South Florida Personal Injury Lawyers

The U.S. Food and Drug Administration Tuesday announced their proposal to ban the sales of over-the-counter skin-bleaching products, citing potentially severe safety risks.

According to studies conducted by the Environmental Protection Agency and the national Toxicology Program, skin lightening creams that contain the drug hydroquinone have been linked to some cases of cancer in rodents including liver lesions and leukemia.

“We ‘re acting for safety reasons,” said Susan Johnson, the associated director of the FDA’s Office of Nonprescription Products. “There is potential for hydroquinone to be a carcinogen in humans. We are looking for additional information.

Furthermore, the FDA cites widely documented reports that date back to 1975 in which hydroquinone containing creams caused the development of ochronosis, a serious skin-disfiguring condition in black men and women in the U.S., Britain, and South Africa.

Ochronosis causes the skin to darken and thicken and develop dome-shaped grayish-brown or yellow bumps leading to permanent disfigurement and in some cases malfunctioning adrenal glands. Some studies found the symptoms of the condition appeared even after short-term use of the creams. Other reports discovered women who had used the products had high levels of mercury in their bodies, which could lead to severe birth defects.

Under the FDA’s proposed guideline, all skin lightening products, whether prescription or over-the-counter, would be deemed new drugs and must go through the FDA approval process.

“The FDA tentatively concludes that the benefits of [over-the-counter] skin bleaching drug products are insignificant when compared to the potential risks,” the proposed rule stated.

Currently, about 65 U.S. companies sell an estimated 130 different skin lightening creams and other hydroquinone products.

An Idaho woman has filed a lawsuit against the makers of the Ortho Evra birth control patch, Ortho McNeil. This 34-year-old woman used Ortho Evra for less than two years before she developed a serious and life threatening condition called severe pulmonary embolism, caused by the birth control patch.

Upon diagnosis of this grave Ortho Evra side effect, this woman was hospitalized for six days. Doctors predict she may require anticoagulant therapy for the rest of her life.

This Ortho Evra case is one among dozens that have been filed on behalf of otherwise healthy women who developed life-threatening injuries caused by the dangerous and arguably defective birth control patch. Other Ortho Evra users have suffered deep vein thrombosis (blood clots in the deep veins of the legs or pelvis), pulmonary embolism (the blood clot breaks off and travels to the lungs), stroke, heart attack, and even death.

Ortho McNeil, a subsidiary of Johnson & Johnson, has known about the serious risks posed by Ortho Evra for a very long time. However, the company has grossly failed to adequately protect its users from serious injury.

In November 2005, the pharmaceutical company released evidence that the Ortho Evra birth control patch exposes women to 60 percent more estrogen than oral contraceptives. This increased estrogen exposure drastically increases the risk of thrombotic adverse events, such as those experienced by injured Ortho Evra users.

The FDA estimates that over four million women have used this dangerous drug since it was first approved in November 2001.

Ortho McNeil continues to aggressively market Ortho Evra to consumers and physicians.

LEXINGTON, Kentucky-The lone air traffic controller on duty the morning Comair Flight 5191 crashed had only two hours of sleep before starting work on the overnight shift, a federal investigator said.National Transportation Safety Board member Debbie Hersman said the controller had only nine hours off between work shifts Saturday. That was just enough to meet federal rules, which require a minimum of eight hours off between shifts, Hersman said.

“He advised our team that he got approximately two hours of sleep,” Hersman said Wednesday.

The controller, a 17-year veteran whose name has not been released publicly, worked from 6:30 a.m. to 2:30 p.m. on Saturday. He came back to work at 11:30 p.m. on the same day to begin an eight-hour overnight shift.

The commuter jet crashed on Sunday morning, in the final hours of the controller’s shift, while trying to take off from Blue Grass Airport.

Hersman said the NTSB also planned to look back at the controller’s schedule in the days leading up to the crash.

Federal officials have been looking for explanations why Flight 5191 mistakenly tried to take off from a runway that was too short, crashing in a nearby field and killing 49 of 50 people on board.

The news conference Wednesday night was the final NTSB briefing in Lexington, but it could take up to a year before the investigation is concluded, Hersman said.

Federal Aviation Administration spokeswoman Laura Brown said the air traffic controller union approved the work schedule rules, and the FAA provides information about how to avoid fatigue.

“If they don’t believe they’re fit for duty, they’re supposed to tell us that,” Brown said. “You won’t be penalized for not reporting for work.”

The crash threw a spotlight on another practice aviation experts say goes on around the country: Small regional airports are sometimes manned by a single air traffic controller, even though federal rules require two.

The FAA has directed Blue Grass Airport and others like it to staff their towers with at least two controllers. But the FAA has acknowledged that only one was working Sunday in Lexington during the crash.

In a policy outlined in a directive last November, the FAA said two controllers must be on duty for all shifts at any airport that handles both control tower observations and radar operations.

But Ken Spirito, director of a regional airport in Peoria, Illinois, said it is common for some late-night and early morning shifts to be staffed with only one controller. Someone may call in sick or take a vacation, and the FAA usually decides to keep the airport open, he said.

“The mandate that is issued by FAA is only as good as the staffing levels at that particular tower,” Spirito said.

FAA spokeswoman Laura Brown said that at the time of the accident, there were only two other towers - in Duluth, Minnesota, and Fargo, North Dakota - that were not following the policy to staff with two controllers.

“We have clarified the guidance for them,” Brown said.

She said staffing was adjusted at four other towers earlier this month, before the Comair crash. “This is an issue we’ve been looking at,” she said.

Scott Zoeckler, who worked as a controller at Blue Grass for 25 years before retiring in 2004, said the overnight and early morning shifts were usually manned by only one person.

On Sunday, the controller on duty at the Lexington airport had turned his back to perform some “administrative duties” when the plane veered onto the wrong runway, investigators said.

The crash’s only survivor, first officer James Polehinke, who was flying the plane when it crashed, remained hospitalized Wednesday in critical condition.

Jed Doty, a Louisville flight instructor who also flew briefly for Comair last year, said it is the pilot’s duty to get on the right runway.

“It’s your responsibility to immediately speak up because, especially in busy airports, you can get in some pretty bad situations pretty quickly,” Doty said.

On Wednesday, six tour buses took the victims’ families to the crash site for the first time. The airport also established a memorial in a parking lot, featuring a banner reading “Remembering 5191″ with pens for people to write messages.

Law firms lined up to represent family members who want to sue for negligence. One Fort Worth, Texas, firm published a full-page ad in Wednesday’s Lexington Herald-Leader promising families it would seek “the greatest amount of damages allowed by law.”

Comair offered to pay $25,000 per passenger to each family who lost a loved one.

Comair spokeswoman Kate Marx would not say how many families had requested the payment, which she said “in no way prejudices their right to any claim they may have under the applicable law.”

The Michigan Department of Environmental Quality is currently in the process of developing a set of guidelines for power companies in an effort to reduce airborne mercury emissions by 90 percent in nine years, thus decreasing the risk of mercury health hazards in fetuses and children.

The plan will require electricity generators to invest finances in an attempt to develop mercury reduction technology, which would ultimately mean higher costs for customers. But many believe that reducing the serious risks of birth defects caused by mercury exposure would be worth the extra cost.

What is mercury?

Mercury, a naturally occurring element, has proven useful in a number of products including mechanical switches, fluorescent light bulbs, thermometers, tooth fillings, and more. However, it is a dangerous toxin that can cause serious harm to the nervous system, prompting a national campaign targeting mercury pollution.

While mercury is harmless when embedded in coal, it becomes a serious issue when it’s emitted into the atmosphere. Eventually, the vapors—colorless and odorless—settle into waters and transforms into a bacteria that is absorbed by small sea creatures. The toxin continues to travel up the food chain and grows highly potent.

Mercury birth defects

Humans ingest mercury when they eat tainted fish, which could lead to a series of health problems. However, children are the most affected by the toxin. Experts strongly discourage pregnant women to consume seafood that may contain potent levels of mercury that could lead to neurological development problems in children including mental retardation, cerebral palsy, and even death.

“I don’t want our children getting sick or having disabilities that could have been avoided if we’d been willing to pay more for electricity,” said executive director of the Association for Children’s Mental Health Amy Winans.

According to the Environmental Protection Agency, approximately six percent of women have hazardous levels of mercury in their bloodstream during childbearing age. Furthermore, scientific data has estimated that about 60,000 to 300,000 babies are born every year at the risk of severe neurological damage from exposure to mercury.

“The problem is that once mothers get mercury in their body, it takes six to 12 months to get it out,” said Dr. William Weil, a retired pediatrics professor at Michigan State University. “If they get pregnant in the meantime, that mercury gets transmitted to the fetus…where the brain is still in its development and very susceptible to mercury damage.”

For the last two decades, The Department of Community Health in Michigan has issued periodic mercury consumption alerts regarding the seafood caught in the great lakes area. The state will also continue their efforts to cutback the rate of mercury emissions to decrease the risks caused by mercury exposure.

Consumer advocacy group Public Citizen petitioned the Food and Drug Administration this week urging them to order drug makers to add stronger label warnings to Cipro and similar antibiotics.

Petitioners cited the serious risk of tendon ruptures linked with a class of antibiotics known as fluoroquinolone, commonly prescribed for respiratory, urinary tract, and gastrointestinal infections.

Public Citizen researchers evaluated the FDA’s adverse events database and discovered 262 cases of ruptured tendons in patients taking fluoroquinolones drugs between 1997 and 2005—more than 60 percent of which were linked to Levaquin and 23 percent to Cipro.

“The numbers are startling. Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of early warning signals, such as the onset of tendon pain, and switched to other antibiotics,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.

Besides the risk of tendon rupture, the group also noted about 260 reports of tendonitis and tendon disorders among patients—a risk they deem significant enough to order “black box” warnings on all fluoroquinolone class of drugs.

Furthermore, petitioners want drug makers to issue “Dear Doctor” letters updating them of potential risks of the drug and of the requested label changes.

Public Citizen together with the Illinois Attorney General’s office, is urging the FDA to compel drug makers to add a black box warning—the most severe FDA warning—to these antibiotics, including:

•  Cipro

•  Penetrex

•  Tequin

•  Levaquin

•  Maxaquin

•  Avelox

•  Noroxin

•  Floxin

On March 2, 1995, plaintiff Cynthia Morales, an 18-month-old girl who resided in a Bronx apartment building that was located at 2429 East Tremont Ave., underwent a medical test that revealed that her blood’s lead concentration measured 20 micrograms per deciliter. Such a concentration is 100% greater than the generally accepted toxicity threshold.In May 1995, the New York State Department of Health inspected Cynthia’s apartment and determined that two radiators were covered by lead-based paint. The inspection did not reveal the presence of any other chipping or peeling lead-based paint. The building’s owner and landlord promptly addressed the hazard that was created by the radiator, and the paint was completely removed within the ensuing week. However, Cynthia’s mother, Marisol Tolentino, claimed that Cynthia suffers lingering cognitive deficits that stem from lead poisoning that occurred during the child’s residency in the apartment.Tolentino, acting as Cynthia’s parent and natural guardian, sued her apartment’s owner and landlord, Puccio Properties of New York Inc. Tolentino alleged that the defendant failed to recognize and abate the apartment’s lead-based hazard and that its failure created a dangerous condition.

Morales claimed that she had previously reported that the apartment harbored chipping, peeling lead-based paint, but that the landlord did not act until after the New York State Department of Health had conducted its inspection.

Tolentino’s landlord testified that Tolentino’s apartment underwent a total renovation that occurred several years before Cynthia’s alleged poisoning. He noted that the renovation included the replacement of all of the apartment’s plasterboard.

Defense counsel noted that Tolentino had spoken to the New York State Department of Health’s inspectors and that the conversation included her indication that she believed that Cynthia’s lead poisoning occurred during the child’s stay in a babysitter’s residence.

Tolentino claimed that Cynthia suffered lead poisoning. On March 2, 1995, a test revealed that the child’s blood’s lead concentration measured 20 mcg/dL. Eleven days later, a follow-up test revealed that her blood’s lead concentration measured 8 mcg/dL. Such a reading is within tolerable limits. No treatment was rendered during the intervening 11 days, and Cynthia’s environment did not change during that time. The plaintiffs’ expert neurologist and the defense’s expert pediatric neurologist agreed that such a sharp decline is unusual.

Cynthia’s blood’s lead concentration continually declined until it reached 1 mcg/dL. The plaintiffs’ expert neurologist agreed that Cynthia suffers lead poisoning that was sustained during the child’s residency in the East Tremont Avenue apartment.

Tolentino claimed that Cynthia suffers residual injuries that include cognitive deficits, headaches and pain that stems from her stomach. Cynthia, now 12, is a seventh-grade student, but she does not perform well. The plaintiffs’ expert neuropsychologist opined that Cynthia’s verbal skills exceed average levels, but that the child’s intelligence does not reach average levels. The expert contended that the disparity is a product of lead poisoning. She also contended that Cynthia suffers a learning disability and that the New York City Board of Education is considering Cynthia’s candidacy for special-education classes.

The plaintiffs’ expert economist opined that Cynthia’s cognitive deficits have diminished her potential earnings. He contended that Cynthia will probably not earn significantly more than the minimum wage.

Tolentino sought recovery of a total of $2 million, which included damages for Cynthia’s reduced earning capacity and damages for the child’s past and future pain and suffering.

Defense counsel presented a pediatric neurologist who conducted an independent medical examination of Cynthia. The doctor opined that Cynthia does not exhibit any evidence of lead poisoning. He further opined that the March 2 test results could have been the product of an erroneous testing process or that it could have revealed a lead-concentration spike that was caused by a single, massive ingestion of lead paint. He opined that the latter explanation would justify the quick subsequent decline of Cynthia’s blood’s lead concentration. However, neither side presented evidence that indicated that Cynthia had ingested lead-based paint.

The jury rendered a defense verdict. Although the jury did not specifically indicate the basis of its finding, defense counsel believes that the verdict was based on a lack of causation.
Plaintiff’s counsel has moved to set aside the verdict. He has also moved for Judge Stanley Green’s recusal from the post-trial process. He contended that Green remarked that the plaintiff’s expert neuropsychologist delivered “ridiculous” testimony. Plaintiff’s counsel is also contesting comments that Green allegedly delivered during in-trial testimony

TYLER, Texas-Wal-Mart Stores Inc. has settled a wrongful death lawsuit filed by the parents of a 19-year-old store clerk who was abducted, raped and killed following her night shift.The parents of Megan LeAnn Holden said the terms of the settlement were confidential. The lawsuit filed by Sheri Kay Dunlap and James Vincent Holden had been set to go to trial Tuesday.

Dunlap and Holden sued Wal-Mart and the store’s security company, The Wackenhut Corp., in 2005, claiming their negligence resulted in their daughter’s death. They claimed Wal-Mart didn’t take reasonable security precautions in failing to remove Johnny Lee Williams Jr. from the property or come to their daughter’s aid.

Holden was kidnapped Jan. 19, 2005, from the parking lot of a Wal-Mart Supercenter in Tyler. Her body was found on the side of a highway in West Texas, about 400 miles from her home. Williams was later arrested in Arizona.

Following the settlement, attorney John “Rusty” Phenix said Dunlap “would like to see this as a beginning to Wal-Mart making its parking lots safer for its customers and employees, not just in Tyler, but everywhere,” the Tyler Morning Telegraph reported in its Tuesday editions.

Phenix sent a letter to the court Friday announcing the sealed settlement.

Wal-Mart’s attorney Edward Merritt confirmed the case had been settled but said he could not comment on the details.

“This was a tragic situation,” said Wal-Mart spokesman John Simley. “We’re glad the matter is closed. And we take some consolation in the fact that our video (surveillance) tape helped put the assailant behind bars.”

The Wackenhut Corp. settled earlier for $1.3 million, according to court records.

Williams pleaded guilty last year to capital murder, saying he kidnapped, raped, strangled and shot Holden. Williams was sentenced to five concurrent life sentences.

WESTPORT, N.Y.-A Greyhound bus traveling from New York City to Montreal crashed through a guard rail and landed upside down in an embankment Monday, killing at least five people and injuring many others, officials said.The bus departed New York at 1 p.m. and made stops in Albany and Saratoga Springs before the crash, said Greyhound spokeswoman Anna Folmnsbee. There were 52 passengers and one driver onboard, she said.

Ray Thatcher, Director of Emergency Services for Essex County, said at least five people were dead. By 1 a.m. Tuesday firefighters had not yet reached the body of the driver, which was still stuck deep inside the wreckage.

It was unlikely that more bodies remained inside, but rescue workers continued to pick through the wreckage of the crushed bus, he said.

“We won’t know until we get the bus turned over,” he said.

Mike Hildebran, a spokesman for Champlain Valley Physicians Hospital Medical Center in Plattsburgh, said more than 30 people had been treated there and several more were en route. The patients were of all ages, including a few children, and had injuries including cuts, bruises and broken bones.

The bus was traveling north on Interstate 87 at about 6:45 p.m. when it overturned near Elizabethtown, went down a small embankment and stopped wedged between the median.

The highway remained closed early Tuesday near the crash site. Westport is 110 miles north of Albany.

LEXINGTON, Ky.-The lone air traffic controller on duty the morning Comair Flight 5191 crashed cleared the jet for takeoff, then turned his back to do some “administrative duties” as the aircraft veered down the wrong runway, a federal investigator said Tuesday.Separately, the Federal Aviation Administration acknowledged violating its own policies when it assigned only one controller to the Lexington tower.

The commuter jet struggled to get airborne and crashed in a field before daybreak Sunday, killing 49 of the 50 people aboard, after taking off from a 3,500-foot runway instead of an adjoining one that was twice as long. Experts said the plane needed at least 5,000 feet for takeoff. The sole survivor, first officer James Polehinke, was in critical condition Tuesday.

The air traffic controller had an unobstructed view of the runways and had cleared the aircraft for takeoff from the longer runway, said National Transportation Safety Board member Debbie Hersman.

Then, “he turned his back to perform administrative duties,” Hersman said. “At that point, he was doing a traffic count.”

The controller, whose name was not released, had been working at the Lexington airport for 17 years and was fully qualified, Hersman said.

Polehinke was flying the plane when it crashed, but it was the flight’s captain, Jeffrey Clay, who taxied the aircraft onto the wrong runway, Hersman said. Clay then turned over the controls to Polehinke for takeoff, the investigator said.

Polehinke was pulled from the burning plane after the crash but has not been able to tell investigators why the pilots tried to take off from the wrong runway.

Both crew members were familiar with the Lexington airport, according to Hersman. She said Clay had been there six times in the past two years, and Polehinke had been there 10 times in the past two years - but neither had been to the airport since a taxiway repaving project just a week earlier that had altered the taxiway route.

Earlier Tuesday, the FAA admitted it violated a policy, outlined in a November 2005 directive, requiring that control tower observations and radar approach operations be handled by separate controllers.

FAA spokeswoman Laura Brown said the controller at the Lexington airport had to do his own job - keeping track of airplanes on the ground and in the air up to a few miles away - as well as radar duties.

Before Hersman’s briefing on Tuesday, the NTSB said Polehinke was flying the plane; it made no mention of Clay being the one who taxied the plane into position.

The crew checked in at 5:15 a.m. but boarded the wrong plane at first, Hersman said. They started preparations before a ramp worker alerted them to the error. Even with the delay, passengers boarded on time, and a ramp worker found no problems during an inspection, she said.

Polehinke’s mother, Honey Jackson, said her son is not to blame for the crash, and she asked people to be patient until all the facts were revealed.

“He could die at any moment,” said Jackson, a lounge singer who lives in Miami.

It was miraculous that Polehinke was still alive, said Dr. Andrew Bernard, a surgeon at the University of Kentucky Hospital. He was not burned, but he had facial fractures; two spinal fractures; a complex pelvis fracture; a broken leg, foot and hand; three broken ribs; a broken breastbone; and a punctured lung.

Polehinke’s family issued a statement thanking the officers who saved his life and said their thoughts were with the victims’ families: “We know that if he were able to, Jimmy would join us in telling them that they are in our constant prayers.”

Federal officials are looking into whether runway lights or a repaving project a week before the crash confused the crew into turning onto the wrong runway.

On Monday night, investigators used the same model of aircraft that crashed, a CRJ-100, to try to recreate the last few minutes of Flight 5191 as it taxied away from Blue Grass Airport’s terminal.

Polehinke had a clean record as a pilot, with no accidents or mistakes, authorities said.

Polehinke spent five years - from 1997 to 2002 - flying short-range, twin-engine planes for Florida-based Gulfstream International Airlines. He flew at small airports all over Florida and the Bahamas, starting as a first officer and getting promoted to captain in 2000.

Tom Herfort, director of operations for Gulfstream, was a pilot for the company at the same time as Polehinke. He recalled no problems with his colleague.

“You know who’s got the good reputation and who doesn’t. I didn’t hear anything bad about the guy,” Herfort said. “As far as I know, he was a good captain for us.”

Jackson said newspaper reports about her son were lies, but her boyfriend and business manager, Antonio Cruz, confirmed newspaper reports that Polehinke’s wife, Ida, shot him in the abdomen with a handgun in 1999. Polehinke said the shooting was an accident, but his wife told police she shot Polehinke because she feared for her life after her husband threatened to kill her, The Miami Herald reported.

Polehinke declined to press charges, and Cruz said the couple had resolved their problems.

“They have overcome it, and they are working it out,” he said. “It is a good relationship. They were supposed to travel to Italy or something, just the two of them.”

NEW ORLEANS-The $50 million damage award in the federal Vioxx case this month was excessive, and a new trial must be held on damages for a retired FBI agent who suffered a heart attack after taking the painkiller, a federal judge ruled Monday.

“No reasonable jury could have found” that Gerald Barnett was entitled to $50 million in compensatory damages, U.S. District Judge Eldon E. Fallon ruled.