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FDA Study Identifies Toxins in Electronic Cigarettes

Greg Webb — Sun, 02 Aug 2009 17:42:28 GMT

According to a preliminary analysis by the FDA, electronic cigarettes contain traces of carcinogens and toxins. These findings contradict electronic cigarette manufacturers’ statements that their products are a safe alternative to tobacco. Manufacturers claim that the battery-powered cigarettes contain nothing more than water vapor, nicotine, and propylene glycol, which is used to create artificial smoke. When heated, the liquid produces a vapor that users inhale.

The FDA analyzed 19 varieties of the cartridges that hold the liquid and two types of cigarettes made by NJoy and Smoking Everywhere. It found that several cartridges contained nitrosamines, tobacco-specific compounds known to cause cancer, and one cartridge from Smoking Everywhere contained diethlyene glycol, a common ingredient in antifreeze. Dr. Joshua Sharfstein, the FDA’s principal commissioner, reports concerns because, while the FDA knows what’s in the cigarettes, it doesn’t know how those ingredients affect the body when inhaled through electronic cigarettes.

The Electronic Cigarette Association said in a statement that the FDA’s testing was too narrow to be reliable and that its members only sell and market their product to adults. CEO of NJoy Jack Ledbetter said a third party had tested its products and pronounced them an appropriate alternative to cigarettes, but he did not release those findings. He said experts would review both NJoy’s tests and the FDA’s.

Dr. Sharfstein said that electronic cigarettes are manufactured in China and subject to little quality control, adding that the study found nicotine levels to vary in cartridges who claimed to have a standard amount and found the drug in cartridges who claimed to be nicotine-free.

The FDA has called the cigarettes electronic drug delivery devices, turning away approximately 50 shipments of them at the border. It would not comment on whether it planned to ban electronic cigarettes, but public health officials are worried that the cherry and bubblegum flavors are enticing to children and may be easy for minors to obtain. Smoking Everywhere filed a lawsuit against the FDA in April, claiming that it did not have jurisdiction to bar electronic cigarettes from entering the U.S.

Originally posted at InjuryBoard by Greg Webb

Federal Concerns About Electronic Cigarettes Are Growing

Greg Webb — Thu, 13 Aug 2009 12:17:06 GMT

Because so little is known regarding what is in electronic cigarettes, regulators are growing more and more concerned due to the increase in popularity of the product over the past several years. Preliminary tests carried out by the Food and Drug Administration (FDA) show e-cigarettes, which are battery operated tubes that deliver a nicotine vapor instead of burned tobacco smoke, contain some of the dangerous carcinogens that traditional cigarettes do, but at lower levels. The samples also revealed quality-control issues with some of the products, which are marketed the exact same, having wildly variable amounts of nicotine and one of the products even having poison (diethylene glycol) in it; this indicates that regulators do not know enough about how the product is being produced. Due to the study’s findings, the FDA Commissioner has warned consumers to beware.

Since e-cigarettes, or "e-cigs", are being subject to FDA approval as a drug or medical device, they are illegal until they are cleared. Smoking Everywhere, one of the two major importers of e-cigarettes, has since sued the FDA, claiming it should not be regulated like a drug but as a tobacco product. While the company engages in this legal battle, however, its sales representatives at one point claimed the product had been approved and deemed safe by the FDA. An attorney for the company claims this misinformation has since been corrected.

Michael Siegel, a Boston University School of Public Health Professor, says the FDA’s newest consumer warning is misleading because the agency found very low levels of carcinogens in e-cigarettes. Siegel claims these levels were comparable to what is present in nicotine-replacement products, which are currently on the market. He also states the levels of carcinogens in the e-cigarettes are about 1,400 times lower than in Marlboros. The FDA deputy commissioner, however, says it is premature to claim e-cigarettes are safe until regulators know what is in them. If the product is meant to help some Americans stop smoking, it is the manufacturers obligation to present that data to the FDA.

Many anti-smoking advocates are putting pressure on the FDA to officially ban e-cigarettes from the U.S. They claim these and similar products should be taken off the market because the lack of testing to determine the hazardous ingredients in the product would lead to smokers becoming guinea pigs. The public health community is also split over the issue regarding whether to advocate smokers switch to a less harmful product even if they are not completely safe. Though the government has blocked the product from the border, it has not shut down domestic retailers. This means consumers can find the $40 to $100 e-cigarette starter kit in mall kiosks, travel centers and online. So far, the e-cigarettes have also been banned in Canada, Australia, Mexico and Israel.

Originally posted at InjuryBoard by Greg Webb

Chrysler-Fiat to Be Immune from Liability for Certain Defective Automobiles

Greg Webb — Sun, 14 Jun 2009 22:14:03 GMT

When bankruptcy Judge Arthur J. Gonzalez approved the sale of most of Chrysler’s assets to a new company run by Fiat, he also granted the request that the new company not face liability for future product-liability problems involving current Chrysler owners. This leaves owners of Chrysler, Dodge, or Jeep vehicles without the right to sue if they are injured by a safety defect.

Fiat argued in court filings that it was unfair to burden it with financial obligations from the original Chrysler. Chrysler’s CEO, Robert L. Nardelli, testified during the bankruptcy hearing that the idea of not allowing current owners to sue the Fiat-owned company came up during discussions between the Treasury and Fiat.

Consumer groups, including Public Citizen, the Center for Auto Safety, and Consumers for Auto Reliability and Safety, have objected, saying that granting the request deprives consumers of their rights. Judge Gonzalez dismissed the objection, but an attorney for the groups reports that they plan to appeal. The consumer groups are also concerned about individuals injured in accidents who have already filed suit alleging safety defects in Chrysler vehicles. Even if they win in court, those people have very little chance of recovering from the automaker after Chrysler’s debts are settled.

Law professors have expressed reservations as to whether the bankruptcy judge’s can remove an owner’s future legal rights without due process. Many citizens may support this law, at least at first glance, given Chrysler's precarious position. But, if one's loved one suffered serious injury or death because of a defective Chrysler vehicle, one may feel a bit differently about the law. Should a company be granted immunity from responsibility for building a defective product because of its financial status?

Originally posted at InjuryBoard by Greg Webb

Aluminum Bat Manufacturer Found Liable For Player’s Death

Greg Webb — Mon, 16 Nov 2009 14:58:24 GMT

After twelve hours of deliberation, a jury in Lewis and Clark County, Montana recently sided with the parents of former Miles City American Legion baseball pitcher Brandon Patch, who died after being struck in the temple by a batted ball in a 2003 baseball game against the Helena Senators. Hillerich & Bradsby Co., an aluminum bat manufacturer best known for their Louisville Slugger bats, was found liable for Patch’s death because it failed to provide adequate warning as to the dangers of the bat used by a Helena Senators batter. Hillerich & Bradsby Co.’s attorneys argued any other bat would not have hit the ball any differently; in fact, they claimed most bats on the market would have stuck the ball even harder and that Patch’s death was a tragic accident. The Patch family’s attorneys, however, argued Brandon only had 378 milliseconds to respond to the batted ball, whereas most bats on average give 400 milliseconds to respond. The bat manufacturer was ordered to pay $792,000 to Patch’s estate. The funds were allocated to cover the earnings Patch would have made had he lived, and the pain he suffered for four hours after the injury before ultimately dying. Another $58,000 was awarded to Patch’s parents for funeral expenses and their mental grief.

Aluminum bats have faced a lot of scrutiny due to their internal wall structure and because their weight is more evenly distributed than wooden ones, making them easier to swing harder and faster. A third decision made in the suit was that the bat was not defective, therefore making it more dangerous like the Patch family attorneys claimed. The Patch family said the suit was never about the money but was to get adequate warning about the dangers of these bats so something like this will not happen again. They have also started to advocate for the use of wooden bats. Brandon Patch’s baseball team reverted to wooden bats after his death.

Originally posted at InjuryBoard by Greg Webb

Gulf War Syndrome is Real Says Congressionally Mandated Panel

Greg Webb — Mon, 01 Dec 2008 08:00:00 GMT

Gulf War syndrome is real and afflicts one-fourth of the 700,000 U.S. troops who served in the War, says a panel report issued in November. A congressionally mandated scientific panel released the report concluding that the syndrome exists, which contradicts almost two decades of government denials. “The extensive body of scientific research now available consistently indicates that Gulf War illness is real, that it is a result of neurotoxic exposures during Gulf War deployment, and that few veterans have recovered or substantially improved with time,” according to the report.

The report comes from the Research Advisory Committee on Gulf War Veterans’ Illnesses, chartered by Congress in 1998 but with no appointed members until 2002. The panel is made up of 15 members, including both scientists and veterans. Their report referred to two chemical exposures typically associated with the disorder: pyridostigmine bromide, given to troops to protect against nerve gas, and pesticides, often overused to protect against sand flies and other pests.

Many veterans reported memory loss, concentration problems, persistent headaches, unexplained fatigue, and widespread pain. Many also reported chronic digestive problems, respiratory symptoms, and skin rashes. The government maintained that the symptoms were due to stress or other unknown causes. “Veterans repeatedly find that their complaints are met with cynicism and a ‘blame the victim’ mentality that attributes their health problems to mental illness or non-physical factors,” said Roberta F. White, associate dean of research at the Boston University School of Health and the panel’s scientific director.

Prior reports issued by the Institute of Medicine, an arm of the National Academy of Sciences, concluded that there was little evidence to support existence of the syndrome. The newest report claims that those reports and studies were restricted by the VA. The bulk of research and experiments on the effects of the chemicals were done on animals, but the VA ordered the Institute of Medicine to only consider human studies, which skewed the results. The panel called for the VA to allow the Institute of Medicine to redo its reports, taking into account all available research, including that done on animals.

Additionally, critics believe the VA was reluctant to spend funds on research and treatments that a research committee might recommend. The current panel has called for Congress to appropriate $60 million per year for research into finding a cure for the disorder.

Pyridostigmine bromide, a major cause of the disorder, was given to troops in the fear that Iraqis would resort to chemical warfare. Pesticides, another major cause, were sprayed around living and dining areas, as well as on tents and uniforms, the report stated. Another lesser cause was the demolition of Iraqi munitions, which may have exposed almost 100,000 troops to nerve gases stored at the facility.

Also observed in the report are the significantly higher rates of amyotrophic lateral sclerosis than other veterans, and that troops downwind from the munitions demolition had twice the rate of deaths from brain cancer as other veterans.

“Recognition of the full extent of the illnesses suffered by these veterans of the conflict and the obligation owed them is long overdue,” said Marshal of the Royal Air Force Lord David Craig, chief of the British defense staff during the war. “They are victims of the war as much as anyone struck by a bullet or shell.” Panel chair James H. Binns emphasized, “The importance … lies in what is done with it in the future.”

Originally posted at InjuryBoard by Greg Webb

Congress Debates Medical Device Safety Act to Counter Riegel v. Medtronic

Greg Webb — Mon, 25 May 2009 21:25:32 GMT

The House Energy and Commerce Subcommittee on Health began hearing testimony on the Medical Device Safety Act of 2009, which proposes the Supreme Court decision in Riegel v. Medtronic, Inc be overturned. The Reigel ruling prevents patients that were injured by certain federally approved medical devices from seeking compensation via state product liability suits – in other words, federal law trumps (preempts) state law in these cases. The House bill has been a catalyst in the legal community. The American Tort Reform Association, for example, claims the bill would be an economic stimulus for personal injury attorneys. The American Association for Justice, on the other hand, says the bill would restore victims’ rights.

The subcommittee’s hearing was just as divided. While the arguments within the subcommittee hearing were relatively tame, an argument broke out between Subcommittee Chairman Henry Waxman (Democrat) and Steve Buyer (Republican). Waxman argued the FDA’s ability to protect the American public has plummeted due to severe underfunding. Buyer claimed this was “bizarre logic.”

A former chief counsel of the Food and Drug Administration (FDA) testified at the hearing and argued ultimate authority should rest with the FDA and not a group of people that listen to lawyers “rant” at them. He further argues that making it easier for the companies to be sued would lead to limits in innovation because companies would be deterred from taking risks in developing new products. David Vladeck, who will become the Federal Trade Commission’s consumer protection chief next month, claims the Riegel decision gave consumers the “worst of both worlds” since the FDA cannot assure every medical device is safe and with Riegel, consumers can no longer rely on the tort system if they are injured.

Mr. Vladeck is dead-on with his comment. There have to be checks and balances on any system. It is no secret that the FDA (and most other federal oversight agencies) do not have adequate resources to police drug companies, medical device companies, automobile manufacturers, and much of the banking industry (Exhibit A being what has occurred in our economy over the past 12-24 months), just to name a few. While lawyers, especially trial lawyers, are not a favorite profession of most citizens, trial lawyers (of which I am a card-carrying member) are needed as an enforcement mechanism. The possibility of litigation is a deterrent, and it is also a means to hold those who place profits ahead of safety accountable.

Originally posted at InjuryBoard by Greg Webb

Four Out of Five Ain’t Bad? – Research Finds 1 out of 5 Trucks Unfit

Greg Webb — Wed, 02 Sep 2009 09:54:11 GMT

Recently, a new batch of statistics has emerged from research done by the American Association for Justice (AAJ) regarding motor carrier safety violations. Violations found include such unsafe practices as "overloading trucks, allowing unqualified or untrained drivers behind the wheel, failing to maintain tires and brakes, and salary systems that encourage truck drivers to exceed speed limits and maximum driving hours."

AAJ reports that 9 million trucks occupy U.S. roadways each year. And, although they represent less than 4% of all passenger vehicles, they make up 12% of vehicles involved in motor vehicle fatalities, with 4,000 people dying every year from accidents involving collisions with trucks. The most distressing part about these figures is that most of these violations result from companies trying to cut corners and maximize profits; most of these accidents are preventable, if not largely resulting from judgment errors.

In April 2009, the AAJ found that there were more than 28,000 trucking companies, with over 200,000 trucks (collectively) driving on U.S. roads, incurring thousands of violations – "defective brakes, bald tires, loads that dangerously exceed weight limits, and drivers with little or no training or drug and alcohol dependence." The real issue at hand is that, to other motorists, these problems are impossible to detect. One simply cannot tell that the truck riding in front of it, the one doing 75 in the left hand lane, has defective brakes and bald tires until it’s too late. This is exactly what happened to young, "newly-commissioned Army officer" Matthew Giuliano.

Matthew drove directly into the back of a truck that, earlier, was having air brake issues due to a small eroded hole caused by a dragging hose. The drivers – a husband and wife duo – repaired the malfunction with a toothpick and electrical tape.

A toothpick. And electrical tape.

It was only a matter of time before such a jury-rigged repair gave way, and, somewhat predictably, it did. Sadly, there was no way for Mr. Giuliano to avoid the accident that took his life. However, it could have been easily avoided if the drivers of that truck stopped at any of the repair shops they passed in the two hours between their makeshift solution and the time of the accident.

Reportedly, it would have cost them $12.

Even more disheartening is the fact that the dispatcher for the trucking company commended them for their thriftiness and quick-thinking. For some reason, one would like to think that a driver – a professional driver – would know better than to employ such unproven Boy Scout heroics on the forty-ton metal missile he’s driving. More so, one would like to think that the checks-and-balances in place would tell him he was off base.

Now, while this may have been a case leaning on the extreme shoulders of the "miserable judgment" scale, it doesn’t change the fact that the method of thinking apparently used by the two drivers in Mr. Giuliano’s case appears to be part of a greater collective consciousness that envelops a large part of the trucking industry: time over safety.

What’s worse is that smaller trucking companies will rarely spring for more than the minimum required insurance coverage – $750,000 – a number that hasn’t change in almost 30 years. The AAJ’s research indicates that 87% of the companies in violation are operating fleets of 10 trucks or less. This number, relative to the number of accidents each year involving trucks, seems to call for a change in that minimum, considering the number of victims that are forced to rely on Medicare/Medicaid to pick up the slack.

Similarly, the AAJ cites Florida trucking company Benton’s Express, who had a driver come to it and complain about his regularly overloaded truck and its difficulty to control. That was until he blew out a tire in 2004, leading to an investigation that found several companies in the Florida area who routinely faked paperwork in order to get away with illegally overloading their trucks.

It all ties back to this theme of time over safety. It is easier (unsafe) to load a truck with product beyond its maximum, so that it takes fewer trips to move said product, than it is to safely (not as easily) transport the maximum number of product until the product is fully delivered.

Furthermore, the AJJ states that its research concluded that "A 2005 Government Accountability Office (GAO) report found that ‘nearly one-third of commercial motor vehicle crashes that states are required to report to the federal government were not reported, and those that were reported were not always accurate, timely, or consistent.’" In addition, companies that incur a large number of violations or particularly severe violations often change their names, coming back as "reincarnations." Such is the case with Iguala BusMex Inc., which was a new company waiting for approval for a federal license when one of its busses crashed after it blew a tire and ran into a guard rail, killing 17 passengers. A later investigation revealed that Iguala BusMex was incorporated and owned by the same individual as Angel Tours Inc., a company that was shut down after accruing a large number of violations.

The research done by the AAJ was compiled and can be found at: www.justice.org/trucksafetyviolations. It includes all 28,274 trucking companies with violations and is broken down by state. The AAJ states that "All of the listed companies have either conditional or unsatisfactory safety ratings. A conditional rating means that the truck company’s records indicate the truck was out of compliance with one or more safety requirements. An unsatisfactory rating means that the truck company’s records indicated evidence of substantial noncompliance with safety requirements."

In addition to these figures, the Commercial Vehicle Safety Alliance conducted its own set of comprehensive roadside inspections in June 2009. It announced the inspection dates four months ahead of time, giving plenty of warning for companies to address problems. These dates were publicly aware within the bounds of the trucking industry. Regardless, 22.2% of the trucks inspected failed and were taken out of service.

"Even still, Bill Graves, President and CEO of the American Trucking Association (ATA), said the results ‘illustrate the trucking industry’s deep commitment to the safety of all motorists.’"

This writer has represented many victims (and families) of tractor-trailer crashes. Some of the driver "training" (or lack thereof), maintenance (or lack thereof), and supervision (or lack thereof) I have seen is astounding. Suffice it to say that, whenever I am on a highway and happen to be in the vicinity of a tractor trailer, I try to get out of the vicinity as safely and quickly as possible.

Originally posted at InjuryBoard by Greg Webb

Family Medicine Doctor Numbers Declining

Greg Webb — Tue, 01 Sep 2009 17:40:44 GMT

In recent years, there has been a decline in the number of medical students who want to pursue family medicine, though many say it is the frontline for wellness and preventive-care programs that can help reduce healthcare costs. According to the American Academy of Family Physicians (AAFP), the number of U.S. medical students going into primary care, which includes family physicians, general internists and general pediatricians, has dropped 51.8% since 1997. Medical specialists have cited the decline to such factors as longer days, lower wages, less prestige and less administrative headaches. Some experts believe the biggest problem is the payment model because the more procedures a doctor performs, the more money he or she makes. This encourages medical students to pursue a procedure-based specialty as opposed to a primary-care track.

Because it takes about ten to eleven years to educate doctors, health-care experts are worried that the decline will cause a shortage of 40,000 family physicians in 2020 when the demand is expected to spike. Eleven of the top conventional medical schools in the U.S., including Johns Hopkins and Harvard, do not even have a separate family-medicine department. Finding a doctor will become increasingly difficult; there will be longer waits in the waiting rooms and more people will turn to the emergency rooms to get help because the waves of patients will be enormous. When patients visit the doctor’s office, they may also see a nurse practitioner or physician’s assistant instead of the doctor due to the increasing demand. This practice of involving nurse practitioners and physician’s assistants in care is already in place to alleviate physicians from time-consuming tasks in order to focus on the continuity of quality care.

While the U.S. healthcare system has about 100,000 family physicians, it will need 139,531 in ten years; the current environment is only attracting half the number needed to meet the demand. At the heart of the rising demand for primary-care physicians is not only the current group of underserved patients, but the baby boomer generation also, born from 1946 to 1964. This generation will be turning sixty-five in 2011 and will need increasing medical care. If Congress passes healthcare legislation that extends coverage to a significant part of the forty-seven million that do not have insurance, the number of people requiring care will continue to escalate.

In March 2009, U.S. medical school graduates only filled forty-two percent (1,083) of the 2,555 resident positions for family medicine. More than two hundred positions were left unfilled nationwide. More than half of the other spots were filled by non-U.S. students educated internationally, U.S. citizens educated internationally and graduates of colleges of osteopathic medical schools, though graduates of international medical schools and osteopathic medical schools seem to be losing interest in primary care also. This presents the problem of some foreign students with poor English skills not being able to communicate well with their patients.

Members of Congress have taken notice of the potential “crisis” associated with the lack of primary care physicians and have begun looking into bills that could help doctors who choose primary care with loan forgiveness or other debt relief and payment increases for their services.

Originally posted at InjuryBoard by Greg Webb

Homeopathic Drugs - "Remedies" - Potentially Hazardous?

Greg Webb — Mon, 29 Jun 2009 08:00:00 GMT

Although it was sold for many years as a drug for colds, Zicam Cold Remedy was never tested by federal regulators for safety like many other drugs. Because the drug is considered a “homeopathic remedy,” categorized as a highly diluted drug made from natural ingredients, they can legally be sold without any checks for safety, effectiveness, or even the right ingredients by the federal government. This was perfectly legal until consumers began losing their sense of smell.

Many scientists and health care professionals regard these homeopathic remedies as modern day snake oil, ineffective but mostly harmless because the substances in them are in such small amounts. They are similar to dietary supplements, which use many of the same natural ingredients and are also not tested for safety or benefit. The AP’s analysis of side-effect reports filed by the Food and Drug Administration (FDA), however, found more than eight hundred homeopathic ingredients were implicated in health problems last year; complaints ranged from vomiting to attempted suicide.

In the case of Zicam, the FDA tied the drug to 130 cases of consumers losing their sense of smell. Because of this, the agency asked Zicam manufacturer Matrixx Initiatives to stop marketing three products that contain zinc gluconate: Zicam Cold Remedy Nasal Gel, Nasal Swabs, and the discontinued Swabs in Kids' Size. In order for the drugs to be marketed again, the FDA requires they be tested for safety and benefit like other conventional drugs.

Are homeopathic remedies like Zicam effective? Many people swear by them, but is it essentially having a “placebo effect” on them? This writer is highly skeptical of these remedies, but, as long as they are essentially “harmless”, it is effectively just a situation of folks’ throwing away good money on these “remedies”. When the harm shifts from merely economic to real health problems, however, then a true harm to society may be occurring. The latter result may be indicative of a systemic problem requiring some form of intervention and oversight. Because of the number of issues that have arisen over the past decade or so with supplements and remedies, it seems as if we may be seeing a systemic problem, compounded by the greed of manufacturers producing and marketing these products.

Originally posted at InjuryBoard by Greg Webb

Dangerous Drug-Resistant Staph Germ (MRSA) Rising in Children ENT Infections

Greg Webb — Mon, 09 Feb 2009 08:00:00 GMT

Researchers have found an alarming increase in the number of children’s ear, nose and throat infections nationwide, which are caused by dangerous drug-resistant staph germs, nicknamed MRSA. These infections can include ear and sinus infections, and abscesses that can form in the tonsils and throat. Other studies have found the number of skin infections in adults and children has also risen due to MRSA, though the recent study of ear, nose and throat infections is the first to find how common the germ is in deeper tissue infections of the head and neck. MRSA can cause life-threatening invasive infections and because of the germ not responding to penicillin-based antibiotics, doctors are scared it is becoming resistant to other antibiotics as well. Doctors believe the inappropriate use of antibiotics has contributed to the rise.

MRSA head and neck infections most often develop in MRSA carriers, who become susceptible to the germ because of ear, nose or throat infections caused by some other bug. The germ can be picked up in normally healthy people through direct skin-to-skin contact or contact with surfaces contaminated with the germs from cuts or other open wounds. Unlike cold and flu bugs, MRSA germs are not airborne and do not spread through sneezing. Symptoms that it could be MRSA include ear infections that drain pus, or swollen neck lymph nodes caused by pus draining from a throat or nose abscess.

The study, which took results from a national electronic database collected from more than 300 hospitals, found 21,009 pediatric head and neck infections caused by staph germs from 2001 to 2006. The percentage that was caused by hard to treat MRSA bacteria more than doubled during that time from twelve percent to twenty-eight percent. While MRSA infection were once limited to mostly hospitals and other health-care settings, almost sixty percent of the MRSA infections are believed to have been contracted outside of a hospital setting.

Originally posted at InjuryBoard by Greg Webb