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  • Risk of Uncontrolled Bleeding Higher with Pradaxa

    Posted Apr 4th, 2012 By in Pradaxa, Product Liability With | No Comments

    There were more than 500 reports life threatening bleeding from Pradaxa in early 2011. Pradaxa is a blood thinner used in patients who have “Non-Valvular atrial fibrillation”- an irregularity of the heart that increases that chance of stroke.

    The Institute of Safe Medication Practices reviews reports filed through the FDA MedWatch program. In its quarterly report they identified Pradaxa as having more problems than all the others being monitored. This is mostly because there is no current treatment in the event the patient has bleeding related to Pradaxa.

    Pradaxa Overview

    Pradaxa was released in October 2010 and is a product of Boehringer Ingelheim Pharmaceuticals. Critics are now raising questions about the clinical trials that were done prior to the products approval, due to the fact that within the first 3 months of its release there were 98.7% more reports of adverse effects than all the other drugs.

    Pradaxa was to be used in place of the usual medication Warfarin. It is thought that users of Pradaxa would require less supervision than users of warfarin. However, if there is a problem with bleeding with warfarin the problem can be treated with Vitamin K. Pradaxa related bleeding increases the risk profile because there is no treatment if that happens.

    More Pradaxa Dangers

    There is a prevalence of bleeding associated with Pradaxa, especially when used in patients with kidney problems and elderly patients. Additionally, there have been reports of pulmonary embolism and deep vein thrombosis due to blood clots, and Pradaxa failed to address it.

    In December 2011 about 14 months after Pradaxa came on the market, the FDA began a safety review of the drug. The official investigation started about a month after the Boehringer Ingelheim- the maker of the drug- started its own investigation into the drug related deaths.

    Potential Lawsuits with Pradaxa

    Pradaxa lawsuits are expected to increase in numbers in the coming months, because the manufacturers of the drug did not appropriately warn consumers about the risks of Pradaxa use. If you or someone you know has used Pradaxa and had adverse results, it is highly advisable to speak to an attorney.

  • What is Pradaxa and what are the side effects?

    Posted Apr 4th, 2012 By in Pradaxa, Product Liability With | No Comments

    The FDA approved a new prescription medication in October 2010 by Boehringer Ingelheim under the brand name Pradaxa. This medicine is a blood thinner used in patients who suffer from a condition in which the heart’s upper chambers beat irregularly or flutter- known as Non-Valvular Atrial Fibrillation. This condition leaves patients with an increased risk of stroke. Pradaxa helps to prevent this by lowering the chance of clotting, because it is a direct thrombin inhibitor.

    No Treatment for Internal Bleeding

    After only 3 mos. of being on the U.S. market, Pradaxa was prescribed to around 86,000 patients. They were given the standard warnings of this type of drug; internal bleeding. It was thought that Pradaxa was safer than the older drug warfarin, which has many side effects. However, when warfarin causes bleeding Vitamin K can be used to treat the issue. Unfortunately, there is no treatment for Pradaxa patients if bleeding occurs.

    In addition to internal hemorrhaging, there are other side effects including;

    • GI diseases
    • Nausea
    • Dizziness
    • Pain and swelling in joints
    • Excessive external bleeding

    Review of Pradaxa by FDA

    The FDA issued a statement on December 7, 2011 stating that it was under review due to the reports of fatal bleeding; however, the source was not disclosed.

    If you or anyone you know has had a poor reaction or experience with Pradaxa, you may be entitled to a product liability laws8uit. In order to have your case properly evaluated, you should speak to a qualified Pradaxa side effects lawyer.

  • FDA Warns Makers of “Caffeine Inhaler” of Safety Concerns

    Posted Apr 4th, 2012 By in Personal Injury, Personal Injury Lawyer, Product Liability With | No Comments

    News sources reported that the US Food and Drug Administration (FDA) issued a letter of warning to Breathable Foods Inc, the makers of a “caffeine inhaler” called Aeroshot. The letter expressed the agency’s concerns over false or misleading statements found on the labeling of Aeroshot and the overall safety of the product.

    Breathable Foods claims that the product is meant to provide “breathable energy, anytime, anyplace.” However, the company’s website states that Aeroshot is meant to be ingested by swallowing. This presents a situation of false or misleading labeling, because these two actions contradict each other. A product cannot be simultaneously inhaled and ingested due to the epiglottis, which keeps swallowing and inhaling separate. The FDA is concerned that consumers may be confused by statements like “breathable energy”, and attempt to inhale the product into their lungs. Caffeine is not usually inhaled, and the safety of doing so has not been thoroughly evaluated. The company’s website claims that decades of research has found that the particles in the product are too large to enter the lungs, the company does not cite specific sources to support this claim.

    The FDA has instructed the company to correct these violations, as well as several others, and to provide the agency with information on the research cited so that the FDA may evaluate it. Breathable Foods was given 15 days to respond with a plan to begin procedures that would bring the product into compliance with FDA regulations.

    As a Harrisburg personal injury lawyer, I’ve seen the resulting injuries and adverse health effects of mislabeled and defective food products many times in the past. If you’ve fallen ill due to the consumption of a defective food product, speak with a Lancaster personal injury attorney to learn more about your rights as a consumer.

  • Hondas Recalled Due to Headlight Defect

    Posted Apr 4th, 2012 By in Personal Injury, Product Liability, Product Recall With | No Comments

    In a news statement, the American Honda Motor Company, in conjunction with and in compliance with the rules and regulations of the US National Highway Traffic Safety Administration (NHTSA), announced a recall of all Honda CR-Vs, model year 2002-2004, and all Honda Pilots of model year 2003. The recall of the Honda CR-V and Pilot models is due to faults with the switch wiring harness that could potentially lead to decreased functionality of the low beam headlights. The company believes that if this defect were to occur in these vehicles, drivers may be unable to navigate properly due to poor visibility, and may increase their chances of being involved in a crash. Honda wishes to let owners know that dealers will repair all faulty parts for free, and that Honda is working quickly to notify all owners.

    As a Harrisburg car accident lawyer, I’ve seen this kind of safety recall several times over the course of my career and I understand the devastating injuries that can occur through the use of defective auto products. Manufacturers have many safety measures in place to ensure the quality of their products, however, occasionally, mistakes can be made. If you’ve suffered an injury in a crash that you think was the result of a defective auto product, it may be in your best interests to contact a Harrisburg personal injury attorney to learn more about your rights as a consumer and the possible legal avenues that may be open to you.

  • FDA Rejects BPA Ban, Consumers Union Reacts

    Posted Apr 3rd, 2012 By in Personal Injury, Personal Injury Lawyer, Product Liability With | No Comments

    According to news reports, the US Food and Drug Administration (FDA) recently rejected a petition that would ban the use of the chemical bisphenol-A (BPA) in food and beverage containers.

    The FDA contends that the information submitted with in the petition by the Natural Resources Defense Council (NRDC) “was not sufficient to persuade FDA… to initiate rulemaking to revoke the food additive approvals for BPA. The agency stated that it plans to continue its analysis and review of emerging data and reports of the chemical.

    The director of food policy initiatives at Consumers Union, a consumer advocacy group and policy section of Consumer Reports, Jean Halloran said, “We’re disappointed with the FDA’s decision because we think there’s ample scientific evidence about the health risks of BPA for the agency to take action now and ban it from food and drink packaging.” The advocacy group plans to continue pressuring the FDA to ban BPA, as well as seeking a congressional backing to remove the chemical from the market altogether.

    BPA is a chemical that lines cans and certain plastic products. It has shown potential links to various health conditions such as an increased risk of diseases and disorders in the brain, reproductive and immune systems.

    As a York personal injury lawyer, I know the dangers that certain chemical additives pose to consumers and hope that this issue can be resolved to ensure the safety of all consumers. If you’ve fallen ill due to the consumption of a defective or contaminated food product, contact a Harrisburg personal injury attorney to learn about the possible legal options that may be at your disposal.

  • Cyanocobalamin Recalled Because of Vial Cracks

    Posted Apr 3rd, 2012 By in Personal Injury, Product Liability, Product Recall With | No Comments

    In a news statement, American Regent, in cooperation with and in compliance with the rules and guidelines of the US Food and Drug Administration (FDA), announced the voluntary safety recall of three lots of their Cyanocobalamin Injection, USP, 1000 mcg/mL, 1 mL Vials due to cracks in the vials that raise concerns over sterility assurance and pose the risk of glass particulate matter.

    This recall only affects lots of this product with lot numbers 1662, 1679, 1683 and expiration dates of November 2013. The recall was put into action when American Regent learned that certain vials in these lots have the potential to form cracks in their bottoms and sides. These cracks draw into question the assurance of sterility and could possibly result in the presence of glass particulate matter. Though the company can only confirm cracks in the vials of lot 1683, they have decided to proceed with the recall of all three lots because they were manufactured with the same lot of glass vials. Lack of sterility in these injection vials could result in systemic infection, abscess formation, or an infection at the site of injection. Should particulate matter be present, muscle and other tissue damage could occur through an intramuscular or subcutaneous injection. No reports of adverse health effects have been received thus far.

    The company is currently in the process of notifying the distributors, hospitals, retail pharmacies, clinics and physician offices that may have received these injection vials. Consumers are instructed to review their inventory for the recalled lots and to quarantine any recalled product until it can be returned to the company.

    As a York personal injury attorney, I’ve seen many similar safety recalls over the course of my career and understand the dangers effects that contaminated medical products pose to consumers. If you’ve suffered adverse health effects due to the use of a contaminated or otherwise defective medical product, it may be in your best interests to consult a Harrisburg personal injury lawyer to talk about your legal rights as they apply to the situation.

  • Recalls Decrease, Injuries Increase for Kids’ Products

    Posted Apr 3rd, 2012 By in Child Safety, Product Liability, Product Recall With | No Comments

    News agencies reported that the amount of children’s products that were recalled in 2011 fell by almost one-fourth, however 32 percent of those were backed by reports of injury, according to the safety advocacy group Kids in Danger.

    Kids in Dangers claims that they cannot explain the decrease in the amount of recalls “because of the secrecy surrounding the recall process. We don’t know if CPSC (US Consumer Product Safety Commission) looked to recall more products and were unable to persuade manufacturers, or if this represents a decrease in dangerous products in the marketplace. It is clear that recalls for lead violations and drop-side cribs were down, just as new requirements for standards and testing came into effect.”

    According to a report from the CPSC, 121 of the product recalled during 2011 were children’s products. Of those, 30 percent were nursery products and 26 percent were toys. Three of the products had been reported more than 100 times prior to a recall being initiated. The challenge, in certain instances, could be just reaching the affected consumers. Kevin Stemeckert, retail research chief at technology advisory firm Gartner Group, said, “Stores track shoppers’ purchases closely, but their ability to link a person with a purchase depends on the payment method, whether the consumer has a store loyalty card and privacy issues.” According to Stemeckert, online retailers are the most efficient at contacting consumers affected by recalls.

    As a Lancaster personal injury lawyer, I know the dangers that defective products pose to consumers and have seen the devastating injuries that can result from their use. If you’ve sustained an injury due to the normal use of a poorly designed or defective product, consult a Harrisburg personal injury attorney to learn more about your legal rights as a consumer and the legal avenues that may be open to you.

  • 2012 Kia Rio Named Best Teen Vehicle

    Posted Apr 3rd, 2012 By in Car Safety, Child Safety, Personal Injury With | No Comments

    Media outlets reported that the Kia Rio, which has already garnered numerous awards, has recently been named one of the “Six Best New Cars for your Teenager” by Vroomgirls.com, the first automotive website created by and for women.

    Vice president for marketing and communications at Kia Motors America Michael Sprague stated, “Rio being recognized as one of the ‘Six Best New Cars for your Teenager’ by Vroomgirls.com further validates all of the virtues which have made it popular with both parents and young drivers. Excelling in design, fuel economy, value and driving enjoyment makes the Rio a truly well-rounded choice in the competitive subcompact segment.”

    The website praised the vehicle for its modern styling, efficient fuel economy and good overall value. They also hailed the subcompact’s various standard amenities, such as its USB connectivity and steering-wheel controls. The vehicle also has an impressive warranty and navigation system. The website’s editor-in-chief Tara Weingarten said, “Parents want a safe, reliable car for their kids, but teens only care about what’s cool. The 2012 Kia Rio checks both of those boxes.”

    As a Harrisburg car accident attorney, I know just how important safety features are on any vehicle, especially in the event of a collision. I urge everyone to follow traffic safety rules and always wear their seatbelts to ensure the safety of all. If you’ve suffered an injury in an accident that you think was the result of a defective auto product, contact a Harrisburg personal injury lawyer to discuss your rights as a consumer.

  • New PA Law Requires Cars Give Bicycles More Room

    Posted Apr 3rd, 2012 By in Car Accident Lawyer, Car Safety, Personal Injury With | No Comments

    News sources reported that a recently passed law in Pennsylvania now requires that cars and trucks maintain at least four feet of clearance when passing a cyclist. According to the bill’s main supporters, the law was passed simply to make what drivers should already be doing for safety purposes official.

    Spokesman for the mayor’s office of transportation in Philadelphia Andrew Stober said, “All it does is codify what smart drivers and safe drivers already do. There are 20 states that have this law.” The law went into effect across the state Monday, allowing drivers to legally cross over yellow lane lanes to provide more room for cyclists. The law also requires that vehicles turning left yield to oncoming cyclists.

    But the law doesn’t just effect motor vehicles; there are many stipulations for cyclists in the bill as well. The law requires that cyclists “use reasonable efforts” to prevent disrupting traffic flow by staying “as close as practicable” to the right-hand curb.

    AAA MidAtlantic spokeswoman Jenny Robinson stated, “It really clarifies what we all need to do whether we’re in a car or on a bicycle.”

    As a Harrisburg car accident lawyer, I know the importance of adhering to traffic safety laws to ensure the safety of everyone on the road. I urge everyone to follow the rules of the road and always wear their seatbelt. If you’ve sustained an injury in an accident that you think was the result of another driver’s negligent actions, speak with a Harrisburg personal injury attorney to discuss your legal rights as they pertain to the matter.

  • Lacrosse Helmets Recalled Because of Injury Hazard

    Posted Apr 3rd, 2012 By in Personal Injury, Product Liability, Product Recall With | No Comments

    In a press release, Easton Sports, in conjunction with and in compliance with the US Consumer Product Safety Commission (CPSC), announced the voluntary safety recall of their Easton Raptor Lacrosse Helmets due to potential jaw and facial injury hazards the products pose to consumers. The recall affects roughly 12,000 lacrosse helmets that were available in various sporting goods stores across the country and online from November 2011 through March 2012. This recall was put into action after the company learned that the chin bars on these helmets could potentially break and result in jaw or facial injury to the consumer. Easton has gotten six reports of the chin bar cracking or breaking upon impact with a ball or lacrosse stick. One incident resulted in a laceration injury. Consumers are being instructed to stop using the Raptor Lacrosse Helmets at once and to contact the company directly to receive a full refund.

    As a Harrisburg personal injury lawyer, I have seen this sort of safety recall several times in the past and I am aware of the devastating injuries that can result through the use of defective products. Manufacturers have many safety measures in place to ensure the safety and quality of their products, however, even under the most meticulous eye, mistakes can be made. If you’ve suffered an injury due to the use of a defective product, speak with a personal injury lawyer in your area to discuss your legal rights as a consumer.

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