Archive for June, 2006

Just How Much Is a 10-Year Erection Worth?

Monday, June 26th, 2006

A former handyman has won more than $400,000 in a lawsuit over a penile implant that gave him a 10-year erection.

Charles “Chick” Lennon, 68, received the steel and plastic implant in 1996, about two years before Viagra went on the market. The Dura-II is designed to allow impotent men to position the penis upward for sex and then lower it.

But Lennon could not position his penis downward. He said he could no longer hug people, ride a bike, swim or wear bathing trunks because of the pain and embarrassment. He has become a recluse and is uncomfortable being around his grandchildren, his lawyer said.

In 2004, a jury awarded him $750,000. A judge called that excessive and reduced it to $400,000. On Friday, the Rhode Island Supreme Court affirmed that award in a ruling that turned on a procedural matter.

“I don’t know any man who for any amount of money would want to trade and take my client’s life,” said Jules D’Allessandro, Lennon’s attorney. “He’s not a whole person.”

A lawyer representing both Dura-II manufacturer Dacomed Corp. and the company’s insurer declined to comment. Dacomed maintained that nothing was wrong with the implant. It filed for bankruptcy after the lawsuit was filed.

Lennon cannot get the implant removed because of health problems, including open-heart surgery, his lawyer said. Impotence drugs could not help Lennon even if he were able to have the device

Family of Woman Killed by Drunk Driver Brings Lawsuit

Monday, June 26th, 2006

BALLSTON SPA, N.Y. (AP) _ The family of a New Jersey woman who was run over and killed outside a concert in upstate New York last summer is suing for wrongful death.

Thirty-three-year-old Grania Maggio of Lake Como, N.J. was killed last July following a Dave Matthews Band concert at the Saratoga Performing Arts Center. Maggio was walking with her friends back to their car when she was hit so hard that the impact tossed her into nearby brush.

She was killed instantly.

Earlier this week Maggio’s parents filed a lawsuit against the car’s driver, 31-year-old Alexander Bennett, and his father, Bruce Bennett.

The younger Bennett was drunk at the time of the accident, and police also found cocaine and marijuana in his system. The Maggios’ suit alleges that the elder Bennett shouldn’t have allowed his son to drive his pickup truck.

The younger Bennett pleaded guilty to second-degree manslaughter, leaving the scene of a fatal crash and first-degree vehicular manslaughter. He was sentenced in March to 3{ to 10{ years in state prison.

The suit also names the owners of the three Saratoga bars that Bennett was allegedly drinking in prior to Maggio’s death as defendants.

Another Ortho Evra Lawsuit

Monday, June 26th, 2006

This week, an Ortho Evra lawsuit was filed on behalf of a 37-year old woman who suffered a bilateral pulmonary embolism, or blood clot in the lungs, due to use of the contraceptive patch. The lawsuit was filed in New Jersey against the makers of the patch, Ortho McNeil, a subsidiary of Johnson &Johnson.

The claim contends that the company knew of Ortho Evra’s serious risks before the drug was approved. Once the FDA approved Ortho Evra in 2001, its maker failed to adequately warn patients about the serious risks of Ortho Evra blood clot, stroke, and even death, according to the lawsuit.

The injured woman had been using the Ortho Evra patch for approximately one year before she was admitted to the hospital on June 17, 2005. The Ortho Evra user was admitted to Atlanta, Georgia’s Piedmont Hospital with complaints of severe lower chest pain. She was diagnosed with bilateral pulmonary embolism and was started immediately on anticoagulant therapies Coumadin and Lovenox. Doctors believe she might require this treatment for the rest of her life.

Months later, in November 2005, Ortho McNeil announced that the patch can deliver 60 percent more estrogen than oral contraceptives, thus drastically increasing the risk of thrombotic events such as stoke or blood clot. In fact, experts have found that the amount of estrogen Ortho Evra releases into the blood stream is at the same levels outlawed by the FDA decades ago, in light of numerous deaths and serious injuries related to the drug.

Prior to this announcement, however, several reports indicated that women were developing serious and life threatening Ortho Evra side effects. Young and otherwise healthy women were suffering serious injuries or dying because of this drug and its maker did nothing to inform consumers or prevent these risks.

Now fully knowing what serious risks are posed by Ortho Evra, its maker has still done nothing to protect patients from the potentially fatal risks posed by the contraceptive patch. In fact, to this day, Ortho McNeil continues to aggressively market Ortho Evra to both patients and doctors.

Thousands of patients have suffered adverse reactions caused by Ortho Evra. Dozens have died or suffered serious injuries that will adversely affect them for the rest of their lives.

Pulmonary embolism , one serious adverse reaction of Ortho Evra, occurs when a blood clot, usually originating from a deep vein in the legs or pelvis, enters an artery in the lungs. This condition can be fatal or result in permanent long-term injury, including pulmonary infarction, pulmonary arterial obstruction, chronic pulmonary hypertension, and difficulty breathing.

Tremors from Exposure to Welding Fumes

Monday, June 26th, 2006

A lawsuit brought by a former welder who claims that he suffers tremors from exposure to welding fumes has raised a serious and intriguing question: Do welding fumes cause neurological diseases like Parkinson’s, Ernest G. Solis, a 57-year-old Corpus Christi man with Parkinson’s-like symptoms, is seeking unspecified damages from four welding rod makers. His case, which is being heard in a Cleveland federal court, could have implications for 3,800 similar lawsuits around the country.

The question the jury will have to answer is whether or not manganese – a chemical element emitted when welding rods are burned – leads to tremors, poor balance, and difficulty walking and swallowing after high levels of exposure.

“It’s a really hot topic. A lot of people weld and there is manganese in welding rods. Manganese is very bad stuff at very high doses. The problem is defining when doses are high enough to cause a neurological disease,” said Alan Ducatman, chairman of community medicine at West Virginia University.

Manufacturers of welding equipment contend that there is no established link between fumes and Parkinson’s. They further argue that welding rods come in packages with warning labels suggesting that fumes may be hazardous.

James Antonini, a toxicology researcher at the National Institute for Occupational Safety and Health, is leading a study examining the effects of welding-type fumes on rats to try to determine if there is in fact a link the fumes and neurological diseases.

However, Dr. Edward Baker, director of the North Carolina Institute of Public Health and lead witness in Solis’ case, argued that extensive research has already established a link between manganese fumes emitted from welding rods and neurological disorders such as Parkinson’s.

According to the Parkinson’s Disease Foundation, nearly 1 million Americans suffer from the disorder. The foundation says that some of those cases may be caused by welding fumes.

A welder’s risk of exposure depends on the concentration of manganese as well as the size of the working space. Some welders use fans to blow away the potentially toxic fumes while others wear breathing devices.

Fire Truck Manufacturer Sued

Monday, June 26th, 2006

The parents of a Texas firefighter killed in a fire truck accident have filed a lawsuit against the vehicle’s manufacturer, citing negligence and disputing the state’s punitive damages cap.

Christopher Brian Hunton, a 27-year-old Amarillo firefighter, died in April after falling through the rear passenger door of an American LaFrance ladder truck as it was rounding a turn en route to a call.

The lawsuit alleges that the vehicle was designed with a defective and dangerous door latch system and that the makers failed to provide proper warnings.

Among the parties named in the lawsuit are American LaFrance, Freightliner, Patriarch Partners, Dalmatian Corp., and DaimlerChrysler Corp. Amarillo Truck Center was also name for negligence in performing service and repairs to the defective door latch.

The petition is also challenging the constitutionality of Texas’ product liability punitive damages cap of $750,000.

Fosamax lawsuit brings risks to light

Friday, June 23rd, 2006

Pamela Hines went from an active lifestyle of running five miles a day and working full-time to being unable to eat most foods and feeling constant pain.
   The 52-year-old Sandy woman was diagnosed last year with osteonecrosis of the jaw (ONJ), a disfiguring condition that leads to the breakdown of the jawbone and loss of teeth. After having a tooth extracted, she became deeply concerned when her mouth failed to heal. After visiting several doctors, one told her she might have ONJ - and that it could be linked to her taking the popular osteoporosis drug Fosamax, for stronger bones.
   Once she learned other dental patients who took Fosamax were suing the drug maker, Merck & Co., she joined a class-action lawsuit being handled by Tim O’Brien, a Pensacola, Fla., lawyer with the firm Levin Papantonio.
   ”The problem was known to Merck well prior to the present day,” O’Brien said. “The [Food and Drug Administration] asked them to warn about ONJ. They needed to inform doctors and patients sooner.”
    For years, physicians and dentists have known about the increased risk of ONJ  caused by chemotherapy. But the reason for the potential risk of ONJ for dental patients on bisphosphonates - the class of bone-strengthening drugs that includes Fosamax - is relatively unknown and has puzzled some experts.
    In January 2005, the FDA recommended Merck change Fosamax’s label to include ONJ warnings. The company revised its packaging information in July. The drug is one of Merck’s best sellers, with $3.2 billion in sales and 22.4 million prescriptions written in 2005.
   The company, still reeling from lawsuits on the recalled pain medication Vioxx, says on its Web site that most reported cases of bisphosphonate-associated osteonecrosis have been in cancer patients treated with the drugs intravenously.
   ”ONJ is not well understood and may occur for a number of reasons. . . . In controlled clinical trials involving more than 17,000 patients, contributing as much as 10 years’ data with alendronate [the technical name for Fosamax] there have been no reports of ONJ,” the statement says.
   O’Brien filed his first Fosamax lawsuit in April in Fort Myers, Fla., on behalf of Linda Secrest, 60, who had been taking the drug for six years. She blames the drug for rotting her mouth and exposing her jawbone and alleges Merck withheld information about its health risks.
   At its 2006 annual meeting, the American Association of Endodontists said that, until further information becomes available, all patients taking bisphosphonates be considered at some risk for ONJ, and should inform their dental care providers and other specialists they are on the medications.
   Some dentists turn away patients who reveal they are on bisphosphonates, possibly because they fear lawsuits. Others ask those patients to quit the medication until their dental treatment is finished.
   For Hines, the aftermath has been devastating. Now unemployed, she receives an intravenous antibiotic - ironically made by Merck - to help clear the infection in her mouth. She also undergoes hyperbaric treatment five days a week.
   Patients who have hyperbaric treatment lie in an oxygen-rich, pressurized chamber that increases the blood and oxygen pumped to the wound, triggering the growth of new capillaries and accelerating healing.
   Weighing a mere 85 pounds and appearing emaciated, Hines can only consume liquids and has lost 25 pounds. Once avid travelers and kayakers, she and her husband, Larry, have been mostly confined to their Sandy home so she can be close to her doctors.
   Hines decided to take Fosamax after watching her grandmother suffer from osteoporosis, which severely weakened her spine.
   ”Your body is like a temple and you take care of it and then this happens,” she said. “I want women to know if they have any problems with their mouth and they are on Fosamax, they should make the dentist aware of this. [ONJ] affects your life greatly. It turns your life upside down.”
   Others also want to raise awareness. After researching ONJ and being diagnosed with it, Beverly Hurwitz, a Salt Lake City doctor who treats chronic pain, sent out about 50 letters to dentists and oral surgeons in the state. She does not know whether her condition was caused by Fosamax because she only took a few doses. But because she only received a few responses to her letters, she is worried that dentists and the public are uninformed about the condition.
   ”I know there are millions of women who are on these drugs who need a root canal or other work,” Hurwitz said. “There are probably thousands of people who have this and haven’t been diagnosed. People say this is a rare condition, but it’s only rare because it hasn’t been identified” well.
    Patrick Brain, an oral surgeon in Sandy, said more dentists and oral surgeons are becoming educated about the potential link between Fosamax and ONJ.
   ”It’s a big problem, and it’s becoming more pervasive,” he said.
    chamilton@sltrib.com 
        
   What is osteoporosis?
   * Osteoporosis is thinning and weakening of the bones.
   * It affects mostly women after menopause.
   * In both men and women, osteoporosis may also be caused by certain medicines called corticosteroids, used in the treatment of some leukemias and also to suppress rejection after bone marrow and organ transplants.
   * Osteoporosis can cause fractures, which may happen during everyday activities, such as lifting, or from a minor injury that would normally not cause bones to break.
   
   Fosamax is for:
   * The treatment or prevention of osteoporosis in women after menopause.
   * Treatment to increase bone mass in men with osteoporosis.
   * The treatment of osteoporosis in people taking corticosteroids.
   
   To help prevent osteoporosis:
   * Stop smoking.
   * Reduce the use of alcohol.
   * Exercise regularly.
   * Eat a balanced diet with calcium.
   * Ask your doctor if you need to take a calcium or vitamin D dietary supplement.

Woman Charged With Beating Bus Passengers

Friday, June 23rd, 2006

A bus monitor is accused of taking a leather belt to disabled passengers, claiming they were rowdy.Martine Barber, 26, was arrested and charged with three counts of endangering the welfare of an incompetent or physically disabled person.

She is accused of beating three developmentally disabled passengers with the belt on a bus contracted by a therapeutic institute in suburban Tarrytown, police said. Barber told police that the passengers ages 20, 21 and 30 were unruly.

Barber worked for Tremont Ambulette Service in the Bronx. She was released on bail Thursday. The bus driver was not charged.

A woman witnessed the alleged incident Monday, when the bus made a stop in Tarrytown, and she called police

Vioxx Lawsuit Claims Merck “Neutralized” Dissenting Doctors

Friday, June 23rd, 2006

Associated Press (AP) reported on June 16, 2006 that evidence came to light in one Vioxx lawsuit trial that showed Merck “neutralized” up to 36 doctors who had voiced concerns about Vioxx. According to internal documents, the company set up teams to essentially shut the doctors up. Later documents showed that this mission was accomplished by several means including handing out paid advisory board positions or offering participation in Merck research studies.The jury in the Vioxx lawsuit also saw a training video featuring what Merck called the “V Squad” This reportedly comical instructional guide was designed to help pharmaceutical reps overcome “sales obstacles” such as doctors’ apprehensions and questions about the drug’s safety.

It is clear that Merck had one focus in mind throughout the whole Vioxx journey to date: profit. If that profit came at the expense of the health of the patients they were supposed to be helping, then so be it. Internal Merck documents from as early as the mid-90’s showed that some scientists were worried about the cardiovascular side effects of Vioxx. One FDA scientist has claimed that he was pressured by his superiors to keep quiet about the research that showed up to a five-fold increase in heart attacks.

Other Merck documents came up in a past Vioxx lawsuit, including one indicating that the manufacturer at least considered reformulating the drug to reduce the cardiovascular risk. That never happened.

Now, AP reports, more news came to light in the same Vioxx lawsuit that revealed the neutralization of doctors. Merck had planned to conduct a study regarding the cardiac safety of Vioxx, but canceled its launch the day after Merck and the FDA agreed on adding cardiovascular risk into the fine print of the safety precautions. The former head of Merck’s U.S. marketing reportedly testified that he did not know of any connection between the two decisions, and that it was coincidental.

There have been 13,000 Vioxx lawsuits filed in courts around the country, and indications are that Merck plans to fight them all. Some medical experts claim that this move could be beneficial to the company since many of the claimants are older, had existing cardiovascular risk factors, or had other health problems that could explain the heart attacks. Juries, however, may not see it that way especially since research is indicating that these “high risk” patients never should have been given Vioxx in the first place - something the company knew (or should have known) but did not reveal to patients or their caregivers.

If you or a loved one has experienced cardiovascular problems including heart attack and stroke while taking Vioxx, contact Florida personal injury lawyer David I. Fuchs at 800-570-2858 for a free case evaluation. 

Vioxx and FDA Reform

Friday, June 23rd, 2006

The recent breakdown in the system that allowed Vioxx to remain on the market years after it was identified as a probable cause of cardiovascular problems like heart attack and stroke has many calling for Food and Drug Administration (FDA) reform. However to date Congress as a whole does not see this as a particularly high priority. Several legislative members including Senator Charles Grassley of Iowa and Representative Maurice Hinchey of New York have both been critical of the FDA’s current structure - and lawmakers’ reluctance to move on it.

“The Vioxx example showed that the FDA and Merck were too close for comfort,” Sen. Grassley has said in the past. “Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck.” Despite this, everyone around the table seems content to keep the status quo - except the patients who have been harmed by Vioxx and other drugs deemed “safe” by the FDA.

“We expected more urgency and we wanted more urgency,” Diana Zuckerman of the National Research Center for Women and Families, told Newhouse News Service (NNS). “There has been a lot of talking, but that’s all.”

And that’s all there is likely to be for some time. NNS also reported that those on both sides in the industry don’t believe it will become an issue until 2007 when Congress reviews pharmaceutical payments to the FDA, used to fund agency drug reviews.

However this debate will likely not touch on the fundamental flaws in the system that allowed Vioxx and other potentially deadly drugs to make it to market. In some instances, it is not even a matter of a drug like Vioxx “falling through the cracks” but a deliberate attempt on the FDA’s part to cover up a drug’s short comings. Many scientists in the FDA (and for that matter Merck) saw that there was a potential risk of cardiovascular problems with the drug, but were told to be quiet about it. There are several whistleblower stories, including a key one from within the FDA in the Vioxx scandal, that helped alert the public to the dangers.

But the FDA is supposed to be the “whistleblower” itself, the ultimate protector of patients from dangerous drugs through a supposedly rigorous testing process. Some have speculated that because many FDA members advance their careers by joining pharmaceutical companies, they regard their work at the FDA as a sort of training camp with potential future employers always watching. It could also be, as Sen. Grassley commented, that the system has allowed the FDA and pharmaceutical companies to work too closely together, instead of at an arm’s length as common sense would require.

Regardless of the shortcomings of the system, it is ultimately the responsibility of the pharmaceutical companies who make Vioxx and other drugs to ensure their safe use. If you have been injured using Vioxx or any other medication, contact South Florida personal injury lawyer David I. Fuchs at 800-570-2858 for a free case evaluation. 

Senator Accuses FDA of Ketek “Cover-Up”

Friday, June 23rd, 2006

accusing the Food and Drug Administration of attempting to cover up information pertaining to its review of the controversial antibiotic Ketek .The Senate Finance Committee, led by Republican Charles Grassley, is currently reviewing the FDA’s approval of Ketek and the monitoring of the drug’s safety.

Grassley said he smelled a “cover-up” after the agency refused to make available one of its criminal investigators who earlier had conducted a probe into allegations of fraud surrounding the drug.

The FDA said the investigator was not available because the probe is ongoing and might compromise the investigation.

The senator addressed reporters yesterday after meeting with FDA officials at the Department of Health and Human Services headquarters. It was the first time he had personally visited a federal agency to make a demand since 1983, he said.

“This is very extraordinary for me to do this. We are tired of the run-around,” Grassley told reporters. He added that he may call the FDA investigator to testify at a congressional hearing on the issue, although he has not determined if a hearing is needed yet.

Ketek, a Sanofi-Aventis drug used to treat respiratory infections in adults, recently came under scrutiny when research reports linked it to severe, potentially fatal, liver damage. Reports also alleged that a major Ketek study contained falsified data and that some doctors failed to keep proper records. One doctor was convicted of fraud.

The FDA approved Ketek in April 2004 after twice rejecting it for inadequate safety information. While the agency has acknowledged problems with some of the drug’s safety data, it said that the approval of the drug was based on sound evidence.

This is not the first time the FDA’s handling of drug safety issues has come under fire by the senator and his committee. In November 2004, one of the committee’s FDA safety reviewers accused the agency of being incapable of protecting the public from harmful drugs.