Archive for June, 2006

Mediterranean Cruise Ship Death Probed By U.S., Italian Authorities

Wednesday, June 28th, 2006

AP) - MISSION VIEJO, California-U.S. and Italian authorities are investigating the death of an American woman who went overboard from a cruise ship last month, the FBI said.Micki Kanesaki, 52, plunged into the Mediterranean on May 26 off the Island Escape, which was sailing between Sicily and Naples, said Laura Eimiller, an FBI spokeswoman in Los Angeles. Her body washed ashore the next day in Calabria in southwest Italy.

Kanesaki was sharing a cabin with her ex-husband, Lonnie Kocontes, 48. They divorced in 2002 after six years of marriage but continued to live together in their Mission Viejo home at least until last year, court records show.

Kanesaki left the cabin around 1 a.m. to get a cup of tea, said Andy Furlong, a spokesman for Island Cruises, the ship’s owner. Kocontes, a lawyer, reported her missing after he woke up and could not find her after searching the ship, Furlong said.

Italian police boarded the ship, seized records and videotapes and took statements from the crew.

Kanesaki’s mother, Setsuko Kanesaki, said her daughter was in good spirits before the trip.

“I can’t imagine what happened to her. There’s no reason to believe it was a suicide,” she said.

The investigation into the cause of death is continuing, Eimiller said.

California Prosecutors Reach $1 Million Deal With Diet Pill Maker

Tuesday, June 27th, 2006

AP) - SACRAMENTO, California-The state of California and 10 local prosecutors have reached a $1 million settlement with diet-pill maker Nutraquest Inc., which was accused of using deceptive techniques to sell weight-loss products that contained ephedra.U.S. regulators banned ephedra in April 2004 after it was linked to dozens of deaths and thousands of reports of health problems such as heart attack or increased blood pressure.

A federal judge subsequently lifted the Food and Drug Administration’s ban for supplements containing smaller doses, but the FDA determined the supplement presents an unreasonable risk of illness or injury at any dose and is appealing the judge’s ruling.

Nutraquest Inc. was accused in a lawsuit filed by the California prosecutors of making numerous deceptive advertising claims about its best-selling diet pill, Xenadrine RFA-1.

Among the claims, Nutraquest said the drug was “clinically proven to increase fat-loss by an unprecedented 1,700 percent,” and is “the only diet supplement in the world clinically proven to increase fat loss by an extraordinary 38.6 times more than diet and exercise alone.”

Nutraquest filed for bankruptcy protection in 2003 after a flood of lawsuits claiming the ephedra in Xenadrine caused medical problems, including at least one death.

As part of the settlement announced Thursday, Nutraquest president Robert Chinery is required to pay $600,000 in civil penalties and $400,000 (€317,000) in costs.

The prosecutors are Attorney General Bill Lockyer, the city attorney of San Diego and district attorneys in Alameda, Kern, Marin, Monterey, Napa, San Benito, San Francisco, Solano and Sonoma counties.

Some people who bought the diet pills also will be eligible for restitution as part of the bankruptcy proceedings.

Cadbury Defends Safety of Its Products

Tuesday, June 27th, 2006

AP) - LONDON-British confectioner Cadbury Schweppes PLC defended the safety of its products despite the recall of 1 million chocolate bars after finding traces of salmonella contamination.Britain’s food standards regulator said it was investigating why the company did not tell authorities earlier about a contamination incident at one of its factories in January.

Cadbury announced Friday that it was recalling about 1 million chocolate bars - including varieties of the popular Dairy Milk bar - in Britain and Ireland after finding traces of salmonella bacteria.

Cadbury said a batch of chocolate was contaminated with waste water from a leaking pipe at its factory in Marlbrook, western England, in January.

Cadbury managing director Simon Baldry said tests found only “minute traces” of bacteria.

“Our products were perfectly safe. We’d gone through our rigorous testing process,” Baldry told British Broadcasting Corp. television.

The company said it had rectified the problem and was withdrawing the products “purely as a precautionary measure.”

Cadbury is the world’s largest confectionary company, and includes brands like Trident, Halls, Dr Pepper, Snapple, Cadbury, Schweppes and Dentyne.

The Food Standards Agency said on Sunday Cadbury did not tell authorities about the contamination until this week.

“We were told on Monday that there was a problem occurring in January and that problem has gone on for a number of weeks before being corrected. We would have expected them to tell us,” an agency spokesman said on condition of anonymity in accordance with the agency’s practice.

He said any trace of salmonella in ready-to-eat foods was “not acceptable.”

The company said there was no proven link between its products and a rise in the number of cases of poisoning from a rare strain of salmonella. The bug causes diarrhea, fever and abdominal cramps and in some cases requires hospital treatment.

The Health Protection Agency said it was too early to say whether there was a link between the chocolate and an outbreak of 45 cases of the rare montevideo strain of salmonella over the last four months.

Hugh Pennington, a bacteriologist at Aberdeen University in Scotland, said even tiny amounts of salmonella in chocolate could cause illness.

“The fat in chocolate actually preserves the salmonella from the normal intestinal defenses, so you don’t have to eat very many salmonellas to get infected,” Pennington told the BBC. “It’s about a thousand times less than if you’re eating it from traditional sources like meats.”

Boston Scientific Recalls More Heart Devices, Expects More Problems

Tuesday, June 27th, 2006

BOSTON –Boston Scientific Corp. on Monday recalled nearly 23,000 pacemakers and defibrillators that could fail because of an electrical flaw, and the company asked doctors to check 27,000 patients already implanted with potentially faulty devices.

The announcement marked the second time Boston Scientific has issued a warning about products of the former Guidant Corp. since the Natick, Mass.-based company bought Guidant in April for $27 billion.

Shares of Boston Scientific fell nearly 7 percent Monday to close at their lowest level in nearly four years.

The company’s executives reiterated earlier warnings that they expect additional recalls involving Guidant heart devices.

The officials said Guidant-related troubles were no worse than they had expected when they launched a successful bidding war against Johnson & Johnson in December to acquire Guidant’s business in the $10 billion market for devices to restore a normal heart rhythm.

However, Jim Tobin, Boston Scientific’s president and CEO, said it could take as long as two years to fix design, manufacturing and supplier problems that triggered a wave of recalls and warnings starting last year involving nearly 300,000 devices of Indianapolis-based Guidant.

The problems involve far more than just Guidant’s shortcomings in promptly notifying doctors, patients and regulators about device flaws, Tobin said.

“In truth, there are deeper issues that will require time to address, that will lead to problems that will then have to be communicated,” Tobin told analysts during a conference call.

“It will take 18 months to two years to get all of those things taken care of,” Tobin said.

The latest recall involved certain manufacturing batches of an electrical component — a low-voltage capacitor — provided by an outside supplier.

Tobin said quality control reviews should have detected the problem. Instead, five malfunctions were reported in devices that either had already been surgically implanted or were about to be implanted.

“That should never happen, and it happened batch after batch after batch, and now we’re paying the price,” Tobin said.

No deaths were linked to the five malfunctions, but in two cases pacemaker patients temporarily became unconscious. In four cases, patients required surgery to replace devices.

Boston Scientific asked its sales force and managers of hospital inventories to return about 22,600 units of six models of pacemakers and defibrillators that have potentially faulty capacitors, which are used to store electrical charges.

A letter sent to doctors did not recommend potentially risky surgeries to remove another 27,200 implanted devices.

“Instead, we’re recommending that people see their doctors at the earliest opportunity,” company spokesman Paul Donovan said.

Boston Scientific advised doctors to check for signs of a malfunctioning capacitor, such as prematurely dead batteries or a device that stops working as intended.

Devices affected by the recall include certain units of Insignia and Nexus brand pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality, and Vitality 2 cardioverter defibrillators.

Boston Scientific is trying to determine the expected failure rate for devices already implanted. Executives said the rate was probably around one in 10,000.

Executives declined to estimate how much the recall would cost the company, but said they were quickly replacing recalled inventory with new units and did not expect a drop-off in sales.

But Tobin warned, “This is probably not the last problem we are going to find. … I also know that everybody in the industry will have further recalls. It’s just that kind of business. The bottom line is nobody should panic because of a faulty capacitor.”

Shares of Boston Scientific fell $1.20 to close at $17.06 on the New York Stock Exchange, where the stock traded at triple its normal daily volume. Adjusted for dividends and stock splits, the company’s shares last traded below $17.06 in October 2002.

On May 15, Boston Scientific issued its first warning involving products it acquired from Guidant when it advised doctors that 996 defibrillator units could have a defect causing batteries to go dead prematurely.

Study Correction Shows Early Vioxx Risks

Tuesday, June 27th, 2006

A correction published Monday by a medical journal to a key study on withdrawn painkiller Vioxx reveals the risk of heart problems was elevated throughout the time people took the drug and did not develop only after 18 months of use as the drug’s maker, Merck&Co., has contended.

The correction in the New England Journal of Medicine supports many doctors’contention that risks showed up with as little as four months of use.

Heart attacks and strokes occurred more frequently after people had been on the drug for at least 18 months, but the actual harm might have occurred much earlier, said Dr. Jeffrey Drazen, editor-in-chief of the journal, who worked with the authors to correct their original findings of the APPROVe trial, published in March 2005.

“It’s a subtle but very critical point,”Drazen said, comparing the situation to health problems being detected months after exposure to excessive radiation.

Cleveland Clinic cardiologist Dr. Steven Nissen, who has challenged the study’s conclusions in the past and did so again in a separate letter also published by the medical journal on Monday, agreed.

“A key legal defense in the liability cases has been the suggestion that there was no risk until patients had taken the drug for 18 months,”he said. Now, with the correction,”the authors have removed any claim that there was a delay in risk.”

The main authors, Dr. Robert Bresalier of the University of Texas’M.D. Anderson Cancer Center and Dr. John A. Baron of Dartmouth Medical School, could not be reached for comment but acknowledge in a letter released by the journal that their statistical analysis had been flawed.

Merck, which paid for the study and helped conduct it, acknowledged the flawed analysis last month but claimed it did not change the results.

On Monday, the company posted on its Web site what it called”an open letter to the scientific community,”saying it stands behind the original results of the study.

“This correction did not change the datain the APPROVe study or its results,”said a statement from Peter S. Kim, president of Merck Research Laboratories.”It is important to understand that the correction centered on the description of a single statistical method.”

“The scientific debate surrounding the APPROVe study in no way changes our commitment to defending the VIOXX litigation on a case-by-case basis,”says a statement from Kenneth C. Frazier, senior vice president and general counsel of the company.

Merck faces more than 13,000 lawsuits over Vioxx, a blockbuster arthritis drug until it was pulled from the market in September 2004.

An ongoing trial in Atlantic City, N.J., is the seventh case to reach trial. Merck has won half of the previous six.

Legal experts think there could be a spurt of additional suits filed against Merck soon, as a two-year statute of limitations affecting patients in most states ends at the end of September.

Shares of Whitehouse Station, N.J.-based Merck rose 8 cents to close at $35.02 on the New York Stock Exchange.

FDA Violation Warnings Dropped 50% Under Bush Administration: Congressman

Tuesday, June 27th, 2006

The US Food and Drug Administration (FDA) issued 50% fewer warning letters to companies violating federal drug and safety regulations in the past five years under the Bush administration, according to a report released Monday by US Rep. Henry Waxman (D-CA) In 2000, the FDA issued 1,154 warning letters, while in 2005, only 535 letters went out, and Waxman said the numbers dropped despite a constant level of violations. David Elder, the director of the FDA Office of Enforcement, responded by saying the number of letters sent does not accurately reflect the agency’s activities, noting that the department has instead focused its efforts on blocking major health risks to the public resulting in $2.5 billion in fines and restitutions since 2000.

Waxman’s investigative report also cites recommendations by FDA field monitors during site inspections that were rejected by departmental officials. One incident involved the lack of a warning to a company that marketed a drug to remedy hangovers which contained toxic caffeine amounts. Waxman said the FDA’s response that it does not keep a record of violation recommendations is a breach of federal documentation tracking laws. 

Pilots Warned About Ill. Runway Conditions

Monday, June 26th, 2006

WASHINGTON (AP) _ Southwest Airlines pilots received differing reports on runway conditions as they approached Chicago’s Midway airport, where their jet skidded off the runway and killed a 6-year-old boy, according to a cockpit transcript released Tuesday.

The National Transportation Safety Board is looking into procedures for landing at short or slippery runways as a result of the Dec. 8 accident. The jet, landing in snowy conditions, crashed through a fence into the street, killing Joshua Woods of Leroy, Ind., as he was riding in a car.

During Tuesday’s NTSB hearing, safety officials were told that there is no single, reliable way to measure a runway’s slickness in bad weather, making it hard for pilots to figure out how much room they need to land.

‘’It continues to be more of an art than a science,’’ said Bill DeGroh, a safety representative for the Air Line Pilots Association, the largest pilots’ union. The organization has urged the Federal Aviation Administration to develop a standard method of describing and reporting runway surface conditions.

Fifty-two minutes before the Boeing 737 touched down at Midway, the pilots were told runway conditions were ‘’fair,’’ with snow-covered taxiways. Nine minutes before touchdown, they got a report that conditions were ‘’fair,’’ except at the end, where they were ‘’poor.’’ Five minutes later, they were told conditions were ‘’good’’ for the first half of the runway, ‘’poor’’ for the second.

And one minute before touchdown _ at 7:13 p.m. CST _ they were told conditions were ‘’fair to poor.’’

The pilots knew they couldn’t land safely in poor conditions because there was a 9 mph tailwind; tailwinds of nearly 6 mph are Southwest’s upper limit for a safe landing in poor conditions.

Southwest Airlines Co. now requires pilots to use the more restrictive condition when calculating how much room they need to land. If conditions are reported as ‘’fair to poor,’’ they must use ‘’poor.’’

The FAA also set stricter standards for landings by passenger jets, starting Oct. 1.

Pilots will have to add 15 percent to the length of runway they think they need to land safely. They will also have to take the more conservative value when they receive differing reports on conditions.

The FAA has also given a $15 million grant to Midway to build soft concrete beds that can slow airplanes that overshoot runways.

The Midway runway, like many others at commercial airports in the United States, does not have a 1,000-foot buffer zone at the end for airplanes that overshoot their landings.

The FAA had identified 456 runways at U.S. airports that don’t meet safety standards. As of August, 208 runways had been improved as much as they could be through various means _ adding concrete beds, construction, buying more land or changing their layout _ according to agency spokesman Les Dorr.

Congress passed a law last year requiring all runways to meet safety standards by 2015.

David Bennett, the FAA’s director of Airport Safety and Standards, said the agency expects that deadline to be met.

During the flight, the pilots wrestled with the question of how they would land in bad weather at Midway, even considering other airports, according to the recording.

They even talked about crashing through the fence at Midway if their automatic brakes failed.

‘’No procedure if that sucker fails when you touch down?’’ said co-pilot Steven Oliver. ‘’We just go through the fence? We never talk about any of that stuff, ya know?’’

The recording revealed the unfolding drama in the cockpit as the plane skidded toward a fence.

‘’Son of a (expletive),’’ Capt. Bruce Sutherland said.

‘’Jump on the brakes, are ya?’’ Oliver said.

‘’Get that back there,’’ Sutherland said moments later. ‘’We ain’t goin’, man.’’

The pilots then told each other to ‘’hang on’’ just seconds before the airplane crashed through the fence.

Emergency Workers Gauge 9/11 Health Toll

Monday, June 26th, 2006

(AP) - NEW YORK-Two days after arriving at ground zero to clear debris from the smoking ruins of the World Trade Center, David Miller could feel the physical effects.

“I was practically blind, I was coughing, I had blisters all up and down my arms,” the National Guardsman said Sunday at a discussion about lingering health problems among first responders. “If I’d been smart, I wouldn’t have gone back.”

Nearly five years later, the 39-year-old suffers from hacking, bloody coughs, chronic lung infections, skin rashes and a 60 percent loss of lung capacity, he said.

Miller was among several first responders to speak Sunday at the event organized by the nonprofit group New York 9/11 Truth, which claims that the government covered up intelligence failures leading to the attacks and accuses officials of exposing rescue workers to toxic conditions at ground zero.

Kevin McPadden, a former Air Force medic, said his rescue and recovery work in the days after the Sept. 11, 2001, left him struggling with depression and anger.

“Every day is a challenge,” he said. “I really don’t feel alive. I’m a very bitter man.”

Last week, a U.S. federal court judge heard arguments over whether the city and its contractors should be granted immunity against lawsuits filed on behalf of thousands of emergency workers who got sick after working in the dust of the World Trade Center. The city has argued it has legal immunity against the claims.

Les Jamieson, who organized Sunday’s event at The Community Church of New York in Manhattan, said that, for some who felt they should have been financially compensated, the panel offered an opportunity to speak out.

“We’re not just talking about health here,” he said. “There are serious financial and psychological issues as well, and a lot of people are being left out in the cold.”

If you, a family member or a friend were present at the site of the World Trade Center on September 11, 2001 you may have suffered physical effects of the toxic substances released by the collapse of the twin towers. If you have any questions about your legal rights contact attorney David I. Fuchs at 800-570-2858 for a free consultation.

Doctors Chief Says British Hospitals Shouldn’t Copy American-Style Competition

Monday, June 26th, 2006

(AP) - BELFAST, Northern Ireland-The United Kingdom’s state-funded health system is being harmed by moving toward an American-style system that forces hospitals to compete for funds and patients, the leader of the major British doctors association warned Monday.

“In America, people with health insurance have loads of choice and lots of competition. But is it keeping prices down? No. Prices are rocketing up,” the chairman of the British Medical Association, James Johnson, told the opening day of the group’s annual conference, which runs through Thursday in Belfast.

“Is it keeping quality high? No. there is more variability in U.S. health care than anywhere,” Johnson said. “Take heart transplants. They are offered in 139 hospitals. The best has a one-year survival rate of close to 100 percent; the worst is close to zero.

“In the United States, diagnostic errors are common. Preventable treatment errors are common. They have a health system where all the parameters of choice and competition are not working. The very last thing the U.K. should do is go for the American model of health care. Of all the systems in the world, we shouldn’t go for that one,” he said.

The government of Prime Minister Tony Blair has made reform of Britain’s National Health Service a high priority, citing long waiting lists for operations and other critical care. But doctors and nurses groups have resisted government efforts to introduce competition and greater reliance on private sources of funding, insisting better state funding to ensure higher standards at all hospitals is the better way to go.

Addressing more than 1,000 doctors, Johnson said, “You tell me that the breakneck pace and the incoherent planning behind systems reform are seriously destabilizing the NHS. The message I am getting from the medical profession is that the NHS is in danger and that doctors have been marginalized.”

The British Medical Association represents about 135,000 doctors throughout the United Kingdom.

Pilot Killed in Twin-Engine Plane Crash in Florida

Monday, June 26th, 2006

(AP) - FORT PIERCE, Florida-A pilot was killed when a twin-engine plane crashed in a wooded area shortly after takeoff, authorities said.

The pilot, Stephen P. Hodges, 57, of South Carolina, was the only person aboard when the plane went down Sunday just north of Fort Pierce near U.S. 1, St. Lucie County Sheriff Ken Mascara said in a news release.

The plane, which was destroyed beyond recognition, had flown to St. Lucie International Airport from the Bahamas earlier Sunday. The plane landed and passengers left the plane before the pilot took off again, Mascara said.

Witnesses reported that the plane took off into dark skies, experienced engine trouble and crashed with only one of the plane’s two engines still operating.

Hodges was en route to Tenneseesse, said Federal Aviation Administration spokeswoman Kathleen Bergen.

The National Transportation Safety Board and Federal Aviation Administration were sending investigators to the scene.

If you have had a member member, loved one or a friend who has died in a plane crash call South Florida personal injury lawyer David I. Fuchs at 800-570-2858 for a free case evaluation and consultation.