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40–884 PDF 2008

S. HRG. 110–479 

EVALUATING THE PROPRIETY AND ADEQUACY 

OF THE OXYCONTIN CRIMINAL SETTLEMENT 

HEARING 

BEFORE THE

COMMITTEE ON THE JUDICIARY 

UNITED STATES SENATE 

ONE HUNDRED TENTH CONGRESS 

FIRST SESSION 

JULY 31, 2007 

Serial No. J–110–50 

Printed for the use of the Committee on the Judiciary 

( 

(II) 

COMMITTEE ON THE JUDICIARY 

PATRICK J. LEAHY, Vermont, Chairman 

EDWARD M. KENNEDY, Massachusetts 

JOSEPH R. BIDEN, JR., Delaware 

HERB KOHL, Wisconsin 

DIANNE FEINSTEIN, California 

RUSSELL D. FEINGOLD, Wisconsin 

CHARLES E. SCHUMER, New York 

RICHARD J. DURBIN, Illinois 

BENJAMIN L. CARDIN, Maryland 

SHELDON WHITEHOUSE, Rhode Island 

ARLEN SPECTER, Pennsylvania 

ORRIN G. HATCH, Utah 

CHARLES E. GRASSLEY, Iowa 

JON KYL, Arizona 

JEFF SESSIONS, Alabama 

LINDSEY O. GRAHAM, South Carolina 

JOHN CORNYN, Texas 

SAM BROWNBACK, Kansas 

TOM COBURN, Oklahoma 

BRUCE A. COHEN, Chief Counsel and Staff Director 

MICHAEL O’NEILL, Republican Chief Counsel and Staff Director 

(III) 

C O N T E N T S 

STATEMENTS OF COMMITTEE MEMBERS 

Page 

Coburn, Hon. Tom, a U.S. Senator from the State of Oklahoma ........................ 4 

Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont .................... 1 

prepared statement .......................................................................................... 126 

Specter, Hon. Arlen, a U.S. Senator from the State of Pennsylvania ................. 2 

WITNESSES 

Brownlee, John L., U.S. Attorney, Western District of Virginia, Roanoke, 

Virginia ................................................................................................................. 6 

Campbell, James N., M.D., Professor of Neurosurgery, School of Medicine, 

Johns Hopkins University, Baltimore, Maryland .............................................. 28 

Khanna, Vikramaditya, Professor of Law, University of Michigan Law School, 

Ann Arbor, Michigan ........................................................................................... 20 

McCloskey, Jay P., former United States Attorney, District of Maine, McCloskey, Mina, Cunniff & Dilworth, LLC, Portland, Maine .................................... 27 

Pagano, Virginia, Police Officer, Philadelphia Police Department, Narcotics 

Bureau, Philadelphia, Pennsylvania .................................................................. 25 

Skolek, Marianne, LPN, Myrtle Beach, South Carolina ...................................... 18 

Wolfe, Sidney M., M.D., Director, Health Research Group of Public Citizen, 

Washington, D.C. ................................................................................................. 22 

QUESTIONS AND ANSWERS 

Responses of John L. Brownlee to questions submitted by Senators Leahy 

and Specter ........................................................................................................... 33 

Responses of James N. Campbell to questions submitted by Senator Specter .. 46 

Responses of Vikramaditya Khanna to questions submitted by Senator Specter .......................................................................................................................... 51 

Responses of Jay P. McCloskey to questions submitted by Senators Coburn 

and Specter ........................................................................................................... 56 

Responses of Virginia Pagano to questions submitted by Senator Specter ........ 67 

Responses of Marianne Skolek to questions submitted by Senator Specter ....... 71 

Responses of Sidney M. Wolfe to questions submitted by Senator Specter ........ 74 

SUBMISSIONS FOR THE RECORD 

Blumenthal, Richard, Attorney General, State of Connecticut, Hartford, Connecticut, statement and attachment ................................................................... 77 

Brownlee, John L., U.S. Attorney, Western District of Virginia, Roanoke, 

Virginia, statement and attachment .................................................................. 82 

Campbell, James N., M.D., Professor of Neurosurgery, School of Medicine, 

Johns Hopkins University, Baltimore, Maryland, statement ........................... 110 

Hutt, Peter Barton, Covington & Burling LLP, former Chief Counsel of the 

Food and Drug Administration, Washington, D.C., letter ................................ 117 

Khanna, Vikramaditya, Professor of Law, University of Michigan Law School, 

Ann Arbor, Michigan, statement ........................................................................ 120 

Levy, Michael H., M.D., Vice-Chair, Department of Medical Oncology, Fox 

Chase Cancer Center, Philadelphia, Pennsylvania, letter ................................ 128 

McCloskey, Jay P., former United States Attorney, District of Maine, McCloskey, Mina, Cunniff & Dilworth, LLC, Portland, Maine, statement ................. 132 

National Survey on Drug Use and Health, 2005, charts ...................................... 142 

Pagano, Virginia, Police Officer, Philadelphia Police Department, Narcotics 

Bureau, Philadelphia, Pennsylvania, statement ............................................... 143 

Page

IV 

Reynolds, Siobhan, Founder and President, Pain Relief Network, statement ... 148 

Shapiro, Howard M., Partner, Wilmer Cutler Pickering Hale and Dorr LLP, 

Washington, D.C., statement and attachment .................................................. 153 

Skolek, Marianne, LPN, Myrtle Beach, South Carolina, statement ................... 162 

Wolfe, Sidney M., M.D., Director, Health Research Group of Public Citizen, 

Washington, D.C., statement .............................................................................. 167 

(1) 

EVALUATING THE PROPRIETY AND ADEQUACY OF THE OXYCONTIN CRIMINAL SETTLEMENT 

TUESDAY, JULY 31, 2007 

U.S. SENATE, 

COMMITTEE ON THE JUDICIARY, 

Washington, DC. 

The Committee met, pursuant to notice, at 2:36 p.m., in room 

SD–226, Dirksen Senate Office Building, Hon. Patrick J. Leahy, 

Chairman of the Committee, presiding. 

Present: Senators Leahy, Cardin, Specter, Sessions, and Coburn. 

OPENING STATEMENT OF HON. PATRICK J. LEAHY, A U.S. 

SENATOR FROM THE STATE OF VERMONT 

Chairman LEAHY. Good afternoon, Dr. Coburn. We are just a 

minute or two late because we were all at our various caucuses, 

but I had scheduled this hearing at the request of the distinguished 

senior Senator from Pennsylvania. Senator Specter has long expressed an interest in criminal liability for the introduction of dangerous or defective products into the marketplace. I agree with him 

that this is a very important issue and one where further congressional action may be warranted. 

The hearing will examine the recent plea agreement between the 

makers of OxyContin and the Federal Government. Last month, 

this Committee held a hearing addressing the role of rogue online 

pharmacies in our Nation’s growing prescription drug abuse problem. Among young people, prescription drugs have become the second most abused illegal drug, behind marijuana. In fact, if you exclude marijuana, more adults and teens report abusing prescription 

drugs than all other illicit drugs combined. I noted then that Purdue’s admitted misrepresentations about the addictiveness and 

abuse potential of their product was very troubling. 

The criminal conduct involved in the marketing of OxyContin 

has been one of the most tragic examples in recent memory of a 

company favoring the bottom line over the health of our Nation’s 

citizens. The tragic irony is that the dangerous product they were 

talking about purported to help people manage pain. And I know 

that for many it has been effective. But for many others, this drug, 

and its diversion due to widespread distribution, has caused terrible harm—from addiction to in many instances death. Purdue 

made billions of dollars marketing OxyContin as a less addictive alternative to painkillers. Today, we will hear about what punishVerDate Aug 31 2005 14:37 Sep 08, 2008 Jkt 040884 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\40884.TXT SJUD1 PsN: CMORC
2 

ment the Justice Department found appropriate for this criminal 

conduct. 

I look forward to discussing today with the witnesses how best 

to prevent this type of dangerous corporate decisionmaking from 

ever occurring again. Americans should not have their lives reduced to a mere factor in an actuarial table. While the makers of 

OxyContin have been prosecuted, have pled guilty, and are paying 

a multi-million dollar fine, no one from the company is going to jail. 

Frankly, I felt in my days as a prosecutor and I am sure others, 

like Senator Specter, who had the privilege of serving as prosecutors know that nothing focuses the mind as much as thinking you 

are going to be behind bars. Fines can sometimes become simply 

a cost of doing business. When you sit behind bars, you think far 

more about whether you did the right thing. 

I believe it is fair to ask, in light of Purdue’s profits of approximately $2.8 billion between 1996 and 2001, whether the $680 million in penalties they received in this plea agreement will serve as 

a deterrent to similar future conduct or just simply become part of 

the cost of doing business. 

We will hear testimony today about the way Purdue’s conduct 

has affected the lives of those who have lost loved ones as a result 

of taking OxyContin. Many are asking why the three executives 

who pled guilty were not given jail time. As I said before, nothing 

makes corporate executives think twice about malfeasance more 

than the prospect of the iron bars slamming shut. 

The judge who presided over the plea agreement stated at the 

sentencing hearing: ‘‘I do not doubt that many of our fellow citizens...will deem it inappropriate that no jail time is imposed. It 

bothers me, too.’’ I would say to the judge it certainly bothers me. 

The United States Attorney who prosecuted the case will testify 

today about why he did not insist that the responsible corporate officials pay a similar price as the individuals who sell OxyContin on 

the street. I look forward to hearing from these witnesses. 

[The prepared statement of Senator Leahy appears as a submission for the record.] 

Senator Specter? 

STATEMENT OF HON. ARLEN SPECTER, A U.S. SENATOR FROM 

THE STATE OF PENNSYLVANIA 

Senator SPECTER. Thank you, Mr. Chairman, for scheduling this 

hearing. 

The criminal charge involves a matter where there was a plea to 

a felony offense, including an intent to mislead. According to the 

DEA, in just 2000 and 2001, there were 146 deaths in which 

OxyContin was determined to be the direct ‘‘cause of’’ or ‘‘a contributing factor to’’ the deaths and an additional 318 deaths that were 

‘‘most likely’’ caused by OxyContin. In seeing the reports on this 

matter, with very substantial profits involved and a fine, albeit 

substantial, it has a very ominous overtone of insufficient prosecution efforts. Where someone places a dangerous instrumentality in 

commerce with reason to believe that a death may occur and a 

death does occur, that constitutes malice and supports prosecution 

for murder in the second degree. 

3 

I have long expressed my concern about such products in the 

marketplace, and that is why I suggested to Chairman Leahy that 

a hearing would be useful. 

I believe that as a generalization—and I base this on substantial 

experience on this Committee—that there is insufficient oversight 

by the Committee on what happens in the Department of Justice 

and what happens in the criminal prosecutions. 

I have since been contacted by attorneys representing the defendant company who contend that there is a gross misstatement of 

what the underlying facts are. Well, I am prepared to listen. This 

Committee is prepared to listen. But Senator Leahy puts his finger 

on the issue, that is, if there is reason to believe that it is a dangerous instrumentality and that deaths will occur and deaths do 

occur, that supports a homicide prosecution. And it is not deterred 

by a fine. 

I see fines with some frequency and think that they are expensive licenses for criminal misconduct. I do not know whether that 

applies in this case, but a jail sentence is a deterrent and a fine 

is not—not a corporate fine in the context of the kind of profits 

which are involved here. 

Since this hearing was scheduled, we have a very heavy commitment this afternoon to the Director of National Intelligence. We 

have been called upon to revise the FISA law, so at least speaking 

for myself, I am going to have to conclude my participation by 4 

o’clock. I do not control the gavel, but the Chairman— 

Chairman LEAHY. If you would yield on that, you will control the 

gavel, because I am going to be leaving before that. 

Senator SPECTER. If I control the gavel, the hearing will be over 

by 4 o’clock. 

Chairman LEAHY. And I am going to turn the gavel over to you. 

Senator SPECTER. Well, we have the time limits of 5 minutes, 

and if I have the gavel, I would request—in fact, even if I did not 

have the gavel, I would request the witnesses stay within the time 

limits to give the maximum time for dialog. But we have enough 

time to give this a thorough hearing. 

I had a call from Senator Coburn, who is concerned about the 

adequacy of the witness list, and I immediately said the witnesses 

he wanted to add I thought were fine. And we have an expert 

here—we have a couple of experts: one in the medical field and one 

in the legal field. So we will see how it goes. 

Thank you, Mr. Chairman. 

Chairman LEAHY. Thank you. 

Mr. Brownlee, would you please stand and raise your right hand? 

Do you solemnly swear that the testimony you will give in this 

matter will be the truth, the whole truth, and nothing but the 

truth, so help you God? 

Mr. BROWNLEE. Yes, sir. 

Chairman LEAHY. Thank you. 

Senator COBURN. Mr. Chairman, might I have the privilege of 

having an opening statement? 

Chairman LEAHY. Certainly. 

4 

STATEMENT OF HON. TOM COBURN, A U.S. SENATOR FROM 

THE STATE OF OKLAHOMA 

Senator COBURN. First of all, what has happened with 

OxyContin in terms of how it has been abused represents some of 

the greatest problems we have in this country with poly drug 

abuse. As a practicing physician, as a cancer survivor, as somebody 

who has prescribed this medicine, I am somewhat concerned with 

the direction we are taking, and the question I would ask of the 

Chairman and the Ranking Member is: Where is our study on 

Lortab and the drug and poly drug abuse with Lortab? Where is 

our study and our hearing on Coumadin and the people that die 

every year from Coumadin? The facts are that 98 percent of the 

people who died using this drug are poly drug abusers. 

Now, whether there was intent to distribute outside of there— 

but I think it is really important that everybody recognizes what 

a Class II drug is. It is a highly addictive drug. And where is the 

question and the culpability on the medical community in this 

country who wrote the prescriptions for this drug? They read the 

PDR. They read the approved statement, which fully outlines the 

dangerousness of this drug when used in an inappropriate manner. 

The thing that concerns me, never was it alleged that this drug 

was designed to be ground up and used in an illegal fashion and 

that there was a motivation to do that. And yet we are coming 

after a drug manufacturer who may or may not—according to the 

plea, has pled guilty to something, but we are turning a blind eye 

to all the other areas. 

The problem in this country is poly drug abuse. Ninety-eight percent of the people who have died with this on autopsy are found 

to have multiple other drugs. 

Look at the other side of it. Look at somebody who has bone pain 

from metastatic bone cancer and say, Do we not want them to have 

this wonderful drug that makes life bearable instead of unbearable? We are not considering this in a balanced fashion, and I believe as a physician, No. 1, I ought to challenge my own profession. 

They created this problem by not following their own ethical standards and by writing prescriptions for drugs that they never should 

have written. And the same thing is going on with Lortab right 

now. 

Final point. We need to be careful that we do not act as the FDA. 

This was an approved drug under Schedule II that everybody in 

the medical community understands the addictive potential and 

the danger of. And to hold no culpability for the physician community I think would be seriously in error. 

And I thank the Chairman for allowing me an opening statement. 

Chairman LEAHY. Thank you. 

Mr. Brownlee, I expect that you are aware that your name appeared on at least one termination list of U.S. Attorneys. The 

Washington Post reported this list was prepared November 2006 by 

Mike Elston, who was the chief of staff of then outgoing Deputy Attorney General McNulty. Why do you think Mr. Elston put you on 

that list? 

Mr. BROWNLEE. Well, Mr. Chairman, first of all, thank you for 

allowing me to be here today and to testify. 

5 

Chairman LEAHY. I am glad you are here, because as I told you 

before we started, as a prosecutor you have probably the best job 

in America. Go ahead. 

Mr. BROWNLEE. Thank you, sir. I do not have specific knowledge 

of exactly why Mr. Elston placed me on that list. No one has come 

forward and told me. However, when I learned that I had been 

placed on the list—Mr. Elston is the one who informed me on 

March 14th of this year—I became concerned enough that I reported that event to the Justice Department that very evening. 

And so although I do not have any conclusive information as to 

why I was targeted for termination, I certainly had concerns about 

it and reported that. 

Chairman LEAHY. Did you discuss it with Deputy Attorney General McNulty? 

Mr. BROWNLEE. I spoke to Mr. McNulty the following day, on 

March 15th. I told him that my name had appeared on this list by 

Mr. Elston in an e-mail dated November 1, 2006, that I was concerned about it. And I outlined him the facts that I knew concerning that. He assured me that Mr. Elston was a good man. I 

had my own views of that. 

Chairman LEAHY. Had you ever been given any negative evaluations by Mr. Elston or by anybody at the Department? 

Mr. BROWNLEE. No, sir. 

Chairman LEAHY. I find this interesting because you have such 

an interesting background that I was surprised you were on there. 

I realize I overlooked giving you time for an opening statement, 

which I will. I was just going to ask you two other questions, and 

I will stop with that. 

In your written testimony, you say you began your investigation 

of Purdue’s activities surrounding OxyContin in the fall of 2001. 

Mr. BROWNLEE. That is correct. 

Chairman LEAHY. You then spoke with officials at Main Justice, 

including Mr. Comey, about the charges you were considering. 

Were you given any direction or criticism or pressure from anyone 

in the Justice Department with regard to your investigation or 

your plea negotiations? 

Mr. BROWNLEE. If I may split that into two answers, I spoke to 

Mr. Comey in 2005 concerning an issue regarding our application 

of the Thompson memo, which was in effect at the time that we 

were investigating this case. Mr. Comey had received information 

from defense counsel that the Western District was not applying 

that pursuant to DOJ policy. So Mr. Comey inquired. I felt the inquiry was serious enough that I actually grabbed one of my—not 

grabbed, but one of my prosecutors and I drove up to Washington 

from Roanoke and sat down with Mr. Comey and laid out for him 

exactly what we had done pursuant to Thompson, our methods for 

trying to acquire the necessary records to do this investigation. 

Once Mr. Comey heard my explanation, he said, ‘‘Brownlee, you 

are fine. Go back to Virginia and do your case.’’ And we did, and 

I never spoke to him about the matter— 

Chairman LEAHY. Did you ever get any pressure from anybody 

else even after Mr. Comey left? 

Mr. BROWNLEE. The only thing that ever occurred was from Mr. 

Elston himself. On October 24, I believe, 2006, that is the day that 

6 

this plea was to expire. We had provided counsel for the company 

on October 19th, I believe, the final Government offer to settle this 

case or they would face other things. And so that evening—we had 

received earlier that day authority from the Justice Department to 

go ahead and either accept the plea or charge the company. Mr. 

Elston, who I had only met on one prior occasion, on August 3rd— 

so I had only known him less than 90 days—contacted me and was 

inquiring about the case. He told me he had received a phone call 

from one of the defense lawyers about the case and that that counsel had once again said that we were moving too quickly, that they 

needed more time, those kinds of things. And through his questioning of me, I sensed that he was inquiring almost on their behalf. 

I asked him if he was calling on behalf of the Deputy Attorney 

General, and I was at home at this time. He told me he was not. 

Once I learned that he was not speaking on behalf of Mr. McNulty, 

based on the fact he had never attended any substantive briefings 

and he was one that I did not feel understood the case, I simply 

just kind of dismissed him and told him that I had authority from 

Mrs. Fisher to proceed forward and we were going to do just that 

and he needed to back out of the way of the case. Ultimately, he 

complied with that, and the company accepted the plea that 

evening. 

Chairman LEAHY. Thank you. And please feel free to go ahead 

and give your opening statement. I apologize. Sometimes I forget 

the procedure here, being new in this job. 

Go ahead and give your opening statement, Mr. Brownlee. 

STATEMENT OF JOHN L. BROWNLEE, UNITED STATES ATTORNEY, WESTERN DISTRICT OF VIRGINIA, ROANOKE, VIRGINIA 

Mr. BROWNLEE. Chairman Leahy, Senator Specter, and members 

of the Committee, thank you for holding this hearing and allowing 

me the opportunity to testify. 

During the past 5 years, I led a team of career prosecutors from 

my office and the Department of Justice, as well as State and Federal investigators that conducted a sweeping investigation of the 

manufacturer and distributor of the painkiller OxyContin. Bringing 

this company and its executives to justice was a difficult and important challenge, and I am grateful for the hard work of the law 

enforcement professionals upon whom these convictions rest. They 

represent the very best of our Nation’s law enforcement, and I am 

honored to serve with them. 

According to the evidence, Purdue began using focus groups of 

primary care physicians in 1995 to determine whether such physicians would be willing to prescribe OxyContin for patients with 

non-cancer pain. These focus groups showed that what doctors 

wanted was a long-lasting pain reliever that was less addictive and 

less subject to abuse and diversion. Purdue understood that the 

company that marketed and sold that drug would dominate the 

pain management market. And that is exactly what Purdue set out 

to do. 

Despite knowing that OxyContin had an abuse potential similar 

to that of morphine and was at least as addictive as other pain 

medications on the market, in January 1996, Purdue began marVerDate Aug 31 2005 14:37 Sep 08, 2008 Jkt 040884 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\40884.TXT SJUD1 PsN: CMORC
7 

keting OxyContin as less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other 

pain medications. 

Due in part to Purdue’s aggressive and misleading marketing 

campaign, prescriptions for OxyContin skyrocketed, increasing 

from approximately 300,000 in 1996 to nearly 6 million in 2001. As 

OxyContin became more available, its abuse and diversion increased, and this increase had a devastating effect on many communities throughout Virginia and America. 

On May 10, 2007, Purdue pleaded guilty to a felony charge of illegally misbranding OxyContin in an effort to mislead and defraud 

physicians and agreed to pay $600 million, an amount that represented approximately 90 percent of the profits for the sale of 

OxyContin during the time period of the offense. Purdue also was 

required to subject itself to independent monitoring. 

In addition, Purdue’s President Michael Friedman General Counsel Howard Udell, and former Chief Medical Officer Paul 

Goldenheim pled guilty to a misdemeanor charge of misbranding 

OxyContin. These defendants were placed on supervised probation 

for 3 years, ordered to perform 400 hours of community service, 

and collectively pay $34.5 million in criminal fines. 

Like other high-profile prosecutions, this case has not been free 

of controversy. It has been suggested that my office attempted to 

demonize OxyContin and that our decision to charge the executives 

was ‘‘a regrettable choice of prosecutorial discretion.’’ On the other 

hand, our decision not to seek active incarceration also has been 

questioned. 

After studying this case and the evidence carefully, I am confident that the facts and law compelled our decision to prosecute 

and sentence this company and its executives in precisely the manner in which we did. The three executives pled guilty to a strict liability misdemeanor offense based on the fact that they were the 

responsible corporate officers of this pharmaceutical company. This 

misdemeanor charge required no proof of intent or actual knowledge of the violations to establish their guilt. 

The intent of the statute is to impose the highest standard of 

care on certain corporate officials. The three defendants had no 

prior criminal records, and the Sentencing Guideline range for each 

defendant was 0 to 6 months. Under these circumstances, I decided, and the court has agreed, that prison sentences were not 

necessary to adequately punish these defendants. 

Convictions of the corporate officials will have significant consequences. Each defendant will bear the stigma of being a convicted criminal. These convictions also will send a strong warning 

to executives of other pharmaceutical companies that they, too, will 

be expected to exercise the highest standard of care. 

During the last several years, I have spoken to many people who 

have been harmed or who have had a loved one harmed by 

OxyContin—people like Marianne Skolek, whose daughter Jill died 

from OxyContin and whose grandson, Brian, will now grow up 

without his Mom. My belief is that these convictions have advanced 

the cause of justice and I hope offer some measure of closure for 

those who have suffered. These convictions have confirmed what 

8 

many believed for a long time: that Purdue’s marketing of 

OxyContin was deceptive and criminal. 

It is important to note that most of the people never claimed that 

Purdue was solely responsible for their loved one’s death. They just 

wanted Purdue to tell the truth about the drug. The investigators 

and prosecutors who built this case have brought that truth to 

light. 

On April 1, 1940, Attorney General Robert Jackson spoke to a 

group of United States Attorneys who had assembled in the Great 

Hall at Main Justice. The future Supreme Court Justice reminded 

those Federal prosecutors of their ethical and legal duties in pursuing justice, and I quote: ‘‘What every prosecutor is practically required to do is to select the cases for prosecution and to select those 

in which the offense is the most flagrant, the public harm the 

greatest, and the proof the most certain.’’ 

I am confident that our prosecution of Purdue and its executives 

and the sanctions imposed are consistent with Department policies 

and Robert Jackson’s mandate for justice. 

I thank the Committee for allowing me to appear before you 

today, and I would be pleased to answer your questions. Thank 

you, sir. 

[The prepared statement of Mr. Brownlee appears as a submission for the record.] 

Chairman LEAHY. Well, thank you very much, Mr. Brownlee, and 

I must state that I am very pleased to have you here, as I said to 

you not only publicly but privately before. 

I also should note I appreciate your duties in the Judge Advocates Corps in the Army Reserve. 

Mr. BROWNLEE. Thank you, sir. 

Chairman LEAHY. it is probably a little bit different than your 

days as a paratrooper. 

Mr. BROWNLEE. Yes, sir. 

Chairman LEAHY. And some days that may look like it is more 

enjoyable. 

Mr. BROWNLEE. Some days jumping out of the plane looks pretty 

good, Senator. Thank you. 

Chairman LEAHY. I have done it once with the Golden Knights, 

and I would do it again in a second. And I hope my wife did not 

hear me say that because there would be probably a vote on that. 

I turn the gavel over to Senator Specter. 

Senator SPECTER. [Presiding.] Thank you very much, Mr. Chairman. 

Mr. Brownlee, the company pled to a felony offense, including an 

intent to mislead. 

Mr. BROWNLEE. That is correct. 

Senator SPECTER. Chief Judge Jones said, ‘‘In the absence of 

legal proof by the Government that the individual defendants had 

knowledge of the wrongdoing charged or participated in it, I do not 

think prison appropriate.’’ 

Didn’t the Government establish the underlying facts of the 

guilty plea that there was intent to mislead known to the individual defendants? 

Mr. BROWNLEE. The answer is no, sir. The way we built this case 

was through—in December of 2002, we served an administrative 

9 

health care subpoena on the company, a multi- page document requesting records concerning the marketing of OxyContin. Once we 

got those records, conducted hundreds of interviews—these were 

millions of documents. We put them in a data base, and the investigators and prosecutors, through word search programs, went 

through those records and built a case against the company. 

It was almost putting together a puzzle. It was a piece from a 

training manual. It was a piece from a call note. 

Senator SPECTER. You ended up with an indictment that the corporation and the individual defendants—a corporation does not act 

by itself. A corporation acts through individuals, who become individual defendants—that they had an intent to mislead. 

Mr. BROWNLEE. That is correct. 

Senator SPECTER. And that resulted in, caused a great many 

deaths. 

Mr. BROWNLEE. Yes, sir. 

Senator SPECTER. Well, that being so, wasn’t there legal proof 

that the individual defendants knew, since they intended to mislead, knew what they were doing? 

Mr. BROWNLEE. Well, the evidence that we submitted to the 

court under the Agreed Statement of Facts did not include that, 

and I want to be very careful, Senator Specter, on how I speak concerning facts. All of these—much of these facts are protected under 

Rule 6(e). This was a grand jury— 

Senator SPECTER. It was not presented to the court. Does that 

mean you did not have the facts? You did make a charge of intent 

to mislead? 

Mr. BROWNLEE. We did as to the corporate entity. This was a corporate culture put together by many people. 

Senator SPECTER. Well, I understand that. But the corporation 

does not act by itself. It is inanimate. It acts through people. So 

are you saying you could not identify the people? 

Mr. BROWNLEE. I think it is fair to say that when we looked at 

the proof as to the corporate entity and we looked at the proof as 

to particular individuals, that proof tested out differently. As you 

well know, a corporation can be held criminally responsible for the 

acts of its agents. For instance, if a sales representative in another— 

Senator SPECTER. I understand that. It could only be held liable 

for the acts of its agents. That is the way it is liable. And it can 

only be held liable for intent to mislead if its agents intended to 

mislead. 

Mr. BROWNLEE. Yes, sir. 

Senator SPECTER. But once you have agents who intend to mislead, you have the requisite proof to charge them with wrongdoing. 

Mr. BROWNLEE. Right. 

Senator SPECTER. Which the judge said he did not have. There 

is a total disconnect. Either you have a basis for saying that there 

is an intent to mislead or you do not. And if you have a basis for 

saying there is an intent to mislead, it is because individuals acted 

in a way which led you to that conclusion. And that being so, I do 

not see how you can have a conclusion that the individuals were 

not wrongdoers who deserved jail. 

10 

Mr. BROWNLEE. Well, Senator Specter, I think that the way it 

boils down is that—I mean, the premise, I believe, is correct, but 

when prosecutors and investigators look at particular evidence as 

to a particular individual, the outcome may very well be different. 

For instance, in the example, let’s say that that sales rep did go 

to a physician and provide misleading information about the product. There may be a sense, well, maybe you can prosecute that particular individual based on that statement. But then you look behind it and the defense would be, well, wait a minute, I was 

trained that way and look at the training manual. It has a graph 

in there that tells me this. And then you— 

Senator SPECTER. If they were trained that way, they did not intend to mislead. Unless they knew that they were misleading, they 

did not intend to mislead. 

Mr. BROWNLEE. Exactly. 

Senator SPECTER. Once you have them intending to mislead, you 

have them engaged in conduct which merits jail. 

Mr. BROWNLEE. Well, I think that the Senator is correct in the 

sense that under that scenario, that individual would not—we 

could not prove that that individual had the intent to mislead. But 

as a corporate entity— 

Senator SPECTER. Well, could you prove that any individual had 

the intent to mislead? 

Mr. BROWNLEE. We did not charge any individuals with the intent to mislead. 

Senator SPECTER. I understand you did not charge them. That 

was not my question. 

Mr. BROWNLEE. Yes, sir. 

Senator SPECTER. My question was: Couldn’t you prove that 

some individual had an intent to mislead? 

Mr. BROWNLEE. The evidence in this case was reviewed by career 

prosecutors and investigators, and it was their judgment—and I 

agree with them—that under the evidence in this case, that the 

charging decisions, the felony for the company and the strict liability misdemeanors for the executives, were the appropriate charging 

decisions. 

I must tell you, this case, no one wanted to bring these defendants to justice more than the Western District of Virginia. We initiated this in 2001. We spent 4 years going through millions of 

records, conducting hundreds of interviews. And this is the evidence of the case. And the career prosecutors who have gone 

through this have asked themselves—we asked ourselves the very 

questions you are asking me practically every day for years about 

this case. We are bound by the policies of the Department. The 

Ashcroft memo says you must charge the most serious, readily 

provable charge that the prosecutor has a good-faith belief that he 

or she can prevail at court, which means a lawyer would have to 

stand up and prove beyond a reasonable doubt to a unanimous verdict that a particular individual had the specific intent to mislead. 

And after reviewing this evidence, the charges that we came up 

with were the appropriate charges under this evidence, with this 

evidence. 

Senator SPECTER. Well, the red light went on in our last exchange, and I believe in observing the time limits meticulously beVerDate Aug 31 2005 14:37 Sep 08, 2008 Jkt 040884 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\40884.TXT SJUD1 PsN: CMORC
11 

cause I am asking everybody else to. But I do not agree with you. 

The memo, the famous Thompson memo, Deputy Attorney General 

Larry Thompson, ‘‘Prosecution of a corporation is not a substitute 

for the prosecution of criminally culpable individuals within or 

without the corporation.’’ And where you have a basis for saying 

that there was an intent to mislead by an individual, that is 

enough. 

I respect your professionalism and I respect your judgment, but 

speaking from an oversight capacity, I disagree. 

Mr. BROWNLEE. Yes, sir. 

Senator SPECTER. Senator Cardin? 

Senator CARDIN. Thank you very much, Mr. Chairman. 

Mr. Brownlee, welcome to the Committee. 

Mr. BROWNLEE. Thank you, Senator. 

Senator CARDIN. You are in a difficult position. It does not look 

like you can win on either side on this issue. But I first want to 

compliment you for bringing this case, for challenging the corporate 

structure and doing a professional investigation, which was extremely difficult to establish a case of criminal conduct and then 

presenting it in a way that you could succeed in court. It is challenging, and there are a lot easier cases that you could have 

worked on, but you chose an extremely difficult case. And I think 

it will have a major impact on corporate conduct in our country. 

Mr. BROWNLEE. Yes, sir. 

Senator CARDIN. Now, having said that, I think the point that 

Senator Specter is raising is a legitimate point. When we saw corporate greed hurt shareholders and employees, the Congress 

changed its laws. Sarbanes-Oxley was passed. And we changed the 

attitude that it is all right for corporations and businesses to do 

whatever they wanted to do, that Congress would take a more aggressive role. 

I am just wondering whether we have a similar problem here. I 

think the point that Senator Specter raised about a company that 

is guilty of intentional conduct, misrepresenting information that 

leads to consumers being put at risk and losing their lives, that 

type of criminal conduct is actionable by more than just fines. And, 

yes, it is extremely difficult to be able to prove the actions of the 

agents, but somebody in this company is responsible for intentionally taking action to put the public at risk and cost people their 

lives. 

So I am just wondering whether there is a need for change of law 

or other types of tools that can be made available, because I do 

think there are dual standards in America in our criminal justice 

system, that if you happen to be guilty of traditional type crimes, 

we would not think twice about letting you ought of jail. You are 

going to go to jail. But if you have a sophisticated network in which 

people are killed, you can avoid jail time. To me, that is something 

that is unacceptable in our system, and we need to look for how 

we change policy. 

I want to thank Senator Coburn for his point because I think 

there is responsibility beyond just the pharmaceutical company 

here. People in the medical community who perhaps look for easy 

ways to deal with a problem and do not supervise properly or find 

out the medical history of an individual in prescribing certain 

12 

medications are also at least negligent, if not further than negligent. 

So I think this case brings up the need for further review by perhaps Congress and by prosecutors as to whether we cannot have 

a more effective way to get the message out that our system of justice is going to be equally applied, and people who intentionally 

bring harm to other people are going to pay the consequences and 

not just the fine. 

Mr. BROWNLEE. Thank you, Senator. 

Senator CARDIN. That is more of a statement, I guess, than a 

question, but I really do want to come back to the point that this 

was not an easy case, and I admire your willingness to take this 

on. And I hope that the questioning you hear today is not interpreted as challenging the manner in which you proceeded, but we 

need to learn from this experience to make sure that those that are 

responsible for criminal conduct are held accountable in our system. 

Thank you, Mr. Chairman. 

Senator SPECTER. Thank you, Senator Cardin. 

Senator Coburn? 

Senator COBURN. Thank you. 

Mr. Brownlee, I too want to compliment you for your service, one. 

It is extremely frustrating to be a physician in this country today 

and see all the problems we have in terms of access to care, lack 

of availability of drugs, drugs being used inappropriately. So looking at the problem that you had, I do not find any fault with what 

you did. But I have some questions that I would just like to have 

answered for me. 

As you looked at all this documentation, did you see a systematic 

marketing plan in all areas of the country that was designed to 

oversell this product and underrepresent it, its risks? 

Mr. BROWNLEE. I believe the evidence that was submitted to the 

court established the fact that the company as a corporate entity 

made a judgment that they were going to market this drug in a 

way that—and told doctors essentially that the basic premise is addicts would not like it. There was a graph that they used. 

Senator COBURN. But that was throughout the country? You did 

not see different areas throughout—different areas of the country 

where you saw more penetration and less penetration where you 

saw somebody doing this to a greater extent than other areas? And 

the question I asked you was: Was there a marketing plan that you 

actually saw that said that this was an intent to do this? 

Mr. BROWNLEE. Again, I think the evidence that was submitted 

certainly indicated that the company intentionally marketed the 

drug that it would be less addictive, less subject to abuse and diversion, and that was the evidence that has been submitted to the 

court. 

As far as all parts of the country, I mean, it was a company that 

certainly marketed the drug in all areas of the country, and so, yes, 

that marketing was for everyone. 

Now, some sales reps push harder than others. Some sales reps 

said different things. But you had a training manual that had 

these graphs in it, and I believe that—and some of other pieces of 

marketing that was company-wide. And so— 

13 

Senator COBURN. Well, if that is the case and these executives 

were responsible for that marketing plan, why are they not culpable along the lines that Senator Specter asked you? 

Mr. BROWNLEE. Well, I would say, first of all, that they have 

been held accountable. 

Senator COBURN. But in light of his question, in other words, you 

did not feel like you had the proof to convince a jury 100 percent 

that that was the case. 

Mr. BROWNLEE. That is correct. We looked at this evidence very 

carefully for a long period of time. It was our judgment that the 

charges that we brought—the felony for the corporate entity, the 

strict liability misdemeanor for the executives—was sufficient— 

well, was appropriate under the evidence that we had. 

Senator COBURN. So let me ask you another question. Why were 

the guys that were out doing this and violating what they knew 

this said, which is the label, why weren’t they prosecuted? 

Mr. BROWNLEE. I would answer that in two ways. First of all, the 

proof as to a particular individual, as we reviewed it, was difficult 

to establish beyond a reasonable doubt. As I gave the example to 

Senator Specter, there were some good defenses that because the 

corporation had training manuals, they had marketing materials, 

they had videos in which they were trained this way— 

Senator COBURN. But, Mr. Brownlee, these are professional sales 

representatives. The one thing they are taught everywhere in the 

country is the label is what counts and you cannot go beyond the 

label. They all know that. So whether they were trained to do it 

or not, they are also trained you cannot go beyond the label. So the 

question comes, if you do not have proof that the individual sales 

reps were actually doing it and you do not have proof that will convince a jury that the executives were, how do you know they were? 

Mr. BROWNLEE. Well, I think— 

Senator COBURN. And I am not disputing your case. I have said 

that. But how do you know they were? 

Mr. BROWNLEE. Well, in this case they pled guilty so they told 

us they were. So in that sense, they have admitted it. But it is a 

valid question. How could we have established at trial that this 

company committed a felony? It is my judgment if you look at all 

the pieces of that puzzle and you put it together, I would feel comfortable as a litigator standing in front of a jury and making the 

point this was a corporate culture, this was a company, look at the 

training manual, look at these call notes, look at these statements 

here, and you put it together. It may not equal individual culpability as to a particular person, but as a whole, I felt comfortable 

arguing before a jury that we had sufficient evidence to convict the 

corporate entity. 

This was a case where there was not that smoking gun, there 

was not that ‘‘Aha’’ moment where we found the e-mail that had 

the grand admission. It just was not that kind of case. It was kind 

of a deliberate process. It is one of the reasons why it took so long 

to build that kind of case. 

Senator COBURN. You have become pretty familiar with this 

drug, right? 

Mr. BROWNLEE. I have never taken it, but I— 

Senator COBURN. No, no. I am not accusing you of that. 

14 

[Laughter.] 

Senator COBURN. Hopefully you will not ever have to take it. 

Mr. BROWNLEE. Yes, sir. 

Senator COBURN. When taken properly, it is a very good drug. 

The question I have for you is: If you had significant pain problems 

today and your doctor offered you OxyContin because that is the 

best way to treat it, would you be afraid to take this drug? 

Mr. BROWNLEE. Senator, it is hard to say what I would personally do. 

Senator COBURN. Well, let me rephrase it a different way then. 

If I offered you three Lortab instead of an OxyContin 10, would you 

take that? 

Mr. BROWNLEE. Again, Senator, I have been very blessed, and I 

am not sure what a Lortab does either. 

Senator COBURN. It is oxycodone except it is not slow release. So 

here is the point I am trying to make, is we are talking about a 

drug that I personally have experience with as a physician and 

hundreds of thousands of other physicians do, too, that shows that 

it does a very good job. The problem is the abuse potential of it. 

One point I want to make clear in here is there is a great value 

to this medicine for me as a practitioner and thousands and thousands of other doctors. 

Senator SPECTER. Senator Coburn, how much more time will you 

need? 

Senator COBURN. I will stop with that if we are coming back 

again. Are we coming back again? I guess the point I want to make 

is this is not about the drug. This is about the actions. And I want 

to make sure we keep it separate because if we do to all the other 

abuse potential drugs, all the other Class II drugs, if, in fact, there 

is anything out there in terms of the marketing what we have done 

here, I may be without the kind of drugs that I need for patients 

in the future. So we need to separate the issue. 

Mr. BROWNLEE. Yes, sir. 

Senator COBURN. This has value in terms of this drug does have 

great value. It is also a very dangerous drug, and all narcotics are 

highly susceptible to abuse. 

Mr. BROWNLEE. If I may respond just on one issue, you are absolutely correct, and we were very careful to build this criminal case 

about the specific facts of the misrepresentation, the misbranding, 

and that is what is in the Agreed Statement of Facts, and that is 

what provides the factual basis for the plea. 

But I also believe, as I talked about in my press release and 

press statement, and the court talked about in his order, that there 

was significant harm caused by the misbranding of the drug. So 

much of it got out there that it gave addicts and those dependent 

and others the opportunity to abuse it. 

And so you are absolutely right, sir, that when we are in the 

courtroom conducting a Rule 11 colloquy, it is the facts that support the plea. But as Chief Judge Jones noted in his order, there 

was harm caused by this, and a lot of folks suffered. And it is one 

of the reasons why we pursued it as we did because of that harm. 

Senator COBURN. Well, my only concern is we should have been 

pursuing every physician who was writing a scrip for it when it 

was not needed, and that is the defect on the side of the Justice 

15 

Department and the DEA. Doctors make millions of dollars writing 

this drug when they should not be doing it, and we are not putting 

them in jail, and they need to be in jail for that because they are 

just as guilty as anybody in that company who might have marketed it wrong. 

Mr. BROWNLEE. I will say that my office—and I cannot speak for 

the entire Department, but—and we have 23 Federal prosecutors, 

so we are a pretty small shop. But we have taken an aggressive 

stance against physicians as well. We have prosecuted physicians. 

We recently convicted a physician out in Nevada who was—I think 

he was an OB/GYN—who was prescribing OxyContin to folks from 

southwest Virginia. They were actually driving to Nevada and getting the scrips and coming back and then selling them and taking 

them. So we reached out to Nevada and convicted him. 

Senator SPECTER. Thank you, Senator Coburn. 

Senator Sessions? 

Senator SESSIONS. Thank you. I don’t know why I thought about 

a case I prosecuted. It was a Fortune 500 case, a defendant from 

a Fortune 500 company, and it was so complicated. I had one of 

the best prosecutors in America involved in it and had one of the 

best defense lawyers, several great defense lawyers. And so we finally got a misdemeanor charge on one of the guys, and he was a 

professional lawyer. He said, well, we will tell you what you really 

want to know. Large amounts of money going through a foreign 

consulate and all kinds of things. It was of great interest to us. 

And he pled and testified, and we convicted the top guys for perjury and that sort of thing. 

And we got to court, and the judge chewed me out. He thought 

we had given too sweet a deal to the guy who pled guilty to get 

the other guys. And we never would have had a case. I mean, you 

have to work cases in difficult ways. It was an intense effort. 

But, first of all, with 24 assistants, you have a number of those 

on civil matters, a number of those on training matters, a number 

of those—so you do not have that many line prosecutors, do you? 

It is a fairly small office compared to the several hundred some of 

the big offices have. 

Mr. BROWNLEE. We are fairly small. Of those 23, four are civil, 

19 handle criminal work over three staffed offices, and then the 

U.S. Attorney. 

Senator SESSIONS. You have three different offices. 

Mr. BROWNLEE. Yes, Senator. 

Senator SESSIONS. Well, were you personally involved in this 

case? Did you work it? 

Mr. BROWNLEE. From the very beginning to the end. 

Senator SESSIONS. Well, that is unusual. A lot of the prosecutors 

just sit upstairs and let the assistants do all the work. So I congratulate you on that. 

Are you aware of any U.S. Attorney in recent years that has got 

a $600 million fine against a company? 

Mr. BROWNLEE. Gosh, Senator, I am sure someone out there has 

done better than me, but, again, I am not aware of that this year. 

Senator SESSIONS. That is one of the biggest fines I have observed, and I think first I just want to say that to you. 

Mr. BROWNLEE. Thank you, Senator. 

16 

Senator SESSIONS. First of all, you personally led this case. It 

could have been prosecuted in any district in America, I suppose. 

You stepped up, you led the fight, you really crushed their defense 

ultimately, and I am sure with this much at stake, they had some 

of the best lawyers in America involved in defending the case. And 

you got pleas on two of the top CEOs and a $600 million fine on 

the corporation. And 90 percent of the profit off this drug—Senator 

Coburn makes a valid point. It dawned on me a lot of this drug 

was legitimately sold. It is not in and of itself inherently an evil 

drug. So you got 90 percent of the profit. That means you got far 

more than the abused sales that occurred. I want to make that 

point. 

Second, we created, Congress did at some point in its history, a 

strict liability statute, and that means—I will summarize it and 

see if it is correct—that you simply proved that they ran the red 

light, that they violated the standards, and you do not have to 

show any criminal intent. You are just guilty. Is that correct? 

Mr. BROWNLEE. That is correct. We just have to establish that 

they were the responsible corporate officers of a particular company 

that delivers products under the Food, Drug, and Cosmetic Act. 

Senator SESSIONS. But to convict them of a felony, you have to 

have a specific criminal intent, and you had to prove it as to each 

one of the persons you would individually charge. Is that correct? 

Mr. BROWNLEE. That is correct, Senator. 

Senator SESSIONS. Now, with regard to prosecuting a corporation, 

you can aggregate knowledge, can you not? In other words, you can 

prove this officer knew this, this one knew that, this one knew this, 

and as a whole the corporation was acting unlawfully, and you can 

sue the corporation. It is not an entity. It does not have the same 

constitutional rights that individuals have. 

Mr. BROWNLEE. That is correct. It would obviously have a trial, 

if it went there, and have all its rights in many ways, although I 

am not so sure they actually have grand jury protection. I think 

that is still a debatable issue. But you do aggregate or you do look 

at the actions of all the players, all its agents, when assessing corporate liability. And that is what we have done. 

Senator SESSIONS. And whereas it may not be enough to prove 

personal criminal intent, felony knowledge on an individual, that 

information can be aggregated as proof that the corporation as a 

whole had knowledge and the corporation can be held liable. 

Mr. BROWNLEE. That is correct. 

Senator SESSIONS. And that is what you did on the corporation. 

Mr. BROWNLEE. That is what we have done on the corporation. 

Senator SESSIONS. Now, to convict the officers of a felony—and 

we have got civil libertarians on this Committee that think you 

cannot prosecute terrorists, you know. They want to give them 

every right in the world. But anybody that is a—I should not say 

that. Let me withdraw that. 

[Laughter.] 

Senator SESSIONS. That is not a fair statement. We do have a 

great deal of interest in seeing that even terrorists have a fair 

shake and the law is properly applied. 

But I guess what I am saying with regard now to those individuals defendants, you have to prove to charge them with a felony 

17 

that they had specific knowledge of the standards that were expected of them and that these standards were not being adhered 

to and that they authorized them in some fashion. Is that correct? 

Mr. BROWNLEE. The Government would have had to establish beyond a reasonable doubt that whichever particular individual you 

charged had the intent, showed the intent to defraud or mislead. 

Senator SPECTER. Senator Sessions, how much more time will 

you require? 

Senator SESSIONS. I am about through. 

So you felt you did not have that knowledge, that proof? 

Mr. BROWNLEE. This prosecution team reviewed, as I stated, millions of records, conducted hundreds of interviews, and the charges 

that we brought were the charges we felt we could establish and 

were the proper charges under DOJ policy. 

Senator SESSIONS. Now, the judge in sentencing— 

Senator SPECTER. Senator Sessions, how much more time do 

you— 

Senator SESSIONS. One minute. The judge in sentencing did give 

more probation than you asked for, but he could have given custody. All you could do was make a recommendation. If the judge 

had felt a custody sentence was appropriate, he had every right to 

impose the full 6 months in jail, did he not? 

Mr. BROWNLEE. This was conducted under Rule 11 (c)(1)(C), and 

the Government agreed not to seek active incarceration. The judge 

could have rejected the plea agreement if he felt that these sentences and the plea itself was inappropriate. 

Senator SESSIONS. But he found that he did not think, based on 

the facts there, that prison was appropriate. 

Mr. Chairman, I do not dismiss your concerns, and maybe we 

need to review the law also to see if it needs to be tightened up. 

But I just feel like this fine young United States Attorney committed several years of his life to this case and did something nobody else had done: put an end to this OxyContin abuse, which is 

an absolute national problem. 

I thank you for having the hearing. 

Senator COBURN. Mr. Chairman, I would just ask unanimous 

consent—he is our Chairman today—that the full opinion of Judge 

Jones and the court order be placed in the record. 

Senator SPECTER. Without objection, it will be included. 

Senator COBURN. And I would also note that there was no pleading of guilty to knowing by the executives of this company misbranding with intent to mislead. 

Senator SPECTER. Mr. Brownlee, thank you very much for your 

service. 

Mr. BROWNLEE. Thank you. 

Senator SPECTER. It is a tough job, but it is a very rewarding job, 

and we appreciate what you are doing. 

Mr. BROWNLEE. It is a honor. Thank you, Senator. 

Senator SPECTER. I call the second panel now. Will you step forward? Will you, ladies and gentlemen, stand please and raise your 

right hands? Do you solemnly swear that the testimony you will 

give before the Senate Judiciary Committee will be the truth, the 

whole truth, and nothing but the truth, so help you God? 

Ms. SKOLEK. I do. 

18 

Mr. KHANNA. I do. 

Dr. WOLFE. I do. 

Ms. PAGANO. I do. 

Mr. MCCLOSKEY. I do. 

Dr. CAMPBELL. I do. 

Senator SPECTER. You may be seated. 

We have a very limited amount of time, so I am going to ask all 

of you to stay right within the time limits, and we begin with Ms. 

Marianne Skolek, who began looking into Purdue Pharma after the 

death of her daughter, who took OxyContin. Thank you for joining 

us, Ms. Skolek, and the floor is yours. 

STATEMENT OF MARIANNE SKOLEK, LPN, MYRTLE BEACH, 

SOUTH CAROLINA 

Ms. SKOLEK. Thank you, Senator Specter. My name is Marianne 

Skolek. I had a beautiful 29-year-old daughter named Jill. She had 

the misfortune of being prescribed OxyContin in January 2002 and 

was killed on April 29, 2002. Jill left behind her son, Brian, who 

was 6 years old at the time of his mom’s death. Brian is with me 

in the Senate today. 

Why did a $9 billion privately held pharmaceutical corporation 

take the life of my precious daughter? My work against Purdue 

Pharma for the past 5 years initially focused on J. David Haddox, 

dentist turned psychiatrist and senior medical director of Purdue 

Pharma. I also focused on Robin Hogen, former public relations 

spokesman for Purdue Pharma. 

In 1996, the American Academy of Pain Medicine and the American Pain Society issued a set of guidelines for the use of opiates 

in the treatment of chronic pain. These guidelines are referred to 

as a ‘‘consensus statement.’’ The statement leaning toward a more 

liberal use of opiates was adopted just as the marketing push for 

OxyContin began. This consensus statement was produced by a 

task force, which was headed by J. David Haddox, former president 

of the American Academy of Pain Medicine, who was senior medical advisor for Purdue Pharma, the maker of OxyContin. Haddox 

was quoted as saying that ‘‘the point was to gather consensus. If 

you are going to do this, this is how it should be done.’’ There was 

question as to whether it was ethical for Haddox to be associated 

with a pharmaceutical manufacturer to guide the formation of a 

document that would play a key role in promoting the use of products made by the company Purdue Pharma. 

When OxyContin was introduced on the market, it was intended 

for the treatment of cancer patients, and they were losing the patent on MS Contin. At one point, in the greed and sheer evil of Purdue Pharma, they intended to market OxyContin to OB/GYN patients. I flooded the country with e-mails and faxes to Attorney 

Generals and the media reporting that we had had enough devastation in the country without addicting infants to OxyContin. This 

marketing ploy was terminated by Purdue Pharma. 

Pain patients from various pain societies will speak of the merits 

of OxyContin and their quality of life being restored because of the 

drug. These pain societies throughout the country are funded by 

Purdue Pharma. Let the pain patients not a part of any funded 

pain society of Purdue Pharma speak about the quality of life they 

19 

have after becoming addicted to OxyContin—and when their physicians refuse to renew prescriptions for the drug and they go on the 

street to buy the drug because they can’t kick the habit of this less 

addictive drug. Ask the FDA and the DEA why OxyContin is in 

such plentiful supply on the streets all over the country. 

Jill and thousands of victims of an out-of-control, greedy pharmaceutical company headed by three convicted criminals marketed 

OxyContin as less likely to be addictive and abused. There are assertions that the only victims in the criminal activities of Purdue 

Pharma were the physicians who were misled by Purdue Pharma’s 

sales representatives. The physicians, who were used as pawns by 

Purdue Pharma, were not ingesting a powerful narcotic that was 

being marketed as less likely to be addictive or abused. The patients were ingesting OxyContin and were becoming addicted and 

dying. If patients aren’t victims of Purdue Pharma’s criminal activities, tell me what they should be called. 

The addiction and loss of lives because of OxyContin continue to 

impact every State in the country every single day. The far-reaching consequences of the criminal activity of Purdue Pharma did not 

end in 2001 or 2002 as they would like it to be believed. No one 

can turn the clock back. This has been allowed to become a national crisis because there was no conscience in the marketing of 

OxyContin; there was only greed. 

We all hear on the news every day about individuals who work 

for Government agencies or private industry who embezzle funds. 

Purdue Pharma has been found criminally responsible for marketing OxyContin which resulted in death and addiction. Is it justice to have these convicted criminals—these monsters—fined an 

amount of money that is very well afforded by them? Or will the 

Senate send a message that because of the magnitude of the crime 

committed, they deserve to be further investigated by the Senate? 

Anything that is imposed against these convicted criminals will 

not give us back Jill, but I will guarantee that Purdue Pharma will 

never forget the name Jill Skolek. When I began my work at exposing these three convicted criminals and Haddox and Hogen, I told 

Hogen that you messed with the wrong mother. And they did because my work is not over. 

I want to know why the FDA allowed OxyContin to cause such 

destruction to the lives of scores of innocent victims. I want to 

know why 12 warning letters were sent by the FDA to Purdue 

Pharma about their marketing of OxyContin and to this day they 

are not required to put ‘‘highly addictive’’ or ‘‘addictive’’ on the label 

of the drug. I want to know why the FDA deleted so many of my 

e-mails about the marketing of OxyContin until this last month. I 

want to know why Curtis Wright while employed by the FDA 

played an intricate part— 

Senator SPECTER. How much more time will you need? 

Ms. SKOLEK. One more minute. In the approval of OxyContin 

and then was hired by Purdue Pharma. I want to know why Attorney General Blumenthal of Connecticut’s Citizen Petition which requests strengthened warnings for OxyContin is still sitting at the 

FDA—without any action—since January 2004. I want to know 

how Rudy Giuliani could be the ‘‘big star’’ hired by Purdue Pharma 

to play down the abuse and diversion of OxyContin and then get 

20 

paid by the DEA for work performed for them. I want to know why 

the Sackler family has not been held accountable for their involvement. 

Eventually Purdue Pharma will introduce another blockbuster 

drug similar to OxyContin, as they did with Palladone. Palladone 

was removed from the market after a couple of months. My advice 

to Purdue Pharma is when you are ready to introduce another drug 

such as OxyContin or Palladone, look behind you, because I will be 

right there. 

I will be working at having Howard Udell disbarred for his criminal activities and Paul Goldenheim’s medical license revoked for 

what amounts to white-collar drug trafficking. I will accomplish 

this—hopefully with the help of Attorney General Blumenthal. Do 

not doubt me at not being successful at achieving this. 

Her name was Jill Carol Skolek. She did not deserve to be prescribed OxyContin and die because of the criminal activities of individuals of Purdue Pharma. Please give my family justice and investigate the criminal activity of Purdue Pharma. 

Thank you, Senators, for giving me the opportunity to speak for 

thousands of victims of an out-of-control pharmaceutical corporation. 

[The prepared statement of Ms. Skolek appears as a submission 

for the record.] 

Senator SPECTER. Thank you very much for your testimony, Ms. 

Skolek. I am very sorry about your daughter. 

Ms. SKOLEK. Thank you very much. 

Senator SPECTER. This Committee and the Senate has no authority, no power, once the case is concluded. It is what we call res judicata, double jeopardy. But there are important principles, which 

is the reason we are proceeding with this hearing. Thank you. 

Ms. SKOLEK. Thank you. 

Senator SPECTER. We now turn to Professor Khanna, S.J.D., from 

Harvard Law School, Professor of Law at the University of Michigan. 

Thank you for joining us, Professor Khanna, and the next 5 minutes are yours. 

STATEMENT OF VIKRAMADITYA KHANNA, PROFESSOR OF 

LAW, UNIVERSITY OF MICHIGAN LAW SCHOOL, ANN ARBOR, 

MICHIGAN 

Mr. KHANNA. Thank you, Chairman Specter, and thank you very 

much for inviting me to testify today. I will focus my comments 

today on basically two questions. 

The first is: Are criminal sanctions on executives something we 

should consider when executives knowingly introduce defective and 

dangerous products into the market? And my short response to 

that question is yes, with the qualification that we should try to 

exhaust the deterrent effect of civil penalties first. 

The second question I will address briefly is: If we do decide to 

go forward with criminal sanctions on executives, then what safeguards should we begin to think about putting in place to help reduce the cost of criminal— 

Senator SPECTER. Professor Khanna, pull the microphone a little 

closer to you. 

21 

Mr. KHANNA. Sorry. What sort of safeguards should we bring 

into place to help reduce the cost of criminal liability on executives? 

And my response here is that a well-defined and -implemented 

mental state requirement, such as a knowledge requirement, would 

be ideal with good examples of what satisfies this particular mental 

state requirement. Also, I would suggest some adjustments to the 

liability that corporations bear that I will hopefully be able to discuss in the next few moments. 

Turning to the first point, whether a case can be made for imposing criminal liability on executives, I would say that yes, there can 

be a case made for that, but before doing so, one should try to exhaust the deterrent effect of civil penalties. The reason I sort of 

mention this is that in this area we frequently rely more on corporate civil liability rather than direct liability on executives. The 

reason for this usually is that executives do not have the assets to 

pay for the large amounts of harm that might be caused through 

the corporate products they are selling. If they do not have the assets to pay for it, their incentives to sort of take appropriate care 

are somewhat less. 

The corporation, of course, has more assets, and it can also monitor its employees, so in some respects we deputize the corporation 

to monitor what its employees are doing to prevent them from engaging in harmful activity. 

Of course, there are some kinds of harms that are so large, such 

as drugs that induce death or serious injury, that sanctions on the 

corporation will not be sufficient. They may not also have the assets to pay for all the harm caused. In those cases, we may go one 

step further and decide to impose liability on executives, for example, criminal sanctions. 

Senator SPECTER. Were the sanctions sufficient in this case? 

Mr. KHANNA. Well, clearly, when the harm caused is death and 

serious injury, it is quite likely that most corporate assets will not 

be sufficient to pay for the harm caused, especially given the numbers that are suggested here. I am not familiar with all the people 

who have been injured and died from using OxyContin, but if the 

numbers are as suggested in the news reports, then we are in that 

range. 

Moving sort of quickly on to talking a little bit about safeguards, 

if we decide to go forward with criminal liability, my primary concerns with imposing criminal liability are largely the effects they 

are likely to have on who decide to become executives at firms that 

produce these sort of high-risk products. I can imagine a lot of good 

people, good, conscientious, careful people, who might become a little reluctant to take on the position of an executive at a firm that 

is producing high-risk products because of the fear of criminal liability. The primary concern that comes to me from that is that if 

the good, conscientious, and careful people refuse to be executives 

of these firms, then who do become the executives of these firms? 

Perhaps people not so careful, not so conscientious may be a little 

bit more tolerant of risk. That might lead to more dangerous products being marketed and in commerce in the U.S. 

One way to address that particular concern, of course, is to have 

a high mental state requirement; that is, to only target liability to 

22 

those people who were knowingly involved in marketing dangerous 

products or defective products to the U.S. public. 

Of course, if you have a nice high mental state requirement like 

knowledge, one additional concern is raised, which is, if it is very 

hard to prove or difficult to prove that executives knew about a 

particular product’s defectiveness or dangerousness, then many executives might find it in their interest not to learn much about 

what are the safety risks of their products. It may prove to them, 

at least in their mind, to be a safer course to follow to not know 

much; that is, to have their head in the sand, essentially. 

Senator SPECTER. A corporate executive deliberately decides not 

to know much, does that expose him to some liability for failing to 

do his duty? 

Mr. KHANNA. It does under the willful blindness standard. The 

only difficulty is that that is a rather difficult standard to prove. 

Senator SPECTER. They are all hard to prove. 

Mr. KHANNA. They are all hard to prove. That is true. But it 

raises the same similar concern that if you have a mental state requirement that is uncertain and difficult to prove, then the careful 

people will probably be a little bit reluctant to take on a position 

that exposes them to that kind of uncertainty, especially when the 

consequences are spending time in jail. 

But there are ways to address the— 

Senator SPECTER. How much more time will you need? 

Mr. KHANNA. Probably about 1 minute, if that is OK. 

Very briefly, there is a way to address the concern that executives may stick their heads in the sand, which is to impose liability 

directly on the corporation in addition to liability on the executive. 

And that may induce a corporation to put in place measures to 

gather information about product risk. Once the corporation has 

measures in place, it is very difficult for executives to claim that 

they did not know what was going on when reports are passing by 

their table on a regular basis about product risk. 

With that, I will conclude my testimony, and I thank the Committee for allowing me to testify here today. Thank you. 

[The prepared statement of Mr. Khanna appears as a submission 

for the record.] 

Senator SPECTER. Thank you very much, Professor Khanna. 

We now turn to Dr. Sidney Wolf, Director of Public Citizen’s 

Health Research, adjunct professor of medicine at Case Western 

Reserve University. Thank you very much for joining us today, Dr. 

Wolfe, and we look forward to your testimony. 

STATEMENT OF SIDNEY M. WOLFE, M.D., DIRECTOR, HEALTH 

RESEARCH GROUP OF PUBLIC CITIZEN, WASHINGTON, D.C. 

Dr. WOLFE. Thank you, Senator Specter. I will discuss three 

issues that have arisen from the highly touted prosecution by the 

Justice Department of the Purdue Frederick Corporation for ‘‘misbranding Oxycontin with the intent to defraud and mislead the 

public.’’ The issues highlight the double standard in this country 

for prosecuting corporations and individual corporate officials 

whose intentional activities result in hundreds of deaths, versus 

the much more stringent penalties imposed on non-corporate individuals who serve long jail sentences for activities resulting in a 

23 

tiny fraction of the damage done by such corporate criminal activity. 

The first issue is the prosecution of Purdue and subsequent financial penalties that were inexplicably and unacceptably limited 

to a time period—1996 to 2001—ending well before the company 

ceased engaging in illegally misbranding Oxycontin. The evidence 

for this is that on January 17, 2003, the FDA sent Purdue a warning letter concerning clearly illegal promotion of OxyContin during 

late 2002, almost a year after the curtain dropped on the period for 

which they were prosecuted. And the nature of the violations 

then—again, after December 31, 2001—was almost exactly the 

same as those in the earlier periods of time. 

The beginning of the letter, which was, interestingly, to one of 

the three company officials who were convicted of misdemeanors— 

Michael Friedman—is reproduced here, and I will just read a couple sentences from it. 

First, it states that this is clearly a violation of the Food, Drug, 

and Cosmetic Act. ‘‘Your advertisements thus grossly overstate the 

safety profile of OxyContin by not referring in the body of the advertisement to serious, potentially fatal risks associated with 

OxyContin, thereby potentially leading to prescribing of the product based on inadequate consideration of the risk. In addition, your 

journal advertisements fail to present in the body of the advertisement critical information regarding limitations on indicated use, 

thereby promoting OxyContin for a much broader range of patients,’’ and so on. 

In addition to this, under the first point about the limited period 

of time of the prosecutions, the ending period of prosecution, there 

was a nonprosecution agreement signed by the three individual corporate criminals and the company itself and agreed to by the Justice Department that prevents any further prosecution of the company or the three guilty officials for any activities before May 10, 

2007—and, implicitly, after December 31, 2001, including the one 

illegal activity I just cited. This nonprosecution agreement includes 

the promise not to seek additional criminal penalties or forfeiture 

actions during this period of time. And I include in the testimony 

from their own statements the nature of this nonprosecution agreement. 

The second point is the criminal penalties paid by the company, 

said to be 90 percent of their profits on Oxycontin, were apparently 

limited to the 1996 to 2001 interval even though much of the subsequent 2002 to 2006 sales and profits were unequivocally derivative of the earlier—and subsequent—illegal promotional activities. 

I include a chart in here of the sales. The Justice Department 

has stated the financial penalties of $634 million that they were assessed was 90 percent of the profits, which would mean that the 

profits during the interval ending in 2001 December were about 

$700 million. Aside from the obvious, continuing impact of the illegal pre-December 2001 promotional activities, as evidenced by the 

massive continued prescribing, the peak years of sales were 2002, 

2003, and 2004, after the end of this period. The further illegal activity that the FDA caught them at adds to the need for their having gone farther. 

24 

In an affidavit in this case signed by the IRS, they themselves 

said that going up through September 2004, there were $2.67 billion in profits, and there are more since then. The standard for the 

Government forcing a company to disgorge profits is that the 

money was obtained through illegal means. The illegal promotional 

activities of Purdue in 2002 were clearly successful in continuing 

the earlier illegal activities, as evidenced by the peak year of sales 

being 2003. The subsequent sharp decrease in sales, with 2006 

sales being only 37 percent of the peak sales year in 2003, confirms 

that once, belatedly, illegal promotion was finally stopped, the illgotten sales and profits dropped significantly. 

And the final point, no company official is going to jail—and this 

is what you have focused on, Senator Specter—because there was 

no felony conviction of any company person, just of the corporation 

itself, which cannot go to jail. U.S. Attorney Brownlee has said that 

the many prosecutors ‘‘spent years culling through millions of documents, looking for the evidence. And what they did is they were 

able to piece together a corporate culture that allowed this product 

to be misbranded with the intent to defraud and mislead.’’ 

Senator SPECTER. Dr. Wolfe, how much more time will you need? 

Dr. WOLFE. A minute, at the most. Why was it that there were 

no individual humans who carried out the deadly missions of the 

‘‘corporate culture’’ such as the admitted activities—and I quote 

from their own statement: ‘‘Purdue supervisors and employees 

sponsored training that used graphs that exaggerated the differences...’’ and so on. They had caught people doing illegal kinds 

of things, and yet these people were never criminally prosecuted 

and put in jail. This is from their own press statement. 

Why is it that no individual who had engaged in ‘‘misbranding 

OxyContin with the intent to defraud and mislead the public’’ could 

be found and sent to jail? In 2002, a physician who recklessly dispensed prescriptions for OxyContin was convicted and subsequent 

sentenced for his crime. James Graves, M.D., former naval flight 

surgeon, was sentenced to 63 years in jail for manslaughter for patients overdosed on OxyContin. He was imprisoned in Santa Rosa 

County Jail in Milton, Florida, pending appeal. Other non-physicians who illegally sold OxyContin have also received jail sentences. 

Employees of Purdue orchestrated an illegal scheme to promote 

the same drug—OxyContin—as being safer, more effective, and less 

subject to abuse than it actually was, and pushed— 

Senator SPECTER. Dr. Wolfe, we are going to have to move on 

now. Very limited time. 

Dr. WOLFE. Just 10 more seconds, really. Two more sentences to 

go. And pushed hundreds of millions of prescriptions for the drug 

based on the false pretenses of their promotional campaigns. 

Why are there no manslaughter charges, no jail sentences, and 

such relatively low amounts of financial penalties? Is it perhaps because Purdue has the money to hire Rudy Giuliani and the best 

white-collar criminal defense lawyers to minimize the damage to 

itself and its executives? If this does not represent a double standard of justice, what does? 

Thank you. 

25 

[The prepared statement of Dr. Wolfe appears as a submission 

for the record.] 

Senator SPECTER. Thank you very much, Dr. Wolfe. 

Our next witness is Police Officer Virginia Pagano from the 26th 

Police District in Philadelphia, DEA certificate for outstanding contribution in the field of drug law enforcement. 

Thank you for joining us, Officer Pagano, and we look forward 

to your testimony. 

STATEMENT OF VIRGINIA PAGANO, POLICE OFFICER, PHILADELPHIA POLICE DEPARTMENT, NARCOTICS BUREAU, 

PHILADELPHIA, PENNSYLVANIA 

Ms. PAGANO. Thank you, Senator. Good afternoon to the Senate 

Committee. I am honored to be here today to speak to you on behalf of the Philadelphia Police Department. I will speak to you 

today on the devastation caused by OxyContin on family, friends, 

and the communities that we serve. 

I have been a police officer in the city of Philadelphia for 20 

years, and my current assignment is with the Philadelphia Police 

Department, Narcotics Bureau’s Drug Education Program entitled 

‘‘H.E.A.D.S.–U.P.’’ The Heads-up Program has joined together law 

enforcement, family members, unfortunately, who have lost loved 

ones, and the recovery community. The response to this program 

has been overwhelming. 

Since its inception, the Heads-up Program has been viewed by 

approximately 449,000 people at 3,032 different locations. We have 

been across the State of Pennsylvania, New Jersey, Delaware, Massachusetts, and Connecticut. The program for the past 6 years has 

exposed me to a completely different aspect of law enforcement: the 

education side. It is of the utmost importance to educate not only 

the law enforcement officers that I work with, but the general public so that they can better understand the devastation that is 

caused by drug addiction. 

The abuse of OxyContin is a problem that we cannot arrest our 

way out of. It will primarily require education, along with treatment and enforcement. We must educate every child before they 

pick up that first drug because after that, we are just simply playing catch-up. 

I am inspired every day to continue the Heads-up Program, and 

I often listen to story after story of how addictive OxyContin is. 

The story seems to stay the same, but the faces continue to change. 

Whether black, white, Hispanic, or Asian, no matter what religion 

or political party, OxyContin has crossed all boundaries. 

It seems to me that among our young people, ‘‘prescription 

drugs’’—namely, OxyContin, which is one of the most commonly 

abused by our teens—just sounds safe, and yet the progression 

from Oxy to heroin is a very common one. 

One young lady’s story always comes to mind, and I tell these 

stories day in and day out. She stated to me that she started using 

Percocet at the age of 13. She couldn’t get Percocet one night, and 

someone suggested Oxy. Then one night she didn’t have enough 

money to get OxyContin, so she tried heroin, and as she says, that 

is when her life changed forever. At 18 years old, this young lady 

26 

is now in treatment because of one little pill. But so many more 

are not as fortunate. 

The abuse numbers are chilling. OxyContin addiction has increased dramatically over the past 10 years, by 300 percent in the 

United States alone. 

In 2006, this past year’s abuse of OxyContin among eight graders 

drastically doubled—increasing 100 percent over the last 4 years. 

Fifty-six percent of our teens agreed that prescription drugs are 

now easier to get than any illegal drug on the street. 

I could spend the next 5 hours talking about statistics—300 percent, 100 percent, 56 percent. But today I would like to concentrate 

on the number ‘‘one.’’ Over the past 61⁄2 years I have met countless 

families who have lost a son, a daughter, a husband, or a mother, 

and what I know is 300 percent, 100 percent, 56 percent means 

nothing. The only thing that matters is that ‘‘one’’—the ‘‘one’’ who 

is and will always be missing from that family from OxyContin addiction or overdose. 

Because of these addictions, we continue to meet family after 

family who live every day thinking about what it would be like if 

their loved ones were still here, always asking themselves, ‘‘Who 

would they be today? ’’ 

The ‘‘cost’’ I believe you will never be able to measure. The son 

who died from Oxy might have held the cure for cancer; the daughter will never be able to walk down the aisle with her father. A father who was selling OxyContin is sitting in prison, and the mother 

who was originally prescribed the drug because of her pain from a 

car accident is now addicted and can no longer care for her children. 

Too many people realize too late that OxyContin abuse could lead 

to incredible losses—lost families, lost friends, lost jobs, lost opportunities, and lost lives either to the lifelong addictions or overdose. 

The $634.5 million in fines and three executives who pled guilty 

for ‘‘misbranding’’ the drug as a ‘‘low-risk’’ painkiller will never 

equal the ‘‘one’’ who has been lost to these addictions or overdoses. 

For that ‘‘one’’ who has been lost will affect a whole family, a whole 

community, a whole generation. 

There are many, many faces that have been entrusted to us with 

the Heads-up Program, and my only hope is that somehow ‘‘one’’ 

story, ‘‘one’’ face will somehow save another— 

Senator SPECTER. Officer Pagano, how much more time will you 

need? 

Ms. PAGANO. Ten seconds.—from the pain and never-ending 

heartache that comes with addiction, because dead is dead whether 

it comes at the hands of illegal drugs or prescription drugs like 

OxyContin. 

When I hit the street tomorrow, I will tell you honestly, the 

abuse is not over from Oxy, as the Senator said. 

Thank you. 

[The prepared statement of Ms. Pagano appears as a submission 

for the record.] 

Senator SPECTER. Thank you very much, Officer Pagano. 

We now turn to Attorney Jay McCloskey, a very distinguished 

record in the U.S. Attorney’s Office in Maine, held the position as 

Assistant for 13 years and then was the U.S. Attorney for 8 years. 

27 

Thank you for coming in from Portland, where you now practice 

law, to join us here. The floor is yours. 

STATEMENT OF JAY P. MCCLOSKEY, FORMER UNITED STATES 

ATTORNEY, DISTRICT OF MAINE, MCCLOSKEY, MINA, 

CUNNIFF & DILWORTH, LLC, PORTLAND, MAINE 

Mr. MCCLOSKEY. Thank you very much, Senator, and thank you 

for allowing me to testify today. I served as the United States Attorney, as you said, for the District of Maine from 1993 to 2001 

and, prior to that, as an Assistant United States Attorney in that 

office from 1980 to 1993. I was an active drug prosecutor and prosecuted literally dozens upon dozens of cases and individuals as an 

Assistant United States Attorney. 

In late 1999 and early 2000, I became aware of a growing problem in Maine of prescription drug abuse that included, but was not 

limited to, OxyContin. That prompted me in February 2000 to send 

a letter to all Maine practicing physicians warning them about the 

abuse. Shortly thereafter, in March 2000, I received a call from 

Purdue’s medical director, asking me to meet and discuss the problem, but I deferred his request. 

At the time, law enforcement officials were just discovering the 

extent of the opiate abuse problem, and I didn’t see what the manufacturer could provide in the way of helping law enforcement. 

However, as I got into the problem, I came to realize that traditional law enforcement was not going to solve this problem and 

really was not going to even make a dent. I also came to realize 

that Purdue Pharma could actually help law enforcement reach 

health care providers to whom law enforcement generally did not 

have access. 

In September of 2000 I organized a meeting attended by Federal, 

State and local enforcement, and Purdue executives. Rather than 

sending lower-level executives, Michael Friedman, the company’s 

CEO; Howard Udell, the chief legal officer; and the Purdue medical 

director attended this meeting and pledged to do whatever they 

could to help. Howard Udell specifically said to me—and I remember this very distinctly—‘‘We want to do what is right.’’ That is 

what he said to me directly as a United States Attorney, and I remember those words. But I did not give them much moment at 

that point. But as I watched what Purdue did and what they tried 

to do, I recalled those words later on. 

I worked with Purdue Pharma as the United States Attorney because I saw that the company wanted to stop the abuse and diversion of drugs, and it was able to help law enforcement do that. 

They allowed me and others in my office to make unrestricted presentations to doctors about the dangers of overprescribing. That was 

sort of the chief problem at the time. It was doctors overprescribing, not realizing that there were drug seekers in the office, 

and the only way to reach large numbers was at these medical 

seminars. 

Purdue offered to provide, at no cost, tamper-resistant prescription pads. This was very helpful, and they helped develop those, 

and they helped distribute those. They developed brochures to send 

out to all Maine doctors, and I think across the Nation, about the 

dangers of drug abuse. And they showed me those brochures as 

28 

United States Attorney and gave me an opportunity to change 

some of the information in there as I saw fit in terms of making 

doctors and pharmacists aware of the problems. These were the 

sort of steps that Purdue took while I was United States Attorney. 

In April 2001, I told Purdue executives that drug agents in 

Maine had discovered that OxyContin 160’s were being sold on the 

street. I told them that if OxyContin 160 was abused, it could result in death almost immediately. 

A couple of weeks later, one of the executives called me and, 

without any prompting from me, said, ‘‘We are going to take that 

product off the market.’’ I can tell you, Senator, at the time—this 

was the early stages of the OxyContin problem—that was very impressive, that a company offered to take a legitimate product off 

the market. And there were people who did not want that to happen, especially in the cancer community. 

After I left the Government in 2001, I continued to work with 

Purdue as a consultant, and I counseled them and worked with 

them to implement continuing programs to try to prevent the abuse 

and diversion of OxyContin. In each and every occasion, they took 

my recommendations. The executives saw that it was carried out. 

And I was persuaded many, many times that these executives 

wanted to do the right thing, as the chief legal officer said. They 

wanted to stop the abuse and diversion of OxyContin, and everything they did established that to my satisfaction. They marked the 

drugs for law enforcement so they could tell where they were coming from. They stopped the distribution in Mexico when there was 

a problem with diversion in Mexico. Everything you could ask a 

company to do in terms of trying to stop illegal diversion, they did. 

Now, I do not condone any of the misstatements by the sales representatives of any of the marketing problems. But it clearly did 

not reach to the higher levels of the organization. I was involved 

for a couple of years in very much detail and heard nothing about 

the marketing— 

Senator SPECTER. Mr. McCloskey, how much more time will 

you— 

Mr. MCCLOSKEY. Another minute, Senator. The marketing problems that have resulted in the criminal plea. 

So I believe that this company did what any law enforcement officer would hope that a company would do whose product was being 

abused and diverted. 

Thank you. 

[The prepared statement of Mr. McCloskey appears as a submission for the record.] 

Senator SPECTER. Thank you very much, Mr. McCloskey. 

Our final witness is Dr. James Campbell, Professor of Neurosurgery at Johns Hopkins. 

Thank you very much for coming down today, Dr. Campbell, and 

we look forward to your testimony. 

STATEMENT OF JAMES N. CAMPBELL, M.D., PROFESSOR OF 

NEUROSURGERY, SCHOOL OF MEDICINE, JOHNS HOPKINS 

UNIVERSITY, BALTIMORE, MARYLAND 

Dr. CAMPBELL. Thank you, Senator Specter. I am Professor of 

Neurosurgery at the School of Medicine at the Johns Hopkins UniVerDate Aug 31 2005 14:37 Sep 08, 2008 Jkt 040884 PO 00000 Frm 00032 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\40884.TXT SJUD1 PsN: CMORC
29 

versity. I have dedicated my career, spanning 30 years, to the mission of decreasing the suffering associated with pain. 

My perspective also arises from my work with the American Pain 

Foundation. The APF is the Nation’s leading nonprofit organization 

devoted exclusively to serving the needs of people with pain. Purdue has contributed generously during the 10 years that the APF 

has been in existence. 

Let me begin by just indicating once again that chronic pain is 

a serious health problem that afflicts more than 50 million Americans. Untreated pain has serious consequences. This is not a benign condition. It interferes with sleep, work, family relations, and 

induces depression and anxiety. Patients with chronic pain become 

demoralized, and some even commit suicide. 

OxyContin is an opioid, and it is important to know that opioids 

continue to be the most effective class of medications there is for 

treatment of serious pain. 

OxyContin is a form of oxycodone, prepared in such a way that 

release into the bloodstream occurs in a steady manner over a 12- 

hour period of time. The FDA was correct when they originally, in 

1996, approved the statement in the OxyContin package insert— 

that is, the label—which said, and I quote from the package inset 

approved by the FDA: ‘‘Delayed absorption as provided by 

OxyContin tablets is believed to reduce the abuse liability of the 

drug.’’ 

The popularity of OxyContin among addicts stems from one simple fact: When the addict crushes an OxyContin pill, more 

oxycodone is available than when the addict crushes a typical immediate-release oxycodone pill. That this simple difference could be 

associated with a problem of enhanced abuse was not anticipated 

when the drug came out. No one in industry, no one in academia, 

and no one at the FDA anticipated the problems with OxyContin. 

OxyContin, as Senator Coburn pointed out in his comments, was 

always designated as a Schedule II medication. This is the strictest 

label for prescribed drugs. The Schedule II designation means that 

the drug has significant addiction and abuse risk. Every doctor 

knows this. I find it very unlikely that any competent doctor would 

not understand this simple fact. Whatever a sales representative 

might or might not say to a doctor, the doctor is obligated to know 

what he is prescribing. 

The numbers of prescriptions of OxyContin, unlike what Dr. 

Wolfe indicated, continue to climb, regardless of the adverse publicity associated with this drug and regardless of what clearly now 

are responsible marketing efforts. If criminal misconduct and reckless promotion were the sole drivers of OxyContin use, why would 

sales continue to increase after these alleged practices stopped? 

The answer is that OxyContin is a good pain drug. The drug sells 

itself because pain is in large part an unmet medical problem in 

America, and Americans are desperate to get relief of their pain. 

My heart, Senator Specter, goes out to those who have had family members that have suffered complications of OxyContin therapy 

or, for that matter, any drug therapy. I would like to point out that 

last year over 10,000 Americans lost their lives because of problems 

with NSAIDs, that is, drugs like aspirin and ibuprofen. I wish we 

had perfect drugs, and I hope for the day when we can offer relief 

30 

of pain with greater safety and efficacy. It is important to note, 

however, that the risk of OxyContin arises in large part from a deliberate and intentional misuse of the drug. When taken as directed by the physician, the risk of OxyContin is no greater than 

with any other opioid. 

I think you should know also that when the abuse problems with 

OxyContin became clearly apparent, Purdue undertook many programs to combat addiction. I identify in my written statement six 

programs initiated by Purdue. I know of no other company that 

sells opioids that has instituted as aggressive a program to fight 

abuse and addiction. 

In conclusion, we here should all acknowledge that many thousands, if not millions, of patients have benefited and continue to 

benefit from use of OxyContin. The majority of patients and doctors 

use this medication responsibly. Abuse is a major problem as well. 

Making the executives at Purdue out to be criminals does not engage us in a proactive fight against abuse; rather, casting Purdue 

and its leadership as criminals sends a chilling message to industry: ‘‘Develop drugs at your own peril. If problems develop with the 

drugs you develop, you may end up in jail.’’ 

I think we can do better, Senator Specter. I think we can send 

a proactive message, and that is that both pain treatment and drug 

abuse are major problems in our society, and we need academia, 

industry, and Government to work together to address these critical problems. 

Thank you. 

[The prepared statement of Dr. Campbell appears as a submission for the record.] 

Senator SPECTER. Thank you very much, Dr. Campbell. 

Well, I think there is a fair amount to be learned from the hearing which we have had today. I cannot quite agree with you, Dr. 

Campbell, about the lack of complicity of the manufacturers. There 

at least appears to be substantial evidence of misleading conduct 

on their part. They certainly have defended the case. I understand 

the risks of litigation, but there are serious, serious problems. 

Senator Coburn may well be right when he talks about doctors’ 

culpability, and I would not let anybody off the hook, and this need 

not be the last hearing on this subject with respect to doctors who 

have not prescribed the proper recourse. But there have been a lot 

of deaths, and to the extent that you have misuse of the drugs, the 

manufacturer cannot prevent that. There is no doubt about that. 

But there has to be an evenhanded approach by the Department 

of Justice, and the U.S. Attorney who appeared here is obviously 

an able man who approached this in very good faith and in a very 

professional way. So I believe that this kind of oversight is very important, and we have the benefit of Dr. Coburn’s medical expertise 

to provide an extra dimension, which he does on quite a number 

of subjects. 

Again, our regrets to you, Ms. Skolek. 

As I said, I am past due on excusing myself, and Senator Coburn 

is left in charge to keep the last questioning Senator in tow. 

Senator COBURN. I will. Thank you, Mr. Chairman. 

First of all, I would like unanimous consent to put some things 

in the record from the National Survey on Drug Use and Health, 

31 

which directly contradicts some of the testimony we have heard 

today. OxyContin accounts for less than 7 percent in 2005 and less 

than 4 percent in 2006 of the opioid abuse. 

Senator SPECTER. Senator Coburn, you are going to have to persuade the substitute Chairman to give you consent on that because 

I am leaving. 

Senator COBURN. Well, I am the substitute Chairman so I will 

grant such a thing. 

I will also ask unanimous consent that the breakdown of drugs 

of abuse from the National Survey on Drug Use and Health be 

placed in the record. 

Senator SPECTER. Senator Coburn, thank you for taking over the 

balance of the hearing. 

Senator COBURN. [Presiding.] I will be happy to. It will be the 

first it has happened from the far right. 

[Laughter.] 

Senator SPECTER. I refer to you most often as the ‘‘far correct.’’ 

Senator COBURN. ‘‘Far correct,’’ well, thank you. That is a nice 

compliment. 

I want to thank each of you for your testimony. You know, what 

we have in front of us is we are struggling with problems in our 

society. Lortab is a far greater problem out there than OxyContin, 

and I think you would probably agree. You see it a whole lot more. 

It is abused more. The problem is you cannot kill yourself as easy 

with it. That is the problem. 

We are struggling in our Nation and we are looking for things, 

and oftentimes I have the feeling that maybe somebody might have 

done something wrong, but maybe they did not. What if there was 

no intent on this case? You know, we had testimony there was not 

an organized marketing plan that was intended to violate the 

standard. There was nothing from the FDA that ever said they— 

there is no change in the label. The question is: Are we going to, 

regardless of what happened, continue to have medicines available 

for people that solve tons of problems? As noted by Dr. Campbell, 

we did have over 40,000 people die last year just from Motrin and 

Advil and aspirin and Aleve, complications of it. 

Every death is a tragedy, but we should not confuse good medicines that are abused and ruin what can be great success for individuals with serious pain. And my hope is with all the people that 

are suffering grief from the consequences of this, for all the doctors 

who have written a prescription when they should not, for those of 

us who assume that chronic pain is not as big a problem as it is— 

which we do every day. We fail to listen properly to those people 

who are having that. To our law enforcement who are struggling 

to try to control this thing, to the real absence of the problem—and 

here is the real problem. We do not have great drug treatment in 

this country, and instead, we incarcerate people rather than put 

them into a drug treatment center where we know two-thirds to 

three-quarters of them will come out of that and never use drugs 

again, but yet we incarcerate them. 

We need to change the channel on how we do that. We need to 

offer a helping hand to life back on people who are drug addicted. 

And we know it will work if we will invest in it. 

32 

So to all of you that testified, I want to thank you for making 

an effort to put forth your views. I would affirm that I think this 

is a valuable drug in our armamentarium to help people in this 

country, and until you can get us something better, we ought to 

continue to use it. 

I also agree with Senator Specter that we ought to look at the 

responsibility of physicians in this country on Class II drugs and 

do we need to change that. Do we need to restrict—as a physician, 

I hate that word, ‘‘restricting’’ my ability to practice medicine. But 

if my peers are not going to be responsible in distributing and writing prescriptions for these medicines, maybe we need to make them 

more responsible. 

The drugs that are on the street, somebody wrote a prescription 

for. They did not just get out there. They did get them out of the 

warehouse. Somebody wrote a prescription. 

I also am going to enter into the record a statement of Howard 

Shapiro evaluating the propriety and adequacy of the OxyContin 

criminal statement. That is at the request of an absent Senator, 

and I thank each of you for being here, and the hearing is adjourned. 

[Whereupon, at 4:16 p.m., the Committee was adjourned.] 

[Questions and answers and submissions for the record follow.] 

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