Charlottesville Personal Injury Lawyer

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

FDA Panel Decides Acetaminophen Doses Should Be Changed

Greg Webb — Tue, 30 Jun 2009 22:07:43 GMT

On Tuesday, June 30, 2009, thirty-nine government safety experts, who were assembled by the Food and Drug Administration (FDA), recommended ways to reduce deadly overdoses of acetaminophen, which is the leading cause of liver failure in the United States. This liver failure sends about 56,000 people into the emergency room causing about 200 deaths each year. Due to these staggering numbers, the panel called for sweeping safety restrictions on the most widely used painkillers, including decreasing the maximum dose of Extra Strength Tylenol from eight pills of medication to a not yet determined amount and endorsed limiting the maximum single dose from 1,000 mg, or two tablets, to 650 mg; the 1,000 mg dosage should only be available by prescription.

The panel also narrowly voted to eliminate prescription drugs that combine painkilling ingredients with acetaminophen, such as Percocet and Vicodin, citing sixty percent of acetaminophen-related deaths are related to the prescription products. Some panel members, however, disagreed with this decision because so many Americans deal with chronic pain and depend on the medications. If these drugs stay on the market, members of the panel ask that the drugs’ label carry a black box warning, which is the most serious safety label available.

Drug companies avoided the most damaging potential outcome after the panel decided that over-the-counter cold medications, such as Nyquil and Theraflu, which combine other drugs with acetaminophen, could stay on the market. Though these drugs can be dangerous when taken with Tylenol or other drugs containing acetaminophen, the FDA claims they only cause about ten percent of the acetaminophen-related deaths.

Although the FDA is not required to follow the advice of its panels, it usually does. Many doctors believe this is the opportunity to save a lot of people from inadvertent overdoses. For example, college sophomore Madalyn Byrne died after taking eight Tylenol a day for a week due to a toothache. Madalyn’s mother believes that had the bottle said to take four tablets a day instead of eight, her daughter would still be alive.

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

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

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

Alarming Data in the Amount of Children Injured While Playing Baseball

Greg Webb — Mon, 22 Jun 2009 08:00:00 GMT

While baseball may seem to be a fairly safe sport, researchers have found that over a thirteen year period, more than one and a half million players under eighteen years of age were injured enough to be treated in emergency rooms. Although it is unclear how many children are involved in the sport, the Consumer Product Safety Commission (CPSC) claims there are about six million in leagues and another thirteen million playing baseball on their own.

Researchers discovered this alarming data after analyzing a nationally representative sample of emergency room visits from baseball-related injuries during the years 1994 to 2006 using data that was gathered by the CPSC. Though most of the injuries were minor and more than ninety-eight percent were treated in the emergency room and released, 24,350 required hospitalization, mostly due to fractures and concussions.

The data has shown a decline in the amount of injuries from 147,357 in 1994 to 110,602 in 2006 possibly due to improvements in equipment. For example, the most common injuries were caused by children being hit by the ball, however, the now softer safety balls have been offering more protection. A separate study has also shown there have been no facial injuries to batters wearing helmets with face guards. Doctors hope there can also be a change to encourage children to wear mouth guards while playing the sport for added protection.

It seems clear to this writer that the improvements in safety equipment have helped to reduce injuries. Having played baseball as a young man from age 7 to 18, when we did not use batting gloves and wore metal spikes, it is nice to see the game is a bit safer than in the "old days" when I played. But, for traditionalists, it may be shocking to see a young person going to bat with a helmet and face mask, and hitting a "safety ball". I guess it depends upon the angle from which you view the situation, but it is hard to argue with the above numbers.

Originally posted at InjuryBoard by Greg Webb

Johnson & Johnson Under Fire Over Baby Products

Greg Webb — Fri, 19 Jun 2009 13:46:52 GMT

The Campaign for Safe Cosmetics, a coalition of health, environmental and consumer groups, is demanding that Johnson & Johnson remove tiny amounts of two chemicals, which are believed to cause cancer, from their baby shampoo and other products. They are asking the company to reformulate its personal care products so that by the end of August the products can be free of 1,4-dioxane and any preservatives that release formaldehyde. According to the Food and Drug Administration (FDA), these two chemicals are probable carcinogens; formaldehyde is also an eye, skin and respiratory irritant. The Campaign for Safe Cosmetics believes the shampoo marketed as the number one choice for hospitals should not contain possible carcinogens.

In tests run by the campaign, an independent laboratory found the shampoo contained about 210 parts per million of formaldehyde. About two dozen other products out of forty-eight tested had similar or even higher levels. The shampoo also had low levels of 1,4-dioxane, which has been banned by the European Union. The chemical was found in three Aveeno baby wash products made by Johnson & Johnson, Johnson's moisture care and oatmeal baby washes, and about twenty-five baby and personal care products made by other companies. The campaign claims there are no safe levels of carcinogens. They also note the fact that these chemicals are not listed on the products labels because they are contaminants, not ingredients. In a letter to Johnson & Johnson’s chief executive, the campaign states many other companies make similar products by using ingredients with no contamination concerns. It is also noted that Johnson & Johnson does not include formaldehyde in the same products sold in Japan since it is banned in that country. Because the FDA does not regulate cosmetic products, the same has not been done in America.

Johnson & Johnson claims the figures the organizations are using can result from making the products safe from bacteria growth and gentle for the use of babies. They further claim many global regulatory agencies consider these trace levels found by the Campaign for Safe Cosmetics to be safe. Johnson & Johnson claim to take concerns about their products very seriously and would consider meeting with the campaign, though they have no plans to remove the two ingredients from their products.

Originally posted at InjuryBoard by Greg Webb

GM Asbestos Claimants Seek Formal Panel in Bankruptcy

Greg Webb — Fri, 19 Jun 2009 13:37:39 GMT

Asbestos-injury claimants have asked for an official committee in the General Motors bankruptcy case, saying that the plan to sell the corporation might be unconstitutional since they’ve been excluded from the negotiations.

Lawyers for the claimants stated in a filing with the U.S. Bankruptcy Court in New York that the authority to approve GM’s plan to sell its assets would be limited without the participation of future asbestos claimants. The filing argued that there are due process concerns that limit the court’s ability to enter an order binding the rights of unknown future claimants in a reorganization of which they are unaware and in which they have not been appointed a legal representative.

Creditors are fighting the spinoff of Chrysler LLC’s core business to a new company owned 20 percent by Fiat SpA. Detroit-based GM has said in regulatory filings that its liability for asbestos-related legal claims was $648 million in 2008 and $637 in 2007. The claimants’ filing said that the magnitude of GM’s asbestos liability has been public knowledge and should have been considered by both the auto corporation and the Auto Task Force in their restructuring activities. Spokeswoman for GM Europe Karin Kirchner declined to comment.

The U.S. Trustee appointed an official committee of GM’s unsecured creditors last week, including two people suing GM for asbestos exposure and product liability. The automaker filed for Chapter 11 protection on June 1. Under U.S. bankruptcy law, companies with asbestos-related liabilities can funnel legal claims into a trust, although lawyers’ bills and costs of official committees in bankruptcy cases are paid by the company.

The GM case is In Re General Motors Corp, 09-50026, U.S. Bankruptcy Court, Southern District of New York (Manhattan).

Originally posted at InjuryBoard by Greg Webb

Zicam Cold Remedy Should Stop Being Used Says FDA

Greg Webb — Tue, 16 Jun 2009 15:14:43 GMT

The U. S. Food and Drug Administration (FDA) stated via a press release today that consumers should stop using three over-the-counter Zicam Cold Remedy products, including: nasal gel, nasal swabs and the "kids size" swabs (which were discontinued). The reason for the FDA warning is because these products can cause the loss of smell, or "anosmia", which could be permanent.

Anyone who has experienced problems after using the Zicam products should immediately contact a doctor. The loss of smell, while obviously affecting one's quality of life, can be dangerous as well, eliminating one of the senses that protects us from danger.

The FDA does not officially have oversight power over Zicam's manufacturer, Matrixx Initiatives out of Arizona, because Zicam is considered a "remedy" rather than a drug. This is further evidence of the need to regulate the herbal remedy and supplement industry, which may be a ticking timebomb waiting to go off. The fact that these manufacturers have what amounts to a blank check with regard to the products they produce is astounding, not to mention many of the claims they make regarding their products.

Matrixx claims that Zicam is safe and that the allegations are "scientifically unfounded and misleading". Matrixx concedes that about 130 consumers have reported loss of smell since 1999 after using Zicam products.

Originally posted at InjuryBoard by Greg Webb

FDA Commissioner Supports Direction of Food Safety Bill

Greg Webb — Mon, 15 Jun 2009 08:00:00 GMT

The new commissioner of the Food and Drug Administration, Dr. Margaret A. Hamburg, entered the debate over how to fix the nation’s food safety system in her first appearance before Congress as commissioner recently. Dr. Hamburg told the House Energy and Commerce Subcommittee on Health that the safety legislation sponsored by several Democrats was moving in the right direction, but that the FDA would need more money to make it happen. Republicans complained about specific aspects of the measure that may go to a vote as soon as next week, highlighting the loss of the bipartisan consensus that had existed during earlier hearings.

The legislation blends provisions from bills offered by several Democrats, requiring that food manufacturers write and enact safety plans, pay an annual fee of $1,000 to the FDA, and track the distribution of all food products. In turn, the agency would be required to inspect all food facilities at least once every four years, inspecting high-risk facilities every year and a half. Dr. Hamburg noted that the registration fees will not provide enough funding to implement the legislation’s targets when evaluated realistically.

Texas Representative Joe Barton, the senior Republican on the full committee, said in March that he and the chairman of the committee, Democrat California Representative Henry Waxman, were in agreement on the subject of food safety. During the hearing, however, Mr. Barton said that the registration fees were too high and that a provision requiring food labels indicating country of origin was burdensome. He also objected to provisions that will expand the FDA’s powers, giving it the power to compel manufacturers to recall their products and subpoena manufacturing records. Mr. Waxman defended the fees as asking the industry to chip in to fund measures necessary to help avoid expensive recalls.

Pamela Bailey, president of the Grocery Manufacturers Association, told the committee that the industry was concerned about the size of the fees and their effect on the FDA’s credibility. Ms. Bailey issued a statement saying that while the industry is responsible for the safety of its products, securing the safety of the food supply is a government function which should be financed with government resources.

Dr. Hamburg also addressed the agency’s new safety review of bisphenol-A, a chemical used to harden plastics that is also known as BPA. Studies have suggested that BPA may accelerate puberty, but the agency concluded during the Bush administration that it wasn’t harmful at levels found in the American market. The FDA’s science advisory panel rejected that conclusion in October, and the new review is expected by the end of the summer.

Before the hearing, activists passed out fliers protesting increased levels of antibiotic-resistant bacteria due to the routine use of antibiotics in livestock. Dr. Hamburg said that the growing problem of antibiotic resistance was also a concern of hers. No decisions were made in this regard, however.

Originally posted at InjuryBoard by Greg Webb