Thursday, January 19, 2012

TMAP: Texas Mediates Amiable Payoff - Johnson & Johnson Will Pay Texas $158 Million

Johnson & Johnson has agreed to pay $158 million to settle a lawsuit and put an end to the trial that began last Monday in Austin, Texas. The settlement was announced this morning; one and-a-half weeks into a trial that has led to a great deal of negative press regarding the illegal marketing practices undertaken by J&J to promote its antipsychotic drug, Risperdal.

The lawsuit was originally filed in 2004 by Allen L. Jones, a former investigator in the inspector general's office in Pennsylvania, who said he learned of Johnson & Johnson’s actions in Texas while investigating similar claims in his home state. Texas joined the case in 2006.

Sometime in 2002, Jones discovered that the state’s chief pharmacist, Steven Fiorello, had opened an unregistered bank account and was depositing into it checks written by drug companies. Jones traced the checks back to J&J/Janssen and to TMAP (Texas Medicaid Algorithm Project), which was adopted for use in Pennsylvania in 2003. The more he learned, the more his boss at OIG discouraged him from pursuing the investigation. At one point Jones’ boss agreed that obsession over the case was “ethically correct” but it was also “politically dead.”  In frustration, Jones reported his findings to Melody Petersen at the New York Times in February 2004. And for that – he was fired.

Today’s settlement comes after several consecutive days in which testimony placed the health care giant in a highly unflattering light. Yesterday, for instance, an expert witness for the state testified that J&J hid three studies showing some patients using Risperdal developed diabetes, even as the company claimed its antipsychotic did not cause the disease.

Johnson & Johnson and Texas were most certainly conducting ongoing negotiations while the trial was playing out in Austin. J&J’s offer of $158 million was good enough for Texas Attorney General Gregg Abbott to put an end to the proceedings. For Johnson & Johnson, this settlement also puts an end to the daily barrage of bad press coming out of Austin.

After seven years of legal maneuvering, the failure to continue the course for a few more days and get a jury verdict is certainly an unsatisfactory conclusion to many who have been closely watching this case.

For those of you who have been following this case and fully expected a guilty verdict – be happy that the travesty against Allen Jones has finally ended. You never needed a guilty verdict to to know that Allen Jones was vindicated and that Allen Jones was right all along. Allen Jones followed his moral compass and he was vindicated from the moment you learned the facts in this case.

UPDATE: Allen Jones statement regarding verdict

When asked if the $158 million settlement was enough to punish the drug companies he accused of wrongdoing, Jones said, “They’ll feel it, they’ll feel it, but I really believe that  this industry will not change its behavior until executives are prosecuted, until executives actually go to jail for they frauds the perpetrate.”
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Scott Bartz is the author of The Tylenol Mafia: Marketing, Murder, and Johnson & Johnson. He held various sales, marketing, and management positions during his eleven years in the pharmaceutical industry (7 years at J&J). He has gained a unique perspective on jurisprudence in this country during four years of research into the 1982 and 1986 Tylenol murders cases and through his ongoing involvement as the relator in the qui tam lawsuit, “United States of America, ex rel. Scott Bartz, vs. Johnson & Johnson, et al.” (Case 1:11-cv-10316-RGS)

Wednesday, January 18, 2012

Did the FBI “Blackball” All Documents From Tylenol Murders Investigation?

A document retrieved through a Freedom of Information Act (FOIA) request reveals a secret policy at the Federal Bureau of Investigation (FBI) to deny the existence of certain documents. This policy, called “blackballing,” was disclosed publicly for the first time yesterday in an article by Jason Leopold, and published on Truthout.
Malcolm X: A Life of Reinvention [Book]
Labor historian Trevor Griffey learned about "blackballing" last year when he filed a FOIA/Privacy Act request with the FBI to determine whether Manning Marable, a Columbia University professor who founded the Institute for Research in African-American Studies, sought to obtain the FBI's files on Malcolm X. At the time of his death last April, Marable had just finished writing an exhaustive biography on the late civil rights activist.

An FBI analyst eventually disclosed that a search on Marable turned up a single file that was "blackballed" per the "standard operating procedure." Griffey made another request for documents about the blackballing procedure, and the FBI turned over a five-page PowerPoint presentation that described the blackballing policy. It says the FBI would blackball a record if it “would disclose techniques and procedures for law enforcement investigations or prosecutions or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law.”

Instead of producing documents with the classified information blacked out, the FBI, through its blackballing policy, has been denying the existence of documents that actually do exist.

It appears that the FBI - in addition to invoking its blackballing policy to deny the existence of documents related to Malcolm X -  has also used this policy to deny the existence of documents related to the 1982 Tylenol murders investigation.

The FBI has used three different tactics to keep documents from the Tylenol murders case hidden from the general public. It has produced heavily redacted documents that provided no new information about the case. It has denied the existence of documents related to the Tylenol murders investigation. And it has denied FOIA requests, citing the FOIA exemption, pursuant to 5 U.S.C. 552(7), which exempts from disclosure: records of information that are part of an active and ongoing investigation.

Currently, the FBI will not honor FOIA requests seeking documents related to the Tylenol murders. However, this wasn't always the case. Many years ago, an individual who has asked to remain anonymous, sought and received documents about the Tylenol murders case through an FOIA request. (FBI’s list of document categories for the Tylenol murders here and here.) However, the documents he received were heavily redacted and some pages were simply blank.

Sometime after providing documents to at least one FOIA requester, the FBI apparently applied its blackballing policy to the Tylenol murders case.

Wally Kowalski, of the Department of Engineering at Pennsylvania State University, filed an FOIA request in 1999 seeking documents related to the Tylenol murders investigation. Instead of providing Kowalski with redacted documents, the FBI denied it had any documents at all. In fact, the FBI even denied having ever been involved in the Tylenol murders investigation. John M. Kelso Jr., the FBI Section Chief who responded to Kowalski’s FOIA request, said a search of the central records system at FBI headquarters “located no records indicating that your subject [the 1982 Tylenol murders] was the subject of an investigation by the FBI.”

Of course, the FBI’’s conjecture that it had not been involved in the Tylenol murders investigation was absurd. Obviously, the FBI would not fare well if anyone were to appeal such a ludicrous FOIA request denial. Moreover, the FBI would certainly not be able to usurp the FOIA provision that requires federal agencies to declassify documents more than 25 years old and of historical interest.

Under the federal Freedom of Information Act, the FBI should have declassified documents from the Tylenol murders investigation on the 25th anniversary of the case – but not if the case was being actively investigated.
TM Cover
The FBI announced on February 4, 2009 that the Tylenol murders investigation had been officially reactivated. However, as I detail in my book, The Tylenol Mafia, the FBI had already reactivated the Tylenol murders investigation just prior to the 25th anniversary, thus ensuring that documents from the case would remain classified. In July 2007, with the imminent declassification of documents from the Tylenol murders investigation drawing near, “retired” FBI Agent, Roy Lane, and “Sherry Nichols,” posing as a freelance journalist writing a book about the Tylenol murders, initiated an operation that looked an awful lot like a failed attempt to frame James Lewis for the Tylenol murders.

I filed an FOIA request in July 2011 seeking documents and information related to the 1982 Tylenol tampering incident. The FBI denied my request, stating:
The material you requested is located in an investigative file which is exempt from disclosure pursuant to 5 U.S.C. 552(7) exempts from disclosure: records of information compiled for law enforcement purposes, but only to the extent that the production of such law enforcement records or information…could reasonably be expected to interfere with enforcement proceedings.
The FBI led the charge to reactivate the Tylenol murders investigation. But the FBI does not have jurisdiction to bring charges in this case. At the time of the 1982 Tylenol murders, tampering with Tylenol was a misdemeanor, and the murders fell under the jurisdiction of the state of Illinois.

In 2002, FBI officials told the Chicago Tribune that they were no longer involved in the Tylenol murders investigation. The FBI said the case was “a murder investigation that falls under the jurisdiction of the police departments where the deaths occurred.” So why did the FBI get so actively re-involved in this ongoing sham of an investigation?

The continued suppression of information related to the Tylenol murders ensures that the victims of the Tylenol killer will never see any semblance of justice.

Tuesday, January 10, 2012

Does Illinois Have the Most Corrupt Prosecutors in the Country?

In 1999, Lawrence Marshall, a Professor of Law at Northwestern University, said, “We generally condone a great deal of misconduct when we think it serves the ultimate ends of justice. Many players in the system - judges, defense lawyers, prosecutors - know some of the stuff that happens, but nonetheless tend to turn a blind eye. There’s a feeling that that is how it works, that it’s legitimate to bend the truth sometimes when you are doing it with - quote, the greater good, end quote - in mind.”

A series of articles that appeared in the Chicago Tribune in 1999, documented a consistent and troubling pattern of prosecutorial misconduct.  With impunity, wrote journalists Ken Armstrong and Maurice Possley, prosecutors across the country have violated their oaths and the law, committing the worst kinds of deception in the most serious of cases.

They have prosecuted black men, hiding evidence the real killers were white. They have prosecuted a wife, hiding evidence her husband committed suicide. They have prosecuted parents, hiding evidence their daughter was killed by wild dogs. They do it to win.

The Tribune investigation found that the Illinois record for misconduct by prosecutors was particularly abysmal. Of the 381 people whose homicide convictions were reversed between 1963 and 1999, forty-six were tried in Illinois. Yet not a single prosecutor in those cases was ever brought to trial for misconduct or disbarred.

Thirteen years after the Tribune’s investigation, we are reminded that not much has changed in Illinois. This past Friday Juan Rivera was released from prison after being incarcerated for nearly 20 years for a crime that he did not commit.

Rivera had been convicted for the rape and murder of 11-year-old Holly Staker. On December 9, 2011, the Illinois Second Appellate Court reversed his murder conviction – for the third time. The reason Rivera was kept in prison until Friday is that the State’s Attorney in Lake County, Michael Waller, waited four weeks before deciding not to attempt to try the innocent-Rivera for a fourth time.

The Appellate Court’s harshly worded, 24-page ruling states that the theories that prosecutors offered at trial were “highly improbable” and “distort to an absurd degree” the testimony from witnesses. The Court began its discussion of the evidence by stating: “First, we discuss the physical evidence linking defendant to the offense. There was none.”

The Court then wrote: “With respect to the DNA evidence linking defendant to the offense, there was none. The State’s theories distort to an absurd degree the real and undisputed testimony that the sperm was deposited shortly before the victim died…

…The State failed to provide sufficient independent evidence to corroborate defendant’s confession, especially in light of the DNA evidence. The State failed to provide corroboration for defendant’s use of a dangerous weapon; defendant’s sexual penetration of the victim by the use of force; and the victim’s death during the attempt or commission of the aggravated criminal sexual assault. The only evidence of defendant’s commission of the offense came from the statements that the police prepared for defendant to sign. Because the State failed to establish the offense aliunde the confession, defendant’s conviction was unjustified and cannot stand.”

Rivera conviction reminiscent of Cruz conviction

The Appellate Court’s ruling is reminiscent, though not as direct, as the ruling made in 1995 by Judge Ronald Mehling in the Jeanine Nicarico murder case.

Rolando Cruz and Alejandro “Alex” Hernandez were convicted in 1985 for the 1983 rape and murder of ten-year-old Jeanine Nicarico in DuPage County, Illinois, The similarities between the Nicarico and Staker cases – the crimes themselves, as well as the wrongful prosecutions that followed - are remarkable.

In the Staker case, police wrote a confession and then coerced Rivera into signing it. In the Nicarico case, police made up a confession, claiming it had come from Rolando Cruz. In both cases the prosecutors misrepresented the evidence, used jail-house snitches as star witnesses, and ignored exculpatory DNA evidence. In the Nicarico case, DuPage County prosecutors even ignored the confession of the man who actually did rape and murder Jeanine Nicarico.

Like Rivera, Cruz and Hernandez were granted new trials after being convicted once, and then again a second time. However, early in Cruz’s third trial, Judge Mehling put an end to this farce shortly after the state’s so-called evidence was thoroughly debunked and one of the state’s witnesses revealed that the phony confession did not happen.

After the bombshell revelation about the bogus confession, Judge Mehling took a short break. Then, upon reconvening, he held up a picture of Jeanine Nicarico and proceeded to disparage the DuPage County Sheriff’s police officers and the case brought by DuPage County prosecutors. “Let’s look at what the evidence shows or does not show,” Mehling said. “And what troubles me in this case is what the evidence does not show… Is there any physical evidence in connection with this case, anything at all, that connects this hideous crime and connects Mr. Cruz? Anything? Fingerprints, blood spots, blood, DNA, hair, fibers, clothes, something left there, something taken from the home that he had? Anything? . . . There is none. There is absolutely none.”

“I as a judge, frankly… can’t recall so many witnesses that have testified one way at one time and then now testified a different way,” said Judge Mehling. “I am sure the defense and State realize what actually occurred here today. It was devastating. It was unique in the annals of criminal justice. Did Cruz ever make that dream statement? I don’t think I need to answer that, because I’m going to enter a judgment of not guilty, and he will be discharged today. Case closed.”

History of Prosecutorial Misconduct

In the 1980s and 1990s, the State of Illinois was a hotbed of wrongful prosecution in death penalty cases. In 2004, of the 289 men and women who had been sentenced to death in Illinois since 1977, eighteen had been exonerated and released from prison – an error rate of over 6 percent. Fourteen others had won reversals and were awaiting retrial or re-sentencing. The Illinois Governor’s Commission on Capital Punishment found that these wrongful convictions were not the result of innocent “mistakes,” but rather were the product of the deliberate actions of prosecutors and law enforcement officials in the state of Illinois who engaged in such practices as falsifying evidence, extracting coerced confessions, and relying on the testimony of jailhouse “snitches.”

The statistics on wrongful prosecution in Illinois do not, however, include the wrongful prosecution attempts that fell apart before they had a chance to go to trial. One such failed attempt occurred in the highest-profile case ever in Illinois – the 1982 Tylenol murders case.

DuPage County, Illinois had two highly publicized and politicized murder cases in the 1980s - the Jeanine Nicarico murder on February 25, 1983, and the Tylenol murders on September 29, 1982. In both of these cases, officials in DuPage County fabricated, hid, and lied about evidence.

DuPage County Sheriff’s detectives working on the Nicarico case hid evidence that should have exonerated Rolando Cruz and Alex Hernandez. They made up a phony “vision statement,” claiming it was Cruz’s confession to the Nicarico murder. That false story was the centerpiece of a disgraceful prosecution that led to the wrongful convictions and death sentences of Cruz and Hernandez..

In 1982, as revealed in my new book, The Tylenol Mafia: Marketing, Murder, and Johnson & Johnson, authorities in DuPage County planted the eighth bottle of cyanide-laced Tylenol into evidence. They intended to use that planted evidence to get a conviction in the Tylenol murders case. If they had gotten that conviction, an innocent man would likely have been sentenced to death.
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Scott Bartz is the author of The Tylenol Mafia: Marketing, Murder, and Johnson & Johnson. He held various sales, marketing, and management positions during his eleven years in the pharmaceutical industry (7 years at J&J). He has gained a unique perspective on jurisprudence in this country during four years of research into the 1982 and 1986 Tylenol murders cases and through his ongoing involvement as the Relator in the qui tam lawsuit, “United States of America, ex rel. Scott Bartz, vs. Johnson & Johnson, et al.” (Case 1:11-cv-10316-RGS)

Monday, January 9, 2012

Illinois Prosecutors Forced to Free Innocent Man Wrongly Incarcerated For Nearly 20 Years


After nearly 20 years of incarceration for a crime he did not commit, Juan Rivera walked out of prison a free man on Friday, January 6, 2012. His release came after the Illinois Second Appellate Court threw out his murder conviction. This was the third time the Appellate Court had reversed the wrongful conviction of Rivera for the murder of 11-year-old Holly Staker.

The Appellate Court’s harshly worded, 24-page ruling states that the theories that prosecutors offered at trial were “highly improbable” and “distort to an absurd degree” the testimony from witnesses.

The Chicago Tribune reported that Rivera's incarceration came at the hands of a persistent Lake County state's attorney's office likely will add to the growing criticism of the office for its prosecution of cases in which DNA excludes their suspect, as it did in Rivera's case.

In at least two other cases, one of them a death penalty case and all of them documented by the Tribune over the years, Lake County prosecutors stretched credulity in seeking to blunt DNA evidence.

In the Rivera case and in the case in which they sought the death penalty, they insisted that a disputed confession was more reliable. That suggested to many attorneys and other close observers of the Lake County system that the prosecutors there had failed to learn about the frailties of confessions, highlighted in cases across the country by DNA evidence that proved those confessions false.

"This is just one of the very highly problematic cases that have been prosecuted in defiance of common sense and overwhelming physical evidence, especially DNA evidence," Rob Warden, executive director of Northwestern University's Center on Wrongful Convictions, which represents Rivera, said after the ruling was issued. "The people of Lake County need to wake up to what their prosecutors are doing."

In reversing the lower court’s decision, the appellate court said Rivera “has suffered the nightmare of wrongful incarceration.”

The nightmare began on August 17, 1992, when police responded to a call in Waukegan, Illinois after a woman living there, Dawn Engelbrecht, reported that her babysitter, Holly Staker, was missing. The back door to Engelbrecht’s apartment had been kicked in. The police found the victim’s partially clothed body on the floor of the children’s bedroom. She had been raped and then stabbed 27 times. She was pronounced dead at the scene.

Juan Rivera was brought in for questioning. He told interrogators that he had never been in the apartment where the murder occurred and that he had not committed the crime. However, in subsequent interrogations, Rivera gave inconsistent statements regarding his whereabouts at the time of the murder.

After four days of police interrogation, in which, according to the Appellate Court, detectives psychologically manipulated the fragile Rivera, who was banging his head against a wall and pulling his hair out at one point, Rivera signed two confessions, saying Holly had invited him into the home where she was baby-sitting and had sex with him. When she mocked his performance, according to the statements, he stabbed her to death.

Rivera’s lawyers later argued that the confessions used words that were beyond the vocabulary of Rivera, who had an IQ of 79 and a 3rd-grade reading level. Incredibly, police did not retain the notes they used when writing the confessions signed by Rivera, and they did not tape Rivera’s statements.

Rivera had recently been arrested for allegedly stealing a car stereo, and the electronic monitoring device a court had ordered Rivera to wear while awaiting trial showed Rivera was home at the time of the murder. The state claimed that the device must not have been functioning.

As for the lack of an eyewitness who could place Rivera at the crime scene – Illinois authorities took care of that problem too.

Dawn Engelbrecht testified that on August 17, 1992, while the police were at her home collecting evidence, a crowd gathered in the street and someone, who she later identified as Rivera, approached her. However, in Rivera’s third trial, Engelbrecht testified that she did so only because the police had shown her photos of Rivera and told her that he had admitted being the person who approached her in the street.

The prosecutors’ star witness was Frank McDonald, a jail house snitch. According to McDonald, Rivera had asked him to read some of the trial discovery materials to him. Upon reading the materials, McDonald accused Rivera of killing the victim. McDonald testified that Rivera admitted that he had. Prior to testifying in court, McDonald admitted that he had attempted to sell Rivera’s discovery materials to a reporter for the Chicago Tribune.

On November 19, 1993, a jury convicted Rivera for the murder of 11-year-old Holly Staker. Rivera was convicted largely on the basis of his disputed confession and the testimony from McDonald. That conviction was set aside in 1996 by the Illinois Second Appellate Court, which ruled that the trial judge, Christopher Starck, had made a series of errors as he presided over the case.

At Rivera’s second trial, in 1998, prosecutors brought in a second jail-house snitch, David Crespo, a drug addict who testified that after he and Rivera had attended a Spanish Bible study class together; Rivera admitted that he had killed the victim. Crespo’s decision to testify against Rivera came after a falling out with Rivera’s family. Upon Crespo’s release from jail, Rivera’s family had taken him in. Crespo came forward with his claim about Rivera only after Rivera’s family made him leave their home for using drugs while living there.

Rivera was again convicted and sentenced to life. Once again, Rivera’s lawyers sought, and were granted, a new trial.

In 2004, the trial court granted Rivera’s motion for DNA testing of material from vaginal swabs taken at the victim’s autopsy. In 2005, a forensic testing company tested sperm from a swab stick, and the vial in which it had been held, and made a finding that Rivera was “excluded as the source of the DNA obtained from the swab and vial.” Nevertheless, prosecutors pressed on.

In Rivera’s third trial, prosecutors relied heavily on the hearsay testimony of the jail-house snitches who had previously testified for the state. Prosecutors presented the 1993 trial testimony of Frank McDonald, now deceased; and read the 1998 trial testimony of David Crespo to the jury.

The defense poked numerous holes in the state’s so-called evidence, leading some Chicago journalists to predict that Rivera would finally be set free. Eric Zorn, in his Chicago Tribune column, said the state's theory of the crime had become increasingly hard to believe as time had gone on.

The defense questioned why authorities did not retain the notes they used when writing the confessions signed by Rivera, and why the statements were not taped.

Dawn Engelbrecht testified that she had identified Rivera as the man who had approached her on August 17, 1992, only after police showed her a picture of Rivera and told her that Rivera had admitted to approaching her. She later told the Chicago Tribune that she had "caved" against pressure from detectives.

"I was wrong, and I knew I was wrong," she said in a recent interview. "I just went along with it. And I shouldn't have."

Alan Keel, of Forensic Science Associates, testified that the DNA evidence was from an “Unidentified Male #1.” Keel determined conclusively that Rivera was not the source of the sperm. Keel further testified that the “high ratio of sperm DNA to epithelial cell DNA demonstrate that the semen had not been in the vagina long” and it “had not had time to dissipate,” and thus, the sperm had been “recently deposited in the vagina.”

William Frank, the senior DNA analyst for the Illinois State Police crime laboratory, testified that he agreed with Keel’s conclusion that the DNA profile was a single-source male DNA profile and that “there was no indication that the sample was mixed with DNA from more than one male.” At the State’s request, the police crime lab conducted independent testing of the evidence and found that Rivera was absolutely excluded.

Kenneth Moses, a crime scene investigator and director of an independent forensics laboratory in San Francisco, testified that investigators had recovered approximately 70 images of finger and palm prints. He said unidentified prints were referred to as “open” prints. Moses concluded that all of the open prints excluded defendant; that is, the prints were not Rivera’s.

Despite the lack of any physical evidence connecting Rivera to the crime, and the DNA evidence exculpating him, Rivera was convicted of Holly’s murder for a third time on May 8, 2009.

This past Friday, Juan Rivera was released from prison after the Illinois Appellate Court threw out Juan Rivera's murder conviction. Lake County State's Attorney, Michael Waller, said he will not attempt to overturn the Appellate Court's decision.

The appellate court determined that with respect to the physical evidence linking defendant to the offense. “There was none.”

With respect to the DNA evidence linking defendant to the offense, the appellate court found “there was none.”

The court found that “In light of all the evidence, the State’s theories are highly improbable.”

“After viewing the evidence in the light most favorable to the prosecution,” the Appellate Court concluded, “we hold that no rational trier of fact could have found the essential elements of the crime beyond a reasonable doubt. Because the State’s evidence was insufficient to establish guilt beyond a reasonable doubt, we must reverse the conviction of Juan A. Rivera, Jr.”

Illinois prosecutors, with absolutely no physical evidence connecting Rivera to the rape and murder of Holly Staker, used bogus hearsay testimony and a highly-implausible coerced confession to fabricate a case against Rivera. Their actions likely ensured that the person who really did kill Holly will never be brought to justice.

Following are some notable excerpts from the appellate court’s ruling:
¶ 29 First, we discuss the physical evidence linking defendant to the offense. There was none. The State and defendant presented a stipulation that, although there were many fingerprints lifted from the Engelbrecht residence that were suitable for comparison, no fingerprints were matched to defendant. Further, Moses concluded that the open prints, those which had not been identified, excluded defendant. The blood found in the bedroom was not matched to defendant. The physical evidence with respect to the damaged back door was not matched to defendant. The bloody streaks near the banister on the front staircase were not matched to defendant. The knife, which was broken into two pieces and found in a neighbor’s yard, was not matched to defendant. The blue mop handle and towel were not matched to defendant.
¶ 30 With respect to the DNA evidence linking defendant to the offense, there was none. Keel, who conducted DNA testing on evidence from the rape kit taken at the victim’s autopsy, i.e., one of two vaginal swabs and the vial in which the swab had been stored, determined that the epithelial cells all matched the victim and that the sperm was from a single male profile, which he labeled as “Unidentified Male #1.” Keel determined conclusively that defendant was not the source of the sperm. Keel also testified that the high ratio of sperm cells to epithelial cells indicated that the sperm was deposited shortly before the victim died. 
¶ 34 The State’s theories distort to an absurd degree the real and undisputed testimony that the sperm was deposited shortly before the victim died. Simply put, the State’s rationalizations of how the DNA from “Unidentified Male #1” came to be found in the victim’s body (“as unlikely as it seems, this young [11-year-old] girl apparently had sex with someone else”) and why none of defendant’s DNA appeared in or around the victim or anywhere at the crime scene cannot save a conviction obtained on a theory of a violent sexual assault and murder. The State did not present any evidence that the victim was in a relationship with anyone. The undisputed evidence from the trial reflects that there was only one male whose bodily fluids were found on the victim; this male was not defendant but rather “Unidentified Male #1.” The most reasonable explanation of the DNA evidence is not  defendant but rather “Unidentified Male #1.” The most reasonable explanation of who sexually penetrated the victim, based on the DNA evidence, is not defendant but rather “Unidentified Male #1.” The most reasonable explanation, therefore, of who murdered the victim is not defendant but rather someone who, unfortunately, has not yet been identified.” 
¶ 38 …because defense counsel exposed McDonald’s motivation to profit financially by involving himself in the case, his testimony should be subject to suspicion, viewed with distrust, scrutinized carefully, and acted upon with caution… Crespo was exposed as a drug user, who came forward only after defendant’s family turned their backs on him for using drugs while staying at their house. Our supreme court has plainly stated that “the testimony of a narcotics addict is subject to suspicion due to the fact that habitual users of narcotics become notorious liars.” (People v. Lewis, 25 Ill. 2d 396, 399 (1962) (citing People v. Boyd, 17 Ill. 2d 321, 326 (1959)). 
¶ 43 On our review of the record, the State’s independent evidence does not inspire belief in defendant’s candid acknowledgment of guilt. The State acknowledges that 15 of the 54 “facts” contained in defendant’s statements had all been published in newspapers, and it acknowledges that defendant’s father had learned about the crime in the newspapers and on television and discussed it with defendant. Although the State argues that no evidence reflected that defendant had read the newspapers or which specific details of the crime defendant’s father had discussed with defendant, this does not establish defendant’s independent knowledge of the facts beyond a reasonable doubt… It was the State’s burden to establish that defendant had not read the newspapers or was not otherwise privy to these details. It was the State’s burden to establish that defendant’s father had not discussed with defendant the media coverage of the murder. 
¶ 44 Contrary to the State’s argument that there was no evidence that the police fed information to defendant, the record reflects that officers used leading questions during their interrogation of defendant. Both Maley and Tessmann interrogated defendant using facts of the case. Maley testified that, during the interrogation, he questioned defendant as to whether the victim was really wearing a nightgown. Tessmann admitted using leading questions regarding the victim’s attire, asking “She had a multi-colored shirt on, right?” Maley’s testimony reflected that Tessmann asked defendant questions “about facts in the previous statement that he believed were untrue.” Following this session of interrogation, defendant’s new statement reflected the victim’s correct attire, that was “black stretch pants with stirrups on the bottoms and a multi-colored shirt.” Cf. People v. Nelson 235 Ill. 2d 386, 432 (2009) (noting that the defendant’s confession and videotaped statement disclosed facts of murder, home invasion, and aggravated arson that could not have been suggested to him because the autopsy had not yet been performed and the police had been unable to enter parts of the crime scene). 
¶ 45 …The State failed to provide sufficient independent evidence to corroborate defendant’s confession, especially in light of the DNA evidence. The State failed to provide corroboration for defendant’s use of a dangerous weapon; defendant’s sexual penetration of the victim by the use of force; and the victim’s death during the attempt or commission of the aggravated criminal sexual assault. The only evidence of defendant’s commission of the offense came from the statements that the police prepared for defendant to sign. Because the State failed to establish the offense aliunde the confession, defendant’s conviction was unjustified and cannot stand. 
¶ 46 After viewing the evidence in the light most favorable to the prosecution, we hold that no rational trier of fact could have found the essential elements of the crime beyond a reasonable doubt. Because the State’s evidence was insufficient to establish guilt beyond a reasonable doubt, we must reverse the conviction of Juan A. Rivera, Jr. See Smith, 185 Ill. 2d at 541 (citing Bartall, 98 Ill. 2d at 306).
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Scott Bartz is the author of The Tylenol Mafia: Marketing, Murder, and Johnson & Johnson. He held various sales, marketing, and management positions during his eleven years in the pharmaceutical industry (7 years at J&J). He has gained a unique perspective on jurisprudence in this country during four years of research into the 1982 and 1986 Tylenol murders cases and through his ongoing involvement as the relator in the qui tam lawsuit, “United States of America, ex rel. Scott Bartz, vs. Johnson & Johnson, et al.” (Case 1:11-cv-10316-RGS)

Friday, January 6, 2012

J&J’s Billion Dollar Settlement is Just Pennies on the Dollar

Bloomberg reported yesterday that Johnson & Johnson will pay more than $1 billion to the U.S. and most states to resolve a civil investigation into marketing of the antipsychotic Risperdal, according to people familiar with the matter. J&J is reportedly in negotiations to pay $400 million in fines to settle the criminal portion of the investigation.

By my calculation; this pending $1 billion civil settlement represents just 9 percent of the damages the law requires under 42 USC 1396R-8(k)(3, which prohibits reimbursement under Medicaid for any outpatient drugs "used for a medical indication which is not a medically accepted indication."

42 USC 1396R-8(k)(6) defines "medically accepted indication" as a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act, or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(i) of this section.

42 USC 1396R-8(g)(1)(B)(i), in turn, designates the Compendia as:
(I)     American Hospital Formulary Service Drug Information;
(II)    United States Pharmacopeia-Drug Information (or its successor publications); and
(III)   the DRUGDEX Information System
Congress didn't prohibit reimbursement by Medicaid for all off-label prescriptions, but specifically limited reimbursement for off-label prescriptions to those that have sufficient scientific "support," as documented in one of the Compendia. The pending Risperdal settlement involves the off-label use of Risperdal in children and the elderly. Such prescriptions are not for "medically accepted indications," and thus automatically constitute Medicaid Fraud.

Calculating the True Damages

Approximately 70 percent of Risperdal prescriptions were written for indications that were not medically accepted indications, of which about 40 percent were reimbursed by Medicaid. These assumptions are based on IMS and J&J data; some of which I presented in earlier posts; here, here, and here.

Risperdal sales in the U.S. during the period covered by this settlement were about $20 billion. Accordingly, Medicaid overpaid $5.6 billion for Risperdal prescribed off-label (Risperdal sales of $20 billion x 70% off-label x 40% reimbursed by Medicaid = $5.6 billion).

The law requires the government to collect damages of twice or triple the actual damages, plus any additional fines. Thus, the law requires the Justice Department to collect at least $11.2 billion in civil damages ($5.6 billion x 2).

The pending $1 billion civil settlement, representing just pennies on the dollar of what J&J should pay, is especially troubling in light of the copious amount of damning evidence regarding the extent of Johnson & Johnson's numerous illegal off-label marketing schemes. A lawsuit filed by Massachusetts provides some detail into Johnson & Johnson’s promotion of Risperdal for medically unaccepted indications in children and the elderly.

Sales Call Notes Documented Illegal Marketing Activities

In an e-mail to Anwar Feroz Siddiqi, the national sales director of the ElderCare sales force, Regional Director Chris Fagnani wrote: "Schizophrenia continues to come up in calls with physicians and pharmacists. The representatives would like to be trained on schizophrenia in order to have more credibility in the eyes of their physicians as a Risperdal expert not a Risperdal for Dementia expert. The FSD/RBD team needs to evaluate if this is an option we feel is important enough to resolve or if this would distract the representatives from their dementia focus."

The following is a sample of call notes prepared by Janssen sales representatives who promoted Risperdal to Massachusetts prescribers. These calls notes are illustrative of the Risperdal marketing pitches used by sales representatives in the field:
An August 2, 2001 call note (000001446802) reports on a sales call with a Brookline doctor: "Reminded him of Risperdal .5mg bid for hostility and excitement in his  dementia patients...." 
A September 24, 2002 call note (4G7-E00) reports on a sales call with a Frarningham doctor: "Follow up w/ her regarding her treatment of dementia. See how ris worked for Dr Delacey's patient. Show cost comparison of Ris and haldol." 
A December 12, 2002 call note (F3N-7B6) reports on a sales call a Brockton nursing home official: "detailed don on diabetes issue with zyprexa and presented risp as first line options for geriatric patients with dementia." 
A January 10, 2003 call note (F3N-AK8) reports on a sales call with a Quincy doctor: . . . also touched upon excellent safety profile of risp and rem. asked that is [sic] patients do present early signs of dementia, consider rem as first line option and then risp for latter stages." 
An April 1, 2003 call note (F3Y-BZC) reports on a sales call with a Holyoke doctor: "Met with Dr. Kaskey for about fifteen minutes and we spoke about alot [sic]. We started around his use of Risperdal and what patient types he typically sees. we spoke about the mood and anxiety symptoms associated with Schizophrenia and dementia and how he could use Risperdal here. We spoke about starting the elderly at .25 and titrating to effect." 
A July 30, 2003 call note (KD6-MUS) reports on a sales call with a Brookline doctor: "Risperdal — doesn't use b/c refers severe psychosis. But he does treat depression and dementia. got him thinking about low dose usage."
Massachusetts also collected call notes documenting the calls of J&J sales reps to child and adolescent psychiatrists. The call notes database shows that from 1994 through February 1999, more than 100,000 sales calls were made on physicians whose primary specialty was identified as child and adolescent psychiatry.

A sampling of call notes shows that sales representatives promoted Risperdal's use in children and did so long before Risperdal was FDA-approved to treat any conditions in pediatric patients. The following call notes are illustrative of the marketing messages presented by Janssen sales representatives to Massachusetts prescribers:
An August 2, 2001 call note (000000244279 ) reports on a sales call with a Braintree doctor: ". . . . She is using Risperdal with great success in kids ala Biederman. She did mention galactarhea so I told her how Biederman is uSing Dostinex. She is going to get more info on this dopamine agonist. She is going to attend the 4 Seasons event." 
A December 5, 2001 call note (000000758930 ) reports on a sales call with a Rehoboth doctor: "Good call. Stuck to the basics of Risperdal of safety and efficacy in kids. He loves it here for agression . . . ." 
An August 16, 2002 call note (4YU-51J) reports on a sales call with a Hingham doctor: "Discussed how the whole key w/Risperdal is dosing especially for the type of patients that they see. Talked low dosing in children for hostility and agression [sic] as well as low dose for mood and anxiety. . . . ." 
A February 2, 2003 call note (K6F-4Q5) reports on a call with a Boston doctor: "Introduction and left a low dose message especially in kids . . . ." 
An October 6, 2003 call note (PTX-OSA ) reports on a call with a Holyoke doctor: "also disc. ris as solog agent and mtab for kids . . . ." 
An October 7, 2003 call note (K3W-Y8S) reports on a call with a New Bedford doctor: "Core message and discussed her using more rn-tab wioth [sic] some of the kids she treats." 
A June 10, 2004 call note (ZPU-AAV) reports on a call with a Fitchburg doctor: "We also discussed Risperdal for irritibility [sic], aggression and outbursts in children. He comitted [sic] to using Risperdal for these symptoms. F/up with him re the outcomes on the next visit." Call Record, James Dunn to Paul Epstein, 6/10/2004 
A June 22, 2004 call note (10FE-OFM) reports on a call with a Salem doctor: "Disc'd Riseff & safety in adult, child and elderly pts . . . ."
A July 30, 2004 call note (ZTW-LTX) reports on a call with an Agawam doctor: "said she was using ris lots for kids and geri's who are angry/impulsive/agitated. I said great — those are the most sensitive and it works . . . ."

The Massachusetts complaint states that despite Defendant's knowledge of the risks associated with prescribing Risperdal to treat children and adolescents, and the lack of data supporting Risperdal's safety or efficacy in this patient population, one of the marketing objectives for Risperdal in 2001 was to "grow and protect share in children/adolescents" via medical education initiatives and "effective rep targeting with a year-end exit share of 70%."

The Massachusetts complaint provides numerous additional examples of J&J’s off-label promotion of Risperdal.

The federal government and most states have agreed to settle with Johnson & Johnson for $1 billion; a tiny fraction of the damages the law requires. Further, this settlement does not address the approximately $6 billion in Risperdal revenue generated through the Medicare program. Combined, Medicaid and Medicare paid about $14 billion to reimburse Risperdal prescriptions. of which about 70 percent were for medically unaccepted indications. Johnson & Johnson’s illegal marketing schemes thus cost taxpayers about  $9.8 billion (Risperdal sales of $20 billion x 70% off-label x 70% reimbursed by Medicaid/Medicare = $9.8 billion).

For well over a decade, Johnson & Johnson blatantly violated the law by marketing Risperdal off label – all the while thumbing its nose at the feckless FDA. The Justice Department has now sanctioned this behavior by allowing Johnson & Johnson to keep all but $1 billion of the $9.8 billion fraudulently taken from U.S. taxpayers.
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Scott Bartz is the author of The Tylenol Mafia: Marketing, Murder, and Johnson & Johnson. He held various sales, marketing, and management positions during his eleven years in the pharmaceutical industry (7 years at J&J).

Wednesday, January 4, 2012

Marketing Risperdal Part III: Marketing to the Elderly

In 1993, J&J subsidiary, Janssen Pharmaceutica, won FDA approval to sell Risperdal for the treatment of psychosis in patients with schizophrenia. Only about 1.1 percent of adults suffer from this condition, according to the National Institute of Mental Health, so the market potential for Risperdal was apparently quite small.

But Johnson & Johnson, recognizing an opportunity to expand the Risperdal market beyond its approved indication, immediately implemented a strategy to promote the drug for unapproved uses.

Ivo Caers, a Janssen executive, wrote in a 1994 report that “Schizophrenia represents only 35 percent” of antipsychotic prescriptions. “Aggressive expansion of Risperdal use in other indications is therefore mandatory.”

As the amount of money spent promoting Risperdal and other new generation ”atypical” antipsychotics for off-label use grew; schizophrenia made up an ever smaller portion of the antipsychotic market. By 2006, Risperdal use in schizophrenia represented just 19 percent of total Risperdal use.

When Risperdal lost patent protection in 2008, the drug had generated more than $20 billion in revenue in the United States alone. The majority of that revenue came from off-label sales. A sizable portion of those off-label sales came from Risperdal sales to elderly patients with dementia.

FDA Warnings Unheeded

In 1999, the FDA warned J&J and its Janssen subsidiary that its marketing materials for geriatric patients overstated Risperdal’s benefits and minimized risks. Yet according to documents turned over to the state of Louisiana; a J&J business plan for the next year called for increasing the drug’s market share for elderly dementia sales, an unapproved use.

“The geriatric market represents Risperdal’s second wave of growth,” wrote J&J officials in the 2000 business plan. “The aging population will continue to drive market growth well into the next century.”

Janssen set sales goals for the year 2000 of $302 million in geriatric sales, or 57 percent of the market, according to the business plan. J&J reached that sales goal with help from its ElderCare sales force, comprised of 50 sales reps who marketed Risperdal directly to psychiatrists with large geriatric patient populations.

The ElderCare sales reps promoted Risperdal off-label, primarily for the treatment of aggression in elderly dementia patients. This off-label marketing strategy continued even after J&J received research data in 2002 showing increased strokes and mortality in elderly dementia patients taking Risperdal. Johnson & Johnson's meek response to these findings was to send a Dear Doctor Letter in October 2002  to physicians in Canada citing 37 reports of Risperdal stroke or Risperdal stroke-like events, including 16 deaths. The letter said in part:
Recent analysis of some clinical trials in elderly patients with dementia suggests that the use of RISPERDAL in dementia patients may be associated with an increased incidence of reports of cerebrovascular adverse events (CVAEs) such as stroke and transient ischemic attacks (TIAs), including fatalities.
In April 2003, J&J sent a Dear Doctor letter to physicians in the United States. The letter repeated the findings referenced in the letter sent months earlier to Canadian doctors, and also cited two additional clinical trials of elderly dementia patients in which “a higher proportion of patients taking Risperdal experienced strokes or related events than those who received placebo.”

Also in 2003, the FDA required J&J to revise the WARNINGS section of the prescribing information for Risperdal:
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Risperdal® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.
Despite this new FDA-mandated Black Box Warning, Johnson & Johnson did not reduce its efforts to promote Risperdal for use in elderly dementia patients. Quite the opposite in fact.

The potentially deadly side-effects associated with Risperdal use in certain elderly patients led J&J to simply tweak its marketing strategy and implement a training program to teach the ElderCare sales reps how to overcome objections voiced by doctors concerned about the adverse-events associated with Risperdal use in the elderly. I know this, because at the time of the Risperdal label change, I was in charge of designing, implementing, and monitoring sales incentive compensation programs for several Johnson & Johnson sales forces, including the ElderCare sales force.

The ElderCare sales force had grown from 50 sales reps in 1999, to 283 reps in 2003. They marketed three drugs: Razadyne (for Alzheimer’s Disease), Duragesic (a narcotic for treating pain), and Risperdal (for treating psychosis).

Since Alzheimer’s Disease almost exclusively strikes the elderly, one might reasonably assume that the ElderCare sales force focused primarily on promoting Johnson & Johnson’s Alzheimer’s drug, Razadyne (then known as Reminyl). But that wasn’t the case. The ElderCare sales force was first and foremost a Risperdal sales force.

How Big Pharma Motivates Pharmaceutical Sales Reps

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The standing of a pharmaceutical sales rep is largely a function of his or her latest quarterly bonus.

In 2004, the ElderCare Incentive Compensation Plan paid a quarterly bonus of $5,500 ($22,000 per year) to a sales rep in a territory with average sales performance. (Link to actual 2004 Incentive Compensation Plan)

Twenty percent of the targeted bonus was based on “discretionary” factors, such as call plan achievement and completion of administrative duties. Eighty percent of the targeted bonus was based on “quantitative” sales results.

The sales performance of all 283 ElderCare sales reps’ territories were ranked according to sales results. Quarterly quantitative bonuses ranged from $0.00 (for the rep in the lowest performing territory) to $12,375 (for the rep in the highest performing territory).

The incentive compensation plan was designed to induce ElderCare sales reps to promote Risperdal for unapproved uses in elderly patients. Risperdal was the first drug detailed in most sales calls, and it was weighted most heavily in determining the quarterly bonuses paid to ElderCare sales representatives.

In 2004, Risperdal sales results made up 50 percent of an ElderCare rep’s performance rating, making it the most important factor in the calculation of quarterly bonuses.

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Every sales rep had a unique call plan directing them to call on psychiatrists with the largest geriatric patient populations. In 1999, Omnicare, the nation’s largest pharmacy service provider to long-term care facilities, had even provided J&J with a physician prescriber list of physicians who were not prescribing much Risperdal. The names were intended “to increase the call frequency on these resistant prescribers and to eventually influence them to use more Risperdal in the elderly demented patient."

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The quarterly bonuses, performance reviews, and annual raises of ElderCare sales reps were all based primarily on sales performance, as measured in the quarterly bonus/performance reports.

In 2005, the ElderCare Incentive Compensation Plan was designed to put even more emphasis on promoting Risperdal to physicians with large geriatric patient populations. The product weight of Risperdal was increased from 50 percent to 70 percent. (Link to 2005 Incentive Compensation Plan)

The ElderCare incentive compensation plan also included a “kicker” bonus, paid to reps whose sales performance ranked in the top 15 percent of the entire ElderCare sales force. Again, the kicker was designed to reward Risperdal sales growth first, and Reminyl growth second.

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Other incentive bonuses paid to sales reps in high performing territories included a 5-day all-expense-paid vacation and additional cash payments to the top reps in each district and region, and in the nation.

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The Incentive Compensation plan was an extremely successful tool for motivating ElderCare reps to promote Risperdal for unapproved uses in the elderly. In 2006, Risperdal use in geriatric patients made up 13.5 percent of total Risperdal use (RIS O). Of the approximately $4 billion in Risperdal sales in the U.S. that year, about $538 million came from sales to the elderly.

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The ElderCare sales force was finally disbanded after the Justice Department initiated an investigation in September 2005 into Johnson & Johnson’s marketing of Risperdal and other drugs to Omnicare. By then, the prescribing of Risperdal and other atypical antipsychotics for unapproved uses in the elderly was standard practice. Yet no data had ever been submitted to the FDA supporting this off-label use.

Time and time again, the FDA had warned Johnson & Johnson to stop promoting Risperdal for unapproved uses in elderly patients. However, when Johnson & Johnson continued to market Risperdal for use in these very same patients, the company was not sanctioned.


Scott Bartz is the author of The Tylenol Mafia: Marketing, Murder, and Johnson & Johnson. He held various sales, marketing, and management positions during his eleven years in the pharmaceutical industry (7 years at J&J).

Friday, December 23, 2011

Johnson & Johnson’s Latest Recall Provides New Insight Into the Company's Secret Drug Distribution Channel

Johnson & Johnson has issued another recall of Motrin pain relievers. The Motrin packages involved in this latest recall were manufactured between February 2009 and July 2011. Some were produced by an outside contract manufacturer and others were manufactured at J&J’s factory in Las Piedras, Puerto Rico.

J&J spokesperson, Bonnie Jacobs, said the company is only recalling packages from retailers, not consumers, because there’s no safety concern. “It’s 59 product lots. It’s about 12 million bottles,” she said.

The packages were distributed in the United States, Puerto Rico, the Bahamas, Fiji, Belize, St. Lucia and Jamaica. Affected lot numbers are listed on the product’s Web site,

One interesting aspect of this recall is that it involved Motrin that had been produced by a contract manufacturer. Johnson & Johnson’s use of contract manufacturers has long been a closely guarded secret. Even the congressional committee that in 2010 initiated an investigation into the manufacture of Motrin, Tylenol, and other J&J over-the-counter (OTC) products was kept in the dark about the company’s use of contract manufacturers.

In 2010, the Congressional Committee on Oversight and Government Reform subpoenaed documents and held two hearings regarding the spate of Good Manufacturing Practices (GMP) violations at J&J’s manufacturing plants and the string of recalls involving Motrin, Tylenol, and other J&J OTC drugs. The Committee received FDA inspection reports documenting a plethora of violations at J&J’s plants in Fort Washington, PA; Lancaster, PA; and Las Piedras, PR. However, it evidently received no information from J&J or the FDA regarding the manufacture of J&J drugs by third party contract manufacturers.

Not long after William Weldon, J&J’s CEO, and Colleen Goggins, then the worldwide chairman of J&J’s consumer group, testified before the Oversight Committee, Johnson & Johnson recalled about 13 million packages of Rolaids on December 9, 2010, saying that metal and wood particles may have contaminated the items during production at a third-party manufacturer. But J&J declined to identify the Rolaids contractor.

The revelation that J&J was using a contract manufacturer to produce Rolaids troubled Representative Darrell Issa, then the ranking minority member of the Oversight Committee. On December 17, 2010, Issa sent a letter to FDA Commissioner Margaret Hamburg, in which he expressed concern about J&J’s use of a third party contractor.

“According to investigations conducted by my staff,” wrote Issa," “this third party manufacturer is Best Sweet, a company whose business model includes manufacturing pharmaceutical, healthcare, candy and food products... I am concerned about FDA’s knowledge of Best Sweet’s contractual relationship with Johnson & Johnson in manufacturing Rolaids and whether or not the FDA is acting appropriately to determine if there are other similar public safety concerns about products manufactured by Best Sweet. Also, this newfound information regarding outsourcing of drug manufacturing at Johnson & Johnson raises fresh questions about the general practices of contract drug manufacturing, as well as FDA’s knowledge and awareness of this issue.”

Johnson & Johnson has not been forthcoming in providing Congress with the information it needs to conduct a complete and proper investigation into J&J’s manufacturing practices. This failure of Johnson & Johnson to provide full disclosure about the manufacturing, packaging, and distribution of adulterated Motrin, Tylenol, and other OTC drugs is consistent with J&J’s well-established history of suppressing information that might be used to hold the company liable for negligence.

Johnson & Johnson’s greatest success in hiding important information about the manufacture and distribution of contaminated OTC drugs dates back to the cyanide Tylenol poisonings in 1982. After that tampering incident, which resulted in the deaths of at least seven Chicago area residents, J&J and the FDA quickly assured the public that the Tylenol capsules had been tampered with at the local retail stores.

In reality, the cyanide-laced Tylenol capsules involved in the 1982 Tylenol murders in Chicago, and the 1986 Tylenol murder in New York, had been adulterated in facilities operated by third party manufacturers that were under contract with Johnson & Johnson to package and distribute Tylenol.

TM Cover
Johnson & Johnson and the FDA did not secure the drug distribution channel after the Tylenol murders in 1982 and 1986. And they continue to keep the public in the dark about the unsecured distribution system today. The truth about the Tylenol killers’ modus operandi, and the reasons why the killers were never brought to justice are revealed in my book, The Tylenol Mafia: Marketing, Murder, and Johnson & Johnson.

In a story both fascinating and dramatic in its warnings, The Tylenol Mafia rips away the facade of an investigation that J&J CEO James Burke labeled “A demonstration without parallel of government and business working with the news media to help protect the public.” This gripping, meticulously documented expose’ unearths the troubling details of an investigation corrupted by well-connected corporate executives and politically motivated government officials who simply buried the truth inside a shadow legal system inaccessible to everyday Americans.

Wednesday, December 14, 2011

Tent Cities: The New American Reality

Doug lives in this tee-pee
The Occupy Wall Street tent-encampments have captured a great deal of media attention over the past several months. Less visible to the public eye are the growing number of tent cities occupied by homeless people across the country. One of these tent cities is tucked away in a public park in Lakewood, NJ, just 40 miles from my home.

Tent City, NJ, was set up by Reverend Steven Brigham five years ago, and is now home to about 70 homeless people who have nowhere else to go. Many of the residents of Tent City used to blame themselves for their misfortune. But with 3.5 million Americans experiencing homelessness every year or over 700,000 people on any given night – their message for politicians has changed.

"The politicians and the government has not protected the American people, they've allowed outsourcing to run rampant, and it's benefiting companies, corporations are making more money than they've ever made before. The American worker is suffering at the expense of the agenda of the politicians," says Brigham.

The residents of Tent City, New Jersey, are getting by the best way they can. But Lakewood officials have been trying to evict them out of the camp.

"They try to force out the poor. I call it discrimination by design. For the sake of pushing the poor out and encouraging the wealthier - the people with money - to move into your town," said Minister Brigham.

After battling with the city for years to have access to the public land here, Brigham found a New Jersey lawyer to represent his case pro bono.

The attorney, Jeff Wild, argued that the homeless population are part of the public and should therefore have access to public lands. Rather than take the case to court, Lakewood City Council settled, and Brigham signed an agreement to put up no more shelters and allow no more than 70 people to stay.

But last winter the community put up three wooden structures to house everyone and keep them warm. "We didn't lose anybody last year," Brigham says, "and nobody got sick."

This year could be different. After City Council members saw the shelters on TV, they sent demolition crews in. The walls were torn down around whatever was inside, and meager furnishings were left to the elements. Brigham says the town is making it impossible to survive there, hoping to get the homeless out, and he's concerned it will end up killing people this year.

The number of homeless in the U.S. has grown 20 percent from 2007 to 2010. But U.S. politicians are simply ignoring the needs of the homeless, while funneling trillions of taxpayer dollars into corporate welfare programs for corporations in the banking, defense, and healthcare industries. 

A recent UN report says the way the U.S. denies its citizens access to water, basic sanitation, and criminalizes homelessness is a violation of the Universal Declaration of Human Rights and the International Covenant on Economic, Social and Cultural Rights.

Wealth inequality has been at the root of the anger for Occupy Wall Street protesters, but some of these homeless seem far from the demonstrators.

"I support them, but our situation is a lot different. We are homeless. We have nowhere to sleep. I am sure they have places to go when they are done with their little rally," said Angelo Villanueva.

"We've got our own Occupy movement in Lakewood. It's more of an occupy movement out of necessity," said Brigham.

"Open your eyes. Open your eyes,” said Tent City Cook David Jones. “All this help that we give out all over the world, we need help here.”




Friday, December 9, 2011

Urine: The Latest Contaminant Found at Johnson & Johnson Manufacturing Plant


Federal inspectors say the contract manufacturer for Johnson & Johnson's cancer drug, Doxil, has not been maintaining equipment or promptly investigating defective product batches and other serious problems at its Bedford, Ohio, factory.

The FDA inspection report, completed December 6th, details lax quality control, failure to follow standard procedures and even lack of follow-up about a container of urine found in the Ben Venue Laboratories’ storage area. According to an internal Ben Venue memo, an independent laboratory "performed a Creatinine Urine test on the substance. The results found a level of 137.3 mg/dL… These results are consistent with the values found in Urine.”

The FDA found that Ben Venue is not capable of producing data to document "that the aseptic manufacturing process consistently produces product meeting an  acceptable level of  sterility assurance." The FDA further concluded that the company’s validation group lacks appropriate oversight and technical expertise to perform their duties.

The problem of contaminated drugs is a decades old theme at Johnson & Johnson. As I document In my book, The Tylenol Mafia: Marketing, Murder, and Johnson & Johnson, Johnson & Johnson had received nearly 300 consumer complaints of contaminated Tylenol in the three years prior to the 1982 cyanide-laced Tylenol poisonings in Chicago. J&J kept these complaints under wraps until 1991 when attorneys for the Tylenol murder victims publicly disclosed the existence of these complaints. In describing the complaints, attorney Bruce Pfaff said, “Either capsules were missing, or some other medication was mixed in or there were foreign objects, pieces of metal, and even fingernails.”

More recently, FDA inspection reports from 2008 through 2010 of J&J’s over-the-counter (OTC) drug manufacturing plants in Fort Washington, PA; Lancaster PA; and Las Piedras, PR, found that Johnson & Johnson had failed to conduct investigations into ANY of the hundreds of consumer complaints of contaminated products, or ANY of the dozens of internal employee complaints of drug mix-ups. Now, the FDA has also found that J&J’s contract manufacturer, Ben Venue, failed to properly investigate or identify the root cause of foreign material, identified as stainless steel particles in two products, and it failed to conduct an investigation to determine how urine got into a container in the plant’s storage area.

When you read The Tylenol Mafia: Marketing, Murder, and Johnson & Johnson you will learn how Johnson & Johnson covered up the evidence of its liability for the 1982 and 1986 Tylenol poisonings, and you will understand how Johnson & Johnson will cover up the evidence of its illegal manufacturing practices identified in numerous recent FDA reports.