South Florida Personal Injury Lawyers

Novartis AG announced a worldwide recall of its Triaminic Vapor Patch yesterday after reports of serious associated health risks, including seizures.

The patch, an over-the-counter cough suppressant for children two years of age and older, is applied to the chest or throat to allow the vapors to reach the nose and mouth. However, the patch can easily be removed by children and potentially ingested.

The company said that ingesting camphor or eucalyptus oils – both ingredients of the patch – can cause side effects ranging from minor symptoms such as headache, nausea, vomiting, or burning sensation in the mouth to more life-threatening reactions such as seizures.

The U.S. Food and Drug Administration has issued a warning against use of the patch and is advising consumers with questions or concerns to contact their physician.

Consumers who have purchased the product are encouraged to discard it or return it to the point of sale for a refund.

Mounting concern over the risk of potentially fatal blood clots in patients with drug-coated stents has led a number of hospitals to cut back on their use.

Drug-coated stents – tiny tubes that keep arteries open and clear of fatty deposits – were introduced in 2003 with more than 3 million patients having received them since that time.

However, recent research is beginning to question the safety and overall effectiveness of the popular stents, which are coated with drugs to prevent scarring of the arteries. One study found that 3.3 more heart attacks and deaths per 100 patients occurred in patients with drug-coated stents than with the uncoated, bare-metal ones.

According to the evidence, the risk of heart attack and death in patients with drug-coated stents began six months post-implantation and endured for as long as a year. Most of the heart attacks and deaths were attributable to blood clots.

Late-stent thrombosis, which refers to the formation of a blood clot inside the stent months or years after the procedure, is a potentially deadly condition rarely seen before drug-coated stents came on the market.

The drug coating can inhibit healing around the stent, creating a kind of open wound that attracts blood clots. To prevent clotting, doctors usually prescribe anti-clotting drugs for patients to take from three to six months after surgery.

Some doctors are beginning to think that the anti-clotting agents may be needed indefinitely, especially since the Swiss study found the risk for heart attack and death increased when patients stopped taking the medications.

“It’s an alarming message,” said cardiologist Matthias Pfisterer, who led the Swiss study. The results of that study were presented at a cardiology conference earlier this year in March.

Other studies have also shown that discontinued use of anti-clotting drugs increases the risk of late thrombosis in patients with drug-coated stents.

Many in the medical community are concerned about the possible implications of this problem given that approximately 1.4 million patients receive the stents annually. In fact, some hospitals have urged patients to continue taking anti-clotting medications for a full year after the surgery, or even indefinitely.

The U.S. Food and Drug Administration said it was working with manufacturers to inform doctors and patients of the risk of thrombosis when anti-clotting drugs are stopped.

Greg Stone, a cardiologist at Columbia University Medical Center, said that manufacturers “realize stent thrombosis is a problem.” He added that manufacturers also “realize the onus is on them to solve the problem.”

Some manufacturers, specifically Abbott and Medtronic, are already trying to solve the problem by using different drugs and coatings on the stents.

Boston Scientific and Johnson & Johnson dominate the drug-coated stent market, which generated $5.3 billion in sales last year. Drug-coated stents are more profitable than the uncoated variety, costing approximately $1,600 more.

A medical malpractice lawsuit involving a baby born with serious brain damage and cerebral palsy as a result of inadequate medical care has been settled for $2.4 million by a California hospital

Morgan Lee, now nearly 2-years-old, was delivered by emergency Caesarean section at Contra Costa Regional Medical Center on July 27, 2004. He was born with central nervous system damage and is quadriplegic.

The lawsuit alleged that hospital officials failed to provide Donna Lee, Morgan’s mother, with adequate care despite knowing that she faced a greater risk of complication because she was diabetic and had high blood pressure.

Lee saw her doctor at the Richmond Health Clinic on July 23, 2004 for high blood pressure. The doctor sent her to the hospital to be induced into labor since high blood pressure can jeopardize the health of the fetus.

High blood pressure can also lead to a condition called preeclampsia, which, if left untreated, can stress on the fetus.

At the hospital, Lee received pitocin – a medication used to increase the rate of contractions and induce labor. Four days later, she still had not given birth.

On the fourth day, a fetal heart-monitoring test suggested that the baby might not be receiving a sufficient supply of oxygen. Other tests done that morning to prompt a response from the baby showed no response.

Even though a doctor called for an immediate C-section, the procedure was postponed until two and a half hours later. At 1:34 p.m., after another test showed that the baby was in serious trouble, the C-section was finally performed.

Stan Casper, attorney for the mother, said that the hospital “wasted precious time” and that the damage might have been avoided had the procedure been performed before 11 a.m.

“You could see that the baby had totally declined – a heart rate way, way depressed and insufficient to properly oxygenate the baby’s brain,” he said.

Casper added that Morgan’s “prognosis is very, very grim in terms of him ever getting better.”

The settlement provides $2.15 million toward the purchase of a lifetime annuity for Morgan. If he lives a normal lifespan, the total annuity payments will amount to nearly $18 million. Morgan’s mother will also receive $250,000 as part of the settlement.

Three common asthma inhalers containing the drugs salmeterol or formoterol may be causing four out of five U.S. asthma-related deaths per year and should be taken off the market, researchers from Cornell and Stanford universities have concluded after a search of medical literature.

They base these conclusions on a statistical analysis of 19 published trials involving 33,826 patients. This so-called meta-analysis found that patients who inhaled the long-acting beta-agonists salmeterol (trade names Serevent and Advair, both made by GlaxoSmithKline) or formoterol (trade name Foradil, made by Novartis Pharmaceuticals) were 3.5 times more likely to die from asthma and 2.5 times more likely to be hospitalized (whether or not death resulted), compared with those taking a placebo.

The reason, say the researchers, is because although these medications relieve asthma symptoms, they also promote bronchial inflammation and sensitivity without warning.

Nevertheless, asthma death is relatively rare — 15 patients in the meta-analysis who were taking the beta-agonists died, compared with three in the placebo group, over a six-month period.

“In total, there are about 5,000 deaths a year due to asthma, whether or not a person is taking a long-acting beta-agonist,” said Edwin Salpeter, the J.G. White Distinguished Professor of Physical Sciences Emeritus at Cornell, who led the statistical analysis in the study. An eminent astrophysicist, Salpeter has more recently focused his attention on medical statistics. “We can show that overall it is statistically significant that, compared to patients taking a placebo, these long-acting beta-agonists kill a lot of people,” he said.

“These asthma deaths are generally in healthy young adults,” said his daughter, Shelley Salpeter, the lead author of the paper appearing online and in the June 20 issue of Annals of Internal Medicine. She is a clinical professor of medicine at Stanford’s School of Medicine and a physician at Santa Clara Valley Medical Center in San Jose, Calif.

“We estimate that approximately 4,000 out of the 5,000 asthma deaths that occur in the U.S. each year are actually caused by these long-acting beta-agonists, and we urge that these agents be taken off the market,” she added.

Adding an anti-inflammatory drug to a long-acting beta-agonist adds little benefit, report the Salpeters. Advair, for example, (the fourth bestselling drug in the world with $5.6 billion in annual sales), combines salmeterol with an anti-inflammatory drug to provide some protection against bronchial inflammation associated with beta-agonists. But hospitalizations still doubled for patients inhaling a long-acting beta-agonist combined with an anti-inflammatory drug compared with asthma patients taking a placebo and an anti-inflammatory drug by itself.

Of the 19 studies surveyed in the meta-analysis, the largest — the Salmeterol Multicenter Asthma Research Trial with 26,000 participants — reported a fourfold increased risk for asthma-related deaths and a twofold increase in life-threatening asthma events in patients using salmeterol. If older people who also suffered from chronic obstructive pulmonary disease were removed from the analysis, the Salpeters report, salmeterol would be associated with a six times greater risk for asthma-related deaths.

The meta-analysis found that 53 of 3,083 patients inhaling beta-agonists were hospitalized for an asthma attack compared with 12 of 2,008 patients who received a placebo, meaning that there was one hospitalization for every 71 patients treated with a long-acting beta-agonist per year.

The Salpeters say that these two long-acting beta-agonists can result in death because tolerance to them develops over time.

“These agents can improve symptoms through bronchodilation at the same time as increasing underlying inflammation and bronchial hyper-responsiveness, thus worsening asthma control without any warning of increased symptoms,” said Shelley Salpeter.

“It is particularly frightening that long-acting beta-agonists are detrimental, whether salmeterol or formoterol, whether taken alone or with anti-inflammatory drugs, both for children and for adults,” said Ed Salpeter.

Co-authors of the study include Shelley Salpeter’s son, Nicholas Buckley, a student at Sequoia High School in Redwood City, Calif., and Thomas Ormiston, a physician at Santa Clara Valley Medical Center in San Jose, Calif.

LOS ANGELES - Jury selection began Wednesday in a lawsuit by a California man who claims he suffered a heart attack after taking the painkiller Vioxx - one of more than 13,000 such claims brought against drug maker Merck & Co. nationwide.

The Southern California man, Stewart Grossberg, claims he took Vioxx for more than two years before he had a heart attack at 66.

His case is the first to go to trial in California and one of some 2,000 filed in the state and consolidated in Los Angeles Superior Court by Judge Victoria G. Chaney.

A judge in New Orleans has been overseeing all the federal lawsuits involving the painkiller.

To handle the large number of Vioxx lawsuits in California, Chaney decided to group a representative number of cases for trial, the outcome of which could serve as a guide in other cases or, potentially, in settlement talks between the parties.

The initial group included four cases involving plaintiffs who claim they suffered a heart attack after taking Vioxx. One of the cases was dismissed, while another was continued because the plaintiff’s attorney is involved in another Vioxx case out of state.

That left Grossberg’s case and that of Rudolph Arrigale, 76, of Orange County, who claims he took Vioxx for five months and then suffered a heart attack that left him permanently injured.

The two cases were set to be tried simultaneously but Chaney severed them Tuesday after attorneys for Whitehouse Station, N.J.-based Merck argued that they needed more time for discovery because of the potential of new medical evidence surfacing in Arrigale’s case, said Thomas Brandi, a San Francisco attorney representing Arrigale.

“The upshot of it was she’s rolling our case over to the next wave of trials,” Brandi said Wednesday.

Calls to the company and Grossberg’s attorney, Thomas Girardi in Los Angeles, were not immediately returned Wednesday.

Merck put Vioxx on the market in 1999 as a treatment for arthritis and acute pain in adults.

It pulled the drug from the market in September 2004 after the company said research showed Vioxx doubled risk of heart attacks and strokes with long-term use.

Grossberg’s case is the eighth to go to trial nationwide. Another trial is ongoing in Atlantic City, N.J.

In that case, the plaintiff blames Vioxx for the heart attack she suffered in January 2004 after taking the drug for 2 1/2 years.

In the six verdicts to date, three have gone in favor of Merck and three others against the drug maker, eliciting multimillion-dollar jury awards.

Merck has said it plans to appeal, and has vowed to fight each of the cases it faces nationwide one by one.

CLEARWATER BEACH, Florida (CNN) — How confident are you when you slather on sunscreen? What do “waterproof,” “all day,” “UVA/UVB protection,” and “sunblock,” mean to you? An important step in protecting against skin cancer, right?

A lawsuit is alleging fraud, negligence and intentional deception in the marketing and labeling of some products sold by Coppertone, Hawaiian Tropic, Banana Boat, Bull Frog and Neutrogena.

The companies deny the claims in the class action, filed by attorneys including Sam Rudman, in late March in California Superior Court.

“This lawsuit is for the American public who, in our view, has been fleeced by sunscreen manufacturers by buying a product that’s been knowingly mislabeled,” Rudman said

Dr. James Spencer is a dermatologic surgeon and spokesman for the American Academy of Dermatology, said current sunscreen labels are “the best tool we’ve got. But they are far from perfect, as the skin cancer rates we see today tell us.”

Those rates are on the rise. In April, the American Academy of Dermatology called skin cancer an “unrecognized epidemic.” More than 1 million new cases of skin cancer are diagnosed in the United States each year.

The labels on most sunscreens sold in American stores today prominently advertise: “UVA-UVB sunblock” or “UVA-UVB protection.” What they don’t reveal is how much protection they’re giving you of each.

The lawsuit also challenges these claims, saying they’re misleading because American sunscreens are more effective at blocking UVB rays than UVA rays.

The sun projects two types of rays harmful to people, ultraviolet A and ultraviolet B, and sunscreen doesn’t provide equal protection against both. The SPF, or sun protection factor, is primarily an indication of a sunscreen’s ability to block out UVB rays, the ones that burn the outer layers of the skin. They make it turn red — nature’s way of saying cover up or go inside.

But UVA rays penetrate to deeper layers of skin and are increasingly thought to be a major cause of early wrinkles and melanoma.

It’s a sunscreen’s ability to filter out these UVA rays that the lawsuit — and some dermatologists — question.

Our UVB blockers and screens are really very good, they’ll block 97, 98 percent of the UVB rays,” Spencer said. “UVA, we fall down. We don’t have that level of protection.”

Sunscreen makers follow a set of labeling rules the FDA released in 1993.

A new set of rules was published in 1999. It banned claims like “all day,” “waterproof,” and SPF values higher than 30 on sunscreen labels, saying they were unsupported and potentially misleading. Instead, the FDA asked sunscreen makers to describe their products as “water resistant” or “very water resistant” based on a product’s ability to last after 40 to 80 minutes in water.

In spite of that recommendation, “waterproof” is prominent on nearly every bottle.

“There is no ‘all day,’ there is no ‘waterproof’ product. It doesn’t exist,” Spencer said. “I would put water-resistant. Waterproof to me means it will not come off in the water. And that’s not true. When you’re … swimming, some of it washes off. That’s a fact.”

Some products do suggest that consumers periodically re-apply. But it’s usually on the back of the label, in fine print.

The FDA permits manufacturers to make these claims because it indefinitely delayed the 1999 guidelines, saying it wanted to give science and the industry more time to work on guidelines for UVA testing and labeling.

The result is that compliance with its 1999 labeling guidelines is voluntary.

CNN asked officials at the Food and Drug Administration why it’s taken so long to come up with a set of labeling rules sunscreen makers have to follow.

FDA officials, in an e-mail, said: “The agency is currently working on the rulemaking for OTC sunscreen drug products to address, among other things, UVA testing and labeling issues. We are working to publish the document for this rulemaking in the Federal Register very soon.

The makers of Neutrogena, Hawaiian Tropic and Coppertone responded to questions in an e-mail, saying their labels fully comply with all current FDA standards and that their products are safe when used as directed.

The makers of Hawaiian Tropic went on to write: “The rhetoric of the plaintiffs’ .. lawyers is motivated by their self interest and greed. Their statements… are contrary to the public’s health and are irresponsible.

Schering Plough, the company that makes Coppertone said in a statement: “We believe the suit is without merit and an attempt to exploit the fact that the FDA has not issued final regulations in this area.”

When asked about UVA versus UVB protection provided by Coppertone products, the company said, “The product labels and advertisements do not say the same protection applies to the full spectrum of UVA rays, nor do we believe they imply that.”

The makers of Banana Boat and Bull Frog sunscreens did not respond to CNN’s inquiries.

YELLOWSTONE NATIONAL PARK, Wyo. (June 18) - A woman lost her footing after stepping over a retaining wall to take a photograph and went over a cliff, falling 500 feet to her death in a canyon, park officials said. The 52-year-old woman was visiting the park with her husband and two children. Her husband flagged down a passing motorist, who called 911 after the Saturday morning accident at an overlook along the Yellowstone River, park officials said. A ranger rappelled down the canyon wall to reach the woman, but she was dead at the scene. In Michigan, The Grand Rapids Press on Sunday identified the woman as Deb Chamberlin, 52, of Rockford, vice president of the school board in the west Michigan community. “It’s hard for me to articulate right now because I’m still in shock,” said Rockford Superintendent Mike Shibler, who said he spoke to Chamberlin’s husband, Gary. It was the second fatal accident in Yellowstone this year. In February, a woman was killed in a snowmobile accident.

Of late there has been an increase in the frequency of injuries occurring when handicapped access features of buildings and parking areas are improperly constructed. One example, is the ramp that far exceeds the maximum slope specified in building codes. Another is the lack of safety barriers which is the situation in the following report from the Columbia Daily Tribune.

A local man has filed a lawsuit against Walgreen Co. for injuries he got from a slip during a shopping trip. In December, Earl Lundgren was walking toward the entrance of the downtown Walgreens at 222 E. Broadway when he stumbled off a concrete embankment near a wheelchair ramp and fell about 3 feet, according to a lawsuit filed last month in Boone County Circuit Court. The lawsuit says Walgreens was negligent because a barrier required under city building codes didn’t exist at the place where Lundgren fell. John Sudduth, building regulation supervisor in the city’s office of protective inspections, said building codes would have required such a barrier, but the report on the building’s final inspection on May 2, 2002, did not disclose any issues. Lundgren could not be reached for comment, and his attorney, Benjamin Nelson of Jones, Schneider and Bartlett LLC, did not return a phone call seeking comment. Lundgren wants a “fair and reasonable sum of money” for “a pelvis fracture in two places, a concussion, scratches and bleeding from his head and hands, and blood clots,” according to the lawsuit. As a result, the lawsuit alleges Lundgren was hospitalized for several weeks and has undergone “extensive home health therapy” and has suffered pain, headaches and memory loss. Officials from the drug store company could not be reached for comment. Founded in 1901 by pharmacist Charles Walgreen, Deerfield, Ill.-based Walgreens Co. has 131,400 employees and 5,222 stores in 45 states. The company plans to have 7,000 stores by 2010. In 2005, the company reported net income of $1.6 billion on sales of $42.2 billion. The stock is traded on the New York Stock Exchange under the symbol WAG.

MELBOURNE, Florida (June 18) - Motorcycle fatalities involving riders without helmets have soared in Florida in the nearly six years since Gov. Jeb Bush repealed the state’s mandatory helmet law, a newspaper reported Sunday.

A Florida Today analysis of federal motorcycle crash statistics found “unhelmeted” deaths in Florida rose from 22 in 1998 and 1999, the years before the helmet law repeal, to 250 in 2004, the most recent year of available data.

Total motorcycle deaths in the state have increased 67 percent, from 259 in 2000 to 432 in 2004, according to National Highway Traffic Safety Administration statistics.

Records, though, also show motorcycle registrations have increased 87 percent in Florida since Bush signed the helmet law repeal on July 1, 2000.

The debate over motorcycle helmet safety resurfaced last week when Pittsburgh Steelers football quarterback Ben Roethlisberger, an advocate of helmet-free riding, broke his jaw, nose and several teeth in an accident. He underwent seven hours of surgery.

Physicians and insurance companies say helmets are crucial safety gear.