Archive for October, 2006

Paxil Makers Sued Over Life-Threatening Birth Defect

Tuesday, October 31st, 2006

The parents of a two-year-old boy who was born with a serious, life-threatening birth defect allegedly caused by maternal use of the popular antidepressant Paxil, have filed a lawsuit against the drug manufacturer seeking compensation for their losses and suffering.

Eric Jackson suffers from Persistent Pulmonary Hypertension of the newborn (PPHN), a severe condition in which the arteries leading to the lungs are constricted, restricting blood flow to the lungs and oxygen into the bloodstream. Nearly 10 to 20 percent of infants born with PPHN will die even with treatment.

The Paxil Lawsuit

Eric’s mother, Lisa Bowden, took Paxil throughout the entire duration of her pregnancy. According to the lawsuit, her son’s condition directly resulted from maternal drug use during pregnancy.

The product liability lawsuit claims that Paxil maker, GlaxoSmithKline (GSK), failed to adequately warn doctors and patients about the serious risks—particularly birth defects risks—associated with the use of Paxil during pregnancy.

“Eric and his family have endured a terrible ordeal. Based on its history, we believe that GSK likely had knowledge or, at minimum, should have known of this very serious risk and warned expectant mothers taking Paxil of this risk,” said Karen Barth Menzies, the family’s attorney.

The Family’s Losses

The Paxil lawsuit, believed to be the first Paxil / PPHN-lung defect claim, seeks unspecified damages to compensate the family for their suffering. Since Eric’s birth, he has undergone a number of medical procedures and treatments in an effort to save his life.

Eric needed prolonged ventilator treatment immediately following his birth, which caused him to develop gastric reflux further requiring another procedure. He also underwent two heart catherization procedures and he still needs medications and oxygen to help him breath.

Paxil and PPHN

There have been three Public Health Advisories issued by the U.S. Food and Drug Administration since December 2005 that warned of the risk of serious birth defects linked to maternal use of Paxil during pregnancy.

Furthermore, a recent study published in the New England Journal of Medicine, found that infants whose mothers ingested Paxil during the last trimester of their pregnancy had six times the risk of developing PPHN and other severe, life-threatening birth defects.

Court Upholds Marshfield Woman’s $6.8 Million Award From Wyeth

Tuesday, October 31st, 2006
Drug maker Wyeth must pay nearly $6.8 million to a Marshfield woman whose arm had to be amputated after she was injected with one of its medications, the Vermont Supreme Court said Friday, upholding a lower court’s ruling. 

In a case hailed as a victory by a national consumers’ group, the court cited a U.S. Food and Drug Administration rule saying drug companies can issue sterner warnings than required by regulators if they think it’s necessary.

The case, which was originally decided by a Washington County Superior Court jury, centered on Diana Levine, who went to the Health Center in Plainfield in April 2000 complaining of nausea stemming from migraine headaches. She was given an injection of Phenergan.

She returned later and received more of the drug by intravenous injection in a technique called “IV push,” according to court documents.

“The second injection resulted in an inadvertent injection of Phenergan into an artery,” wrote Associate Justice Denise Johnson for the court’s 4-1 majority. “As a result, the artery was severely damaged, causing gangrene. After several weeks of deterioration, (Levine’s) hand and forearm were amputated.”

The drug’s label cited such a danger, and a company spokesman said it had sought to strengthen the warnings on the label — a move rejected by the FDA.

Levine’s suit against the Health Center was settled out of court for an undisclosed sum. Wyeth opted to go to trial, arguing that a suit under state law was pre-empted by the FDA’s approval of the warning label the company issued with the drug.

In a dissenting opinion, Chief Justice Paul Reiber agreed with Wyeth. The FDA approves a drug and its label “in the context of public health and the associated risk-benefit analysis,” he wrote.

But a jury “views the safety of the drug through the lens of a single patient who has already been catastrophically injured,” Reiber wrote. “Such an approach is virtually guaranteed to provide different conclusions in different courts about what is ‘reasonably safe’ than the balancing approach taken by the FDA.”

Johnson wrote for the majority that federal labeling requirements “create a floor, not a ceiling” for state regulation, noting that FDA regulations allow drug companies to go beyond required warnings.

“When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action, and if it fails to do so, it cannot rely on the FDA’s continued approval of its labels as a shield against state tort liability,” Johnson wrote.

Levine couldn’t be reached for comment Friday. A recorded message on her home telephone said, “We’re sorry. The number that you are calling cannot receive calls at this time. Please call again later.”

A message left for Levine’s lawyer, Richard Rubin of Barre, was not immediately returned.

Christopher Garland, a spokesman for Wyeth, said the company’s lawyers were still reviewing the decision and would have no comment on it. He said when the company recommended a label change to the FDA, the agency told Wyeth to keep the existing language.

“And we followed the instructions of the FDA,” he said.

Peter Lurie, deputy director of the health research group at Washington-based Public Citizen, said the case appeared to mark a push-back against efforts by the industry, the Bush administration and the FDA to pre-empt state regulation of prescription drugs.

Companies have the opportunity, and sometimes the responsibility, to offer stronger warning labels than are required by the FDA, Lurie argued. “If you have a wide enough berth that you can strengthen the label, you can’t use the FDA-approved label as an automatic protection against lawsuits.”

Scott Lassman, lawyer for the Pharmaceutical Research and Manufacturers of America, said the wasn’t unusual.

He said the industry group agrees with the FDA that its labels “ought to be both a ceiling and a floor, and ought to pre-empt state product liability laws.”

He said the FDA puts drugs through rigorous trials. “When you have the federal regulatory agency that’s the expert in this area approving drug products and getting second-guessed by state courts … that can add a lot of confusion to the label.”

Protecting Kids On Halloween

Tuesday, October 31st, 2006

For children Halloween is a night of costumes, candy, and fun. But for sexual predators October 31st will be an opportunity to take advantage of kids out trick or treating. Kids won’t be the only ones going door-to-door this Tuesday. Parole officers will be checking in on convicted sex offenders who may be tempted to violate their parole. Events like Sunday’s Pittsford Family Fun Fest have become a tradition for parents concerned about letting their little ghosts and goblins out trick or treating.

“In this day and age you can’t be too careful, said Russ Gaenzle of Brighton. “This is a great alternative to even considering letting them go out alone. I’m sure it’s probably an opportune time for people who want to take advantage of kids to get them into their house. As oppose to any other time of year.”

To crack down on the two thousand registered sex offenders state wide parole officers instituted “Operation Halloween Zero Tolerance.” It’s a strict curfew for known sexual predators.

“To ensure that they are in the house, and they’re not taking part in any Halloween activities,” said Michael Hayden of the New York State Division of Parole.

“To make sure they’re not answering the door, and they’re not wearing masks thing of that nature. We’re asking all sex offenders to be in their house by three o’clock. They will be there all night,” added Hayden.

Officers will also be armed with portable DVD players to make sure sex offenders are not possessing pornographic material. “In the past our parole officers have made home visits and we have seen DVDs maybe not labeled as pornography. Of course maybe blank under a different cover,” Hayden added.

Checking the state’s sex offender registry to avoid areas where they live is also a good idea. But it’s not the only answer.

“The reality is there are sex offenders in our community that are not part of the registry,” said Pam weaver of the National Center for Missing and Exploited Children. “They may be answering their door. The rules really have to be making your child is safe with everyone who is out on that night.”

Geanzel says making sure his kids are safe doesn’t mean they can’t have a good time. “You can’t let it be all consuming. You know you always worry about your kids. I’m sure our parents did. But you can’t let it ruin what is a good time,” he said.

Kids are also advised to trick or treat in groups, and to avoid homes that are not well lit

 

Plaintiff Claimed Gun Retalier Sold Gun To Illiterate Man

Tuesday, October 31st, 2006

On Jan. 5, 2005, plaintiff’s decedent, Dwayne Chamberlain, 69, was shot and killed inside his Hollidaysburg home by Thomas Drass, the couple’s grandson. Earlier that day, Drass had purchased the 12-gauge shotgun and ammunition he used at retail chain Dunham’s Sports in the Park Hills Plaza shopping center.Claiming wrongful death, Chamberlain’s estate sued Dunham’s Sports, Waterford, Mich., alleging negligence. Plaintiff’s counsel contended that because Drass was visibly under the influence of drugs (he admitted to being on methamphetamines) and was functionally illiterate and thus unable to fill out a federal firearms form, Dunham’s sale of the gun to Drass violated federal firearms laws and as well as the store’s own policies.The defense contended that Drass displayed no odd behaviors and completely filled out the form by himself, thereby making the sale compliant with firearms laws.Dwayne Chamberlain was pronounced dead at the scene.

Kathryn Chamberlain, the decedent’s wife, along with the couple’s two adult sons, sought damages for pain and suffering damages and loss of companionship damages.

The parties settled for $300,000. The money will go to Kathryn Chamberlain and the couple’s sons, with a portion of the settlement to be dispensed in monthly payments through an annuity.  

Feds Probe Salmonella Outbreak In 18 States

Tuesday, October 31st, 2006

A salmonella outbreak potentially linked to produce has sickened at least 172 people in 18 states, health officials said Monday.

Health officials think the bacteria may have spread through some form of produce; the list of suspects includes lettuce and tomatoes. But the illnesses have not been tied to any specific product, chain, restaurants or supermarkets.

No one has died in the outbreak, which stems from a common form of salmonella bacteria. Eleven people have been hospitalized, health officials said.

“We’re very early in the investigation,” said Dave Daigle, a spokesman for the U.S. Centers for Disease Control and Prevention.

Outbreaks of food-borne illness have repeatedly made headlines this year. Certain brands of packaged spinach, lettuce, carrot juice, beef and unpasteurized milk recently were recalled after they were found to be tainted with illness-causing bacteria.

The most serious outbreak, first reported in September, involved spinach tainted with E. coli bacteria that killed three people and sickened more than 200.

The CDC detected the salmonella outbreak two weeks ago through a national computer lab system that looks for patterns and matches in reports of food-borne illness. The U.S. Food and Drug Administration has joined the investigation and will try to help trace the outbreak to its origin.

Most of the cases are in adults, and more than 60 percent are women, said Dr. Chris Braden, a CDC epidemiologist investigating the outbreak.

The states involved include: Arkansas, Connecticut, Georgia, Indiana, Kentucky, Maine, Massachusetts, Michigan, Minnesota, North Carolina, New Hampshire, Ohio, Pennsylvania, Rhode Island, Tennessee, Virginia, Vermont and Wisconsin.

Fifty-one cases reported in Massachusetts in September are the same strain as that in the national outbreak, said Donna Rheaume, a spokeswoman for the Department of Public Health. It was not immediately clear whether those cases were in addition to the 172 reported nationwide.

Salmonella generally cause a nonfatal, diarrhea-causing illness. Other symptoms can include nausea, vomiting, abdominal cramps, fever and headache.

There are about 2,500 types of salmonella. The type in this outbreak - Salmonella typhimurium - is one of the most common, Braden said.

People can catch the infection from many different sources, including water, soil, insects, factory surfaces, kitchen surfaces, animal feces, and raw meats, poultry and seafoods.

Health officials estimate that more than 1.4 million cases of salmonellosis occur in the U.S. each year. About 1.3 million of those cases come from food, Braden said.

In California, where the E. coli outbreak was traced to, a trade group on Monday proposed mandatory state food safety guidelines for lettuce and spinach farmers and processors. The move by the Western Growers Association would include inspections by state regulators and sanctions for violators.

The California Department of Food and Agriculture, which would be responsible for enforcement, has agreed to work with Western Growers in developing a certification process that would give growers who meet the guidelines a clean bill of health, said Thomas Nassif, the trade group’s president.

“It is not normal for a business to say, ‘Please regulate us and enforce it if we don’t do the right things,”‘ Nassif said. “But that, we believe, is essential to restore public confidence.”

Pick-Up Trucks May Not Get Stronger Roofs Due To Industry Pressure

Monday, October 30th, 2006

The National Highway Traffic Safety Administration (NHTSA) is considering the impact that strengthening roofs of pick-up trucks and all passenger vehicles will have on reducing the number of deaths in rollover accidents. Rollovers cause about 10,000 deaths each year on the nation’s highways, which is about one-quarter of all fatalities. About 600 deaths and 800 serious injuries have been directly linked to “roof crush” when the vehicle’s roof collapse into the cabin after striking the ground one or several times.

Auto manufacturers are quietly trying to pressure the NHTSA to soften its proposal. Currently, the administration is considering a proposal that would increase roof strength by 50% or 2.5 times the weight of the vehicle. The mandate would also include guarantees of sufficient headroom.

But the regulations are too stringent, and will lead to other problems including heavier vehicles, more wind resistance, and therefore lower gas mileage. “Our bottom line is ensuring that any changes or any rule that comes out has sound science behind it,” said Charles Territo, a spokesman for the industry trade group, the Alliance of Automobile Manufacturers.

However, traditionally this has not been the case. The 30-year old standards in place today were based on science that would get the automakers the best results. Until recently, the NHTSA had accepted these tests as true indications of roof strength. But auto experts outside of the industry have recently shown that at the very least these tests do not sufficiently mimic real-world situations, and at worst are simply done for show.

Another argument of the industry, and one again used to fight roof strength regulation, is that seatbelt use is a major contributing factor. Rollover accidents produce, according to the manufacturers, “diving-type” head and neck injuries where the passenger impacts the roof when the vehicle rolls over. Again, this had been accepted as fact by the NHTSA, and again proven to be untrue by researchers. Most serious and fatal injuries are a result of the roof collapsing onto the passengers, not the passengers hitting the roof.

There have been great strides to help SUV owners prevent rollover accidents, but little has been done for pick-up truck owners, whose vehicles have almost the same rollover danger. Should the automakers’ lobby succeed in watering down or stopping this legislation, pick-up truck owners once again will be the biggest losers

ATA Asks for Speed Limiters On 18-Wheelers To Prevent Accidents

Monday, October 30th, 2006

In October 2006, the American Trucking Associations (ATA) formally requested that the National Highway Traffic Safety Administration (NHTSA) require 18-wheelers and all large trucks have speed limiters installed. Maximum speed of any equipped rigs should not exceed 68 mph, according to the ATA.

“For the sake of safety, there is a need to slow down all traffic,” said ATA President and CEO Bill Graves. “The trucking industry is trying to do its part with this initiative. No vehicle should be capable of operating at excessive speeds on our nation’s highways.”

The ATA is the national trade association for the trucking industry, made up of affiliated state trucking associations, conferences and organizations representing 37,000 motor carrier members. Among other things, the ATA helps promote “safety and security” in the trucking industry.

To gain support for this initiative, the ATA also requested that the Federal Motor Carrier Safety Administration (FMCSA) implement regulations that prohibit trucking companies or 18-wheeler drivers from adjusting and/or otherwise tamper with the speed limiter. However the ATA did not make it clear as to what penalties should be imposed, or how the law(s) would be regulated. Obviously, a key to the successful implementation of this plan would be stringent enforcement

In an ATA statement, the organization explained that its requests come in an effort to reduce the number of highway accidents involving 18-wheelers, big rigs, and other large trucks.

“The federal government’s lack of focus on speed in crashes involving large trucks represents a significant gap in its truck safety strategy,” the ATA said in a press release. “The majority of the federal truck safety budget is focused on ensuring safe equipment, driver fatigue and preventing impaired driving, which the industry supports. Research indicates, however, that speed is a more significant factor in crashes involving trucks than any other factor that currently receives a larger proportion of government attention and resources.”

In 2005, the number of 18-wheeler and other truck-related fatalities was 5,212. Although this is down slightly from 2004 (5,235 fatalities), it is up from recent years partially because of an increase in the number of trucks on the road and the number of transport miles logged.

As of October 2006, neither the NHTSA nor the FMCSA have publicly responded to the requests. However if such a measure is introduced, it will likely be years before it is made law.

Plaintiff Had Fatal Heart Attack 5 Days After Going To ER

Monday, October 30th, 2006
On Jan. 23, 2003, plaintiff’s decedent George Rowell, 60, an electrician, began to experience chest pains at home. His wife called 911 and Rowell was taken to the emergency room at St. Lucie Medical Center. While at the emergency room, Rowell was seen and treated by John Mastalski. Rowell claimed that he was sent home from the ER after Mastalski consulted via phone with James Bradley, a cardiologist. Rowell died of a heart attack five days later.Rowell’s estate, represented by his wife, sued Mastalski; Treasure Coast Emergency Associates, the operators of the emergency room; Bradley; and his cardiology group, Stuart Cardiology Group, for medical malpractice, seeking wrongful death damages.  

Plaintiffs’ counsel claimed that as a treating emergency room physician Mastalski had a duty based on the symptoms presented to rule out myocardial infarction. Plaintiffs’ counsel contended that appropriate care would have been to perform serial troponin measurements on a patient presenting with heart attack symptoms. The test measures the level of troponin, which is a protein that confers calcium sensitivity to muscle cells, which is crucial to muscle contraction in the heart. Elevated troponin levels mean the heart has sustained some damage. Rowell thus should never have been sent home; rather he should have stayed in the hospital for further evaluation.

Kim Klancke, plaintiff’s expert cardiologist, opined that when treated properly Rowell’s condition has a 98% cure rate.

The defense disputed whether Mastalski called Bradley regarding Rowell’s care. Bradley claimed that he received no phone call and if he did he would have ordered testing for Rowell and not sent him home.

Defense counsel argued that Rowell left against Mastalski’s orders and went home from the hospital. Defense counsel contended that Rowell was negligent for not returning to the hospital when he felt chest pains the next day.

Rowell died five days after going to the emergency room. He was having sexual intercourse with his wife when he suffered a myocardial rupture and died instantly. He left behind his wife and adult children, who were not factored into this lawsuit. Plaintiff’s counsel sought damages for Sandra’s pain and suffering, loss of services and income from her husband and funeral expensesThe jury found that Bradley was not negligent. The jury found that Mastalski was 73% negligent and Rowell was 27% negligent. It awarded $4,303,145.50, which was reduced to $3,141,296.30. No damages were assessed against Bradley and his cardiology group.    

BP’s Own Experts Knew Of Risks At Plant In Texas Where Blast Killed 15, Report Says

Monday, October 30th, 2006

Safety experts for BP PLC warned their bosses of the potential for a “major site incident” 2 1/2 years before an explosion at the company’s Texas City refinery killed 15 people, according to a broadcast report.CBS’ “60 Minutes” also reported Sunday that the Texas City plant manager, Don Parus, told his bosses in the company’s London headquarters that most workers at the refinery felt the plant was unsafe.

Safety experts for BP PLC warned their bosses of the potential for a “major site incident” 2 1/2 years before an explosion at the company’s Texas City refinery killed 15 people, according to a broadcast report.

CBS’ “60 Minutes” also reported Sunday that the Texas City plant manager, Don Parus, told his bosses in the company’s London headquarters that most workers at the refinery felt the plant was unsafe.

Jury Awards Widow $3.6M In Failed Body Armor Lawsuit

Saturday, October 28th, 2006

The widow of a police officer, who died when the protective vest he was wearing failed to halt a fired bullet, was awarded $3.6 million to compensate for her losses and suffering.

In 2003, the 27-year-old police officer pulled over a drug addict and ex-convict during a routine traffic stop. He was shot in the chest and killed because the body armor did not prevent the bullet from wounding him.

The product liability lawsuit filed against the vest manufacturer, Second Chance Armor Inc. and the Japanese fiber-maker Toyobo Co., claims that the companies failed to warn consumers of the product’s defects, which directly resulted in the death of a police officer.

The San Diego County Superior Court jury found the vest makers liable for the damages because they neglected to warn the officer that the synthetic fibers on the vest would degrade over time causing the body armor to fail.

Evidence presented in court also proved that Zylon synthetic fibers, used on the vests, did indeed wear out with age.