Daily Caller
Ethan Barton | Senior Editor 1/20/2019
The head of the Justice Department’s criminal division during the George W. Bush administration reportedly opposed pursuing felony charges against pharmaceutical company executives for downplaying OxyContin’s dangers.
Top DOJ officials similarly rejected a prosecutor’s recommendation to file felony charges after they met with executives from Purdue Pharma and their defense team, according to The New York Times.
Members of the Sackler family, who own Purdue Pharma, sought to mislead the public about abuse surrounding OxyContin, a lawsuit alleges, citing company emails and other documents.
The head of the Justice Department’s criminal division under President George W. Bush reportedly opposed levying felony charges against executives of a pharmaceutical company that’s widely blamed for helping start the opioid epidemic.
She has since joined a private law firm and has successfully defended pharmaceutical companies against government investigations.
A federal prosecutor recommended the felony indictments, which could have resulted in jail time if convictions were secured, but the DOJ officials rejected the notion after meeting with the Purdue Pharma executives and their defense team, according to The New York Times. It’s unclear if the criminal division chief attended that meeting.
Over 12 years later, it’s still unknown which senior officials attended that meeting, who rejected the indictment recommendations, and why they were rejected. Local and state governments have since mounted hundred of lawsuits against Purdue alleging the company downplayed the dangers of its blockbuster opioid, OxyContin.
The DOJ declined to comment on this story.
Purdue representatives lobbied top DOJ officials on multiple occasions during the Bush administration, according to news reports and congressional testimony. Future FBI Director James Comey was involved in one instance, and Rudy Giuliani, who now serves as President Donald Trump’s attorney, was tied to another.
The prosecutor who recommended felony indictments against Purdue executives found he was recommended for termination after a third instance that occurred hours before Purdue accepted a plea deal that was offered in lieu of felony charges.
As part of the plea deal, Purdue and three executives conceded they downplayed OxyContin’s addictiveness and collectively paid a historic $635 million in fines in 2007. No one saw jail time.
Meanwhile, more than 200,000 people have died from overdoses involving prescription opioids since OxyContin was launched in 1996, according to the Centers for Disease Control and Prevention.
Purdue is privately owned by the Sackler family, whose wealth skyrocketed after OxyContin sales raked in $35 billion over a 20-year period, giving the family a $13 billion net worth and making them the 19th richest in the U.S. in 2016, according to Forbes. (RELATED: ‘Joy’ And ‘Fury’: Artist And Activist Nan Goldin Reacts To The Met’s Statement About Taking Opioid Money)
Massachusetts was one of the states to file a lawsuit against Purdue in 2018, but it uniquely named eight members of the Sackler family. A recent complaint cites documents indicating the Sacklers headed a campaign to deceive doctors about the dangers of OxyContin and passed blame of negative press onto addicts.
“The launch of OxyContin tablets will be followed by a blizzard of prescriptions that will bury the competition,” Richard Sackler, the son of a Purdue founder and the company’s president from 1999 to 2003, said while celebrating the drug’s entrance to the market, according to a document cited in the complaint. “The prescription blizzard will be so deep, dense, and white.”
Bush’s Justice Department Rejected Felony Charges After A Four-Year Investigation
Then-U.S. Attorney John Brownlee concluded a four-year investigation and recommended indicting the three Purdue executives on felony charges, including conspiracy to defraud the government, in September 2006, the Times reported in May 2018.
But top DOJ officials didn’t support his recommendation after meeting with Purdue executives and their defense team, according to Times reporter Barry Meier.
One defense lawyer for Purdue was Mary Jo White, a former federal prosecutor, and an adviser to the company’s legal team was former New York Mayor Rudy Giuliani, who was also once a U.S. attorney.
The head of DOJ’s criminal division at the time, Alice Fisher, was one of the officials who didn’t support Brownlee’s recommendation, according to the Times. She’s now a partner at the law firm Latham & Watkins.
Her bio page says she recently represented “[g]lobal pharmaceutical companies in [Securities and Exchange Commission] and DOJ [Foreign Corrupt Practices Act] investigations resulting in settlement resolutions and declinations of prosecutions.”
It also says she represented “Several global manufacturing companies about maintaining FCPA compliance and obtaining two declinations of prosecution.”
Fisher did not respond to multiple requests for comment.
Brownlee publicly supported the decision not to prosecute the Purdue executives, but, according to Meier, he was privately upset. Brownlee did not respond to The Daily Caller News Foundation’s request for comment, and he’s previously declined to comment to other publications.
Top DOJ Officials Questioned Purdue Probes After Hearing From Company Representatives
There were additional occasions when top DOJ officials scrutinized Brownlee’s investigation after Purdue representatives contacted them.
After speaking with the company’s defense attorneys in 2005, then-Deputy Attorney General James Comey asked Brownlee why he was pursing Purdue, Brownlee said during a 2007 congressional hearing. Brownlee, who was the federal prosecutor for the western district of Virginia, drove to Washington to explain the situation to Comey, who ultimately gave Brownlee the go-ahead to continue.
Additionally, Brownlee’s name appeared on a list of U.S. prosecutors recommended for termination soon after he ignored a top DOJ aide’s request to delay the plea deal.
Hours before the plea deal was set to expire in October 2006, Deputy Attorney General Paul McNulty’s chief of staff, Michael Elston, called Brownlee and asked him to extend Purdue’s deadline, the U.S. attorney testified.
“He told me he received a phone call from the defense lawyers about the case and that that the counsel had once again said that we were moving too quickly, that we had needed more time,” Brownlee said.
“Through his questions of me, I sensed that he was inquiring almost on their behalf,” he continued, noting Elston said he wasn’t calling at McNulty’s request.
Elston’s lawyer later said McNulty, who had replaced Comey, had asked Elston to call Brownlee, according to The Washington Post.
Elston told TheDCNF on Friday he called Brownlee on behalf of McNulty after the deputy attorney general noticed the deadline for the plea agreement was unusually tight. Elston said he was asking the prosecutor for information and not to tell Brownlee to give Purdue more time.
McNulty did not respond to a request for comment.
Regardless, Brownlee stuck with the original deadline and Purdue agreed to it hours later, Brownlee testified.
Eight days later, Brownlee’s name was included on a list Elston compiled of prosecutors recommended for termination, though he ultimately was not fired, the Post reported in 2007.
Elston told TheDCNF he did not recall any connection between Brownlee being included on the list and the Purdue case.
Also during the course of the government’s investigation into Purdue, Giuliani met with Asa Hutchinson in 2005, who was then the Drug Enforcement Administration’s chief, Vanity Fair reported in 2007. The meeting came after the DEA found OxyContin could be responsible for 464 deaths over a two-year period.
Following his meeting with Giuliani, Hutchinson began asking DEA officials why they were still looking into Purdue.
Hutchinson is now the governor of Arkansas. He did not return a request for comment.
Legal Battles Against Purdue And The Sacklers Intensify
Deaths related to opioids have skyrocketed since the 2007 plea agreement, and the Sackler family, Purdue’s owners, largely kept its name separate from the epidemic, until recently.
TheDCNF began its “American Cartel” series in 2017, which tied the Sackler name to Purdue and investigated the family’s charitable givings. The Sacklers, until then, were known for their philanthropy, with famous institutions like New York’s Metropolitan Museum of Art naming entire sections after the family.
Meanwhile, lawsuits against Purdue from across the country have racked up. Evidence has trickled out showing the Sacklers knew about OxyContin’s dangers earlier than they said and showing they kept that information from the public. (RELATED: Purdue Pharma Looks To ‘Turnaround Kid’ As Opioid Lawsuits Pile Up)
Federal prosecutors discovered that Purdue Pharma knew OxyContin was being abused soon after the drug’s 1996 launch, a confidential DOJ report shows, the Times reported in May 2018. The report also found members of the Sackler family were aware that OxyContin and its morphine-based predecessor were being abused.
And a Tuesday court filing alleged that the Sacklers knew that Purdue knew OxyContin was being illegally dealt and abused, but failed to report it to authorities.
“This is not too bad,” Richard Sackler said in 2001 while serving as Purdue’s president and after a federal prosecutor reported that there were 59 deaths involving OxyContin in just one state, according to a document cited in the complaint. “It could have been far worse.”
Purdue, at the direction of the Sacklers, pushed for doctors to prescribe higher doses of OxyContin and for longer periods, resulting in massive profits for the company and the family, the lawsuit claims.
The Massachusetts complaint “irresponsibly and counterproductively casts every prescription of OxyContin as dangerous and illegitimate,” Purdue spokesman Bob Josephson said in a statement, calling the allegations “sensational” and “misleading.”
He accused the state of trying to “vilify” the company.
Josephson did not comment on Purdue’s communications with the DOJ.
He also said the Food and Drug Administration has ruled OxyContin continues to be “safe and effective for their intended use” and that the government determined in 2013 Purdue had fulfilled its obligations related to the marketing of its medications.
“The complaint is littered with biased and inaccurate characterizations,” Josephson said.
The only known instance where a Sackler was deposed was sealed as part of a $24 million settlement with Kentucky in December 2015.
Purdue recently lost an appeal to keep Richard Sackler’s deposition secret, but the company is continuing to contest the ruling. The testimony remains sealed while legal battles persist.
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Tags : department of justice oxycontin purdue pharma sackler family
Thank You DC and Mr Barton.
Showing posts with label Lawsuit. Show all posts
Showing posts with label Lawsuit. Show all posts
Monday, January 21, 2019
Wednesday, March 28, 2018
Penn Appeals Court Won't Reconsider Risperdal Lawsuit Punitive Damages Ruling
RX Injury Help
Published on March 27, 2018 by Sandy Liebhard
The Pennsylvania Superior Court has denied a defense motion seeking reconsideration of a recent ruling that could allow thousands of Risperdal lawsuit plaintiffs to pursue punitive damages against Johnson & Johnson and its Janssen Pharmaceuticals unit.
In January, a 3-judge panel of the Superior Court remanded a Risperdal gynecomastia lawsuit filed on behalf of Timothy Strange back to the Philadelphia Court of Common Pleas, ordering the trial court to determine whether or not punitive damages were warranted in the case.
Strange was awarded $500,000 in compensatory damages in December 2015. But like other Pennsylvania Risperdal plaintiffs, he was initially barred from seeking punitive damages because of a trial court ruling that applied New Jersey law to his claim. Johnson & Johnson and Janssen are headquartered in New Jersey, which forbids punitive damages in product liability claims involving federally-approved medications.
However, the Superior Court panel found that the trial court should have considered the law of plaintiffs’ home states when considering whether or not punitive damages should be allowed, opening the door for Strange and other plaintiffs to seek such awards.
Earlier this month, Janssen motioned the entire Pennsylvania Superior Court for reconsideration of the Panel’s ruling. That motion was denied on March 16th, allowing the January decision to stand.
Risperdal Gynecomastia
More than 6,200 Risperdal lawsuits are currently pending in the Philadelphia Court of Common Pleas, all of which were filed on behalf of men and boys who allegedly experienced excessive male breast growth (gynecomastia) due to their use of the atypical antipsychotic drug. Many of these plaintiffs were prescribed Risperdal as children, long before it had been approved for any pediatric uses by the U.S. Food & Drug Administration.
Plaintiffs claim that Johnson & Johnson and Janssen knowingly concealed the potential for Risperdal to cause excessive male breast growth from doctors and patients. They also contend that, prior to October 2006, the companies illegally marketed Risperdal for off-label pediatric indications.
Risperdal was not approved for use in children until October 2006. That same month, the drug’s label was updated to indicate that gynecomastia had occurred in 2.3% of male adolescents prescribed the medication. Up until that point, the label described the condition as a rare side effect affecting just 1 in 1,000 patients.
Thank You Ms Liebhard and RX Injury Help.
Published on March 27, 2018 by Sandy Liebhard
The Pennsylvania Superior Court has denied a defense motion seeking reconsideration of a recent ruling that could allow thousands of Risperdal lawsuit plaintiffs to pursue punitive damages against Johnson & Johnson and its Janssen Pharmaceuticals unit.
In January, a 3-judge panel of the Superior Court remanded a Risperdal gynecomastia lawsuit filed on behalf of Timothy Strange back to the Philadelphia Court of Common Pleas, ordering the trial court to determine whether or not punitive damages were warranted in the case.
Strange was awarded $500,000 in compensatory damages in December 2015. But like other Pennsylvania Risperdal plaintiffs, he was initially barred from seeking punitive damages because of a trial court ruling that applied New Jersey law to his claim. Johnson & Johnson and Janssen are headquartered in New Jersey, which forbids punitive damages in product liability claims involving federally-approved medications.
However, the Superior Court panel found that the trial court should have considered the law of plaintiffs’ home states when considering whether or not punitive damages should be allowed, opening the door for Strange and other plaintiffs to seek such awards.
Earlier this month, Janssen motioned the entire Pennsylvania Superior Court for reconsideration of the Panel’s ruling. That motion was denied on March 16th, allowing the January decision to stand.
Risperdal Gynecomastia
More than 6,200 Risperdal lawsuits are currently pending in the Philadelphia Court of Common Pleas, all of which were filed on behalf of men and boys who allegedly experienced excessive male breast growth (gynecomastia) due to their use of the atypical antipsychotic drug. Many of these plaintiffs were prescribed Risperdal as children, long before it had been approved for any pediatric uses by the U.S. Food & Drug Administration.
Plaintiffs claim that Johnson & Johnson and Janssen knowingly concealed the potential for Risperdal to cause excessive male breast growth from doctors and patients. They also contend that, prior to October 2006, the companies illegally marketed Risperdal for off-label pediatric indications.
Risperdal was not approved for use in children until October 2006. That same month, the drug’s label was updated to indicate that gynecomastia had occurred in 2.3% of male adolescents prescribed the medication. Up until that point, the label described the condition as a rare side effect affecting just 1 in 1,000 patients.
Thank You Ms Liebhard and RX Injury Help.
Saturday, February 3, 2018
Phila.'s Mass Tort Inventory Skyrockets As Risperdal Continues To Grow
Max Mitchell | February 02, 2018 at 03:53 PM
With an inventory of pharmaceutical cases that nearly doubled over the past 12 months, Philadelphia’s pharma-related mass tort programs have reached record heights for the second year in a row.
According to latest statistics from the First Judicial District, the total inventory of the city’s mass tort programs went from 6,196 at the beginning of the year to 10,984 by Dec. 31. That is a 77 percent increase for the Complex Litigation Center’s overall inventory.
And when it comes to the pharmaceutical-specific cases, the numbers are even more striking.
At the beginning of 2017, the court had 5,601 pharmaceutical cases pending, which was a record for the court. The latest statistics, however, say that by the end of December, the pharmaceutical inventory jumped to 10,395, which is an 85.5 percent increase.
According to the numbers, the vast majority of the growth is due to the drug Risperdal, which now accounts for more than 56 percent of the total mass tort inventory.
Since Jan. 2, 2017, the number of Risperdal cases jumped from 1,945 to 6,200 by late December, according to the data. That is a 219 percent increase over the 12-month period.
Kline & Specter attorney Thomas R. Kline, who is a lead attorney in the Risperdal litigation, said the significant increase is due to Janssen Pharmaceutical ending a tolling agreement, which then required the plaintiffs to file their cases in court so their claims would not be lost due to the statute of limitations running out.
Kline said he does not expect another wave of cases to be filed soon, but he added there have been no substantive talks regarding a global settlement. However, he said the increase in cases, which he said mostly involve claims related to an earlier version of the Risperdal label that was later updated, as well as a recent ruling by the state Superior Court allowing plaintiffs to push for punitive damages, should put increased pressure on the defendants.
“The inventory increase has been not only, in my view, one of quantity, but also one of quality,” he said.
A spokeswoman for Janssen, the Johnson & Johnson subsidiary that makes Risperdal, said the company plans to “continue to defend this litigation and will try cases where appropriate.”
[Ed: How the hell does Anyone Defend poisoning little children, or anyone of any age with this horror?]
The percentage of out-of-state plaintiffs filing cases in Philadelphia in 2017 also reached a new high, according to the latest number.
Last year, the number of plaintiffs coming from outside the Keystone State was at its lowest period in more than 10 years, at 74 percent, but the number of out-of-state plaintiffs filing in 2017 jumped to 90 percent. That is the highest number since the court began measuring the statistic in 2005.
The mass tort program that saw the second-highest level of growth was the program focused on Xarelto litigation. That litigation grew 33 percent over 2017, going from 1,214 to 1,619 cases, according to the court’s statistics.
It has been an active year for the Xarelto docket, with three bellwether trials happening in the federal wing of the litigation, and one trial coming to a $27.8 million verdict in Philadelphia. That award was later overturned, and the case is on appeal to the Superior Court.
Despite the growth, the litigation saw a much smaller increase in 2017 than it did in 2016. In 2016, the total number of Xarelto cases in Philadelphia grew by 121 percent.
Attorney Michael Weinkowitz of Levin Sedran & Berman, who is co-liaison counsel, said there is nothing on the horizon indicating that the program will see an influx of cases.
“I don’t expect it to grow substantially,” Weinkowitz said.
The mass tort program that saw the largest verdicts over the past year also saw a significant decline over 2017. The pelvic mesh mass tort, which saw a $57.1 million verdict and a $20 million verdict last year, shrunk by 27 percent, according to the latest numbers.
Court records said that, although 37 new pelvic mesh cases were filed, 82 were disposed of during 2017, dropping the total number of pelvic mesh cases from 164 in January 2017 to 119 by the end of the year.
Shanin Specter, who is also of Kline & Specter and is a leading attorney in the pelvic mesh litigation, said most of that dip was due to settlements in cases being handled by other firms.
Thank You Mr Mitchell and Legal Intelligencer.
Ed; And as for the Doctors not being held responsible in this, just, . . . don't, . . . don't even try hiding behind the BS they were lied to by Janssen Sales Reps and they actually fell for it.
Those Doctors weren't about to poison themselves with Risperdal. They knew better.
In fact those Doctors knew So Much better they were paranoid about swallowing it.
Why?
Saturday, April 23, 2016
Former Obama FDA Commish Margaret Hamburg Named In Massive Conspiracy and Racketeering Lawsuit Involving, (Who Else?) Johnson and Johnson
FDA's own Fast and Furious.
naturalnews
Friday, April 22, 2016
by Mike Adams, the Health Ranger
NaturalNews) The former head of the FDA, Margaret Hamburg, used the federal agency to run a massive conspiracy of racketeering and fraud in order to generate millions of dollars in drug company profits for her husband's hedge fund firm, alleges a damning lawsuit filed in the United States District Court for the District of Columbia.
The lawsuit alleges that while acting as FDA commissioner, Margaret Hamburg engaged in a wide-ranging conspiracy to approve an extremely dangerous drug known to cause severe (and even deadly) side effects, in order to financially benefit her husband's hedge fund which held very large financial positions in Johnson & Johnson, makers of the drug. "Defendants, each and every one of them, operated a criminal conspiracy at least between the years 2009 to 2015 to fraudulently suppress warnings about the devastating effects of Levaquin," says the complaint.
"This Amended Complaint sets forth allegations that involve a conspiracy by Defendants, each and every one of them, to reap large financial returns by failing to disclose to Plaintiffs and the public at large the full extent of the devastating, life-threatening, and deadly effects of a highly dangerous pharmaceutical drug named Levaquin," reads the opening of the lawsuit. The conspiracy complaint also alleges that over 5,000 people died as a result of Hamburg's conspiracy cover-up at the FDA:
Once confirmed as FDA Commissioner, Dr. Margaret A. Hamburg acted as the instrumentality that all Defendants used to perpetrate their conspiracy and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA Commissioner to suppress material information to Plaintiffs and the public that Levaquin was inherently dangerous and in fact, deadly. Had this information been disclosed to Plaintiffs and the public at large, her and her husband's financial gain and net worth would have plummeted, since Dr. Margaret A. Hamburg's husband, Peter F. Brown, reaped and continues to reap huge financial gain as a result of Renaissance Technologies, L.L.C.'s holdings of Johnson & Johnson stock.
To further this conspiracy, Dr. Margaret A. Hamburg, acting in concert with each and every Defendant, jointly and severally, appointed officials of Johnson & Johnson to key FDA Advisory Committees and colluded with Johnson & Johnson and its officials and subsidiaries to suppress information about the dangerous and deadly effects of Levaquin. As a result, during Dr. Margaret A. Hamburg's tenure as FDA Commissioner from 2009 to 2015, over 5,000 people died as a result of consuming Levaquin and other dangerous drugs promoted, manufactured, marketed, distributed and sold by Johnson & Johnson, suffered debilitating, life-threatening, and deadly illnesses and effects. This deadly harm is continuing as Plaintiffs and thousands of other people are suffering and dying from the highly dangerous effects of Levaquin.
"Both Alkermes and Johnson & Johnson stock value increased significantly during Hamburg's tenure," reports The Daily Caller.
Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton's recommendation. During the confirmation process before Congress, Dr. Margaret A. Hamburg, acting in concert with her husband, Peter F. Brown and the other Defendants named in this Amended Complaint, at all material times the Co-CEO of a hedge fund named Renaissance Technologies, L.L.C., failed to disclose to Congress and other relevant authorities, her and her husband's clear-cut conflict of interest – specifically, that Renaissance Technologies, L.L.C. held hundreds of millions of dollars of Johnson & Johnson stock, the manufacturer of the deadly drug, Levaquin.
...Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to Hillary Clinton in 2005, 2006, 2007, and 2008 to induce Mrs. Clinton to recommend and push for Defendant Hamburg to be nominated by President Obama.
...Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.
From what we now know about the Clinton Foundation's deep financial ties to Big Pharma and Wall Street hedge funds, none of this comes as any sort of surprise. In fact, while these allegations may have been easily dismissed as a "conspiracy theory" in 2008, so much more awakening has happened among the American public that they are now likely to be understood as an "actual conspiracy" being carried out among the political and financial elite who routinely conspire against the people in order to enrich themselves.
From May 2009 to March 2015, Plaintiffs suffered mitochondrial toxicity, neuropsychiatric adverse events, and multi-system disability related to their consumption of Levaquin, including a constellation of medical issues related to the following body systems: neuromuscular, neuropsychiatric, peripheral neuropathy, senses, skin, cardiovascular, plus, endocrine, nutritional, metabolic and immunity; blood and blood forming organs; circulatory system; respiratory system; digestive system; genitourinary system; and connective tissue.
Specifically, Plaintiffs suffer from a constellation of medical issues, including but not limited to widespread bodily pain, fatigue, muscle weakness, muscle twitching, muscle wasting, gait disturbances, severe balance issues, stiffness, spasms, joint pain, tendon issues, seizures, tremors, numbness, burning, tingling, fasciculation, spasticity, nerve damage, autonomic issues, voice issues, exercise intolerance, difficulty swallowing, slow digestive motility, abdominal pain, acid reflux, gastritis, nausea, constipation, diarrhea, colitis, cognitive impairment, memory impairment, cardiac issues, urinary issues, kidney damage, liver damage, pancreatic damage, thyroid abnormalities, hair loss, glucose issues, respiratory issues, emotional issues, depression, psychosis, depersonalization, dissociation, anxiety, insomnia, abnormal dreams, suicidal thoughts, thought alterations, agitation, fatigue, dizziness, inability to concentrate, panic attacks, difficulty communicating, forgetfulness, bruising, vision issues, hearing issues, tinnitus, dental issues, gum issues, skin issues, rashes, multiple chemical sensitivity, sexual dysfunction, reproductive issues, and DNA damage.
This Amended Complaint sets forth allegations that involve a conspiracy by Defendants, each and every one of them, to reap large financial returns by failing to disclose to Plaintiffs and the public at large the full extent of the devastating, life-threatening, and deadly effects of a highly dangerous pharmaceutical drug named Levaquin.
Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton's recommendation. During the confirmation process before Congress, Dr. Margaret A. Hamburg, acting in concert with her husband, Peter F. Brown and the other Defendants named in this Amended Complaint, at all material times the Co-CEO of a hedge fund named Renaissance Technologies, L.L.C., failed to disclose to Congress and other relevant authorities, her and her husband's clear-cut conflict of interest – specifically, that Renaissance Technologies, L.L.C. held hundreds of millions of dollars of Johnson & Johnson stock, the manufacturer of the deadly drug, Levaquin.
Once confirmed as FDA Commissioner, Dr. Margaret A. Hamburg acted as the instrumentality that all Defendants used to perpetrate their conspiracy and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA Commissioner to suppress material information to Plaintiffs and the public that Levaquin was inherently dangerous and in fact, deadly. Had this information been disclosed to Plaintiffs and the public at large, her and her husband's financial gain and net worth would have plummeted, since Dr. Margaret A. Hamburg's husband, Peter F. Brown, reaped and continues to reap huge financial gain as a result of Renaissance Technologies, L.L.C.'s holdings of Johnson & Johnson stock.
To further this conspiracy, Dr. Margaret A. Hamburg, acting in concert with each and every Defendant, jointly and severally, appointed officials of Johnson & Johnson to key FDA Advisory Committees and colluded with Johnson & Johnson and its officials and subsidiaries to suppress information about the dangerous and deadly effects of Levaquin. As a result, during Dr. Margaret A. Hamburg's tenure as FDA Commissioner from 2009 to 2015, over 5,000 people died as a result of consuming Levaquin and other dangerous drugs promoted, manufactured, marketed, distributed and sold by Johnson & Johnson, suffered debilitating, life-threatening, and deadly illnesses and effects. This deadly harm is continuing as Plaintiffs and thousands of other people are suffering and dying from the highly dangerous effects of Levaquin.
Because of the Defendants' racketeering scheme and conspiracy to suppress warnings and other material information about the extent of the deadly effects of Levaquin, Plaintiffs were precluded from discovering the extent of their injuries until 2015, not coincidentally after Dr. Margaret A. Hamburg no longer held her position as FDA Commissioner in 2015 and material information about the full extent of the dangers of Levaquin were disclosed thereafter.
Defendants, each and every one of them, profited handsomely from their racketeering conspiracy by their agreed-upon failure to disclose the harmful effects of Levaquin to Plaintiffs and the public at large. This case is thus of seminal importance not only for Plaintiffs, but also for the consuming public at large. It is a tragic testament to how corrupt companies like Johnson & Johnson and their officials bribe and illegally collude with government officials and line their pockets at the expense of persons such as Plaintiffs.
Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to Hillary Clinton in 2005, 2006, 2007, and 2008 to induce Mrs. Clinton to recommend and push for Defendant Hamburg to be nominated by President Obama.
Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.
In and around May 26, 2009, Defendant Hamburg was forced to divest herself of several hedge fund holdings, as was her husband, Defendant Brown. This was done in order for her to take the position as the top food and drug regulator without any real or apparent conflicts of interest. However, the conflict of interest herein was never resolved. Neither Defendant Hamburg nor Defendant Brown, nor any other Renaissance Technologies executive had fully disclosed to Congress and other authorities that Defendant Brown, Defendant Hamburg's husband at all material times, still held shares in – and benefits financially from – all of the stocks of Renaissance, via Renaissance Technologies profit-sharing, as explained in detail by Defendant Simons, regardless of whether Defendant Brown divested himself of a particular hedge fund, in furtherance of the racketeering enterprise and conspiracy.
While Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown's annual income, not coincidentally, increased from a reported $10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012, due in whole or in part to Defendants' racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin.
As part of Defendant Hamburg's pattern and practice of acting illegally outside of the scope of her authority as FDA Commissioner in furtherance of the racketeering enterprise and conspiracy, she counseled the FDA to also approved another highly dangerous pharmaceutical drug that Renaissance Technologies owns stock in, Zohydro, despite the fact that on December 7, 2012, an FDA Advisory Committee voted 11 to 2 against its approval. In or around March 2013, Defendant Hamburg personally testified to members of Congress that she supported Zohydro's approval.
Defendant Hamburg, as part of her pattern and practice of illegally acting outside the scope of her authority as Commissioner of the FDA, fraudulently used the U.S. mails and wires to commit overt acts in furtherance of the racketeering enterprise and conspiracy by willfully and intentionally and illegally preventing the FDA from issuing warnings about the devastating and life-threatening effects of Levaquin.
On November 5, 2015, after Defendant Hamburg had resigned, an FDA employee, Debra Boxwell, finally exposed to Plaintiffs, and the public at large, that Defendant Hamburg and the FDA had been aware that Levaquin may result in multi-system disability since 2013, but that it did nothing to add this information to the Levaquin label and instead conspired with the other Defendants to fraudulently withhold it.
From May 2009 to March 2015, Plaintiffs suffered mitochondrial toxicity, neuropsychiatric adverse events, and multi-system disability related to their consumption of Levaquin, including a constellation of medical issues related to the following body systems: neuromuscular, neuropsychiatric, peripheral neuropathy, senses, skin, cardiovascular, plus, endocrine, nutritional, metabolic and immunity; blood and blood forming organs; circulatory system; respiratory system; digestive system; genitourinary system; and connective tissue.
Specifically, Plaintiffs suffer from a constellation of medical issues, including but not limited to widespread bodily pain, fatigue, muscle weakness, muscle twitching, muscle wasting, gait disturbances, severe balance issues, stiffness, spasms, joint pain, tendon issues, seizures, tremors, numbness, burning, tingling, fasciculation, spasticity, nerve damage, autonomic issues, voice issues, exercise intolerance, difficulty swallowing, slow digestive motility, abdominal pain, acid reflux, gastritis, nausea, constipation, diarrhea, colitis, cognitive impairment, memory impairment, cardiac issues, urinary issues, kidney damage, liver damage, pancreatic damage, thyroid abnormalities, hair loss, glucose issues, respiratory issues, emotional issues, depression, psychosis, depersonalization, dissociation, anxiety, insomnia, abnormal dreams, suicidal thoughts, thought alterations, agitation, fatigue, dizziness, inability to concentrate, panic attacks, difficulty communicating, forgetfulness, bruising, vision issues, hearing issues, tinnitus, dental issues, gum issues, skin issues, rashes, multiple chemical sensitivity, sexual dysfunction, reproductive issues, and DNA damage.
Defendants, each and every one of them, operated a criminal conspiracy at least between the years 2009 to 2015 to fraudulently suppress warnings about the devastating effects of Levaquin.
Specifically, the purpose of Defendants' racketeering enterprise included, but was not limited to, reaping large financial gain by willfully and intentionally suppressing material information, through the fraudulent use of the U.S. mails and wires, about the devastating, life threatening, and deadly effects of Levaquin. These Defendants form this association in fact for the common and continuing purpose described herein and constitute an enterprise within the meaning of 18 U.S.C. SS 1961(4) engaged in the conduct of their affairs through a continuing pattern of racketeering activity. As described in the foregoing paragraphs of this Amended Complaint, Defendants, each and every one of them, maintained an ongoing relationship during the course of their ongoing criminal enterprise.
PREDICATE ACTS Bribery in Violation of 18 U.S.C. SS 201, Predicate Act No. 1
From May 2009 to March 2015, Defendants Johnson & Johnson, Johnson & Johnson PRD, and Janssen committed acts constituting indictable offenses under 18 U.S.C. SS 201(b)(1)(A)-(C) in that they directly or indirectly, corruptly gave, and offered and promised things of valuable, such as money, to Defendant Hamburg, who for the purposes of this predicate act was a public official as FDA Commissioner, with the intent to influence Defendant Hamburg to suppress material information about the devastating, life-threatening, and deadly effects of Levaquin. This is evidenced by Defendants Johnson & Johnson, Johnson & Johnson PRD, and Janssen's pattern and practice of using gratuities and bribery to secure favorable treatment for its products, as described in paragraph 40 of this Amended Complaint. 109.
Predicate Act No. 19
From May 2009 to March 2015, Defendants Renaissance Technologies, Brown, Mercer, and Simons, in furtherance of the racketeering enterprise and conspiracy, transferred ill-gotten and illegal financial gains from Defendant Renaissance Technologies' holdings of Defendant Johnson & Johnson stock to Defendants in order to continue to carry out Defendants unlawful conspiracy to conceal material information about the devastating and life-threatening effects of Levaquin.
As set forth previously, in every quarter except one, from May 2009 to March 2015, while Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown's employer, Defendant Renaissance Technologies, held significant amounts of Defendant Johnson & Johnson stock, including as much as half a billion dollars in Defendant Johnson & Johnson stock.
Tags: Margaret Hamburg, FDA commissioner, conspiracy and racketeering
Thank You Mr Adams and Natural News.
If you want a pdf of the complaint rather than a scribd doc, we got ours here:
http://www.larryklayman.com/pdf/160416-filed%20am.%20comp.%20levaquin.pdf
You may also find this FDA/JNJ footnote interesting.
http://psychroaches.blogspot.com/search/label/Brenner-Gati
naturalnews
Friday, April 22, 2016by Mike Adams, the Health Ranger
NaturalNews) The former head of the FDA, Margaret Hamburg, used the federal agency to run a massive conspiracy of racketeering and fraud in order to generate millions of dollars in drug company profits for her husband's hedge fund firm, alleges a damning lawsuit filed in the United States District Court for the District of Columbia.
The lawsuit alleges that while acting as FDA commissioner, Margaret Hamburg engaged in a wide-ranging conspiracy to approve an extremely dangerous drug known to cause severe (and even deadly) side effects, in order to financially benefit her husband's hedge fund which held very large financial positions in Johnson & Johnson, makers of the drug. "Defendants, each and every one of them, operated a criminal conspiracy at least between the years 2009 to 2015 to fraudulently suppress warnings about the devastating effects of Levaquin," says the complaint.
"This Amended Complaint sets forth allegations that involve a conspiracy by Defendants, each and every one of them, to reap large financial returns by failing to disclose to Plaintiffs and the public at large the full extent of the devastating, life-threatening, and deadly effects of a highly dangerous pharmaceutical drug named Levaquin," reads the opening of the lawsuit. The conspiracy complaint also alleges that over 5,000 people died as a result of Hamburg's conspiracy cover-up at the FDA:
Once confirmed as FDA Commissioner, Dr. Margaret A. Hamburg acted as the instrumentality that all Defendants used to perpetrate their conspiracy and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA Commissioner to suppress material information to Plaintiffs and the public that Levaquin was inherently dangerous and in fact, deadly. Had this information been disclosed to Plaintiffs and the public at large, her and her husband's financial gain and net worth would have plummeted, since Dr. Margaret A. Hamburg's husband, Peter F. Brown, reaped and continues to reap huge financial gain as a result of Renaissance Technologies, L.L.C.'s holdings of Johnson & Johnson stock.
To further this conspiracy, Dr. Margaret A. Hamburg, acting in concert with each and every Defendant, jointly and severally, appointed officials of Johnson & Johnson to key FDA Advisory Committees and colluded with Johnson & Johnson and its officials and subsidiaries to suppress information about the dangerous and deadly effects of Levaquin. As a result, during Dr. Margaret A. Hamburg's tenure as FDA Commissioner from 2009 to 2015, over 5,000 people died as a result of consuming Levaquin and other dangerous drugs promoted, manufactured, marketed, distributed and sold by Johnson & Johnson, suffered debilitating, life-threatening, and deadly illnesses and effects. This deadly harm is continuing as Plaintiffs and thousands of other people are suffering and dying from the highly dangerous effects of Levaquin.
"Both Alkermes and Johnson & Johnson stock value increased significantly during Hamburg's tenure," reports The Daily Caller.
Margaret Hamburg "bought" her way into the FDA with financial contributions to Hillary Clinton and Barack Obama, alleges the lawsuit
A fascinating finding in the lawsuit alleges that Margaret Hamburg bribed her way into the top position at the FDA by making large financial contributions to Hillary Clinton and Barack Obama:Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton's recommendation. During the confirmation process before Congress, Dr. Margaret A. Hamburg, acting in concert with her husband, Peter F. Brown and the other Defendants named in this Amended Complaint, at all material times the Co-CEO of a hedge fund named Renaissance Technologies, L.L.C., failed to disclose to Congress and other relevant authorities, her and her husband's clear-cut conflict of interest – specifically, that Renaissance Technologies, L.L.C. held hundreds of millions of dollars of Johnson & Johnson stock, the manufacturer of the deadly drug, Levaquin.
...Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to Hillary Clinton in 2005, 2006, 2007, and 2008 to induce Mrs. Clinton to recommend and push for Defendant Hamburg to be nominated by President Obama.
...Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.
From what we now know about the Clinton Foundation's deep financial ties to Big Pharma and Wall Street hedge funds, none of this comes as any sort of surprise. In fact, while these allegations may have been easily dismissed as a "conspiracy theory" in 2008, so much more awakening has happened among the American public that they are now likely to be understood as an "actual conspiracy" being carried out among the political and financial elite who routinely conspire against the people in order to enrich themselves.
Horrible side effects from the drug destroyed the lives of countless victims
From the lawsuit:From May 2009 to March 2015, Plaintiffs suffered mitochondrial toxicity, neuropsychiatric adverse events, and multi-system disability related to their consumption of Levaquin, including a constellation of medical issues related to the following body systems: neuromuscular, neuropsychiatric, peripheral neuropathy, senses, skin, cardiovascular, plus, endocrine, nutritional, metabolic and immunity; blood and blood forming organs; circulatory system; respiratory system; digestive system; genitourinary system; and connective tissue.
Specifically, Plaintiffs suffer from a constellation of medical issues, including but not limited to widespread bodily pain, fatigue, muscle weakness, muscle twitching, muscle wasting, gait disturbances, severe balance issues, stiffness, spasms, joint pain, tendon issues, seizures, tremors, numbness, burning, tingling, fasciculation, spasticity, nerve damage, autonomic issues, voice issues, exercise intolerance, difficulty swallowing, slow digestive motility, abdominal pain, acid reflux, gastritis, nausea, constipation, diarrhea, colitis, cognitive impairment, memory impairment, cardiac issues, urinary issues, kidney damage, liver damage, pancreatic damage, thyroid abnormalities, hair loss, glucose issues, respiratory issues, emotional issues, depression, psychosis, depersonalization, dissociation, anxiety, insomnia, abnormal dreams, suicidal thoughts, thought alterations, agitation, fatigue, dizziness, inability to concentrate, panic attacks, difficulty communicating, forgetfulness, bruising, vision issues, hearing issues, tinnitus, dental issues, gum issues, skin issues, rashes, multiple chemical sensitivity, sexual dysfunction, reproductive issues, and DNA damage.
Highlights of the complaint
You can read the complaint here, posted by the Daily Caller News Foundation. I've extracted some of the highlights of the complaint for reference, shown below.This Amended Complaint sets forth allegations that involve a conspiracy by Defendants, each and every one of them, to reap large financial returns by failing to disclose to Plaintiffs and the public at large the full extent of the devastating, life-threatening, and deadly effects of a highly dangerous pharmaceutical drug named Levaquin.
Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton's recommendation. During the confirmation process before Congress, Dr. Margaret A. Hamburg, acting in concert with her husband, Peter F. Brown and the other Defendants named in this Amended Complaint, at all material times the Co-CEO of a hedge fund named Renaissance Technologies, L.L.C., failed to disclose to Congress and other relevant authorities, her and her husband's clear-cut conflict of interest – specifically, that Renaissance Technologies, L.L.C. held hundreds of millions of dollars of Johnson & Johnson stock, the manufacturer of the deadly drug, Levaquin.
Once confirmed as FDA Commissioner, Dr. Margaret A. Hamburg acted as the instrumentality that all Defendants used to perpetrate their conspiracy and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA Commissioner to suppress material information to Plaintiffs and the public that Levaquin was inherently dangerous and in fact, deadly. Had this information been disclosed to Plaintiffs and the public at large, her and her husband's financial gain and net worth would have plummeted, since Dr. Margaret A. Hamburg's husband, Peter F. Brown, reaped and continues to reap huge financial gain as a result of Renaissance Technologies, L.L.C.'s holdings of Johnson & Johnson stock.
To further this conspiracy, Dr. Margaret A. Hamburg, acting in concert with each and every Defendant, jointly and severally, appointed officials of Johnson & Johnson to key FDA Advisory Committees and colluded with Johnson & Johnson and its officials and subsidiaries to suppress information about the dangerous and deadly effects of Levaquin. As a result, during Dr. Margaret A. Hamburg's tenure as FDA Commissioner from 2009 to 2015, over 5,000 people died as a result of consuming Levaquin and other dangerous drugs promoted, manufactured, marketed, distributed and sold by Johnson & Johnson, suffered debilitating, life-threatening, and deadly illnesses and effects. This deadly harm is continuing as Plaintiffs and thousands of other people are suffering and dying from the highly dangerous effects of Levaquin.
Because of the Defendants' racketeering scheme and conspiracy to suppress warnings and other material information about the extent of the deadly effects of Levaquin, Plaintiffs were precluded from discovering the extent of their injuries until 2015, not coincidentally after Dr. Margaret A. Hamburg no longer held her position as FDA Commissioner in 2015 and material information about the full extent of the dangers of Levaquin were disclosed thereafter.
Defendants, each and every one of them, profited handsomely from their racketeering conspiracy by their agreed-upon failure to disclose the harmful effects of Levaquin to Plaintiffs and the public at large. This case is thus of seminal importance not only for Plaintiffs, but also for the consuming public at large. It is a tragic testament to how corrupt companies like Johnson & Johnson and their officials bribe and illegally collude with government officials and line their pockets at the expense of persons such as Plaintiffs.
Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to Hillary Clinton in 2005, 2006, 2007, and 2008 to induce Mrs. Clinton to recommend and push for Defendant Hamburg to be nominated by President Obama.
Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.
In and around May 26, 2009, Defendant Hamburg was forced to divest herself of several hedge fund holdings, as was her husband, Defendant Brown. This was done in order for her to take the position as the top food and drug regulator without any real or apparent conflicts of interest. However, the conflict of interest herein was never resolved. Neither Defendant Hamburg nor Defendant Brown, nor any other Renaissance Technologies executive had fully disclosed to Congress and other authorities that Defendant Brown, Defendant Hamburg's husband at all material times, still held shares in – and benefits financially from – all of the stocks of Renaissance, via Renaissance Technologies profit-sharing, as explained in detail by Defendant Simons, regardless of whether Defendant Brown divested himself of a particular hedge fund, in furtherance of the racketeering enterprise and conspiracy.
While Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown's annual income, not coincidentally, increased from a reported $10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012, due in whole or in part to Defendants' racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin.
As part of Defendant Hamburg's pattern and practice of acting illegally outside of the scope of her authority as FDA Commissioner in furtherance of the racketeering enterprise and conspiracy, she counseled the FDA to also approved another highly dangerous pharmaceutical drug that Renaissance Technologies owns stock in, Zohydro, despite the fact that on December 7, 2012, an FDA Advisory Committee voted 11 to 2 against its approval. In or around March 2013, Defendant Hamburg personally testified to members of Congress that she supported Zohydro's approval.
Defendant Hamburg, as part of her pattern and practice of illegally acting outside the scope of her authority as Commissioner of the FDA, fraudulently used the U.S. mails and wires to commit overt acts in furtherance of the racketeering enterprise and conspiracy by willfully and intentionally and illegally preventing the FDA from issuing warnings about the devastating and life-threatening effects of Levaquin.
On November 5, 2015, after Defendant Hamburg had resigned, an FDA employee, Debra Boxwell, finally exposed to Plaintiffs, and the public at large, that Defendant Hamburg and the FDA had been aware that Levaquin may result in multi-system disability since 2013, but that it did nothing to add this information to the Levaquin label and instead conspired with the other Defendants to fraudulently withhold it.
From May 2009 to March 2015, Plaintiffs suffered mitochondrial toxicity, neuropsychiatric adverse events, and multi-system disability related to their consumption of Levaquin, including a constellation of medical issues related to the following body systems: neuromuscular, neuropsychiatric, peripheral neuropathy, senses, skin, cardiovascular, plus, endocrine, nutritional, metabolic and immunity; blood and blood forming organs; circulatory system; respiratory system; digestive system; genitourinary system; and connective tissue.
Specifically, Plaintiffs suffer from a constellation of medical issues, including but not limited to widespread bodily pain, fatigue, muscle weakness, muscle twitching, muscle wasting, gait disturbances, severe balance issues, stiffness, spasms, joint pain, tendon issues, seizures, tremors, numbness, burning, tingling, fasciculation, spasticity, nerve damage, autonomic issues, voice issues, exercise intolerance, difficulty swallowing, slow digestive motility, abdominal pain, acid reflux, gastritis, nausea, constipation, diarrhea, colitis, cognitive impairment, memory impairment, cardiac issues, urinary issues, kidney damage, liver damage, pancreatic damage, thyroid abnormalities, hair loss, glucose issues, respiratory issues, emotional issues, depression, psychosis, depersonalization, dissociation, anxiety, insomnia, abnormal dreams, suicidal thoughts, thought alterations, agitation, fatigue, dizziness, inability to concentrate, panic attacks, difficulty communicating, forgetfulness, bruising, vision issues, hearing issues, tinnitus, dental issues, gum issues, skin issues, rashes, multiple chemical sensitivity, sexual dysfunction, reproductive issues, and DNA damage.
Defendants, each and every one of them, operated a criminal conspiracy at least between the years 2009 to 2015 to fraudulently suppress warnings about the devastating effects of Levaquin.
Specifically, the purpose of Defendants' racketeering enterprise included, but was not limited to, reaping large financial gain by willfully and intentionally suppressing material information, through the fraudulent use of the U.S. mails and wires, about the devastating, life threatening, and deadly effects of Levaquin. These Defendants form this association in fact for the common and continuing purpose described herein and constitute an enterprise within the meaning of 18 U.S.C. SS 1961(4) engaged in the conduct of their affairs through a continuing pattern of racketeering activity. As described in the foregoing paragraphs of this Amended Complaint, Defendants, each and every one of them, maintained an ongoing relationship during the course of their ongoing criminal enterprise.
PREDICATE ACTS Bribery in Violation of 18 U.S.C. SS 201, Predicate Act No. 1
From May 2009 to March 2015, Defendants Johnson & Johnson, Johnson & Johnson PRD, and Janssen committed acts constituting indictable offenses under 18 U.S.C. SS 201(b)(1)(A)-(C) in that they directly or indirectly, corruptly gave, and offered and promised things of valuable, such as money, to Defendant Hamburg, who for the purposes of this predicate act was a public official as FDA Commissioner, with the intent to influence Defendant Hamburg to suppress material information about the devastating, life-threatening, and deadly effects of Levaquin. This is evidenced by Defendants Johnson & Johnson, Johnson & Johnson PRD, and Janssen's pattern and practice of using gratuities and bribery to secure favorable treatment for its products, as described in paragraph 40 of this Amended Complaint. 109.
Predicate Act No. 19
From May 2009 to March 2015, Defendants Renaissance Technologies, Brown, Mercer, and Simons, in furtherance of the racketeering enterprise and conspiracy, transferred ill-gotten and illegal financial gains from Defendant Renaissance Technologies' holdings of Defendant Johnson & Johnson stock to Defendants in order to continue to carry out Defendants unlawful conspiracy to conceal material information about the devastating and life-threatening effects of Levaquin.
As set forth previously, in every quarter except one, from May 2009 to March 2015, while Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown's employer, Defendant Renaissance Technologies, held significant amounts of Defendant Johnson & Johnson stock, including as much as half a billion dollars in Defendant Johnson & Johnson stock.
Tags: Margaret Hamburg, FDA commissioner, conspiracy and racketeering
If you want a pdf of the complaint rather than a scribd doc, we got ours here:
http://www.larryklayman.com/pdf/160416-filed%20am.%20comp.%20levaquin.pdf
You may also find this FDA/JNJ footnote interesting.
http://psychroaches.blogspot.com/search/label/Brenner-Gati
Thursday, January 21, 2016
SCOTUS Rejects Yet Another Case Challenging ObamaCare.
fiercehealthpayer.
January 20, 2016 | By Leslie Small
Thank You Ms Small and FHP.
January 20, 2016 | By Leslie Small
The Supreme Court has declined to hear another case challenging the Affordable Care Act, denying a petition for a writ of certiorari in the case of Sissel v. Department of Health and Human Services. In doing so, the Court let stand a lower court ruling that dismissed the case, which claims the ACA violates the constitutional requirement that bills raising taxes must originate in the House,according to the Associated Press.
The complaint was filed on behalf of small-business owner Matt Sissel, with backing from the Pacific Legal Foundation (PLF), the AP adds.
"It is very disappointing that the Court has chosen not to hear this important case, because the justices were being asked to uphold and enforce an important constitutional protection for all taxpayers," PLF Principal Attorney Timothy Sandefur said in a statement about the Court's decision. Court order
Thank You Ms Small and FHP.
Monday, January 11, 2016
SCOTUS Denies J&J's Final Appeal of South Carolina Risperdal Verdict: PAY UP, $124 Million
fiercepharma
January 11, 2016 | By Tracy Staton
Johnson & Johnson ($JNJ) fell short Monday in its final effort to escape a Risperdal marketing penalty in South Carolina. The U.S. Supreme Court declined to take up J&J's last appeal in the case, putting the company on the hook for a $124 million penalty.
J&J had cited the Eighth Amendment in arguing against the penalty, saying it qualified as an "excessive fine." As Reuters notes, the U.S. Chamber of Commerce had backed the drugmaker in seeking Supreme Court review.
J&J's Janssen unit has been fighting South Carolina's deceptive trade practices court win since 2011, when a jury ordered the drugmaker to pay $327 million for Risperdal marketing violations. The company succeeded in lowering the judgment twice, first to $136 million and then, last year, to the final $124 million.
The lawsuit centered on promotional materials Janssen used to market the antipsychotic drug. Key to the case was a letter sent to South Carolina physicians, which overstated Risperdal's benefits compared with other drugs in its class and downplayed side effects, the jury found. The trial court judge ordered Janssen to pay about $4,000 for each of the more than 7,000 letters mailed.
The original $327 million judgment dwarfed other similar rulings in drug-marketing lawsuits, including sizable decisions and settlements in other Risperdal-related litigation, but it fell far short of a $1.2 billion verdict in Arkansas. The Arkansas Supreme Court struck down that judgment in March 2014, and the company later negotiated a settlement of $7.5 million.
The South Carolina decision survived that state's top court in a ruling last year, in which Justice John Kittredge backed the decision at trial, but lowered the $327 million penalty to $136 million.
In affirming the judgment against the company, Kittredge echoed the trial judge's "profit-at-all-costs" characterization of Janssen's marketing efforts. "Janssen's desire for market share and increased sales knew no bounds, leading to its egregious violation of South Carolina law," Kittredge wrote in the February 2015 ruling.
Janssen had argued that it did not intentionally deceive doctors with the now-notorious "Risperdal letter" that has featured in several state-court lawsuits. The drugmaker also contended that South Carolina's attorney general didn't prove patients were actually harmed by the drug. It was on that point that Kittredge lowered the judgment.
The "Risperdal letter" lawsuits compose only part of the mountain of litigation J&J has fought over the antipsychotic drug. The company agreed to pay $2.2 billion in a marketing settlement with the U.S. Justice Department and a group of states.
And the litigation isn't over yet. The company now faces more than 1,000 lawsuits over Risperdal's ability to trigger breast development in boys. J&J lost the first court battle last February, as a Philadelphia jury ordered J&J to pay almost $2.5 million to a young man who developed breasts while using Risperdal. In November, another jury awarded $1.75 million in a similar case.
- see the Reuters story
Special Reports: Top 15 pharma companies by 2014 revenue - J&J | Pharma's Top 11 Marketing Settlements
Related Articles:
J&J slapped with $1.75M verdict in Risperdal breast growth case
J&J nears $7.5M deal in Risperdal case that could have cost $1.2B
J&J loses first court battle over Risperdal's breast-growth side effects
Arkansas court boots $1.2B J&J verdict on technical grounds
J&J persuades LA Supreme Court to toss $257M Risperdal marketing verdict
J&J to pay $2.2B to wrap up long-standing Risperdal marketing probe
J&J slapped with $1.75M verdict in Risperdal breast growth case
J&J nears $7.5M deal in Risperdal case that could have cost $1.2B
J&J loses first court battle over Risperdal's breast-growth side effects
Arkansas court boots $1.2B J&J verdict on technical grounds
J&J persuades LA Supreme Court to toss $257M Risperdal marketing verdict
J&J to pay $2.2B to wrap up long-standing Risperdal marketing probe
Thank You Ms Staton and Fierce Pharma.
J&J had cited the Eighth Amendment in arguing against the penalty, saying it qualified as an "excessive fine."
Un real. J&J crying about the 8th Amendment.
They made $28.90 Billion - a 97% return - on Risperdal between 1994 to and 2010 and $124 Million is Excessive.
but Tardive Dyskinesia isn't excessive, nor does it constitute Cruel and Unusual Punishment, for committing a thought crime.
Thursday, December 10, 2015
Janssen Defends Data Reanalysis In Risperdal Trial
Legal Intelligencer
Max Mitchell, The Legal Intelligencer
A Janssen Pharmaceuticals official and the statistician who recently conducted a hotly contested reanalysis of data purportedly linking Risperdal to gynecomastia were "hoagie buddies," according to the plaintiff's attorney in the ongoing Risperdal-related case.
Max Mitchell, The Legal Intelligencer
A Janssen Pharmaceuticals official and the statistician who recently conducted a hotly contested reanalysis of data purportedly linking Risperdal to gynecomastia were "hoagie buddies," according to the plaintiff's attorney in the ongoing Risperdal-related case.
To illustrate that point, Thomas R. Kline of Kline & Specter, who is representing plaintiff Timothy Stange in Stange v. Janssen Pharmaceuticals, read portions of emails between the statistician, Warren Bilker, and a Janssen official who had been tasked with helping to find a researcher to perform the reanalysis of data that first appeared in a 2003 medical article.
Kline used the email, and others, to refute arguments from the defense that Janssen played a limited role in the reanalysis, which has become a major point of contention. While Janssen has pointed to the newer study as confirmation of earlier findings suggesting no significant statistical relationship between Risperdal and gynecomastia—a condition causing excessive breast tissue in young males—the plaintiffs have argued that some results linking the condition to Risperdal were omitted from the earlier study to conceal the risks and manipulate the marketplace.
In the email, Bilker and the Janssen research vice president, Jesse Berlin, appeared to discuss meeting up for a dinner before going to a Philadelphia Phillies game. One of the places they talk about eating is at a sandwich restaurant by Citizens Bank Park, where the Phillies play.
"They're old hoagie buddies," Kline said. "Why, they're guys that are heading to the ball game. To the Phils."
The email, and others that appeared to discuss the vetting process between Janssen officials and Bilker in regards to his reanalysis, were read during trial Wednesday after a three-week break. The case had been put on hold so Janssen could provide more than 30,000 responsive documents, consisting of about 300,000 pages, related to the reanalysis.
The reanalysis at issue was of a 2003 medical article published in the Journal of Clinical Psychiatry, which has been referred to in the litigation as the Findling article.
However, Janssen development leader Dr. Danielle Coppola, who was on the stand Wednesday, testified the data was omitted from the initial analysis because it was not statistically significant, and the reanalysis, which included the omitted information, confirmed the results of the Findling report.
Coppola further testified Janssen had a limited role in the reanalysis, and only asked Bilker to perform the work after other statisticians were unable to do the project. She further noted that the authors of the Findling report had the ultimate say in who would perform the reanalysis.
According to Coppola, the reanalysis was done after questions about the validity of the findings were raised in litigation and in the media. She said the author of the Findling article initially reached out to Janssen about having a reanalysis performed, and Janssen had to be involved in the study because it is the only entity with access to all the Risperdal-related research data.
"I wanted to make sure the data was safe, and the label accurately reflected that," Coppola said.
When asked by defense attorney Melissa Graff of Drinker Biddle & Reath how the reanalysis compared to the original findings, which did not indicate a significant link between Risperdal and gynecomastia, Coppola said they were "entirely consistent."
Coppola said no information had been withheld from the authors of the Findling article. She also said that one of the original authors, who had threatened to take his name off the Findling article if there were any problems, was satisfied with the reanalysis, and the newer findings were also given to the U.S. Food and Drug Administration.
"We thought that, under the circumstances, it would be important to share," she said. "We all have an interest in the safety of the product."
Coppola also told the jurors that the table initially omitted did not deal with the frequency of patients experiencing elevated prolactin while taking Risperdal, but instead showed the proportion of elevated prolactin levels to all adverse reactions that Risperdal users experienced. She also noted that statistics mentioned on the label were based on clinical trial, while the omitted data came from reports of adverse effects by users.
When asked by Kline about the emails involving Bilker, one of which included Berlin telling Bilker that the authors of the Findling report "will want to be convinced that you are a legitimate scientist (a tough sell, I know)," Coppola said she had never seen the emails before, but knew that Bilker and Berlin knew each other. She said the Findling authors knew the two knew each other as well.
"They were buddies," Kline said, adding that the two appeared to be joking in the emails.
Kline went on to review the findings in the omitted tables regarding elevated levels of prolactin, and noted that the ratios of higher prolactin were significantly greater in children and adolescents than in adults.
The case, which is before Philadelphia Court of Common Pleas Judge Kenneth Powell, is expected to end before the end of the week.
Max Mitchell can be contacted at 215-557-2354 or mmitchell@alm.com. Follow him on Twitter @MMitchellTLI. •
Thank You Mr Mitchell and Legal Intelligencer
Saturday, November 14, 2015
Janssen Must Produce "Reanalysis" Records In Risperdal Trial
legalintelligencer
Max Mitchell, The Legal Intelligencer
Thank You Mr Mitchell and Legal Intellingencer.
Hope they get better documents from Janssen than Congressman Issa got from Obama's AG.
Max Mitchell, The Legal Intelligencer
The Philadelphia judge overseeing an ongoing Risperdal-related trial has ordered Janssen Pharmaceuticals to turn over by Sunday any documents it may have pertaining to the reanalysis of a key medical report in the litigation, or face possible sanctions.
Philadelphia Court of Common Pleas Judge Kenneth Powell ordered the drug maker to produce all evidence, documents, reports, emails and other nonprivileged information related to a “reanalysis of data” by noon Nov. 15. The order added that, if the deadline is not met, the “custodian” of the items will need to appear Nov. 16 to show why the order was not complied with. Failure to appear will result in sanctions, the order said.
Although the order did not specify what the “reanalysis” pertains to, Thomas R. Kline, who is representing the plaintiff in the ongoing Stange v. Janssen case, said it is related to a 2003 medical article published in the Journal of Clinical Psychiatry, referred to in the litigation as the Findling article, which has become a major point of contention in the litigation.
The plaintiffs have argued in court documents and proceedings that some results linking gynecomastia—a condition causing excessive breast tissue in young males—to the drug were omitted from the report to conceal the risks and manipulate the marketplace.
Kline said attorneys were recently notified that a reanalysis had been done indicating that none of the omitted data showed a more significant link between Risperdal and gynecomastia, and about 3,000 documents were turned over in the litigation.
Kline said the order should result in about 12,000 additional pages of documents being filed, and said he expects the documents to show Janssen recently communicated with the authors of the articles.
“We now have an order requiring defendants to turn over all documents relating to the back-and-forth between Janssen and the authors of the article who sent this so-called reanalysis to the journal,” Kline said.
In an emailed statement, Janssen spokeswoman Robyn Frenze said, “We are in the process of complying with the court’s order and we look forward to continuing to present our case to the jury.”
Max Mitchell can be contacted at 215-557-2354 or mmitchell@alm.com. Follow him on Twitter @MMitchellTLI.
Thank You Mr Mitchell and Legal Intellingencer.
Hope they get better documents from Janssen than Congressman Issa got from Obama's AG.
Tuesday, November 10, 2015
UPDATED: J&J Slapped With $1.75 Million Verdict In Risperdal Male Breast Growth Case
fiercepharma
November 10, 2015 | By Emily Wasserman
[Ed; "Contains No Active Drug". The Doctors pushing Risperdal are so paranoid themselves - and with good reason considering the drug maker they're dealing with - that they need a written disclaimer because despite what they tell the consumer about Risperdal, they know better than to be made 'Mentally Healthy' themselves with the stuff.]
On to the Fierce Pharma article:
November 10, 2015 | By Emily Wasserman
[Ed; "Contains No Active Drug". The Doctors pushing Risperdal are so paranoid themselves - and with good reason considering the drug maker they're dealing with - that they need a written disclaimer because despite what they tell the consumer about Risperdal, they know better than to be made 'Mentally Healthy' themselves with the stuff.]
On to the Fierce Pharma article:
Johnson & Johnson ($JNJ) lost another courtroom battle over claims that the company failed to warn doctors and patients that its antipsychotic drug Risperdal could cause breast growth in boys, a blow for the company as it continues to deal with related cases.
A state court jury in Philadelphia ordered J&J to pony up $1.75 million, including damages for disfigurement and mental anguish, to a young man who developed gynecomastia, or abnormal breast development, while taking the drug as a teen, Bloomberg reports. The company and its Janssen unit still face about 1,500 cases in the same court that were filed by men who grew breasts after taking Risperdal.
"We will consider our options going forward," J&J spokeswoman Robyn Frenze told FiercePharma in an emailed statement. "Risperdal has helped and is still helping millions of patients with debilitating mental illnesses and neurodevelopmental conditions as part of a comprehensive treatment plan."
The verdict marks a dark point for J&J as it deals with breast growth claims over the drug. Earlier this year, former FDA chief David Kessler testified in the Philadelphia court that the company knew as early as 2001 that Risperdal could cause boys to grow breasts, about 5 years before adding a warning about the side effect to the drug's official label. J&J also got flak for allegedly marketing the drug off-label for pediatric patients before the breast growth side effect went on the label.
[Ed: more on and from David Kessler below:
[Ed: more on and from David Kessler below:
"Kessler's report was posted to the Court of Common Pleas electronic docket system late Wednesday in four pieces, as part of the J&J motion to preclude him from testifying. The pieces are all PDFs and links are here, here, here and here." ]
J&J struck back, saying that Kessler was a "hired gun" known for testifying against drugmakers and that he cherry-picked information to support his claims against the company. J&J lawyer Diane Sullivan also said that Janssen requested to add information about safe dosing in children to Risperdal's label before the breast-development warning was added in 2006.
 |
| Former FDA commissioner David Kessler |
But a Philadelphia jury didn't buy those arguments and shot down J&J/Janssen in the first court battle over breast growth claims, ordering the company in February to pay $2.5 million to a young man who grew 46DD breasts while taking Risperdal. None too pleased with the ruling, J&J said it would consider all of its legal options including a potential appeal. "We firmly believe this verdict should be overturned," Frenze said at the time.
J&J has traveled a long legal road with Risperdal. In 2013, the company agreed to shell out $2.2 billion to settle off-label marketing allegations by the Justice Department and several U.S. states over claims that J&J pushed the drug for use in children and teens before the FDA approved pediatric indications.
The drugmaker also settled marketing claims with 36 states and the District of Columbia over Risperdal marketing for more than $180 million, plus another settlement in Texas for $158 million. In October, J&J and Janssen revealed that they set up a reserve to deal with 5,400 pending Risperdal cases, Bloombergreports.
Still, J&J has chalked up some victories along the way in state courts. The company fended off a $257 million award in Louisiana after convincing the state's Supreme Court that its marketing practices did not violate state law. J&J also escaped a $1.2 billion verdict in Arkansas after the Arkansas Supreme Court ruled that the state filed the case under a statute that did not apply to pharma companies.
In July, South Carolina's Supreme Court further reduced the penalty against J&J from a Risperdal marketing lawsuit. The court originally ordered the company to pay $327 million but shaved the judgment down to $124 million.
- read the Bloomberg story
Special Reports: Pharma's Top 11 Marketing Settlements - J&J | 10 Largest Settlements and Judgments
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Editor's note: This story was updated with a comment from Johnson & Johnson.
Thank You Ms Wasserman and Fierce Pharma.
Psychiatry's Ethics.
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