-
13
14
educated and successful professionals in the health field to
15
create and implement a strategy of putting the United States'
16
regulatory authority out of the loop.
17
caused you to think that you could lie to them -- because
18
there's a history of lies to them.
19
responsibility.
20
lot of medical devices, probably ninety-five percent of the
21
medical devices are approved by the 510 route.
22
that.
23
a good need for that.
24
25
I don't know what
And that's their
Because I mean, I understand that an awful
Or the medical usage is.
I understand
And there's a legitimate and
But that's what doctors do.
What's improper, is when you promote it.
And this
entire Synthes course from day one was a promotion, and a

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promotion that was conceived and implemented with the
objective of keeping the FDA out of the loop.
And I understand that some good medical innovations
have come about as a result of off-label use by doctors.
I understand that your lawyers have written that the line
isn't clear.
ambiguity about the line.
promoting.
on your part, on your co-defendants' part, and the
10
11
And
But I actually -- I don't see any great

Promoting means promoting means
And there is just too much promotion that occurred
institution's part.
So those are my very broad thoughts.
But where we
12
wind up is that the sentence -- I agree with Mr. Poe, you
13
don't need rehabilitation; you don't need specific deterrence,
14
because this is it for you.
15
through your conduct, through your egregious conduct, you and
16
your co-defendants have put yourselves in the place where the
17
eyes of your small world, the medical professionals, the
18
manufacturers, are cast upon you.
19
But what you've done now, is that
And I certainly read in the Synthes file where one of
20
your regulatory people -- no one who's going to be in this
21
courtroom today -- said that you get a warning letter if you
22
violate the Synthes protocols.
23
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
And I also read where Synthes says that any
And I also read that the comment was, we have

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to decide -- this is not your comment -- we have to decide
whether we accept their advice.
whether the advice and the structure and the oversight of the
regulatory authority matters, then the needs, the purposes of
the sentencing in this case, become very clear.
If that's the question,
One is punishment for a deliberate course of
6
7
wrongful -- knowingly wrongful behavior, a course of behavior
that can only be viewed as fairly having been generated by a
desire to realize the immense profits that one thought were
10
available in this market, to the total disregard of what's
11
important, which is the care and the treatment and the
12
continued existence of the patients.
13
Synthes manufactures these devices, to help people who are
14
infirm.
15
choices.
16
That's a fact.
Right?
That's why
So you need to be punished for your
And it's about fifteen or twenty, it's not just one.

And then secondly, to the extent that other people
17
learn, other manufacturers learn from what we do here today,
18
then they need to hear the lesson loud and clear.
19
to be no mistake about what I say.
20
ambiguous, because the conduct, the institutional conduct,
21
needs to be changed.
There needs
It cannot be in any way
22
So, stand up for me, please.
23
You tendered a plea, and you tendered an early plea,
24
and you spared the government of a trial.
25
received consideration for that.
And you absolutely
If we had a trial, it would

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have been a lengthy trial.
You might have been convicted of
the felonies.
You might have been convicted of the
misdemeanors.
You might have been convicted of nothing.
there was uncertainty.
But
I knew that the biggest challenge in this case is how
5
6
do you master the sort of the wealth of the evidence and
information.
think that the negotiations that existed by and between the
parties on charges were fair.
10
How do you put it in a coherent fashion.
So I
Your lawyer did well by you.
You entered a plea, and for that you receive consideration.

And the government has asked for the maximum sentence
11
12
on the misdemeanor that we have in front of us, but the
13
maximum sentence at this point, wouldn't recognize the fact
14
that he has acknowledged his responsibility.
15
recognize the fact that you don't have to undergo a two- to
16
three-month trial, which is really what I would expect this to
17
be.
18
And the maximum sentence is therefore not appropriate.
19
It wouldn't
And so he receives consideration for entering a plea.
But at the same time, the conduct is egregious.
So
20
I'm going to vary upward, because -- from the recommended
21
guidelines range which is zero to six months -- because I
22
actually do not believe that the range adequately encompasses
23
the societal harm and damage that you've done.
24
25
So I will impose, pursuant to the Sentencing Reform

Act, a sentence of nine months incarceration, total

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confinement.
pay is in fact imposed.
assessment.
The 100,000 dollar fine that you have agreed to

You have to pay a 100 dollar special
I think that a lesser sentence would not speak to the
harm that has been done here.
And I will say, this is the --
certainly the first instance for me as a federal judge, where
on a plea I went above the guidelines.
judge for ten years -- state court judge for fifteen.
actually can't remember ever doing it.
I've been a federal

I
And if I did it
10
before, I would have remembered it, because it's a very
11
significant act.
12
But I do it because it is necessary; because what has
13
occurred in this case, in terms of wrongfulness, it's eleven
14
on a scale of ten.
15
So nine months incarceration.
That's pursuant to the
16
Sentencing Reform act.
17
immediately -- excuse me -- special assessment in this case is
18
25 dollars.
19
A 100,000 dollar fine, payable
That's payable immediately.
There will be, of course, no -- there's no need for
20
three months' worth of supervised release in this case.
21
Because this is a general deterrence and a punitive sentence.
22
Oh, no, actually, I take that back.
23
months of supervised release, to make sure that the financial
24
penalties are appropriately paid.
25
We should impose three
So during that three month period, you obviously

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can't commit new federal, state or local offenses.
have to cooperate with the probation department and pay any
outstanding fines and costs.

Anything else that needs to be said in terms of
4
5
sentence, government, from your perspective?

MS. CRAWLEY:
6
7
Nothing further from the government,
Your Honor.
THE COURT:
MR. POE:
From your end, sir?
THE COURT:
11
MR. POE:
12
THE COURT:
Your Honor, we just --
10
13
And you'll
Have a seat for a second.

Yes, sir.
No, no, no.
Im talking to your client.
Go ahead.
MR. POE:
14
Your Honor, just we would request that the
15
Court permit Mr. Huggins to surrender voluntarily to an
16
institution.
And we have a designation request.
THE COURT:
17
I knew that's what you were going to say.
18
Actually, I really respect your skill.
19
that.
20
MR. POE:
21
THE COURT:
I should tell you

I've enjoyed you in this case.
It's a
22
shame that you've chosen to live in Washington, because you
23
would be invited back here any day.
24
what I've been thinking about since about 4:30 this morning,
25
is whether I would allow him to surrender.
But that was actually

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And I think not, because of the magnitude of the
1
2
wrongful conduct.
See, if I allowed him to surrender, it
would be purely because of his individual circumstances and
ability to transition.
convenience, a courtesy, almost.
to you, that I allow almost everyone to self-surrender.
And it would be a matter of

And I will say that -- say
But I don't know if I'm finding the words to
adequately communicate how wrongful this conduct was.
knew it, right?
He knew it.
10
knew it.
11
good and decent life.
12
accident and without looking.
And that's the rub.
And he
Because he
Because he's a good and decent man who's lived a

And this just didn't happen sort of by
And there are really about fifteen, sixteen
13
14
decisional steps that he made over a long period of time, he
15
intentionally made, which he shouldn't have made.
16
think the point needs to be clearly made.
17
starts today.
So the sentence
That's where I am.
MR. POE:
18
And so I
May I just say, Your Honor, that the
19
government had represented to us on Friday that it had no
20
objection to self-surrender, but we respect the Court's
21
decision.
22
THE COURT:
Right.
No, I understand that.
And I
23
know you do.
And I know the government is -- despite the
24
spirit of which you guys contest these legal points -- the
25
government has proceeded in a fair and rational manner.
And

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it's not out of spite, but out of their view, as to what's
right and correct.
made that concession to you, but I just disagree.
honor it.
But I expected that the government had

And I can't
And so that's where we are.

But sir, you have a right to appeal anything that has
occurred in this case.
the plea agreement.
takes it out of much of what's contemplated in the plea
agreement.
10
It's certainly limited by what's in
But the nature of the sentence, I think,
If you wish to appeal, you have to do so in writing.
11
You have to do so within fourteen days of today's date.
12
Because if you fail to take this action in writing within
13
fourteen days of today's date, you would waive or forever give
14
up the right to take this action.
15
THE DEFENDANT:
16
THE COURT:
Do you understand that?
Yes, I do.
All right.
And you have a right to
17
assistance of counsel in doing this.
18
very competent counsel.
19
if you ask.
20
afford him, all you have to do is let me know, and I'll
21
appoint counsel for you free of charge.
22
And you certainly have
And he'll certainly file this for you
But if for whatever reason, you can't continue to
And secondly, if, in the unlikely event that Mr. Poe
23
doesn't file this, is unwilling to file this appeal for you,
24
just let me know, and I will file it on your behalf.
25
understand that?
Do you

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THE DEFENDANT:
THE COURT:
Yes.
Okay.
So all I ask of you is that you
think about the things that I've said.
it's not what you expected.
and fair.
thought processes that I went through in imposing this.
right?
But it is what I know to be just
And so I suggest that you sort of think about the

All
And all the best to you.
MR. POE:
THE COURT:
10
And I know it's a --
Your Honor, may I raise two more points?
MR. POE:
Sure.
The first is, we'd request the Court -- if
11
the Court's willing, recommend a designation to the Schuylkill
12
camp, on page 2 of the judgment and commitment order.
13
THE COURT:
I will make the recommendation that he be
14
housed as close to his residence as the Bureau of Prisons'
15
classification and capacity issues allow.
16
recommendations to specific facilities, if you will.
17
MR. POE:
18
THE COURT:
19
MR. POE:
20
THE COURT:
21
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
identified, the plea agreement does preserve an appellate
23
right for an upward variance above --
24
THE COURT:
25
MR. POE:
Right.
-- it's six months.

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THE COURT:
MR. POE:
Absolutely.
And so, Your Honor under -- I do have a
motion to make under 18 U.S. Code 3143(b)(1)(B)(iv), which
states that if a -- if there is clear and convincing evidence
that a person is not likely to flee or pose a danger, which we
submit the record shows here -- and it is our burden at this
point -- and the appeal is not for the purpose of delay, and
raises a substantial question of law or fact likely to result
in -- and then this is the provision, "a reduced sentence to a
10
term of imprisonment less than the total of the time already
11
served plus the expected duration of the appeal process," then
12
in that circumstance, "the judicial officer shall order the
13
detention terminated at the expiration of the likely reduced
14
sentence."
And so under the
15
Third Circuit's Messerlian case,
16
the issue needs to be fairly debatable.
17
the Court grant that motion, because -- for two reasons.
18
think it's fairly debatable about that a preponderance
19
standard of proof should not apply to the sentencing
20
determination.
21
convincing, if not proof beyond a reasonable doubt should
22
apply.
23
And we would ask that

We
A higher standard, at least clear and
That's the first thing.

And then the second thing is, we of course, respect
24
the Court's authority and the Court's rulings.
We believe
25
that the factual basis for those Court's rulings, under any

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standard does not support the upward variance.
therefore we would ask the Court to grant that motion and put
on page 2 of the J and C that Mr. Huggins is to be released at the
expiration of six months, if the issue is not res -- that Mr.
Huggins should be released at the expiration of six months
absent a contrary ruling by a court.
THE COURT:
Well, you said a lot.
And so
Let's start by
saying that after I inherited this case from my colleague, we
have proceeded very slowly and very cautiously because of just
10
the host of legal issues that are involved.
11
sentencing guidelines document that was issued, it was a
12
product of a lot of reflection, a lot of examination of the
13
records and the exhibits, consideration of what both sides
14
ably and competently argued in front of me.
15
factual/legal determinations which I stand by.
16
And as far as the
So those are my
I think that the process has been very fair, very
17
thorough, very complete.
18
calculations, where there would be error.
19
where we'd find error in the factual basis upon which I based
20
the sentence, because we've corrected this report in 110
21
different ways.
22
So I'm not so sure, in terms of

I'm not so sure
So we're left with what we have today, what we've
23
heard today.
And I do not have any doubt about the
24
correctness of an upward variance in this case, because I knew
25
very clearly that I could quell your right to appeal by

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imposing six months.
couldn't do it.
measure the wrongfulness of the conduct.
send the right message.
And I just -- I wouldn't do it.
Because six months does not adequately

Six months does not
When people write to my pre-sentence investigator,
for example, when a case is still in front of Stengel, that in
the history of this country, no one's ever gone to jail over
this, then that means there is a perception that needs to be
addressed.
When you read the tail end of all four sentencing
10
documents that were filed last week and the language -- I
11
think actually you said it less vigorously than anyone else --
12
that there is a perception that this is not the type of
13
conduct that results -- tends to result in a jail sentence.
14
And if that's what the industry thinks, then we lose the
15
ability to cause the industry to self-regulate.
16
Because the fear of jail for professionals is far
17
greater than the fear of jail for a young drug dealer from the
18
'hood, right?
19
quite frankly, do not see an adequate basis, where a
20
reasonable jurist would disagree with me.
21
think the basis was strong, was clear, if I hadn't made all of
22
my determinations, not by a preponderance of the evidence, not
23
by clear and convincing -- but I mean, the things I say, I
24
know, beyond a reasonable doubt.
25
So that's in part why we varied upward.
And I,
Because if I didn't
I know that's not the legal standard.
But I don't

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have any doubt whatsoever.
because I do not believe that an adjustment to my sentence
will occur.
So, it's denied.
MR. POE:
THE COURT:
MR. POE:
THE CLERK:
8
9
So I am not going to stay it,
Nothing further, Your Honor.

Okay.
Good day.
Good day.
All rise.
(Court is adjourned)
* * * * *
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25

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A
AAERT 87:11
ability 80:4 85:15
abject 26:1
able 41:4
ably 84:14
above-entitled 87:6
absent 84:6
absolute 70:24
absolutely 6:23
22:19 76:24 83:1
abstract 28:22
abundant 28:22
accept 9:1 12:14
65:1 76:2
accepted 64:22
accident 80:12
accurately 3:14
22:24
achieve 15:7,16,21
achieved 13:21
acknowledge 26:1
acknowledged
77:14
acoustics 5:15 41:2
act 6:20 13:10,13
13:15 16:17 77:25
78:11,16
acted 25:13
acting 69:23
action 81:12,14
actions 18:14,15
26:8 30:23
active 33:24 38:3
activities 52:19
53:11 62:3
activity 49:7 51:24
58:2 62:4,21
acts 17:23 67:4
73:5
actual 6:20 45:13
additional 13:23
addressed 13:15
85:9
adequate 85:19
adequately 24:6
48:24 77:22 80:8
85:2
adjourned 86:8
adjustment 86:2
Administration
1:14 41:24 42:1
45:5
admit 26:2
advances 48:25
adverse 4:2 17:18
19:25 20:12,23
22:5 24:6 32:16
36:4,11 48:17
69:25 70:11,13,16
70:18,20,22 72:7
72:10
advice 76:2,3
advised 55:5
advocate 27:9,9
affect 32:22
affirmative 9:2
afford 14:15 81:20
afternoon 65:23
after-tax 28:9
age 29:7 37:25
agency 43:18 47:15
aggressively 25:20
agree 5:8,9 6:23
9:16 10:25 75:12
agreed 4:24 10:25
13:17,19 14:21
26:19,19,21 78:1
agreement 13:18
13:19 37:11,15
81:7,9 82:22
ahead 9:15 11:16
19:7 23:16,21
27:18 30:20 38:25
45:18 47:14,24
49:3,3 51:4 52:10
54:10,20 55:13
56:7,7,12 58:17
60:1 79:13
air 32:10,12
aisle 64:15
alarming 20:18,19
71:3
alert 33:24
allegation 36:1
allow 51:12 79:25
80:6 82:15
allowed 44:20,22
80:2
allows 40:2
alluded 65:5
alter 72:13,24
alternative 16:2
alternatives 26:23
27:3
ambiguity 75:7
ambiguous 76:20
amendments 5:7
America 1:2 3:2
amount 46:6 57:17
57:18,19,20 66:5
analogous 59:3
62:17 73:2
analyses 49:22
analysis 64:18
analyze 8:24 69:2
analyzed 32:24
and/or 18:9
anesthesiologist
32:10,11
animal 48:2 49:16
49:17,19,21 50:5
50:6 51:20 56:14
57:4,9,10 58:4,6
58:15,16 59:11
71:1,3
animals 42:18
49:23 50:11,14
answered 51:20
66:24 67:2
answers 41:15
Antlers 31:22
appeal 81:5,10,23
83:7,11 84:25
appear 26:7
APPEARANCES
1:9
appeared 56:21
appears 21:16
appellate 82:22
application 49:9
apply 83:19,22
appoint 81:21
appreciate 63:10
appreciation 23:12
approach 9:5 16:10
approaches 30:13
approaching 45:14
appropriate 10:11
11:2 13:19 15:15
44:19 49:21 65:15
68:25 69:9,10
77:18
appropriately
78:24
approval 46:10
48:12 71:25
approved 45:7
68:13,16 69:4,5
74:21 87:3
approximately
38:14
area 16:21 52:2,7
argue 10:14 64:14
argued 73:8 84:14
argues 64:11
argument 5:22 8:8
9:17,19,24 10:8
11:25
arguments 10:15
Army 42:23,23
arrival 51:21
arrive 40:6
arrived 52:16
54:15
arrives 31:12
article 31:25 72:9
asked 52:16 53:25
55:4 59:19,21
72:15 77:11
asking 54:1,21
aspect 3:15 6:10
13:8
aspects 18:23 21:4
assemble 35:15
assess 65:17 70:6
assessment 78:3,17
assigned 43:22
assignment 43:23
45:11,14
assistance 81:17
assisted 37:23
61:14
ASSOCIATE 1:13
associated 13:9
72:2
assuring 15:2
attempt 26:6
attended 37:4
attention 33:17
ATTORNEY 1:11
attractive 26:5
augmentation
36:13
augmenting 68:24
August 30:2 33:9
37:4
AUSA 1:10,10
authority 10:5,7
11:2,7 12:24,25
15:12 16:19 68:20
74:16 76:4 83:24
authorized 18:8,9
58:21
autopsy 32:5 34:9
39:2
available 36:2
76:10
Avenue 1:14
aware 20:4,12,16
24:20 25:4 33:10
33:12 45:10 56:13
awful 74:19
a.m 63:21,21
B
B 1:10
back 15:3 30:14
32:4 34:7 37:2
38:1 42:10 44:18
48:7,9,10 49:15
52:19 71:6 78:22
79:23
background 43:11
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back-table 20:6
bad 51:16,17
balance 48:24
65:14,15
balancing 64:9
Ball 36:21,25 37:1
37:6,10,12 38:8
Ball's 36:20
bankers 28:1
banker's 68:2
Barbara 37:19
barium 18:5 20:6
base 44:12 55:19
based 10:13 14:13
44:19 72:18 84:19
baseline 36:7
basically 36:7
67:20 71:16
basis 8:9 11:2
33:25 50:11 83:25
84:19 85:19,21
bear 19:24
befriended 6:4
beg 29:9,11
began 22:8,9 32:3
38:8,15 42:22
beginning 5:25
70:10
behalf 7:14 8:5
64:4 81:24
behavior 28:14,16
32:22 39:14 72:17
72:24 76:7,7
behaviors 67:4,11
believe 3:9 10:8
14:14 15:19 16:9
16:12,20 17:12
29:15,17 31:4,25
57:20 71:4,14,18
77:22 83:24 86:2
believed 29:5 32:12
Berkley 33:19
best 9:5 30:9,9 33:2
70:8 82:7
bet 63:18
better 21:6 27:17
beyond 22:10 27:3
83:21 85:24
biggest 77:5
bio 42:12
biologic 42:11
biological 51:12
bit 4:6 49:13 53:4
blind 26:17
blog 12:21
blood 34:7,18
38:15 39:5 56:18
56:18 57:8,12,23
bluntly 25:10
board 24:1,22 47:9
47:14 48:11
boards 24:3 42:14
body 36:13 39:4
45:20 75:24
Bohner 20:10
Booker 6:14
boxes 28:1 68:3
boy 6:4
brand 21:1
break 63:19
briefly 30:25 63:8
bring 6:5 33:16
74:7
bringing 10:17
broad 75:11
broader 63:9
brother 6:1
brought 19:8
bulletin 52:8
bulletins 52:6,11
burden 73:23 83:6
Bureau 82:14
burst 4:5
BURTON 1:16
business 10:16,17
18:4
buy 26:6
C
C 84:3 87:1,1
calculation 14:20
calculations 84:18
California 24:21
33:21 37:20
call 22:14
called 42:12 48:15
camp 82:12
cancelled 38:19
capacity 42:3 82:15
Captain 18:25 19:3
19:8,17 40:13,19
40:21
capture 68:4
captured 22:25
29:4
cardiopulmonary
32:8
care 76:11
career 66:7
carefully 46:13
caretaker 37:25
carried 24:1
case 6:9 7:25 8:24
9:25 10:2,4 11:18
11:22 13:1,12
14:12,24 15:4,6
15:15,18,21 17:12
22:1,1 24:19,20
26:8 27:6 28:22
32:15 44:10,23
47:10 64:15 65:14
65:22 67:5,19
73:15,17,25 74:8
74:11 76:5 77:5
78:13,17,20 79:21
81:6 83:15 84:8
84:24 85:6
cases 3:20 4:3,4
14:22,25 29:20,22
43:20 74:9
cast 75:18
catastrophic 58:5
category 74:12
CATHERINE 1:19
cause 9:21,23 20:14
32:9 34:15,18,22
56:18,22 58:3
72:12,13,13 85:15
caused 67:12 74:17
causes 74:13
cautiously 84:9
cavity 34:24 37:13

cement 34:14,21
37:8 38:14
central 11:12
centralized 47:18
CEO 69:11 71:20
certain 8:23 12:11
20:22
certainly 11:15
15:11 31:13 41:17
53:8 61:10 66:7
73:10,19 74:11
75:19 78:6 81:6
81:17,18
Certified 87:11
certify 87:4
CET 87:11
cetera 35:15
challenge 77:5
changed 76:21
changes 25:21 48:8
48:10
chapter 25:20,24
character 65:9,9
characteristics
5:25 6:7,12,13,15
6:17,23
characterize 27:25
charge 23:5 24:5
81:21
charges 77:9
check 40:5
chemical 56:21
Chestnut 1:11
chief 1:13 69:8
choice 32:13 40:15
choices 74:7 76:15
chose 69:15
chosen 70:9 79:22
Circuit's 83:15
circumstance
83:12
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Case 2:09-cr-00403-LDD Document 207 Filed 01/03/12 Page 1 of 104

UNITED STATES DISTRICT COURT

UNITED STATES OF AMERICA,

NORIAN CORPORATION, and

TRANSCRIPT OF SENTENCING MICHAEL D. HUGGINS

For the Defendant:

MARY E. CRAWLEY, AUSA

Veritext National Court Reporting Company

VERITEXT NATIONAL COURT REPORTING COMPANY

Case 2:09-cr-00403-LDD Document 207 Filed 01/03/12 Page 2 of 104

For the Defendant

VERITEXT NATIONAL COURT REPORTING COMPANY

Case 2:09-cr-00403-LDD Document 207 Filed 01/03/12 Page 3 of 104

This is the matter of the

United States of America versus Mr. Michael D. Huggins, which

front of Judge Stengel, we are here for sentencing.

Ms. Crawley and Mr. Sullivan are here for the

As everyone is familiar, we had a several day hearing

on sentencing guidelines and last week I issued a ruling,

which I believe resolved all of the questions, both factual

issues -- factual issues; excuse me, that the parties need to

I'm not sure if there are any other legal

Anything from you, sir, Mr. Poe?

Your Honor, I did note one -- the probation

office, I think, did not accurately reflect, in the final

report, one of Your Honor's -- one aspect of Your Honor's

order, in paragraph 42.

Tell me about it.

Your Honor directed the PO to correct PSR paragraph

42 to reflect that eight of the thirty-four cases involved the

Yes, Your Honor.

And the second revised

also discussed Synthes' failure to file an MDR on the first

VERITEXT NATIONAL COURT REPORTING COMPANY

Case 2:09-cr-00403-LDD Document 207 Filed 01/03/12 Page 4 of 104

adverse events with a Norian product in eight out of the

thirty-four VCF cases to date".

So as the Court may recall, twenty-six of those cases

were burst fractures and therefore, I think, it just got lost

in translation a bit, Your Honor.

We just ask that that be

And you would propose -- well,

actually, the language is in the order, right?

So any concern about that?

No, Your Honor.

Any other factual findings

that needed to be made, from either party, that I might have

No, Your Honor.

So obviously the concerns

that the defendant raised about the guidelines, they're all

But with that in mind it's a four-one, the guideline range is

zero to six months.

We don't need to, hopefully, discuss those again.

That's where we stand, correct?

Agreed, Your Honor.

Yes, Your Honor.

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Case 2:09-cr-00403-LDD Document 207 Filed 01/03/12 Page 5 of 104

And obviously, Mr. Poe, you have

discussed this pre-sentence with your client on multiple

occasions, is that correct?

determinations in my order there are no other factual

corrections or amendments to be made?

Yes, Your Honor.