(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.

The world's third largest publicly traded oil company BP Plc, agreed to settle a lawsuit brought by a woman whose parents died in a Texas refinery explosion, woman's lawyer said.

Though the terms of the agreement were confidential, BP set aside $1.6 billion to resolve the claims.

The London based BP, has acknowledged safety shortcomings at the plant, and settled about 1,000 suits, including all death claims except the two filed by Eva Rowe, 22. She lost both her parents in the explosion and has refused to settle unless BP agrees to change safety procedures and equipment.

Roddy Kennedy, who heads BP's press office in London, said he couldn't comment on the reported settlement. BP will pay money to community groups as part of the settlement, attorney Brent Coon said.

If if the trial had gone forward, BP faced unlimited damages and harm to its reputation. The March 23, 2005, explosion killed 15 and injured hundreds at its Texas City, Texas, refinery led to more than 1,300 suits against BP, a record fine from the U.S. Occupational Safety and Health Administration and a finding by another safety agency that the company endangered workers by cutting costs.

The evidence to be introduced, including an internal study showing the company ignored safety problems at the Texas City refinery, could have produced sizable punitive damages. The trial was set to begin with jury selection today.

Breaking Legal News.com
Sheryl Jones
Staff Writer

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.

South Dakota voters Tuesday rejected a controversial law banning most abortions  passed by the state legislature earlier this year. With 818 out of 818 precincts reporting Wednesday, the final unofficial results for Referred Law 6 were:

NO 185948 56%
YES 148666 44%

The abortion ban, seen as a direct challenge to the US Supreme Court's abortion precedents, was placed on the South Dakota ballot after an advocacy group gathered more than 37,000 signatures on a petition to force a referendum. The US Court of Appeals for the Eighth Circuit had already upheld a preliminary injunction against the law's enforcement pending a lawsuit.

Dhiren Barot, a British man who pleaded guilty to planning a series of bombs on US and British targets, was sentenced to life in prison Tuesday. Barot was accused of planning several attacks, including the "Gas Limo Project" to blow up three limousines filled with explosives in underground parking garages in Britain.

Justice Butterfield of the Woolwich Crown Court handed down the sentence, saying a successful execution of Barot's plans would have resulted in a catastrophe on a "colossal and unprecedented scale." Prosecutors presented evidence that Barot wrote a proposal to obtain approval and funding for the plan from al Qaeda leadership in Pakistan. Barot pleaded guilty to conspiracy charges for his involvement in the plot last month, but his seven co-defendants maintain their innocence.

Prosecutors also said Barot planned to detonate a bomb below the River Thames in an attempt to immerse the London subway system in water. In addition to attacks planned throughout the UK, prosecutors alleged that Barot planned to attack the International Monetary Fund and World Bank buildings in Washington DC, the New York  buildings in Newark, New Jersey. Barot was indicted in New York for the US-related bomb plans last April, along with two other men.

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.

The Australian Senate voted Tuesday to lift restrictions on stem cell research and permit the therapeutic cloning of human embryos. By a 34-32 vote, lawmakers approved the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006, which also includes stricter penalties of up to 15 years in prison for anyone convicted of attempting to buy human egg, sperm or embryo faces.

Australia's parliament voted in 2002 to allow researchers to extract stem cells from extra embryos originally intended for use in in vitro fertilization, but did not permit the use of those cells in cloning. The Australian House of Representatives will consider the latest legislation later this month.