Charlottesville Personal Injury Lawyer - EPA

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

Bottled Water Safer Than Tap?

Greg Webb — Sun, 19 Jul 2009 22:08:17 GMT

Members of Congress were recently briefed on two new studies that question whether bottled water is safer than tap water. Following the meeting, the Congressional committee sent letters to thirteen companies requesting more information regarding the source of their water and how it is tested. Congressman Bart Stupak, chairman of the oversight committee of the House Energy and Commerce Committee, stated neither consumers nor federal regulators know enough about the origins of the bottled water and what safeguards are in place to ensure its safety; consumers purchase the bottled water for health benefits, however, they do not know the actual quality of the water.

Though the Environmental Protection Agency (EPA) regulates tap water, the Food and Drug Administration (FDA) regulates bottled water because it is considered a food. Since 1999, the EPA requires municipalities to annually distribute reports to consumers disclosing the source of their water and any contaminants found in testing, along with the potential health risks from these contaminants. Tap water providers are also required to notify customers within twenty-four hours if the water’s contaminants exceeded federal levels; this rule does not apply to bottled water. Additionally, bottled water companies are not required to have their water tested by certified laboratories.

Two new reports from the Government Accountability Office and the Environmental Working Group, a nonprofit research organization, question whether the federal regulation is sufficient. The environmental group asks that companies that produce bottled water release the same detailed information that is required of tap water providers. Almost one-third of bottled water, for example, has no information regarding the source of the water on its labels. Some Congressmen, however, question the need for regulation on bottled water, calling it a “secondary” issue to all of the more life-threatening situations the FDA faces.

In response to the two studies, the FDA announced that by fall it would require bottlers report the results of tests displaying whether their products pose health risks. In the meantime, FDA officials say not to worry about the safety of bottled water since it is monitored and inspected.

Originally posted at InjuryBoard by Greg Webb

FDA’s Lax Investigation Leads to Shipment of Contaminated Syringes

Greg Webb — Wed, 01 Jul 2009 08:00:00 GMT

Natalie Fullerton’s parents were thrilled to see their year-old daughter recover from a double-lung transplant. Her father dutifully used fluid-filled syringes to clean a tube that doctors had implanted in her chest to deliver intravenous medication. Despite his fear, bacteria infected the toddler’s blood and she was rushed to the hospital. Four months later, Natalie died in her mother’s arms.

The syringes Mr. Fullerton had been using were part of a contaminated lot made in a factory owned by Lake Zurich businessman Dushyant Patel. That batch and another have since been linked to 4 deaths and 162 illnesses across the country. Inspection reports and other documents show that the U.S. Food and Drug Administration missed several opportunities to prevent the tainted syringes from being used.

Three months before the prefilled syringes were shipped in October 2007, an FDA inspector investigated reports of red, brown, and black particles floating in syringes. She reported that the North Carolina plant managers had a plan to deal with rust, but did not note that the plant had switched to an unreliable sterilization tactic. When the FDA learned a week later that a distributor had recalled 1.3 million syringes, it should have conducted a thorough inspection of the plant, according to its operations manual. An FDA spokeswoman reports that this didn’t happen because the agency is so understaffed that it no longer follows the policy unless the recalled product poses a reasonable probability of serious injuries or death.

Federal prosecutors zeroed in on AM2PAT President Patel. An indictment on fraud, conspiracy, and other charges alleges that his firm produced syringes laced with bacteria and lied about performing sterility tests. Two employees, one a plant manager, were sentenced in February to 4 ½ years in prison for fraud and allowing tainted drugs into the marketplace. Authorities believe that Patel fled to India and are seeking to extradite him.

Patel bought a share of the North Carolina business and took over as president in 2001. Prosecutors allege that the operation was a fraud from the start, and that the firm’s application to make syringes incorporated fake data for a test to establish shelf life of the syringes. Unaware, the FDA gave Patel permission to start production in 2003.

The firm bought empty syringes and filled them with saline or heparin, solutions designed to prevent blood clots from forming in catheters. AM2PAT then sold the syringes to distributors who marketed them to hospitals and pharmacies, earnings nearly $7 million in profits in its last two years. In March 2005, a pharmacist reported finding orange sediment floating in one syringe and spotting an inch-long hair in another. An FDA inspector spent six days in the Raleigh plant three months later, noting nine significant violations, some of which could have an adverse effect on product quality. Shortly after, the FDA sent a warning letter, but it reported in January 2006 that Patel had either fixed or promised to address the major problems. New complaints were lodged in the spring and summer of 2007, including an AM2PAT employee who claimed that management was not adhering to appropriate clean-room temperatures during manufacturing.

The FDA’s Atlanta branch scheduled an inspection for June 26, 2007, but the plant was shuttered when the inspector arrived in Raleigh. By the time an inspector located the new plant, B. Braun Medical had recalled more than 1 million syringes following reports of particles floating in the saline. Six weeks after the inspection, the FDA issued a news release on the B. Braun recall’s finding that the particles were medical-grade silicone, which is capable of causing brain damage or a deadly clot. The FDA now admits that, until reports of injuries mounted, its Philadelphia office did not communicate information about the recall to its Atlanta office.

Toward the end of October 2007, the plant shipped the contaminated heparin-filled syringes. Authorities now link four deaths to the contamination. After the CDC linked the syringes, two investigators and a microbiologist interviewed workers, dug through records, examined equipment, and studied quality control in the factory. Patel had apparently concluded that the white particles that spurred the recall were caused by the failure of a standard sterilization process involving radiation. He adopted “UV light” sterilization, which the FDA says is a non-traditional technique. An employee also told investigators that the company kept two sets of records: one revealing rushed shipments of syringes that hadn’t completed sterilization tests and another fraudulently indicating that the plant was holding syringes on-site for two weeks while chemists conducted sterility tests. Patel responded that someone was sabotaging his records.

Gordon Harnack, a consultant who helps companies prepare for inspections, reviewed more than 120 pages of FDA reports on the AM2PAT plant and concluded that inspectors didn’t look deep enough, even as contamination problems became apparent. Although the syringe case has not received the attention that followed deaths from salmonella-laden peanut paste, consumer advocates say that both breakdowns are the result of a shift from aggressive enforcement to FDA partnership with the industries it is meant to oversee.

In response, FDA Commissioner Margaret Hamburg has pledged to make product safety a top priority. She said that she believes that it is critical for the FDA to take an aggressive approach to inspections and to maintain vigilance in ensuring that manufacturers comply with regulatory, legal, and moral obligation to provide safe products. FDA spokeswoman Siobhan DeLancey had previously defended the agency’s actions, saying that they had inspected the plant multiple times on a relatively low number of complaints and that the agency worked hard to prosecute the plant managers once reports of infections came in. This prosecution came too late for the Fullerton family, however, and many affected individuals have filed lawsuits in Cook County.

Originally posted at InjuryBoard by Greg Webb

EPA Declares Public Emergency Due To Asbestos At Montana Mine

Greg Webb — Sat, 27 Jun 2009 10:23:05 GMT

The Environmental Protection Agency (EPA) has declared its first-ever “public emergency,” stating the federal government will give $6 million to the health authority in Lincoln County, Montana to provide medical care to people who were sickened by asbestos from a mine. The money is intended to pay for what insurance will not, and cover the medical bills of people without insurance. The declaration applies to the towns of Libby and Troy, where for decades workers in the town mined for vermiculite, a mineral used in insulation. Unknowingly, the workers were poisoning themselves because the vermiculite contained a toxic form of asbestos, which the workers carried home on their clothes.

Although the two towns’ combined population is only 3,900, the Department of Health and Human Services estimates about 500 residents have asbestos-related illnesses such as lung cancer and asbestosis. A department spokesperson estimates fifty new cases are diagnosed every year, including some in family members who never stepped foot in the mine. Senator Jon Tester of Montana claims no family in the area has escaped exposure.

The EPA’s announcement came about six weeks after a Montana jury acquitted the chemical company W.R. Grace and three of its executives on charges that they withheld important information regarding the dangers of the mine. W.R. Grace ran the mine from 1963 until it closed in 1990, though vermiculite had been removed from the mine since the early 20^th century. Although the Department of Health and Human Services has spent about $46 million in the past ten years for diagnostic screening programs and paying to improve health care, the new $6 million is to be given directly to patients.

Originally posted at InjuryBoard by Greg Webb

Heparin Product Investigated In Deaths

Greg Webb — Wed, 20 May 2009 08:00:00 GMT

Baxter International Inc. has admitted medical care providers at a hospital in Delaware, as well as United States health officials, are investigating whether the deaths of two patients were caused by a brand of heparin blood thinners that Baxter sells in pre-mixed intravenous bags. Officials at the Beebe Medical Center in Delaware have suspended the use of Baxter’s heparin, a diluted form contained in pre-mixed bags used for a variety of blood thinning purposes, due to adverse reactions reported in five patients, such as internal bleeding in the brain.

These pre-mixed bags are different from the vials of heparin that were recalled last year. For example, the bags came from a United States manufacturer unlike the dangerous heparin that came from the China-based supply chain; in this incident, the active ingredients were supplied by Pfizer Inc. Results of product testing from the Food and Drug Administration (FDA) and Baxter have revealed no problems and Baxter claims no similar incidents have been reported. The FDA further believes the situation was an isolated incident.

Originally posted at InjuryBoard by Greg Webb

AP Report Shows Pharmaceuticals Tainting Drinking Water

Greg Webb — Mon, 27 Apr 2009 08:00:00 GMT

According to an investigation by the Associated Press, U.S. manufacturers, including drugmakers, have legally released at least 271 million pounds of pharmaceuticals into the waterways that often supply drinking water. Hundreds of pharmaceutical ingredients are used in drug manufacturing. For example, copper, which is also used in piping, is also used in contraceptives; nitroglycerine, which is used in explosives, is a heart drug.

Federal and industry officials say they do not know the extent to which manufacturers release the pharmaceuticals because no one tracks them. An analysis of about twenty years of federal data, however, found the government does unintentionally keep data on a few. Twenty-two of the compounds showed up on lists compiled by the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). The EPA classifies them as industrial chemicals released into water under federal pollution laws, while the FDA monitors them as active pharmaceutical ingredients.

It is unknown how much of that 271 million pounds comes from drug manufacturers versus other manufacturers. Researchers claim the lack of testing has created a “don’t ask, don’t tell” policy regarding whether drugmakers are contributing to the pollution. Drugmakers have insisted that their manufacturing does not significantly contribute to what is being found in the water. Federal drug and water regulators concur, although there have been trace amounts of a wide variety of pharmaceuticals in drinking water, such as antibiotics, mood stabilizers and sex hormones.

Originally posted at InjuryBoard by Greg Webb

Manufacturer of Lexapro - Forest Laboratories - Accused of Fraud

Greg Webb — Wed, 11 Mar 2009 12:28:39 GMT

The Justice Department has charged drug manufacturer Forest Laboratories with defrauding the government of millions of dollars after it, allegedly, illegally marketed popular antidepressants Lexapro and Celexa for unapproved uses in children and teenagers. Lexapro is Forest Lab’s biggest seller, with total sales of $2.8 billion in 2008. In the civil complaint, filed by the United States Attorney’s office in Boston, prosecutors claimed that for many years, former top executives of the company concealed many clinical studies that showed the drugs were not effective in children and may even cause some to become suicidal. Although current rules demand companies provide the results of all clinical trials, the trials of Lexapro and Celexa date to before these rules were in place.

Prosecutors also claim Forest Labs provided kickbacks, such as baseball tickets and gift certificates to expensive restaurants, to physicians who prescribed the drugs. Though it did not specify a figure, the government is attempting to recover three times the amount of money spent by federal programs to pay for pediatric prescriptions of the two drugs.

From 2001 to 2004, Forest Labs heavily publicized the clinical research that showed the drugs were effective; it did not disclose the negative clinical trial results within the company or to outside researchers. Prosecutors claim that by this failure to disclose negative results, the company told a half-truth to doctors who prescribe the medication. While it is legal for doctors to prescribe medication to patients, including children, for whom the drugs are not yet approved by regulators, it is illegal for companies to advertise these uses.

Lexapro and Celexa are forms of the drug citalopram. The Food and Drug Administration (FDA) currently approves the use of the drugs for adults only, though doctors still widely use these drugs to treat children. Now, however, these drugs, including Lexapro and Celexa, carry a "black box" warning that states the drugs may create suicidal thoughts or behavior in children. Forest Labs does not currently have a comment regarding the situation.

Originally posted at InjuryBoard by Greg Webb

End of 2008 Brings A Burst of Settlements With Justice Department

Greg Webb — Sun, 25 Jan 2009 18:52:49 GMT

Since the presidential election, the Justice Department reached more than a dozen business-related settlements. There are also more in the pipeline for this month (January 2009), which prompted interest groups and lawyers to claim that companies were rushing to seek more favorable outcomes before the new administration took over. Corporate lawyers say the climate for business settlements is to be much more harsh under President Obama’s appointees as they take charge of the Justice Department. For example, the Attorney General-designate told an audience he would expand the concentration of federal prosecutors into corporate suites.

Three lawyers, who regularly represent companies before the Justice Department, began to take notice of the increase after the November 4 election. An examination of fifteen agreements involving corporations since early November alleges that a majority of the misconduct dates back five years or more. This makes many wonder why the cases took so long to mature and why resolutions were finally being made only weeks before the Bush administration was out of office. They assume companies were trying to take advantage of an administration that was more favorable to business, and push the settlements through between Christmas and New Years while no one noticed. Siemens, for example, decided to pay $450 million in criminal fines, which would allow it to still be eligible to bid on and win U.S. government contracts.

The Justice Department, however, claims there is nothing unusual about end-of-year settlements. A spokesman asserts the department makes its enforcement decisions solely on the facts of the investigation and the law; an examination of previous months and years shows a steady stream of cases that have been resolved through a settlement or plea agreement and that it is not unusual for parties to resolve their matters before the end of the year. Since November, the Justice Department has announced nineteen settlements or plea deals with companies, compared with sixteen in the same time frame during this time period in 2007 and five in 2006.

Two other explanations for the spike, pointed out by corporate attorneys and interest groups, were companies not wanting to ruin their reputation during the holiday season and government attorneys wanting to complete big cases before they left for private-sector work.

Originally posted at InjuryBoard by Greg Webb