Archive for April, 2008

FDA Takes Closer Look At Lasik Complaints

Monday, April 28th, 2008

A decade after Lasik eye surgery hit the market, patients left with fuzzy instead of clear vision are airing their grievances before federal health officials.

Make no mistake: Most Lasik recipients do walk away with crisper vision, some better than 20/20.

But not everyone’s a good candidate, and an unlucky few do suffer life-changing side effects: poor vision, painful dry eyes, glare or problems seeing at night.

How big are the risks? The Food and Drug Administration thinks about 5 percent of patients are dissatisfied with Lasik. How many struggle daily with side effects? How many are just unhappy that they couldn’t completely ditch their glasses? The range of effects on patients’ quality of life is a big unknown.

So with a public hearing Friday, the FDA is beginning a new effort to determine if warnings about Lasik’s risks are appropriate. The agency also is pairing with eye surgeons for a major study expected to enroll hundreds of Lasik patients to better understand who has bad outcomes and exactly what their complaints are.

“Clearly there is a group who are not satisfied and do not get the kind of results they expect,” FDA medical device chief Dr. Daniel Schultz said Thursday. The study should “help us predict who those patients might be before they have the procedure.”

About 7.6 million Americans have undergone some form of laser vision correction, including the $2,000-per-eye Lasik. Lasik is quick and, if no problems occur, painless: Doctors cut a flap in the cornea - the clear covering of the eye- aim a laser underneath it and zap to reshape the cornea for sharper sight.

The vast majority of patients, 95 percent, see better and are happy they had Lasik, said Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of Lasik’s safety for the American Society of Cataract and Refractive Surgery.

But doctors advise against Lasik for one in four people who seek the surgery. Their pupils may be too large or corneas too thin or they may have some other condition that can increase the risk of a poor outcome.

Solomon estimates that fewer than 1 percent of patients have severe complications that leave poor vision. Other side effects, however, are harder to pin down. Dry eye, for instance, can range from an annoyance to so severe that people suffer intense pain and need surgery to retain what little moisture their eyes form. That’s the kind of question the FDA’s new study is being designed to answer.

Dry eye is common even among people who never have eye surgery, and increases as people age. Solomon says that 31 percent of Lasik patients have some degree of it before the surgery and that about 5 percent worsen afterward.

But dry-eye specialist Dr. Craig Fowler of the University of North Carolina says other research suggests 48 percent of patients experience some degree of dry eye at least temporarily after Lasik. Cutting the corneal flap severs nerves responsible for stimulating tear production, and how well those nerves heal in turn determines how much dry eye lingers long-term, he said.

Even if the risks are low, that’s little consolation to suffering patients.

“As long as you know any ophthalmologist that’s wearing glasses, don’t get it done,” says Steve Aptheker, 59, a Long Island lawyer who was lured by an ad for $999 Lasik.

The flaps cut in Aptheker’s cornea literally became wrinkled during the surgery, blocking vision and causing severe pain. It took seven additional surgeries over four years to restore his vision, which Aptheker says still isn’t quite as good as before his Lasik in 2000.

Tunnel Was Seen As Dangerous Long Before Deadly Crash

Monday, April 28th, 2008

More than a decade before a fiery, 34-vehicle pileup last fall killed three people inside a curving, dimly lighted tunnel, state police and a California transportation official warned that the stretch of freeway was perilous and that steps should be taken to improve safety, according to documents obtained by The Associated Press.

Highway officials did cut grooves into the pavement to improve traction, and it seemed to make a difference. But a state police request to routinely close the road in stormy weather was rejected. And later, the state raised the speed limit in the tunnel from 45 mph to 55 mph.

Now California officials are facing accusations they contributed to the tragedy by turning a blind eye to the dangers.

The tunnel was “a recipe for disaster - always was,” said Marvin Louis Wolf, a lawyer who has filed a claim against the state on behalf of a trucking company involved in the crash. “It was outdated the minute it was completed.”

Thirty-three trucks and a car crashed during a rainstorm in the Oct. 12 wreck, which happened on Interstate 5 at a mountain pass north of Los Angeles. The inferno closed the major West Coast route between Mexico and Canada for two days, and the cleanup and repairs totaled $17 million.

In the aftermath, state highway officials assured the public the road was safe.

“I’m aware of no safety concerns,” Douglas Failing, a regional director for the California Department of Transportation, said at the time.

But victims’ lawyers and freight companies are challenging that assessment, which conflicts with the road’s notorious reputation among truckers and locals alike. Claims filed with the state since the accident depict the tunnel as dangerously dark and poorly designed, with too few warning signs and a speed limit that invited catastrophe.

Trucker Jose Medina, who escaped after his rig was rear-ended in the pileup, said its abrupt curve made it impossible for oncoming truckers to see the danger after the first rig crashed near the exit of the tunnel.

“You’re coming down a hill, there is a tunnel, a big curve,” said Medina, who gave up trucking after the crash and now works as a bartender in Puerto Rico. “It was like dominoes. You don’t have any chance.”

The tunnel was repaired and reopened a month after the disaster, and now bears little resemblance to its 1970s-era predecessor. White concrete was used to increase illumination, 500 computerized lights can create a noontime-like brilliance inside, and flashing signs mark the entrance. The tunnel speed has been lowered back to 45 mph.

A second tunnel, farther downhill, was not damaged and has not been redesigned.

Drivers descending the mountain pass toward Los Angeles go through the two tunnels while passing through a 2.4-mile network of curving bypass roads designed to allow trucks to come down along a gentler grade. Cars are also allowed in those lanes.

Driving those lanes can be tricky and can include frequent stops and starts, with curves, merges and slow-moving trucks that can obscure what’s ahead.

Records show the 550-foot tunnel where the crash happened has been nearly accident-free in recent years. However, between 2002 and 2006, there was an average of nearly one collision a week on the network of bypass roads going both directions.

In 1996, the California Highway Patrol was so distressed it recommended shutting the truck lanes and the tunnel in stormy weather - an idea state officials deemed unacceptable because they did not have the manpower to pull that off, according to internal documents obtained by the AP.

That same year, state maintenance supervisor Charles Payne, alarmed by numerous crashes in stormy weather, wrote a letter urging engineers to review speeds and road conditions. “It is my concern that if these issues are not addressed immediately, that a major incident will happen with possible loss of life,” he wrote.

The state spent $250,000 in 1998 to grind and groove the pavement to improve traction. Accidents on the cluster of roads in both directions dropped from 1999 through 2001, government records show, but then began to climb. There were 32 accidents in 1999 and 55 by 2003, the year after the speed limit was raised to 55 mph.

Traffic in both directions on the busy stretch of highway increased 32 percent from 1996 to 2006, to an average of 281,000 vehicles a week.

In an interview, Failing said that the overall crash rate is slightly above the norm, but that serious collisions - those involving deaths or injuries - are slightly below average.

“The statistics, the accident records, everything showed that this roadway was safe, especially when driven with due care,” Failing said. “If there was any doubt in our minds, we would have been out making changes.”

The California Highway Patrol is still investigating the cause and declined to comment on safety questions about the tunnel. The official cause is certain to have a powerful effect on the legal claims, which could expose the state to millions of dollars in damages.

John Woodrooffe, who heads the safety analysis division at the University of Michigan’s Transportation Research Institute, said the increase in accidents in 2002 and 2003, after several years of relatively stable numbers, could be explained by increased traffic, weather or the economy. But one trend was clear: wet-weather crashes dropped, suggesting the 1998 road work helped reduce accidents.

The deadly crash took place after the first significant rain in months made the road slick. The pileup is believed to have started with a tractor-trailer that went out of control and crashed as it was leaving the tunnel.

The pileup spread wreckage over a half-mile and sent motorists running for their lives from the 1,400-degree fire. Among the three victims was a 6-year-old boy, Isaiah Matthew Rodriguez, who was riding in his father’s truck.

The boy’s mother has charged in state documents that officials were aware of a “significant number” of accidents in and around the tunnel but looked the other way. Water pooled inside, light fixtures weren’t working and it was improperly banked and graded, the mother said.

“This tunnel should have had a lower speed limit, a highway patrol car parked three miles from the entrance as a reminder to slow down. There should have been warning signs to the entrance of the tunnel that there is something going on inside the tunnel,” said Wolf, who represents Western Regional Delivery Service. “They’ve done it after people died.”

 

Woman Sues Maker Of Nalgene Sports Bottles

Monday, April 28th, 2008

A California woman has filed lawsuit against the maker of popular Nalgene plastic sports bottles, claiming that the toxic substance used in the manufacture of the product —

Bisphenol A (BPA) — could sicken consumers.

Harmful Health Effects

The lawsuit is believed to be the first of its kind to seek class action status and is suing for unspecified damages. It alleges that Nalge Nunc International Corp. continued to stress the safety of BPA-containing products despite studies linking the substance to:

  • Infertility
  • Hormone disruptions
  • Early puberty
  • Cancer

Phasing Out BPA

Nalge Nunc announced plans to stop manufacturing its Outdoor BPA-containing products within the coming months. The move comes after government officials expressed concern over the safety of BPA last week.

Canada recently banned baby bottles containing the chemical, and Wal-Mart Stores Inc. said it would phase BPA-containing bottles and other products from its U.S. stores next year.

5 South Florida Teens Lost While Riding ATVs Rescued

Monday, April 28th, 2008

Five teenagers were rescued Monday morning after spending the night in a rural area west of Florida’s Turnpike.

With the help of night-vision goggles, a Miami-Dade County air-rescue crew located the four men and one woman near Northwest 41st Street and 130th Avenue. The five had been riding all-terrain vehicles when they became disoriented. One teen told rescuers the ATVs eventually ran out of gas.

The group only brought one cell phone on the excursion and the battery on the cell phone died. The mother of one of the teens called and reported the group missing.

As air rescue crews searched for the teenagers, one climbed a tree and flashed a light from his key chain. Rescuers were able to spot the group.

The terrain was rough and there was nowhere for the helicopter to land, so the teens had to be hoisted into the helicopter.

Three teens were rescued by one helicopter and another rescued the other teens. All are doing just fine.

Rib Injuries Caused By Seat Belts

Friday, April 25th, 2008

Rib injury seat belt accidents are those during which a person suffers some degree of physical trauma involving the ribs because of a defective seat belt. Proper seat belt use is estimated to prevent more than 300,000 injuries and nearly 12,000 lives every year. Despite the enormous protection seat belts provide, these protections may not be afforded to passengers when there is a design or construction flaw in the seat belt.

Rib injury seat belt trauma can occur in even low-impact collisions when the positioning or integrity of the seat belt contributes to the damage caused in the accident. Rib injuries often cause soft tissue injuries to the organs which are normally protected by the rib cage. Rib injury can cause bruising or other types of superficial trauma to underlying organs. Rib injury seat belt trauma can also cause one or more of a victim’’s ribs to crush or break.

Broken or shattered rib injuries can be very dangerous, because the sharp edges and broken portions of a damaged rib can cause serious and sometimes fatal injury to the internal organs of the chest and abdominal region. Punctured or damaged lungs, major veins and arteries, and any of the organs located in the chest and abdomen are all possible rib injury seat belt traumas that a victim could sustain in an accident.

Rib injury seat belt trauma is an immediate injury that is sustained in a vehicle accident. Because the human body is not as strong as the body of a car, a person may sustain significant rib injury seat belt trauma even in accidents where there is little damage done to the external structure of the vehicle. Some symptoms of rib injury seat belt trauma include chest or stomach pain, bruising or discoloration of the skin, pain in the chest, side, or abdominal area, shortness of breath or difficulty breathing, the presence of blood in the urine or stool, and other related problems.

Rib injury seat belt trauma victims should receive immediate medical care to ensure that the internal organs are not compromised and to ensure that further injury is not caused. Doctors can diagnose rib injury seat belt trauma through the use of x-rays, CT scans, bronchoscopy, angiogram, and other medical techniques.

Seat belt defects that can increase a person’’s chance of suffering rib injuries are those that fail to provide adequate passenger protection by keeping them in place and preventing impact with unyielding objects during an accident. Passive restraint seatbelt systems, such as those with an automatic shoulder belt design, fail to properly restrain the body during impact. Belt retraction failure can result in too much belt slack in an accident, thereby increasing a person’’s chance of suffering rib injury seat belt trauma. Seat belt buckle failure can also fail to properly restrain a person in a vehicle accident, increasing the risk of rib injury seat belt trauma.

If you or a loved one has suffered rib injury seat belt trauma in a motor vehicle accident, you may wish to contact an attorney to determine if you might be eligible to seek compensation for your damages from the party responsible.

Bartender Struck By Drunk Driver Who Was Denied Entrance

Friday, April 25th, 2008

Plaintiff Ellen Ordoyne, 40, a bartender at Mc B’s Lounge in Jacksonville, was closing down the bar in for the night when Amy Mullee Fennell attempted to enter and was turned away because it was closing time. Moments later while Ordoyne was locking the door, Fennell drove her car through the front doors, hitting Ordoyne and throwing her back 30 feet. In addition to hitting Ordoyne, Fennell, killed one person, paralyzed two people and injured others. Fennell was intoxicated at the time of the accident. She is currently serving two consecutive terms for vehicular manslaughter.

Ordoyne sued Fennell, claiming that she intentionally drove through the building because the bar denied her entrance.

Liability was admitted by the defense and the trial was held on damages.

Ordoyne was taken to the hospital where she spent about three months recovering. As a result of the incident she suffered multiple fractures to her legs, ankles, arms and hip. She additionally suffered broken ribs, a concussion and has permanent scarring. She spent about a year in rehabilitation.

As a result of her injuries she now walks with a limp and is in constant pain.

Ordoyne was awarded $1.5 million.

Construction Worker Hurt In Scaffold Fall At NYC Arts Center

Friday, April 25th, 2008

Only hours after the city announced plans to ratchet up scrutiny of construction dangers, a construction worker was seriously hurt in a 25-foot plunge off a scaffold at Lincoln Center for the Performing Arts, authorities said.

The worker fell off a platform in the famed arts complex Wednesday night and was taken to a hospital in serious condition, the Fire Department said. No update on his condition was immediately available early Thursday.

Authorities and construction managers were investigating what caused the fall. The worker had been certified to work on a scaffold and was wearing a safety harness, and the site’s safety experts had followed their standard practice of meeting to discuss the work before it began, said Chris McFadden, a spokesman for construction manager Turner Construction Co.

It wasn’t immediately clear what the worker was doing when he fell. The complex - home to the New York City Ballet, the New York Philharmonic and the Juilliard School, among other arts organizations - is in the midst of a major overhaul involving several of its buildings.

“Those of us at Lincoln Center are sending him our thoughts and prayers tonight,” Lincoln Center spokeswoman Betsy Vorce said of the worker, who she said was conscious when taken for treatment.

The man’s fall came amid heightened attention to construction accidents, which have killed 13 people in the city so far this year - one more victim than in all of 2007. Buildings Commissioner Patricia Lancaster resigned Tuesday after Mayor Michael Bloomberg said he wasn’t satisfied with her agency.

Acting Commissioner Robert LiMandri on Wednesday ordered engineering experts to inspect construction sites and recommend changes he said would swiftly be put into effect.

 

At Least 3 Die In Van-Semi Collision

Thursday, April 24th, 2008

At least three people have been reported dead after a tractor-trailer collided with a van carrying people from a mental health facility in Pennsylvania. 

Authorities said several medical helicopters were called to the scene along Route 136, about 30 miles south of Pittsburgh. 

Police said the accident happened at about 10 a.m. Thursday.

Police said the van was from a mental health center in nearby Bentleyville.

Authorities said the van was pushed into a building and came to rest on its side.

Untreated Arrhythmia Can Lead To Heart Problems

Thursday, April 24th, 2008

A sudden jump in a scary movie or a moment of perfect love can cause people to think their hearts have skipped a beat. In reality, an abnormal heart rate is nothing to ignore.  Any heartbeat that is outside the normal range is something physicians and specialists take seriously, and the longer it is undiagnosed, the more dangerous it can become.  There are many types of arrhythmia, another word for an abnormal rhythm in the heart, and anyone experiencing them should discuss them with their doctor immediately.

 

Abnormal Heartbeats

The least serious of all arrhythmias are palpitations.  Heart palpitations are moments when the heart breaks its normal rhythm.  Everyone experiences heart palpitations occasionally, but if they become frequent, they could be a sign of heart trouble.  When a heart beats too slowly it is known as bradycardia.  Bradycardia causes blood to flow too slowly for the body to function.  The opposite of this is known as tachycardia, or rapid heartbeat.  During tachycardia, the heart pumps blood too quickly until it is exhausted and cannot pump blood anymore.  The four chambers of the heart are created to work together, but when they begin beating out of synch, a person experiences what is known as fibrillation.  Although these are the most common and broad types of irregular heartbeats, there are many more specific titles for them, depending on each case.  It is vital for a person experiencing any kind of heart issue to contact a doctor immediately.

 

What a Heart Needs

The most essential medicine for the human heart is a healthy dose of exercise.  When a person experiences heart problems, though, they may need to seek a more direct approach to treatment.  There might be a food or medication in the patient’s lifestyle that causes the heart to behave abnormally.  In these cases, all the patient must do to achieve a healthy heart rate is to remove the food or medication from his or her life.  It might be a good idea for people with heart problems to try a less stressful lifestyle.  Anxiety and anger can cause many problems for the body and the heart. 

 

Pacemakers

When a patient is at risk for damage or death due to an arrhythmia, doctors might prescribe the use of a pacemaker.  A pacemaker is a small device that helps control heart rates when they become either too fast or too slow to be healthy.  Whether the pacemaker is implanted inside the body, or is worn outside, patients and caregivers need lots of education to manage it. Many companies make pacemakers with approval of the FDA, but it is important that anyone who may need a pacemaker is aware of product defects or recalls

Supreme Court Considers Closely Watched Case That Could Help Workers Claim Disability Benefits

Thursday, April 24th, 2008

The Supreme Court connsidered Wednesday how much credence ot give an insurance company’s potential conflict of interest when it denies an employee’s health or disability benefits claim.

The lawyer representing the woman who sued MetLife Inc. over a disability claim argued that insurance companies have a financial incentive to deny claims. That conflict of interest should weigh heavily in employees’ favor when they challenge benefit claims in court, Joshua Rosenkranz said in court papers.

The dispute is being closely watched by insurance companies and business groups. Depending on how the justices rule, the dispute could make it easier for employees to win benefit payments in court.

Disability benefits are a big business. Disability insurance plans cover 28 million Americans, and insurers paid more than $7.2 billion in long-term disability claims to more than 500,000 people in 2006, according to court papers filed by the U.S. Chamber of Commerce, America’s Health Insurance Plans and the American Benefits Council.

But many health and disability claims are denied, which can lead to lawsuits. The justices’ questions during oral argument echoed the confusion that plagues the issue in lower courts.

Most federal appeals courts consider so-called “dual role insurers” — those that both pay benefits and decide who is eligible to receive them — to have some conflict of interest. But, the question of how much weight to give that conflict has “befuddled the lower courts,” the Legal Aid Society said in a friend of the court brief.

Justice Ruth Bader Ginsburg suggested the question should be, “Has the trustee in fact slipped and taken unfair advantage because of the conflicting interest?”

The case began when Wanda Glenn, 55, sued New York-based insurance provider MetLife Inc. in 2003 after it stopped paying her disability benefits.

“I am not asking for a handout,” she said in an interview Tuesday. “I’d rather be working.”

MetLife administered a disability plan for Sears, where Glenn worked for 14 years. Sears, owned by Sears Holdings Corp., is not involved in the case.

MetLife paid benefits for two years but in 2002 said her condition had improved and refused to continue the benefit payments.

MetLife saved $180,000 by denying Glenn, who lives in Columbus, Ohio, disability benefits until retirement, her lawyers said in court filings.

Dual arrangements like MetLife’s are allowed under ERISA, the Employee Retirement Income Security Act. Approximately 45 percent of all employer health, disability and life insurance plans are administered by such arrangements, Rosenkranz said.

The 6th U.S. Circuit Court of Appeals ordered Glenn’s benefits reinstated in September 2006, ruling that MetLife “acted under a conflict of interest” and made a decision that “was not the product of a principled and deliberative reasoning process.”

MetLife appealed that ruling to the Supreme Court, arguing that the standard used by the 6th Circuit would “encourage participants with dubious claims to file suit,” which in turn would raise the costs of benefit plans to both companies and employers.

It is also more efficient to have a single company perform both functions, MetLife said in court papers, and the resulting cost savings to employers allows them to offer better benefit plans.

Unless there is actual evidence that a company’s conflict of interest influenced its decision, MetLife said, the conflict shouldn’t carry much weight in the courts.

The Bush administration weighed in on Glenn’s side. Solicitor General Paul Clement wrote that MetLife “benefits financially if it denies an employee’s claim,” which is a “commonsense understanding of what constitutes a conflict of interest.”

But Nicole Saharsky, assistant to the solicitor general, acknowledged there is no formula for a judge to apply.

Meanwhile, Glenn said Tuesday that MetLife hasn’t resumed paying benefits, pending the outcome of the Supreme Court case. She primarily lives off Social Security disability benefits, which MetLife helped her obtain only a month before removing her from its own rolls.

Ginsburg said the Social Security claim could be evidence that the insurer had acted in its own interest, rather than the employee’s.

The case is MetLife v. Glenn, 06-923. The Court is expected to rule by July.