WASHINGTON (AP) — Almost two years ago, the Food and Drug Administration ignored the advice of its scientists and approved a knee implant after being lobbied by members of Congress. On Thursday, the agency issued an unprecedented "mea culpa," saying the device should not have been approved.
The agency said it is taking steps to revoke approval of the Menaflex implant, made by ReGen Biologics. The announcement comes a year after the agency first acknowledged that its decision to approve the device was influenced by outside pressure, including lobbying by four lawmakers from the company's home state of New Jersey.
The 2008 decision to approve the implant was made despite protests by FDA scientists that Menaflex — which reinforces damaged knee tissue — provides little, if any, benefit to patients.
The day after Councilwoman Beth Mason called for Councilman Ravi Bhalla to resign for pay-to-play violations, Bhalla struck back with a claim that Mason committed more severe violations of state election commission laws.
A review of records filed by Mason with the Election Law Enforcement Commission (ELEC) show that Mason paid out $15,000 in "street money" - cash used for such things as get-out-the-vote efforts - apparently in violation of ELEC rules.
He was not the one accused of human organ trafficking, nor the money-laundering rabbi. No, in the sprawling corruption sting that shook New Jersey last year, what marked Peter J. Cammarano III, then the mayor of Hoboken, was the spectacle of a promising career blown apart almost before it started.
His downfall became complete on Tuesday, in Federal District Court in Newark, where Mr. Cammarano, 32, pleaded guilty to accepting illegal campaign contributions in return for aiding proposed development projects. The youngest mayor in the city’s history, he served 23 days in that office last year before being arrested and charged, and eight more before resigning. He now faces a probable sentence of 24 to 30 months in prison.
Some of the requirements of the Local Government Ethics Law, set forth at N.J.S.A. 40A: 9-22.1 et seq., are relatively straightforward and easy to understand. Local public officials must file financial disclosure statements under N.J.S.A. 40A:9-22.6, and members of independent authorities cannot do business with or appear before those authorities for a year after they leave the body under N.J.S.A. 40A:9-22.5(b).
However, perhaps the central concept of this law, enacted in 1991 to restore and preserve the public trust in local government, is far less clear. Exactly what type of interest must an official have in a given issue to create a conflict sufficient to prevent him or her from participating in any decisions concerning the matter?
The solution is so simple that the stubbornness of the Hudson County freeholders could lead people to believe there is something shady going on with a five-year, $22 million medical services contract for the county jail.
At every level, the courts have instructed the county to rebid the contract, but instead, freeholders are running up taxpayer costs by filing costly (and fruitless) appeals.
Hudson County was defeated twice in court last week over a controversial $22 million medical services contract it gave a politically connected bidder. Wednesday a two judge panel of the New Jersey Appellate Division refused the county’s request to stay a previous court decision throwing out an amendment to the awarded contract. The New Jersey Supreme Court later similarly refused to issue a stay.
Despite the consecutive court rulings, the county continues to appeal.
The Hudson County Board of Freeholders should have sought new bids rather than drastically reducing a contract to provide medical services at the county jail and juvenile detention center.
Superior Court Assignment Judge Maurice Gallipoli voided that amendment in a written decision Tuesday, saying the Board of Freeholders shouldn't have awarded the contract in the first place.
In his 14-page opinion, Gallipoli said allowing the amended contract to stand "would allow for the award of a contract which was never really put out for public bid."
Hudson County Assignment Judge Maurice Gallipoli is scheduled to hear arguments tomorrow on whether Hudson County improperly awarded a contract for prison medical services.
CFG Health Systems of Evesham filed a suit last month accusing the county of circumventing the law when it awarded the contract to a campaign donor to a freeholder and a former county employee.
A $1,000 political donation made to Freeholder Anthony Romano should have disqualified the winning company from bidding, CFG contends, adding in other counts that the whole process violated the Local Public Contracts Law. CFG officials say they believe their suit is the first to use the state's pay-to-play law to challenge a contract.
Hudson County is in the cross-hairs of what may be the state's first pay-to-play lawsuit, a challenge to a $22 million contract for medical services at the jail and juvenile detention center.
CFG Health Systems of Evesham is accusing the county of circumventing the law when it awarded the contract to a campaign donor and former employee.
A $1,000 political donation made to Freeholder Anthony Romano should have disqualified the winning company from bidding, CFG contends, adding in other counts that the whole process violated the Local Public Contracts Law.
WASHINGTON: The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.
The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.
But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.
Bergen County Democratic Chairman Joseph Ferriero has collected more than $195,000 in a private fund from donors — including county contractors and public employees — interested in securing his position as the leader of the county party.
Ferriero has maintained and controlled a fund called “Ferriero for County Chairman” since 2004, according to four years of disclosure forms he filed with the Internal Revenue Service last month.
The fund — which is not subject to state campaign disclosure laws because Ferriero is not a publicly elected official — collected tens of thousands in unlimited donations from some of the county’s and state’s biggest professional contractors. They include partners in the Teaneck law firm of DeCotiis Fitzpatrick Cole & Wisler, PMK Group and Neglia Engineering.
Federal investigators have intensified their investigation of powerful Democratic powerbroker Joseph Ferriero, issuing subpoenas for all documents related to his work for a public authority long criticized for political patronage.
The law firm of Ferriero, who serves as Bergen County Democratic chairman, has earned millions of dollars from the Passaic Valley Sewerage Commission since he became its chief counsel in 2002.
Earlier this month, investigators from U.S. Attorney Christopher Christie's office delivered two subpoenas to the commission, which operates one of the country's largest sewage treatment plants. One sought billing records and all other documents pertaining to Scarinci Hollenbeck, the prominent Bergen County law firm in which Ferriero is a partner.
The other demanded all records related to Ferriero and two other entities: a consulting firm he established in 2001 called SVC Consulting LLC, and Vision Media Marketing, a Secaucus-based public relations firm that has a contract with the commission.
A Hoboken watchdog group has the right to sue the city in an effort to enforce a municipal "pay-to-play" ordinance, a state appeals court said yesterday.
The court slapped down a prior decision by Hudson County Assignment Judge Maurice J. Gallipoli, who ruled in April 2006 that People for Open Government had no legal standing to bring a lawsuit - filed just before the June 2005 municipal runoff election - challenging what it saw as a failure to enforce the ordinance.
A three-judge panel of the Appellate Division of Superior Court said yesterday it disagreed and sent the matter back to the lower court.
"The individual plaintiffs in this case of great public interest have sufficient private interest to confer standing to prosecute this suit," the panel ruled.
POG claims in the lawsuit that a slate led by Hoboken Mayor David Roberts collected more than $1 million in campaign contributions from businesses that had no-bid professional contracts with the city, in violation of the "Hoboken Public Contracting Reform Ordinance," which voters approved by a 9-to-1 margin in a 2004 ballot initiative.
For the second time in a year, Assemblyman and Union City Mayor Brian Stack has been accused in court papers of orchestrating rulings by the Union City Zoning Board to benefit his political supporters.
"Simply put, Zoning Board approvals are for sale," states the lawsuit filed in U.S. District Court in Newark yesterday by Leonia developer Ralph Lieber. "Developers who contribute to the mayor's various war chests are rewarded with unanimous decisions for their projects. ... Those few dissenters who refuse to 'play the game' or those not savvy enough to even know the game is being played, risk almost certain rejection."
A non-partisan civic group is pushing for the city to adopt an ordinance that would extend pay-to-play prohibitions to developers.
The proposal is very similar to a proposal made last week by Jersey City Councilman Steve Fulop for his city.
Both ordinances would essentially bar developers from contributing to local politicians once the city decides to study an area for redevelopment, until a developer is chosen and the project is complete.
"We're not an anti-development group," said Eric S. Kurta, president of the Hoboken-based People for Open Government. "We are just curious about the city's intentions when it comes to areas in need of redevelopment."
If Councilman Greg Puliti can translate his vision into law, Lawrence may be the first town in New Jersey to use taxpayer dollars to finance municipal election campaigns. But such an ordinance would need to clear significant hurdles, attorneys say.
Funding an election campaign would cost taxpayers about $5,000 per candidate, Puliti estimated. In a typical election involving six candidates, the cost to the township for the campaigns would be $30,000. That equals 1/10th of 1 percent of the $37 million municipal budget, he said.
In 2004, Lawrence was one of more than two dozen towns across the state to adopt its own anti-pay-to-play laws. They are meant to constrict the money flow from contractors to candidates and political parties.
They've complained about no-bid contracts being awarded to party contributors, and in June, members of the Citizens' Campaign set out to do something about it in Bergen County.
First, they drafted an ordinance that would drastically revise the way contracts are awarded in the county -- and gave it to the Board of Freeholders to consider.
Next, they attended every freeholder meeting between June and October to check on their plan's progress.
And when the freeholders raised constitutional concerns about the proposal, the citizens group returned this month with a favorable legal opinion -- drafted by a panel of lawyers that includes a former justice of the New Jersey Supreme Court.
The Hoboken City Council has to decide if it’s worth giving a development company permission to build 100 units of market-rate housing so that they can also build a movie theater. The theater would not have to have any parking.
Get out a tub of buttery popcorn, Gummi bears, and a large soda, because some drama is unfolding regarding the city's proposal to rezone a block of northern Hoboken to build a new movie theater.
Incoming Schools Superintendent LeRoy E. Seitz will not start until Oct. 2 but he is already the subject of an anonymous, "Saturday Night Live"-style spoof on the hugely popular YouTube Internet site.
New Jersey Democrats are in trouble again over ethics, as if gripped by a curse that will simply not let go.
With FBI agents on their trail, they were sinking into deep denial last week, inventing conspiracy theories to explain away their own bad behavior.
This time the candidate on the hot seat was Sen. Robert Menendez, who faces voters in just two months.
Hoboken Mayor David Roberts is inviting residents interested in the future of St. Mary Hospital to submit resumes to serve as community representatives on its Board of Advisors.
The Board will consist of 11 members, six of whom will be private citizens and four who must be Hoboken residents.
At least two of the Hoboken must have expertise in finance of private or non-profit organizations, or have extensive expertise in non-profit organizational management.
The other members will be formed of Hospital staff and the State of New Jersey.
Those interested should send their resume to the Mayor's office, City Hall, 94 Washington Street, Hoboken, NJ, 07030. For further information, contact 201-420-2000.
See Political Commentary
ACS State & Local Solutions once was a great source of campaign cash for New Jersey politicians.
The company, which operates the state's E-ZPass toll collection system and also is a major contractor with the Department of Human Services, sank $250,000 into political war chests in 2002 through 2004 -- most of it to ruling Democrats.
All that changed in September 2004, when Gov. James E. McGreevey issued an executive order, which later became law, broadening curbs on political donations by state, county and local contractors.
ACS hasn't given a dime since. And it is not alone.
Both candidates vying for the Democratic nomination in the 13th District Congressional race are tapping into local sources for their campaign cash, according to federal elections reports.
Perth Amboy Mayor and Assemblyman Joseph Vas raised $170,200 between Jan. 1 and March 31 and almost $70,000 of it came from the developers who are involved in the city's redevelopment.
West New York Mayor and Assemblyman Albio Sires raised $437,000 in the same period, more than $60,000 of it coming from two groups: employees of West New York's Town Hall and the Board of Education.
Hoboken Ethics - NUMERO UNO!
By Ed Mecka@edmecka.com
April 13, 2006
Hoboken: On Monday, April 10, 2006 the City of Hoboken made the history books by the unanimous passing of a Pay to Play resolution at the Hoboken Board of Education. Hoboken is now the only city in New Jersey to have both Municipal and Board of Education financial restrictions with respect to political donations and public contracts.
Outgoing Board of Education member RON ROSENBERG fought long and hard to forge an unprecedented consensus among Board members who have often demonstrated unique differences of opinion on many issues. According to ROSENBERG, the passing of the resolution will go a long way in instilling public confidence in the financial decisions of the Board which recently approved a $ 51 million budget.
1-08-2006
Court upholds city law requiring developers to disclose political contributions. Over the past several years, there has been a growing movement by good government activists to add transparency and openness to government, especially in monitoring campaign contributions.
In January 1998, Kay Elizabeth LiCausi, a 26-year-old graduate of Rutgers University and a former Congressional intern, walked into the second-story office of a New Jersey congressman to start a job as scheduler.
The work was not glamorous - sorting through invitations, checking Amtrak timetables and fetching breakfast. But Ms. LiCausi was working for Representative Robert Menendez, a rising star in Democratic Party politics and the de facto political leader of Hudson County, who was soon to become the highest-ranking Hispanic member of Congress. She quickly gained his trust, and less than three years later was promoted to director of his New Jersey headquarters.
It's supposed to be an innovative addition to the way government contracts are awarded, but Hudson County's first attempt at using it has run afoul of politics.
It's called competitive contracting, and it falls in between the awarding of no-bid contracts and conventional bidding, under which contracts are supposed to be awarded to the low bidder, even if another firm might provide better overall value despite a higher price.