Archive for July, 2007

Ground Zero 9/11 Workers, Residents Still Struggling With Asbestos Illnesses

Tuesday, July 31st, 2007

When the World Trade Center was destroyed by terrorist attacks on September 11, 2001, about 10,000 “first responders” such as police, firefighters and rescue workers were on the scene immediately. Their exposure to toxic materials such as asbestos, lead, and other contaminants caused many respiratory illnesses and possibly cancer.

The Environmental Protection Agency (EPA) and the White House are now dealing with accusations that they played down the risks of being at or near Ground Zero in the months after 9/11, telling workers and residents that it was safe to go back into the area although evidence indicated otherwise.

Thousands Sickened by Contaminants

The clean-up workers comprise another few thousand people exposed to contaminants, and the residents in the area and those who came into Lower Manhattan for their jobs were also exposed. The World Trade Center Health Registry is tracking the health of some 71,000 New York City residents and workers.

Researchers with the Mount Sinai Medical Center in New York found that nearly 70 percent of the 10,000 first responders they examined had newly developed or worsened lung problems after their work on and after 9/11. The same medical problems have been documents among lower-Manhattan residents by doctors at the New York University School of Medicine.

Bellevue Hospital in lower Manhattan has a new World Trade Center health clinic for treating people exposed to dust or fumes from the tragedy on 9/11. The clinic is currently treating more than 1,300 such patients, with many more on a waiting list.

EPA Assurances about Safety

A June 2007 hearing in the U.S. House of Representatives examined the charges that the EPA issued reassuring public statements about air safety and asbestos levels in the Ground Zero area even though the agency was informed of unsafe levels of toxins there. Former EPA director Christine Todd testified that the EPA’s early assurances were based on reports by scientists, not on political expedience.

However, an August 2003 report by the EPA’s own inspector noted that some of the EPA statements about the air quality and safety soon after the attacks were made without scientific evidence, and the report also implicated the Bush administration in the mitigation of the health warnings to New Yorkers.

In early 2007, a federal judge ruled that Whitman knowingly lied to residents of lower Manhattan about the health risks rising from 9/11. An appeal of the ruling is underway.

Estate Claimed Cancer Unnoticed During Drug Trial Study

Tuesday, July 31st, 2007

On Aug. 10, 2000, plaintiff’s decedent Morris Lundy, 56, an insurance broker, was referred to Dr. Eliot Howard Zimbalist’s office to participate in a clinical trial of Interleuken 11, a drug that was being tested as a treatment for Crohn’s disease.In 1995, Lundy had been diagnosed with Crohn’s disease and in 2000 underwent a CT scan of his abdomen prior to seeing Zimbalist, a gastroenterologist performing the trial study of Interleuken 11. The CT scan showed a 1-centimeter lesion on Lundy’s liver that a radiologist diagnosed as being benign. The CT scan report was then given to Zimbalist, who recommended that Lundy undergo a laparotomy and advised that surgery would be the best treatment for his illness. Lundy decided not to undergo the surgery and instead participate in the clinical study.Several times throughout his treatment with Zimbalist, Lundy made complaints of abdominal pain, diarrhea and constipation. Lundy remained in the study until March 11, 2001, when he presented to Maimonides Medical Center, in Brooklyn, with gastrointestinal complaints, including abdominal pain. After being discharged, Zimbalist followed up with Lundy.

Zimbalist decided to withdraw Lundy from the drug trial because of the hospitalization. After finding out that he had been withdrawn from the trial, Lundy returned to Zimbalist on April 24, 2001. At this visit, Zimbalist again recommended surgery and referred Lundy to another doctor. Zimbalist did not see Lundy after that date.

On Aug. 6, 2001, Lundy presented to a Florida hospital and reported increased abdominal symptoms. There he was diagnosed with cancer of the colon with metastasis to the liver. He died one week later.

Lundy’s widow, Yamilee Clermont-Lundy, acting individually and as executrix of the goods, chattels and credits of her husband, sued Zimbalist; Maimonides Medical Center; two of her husband’s prior treating physicians, Drs. Sam Weissman and Moshe Schein; and a prior treating facility, New York Methodist Hospital. The plaintiffs alleged that the defendants failed to diagnose and treat Lundy’s cancer and that these failures constituted medical malpractice.

The action against Weissman, Schein, Maimonides Medical Center and New York Methodist Hospital was discontinued prior to trial. The matter continued against Zimbalist.

Plaintiffs’ counsel claimed that Zimbalist failed to follow up on the abdominal CT scan and failed to treat the lesion that was found on Lundy’s liver. Counsel also contended that Zimbalist failed to appropriately treat and follow up with Lundy when he complained of abdominal pain, diarrhea and constipation. The estate contended that if Lundy’s cancer was diagnosed sooner, it could have been treated. It contended that the delay in diagnosis decreased Lundy’s chance of survival. The estate also claimed that if there was only a single lesion on Lundy’s liver, then it could’ve been effectively treated.

Zimbalist contended that he did not depart from good and accepted medical standards. He argued that he appropriately recommended that Lundy undergo a laparotomy on the first day he saw him, to better investigate his abdominal problems. He claimed that he recommended surgery to Lundy on several occasions, but that Lundy wanted to exhaust all other medical therapies first. He also claimed that the CT scan was appropriately ordered by Lundy’s prior gastroenterologist and that the lesion on Lundy’s liver was diagnosed as being benign by a radiologist. He contended that this report is what was given to him. Zimbalist argued that if Lundy’s cancer had already metastasized to his liver by the time he saw him, there was nothing he could have done to treat him.

Lundy suffered colon cancer that metastasized to his liver. He died Aug. 15, 2001, at age 57.

Lundy’s estate sought recovery of wrongful-death damages that included one year of conscious pain and suffering and damages for Lundy’s 5-year-old daughter’s loss of parental guidance. Lundy’s wife also presented a derivative claim. The plaintiffs sought a total of about $2 million.

The jury rendered a defense verdict. It found that there was no malpractice on the part of Zimbalist.

Plaintiff’s counsel made a motion to set aside the verdict as against the weight of the evidence, but it was denied.

California Court Of Appeals Affirms $1.8 Million Verdict In Forklift Injury Case

Tuesday, July 31st, 2007

A state appeals court in California has affirmed a $1.8 million jury award to a forklift operator who lost a leg in an accident, rejecting defense arguments that the plaintiff should have been required to prove the existence of a feasible safer design.

The appeals court said the burden was on the defendant, Toyota Industrial Equipment Manufacturing Inc., to show that the benefits of the allegedly defective design outweighed the risks.

Court records say Eugenio Feliciano was severely injured in January 2003 when a tire on a Toyota Series 7 forklift split and caused the machine to topple over, crushing his leg.

Feliciano sued Toyota in the San Mateo County Superior Court, claiming that the defective design of the Series 7 put excessive stress on the tires.

In 2005 the jury returned a 9-3 verdict and awarded Feliciano $1.8 million for lost wages, medical expenses, and pain and suffering.

Affirming, the California 1st District Court of Appeal held, “Toyota’s assertion that a plaintiff in a strict-liability design-defect case must prove the feasibility of a safer alternative design is an assertion that is founded on cases from other jurisdictions and has no support under California law.”

The panel said that contrary to the defendant’s argument, there is no split on this issue, with the California Supreme Court having “spoken unequivocally” in Barker v. Lull Engineering Co., 20 Cal. 3d 413, 429 (1978); Campbell v. General Motors Corp. 32 Cal. 3d 112, 118-119 (1982); and Soule v. General Motors Corp., 8 Cal. 4th 548, 560 (1994).

The appeals court also said sufficient evidence supported the verdict.

It was undisputed, the court noted, that Toyota’s “system of active stability” suspension mechanism puts greater lateral force on forklift tires than a conventional design.

Feliciano presented evidence that Series 7 forklifts used the same tires as conventional models that did not have the SAS mechanism, the panel added.

Rail Crossings Deaths Called ‘Preventable’

Monday, July 30th, 2007

Deaths at railroad crossings generally have dropped in the past 10 years, but the annual rate remains the equivalent of one person killed a day.

That, plus accidents at crossings averaging to about eight a day, has members of Congress, railroad officials and a consumer safety group pushing legislation that would provide the first major upgrade to rail-safety law since 1970.

There were 368 deaths last year, 3% more than the previous year but 20% fewer than in 1997, according to the Federal Railroad Administration (FRA). Overall, there were fewer than 3,000 accidents last year, down from almost 4,000 a decade ago, the FRA reports. The number of deaths and accidents have continued to fall in 2007, dropping 10% and 4% respectively through April compared with the same period last year.

While that trend is encouraging, FRA spokesman Warren Flatau said, the numbers remain troublesome because most accidents are “largely avoidable and preventable.”

Rep. Jim Oberstar, D-Minn., has proposed legislation that includes safety provisions aimed at bringing the number of accidents down further.

The bill has cleared the transportation and infrastructure committee and is expected to be taken up by the full House after Labor Day, Oberstar said. Sixty-three co-sponsors, most of them Democrats, have signed onto the bill.

“Although I am encouraged by improvements in the 2006 rail-safety statistics, I believe we still have a long way to go,” he said in a May hearing.

“Serious accidents resulting in fatalities, injuries and environmental damages continue to occur.”

The legislation would:

– Require that railroad companies keep up to date the FRA’s National Crossing Inventory, a database that tracks the condition of the warning devices and maintenance records at crossings.

For example, Flatau said there are crossings listed in the inventory that have been closed for almost two decades.

– Create a toll-free number to report grade-crossing problems, such as damaged lights or gates, overgrown vegetation blocking sight or warning-device malfunction.

– Establish more uniform regulations for removing brush and other vegetation from obstructing the view of pedestrians and motorists.

– Reform the hours that railroad employees can work and the hours of rest required between their shifts.

Union Pacific Railroad spokesman James Barnes said it was “premature to comment” on the bill because it still could change.

Flatau said the FRA agrees with most of the legislation, except for minor changes in language.

Patricia Abbate, executive director of Citizens for Rail Safety, said the lack of updated information for the FRA’s database about broken signals and other problems at crossings is a reason why some accidents still occur.

Abbate supports the safety legislation.

“If you don’t start with accurate information, how can you move forward to make these places better?” Abbate asked.

Citizens for Rail Safety is a non-profit citizens activist group that sponsors university studies on rail-safety issues and reports the findings and recommendations.

A major concern of Citizens for Rail Safety, Abbate said, is the fact that of the approximately 144,000 existing public grade crossings, 55% do not have active warning devices, such as lights or gates.

“We’re complacent when it comes to rail safety and security,” she said.

F.D.A. Scientist Warns Of Heart Risk From Diabetes Drug Avandia

Monday, July 30th, 2007

A federal drug safety official recommended during an advisory committee hearing today that Avandia, a controversial diabetes medicine made by GlaxoSmithKline, be withdrawn from the market because it increases heart risks.Dr. David Graham noted in a written preview of his presentation that Avandia is no better at controlling blood sugar levels than similar diabetes medicines like Actos, made by Takeda. With a clear risk to the heart, and nothing to recommend it over other therapies, Avandia should be withdrawn, Dr. Graham argued in written remarks.

Dr. Graham is scheduled to speak to the committee later today. But it is not clear that the advisory committee, or indeed the Food and Drug Administration itself, will agree with Dr. Graham, a drug safety official at the F.D.A. who has a long history of arguing against the use or marketing of some widely-used drugs.

The committee may instead recommend that Avandia’s label include stronger warnings about its heart risks.

A committee vote is scheduled for later this afternoon.

The F.D.A. called the advisory committee meeting today after a study, published in May in the New England Journal of Medicine, called into question the safety of Avandia.

Since then, the controversy about Avandia has wounded GlaxoSmithKline and led to severe criticism of the F.D.A., which has known for a year that Avandia might increase the risks of heart attacks but waited until May to warn patients about a possible risk.

This delay has helped to push through legislation on Capitol Hill that would provide the F.D.A. with more authority and money to police the safety of marketed medicines. Both the House and Senate have passed F.D.A. reform bills but a conference committee has yet to come to agreement.

About a million patients in the United States took Avandia last year, and a similar number took Actos. Since May, Avandia’s sales have plunged.

Many patients who take Avandia, and their doctors, have been presented with conflicting advice about whether to switch to other drugs.

The controversy largely revolves around whether several highly complex statistical analyses of dozens of studies of Avandia have shown that the drug is too dangerous to use.

There are fierce disagreements about the answer to this question not only among academic experts but within the F.D.A. itself.

The heart attack risk comes on top of a problem with swelling that has long been known to occur in those taking both Avandia and Actos. The swelling is especially risky for patients suffering from heart failure.

GlaxoSmithKline argued forcefully before the committee that its drug is safe.

Dr. Murray Stewart, a GlaxoSmithKline vice president, said that in recent months the company has examined data from several large managed care companies in the United States that altogether included 1.35 million diabetes patients.

The company’s analyses, he said, showed that patients who took Avandia suffered no greater risk of heart attack or death from heart problems than those taking other diabetes medications, including Actos.

The hearing began today with a presentation by Dr. Robert Ratner of the MedStar Research Institute in Washington, about the epidemic of diabetes.

He noted that each day in the United States, there are 4,100 new cases and 810 deaths from diabetes. In addition, 230 patients suffer amputations, 120 suffer kidney failure, and 55 go blind because of the disease every day.

He said that while controlling blood sugar levels has proven health benefits in the short term, no study has proved that diabetes drugs extend lives.

“We’re not keeping people alive with our drug therapy because our drug therapy isn’t adequate,” he said. And he said that no diabetes medicine has conclusively proven that it helps protect the heart. He also noted that diabetes patients often fail to take their medicines properly, and doctors often fail to treat the disease aggressively enough.

“Why do we need new therapies for type two diabetes?” Dr. Ratner asked. “We have an epidemic of diabetes and its complication that will soon swamp our medical delivery system.”

Most diabetics die from heart disease, since diabetes has severe effects on the heart. If Avandia actually increases the risks of heart attacks, that “denotes a serious limitation” of the drug’s usefulness, an F.D.A. reviewer concluded in a report before the meeting.

Excavation Damage Cited In Gas Explosion At New Jersey Apartment Building

Monday, July 30th, 2007

The National Transportation Safety Board has determined that the probable cause of a natural gas explosion and fire in Bergenfield, NJ, on December 13, 2005, was the failure of a service company to adequately protect a natural gas line while excavating a fuel storage tank. During the excavation, shifting soil resulted in damage to the service line and the migration of natural gas into a nearby apartment building.Contributing to the accident, the Board said, was the gas company’s failure to conduct effective oversight of the excavation and to be prepared to promptly shut off the flow of gas after the service line was damaged.

Additionally, the Board found that the Bergenfield Fire Department’s failure to evacuate the building, despite the strong evidence of a gas leak, contributed to the casualties in the accident.

“Excavation damage continues to be a significant cause of dangerous gas pipeline explosions,” said NTSB Chairman Mark V. Rosenker. “There is a need for greater vigilance in preventing these accidents, and for increased emphasis on training service workers and first responders to deal with these emergencies when they unfortunately do occur.”

Investigators found a break in the 1 1/4-inch service line at an underground connection downstream from where excavators were removing a 5,000-gallon fuel oil tank that was buried under an asphalt parking lot adjacent to the apartment building. Workers told investigators that the ground surrounding and supporting the pipeline had collapsed. Three residents of the building were killed; four other residents and a service company worker were injured. The building was estimated to be a total loss.

As a result of its investigation, the NTSB made the following safety recommendations:

To the New Jersey Department of Community Affairs:

Establish a requirement that all career and volunteer firefighters receive recurrent training on natural gas safety and incident response.

To the Borough of Bergenfield:

Establish and implement written operating procedures for responding to natural gas incidents and emergencies.

To the American Tank Service Company:

Establish and implement written procedures for safe excavation near pipelines, and provide initial and recurrent training on these procedures to employees.

To the Public Service Electric and Gas Company:

Modify your excavation damage prevention program and emergency plan to require site-specific risk assessments of excavators’ plans, and implement procedures to effectively manage the risk, such as increased surveillance of excavator actions to protect the pipeline and ensuring that gas shut- off valves are tested so that they can be closed promptly if the pipeline is damaged.

To the International Association of Fire Chiefs:

Notify your members of the circumstances surrounding the December 13, 2005, accident in Bergenfield, New Jersey, and urge them to establish and implement procedures for emergency responders to rapidly assess situations involving natural gas leaks and to determine whether prompt evacuations are warranted.

To the Pipeline and Hazardous Materials Safety Administration:

Make the recipients of PHMSA emergency planning and response grants aware of the circumstances of the Bergenfield, New Jersey, accident for use in training on natural gas safety and incident response.

Botulism Outbreak From Canned Goods

Monday, July 30th, 2007

Botulism, a potentially fatal form of food poisoning, has become the basis of a nationwide recall of canned goods such as chili, stew, hot dog sauce, and pet food. The U.S. Food and Drug Administration has issued a warning to consumers, stating that more than 90 products from Castleberry’s Food Co. are potentially contaminated with botulism.

Millions of Potentially Contaminated Cans of Food

Four people in Texas and Indiana have been hospitalized after consuming botulism bacteria from Castleberry’s products, according to the Centers for Disease Control and Prevention (CDC). Food safety officials are assuming that the number of infected people will increase, as literally millions of cans of possibly contaminated food have been distributed throughout the 50 states.

The number of infected patients is small, but as Dr. David Acheson, the FDA’s leading food safety expert stated, “Frankly, the fact we have had only four illnesses in this situation has people saying, ‘Well, what is the big deal?’ The deal is this is something that can land you in the ICU, not being able to breathe, for weeks.”

Symptoms of Botulism

The symptoms of botulism poisoning usually begin between six hours and two weeks after someone eats food that contains the toxin. Botulism symptoms include:

  • Blurred vision
  • Double vision
  • Slurred speech
  • Drooping eyelids
  • Difficulty swallowing
  • Dry mouth
  • Muscle weakness that moves down the body, affecting the shoulders first and then the upper arms, lower arms, thighs, and calves

Most seriously, botulism can cause paralysis of the breathing muscles — an affected person can die from being unable to breathe unless mechanical ventilation is available.

Recall of Two Years’ Worth of Production

The recall of Castleberry’s products has been expanded to cover two years’ of production at the Augusta, Georgia facility where the botulism source is suspected. The FDA has postulated that the facility failed to adequately cook some of the products, allowing the botulism bacteria to survive the canning process.

Inside the sealed cans, the bacteria thrive and produce the toxin that causes the symptoms. As Dr. Acheson of the FDA noted, “The longer this stuff stays in the can, the worse it gets.”

Cans Bursting Open

The bacteria also produce gas that can cause a can to burst open — in fact, cans of Castleberry’s products being held in a company warehouse have already begun to explode. The CDC notes that people can be infected with botulism toxin by inhaling it or absorbing it through the eyes or a break in the skin.

The FDA is conducting spot checks around the U.S., and they’re finding that recalled Castleberry’s products continue to be available in many stores. Although large franchise supermarkets have been responding well to the recall, the FDA warns that smaller outlets such as convenience stores, gas stations, and family-run grocery stores may still be stocking the contaminated products.

Estate Claims Plaintiff Died From Overdose Of Fentanyl

Monday, July 30th, 2007

During the late evening of Dec. 16, 2003, or the early morning of Dec. 17, 2003, plaintiff’s decedent Adam Hendelson, 28, a computer technician, was in his apartment at his computer while using a 75-microgram Duragesic pain patch prescribed by his doctor. The patch was for chronic hip pain from an injury in a car accident in 1996. The Duragesic patch delivers a powerful pain medication called Fentanyl. He died sometime that night.Individually and on behalf of his son’s estate, Lee Hendelson sued Janssen Pharmaceutical Products L.P. and ALZA Corp., on a products liability theory (failure to warn and design defect), seeking wrongful death damages. Plaintiff’s counsel contended that the patch delivered three times the dosage it was intended to provide, killing Hendelson.At the time of his death, Hendelson was taking two commonly prescribed antidepressants in addition to using the pain patch. The autopsy report attributed the cause of death to the combined effect of the three drugs in his system.

Plaintiff’s counsel argued that the only drug in the fatal range was the Fentanyl from the Duragesic patch and that the other two medications were within the therapeutic range.

The defense denied that the Duragesic patch was defective. Hendelson’s death was from an overdose of antidepressant medications. Defense counsel further argued that Hendelson must have used more than one pain patch shortly before his death. The defense disputed the level of Fentanyl in the decedent’s system as stated in the toxicology report from the medical examiner, claiming that it was inflated due to post-mortem redistribution.

Hendelson died. His father sought to recover for his mental pain and suffering.

A jury found in favor of the plaintiffs and awarded $5.5 million.

Massive Explosion At Kansas Chemical Plant Still Raising Questions

Friday, July 27th, 2007

The Barton Solvent tank farm explosion that ignited about 300,000 pounds of toxic chemicals last week has not been explained by the company’s owners, and local and state fire officials acknowledged that neither agency had ever inspected the tank area. The huge fire engulfed the 43-tank chemical storage and distribution facility on July 19.

Huge Explosion, Town Evacuation

The thunderous explosions, fire, and billows of black smoke hundreds of feet into the air prompted the evacuation of the 6,000 residents in nearby Valley Center, Kansas. After an inspection of the destroyed facility, a state fire marshal investigator said that the explosion occurred when liquid naptholite solvent was being pumped from a truck into a tank at the facility, and that an electrical charge, perhaps static electricity, ignited the chemical solvent. There were no injuries on the site.

No Inspections of Tanks

The Valley Center Fire Department, the Sedgwick County Fire Department, and state fire officials all admitted that none of their agencies does regular inspections of the Barton Solvent tanks that hold chemicals such as hydrocarbon solvents, ketones, alcohols, and oils.

The county’s top fire official, Sedgwick County Fire Marshal Tim Millspaugh said, “These things should be inspected by somebody … just like any commercial building should be. Maybe it’s something the state should look into.”

Air and Groundwater Contamination Possible

The town’s evacuees were not allowed to return to their homes for one week. The Environmental Protection Agency (EPA) sent staff to the explosion site to test the air and groundwater for toxic chemicals. Although the EPA’s preliminary reports state that the groundwater had not been significantly impacted by the explosion, the Kansas Department of Health and Environment (KDHE) said that “The need for groundwater monitoring may continue for some time.”

The KDHE’s press release noted that “Solvent-contaminated water and soil is already being removed from Barton Solvents property, staged for analysis and properly disposed.”

Nurse Slipped At Hospital While Employee Was Mopping

Friday, July 27th, 2007

On Feb. 6, 2003, plaintiff Susan Hanson, 37, a registered nurse, slipped and fell at Valley Regional Medical Center in Brownsville. Hanson worked at the hospital, but her employer was an agency. The incident occurred at the nurses’ station, where a housekeeping employee was mopping, as Hanson was providing emergency treatment of a patient with a low glucose level.Hanson sued the hospital for its employee’s failure to place caution signs where they could be seen.

The employee testified that he put the signs at the entrances, where they were supposed to be placed.

Hanson denied that the signs were there.

Hanson claimed a herniated disc at L5-S1, for which she underwent a microlaminectomy. She also claimed neck and back sprains and strains. She underwent chiropractic care and physical therapy, one neck injection and two back injections. Her past medical bills were $46,000. She claimed $100,000 in past lost wages and $1.2 million in future lost earning capacity, saying she could no longer do “hands-on” nursing and was limited to administrative work. She also claimed past and future pain and suffering, physical impairment and, based on surgical scarring, disfigurement.

Hanson’s husband claimed loss of consortium.

The defense noted that, earlier in the litigation, Hanson had claimed many complications from the injections and medication she received, but that she dropped those claims before trial, and that none of them were supported by her doctors.

The defense also argued that she’d had prior falls, prior similar back problems and prior chiropractic treatment. The defense denied that the herniation resulted from the fall on Feb. 6.

The defendant’s economics expert submitted that Hanson’s past wage loss because of the herniation was $55,000 and that she would have no future loss of earning capacity.

The jury found that Hanson’s negligence, not the hospital’s, caused Hanson’s fall. The jury found $146,000 in damages for Hanson ($100,000 in past medical and $46,000 in past lost wages), but because the hospital was not liable, she took nothing.

The deliberations took place over two days.