Charlottesville Personal Injury Lawyer - problems

Post-LASIK Problems Underplayed and Unreported

Paul Thomson — Thu, 22 Oct 2009 12:24:29 GMT

Aggressive marketing has made the well known vision correction surgery known as LASIK surgery (laser-assisted in situ keratomileusis) a $2 billion industry, with it coming under fire for overstating the benefits of the surgery and downplaying its risks. As many as 75,000 patients a year are estimated to have lasting post operative problems including poorer vision and even blindness! Even more alarming is that the FDA has recorded only a tiny fraction of these problems. From 1998 to 2008, the agency admitted that it had received only 140 reports of post operative problems!!! Clearly, these problems are not getting recorded effectively.

The FDA issued reminders on the need to record adverse results to clinics offering the surgery after they discovered that many did not have systems to do so. Poor results include dry eye, poorer vision, halos, glare, and sometimes blindness. Not only is there insufficient data to confirm the estimated 75,000 patients experiencing these results, but the existence of such complications is often downplayed by marketing schemes.

This has led three federal agencies, the Food and Drug Administration, Defense Department, and National Eye Institute, to develop a plan outlined in this article. The plan starts with the FDA creating a website for patients to report results, followed by the Defense Dept. measuring how many active-duty military patients had poor results, and ending with a larger study of patients to determine how many had postoperative problems. The plan will end in 2012 and officials hope this more accurate data will help improve the surgery in the future.

Originally posted at InjuryBoard by Paul Thomson

Popular Contraceptives Raise Health Concerns

Greg Webb — Thu, 08 Oct 2009 07:00:00 GMT

Oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer Healthcare, largely because the products’ marketing presents them as much more than just pregnancy prevention. In fact, the franchise had worldwide sales of $1.8 billion last year, based on Bayer successfully positioning the brands as the go-to medication for women under the age of thirty-five. Yaz, which contains less estrogen than Yasmin, is the top-selling birth control pill in the U.S., garnering much of its popularity from a multi-million dollar ad campaign that promotes the drug as one that combats acne and severe pre-menstrual depression.

Recently, however, the Yaz franchise has faced criticism from several researchers, trial lawyers and health advocates who fear the drugs place women at a higher risk for developing blood clots, strokes and other health problems, as opposed to other birth control medications; because the drug contains drospirenone, which can increase potassium levels in the body, it may put women who have liver or kidney problems at risk for serious heart problems. The critics of Yaz are up against a recent European study, sponsored by Bayer, which reported the opposite conclusion. This study claims the cardiovascular risks in women taking Bayer products that contain drospirenone were the same as those taking an older formula of birth control pills that contain levonorgestrel. One doctor, who is a paid consultant for Bayer, claims the risk of developing blood clots is far less in taking birth control pills than being pregnant and having a baby.

Despite Bayer’s report, regulators and other scientists are finding other problems with the company. For example, two other studies on Danish and Dutch women did find a higher risk of venous blood clots for women taking newer progestins, including drospirenone. One of the doctors who authored the Dutch study says the reports of an increased risk were worth acting on by switching the pills from drospirenone to levonorgestrel; he said, "Even if the risk of thrombosis is low, why not choose the lowest risk, just in case?" Earlier this year, the Food and Drug Administration (FDA) also asked Bayer to correct misleading television commercials that overstated the drug’s efficacy, promoted it for conditions for which the drug is not approved and minimized serious risks associated with the drug. In September, the FDA also cited the company for failing to follow proper quality control procedures at a German plant that makes drospirenone and other hormone ingredients

Attorneys suing Bayer on behalf of patients who claim they developed blood clots and other health problems due to the drugs are arguing the company knew or should have known the pills created a higher risk. One such patient has lost partial function in her right lung after developing a blood clot from the birth control pill; she claims to have not known there was a higher risk using Yaz than any other birth control pill. Because Yaz and Yasmin contain warnings on their packages about the risk of side effects like blood clots and strokes, it may be hard for plaintiffs to win lawsuits. The one ray of hope may be the argument that due to misleading Yaz commercials, women were enticed to take the drug, thereby becoming exposed to health risks they may not have otherwise incurred.

In response to a reporter’s inquiries, Bayer stated its birth-control pills had been and continue to be studied extensively and the company stands behind their safety. The drugmaker also claims to have responded to the FDA’s inquiry into its manufacturing practices. Even if Bayer can adequately respond to the safety and other concerns, some industry analysts believe the outpouring of criticism may tarnish Yaz’s line image. Bayer said it has been served with seventy-four lawsuits brought by women who claim to have developed problems after taking Yaz or Yasmin; the company says it will defend itself vigorously against the allegations. While the lawsuits may rattle some consumer confidence, the warnings from federal health authorities concerning quality control and advertising raise larger questions regarding Bayer’s compliance with government rules.

Originally posted at InjuryBoard by Greg Webb

Toxic Water Is Major Problem In US Cities

Greg Webb — Thu, 17 Sep 2009 21:32:54 GMT

Residents in an area near Charleston, West Virginia have started to avoid contact with tap water after scabs began developing on their arms, legs and chests where the bathwater, which is polluted with lead, nickel and other heavy metals, caused painful rashes. The residents also began complaining of increased health problems, such as losing the enamel on their teeth, gall bladder diseases, fertility problems, miscarriages and kidney and thyroid issues. Tests have shown tap water contains arsenic, lead, magnesium, barium and other chemicals at concentrations that federal regulators say could contribute to cancer and damage to the kidneys and nervous system. A survey of more than 100 residents conducted by a nurse, who was hired by a lawyer representing a resident in a lawsuit regarding the dangerous water quality, indicated that as many as thirty percent of people in this area have had their gallbladders removed, and as many as half the residents have significant tooth enamel damage, chronic stomach problems and other illnesses.

The contamination began when nearby coal companies began pumping sludge, or leftover liquid used to wash coal of its impurities, into the ground, contaminating ground water. According to state reports, the companies injected about 1.9 billion gallons of waste into the ground since 2004; millions of gallons were also dumped into lagoons. These injections have contained chemicals at concentrations that pose serious health risks and break not only the federal law but state laws as well. Sometimes these amounts exceeded the imposed limit by as much as one thousand percent. Due to the dangers posed by the water, two hundred and sixty people sued nine nearby coal companies, accusing them of putting dangerous waste in local water supplies. It is very hard to hold a company responsible, however, since it is hard to tell what company put which contaminants in the ground and caused the most problems. As required by state law, some of the coal companies had disclosed in reports to regulators that they were pumping illegal concentrations of chemicals, the same pollutants that flowed from residents’ taps, into the ground; state regulators did not punish the companies, however, for breaking these pollution laws, nor were they warned that their activities had been noticed. When asked why the illegal activity had been ignored, West Virginia officials said the issue was accidently overlooked but their studies suggest the contamination would not have affected drinking water in the area.

This pattern is unfortunately not limited to West Virginia. According to a study in the scientific journal Reviews of Environmental Contamination and Toxicology, an estimated 19.5 million Americans become ill each year from drinking water that contains parasites, bacteria or viruses. This figure does not include illnesses caused by contaminants or toxins. About forty years ago, Congress passed the Clean Water Act as a way to force polluters to disclose the toxins they dump into bodies of water and to give regulators the power to fine or jail offenders. Many states also passed their own versions of the law, though an extensive report by the New York Times showed violations of the act have risen steadily across the nation. For example, since 2004, manufacturing plants, chemical factories and other workplaces have violated water pollution laws more than half a million times. This number only accounts for violations reported by the companies themselves; illegal violations would increase the figure dramatically. These violations include failure to report emissions to dumping toxins that regulators fear may cause birth defects, cancer and other illnesses. Though some of the violations were minor, about sixty percent of the polluters were deemed in “significant non-compliance”, meaning their violations were the most serious kind, for example dumping cancer-causing materials into the water. The report also showed that only three percent of the polluters have faced punishment from either the state or the Environment Protection Agency (EPA), which can prosecute polluters when states fail to act. The EPA has faced scrutiny following the dissemination, through leaks and the Freedom of Information Act, of memos labeled “DO NOT DISTRIBUTE”, which showed federal regulators were aware that more than thirty states had companies that were violating pollution laws. Another memo showed the EPA was aware that the “states’ personnel lack direction, ability or training” to levy fines large enough to deter and punish polluters. Still, other memos explained that the agency was not going to correct the problems out of fear that it would risk its relationships with the states.

Many state and federal legislators claim they had no idea the pollution was so widespread and have vowed to make appropriate changes. In one controversial case in West Virginia, however, a state official attempted to close polluted mines and was then fired from his job, creating a bureaucracy clambering for job security. Since this time, hundreds of workplaces in West Virginia have violated pollution legislation without paying fines. Six current and former employees said their enforcement efforts had been undermined by bureaucratic disorganization, a departmental preference allowing polluters to escape punishment if they promise to try harder, and a revolving door of regulators who leave for higher-paying jobs at the companies they once regulated. Many state officials are defending their efforts, pointing out that there has been a ten percent increase in the number of cease-operation orders issued by regulators from 2006 to 2008.

Since it is difficult to determine what pollutants cause diseases like cancer, it is impossible to know how many illnesses are caused by water pollution or the contaminants’ role in the health problems of specific individuals. However, concern over contaminants are great enough that the EPA and Congress regulate more than one hundred pollutants through the Clean Water Act and strictly limit ninety-one chemicals or contaminants in drinking water through the Safe Drinking Water Act. Lisa P. Jackson, the new EPA administrator, has acknowledged the fact that despite the Clean Water Act’s many successes, the nation’s water does not currently meet public health goals. She also recognizes the enforcement of water pollution is very low, but has made it one of her top priorities to strengthen water protections and pressure states to enforce the law; state officials claim they are doing all they can with the limited resources provided.

Though the number of regulated facilities has more than doubled in the last ten years, many state enforcement budgets have remained basically flat when adjusted for inflation. For example, in New York, the number of regulated polluters has almost doubled to 19,000 in the last ten years, but the number of annual inspections has remained about the same. Limited state budgets are only part of the problem. The New York Time’s investigation also found that in states, such as West Virginia, with powerful industries, the companies lobby for and are awarded relaxed regulation. State officials also point out that water pollution statistics include minor, non-life threatening infractions, such as failing to file reports.

The New York Times research was turned into a database, and can be accessed at http://www.nytimes.com/toxicwaters. That research showed an estimated one in ten Americans have been exposed to drinking water that contains hazardous chemicals, including carcinogens, or fails to meet a federal health benchmark in other ways; wells, which are not typically regulated by the Safe Drinking Water Act, are more likely to contain dangerous contaminants than municipal water systems. The research also showed that last year, forty percent of the nation’s community water systems violated the Safe Drinking Water Act once. The violations ranged from failing to maintain proper paperwork to allowing carcinogens into tap water. Therefore, more than 23 million people received drinking water from municipal systems that violated a health-based standard. Following this study by the Times, West Virginia officials have declared a statewide moratorium on issuing injection permits and told some companies that regulators were investigating their injections.

Lawmakers and environmental activists claim the best solution to the problem is for Congress to hold the EPA and states accountable for their failures. They also believe the Clean Water Act should be expanded to police other types of pollution, such as farm and livestock runoff, since they are largely unregulated and the government should give state agencies more resources. Many experts do not believe major change will happen, however, until there is a large public outcry.

Unfortunately, the people usually affected by these polluters, these large, powerful, corporate interests, are people who do not have the means to combat the power and money arrayed against them. That is precisely why, in many instances, the polluters located and dumped in the locations they did - because they believed they could get away with the behavior. And, in many cases, they have gotten away with it, with the exception of a slap on the wrist - a fine that amounts to little more than lunch money for many of these corporations.

Originally posted at InjuryBoard by Greg Webb

Popular Dietary Supplements Alleged to Contain Steroids

Greg Webb — Wed, 12 Aug 2009 10:46:31 GMT

Federal authorities filed court papers last month alleging that two over-the-counter dietary supplements commonly used by high school football players contain steroids. Tren Extreme and Mass Extreme, manufactured by American Cellular Labs, are marketed as a potent legal alternative to steroids. However, search warrants were executed alleging that the supplements contain illegal designer steroids including Madol, a substance first identified six years ago during the investigation into the Bay Area Laboratory Co-operative.

Authorities say that Max Muscle, a supplement store with approximately 100 locations across the country, paid American Cellular Labs to be the exclusive retailer of these products, which are also available online.

An individual at Max Muscle’s corporate office said that no one was available to comment on how many of the company’s stores carried American Cellular products. A Max Muscle outlet in Iowa was offering an online promotion of Tren Xtreme for free, but a salesman reported that the store no longer sold the brand.

Travis Tygart, head of the United States Anti-Doping Agency, said that the substance helps athletes quickly gain strength and muscle mass and is popular amount high school football players because it works. He did not offer an estimate regarding how many high school athletes have used the product.

The investigation into American Cellular Labs is led by Jeff Novitzky of the FDA and prosecutors from the U.S. attorney’s office for the Northern District of California. Novitzky has been the face of the government’s investigation into the distribution of performance-enhancing drugs since 2002.

The FDA has jurisdiction over dietary supplements, which are defined as products that offer general health benefits but do not claim to treat specific conditions. Manufacturers of dietary supplements are responsible for recording and ensuring the accuracy of the claims that they make regarding the safety and efficacy of their products. The FDA is only empowered to act in cases when it identifies a harmful or adulterated product on the market. If authorities find that a supplement contains an undeclared pharmaceutical ingredient like a steroid, the product is considered to be an illegal drug.

Steroids are naturally produced organic compounds that can be used legally to treat conditions like testosterone deficiency. Athletes have also used illegal forms of steroids for performance enhancement. Such usage is particularly concerning in preteen and teenage boys, because artificially high levels of testosterone can stop bone growth.

Investigators first became concerned about products made by American Cellular Labs after reports of severe liver and kidney problems in people who had used the two products. In one case, a liver transplant doctor reported that a 38-year-old male patient who had used the products had to be hospitalized with severe liver dysfunction and acute kidney failure which required dialysis.

While legal steroids entail risks, unknowingly taking supplements that contain illegal compounds is even riskier because the drugs come with unknown risks, according to Dr. Pieter Cohen of the Harvard Medical School. When prescribing similar drugs for men who have a deficiency, doctors closely monitor patients to avoid higher-than-normal hormone levels, but designer steroids have not been studied for safety. Cohen added that while there is no research showing that the new compounds are safe in humans, there is evidence that analogs of pharmaceutical compounds have let to life-threatening diseases that required transplantation in the past.

Originally posted at InjuryBoard by Greg Webb

Lawyers Sinking Their Teeth Into Denture Cream Lawsuits

Greg Webb — Thu, 25 Jun 2009 08:00:00 GMT

Attorneys representing injured consumers are filing product liability suits alleging that denture cream use causes zinc buildup and neurological problems. A dozen cases in federal courts in California, Colorado, Florida, New York, Ohio, Oklahoma, Pennsylvania, and Tennessee target Poligrip manufacturer GlaxoSmithKline PLC, Fixodent manufacturer Procter & Gamble Co., and the companies’ subsidiaries. The cases are currently awaiting the result of a multidistrict litigation panel hearing that took place in Louisville, Kentucky on May 28.

Florida attorney Scott Weinstein, managing partner of Morgan & Morgan’s consumer class action and mass tort department, filed the motion to consolidate the cases on behalf of clients Ronald and Alice Beaver in the Southern District of Florida. Plaintiff Ronald Beaver’s claims include strict products liability and negligence, and Alice Beaver’s claim includes loss of consortium. Weinstein reports that his firm has begun screening more than 3,000 potential cases and is currently ready to pursue approximately 40. He also adds that while elderly people use denture cream to adhere dentures, younger people also use it for devices like bridges.

Morgan & Morgan is working closely with New York-based Parker Waichman Alonso and The Arnold Law Firm in Sacramento, who collectively have another 75 cases to pursue once the multidistrict litigation forum issue is settled.

Weinstein says that long-term use of dental cream leads to zinc buildup and neurological problems because of competition between zinc and copper to bind to receptors, which causes the body to expel excess copper. Doctors use zinc to treat patients with Wilson’s disease, a genetic disorder that causes copper buildup in the tissues, but had not realized that some problems could be traced to zinc buildup from the use of denture cream. He emphasized that we need to educate consumers to see if they are using a dental cream that contains zinc.

Procter & Gamble issued a statement saying that all Fixodent products undergo rigorous scientific evaluations and safety testing and use generally safe levels of zinc. It estimated that the amount of zinc a person would ingest through daily use of Fixodent is approximately equal to six ounces of beef. P & G also said that zinc is a common ingredient in many over the counter products and is such a vital part of our diet that zinc supplements are commonly sold.

Originally posted at InjuryBoard by Greg Webb

Medtronic Heart Device Linked To a Possible Thirteen Deaths

Greg Webb — Mon, 06 Apr 2009 08:00:00 GMT

Medtronic admitted that at least thirteen people might have died in correlation with a heart device, known as Sprint Fidelis, that it recalled in 2007 but was still in widespread use. This number includes four patients who died while surgeons were attempting to remove the product and is the first new data to reflect fatalities since the device was first recalled; the other nine deaths may be tied to the device’s failure to work properly. The Food and Drug Administration (FDA) has also said it received about 2,200 reports of serious injuries related to the device. The heart device is a thin electrical cable that connects an implanted defibrillator to the patient’s heart. It was recalled due to fractures in the cable that may cause the defibrillator to fire for no reason or fail to deliver a life saving shock to a patient’s irregular beating heart. Presently about 150,000 patients still have the Sprint Fidelis leads in their bodies.

A previously disclosed Food and Drug Administration (FDA) report shows Medtronic began receiving reports about the problem in 2004, three years before they declared a recall; they even conducted their own internal investigations. This report is based on a visit by regulators to the Medtronic facility soon after the device was taken off the market, where officials interviewed executives and reviewed records. The company also changed their manufacturing process in the months leading up to taking the device off the market. A top Medtronic official, however, claims this “acute” change had nothing to do with the recall and even at the time of the recall, internal data did not suggest the device was fracturing at higher rates than other company leads.

By 2006, it is believed Medtronic knew there was a problem. The timeline regarding exactly when Medtronic knew about the problems with Sprint Fidelis could be a significant factor if patient lawsuits begin again. The Supreme Court recently agreed that patients may not sue device manufacturers whose products were approved by the FDA, however, new legislation introduced by Democrats in Congress may nullify this decision.

Originally posted at InjuryBoard by Greg Webb

Peanut Salmonella Outbreak Reveals Inspection and Regulatory Problems

Greg Webb — Sun, 15 Feb 2009 18:20:58 GMT

The salmonella outbreak which occurred at the Georgia peanut plant Peanut Corporation of America (PCA) has caused eight deaths and sickened almost 19,000 people in 43 states. While the company, based in Lynchburg, Va., is under criminal investigation, the outbreak identifies a broader problem with thestate and federal regulatory system currently in place.

The plant had a number of health and safety issues, which would have been enough to alert inspectors to problems. Those issues included raw peanuts being stored next to the finished peanut butter, the roaster not being calibrated to kill deadly germs, workers donning their uniforms at home, potentially bringing contaminants into the plant, and rodents in the plant. The roof of the Georgia plant also leaked, giving salmonella water in which to thrive.

In addition to the obvious physical conditions of the plant, PCA’s own tests had found salmonella 12 times since 2007. The FDA accused the company of repeatedly shipping peanut butter and other products right after discovering salmonella; the agency had previously stated that PCA held the shipments until a second test for salmonella came back negative.

State and federal inspectors do not require the peanut industry to report salmonella contaminations to the public or the government.

Georgia was responsible for inspecting the plant, however state inspectors said their duties were hampered by budget cuts and rising needs. The state ran tests for salmonella on three samples from the plant in 2007, and none in 2006 or 2008. The last state inspection in October 2008 found two problems: mildew and dust in a storage room and the reuse of shipping bags.

While state inspectors did not find many problems, federal investigators last month found many, including salmonella living on the plant floors. A federal report shows that plant managers had not decontaminated the peanut butter processing line after detecting salmonella.

Georgia regulators said they will try to change state laws to require more disclosure of food safety tests. But Dr. Steven M. Solomon, an official in the federal agency’s Office of Regulatory Affairs, said such disclosures may be a "double-edged sword" that might prevent companies from testing in the first place.

Some people are questioning why stricter regulations weren’t put in place after a salmonella outbreak in ConAgra Foods’ Peter Pan peanut butter in 2007. A whistleblower reported that the company had found salmonella in its peanut butter produced at its plant in Sylvester, Ga. back in 2004, but the FDA did not pursue records after the plant refused to release the tests. After hundreds of people were sickened three years later, the FDA finally demanded the records. ConAgra spent $33 million to clean and improve its Georgia plant conditions and implement 80 rules employees must follow before beginning work. It has not, however, stated that it would notify the FDA if it found salmonella again.

David Marshall’s mother was one of those sickened by Peter Pan peanut butter back in 2007, and his wife testified before Congress. After hearing a congresswoman recently state that laws need to be enacted to prevent another salmonella outbreak, he thought "You idiot. What have you all been doing? The law should have been enacted years ago, and this made us wonder, what does the FDA even do?"

Originally posted at InjuryBoard by Greg Webb