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FDA Strengthens its Program for Medical Devices
Breaking Legal News | 2006/11/09 10:00

(FDA) - The U.S. Food and Drug Administration (FDA) today announced its action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace.

"Many of today's medical devices are smaller and more complex than ever, offering new medical opportunities that have benefited literally millions of people," said Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs, FDA. "But this technical sophistication sometimes means that the margin for error with device manufacturing shrinks and so we need to be working even harder, after devices and engineering changes are approved, to monitor for potential safety problems."

FDA's Center for Devices and Radiological Health (CDRH) last year completed a comprehensive assessment of the tools used to monitor the safety of medical devices after the agency approves them for marketing. In January, the agency formed a Postmarket Transformation Leadership Team to develop an action plan focusing on four main areas: enhancing the center's culture of collaboration; developing world class data systems; enhancing risk/benefit communication efforts; and collaborating on improved enforcement strategies and outcomes.

"The agency is committed to improving its medical device safety program and ensuring that medical devices and radiation-emitting products remain safe and effective once they are in the hands of health professionals and the public," said Daniel Schultz, M.D., Director, CDRH. "Postmarket systems that enable constant learning and feedback not only help support best medical practices to ensure safe use of devices with maximum effectiveness but they also spur continued innovation. This plan is a major step in that direction."

Today's Postmarket Transformation Leadership Team report outlines actions to transform the postmarket program. These efforts will increase the agency's ability to identify, analyze, and act on the risks that may be posed by the thousands of devices used by health professionals and consumers every day. The action items include the following:

  • creating a cross-cutting organizational structure within CDRH to better integrate premarket, postmarket and enforcement efforts;
  • developing internal performance measurements to track the center's handling of postmarket issues, such as recalls;
  • pursuing the development of a unique identifier system to identify a device and the information associated with that device throughout its lifetime;
  • proposing mandatory use of electronic reporting for required adverse event reports and revising the current system that records reported adverse events for devices (the Manufacturer and User Facility Device Experience Database or MAUDE system);
  • increasing the use of Medical Product Safety Device Network (MedSun) programs—a network comprised of more than 350 hospitals that have been recruited and specifically trained to identify and report device problems, and help provide "real time" data on signals and safety problems;
  • enhancing risk/benefit communication efforts so health practitioners, patients and consumers receive clearer and more timely information on public health news; and
  • increasing the coordination among the agency's compliance and enforcement programs.


Tallahassee College Settles Discrimination Suit
Breaking Legal News | 2006/11/09 09:56

WASHINGTON - (USDOJ) The Justice Department announced today that it has reached an agreement with Tallahassee Community College (TCC) to resolve an employment discrimination complaint that was filed on Nov. 2, 2006. The complaint, filed in the U.S. District Court for the Northern District of Florida, alleged that TCC subjected an African-American applicant to racial discrimination by not selecting him for the position of HomeSafenet Trainer because of his race in violation of Title VII of the Civil Rights Act of 1964, as amended.

The African-American applicant originally filed a charge of discrimination with the U.S. Equal Employment Opportunity Commission (EEOC), which investigated the charge and found reasonable cause to believe a federal civil rights violation had occurred. After unsuccessfully attempting to resolve the matter, the EEOC referred the matter to the Justice Department.

Under the consent decree, which was approved by the court today, TCC has agreed to offer the applicant $34,363 which includes $32,490 in back pay and $1,873 in accumulated interest.

"Racial discrimination in employment is both unlawful and wrong, and the Department of Justice will vigorously enforce the requirements of Title VII," said Wan J. Kim, Assistant Attorney General for the Civil Rights Division. "We are pleased that TCC worked cooperatively with the Justice Department to reach an amicable settlement of this matter."

Additional information about the Employment Litigation Section within the Justice Department's Civil Rights Division is available on the Department's Web site at http://www.usdoj.gov/crt/emp/index.html.



FCC drops indecency charges against TV shows
Breaking Legal News | 2006/11/08 09:27

The Federal Communications Commission (FCC) has dropped charges previously filed against ABC's "NYPD Blue" and CBS's "The Early Show," holding Monday that the shows were not indecent based on language content. The FCC also renewed charges against "The 2003 Billboard Music Awards" and "The 2002 Billboard Music Awards." According to the FCC order, the FCC dismissed the charges relating to the "The Early Show," deferring "to CBS's characterization of the program segment as a news interview" and concluding "regardless of whether such language would be actionable in the context of an entertainment program, that the complained-of material is neither actionably indecent nor profane in this context." The FCC upheld its charges against the "Billboard Music Awards" stating that "the use of offensive language by participants…was indecent and profane."

In April, ABC, NBC, CBS, and Fox filed appeals contesting the original FCC indecency rulings against the shows. The networks argued that the indecency findings for "fleeting" or "unintentional" profanities were inappropriate and that the FCC's inconsistent rulings chilled free speech in violation of the First Amendment. In July, CBS filed an additional appeal on the FCC decision to fine it $550,000 for an incident in the 2004 Super Bowl broadcast when performer Janet Jackson experienced what was later euphemistically labeled a "wardrobe malfunction"  that briefly exposed one of her breasts. A decision has not yet been made on that appeal.



Report Finds FBI Prosecuting Fewer Cases Since 911
Breaking Legal News | 2006/11/06 09:37

A report released by the Transactional Records Access Clearinghouse at Syracuse University concludes that the Justice Department increasingly has refused to prosecute FBI cases targeting suspected terrorists over the past five years. TRAC co-director Susan Long said researchers relied on the Justice Department's own numbers to come up with the findngs. The study was based on the most recent data available from the Justice Department's executive office for U.S. attorneys.

The government disputes the findings as inaccurate and "intellectually dishonest."

Prosecutors declined to bring charges in 87 percent, of international terrorist case referrals from the FBI between October 2005 and June 2006, according to the report.

During the 2001 budget year, prosecutors rejected 33 percent of such cases from the FBI. The data "raise troubling questions about the bureau's investigation of criminal matters involving individuals the government has identified as international terrorists," the report said. Also noted in the report, was the fact that while the number of agents and other employees has risen, prosecutions in traditional FBI investigations since 2001 - including drug cases, white collar crimes and organized crimes - have decreased.

The report states, "So with more special agents, many more intelligence analysts, and many fewer prosecutions the question must be asked: What is the FBI doing?"

A Justice Department spokesman, Brian Roehrkasse noted that terrorist hoax cases that were quickly dismissed may have been included in the government data, adding also that while some cases are referred to prosecutors to obtain subpoenas or other legal orders in investigations, they ultimately never result in criminal charges. Roehrkasse disputed the findings of TRAC and said that prosecutors rejected 67 percent of FBI international terrorist cases in the nine-month period - not 87 percent.

John Miller, the FBI's assistant director, said about half of the FBI's resources go to detection and information gathering of terrorist networks in cases that do not always result in arrests, reflecting changes in how investigations have been conducted since the Sept. 11, resulting in what appears to be a low number of cases prosecuted. Miller said, "It's not about the numbers and for TRAC to suggest as much is to be intellectually dishonest. The FBI has been very clear about how we have changed the way we do business since 9/11."

Breaking Legal News.com
Sheryl Jones
Staff Writer


Soldier Indicted in Iraqi Civilian Deaths
Breaking Legal News | 2006/11/03 09:24

WASHINGTON – (USDOJ) A former Ft. Campbell soldier has been charged with various crimes for conduct including premeditated murder based on the alleged rape of an Iraqi girl and the deaths of the girl and members of her family, Assistant Attorney General Alice S. Fisher of the Criminal Division and U.S. Attorney David L. Huber of the Western District of Kentucky announced today.

Steven D. Green, 21, was charged in the indictment returned today by a federal grand jury in Louisville, Ky., with conduct that would constitute conspiracy to commit murder, conspiracy to commit aggravated sexual abuse, premeditated murder, murder in perpetration of aggravated sexual abuse, aggravated sexual abuse on a person less than 16 years of age, use of firearms during the commission of violent crimes and obstruction of justice. The potential statutory penalties for conviction of these offenses ranges from a term of years to life in prison to death.

The indictment charges Green with crimes arising from an incident that occurred on March 12, 2006, in and around Mahmoudiyah, Iraq. The indictment alleges that during the incident Green and others committed aggravated sexual abuse against a 14-year-old Iraqi girl, whose body was burned after the attack. The indictment also alleges that Green and others killed the girl, her father, mother, and six-year-old sister during the same incident.

Green was discharged from the U.S. Army in May 2006 and is being prosecuted in U.S. District Court under the Military Extraterritorial Jurisdiction Act, a statute that gives U.S. courts jurisdiction to prosecute crimes committed outside the United States by persons who served with the Armed Forces but are no longer subject to military prosecution. Other soldiers who have not been discharged by the Army are currently charged by the Army with taking part in the incident out of which the charges against Green arise.

Green, formerly stationed at Ft. Campbell, Ky., and deployed to Iraq while serving with the 101st Airborne Division of the United States Army, was arrested by the FBI on June 30, 2006, on federal charges of murder and rape pursuant to the Military Extraterritorial Jurisdiction Act. Green is scheduled to be arraigned on the indicted charges on Nov. 8, 2006, at 10 a.m. in Louisville.

An indictment is merely an accusation. All defendants are presumed innocent until proven guilty at trial beyond a reasonable doubt.

The case was investigated by the FBI and the Criminal Investigation Division of the U.S. Army. The case is being prosecuted by the U.S. Attorney’s Office in the Western District of Kentucky and the Domestic Security Section of the Criminal Division.



Ex-Software CEO Sentenced to 12 Years
Breaking Legal News | 2006/11/02 10:52

On Thursday, the former CEO of Computer Associates International Inc., Sanjay Kumar, was sentenced to 12 years in prison and was fined $8 million for his participation in a massive accounting fraud scandal.

Kumar, 44, after pleading guilty in April to obstruction of justice and securities fraud charges, had faced up to 20 years behind bars. The company has been renamed CA Inc.

Kumar could have faced life in prison under federal sentencing guidelines, but the judge called that punishment unreasonable. Noting that Kumar was not a violent individual, U.S. District Judge Leo Glasser said Kumar "did violence to the legitimate expectations of shareholders."

Prosecutor Eric Komitee said Kumar was "the most brazen in the modern era of corporate crime" and he deserved severe punishment as the architect of an elaborate coverup.

Kumar, who is also a co-owner of the New York Islanders hockey team, told the judge at his sentencing," I know that I was wrong and there was no excuse for my conduct." The defense had urged the judge to give Kumar a short prison term followed by lengthy community service.

Said attorney John Cooney, "I hope the court will not lose sight of the good he did for that company," Decribed as one of the "great minds" of the software industry by his attorneys, Kumar is credited for turning Computer Associates into a thriving enterprise.

According to a 2004 indictment, Kumar flew on a corporate jet to Paris in July 1999 to finalize a $19 million deal and signed a backdated contract. The indictment also charged that Kumar along with other executives, instructed salespeople to complete deals after the quarter closing, an industry practice known as the "35-day month" - and "cleaned up" contracts by removing time stamps from faxes.

In 2002, after the FBI began investigating the company, Kumar orchestrated a cover-up that involved lying under oath and trying to buy the silence of a potential witness, authorities said.

CA Inc. is now the world's fifth-largest software provider with 15,000 employees worldwide.

Kumar was ordered to surrender on Feb. 27.


Breaking Legal News.com
Sheryl Jones
Staff Writer


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